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NCT00138073 | Effectiveness of a Computer Application in Improving Pulmonary Artery Catheter Waveform Interpretation | https://clinicaltrials.gov/study/NCT00138073 | null | TERMINATED | Skill with pulmonary artery catheter (PAC) waveform interpretation is inadequate among physicians and nurses. We, the investigators at Massachusetts General Hospital, have developed a web-based computer program to assist physicians and nurses in PAC waveform interpretation. We will study the effectiveness of this program on improving the interpretation of waveforms on a computer-based test. | YES | Pulmonary Artery Catheter Waveform Interpretation | DEVICE: Web-based waveform interpretation guide | Score on a Computer-based Test on Pulmonary Artery Catheter Waveform Interpretation, The study was terminated before the primary outcome could be measured. None of the participants took the post-intervention test., 1 month | Individual and Collective Frequency of Use and Usage Patterns of the Web-based Waveform Interpretation Guide, The study was terminated before the secondary outcome could be measured. Usage data was not collected over the following year., 1 year | null | Massachusetts General Hospital | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 55 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: | 2005-P-001381/1; MGH | 2005-12 | 2012-04 | 2012-04 | 2005-08-30 | 2014-06-30 | 2014-06-30 | Massachusetts General Hospital, Boston, Massachusetts, 02114, United States | null | {
"Web-based waveform interpretation guide": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT01798173 | Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients | https://clinicaltrials.gov/study/NCT01798173 | CIRCE | COMPLETED | Available data do not allow carcinogenesis mechanisms in cirrhotic patients to be well understood in absence of studies taking into account all recognised factors. A large scale clinical, biochemical and molecular studies is potentially relevant to the understanding of nutrition, physical activity, body weight metabolic syndrome whatever the etiology of underlying cirrhosis. It will open new perspectives :
* in prevention of hepatocellular carcinoma development in cirrhotic patients through dietary counselling and therapeutics of metabolic syndrome,
* in early screening of hepatocellular carcinoma in cirrhotic patients through spectroscopic technology and later proteomic study resulting in an improvement of hepatocellular carcinoma prognosis. | NO | Cirrhosis With Hepatocellular Carcinoma|Cirrhosis Without Hepatocellular Carcinoma | BIOLOGICAL: Serum, plasma and DNA samples|PROCEDURE: Radiological exploration by CT scan or MRI | Dosage of the vitamin B12 and the folates, Baseline | null | null | Centre Hospitalier Universitaire Dijon | null | ALL | ADULT, OLDER_ADULT | null | 1,246 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | HILLON HORS AOI 2008 | 2008-06-20 | 2018-01-25 | 2018-01-25 | 2013-02-25 | null | 2022-04-21 | Hôpital Jean Minjoz, Besancon, 25000, France|Hôpital du Bocage, Dijon, 21079, France|Centre Hospitalier de METZ, Metz, 57038, France|CHU Robert DEBRE, Reims, 51092, France|Clinique médicale B. Hôpital Civil-Hôpitaux Universitaires, Strasbourg, 67091, France|Hôpital de BRABOIS, Vandoeuvre-les-nancy, 54511, France | null | {
"Serum, plasma and DNA samples": [
{
"intervention_type": "BIOLOGICAL"
}
],
"Radiological exploration by CT scan or MRI": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT01048073 | Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia | https://clinicaltrials.gov/study/NCT01048073 | null | COMPLETED | Acute respiratory infection (ARI) constitutes a leading cause of morbidity, hospitalization and mortality worldwide. The most common etiologic agents of ARI s, especially in children, are viruses.
The study objective is to determine the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection in South East Asia.
This is a laboratory based surveillance study, in which the archival specimens from hospitalized patients will be tested for respiratory pathogens other than influenza viruses Standard descriptive statistics will be used to present the findings | NO | Lower Respiratory Tract Infection | null | the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection, 12 months | null | null | South East Asia Infectious Disease Clinical Research Network | National Institute of Allergy and Infectious Diseases (NIAID)|University of Oxford | ALL | CHILD, ADULT, OLDER_ADULT | null | 1,200 | NETWORK | OBSERVATIONAL | Observational Model: |Time Perspective: p | SEA 019 | 2010-05 | 2010-09 | 2010-12 | 2010-01-13 | null | 2011-05-27 | National Institute of Health Research and Development, Jakarta,, Indonesia|Siriraj Hospital, Bangkok,, Thailand|Queen Sirikit National Institute of Child Health, Bangkok, Thailand|National Hospital of Pediatrics, Hanoi, Vietnam|National Hospital of Tropical Diseases, Hanoi, Vietnam|Oxford University Clinical Research Unit, Hanoi, Vietnam|Children s Hospital No 1, Ho Chi Minh City, Vietnam|Children s Hospital No 2, Ho Chi Minh City, Vietnam|Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam | null | {} |
NCT03337373 | The Study of Pharmacokinetics and Pharmacodynamics of Cisatracurium | https://clinicaltrials.gov/study/NCT03337373 | null | COMPLETED | Pathophysiological changes influenced by multiple factors in critically ill patients, has a significant impact on pharmacokinetics (PK) and pharmacodynamics (PD) of cisatracurium. In order to understand better and find an appropriate dosing regimen, the purpose of this study is to investigate the PK and PD of a loading dose cisatracurium in critically ill patients.
Cisatracurium, nondepolarizing neuromuscular blocking agents (NMBAs), are commonly used in intensive care units because of a lesser effect on hemodynamic parameters and a reduction in mortality rate in ARDS patients. Loading dose recommended in clinical practice guidelines for sustained neuromuscular blockade in the adult critically ill patient is 0.1-0.2 mg/kg. Then, maintenance dose of 1-3 mcg/kg/min is followed regarding indications, such as ARDS. However, this recommended loading dose might not be adequate in critically ill patients, the study in this specific population might be needed. | NO | Critical Illness|Respiratory Distress Syndrome, Adult|Neuromuscular Blockade|Respiratory Failure|Paralysis|ARDS, Human | DRUG: cisatracurium | Total plasma concentration-time data, Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS., Pre-dose through 60 minutes post-dose|Patient-ventilator asynchrony - time data, Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS., Pre-dose through 60 minutes post-dose|The degree of neuromuscular block by train-of-four-watch monitor - time data, Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS., Pre-dose through 60 minutes post-dose | Time to maximum concentration, Analysis of time to maximum concentration will be performed with a nonlinear mixed-effects population modelling approach as implemented in NONMEM software., Pre-dose through 60 minutes post-dose|Half-life, Analysis of half-life will be performed with a nonlinear mixed-effects population modelling approach as implemented in NONMEM software., Pre-dose through 60 minutes post-dose|Clearance, Analysis of clearance will be performed with a nonlinear mixed-effects population modelling approach as implemented in NONMEM software., Pre-dose through 60 minutes post-dose|Elimination rate constant, Analysis of elimination rate constant will be performed with a nonlinear mixed-effects population modelling approach as implemented in NONMEM software., Pre-dose through 60 minutes post-dose|Time to maximum block, Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS., Pre-dose through 60 minutes post-dose|Percentage of maximum block, Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS., Pre-dose through 60 minutes post-dose|Time to patient-ventilator synchrony, Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS., Pre-dose through 60 minutes post-dose | Bispectral index (BIS) - time data, Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS., Pre-dose through 60 minutes post-dose | Mahidol University | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 10 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 06-60-07 | 2017-12-15 | 2018-08-31 | 2018-08-31 | 2017-11-09 | null | 2019-03-06 | Faculty of Medicine Ramathibodi Hospital, Bangkok, 10400, Thailand | null | {
"Cisatracurium": [
{
"intervention_type": "DRUG",
"description": "cisatracurium",
"name": "Cisatracurium",
"synonyms": [
"Cisatracurium",
"Cisatracurium ion",
"(1r,2r,1'r,2'r)-2,2'-{pentane-1,5-diylbis[oxy(3-oxopropane-3,1-diyl)]}bis[1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolinium]",
"Cisatracurium cation"
],
"drugbank_id": "DB00565",
"generic_names": [
"Cisatracurium"
]
}
]
} |
NCT05278273 | A Feasibility Trial and Protocol for Remote Cognitive Training Developed for Use in a Cognitively Healthy Adult Population During the COVID-19 Pandemic | https://clinicaltrials.gov/study/NCT05278273 | null | COMPLETED | The COVID-19 pandemic has created a shift in the use of at-home spaces for work, play and research. In the current study, the feasibility of implementing an at-home cognitive training tool called NeuroTrackerX, an anaglyph version of the three-dimensional multiple object tracking (3D-MOT) software NeuroTracker was examined, and with the intent of developing an effective protocol and determining the suitability of this tool for research purposes . | NO | Cognition Disorders in Old Age | DEVICE: NeurotrackerX | Neurotracker scores, Performance on the multiple-object tracking program across 10 sessions. Scores are between 0 - 4, with increasing scores indicating increasing performance., 5 weeks | null | null | University of Victoria | null | ALL | ADULT, OLDER_ADULT | null | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 20-0531 | 2021-01-04 | 2021-02-14 | 2022-03-10 | 2022-03-14 | null | 2022-03-14 | University of Victoria, Victoria, British Columbia, V8P5C2, Canada | null | {
"NeurotrackerX": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT00791973 | Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen | https://clinicaltrials.gov/study/NCT00791973 | null | COMPLETED | The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies. | YES | Allergic Rhinitis | DRUG: fluticasone furoate|DRUG: Placebo | Change in Tryptase Level From Baseline to Post-antigen Challenge, Tryptase levels (mcg/L) were measured from nasal lavages, After one week of treatment wtih veramyst or placebo | Total Eye Symptom Scores After Antigen Challenge, Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe, After one week of treatment wtih veramyst or placebo | null | University of Chicago | GlaxoSmithKline | ALL | ADULT | PHASE4 | 15 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 16367B (OC 3) | 2008-11 | 2009-04 | 2010-05 | 2008-11-17 | 2014-07-08 | 2014-07-08 | University of Chicago Medical Center, Chicago, Illinois, 60637, United States | null | {
"Fluticasone furoate": [
{
"intervention_type": "DRUG",
"description": "fluticasone furoate",
"name": "Fluticasone furoate",
"synonyms": [
"Furoate de fluticasone",
"",
"Fluticasone furoate",
"Furoato de fluticasona",
"Fluticasonum furoas"
],
"drugbank_id": "DB08906",
"generic_names": [
"Fluticasone furoate"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Fluticasone%20furoate"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03644173 | Personal Resilience Empowerment Program Study | https://clinicaltrials.gov/study/NCT03644173 | null | COMPLETED | The Personal Resilience Empowerment Program (PREP) at Hackensack Meridian Integrative Health & Medicine was designed in Legacy Meridian to assist all selected patients with upcoming hospitalization. For the Personal Resilience Empowerment Program (PREP) in the perioperative setting of surgically treated cancer patients , hereafter the Project or PREP , the Hackensack Meridian Integrative Health & Medicine is designing a new pilot program to focus on the needs of oncology patients.
All patients diagnosed with cancer that will undergo a scheduled surgical (Hepato-Biliary, and Thoracic) procedure in Hackensack Meridian Health and specifically in the Jersey Shore University Medical Center, will be eligible to participate (for more details please see eligibility criteria, section 4).
Overall, this pilot project will include 5 coaching sessions and an introductory session/visit that will take place on the physician s office. The initial physician visit will focus on patient eligibility, introduction to the Project, informed consent and a pre-intervention survey and will be conducted by the principal investigator or one of the sub-investigators listed above. The following 5 sessions will be conducted by one of the integrative health coaches/registered nurses (for details please see section 5). A post-intervention survey will be completed during the final session and repeated at one month, and at 3 months from the final session.
The goal of this project is to investigate whether using the PREP as an intervention in patients diagnosed with cancer would result in improving various metrics including improvements to resilience, sleep, activity, purpose, nutrition, empowerment to manage one s own health and well-being, decrease in pain medication use and more rapid return to previous functional status according to Eastern Cooperative Oncology Group (ECOG). | YES | Lung Cancer|Cholangiocarcinoma|Pancreatic Cancer|Liver Cancer | BEHAVIORAL: Personal Resilience Empowerment Program including 5 sessions with health coaches | Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep, Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the post intervention survey, Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)|Change in Quality of Life Post Intervention (Coaching Sessions) - Activity, Quality of life concerning activity (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the post intervention survey, Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)|Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose, Quality of life concerning feeling of purpose (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the post intervention survey, Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)|Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition, Quality of life concerning nutrition (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the post intervention survey, Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)|Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep, Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre-intervention survey and 1-month post intervention survey, At 1 month Post intervention (survey was sent at 30 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Activity, Quality of life concerning activity (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the 1-month post intervention survey, At 1 month Post intervention (survey was sent at 30 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose, Quality of life concerning feeling of purpose (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the 1-month post intervention survey, At 1 month Post intervention (survey was sent at 30 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition, Quality of life concerning nutrition (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the 1-month post intervention survey, At 1 month Post intervention (survey was sent at 30 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep, Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre-intervention survey and 3-month post intervention survey, At 3 month Post intervention (survey was sent at 90 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Activity, Quality of life concerning activity (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the 3-month post intervention survey, At 3 month Post intervention (survey was sent at 90 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose, Quality of life concerning feeling of purpose (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the 3-month post intervention survey, At 3 month Post intervention (survey was sent at 90 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition, Quality of life concerning nutrition (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the 3-month post intervention survey, At 3 month Post intervention (survey was sent at 90 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience, Quality of life concerning resilience (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the post intervention survey, Post intervention (survey completed at the end of last coaching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience, Quality of life concerning resilience (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the 1-month post intervention survey, At 1 month Post intervention (survey was sent at 30 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience, Quality of life concerning resilience (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the 3-month post intervention survey, At 3 month Post intervention (survey was sent at 90 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment, Quality of life concerning Empowerment (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the post intervention survey, Post intervention (survey completed at the end of last coaching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment, Quality of life concerning Empowerment (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the 1-month post intervention survey, At 1 month Post intervention (survey was sent at 30 days after the last couching session)|Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment, Quality of life concerning Empowerment (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.
Change between the pre and the 3-month post intervention survey, At 3 month Post intervention (survey was sent at 90 days after the last couching session) | null | null | Hackensack Meridian Health | null | ALL | ADULT, OLDER_ADULT | null | 37 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | IRB#201801121J | 2018-05-30 | 2021-06-14 | 2021-06-14 | 2018-08-23 | 2021-10-15 | 2021-10-15 | Hackensack Meridian Health - Jersey Shore University Medical Center, Neptune, New Jersey, 07753, United States|Hackensack Meridian Health - Riverview Medical Center, Red Bank, New Jersey, 07701, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT03644173/Prot_SAP_000.pdf | {
"Personal Resilience Empowerment Program including 5 sessions with health coaches": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT04550273 | Leptin and Liver Enzymes Responses to Aerobic Training in Hepatitis c Patients | https://clinicaltrials.gov/study/NCT04550273 | null | UNKNOWN | Exercise is one of the most vital components of health maintenance. Exercising regularly maintains the cardiovascular system health, promotes the health of liver, and declines the risks of complications induced by CHCV. Since overweight is the main risk factor for IR and type 2 DM which may speed the liver disease progression among HCV patients, exercise is very important for maintenance and loss of weight. Further, exercise can relieve the side effects of medications of HCV, improve immunity, promote a sense of well-being, reduce levels of chronic fatigue, improve blood oxygen levels and increase the endorphins excretion which makes the patients fully energized (Elgendi, Shebl A, Sliem M, and Gary FA, 2018).
Studies on exercise effect in patients with CHCV are quite scarce (de Sousa Fernandes et al., 2019). Decreased leptin levels by exercise positively modulate insulin signaling and inhibit pathology progression (Anaruma et al., 2019). Since studies investigated physical activity effect on regulating HCV related leptin levels are very little, the present study aimed to explore the response of serum leptin and liver enzymes to aerobic exercise in nondiabetic overweight men with CHCV. | NO | Hepatitis C | BEHAVIORAL: aerobic treadmill exercise | Leptin, It will be measured in plasma, It will be after 12-week training|Liver enzymes, Serum alanine and aspartate transaminases (AST), (ALT) will be measured in plasma, liver enzymes will be after 12-week training | weight, With an empty bladder and stomach, weight will be measured for every participant, It will be after 12-week training|Waist circumference (WC), WC will be measured with an inelastic tape at the umbilicus level, It will be after 12-week training|fasting blood glucose (FBG), FBG will be measured by On Call ® Plus Acon, REF G113- 214, made in China, It will be after 12-week training | null | Cairo University | null | MALE | ADULT, OLDER_ADULT | null | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT | P.T.REC/012/002650 | 2020-02-09 | 2021-01 | 2021-03 | 2020-09-16 | null | 2020-09-16 | Faculty of Physical Therapy Cairo University, Giza, Dokki, Egypt | null | {
"aerobic treadmill exercise": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT00001473 | Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides | https://clinicaltrials.gov/study/NCT00001473 | null | COMPLETED | This study will evaluate the safety and effectiveness of a staged approach to therapy for Wegener s granulomatosis and other systemic vasculitides using prednisone plus cyclophosphamide followed by methotrexate. Vasculitides involve inflammation of blood vessels (vasculitis) that may affect the brain, nerves, eyes, sinuses, lungs, kidneys, intestinal tract, skin, joints, heart and other sites. Standard treatment with prednisone and cyclophosphamide is very effective, but has significant toxicity (adverse side effects). Methotrexate is also an effective treatment and is less toxic, but it is associated with a higher rate of disease recurrence and has not been used in patients with severe lung or kidney disease. Staged therapy using cyclophosphamide first and then methotrexate may provide better results for overall safety and effectiveness.
Patients 10 to 80 years of age with active Wegener s granulomatosis, polyarteritis nodosa or a related systemic vasculitis may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, chest X-ray, electrocardiogram (EKG) and pulmonary function tests. Other procedures, such as biopsies, will be done only as medically indicated.
Participants will be treated initially with 1 milligram/kilogram body weight of prednisone once a day and 2 to 4 mg/kg cyclophosphamide once a day. If the disease improves significantly, prednisone will be gradually reduced and stopped, and if remission is achieved, cyclophosphamide will be stopped. Methotrexate will then be started at 0.3 mg/kg body weight once a week and then increased to 0.5 mg/kg after 2 to 4 weeks. Methotrexate therapy will continue for at least 2 years. If at the end of 2 years the disease remains in remission, the methotrexate will be gradually reduced and stopped. If, on the other hand, active disease recurs during methotrexate treatment, the therapy will be changed. The new choice of treatment will depend on the severity of recurrence, pre-existing medical conditions, and previous adverse reactions to prednisone, cyclophosphamide and methotrexate.
Patients will be seen periodically for a physical examination and blood tests to evaluate disease activity, response to therapy and drug side effects. X-rays will be done as medically indicated. Evaluations will be scheduled once a month until the patient has been on methotrexate for 3 months and then every 3 months for the next 18 months. Patients whose disease remains in remission at that time and are off all medications will be seen every 6 months for another 4 visits. | NO | Vasculitis|Wegener s Granulomatosis | null | null | null | null | National Institute of Allergy and Infectious Diseases (NIAID) | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 100 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 950091|95-I-0091 | 1995-03 | null | 2004-03 | 1999-11-04 | null | 2008-03-04 | National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, Maryland, 20892, United States | null | {} |
NCT02764073 | Bioimpedance Spectroscopy for the Evaluation of Heart Failure | https://clinicaltrials.gov/study/NCT02764073 | BIS-HF | COMPLETED | Despite impressive improvements in treatment strategies, heart failure (HF) morbidity and mortality remains substantially high worldwide. Pulmonary congestion is considered the leading cause for hospital admissions and death among patients with HF. Physical examination is crucial for titrating medical treatment in these patients, but despite a good specificity it is not sensitive enough to detect early elevated cardiac filling pressures.
The N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a recognized powerful predictor for HF prognosis. Recently, cardiotrophin-1 and galectin-3 have been proposed as new relevant biomarkers for HF evaluation.
Echocardiography can be also used to noninvasively measure left ventricular filling pressures. Lung ultrasound (LUS) through interstitial B-line evaluation has been recently proposed as a bed-side, noninvasive tool to assess interstitial lung water. B-lines correlate with NT-proBNP and E/e levels in patients with acute dyspnea, chronic HF or after a stress test. LUS can also identify clinically silent pulmonary edema, suggesting that it may complement clinical evaluation to improve hemodynamic profiling and treatment optimization.
Biompedance is a bedside method for total body fluid status assessment. It defines individual fluid status/compartments/overload on the basis of an individual s normal extracellular volume and body composition. Recent studies indicate that bioimpedance-derived fluid overload indices are independent predictors of mortality in renal failure patients.
To date, no study has evaluated bioimpedance performance for fluid assessment in HF patients. The investigators aim to cross-sectionally compare bioimpedance parameters with clinical evaluation, LUS, cardiac biomarkers, and echocardiographic characteristics, in a cohort of incident consecutive patients with HF. Two years patients survival will be evaluated to propose the best evaluative algorithm and rank the various methods for prognostic significance. | NO | Heart Failure | DEVICE: Bioimpedance spectroscopy|DEVICE: Lung Ultrasonography|DEVICE: Echocardiography | The relationship between bioimpedance derived parameters (TBW, ICW, ECW, RFO), clinical assessment, lung congestion (as assessed by lung ultrasonography), echocardiography and different cardiac biomarkers., 2 years | The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on all-cause mortality., 2 years|The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on fatal and non-fatal cardiovascular events., 2 years|The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on hospitalizations., 2 years | null | Grigore T. Popa University of Medicine and Pharmacy | null | ALL | ADULT, OLDER_ADULT | null | 150 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | BIS-HF | 2016-05 | 2020-05 | 2020-05 | 2016-05-06 | null | 2021-01-26 | Dr. CI Parhon, Iaşi, Romania | null | {
"Bioimpedance spectroscopy": [
{
"intervention_type": "DEVICE"
}
],
"Lung Ultrasonography": [
{
"intervention_type": "DEVICE"
}
],
"Echocardiography": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT01321073 | DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study | https://clinicaltrials.gov/study/NCT01321073 | DelIVery | ACTIVE_NOT_RECRUITING | The purpose of the DelIVery for PAH clinical study is to evaluate the safety of the Medtronic Model 10642 Implantable Intravascular Catheter when used with the Medtronic SynchroMed® II Implantable Infusion System to deliver Remodulin® (treprostinil) Injection.
As of June 2021, PMA approval of the Implantable System for Remodulin (ISR) is no longer being pursued and development and commercialization efforts have been halted. The approximately 30 subjects still implanted with the PIVoT system require a pathway for continued support. This protocol is amended and is designed to allow such ongoing support. | YES | Pulmonary Arterial Hypertension | DEVICE: Model 10642 Implantable Intravascular Catheter | Rate of Catheter-related Complications Per 1000 Patient Days, A complication is an adverse event that required an invasive intervention. Complications related to the implanted catheter are counted. In addition, because pneumothoraxes are counted as part of the endpoint., Implant to 2 years | null | null | Medtronic Cardiac Rhythm and Heart Failure | United Therapeutics | ALL | ADULT, OLDER_ADULT | null | 64 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | PAH-D | 2011-06 | 2013-06 | 2032-12 | 2011-03-23 | 2018-05-04 | 2023-09-21 | University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|VA Greater Los Angeles Healthcare System, Los Angeles, California, 90073, United States|AdventHealth Orlando, Orlando, Florida, 32803, United States|University of Chicago Medical Center, Chicago, Illinois, 60637, United States|Brigham & Women s Hospital, Boston, Massachusetts, 02115, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States|Aurora St. Lukes Medical Center, Milwaukee, Wisconsin, 53234, United States | null | {
"Model 10642 Implantable Intravascular Catheter": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04335773 | COVID-19 in Hospitalised Norwegian Children - Risk Factors, Outcomes and Immunology | https://clinicaltrials.gov/study/NCT04335773 | null | RECRUITING | Prospective cohort study of COVID-19 infection among children in Norway. | NO | Pediatric Respiratory Diseases|COVID|Fatigue Post Viral | null | Risk Factors for severe infection, Identify comorbidities predisposing for severe infection, 2030|Immunulogical mechanisms, Immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course., 2030|Long term outcome, prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue, 2030 | null | null | University Hospital, Akershus | St. Olavs Hospital|Helse Stavanger HF|Haukeland University Hospital|University Hospital of North Norway|Alesund Hospital|Norwegian Institute of Public Health|The University of New South Wales|University of Bristol|Sykehuset Ostfold|Nordlandssykehuset HF|Vestre Viken Hospital Trust|Helse Fonna|Helse Nord-Trøndelag HF|Oslo University Hospital|Sykehuset Innlandet HF | ALL | CHILD, ADULT | null | 350 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 20/03794 | 2020-04-03 | 2030-12-31 | 2030-12-31 | 2020-04-06 | null | 2022-02-16 | Akershus universistetssykehus, Lørenskog, Norway | null | {} |
NCT03411473 | Study of AGEN1884 With Pembrolizumab in 1L NSCLC | https://clinicaltrials.gov/study/NCT03411473 | null | TERMINATED | A Phase IIa Open-Label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination with Pembrolizumab in Subjects with Chemotherapy Naïve, PD-L1 high, metastatic Non-Small Cell Lung Cancer (NSCLC) | NO | NSCLC Stage IV | BIOLOGICAL: AGEN1884 in combination with pembrolizumab | Occurrence of DLTs in subjects in the Safety Run-in Phase of the trial, Occurrence of DLTs in subjects in the Safety Run-in Phase of the trial, 21 days | Frequency, severity, and duration of treatment-emergent AEs (TEAEs), Frequency, severity, and duration of treatment-emergent AEs (TEAEs), 116 weeks|Frequency, severity, and duration of treatment-related AEs, Frequency, severity, and duration of treatment-related AEs, 116 weeks|Confirmed BOR per RECIST 1.1, Confirmed BOR per RECIST 1.1, 116 weeks|Duration of response per RECIST 1.1, Duration of response per RECIST 1.1, 36 months|PFS time, PFS time, 36 months|OS time, OS time, June 2020 ( When 14 patients have completed 2 years of treatment)|Unconfirmed response at 12 weeks from first dose per RECIST 1.1, Unconfirmed response at 12 weeks from first dose per RECIST 1.1, Up to 24 months from 1st dose of treatment|Pharmacokinetic profile of AGEN1884 and pembrolizumab, Pharmacokinetic profile of AGEN1884 and pembrolizumab, At least 20 patients have completed 12 weeks from 1st dose of treatment|Immunogenicity of AGEN1884 and pembrolizumab, Immunogenicity of AGEN1884 and pembrolizumab, All patients on study have completed 6 weeks from 1st dose of treatment | null | Agenus Inc. | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 2 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | C-500-03 | 2017-10-04 | 2018-05-01 | 2019-03-01 | 2018-01-26 | null | 2020-06-02 | Mater Research, Brisbane, Australia|Scientia Clinical Research, Sydney, Australia|John Flynn Private Hospital, Tugun, Australia|Sydney Adventist, Wahroonga, Australia|Auckland City Hospital, Auckland, New Zealand | null | {
"Pembrolizumab": [
{
"intervention_type": "BIOLOGICAL",
"description": "AGEN1884 in combination with pembrolizumab",
"name": "Pembrolizumab",
"synonyms": [
"Keytruda",
"Lambrolizumab",
"Pembrolizumab"
],
"medline_plus_id": "a614048",
"generic_names": [
"Pembrolizumab"
],
"drugbank_id": "DB09037",
"wikipedia_url": "https://en.wikipedia.org/wiki/Pembrolizumab"
}
]
} |
NCT05344573 | Optimizing Pulsatility During Cardiopulmonary Bypass | https://clinicaltrials.gov/study/NCT05344573 | null | RECRUITING | Cardiopulmonary bypass during cardiac surgery provides blood flow to the body during surgery but has adverse effects on different organs. Blood flow during cardiopulmonary bypass may be pulsatile or non-pulsatile, which may impact normal organ function after surgery. The study will collect data on the type of cardiopulmonary bypass used during surgery and organ function to determine if there is an association between the type of bypass and organ function. | NO | Endothelial Dysfunction|Acute Kidney Injury | null | Endothelial function, Percent change in flow mediated dilation of the brachial artery after cardiac surgery, From intensive care unit admission after surgery to hospital discharge, up to 30 days | Acute kidney injury, Acute kidney injury by the KDIGO criteria, From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days|Renal blood flow velocity, Renal blood flow velocity measured by pulse wave doppler, Intra-operative time point: after cardiopulmonary bypass, up to 12 hours|Acute kidney injury risk, Acute kidney injury risk measured by urinary TIMP2*IGFBP7, Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours|Perioperative death, Death after surgery during the surgical hospital encounter, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Myocardial infarction, Myocardial infarction after surgery, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Stroke, Stroke after surgery, From intensive care unit admission after surgery to hospital discharge, up to 30 days|New renal failure requiring renal replacement therapy, New renal failure requiring renal replacement therapy after surgery, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Re-exploration for bleeding, Need for surgical re-exploration to control hemorrhage, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Post-operative sepsis, Post-operative sepsis determined by positive blood culture, From intensive care unit admission after surgery to hospital discharge, up to 30 days|New onset atrial fibrillation, Post-operative new onset atrial fibrillation, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Post-operative blood loss, Post-operative blood loss determined by total surgical drain output, From intensive care unit admission to 24 hours after intensive care unit admission, up to 24 hours|Duration of mechanical ventilation, Duration of mechanical ventilation after surgery, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Post-operative delirium, Post-operative delirium determined by the Confusion Assessment Method for the Intensive Care Unit score, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Post-operative hospital length of stay, Duration of hospital stay after surgery, From intensive care unit admission after surgery to hospital discharge, up to 30 days|New requirement for mechanical circulatory support, Post-operative initiation of mechanical circulatory support, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Intra-operative red blood cell transfusion, Intra-operative red blood cell transfusion in units, During the intra-operative time period, up to 12 hours|Post-operative red blood cell transfusion, Post-operative red blood cell transfusion in units, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Post-operative platelet transfusion, Post-operative platelet transfusion in units, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Post-operative plasma transfusion, Post-operative plasma transfusion in units, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Post-operative cryoprecipitate transfusion, Post-operative cryoprecipitate transfusion in units, From intensive care unit admission after surgery to hospital discharge, up to 30 days|Intra-operative platelet transfusion, Intra-operative platelet transfusion in units, During the intra-operative time period, up to 12 hours|Intra-operative plasma transfusion, Intra-operative plasma transfusion in units, During the intra-operative time period, up to 12 hours|Intra-operative cryoprecipitate transfusion, Intra-operative cryoprecipitate transfusion in units, During the intra-operative time period, up to 12 hours|Glycocalyx thickness, Glycocalyx thickness determined by sublingual microcirculation microscopy, Start of the intra-operative period to 24 hours after intensive care unit admission|Microvascular circulatory function, Microvascular circulatory function determined by sublingual microcirculation microscopy, Start of the intra-operative period to 24 hours after intensive care unit admission|New onset of acute lung injury, Diagnosis of acute lung injury by PaO2 to FiO2 ratio, From intensive care unit admission after surgery to hospital discharge, up to 30 days|New onset of left ventricular diastolic dysfunction, Diagnosis new onset diastolic dysfunction by annular e velocity: septal e < 7 cm/sec, lateral e <10 cm/sec, average E/e ratio > 14, LA volume index > 34 mL/m2, and peak TR velocity > 2.8 m/sec., From intensive care unit admission after surgery to hospital discharge, up to 30 days|New onset of left ventricular systolic dysfunction, New onset of left ventricular systolic dysfunction determined by a LV ejection fraction <50%, From intensive care unit admission after surgery to hospital discharge, up to 30 days|New onset of right ventricular systolic dysfunction, New onset of right ventricular systolic dysfunction determined by a tricuspid annular plane systolic excursion less than 16 mm, From intensive care unit admission after surgery to hospital discharge, up to 30 days | null | University of Colorado, Denver | National Heart, Lung, and Blood Institute (NHLBI) | ALL | ADULT, OLDER_ADULT | null | 66 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 20-2465|K23HL151882 | 2022-07-05 | 2024-12-01 | 2025-07-01 | 2022-04-25 | null | 2024-01-03 | University of Colorado Hospital, Aurora, Colorado, 80045, United States | null | {} |
NCT05781373 | Effect of Intraoperative PEEP Individualization According to Driving Pressure in Major Abdominal Surgery | https://clinicaltrials.gov/study/NCT05781373 | null | NOT_YET_RECRUITING | In this prospective, randomized trial, including patients scheduled for a major open or laparoscopic abdominal surgery (duration >2 hours) under general anesthesia , the investigators will compare 2 strategies of protective mechanical ventilation: a fixed intraoperative PEEP of 6 cmH2O and an individualized intraoperative PEEP according to the driving pressure. | NO | Mechanical Ventilation Complication | PROCEDURE: Peep individualization | incidence of pulmonary post operative complications, SpO2< 92%, new chest Xray infiltrates, acute respiratory failure requiring intervention, first 7 post operative days | lung aeration score (LAS), assessment LAS with lung ultrasound minimum 0 maximum: 36 (worse outcome), day 1, day 3 and day 7 after surgery | null | Mongi Slim Hospital | null | ALL | ADULT, OLDER_ADULT | null | 100 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION | individualized Peep | 2023-04-01 | 2024-04-30 | 2024-06-30 | 2023-03-23 | null | 2023-03-23 | null | null | {
"Peep individualization": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT00944073 | Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels | https://clinicaltrials.gov/study/NCT00944073 | null | COMPLETED | The purpose of this study is to assess the safety and the body s immune response (body s defense against disease) to an experimental H1N1 influenza vaccine. Up to 650 healthy volunteers from three age groups (greater than or equal to 6 months to less than 36 months, greater than or equal to 36 months to 9 years, and 10 - 17 years) with no history of influenza H1N1 2009 influenza infection or influenza H1N1 2009 vaccination will participate. Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups. Group 1 will receive 15 mcg of vaccine; Group 2 will receive 30 mcg of vaccine. Participants will receive vaccine injections on Days 0 and 21 in the arm or thigh muscle. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months. | YES | Influenza | BIOLOGICAL: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A | Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination, Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days., Day 0-7 after first vaccination|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination, Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days., Day 0-7 after second vaccination|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination, Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days., Day 0-7 after first vaccination|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination, Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days., Day 0-7 after second vaccination|Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination, Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days., Day 0-7 after first vaccination|Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination, Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days., Day 0-7 after second vaccination|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination, Participants parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days., Day 0-7 after first vaccination|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination, Participants parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days., Day 0-7 after second vaccination|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination, Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days., Day 0-7 after first vaccination|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination, Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days., Day 0-7 after second vaccination|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination, Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days., Day 0-7 after first vaccination|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination, Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days., Day 0-7 after second vaccination|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs), Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses., Day 0 through Day 180 after last vaccination|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0, Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 0|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine, Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 8-10|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine, Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 21|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0, Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 0|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine, Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 8-10|Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine, Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 21|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine, Blood was collected from all participants prior to vaccination and at Days 8-10 and 21 for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 0 prior to vaccination and Days 8-10 and 21 after first vaccination|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine, Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more., Day 0 prior to and Day 8-10 after first vaccination|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine, Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more., Day 0 prior to and Day 21 after first vaccination|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine, Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more., Day 0 prior to and Day 8-10 after first vaccination|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine, Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more., Day 0 prior to and Day 21 after first vaccination|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine, Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 8-10 or Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 or Day 21 titer was an increase by 4-fold or more., Day 0 prior to and Days 8-10 and 21 after first vaccination | Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 8-10 after the second vaccination|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 21 after the second vaccination|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 8-10 after the second vaccination|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 21 after the second vaccination|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 8-10 after the second vaccination|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 21 after the second vaccination|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more., Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more., Day 0 prior to first vaccination and Day 21 after the second vaccination|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more., Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more., Day 0 prior to first vaccination and Day 21 after the second vaccination|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine, Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more., Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine, Blood was collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay s lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more., Day 0 prior to first vaccination and Day 21 after the second vaccination | null | National Institute of Allergy and Infectious Diseases (NIAID) | null | ALL | CHILD | PHASE2 | 583 | NIH | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 09-0054 | 2009-08 | 2010-04 | 2010-04 | 2009-07-22 | 2011-04-13 | 2015-02-18 | University of Maryland School of Medicine - Center for Vaccine Development - Baltimore, Baltimore, Maryland, 21201, United States|Children s Mercy Hospital and Clinics - Infectious Diseases, Kansas City, Missouri, 64108, United States|Saint Louis University - Center for Vaccine Development, Saint Louis, Missouri, 63104-1015, United States|Duke Translational Medicine Institute - Clinical Vaccine Unit, Durham, North Carolina, 27704, United States|Cincinnati Children s Hospital Medical Center - Infectious Diseases, Cincinnati, Ohio, 45231, United States|Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center, Nashville, Tennessee, 37232-2573, United States|University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston, Galveston, Texas, 77555-5302, United States|Baylor College of Medicine - Molecular Virology and Microbiology, Houston, Texas, 77030-3411, United States|Seattle Children s Hospital - Infectious Diseases, Seattle, Washington, 98105, United States | null | {
"Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A": [
{
"intervention_type": "BIOLOGICAL"
}
]
} |
NCT02784873 | High Intensity Interval Training in UK Cardiac Rehabilitation Programmes | https://clinicaltrials.gov/study/NCT02784873 | HIIT-or-MISS | COMPLETED | The purpose of the trial is to compare the effects of high intensity interval training (HIIT) with usual care - moderate intensity steady state training (MISS) - in UK cardiac rehabilitation (CR) programmes. | NO | Coronary Disease | OTHER: High intensity interval training | Change in peak oxygen uptake (VO2 peak), Cardiopulmonary exercise test, Baseline, 8 weeks and 12 months | Compliance and adherence, Compliance and adherence will be determined by recording the number of training sessions attended and successfully completed in accordance with the exercise protocol. Drop-out from the programme will also be documented for both study groups in addition to reason for drop-out, where provided voluntarily by participants., Every exercise session (8 week exercise programme duration)|Psychological factors associated with compliance and adherence (1), Quantitative psychology - questionnaires: 1) the Multidimensional Self-Efficacy for Exercise Scale (MSES), Baseline, 8 weeks|Psychological factors associated with compliance and adherence (2), Quantitative psychology - questionnaires: 2) the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2), Baseline, 8 weeks|Psychological factors associated with compliance and adherence (3), Quantitative psychology - questionnaires: 3) the Psychological Need Satisfaction in Exercise Scale (PNSES), Baseline, 8 weeks|Psychological factors associated with compliance and adherence (4), Quantitative psychology - questionnaires: 4) Courneya and Bobick s 7-point bipolar adjectival rating scale;, Baseline, 8 weeks|HR-QOL, Questionnaire - EQ-5D-5L, Baseline, 8 weeks and 12 months|Service and resource use, Questionnaire - client service receipt inventory (CSRI), Baseline, 8 weeks and 12 months|Lifestyle physical activity, Physical activity monitor (worn for 1 week) - total energy expenditure, Baseline, 8 weeks and 12 months|Metabolic reserve, Cardiopulmonary exercise test - ventilatory threshold (VT), Baseline, 8 weeks and 12 months|Ventilatory efficiency, Cardiopulmonary exercise test - slope of ratio of ventilation to carbon dioxide (VE/VC02 slope), Baseline, 8 weeks and 12 months|Cardiac remodelling, Echocardiography - left ventricular volumes, Baseline, 8 weeks and 12 months|Arterial remodelling, Arterial oscillometry - pulse wave velocity, Baseline, 8 weeks and 12 months|Cardiovascular health, CHD risk factor assessment, Baseline, 8 weeks and 12 months|Palatability, Qualitative psychology - thematic analysis of semi structured interviews, 8 weeks | null | University Hospitals Coventry and Warwickshire NHS Trust | Cardiff Metropolitan University|City Health Care Partnership CIC (Hull)|University of Hull|Aneurin Bevan University Health Board|Wake Forest University Health Sciences|Bangor University|University of Warwick | ALL | ADULT, OLDER_ADULT | null | 382 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | GM164715 | 2016-09 | 2021-03 | 2021-03 | 2016-05-27 | null | 2021-05-05 | University Hospital, Coventry, CV2 2DX, United Kingdom | null | {
"High intensity interval training": [
{
"intervention_type": "OTHER"
}
]
} |
NCT03761173 | FlowTriever All-Comer Registry for Patient Safety and Hemodynamics | https://clinicaltrials.gov/study/NCT03761173 | FLASH | ACTIVE_NOT_RECRUITING | To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.
Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only). | NO | PE - Pulmonary Embolism|PE - Pulmonary Thromboembolism | DEVICE: FlowTriever System|DRUG: Anticoagulation Agents | Composite Major Adverse Events, Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events, 48-hours | Individual Major Adverse Events, Rate of subjects with individual components of composite MAE, 48-hours|All-cause mortality, Rate of deaths, 30-days|Device-related serious adverse events, Rate of device-related SAEs, 30-days | null | Inari Medical | null | ALL | ADULT, OLDER_ADULT | null | 1,300 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | 18-002 | 2018-12-15 | 2024-10-31 | 2024-10-31 | 2018-12-03 | null | 2024-05-23 | UAB Division of Cardiovascular Disease, Birmingham, Alabama, 35294, United States|University of Arizona College of Medicine, Tucson, Arizona, 85719, United States|Pima Heart and Vascular, Tucson, Arizona, 85741, United States|University of Colorado, Aurora, Colorado, 80045, United States|Yale University, New Haven, Connecticut, 06511, United States|Christiana Care Health Services, Newark, Delaware, 19713, United States|Memorial Hospital Jacksonville, Jacksonville, Florida, 32216, United States|Lakeland Vascular Institute, Lakeland, Florida, 33801, United States|Palmetto General Hospital, Miami, Florida, 33016, United States|University of Miami, Miami, Florida, 33125, United States|Mount Sinai Medical Center of Florida, Miami, Florida, 33140, United States|Ascension Sacred Heart, Pensacola, Florida, 32504, United States|Sarasota Memorial Hospital, Sarasota, Florida, 34239, United States|Tallahassee Memorial Hospital, Tallahassee, Florida, 32308, United States|Emory University, Atlanta, Georgia, 30308, United States|Rush Medical Center, Chicago, Illinois, 60612, United States|University of Chicago, Chicago, Illinois, 60637, United States|Northwestern University, Evanston, Illinois, 60208, United States|Javon Bea Hospital, Rockford, Illinois, 61103, United States|Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States|Norton Healthcare, Louisville, Kentucky, 40205, United States|Baptist Health Lousville, Louisville, Kentucky, 40207, United States|Opelousas General, Opelousas, Louisiana, 70570, United States|Henry Ford Health System, Detroit, Michigan, 48202, United States|Ascension Genesys Hospital, Grand Blanc, Michigan, 48439, United States|Ascension Providence Hospital, Madison Heights, Michigan, 48334, United States|Ascension Providence Rochester Hospital, Rochester, Michigan, 48307, United States|Beaumont Health, Royal Oak, Michigan, 48073, United States|St. Joseph Mercy, Ypsilanti, Michigan, 48106, United States|Metropolitan Heart and Vascular Institute, Minneapolis, Minnesota, 55433, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|CentraCare Heart & Vascular Center, Saint Cloud, Minnesota, 56303, United States|Missouri Cardiovascular Specialists, Columbia, Missouri, 65201, United States|University of Missouri, Columbia, Columbia, Missouri, 65212, United States|Saint Luke s Hospital of Kansas City, Lee s Summit, Missouri, 64086, United States|Valley Health, Ridgewood, New Jersey, 07450, United States|Albany Medical Center, Albany, New York, 12208, United States|SUNY, The University at Buffalo, Buffalo, New York, 14203, United States|Northwell Health, Manhasset, New York, 11030, United States|NYU Langone Medical Center, New York, New York, 10016, United States|Mount Sinai, New York, New York, 10029, United States|Jamaica Hospital, Queens, New York, 11418, United States|St. Francis Hospital & Heart Center, Roslyn, New York, 11576, United States|Westchester Medical Center, Valhalla, New York, 10595, United States|Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, 27157, United States|University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States|Lexington Medical Center, West Columbia, South Carolina, 29169, United States|Methodist Healthcare Foundation, Germantown, Tennessee, 38138, United States|UTMC Knoxville, Knoxville, Tennessee, 37920, United States|St. Thomas West, Nashville, Tennessee, 37205, United States|CardioVoyage, Denison, Texas, 75071, United States|Inova Fairfax, Falls Church, Virginia, 22042, United States|Sentara, Norfolk, Virginia, 23507, United States|Providence Regional Medical Center Everett, Everett, Washington, 98201, United States|Providence Sacred Heart, Spokane, Washington, 99204, United States|Aurora St. Luke s Medical Center, Milwaukee, Wisconsin, 53215, United States|Allgemeines Krankenhaus AKH Wien, Vienna, Austria|UZ Antwerpen, Antwerpen, Belgium|UZ Brussel, Brussel, Belgium|Centre Hospitalier Universitaire de Besançon, Besançon, France|Hopital de la Cavale Blanche - CHU Brest, Brest, France|CHU Grenoble, Grenoble, France|Institut Coeur Poumon - CHU de Lille, Lille, France|HCL Hôpital Louis Pradel - Hôpital Cardiologique, Lyon, France|European Hospital Georges Pompidou, Paris, France|Charité Hospital - Campus Virchow-Klinikum, Berlin, Germany|Cardioangiologisches Centrum Bethanien, Frankfurt, Germany|University Hospital, Heidelberg, Germany|Universitatsklinikum des Saarlandes, Homburg, Germany|Helios Kliniken Schwerin, Schwerin, Germany|Universitair Medisch Centrum Utrecht, Utrecht, Netherlands|Hospital Clínico San Carlos, Madrid, 28040, Spain|Gregorio Maranon University Hospital, Madrid, Spain|Inselspital, Bern, Switzerland|Kantonsspital Sankt Gallen, Saint Gallen, Switzerland|Unispital, Zürich, Switzerland|The Royal Free Hospital, London, United Kingdom|The Royal London Hospital, Bart s Health, London, United Kingdom | null | {
"FlowTriever System": [
{
"intervention_type": "DEVICE"
}
],
"Anticoagulation Agents": [
{
"intervention_type": "DRUG"
}
]
} |
NCT00920673 | Age Influence on the Modifications of the Oral, Pharyngeal and Laryngeal Axis Alignment in Children Induced by Head Extension: an MRI Study | https://clinicaltrials.gov/study/NCT00920673 | null | COMPLETED | In pediatric anesthesia and in pediatric intensive care, tracheal intubation is one of the most important procedure. To achieve this procedure as fast as possible and in is best conditions, the physician should choose the head posture which a priori will enable at first the best glottic visualisation during laryngoscopy, and at second will facilitate the route of the tube from the larynx to the trachea.
Tracheal intubation is a procedure used for years, and many textbooks recommendations on the best head posture for tracheal intubation in paediatrics have been made. Briefly summarized, depending on the age of the child, the head should (or not) be slightly extended, and a pillow should (or not) be positioned under the occiput. These recommendations are questionable for three majors reasons:
* despite an apparent consensus, some recommendations are quite different.
* none are based on anatomical nor clinical studies
* if for all of them, the age of the child is considered as critical point, but children are only grossly categorized in three categories (newborn, infants and old children). And the clinician has no way, facing a child, to make his choice between dichotomic attitudes.
Actually, the responses to these questions should need rigourous clinical studies on laryngoscopy, hard to design and very difficult to make. P.Adnet et coll. (Anesthesiology 2001) showed that an anatomical study with resonance magnetic imaging (MRI) can bring indirect but strong evidence and can be a first step leading to clinical studies. Many children need MRI study for different reasons, and it is fast and easy to get during their examination additional images of the superior airway.
In their unit, the investigators are experienced in this kind of study, as they recently published (Pediatric Anesthesia 2008) an MRI study demonstrating that in children, head extension improves the alignment of the visualisation axis on the laryngeal axis, but worsens the alignment of the pharyngeal axis on the laryngeal axis. However, patients included in their study were in major part infants, so the influence of the age could not be properly analyzed. Morevover, this study suffered of two main limitations, the lack of standardisation of head postures, and that a laryngeal mask the children, who were on general anesthesia (required for the MRI examination) were made using a laryngeal mask (as it was at this time the standard in their institution).
The investigators propose an MRI study of the influence of age on the consequences of head extension on the anatomic axes of the superior airway in children, with a prospective stratified on age study. Several modifications and improvement in the design of this study would diminished the limitations of the first study. | NO | Head Extension on the Anatomic Axes of the Superior Airway | PROCEDURE: MRI | To study the influence of age on the consequences of head extension on the anatomic axes of the superior airway in children, 2 years | null | null | Assistance Publique Hopitaux De Marseille | null | ALL | CHILD, ADULT | null | 150 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 2009/06|2009-A00163-54 | 2009-05 | 2012-03 | 2012-03 | 2009-06-15 | null | 2014-02-25 | Assistance Publique - Hôpitaux de Marseille, Marseille, France|Assistance Publique-Hopitaux de Marseille, Marseille, France | null | {
"MRI": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT00128973 | Evaluation of Patients With Immune Function Abnormalities | https://clinicaltrials.gov/study/NCT00128973 | null | RECRUITING | This study will evaluate patients with abnormal immune function that results in recurrent or unusual infections or chronic inflammation. This may include inherited conditions, such as X-linked severe combined immunodeficiency (XSCID), chronic granulomatous disease (CGD), and leukocyte adhesion deficiency (LAD), or conditions resulting from outside factors, such as graft-versus-host disease (GVHD). The information from this study will be used to establish the pattern and pace of change of the disease and to help develop new treatments. The period of observation and study following enrollment in this study may be for up to one year. In addition these studies may provide the medical information needed to determine eligibility for enrollment in other clinical study protocols and more prolonged follow up.
Patients of any age with abnormal immune function who have recurrent or unusual infections, whose blood tests show evidence of immune dysfunction, or who have GVHD, XSCID, CGD or LAD may be eligible for this study. Patients parents, siblings, grandparents, children, aunts, uncles and first cousins of any age also may be included. Healthy normal volunteers between 18 and 85 years of age are recruited as controls.
Normal volunteers undergo a physical examination and provide blood, saliva, and urine samples for immune function studies. Patients family members provide a medical history, have a physical examination, and give blood and urine samples, and possibly a saliva sample. The samples are used for genetic and routine laboratory studies. Investigators may request tissue samples, such as biopsy specimens, previously removed for medical reasons to be sent to NIH for study. Patients undergo the following tests and procedures:
1. Medical history and physical examination.
2. Blood and urine tests, including analysis for genes involved in immune disorders.
3. Buccal smear (in some patients) for genetic studies. This involves scraping the lining of the mouth near the cheek.
4. Specialized tests to evaluate specific conditions in patients who have an immune disorder that might affect lung function, gum infections or eye problems. These may include chest x-ray, CT scan, breathing function test, dental, eye, and hearing examinations.
5. Follow-up visits of patients with immune problems may occur at 6 months and at one year after the first visit (or more frequently if medically required) to include:
* Medical history update
* Physical examination
* Follow-up on abnormal test results and medical treatments initiated at NIH
* Collection of blood, saliva, urine, or wound drainage samples for repeat immune function studies
* Tissue study of specimens removed for medical reasons at other institutions besides NIH | NO | Chronic Granulomatous Disease (CGD)|X-Linked Severe Combined Immune Deficiency (XSCID)|Leukocyte Adhesion Deficiency 1 (LAD)|Graft Versus Host Disease (cGvHD) | null | To establish the pattern and pace of change of disease (frequency, distribution, type and extent of infections, inflammatory lesions and abnormalities of immune function) during a period of up to one year baseline assessment., Identification pregression and pattern of disease over time, ongoing throughout study|To establish the extent of organ involvement (infection and/or inflammation) and organ damage or dysfunction resulting from the abnormality of immune function., Identification of severity of disease as it relates to immune function in PID, ongoing throughout study|To determine genetic linkage and biochemical correlates of the patient s abnormality of immunity by study of first and second-degree related family members blood cells (buccal smears instead of blood for genetic studies in some individuals)..., Identification of genetic links and biochemical correlates of PID to clinical manifestations, ongoing throughout study|To characterize the physiologic, biochemical or genetic basis of the abnormality of immunity., Identification of the pathophysiology and genetic basis of abnormalities of immune function under study, ongoing throughout study | To establish a baseline assessment of the pace and extent of the disease before entering a therapeutic clinical trial., Identification of best time with respect to disease process to place pts on a treatment protocol, ongoing throughout study|To determine a patient s eligibility for other studies., Patient recruitment to treatment protocols, ongoing throughout study|To assess the patient s ability to safely tolerate specific aspects of other diagnostic or therapeutic research protocols., Patients tolerate treatment for PID disease, ongoing throughout study | null | National Institute of Allergy and Infectious Diseases (NIAID) | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 3,500 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 050213|05-I-0213 | 2005-09-19 | null | null | 2005-08-10 | null | 2024-06-12 | National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States | null | {} |
NCT02903173 | An Observational Study of Post-cesarean Delivery Respiratory Patterns Using a Non-invasive Minute Ventilation Monitor (Exspiron ™ System) | https://clinicaltrials.gov/study/NCT02903173 | null | COMPLETED | The purpose of this study is to evaluate the breathing patterns of women who undergo cesarean delivery with spinal or epidural morphine for post-operative pain control in the first day after surgery. Some women who undergo cesarean delivery may be at risk for respiratory complications related to opiate administration for post-operative pain. The primary aim of this study is to evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring, and to see if there are predictive risk factors that may predispose women to post-operative hypoventilation. | NO | Pregnancy|Analgesia|Respiratory Depression|Obstructive Sleep Apnea|Postpartum | null | Change in minute ventilation, baseline and 24 hours post cesarian delivery | Berlin Questionnaire, Baseline|STOP-BANG Questionnaire, Baseline|Epworth Sleepiness Scale, Baseline | null | Duke University | Respiratory Motion, Inc. | FEMALE | ADULT, OLDER_ADULT | null | 54 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | Pro00057206 | 2015-02 | 2018-06-27 | 2018-06-27 | 2016-09-16 | null | 2019-09-24 | Duke University Medical Center, Durham, North Carolina, 27710, United States | null | {} |
NCT02671773 | Characterising the Microbiota in Asthma | https://clinicaltrials.gov/study/NCT02671773 | MIA | COMPLETED | Previous work has determined that there are significant differences in the communities of bacteria found in the airways of asthmatic patients compared to those found in the airways of healthy people.
It is not yet clear if these bacterial communities are similar in all patients with asthma or if they are different in people with more severe asthma, with different types of asthma or between asthma patients taking different treatment. This is important to know as any differences in the bacteria present between groups may help to explain why people with asthma do not have the same features of disease.
This research aims to determine if there are any differences in the number and type of bacteria found in the airways of asthmatic patients (1) with different severities of asthma and (2) who use different types of inhaled steroid treatment for asthma.
We will do this by detecting the DNA of bacteria present in phlegm samples from these patients. We will also take measurements of the different components of asthma to see if the bacteria are different in people with different types of disease.
As it is not yet clear if the bacteria detected in phlegm samples from one person may differ on different occasions, we will be taking more than one sample from some patients to see how similar this is over time. | NO | Asthma | DRUG: Inhaled corticosteroid dose/type | Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs subject BTS treatment step, 1 day|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) vs subject BTS treatment step, 1 day | Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs FEV1, 1 day|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) vs FEV1, 1 day|Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs sputum differential cell count (%eosinophils/%neutrophils), 1 day|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) vs sputum differential cell count (%eosinophils/%neutrophils), 1 day|Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs exhaled nitric oxide level (ppb), 1 day|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) vs exhaled nitric oxide level (ppb), 1 day|Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v PC20 (mg/ml), 1 day|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) v PC20 (mg/ml), 1 day|Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v Leicester Cough Questionnaire (LCQ) score, 1 day|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) v Leicester Cough Questionnaire (LCQ) score, 1 day|Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v Asthma Control Questionnaire Score, 1 day|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) v Asthma Control Questionnaire Score, 1 day|Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide, 1 day|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide, 1 day|Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%)), 1 day|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%)), 1 day|Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) stability over 24 hour period, 2 days|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) stability over 24 hour period, 2 days|Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) over 2 week period, 2 weeks|Subject sputum microbiota bacterial diversity (as quantified by Simpson s diversity index) over 2 week period, 2 weeks|Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs subject BTS treatment step, 1 day|Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs subject BTS treatment step vs FEV1, 1 day|Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs sputum differential cell count (%eosinophils/%neutrophils), 1 day|Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs exhaled nitric oxide level (ppb), 1 day|Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs PC20 (mg/ml), 1 day|Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs Leicester Cough Questionnaire (LCQ) score, 1 day|Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs Asthma Control Questionnaire Score, 1 day|Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide, 1 day|Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) stability over 24 hour period, 2 days|Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%)), 1 day | null | University of Nottingham | King s College London | ALL | ADULT, OLDER_ADULT | null | 72 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 14016 | 2014-06 | 2015-06 | 2015-06 | 2016-02-02 | null | 2016-02-02 | Respiratory Research Unit, Nottingham, Nottinghamshire, NG5 1PB, United Kingdom | null | {
"Inhaled corticosteroid dose/type": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03380273 | AO Multicenter Intervention Trial for Prevention of Surgical Site Infection | https://clinicaltrials.gov/study/NCT03380273 | AOPOSSI | TERMINATED | This study is designed to collect data from 8,476 fracture patients during a pre-and post-intervention phases of two years length each. The intervention consists on the implementation of the AOT SSI Prevention Bundle.
D | NO | Surgical Site Infection | BEHAVIORAL: Implementation of the AO Trauma SSI Prevention Bundle | Infection Rate, Surgical site infection rate as defined by CDC or FRI definition, within 3 months after surgery | Implementation success of the AOT SSI Prevention Bundle, Compliance rate for each measure of the bundle before and after the intervention, up to 48 months|Evaluation of attitudes, perception and knowledge concerning SSI, Cross sectional survey of surgeons at participating sites performed before and after the implementation of the AOT SSI Prevention Bundle, up to 48 months|Surgeon satisfaction, Cross sectional survey of opinion concerning user friendliness of the AOT SSI Prevention Bundle, value of the educational intervention and intention to adopt the AOT SSI Prevention Bundle long term before and after its implementation, up to 48 months|Health-economic analysis, The clinical effectiveness of the implementation of the AOT SSI Prevention Bundle and consecutively the costs saved by preventing infections and its treatment is compared against the costs which have to be invested in order to implement the AOT SSI Prevention Bundle (e.g. costs generated by development of teaching material, time needed to teach/implement the intervention, extra material needed according to the interventions etc.)., up to 48 months | null | AO Clinical Investigation and Publishing Documentation | null | ALL | ADULT, OLDER_ADULT | null | 222 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION | AOPOSSI | 2019-12-06 | 2021-12-30 | 2021-12-31 | 2017-12-21 | null | 2022-01-18 | Cedars Sinai Medical Center, Los Angeles, California, 90048, United States|University of Kentucky Healthcare, Lexington, Kentucky, 40536-0284, United States|UMass Memorial Medical Center, Worcester, Massachusetts, 01655, United States|Missouri Orthopaedic Institute, Columbia, Missouri, 65212, United States|Saint Louis University, Saint Louis, Missouri, 63110, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|University of Virginia, Charlottesville, Virginia, 22908-0159, United States|VCU Medical Center, Richmond, Virginia, 23298-0153, United States|Hospital Italiano de Buenos Aires, Buenos Aires, Argentina|University Hospital Gießen, Gießen, Germany|University Hospital Regensburg, Regensburg, Germany|Korea University Guro Hospital, Seoul, Korea, Republic of|Spitalul Clinic de Urgenta Floreasca, Bucuresti, Romania|Hospital Universitari Parc Tauli, Sabadell, Spain | null | {
"Implementation of the AO Trauma SSI Prevention Bundle": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT03429673 | A Study to Evaluate Effectiveness and Safety of Surgeries in Elderly NSCLC Patients | https://clinicaltrials.gov/study/NCT03429673 | null | COMPLETED | The trial was designed to compare effectiveness and safety of surgeries in the patients with non-small cell lung cancer | NO | Non-small Cell Lung Cancer | PROCEDURE: Surgeries | Overall survival, Overall survival, 2015-2017 | null | Overall survivals in the subgroups, Overall survivals in the subgroups categorised by age, tumor size, and clinical/pathological staging, 2015-2017|Impact factors of overall survival, Impact factors of overall survival as measured by patient demographic/tumor biological characteristics, 2015-2017|Death rate within 30/90 days after surgeries, Death rate within 30/90 days after surgeries, 2015-2017|Incidence of perioperative complications, Incidence of perioperative complications, 2015-2017 | China-Japan Friendship Hospital | LinkDoc Technology (Beijing) Co. Ltd. | ALL | OLDER_ADULT | null | 10,885 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | CJ-LC-01 | 2017-12-01 | 2017-12-01 | 2018-03-30 | 2018-02-12 | null | 2018-05-21 | China-Japan Friendship Hospital, Beijing, Beijing, 100029, China|China People s Liberation Army Hospital, Beijing, Beijing, 100853, China|Henan Cancer Hospital, Zhengzhou, Henan, 450008, China|Tongji Hospital Affiliated to Huaxi Technology University, Wuhan, Hubei, 430030, China|Jiangsu Cancer Hospital, Nanjing, Jiangsu, 210009, China|Xi an Tangdu Hospital, Xi an, Shaanxi, 710000, China|Shanghai Chest Hospital, Shanghai, Shanghai, 200030, China|Huaxi Hospital Affiliate to Sichuan University, Chengdu, Sichuan, 610041, China|Tianjin Chest Hospital, Tianjin, Tianjin, 300051, China|First Hospital Affiliated to Zhejiang University, Hangzhou, Zhejiang, 310003, China | null | {
"Surgeries": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT04442373 | Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm | https://clinicaltrials.gov/study/NCT04442373 | I-SIGHT-THR | RECRUITING | Total hip replacement (THR) is associated with extensive tissue injury and considerable blood loss that can be complicated by hyperfibrinolysis with an increased need for blood transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve or maintain the function and quality of life. However, these patients have an increased likelihood of haemostatic abnormalities, such as thrombosis or extensive blood loss. Rotational thromboelastometry is a point-of-care viscoelastic assay that can provide a measure of coagulation disorders in the above settings, and this is still under review. The objective of this prospective cohort study is to quantitate the changes in clot formation dynamics following THR with a subgroup analysis of patients with cancer. | NO | Total Hip Replacement|Thromboelastometry|Bone Neoplasm of Hip | DIAGNOSTIC_TEST: Rotational thromboelastometry | INTEM parameters change from preoperative to postoperative values, 30 minutes before and 30 minutes after surgery|EXTEM parameters change from preoperative to postoperative values, 30 minutes before and 30 minutes after surgery|FIBTEM parameter change from preoperative to postoperative values, 30 minutes before and 30 minutes after surgery | Total volume of infused fluids, Crystalloids, blood products, From first fluid on day of surgery to end of surgery, an average of 12 hours|Pre- and postoperative haemoglobin and haematocrit, From day before surgery to postoperative day 3|Intraoperative blood loss, Amount of blood loss in millilitres, Blood loss as measured during surgery|Hip Disability and Osteoarthritis Outcome Score (HOOS), Instrument for measuring outcome following surgery with higher scores representing better function. Score from 0 to 100., The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery|The 36-Item Short Form Health Survey (SF-36), Health related Quality of Life measure. Higher score indicates better health state with eight scaled scores each from 0 to 100., The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery|Visual Analogue Scale (VAS) score, The ends of the scale are defined as the extreme limits of the pain. Orientated from the left (no pain) to the right (worst imaginable pain) measured in millimeters from 0 to 100., The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery | Rate of thrombotic events, Pulmonary embolism, deep and superficial vein thrombosis, up to 12 months after surgery | Medical University of Warsaw | null | ALL | ADULT, OLDER_ADULT | null | 50 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | ROTEM-THR | 2020-01-01 | 2024-12-31 | 2024-12-31 | 2020-06-22 | null | 2024-01-17 | I Department of Anesthesiology and Intensive Care Warsaw Medical University, Warsaw, Mazowieckie, 02-005, Poland | null | {
"Rotational thromboelastometry": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
]
} |
NCT00602173 | Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions | https://clinicaltrials.gov/study/NCT00602173 | null | COMPLETED | The objective of this study was the bioequivalence of a Roxane Laboratories Cilostazol Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design. | NO | Intermittent Claudication | DRUG: Cilostazol | Bioequivalence, Baseline, Two period, Seven day washout | null | null | Roxane Laboratories | null | ALL | ADULT | null | 32 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT | CILO-03 | 2003-05 | 2003-05 | 2003-05 | 2008-01-28 | null | 2018-01-23 | CEDRA Clinical Research, LLC, Austin, Texas, 78759, United States | null | {
"Cilostazol": [
{
"intervention_type": "DRUG",
"description": "Cilostazol",
"name": "Cilostazol",
"synonyms": [
"OPC-13013",
"6-[4-(1-Cyclohexyl-1H-tetrazol-5-yl)-butoxy]-3,4-dihydro-1H-quinolin-2-one",
"OPC 13013",
"6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-dihydro-2(1H)-quinolinone",
"Cilostazolum",
"3,4-dihydro-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-2(1H)-quinolinone",
"6-(4-(1-Cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-dihydro-2(1H)-quinolinone",
"6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-dihydrocarbostyril",
"Pletal",
"Cilostazol",
"Cilostazole"
],
"medline_plus_id": "a601038",
"generic_names": [
"Cilostazol"
],
"mesh_id": "D058987",
"drugbank_id": "DB01166"
}
]
} |
NCT05412173 | Pharmacokinetics and Bioequivalence of Molnupiravir, 200 mg Capsules and Lagevrio, 200 mg Capsules in Healthy Volunteers | https://clinicaltrials.gov/study/NCT05412173 | null | COMPLETED | The study aimed for:
1. Comparative evaluation of the safety of the drug Molnupiravir, capsules, 200 mg (JSC Valenta Pharm , Russia), and Lagevrio, capsules, 200 mg (Merck Sharp & Dohme (UK) Limited, UK), based on the analysis of adverse events (AEs);
2. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug Molnupiravir, capsules, 200 mg (Valenta Pharm JSC, Russia), and Lagevrio, capsules, 200 mg (Merck Sharp & Dohme (UK) Limited, UK), in healthy volunteers in fasted conditions. | NO | Viral Infection|COVID-19 | DRUG: Molnupiravir | Pharmacokinetics - Cmax, Maximum plasma concentration (Cmax) of β-D-N-4-hydroxycytidine (NHC), From 0 to 24 hours (Day 1-2 and Day 8-9)|Pharmacokinetics - tmax, Time to reach Cmax (tmax) of NHC, From 0 to 24 hours (Day 1-2 and Day 8-9)|Pharmacokinetics - AUC0-t, Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of NHC, From 0 to 24 hours (Day 1-2 and Day 8-9)|Pharmacokinetics - AUC0-inf, Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of NHC, From 0 to 24 hours (Day 1-2 and Day 8-9)|Pharmacokinetics - AUCextr, Extrapolated AUC of NHC, defined as (AUC0-inf - AUC0-t)/AUC0-inf, From 0 to 24 hours (Day 1-2 and Day 8-9)|Pharmacokinetics - t1/2, Elimination half-life (t1/2) of NHC, From 0 to 24 hours (Day 1-2 and Day 8-9)|Pharmacokinetics - kel, Elimination constant (kel) of NHC, From 0 to 24 hours (Day 1-2 and Day 8-9)|Pharmacokinetics - MRT, Mean residence time (MRT) of NHC, From 0 to 24 hours (Day 1-2 and Day 8-9)|Bioequivalence - ratio of Cmax, Ratio of geometric mean Cmax for NHC after intake of R or T (with 90% confidence intervals), From 0 to 24 hours (Day 1-2 and Day 8-9)|Bioequivalence - ratio of AUC0-t, Ratio of geometric mean AUC0-t for NHC after intake of R or T (with 90% confidence intervals), From 0 to 24 hours (Day 1-2 and Day 8-9)|Bioequivalence - ratio of AUC0-inf, Ratio of geometric mean AUC0-inf for NHC after intake of R or T (with 90% confidence intervals), From 0 to 24 hours (Day 1-2 and Day 8-9) | Safety and Tolerability: adverse event (AE) number and frequency, Number and frequency of adverse events (AEs) or serious AEs (SAEs), From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: adverse event (AE) characteristics, Description and severity of AEs or serious AEs (SAEs), concomitant therapy for AEs/SAEs, causal relationship, outcomes., From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: vital signs - systolic blood pressure (SBP), SBP, mmHg, Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: vital signs - diastolic blood pressure (DBP), DBP, mmHg, Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: vital signs - respiratory rate (RR), RR, breaths per minute, Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: vital signs - heart rate (HR), HR, beats per minute, Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: vital signs - body temperature, Body temperature, centigrade scale, Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: physical examination results, Physical examination results, Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis - color, Color of the urine, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis - transparency, Transparency of the urine, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis - pH, pH of the urine, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis - specific gravity, Specific gravity of the urine, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis - nitrites, Nitrites in the urine (+/-), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis - protein, Protein in the urine (g/L), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis - glucose, Glucose in the urine (mmol/L), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis - ketones, Ketones in the urine (mmol/L), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis - urobilinogen, Urobilinogen in the urine (mmol/L), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis - bilirubin, Bilirubin in the urine (+/-), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis (microscopy) - red blood cells, Red blood cells in the urine (number in sight), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis (microscopy) - white blood cells, White blood cells in the urine (number in sight), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis (microscopy) - cylinders (except hyaline), Cylinders (except hyaline) in the urine (number in sight), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: urinalysis (microscopy) - bacteria, Bacteria in the urine (number in sight), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - hemoglobin, Hemoglobin, g/dL, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - red blood cells, Red blood cells, 10^6/uL, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - hematocrit, Hematocrit, %, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - platelets, Platelets, 10^3/uL, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - white blood cells, White blood cells, 10^3/uL, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - erythrocyte sedimentation rate, Erythrocyte sedimentation rate, mm per hour, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - neutrophils, Neutrophils, %, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - lymphocytes, Lymphocytes, %, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - eosinophils, Eosinophils, %, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - monocytes, Monocytes, %, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: complete blood count - basophils, Basophils, %, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - total protein, Total protein in blood serum, g/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - creatinine, Creatinine in blood serum, umol/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - urea, Urea in blood serum, mmol/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - glucose, Glucose in blood serum, mmol/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - total bilirubin, Total bilirubin in blood serum, umol/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - direct bilirubin, Direct bilirubin in blood serum, umol/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - total cholesterol, Total cholesterol in blood serum, mmol/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - triglycerides, Triglycerides in blood serum, mmol/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - alanine transaminase (ALT), ALT in blood serum, U/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - aspartate transaminase (AST), AST in blood serum, U/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: blood test results - alkaline phosphatase (ALP), ALP in blood serum, U/L, Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate, 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval, 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex, 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)|Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc), 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms), Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) | null | Valenta Pharm JSC | null | ALL | ADULT | null | 37 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER | MOL-05-02-2021 | 2022-04-22 | 2022-05-17 | 2022-06-02 | 2022-06-09 | null | 2023-07-27 | Limited Liability Company Research Center Eco-Safety , Saint Petersburg, 196143, Russian Federation | null | {
"Molnupiravir": [
{
"intervention_type": "DRUG",
"description": "Molnupiravir",
"name": "Molnupiravir",
"synonyms": [
"Molnupiravir",
"<ref name="Lagevrio SmPC" /><ref name="UKgov-MHRA-Lagevrio(molnupiravir)-20211104"/> Molulife",
"Lagevrio"
],
"nhs_url": "https://www.nhs.uk/medicines/molnupiravir",
"generic_names": [
"Molnupiravir"
],
"drugbank_id": "DB15661",
"wikipedia_url": "https://en.wikipedia.org/wiki/Molnupiravir"
}
]
} |
NCT04975373 | Intrauterine Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions | https://clinicaltrials.gov/study/NCT04975373 | null | UNKNOWN | Women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups.
1. study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity
2. control group - no injection
4-8 weeks after operative hysteroscopy, participants will undergo diagnostic hysteroscopy with no anesthesia , as a part of routine evaluation after removal of retained placenta in Israel.
during diagnostic hysteroscopy the uterine cavity will be evaluated and the presence of adhesions and severity of adhesions will be recorded. | NO | Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel | DRUG: Intrauterine injection of hyaluronic acid | any adhesions, presence of any adhesions in uterine cavity during diagnostic hysteroscopy, 4-8 weeks after intervention | adhesion scorring, American Fertility Society score for intrauterine adhesions, 4-8 weeks after intervention | null | Barzilai Medical Center | null | FEMALE | ADULT | null | 160 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 0002-21 | 2021-06-25 | 2022-07-25 | 2022-07-25 | 2021-07-23 | null | 2021-07-23 | Barzilai University Medical Center, Ashkelon, Israel | null | {
"Hyaluronic acid": [
{
"intervention_type": "DRUG",
"description": "Intrauterine injection of hyaluronic acid",
"name": "Hyaluronic acid",
"synonyms": [
"Hyaluronan",
"Hyaluronic acid",
"Hyaluronate"
],
"drugbank_id": "DB08818",
"generic_names": [
"Hyaluronic acid"
]
}
]
} |
NCT04849273 | A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC | https://clinicaltrials.gov/study/NCT04849273 | null | TERMINATED | A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or metastatic non-small cell lung cancer (NSCLC). | NO | Non Small Cell Lung Cancer|Non-Small Cell Lung Cancer|NSCLC|Advanced Solid Tumor|Metastatic Solid Tumor|ALK Gene Mutation | DRUG: TPX-0131 | Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131, Evaluate the safety and tolerability of TPX-0131, Within 28 days of the first TPX-0131 dose for each patient|Define the Recommended Phase 2 Dose, Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131, Approximately 24 months | Adverse events (AEs), Evaluate the overall safety profile of TPX-0131, Approximately 34 months | null | Turning Point Therapeutics, Inc. | null | ALL | ADULT, OLDER_ADULT | PHASE1 | 11 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | CA226-1036|CA226-1036|TPX-0131-01 | 2021-07-28 | 2023-04-18 | 2023-04-18 | 2021-04-19 | null | 2023-05-26 | Local Institution - 2104, Orange, California, 92868, United States|Local Institution - 2105, Aurora, Colorado, 80045, United States|Local Institution - 2106, Boston, Massachusetts, 02114-2696, United States|Local Institution - 2108, Boston, Massachusetts, 02215, United States|Local Institution - 2103, Hackensack, New Jersey, 07601, United States|Local Institution - 2107, Nashville, Tennessee, 37203, United States|Local Institution - 2102, Fairfax, Virginia, 22031-4629, United States|Local Institution - 6102, Blacktown, New South Wales, 2148, Australia|Local Institution - 6103, Heidelberg, Victoria, 3084, Australia|Local Institution - 6104, Melbourne, Victoria, 3000, Australia|Local Institution - 6101, Nedlands, Western Australia, 6009, Australia|Local Institution - 6303, Seoul, Seoul-teukbyeolsi, 05505, Korea, Republic of|Local Institution - 6301, Seoul, 03722, Korea, Republic of|Local Institution - 6302, Seoul, 06351, Korea, Republic of|Local Institution - 6304, Seoul, 110-744, Korea, Republic of | null | {
"TPX-0131": [
{
"intervention_type": "DRUG"
}
]
} |
NCT06378073 | Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery | https://clinicaltrials.gov/study/NCT06378073 | null | ACTIVE_NOT_RECRUITING | A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups.
In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS | NO | Surgery-Complications | DIAGNOSTIC_TEST: Incentive Spirometer|DIAGNOSTIC_TEST: Numeric Pain Rating Scale | Incentive Spirometer, A pain screening NRS score of 1 was 69% sensitive for pain that interferes with functioning. (4) Specificity: The diagnostic value of different NRS cut-off values for administering analgesics is determined by an ROC curve. Sensitivity of NRS > 3 for unbearable pain in older patients was 72% with a specificity of 97·2%. With a cut-off point NRS > 4, sensitivity increased to 83%, while specificity was 96·7%. (5) Validity and reliability: The numerical rating scale is a reliable and valid tool for pain assessment in patients with musculoskeletal impairments., 6 Month|Incentive Spirometer, Specificity and sensitivity: Incentive spirometry is a specific type of spirometry that aims to encourage people to breathe deeply intentionally but does not provide a measurement or inform management of chronic lung diseases. Less than 5 repetitions per day (sensitivity 93%, specificity 77%) and less than 2 balls per repetition (sensitivity 93%, specificity 77%) were predictive of postoperative pulmonary complications., 6 Months | null | null | Superior University | null | ALL | ADULT, OLDER_ADULT | null | 189 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC | DPT/Batch-Fall19/557 | 2024-04-05 | 2024-06-01 | 2024-09-01 | 2024-04-22 | null | 2024-04-22 | Azra Naheed Medical College, Superior University, Lahore, Punjab, Pakistan|Bahria Hospital, Lahore, Punjab, Pakistan|Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University, Lahore, Punjab, Pakistan|The University of Lahore Teaching Hospital, Lahore, Punjab, Pakistan|Punjab Institute of Cardiology Hospital, Lahore, Pakistan | null | {
"Incentive Spirometer": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
],
"Numeric Pain Rating Scale": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
]
} |
NCT02923973 | Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth | https://clinicaltrials.gov/study/NCT02923973 | null | UNKNOWN | Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations.
However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB | NO | Preterm Birth | OTHER: Transvaginal ultrasound cervical length screening | Preterm delivery, Less than 37 weeks gestation | Gestational age at delivery, Time of delivery|preterm birth rates, Less than 24, 28, 34 weeks gestation|Birth weight, Time of delivery|Low birth weight, Birth weight <2500g, Time of delivery|Neonatal death, Between birth and 28 days of age|Composite adverse neonatal outcome, Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death, Between birth and 28 days of age|Admission to neonatal intensive care unit, Between birth and 28 days of age | null | Federico II University | null | FEMALE | ADULT | null | 500 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | #30/18 | 2018-06-01 | 2021-12-01 | 2022-03-01 | 2016-10-05 | null | 2020-02-24 | Gabriele Saccone, Naples, 80100, Italy | null | {
"Transvaginal ultrasound cervical length screening": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05089773 | Outcomes of Transposition of the Great Arteries After Arterial Switch Operation | https://clinicaltrials.gov/study/NCT05089773 | null | COMPLETED | Transposition of the great arteries (TGA) is a complex cyanotic congenital heart disease and patients suffer from a high mortality rate within one year of age without appropriate management. The therapeutic effect of arterial switch operation (ASO) is satisfactory with low surgery mortality of 2-5%, and thus, has become the treatment of choice for surgical correction of d-TGA. Outcomes of ASO in TGA in china are rare. This is a retrospective study reporting the outcomes of ASO in TGA. | NO | Transposition of Great Vessels|Outcome, Fatal | PROCEDURE: The arterial switch operation | hospital mortality, death occurred within the hospital, within 1 month after ASO|late death, death occurred after discharge, after 1 month after ASO|redo operation, reintervention after the ASO procedure, through study completion, an average of 10 year | null | null | Children s Hospital of Fudan University | Shanghai Children s Medical Center | ALL | CHILD, ADULT, OLDER_ADULT | null | 1,281 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | TGA-CTS | 2019-12-01 | 2020-03-30 | 2020-04-30 | 2021-10-22 | null | 2021-10-22 | Children s Hospital of Fudan University, Shanghai, 200000, China|Shanghai Children s medical center, Shanghai, China | null | {
"The arterial switch operation": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT02530073 | Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) | https://clinicaltrials.gov/study/NCT02530073 | FETO | RECRUITING | The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival. | NO | Congenital Diaphragmatic Hernias | DEVICE: Fetoscopic Endoluminal Tracheal Occlusion (FETO) | Percent of neonatal survivors at time of discharge, Discharge from the hospital, an expected average of 12 weeks. | Prenatal increase in lung volume, Lung volume after FETO procedure, 2 weeks (prenatally)|Number of days of Postnatal mechanical ventilator support, mechanical ventilator support will be monitored and recorded in days of use, First 28 days of postnatal life | null | Connecticut Children s Medical Center | null | FEMALE | ADULT, OLDER_ADULT | null | 15 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 15-0874 | 2015-09 | 2028-08 | 2030-08 | 2015-08-20 | null | 2024-03-12 | Medical City Children s Hospital, Dallas, Texas, 75230, United States | null | {
"Fetoscopic Endoluminal Tracheal Occlusion (FETO)": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04548973 | A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During Cesarean Section | https://clinicaltrials.gov/study/NCT04548973 | null | RECRUITING | This study proposed applying intravenous Esketamine to cesarean section in parturient, detecting the plasma concentration of Esketamine in maternal blood, neonatal umbilical venous blood and umbilical arterial blood when the baby is delivered ketamine blood drug concentration, observing vital signs, adverse visual analog pain score (VAS), and sedation score (Ramsay) in parturient, neonatal Apgar score 1, 5 to 10 minutes after birth, the umbilical arterial blood gas and neurobehavioral scores (NBNA) 2, 24 hours after the birth. This study aims to address placental transfer, metabolism and analgesic and sedative effects in neonates and parturients of Esketamine so as to explore the feasibility, efficacy and safety of Esketamine as adjuvant medication for cesarean section. | NO | Fetal or Neonatal Effect of Damage to Placenta From Caesarean Section | DRUG: Esketamine|DRUG: Normal saline | Maternal pain intensity, Pain intensity was assessed with the numeric rating scale (NRS; an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain), immediately after fetal delivery|Maternal sedation level, Maternal sedation level was assessed with Ramsay Sedation Scale (with 1 indicating restless; 2, completely awake, quiet, and cooperative; 3, drowsy but responding to verbal commands; 4, lightly asleep but responding to touch or pain; 5, asleep but slowly responding to touch or pain; and 6, deeply asleep and does not respond), immediately after fetal delivery | Maternal pain intensity at other timepoints, Maternal pain intensity at other timepoints were assessed with the numeric rating scale (NRS; an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain), before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration,|Maternal sedation level at other timepoints, Maternal sedation level at other timepoints were assessed with Ramsay Sedation Scale (with 1 indicating restless; 2, completely awake, quiet, and cooperative; 3, drowsy but responding to verbal commands; 4, lightly asleep but responding to touch or pain; 5, asleep but slowly responding to touch or pain; and 6, deeply asleep and does not respond), before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration,|systolic blood pressure, diastolic blood pressure, and mean blood pressure, systolic and diastolic blood pressure were assessed by non-invasive blood pressure cuff，mean blood pressure was measured by the Calculation formula: Mean arterial pressure =(systolic pressure +2× diastolic pressure)/3, before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery|maternal heart rate, maternal heart rate, before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery|pulse oxygen saturation, pulse oxygen saturation, before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery|Apgar score of newborn, Apgar was assessed by appearance, pulse, grimace, activity, respiration. Each item was measured on a scale of 0, 1, and 2, respectively, with a maximum total score of 10., at 1 minute and 5 minute after birth|postnatal umbilical vein blood gas pH value, postnatal umbilical vein blood gas pH value, Results of umbilical arterial blood gas analysis after birth|Esketamine concentrations in maternal arterial blood and neonatal umbilical arterial, Esketamine concentrations was assessed by reverse-phase high-performance liquid chromatography, Immediately after fetal delivery | Adverse events including hypotension, hypertension, bradycardia, tachycardia and desaturation, hypotension was defined as a systolic blood pressure decrease less than 20% of baseline, hypertension was defined as a systolic blood pressure increase greater than 20% of baseline, bradycardia was defined as a heart rate less than 60 beats per minute, tachycardia was defined as a heart rate greater than 100 beats per minute, and desaturation was defined as oxygen saturation less than 90%., Adverse events were recorded as Frequency of occurrence between the time the patient entered the operating room and the end of surgery|offspring s neurodevelopment, Neurodevelopment was measured by the Ages and Stages Questionnaire, third edition (ASQ-3).The ASQ-3 assesses 5 developmental domains: gross motor skills, fine motor skills, problem-solving ability, communication, and personal and social skills. Each domain is assessed by 6 questions ascertaining achievement of relevant skills and answered as yes (10 points), sometimes (5 points), or not yet (0 points). Scores for individual items are summed to give an overall continuous score for each of the 5 domains (possible range, 0-60)., 2 years after birth|Mothers memories of childbirth, Mothers memories of childbirth was assessed by The Birth Memories and Recall Questionnaire (BirthMARQ),which focused on parents positive, negative or mixed emotions at the birth/in recalling the event. Each item (e.g. my emotions at the time were extremely negative ) was rated on a scale ranging from 1 (strongly disagree) to 7 (strongly agree)., at 2 years after birth | Women s Hospital School Of Medicine Zhejiang University | null | FEMALE | ADULT | PHASE4 | 600 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | MZK20200831 | 2021-01-01 | 2024-09-30 | 2024-09-30 | 2020-09-16 | null | 2024-06-18 | Women s Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, 310000, China | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/73/NCT04548973/Prot_000.pdf | {
"Esketamine": [
{
"intervention_type": "DRUG",
"description": "Esketamine",
"name": "Esketamine",
"synonyms": [
"(\u2212)-ketamine",
"(S)-(\u2212)-ketamine",
"(-)-Ketamine",
"Esketamine",
"(S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone",
"(S)-ketamine",
"S-(-)-Ketamine",
"Ketanest",
"Spravato",
"S-ketamine",
"L-ketamine",
"CI 581",
"Ketanest",
"2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone",
"Calipsol",
"2-(o-chlorophenyl)-2-(methylamino)-cyclohexanone",
"2-(methylamino)-2-(2-chlorophenyl)cyclohexanone",
"DL-ketamine",
"Ketamine",
"NMDA",
"CI-581",
"Ketaset",
"Special K",
"(\u00b1)-ketamine",
"Ketamina",
"Calypsol",
"Ketamine Hydrochloride",
"K\u00e9tamine",
"Kalipsol",
"Ketaminum",
"Ketalar",
"(+-)-Ketamine",
"CI581",
"2-(2-Chloro-phenyl)-2-methylamino-cyclohexanone",
"CI 581",
"Ketanest",
"2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone",
"Calipsol",
"2-(o-chlorophenyl)-2-(methylamino)-cyclohexanone",
"2-(methylamino)-2-(2-chlorophenyl)cyclohexanone",
"DL-ketamine",
"Ketamine",
"NMDA",
"CI-581",
"Ketaset",
"Special K",
"(\u00b1)-ketamine",
"Ketamina",
"Calypsol",
"Ketamine Hydrochloride",
"K\u00e9tamine",
"Kalipsol",
"Ketaminum",
"Ketalar",
"(+-)-Ketamine",
"CI581",
"2-(2-Chloro-phenyl)-2-methylamino-cyclohexanone"
],
"medline_plus_id": "a619017",
"generic_names": [
"Esketamine",
"Ketamine",
"Ketamine"
],
"drugbank_id": "DB11823",
"wikipedia_url": "https://en.wikipedia.org/wiki/Esketamine"
}
],
"Normal saline": [
{
"intervention_type": "DRUG"
}
]
} |
NCT04420273 | Targeted Melanoma Detection With Skin Self-Examination During COVID-19 Restricted Physician Access | https://clinicaltrials.gov/study/NCT04420273 | TMD | COMPLETED | The purpose of this study is to reduce melanoma mortality by improving early detection of melanoma with skin self-examination (SSE) among people who self-identify as being at risk and seek care for a concerning mole. Because women are more likely than men to perform SSE, women who are engaged in health promotion by having a recent screening mammogram are the focus of this research. Self-management of melanoma detection with SSE depends on ready access to dermatologists when a concerning mole is detected. In March 2020, the Illinois stay at home order (COVID-19) prohibited non-essential health care, including screening mammography and dermatology office-based care, and both are expected to remain limited until fall 2020. This submission explores a) the effectiveness of targeted melanoma detection (TMD) among women, who identify their risk of having a melanoma, learn to perform SSE, and perform SSE, and b) the effectiveness of adhesive patch-based home sample collection for genomic analysis to rule out melanoma in moles identified by women (who received the intervention) as concerning will be explored. | YES | Melanoma | BEHAVIORAL: SSE educational intervention|BEHAVIORAL: Active control:Healthy Living | Number of Participants Who Completed SSE at Specified Time Points, Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey, 90 days|Number of Participants Who Identified Concerning Moles at Specified Time Points, Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician., 90 days | Participants Reported Skin Self-examination Anxiety, Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome, 90 days|Participants Confidence Performing Mole Checks, Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome)., 90 days|Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles, Electronic medical record review of physician s clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months, 5 months|Pathologic Diagnosis of Concerning Moles, Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning, 5 months|Biopsy Performed, EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed, 5 months | null | Northwestern University | null | FEMALE | ADULT, OLDER_ADULT | null | 1,000 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | STU00212165 | 2020-07-02 | 2021-03-01 | 2021-03-01 | 2020-06-09 | 2021-11-23 | 2021-11-23 | Northwestern University Feinberg School of Medicine Department of Dermatology, Chicago, Illinois, 60611, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT04420273/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/73/NCT04420273/ICF_001.pdf | {
"SSE educational intervention": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Active control:Healthy Living": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT05731973 | Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum | https://clinicaltrials.gov/study/NCT05731973 | ICE | RECRUITING | Primary objective of the current study is to determine the impact of intercostal nerve cryoablation on postoperative length of hospital stay compared to standard pain management of young pectus excavatum patients (12-24 years) treated with the minimal invasive Nuss procedure. The study is designed as a single center, prospective, unblinded, randomized clinical trial. | NO | Pectus Excavatum|Funnel Chest | PROCEDURE: Intercostal nerve cryoablation|DRUG: Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))|DRUG: Intercostal nerve block (single shot bupivacaine (1.25 mg/ml))|DRUG: Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed) | Length of hospital stay, Number of days of hospital admittance after the Nuss procedure., Hospitalization period, average of 5 days | Pain intensity, Pain intensity at rest and during mobilization. Pain scores will be rated on the numeric rating scale (NRS, 1-10), Preoperative care unit before surgery, in the morning on postoperative day 1 and 2, and 7 days, 14 days, 3 months and 6 months post operation|Operative time, Operative time in minutes. Duration of cryoablation will be assessed separately. Operative time will not include the time needed for the placement of the thoracic epidural as placement will be performed in the preoperative care unit., During Nuss procedure|Opioid usage, A) Intraoperative administered opioids; B) Opioid usage during postoperative day 0, 1 and 2 at the recovery unit and surgical ward; C) Opioid usage within the first 2 weeks after surgery. Opioid usage will be converted to oral morphine milligram equivalents (MME)., postoperative day 1 and 2, and first 2 weeks after surgery|Complications, Complications graded according to the Clavien-Dindo classification. The most common procedure- and analgesia-related complications are defined in Supplementary Materials Table 1-2 for transparency, including neuropathic pain. Occurrence of neuropathic pain will be actively monitored during the hospitalization period, and during all follow-up appointments., 6 months postoperative|Creatine kinase (CK) activity, CK levels will be assessed prior to the surgical procedure (i.e., baseline measurement during routine blood evaluation on the day of surgery) and on postoperative day 1. CK levels will be denoted in U/L., Preoperative and day 1 postoperative|Intensive care unit admission, Intensive care unit admission due to the occurrence of perioperative complications in absolute numbers, Hospitalization period, average of 5 days|Length of intensive care unit admission, Length of admission due to the occurrence of perioperative complications in absolute numbers., Hospitalization period, average of 5 days|Number of readmissions, Number of readmissions denoted as absolute numbers., 6 months postoperative|Length of readmissions, length of readmissions denoted as absolute numbers., 6 months postoperative|Degree of mobility, Degree of mobility measured on a 4-point scale (i.e., 1. on the bed, 2. to the chair, 3. to the toilet, 4. outside the patient s hospital room) during postoperative day 1 and 2., Postoperative day 1 and 2|HRQOL - PEEQ, HRQOL, measured by the Dutch version of the pectus evaluation questionnaire (PEEQ). The PEEQ is a validated disease specific questionnaire evaluating the quality of life in pectus excavatum patients (37,38)., Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure|HRQOL - SF-36, HRQOL, measured by the Dutch version of the short form health survey (SF-36)(37-40). The SF-36 is a generic questionnaire that taps health in eight dimensions (39)., Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure|HRQOL - EQ-5D-5L, HRQOL, measured by the Dutch version of the EuroQol 5 dimensions 5 levels (EQ-5D-5L) (37-40). For the EQ-5D-5L, participants will rate their health in 5 dimensions on 5 levels and will give an overall score of their health on a visual analogue scale (VAS) (40)., Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure|Days to return to work/school, Days to return to work/school, reported as days between discharge from hospital and return to work or school., 6 months postoperative|Postoperative visits, Number of postoperative outpatient visits and telephone appointments denoted as absolute numbers in the first 6 months after the surgical procedure., 6 months postoperative|Hospital costs, Hospital costs, reported as hospital costs during initial hospitalization (e.g., medication, patient care supply, surgical equipment), and hospital costs after discharge until 6 months follow-up (e.g., medications, outpatient visits, (opioid related) readmissions)., 6 months postoperative | null | Zuyderland Medisch Centrum | AtriCure, Inc. | ALL | CHILD, ADULT | null | 50 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER | Z2023005 | 2023-12-08 | 2025-01 | 2025-09 | 2023-02-16 | null | 2024-01-05 | Zuyderland Medical Center, Heerlen, Limburg, 6419 PC, Netherlands | null | {
"Intercostal nerve cryoablation": [
{
"intervention_type": "PROCEDURE"
}
],
"Sufentanil": [
{
"intervention_type": "DRUG",
"description": "Thoracic epidural analgesia (continuous infusion with sufentanyl (1 \u00b5g/ml) and bupivacaine (1.25 mg/ml))",
"name": "Sufentanil",
"synonyms": [
"Sufentanil Curasan",
"Sufentanil-Hameln",
"Sufentanil Hameln",
"Sufentanil-Ratiopharm",
"Sulfentanil",
"Sufentanil",
"SufentanilHameln",
"Citrate, Sufentanil",
"Sulfentanyl",
"Curasan, Sufentanil",
"N-(4-(Methoxymethyl)-1-(2-(2-thienyl)ethyl)-4-piperidyl)propionanilide",
"Sufentanil Citrate",
"Sufentanyl",
"Sufenta",
"Sufentanilo",
"N-(4-(Methoxymethyl)-1-(2-(2-thienyl)ethyl)-4-piperidinyl)-N-phenylpropanamide",
"Sufentanil Ratiopharm",
"R 30730",
"R30730",
"SufentanilRatiopharm",
"R-30730",
"Sufentanilum"
],
"mesh_id": "D018686",
"generic_names": [
"Sufentanil"
],
"drugbank_id": "DB00708"
}
],
"Bupivacaine": [
{
"intervention_type": "DRUG",
"description": "Thoracic epidural analgesia (continuous infusion with sufentanyl (1 \u00b5g/ml) and bupivacaine (1.25 mg/ml))",
"name": "Bupivacaine",
"synonyms": [
"Buvacaina",
"Svedocain Sin Vasoconstr",
"DL-Bupivacaine",
"Marcaine",
"Carbostesin",
"Bupivacain-RPR",
"Bupivacaine Carbonate",
"Bupivacaina Braun",
"Posimir",
"Marcain",
"1-Butyl-2',6'-pipecoloxylidide",
"Bupivacain RPR",
"Bupivacaina",
"Bupivacaine Anhydrous",
"Bupivacaine Hydrochloride",
"Bupivacaine Monohydrochloride, Monohydrate",
"1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide",
"dl-1-Butyl-2',6'-pipecoloxylidide",
"Bupivacain Janapharm",
"Bupivacaine",
"(RS)-bupivacaine",
"Dolanaest",
"Bupivacainum",
"Racemic bupivacaine",
"(\u00b1)-bupivacaine",
"Sensorcaine"
],
"mesh_id": "D000779",
"generic_names": [
"Bupivacaine"
],
"drugbank_id": "DB00297",
"wikipedia_url": "https://en.wikipedia.org/wiki/Bupivacaine"
},
{
"intervention_type": "DRUG",
"description": "Intercostal nerve block (single shot bupivacaine (1.25 mg/ml))",
"name": "Bupivacaine",
"synonyms": [
"Buvacaina",
"Svedocain Sin Vasoconstr",
"DL-Bupivacaine",
"Marcaine",
"Carbostesin",
"Bupivacain-RPR",
"Bupivacaine Carbonate",
"Bupivacaina Braun",
"Posimir",
"Marcain",
"1-Butyl-2',6'-pipecoloxylidide",
"Bupivacain RPR",
"Bupivacaina",
"Bupivacaine Anhydrous",
"Bupivacaine Hydrochloride",
"Bupivacaine Monohydrochloride, Monohydrate",
"1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide",
"dl-1-Butyl-2',6'-pipecoloxylidide",
"Bupivacain Janapharm",
"Bupivacaine",
"(RS)-bupivacaine",
"Dolanaest",
"Bupivacainum",
"Racemic bupivacaine",
"(\u00b1)-bupivacaine",
"Sensorcaine"
],
"mesh_id": "D000779",
"generic_names": [
"Bupivacaine"
],
"drugbank_id": "DB00297",
"wikipedia_url": "https://en.wikipedia.org/wiki/Bupivacaine"
}
],
"Oxycodone": [
{
"intervention_type": "DRUG",
"description": "Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)",
"name": "Oxycodone",
"synonyms": [
"4,5alpha-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one",
"Dinarkon",
"Oxecta",
"Oxycone",
"Dihydrone",
"Oxypro",
"Reltebon",
"Oxycontin",
"Oxiconum",
"4,5-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one",
"Longtec",
"4,5\u03b1-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one",
"Eucodal",
"Xartemis XR",
"Percolone",
"Dihydroxycodeinone",
"OxyContin",
"Zomestine",
"Dihydro-14-hydroxycodeinone",
"Oxyfast",
"(-)-14-Hydroxydihydrocodeinone",
"Theocodin",
"Oxycodonum",
"ETH-Oxydose",
"Oxycodone",
"Dazidox",
"Xtampza",
"Pancodine",
"Dihydrohydroxycodeinone",
"Endone",
"Oxycodone Hydrochloride",
"Oxycodeinon",
"Oxicodona"
],
"medline_plus_id": "a682132",
"generic_names": [
"Oxycodone"
],
"nhs_url": "https://www.nhs.uk/medicines/oxycodone",
"mesh_id": "D009294",
"drugbank_id": "DB00497",
"wikipedia_url": "https://en.wikipedia.org/wiki/Oxycodone"
}
]
} |
NCT04266873 | Feasibility Study of the AffloVest in Bronchiectasis | https://clinicaltrials.gov/study/NCT04266873 | null | SUSPENDED | Feasibility study of High Frequency Chest Wall Oscillation (HFCWO) using the AffloVest in 30 patients with Bronchiectasis over a 6 week period. Outcome measures include lung function, quality of life questionnaire, High resolution computed Tomography and visual analogue scale for ease of clearance. | NO | Bronchiectasis | DEVICE: AffloVest | High Resolution Computed Tomography (HRCT), HRCT will be done at full inspiration and full expiration and reviewed by two independent radiographers who will be blinded to timepoint and participant. Radiographers will then use the Brody score to give the scans a score reflecting any changes to sputum volume or otherwise from intervention. Scans will be done and reviewed at baseline, three weeks of intervention and six weeks of intervention, 6 weeks | Forced Expiratory Volume at 1 second (FEV1), FEV1, the forced air expelled at 1 second will be measured at baseline, after three weeks intervention and after six weeks intervention, 6 weeks|Visual Analogue Score for ease of sputum expectoration (VAS), A likert scale from 0-10 will be used for participants to score how easy it is for them to expectorate. Again, this will be assessed at baseline, after 3 weeks intervention and after 6 weeks intervention. 0 will be very easy to clear and 10 will be very difficult to clear, 6 weeks|Quality of Life in Bronchiectasis questionnaire (QOL-B), This subjective questionnaire will be completed as baseline, after three weeks intervention and after six weeks intervention. This is completed by the patient to assess how symptoms affect the quality of their lives. Final scores will be between 0 and 100 with higher scores representing better quality of life., 6 weeks | null | Papworth Hospital NHS Foundation Trust | null | ALL | ADULT, OLDER_ADULT | null | 30 | OTHER_GOV | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | PO2552 | 2020-02-01 | 2023-09-30 | 2023-12-31 | 2020-02-12 | null | 2023-04-04 | Royal Papworth Hospital NHS Trust, Cambridge, CB2 0AY, United Kingdom | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/73/NCT04266873/Prot_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/73/NCT04266873/ICF_001.pdf | {
"AffloVest": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT05087173 | Effectiveness of Using Interactive Consulting System to Enhance Decision Aids of COVID-19 Vaccination | https://clinicaltrials.gov/study/NCT05087173 | null | RECRUITING | To evaluate the performance of an interactive chatbot and assess its effectiveness for enhancing informed decisions made by cataract patients. | NO | COVID-19 | DEVICE: Chatbot | Informed choice about COVID-19 vaccination (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score), Informed choice is an aggregated measure of multiple measurements, including knowledge (a 10-item questionnaire that assesses knowledge), attitudes (6 items, with 5 responses for each), and intentions (single item with 5 responses), 2 weeks post intervention | null | null | Sun Yat-sen University | null | ALL | ADULT, OLDER_ADULT | null | 1,200 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH | 2021KYPJ182 | 2021-10-11 | 2023-08-31 | 2023-12-31 | 2021-10-21 | null | 2023-01-18 | Yingfeng Zheng, MD, PhD, Guangzhou, Guangdong, China | null | {
"Chatbot": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04863573 | COVID-19 Antibody Responses In Cystic Fibrosis | https://clinicaltrials.gov/study/NCT04863573 | CAR-CF | UNKNOWN | Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres throughout the United Kingdom. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments.
Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed. | NO | Covid19|Cystic Fibrosis | null | SARS-COV-2 seroprevalence, proportion of pwCF with at least 1 seropositive result over the study period and the difference in this proportion by age, geographical area and over time., 3-year period (comprising a 1-year enrollment period and a 2-year follow-up)|Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF, incidence of symptomatic COVID-19 over the study period and severity; proportion of seropositive pwCF with subsequent CF exacerbation compared to pwCF who are seronegative; death rate in pwCF with at least one seropositive result compared to pwCF who are seronegative., 3-year period (comprising a 1-year enrollment period and a 2-year follow-up)|Longitudinal comparison of the detection of anti-SARS-CoV-2 antibodies in pwCF following natural infection and SARS-CoV-2 vaccination., Measuring detectable antibody levels for each study participant at baseline and at each study time point including 6,12, 18 and 24 months post enrollment with additional samples if participant has blood drawn for other clinical care reason., 3-year period (comprising a 1-year enrollment period and a 2-year follow-up) | Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive and seronegative., Measuring detectable proteomic and genomic responses in pwCF according to serostatus (positive or negative for antibodies) as well as according to natural infection versus vaccination, anticipated 5-10 years | null | Queen s University, Belfast | Cystic Fibrosis Foundation | ALL | CHILD, ADULT, OLDER_ADULT | null | 1,000 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | B21/07 | 2021-11-19 | 2024-05 | 2024-05 | 2021-04-28 | null | 2022-02-01 | University Hospital Southampton Nhs Foundation Trust, Southampton, Engladn, SO16 6YD, United Kingdom|University Hospitals Birmingham Nhs Foundation Trust, Birmingham, England, B15 2GW, United Kingdom|Birmingham Women S and Children S Nhs Foundation Trust, Birmingham, England, B4 6NH, United Kingdom|Leeds Teaching Hospitals Nhs Trust, Leeds, England, LS9 7TF, United Kingdom|King S College Hospital Nhs Foundation Trust, London, England, SE5 9RS, United Kingdom|Royal Brompton & Harefield Nhs Foundation Trust, London, England, SW3 6NP, United Kingdom|Nottingham University Hospitals Nhs Trust, Nottingham, England, NG7 2UH, United Kingdom|Queens University Belfast, Belfast, Northern Ireland, United Kingdom|NHS Greater Glasgow and Clyde, Glasgow, Scotland, G12 0XH, United Kingdom|Cardiff & Vale University Lhb, Cardiff, Wales, CF14 4HH, United Kingdom|Cardiff & Vale University Lhb, Cardiff, Wales, United Kingdom | null | {} |
NCT04474873 | Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy? | https://clinicaltrials.gov/study/NCT04474873 | null | UNKNOWN | This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL. | NO | Postoperative Pain|Nephrolithotomy, Percutaneous|Erector Spinae Plane Block | PROCEDURE: erector spinae block | Visual Analog Scale, the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart., postoperative 24 hours|Dynamic Visual Analog Scale, the amount of pain during mobilization, deep breathing or coughing that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart, postoperative 24 hours|Peak Expiratory Flow Rate( PEFR), maximum speed of expiration as measured with a peak flow meter, postoperative 24 hours | Time for first analgesic requirement, Time between end of surgery and patients first analgesic demand, 24 hours|ambulation time, first postoperative mobilization time of the patient, 5 days|length of hospital stay, day of hospitalization, 1 week|Rikert Agitation Scale, postoperative agitation score
1. unarousable
2. very sedated
3. sedated
4. calm and cooperative
5. agitated
6. very agitated
7. dangerous agitation, 24 hours|nausea and vomiting, incidence of nausea and vomiting, 24 hours|patient satisfaction with anesthesia and analgesia, 4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4), 24 hour|starting oral intake, first oral intake, 48 hours|urinary catheter releated pain score(Visual Analog Scale), the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart., postoperative 24 hours|surgeon satisfaction with anesthesia and analgesia, 4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4), 24 hour | null | Ankara City Hospital Bilkent | null | ALL | ADULT, OLDER_ADULT | null | 3 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | E1-20-315 | 2020-03-01 | 2020-08-01 | 2020-08-30 | 2020-07-17 | null | 2020-07-17 | Ankara City Hospital, Ankara, 06800, Turkey | null | {
"erector spinae block": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT05743673 | SHAPE Test for Preoperative Risk Stratification | https://clinicaltrials.gov/study/NCT05743673 | SHAPEPAT | RECRUITING | Primary Objective Characterizing precise functional capacity in surgical patients is critical for risk stratification and identification of patients at high risk for perioperative complications. The primary objective for the study is to evaluate the feasibility of effective subject recruitment of an FDA-approved simplified cardiopulmonary exercise testing apparatus in adults >60 years old prior to moderate to high-risk surgery. In addition, by development of a validation cohort of older adults, defined as >60 years old, self-reporting >4 METS and with a score of <2 on the revised cardiac risk index (RCRI)1 we will compare its effectiveness when compared to conventional preoperative evaluation measures (METS determination by standard scoring and Duke Activity Status Index) to SHAPE™ testing. | NO | Perioperative/Postoperative Complications|Aerobic Capacity | DEVICE: Shape II | Recruitment Success, The primary objective for the study is a study enrollment rate of 25% of eligible candidates.
Within the parameters of a feasibility study, the following questions will also be addressed:
* Physical capacity of clinic to handle the number of participants in the study.
* Adequate communication and time frame to efficiently perform abbreviated cardiopulmonary exercise testing in high-volume preoperative testing environment.
* Adequate software and hardware to capture and use data obtained from abbreviated cardiopulmonary exercise testing.
* Determination of adequate institutional, departmental and clinical support to maintain and perform abbreviated cardiopulmonary exercise testing as an adjunct for preoperative testing.
* Does abbreviated cardiopulmonary testing in a preoperative testing environment improve access to care in a diverse and at-risk surgical population, 0-30 days | Conventional measure of metabolic equivalents (METS), If conventional measures of METS (subjective METS, Duke Activity Status Index) compare favorably to the SHAPE testing performance variables., 0-1 day|Perioperative Morbidity Survey, • If SHAPE™ performance variables predict a higher risk of postoperative morbidity after surgery using the Postoperative Operative Morbidity Survey (POMS), a short-term measure of postoperative morbidity after major elective surgery., 0-30 days|Major postoperative outcomes, • If SHAPE™ performance variables predict a higher risk of postoperative major morbidity as measured by traditional major 30-day complications (myocardial infarction, stroke, atrial fibrillation, surgical site infection, postoperative pulmonary complications), 0-30 days | null | Yale University | null | ALL | ADULT, OLDER_ADULT | null | 100 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2000033885 | 2023-05-03 | 2025-01 | 2025-03 | 2023-02-24 | null | 2024-03-07 | Yale New Haven Hospital, New Haven, Connecticut, 06520, United States | null | {
"Shape II": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT05994131 | IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC | https://clinicaltrials.gov/study/NCT05994131 | null | RECRUITING | This is a multicenter, open-label, phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and antitumor efficacy of IN10018 in combination with third-generation EGFR-TKI (Furmonertinib is the proposed) in previously-treated or naïve advanced EGFR-mutation positive NSCLC. | NO | NSCLC | DRUG: IN10018|DRUG: Furmonertinib | Recommended phase II dose (RP2D) of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC., Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced NSCLC., 3 years|ORR of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC., Defined as the proportion of subjects with complete response (CR) or partial response (PR), 3 years|Tumor Shrinkage Rate (TSR) of IN10018 in combination with third-generation EGFR-TKI in cohort 3 of advanced treatment-naive EGFR mutation-positive NSCLC., Defined as the percentage of subjects with the best shrinkage rate of target lesions ≥ 70% and simultaneously with a best response of partial response (PR) or complete response (CR)., 3 years | PFS of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC., Defined as the time from the first dose of study treatment/randomization to first documentation of disease progression or to death due to any cause, whichever comes first., 3 years|DOR of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC., Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first., 3 years|DCR of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC., Defined as the proportion of patients with CR, PR, or stable disease (SD)., 3 years|OS of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC., Defined as the time from the first dose of study treatment/randomization to the date of death due to any cause., 3 years|Number of patients with adverse event, The number of participants who experienced AEs is presented., 3 years|PK: AUC of IN10018 following single dose administration and at steady state, Area under the concentration-time curve (AUC), 3 years|PK: Cmax of IN10018 following single dose administration and at steady state, Maximum concentration (Cmax), 3 years|PK:Ctrough of IN10018 following single dose administration and at steady state, Trough concentration (Ctrough), 3 years|PK:Tmax of IN10018 following single dose administration and at steady state, Time to Cmax (Tmax), 3 years|PK:t1/2 of IN10018 following single dose administration and at steady state, Elimination half-life (t1/2)., 3 years|PK:CL/F of IN10018 following single dose administration and at steady state, apparent clearance (CL/F), 3 years|PK:Vd/F of IN10018 following single dose administration and at steady state, Apparent volume of distribution (Vd/F), 3 years | null | InxMed (Shanghai) Co., Ltd. | null | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 110 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | IN10018-014 | 2023-07-13 | 2026-07-31 | 2026-07-31 | 2023-08-16 | null | 2023-08-16 | Shanghai Pulmonary Hospital, Shanghai, China | null | {
"IN10018": [
{
"intervention_type": "DRUG"
}
],
"Furmonertinib": [
{
"intervention_type": "DRUG"
}
]
} |
NCT05078931 | A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients | https://clinicaltrials.gov/study/NCT05078931 | null | UNKNOWN | This study will investigate the efficacy and safety of the combination of pembrolizumab and lenvatinib in PD-L1 positive patients with TKI-resistant EGFR-mutated advanced NSCLC. | NO | NSCLC | DRUG: Pembrolizumab|DRUG: Lenvatinib | Progression-free survival, the time from the start of intervention to evidence of radiographic progression as defined by RECIST criteria or death from any cause without evidence of disease progression, whichever occurs first. Cases with incomplete follow up or without adequate disease evaluations will be censored at date last documented to be progression free., Up to approximately 12 months | Overall survival, the time from the start of treatment until death from any cause., Up to approximately 24 months|Objective Response Rate, the proportion of the total number of subjects with a confirmed CR or confirmed PR, Up to approximately 24 months|Duration of Response, the time from the earliest date of qualifying response until earliest date of PD or death from any cause, whichever comes first., Up to approximately 24 months | null | Shanghai Chest Hospital | Merck Sharp & Dohme LLC | ALL | ADULT, OLDER_ADULT | PHASE2 | 35 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | TBA | 2021-09-23 | 2022-10 | 2024-05 | 2021-10-15 | null | 2021-12-08 | Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, China | null | {
"Pembrolizumab": [
{
"intervention_type": "DRUG",
"description": "Pembrolizumab",
"name": "Pembrolizumab",
"synonyms": [
"Keytruda",
"Lambrolizumab",
"Pembrolizumab"
],
"medline_plus_id": "a614048",
"generic_names": [
"Pembrolizumab"
],
"drugbank_id": "DB09037",
"wikipedia_url": "https://en.wikipedia.org/wiki/Pembrolizumab"
}
],
"Lenvatinib": [
{
"intervention_type": "DRUG",
"description": "Lenvatinib",
"name": "Lenvatinib",
"synonyms": [
"4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxamide",
"Lenvatinib",
"Lenvima"
],
"medline_plus_id": "a615015",
"generic_names": [
"Lenvatinib"
],
"drugbank_id": "DB09078"
}
]
} |
NCT04771273 | A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3) | https://clinicaltrials.gov/study/NCT04771273 | null | COMPLETED | This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine.
Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants. | NO | Non-alcoholic Steatohepatitis (NASH) | DRUG: BI 456906|DRUG: Placebo | Percentage of patients with histological improvement of NASH (NAS reduction of 2 or more points) after 48 weeks of treatment, Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) represents the sum of scores for steatosis (0-3), lobular inflammation (0-3) and ballooning (0-2); the total score ranges from 0 to 8.
Improvement in histological findings is defined as a composite of:
* Improvement in NASH is defined as a composite of: Decrease of at least 2 points in NAS with at least 1 point decrease in NAS subscore of either lobular inflammation or ballooning AND
* No worsening of fibrosis, defined as absence of any increase in the fibrosis stage., Week 48 | Improvement of liver fat content (yes/no) defined as at least 30 percent (%) relative reduction in liver fat content after 48 weeks of treatment compared to baseline, Assessment will be done by magnetic resonance imaging proton density fat fraction measurement (MRI-PDFF), Week 48|Absolute and relative change of liver fat content from baseline after 48 weeks of treatment assessed by MRI-PDFF, Week 48|Improvement of fibrosis (yes/no) defined as at least one stage decrease in fibrosis stage after 48 weeks of treatment assessed by liver biopsy, Week 48|Absolute change from baseline in NAS after 48 weeks of treatment assessed by liver biopsy, Week 48 | null | Boehringer Ingelheim | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 295 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 1404-0043|2020-002723-11 | 2021-04-27 | 2023-11-09 | 2023-12-21 | 2021-02-25 | null | 2024-04-30 | North Alabama Health Research, LLC, Huntsville, Alabama, 35801, United States|Southern California Research Center, Coronado, California, 92118, United States|Velocity Clinical Research, Huntington Park, California, 90255, United States|Velocity Clinical Research, Panorama City, California, 91402, United States|Quest Clinical Research, San Francisco, California, 94115, United States|Peak Gastroenterology Associates, Colorado Springs, Colorado, 80907, United States|Integrity Clinical Research, LLC, Doral, Florida, 33166, United States|Covenant Metabolic Specialists, LLC, Fort Myers, Florida, 33912, United States|Optimus U Corporation, Miami, Florida, 33135, United States|Sanchez Clinical Research ,Inc, Miami, Florida, 33157, United States|Ocala GI Research, Ocala, Florida, 34471, United States|Omega Research Orlando, LLC, Orlando, Florida, 32808, United States|Covenant Metabolic Specialists, LLC, Sarasota, Florida, 34240, United States|Gastrointestinal Specialists of Georgia, Marietta, Georgia, 30060, United States|Digestive Research Alliance of Michiana, South Bend, Indiana, 46635, United States|University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States|Delta Research Partners, LLC, Bastrop, Louisiana, 71220, United States|Centex Studies, Inc., Lake Charles, Louisiana, 70601, United States|Tandem Clinical Research, Marrero, Louisiana, 70072, United States|NECCR PrimaCare Research, LLC, Fall River, Massachusetts, 02721, United States|National Diabetes and Obesity Research Institute, Biloxi, Mississippi, 39532, United States|Gastrointestinal Associates, Flowood, Mississippi, 39232, United States|AIG Digestive Disease Research, Florham Park, New Jersey, 07932, United States|Northeast GI Research Division, Concord, North Carolina, 28027, United States|Lucas Research, Inc., Morehead City, North Carolina, 28557, United States|Digestive Diseases Research Center, Greenwood, South Carolina, 29646, United States|Palmetto Clinical Research, Summerville, South Carolina, 29485, United States|Digestive Health Research, LLC, Hermitage, Tennessee, 37076, United States|Texas Clinical Research Institute, LLC, Arlington, Texas, 76012, United States|Texas Liver Institute, Austin, Texas, 78757, United States|South Texas Research Institute, Brownsville, Texas, 78520, United States|South Texas Research Institute, Edinburg, Texas, 78539, United States|Houston Methodist Hospital, Houston, Texas, 77030, United States|American Research Corporation at the Texas Liver Institute, San Antonio, Texas, 78215, United States|Pinnacle Clinical Research, San Antonio, Texas, 78229, United States|Virginia Commonwealth University, Richmond, Virginia, 23298, United States|Gold Coast University Hospital, Southport, Queensland, 4215, Australia|Monash Medical Centre, Clayton, Victoria, 3168, Australia|Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|Medical University of Graz State Hospital - University Hospital Graz, Graz, 8036, Austria|Medical University of Innsbruck, Innsbruck, A-6020, Austria|Ordensklinikum Linz GmbH - Barmherzige Schwestern, Linz, A-4010, Austria|Edegem - UNIV UZ Antwerpen, Edegem, 2650, Belgium|University Hospital (LHSC), London, Ontario, N6A 5A5, Canada|Toronto Liver Centre, Toronto, Ontario, M6H 3M1, Canada|Ecogene-21, Chicoutimi, Quebec, G7H 7K9, Canada|Beijing Ditan Hospital Capital Medical University, Beijing, 100015, China|Beijing Tsinghua Changgung Hospital, Beijing, 100044, China|Peking University People s Hospital, Beijing, 100044, China|Beijing Friendship Hospital, Beijing, 100050, China|The First Hospital of Jilin University, Changchun, 130021, China|The First Afiliated Hospital, Sun Yet-sen University, Guangzhou, 510080, China|NanFang Hosptial, Guangzhou, 510515, China|Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou, 310016, China|First People s hospital of Yunann Province, Kunming, 650032, China|The Second Hospital of Nanjing, Nanjing, 210003, China|Shanghai Public Health Clinical Center, Shanghai, 201508, China|Tianjin Third Central Hospital, Tianjin, 300170, China|The First Affiliated Hospital of Wenzhou Med College, Wenxzhou, 325000, China|Regional Hospital Liberec, Liberec, 460 63, Czechia|General Faculty Hospital, Prague, Prague, 128 08, Czechia|HOP l Archet, Nice, 06200, France|HOP La Pitié Salpêtrière, Paris, 75651, France|HOP Haut-Lévêque, Pessac, 33604, France|HOP Civil, Strasbourg, 67091, France|Universitätsklinikum Aachen, AöR, Aachen, 52074, Germany|Synexus Clinical Research GmbH, Berlin, 12627, Germany|Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Bochum, 44892, Germany|Universitätsklinikum Düsseldorf, Düsseldorf, 40225, Germany|Synexus Clinical Research GmbH, Frankfurt, 60313, Germany|Synexus Clinical Research GmbH, Leipzig, 04103, Germany|Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, 55131, Germany|Universitätsklinikum Mannheim GmbH, Mannheim, 68167, Germany|Universitätsklinikum Ulm, Ulm, 89081, Germany|Attikon University Hospital, Haidari-Athens, 12462, Greece|General Hospital of Thessaloniki Hippokrateio , Thessaloniki, 54642, Greece|Prince of Wales Hospital, Hong Kong, 999077, Hong Kong|Queen Mary Hospital, Hong Kong, 999077, Hong Kong|Synexus Hungary Healthcare Service Ltd., Budapest, 1036, Hungary|Fed.St. Istvan&Szent Laszlo Hospital, Budapest, 1097, Hungary|Synexus Hungary Healthcare Service Ltd, Gyula, 5700, Hungary|Shaare Zedek Medical Center, Jerusalem 91031, Jerusalem, 9103102, Israel|Western Galilee Hospital, Nahariya, 22100, Israel|Rabin Medical Center Beilinson, Petach Tikva, 49100, Israel|Sourasky Medical Center, Tel Aviv, 64239, Israel|The Chaim Sheba Medical Center, Tel-Hashomer, 5265601, Israel|Ospedale Civile di Baggiovara, Baggiovara (MO), 41126, Italy|A.O. Univ. Policlinico Paolo Giaccone , Palermo, 90127, Italy|Poli Univ A. Gemelli, Roma, 00195, Italy|Istituto Clinico Humanitas, Rozzano (MI), 20089, Italy|IRCCS Ospedale Casa Sollievo della Sofferenza , SAN Giovanni Rotondo (FG), 71013, Italy|AO Città della Salute e Scienza, Torino, 10126, Italy|Ehime University Hospital, Ehime, Toon, 791-0295, Japan|Fukuiken Saiseikai Hospital, Fukui, Fukui, 918-8503, Japan|Kurume University Hospital, Fukuoka, Kurume, 830-0011, Japan|Ogaki Municipal Hospital, Gifu, Ogaki, 503-8502, Japan|Japan Community Health Care Organization Hokkaido Hospital, Hokkaido, Sapporo, 062-8618, Japan|Kagawa University Hospital, Kagawa, Kita-gun, 761-0793, Japan|Kagawa Prefectural Central Hospital, Kagawa, Takamatsu, 760-8557, Japan|St. Marianna University Hospital, Kanagawa, Kawasaki, 216-8511, Japan|Kitasato University Hospital, Kanagawa, Sagamihara, 252-0375, Japan|Yokohama City University Hospital, Kanagawa, Yokohama, 236-0004, Japan|National Hospital Organization Yokohama Medical Center, Kanagawa, Yokohama, 245-8575, Japan|Kumamoto University Hospital, Kumamoto, Kumamoto, 860-8556, Japan|University Hospital Kyoto Prefectural University of Medicine, Kyoto, Kyoto, 602-8566, Japan|Shinshu University Hospital, Nagano, Matsumoto, 390-8621, Japan|Nagano Municipal Hospital, Nagano, Nagano, 381-8551, Japan|Nara Medical University Hospital, Nara, Kashihara, 634-8522, Japan|Suita Hospital, Osaka, Suita, 564-0013, Japan|Saga University Hospital, Saga, Saga, 849-8501, Japan|Hamamatsu University Hospital, Shizuoka, Hamamatsu, 431-3192, Japan|Juntendo University Shizuoka Hospital, Shizuoka, Izunokuni, 410-2295, Japan|Tokyo Medical and Dental University Hospital, Tokyo, Bunkyo-ku, 113-8519, Japan|Pusan National Univ. Hosp, Busan, 49241, Korea, Republic of|Keimyung University Dongsan Hospital, Daegu, 42601, Korea, Republic of|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Universiti Sains Malaysia Hospital, Kelantan, 16150, Malaysia|University of Malaya Medical Centre, Kuala Lumpur, 59100, Malaysia|Hospital Selayang, Selangor, 68100, Malaysia|Amsterdam UMC, Locatie AMC, Amsterdam, 1105 AZ, Netherlands|Leids Universitair Medisch Centrum (LUMC), Leiden, 2333 ZA, Netherlands|Sint Franciscus, Locatie Vlietland, Rotterdam, 3045 PM, Netherlands|New Zealand Clinical Research (NZCR), Auckland, 1010, New Zealand|Middlemore Clinical Trials, Papatoetoe, 2025, New Zealand|INTERCORE Medical Center, Bydgoszcz, 85-605, Poland|Synexus Poland, Branch in Czestochowa, Czestochowa, 42202, Poland|Private health care facility Your Health EL LLC, Elblag, 82-300, Poland|Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk, Gdansk, 80-382, Poland|Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia, Gdynia, 81-384, Poland|University Clinical Center Professor Gibinskiego, Katowice, 40-752, Poland|University Hospital in Krakow, Krakow, 30688, Poland|Medicome Limited Liability Company, Oswiecim, 32600, Poland|Centrum Medyczne Synexus, Warszawa, 01-192, Poland|Synexus Poland, Branch in Wroclaw, Wroclaw, 50-088, Poland|ETG Zamosc, Zamosc, 22400, Poland|ULS de Santa Maria, E.P.E, Lisboa, 1649-035, Portugal|Centro Hospitalar Universitário São João,EPE, Porto, 4202-451, Portugal|National University Hospital, Singapore, 119074, Singapore|Singapore General Hospital, Singapore, 168753, Singapore|Hospital Vall d Hebron, Barcelona, 08035, Spain|Hospital Puerta de Hierro, Majadahonda, 28222, Spain|Hospital de Montecelo, Pontevedra, 36071, Spain|Hospital Universitario Marqués de Valdecilla, Santander, 39008, Spain|Hospital Virgen del Rocío, Sevilla, 41013, Spain|Hospital General Universitario de Valencia, Valencia, 46014, Spain|Chia Yi Christian Hospital, ChiaYi, 60002, Taiwan|Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, 807, Taiwan|National Chen Kung University, Dept of Neurology, Tainan, 704, Taiwan|Chang Gung Memorial Hospital(Linkou), Taoyuan County, 333, Taiwan|Queen Elizabeth Hospital, Birmingham, B15 2TH, United Kingdom|Synexus - Hexham, Hexham, NE46 1QJ, United Kingdom|Aintree University Hospital, Liverpool, L9 7AL, United Kingdom|King s College Hospital, London, SE5 9RS, United Kingdom|Queen s Medical Centre, Nottingham, NG7 2RD, United Kingdom | null | {
"BI 456906": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT02322073 | Inflammation and Obesity-associated Disease | https://clinicaltrials.gov/study/NCT02322073 | Adipos2 | RECRUITING | Visceral obesity and adipose inflammation is considered a driving force of obesity-related systemic disease, e.g. cardiometabolic disease, liver cirrhosis and chronic kidney disease (CKD). Inflammatory resolution is actively regulated by specialized pro-resolving mediators (SPMs), including the endogenous eicosanoid LXA4. Impairment of SPMs may underlie development of obesity-related pathology.We hypothesize that obese patients who develop obesity-related disease do so because they suffer from impaired endogenous production of pro-resolving lipids. This will result in aggravated adipose inflammation and fibrosis, which contribute to the systemic pathologies. We thus wish to investigate adipose inflammation and the pro-resolving lipid profile of obese subjects with and without obesity associated metabolic disease. We also aim to investigate whether LXA4, LXB4 and other anti-inflammatory agents (such as AICAR) can alter the phenotype of human adipose macrophages in ex vivo tissue culture. We also investigate basic pathways in inflammatory regulation and obesity related cardiometabolic disease. | NO | Obesity|Inflammation|Kidney Disease|Liver Disease|Metabolic Syndrome|Cardiometabolic Syndrome|Fibrosis | PROCEDURE: Laparoscopic surgery | Inflammatory status, inflammatory status vs cardiometabolic disease and tissue fibrosis, One year | null | null | Göteborg University | Vastra Gotaland Region | ALL | ADULT, OLDER_ADULT | null | 80 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 682-14 | 2014-12-01 | 2025-12 | 2025-12 | 2014-12-22 | null | 2021-10-21 | Sahglrenska University Hospital, Gothenburg, S41345, Sweden | null | {
"Laparoscopic surgery": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT05425173 | Limbs Range of Motion Exercises Along With Chest Physical Therapy After Correction of Congenital Heart Diseases in ICU | https://clinicaltrials.gov/study/NCT05425173 | null | COMPLETED | 1. To determine the effect of limb ROMs along with chest Physical therapy on cardiopulmonary parameters after correction of congenital heart diseases in ICU
2. To determine the response of Inotropic drug in relation to Limb ROMs after Correction of Congenital heart diseases in ICU | NO | Congenital Heart Disease | OTHER: Conventional treatment|OTHER: Limb Range of Motion Exercises + Chest Physical Therapy | Heart Rate, Changes from baseline, Heart rate was measured per minute through cardiac monitor, Upto 10 days|Respiration Rate, Changes from baseline,respiratory rate was measured per minute through cardiac monitor, Upto 10 days|Systolic Blood Pressure, Changes from the Baseline, Blood pressure is measured through sphygmomanometer, Upto 10 days|Diastolic Blood Pressure, Changes from the Baseline, Blood pressure is measured through sphygmomanometer, Upto 10 days|Partial pressure of oxygen, Changes from the Baseline, Blood pressure is measured through sphygmomanometer, Upto 10 days|Partial Pressure of carbon dioxide, Changes from the Baseline, Blood pressure is measured through sphygmomanometer, Upto 10 days|Arterial blood gas (ABG) parameter like potential of hydrogen (PH), Above parameter was measured by serial ABG analysis. Its normal reference range is 7.35-7.45. baseline reading will be taken at 10 minutes before starting Non invasive ventilation training. Changes from the Baseline, Upto 10 days|Arterial blood gas parameter like bicarbonate(HCO3)., Above parameter was measured by serial ABG analysis. Its normal reference range is 22-28 nmol/L. Baseline reading will be taken at 10 minutes before starting Non invasive ventilation training. Changes from the Baseline, Upto 10 days|Oxygen saturation, Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it., Upto 10 days|Ejection fraction, Change from baseline Ejection fraction through Echocardiography, Upto 10 days | null | null | Riphah International University | null | ALL | CHILD | null | 20 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | Muneeba Gul | 2022-06-20 | 2022-12-30 | 2022-12-30 | 2022-06-21 | null | 2023-01-25 | Rehman Medical Institute, Peshawar, Khyber PkahtoonKhwa, 25000, Pakistan | null | {
"Conventional treatment": [
{
"intervention_type": "OTHER"
}
],
"Limb Range of Motion Exercises + Chest Physical Therapy": [
{
"intervention_type": "OTHER"
}
]
} |
NCT03128827 | Use of Rainbow Acoustic Monitoring in Pediatric Patients - A Clinical Engineering Data Collection Protocol | https://clinicaltrials.gov/study/NCT03128827 | null | COMPLETED | The study will capture high resolution waveform data and numerical data from three respiratory rate methods: end tidal CO2, impedance pneumography, and bioacoustic sensing (Rainbow Acoustic Monitoring, RAM). | NO | Surgery | DEVICE: RAM sensor | Accuracy of RAM sensor to detect respiration rate, Accuracy will be determined by comparing the noninvasive respiratory rate measurement of the sensor to that obtained from a reference and calculating the arithmetic root mean square (Arms) error value., 1-6 hours | null | null | Masimo Corporation | null | ALL | CHILD, ADULT | null | 170 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER | SZMU0002 | 2011-08-04 | 2015-01-20 | 2015-07-24 | 2017-04-25 | null | 2018-10-22 | Children s Medical Center Dallas, Dallas, Texas, 75235, United States | null | {
"RAM sensor": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04764773 | Persistence of Symptoms After Improvement of Acute COVID-19 | https://clinicaltrials.gov/study/NCT04764773 | COVID-19 | COMPLETED | Coronavirus disease pandemic has been started in late 2019. Survivors of COVID-19 are significantly more likely to develop clinical sequelae three months after discharge from the hospital than those without COVID-19 infection. This is true not only for general and respiratory symptoms but also for cardiovascular and psychosocial symptoms. This suggests that these symptoms may indeed be the sequelae of recovery for COVID-19 survivors. So, we aimed to detect the prevalence and to evaluate the type of symptoms that could persist after the recovery from COVID19 infection in Sohag governorate, Egypt. | NO | Corona Virus Infection | OTHER: No intervention | Percentage of patient who had persistent symptoms after recovery of acute covid19, during the period from 15th May,2020 to the end of February, 2021|Type of persistent symptom after acute covid19, during the period from the start of June 2020 to the end of July 2020|Risk factors for persistent symptoms after recovery of acute covid19, during the period from 15th May,2020 to the end of February, 2021 | null | null | Sohag University | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 172 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | Soh-Med-21-02-46 | 2020-05-01 | 2021-02-28 | 2021-03-31 | 2021-02-21 | null | 2021-11-02 | Mona Mohammed Abdelrahman, Sohag, Egypt | null | {
"No intervention": [
{
"intervention_type": "OTHER"
}
]
} |
NCT03992573 | CGF Influence on Post-operative Complications. | https://clinicaltrials.gov/study/NCT03992573 | null | UNKNOWN | The aim of the study is to evaluate the influence of CGF application into post-operative soft tissue and bone defects on post-operative complications and wound healing. | NO | CGF|Bone Loss|Post-operative Wound Healing | PROCEDURE: CGF application | Intensity of pain vs. CGF application, In order to evaluate the relationship between intensity of pain after surfery and filling the alveolus with platelet-rich plasma, , NRS (Numeric Rating Scale) pain scale is used.
NRS scale, ranges from 0 to 10; where 0 refers to no pain and 10 refers to most severe pain., 24 hours | Occurrence of swelling, The presence of swelling was evaluated using zero one system., 24 hours | null | Medical University of Lodz | null | ALL | ADULT, OLDER_ADULT | null | 50 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 1 | 2017-10-01 | 2020-03-01 | 2020-06-01 | 2019-06-20 | null | 2019-07-08 | Department of Oral Surgery, Lodz, 92-213, Poland | null | {
"CGF application": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT04950673 | Open-label, Post-marketing, Prospective Study to Assess Impact of COVID-19 on Cognitive Function in Patients | https://clinicaltrials.gov/study/NCT04950673 | COVID19 | UNKNOWN | The objective of this study is to compare the impact of the coronavirus disease (SARS-CoV-2, or COVID-19) on cognitive function in the population of patients who have been diagnosed, treated and recovered from the COVID-19 infection versus patients who have not been infected. Primary endpoint is to evaluate the percentage of cognitive decline observed in both study arms (subjects with or without COVID-19 history) using assessments of Cognivue Clarity, MMSE and MoCA. Secondary endpoint is to see the correlation of Depression and anxiety scales (i.e., Patient Health Questionnaire-9 (PHQ-9) and/or Geriatric Depression Scale (GDS)) and Cognivue scores while comparing the trend of difference between both study arms. | NO | Cognitive Decline|Cognitive Dysfunction|Brain Health|Post CoV-2 Syndrome|COVID Long-Haul | DEVICE: Cognivue | Cognitive decline, The percentage of cognitive decline observed in both study arms (subjects with or without COVID-19 history) using assessments of Cognivue Clarity, Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)., 24 months | Comparison between Cognivue and other paper-pencil cognitive assessment batteries, Depression and anxiety scales, i.e., Patient Health Questionnaire-9 (PHQ-9) or Geriatric Depression Scale (GDS)., 24 months | null | Cognivue, Inc. | Kaweah Delta District Hospital|Riiid Research LLC|UH, Cleveland Medical Center|US Medical Care INC | ALL | ADULT, OLDER_ADULT | null | 1,000 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | COG-COVID19 | 2021-07-21 | 2023-11-30 | 2024-04-30 | 2021-07-06 | null | 2022-06-22 | RiiiD Research, LLC, Irvine, California, 92618, United States|Kaweah Health (Kaweah Delta District Hospital), Visalia, California, 93291, United States|US Medical Care Inc, Boca Raton, Florida, 33431, United States|UH Cleveland Medical Center, Cleveland, Ohio, 44106, United States | null | {
"Cognivue": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT05874973 | Effects of TCAV and Volume Control Ventilation on the Distribution of Aerated Lung Parenchyma in ARDS Patients | https://clinicaltrials.gov/study/NCT05874973 | TCAV-CT | RECRUITING | Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure with mortality rates reaching as high as 35%. Management of ARDS is based on the treatment (if possible) of the underlying cause of ARDS and on invasive mechanical ventilation with positive expiratory pressure (PEEP). Another strategy of invasive ventilation, Time-Controlled Adaptative Ventilation (TCAV), is the application of specific settings to the airway pressure release ventilation (APRV) mode.
TCAV is based on a prolonged time at plateau pressure, creating a phase of continuous positive pressure, associated with brief release phases allowing the elimination of carbon dioxide. In prospective and retrospective clinical reviews, as well as in experimental animal studies, TCAV has demonstrated improvements in oxygenation and lung function, with the ability to prevent ARDS.
The thoracic computed tomography (CT) scan evaluates lung recruitment (re-aeration by positive pressure of non-ventilated lung territories) and the adverse effects of positive pressure on the parenchyma (hyperinflation).
The objective of this study is to evaluate, with CT scans performed to assess lungs of patients with ARDS, the effects of TCAV compared to a standard volumetric controlled ventilation, by measuring alveolar recruitment and over-distension. | NO | ARDS | OTHER: Time-controlled adaptative ventilation (TCAV)|OTHER: Volume-controlled ventilation (VCV) | Percentage of end-expiratory non aerated lung parenchyma, Percentage of non aerated lung parenchyma defined as % of lung at -100 to +100 Hounsfield Units (HU) divided by total lung weight, at the end of expiration., during procedure (10 minutes) | End-inspiratory overdistention in TCAV, Percentage of hyper-aerated lung parenchyma defined as lung volume at ≤ - 901 Hounsfield Units (HU) divided by total lung volume, at the end of inspiration in TCAV., 10 minutes|Tidal hyperinflation in TCAV, Tidal hyperinflation is defined as the volume of the hyper-aerated (density ≤ - 901 HU) compartment at end-inspiration minus hyper-aerated (density ≤ - 901 HU) volume at end-expiration, and standardized to predicted body weight (PBW), expressed in ml/kg of PBW, 10 minutes|Atelectrauma in TCAV and VCV, Tidal recruitment of the non-aerated (-100 to +100 Hounsfield Units) compartment was defined as the weight of the non-aerated compartment at end-expiration minus its weight at end-inspiration, and standardized to total lung weight, expressed in %., 10 minutes|Correlation between transpulmonary driving pressure and tidal hyperinflation in TCAV, Area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation, 10 minutes|Correlation between driving pressure and tidal hyperinflation in TCAV, Area under ROC curve of driving pressure to detect cyclic hyperinflation, 10 minutes | null | Central Hospital, Nancy, France | null | ALL | ADULT, OLDER_ADULT | null | 33 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT | 2021PI212 | 2023-10-25 | 2024-06-30 | 2024-12-30 | 2023-05-25 | null | 2024-02-07 | CHRU, Nancy, France | null | {
"Time-controlled adaptative ventilation (TCAV)": [
{
"intervention_type": "OTHER"
}
],
"Volume-controlled ventilation (VCV)": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01324427 | Telemedicine Evaluation for Stem Cell Transplant Patients | https://clinicaltrials.gov/study/NCT01324427 | null | COMPLETED | Telemedicine is a new area of health care where medical information is transferred through audiovisual media, such as a computer or a video camera, for the purpose of remote doctor s visits or examinations. This new area of health care is important to test because it can potentially provide real-time interactions between the patient and their health care team, including phone conversations, online communication, and/or home visits. Many activities such as a history review or physical examination can be conducted virtually as compared to the traditional face-to face visits.
The purpose of this study is to determine patient and health care team acceptance of a virtual medical visit as a substitute for a face to face visit for patients either preparing to receive a stem cell transplant or previously received a stem cell transplant. | NO | Stem Cell Transplant Patients | BEHAVIORAL: virtual medical visit | Determine patient & physician acceptance of a virtual medical visit as a substitute for a face to face in pts in different settings. This is assessed by analyzing answers to questions 7 & 8 of the Patient Satisfaction Survey. [Question #7: I would, Question #8: Overall, I was very satisfied with today s telemedicine session.]Physician acceptance will be analyzed looking at the answers to question 19 of the Physician/Nurse survey in which the physician or nurse investigator relates the quality of the telemedicine visit. [Question #19: How would you rate the quality of the Telehealth visit to assess the patient compared to an in-person office visit?], 2 years | Confirm that current telemedicine technology a comprehensive stem cell transplant clinical evaluation can be performed., Questions 1-12 of the healthcare provider survey will assess the quality of the information &assessment collected through the virtual medical visit ., 2 years|Evaluate the feasibility of telemedicine facilitated handoffs between the inpatient and the outpatient service at the time of discharge from the inpatient service and at the time of discharge from the transplant center are feasible and useful., The instrument used to analyze the feasibility and utility of the handoff instrument is Provider Satisfaction Survey with Handoff Instrument Survey for Feedback on Handoff Instrument. We will collate these responses to determine whether the handoff instrument was found to be useful and what elements should be modified, removed or added., 2 years|Describe the logistic characteristics of a virtual medical visit performed using telemedicine such as visit times, connection quality, and quality of the clinical information obtained., The time from the first attempt to connect until the time to disconnect will be captured for all encounters as well as the time from the beginning to end of the virtual medical visit . We expect that the virtual medical visit should take on average 20 minutes from attempt to connect to disconnect., 2 years | null | Memorial Sloan Kettering Cancer Center | null | ALL | ADULT, OLDER_ADULT | null | 43 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 11-022 | 2011-03 | 2020-08 | 2020-08 | 2011-03-29 | null | 2020-08-14 | Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States|Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack, New York, 11725, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow, New York, 10591, United States | null | {
"virtual medical visit": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT02251327 | Feasibility and Accuracy of a Novel Xpert Cartridge | https://clinicaltrials.gov/study/NCT02251327 | (XpertDST) | COMPLETED | Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis. | NO | Tuberculosis | DEVICE: Investigational Xpert DST test | Sensitivity and specificity, sensitivity and specificity of the investigational Xpert DST test for detection of drug resistance, using phenotypic drug susceptibility testing, mycobacterial DNA sequencing, and MTB/RIF test as the reference comparator, 10 months | Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test, 10 months|the proportion of specimens with a result of invalid and the proportion of specimens with a result of error , 10 months|Proportion of study participants with TB and DRTB, 10 months | null | Johns Hopkins University | Boston Medical Center | ALL | ADULT, OLDER_ADULT | null | 401 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | NA_0008420|NA_0008420 | 2014-06-04 | 2015-06-15 | 2015-12 | 2014-09-29 | null | 2018-08-22 | null | null | {
"Dihydrostreptomycin": [
{
"intervention_type": "DEVICE",
"description": "Investigational Xpert DST test",
"name": "Dihydrostreptomycin",
"synonyms": [
"N,N'''-[(1R,2R,3S,4R,5R,6S)-4-({5-deoxy-2-O-[2-deoxy-2-(methylamino)-\u03b1-L-glucopyranosyl]-3-C-(hydroxymethyl)-\u03b1-L-lyxofuranosyl}oxy)-2,5,6-trihydroxycyclohexane-1,3-diyl]diguanidine",
"Dihidroestreptomicina",
"N,N'''-[(1R,2R,3S,4R,5R,6S)-4-({5-deoxy-2-O-[2-deoxy-2-(methylamino)-a-L-glucopyranosyl]-3-C-(hydroxymethyl)-a-L-lyxofuranosyl}oxy)-2,5,6-trihydroxycyclohexane-1,3-diyl]diguanidine",
"DHMS",
"Dihydrostreptomycine",
"N,N'''-[(1R,2R,3S,4R,5R,6S)-4-({5-deoxy-2-O-[2-deoxy-2-(methylamino)-alpha-L-glucopyranosyl]-3-C-(hydroxymethyl)-alpha-L-lyxofuranosyl}oxy)-2,5,6-trihydroxycyclohexane-1,3-diyl]diguanidine",
"DST",
"Dihydrostreptomycinum",
"Dihydrostreptomycin"
],
"drugbank_id": "DB11512",
"generic_names": [
"Dihydrostreptomycin"
]
}
]
} |
NCT04631627 | Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort | https://clinicaltrials.gov/study/NCT04631627 | null | UNKNOWN | This study intends to adopt the method of multi-center prospective randomized controlled study. The aim of this study is to obtain localized excision values through a preeclampsia screening model established in early pregnancy, and to evaluate the efficacy of low-dose aspirin intervention for preeclampsia prevention in pregnant women at high risk of screening. | NO | Preeclampsia | DRUG: Aspirin | the rate of preeclampsia, Hypertensive onset after 20 weeks of gestation is accompanied by proteinuria,or with thrombocytopenia, impaired liver function, renal insufficiency,pulmonary edema,headache without other explanation and so on., through study completion, an average of 1 year|the rate of hypertensive disorder during pregnancy, gestational hypertension, preeclampsia, chronic hypertension with preeclampsia, eclampsia, HELLP syndrome, through study completion, an average of 1 year|the rate of placenta abruption, After 20 weeks of pregnancy, the placenta in its normal position is completely or partially removed from the uterine wall before delivery of the fetus, through study completion, an average of 1 year|the rate of fetal growth restriction, The birth weight of the fetus is below two standard deviations of the average weight for the same gestational age or below the 10th percentile of normal weight for the same age, through study completion, an average of 1 year|the rate of postpartum hemorrhage, Within 24 hours after the delivery of the fetus, the bleeding volume of vaginal delivery ≥500ml, cesarean delivery ≥1000ml, within 24 hours after the delivery|the time and type of delivery, gestational week, vaginal delivery and cesarean section, within 24 hours after the delivery | birth weight of newborn, macrosomia, normal weight, low birth weight, delivery time|Apgar score for newborns, ≥8；4-7,；≤3, delivery time|the rate of Neonatal NICU occupancy rate, the day of NICU occupancy, through study completion, an average of 1 year | null | Peking Union Medical College Hospital | null | FEMALE | ADULT | PHASE4 | 1,500 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION | EPRPLACC | 2020-11-16 | 2021-12-30 | 2022-08-30 | 2020-11-17 | null | 2020-11-17 | null | null | {
"Aspirin": [
{
"intervention_type": "DRUG",
"description": "Aspirin",
"name": "Aspirin",
"synonyms": [
"Valomag",
"Endosprin",
"Acetysal",
"Acetylsalicylic acid",
"Azetylsalizyls\u00e4ure",
"Magnecyl",
"Acetylsalicylic Acid",
"2-(Acetyloxy)benzoic Acid",
"Aloxiprimum",
"Polopirin",
"Bonjela",
"Acetylsalicylate",
"Dispril",
"Ecotrin",
"Acylpyrin",
"Acid, Acetylsalicylic",
"Anadin",
"Zorprin",
"Polopiryna",
"Solupsan",
"Colfarit",
"Solprin",
"Micristin",
"Easprin",
"Aspirin",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine"
],
"medline_plus_id": "a621021",
"generic_names": [
"Acetylsalicylic acid",
"Aspirin",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous"
],
"nhs_url": "https://www.nhs.uk/medicines/aspirin-for-pain-relief",
"mesh_id": "D058633",
"drugbank_id": "DB00945",
"wikipedia_url": "https://en.wikipedia.org/wiki/Aspirin"
}
]
} |
NCT01774227 | the Pops-titration Versus the Slow-coagulation Cyclophotocoagulation in Treatment of Refractory Glaucoma | https://clinicaltrials.gov/study/NCT01774227 | null | COMPLETED | * Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma management and is very easy to learn and easy to perform.
* Recent advances in laser technology; the role of TSCPC is being expanded because it has benefits of noninvasive glaucoma procedure.
* The titration (pops), the fixed high-energy, and the fixed-low energy (slow-coagulation) are three energy delivery techniques.
* The present study would report on the outcome (efficacy and safety) of the slow-coagulation versus the titration method in treatment of refractory glaucoma with dark iris.
* The results would provide reliable evidences to supplement clinical judgment when making a decision in favor of each treatment method for glaucoma patients. | NO | Glaucoma|Intraocular Pressure | PROCEDURE: The pops-titration group|PROCEDURE: The slow-coagulation group | Success rate, Success rate defined as the proportion of eyes achieving an intraocular pressure between 6 and 21mmHg with or without topical antiglaucoma medication at the final follow up visit., 60 months | Response rate, Response rate defined as the proportion of eyes achieving an intraocular pressure between < 22 mmHg or > 30% drop in an intraocular pressure with or without topical antiglaucoma medication at the final follow up visit., 60 months|Cyclodiode efficacy index, Cyclodiode efficacy index defined as the ratio of response rate to the mean number of the treatment session., 60 months|Failure rate, Failure rate defined as the proportion of eyes developed hypotony or phthisis bulbi or need to repeat treatment for more than 2 laser sessions., 60 months | null | Prince of Songkla University | null | ALL | ADULT, OLDER_ADULT | null | 98 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | EC 56-094-02-1-2 | 2013-05 | 2020-01 | 2020-01 | 2013-01-23 | null | 2020-04-02 | Ophthalmology Department, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand | null | {
"The pops-titration group": [
{
"intervention_type": "PROCEDURE"
}
],
"The slow-coagulation group": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT00073827 | Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma | https://clinicaltrials.gov/study/NCT00073827 | null | COMPLETED | The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID). | NO | Asthma | DRUG: levalbuterol tartrate MDI|DRUG: racemic albuterol MDI|DRUG: Placebo | percent change in FEV1 from visit predose averaged over the 8-week double-blind period, Weeks 0, 4, 8 | area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period, Weeks 0, 4, 8|peak percent change in FEV1 from study baseline, Weeks 0, 4, 8|peak change in FEV1 from visit predose, Weeks 0, 4, 8|peak percent of predicted FEV1, Weeks 0, 4, 8|area under the FEV1 curve (AUC), Weeks 0, 4, 8|peak change and peak percent change in FEF25-75% from visit predose, Weeks 0, 4, 8|peak change and peak percent change in FVC from visit predose, Weeks 0, 4, 8 | null | Sumitomo Pharma America, Inc. | null | ALL | CHILD, ADULT, OLDER_ADULT | PHASE3 | 445 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 051-353 | 2002-05 | 2003-01 | 2003-01 | 2003-12-11 | null | 2012-02-22 | Alabama Asthma and Allergy Center, Homewood, Alabama, 35209, United States|MDC Research, Mobile, Alabama, 36607, United States|Integrated Research Group, Corona, California, 92879, United States|Allergy & Asthma Medical Group of Diablo Valley, Inc., Danville, California, 94526, United States|Radiant Research, Inc., Encinitas, California, 92024, United States|Allergy & Asthma Specialists Medical Group, Huntington Beach, California, 92647, United States|Allergy, Asthma & Respiratory Care Center, Long Beach, California, 90806, United States|Allergy Research Foundation, Inc., Los Angeles, California, 90025, United States|Clinical Trials of Orange County, Orange, California, 92868, United States|Allergy Associates Medical Group, San Diego, California, 92120, United States|Allergy & Asthma Medical Group & Research Center, San Diego, California, 92123, United States|Allergy & Asthma Prevention & Treatment Center, San Diego, California, 92131, United States|Allergy & Asthma Assoc. of Santa Clara Valley Research Center, San Jose, California, 95117, United States|Bensch Research Associates, Stockton, California, 95207, United States|Southern California Research Center, Viejo, California, 92691, United States|National Jewish Medical & Research Center, Denver, Colorado, 80206, United States|Clinical Research Centers of Colorado PC, Englewood, Colorado, 80112, United States|Asthma & Allergy Associates, PC, Pueblo, Colorado, 81001, United States|Office of Ronald Saff, Tallahassee, Florida, 32308, United States|Aeroallergy Research Laboratories of Savannah, Inc., Savannah, Georgia, 31406, United States|Radiant Research Honolulu, Honolulu, Hawaii, 96814, United States|Clinical Research Center of Indiana, Indianapolis, Indiana, 46208, United States|Allergy & Asthma Care Specialists, Metairie, Louisiana, 70006, United States|Northshore Medical Research, Slidell, Louisiana, 70458, United States|University of Maryland School of Medicine, Baltimore, Maryland, United States|Northeast Medical Research Associates, Inc., N. Dartmouth, Massachusetts, 02747, United States|PCHI, Needham, Massachusetts, 02494, United States|Center for Clinical Research, Taunton, Massachusetts, 02780, United States|Henry Ford Health System, Detroit, Michigan, 48202, United States|Clinical Research Institute, Minneapolis, Minnesota, 55402, United States|Mississippi Asthma & Allergy Clinic, Jackson, Mississippi, United States|Office of Clinical Research, University of Missouri-Columbia, Columbia, Missouri, 65212, United States|The Children s Mercy Hospital, Kansas City, Missouri, 64108, United States|Division of Allergy & Immunology, Washington Univ School of Med, St. Louis, Missouri, 63110, United States|St. Louis University, St. Louis, Missouri, 63110, United States|The Clinical Research Center, LLC, St. Louis, Missouri, 63141, United States|Princeton Center for Clinical Research, Princeton, New Jersey, 08540, United States|Pulmonary and Allergy Associates, Springfield, New Jersey, 07081, United States|PCCS, Albany, New York, 12205, United States|AAIR Research Center, Rochester, New York, 14618, United States|Regional Allergy & Asthma Consultants, Asheville, North Carolina, 28801, United States|Cornerstone Research Care, High Point, North Carolina, 27262, United States|Raleigh Pediatric Associates, Raleigh, North Carolina, 27609, United States|Bernstein Clinical Research Center, LLC, Cincinnati, Ohio, 45231, United States|Allergy & Asthma Research, Eugene, Oregon, 97401, United States|Allergy Associates Research Center, LLC, Portland, Oregon, 97213, United States|Asthma & Allergy Research Associates, Chester, Pennsylvania, 19013, United States|Temple University Hospital, Philadelphia, Pennsylvania, 19140, United States|Children s Hospital of Pittsburgh Division of Allergy, Immunology & Infectious Diseases, Pittsburgh, Pennsylvania, 15213, United States|University of Pittsburgh Division of Pulmonary, Pittsburgh, Pennsylvania, 15213, United States|Radiant Research, Charleston, South Carolina, 29407, United States|Office of Neil Kao, Greenville, South Carolina, 29607, United States|Allergy & Asthma Consultants, LLP, Mt. Pleasant, South Carolina, 29464, United States|Office of Constantine Saadeh, Amarillo, Texas, 79106, United States|Allergy & Asthma Research Associates, Dallas, Texas, 75231, United States|North Texas Institute for Clinical Trials, Fort Worth, Texas, 76132, United States|Breath of Life Research Institute, Houston, Texas, 77054, United States|Lung Diagnostics, San Antonio, Texas, United States|Allergy & Asthma Center, Waco, Texas, United States|Children s Hospital of the Kings Daughters, Norfolk, Virginia, 23507, United States|Pulmonary Associates of Richmond, Inc., Richmond, Virginia, 23225, United States|ASTHMA, Inc., Seattle, Washington, 98105, United States|Allergic Diseases, SC, West Allis, Wisconsin, 53227, United States | null | {
"Levalbuterol": [
{
"intervention_type": "DRUG",
"description": "levalbuterol tartrate MDI",
"name": "Levalbuterol",
"synonyms": [
"(-)-Albuterol",
"(R)-salbutamol",
"Xopenex",
"R-salbutamol",
"Levosalbutamol",
"Levalbuterol Hydrochloride",
"(R)-Salbutamol",
"Hydrochloride, Levosalbutamol",
"(-)-Salbutamol",
"Levosalbutamol Hydrochloride",
"Levalbuterol",
"Hydrochloride, Levalbuterol"
],
"medline_plus_id": "a603025",
"generic_names": [
"Levosalbutamol",
"Levalbuterol"
],
"mesh_id": "D064412",
"drugbank_id": "DB13139"
}
],
"Albuterol": [
{
"intervention_type": "DRUG",
"description": "racemic albuterol MDI",
"name": "Albuterol",
"synonyms": [
"Albuterol Sulfate",
"Albuterol",
"Salbutamolum",
"2-t-Butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol",
"Proair",
"Accuneb",
"Salbutamol",
"Ventolin",
"Sultanol",
"salbutamol",
"ProAir",
"Volmax",
"Proventil",
"Salamol",
"Salbutamol inhaler",
"Ventolin",
"Asmalal",
"Pulvinal",
"Airomir",
"Easi-Breathe",
"Easyhaler",
"Salbulin",
"Salamol",
"Salbutamol inhaler",
"Ventolin",
"Asmalal",
"Pulvinal",
"Airomir",
"Easi-Breathe",
"Easyhaler",
"Salbulin",
"Procaterol Monohydrochloride",
"CI 888",
"Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer",
"Hydrochloride",
"Monohydrochloride, Procaterol",
"Procaterol, (R*,R*)-(+-)-Isomer",
"ProAir",
"Pro Air",
"Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer",
"Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer",
"Pro-Air",
"Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer",
"Hydrochloride, Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer",
"CI-888",
"OPC-2009",
"Procaterol, (R*,S*)-(-)-Isomer",
"OPC2009",
"(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone",
"CI888",
"OPC 2009",
"Procaterolo",
"Procaterolum",
"Procaterol Monohydrochloride",
"CI 888",
"Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer",
"Hydrochloride",
"Monohydrochloride, Procaterol",
"Procaterol, (R*,R*)-(+-)-Isomer",
"ProAir",
"Pro Air",
"Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer",
"Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer",
"Pro-Air",
"Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer",
"Hydrochloride, Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer",
"CI-888",
"OPC-2009",
"Procaterol, (R*,S*)-(-)-Isomer",
"OPC2009",
"(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone",
"CI888",
"OPC 2009",
"Procaterolo",
"Procaterolum"
],
"medline_plus_id": "a682145",
"generic_names": [
"Albuterol",
"Salbutamol",
"Procaterol",
"Procaterol"
],
"mesh_id": "D058666",
"drugbank_id": "DB01001",
"wikipedia_url": "https://en.wikipedia.org/wiki/Salbutamol",
"nhs_url": "https://www.nhs.uk/medicines/salbutamol-inhaler"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT01891773 | Improving Pediatric Asthma Care Through Inhaled Steroids in Schools | https://clinicaltrials.gov/study/NCT01891773 | ISIS | COMPLETED | Asthma is the most common chronic pediatric disease in the United States, and is the most common cause of school absenteeism due to a chronic disease. Socioeconomically disadvantaged minority children receive disproportionately poor asthma care and incur a disproportionate share of asthma-related morbidity. The District of Columbia is particularly severely affected, with a lifetime asthma prevalence rate among children 0-17 years of age in 2010 of 22%, more than double the national average.
One of the major challenges in treating asthma is poor adherence to daily controller medications, particularly inhaled corticosteroids (ICS) which are the cornerstone of the NIH guidelines for asthma management. In an attempt to overcome poor compliance, investigators in Rochester, New York have partnered with primary care providers in their community to arrange for ICS administration at school by school nurses, and this approach yielded significant improvements in several asthma outcomes.
The investigators propose to collaborate in a pilot research project with the overall goal of improving asthma outcomes through reducing barriers to medication adherence. Specifically, the investigators aim to improve adherence to controller medications (inhaled corticosteroids - ICS) among DC children with asthma through the following activities:
1. A pilot prospective randomized clinical trial of home vs. school administration of ICS among DC children in grades kindergarten-8 with persistent asthma.
2. Qualitative interviews with nurses from DC public and public charter school to identify key barriers to administration of daily controller medications in the school setting | NO | Asthma | BEHAVIORAL: Inhaled steroids in school. | Proportion of doses received, Proportion of doses of ICS received during the 60 days outcome period, 60 day treatment period | null | null | Children s National Research Institute | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 48 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH | Pro00003859 | 2013-08 | 2014-08 | 2014-08 | 2013-07-03 | null | 2014-09-12 | null | null | {
"Inhaled steroids in school.": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT05807373 | Differential Diagnosis Between Parkinson s Disease and Multiple System Atrophy Using Digital Speech Analysis - Part 2 | https://clinicaltrials.gov/study/NCT05807373 | Voice4PD-MSA | RECRUITING | Parkinson s disease (PD) is the second most common neurodegenerative disease. Multiple system atrophy (MSA) is a relentlessly progressing rare neurodegenerative disease of unknown etiology. The differential diagnosis between the MSA-Parkinsonism (MSA-P) subtype and PD can be very challenging in early disease stages, while early diagnostic certitude is important for the patient because of the diverging prognosis. At the time being, there exists no validated objective biomarker to guide the clinician. Dysarthria is a common early symptom in both diseases and of different origin. The ambition and the originality of this project are to develop a digital voice-based tool for objective discrimination between PD and MSA-P. | NO | Parkinson Disease|Multiple System Atrophy | PROCEDURE: voice recordings | Evaluation of global vocal performance score based on six acoustic components, 1. Differences between groups (PD, MSA-P, and controls) in global vocal performance score based on six acoustic components (1. Incoordination of articulatory movements: TDV (pseudowords), 2. Difficulty initiating movements: VOT (diadochokinesis), DPI (reading text and monologue), 3. Hyperkinetic movements: stdF0, stdPSD, DVA (held vowel /a/), 4. Reduced range of motion: stdF0 (read text and monologue), 5. Slowness of movement: NSR (read text), DDKR (diadochokinesis), VD (diadochokinesis), and 6. Irregularity of movements: DDKI (diadochokinesis))., Day 1 | measurements of a composite acoustic index assessing speech production subsystems, Differences between groups (PD, MSA-P, and controls) in a composite acoustic index, assessing speech production subsystems. The acoustic index will be calculated by linear combinations, described in [Daoudi et al., 2022], of features evaluating the performance of subsystems of speech production: breathing, phonation, articulation, prosody and timing., Day 1|measurements of a composite acoustic index assessing hypokinetic, ataxic and spastic dysarthria, Differences between groups (PD and MSA-P) in a composite acoustic index assessing hypokinetic, ataxic and spastic dysarthria. The acoustic index will be calculated by linear combinations, described in [Daoudi et al., 2022], of features assessing hypokinetic, ataxic and spastic dysarthria., Day 1|measurements of a vocal impairment score based on perceptual assessment by an expert jury (Range 1-10), Differences between groups (PD and MSA-P) in a vocal impairment score based on perceptual assessment by an expert jury (Range 1-10). The score between 1 (for inaudible voice) and 10 (for normal voice) is calculated by averaging the sub-scores (between 1 and 10) evaluating intelligibility, articulation, prosody and resonance., Day 1 | null | University Hospital, Bordeaux | Institut National de Recherche en Informatique et en Automatique | ALL | ADULT, OLDER_ADULT | null | 60 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC | CHUBX 2016/34 | 2023-03-21 | 2024-01-02 | 2024-01-02 | 2023-04-11 | null | 2023-04-11 | CHU de Bordeaux - Institut des maladies neurodégénératives de Bordeaux, Bordeaux, 33000, France|Centre Hospitalier Universitaire de Toulouse, Toulouse, 31000, France | null | {
"voice recordings": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT04916873 | Rehabilitation Status of Children With Cerebral Palsy and Anxiety of Their Caregivers During the Covid19 Pandemic | https://clinicaltrials.gov/study/NCT04916873 | CP | COMPLETED | Rehabilitation status of children with cerebral palsy (CP) and anxiety of their caregivers during the covid19 pandemic were explored. 206 caregivers who voluntarily accepted to participate were administered the State-Trait Anxiety Inventory and evaluated about the rehabilitation status of their children.The anxiety levels of all caregivers were found high and the rehabilitation programmes of the children were interrupted. | NO | Cerebral Palsy|Covid19|Anxiety | null | Anxiety of the caregivers of the children with cerebral palsy, State-Trait Anxiety levels of caregivers of the children with cerebral palsy during the covid19 pandemic.The total score of the State-Trait Anxiety scale varies between 20 and 80. Those who score below 36 are classified as no anxiety , those between 37-42 points as mild anxiety and those with 42 points and above as high anxiety ., 1 month|Rehabilitation process of the children with cerebral palsy, Rehabilitation status of the children with cerebral palsy during the covid19 pandemic. Rehabilitation frequency of children and home exercise status are evaluated, 1 month | null | null | Fatih Sultan Mehmet Training and Research Hospital | null | ALL | CHILD, ADULT | null | 206 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | FSMEAH-KAEK 2020/56 | 2020-05-28 | 2020-06-26 | 2020-07-30 | 2021-06-08 | null | 2021-06-08 | Pinar Akpinar, Istanbul, Atasehir, 34750, Turkey | null | {} |
NCT03620773 | Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes | https://clinicaltrials.gov/study/NCT03620773 | IMPROVE-T2D | ACTIVE_NOT_RECRUITING | Type 2 diabetes (T2D) in youth is increasing in prevalence in parallel with the obesity epidemic. In the US, almost half of patients with renal failure have DKD, and ≥80% have T2D. Compared to adult-onset T2D, youth with T2D have a more aggressive phenotype with greater insulin resistance (IR), more rapid β-cell decline and higher prevalence of diabetic kidney disease (DKD), arguing for separate and dedicated studies in youth-onset T2D. Early DKD is characterized by changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure with resultant hyperfiltration, is common in Y-T2D, and predicts progressive DKD.
Studies evaluating the two currently approved medications for treating T2D in youth (metformin and insulin) have shown these medications are not able to improve β-cell function over time in the youth. However, recent evidence suggests that bariatric surgery in adults is associated with improvements in diabetes outcomes, and even T2D remission in many patients. Limited data in youth also supports the benefits of bariatric surgery, regarding weight loss, glycemic control in T2D, and cardio-renal health. While weight loss is important, the acute effect of bariatric surgery on factors such as insulin resistance likely includes weight loss-independent mechanisms. A better understanding of the effects of bariatric surgery on pancreatic function, intrarenal hemodynamics, renal O2 and cardiovascular function is critical to help define mechanisms of surgical benefits, to help identify potential novel future non-surgical approaches to prevent pancreatic failure, DKD and cardiovascular disease.
The investigators overarching hypotheses are that: 1) Y-T2D is associated with IR, pancreatic dysfunction, intrarenal hemodynamic dysfunction, elevated renal O2 consumption and cardiovascular dysfunction which improve with bariatric surgery, 2) The early effect of bariatric surgery on intrarenal hemodynamics is mediated by improvement in IR and weight loss. To address these hypotheses, the investigators will measure GFR, RPF, glomerular pressure and renal O2, in addition to aortic stiffness, β-cell function and insulin sensitivity in youth ages 12-21 with T2D (n=30) before and after vertical sleeve gastrectomy (VSG). To further investigate the mechanisms of renal damage in youth with T2D, two optional procedures are included in the study prior to vertical sleeve gastrectomy: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue. | NO | Type 2 Diabetes Mellitus|Obesity|Bariatric Surgery Candidate|Nephropathy|Diabetic Kidney Disease|Diabetes Mellitus, Type 2|Diabetes Mellitus|Diabetes Complications|Weight Loss|Diabetic Nephropathies|Adolescent Obesity|Pediatric Obesity | DRUG: Aminohippurate Sodium Inj 20%|DRUG: Iohexol Inj 300 mg/mL|PROCEDURE: Vertical Sleeve Gastrectomy|PROCEDURE: Renal Biopsy | Pancreatic β-cell function, Measured by Mixed Meal Tolerance Test (MMTT), 4 hours (MMTT)|Pancreatic β-cell function, Measured by blood draws during/after hyperglycemic clamp, 4 hours (hyperglycemic clamp)|Effective Renal Plasma Flow (ERPF), Measured by PAH clearance, 4 hours|Glomerular Filtration Rate (GFR), Measured by iohexol clearance, 4 hours | Renal Perfusion, Measured by Arterial Spin Labeling (ASL) MRI, 10 min|Renal Oxygenation, Measured by Blood Oxygen Level Dependent (BOLD) MRI, 60 min|Aortic Stiffness & Wall Shear Stress, Measured by Aortic MRI, 30 min | Podocyte numerical density and number per glomerulus, Measured by light microscopy from tissue obtained by renal biopsy, 4 hours|Foot process width of glomeruli, Measured from tissue obtained by renal biopsy, 4 hours|Detachment and endothelial fenestration of glomeruli, Measured by electron microscopy from tissue obtained by renal biopsy, 4 hours|Podocyte volume of glomeruli, Measured by electron microscopy from tissue obtained by renal biopsy, 4 hours|Number and identity of RNA in kidney cells, Measured from tissue obtained by renal biopsy, 4 hours|Epigenetic profiling, Measured from tissue obtained by renal biopsy, 4 hours | University of Colorado, Denver | null | ALL | CHILD, ADULT | PHASE1|PHASE2 | 30 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | 18-0704 | 2018-10-01 | 2024-10-01 | 2024-10-01 | 2018-08-08 | null | 2024-04-05 | Children s Hospital Colorado, Aurora, Colorado, 80045, United States | null | {
"Aminohippurate Sodium Inj 20%": [
{
"intervention_type": "DRUG"
}
],
"Iohexol": [
{
"intervention_type": "DRUG",
"description": "Iohexol Inj 300 mg/mL",
"name": "Iohexol",
"synonyms": [
"N,N'-Bis(2,3-dihydroxypropyl)-5-(N-(2,3-dihydroxypropyl)acetamido)-2,4,6-triiodoisophthalamide",
"Nycodenz",
"Iohexol",
"Omnipaque",
"Iohexolum",
"Exypaque",
"Compound 545",
"Iohexol 350"
],
"mesh_id": "D003287",
"generic_names": [
"Iohexol"
],
"drugbank_id": "DB01362"
}
],
"Vertical Sleeve Gastrectomy": [
{
"intervention_type": "PROCEDURE"
}
],
"Renal Biopsy": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT05332873 | Rivet PVS Therapy in Group 2 PH-HFpEF Canada | https://clinicaltrials.gov/study/NCT05332873 | null | WITHDRAWN | This clinical investigation is a prospective, multicenter, non-randomized, open-label, Early Feasibility Study to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with symptomatic pulmonary hypertension. | NO | Heart Failure|Pulmonary Hypertension | DEVICE: Rivet Shunt | Rate of Major Adverse Events, Composite of major adverse cardiac, cerebrovascular, or renal events (MACCRE) and re-intervention for study device related complications at implantation procedure (Day 0) and up to 1-month post-procedure (Day 30), 1 month|Rate of Technical Success of the Rivet Shunt Implantation Procedure, Study device is implanted as intended and confirmation of a patent pulmonary-to-venous shunt between the RPA and SVC by qualitative assessment via angiography and/or echocardiography at implantation procedure., At time of procedure | Adverse Events through 12 months, Composite of MACCRE and re-intervention for study device related complications (as described above), progression of PH and/or HF disease, and all-cause mortality to 12 months post-procedure, 12 months|Change in Hemodynamics at 12 months - PCWP, Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline, 12 Months|Change in Kansas City Cardiomyopathy Questionnaire, Change in KCCQ score between baseline and 12 months., 12 months|Change in RV Chamber Size at 12 months - Diameter, Change in RV Chamber Size (Diameter) assessed by a core lab between baseline and 12 months, 12 months | null | NXT Biomedical | null | ALL | ADULT, OLDER_ADULT | null | 0 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | CIP-A-21-0001-CAN | 2023-10 | 2024-05 | 2025-05 | 2022-04-18 | null | 2024-06-03 | University of Ottawa Heart Institute, Ottawa, Ontario, K1Y 4W7, Canada | null | {
"Rivet Shunt": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT02944773 | Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants | https://clinicaltrials.gov/study/NCT02944773 | UTER | COMPLETED | Randomized crossover clinical trial in which is intended to assess the effect of facilitated tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale stress (ALPS-Neo) be observed before, during and one hour after the weight, and compared with normal practice, without facilitated tucking device. | NO | Stress | PROCEDURE: Facilitated tucking device | Heart rate and breathing rate will be decreased compared to baseline measurement., Heart rate (beats / minute)and respiratory rate will decrease significantly during facilitated tucking weight., one year | Behavioral signs, ALPS-Neo scale will decreased significantly during facilitated tucking weight. Evaluate the behaviors: facial expression, respiratory pattern, tone of limbs, activity of hands and feet, and level of activity collected on the scale ALPS-Neo during weight, and compare them with facilitated tucking weight, one year | null | Fundació Institut de Recerca de l Hospital de la Santa Creu i Sant Pau | Spanish Clinical Research Network - SCReN | ALL | CHILD | null | 20 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | IIBSP-EST-2015-97 | 2016-10 | 2017-10 | 2017-12 | 2016-10-26 | null | 2018-01-24 | Silvia Vicente Pérez, Castelldefels, Barcelona, 08860, Spain | null | {
"Facilitated tucking device": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT05388773 | Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer | https://clinicaltrials.gov/study/NCT05388773 | null | RECRUITING | This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment. | NO | Oropharynx Cancer | PROCEDURE: therapeutic conventional surgery|OTHER: laboratory biomarker analysis|OTHER: quality-of-life assessment|RADIATION: intensity-modulated radiation therapy|DRUG: Cisplatin|DRUG: Carboplatin | Recurrence-Free Survival (RFS), Time to recurrence, defined as local and/or regional progression (identification of disease growth that is present within the area in which it was first located) and/or distant metastasis (identification of disease growth that is present in area(s) distant to that previously located). Local progression is defined as progression at the primary tumor site. Regional progression is defined as progression in the draining lymphatics (typically the cervical, retropharyngeal/retrostyloid and supraclavicular lymph nodes). Distant progression is defined as tumor recurrence in one or more non-local and non-regional sites (e.g., bone, lung, liver, etc.). Recurrent malignancy will be determined based on clinical exam and imaging findings. Patients who are disease-free but who die from other causes will be censored., Up to 2 years (for cohort) | Loco-regional control (at 1 year), Loco-regional control will be evaluated based on the percentage of patients without recurrence (identification of disease growth) in the primary site or regional lymphatics based on imaging and/or clinical exam., Up to 1 year|Loco-regional control (at 2 years), Loco-regional control will be evaluated based on the percentage of patients without recurrence (identification of disease growth) in the primary site or regional lymphatics based on imaging and/or clinical exam., Up to 2 year|Time to distant metastasis (at 1 year), Percentage of patients with distant metastasis (identification of disease growth that is present in area(s) distant to that previously located) evident on imaging and/or clinical exam. Distant metastasis is defined as tumor recurrence in one or more non-local (at the primary tumor) and non-regional (draining lymphatic) sites such as bone, lung, liver, etc., Up to 1 year|Time to distant metastasis (at 2 years), Percentage of patients with distant metastasis (identification of disease growth that is present in area(s) distant to that previously located) evident on imaging and/or clinical exam. Distant metastasis is defined as tumor recurrence in one or more non-local (at the primary tumor) and non-regional (draining lymphatic) sites such as bone, lung, liver, etc., Up to 2 years|Overall survival at 1 year, Overall survival will be measured as the time from start of treatment to death from any cause., Up to 1 year|Overall survival at 2 years, Overall survival will be measured as the time from start of treatment to death from any cause., Up to 2 years|Distribution of patients based on histologic risk features, The percentage of total patients enrolled in the study allocated to low (Arm S), intermediate (Arm RT) and high risk (Arm CRT) groups. Histologic risk features are defined as follows: Low risk (ARM S) - T1-T2 AND 0 or 1 metastatic lymph nodes AND <3 cm AND clear (≥3mm) margins AND no extracapsular extension (ECE) AND no perineural invasion AND no lymphovascular invasion; Intermediate risk (ARM RT) - Any of the following features: One or more close (<3mm) margins, OR minimal ≤1 mm ECE OR 1 or more metastatic lymph nodes >3 cm in diameter OR 2-4 lymph nodes positive (≤ 6 cm in diameter), OR perineural invasion OR lymphovascular invasion; High risk (ARM CRT) - Any of the following features: One or more positive margins OR >1 mm ECE OR ≥ 5 metastatic lymph nodes., Up to 3 years|Assessment of PEG tube dependence, The percentage of patients that have a feeding tube, by Arm, for the low (Arm S), intermediate (Arm RT) and high risk (Arm CRT) groups following treatment with transoral resection and adjuvant therapy., At 1 year (post treatment)|Adverse Events Related to Treatment, Number of patients experiencing toxicities related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE v5.0) determined at each follow-up summarized by frequency and grade., Up to 5 years|Quality of Life via FACT-HN, FACT-HN is a self-administered questionnaire. Item responses are on a Likert scale score ranging from 0 to 4. Individual responses are summed to compute subscale scores, and the subscales to compute overall total scores. FACT-HN includes 2 parts - FACT-G and FACT-HN. The basic FACT-G (general) is comprised of 27 items, with four subscales including Physical Well-Being (score = 0-28), Social/Family Well-Being (score= 0-28), Emotional Well-Being (score = 0-24), and Functional Well-Being, (score = 0-28), for a total score min/max = 0-108. The FACT-HN is comprised of 12 head and neck specific items (0-48). Thus, the overall total possible score range is 0-156. Analysis will include the FACT Head & Neck Trial Outcome Index, a composite score which includes only physical, functional, and FACT-HN, thus, scores range from 0-104. Higher scores indicate better Quality of Life., Baseline (before treatment), at 4-8 weeks post-surgery, at 3 months, 6 months, 1 year, up to 2 years following treatment|MD Anderson Symptom Inventory-Head & Neck (MDASI-HN), Patient-reported swallowing perception and performance using MDASI-HN measures treatment related symptom burden in head and neck cancer patients. The 20-item MDASI measures both severity and burden of symptoms and their effect on patients daily activities, using a numeric rating scale of 0-10. This instrument includes 13 core symptoms and 9 head and neck specific items. Higher scores indicate superior perception of function., Baseline (before treatment), at 4-8 weeks post-surgery, at 3 months, 6 months, up to 2 years following treatment|Modified Barium Swallow (MBS) rating, Three swallowing outcomes will be rated by the SLP conducting the MBS study and reported by research staff: 1) laryngeal penetration (yes, no); 2) aspiration (no, sensate, silent), and 3) pharyngeal residue (no, < 50%, > 50%). These have been selected as universal items generally reported by swallowing clinicians that have been shown to significantly predict pneumonia in patients with oropharyngeal cancers. Prevalence of these dysphagia endpoints will be estimated at each time point., Before treatment, at 4-8 weeks post-surgery, 6 months and 24 months following treatment|Voice outcomes, Patient-reported voice outcomes will be assessed using the Voice Handicap Index-10 (VHI-10) survey. The VHI-10 is a patient self-assessment instrument that quantifies patients perception of their voice handicap. It evaluates patient s physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always ). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. The patient s values are compared to published norms., Baseline (before treatment), at 4-8 weeks post-surgery, at 1 year, up to 2 years following treatment|Performance Status Scale (PSS-HN), The Performance Status Scale (PSS-HN) is a clinician-rated instrument consisting of 3 questions: normalcy of diet, public eating/swallowing, and understandability of speech subscales in patients with head and neck cancer. Each subscale is rated from 0 to 100, with higher scores indicating better performance., Baseline (before treatment), at 4-8 weeks post-surgery, at 3 months, 6 months, 1 year, up to 2 years following treatment|MD Anderson Dysphagia Inventory (MDADI), Patient-reported swallowing-related quality of life will be measured using the MD Anderson Dysphagia Inventory (MDADI). It evaluates the patient s physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. The MDADI is a 20-item questionnaire in which the patient circles the response that best reflects their experience in the past week on a 5-point Likert Scale with answers ranging from Strongly Agree (scored as 1 point on all questions except E7 and F2, where it is scored as 5 points) to Strongly Disagree (scored as 5 points on all questions except E7 and F2, where it is scored as 1 point). Scores for individual questions are summed and averaged to obtain a composite score ranging from 20 (extremely low swallow functioning) to 100 (high swallow functioning)., Baseline (before treatment), at 4-8 weeks post-surgery, at 1 year, up to 2 years following treatment | null | Heath Skinner | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 150 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | HCC 22-030 | 2022-07-20 | 2028-06 | 2030-06 | 2022-05-24 | null | 2024-06-06 | UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, 15232, United States | null | {
"therapeutic conventional surgery": [
{
"intervention_type": "PROCEDURE"
}
],
"laboratory biomarker analysis": [
{
"intervention_type": "OTHER"
}
],
"quality-of-life assessment": [
{
"intervention_type": "OTHER"
}
],
"intensity-modulated radiation therapy": [
{
"intervention_type": "RADIATION"
}
],
"Cisplatin": [
{
"intervention_type": "DRUG",
"description": "Cisplatin",
"name": "Cisplatin",
"synonyms": [
"CDDP",
"Platinol",
"PLATINUM, DIAMMINEDICHLORO-, (SP-4-2)-",
"cis-DDP",
"CIS-DIAMMINEDICHLOROPLATINUM",
"INT-230-6 COMPONENT CISPLATIN",
"CIS-DIAMMINEDICHLOROPLATINUM II",
"cis-diamminedichloroplatinum(II)",
"(SP-4-2)-DIAMMINEDICHLOROPLATINUM",
"Cisplatin",
"INT230-6 COMPONENT CISPLATIN",
"Cis-DDP",
"cis-Platinum II",
"cisplatino"
],
"medline_plus_id": "a684036",
"generic_names": [
"Cisplatin"
],
"drugbank_id": "DB00515"
}
],
"Carboplatin": [
{
"intervention_type": "DRUG",
"description": "Carboplatin",
"name": "Carboplatin",
"synonyms": [
"Carboplatino",
"Carboplatin",
"cis-diammine(1,1-cyclobutanedicarboxylato)platinum",
"cis-diammine(1,1-cyclobutanedicarboxylato)platinum(II)",
"Paraplatin",
"Carboplatine",
"cis-(1,1-cyclobutanedicarboxylato)diammineplatinum(II)",
"CBDCA"
],
"medline_plus_id": "a695017",
"generic_names": [
"Carboplatin"
],
"drugbank_id": "DB00958"
}
]
} |
NCT05374473 | An Online Lifestyle Modification Course for People With Multiple Sclerosis | https://clinicaltrials.gov/study/NCT05374473 | null | ACTIVE_NOT_RECRUITING | Lifestyle factors are known to affect the progression of multiple sclerosis (MS). Studies of participants with MS attending an evidence-based lifestyle modification program, delivered via face-to-face workshops, have demonstrated improved mental and physical health, reduced relapse rate and improved quality of life over 3 years follow up, and that behaviour change was feasible and sustainable. However, the face-to-face modality of this educational intervention is resource intensive, and accessibility may be impeded by geography, cost, and MS-specific factors such as illness, fatigue, and disability. Furthermore, the COVID-19 pandemic has highlighted the unpredictable ability to travel and the importance of flexibility of health-related education.
The Neuroepidemiology Unit at the University of Melbourne has developed the Multiple Sclerosis Online Course (MSOC) to deliver a widely accessible and user-friendly educational tool for people with MS. The course aims to deliver the best available evidence regarding lifestyle-related risk factors in the development and progression of MS and behaviour modification to improve health outcomes.
Two forms of the course were developed:
1. an intervention course delivering evidence-based information regarding modifiable lifestyle related risk factors implicated in disease progression; and
2. a standard-care course, similar in format and presentation, but containing general information sourced from standard MS websites. Both courses have seven modules delivered over six weeks.
A feasibility study involving the delivery of the intervention and standard-care course was conducted from April to June 2021. The study assessed the primary outcomes of attrition in both intervention and standard-care arm. Secondary outcomes assessed assessed learnability, accessibility, and desirability via a Likert scale follow-up survey. A qualitative analysis examining motivation, expectations and outcomes was also conducted. Tertiary outcomes assessed the completion of the baseline surveys, a requirement to enter the course. Based on the feasibility study, the investigators have modified recruitment strategies, functionality, and the community forum aspects of the course. Investigators now aim to test the effectiveness of the intervention arm of the course versus the standard-care arm in a larger randomised controlled trial.
Objective:
To prospectively examine whether an MS Online intervention course (intervention arm) can deliver an evidence-based educational intervention that results in behaviour change which can be sustained and translated into improved health outcomes for people with MS, and whether these effects are superior to the MS Online standard-care course (control arm).
Participants who are 18 or older, diagnosed with multiple sclerosis by a doctor are welcome to join our study.
The online course will run for 6 weeks. During this time, there are no formal assessments or minimum time investment required, which means participants are free to navigate the course as they see fit.
Prior to commencing the study, participants will be asked fill-out a survey about their health (e.g., fatigue) and lifestyle (e.g., diet) and will be asked to fill this out again during the study. | NO | Multiple Sclerosis | BEHAVIORAL: Lifestyle modification|BEHAVIORAL: Standard-care | Change in physical health-related quality of life from baseline to 6- 12- and 30-month follow-up, Health-related quality of life will be measured using the Multiple Sclerosis Quality of Life survey (MSQOL-54) (Vickrey, Hays, Harooni, Myers, & Ellison, 1995). The MSQoL-54 is a psychometrically validated, MS-specific, multi-dimensional inventory of patient-centered health status, and consists of 54 questions on items relevant to people with Multiple Sclerosis in the areas of health distress, sexual function, satisfaction with sexual function, overall quality of life, cognitive function, energy, and pain and social function. A physical and a mental dimension underlie the MSQOL-54: the Physical Health Composite (PHC) and Mental Health Composite (MHC). PHC scores range from 0 to 100, where higher values indicate better physical quality of life. Changes in PHC scores (from baseline to 6- 12- and 30-month follow-up) will be assessed and compared between participants in the intervention and standard care groups., Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)|Change in mental health-related quality of life from baseline to 6- 12- and 30-month follow-up, Health-related quality of life will be measured using the Multiple Sclerosis Quality of Life survey (MSQOL-54)(Vickrey, Hays, Harooni, Myers, & Ellison, 1995). The MSQoL-54 is a psychometrically validated, MS-specific, multi-dimensional inventory of patient-centered health status, and consists of 54 questions on items relevant to people with Multiple Sclerosis in the areas of health distress, sexual function, satisfaction with sexual function, overall quality of life, cognitive function, energy, and pain and social function. A physical and a mental dimension underlie the MSQOL-54: the Physical Health Composite (PHC) and Mental Health Composite (MHC). MHC scores range from 0 to 100, where higher values indicate better mental quality of life. Changes in MHC scores (from baseline to 6- 12- and 30-month follow-up) will be assessed and compared between participants in the intervention and standard care groups., Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up) | Change in depression, Participants in the intervention group will be compared to those in the standard-care group on their changes in depression from baseline to 6-, 12- and 30-month follow-up. The Hospital Anxiety and Depression Scale (HADS) is used to measure depressive symptoms. The HADS is commonly used for screening for anxiety and depression, as well as selecting and monitoring treatment and has been used to measure anxiety and depression in Multiple Sclerosis (Zigmond & Snaith, 1983). The HADS contains 14 items and consists of two subscales: anxiety and depression. The depression subscale ranges from 0 to 21 points. Scores of 11 or more indicate a significant condition of depression, with scores of 8-10 represents mild to moderate and 0-7 no depression . Changes in depression (increased or decreased depression scores and shifted depression classification) will be assessed and compared between participants in the intervention and standard care groups., Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)|Change in anxiety, Participants in the intervention group will be compared to those in the standard-care group on their changes in anxiety, from baseline to 6-, 12- and 30-month follow-up. The Hospital Anxiety and Depression Scale (HADS) is used to measure anxiety. The HADS is commonly used for screening for anxiety and depression, as well as selecting and monitoring treatment and has been used to measure anxiety and depression in Multiple Sclerosis (Zigmond & Snaith, 1983). The HADS contains 14 items and consists of two subscales: anxiety and depression. The anxiety subscale ranges from 0 to 21 points. Scores of 11 or more indicate a significant condition of anxiety, with scores of 8-10 represents mild to moderate and 0-7 no anxiety . Changes in anxiety (increased or decreased anxiety scores or shifted anxiety classification) will be assessed and compared between participants in the intervention and standard care groups., Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)|Change in fatigue, Participants in the intervention group will be compared to those in the standard-care group on changes in fatigue from baseline to 6-, 12- and 30-month follow-up. Fatigue will be measured by the 9-item Fatigue Severity Scale (FSS)(Krupp, LaRocca, Muir-Nash, & Steinberg, 1989). The FSS has mean score range from 1-7, with higher score indicates more fatigue. A mean score ≥ 4 will be used as a cut-off to indicate clinically significant fatigue. A meaningful change on the FSS has been reported demonstrated to be a change of ≥1.9 points in people with MS (Learmonth et al., 2013) and so here a change in mean score of 1.9 points or more will be considered clinically meaningful. Changes in fatigue (increased or decreased fatigue scores or shifted fatigue classification) will be assessed and compared between participants in the intervention and standard care groups., Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)|Change in disability, Participants in the intervention group will be compared to those in the standard-care group on their changes in level of disability, from baseline to 6-, 12- and 30-month follow-up. The Patient-Determined Disease Steps (PDDS) will be used to measure disability (Hohol, Orav, &Weiner, 1999). The PDDS is a self-reported measure of disability, scored ordinally from 0 (normal) to 8 (bed bound) with detail descriptors and definitions. Changes in disability (increased or decreased PDDS scores) will be assessed and compared between participants in the intervention and standard care groups., Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)|Change in self-efficacy, Participants in the intervention group will be compared to those in the standard-care group on changes in self-efficacy (the belief in one s ability to produce the effects or outcomes one wants). Self-efficacy will be measured using the University of Washington Self-Efficacy (UWSE) survey, a psychometrically sound instrument that includes 6 items for measuring self-efficacy, validated in MS (Amtmann et al., 2012). UWSE MS total score range from 6 to 30, higher scores indicate higher self-efficacy. Total scores will be converted to standardised T-scores, which have a mean of 50 and standard deviation of 10. Higher T-scores indicate greater self-efficacy. Changes in self-efficacy (increased or decreased T-scores) will be assessed and compared between participants in the intervention and standard care groups., Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up) | null | University of Melbourne | null | ALL | ADULT, OLDER_ADULT | null | 945 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE | 23458 | 2022-06-24 | 2024-12 | 2024-12 | 2022-05-16 | null | 2023-12-12 | The University of Melbourne, Melbourne, Victoria, 3010, Australia | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT05374473/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/73/NCT05374473/ICF_001.pdf | {
"Lifestyle modification": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Standard-care": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT05830773 | Resonance Breathing Intervention Opioid Use Disorder | https://clinicaltrials.gov/study/NCT05830773 | null | COMPLETED | This study aims to assess the feasibility of an intervention for the management of craving, stress, anxiety, and depression among people who use opioids via a resonance breathing smartphone app. | NO | Substance-Related Disorders | OTHER: Resonance Breathing Exercises | Average rating of participant satisfaction with the app as assessed by the Acceptability of Intervention Measure, The measure has 4 items on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores are better outcomes. The citation for the measure is Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1):108., 8 weeks|Average rating of participant assessment that the app is appropriate for managing cravings, stress, and anxiety as assessed by the Intervention Appropriateness Measure, The measure has 4 items on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores are better outcomes. The citation for the measure is Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1):108., 8 weeks|Average rating of participant assessment of whether the app was easy and practical to use as assessed by the Feasibility of Intervention Measure., Feasibility entails participant assessment of whether the app was easy and practical to use. The measure has 4 items on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores are better outcomes. The citation for the measure is Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1):108., 8 weeks | Average rating of participant assessment of their frequency of drug craving as assessed by the Aggregated Drug Craving Scale., The measure has 5 items on a scale from 0 (Never - 0 times over the past month) to 6 (Nearly all of the time - more than 40 times or more than 6 times per day). Lower scores are better outcomes. The citation for the measure is: Costello MJ, Viel C, Li Y, Oshri A, MacKillop J. Psychometric validation of an adaptation of the Penn Alcohol Craving Scale to assess aggregated drug craving. J Subst Abuse Treat 2020; 119:108127., 8 weeks|Average rating of participant assessment of their frequency of experieincing stress as assessed by the Peceived Stress Scale., The measure has 10 items on a scale from 0 (Never) to 4 (Very Often). Lower scores a better outcomes. The citation for the measure is: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and social behavior. 1983 Dec 1:385-96., 8 weeks|Average rating of participant assessment of their frequency of experieincing anxiety as measured by the Beck Anxiety Inventory., The measure has 21 items on a scale from 0 (Not at all) to 4 (Severely). Lower scores are better outcomes. The citation for the measure is: Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol 1988; 56(6):893-7., 8 weeks | null | University of Texas at Austin | Substance Abuse and Mental Health Services Administration (SAMHSA) | ALL | ADULT, OLDER_ADULT | null | 60 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | STUDY00000590 | 2021-03-09 | 2023-08-31 | 2023-08-31 | 2023-04-26 | null | 2024-01-09 | Online, Austin, Texas, 78712, United States | null | {
"Resonance Breathing Exercises": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05527873 | Respiratory Complications of Operated Esophageal Atresia in Children | https://clinicaltrials.gov/study/NCT05527873 | ATRESIA | COMPLETED | The respiratory complications of esophageal atresia have already been identified.
They are mainly related to tracheomalacia linked to the esophageal malformation, and are aggravated by frequently associated gastroesophageal reflux.
In this context, symptoms of asthma (or bronchial hyperreactivity) occur more frequently than in the general population and persist into adulthood. Their pathogenesis is still poorly understood and is the subject of much discussion.
The therapeutic management of these respiratory complications, poorly codified, remains very heterogeneous from one center to another. In France, the summary of knowledge is updated by the Reference Center for chronic and malformative diseases of the esophagus. | NO | Esophageal Atresia | null | Retrospective study of respiratory complications of esophageal atresia in children, Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined | null | null | University Hospital, Strasbourg, France | null | ALL | CHILD | null | 67 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 8562 | 2022-03-16 | 2022-10-16 | 2022-12-16 | 2022-09-06 | null | 2023-11-08 | Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France, Strasbourg, 67091, France | null | {} |
NCT05274373 | Clinical, Virological, Serological and Immunological Characteristics During and Following COVID-19 Hospitalization | https://clinicaltrials.gov/study/NCT05274373 | COVISERA | UNKNOWN | Assessment of the association between the severity of COVID-19 and SARS-CoV-2 NAb titers levels for up to six months following primary infection using a live virus NAb assay. Description of SARS-CoV-2 viral shedding and infectiousness during the first 30 days after infection in a group of unvaccinated hospitalized patients. | NO | COVID-19 Pneumonia|COVID-19 | null | Neutralizing Antibody Titer - Day 0, Baseline Log10 Spike protein neutralizing antibody titer, Day 0|Change from baseline in Neutralizing Antibody Titer - Day 30, Log10 Spike protein neutralizing antibody titer, Day 30|Change from baseline in Neutralizing Antibody Titer - Day 90, Log10 Spike protein neutralizing antibody titer, Day 90|Change from baseline in Neutralizing Antibody Titer- Day 180, Log10 Spike protein neutralizing antibody titer, Day 180|Viral culturing - Day 0, Number of successful viral culturing attempts (SARS-CoV-2), Day 0|Viral culturing - Day 3, Number of successful viral culturing attempts (SARS-CoV-2), Day 3|Viral culturing - Day 7, Number of successful viral culturing attempts (SARS-CoV-2), Day 7|Viral culturing - Day 10, Number of successful viral culturing attempts (SARS-CoV-2), Day 10|Viral culturing - Day 14, Number of successful viral culturing attempts (SARS-CoV-2), Day 14|Viral culturing - Day 17, Number of successful viral culturing attempts (SARS-CoV-2), Day 17|Viral culturing - Day 24, Number of successful viral culturing attempts (SARS-CoV-2), Day 24|Viral culturing - Day 30, Number of successful viral culturing attempts (SARS-CoV-2), Day 30 | Baseline Viral Load - Day 0, Log10 copies/ml, Day 0|Change from Baseline Viral Load - Day 3, Log10 copies/ml, Day 3|Change from Baseline Viral Load - Day 7, Log10 copies/ml, Day 7|Change from Baseline Viral Load - Day 10, Log10 copies/ml, Day 10|Change from Baseline Viral Load - Day 14, Log10 copies/ml, Day 14|Change from Baseline Viral Load - Day 17, Log10 copies/ml, Day 17|Change from Baseline Viral Load - Day 24, Log10 copies/ml, Day 24|Change from Baseline Viral Load - Day 30, Log10 copies/ml, Day 30 | null | Nordsjaellands Hospital | Statens Serum Institut|Rigshospitalet, Denmark | ALL | ADULT, OLDER_ADULT | null | 47 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | Covisera | 2020-05-24 | 2021-05-05 | 2023-10-01 | 2022-03-10 | null | 2022-03-10 | Copenhagen University Hospital at North Zealand, Copenhagen, 25482, Denmark | null | {} |
NCT03602573 | Liver Fibrosis in Peri-menopausal Women | https://clinicaltrials.gov/study/NCT03602573 | null | UNKNOWN | This is a prospective observational study in a single medical center.
The aim is to evaluate the status of fibrosis and steatosis of liver parenchyma in peri-menopausal women using noninvasive methods of vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) and serum biomarkers.
Recruitment period: 2018/08/01 to 2019/07/31
Patient number: 200 females
Inclusion criteria:
1. Females, age of 46-55 years
2. Willing and able to comply with the study requirements
3. Willing and able to provide written informed consent to participate in the study
Exclusion criteria:
1. Unable to complete the noninvasive procedure of VCET and CAP
2. Unwilling to provide written informed consent to participate in the study
Laboratory tests and examinations:
Baseline and two follow-up visits (every 6 months):
1. Blood pressure
2. BW, BH, waist circumference, BMI
3. Complete blood cell (CBC) count
4. Albumin, AST, ALT, alkaline phosphatase, total bilirubin, r-GT, uric acid, hsCRP
5. Sugar (fasting), HbA1c, insulin, HOMA-IR
6. DM lipid profiles, adiponectin, leptin
7. Liver ultrasound, FibroScan touch 520
8. FSH, Estrodiol (E2), LH
9. TSH, free T4
10. HBsAg, anti-HCV, HBV DNA, HCV RNA, HBsAg quantification, HBV genotype (if HBsAg or anti-HCV positive)
11. ANA, Anti-mitochondrial antibody
12. Review history of drug and menstruation cycles | NO | Nonalcoholic Steatohepatitis|Liver Fibroses|Menopause | null | The impact of estrogen level on liver steatosis by FibroScan touch 520, The association of estrogen level with the severity of liver steatosis., 1 year|The impact of estrogen level on liver fibrosis by FibroScan touch 520, The association of estrogen level with the severity of liver fibrosis., 1 year | null | null | Chang Gung Memorial Hospital | null | FEMALE | ADULT | null | 200 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | LSM-PMW | 2018-08-01 | 2019-07-31 | 2019-07-31 | 2018-07-27 | null | 2018-08-21 | Chang Gung Memorial Hospital, Taoyuan, 333, Taiwan | null | {} |
NCT00353873 | Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids | https://clinicaltrials.gov/study/NCT00353873 | null | COMPLETED | This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily. | YES | Asthma | DRUG: Fluticasone propionate|DRUG: Fluticasone propionate/salmeterol | Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population, PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment., Baseline; Week 1 up to Week 12|Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population, PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment., Baseline; Week 1 up to Week 12 | Number of Participants Who Achieved Totally Controlled (TC) Asthma, TC asthma is defined as no daily symptoms, no night-time wakening due to asthma, no exacerbations, no rescue salbutamol/albuterol use, no emergency visits, >=80% predicted morning PEF, and no treatment related adverse events enforcing a change in asthma therapy over 7 consecutive days. Number of participants/group who achieved the status of at least TC during the last 8 weeks (wks) of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator Forced Expiratory Volume in one second (FEV1). Asthma control was assessed each week for the last 8 wks of treatment period. Each week was classified as TC , Well Controlled (WC), Not Controlled or Unevaluable . A participant was considered to have TC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were TC. Unevaluable classification included participants with less than 4 wks of data during the assessment period., Week 5 up to Week 12|Number of Participants Who Achieved WC Asthma, WC asthma is defined as two or more of symptom score >1 only allowed on <=2 days/week, rescue salbutamol/albuterol use on <=2 days/week and up to a maximum of 4 times per week, >=80% predicted morning PEF daily assessed for 7 consecutive days and all the following criteria: no night-time awakening due to asthma, no exacerbations, no emergency visits, no treatment related adverse events enforcing a change in any asthma therapy. Number of participants/group who achieved the status of at least WC during the last 8 wks of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline prebronchodilator FEV1. Each week was classified as WC , Not Controlled or Unevaluable . A participant was considered to have WC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were WC. Unevaluable classification included participants with less than 4 wks of data during the assessment period., Week 5 up to Week 12 | null | GlaxoSmithKline | null | ALL | CHILD | PHASE4 | 506 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | SAM104926 | 2005-11-18 | 2006-10-26 | 2006-10-26 | 2006-07-19 | 2017-04-24 | 2018-05-29 | GSK Investigational Site, Brugge, 8000, Belgium|GSK Investigational Site, Brussel, 1090, Belgium|GSK Investigational Site, Edegem, 2650, Belgium|GSK Investigational Site, Gent, 9000, Belgium|GSK Investigational Site, Leuven, 3000, Belgium|GSK Investigational Site, Aalborg, 9000, Denmark|GSK Investigational Site, Odense, 5000 Odense C, Denmark|GSK Investigational Site, Essey les Nancy, 54270, France|GSK Investigational Site, Grasse, 06130, France|GSK Investigational Site, Laon, 02000, France|GSK Investigational Site, Nimes, 30900, France|GSK Investigational Site, Oyonnax, 01100, France|GSK Investigational Site, Paris cedex 15, 75730, France|GSK Investigational Site, Paris, 75019, France|GSK Investigational Site, Rouen Cedex, 76031, France|GSK Investigational Site, Rouen, 76000, France|GSK Investigational Site, Saint Michel, 16470, France|GSK Investigational Site, Tours Cedex 1, 37000, France|GSK Investigational Site, Vaux En Velin, 69120, France|GSK Investigational Site, Villejuif, 94800, France|GSK Investigational Site, Napoli, Campania, 80138, Italy|GSK Investigational Site, Foggia, Puglia, 71100, Italy|GSK Investigational Site, Palermo, Sicilia, 90127, Italy|GSK Investigational Site, Perugia, Umbria, 06122, Italy|GSK Investigational Site, Daugavpils, LV5403, Latvia|GSK Investigational Site, Riga, LV 1004, Latvia|GSK Investigational Site, Riga, LV 1064, Latvia|GSK Investigational Site, Kaunas, LT-50425, Lithuania|GSK Investigational Site, Taurage, LT-72214, Lithuania|GSK Investigational Site, Vilnius, LT-10207, Lithuania|GSK Investigational Site, Almere, 1315 RA, Netherlands|GSK Investigational Site, Beek En Donk, 5741 CG, Netherlands|GSK Investigational Site, Den Haag, 2517 EW, Netherlands|GSK Investigational Site, Deurne, 5751 XJ, Netherlands|GSK Investigational Site, Emmen, 7824 AA, Netherlands|GSK Investigational Site, Ermelo, 3851 EX, Netherlands|GSK Investigational Site, Nieuwegein, 3435 CM, Netherlands|GSK Investigational Site, Spijkenisse, 3207 NB, Netherlands|GSK Investigational Site, Tiel, 4002 WP, Netherlands|GSK Investigational Site, Woerden, 3447 GN, Netherlands|GSK Investigational Site, Drammen, N-3018, Norway|GSK Investigational Site, Kongsvinger, N-2226, Norway|GSK Investigational Site, Oslo, N-0855, Norway|GSK Investigational Site, Bialystok, 15-274, Poland|GSK Investigational Site, Krakow, 31-159, Poland|GSK Investigational Site, Lodz, 93-513, Poland|GSK Investigational Site, Lublin, 20-093, Poland|GSK Investigational Site, Krasnoyarsk, 660022, Russian Federation|GSK Investigational Site, Moscow, 115446, Russian Federation|GSK Investigational Site, Moscow, 119435, Russian Federation|GSK Investigational Site, Moscow, 119991, Russian Federation|GSK Investigational Site, Novokuznetsk, 654063, Russian Federation|GSK Investigational Site, Novosibirsk, 630099, Russian Federation|GSK Investigational Site, St Petersburg, 191144, Russian Federation|GSK Investigational Site, Syktyvkar, 167011, Russian Federation|GSK Investigational Site, Tomsk, 634 050, Russian Federation|GSK Investigational Site, Almeria, 04009, Spain|GSK Investigational Site, Barcelona, 08035, Spain|GSK Investigational Site, Madrid, 28006, Spain|GSK Investigational Site, Madrid, 28009, Spain|GSK Investigational Site, San Sebastián, 20014, Spain|GSK Investigational Site, Sevilla, 41071, Spain|GSK Investigational Site, Sollentuna, SE-191 24, Sweden|GSK Investigational Site, Stockholm, SE-141 86, Sweden|GSK Investigational Site, Stockholm, SE-171 76, Sweden | null | {
"Fluticasone": [
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"nhs_url": "https://www.nhs.uk/medicines/fluticasone-skin-creams",
"mesh_id": "D018926",
"drugbank_id": "DB13867"
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"mesh_id": "D018926",
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NCT03692273 | Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar | https://clinicaltrials.gov/study/NCT03692273 | null | RECRUITING | Laser treatment of hypertrophic burn scars has become increasingly popular for improving scarring in burn survivors. Despite its common use, there a gap in knowledge regrading randomized control trials that demonstrate whether the laser is beneficial. Such a trial is important because if it shows the laser does work, it would provide the evidence to make such treatments more accessible to all patients.
Furthermore, there is no knowledge whether the burn injury used to remove tissue is beneficial or not. This study aims to evaluate the laser treatment, removal of similar tissue amounts with 0.5mm punch biopsies, to controls to fill this knowledge gap.
The hypothesis is the laser is beneficial at improving patient s burn scars. Also the punch biopsies work better at improving scars by removing tissue without burning and injuring the surrounding tissue as the laser does.
To evaluate these treatments (laser, punch biopsies, and no treatment), 3 small areas will be chosen in a study scar area that meets specific criteria to receive . Patients will still be able to receive laser and burn reconstruction procedures in all other areas not involving the study scar area that are clinically indicated.
In the study, the scar will be evaluated with photographs, surveys, and tissue samples taken either while under anesthesia except for one set taken with numbing medicine. The tissue samples will be looked at under a microscope to see how the treatments change the scar tissue. The tissue will also have tests done to evaluate how the laser impacts genes from cells in the scar tissue.
Lastly, to understand how reconstructive procedures (laser and surgical treatments) change a patient s quality of life, patients will be asked a limited set of questions to learn more how these procedures improve their lives. | NO | Burns|Hypertrophic Scar | PROCEDURE: Luminis ultrapulse fractional ablative carbon dioxide laser|PROCEDURE: 0.5mm punch biopsy | Vancouver Scar Scale, scar scale to evaluate severity of hypertrophic burn scars This is a 3 question scale, the first question graded from 0-3, the second and third questions graded from 0-5. The final score is the sum of the scores of the three questions, giving a possible total score range of 0-13. The higher the score, the worse the outcome., 14 months (from first treatment to follow-up) | photography of treatment areas in scar for evaluation, Evaluation of photographs of the treatment areas in the study scar, 14 months (from first treatment to follow-up)|elasticity of treatment areas of scar, Measure elasticity using a cutometer, 14 months (from first treatment to follow-up)|histology of treatment areas of scar, tissue samples will be evaluates for changes in cell architecture, collagen, and cells within the scar, 14 months (from first treatment to follow-up)|Gene expression, Inflammatory gene expression will be evaluated between laser treatment and control tissue, 14 months (from first treatment to follow-up) | Patient Reported Outcome Measures Burn Specific, LIBRE (Life Impact Burn Recovery Evaluation), 14 months (from first treatment to follow-up)|Patient Reported Outcome Measures Generic, PROMIS 28 (Patient-Reported Outcomes Measurement Information System), 14 months (from first treatment to follow-up) | Massachusetts General Hospital | United States Department of Defense | ALL | ADULT, OLDER_ADULT | null | 120 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | MB170043 | 2019-03-20 | 2024-12-01 | 2024-12-01 | 2018-10-02 | null | 2023-03-02 | Massachusetts General Hospital, Boston, Massachusetts, 02114, United States | null | {
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"description": "Luminis ultrapulse fractional ablative carbon dioxide laser",
"name": "Carbon dioxide",
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"drugbank_id": "DB09157",
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],
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NCT03969173 | Determination of Best PEEP (Positive End-expiratory Pressure) in Anesthetized Infants in Terms of Prevention of Atelectasis | https://clinicaltrials.gov/study/NCT03969173 | null | COMPLETED | Purpose of research; to determine the appropriate positive end-expiratory pressure to minimize atelectasis during general anesthesia in infants.
Study design : Application of one pressure of PEEP among 3, 6, or 9 cmH2O during mechanical positive ventilation for general anesthesia to randomly assigned infants over 6 months to 13 months of age . Immediately after the start of anesthesia (PEEP=0) and before the end of anesthesia, the score of atelectasis is measured by lung ultrasonography with the standardized method. The scores at PEEP3, PEEP6, and PEEP9 will be compared to identify the appropriate PEEP at which atelectasis is the least likely to occur during anesthesia.
Medical Equipment : Ultrasonography with 6 - 13 MHz linear probe, Cardio-Q esophageal Doppler
The number of target subjects: According to the results of previous studies, the lung ultrasound score by ultrasonography at the end of anesthesia was 28.5 (IQR 21.8-37) without any recruitment (PEEP 0 cmH2O) (IQR 6-21.3). When PEEP of 5 cmH2O was maintained, the lung ultrasound score is 12.5 (IQR 6-21.3), which is lower than PEEP 0. It is assumed that the score at PEEP3 is 20, the score at optimal PEEP is 10, and the standard deviation is 11. Bonferroni correction is required for statistical analysis. In comparison between the two groups, alpha is used as the Bonferroni corrected alpha level of 0.05 / 3 = 0.017. The significance level alpha is fixed at 0.017 and the number of samples considering the 10% dropout rate when the power (1-β) is 80% is required to be 30 for each group.
Data analysis and statistical methods: Atelectasis score, cardiac index, peak inspiratory pressure, and dynamic compliance will be compared by t-test between groups(PEEP3 vs PEEP 6, PEEP 3 vs PEEP 9, PEEP 6 vs PEEP 9). P < 0.017 is going to be considered statistically significant. | NO | Pediatric Surgery | PROCEDURE: applying PEEP3|PROCEDURE: applying PEEP6|PROCEDURE: applying PEEP9 | Lung atelectasis score after surgery, Before the end of anesthesia, the degree of atelectasis is measured by lung ultrasonography and scored according to the standardized method. Comparison of the scores at PEEP3, PEEP6, and PEEP9 to identify the appropriate PEEP at which atelectasis is the least likely to occur during anesthesia.
Lung atelectasis score:
The 6-13 MHz linear probe of the ultrasonic device is applied perpendicular to the patient s ribs and evaluated using a 2 dimensional classic view. Transthoracic pulmonary ultrasound imaging is performed in 12 areas. One thoracic region is divided into 6 zones (caudal anterior, caudal lateral, caudal posterior, cranial anterior, cranial lateral, and cranial posterior) by three longitudinal lines (parasternal, anterior, and posterior axilla) and two axial lines (just above the diaphragm, nipple line). The degree of atelectasis(0-72 points) is the sum of the consolidation score (0-36 points) and the B-line score (0-36 points) in 12 areas., before the end of anesthesia | Cardiac index, The pediatric oesophageal doppler probe is used to compare the cardiac index for PEEP3 (baseline) and PEEP according to each group.
Cardiac index:
The CardioQ-ODM + can calculate Cardiac Index in Doppler flow mode. Cardiac Index relates the Cardiac Output to body surface area (BSA), thus relating heart performance to the size of the individual. The unit of measurement is litres per minute per square metre (l/min/m2).
Cardiac Index = Cardiac Output/Body Surface Area The range of cardiac index is 2 to 6 L/min/m2., During surgery, the cardiac index is measured using a transesophageal doppler for 5 minutes each before and after application of PEEP (3, 6, 9 cm H 2 O) according to the randomized, defined group of patients.|Peak inspiratory pressure, Peak inspiratory pressure and dynamic compliance on the ventilator monitor during each PEEP are recorded., During surgery, the cardiac index is measured using a transesophageal doppler for 5 minutes each before and after application of PEEP (3, 6, 9 cm H 2 O) according to the randomized, defined group of patients.|Dynamic compliance, Peak inspiratory pressure and dynamic compliance on the ventilator monitor during each PEEP are recorded., During surgery, the cardiac index is measured using a transesophageal doppler for 5 minutes each before and after application of PEEP (3, 6, 9 cm H 2 O) according to the randomized, defined group of patients. | null | Yonsei University | null | ALL | CHILD | null | 89 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 4-2019-0224 | 2019-05-09 | 2020-03-13 | 2020-03-13 | 2019-05-31 | null | 2020-03-31 | Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine, Seoul, 120-752, Korea, Republic of | null | {
"applying PEEP3": [
{
"intervention_type": "PROCEDURE"
}
],
"applying PEEP6": [
{
"intervention_type": "PROCEDURE"
}
],
"applying PEEP9": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT03809273 | Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI | https://clinicaltrials.gov/study/NCT03809273 | HEARTRIP | UNKNOWN | This study compared the effect of Yangxinshi on exercise tolerance of patients with percutaneous coronary intervention (PCI) for the first time with Trimetazidine.Half of participants will receive Yangxinshi and Trimetazidine mimic tablets in combination,While the other half will receive Trimetazidine and Yangxinshi mimic tablets. | NO | Percutaneous Coronary Intervention | DRUG: Yangxinshi|DRUG: Trimetazidine|DRUG: Yangxinshi mimic|DRUG: Trimetazidine mimic | Change in METs assessed by the CPET, MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test, 24 weeks | Changes of anaerobic threshold (AT) by CPET, 24 weeks|Incidence of major cardiovascular events (MACE), 4,12,24 and 28 weeks|PHQ-9 Depression Scale, PHQ=Patient health questionaire, score range: 0-27, 24 weeks|Changes of Seattle Angina Questionnaire, The Seattle Angina Questionaire (SAQ) quantifies patients physical limitations caused by angina. The scale is transformed to a score of 0 to 100, where higher scores indicate better function (less physical limitation), 24 weeks|Frequency of angina pectoris, 24 weeks|The proportion of METs>7 patients, MET=Metabolic Equivalent of Task, 24 weeks|Changes of VO2max by CPET, 24 weeks|Changes of VO2/HR by CPET, 24 weeks|Changes of VO2/W by CPET, 24 weeks|GAD-7 Anxiety Screening Scale, GAD=Generalized Anxiety Disorder, score range: 0~21, 24 weeks | null | Shenyang Northern Hospital | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 668 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | GrowfulPower-001 | 2019-08-01 | 2020-12-31 | 2020-12-31 | 2019-01-18 | null | 2020-10-19 | The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China|Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing, China|Peking University People s Hospital, Beijing, Beijing, China|The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China|Guangdong Provincial People s Hospital, Guangzhou, Guangdong, China|Cangzhou Central Hospital, Cangzhou, Hebei, China|Hebei General Hospital, Shijiazhuang, Hebei, China|Changchun Traditional Medicine University Affiliated Hospital, Changchun, Jilin, China|The Second Hospital of Dalian Medical University, Dalian, Liaoning, China|General Hospital of Northern Theater Command, Shenyang, Liaoning, 110016, China|Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, China|Shandong Provincial Hospital, Jinan, Shandong, China|Qingdao Municipal Hospital, Qingdao, Shandong, China|Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China|First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China | null | {
"Yangxinshi": [
{
"intervention_type": "DRUG"
}
],
"Trimetazidine": [
{
"intervention_type": "DRUG",
"description": "Trimetazidine",
"name": "Trimetazidine",
"synonyms": [
"Trimetazidine Dihydrochloride",
"1-[2,3,4-trimethoxybenzyl] piperazine dihydrochloride",
"Trimetazidine",
"Centroph\u00e8ne",
"Idaptan",
"Trimetazidina",
"Vasartel",
"Dihydrochloride, Trimetazidine",
"Trim\u00e9tazidine Irex",
"Vastarel"
],
"mesh_id": "D014665",
"generic_names": [
"Trimetazidine"
],
"drugbank_id": "DB09069"
},
{
"intervention_type": "DRUG",
"description": "Trimetazidine mimic",
"name": "Trimetazidine",
"synonyms": [
"Trimetazidine Dihydrochloride",
"1-[2,3,4-trimethoxybenzyl] piperazine dihydrochloride",
"Trimetazidine",
"Centroph\u00e8ne",
"Idaptan",
"Trimetazidina",
"Vasartel",
"Dihydrochloride, Trimetazidine",
"Trim\u00e9tazidine Irex",
"Vastarel"
],
"mesh_id": "D014665",
"generic_names": [
"Trimetazidine"
],
"drugbank_id": "DB09069"
}
],
"Yangxinshi mimic": [
{
"intervention_type": "DRUG"
}
]
} |
NCT01461473 | Comparative Outcomes Management With Electronic Data Technology (COMET) Study | https://clinicaltrials.gov/study/NCT01461473 | COMET | COMPLETED | STAGE I of the COMET study was to develop an Electronic Network Informatics Infrastructure that prospectively enabled access to and the sharing of clinical and research data.
STAGE II: This was a Comparative Effectiveness Trial (CET) evaluating positive airway pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data collected during the STAGE II study was incorporated in Part 3 of the STAGE I study.
STAGE III of the COMET study was completion of data analysis and preparation of the electronic network informatics infrastructure for use beyond the four Clinical Centers to interested CTSA institutions. We also explored expanding ontologies, and the use of federated database methodology. | YES | Sleep Apnea, Obstructive | DEVICE: Positive Airway Pressure (PAP)|DEVICE: Oral Appliance (OA) | Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months, Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment, 2 months | Nocturnal Mean Arterial Blood Pressure (NMAP) at 6 Months, Nocturnal mean arterial blood pressure as recorded by 24-hour ambulatory blood pressure monitoring after approximately 6 months of treatment, 6 months|Ratio of Nocturnal Mean Arterial Pressure (NMAP) to Daytime Mean Arterial Pressure at 2 Months, Ratio of NMAP to mean daytime arterial pressure, expressed as a percentage at the 2 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage., 2 months|Ratio of NMAP to Daytime Mean Arterial Pressure at 6 Months, Ratio of NMAP to daytime mean arterial pressure, expressed as a percentage at the 6 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage., 6 months|Mean Absolute Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound, Mean absolute flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter [in millimeters] from baseline to the value that is obtained after the cuff deflation) as measured by vascular ultrasound (VU) at the 6-month visit, 6 months|Mean Relative Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound, Mean relative flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter from baseline to the value that is obtained after the cuff deflation, divided by the baseline value and multiplied by 100) as measured by vascular ultrasound (VU) at the 6-month visit, 6 months | null | Stanford University | null | ALL | ADULT, OLDER_ADULT | null | 131 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | SU-10182011-8536|1R01HS019738-01 | 2011-12 | 2014-05 | 2014-06 | 2011-10-28 | 2017-05-17 | 2017-05-17 | Stanford Sleep Medicine Center, Redwood City, California, 94063, United States|Harvard Brigham and Women s Hospital, Boston, Massachusetts, 02115, United States|Center for Sleep and Circadian Neurobiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, 19104, United States|University of Wisconsin-Madison School of Medicine, Department of Psychiatry, Madison, Wisconsin, 53719, United States | null | {
"Positive Airway Pressure (PAP)": [
{
"intervention_type": "DEVICE"
}
],
"Oral Appliance (OA)": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT02730273 | The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA) | https://clinicaltrials.gov/study/NCT02730273 | null | COMPLETED | This investigation is designed to evaluate the performance (leak and comfort) as well as the participant s overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants. An important factor in this investigation will be the testing of two different seal sizes on the participants (medium and large size). A total number of 12 participants who currently use nasal or nasal pillow masks will be recruited for the trial. Participants have been selected based on their anthropometric measurements collected in previous trials (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher & Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).
Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight polysomnography session at the Fisher & Paykel Healthcare sleep lab. Baseline data will be collected from the participant during the first visit, 7 days of CPAP usage data will be downloaded and stored for analysis. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the trial. | NO | Sleep Disordered Breathing|Obstructive Sleep Apnea | DEVICE: Trial Nasal mask | Objective leak data (L/min), Obtained from the participant s device, Up to 1 week in-home|Subjective measurement of leak, Subjective Questionnaire, Up to 1 week in-home|Comfort, Subjective Questionnaire, Up to 1 week in-home|Stability, Subjective Questionnaire, Up to 1 week in-home|Draft, Subjective Questionnaire, Up to 1 week in-home|Noise, Subjective Questionnaire, Up to 1 week in-home|Objective leak data (L/min), Obtained from the overnight polysomnography, 1 night | Preference of the mask, Subjective Questionnaire, Up to 1 week in-home | null | Fisher and Paykel Healthcare | null | ALL | ADULT, OLDER_ADULT | null | 12 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | CIA-184 | 2016-03 | 2016-03 | 2016-04 | 2016-04-06 | null | 2017-07-17 | Fisher & Paykel Healthcare, Auckland, 2013, New Zealand | null | {
"Trial Nasal mask": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04881773 | Oral Low Doses Tolerance INduction Study for Peanuts | https://clinicaltrials.gov/study/NCT04881773 | OLDTINYpeanut | UNKNOWN | Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn t allow to expect significant levels of peanut protein consumed by the patient, and is associated with an increased risk of anaphylaxis and epinephrine use. Also, in most published protocols, patients with a history of anaphylactic shock, severe asthma, or multiple history of anaphylaxis are excluded.
To date, no protocol has been validated for this type of treatment, and each center follows locally validated schemes. In our unit, the investigators use an OIT protocol that starts at low doses (first dose at 2.68 mg peanut protein) and doses increase is scheduled every 4 to 12 weeks (instead of every 2 weeks). The investigators do not exclude patients with asthma or those with a history of peanut anaphylaxis (grade 2 or 3). The investigators have noted that our protocol is associated with a good safety profile and good efficacy, probably due to the fact that the investigators start at low doses and increase the dose with a prolonged delay, compared to previously published protocols. For this reason, the investigators decided to evaluate the results the investigators obtained in our patients and to better analyze the efficacy and safety profile of our protocol. | NO | Peanut Allergy | null | Percentage of patients who reach a tolerated dose, Percentage of patients who reach a tolerated dose of 2000 mg of PP during the ITO and percentage of patients who reach a cumulative tolerated dose of 4400 mg of PP during the oral challenge, carried out at least 6 month after the end of the ITO., 24 months | Percentage of patients experiencing side effects during OIT, Percentage of patients experiencing side effects during OIT (classified on the basis of their severity); percentage of patients in whom the tolerated dose of PP could be doubled and tripled, compared to the eliciting dose, assessed during an oral food challenge before the beginning of the OIT; percentage of patients who achieve a tolerated dose of 300 mg of PP and 1000 mg of PP during OIT. By doing a subgroup analysis, we will evaluate the same results in patients with a clinical history of grade 2 or grade three anaphylaxis to peanuts., 24 months | null | University Hospital, Montpellier | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 2,000 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | RECHMPL21_0254 | 2018-09-01 | 2021-01-01 | 2022-06-01 | 2021-05-11 | null | 2021-05-11 | Uhmontpellier, Montpellier, 34295, France | null | {} |
NCT03705273 | Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup | https://clinicaltrials.gov/study/NCT03705273 | null | TERMINATED | Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup. | YES | Asthma|Croup | DRUG: Dexamethasone IV for PO|DRUG: Dexamethasone crushed tablets | Number of Participants With Nausea, Presence of nausea after medication administration (yes/no) measured by participant self-report, 1 hour | Number of Participants Requiring Second Dose of Dexamethasone, Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose, 1 hour | null | Vanderbilt University Medical Center | null | ALL | CHILD | PHASE4 | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 181682 | 2018-10-23 | 2020-10-02 | 2020-10-02 | 2018-10-15 | 2021-11-08 | 2021-11-08 | Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT03705273/Prot_SAP_000.pdf | {
"Dexamethasone": [
{
"intervention_type": "DRUG",
"description": "Dexamethasone IV for PO",
"name": "Dexamethasone",
"synonyms": [
"Millicorten",
"1-Dehydro-16\u03b1-methyl-9\u03b1-fluorohydrocortisone",
"Dextenza",
"Decaject-L.A.",
"Cortidex",
"Dexpak",
"Dexam\u00e9thasone",
"Dexasone",
"Decameth",
"Dexametasona",
"Methylfluorprednisolone",
"Decadron",
"Martapan",
"Decaspray",
"16\u03b1-Methyl-9\u03b1-fluoro-1-dehydrocortisol",
"Dexamethasone",
"Decaject",
"Ozurdex",
"16alpha-Methyl-9alpha-fluoro-1-dehydrocortisol",
"Decaject L.A.",
"TobraDex",
"Maxidex",
"Hexadrol",
"Dexair",
"Dexamethasonum",
"Dexacidin",
"Oradexon",
"Hexadecadrol",
"Glensoludex",
"Neofordex",
"Maxitrol",
"1-Dehydro-16alpha-methyl-9alpha-fluorohydrocortisone",
"9\u03b1-Fluoro-16\u03b1-methylprednisolone",
"9alpha-Fluoro-16alpha-methylprednisolone",
"Maxidex",
"Dexamethasone eye drops",
"Eythalm",
"Dexafree",
"Dropodex",
"Maxidex",
"Dexamethasone eye drops",
"Eythalm",
"Dexafree",
"Dropodex"
],
"medline_plus_id": "a682869",
"generic_names": [
"Dexamethasone"
],
"nhs_url": "https://www.nhs.uk/medicines/dexamethasone-tablets-and-liquid",
"mesh_id": "D018931",
"drugbank_id": "DB01234",
"wikipedia_url": "https://en.wikipedia.org/wiki/Dexamethasone"
},
{
"intervention_type": "DRUG",
"description": "Dexamethasone crushed tablets",
"name": "Dexamethasone",
"synonyms": [
"Millicorten",
"1-Dehydro-16\u03b1-methyl-9\u03b1-fluorohydrocortisone",
"Dextenza",
"Decaject-L.A.",
"Cortidex",
"Dexpak",
"Dexam\u00e9thasone",
"Dexasone",
"Decameth",
"Dexametasona",
"Methylfluorprednisolone",
"Decadron",
"Martapan",
"Decaspray",
"16\u03b1-Methyl-9\u03b1-fluoro-1-dehydrocortisol",
"Dexamethasone",
"Decaject",
"Ozurdex",
"16alpha-Methyl-9alpha-fluoro-1-dehydrocortisol",
"Decaject L.A.",
"TobraDex",
"Maxidex",
"Hexadrol",
"Dexair",
"Dexamethasonum",
"Dexacidin",
"Oradexon",
"Hexadecadrol",
"Glensoludex",
"Neofordex",
"Maxitrol",
"1-Dehydro-16alpha-methyl-9alpha-fluorohydrocortisone",
"9\u03b1-Fluoro-16\u03b1-methylprednisolone",
"9alpha-Fluoro-16alpha-methylprednisolone",
"Maxidex",
"Dexamethasone eye drops",
"Eythalm",
"Dexafree",
"Dropodex",
"Maxidex",
"Dexamethasone eye drops",
"Eythalm",
"Dexafree",
"Dropodex"
],
"medline_plus_id": "a682869",
"generic_names": [
"Dexamethasone"
],
"nhs_url": "https://www.nhs.uk/medicines/dexamethasone-tablets-and-liquid",
"mesh_id": "D018931",
"drugbank_id": "DB01234",
"wikipedia_url": "https://en.wikipedia.org/wiki/Dexamethasone"
}
]
} |
NCT00985673 | Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults | https://clinicaltrials.gov/study/NCT00985673 | null | COMPLETED | The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age. | YES | Influenza | BIOLOGICAL: GSK2340274A|BIOLOGICAL: GSK2340273A|BIOLOGICAL: Seasonal trivalent influenza vaccine (TIV)|BIOLOGICAL: Saline placebo | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain., The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone.
Titers were expressed as geometric mean antibody titers (GMTs)., 21 days after the second dose of Arepanrix vaccine (at Day 42).|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain., The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of the unadjuvanted formulation of Arepanrix vaccine, and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.
Titers were expressed as geometric mean antibody titers (GMTs)., 21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (at Day 42) | Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α)., Influenza-specific CD4 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.
Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU., On Days 0, 7, 21, 28, 42, 63 and 182|Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α)., Influenza-specific CD8 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.
Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU., On Days 0, 7, 21, 28, 42, 63 and 182|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed, Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), bilirubin (BIL) (total (T)), basophils (BAS). For each parameter and for each range it was assessed whether the values of the subjects were in unkown, above, below or within the range., On Days 0, 7, 21, 28, 42, 63 and 182|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed, Laboratory parameters assessed were creatinine (CREA), bilirubin (BIL) (direct (D)), eosinophils (EOS), hemoglobin (Hgb), hematocrit (Hct). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range., On Days 0, 7, 21, 28, 42, 63 and 182|Number of Subjects Reporting Solicited Local Symptoms., Solicited local symptoms assessed were pain, redness and swelling, During a 7-day follow-up period (Days 0-6) post-vaccination period|Number of Subjects Reporting Solicited General Symptoms., Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature. Temperature is defined as an axillary temperature equal to or above 38.0 degrees Celsius (°C)., During a 7-day follow-up period (Days 0-6) post-vaccination period|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed, Laboratory parameters assessed were serum urea nitrogen (SUN), white blood cells (WBC), red blood cells (RBC). For each parameter and for each range it was assessed whether the values of the subjects were unknown, above, below or within the range., On Days 0, 7, 21, 28, 42, 63 and 182|Number of Subjects Reporting Unsolicited Adverse Events (AEs)., An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms., Within the 84-day (Days 0-83) post-vaccination period.|Number of Subjects Reporting Medically Attended Visits (MAEs)., The day 368 was the last contact day for the last subject reporting the event. For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason., During the entire study period (Days 0-368).|Number of Subjects Reporting Potential Immune Diseases (pIMDs)., The day 406 was the last contact day with the subjects reporting the event. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology., During the entire study period (Days 0-406).|Number of Subjects Reporting Serious Adverse Events (SAEs)., The day 329 was the last contact day with the subjects reporting serious adverse events.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects., During the entire study period (Days 0-329).|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed, Laboratory parameters assessed were neutrophils (NEU), lymphocytes (LYM), monocytes (MON) and platelets (PLA). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range., On Days 0, 7, 21, 28, 42, 63 and 182|Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain., Titers were expressed as geometric mean titers (GMTs) and measured by microneutralization.
Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).
Microneutralization testing was cancelled., On Days 0, 21, 42, 63 and 182|Number of Subjects With a Microneutralization Titer Greater Than or Equal to 1:28 for Antibodies Against A/California/7/2009 (H1N1) Strain., Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).
The antibody cut-off value assessed was a titer of 1:10 and this value was considered as seropositivity.
Seronegative subject is a subject whose antibody titer is below the cut-off value, a seropositive subject is a subject whose antibody titer is greater than or equal to the cut-off value. Microneutralization titers < 1:28 were considered below the cut-off.
Microneutralization testing was cancelled., On Days 0, 21, 42, 63 and 182|Vaccine Response Rates (VRR) for Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain., Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).
Vaccine Response Rate for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0.
Microneutralization testing was cancelled., On Days 0, 21, 42, 63 and 182|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain., The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of Arepanrix vaccine alone.
Titers were expressed as geometric mean antibody titers (GMTs)., 21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group)|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain., The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.
Titers were expressed as geometric mean antibody titers (GMTs)., 21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (Day 63 for Flulaval/placebo/unadjuvanted Arepanrix Group and Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group)|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain., The A/California vaccine virus-homologous antibody response was measured in subjects pre-treated with Flulaval who subsequently received two doses of the unadjuvanted formulation of Arepanrix vaccine compared to subjects pre-treated with Flulaval vaccine who subsequently received two doses of Arepanrix vaccine.
Titers were expressed as geometric mean antibody titers (GMTs)., 21 days after the second dose of the pandemic vaccine (at Day 63)|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains., The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs)., 21 days after the Flulaval vaccination (at Day 21).|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains., The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs)., 21 days after the Flulaval vaccination (at Day 21).|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains., The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs)., 21 days after the Flulaval vaccination (Day 63 for Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains., The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs)., 21 days after the Flulaval vaccination (Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain., Titers were expressed as geometric mean antibody titers (GMTs)., On Days 0, 21, 42 and 63|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain., Titers were expressed as geometric mean antibody titers (GMTs)., At Day 182|Number of Seroconverted Subjects for Antibodies Against A/ California Strain., Seroconversion rate was defined as the incidence rate of vaccinees who had either a pre-vaccination titer recorded as < 1:10 and a post-vaccination reciprocal titer ≥ 40 or a pre-vaccination reciprocal titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer.
Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer, At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups|Number of Seroprotected Subjects for Antibodies Against A/California Strain., Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus., At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups.|Seroconversion Factor for Antibodies Against A/California Strain., Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the prevaccination reciprocal HI titer., At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains., Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled., At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains, Seroprotection was defined as the proportion of subjects with H1N1 reciprocal Hemagglutination Inhibition (HI) titers ≥ 1:40 against the tested vaccine virus.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled., At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains., Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal Hemagglutination Inhibition (HI) titer to the prevaccination reciprocal HI titer.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled., At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains, Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008., on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains, Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008., At Day 182 from Day 0|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains., Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008., before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains., Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008., At Day 182 after the first dose|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains., Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008., On Days 21 and 63 from Day 0 for the first 4 groups and on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains., Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008., At Day 182 from Day 0|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains., Titers were expressed as geometric mean titers (GMTs).
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008., On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains., Titers were expressed as geometric mean titers (GMTs).
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008., At Day 182 after dose 1 vaccination | null | GlaxoSmithKline | null | ALL | ADULT | PHASE2 | 611 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 113536 | 2009-10-01 | 2009-12-28 | 2010-12-29 | 2009-09-28 | 2012-01-30 | 2018-08-01 | GSK Investigational Site, Stockbridge, Georgia, 30281, United States|GSK Investigational Site, Raleigh, North Carolina, 27612, United States|GSK Investigational Site, Austin, Texas, 78705, United States|GSK Investigational Site, Fort Worth, Texas, 76135, United States|GSK Investigational Site, Halifax, Nova Scotia, B3K 6R8, Canada|GSK Investigational Site, Montreal, Quebec, H2K 4L5, Canada|GSK Investigational Site, Sherbrooke, Quebec, J1H 4J6, Canada | null | {
"GSK2340274A": [
{
"intervention_type": "BIOLOGICAL"
}
],
"GSK2340273A": [
{
"intervention_type": "BIOLOGICAL"
}
],
"Influenza vaccine": [
{
"intervention_type": "BIOLOGICAL",
"description": "Seasonal trivalent influenza vaccine (TIV)",
"name": "Influenza vaccine",
"synonyms": [
"Afluria",
"Influenza vaccine",
"Fluarix",
"Fluzone",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine",
"Afluria",
"Influenza Vaccine, Inactivated or Recombinant",
"Flucelvax",
"Fluarix",
"Fluzone",
"Flu Vaccine"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Influenza%20vaccine",
"generic_names": [
"Influenza Vaccine, Inactivated or Recombinant",
"Influenza Vaccine, Inactivated or Recombinant",
"Influenza Vaccine, Inactivated or Recombinant",
"Influenza Vaccine, Inactivated or Recombinant",
"Influenza Vaccine, Inactivated or Recombinant",
"Influenza Vaccine, Inactivated or Recombinant"
]
}
],
"Saline placebo": [
{
"intervention_type": "BIOLOGICAL"
}
]
} |
NCT02611973 | Hydroxyurea Versus Aspirin and Hydroxyurea in Essential Thrombocythemia | https://clinicaltrials.gov/study/NCT02611973 | FAST | UNKNOWN | The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes less useful once patients have achieved a hematologic response (HR) (modified by amendment 1/03/2017) and/or that this benefit is hampered by an increased hemorrhagic risk especially in elderly patients.
Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio of aspirin maintenance in high risk Essential thrombocythemia (ET) patients, in hematological response (modified by amendment 1/03/2017) on Hydroxyurea. | NO | MPN|Essential Thrombocythemia | OTHER: Aspirin therapy interruption|OTHER: Usual treatment by aspirin 100 mg/d in the active comparator arm|OTHER: No interruption of aspirin in the Observational arm|DRUG: Hydroxyurea treatment (HU) | Cumulative incidence of death from vascular origin and other thrombotic and hemorrhagic events (combined endpoint), Definition of vascular events:
Thrombotic events: Myocardial infarction, unstable angina, stroke, transient ischemic attack, peripheral arterial thrombosis, splanchnic or limb deep vein thrombosis, pulmonary embolism, and erythromelalgia
Hemorrhagic events:
Intracranial or retroperitoneal bleed, overt hemorrhage associated with a decrease in hemoglobin ≥20 g/l or overt hemorrhage requiring a blood transfusion of two red blood cell (RBC) units or more, and hemorrhage of grade >=2 according to the NCI Common Toxicity criteria (CTC) V.4.0 scale.
Deaths will be included as a death from thrombosis or hemorrhage if they satisfied criteria for one of the above diagnoses immediately ANTE-MORTEM or if they had a POST-MORTEM examination confirming the diagnosis. Sudden death of presumed vascular origin without a POST-MORTEM examination will be included as a thrombotic death., at 2-years follow-up | Cumulative incidence and characteristics of vascular complications: thrombosis and hemorrhage, (grade, site, recurrence), assessed yearly over a 5-year follow-up period., at 5 years|Rate of hematological response every 6 months, Hematological response as assessed by European Leukemia Net (ELN) criteria, revised ELN International Working Group on Myeloproliferative Neoplasms Research and Treatment (ELN -IWG MRT)., at 5 years|Adverse event (AE) frequency and incidence, comparison in the two arms, at 5 years|Number of HU-related nonhematologic toxicities, at 5 years|Cumulative incidence of thrombosis, at 5 years|Cumulative incidence of hemorrhagic complications, at 5 years|Estimation of the progression-free survival, at 5 years|Estimation of overall survival, at 5 years|Short Form 36 (SF36) Health Survey, Evaluation of quality of life by using SF36, through study completion, an average of 1 year|Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF), Evaluation of quality of life by using (MPN-SAF), through study completion, an average of 1 year|Number of mortality cause., at 5 years|Cumulative incidence of progression to polyglobulia, at 5 years|Cumulative incidence of progression to myelofibrosis (MF), at 5 years|Cumulative incidence of progression to myelodysplastic syndrome (MDS), at 5 years|Cumulative incidence of progression AML, at 5 years|Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden (in blood DNA) in patients presenting thrombosis or not ., at 5 years|Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patients in persistent hematological response (modified by amendment 1/03/2017)., responses and intolerance define according to ELN criteria, at 5 years|Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patient who will lose their hematological response (modified by amendment 1/03/2017)., responses and intolerance define according to ELN criteria, at 5 years|Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patients presenting intolerance to treatment., responses and intolerance define according to ELN criteria, at 5 years | null | Assistance Publique - Hôpitaux de Paris | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 2,250 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | P140933 | 2016-03-10 | 2019-11 | 2022-11 | 2015-11-23 | null | 2017-07-26 | Henri Mondor Hospital, Creteil, 94010, France | null | {
"Aspirin": [
{
"intervention_type": "OTHER",
"description": "Aspirin therapy interruption",
"name": "Aspirin",
"synonyms": [
"Valomag",
"Endosprin",
"Acetysal",
"Acetylsalicylic acid",
"Azetylsalizyls\u00e4ure",
"Magnecyl",
"Acetylsalicylic Acid",
"2-(Acetyloxy)benzoic Acid",
"Aloxiprimum",
"Polopirin",
"Bonjela",
"Acetylsalicylate",
"Dispril",
"Ecotrin",
"Acylpyrin",
"Acid, Acetylsalicylic",
"Anadin",
"Zorprin",
"Polopiryna",
"Solupsan",
"Colfarit",
"Solprin",
"Micristin",
"Easprin",
"Aspirin",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine"
],
"medline_plus_id": "a621021",
"generic_names": [
"Acetylsalicylic acid",
"Aspirin",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous"
],
"nhs_url": "https://www.nhs.uk/medicines/aspirin-for-pain-relief",
"mesh_id": "D058633",
"drugbank_id": "DB00945",
"wikipedia_url": "https://en.wikipedia.org/wiki/Aspirin"
},
{
"intervention_type": "OTHER",
"description": "Usual treatment by aspirin 100 mg/d in the active comparator arm",
"name": "Aspirin",
"synonyms": [
"Valomag",
"Endosprin",
"Acetysal",
"Acetylsalicylic acid",
"Azetylsalizyls\u00e4ure",
"Magnecyl",
"Acetylsalicylic Acid",
"2-(Acetyloxy)benzoic Acid",
"Aloxiprimum",
"Polopirin",
"Bonjela",
"Acetylsalicylate",
"Dispril",
"Ecotrin",
"Acylpyrin",
"Acid, Acetylsalicylic",
"Anadin",
"Zorprin",
"Polopiryna",
"Solupsan",
"Colfarit",
"Solprin",
"Micristin",
"Easprin",
"Aspirin",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine"
],
"medline_plus_id": "a621021",
"generic_names": [
"Acetylsalicylic acid",
"Aspirin",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous"
],
"nhs_url": "https://www.nhs.uk/medicines/aspirin-for-pain-relief",
"mesh_id": "D058633",
"drugbank_id": "DB00945",
"wikipedia_url": "https://en.wikipedia.org/wiki/Aspirin"
},
{
"intervention_type": "OTHER",
"description": "No interruption of aspirin in the Observational arm",
"name": "Aspirin",
"synonyms": [
"Valomag",
"Endosprin",
"Acetysal",
"Acetylsalicylic acid",
"Azetylsalizyls\u00e4ure",
"Magnecyl",
"Acetylsalicylic Acid",
"2-(Acetyloxy)benzoic Acid",
"Aloxiprimum",
"Polopirin",
"Bonjela",
"Acetylsalicylate",
"Dispril",
"Ecotrin",
"Acylpyrin",
"Acid, Acetylsalicylic",
"Anadin",
"Zorprin",
"Polopiryna",
"Solupsan",
"Colfarit",
"Solprin",
"Micristin",
"Easprin",
"Aspirin",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine",
"Boots Haemorrhoid",
"2-(Diethylamino)-2',6'-acetoxylidide",
"2-2EtN-2MePhAcN",
"\u03b1-diethylamino-2,6-dimethylacetanilide",
"Xylocaine",
"Lidocaine Monohydrochloride, Monohydrate",
"Lidocaine Carbonate",
"Xyloneural",
"2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide",
"Ztlido",
"EMLA",
"Lidocaina",
"Lidocaine",
"2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide",
"Covonia",
"Xylopract",
"Nulbia",
"Lidoca\u00edna",
"Octocaine",
"Lidocainum",
"LMX4",
"Bonjela",
"Lidocaine Hydrochloride",
"Dalcaine",
"Lidocaine Sulfate (1:1)",
"Anbesol",
"Perinal",
"Anusol",
"Lidocaine Monohydrochloride",
"Germaloids",
"Iglu",
"Xylesthesin",
"Lidocaine Monoacetate",
"Lignocaine",
"Calgel",
"Lidocaine Carbonate (2:1)",
"Denela",
"Lidocaine Hydrocarbonate",
"alpha-diethylamino-2,6-dimethylacetanilide",
"Xylocitin",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Dermalid",
"Ztlido",
"Lidoderm",
"Absorbine Jr",
"Lidocaine Patch",
"Xylocaine",
"Lidocaine Viscous",
"Xylocaine",
"Lidocaine Viscous",
"Senstend",
"Emla",
"Fortacin",
"Lidocaine/prilocaine"
],
"medline_plus_id": "a621021",
"generic_names": [
"Acetylsalicylic acid",
"Aspirin",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous",
"Lidocaine",
"Lidocaine Patch",
"Lidocaine Patch",
"Lidocaine Viscous",
"Lidocaine Viscous"
],
"nhs_url": "https://www.nhs.uk/medicines/aspirin-for-pain-relief",
"mesh_id": "D058633",
"drugbank_id": "DB00945",
"wikipedia_url": "https://en.wikipedia.org/wiki/Aspirin"
}
],
"Hydroxyurea": [
{
"intervention_type": "DRUG",
"description": "Hydroxyurea treatment (HU)",
"name": "Hydroxyurea",
"synonyms": [
"Carbamohydroxamic acid",
"Hidroxicarbamida",
"Carbamoyl oxime",
"Carbamohydroximic acid",
"Hydroxycarbamide",
"Carbamyl hydroxamate",
"N-Carbamoylhydroxylamine",
"Siklos",
"Hydroxycarbamid",
"Hydroxycarbamidum",
"Hydrea",
"Hydroxyurea",
"Oncocarbide",
"Hydroxyharnstoff",
"N-Hydroxyurea",
"Oxyurea",
"Droxia"
],
"medline_plus_id": "a682004",
"generic_names": [
"Hydroxyurea"
],
"mesh_id": "D019384",
"drugbank_id": "DB01005",
"wikipedia_url": "https://en.wikipedia.org/wiki/Hydroxycarbamide"
}
]
} |
NCT01057173 | The Nordic Aortic Valve Intervention Trial | https://clinicaltrials.gov/study/NCT01057173 | NOTION | ACTIVE_NOT_RECRUITING | A randomized clinical trial of transcatheter aortic valve implantation (TAVI) versus conventional surgical aortic valve replacement (SAVR) in patients older than 70 years of age suffering from severe aortic valve stenosis.
Study hypothesis: TAVI will reduce post-interventional morbidity and mortality compared to SAVR. | NO | Critical Aortic Stenosis | PROCEDURE: Transcatheter Aortic Valve Implantation|PROCEDURE: Surgical Aortic Valve Replacement | Combined rate of death from any cause, myocardial infarction, and stroke, Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC), 1 year | Procedural complications, Within first 30 days|Admission lengths (ICU and interventional center), Within first 30 days|Combined rate of noncardiac and cardiac death, prosthesis reintervention, cardiac-, cerebral-, renal-, and pulmonary complications, 1 year|Functional status (NYHA-classification) and Quality of Life (SF-36), 1 year|Echocardiographic prosthesis and ventricular structural and functional status, 1 year | null | Rigshospitalet, Denmark | Odense University Hospital|Sahlgrenska University Hospital, Sweden|Danish Heart Foundation|Copenhagen Trial Unit, Center for Clinical Intervention Research | ALL | OLDER_ADULT | null | 280 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | HA2009046 | 2009-12 | 2014-04 | 2033-04 | 2010-01-27 | null | 2023-11-22 | Copenhagen University Hospital, Copenhagen, 2100, Denmark|Odense University Hospital, Odense, 5000, Denmark|Sahlgrenska University Hospital, Gothenburg, 413 45, Sweden | null | {
"Transcatheter Aortic Valve Implantation": [
{
"intervention_type": "PROCEDURE"
}
],
"Surgical Aortic Valve Replacement": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT00378573 | Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer | https://clinicaltrials.gov/study/NCT00378573 | null | TERMINATED | This is a Phase II prospective, multicenter study evaluating Progression Free Survival (PFS) after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). PFS will be measured from the date of registration (ie, assignment of subject number when subject meets all entry criteria) to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurs first. | YES | Non-small Cell Lung Cancer | DRUG: docetaxel|DRUG: gemcitabine|DRUG: bevacizumab | Progression Free Survival for Subjects With Locally Advanced or Metastatic (Stage IIIB or Stage IV) Non-Small Cell Lung Cancer (NSCLC) After Systemic Treatment With Gemcitabine, Docetaxel, and Bevacizumab as First Line Therapy, 1 year post-registration | Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST), Complete response is defined as disappearance of all target and nontarget lesions identified and reported at baseline (at or within 4 weeks before the beginning of treatment) by image-based evaluations such as computerized tomography (CT) or magnetic resonance imaging (MRI).
Partial response is defined as persistence of one or more nontarget lesions and at least 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters., 1 year from start of treatment|Overall Survival, Survival is defined as the time from the date of registration to the study to the date of death., 2 years post-registration | null | Sanofi | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 17 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | DOCET_L_00730 | 2007-01 | 2008-09 | 2008-09 | 2006-09-20 | 2010-01-18 | 2010-01-26 | Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States | null | {
"Docetaxel": [
{
"intervention_type": "DRUG",
"description": "docetaxel",
"name": "Docetaxel",
"synonyms": [
"Docetaxel Hydrate",
"N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol",
"Taxotere",
"Docefrez",
"Taxoltere Metro",
"Docetaxol",
"RP-56976",
"RP56976",
"Docetaxel anhydrous",
"TXL",
"Docetaxel Trihydrate",
"N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetylpaclitaxel",
"Docetaxel",
"RP 56976",
"N-Debenzoyl-N-tert-butoxycarbonyl-10-deacetyltaxol",
"N Debenzoyl N tert butoxycarbonyl 10 deacetyltaxol",
"Docetaxel Anhydrous",
"NSC 628503"
],
"medline_plus_id": "a696031",
"generic_names": [
"Docetaxel"
],
"mesh_id": "D050257",
"drugbank_id": "DB01248"
}
],
"Gemcitabine": [
{
"intervention_type": "DRUG",
"description": "gemcitabine",
"name": "Gemcitabine",
"synonyms": [
"Gemcitabine",
"4-amino-1-((2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)-tetrahydrofuran-2-yl)pyrimidin-2(1H)-one",
"Gemzar",
"2',2'-Difluorodeoxycytidine",
"Gemcitabina",
"2'-Deoxy-2',2'-difluorocytidine",
"Gemcitabinum",
"Gemcitabin"
],
"medline_plus_id": "a696019",
"generic_names": [
"Gemcitabine"
],
"drugbank_id": "DB00441"
}
],
"Bevacizumab": [
{
"intervention_type": "DRUG",
"description": "bevacizumab",
"name": "Bevacizumab",
"synonyms": [
"Bevacizumab",
"Bevacizumab awwb",
"bevacizumab-awwb",
"rhuMAb-VEGF",
"Zirabev",
"Avastin",
"Anti-VEGF monoclonal antibody",
"Bevacizumab-awwb",
"Mvasi",
"Anti-VEGF Humanized Monoclonal Antibody"
],
"medline_plus_id": "a607001",
"generic_names": [
"Bevacizumab"
],
"mesh_id": "D000074322",
"drugbank_id": "DB00112",
"wikipedia_url": "https://en.wikipedia.org/wiki/Bevacizumab"
}
]
} |
NCT03818373 | Respiratory Drive in Patients With Univentricular Congenital Heart Disease | https://clinicaltrials.gov/study/NCT03818373 | null | COMPLETED | The aim is to evaluate the correlation between the respiratory control to hypercapnia at rest and the VE/VCO2 slope measured during cardiopulmonary exercise testing.
The hypothesis is that patient with univentricular congenital heart disease have a increasing of respiratory drive like chronic heart failure. This increasing of respiratory drive could participate in the increasing of VE/VCO2 slope measured during cardiopulmonary exercise testing and in the genese of central apnea index during the sleep. | NO | Univentricular Heart|Children, Adult | PROCEDURE: polysomnography | Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest, between the measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest
- between VE/VCO2 slope during a cardiopulmonary exercise, day 90 after inclusion visit (visit 2) | Pearson correlation, * between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and Central apnea index scored with a polysomnography during a night
* between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and NYHA, New York Heart Association Functional Classification
* between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and the quality of life evaluated by questionary
* between the measure of the respiratory drive to hypercapnia with P0.1, the rebreathing technique at rest and data of cardiac echography, day 90 after inclusion visit (visit 2) | null | University Hospital, Montpellier | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 32 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | RECHMPL17_0400|UF 7512 | 2017-10-16 | 2021-07-07 | 2021-07-07 | 2019-01-28 | null | 2023-01-04 | Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C, Montpellier, Occitanie, 34295, France|Institut Saint-Pierre, Palavas-les-Flots, France | null | {
"polysomnography": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT02440373 | Plasma Cytochrome c as Biomarker of Traumatic Injury and Predictor of Outcome | https://clinicaltrials.gov/study/NCT02440373 | null | COMPLETED | Cytochrome c is a mitochondrial protein that plays a key role in energy metabolism. When mitochondria are injured, cytochrome c may leave mitochondria and reach the bloodstream. The investigators plan to investigate whether circulating cytochrome c levels may serve as biomarker of traumatic injury correlating with (1) severity of traumatic injury, (2) development of organ dysfunction, and (3) clinical outcomes. The Trauma Services at ALGH will enroll over 8 months 100 consecutive trauma patients who require intubation for mechanical ventilation and survive to hospital admission. The Resuscitation Institute at RFUMS will measure cytochrome c levels in plasma taken upon hospital admission and subsequently at 24, 48, and 72 hours, with additional plasma stored for markers to be defined at a later time. Blood cytochrome c levels will be analyzed in relation to severity of traumatic injury, development of organ dysfunction, and clinical outcomes including survival and functional status (adjusted for covariates such as age, gender, type of trauma, time to stabilization, comorbidities, etc.) using information obtained as part of routine medical care. Successful completion of this project will support blood cytochrome c as biomarker of traumatic injury which could be used to identify severity, predict outcomes, and assess novel mitochondrial protective strategies. | NO | Trauma|Blunt Injury|Blunt Trauma|Accident|Multiorgan Injury | null | Plasma cytochrome c levels in relation to severity of traumatic injury, Relationship between plasma levels of cytochrome c and the initial severity of traumatic injury as assessed by the TRISS and the severity of initial presentation based on transfusion requirements and (if available) by blood gas and chemistry analysis along with lactic acid., Day one. | Plasma cytochrome c levels in relation to development of organ dysfunction and hospital outcomes, Relationship between plasma levels of cytochrome c and subsequent development of organ dysfunction assessed by daily measurements of MODS and SOFA and various clinical outcomes including length of stay in ICU and in the hospital, survival to hospital discharge, and functional status upon discharge., From hospital admission until the date of discharge from the hospital, up to 26 weeks.|Individual organ contribution to plasma cytochrome c levels, Contribution of individual organs injured to plasma cytochrome c levels (e.g., liver injury is likely to produce greater mitochondrial injury that thoracic injury given the greater mitochondrial density in liver tissue)., From hospital admission until the date of the last cytochrome c measurement (i.e., day three from hospital admission). | null | Advocate Health Care | Rosalind Franklin University of Medicine and Science | ALL | ADULT, OLDER_ADULT | null | 12 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | AHC IRB# 5458 | 2014-03 | 2017-03 | 2017-03 | 2015-05-12 | null | 2018-03-23 | Advocate Lutheran General Hospital, Park Ridge, Illinois, 60068, United States | null | {} |
NCT04106973 | Mesothelioma Early Detection by VOCs | https://clinicaltrials.gov/study/NCT04106973 | MED-VOC | TERMINATED | This is a two phase study, The first phase (phase 1) will identify potential biomarkers among asbestos exposed individuals with pleural mesothelioma. The second phase (phase 2), is a double blinded case-matched controlled study to determine the predictive capability, sensitivity, and specificity of these biomarkers in detecting early stage pleural mesothelioma. Biomarkers in the form of volatile organic compounds (VOC) in exhaled breath samples from subjects with either pleural mesothelioma or pleural plaques, will be evaluated. A biomarker present in serum will also be concurrently evaluated in the same cohort. The soluble serum biomarker mesothelin related peptides (SMRP), which has been posited as a biomarker for mesothelioma, will be analyzed for its relationship to the breath VOC profile. | NO | Pleural Mesothelioma|Asbestos Exposure|Pleural Plaque | null | VOC markers in breath samples. Predictive capability, sensitivity and specificity of biomarkers present in volatile organic compounds (VOC) for the early detection of pleural Mesothelioma in patients exposed to asbestos., Predictive capability, sensitivity and specificity of biomarkers present in volatile organic compounds (VOC) for the early detection of pleural Mesothelioma in patients exposed to asbestos., At study completion, approximately 2 years | Predictive capability, sensitivity and specificity of Soluble Mesothelin Related Peptides (SMRP) in serum when combined with VOC biomarkers for pleural mesothelioma., Determine the additive predictive capability, sensitivity and specificity of SMRP serum biomarkers with VOC biomarkers for the early detection of pleural mesothelioma, At study completion, approximately 2 years | null | Ascension South East Michigan | International Association of Heat and Frost Insulators and Allied Workers|Owlstone Ltd|Fujirebio Diagnostics, Inc. | ALL | ADULT, OLDER_ADULT | null | 12 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1432436 | 2019-06-05 | 2022-01-01 | 2022-01-01 | 2019-09-27 | null | 2022-09-14 | Consultants in Sleep and Pulmonary Medicine, Farmington Hills, Michigan, 48336, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT04106973/Prot_SAP_000.pdf | {} |
NCT01059773 | A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate | https://clinicaltrials.gov/study/NCT01059773 | TRANSIT | COMPLETED | This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. The study will provide information for doctors on how to manage the transfer from methotrexate to the biologic agent ustekinumab. The study is designed to compare two methods of transferring patients from methotrexate to ustekinumab. The two methods being compared are discontinuation of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over 4 weeks. | YES | Psoriasis | DRUG: Ustekinumab|DRUG: Methotrexate | Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12, from week 0 to week 12 | Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period, The number of patients with any of the following Treatment Emergent AEs (TEAEs) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE; SAE and Death., at week 12, 16, 28 40 and 52|Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period, The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE with severe intensity; AE or SAE reasonably related to ustekinumab (i.e., AEs classified by the investigator as possibly , probably , or very likely related to study agent); AE or SAE leading to permanent discontinuation of ustekinumab., at week 12, 16, 28 40 and 52|Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period, The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): infections, serious infections, and infections requiring oral or parenteral antimicrobial treatment (infections being considered any event that by the investigator was indicated as infection on the CRF)., at week 12, 16, 28 40 and 52|Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction), The number of patients with a malignancy and other event of clinical interest (tuberculosis, serious cardiovascular events, anaphylactic/serum sickness reaction) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg), at week 12, 16, 28 40 and 52|Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline, Change from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person s psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score., at Weeks 0, 2, 4, 12, 16, 28, 40 and 52|Proportion of Patients Achieving PASI 50 Response, This is based on the number of participants achieving at least 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person s psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score., at Weeks 2, 4, 12, 16, 28, 40 and 52|Proportion of Patients Achieving PASI 75 Response, This is based on the number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person s psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score., at Weeks 2, 4, 12, 16, 28, 40 and 52|Proportion of Patients Achieving PASI 90 Response, This is based on the number of participants achieving at least 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person s psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score., at Weeks 2, 4, 12, 16, 28, 40 and 52 | null | Janssen-Cilag International NV | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 490 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | CR016639|CR016639|CNTO1275PSO4004 | 2009-10 | 2010-11 | 2011-08 | 2010-02-01 | 2012-01-30 | 2014-11-24 | Wien, Austria|Brussels, Belgium|Gent, Belgium|Liège, Belgium|Pleven, Bulgaria|Sofia, Bulgaria|Aarhus, Denmark|Roskilde N/A, Denmark|Tampere, Finland|Turku, Finland|Chambray-Lès-Tours, France|Creil, France|Jarez, France|Lille Cedex, France|Marseille, France|Montpellier N/A, France|Nantes Cedex 01 N/A, France|Nantes Cedex 1, France|Nice Cedex 3, France|Paris, France|Pessac, France|Pierre Benite, France|Poitiers, France|Rouen, France|Toulouse, France|Berlin, Germany|Dresden, Germany|Erlangen, Germany|Essen, Germany|Frankfurt, Germany|Gottingen, Germany|Hamburg, Germany|Kiel, Germany|Landau, Germany|Leipzig, Germany|Mahlow, Germany|Marburg, Germany|Munster, Germany|München, Germany|Tÿbingen, Germany|Witten, Germany|Athens, Greece|Thessaloniki, Greece|Debrecen, Hungary|Szeged, Hungary|Petah-Tikva, Israel|Tel-Aviv, Israel|Kaunas, Lithuania|Vilnius, Lithuania|Nijmegen, Netherlands|Rotterdam, Netherlands|Oslo N/A, Norway|Stavanger, Norway|Poznan, Poland|Wrocław, Poland|Łódź, Poland|Lisboa, Portugal|Porto, Portugal|Bratislava, Slovakia|Alicante, Spain|Badalona, Spain|Barcelona, Spain|Cordoba, Spain|La Coruÿa N/A, Spain|Madrid, Spain|Göteborg, Sweden|Malmö, Sweden|Solna, Sweden|Uppsala, Sweden|Aberdeen, United Kingdom|Cardiff, United Kingdom|Craigavon, United Kingdom|Glasgow, United Kingdom|London, United Kingdom|Nottingham, United Kingdom|Salford, United Kingdom | null | {
"Ustekinumab": [
{
"intervention_type": "DRUG",
"description": "Ustekinumab",
"name": "Ustekinumab",
"synonyms": [
"Stelara",
"CNTO 1275",
"Ustekinumab-auub",
"CNTO-1275",
"Stelera",
"Ustekinumab"
],
"medline_plus_id": "a611013",
"generic_names": [
"Ustekinumab"
],
"mesh_id": "D003879",
"drugbank_id": "DB05679",
"wikipedia_url": "https://en.wikipedia.org/wiki/Ustekinumab"
}
],
"Methotrexate": [
{
"intervention_type": "DRUG",
"description": "Methotrexate",
"name": "Methotrexate",
"synonyms": [
"Methotrexate, Dicesium Salt",
"Nordimet",
"Amethopterin",
"Hydrate, Methotrexate",
"Dicesium Salt Methotrexate",
"Methotrexate, (DL)-Isomer",
"Sodium, Methotrexate",
"Zlatal",
"4-amino-10-methylfolic acid",
"Methotrexate",
"Metoject",
"N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-L-glutamic acid",
"Methotrexatum",
"Methotrexate Hydrate",
"Abitrexate",
"Methotrexate, (D)-Isomer",
"M\u00e9thotrexate",
"MTX",
"Rasuvo",
"Methotrexat",
"Methotrexate Sodium",
"Jylamvo",
"Methotrexate, Disodium Salt",
"Methofill",
"Mexate",
"Maxtrex",
"Rheumatrex",
"Metotrexato",
"Methotrexate, Sodium Salt",
"4-amino-N(10)-methylpteroylglutamic acid"
],
"medline_plus_id": "a682018",
"generic_names": [
"Methotrexate"
],
"nhs_url": "https://www.nhs.uk/medicines/methotrexate",
"mesh_id": "D019384",
"drugbank_id": "DB00563"
}
]
} |
NCT04654273 | EX-PO Trial : Evaluation of the Occlusion Pressure (PO.1) in Extubation Failure | https://clinicaltrials.gov/study/NCT04654273 | null | UNKNOWN | Measuring bedside occlusion pressure in neurosurgical or surgical critically ill patients could tell us about the patient s respiratory drive, and therefore, tell us whether or not extubation will be successful. | NO | Respiratory Failure | null | Number of re-intubations after extubation, 7 days | null | null | Poitiers University Hospital | null | ALL | ADULT, OLDER_ADULT | null | 152 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | EX-PO | 2020-11-30 | 2021-12-31 | 2022-01-31 | 2020-12-04 | null | 2021-07-08 | CHU POitiers, Poitiers, 86000, France | null | {} |
NCT02543073 | MSC for Treatment of Interstitial Lung Disease After Allo-HSCT | https://clinicaltrials.gov/study/NCT02543073 | null | UNKNOWN | Interstitial lung disease (ILD） is the late pulmonary complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT) leading to high morbidity and mortality. At present, the treatment for ILD after allo-HSCT remains in discussion. In this study, the efficacy of mesenchymal stem cells (MSCs) combined azithromycin as well as glucocorticoid as the treatment of ILD will be evaluated in the recipients of allo-HSCT. | NO | Lung Diseases, Interstitial|Hematopoietic Stem Cell Transplantation|Bronchiolitis Obliterans | BIOLOGICAL: MSCs|DRUG: AZM|DRUG: Glucocorticoid | Response rate of ILD, Response includes complete response (CR) and partial response (PR). CR is defined as resolution of all manifestations related to ILD, except for some irreversible changes. PR is defined as sustained, measurable improvement in pulmonary function tests(carbon monoxide lung diffusion capacity, forced expiratory volume, or both) or the ability to reduce corticosteroids by at least 50% or both without deterioration of pulmonary function., 4 weeks | Overall Survival, The 3-year overall survival after HSCT will be evaluated, 3 year | null | Nanfang Hospital, Southern Medical University | Sun Yat-sen University | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 60 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | MSC-ILD-2015 | 2014-09 | 2017-12 | 2018-06 | 2015-09-07 | null | 2017-05-10 | Department of Hematology,Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510515, China | null | {
"MSCs": [
{
"intervention_type": "BIOLOGICAL"
}
],
"AZM": [
{
"intervention_type": "DRUG"
}
],
"Glucocorticoid": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03069573 | Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients | https://clinicaltrials.gov/study/NCT03069573 | null | COMPLETED | The purpose of this study is to find out some potential biomarkers for the Eosinophilic Esophagitis (EoE) in pediatric patients through the prospective clinical characterization and assessment of samples collected during the diagnostic process | NO | Eosinophilic Esophagitis|Gastroesophageal Reflux | null | Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis, Identify diagnostic biomarker, able to distinguish EoE patients from GERD patients and other nonspecific gastrointestinal complains, 2016 August - 2017 March and 2018 November-December | Endoscopic features of EoE, Evaluation of the EREFS ability (endoscopic reference score) to identify EoE patients and the inflammatory or fibrosis phenotype, 2017 January-March and 2018 November-December|Symptoms of active EoE, Evaluation of the symptom score s ability to identify EoE patients in active disease, 2017 January-March and 2018 November-December|Histological features of EoE, Evaluation of the histologic score s ability to identify EoE patients and the inflammatory or fibrosis phenotype, 2017 January-March and 2018 November-December | null | Federal University of Uberlandia | null | ALL | CHILD, ADULT | null | 110 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | CAAE-36787714.0.0000.5152 | 2015-01-01 | 2016-08-31 | 2019-09-30 | 2017-03-03 | null | 2020-10-01 | Federal University of Uberlandia, Uberlândia, Minas Gerais, 38400-902, Brazil | null | {} |
NCT01113073 | The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation | https://clinicaltrials.gov/study/NCT01113073 | null | UNKNOWN | Fluid administration is a daily intervention on the intensive care unit to improve cardiac output (CO) and stabilize circulation in critically ill patients. Simultaneously, the volume status of the patient is very difficult to assess. Too little volume leads to inadequate organ perfusion followed by ischemia and organ failure. Too much volume may worsen heart failure and cause pulmonary and peripheral edema and contribute to further tissue injury and organ dysfunction. Although dynamic indices have been shown to be more accurate predictors of fluid responsiveness, this relevant and complex task is usually guided by static clinical variables and the specialist s interpretation due to the fact that the interpretation of dynamic parameters is not fully developed and that they are not universally available. This lack of understanding is partially because of the complex interaction with mechanical ventilation. The investigators hypothesize that knowing the distribution of ventilatory pressures will make it possible to index dynamic parameters to tidal volume and improve their predictive value concerning the volume status of the patient. In addition, it would be of interest to be able to predict fluid responsiveness in a non-invasive way, especially in critically ill patients. Up to now, continuous non-invasive cardiac output monitoring using Nexfin in critically ill patients has not been validated and also not tested for its ability to predict fluid responsiveness. The present research proposal evaluates the possibility and accuracy of the model flow analysis obtained by non-invasive finger arterial pressure measurements to determine fluid responsiveness using passive leg raising. It will also be compared to a more invasive method (that is currently used in the clinic) to assess its ability to measure absolute CO levels accurately. It may make it possible to assess fluid responsiveness in a non-invasive and patient friendly way. | NO | Fluid Responsiveness | OTHER: ventilatory protocol|OTHER: Elastic band|OTHER: passive leg raising test | fluid responsiveness, pulse pressure variation (PPV), systolic pressure variation (SPV), stroke volume variation (SVV), pre-ejection period variation (dPEP), 30 minutes around fluid challenge | Pressure distribution in thorax due to mechanical ventilation, mechanical ventilation with 4 different tidal volumes and decreased chest compliance, 30 minutes of varying tidal volumes|Dynamic indices in pressure support ventilation, 30 minutes of pressure support|non invasive prediction of fluid responsiveness, pulse contour analysis of cardiac output with finger cuff combined with passive leg raising test, 30 minutes around fluid challenge|pressure distribution and dynamic indices during spontaneous breathing, 5 minutes of spontaneous breathing | null | Radboud University Medical Center | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | UMCN_IC_BL_01/2010 | 2010-01 | 2010-09 | 2010-09 | 2010-04-29 | null | 2010-08-31 | Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands | null | {
"ventilatory protocol": [
{
"intervention_type": "OTHER"
}
],
"Elastic band": [
{
"intervention_type": "OTHER"
}
],
"passive leg raising test": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01799473 | Tyvaso Dosing and Titration Evaluation: TyTRATE Registry | https://clinicaltrials.gov/study/NCT01799473 | null | COMPLETED | This prospective, observational, multi-center, patient registry will follow patients who are newly initiated on Tyvaso for the treatment of Pulmonary Arterial Hypertension (PAH). Once enrolled, the patients dose and titration will be followed for the first 6 months of treatment with Tyvaso.
A call-center will contact the patients directly at weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 to review their dose and titration schedule. In addition to patient-reported dosing data, some patient demographic information, will be collected by the investigative site at Baseline. | NO | Pulmonary Arterial Hypertension | null | Observe dose changes of Tyvaso over time, 6 Months | null | null | United Therapeutics | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 98 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | RIN-PH-404 | 2013-01 | 2014-12 | 2014-12 | 2013-02-26 | null | 2015-03-24 | The Regents of the University of California, La Jolla, California, 92037, United States|UCLA Medical Center, Los Angeles, California, 90095, United States|Southern California Permanente, Pasadena, California, 91101, United States|Central Coast Chest Consultants, San Luis Obispo, California, 93401, United States|Pacific Sleep Disorders Center, Stockton, California, 95210, United States|Prime Healthcare, PC, West Hartford, Connecticut, 06107, United States|Bay Area Cardiology Associates, PA, Brandon, Florida, 33511, United States|Florida Lung & Sleep Specialist, Celebration, Florida, 32747, United States|Jacksonville, Florida, 32216, United States|Sacred Heart Medical Group, Miramar Beach, Florida, 32550, United States|Cardiology Consultants, Pensacola, Florida, 32501, United States|Pensacola Lung Group, Pensacola, Florida, 32504, United States|Sacred Heart Medical Group, Pensacola, Florida, 32504, United States|Pediatrix Cardiology Associates, Tampa, Florida, 33607, United States|Doctors Hospital of Augusta, Augusta, Georgia, 30909, United States|On Site Clinical Solutions, Cumming, Georgia, 30041, United States|Duluth Biomedical Research, Duluth, Georgia, 30096, United States|Gwinnett Consultants in Cardiology, Lawrenceville, Georgia, 30046, United States|Atlanta Cardiology Consultants, Roswell, Georgia, 30076, United States|Queens Medical Center - Honolulu, Aiea, Hawaii, 97601, United States|Ann & Robert H. Lurie Children s Hospital of Chicago, Chicago, Illinois, 60611, United States|Dor Heart and Vascular Clinic, Gurnee, Illinois, 60031, United States|Loyola University of Chicago, Maywood, Illinois, 60153, United States|Advocate Medical Group, Oakbrook, Illinois, 60523, United States|Methodist Medical Center of Illinois, Peoria, Illinois, 61636, United States|Clarian Health Methodist Hospital, Indianapolis, Indiana, 46202, United States|MedStar Health Institute, Hyattsville, Maryland, 20782, United States|Pulmonary and Care Associates of Baltimore, Pikesville, Maryland, 21117, United States|Madison Medical Affiliates, Milwaukee, Michigan, 53212, United States|Singing River Health System, Pascagoula, Mississippi, 39581, United States|AZ Perfection Clinical, Union, New Jersey, 07083, United States|Presbyterian Heart Group, Albuquerque, New Mexico, 87106, United States|Heart and Lung Associates, PC, Bayside, New York, 11361, United States|New York Methodist Hospital, Brooklyn, New York, 11215, United States|Asheville Cardiology Associates, Asheville, North Carolina, 28803, United States|Sanford Heart Hospital, Fargo, North Dakota, 58122, United States|Children s Hospital Medical Center, Cincinnati, Ohio, 45229, United States|The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Midwest Pulmonary & Sleep Research, Dayton, Ohio, 45459, United States|Southwest General Health Center, Middleburg Heights, Ohio, 44130, United States|INTEGRIS Baptist Medical Center, Inc, Oklahoma City, Oklahoma, 73112, United States|The Lankenau Institute for Medical Research, Wynnewood, Pennsylvania, 19096, United States|WellSpan Health, York, Pennsylvania, 17405, United States|Maury Regional Medical Center, Columbia, Tennessee, 20910, United States|Pulmonary Consultants of San Antonio, PA, San Antonio, Texas, 78229, United States|The Rector and Visitors of the University of Virginia, Charlottesville, Virginia, 22903, United States|Carilion Medical Center, Roanoke, Virginia, 24014, United States|Pulmonary & Sleep Research, Spokane, Washington, 99204, United States|University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, 53705, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|The Medical College of Wisconsin, Inc., Milwaukee, Wisconsin, 53226, United States|CardioPulmonary Research Center, Guaynabo, 00968, Puerto Rico | null | {} |
NCT06315673 | Digital Assessment of Speech and Fine Motor Control in ALS | https://clinicaltrials.gov/study/NCT06315673 | null | NOT_YET_RECRUITING | This is a single-session, case-control study that incorporates digital tools for assessing speech and motor function in motor neuron disease. Patients with motor neuron disease (including amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA)) and age-matched healthy controls will be enrolled. Subjects will complete a speech and handwriting assessment during the study visit on a tablet computer (BioSensics LLC, Newton, MA). We will explore whether these digital biomarkers are sensitive to functional disease severity as reported by the ALS Functional Rating Scale - Revised (ALFRS-R) [1]. We will also compare assessment data between the patient and control groups. | NO | Amyotrophic Lateral Sclerosis|Primary Lateral Sclerosis|Progressive Muscular Atrophy | BEHAVIORAL: Digital Speech and Handwriting Assessment | Speaking rate during a standardized passage, Speaking rate, in words per minute, will be determined from an audio recording of a standardized reading passage., baseline|Residual on spiral tracing task, Handwriting tasks include tracing of a spiral. The average residual, or deviation from the target spiral (in pixels), will be determined from the handwriting file associated with the tracing task., baseline | ALS Functional Rating Scale- Revised (ALSFRS-R), The ALSFRS-R measures 12 aspects of physical function, ranging from one s ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0., baseline|Forced vital capacity (FVC), FVC is collected at clinical appointments by a respiratory therapist. FVC is the volume of air that is forcefully expelled into a spirometer. FVC is expressed as a percentage (%) of predicted volume against an age, height, and ethnicity matched standard. The best result of three trials is used., baseline|Upper motor neuron function, Reflex testing is performed by the attending neurologist at clinical appointments. Bilateral biceps, triceps, and brachioradialis reflexes will be documented according to Modified Ashworth Scale grade 0 (no tone increase) to 4 (limb rigid). Total score for bilateral muscle groups ranges from 0 to 24., baseline|Strength testing, Strength testing is performed by the attending neurologist at clinical appointments. Bilateral deltoids, biceps, triceps, wrist extension, and interossei strength will be documented according to Medical Research Council (MRC) grade 0 (no power) to 5 (normal power). Total score for bilateral muscle groups ranges from 0 to 50., baseline | null | Milton S. Hershey Medical Center | BioSensics | ALL | ADULT, OLDER_ADULT | null | 50 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | STUDY00024562 | 2024-06-01 | 2026-03-30 | 2027-03-30 | 2024-03-18 | null | 2024-05-09 | null | null | {
"Digital Speech and Handwriting Assessment": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT02580773 | Therapeutic Anticoagulation Strategy for Acute Chest Syndrome | https://clinicaltrials.gov/study/NCT02580773 | TASC | COMPLETED | Acute Chest Syndrome (ACS) is a pulmonary complication of sickle cell disease (SCD) representing the leading cause of death and the second cause of hospitalization among adult patients. Pulmonary vaso-occlusion is one of the main pathophysiologic hypotheses during ACS. Our hypothesis is that therapeutic anticoagulation may reduce the severity of ACS via the alleviation of pulmonary thrombosis. The main objective of this prospective, randomized, double-blind study is to test the efficacy and safety of a curative anticoagulation strategy during ACS. The main efficacy endpoint is time to ACS resolution. The main safety endpoint is number of major bleedings.
A thoracic CT scan will be performed to check for pulmonary artery thrombosis. If the CT scan is positive (thrombosis within a large elastic artery), the patient will not be randomized and will be treated with a curative anticoagulation. If the CT scan is negative, the patient will be randomized to receive subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) either at a curative dose (175 Unit International (UI)/kg/day for 7 days) or at a prophylactic dose (4500 UI/day). | NO | Anemia|Sickle Cell|Acute Chest Syndrome|Low-Molecular-Weight Heparin | DRUG: Prophylactic anticoagulation ( INNOHEP®)|DRUG: Curative anticoagulation ( INNOHEP®) | The main efficacy endpoint is time to ACS resolution, The delay between randomization and ACS resolution, up to 15 days|Number of major bleedings, up to 15 days | Number of complicated ACS, up to 15 days|Blood volume exchanged, up to 15 days|Cumulative dose of opioids, up to 15 days|Hospital mortality, up to 15 days|Duration of hospital stay, up to 15 days|Number of non-major bleedings, up to 15 days|Number of readmissions and thromboembolic events within 6 months, at 6 months | null | Assistance Publique - Hôpitaux de Paris | LEO Pharma | ALL | ADULT, OLDER_ADULT | PHASE3 | 198 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | AOR 14068.00 | 2016-12-16 | 2021-02-04 | 2021-09-15 | 2015-10-20 | null | 2024-02-09 | Henri Mondor Hospital, Creteil, 94010, France | null | {
"Prophylactic anticoagulation ( INNOHEP\u00ae)": [
{
"intervention_type": "DRUG"
}
],
"Curative anticoagulation ( INNOHEP\u00ae)": [
{
"intervention_type": "DRUG"
}
]
} |
NCT02757573 | The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery | https://clinicaltrials.gov/study/NCT02757573 | null | COMPLETED | The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography. | NO | Heart; Decompensation, Right Ventricle|Echocardiography|Hypercapnia | PROCEDURE: Hypercarbia | Tricuspid annular plane systolic excursion (TAPSE), TAPSE will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa), Change from baseline TAPSE at hypercarbia (in approximately 30 min)|Mean pulmonary artery pressure (MPAP), MPAP will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa), Change from baseline MPAP at hypercarbia (in approximately 30 min) | null | null | Tampere University Hospital | null | ALL | ADULT, OLDER_ADULT | null | 31 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | R16005 | 2016-04 | 2018-12 | 2019-12 | 2016-05-02 | null | 2023-04-25 | Tampere University Hospital Heart Center, Tampere, 33521, Finland | null | {
"Hypercarbia": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT04992273 | COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age | https://clinicaltrials.gov/study/NCT04992273 | null | TERMINATED | The primary objective of the study is to characterize the concentrations of casirivimab+imdevimab in serum over time after a single subcutaneous (SC) administration
The secondary objectives of the study are:
* To assess the safety and tolerability of SC or single administration of casirivimab+imdevimab
* To assess the occurrence of grade ≥3 injection site reactions and grade ≥3 hypersensitivity reactions, in participants treated with SC doses of casirivimab+imdevimab
* To assess the immunogenicity of casirivimab+imdevimab | YES | COVID-19 | DRUG: casirivimab+imdevimab | Concentrations of Casirivimab+Imdevimab in Serum Over Time., Concentrations reported in milligrams per Liter (mg/L), Day 0 and Day 14 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Through end of study, approximately 24 weeks|Number of Participants With Indicated Severity of TEAEs, Treatment-emergent adverse events (TEAEs) are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. The severity of AEs were graded using version 5.0 of NCI-CTCAE., Through end of study, approximately 24 weeks|Number of Participants With Grade ≥3 Injection Site Reactions, Through Day 4|Number of Participants With Grade ≥3 Hypersensitivity Reactions, Through Day 4|Number of Participants With Indicated Immunogenicity as Measured by Anti-drug Antibodies (ADA) to Casirivimab Over Time, Up to 24 weeks|Number of Participants With Indicated Immunogenicity as Measured by ADA to Imdevimab Over Time, Up to 24 weeks|Immunogenicity as Measured by Neutralizing Antibodies (NAb) to Casirivimab Over Time, Up to 24 weeks|Immunogenicity as Measured by NAb to Imdevimab Over Time, Up to 24 weeks | null | Regeneron Pharmaceuticals | null | ALL | CHILD | PHASE2 | 7 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | R10933-10987-COV-2121|2021-004590-30 | 2021-09-13 | 2022-06-01 | 2022-06-01 | 2021-08-05 | 2023-03-06 | 2023-03-06 | Advanced Research Center, Inc, Anaheim, California, 92805, United States|Batchelor s Children s Research Institute, Miami, Florida, 33136, United States|Jacobi Medical Center, Bronx, New York, 10461, United States|Stony Brook University Hospital, Stony Brook, New York, 11794, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|Coastal Pediatric Research, Charleston, South Carolina, 29414, United States|Regeneron Research Site, Richmond, Virginia, 23226, United States | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/73/NCT04992273/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT04992273/SAP_001.pdf | {
"casirivimab+imdevimab": [
{
"intervention_type": "DRUG"
}
]
} |
NCT02168673 | Modulation of Genes Responsible for Cilia Length by Exposure to Cigarette Smoke | https://clinicaltrials.gov/study/NCT02168673 | null | COMPLETED | Cigarette smoking is the major risk factor for developing chronic obstructive pulmonary disease (COPD). Patients with COPD have difficulty clearing mucus and debris from their airways. Even smokers who have not developed COPD may have difficulty clearing the airways. This is partly because smoking impairs the function of cilia, tiny hairs lining the airways that sweep out mucus to keep the airways clean. The investigators have found that smoking reduces the length of cilia, which may contribute to the worsened cilia function in smoking and COPD. This is true even in smokers who show no signs of lung disease. The investigators believe that smoking affects levels of genes in lung cells, resulting in shorter cilia. | NO | COPD|Smoking | null | Evidence that exposure to cigarette smoke will result in shorter cilia length in human airway epithelial, Cilia length will be measured using three preparation techniques: air-dried cytospins, detached cilia on cytospins, and mounted hydrated aliquots of cells., One Year | null | null | Weill Medical College of Cornell University | null | ALL | ADULT, OLDER_ADULT | null | 1 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1102011549 | 2011-04 | 2015-04 | 2015-04 | 2014-06-20 | null | 2016-05-02 | Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine, New York, New York, 10021, United States | null | {} |
NCT01447173 | Vitamin and Asthma Study | https://clinicaltrials.gov/study/NCT01447173 | null | COMPLETED | The study looks at how vitamin D supplement will improve the severity of asthma and lung function as well as biomarkers in asthmatic children. | NO | Asthma | DRUG: Vitamin D | Change in Pulmonary Function Test (PFT) after vitamin D supplementation, 4 weeks|Change in Asthma Control Test (ACT) scores after vitamin D supplementation, 4-week | null | null | Augusta University | null | ALL | CHILD | PHASE4 | 10 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | VDAS | 2010-12 | 2011-09 | 2011-09 | 2011-10-06 | null | 2012-10-23 | Pediatrics Allergy Clinic at Georgia Health Sciences University, Augusta, Georgia, 30912, United States | null | {
"Vitamin D": [
{
"intervention_type": "DRUG"
}
]
} |
NCT02488031 | Functional and Structural Imaging and Motor Control in Spinocerebellar Ataxia | https://clinicaltrials.gov/study/NCT02488031 | SCA | COMPLETED | The purpose of this research study is to investigate how the brain and motor behavior changes both in individuals with spinocerebellar ataxia and healthy individuals, and to assess whether a therapeutic intervention reduces levels of uncoordinated movement and improves motor function in spinocerebellar ataxia (SCA). | NO | Spinocerebellar Ataxia | BEHAVIORAL: Error-reduction|BEHAVIORAL: International Cooperative Ataxia Rating Scale|BEHAVIORAL: Scale for the Assessment and Rating of Ataxia|BEHAVIORAL: Beck Depression Inventory, 2nd Ed|BEHAVIORAL: Stroop|BEHAVIORAL: Purdue Pegboard|BEHAVIORAL: Brief Test of Attention|BEHAVIORAL: 6-minute Walk|BEHAVIORAL: Hand Grip Dynamometer|BEHAVIORAL: Montreal Cognitive Assessment|BEHAVIORAL: Physical Performance Function|BEHAVIORAL: Biomechanical Assessments of Dysmetria|BEHAVIORAL: Neurophysiological assessment of brain activity|BEHAVIORAL: Biomechanical gait analysis | Change in the Location of the Movement Endpoint Relative to the Target in the Motor Task, Assessment of the subject s ability to stay on target during the motor task. The task is a goal-directed movement that aims to match a spatial target in a specific time(time target)., Change from Baseline to 1 month | International Cooperative Ataxia Rating Scale(ICARS) Assessment, The ICARS is an assessment of the ataxia severity. The ICARS score is the total sum of the sub scores on specific movements and ranges from 0 to 100, with a score of 100 being indicative of the most severely affected outcome., Change from Baseline to 1 month|Change in Motor Unit Discharge Rate Variability, Amount of motor unit activity occurring during the Electromyography(EMG) task. Lower amount of variability is better. The change reflects the difference in values between the pre- and post-training sessions. The discharge rate variability will change by percent., Change from Baseline to 1 month|Change in Blood-oxygen-level-dependent(BOLD) Activity of Motor Cortex, Results of blood-oxygen-level-dependent contrast imaging as analyzed from functional Magnetic Resonance Imaging(fMRI). More colors indicates more excitement of the motor cortex., Change from Baseline to 1 month | null | University of Florida | National Institute of Neurological Disorders and Stroke (NINDS)|University of South Florida | ALL | ADULT, OLDER_ADULT | null | 19 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | IRB201500202-N|R21NS094946 | 2016-03 | 2019-01-17 | 2019-01-17 | 2015-07-02 | null | 2019-05-13 | University of Florida, Gainesville, Florida, 32611, United States | null | {
"Error-reduction": [
{
"intervention_type": "BEHAVIORAL"
}
],
"International Cooperative Ataxia Rating Scale": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Scale for the Assessment and Rating of Ataxia": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Beck Depression Inventory, 2nd Ed": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Stroop": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Purdue Pegboard": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Brief Test of Attention": [
{
"intervention_type": "BEHAVIORAL"
}
],
"6-minute Walk": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Hand Grip Dynamometer": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Montreal Cognitive Assessment": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Physical Performance Function": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Biomechanical Assessments of Dysmetria": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Neurophysiological assessment of brain activity": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Biomechanical gait analysis": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT01124331 | Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis | https://clinicaltrials.gov/study/NCT01124331 | NeOProM | COMPLETED | The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)? | NO | Infant, Premature, Diseases|Bronchopulmonary Dysplasia|Retinopathy of Prematurity|Infant, Newborn, Diseases|Infant, Very Low Birth Weight | PROCEDURE: Higher oxygen saturation target range (91%-95%)|PROCEDURE: Lower oxygen saturation (85%-89%) | composite outcome of death or major disability by 18-24 months corrected age, Major disability is defined as any of the following:
* Bayley-III Developmental Assessment cognitive score <85 and/or language score <85
* Severe visual loss
* Cerebral palsy with Gross Motor Function Classification System (GMFCS) level 2 or higher or Manual Ability Classification System (MACS) level 2 or higher at 18-24 months postmenstrual age
* Deafness requiring hearing aids, by 18-24 months corrected age (gestational age plus chronological age) | Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection, at 18-24 months corrected age|measures of respiratory support, • Measures of respiratory support, including the following separate outcomes a. supplemental oxygen requirement at 36 weeks postmenstrual age, b. postmenstrual age ceased endotracheal intubation, c. postmenstrual age ceased continuous positive airway pressure (CPAP), d. postmenstrual age ceased supplemental oxygen, e. postmenstrual age ceased home oxygen (if received)., 36 weeks postmenstrual age|Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment, at 18-24 months corrected age|Patent ductus arteriosus receiving surgical treatment, at 18-24 months corrected age|Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006), 18-24 months corrected age|Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006), at 36 weeks postmenstrual age and discharge home|Re-admissions to hospital, up to 18-24 months postmenstrual age|Cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher at 18-24 months corrected age, at 18-24 months corrected age|Severe visual impairment (cannot fixate or is legally blind:<6/60 vision , 1.3 logMAR in both eyes or equivalent as defined by trial), at 18-24 months corrected age|deafness requiring hearing aids, at 18-24 months corrected age|Bayley-III Developmental Assessment cognitive score <85 and/or language score <85, 2 years corrected age|death, at 18-24 months corrected age | Subgroup analyses will be undertaken on all pre-specified primary and secondary outcomes., Subgroups:
* Gestational age
* less than 26 weeks
* greater than or equal to 26 weeks
* Inborn or outborn
* Use of any antenatal corticosteroids = yes if any of the following
* incomplete, less than 24 hours before birth
* complete
* more than 7 days before birth
* started less than 24h before birth
* started 24h or more before birth
* Male or female gender
* Small for gestation age
* birth weight below trialist defined cut-point
* birth weight less than 10th percentile using WHO centile charts
* Multiple or singleton birth
* Mode of delivery
* Vaginal if any of the following: vaginal, vaginal-cephalic, vaginal-breech
* Caesarean if any of the following: caesarean, caesarean section before onset of labour, caesarean section after onset of labour, caesarean section
* Time of intervention commencement
* less than 6 hours after birth
* 6 hours or more after birth
* Oximeter calibration software
* original
* revised, at 18-24 months corrected age | University of Sydney | University of Otago|University of Oxford|University of Pennsylvania|University of California, San Diego | ALL | CHILD | null | 4,965 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | NeOProM | 2005-03 | 2014-08 | 2014-08 | 2010-05-17 | null | 2019-03-13 | Canberra Hospital, Canberra, Australian Capital Territory, Australia|Royal Prince Alfred Hospital Women and Babies, Camperdown, New South Wales, 2050, Australia|Liverpool Hospital, Liverpool, New South Wales, 2170, Australia|John Hunter Hospital, New Lambton, New South Wales, 2310, Australia|Royal North Shore Hospital, NSW, St Leonards, New South Wales, Australia|Westmead Hospital,, Westmead, New South Wales, 2145, Australia|Royal Brisbane Women s Hospital, Brisbane, Queensland, 4006, Australia|Royal Women s Hospital, Melbourne, Victoria, 3052, Australia|Monash Medical Centre, Melbourne, Victoria, 3800, Australia | null | {
"Higher oxygen saturation target range (91%-95%)": [
{
"intervention_type": "PROCEDURE"
}
],
"Lower oxygen saturation (85%-89%)": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT01777373 | Conducting Airways in Lung Fibrosis (VACFI) | https://clinicaltrials.gov/study/NCT01777373 | VACFI | COMPLETED | The purpose of this study is to determine whether extension of the conducting airways into the distal lung, or bronchiolization, occurs early in the course of Idiopathic Pulmonary Fibrosis, a disease wherein normal lung structures are destroyed and replaced by non-functional scar tissue. | NO | Idiopathic Pulmonary Fibrosis | null | Fowler dead space, Conducting airway volume is determined by Fowler s method from volumetric capnography data, 1 day | Bohr anatomic dead space, Bohr anatomic dead space is determined from capnography and spirometry data., 1 day | null | Assistance Publique - Hôpitaux de Paris | null | ALL | ADULT, OLDER_ADULT | null | 141 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | P110902|N° IDRCB : 2012-A00295-38 | 2012-08 | 2015-01 | 2015-02 | 2013-01-28 | null | 2015-04-10 | Hôpital Bichat, Paris, 75018, France | null | {} |
NCT03740373 | A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate | https://clinicaltrials.gov/study/NCT03740373 | null | COMPLETED | This study is a 2 treatment period, single dose crossover, gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler.
This study will be investigating how the drug (known as PT010) is distributed in the lungs following a 10 second or 3 second breath hold.
The study will involve the following visits: 1 screening visits, 2 treatment visits, each separated by around 7 days (each with 1 overnight stay; from the evening before dosing until a minimum of 4 hours post-dose on the morning of Day 1) and a post-study follow up phone call.
The study population will be 10 healthy males, aged between 28 and 50 years of age. | NO | Pulmonary Disease, Chronic Obstructive | DRUG: BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold|DRUG: BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold | Percentage lung deposition following 10 s breath hold, The percentage (%) emitted dose of radiolabelled BGF MDI deposited in the lungs following 10 s breath hold., Day 1 (of either Treatment Period 1 or 2) | Percentage lung deposition following 3 s breath hold, The percentage (%) emitted dose of radiolabelled BGF MDI deposited in the lungs following 3 s breath hold., Day 1 (of either Treatment Period 1 or 2)|Regional airway deposition following 10 s breath hold, The regional airway deposition ratios including outer to inner (O/I) and central to peripheral (C/P) regions of the radiolabelled BGF MDI following a 10 s breath hold., Day 1 (of either Treatment Period 1 or 2)|Oropharyngeal and stomach deposition following 10 s breath hold, The fraction of the dose of radiolabelled BGF MDI deposited in the oropharyngeal and stomach regions (expressed as % emitted dose) following a 10 sec breath hold., Day 1 (of either Treatment Period 1 or 2)|Actuator and exhalation filter deposition following 10 s breath hold, The fraction of the dose of radiolabelled BGF MDI deposited on the actuator (expressed as % ex-valve dose) and exhalation filter (expressed as % emitted dose) following a 10 s breath hold., Day 1 (of either Treatment Period 1 or 2)|Regional airway deposition following 3 s breath hold, The regional airway deposition ratios including outer to inner (O/I) and central to peripheral (C/P) regions of the radiolabelled BGF MDI following a 3 s breath hold., Day 1 (of either Treatment Period 1 or 2)|Oropharyngeal and stomach deposition following 3 s breath hold, The fraction of the dose of radiolabelled BGF MDI deposited in the oropharyngeal and stomach regions (expressed as % emitted dose) following a 3 s breath hold., Day 1 (of either Treatment Period 1 or 2)|Actuator and exhalation filter deposition following 3 s breath hold, The fraction of the dose of radiolabelled BGF MDI deposited on the actuator (expressed as % ex-valve dose) and exhalation filter (expressed as % emitted dose) following a 3 s breath hold., Day 1 (of either Treatment Period 1 or 2) | Number of TEAEs, Number of TEAEs, Day 1 to Follow-up (Day 7-14 post-dose)|Number of subjects reporting at least 1 Treatment Emergent Adverse Event, Number of subjects reporting at least 1 Treatment Emergent Adverse Event, Day 1 to Follow-up (Day 7-14 post-dose)|Number of subjects reporting at least 1 serious Treatment Emergent Adverse Event, Number of subjects reporting at least 1 serious Treatment Emergent Adverse Event, Day 1 to follow-up (Day 7-14 post dose)|Number of subjects reporting at least 1 Treatment Emergent Adverse Event leading to withdrawal from the study, Number of subjects reporting at least 1 Treatment Emergent Adverse Event leading to withdrawal from the study, Day 1 to Follow-up (Day 7-14 post dose)|Number of subjects reporting Treatment Emergent Adverse Events by severity and relationship to IMP., Number of subjects reporting Treatment Emergent Adverse Events by severity and relationship to IMP., Day 1 to Follow-up (Day 7-14 post-dose)|Percentage of subjects reporting at least 1 Treatment Emergent Adverse Event, Percentage of subjects reporting at least 1 Treatment Emergent Adverse Event, Day 1 to Follow-up (Day 7-14 post-dose)|Percentage of subjects reporting at least 1 serious Treatment Emergent Adverse Event, Percentage of subjects reporting at least 1 serious Treatment Emergent Adverse Event, Day 1 to follow-up (Day 7-14 post dose)|Percentage of subjects reporting at least 1 Treatment Emergent Adverse Event leading to withdrawal from the study, Percentage of subjects reporting at least 1 Treatment Emergent Adverse Event leading to withdrawal from the study, Day 1 to Follow-up (Day 7-14 post dose)|Percentage of subjects reporting Treatment Emergent Adverse Events by severity and relationship to IMP., Percentage of subjects reporting Treatment Emergent Adverse Events by severity and relationship to IMP., Day 1 to Follow-up (Day 7-14 post-dose) | AstraZeneca | null | MALE | ADULT | PHASE1 | 10 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT | D5980C00007 | 2018-09-04 | 2018-10-11 | 2018-10-11 | 2018-11-14 | null | 2018-11-14 | Research Site, Pentrebach, CF48 4DR, United Kingdom | null | {
"Glycopyrrolate": [
{
"intervention_type": "DRUG",
"description": "BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold",
"name": "Glycopyrrolate",
"synonyms": [
"",
"Lonhala Magnair",
"Bromide, Glycopyrronium",
"Bevespi Aerosphere",
"Glycopyrronium bromide",
"NVA 237",
"Pyrrolidinium, 3-((cyclopentylhydroxyphenylacetyl)oxy)-1,1-dimethyl-, bromide",
"NVA-237",
"Glycopyrronium",
"NVA237",
"Robinul",
"Cuvposa",
"Glycopyrrolate",
"Glycopyrronium Bromide",
"Glycopyrrolate ion",
"Qbrexza",
"Glycopyrronium",
"Glycopyrronium cation",
"Glycopyrronium ion",
"Glycopyrrolate",
"Glicopirronio",
"Glycopyrrolate cation",
"Glycopyrrolate ion",
"Qbrexza",
"Glycopyrronium",
"Glycopyrronium cation",
"Glycopyrronium ion",
"Glycopyrrolate",
"Glicopirronio",
"Glycopyrrolate cation",
"Glycopyrronium bromide/formoterol",
"Bevespi Aerosphere",
"Glycopyrronium bromide/formoterol",
"Bevespi Aerosphere",
"Glycopyrrolate ion",
"Qbrexza",
"Glycopyrronium",
"Glycopyrronium cation",
"Glycopyrronium ion",
"Glycopyrrolate",
"Glicopirronio",
"Glycopyrrolate cation",
"Glycopyrrolate ion",
"Qbrexza",
"Glycopyrronium",
"Glycopyrronium cation",
"Glycopyrronium ion",
"Glycopyrrolate",
"Glicopirronio",
"Glycopyrrolate cation"
],
"medline_plus_id": "a618016",
"generic_names": [
"Glycopyrrolate",
"Glycopyrronium",
"Glycopyrronium",
"Glycopyrronium",
"Glycopyrronium"
],
"mesh_id": "D018727",
"wikipedia_url": "https://en.wikipedia.org/wiki/Glycopyrronium%20bromide"
},
{
"intervention_type": "DRUG",
"description": "BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold",
"name": "Glycopyrrolate",
"synonyms": [
"",
"Lonhala Magnair",
"Bromide, Glycopyrronium",
"Bevespi Aerosphere",
"Glycopyrronium bromide",
"NVA 237",
"Pyrrolidinium, 3-((cyclopentylhydroxyphenylacetyl)oxy)-1,1-dimethyl-, bromide",
"NVA-237",
"Glycopyrronium",
"NVA237",
"Robinul",
"Cuvposa",
"Glycopyrrolate",
"Glycopyrronium Bromide",
"Glycopyrrolate ion",
"Qbrexza",
"Glycopyrronium",
"Glycopyrronium cation",
"Glycopyrronium ion",
"Glycopyrrolate",
"Glicopirronio",
"Glycopyrrolate cation",
"Glycopyrrolate ion",
"Qbrexza",
"Glycopyrronium",
"Glycopyrronium cation",
"Glycopyrronium ion",
"Glycopyrrolate",
"Glicopirronio",
"Glycopyrrolate cation",
"Glycopyrronium bromide/formoterol",
"Bevespi Aerosphere",
"Glycopyrronium bromide/formoterol",
"Bevespi Aerosphere",
"Glycopyrrolate ion",
"Qbrexza",
"Glycopyrronium",
"Glycopyrronium cation",
"Glycopyrronium ion",
"Glycopyrrolate",
"Glicopirronio",
"Glycopyrrolate cation",
"Glycopyrrolate ion",
"Qbrexza",
"Glycopyrronium",
"Glycopyrronium cation",
"Glycopyrronium ion",
"Glycopyrrolate",
"Glicopirronio",
"Glycopyrrolate cation"
],
"medline_plus_id": "a618016",
"generic_names": [
"Glycopyrrolate",
"Glycopyrronium",
"Glycopyrronium",
"Glycopyrronium",
"Glycopyrronium"
],
"mesh_id": "D018727",
"wikipedia_url": "https://en.wikipedia.org/wiki/Glycopyrronium%20bromide"
}
],
"Formoterol": [
{
"intervention_type": "DRUG",
"description": "BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold",
"name": "Formoterol",
"synonyms": [
"Formoterol",
"Foradil",
"N-[2-hydroxy-5-(1-hydroxy-2-{[2-(4-methoxyphenyl)-1-methylethyl]amino}ethyl)phenyl]formamide",
"Oxeze",
"Formoterolum",
"2'-hydroxy-5'-(1-hydroxy-2-((p-methoxy-\u03b1-methylphenethyl)amino)ethyl)formanilide",
"2'-hydroxy-5'-{1-hydroxy-2-[(p-methoxy-\u03b1-methylphenethyl)amino]ethyl}formanilide"
],
"medline_plus_id": "a602023",
"generic_names": [
"Formoterol"
],
"drugbank_id": "DB00983",
"wikipedia_url": "https://en.wikipedia.org/wiki/Formoterol"
},
{
"intervention_type": "DRUG",
"description": "BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold",
"name": "Formoterol",
"synonyms": [
"Formoterol",
"Foradil",
"N-[2-hydroxy-5-(1-hydroxy-2-{[2-(4-methoxyphenyl)-1-methylethyl]amino}ethyl)phenyl]formamide",
"Oxeze",
"Formoterolum",
"2'-hydroxy-5'-(1-hydroxy-2-((p-methoxy-\u03b1-methylphenethyl)amino)ethyl)formanilide",
"2'-hydroxy-5'-{1-hydroxy-2-[(p-methoxy-\u03b1-methylphenethyl)amino]ethyl}formanilide"
],
"medline_plus_id": "a602023",
"generic_names": [
"Formoterol"
],
"drugbank_id": "DB00983",
"wikipedia_url": "https://en.wikipedia.org/wiki/Formoterol"
}
]
} |
NCT06468527 | Clinical Trial to Evaluate the Efficacy and Safety of Dirocaftor/Posenacaftor/Nesolicaftor in Adults With CF | https://clinicaltrials.gov/study/NCT06468527 | CHOICES | RECRUITING | CF is caused by mutations in the gene that encodes the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) channel. To re-establish the function of this complex chloride channel, typically two to three drug modes of action are needed. To date, clinical studies of CFTR modulators have focused on patients carrying the F508del CFTR mutation, which is present in approximately 80% of CF patients, or gating mutations which are present in 5% of CF patients (gating mutations result in a reduced opening of the CFTR-channel at the cell surface which limits the flow of chloride ions through the CFTR channel). Although CF is a monogenetic disease, the 15% remaining patients represent more than 2000 different rare and mostly uncharacterized CFTR mutations. Multiple pharma companies have one or more CF drugs in their developmental pipeline. However, it is not known which patients may respond to the drugs in the pipeline. It is hypothesized that by using individual patient s intestinal organoids to screen for drug response, a subset of patients with rare CFTR mutations can be identified who will clinically respond to drugs in the developmental pipeline. The Human Individualized Therapy of CF (HIT-CF) project has been designed to further evaluate this hypothesis. The project has received funding from the European Union s Horizon 2020 research and innovation program under grant agreement No 755021. The core of the project consists of a two-step approach to identify patients outside the existing drug label who may also benefit from CFTR-modulator treatment. In the first step of the project (HIT-CF Organoid Study, NTR7520), novel CFTR modulators and their combinations were tested on organoids from over 500 European and Israeli CF patients with rare CFTR mutations to identify patients who are predicted to clinically benefit from these treatments. The second step will evaluate the predicted clinical effect of the CFTR modulators in subjects identified by their organoid response to investigational products. CFTR modulators from the HIT-CF participating pharmaceutical company, FAIR Therapeutics, will be evaluated in the CHOICES clinical study described in this protocol. Data from this clinical study will be compared with the HIT-CF Organoid Study results to validate the organoid model. | NO | Cystic Fibrosis | DRUG: Diponecaftor|DRUG: Placebo | Mean percent predicted forced expiratory volume in 1 second (ppFEV1), The primary endpoint in both groups is the mean percent predicted forced expiratory volume in 1 second (ppFEV1) of measurements taken after 4, 6 and 8 weeks of treatment. Period baseline values will be corrected for in the analysis., Measurements taken at 4, 6 and 8 weeks of treatment | Sweat chloride, The average of the sweat chloride measurements taken after 4, 6 and 8 weeks of treatment., Measurements taken at 4, 6 and 8 weeks of treatment|Body weight, The average of the body weight measurements taken after 4, 6 and 8 weeks of treatment, Measurements taken at 4, 6 and 8 weeks of treatment|Cystic Fibrosis Questionnaire Revised (CFQ R) respiratory domain, The average of the Cystic Fibrosis Questionnaire Revised (CFQ R) respiratory domain measurements taken after 4, 6 and 8 weeks of treatment. Scores range from 0 to 100, with higher scores indicating better health., Measurements taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Safety and tolerability assessments based on treatment-emergent Adverse Events (AEs), Through study completion, an average of 30 weeks|Safety and tolerability assessments, Safety and tolerability assessments based on treatment-emergent Serious Adverse events (SAEs), Through study completion, an average of 30 weeks|Safety and tolerability assessments, Platelet count, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Liver function (total bilirubin), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Liver function (alkaline phosphatase (ALP)), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Liver function (alanine transaminase (ALT)), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Liver function (gamma-glutamyl transferase (GGT)), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Anemia (Haemoglobin (Hb)), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Anemia (Haematocrit), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Anemia (Red blood cell count), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, White blood cell count (including differential), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Glucose measured in blood, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Sodium in blood, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Cholesterol in blood, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Total protein in blood, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Potassium in blood, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Chloride in blood, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Bicarbonate in blood, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Lactate dehydrogenase in blood, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Albumine in blood, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Calcium in blood, Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, GFR MDRD (equation based on sex, ethnicity, age, blood urea nitrogen (BUN), creatinine), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Ketonuria (ketones measured by urine dipstick), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Proteinuria (protein measured by urine dipstick), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Hematuria (blood measured by urine dipstick), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Glucosuria (glucose measured by urine dipstick), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, pH of urine (pH measured by urine dipstick), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Specific gravitiy of urine (measured by urine dipstick), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Coagulation (activated partial thromboplastin time (aPTT)), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Coagulation (prothrombin time international normalized ratio (PT-INR)), Measurement taken at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, ECG QT Interval, Measurement taken at 4 weeks of treatment|Safety and tolerability assessments, Systolic and diastolic blood pressure, Measurement taken at start of treatment and at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Heart rate, Measurement taken at start of treatment and at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Respiratory rate, Measurement taken at start of treatment and at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Body temperature, Measurement taken at start of treatment and at 4, 6 and 8 weeks of treatment|Safety and tolerability assessments, Pulse oximetry measurements, Measurement taken at start of treatment and at 4, 6 and 8 weeks of treatment | null | Kors van der Ent | European Union | ALL | ADULT, OLDER_ADULT | PHASE2 | 52 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | HIT-CF-001 | 2024-06-03 | 2025-04-01 | 2025-06-01 | 2024-06-21 | null | 2024-06-21 | UZ Leuven, Leuven, Vlaams-Brabant, Belgium|CHU de Nice, Nice, France|Hôpital Larrey CHU Toulouse, Toulouse, France|Charité Universitätsmedizin Berlin, Berlin, Germany|Medizinische Hochschule Hannover, Hanover, Germany|Instituto Giannina Gaslini, Genova, Italy|Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan, Italy|Ospedale Pediatrico Bambino Gesù, Rome, Italy|Azienda Ospedaliera Universitaria Integrata, Verona, Italy|UMC Utrecht, Utrecht, 3584 CX, Netherlands|Hospital de Santa Maria, Lisboa, Portugal|Hospital Vall d Hebron, Barcelona, Spain|Sahlgrenska University Hospital, Gothenburg CF center, Gothenburg, Sweden|University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom|Royal Brompton Hospital, London, United Kingdom|University Hospital Southampton, Southampton, United Kingdom | null | {
"Diponecaftor": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |