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NCT02767687 | Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery | https://clinicaltrials.gov/study/NCT02767687 | null | COMPLETED | This study evaluates whether noninvasive ventilation with continuous positive airway pressure affects tissue perfusion in patients after cardiac surgery. | NO | Heart Diseases|Coronary Artery Disease | OTHER: Noninvasive ventilation | Evaluation of central venous oxygen saturation to determine tissue perfusion, All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the central venous catheter at different times to evaluate central venous oxygen saturation. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation., Through study completion, an average of 1 year|Evaluation of arterial lactate to determine tissue perfusion, All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the arterial invasive catheter at different times to evaluate arterial lactate. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation., Through study completion, an average of 1 year | Respiratory complications during hospitalization, Respiratory events as pleural effusion and atelectasis will be evaluated by a professional blind to the protocol of study and will be recorded., Through study completion, an average of 1 year|Hemodinamycs complications during hospitalization, Hemodinamycs events as arrhythmia, hypotension and cardiac arrest will be evaluated by a professional blind to the protocol of study and will be recorded., Through study completion, an average of 1 year | null | Federal University of São Paulo | null | ALL | ADULT, OLDER_ADULT | null | 80 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 1.156.460 | 2013-09 | 2014-11 | 2014-11 | 2016-05-10 | null | 2016-05-10 | null | null | {
"Noninvasive ventilation": [
{
"intervention_type": "OTHER"
}
]
} |
NCT02726087 | Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement | https://clinicaltrials.gov/study/NCT02726087 | QUALITY-AVR | COMPLETED | This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at Virgen de la Victoria Universitary Hospital , Málaga, Spain, will be eligible. Ninety-six patients will be randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL). | NO | Aortic Valve Stenosis|Heart Valve Diseases|Aortic Valve Disease | PROCEDURE: ministernotomy|PROCEDURE: Full sternotomy | Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Index at 1, 6 or 12 months, Questionnaire EQ-5D-5L® for quality of life, baseline-1-6-12 months | Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Visual Analogic Scale for pain at 1, 6 or 12 months, Questionnaire EQ-5D-5L® for quality of life, baseline-1-6-12 months|Early postoperative combined endpoint of 6 complications, All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, acute renal failure AKIN (acute kidney injury classification) greater or equal than 2, nosocomial infections (Pneumonia, early endocarditis, mediastinitis, sepsis) and need of any reintervention, 1 month|Satiscore Questionnaire, Satisfaction in cardiac surgery, 1-6 months|Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® severity index at 1, 6 and 12 months, Questionnaire EQ-5D-5L® for quality of life, baseline-1-6-12 months|Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® health index (severity index inverse) at 1, 6 and 12 months, Questionnaire EQ-5D-5L® for quality of life, baseline-1-6-12 months|Late postoperative combined endpoint of 6 complications, All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, acute renal failure AKIN (acute kidney injury classification) greater or equal than 2, nosocomial infections (Pneumonia, early endocarditis, mediastinitis, sepsis) and need of any reintervention, 1-5 years|Total in-Hospital and Intensive Care Unit stay (in days), From date of surgery until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year|Cardiopulmonary bypass time in minutes and cross-clamp ischemic heart time in minutes needed in the surgery, day 1 after surgery|Mechanical Ventilatory Support time needed after surgery (in hours), 7 days|Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets), First 72 hours after surgery|New York Heart Association functional class scale for heart failure, To assess heart failure status between participants, baseline-1-6-12 months|Number of participants alive (Survival), To assess first year mortality, 6-12 months|Number of participants alive (Survival), To assess 5 year mortality, 5 years|Early postoperative combined endpoint of 4 complications, All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, and acute renal failure AKIN (acute kidney injury classification) greater or equal than 2,, 1 month|Late postoperative combined endpoint of 4 complications, All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, and acute renal failure AKIN (acute kidney injury classification) greater or equal than 2,, 1-5 years year | null | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | null | ALL | ADULT, OLDER_ADULT | null | 96 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | CALIDAD-SVAO | 2016-03-20 | 2019-05-20 | 2019-10-20 | 2016-04-01 | null | 2020-02-05 | Hospital Universitario Virgen de La Victoria, Malaga, 29010, Spain | null | {
"ministernotomy": [
{
"intervention_type": "PROCEDURE"
}
],
"Full sternotomy": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT02785887 | Impact of Geriatrician Interventions on Chemotherapy Delivery in Vulnerable Elderly Oncology Patients | https://clinicaltrials.gov/study/NCT02785887 | GIVE | COMPLETED | This is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (RDI). | NO | Breast Cancer|Lung Cancer|Ovarian Cancer|Prostate Cancer|Bladder Cancer|Gastrointestinal Cancer | OTHER: Geriatrician review | Relative dose intensity, Relative dose intensity (RDI) is defined as the ratio (in percentage) of the total administered dose of chemotherapy to the standard dose of the same chemotherapy regimen, as defined by the treating centre. RDI will be calculated as the total dose delivered from the first day of cycle 1 of chemotherapy until completion of the planned chemotherapy (average of 6 months for early, 3 months for metastatic disease), or until date of relapse or death or discontinuation from any cause, whichever occurs first., 6 months | Occurrence of treatment-related toxicity, Severity will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, every 3-4 weeks up to 6 months|Occurrence of hospitalization, Documentation of hospitalization, at 6 months for early and at 3 months for metastatic disease|Early mortality, Documentation of death, death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease | Optional Translational Substudy: Blood metabolites, Proton Nuclear Magnetic Resonance (H-NMR) metabolomics spectra will be derived from a 10ml fasting peripheral serum sample collected prior to commencing chemotherapy, up to 12 months | Azienda USL 4 Prato | null | ALL | OLDER_ADULT | null | 233 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH | GIVE | 2014-08-01 | 2018-09-25 | 2018-09-25 | 2016-05-30 | null | 2019-02-15 | Ospedale Vito Fazi, Lecce, 73100, Italy|Ospedale San Paolo, Milano, 20142, Italy|Istituto Oncologico Veneto, Padova, 35128, Italy | null | {
"Geriatrician review": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01357187 | An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal | https://clinicaltrials.gov/study/NCT01357187 | null | COMPLETED | The objective of this study is to evaluate the clinical effectiveness of AmnioFix™ in the reduction of the tenacity and frequency of soft tissue adhesions during the removal of segmental posterior lumbar instrumentation. | NO | Adhesions of Soft Tissue | OTHER: Scheduled removal of posterior instrumentation with AmnioFix|OTHER: Scheduled removal of posterior instrumentation without AmnioFix | Tenacity and frequency of soft tissue adhesion, At the time of removal of segmental posterior lumbar instrumentation | Presence and extent of scar tissue using histological analysis of the lumbar tissue adjacent to the surgical site, At the time of removal of segmental posterior lumbar instrumentation|Number of intra-operative complications, At the time of removal of segmental posterior lumbar instrumentation | null | MiMedx Group, Inc. | null | ALL | ADULT, OLDER_ADULT | null | 5 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | AFPIR001 | 2011-09 | 2014-05 | 2014-05 | 2011-05-20 | null | 2015-03-17 | Virginia Spine Institute, Reston, Virginia, 20190, United States | null | {
"Scheduled removal of posterior instrumentation with AmnioFix": [
{
"intervention_type": "OTHER"
}
],
"Scheduled removal of posterior instrumentation without AmnioFix": [
{
"intervention_type": "OTHER"
}
]
} |
NCT02706587 | Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment | https://clinicaltrials.gov/study/NCT02706587 | ENS | UNKNOWN | The purpose of this study is to determine whether early neuromuscular electrical stimulation is effective in the prevention of neuromuscular weakness in critical ill patients. | NO | Polyneuropathy, Critical Illness | DEVICE: Neuromuscular electrical stimulation|DEVICE: Sham control | Medical resuscitation council (MRC) score, up to 25 months. From date of randomization to the date of ICU discharge | Total duration of mechanical ventilation (days), up to 25 months. From date of randomization to the date of ICU discharge|Length of ICU stay and hospital stay., up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge|Type of hospital discharge, (alive/deceased/rehabilitation/home...), up to 25 months. From date of randomization to the date of hospital discharge | null | Institut Mutualiste Montsouris | Fondation Paul Bennetot|Assistance Publique - Hôpitaux de Paris | ALL | ADULT, OLDER_ADULT | PHASE3 | 102 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE | REA 01-2014 | 2016-03 | 2018-04 | 2018-06 | 2016-03-11 | null | 2016-09-13 | Insitut Mutualiste Montsouris, Paris, 75014, France | null | {
"Neuromuscular electrical stimulation": [
{
"intervention_type": "DEVICE"
}
],
"Sham control": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT00261287 | Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416) | https://clinicaltrials.gov/study/NCT00261287 | null | COMPLETED | The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis. | NO | Hay Fever|Perennial Allergic Rhinitis | DRUG: Ciclesonide | Safety and tolerability of ciclesonide nasal spray | null | null | AstraZeneca | null | ALL | CHILD | PHASE3 | 102 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT | BY9010/M1-416 | 2005-11 | 2006-06 | 2006-06 | 2005-12-05 | null | 2016-11-30 | Altana Pharma/Nycomed, Long Beach, California, 90806, United States|Altana Pharma/Nycomed, Normal, Illinois, 61761, United States|Altana Pharma/Nycomed, San Antonio, Texas, 78229, United States | null | {
"Ciclesonide": [
{
"intervention_type": "DRUG",
"description": "Ciclesonide",
"name": "Ciclesonide",
"synonyms": [
"Ciclesonida",
"Alvesco",
"Ciclesonide",
"Omnaris"
],
"medline_plus_id": "a609004",
"generic_names": [
"Ciclesonide"
],
"drugbank_id": "DB01410"
}
]
} |
NCT06418087 | Durvalumab With Carboplatin and Etoposide Chemotherapy in Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC) | https://clinicaltrials.gov/study/NCT06418087 | DUPLE | RECRUITING | A prospective multicenter, single-arm phase II study enrolling treatment-naïve patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC) | NO | Pulmonary Large-cell Neuroendocrine Carcinoma | DRUG: Durvalumab 50 MG/1 ML Intravenous Solution [IMFINZI] | Efficacy of the combination of carboplatin + etoposide + durvalumab in treatment-naïve patients, as first line treatment, with metastatic pulmonary LCNEC, Efficacy of the combination of carboplatin + etoposide Overall Survival rate at 1 year, 1 year | Activity of the combination of carboplatin + etoposide + durvalumab as first-line treatment for patients with metastatic pulmonary LCNEC, Activity of the combination of carboplatin + etoposide + durvalumab as first-line treatment for patients with metastatic pulmonary LCNEC Median OS PFS ORR DCR and DoR at 1 year, 1 year|Number of Participants with treatment-related Adverse Events as assessed by CTCAE v. 5.0 - The safety and tolerability profile of the combination of carboplatin + etoposide + durvalumab as first-line treatment for patients with metastatic pulmonary LCNEC, Safety and tolerability profile of the combination of carboplatin + etoposide + durvalumab as first-line treatment for patients with metastatic pulmonary LCNEC, 1 year | null | Gruppo Oncologico Italiano di Ricerca Clinica | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 49 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | DUPLE- GOIRC- 05-2020 | 2022-05-27 | 2026-12-31 | 2026-12-31 | 2024-05-16 | null | 2024-05-16 | IRCCS AOU Policlinico Sant Orsola Malpighi, Bologna, BO, 40138, Italy|Istituto Oncologico del Mediterraneo IOM - Viagrande Catania, Viagrande, CT, 95029, Italy|Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l. IRCCS, Meldola, FC, 47014, Italy|Azienda Ospedaliera Universitaria Careggi, Firenze, FI, 50134, Italy|Humanitas Research Hospital, Rozzano, MI, 20089, Italy|Istituto Oncologico Veneto IRCCS-IOV, Padova, PD, 35128, Italy|Centro di riferimento oncologico di Aviano, Aviano, PN, 33081, Italy|Azienda Ospedaliera San Camillo Forlanini-Ospedale San Camillo, Roma, RM, 00152, Italy|AOU Sassari - Ospedale SS. Annunziata, Sassari, SS, 07100, Italy|AOU Ospedale San Luigi Gonzaga, Orbassano, TO, 10043, Italy|Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari, Bari, 70120, Italy|Azienda Usl Toscana nord ovest Ospedale San Luca, Lucca, 55100, Italy|Ospedale San Gerardo Monza, Monza, 20900, Italy|A.O.R.N. A. Cardarelli , Napoli, 80131, Italy|Azienda Ospedaliera Universitaria di Parma, Parma, 43126, Italy | null | {
"Durvalumab": [
{
"intervention_type": "DRUG",
"description": "Durvalumab 50 MG/1 ML Intravenous Solution [IMFINZI]",
"name": "Durvalumab",
"synonyms": [
"Imfinzi",
"Durvalumab"
],
"medline_plus_id": "a617030",
"generic_names": [
"Durvalumab"
],
"drugbank_id": "DB11714"
}
]
} |
NCT06226987 | Molecular Imaging in Fabry Disease of the Heart | https://clinicaltrials.gov/study/NCT06226987 | null | RECRUITING | Better methods for early detection of cardiac involvement in Fabry disease are needed to inform clinical management decisions that can help prevent or slow the progression of cardiac complications. In the Molecular Imaging of Inflammation in Fabry Disease of the Heart study, we will test the use of 68Ga-DOTATATE PET/MRI for identifying myocardial inflammation in patients with Fabry disease. | NO | Fabry Disease, Cardiac Variant | DIAGNOSTIC_TEST: 68Ga-DOTATATE PET/MRI | PET imaging vs. oedema detected by MRI, Concordance between 68Ga-DOTATATE PET signal and myocardial oedema on MRI assessed by T2-weighted imaging, Baseline|PET imaging vs. fibrosis detected by MRI, Concordance between 68Ga-DOTATATE PET signal and myocardial fibrosis detected by late gadolinium enhancement MRI, Baseline | null | null | University of Cambridge | Sanofi | ALL | ADULT, OLDER_ADULT | null | 12 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | A095007 | 2024-01-02 | 2026-01-02 | 2026-01-02 | 2024-01-26 | null | 2024-01-26 | Cambridge University Hospital NHS Foundation Trust, Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom | null | {
"Dotatate gallium Ga-68": [
{
"intervention_type": "DIAGNOSTIC_TEST",
"description": "68Ga-DOTATATE PET/MRI",
"name": "Dotatate gallium Ga-68",
"synonyms": [
"DOTA-octreotate gallium Ga-68",
"Gallium-DOTA-octreotate, Ga-68",
"Gallium (68Ga) dotatate",
"68Ga-DOTATOC",
"Gallium (Ga 68) dotatate",
"Gallium oxodotreotide Ga-68",
"Dotatate gallium Ga-68",
"Gallium (68Ga) DOTA-tate",
"(68Ga)Gallium dotatate",
"68Ga-DOTATATE",
"Gatate",
"Ga 68 DOTATOC",
"Gallium 68 dotatate",
"Gallium dotatate, Ga-68",
"Gallium-DOTA-octreotate Ga-68"
],
"drugbank_id": "DB13925",
"generic_names": [
"Dotatate gallium Ga-68"
]
}
]
} |
NCT01475487 | Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks | https://clinicaltrials.gov/study/NCT01475487 | null | COMPLETED | Inability to provide oxygen to the patient remains the most fearful anesthesia-related mishap. Cricothyrotomy (CT) is an infrequently performed but life saving procedure for an anesthesiologist, who is encountered with this situation. The current method of cricothyrotomy relies on digital palpation (DP). Several patient populations, including morbidly obese, short neck, radiation to and previous neck surgeries, have difficult landmarks for this procedure. Ultrasound (US) technology has been used in the past to visualize landmarks for cricothyrotomy, but there is no study which has examined the role of ultrasound in patients who have obscure landmarks. There is no data related to the performance of ultrasound guided cricothyrotomy in these patients. In this study, we aimed to determine the outcomes of CT performed on human cadavers using US-guidance, compared to conventional DP, of anatomical landmarks. In particularly, complication rates, failure to cannulate, correct placement of the device and insertion time of CT were assessed. | YES | Airway Management | PROCEDURE: Utrasound guided cricothyrotomy | The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries, The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (< 5 mm laceration); moderate (> 5mm laceration or partial puncture); severe (> 10 mm laceration or full puncture))., On avergae less than 300 seconds | Insertion Time, Defined as palpation of the skin to completion of procedure- cannula in trachea., less than 5 minutes from starting of procedure|Number of Attempts, Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants., not more than 300 seconds|Correct Landmarking, Correct landmarking by all participants between the ultrasound and digital palpation group, less than 300 seconds | null | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 47 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: | CUS-2010 | 2011-04 | 2011-09 | 2013-09 | 2011-11-21 | 2015-06-25 | 2015-06-25 | null | null | {
"Utrasound guided cricothyrotomy": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT03322787 | Effect of Exercise Training Under HFO Device on Endurance Tolerance in Patients With COPD and CRF: a Randomized Controlled Study. | https://clinicaltrials.gov/study/NCT03322787 | HFO | COMPLETED | Current literature clearly shows the benefit of pulmonary rehabilitation in symptomatic COPD (Trooster,2005). However, these patients are frequently unable to sustain a work-load sufficiently high to obtain a full benefit on exercise tolerance (Trooster,2005). Especially in patients with Chronic Respiratory Failure (CRF), the development of hypoxia (O Donnel,2001) and the increase of dead space (Elbehairy,2015) during effort explain the out-of-proportion increase in ventilation leading to an early achievement of the ventilatory reserve. Recent studies on heated and humidified high flow oxygen (HFO) delivered through nasal cannula, show several positive effects on breathing pattern and ventilatory efficiency, mostly in critical care setting and at rest (Spoletini,2015). Some recent physiological studies have evidenced that high flows of humidified oxygen improve exercise performance in patients with COPD and severe oxygen dependency, in part by enhancing oxygenation (Chatila,2004). Recently, a pilot study by our group showed that HFO may improve the exercise performance in severe COPD patients with ventilatory limitation. This effect is associated to an improvement of oxygen saturation (SatO2) and perceived symptoms at iso-time (Cirio,2016). No clinical studies are available about the use of HFO during exercise training. The investigators hypothesize that, in severe COPD patients with CRF and exercise limitation , the use of HFO could improve the efficiency of ventilation, leading to an increase in the patient s exercise performance and outcome.
Primary aim will be to evaluate in patients COPD with CRF the difference in the endurance tolerance improvement (expressed in minutes) after an high intensity training program, at iso-FiO2, using HFO with respect to usual oxygen administration by Venturi Mask .
Secondary objectives will be to study effectiveness of HFO with respect to Venturi Mask in terms of improvement of meters of 6 Minute Walking Test, dyspnea at rest, peripheral and respiratory muscle strength,blood gases, motor and respiratory disability,quality of life,impact of the disease and patients satisfaction. | NO | COPD | DEVICE: HFO | Effectiveness on endurance tolerance, To evaluate the difference in the endurance tolerance improvement (endurance time) with a costant load cycloergometer test., At Baseline | Effectiveness on functional capacity, To evaluate effectiveness of HFO with respect to Venturi Mask in terms of improvement of meters at 6-min walking test., At 1 month|Effectiveness on dyspnea, To evaluate effectiveness of HFO with respect to Venturi Mask in terms of dyspnea evaluation, MRC scale for dyspnea will be used., At 1 month|Effectiveness on respitarory muscle strength, To evaluate effectiveness of HFO with respect to Venturi Mask in terms of improvement in respiratory muscle strenght measured by MIP/MEP., At 1 month|Effectiveness on peripheral muscle strenght, To evaluate effectiveness of HFO with respect to Venturi Mask in terms of improvement in peripheral muscles [biceps and quadriceps] evaluated by manual dinamometer and MRC muscle scale., At 1 month|Effectiveness on blood gases, To evaluate improvement of blood gases (PaO2/FiO2 PaCO2, pH) arterial blood gases analysis will be used., At one month|Effectiveness on disability, To evaluate disability of HFO with respect to Venturi Mask , disability will be measured by Barthel index and Barthel Dyspnea., At 1 month|Effectiveness on quality of life, To evaluate quality of life MRF-26 will be used., At 1 month|Effectiveness on impact of the disease, To evaluate impact of disease CAT will be used., At 1 month|Effectivenes on satisfaction, Patient satisfaction for training session will be assessed by a Likert scale 0-4 (0= no discomfort; 1= minimum discomfort; 2=moderate discomfort; 3= high discomfort; 4= maximum discomfort)., At 1 month | null | Istituti Clinici Scientifici Maugeri SpA | Azienda Ospedaliera Ospedale Maggiore di Crema|University of Modena and Reggio Emilia|Villa Pineta Hospital|Fisher and Paykel Healthcare|Associazione Riabilitatori Insufficienza Respiratoria | ALL | ADULT, OLDER_ADULT | null | 171 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: SCREENING | ICS Maugeri - CE2109 | 2017-11-06 | 2018-12-08 | 2019-03-31 | 2017-10-26 | null | 2019-05-29 | ICS Maugeri, IRCCS Lumezzane, Lumezzane, Brescia, 25065, Italy | null | {
"HFO": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT03334487 | Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer | https://clinicaltrials.gov/study/NCT03334487 | null | WITHDRAWN | A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs). | NO | Small Cell Lung Cancer | DRUG: Dexamethasone|DRUG: Rovalpituzumab tesirine | Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE, Number of participants with a high grade (≥ Grade 3) protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with rovalpituzumab tesirine. Severity of TEAEs will be graded at each study visit according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03., Approximately 32 months | Change in Participant Reported Outcome EORTC QLQC15-PAL, The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Palliative Cancer (EORTC QLQ-C15-PAL) is a 15-item self-report questionnaire composed of 4 multi-item scales (physical & emotional functioning, fatigue and pain) along with 6 individual items (nausea & vomiting, dyspnea, insomnia, appetite loss, constipation, and global quality of life)., Approximately 32 months|Progression Free Survival (PFS), PFS is based on independent review of radiographic assessment, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier., Approximately 32 months|Overall Survival (OS), Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause., Approximately 32 months|Objective response rate (ORR), ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., Approximately 32 months|Change in EORTC QLQ-LC-13, The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ-LC 13) is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients., Approximately 32 months|Duration of Objective Response (DOR), DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first., Approximately 32 months|Clinical Benefit Rate (CBR), CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD) according to RECIST version 1.1., Approximately 32 months | null | AbbVie | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 0 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | M16-292|2017-003173-33 | 2018-03-15 | 2018-12-20 | 2018-12-20 | 2017-11-07 | null | 2018-12-26 | Ironwood Cancer & Res Ctr /ID# 171335, Chandler, Arizona, 85224-5665, United States|Mayo Clinic - Scottsdale /ID# 171359, Scottsdale, Arizona, 85259, United States|VA Central California Health C /ID# 170951, Fresno, California, 93703, United States|Loma Linda University Medical /ID# 171377, Loma Linda, California, 92354, United States|UC Irvine Health /ID# 171343, Orange, California, 92868-3201, United States|Kaiser Permanente - Roseville /ID# 200779, Roseville, California, 95661-3027, United States|Kaiser Permanente-Santa Clara /ID# 203024, Santa Clara, California, 95051-5173, United States|Kaiser Permanente Medical Ctr-Vallejo /ID# 169758, Vallejo, California, 94589-2441, United States|Kaiser Permanente- Walnut Creek /ID# 201305, Walnut Creek, California, 94596, United States|Univ of Colorado Cancer Center /ID# 200810, Aurora, Colorado, 80045, United States|Boca Raton Regional Hospital /ID# 200168, Boca Raton, Florida, 33486, United States|UMHC/Sylvester Comprehensive /ID# 171462, Deerfield Beach, Florida, 33442, United States|Mount Sinai Comp Cancer Ctr /ID# 169759, Miami, Florida, 33140, United States|Illinois Cancer Care, PC /ID# 171310, Peoria, Illinois, 61615, United States|Baptist Health /ID# 171379, Lexington, Kentucky, 40503-1463, United States|Norton Cancer Institute /ID# 200827, Louisville, Kentucky, 40202-3700, United States|Tulane Cancer Center Clinic /ID# 171376, New Orleans, Louisiana, 70112, United States|Sandra Malcolm Berman Cncr Ins /ID# 171346, Baltimore, Maryland, 21204, United States|St. Luke s University Hospital /ID# 171374, Duluth, Minnesota, 55802, United States|Valley Hospital - Westwood, NJ /ID# 171357, Westwood, New Jersey, 07675, United States|Wake Forest Baptist Medical Center /ID# 169799, Winston-Salem, North Carolina, 27157-0001, United States|The Ohio State University Comp /ID# 171352, Columbus, Ohio, 43210, United States|St. Luke s Hematology Oncology /ID# 171378, Bethlehem, Pennsylvania, 18015, United States|Tennessee Oncology PLLC: Sarah /ID# 171380, Nashville, Tennessee, 37203, United States|Vanderbilt Ingram Henry Cancer /ID# 171356, Nashville, Tennessee, 37212, United States|VCS, Virginia Cancer Specialis /ID# 169760, Arlington, Virginia, 22031, United States|Kadlec Clinic Hematology and O /ID# 169797, Kennewick, Washington, 99336, United States|Coffs Harbour Health Campus /ID# 200642, Coffs Harbour, New South Wales, 2450, Australia|The Tweed Hospital /ID# 200646, Tweed Heads, New South Wales, 2485, Australia|The Townsville Hospital /ID# 200640, Douglas, Queensland, 4814, Australia|Austin Hospital /ID# 200639, Heidelberg, Victoria, 3084, Australia|Border Medical /ID# 200645, Wodonga, Victoria, 3690, Australia|Perron Institute for Neurological and Translational Science /ID# 200644, Nedlands, Western Australia, 6009, Australia|Bahia Oncology Center - NOB /ID# 201272, Salvador, Bahia, 40170-110, Brazil|Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496, Ijuí, Rio Grande Do Sul, 98700-000, Brazil|Hospital Sao Lucas da PUCRS /ID# 201258, Porto Alegre, Rio Grande Do Sul, 90610-000, Brazil|Icesp /Id# 201036, São Paulo, Sao Paulo, 01246-000, Brazil|Inca /Id# 202594, Rio de Janeiro, 20231-050, Brazil|Instituto COI de Educacao e Pe /ID# 200499, Rio de Janeiro, 22793-080, Brazil|Fundacao Antonio Prudente /ID# 200218, Sao Paulo, 01509-000, Brazil|Hospital de Cancer de Barretos /ID# 200104, Sao Paulo, 14784-400, Brazil|Tom Baker Cancer Centre /ID# 171561, Calgary, Alberta, T2N 4N2, Canada|QE II Health Sciences Centre /ID# 171569, Halifax, Nova Scotia, B3H 1V7, Canada|London Health Sciences Centre /ID# 171567, London, Ontario, N6A 5A5, Canada|The Ottawa Hospital /ID# 200682, Ottawa, Ontario, K1H 8L6, Canada|Franziskus-Hospital Harderberg /ID# 201145, Georgsmarienhütte, Niedersachsen, 49124, Germany|Charite Universitatsmedizin B- /ID# 170079, Berlin, 13353, Germany|Asklepios Fachkliniken M. Gaut /ID# 170081, Gauting, 82131, Germany|Thoraxklinik Heidelberg gGmbH /ID# 170078, Heidelberg, 69126, Germany|Klinikum Kassel - Onkologie /ID# 170083, Kassel, 34125, Germany|Universitatsklinikum Munster /ID# 170087, Muenster, 48149, Germany|Pius Hospital Oldenburg /ID# 170080, Oldenburg, 26121, Germany|Akademiska Sjukhuset /ID# 171248, Uppsala, Uppsala Lan, 751 85, Sweden|Gavle Hospital /ID# 171253, Gavle, 801 88, Sweden|University Hospital Linkoping /ID# 201666, Linkoping, 58185, Sweden|Karolinska University Hospital /ID# 201967, Stockholm, SE-17176, Sweden|Norrlands Universitetssjukhus /ID# 171250, Umeå, 90185, Sweden|Leicester Royal Infirmary /ID# 201154, Leicester, England, LE1 5WW, United Kingdom|Christie NHS Foundation Trust /ID# 201149, Manchester, M20 4BX, United Kingdom|Royal Preston Hospital /ID# 201146, Preston, PR2 9HT, United Kingdom | null | {
"Dexamethasone": [
{
"intervention_type": "DRUG",
"description": "Dexamethasone",
"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"
}
],
"Rovalpituzumab tesirine": [
{
"intervention_type": "DRUG",
"description": "Rovalpituzumab tesirine",
"name": "Rovalpituzumab tesirine",
"synonyms": [
"Rovalpituzumab tesirine",
""
],
"drugbank_id": "DB13017",
"generic_names": [
"Rovalpituzumab tesirine"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Rovalpituzumab%20tesirine"
}
]
} |
NCT01335087 | Continuous Positive Airway Pressure (CPAP) in Patients With Acute Coronary Syndrome and Obstructive Sleep Apnea (OSA) | https://clinicaltrials.gov/study/NCT01335087 | ISAACC | COMPLETED | OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of ISAACC is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA admitted in a hospital for an acute coronary syndrome.
Overall objective:
To assess the impact of obstructive sleep apnea (OSA) and its treatment on the clinical evolution of patients with acute coronary syndrome (ACS).
Primary objectives:
1. To determine if continuous positive airway pressure (CPAP) treatment will reduce the rate of cardiovascular events (cardiovascular (CV) death, non-fatal events (acute myocardial infarction (AMI), non-fatal stroke, hospital admission for heart failure, and new hospitalizations) for unstable angina or transient ischaemic attack (TIA)) in patients with ACS and co-occurring sleep apnea.
Secondary objectives:
1. Determine the prevalence of OSA in patients who have suffered an episode of ACS.
2. Other secondary objectives will include the effects of CPAP on:
* To evaluate a composite of CV death, myocardial infarction (MI) and ischaemic stroke.
* Components of primary composite endpoints
* Re-vascularization procedures
* To evaluate all-cause death
* To evaluate new onset, ECG-confirmed atrial fibrillation or other arrhythmias
* To evaluate newly diagnosed diabetes mellitus, according to standard definitions
* To evaluate OSA symptoms (Epworth Sleepiness Scale (ESS))
* To evaluate quality of life in patients with ACS (Test EuroQol (EQ-5D).
3. To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS.
4. To establish the relationship between CPAP compliance and CV events incidence.
5. To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients.
6. To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea. | NO | Acute Coronary Syndrome|Obstructive Sleep Apnea | OTHER: Standard care|DEVICE: continuous positive airway pressure | Rate of cardiovascular events in patients with acute coronary syndrome and co-occurring sleep apnea., Cardiovascular events are: cardiovascular death, non-fatal AMI, non-fatal stroke, hospital admission for heart failure, and new hospitalization for unstable angina or TIA., 12 month after the inclusion of the last patient | Prevalence of OSA in patients who have suffered an episode of ACS., Determined at the inclusion of the patient, 24 month (inclusion period)|Composite of major CV events, CV death, myocardial infarction (MI) and ischaemic stroke., 12 month after the inclusion of the last patient|Components of primary composite endpoints separately., Cardiovascular events are: cardiovascular death, non-fatal AMI, non-fatal stroke, hospital admission for heart failure, and new hospitalization for unstable angina or TIA., 12 month after the inclusion of the last patient|Number of re-vascularization procedures., Revascularisation procedures, including PCI, CABG, peripheral arterial revascularisation and intra-cerebral stent insertion, 12 month after the inclusion of the last patient|All-cause mortality., All-cause mortality., 12 month after the inclusion of the last patient|New onset of ECG-confirmed atrial fibrillation or other arrhythmias., ECGs were performed at baseline and during the follow-up period; ECG and medical records were collected tovconfirm a hospitalization for atrial fibrillation event, 12 month after the inclusion of the last patient|Newly diagnosed diabetes mellitus, according to standard definitions., Newly diagnosed diabetes mellitus, according to standard definitions, 12 month after the inclusion of the last patient|Epworth Sleepiness Scale (ESS) and Test EuroQol (EQ-5D)., OSA symptoms: Epworth Sleepiness Scale (ESS). Quality of life: Test EuroQol (EQ-5D)., 12 month after the inclusion of the last patient|Severity and phenotype of patients with OSA and clinical outcomes of ACS., To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS., 12 month after the inclusion of the last patient|CPAP compliance and CV events incidence., To establish the relationship between CPAP compliance and CV events incidence., 12 month after the inclusion of the last patient|Biological risk markers related to mechanisms involved in cardiovascular complications in these patients., To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients., 12 month after the inclusion of the last patient|Cost-effectiveness analysis (Qualys) of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea., Cost-effectiveness analysis (Qualys) of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea, 12 month after the inclusion of the last patient | null | Sociedad Española de Neumología y Cirugía Torácica | ResMed|Fondo de Investigacion Sanitaria|EsteveTeijin Healthcare|Societat Catalana de Cardiologia|Sociedad Madrileña de Neumologia | ALL | ADULT, OLDER_ADULT | null | 1,864 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | PI10/02763 | 2011-04 | 2018-09 | 2018-09 | 2011-04-14 | null | 2018-10-29 | Spanish Respiratory Society, Barcelone, 08009, Spain | null | {
"Standard care": [
{
"intervention_type": "OTHER"
}
],
"continuous positive airway pressure": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT01390987 | Access to Care and Adherence Tuberculosis (TB) Survey | https://clinicaltrials.gov/study/NCT01390987 | TBsurvey | COMPLETED | Prompt access to care and treatment adherence are the hearth of tuberculosis control.
This is a multicentre observational prospective study aimed at studying the factors associated with delayed access to care and low adherence to anti-tuberculosis treatment. Hetero- and self-administered questionnaires will be used at enrollment to assess clinical presentation and time and modalities of the diagnosis. Treatment adherence will be assessed during the follow-up with self administered questionnaires. | NO | Tuberculosis | null | Time to TB diagnosis, Study enrollment | null | null | Azienda Ospedaliera San Gerardo di Monza | null | ALL | ADULT, OLDER_ADULT | null | 137 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | TBsurvey-001 | 2011-06 | 2012-09 | 2012-12 | 2011-07-11 | null | 2014-01-20 | AO Fallacara, Triggiano, BA, Italy|Clinic of Infectious Diseases, AO San Gerardo, Monza, MB, 20900, Italy|Clinica di Malattie Infettive, Spedali Civili, Brescia, 25126, Italy|Clinica di Malattie Infettive, Ospedale San Martino, Genova, Italy|Clinica di Malattie Infettive, Ospedale Luigi Sacco, Milano, Italy|Clinica di Malattie Infettive, Policlinico Gemelli, Roma, Italy | null | {} |
NCT01771887 | Effects of Education Program for Lebanese Diabetic T2 in Their Behavior of Auto Managing, of Self-efficacy and Adhesion | https://clinicaltrials.gov/study/NCT01771887 | null | COMPLETED | Diabetes mellitus is a disease of great frequency and is a major public health problem. In Lebanon, the incidence of diabetes is estimated at 12%, it is expected to double by the year 2025. Given the increasing prevalence of diabetes in Lebanon, the evolution of complications of this disease and the lack of studies at this level, it is appropriate to conduct a study that aims to evaluate the effects an education program for people with type 2 diabetes on their sense of self-efficacy and their ability to self-manage their disease to make them the most optimal therapeutic adherence possible. The design of this study is experimental type before / after randomization by diabetic patients. Education program delivered to the experimental group is the Accu-Chek Education Program of Roche. Membership will be assessed using a biomarker HbA1c should be <7%, and a questionnaire (Summary of Diabetes Self-Care Activities Measure), which measures self-care behaviors. Self-efficacy is measured using the Diabetes Management Self-Efficacy Scale. And this before the intervention and 3 months later. The sample will be 240 diabetic patients T2. Recruitment will be in outpatient diabetology a Hospital located in Beirut. Statistical analyzes used for descriptive variables are measures of central tendency, dispersion and frequency distribution. T-test and chi-square will be used to compare the socio-demographic characteristics of the 2 groups, experimental and control. To test hypotheses and determine the difference in the results of the dependent variables of the 2 groups, analysis of variance and covariance are used. The data will be processed using SPSS version 14.0. | NO | Diabetes Mellitus | BEHAVIORAL: education program | adhesion, HbA1c less than 7 % 3 months after the intervention | Self-management behaviors, self-management behaviors will be measured using a questionnaire of 25 questions, Summary of Diabetes Self-Care Activities Measure SDSCA, which measures five behaviors: diet, exercise, self monitoring blood glucose, medication and foot care (Toobert et al., 2000)., improvement of self-management behaviors 3 months after the intervention | self-efficacy, Self-efficacy is measured using the Diabetes Management Self-Efficacy Scale (DMSES). This instrument was developed in 1999 by van der Bijl, van Poelgeest-Shortridge-Bagget & Eeltink. This instrument consists of 20 items., enhancement of the sense of self-efficacy 3 months after the intervention | Université de Montréal | null | ALL | ADULT, OLDER_ADULT | null | 108 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | ATALLAH-FSI-6 | 2013-02 | 2013-09 | 2014-12 | 2013-01-18 | null | 2014-12-04 | Outpatient of hospital of Hotel Dieu de France, Beirut, 16-6830, Lebanon | null | {
"education program": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT02529787 | A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA) | https://clinicaltrials.gov/study/NCT02529787 | null | COMPLETED | Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA) | NO | Healthy | DRUG: Doxirazole|DRUG: Dexilant | Peak Plasma Concentration (Cmax), Up to 12 hours post dose in each treatment period|Area under the plasma concentration versus time curve (AUC), Up to 12 hours post dose in each treatment period | Number of subjects with adverse events (AE)s, Safety and tolerability parameters will include recording of AEs, Up to 12 hours post dose in each treatment period|Safety assessed by vital sign measurement, Vital sign measurement will include blood pressure, pulse rate, respiration rate and body temperature, Up to 12 hours post dose in each treatment period|Measure of clinical laboratory test values to access safety and tolerability, Clinical laboratory tests will include hematology, clinical chemistry and urinalysis, Up to 12 hours post dose in each treatment period | null | Genuine Research Center, Egypt | Hikma Pharma,Egypt | ALL | ADULT | PHASE1 | 60 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: | GRC/1/12/406 | 2013-02 | 2013-02 | 2013-03 | 2015-08-20 | null | 2015-08-20 | Genuine Research Center GRC, Cairo, Egypt | null | {
"Doxirazole": [
{
"intervention_type": "DRUG"
}
],
"Dexlansoprazole": [
{
"intervention_type": "DRUG",
"description": "Dexilant",
"name": "Dexlansoprazole",
"synonyms": [
"2-((R)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazole",
"Dexilant",
"Dexlansoprazole",
"TAK-390",
"R Lansoprazole",
"TAK390",
"T-168390",
"T168390",
"TAK 390MR",
"Lansoprazole, R-Isomer",
"TAK-390MR",
"R-Isomer Lansoprazole",
"(R)-LANSOPRAZOLE",
"1H-BENZIMIDAZOLE, 2-((R)-((3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)-2-PYRIDINYL)METHYL)SULFINYL)-",
"LANSOPRAZOLE, (R)-",
"LANSOPRAZOLE R-FORM",
"(+)-2-((R)-((3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDIN-2-YL)METHYL)SULFINYL)-1H-BENZIMIDAZOLE"
],
"medline_plus_id": "a609017",
"generic_names": [
"Dexlansoprazole"
],
"mesh_id": "D054328",
"drugbank_id": "DB05351"
}
]
} |
NCT05986487 | Impact of Sleep-Disordered Breathing Management in Systemic Hypertension Control: METASLEEP Project | https://clinicaltrials.gov/study/NCT05986487 | null | RECRUITING | Hypertension is a frequent condition affecting 11M Spanish citizens and is the leading modifiable contributor to cardiovascular disease and death. Our society has already identified balanced diet, physical activity and emotional wellbeing as the 3 pillars of healthy living. Healthy sleep should be incorporated as the fourth pillar, as clearly supported by the extensively available scientific evidence. Targeting sleep is considered the new frontier in cardiovascular prevention. In fact, recent scientific evidence encourages consideration of including sleep disturbances in the top 10 potentially modifiable cardiovascular risk factors. Sleep-disordered breathing affect 30-80% of patients with hypertension. The personalized management of hypertension is challenging due to; i) the misclassification of hypertensive patients (affecting 1 out of 3 patients); ii) the lack of adequate treatment of high mortality risk hypertensive phenotypes today is an unmet clinical need; iii) unawareness of the impact of sleep-disordered breathing as a modifiable risk factor for hypertension. Importantly, the investigators already made the seminal observations showing that the treatment for sleep-disordered breathing reduces blood pressure in the hypertensive phenotypes with the highest mortality risk. Given the need for novel strategies to treat hypertension and, supported by our data, the investigators propose to study and treat sleep-disordered breathing to improve hypertension control. METASLEEP will go beyond current state-of the-art providing a new paradigm for the accurate hypertension classification and treatment. This project will open up a new avenue on the therapeutic potential of the management of sleep-disordered breathing in hypertension. | NO | Hypertension|Obstructive Sleep Apnea | DEVICE: CPAP or usual practice|DEVICE: Monitoring and intervention in follow-up | Changes in nocturnal blood pressure, Change in nocturnal blood pressure at 6 and 18 months with respect to baseline (mean night-time), At 6 and 18 months | Identification of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing., Identification a specific singular cluster of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing., 6 and 18 months|Epigenetic, proteomic and metabolomic/lipidomic phenotype characterization, Characterization of the epigenetic, proteomic and metabolomic/lipidomic phenotype of hypertensive highly responders to CPAP treatment, 6 and 18 months|Clinic phenotype characterization, Characterization of the clinic phenotype of hypertensive highly responders to CPAP treatment, 6 months|Changes induced by exosomes, Changes in morphological, functional and molecular promoted by exosomes isolated from selected patients., 6 months|Validation the HIPARCO-Score tool in an independent cohort, men with resistant hypertension, OSA and CPAP compliance (≥4h/night), Analyse mRNA to validate de HIPARCO score, 2 years|Creation of a predictive tool (like HIPARCO-Score) for women, Identify a plasma miRNA profile that predicts blood pressure response to CPAP treatment., 2 years|Cost-Effectiveness analyses between study groups and to compare the cost of health care utilization between two year before and after the starting of the study related to the study groups., Only direct costs will be considered. Analysis will include an estimation of quality-adjusted life-years (QALYs) gained, After 18 months of follow-up|Validation of the METASLEEP score, Identify specific miRNAs signature that would have the capability to identify patients with nocturnal hypertension, likely to exhibit a favorable blood pressure response to SDB treatment for the blood pressure control., 2 years|CPAP compliance at 6 and 18 months, Objective data to be downloaded from the CPAP device, 6 and 18 months|Satisfaction at 6 and 18 months, Visual analog scale. The Satisfaction test is a self-reported outcome measure composed by 3 items which are measured by ten ranges. Scores range from 0 to 10, with higher scores indicating better satisfaction., 6 and 18 months|Changes in Epworth Sleepiness Scale (ESS), Changes in Epworth Sleepiness Scale (ESS). The ESS test is a self-reported outcome measure composed by 8 items which examine diurnal somnolence. Scores range from 0 to 28, with higher scores indicating more sleepines., 6 and 18 months|Changes in Quality of life: Test EuroQol, Changes in Quality of life: Test EuroQol. The EuroQol test is a self-reported outcome measure composed by 5 items which examine five dimensions of health (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression) and each of them has three levels of severity (no problems, some problems or moderate problems, and severe problems). Scores range from 0 to 1, with higher scores indicating better quality of life, 6 and 18 months | null | Sociedad Española de Neumología y Cirugía Torácica | Instituto de Salud Carlos III | ALL | ADULT, OLDER_ADULT | null | 1,523 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | PMP22/00030 | 2024-04-16 | 2025-12 | 2025-12 | 2023-08-14 | null | 2024-04-17 | Hospital Universitari Arnau de Vilanova, Lleida, 25198, Spain | null | {
"CPAP or usual practice": [
{
"intervention_type": "DEVICE"
}
],
"Monitoring and intervention in follow-up": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT01016587 | Symptom Clusters and Immune Markers in Patients With Chronic Obstructive Pulmonary Disease (COPD) - a Longitudinal Study | https://clinicaltrials.gov/study/NCT01016587 | SGIS | COMPLETED | COPD patients often have a wide range of physical (e.g., dyspnea, fatigue, pain) and psychological (e.g., depression, anxiety) symptoms and various other debilitating conditions that cause considerable suffering for the individual. Unfortunately, many of the symptoms and health problems in patients with COPD are unrecognized and untreated. Due to the irreversible nature of COPD, the aim is not to cure the disease, but to reduce symptoms and improve quality of life.
Therefore, the purpose of this project is to investigate the existence and nature of symptom clusters over time in patients with COPD and their effects on patient outcomes. Since this study aims to identify possible new subgroups of patients with COPD defined by the clustering of certain symptoms, the study also aims to investigate the relationship between the clinical presentation and certain immunologic and genetic factors. | NO | Chronic Obstructive Pulmonary Disease | null | symptom clusters in patients with COPD, 5 times during 12 months | Evaluate potential candidate genes in relation to symptom clusters and investigate the relationship between hypogammaglobulinemia and symptoms in COPD., 2 times during 12 months | null | Oslo University Hospital | University of California, San Francisco | ALL | ADULT, OLDER_ADULT | null | 275 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2009055 | 2009-11 | 2013-10 | 2014-02 | 2009-11-19 | null | 2014-02-11 | Oslo University Hospital, Oslo, Norway | null | {} |
NCT00586287 | Study to Find Out the Appropriate Initial Dose of the Anticoagulant Drug Phenprocoumon | https://clinicaltrials.gov/study/NCT00586287 | null | COMPLETED | Oral anticoagulation is often initiated in hospitalized patients. Although the therapeutic range of phenprocoumon is narrow, the individual drug demands unfortunately vary greatly between persons. Our group recently developed two dosing algorithms for the initiation of anticoagulation based on clinical predictors such as age, gender, body weight and laboratory values.
The aim of the proposed study is to prospectively evaluate the efficacy and safety of these two algorithms in medical and orthopedic inpatients, as well as in a group of outpatients and possibly in a geriatric collective. | NO | Pulmonary Embolism|Atrial Fibrillation|Hip Replacement Postoperative|Knee Replacement Postoperative | OTHER: Algorithm for phenprocoumon|OTHER: algorithm for phenprocoumon|DRUG: Phenprocoumon | rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period, after 30 days | the time-course of the INR-values, the rate of excessive INR-values, defined as INR >3.5 within 10 days, the rate of minor and major bleeding complications, the length of stay, and death within 30 days, 30 days | null | Cantonal Hospital of St. Gallen | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 302 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | EKSG 06/022/1B|Swissmedic 2006 DR 4 2 7 9 | 2007-01 | 2011-12 | 2011-12 | 2008-01-04 | null | 2012-04-02 | Cantonal Hospital St. Gallen, St. Gallen, CH-9007, Switzerland | null | {
"Phenprocoumon": [
{
"intervention_type": "OTHER",
"description": "Algorithm for phenprocoumon",
"name": "Phenprocoumon",
"synonyms": [
"3-(alpha-Ethylbenzyl)-4-hydroxycoumarin",
"Phenprogramma",
"3-(alpha-Phenylpropyl)-4-hydroxycoumarin",
"3-(1'-Phenyl-propyl)-4-oxycoumarin",
"Phenprocoumalol",
"Phenprocoumonum",
"Phenprocoumarole",
"Phenprocumone",
"Phenprocoumone",
"Marcoumar",
"4-Hydroxy-3-(1-phenylpropyl)-2H-1-benzopyran-2-one",
"4-hydroxy-3-(1-phenylpropyl)-2H-chromen-2-one",
"3-(1-Phenylpropyl)-4-hydroxycoumarin",
"Falithrom",
"Marcumar",
"Phenprocoumon",
"Fenprocumon",
"Phenprocoumarol",
"Phenylpropylhydroxycumarinum",
"Liquamar",
"Fenprocumone"
],
"mesh_id": "D000925",
"generic_names": [
"Phenprocoumon"
],
"drugbank_id": "DB00946"
},
{
"intervention_type": "OTHER",
"description": "algorithm for phenprocoumon",
"name": "Phenprocoumon",
"synonyms": [
"3-(alpha-Ethylbenzyl)-4-hydroxycoumarin",
"Phenprogramma",
"3-(alpha-Phenylpropyl)-4-hydroxycoumarin",
"3-(1'-Phenyl-propyl)-4-oxycoumarin",
"Phenprocoumalol",
"Phenprocoumonum",
"Phenprocoumarole",
"Phenprocumone",
"Phenprocoumone",
"Marcoumar",
"4-Hydroxy-3-(1-phenylpropyl)-2H-1-benzopyran-2-one",
"4-hydroxy-3-(1-phenylpropyl)-2H-chromen-2-one",
"3-(1-Phenylpropyl)-4-hydroxycoumarin",
"Falithrom",
"Marcumar",
"Phenprocoumon",
"Fenprocumon",
"Phenprocoumarol",
"Phenylpropylhydroxycumarinum",
"Liquamar",
"Fenprocumone"
],
"mesh_id": "D000925",
"generic_names": [
"Phenprocoumon"
],
"drugbank_id": "DB00946"
},
{
"intervention_type": "DRUG",
"description": "Phenprocoumon",
"name": "Phenprocoumon",
"synonyms": [
"3-(alpha-Ethylbenzyl)-4-hydroxycoumarin",
"Phenprogramma",
"3-(alpha-Phenylpropyl)-4-hydroxycoumarin",
"3-(1'-Phenyl-propyl)-4-oxycoumarin",
"Phenprocoumalol",
"Phenprocoumonum",
"Phenprocoumarole",
"Phenprocumone",
"Phenprocoumone",
"Marcoumar",
"4-Hydroxy-3-(1-phenylpropyl)-2H-1-benzopyran-2-one",
"4-hydroxy-3-(1-phenylpropyl)-2H-chromen-2-one",
"3-(1-Phenylpropyl)-4-hydroxycoumarin",
"Falithrom",
"Marcumar",
"Phenprocoumon",
"Fenprocumon",
"Phenprocoumarol",
"Phenylpropylhydroxycumarinum",
"Liquamar",
"Fenprocumone"
],
"mesh_id": "D000925",
"generic_names": [
"Phenprocoumon"
],
"drugbank_id": "DB00946"
}
]
} |
NCT05756387 | Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach | https://clinicaltrials.gov/study/NCT05756387 | NOCTIVENT | NOT_YET_RECRUITING | The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator.
For this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV. | NO | Chronic Respiratory Failure|Non-invasive Ventilation | DEVICE: Non-invasive ventilation | Gas exchange, Transcutaneous monitoring of gas exchange, baseline|Gas exchange, Transcutaneous monitoring of gas exchange, 2 months|Gas exchange, Transcutaneous monitoring of gas exchange, 4 months|Gas exchange, Transcutaneous monitoring of gas exchange, 6 months|Patient comfort, Patient comfort assessed by VAS scale, baseline|Patient comfort, Patient comfort assessed by VAS scale, 2 months|Patient comfort, Patient comfort assessed by VAS scale, 4 months|Patient comfort, Patient comfort assessed by VAS scale, 6 months|AECOPD, Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics), 2 months, 4 months, 6 months|AECOPD, Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics), 2 months|AECOPD, Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics), 4 months|Hospitalisations for AECOPD, Hospitalisations for acute exacerbations of COPD, 6 months|Sleep quality, Sleep quality assessing sleep depth and sleep stages, 2 months|Sleep quality, Sleep quality assessing sleep depth and sleep stages, 4 months|Sleep quality, Sleep quality assessing sleep depth and sleep stages, 6 months | null | null | University Medical Center Groningen | University of Twente|Löwenstein BV|Vivisol|Sencure BV | ALL | CHILD, ADULT, OLDER_ADULT | null | 100 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 16013 | 2024-09-01 | 2028-01-01 | 2028-09-01 | 2023-03-06 | null | 2024-05-13 | null | null | {
"Non-invasive ventilation": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT05619887 | Muscle Reflex Inhibition in Hypoxic Exercise | https://clinicaltrials.gov/study/NCT05619887 | null | NOT_YET_RECRUITING | The goal of this interventional study is to compare muscle reflex function under settings of normoxia (normal oxygen level), acute hypoxia (brief oxygen-lack) and chronic hypoxia (long-duration exposure to oxygen-lack).
The main question is: Does the muscle reflex adapt to chronic hypoxia?
Young, healthy participants will complete light-to-high intensity cycling exercise with and without suppression of the muscle reflex. Suppression of the muscle reflex will be via spinal administration of the opioid Fentanyl. In the control condition, saline will be administered into the spinal space. Participants will complete control (saline) and experimental (Fentanyl) exercise conditions at sea-level (Kelowna, BC, Canada) breathing room air and whilst breathing a lower fraction of oxygen (acute hypoxia). Thereafter, participants will complete the exercise test after living at high altitude (White Mountain, CA, USA) for 2 weeks whilst breathing room air (chronic hypoxia) and breathing a higher fraction of oxygen (restored normoxia). | NO | Dyspnea|Muscle Strain | DRUG: Fentanyl|OTHER: Saline | Ventilation, Ventilation, in liters per minute., Data collected during steady-state breathing in the last minute of exercise | Mean arterial blood pressure (entire pressure wave), Blood pressure, in millimeters of mercury, Data collected during steady-state breathing in the last minute of exercise | Exercise performance, Time, in seconds, to complete 7 kilometers of cycling, i.e. a time-trial, The duration, i.e., however long it takes to complete the exercise; this is typically 7-14 minutes | University of British Columbia | null | ALL | ADULT | null | 14 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE | Muscle_reflex_hypoxia | 2023-06 | 2023-12 | 2024-06 | 2022-11-17 | null | 2022-11-23 | University of British Columbia - Okanagan Campus, Kelowna, British Columbia, V1V1V7, Canada | null | {
"Fentanyl": [
{
"intervention_type": "DRUG",
"description": "Fentanyl",
"name": "Fentanyl",
"synonyms": [
"Fentanyl CII",
"Abstral",
"R 4263",
"Fentanilo",
"Phentanyl",
"N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)propanamide",
"Fentora",
"1-Phenethyl-4-(N-phenylpropionamido)piperidine",
"Durogesic",
"1-phenethyl-4-N-propionylanilinopiperidine",
"Fentanyl",
"R-4263",
"R4263",
"Transmucosal Oral Fentanyl Citrate",
"N-(1-Phenethyl-piperidin-4-yl)-N-phenyl-propionamide",
"N-(1-phenethyl-4-piperidyl)propionanilide",
"N-(1-phenethyl-4-piperidinyl)-N-phenylpropionamide",
"N-(1-phenethylpiperidin-4-yl)-N-phenylpropionamide",
"Lazanda",
"Fentanil",
"Fentanyl Citrate",
"N-phenethyl-4-(N-propionylanilino)piperidine",
"Sublimaze",
"Fentanila",
"Duragesic",
"Fentanest",
"Fentanylum",
"Fentanyl Patch",
"Duragesic",
"Fentanyl Patch",
"Duragesic"
],
"medline_plus_id": "a612015",
"generic_names": [
"Fentanyl",
"Fentanyl Patch",
"Fentanyl Patch"
],
"nhs_url": "https://www.nhs.uk/medicines/fentanyl",
"mesh_id": "D018686",
"drugbank_id": "DB00813"
}
],
"Saline": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01832987 | Pharmacokinetic Parameters of Co-trimoxazole | https://clinicaltrials.gov/study/NCT01832987 | null | COMPLETED | Rationale:
Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real challenge as failure in response to treatment and serious side-effects are frequently encountered. New, more effective drugs with less side effects are therefore urgently needed to solve this problem. Although several new drugs against TB are in the pipeline, physicians currently have limited treatment options for treatment of complicated MDR/XDR-TB cases. Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB. Co-trimoxazole consists of sulfamethoxazole and trimethoprim. Sulfamethoxazole could be effective in the treatment of tuberculosis as shown by Forgacs et al. and Huang et al.
Furthermore, with dried blood spot (DBS) analysis, the exposure to co-trimoxazole could be analyzed with only some blood drops withdrawn with a finger prick on paper. This paper is suitable for storage, transportation and subsequently analysis without additional cooling or storage requirements.
Objective:
The main objective of this prospective clinical trial is to evaluate pharmacokinetics of 960 mg co-trimoxazole in TB patients. This clinical trial will provide important information on PK of co-trimoxazole in TB patients for future studies.
The second objective is to calculate the T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio as efficacy predicting parameter. Furthermore, the analysis of dried blood spots will be clinically validated by comparing results of blood samples withdrawn from venous blood versus withdrawn by finger prick and transferred to filter paper. Retrospectively, data from this study can be used for limited sampling strategies for co-trimoxazole based on a pharmacokinetic population model constructed from the full PK curves of the patients.
Study design:
A prospective pharmacokinetic study.
Study population: 12 TB patients.
Intervention: on 4 to 6 days, 960 mg co-trimoxazole daily will be added to the normal treatment regimen.
Main study parameters/endpoints:
The pharmacokinetic parameters (Vd, Cl, AUC, etc) of co-trimoxazole are the primary endpoints of the study. The T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most likely the best predictive parameters for efficacy of co-trimoxazole treatment and will be calculated for a range of M tuberculosis isolates. | NO | Tuberculosis | DRUG: co-trimoxazole | AUC, Measuring the AUC over 24 hours of sulfamethoxazole, one out of two compounds of co-trimoxazole after obtaining steady state (960 mg co-trimoxazole)., 4th, 5th or 6th day | Determination of the AUC/MIC and T>MIC, Determination of the area under the curve divided by the mean inhibitory concentration and the time above MIC., 4th, 5th or 6th day|Validating DBS analysis, Validating the analysis of dried blood spots for therapeutic drug monitoring by comparing the concentration measured in venous blood with the concentration measured using the dried blood spot method., 4th, 5th or 6th day | Population pharmacokinetic model and limited sampling strategies, Developing a population pharmacokinetic model to predict pharmacokinetic parameters of sulfamethoxazole. With this population pharmacokinetic model, a limited sampling strategy will be developed., 4th, 5th or 6th day | University Medical Center Groningen | null | ALL | ADULT | PHASE2 | 12 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: | SXT8469 | 2013-10 | 2014-08 | 2014-08 | 2013-04-16 | null | 2014-09-16 | UMCG - Tuberculosis Center, Groningen, Netherlands | null | {
"co-trimoxazole": [
{
"intervention_type": "DRUG"
}
]
} |
NCT01338987 | Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation | https://clinicaltrials.gov/study/NCT01338987 | null | COMPLETED | Background:
* One way to treat certain cancers of the blood and immune system is to give a patient stem cells from the bone marrow of a donor whose genes are very similar but not identical to the patients. One problem with these transplants is that the new immune cells may not work as well in the recipient as they did in the donor. The result may be that the immune system will not work as well. This can increase the risk of severe infections and other complications.
* Researchers are studying the use of drugs that lower hormone levels and may allow the immune system to recover in a way that improves white blood cell function. In this study they will be looking at the drug leuprolide, a drug that lowers estrogen or testosterone levels, to see if it might improve the function of the newly transplanted cells.
Objectives:
* To determine whether leuprolide improves immune system function after bone marrow transplant from a donor with similarities in their immune cells (matched to each other).
* To evaluate the effectiveness of a nuclear medicine test with a radiotracer drug 3-deoxy-3 18F-fluorothymidine (FLT) in imaging studies. FLT will be used to image the immune system function in patients who have received bone marrow from the donor.
Eligibility:
* People between 15 (or as young as 9 in those who have gone through puberty) and 55 years of age. These patients must have acute myelogenous leukemia, acute lymphocytic leukemia, high-risk myelodysplastic syndrome, chronic myelomonocytic leukemia, or chronic myeloid leukemia. They must also be eligible for a bone marrow transplant.
* Genetically similar donors for the patients who are eligible for a transplant.
Design:
* People taking part in the study will be screened with a physical examination, medical history, blood and urine tests, and imaging studies. Patients who are not in remission or who require a bone marrow donor search may receive chemotherapy first.
* Donors will provide bone marrow for transplant according to standard bone marrow transplant (BMT) procedures.
* All women and half of the men will receive regular leuprolide doses 2 weeks before BMT to suppress hormone function.
* All recipients will receive 4 days of radiation followed by 2-4 days of chemotherapy before the bone marrow transplant (depending on age). Recipients will also receive other drugs to prevent transplant rejection and other complications of transplantation.
* Recipients will be monitored in the hospital for 4 weeks after transplant with blood tests and other studies.
* Some recipients will have an imaging study with FLT during the protocol. These imaging studies will take place before the transplant, on days 5 and 28 after transplant, and at a later time to be determined by the study researchers.
* Following discharge, participants will be monitored closely for up to 6 months, with regular but less frequent followup visits for at least 5 years. Study-related medications, including vaccinations for the new immune system, will be provided by the National Institutes of Health during the hospital stay and after discharge. | YES | Myelodysplastic Syndrome|Acute Lymphocytic Leukemia|Acute Myelogenous Leukemia|Chronic Myelogenous Leukemia|Chronic Myelomonocytic Leukemia | PROCEDURE: First Allogeneic Bone Marrow Transplant (BMT)|DRUG: Leuprolide|DRUG: 18F FLT|DRUG: Cyclophosphamide|DRUG: Methotrexate|DRUG: Tacrolimus|RADIATION: Total Body Irradiation|DRUG: Busulfan|DRUG: Fludarabine|PROCEDURE: Second Allogeneic Bone Marrow Transplantation | Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT), B cell percentage is defined as the percentage of lymphocytes that are B cells., after first Bone Marrow Transplant, approximately 12 months post-transplant|Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUV s Less Than 1.4, 18F-FLT imaging was performed serially on patients post transplant to identify the level of uptake of 18F-FLT at a day +5 to +12 scan and the day at which neutrophils recover to >500 (i.e., subclinical bone-marrow recovery within 5 days of Bone Marrow Transplantation (BMT infusion)). On each image for each patient, the region of interest was drawn within each thoracic medullary space (n=12), generating the SUV for each space. The mean of these was calculated for each scan. The analysis was the median of the means of the SUV of the thorax values of the day 5-12 scan (averaged the SUV of the thorax for each patient and then took the medians of these)., 18F FLT scan done between days +5 to +12 and then time from that scan to engraftment measured|Number of Adverse Events Related to Study Drug Experienced by Participants After Second Bone Marrow Transplant (BMT), Serious and non-serious adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned., 12 months after second BMT | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0), Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned., Date treatment consent signed to date off study, approximately 79 months and 11 days. | null | National Cancer Institute (NCI) | null | ALL | CHILD, ADULT | PHASE2 | 76 | NIH | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 110136|11-C-0136 | 2011-04-19 | 2017-12-01 | 2020-11-19 | 2011-04-20 | 2019-04-23 | 2021-03-18 | Childrens National Medical Center, Washington, District of Columbia, 20010, United States|National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States|University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT01338987/Prot_SAP_000.pdf|Informed Consent Form: Donor consent, https://cdn.clinicaltrials.gov/large-docs/87/NCT01338987/ICF_003.pdf|Informed Consent Form: Recipient consent, https://cdn.clinicaltrials.gov/large-docs/87/NCT01338987/ICF_004.pdf | {
"First Allogeneic Bone Marrow Transplant (BMT)": [
{
"intervention_type": "PROCEDURE"
}
],
"Leuprolide": [
{
"intervention_type": "DRUG",
"description": "Leuprolide",
"name": "Leuprolide",
"synonyms": [
"Leuprolide Monoacetate",
"Leuprolide, (DL-Leu)-Isomer",
"Leuproreline",
"Leuprorelinum",
"A43818",
"TAP144",
"Monoacetate, Leuprolide",
"Lucrin",
"Acetate, Leuprolide",
"Eligard",
"Lupron Depot-PED",
"Lupron",
"Enantone",
"A 43818",
"Leuprorelin",
"A-43818",
"Leuprolide Acetate",
"TAP-144",
"Leuprolide, (L-Leu)-Isomer",
"Leuprorelin Acetate",
"Leuprolide",
"TAP 144",
"Leuprorelina"
],
"medline_plus_id": "a685040",
"generic_names": [
"Leuprolide"
],
"mesh_id": "D018931",
"drugbank_id": "DB00007",
"wikipedia_url": "https://en.wikipedia.org/wiki/Leuprorelin"
}
],
"18F FLT": [
{
"intervention_type": "DRUG"
}
],
"Cyclophosphamide": [
{
"intervention_type": "DRUG",
"description": "Cyclophosphamide",
"name": "Cyclophosphamide",
"synonyms": [
"(+-)-Cyclophosphamide",
"Cyclophosphamid",
"Procytox",
"NSC26271",
"CPM",
"Cytophosphane",
"Cyclophosphamide Monohydrate",
"Endoxan",
"Neosar",
"(+,-)-2-(bis(2-Chloroethyl)amino)tetrahydro-2H-1,3,2-oxazaphosphorine 2-Oxide Monohydrate",
"N,N-Bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide",
"Ciclofosfamida",
"Cyclophosphane",
"NSC-26271",
"Cytophosphan",
"Cyclophosphamide anhydrous",
"Anhydrous cyclophosphamide",
"Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester",
"Ciclofosfamide",
"(RS)-Cyclophosphamide",
"(\u00b1)-2-(BIS(2-CHLOROETHYL)AMINO)TETRAHYDRO-2H-1,3,2-OXAZAPHOSPHORINE 2-OXIDE MONOHYDRATE",
"B 518",
"CYT",
"B518",
"Cytoxan",
"Cyclophosphamide Anhydrous",
"2-[Bis(2-chloroethylamino)]-tetrahydro-2H-1,3,2-oxazaphosphorine-2-oxide",
"Cyclophosphamide, (R)-Isomer",
"Sendoxan",
"NSC 26271",
"B-518",
"Cyclophosphamidum",
"Cyclophosphamide, (S)-Isomer",
"Cyclophosphamide"
],
"medline_plus_id": "a611044",
"generic_names": [
"Cyclophosphamide"
],
"mesh_id": "D019653",
"drugbank_id": "DB00531"
}
],
"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"
}
],
"Tacrolimus": [
{
"intervention_type": "DRUG",
"description": "Tacrolimus",
"name": "Tacrolimus",
"synonyms": [
"Anhydrous Tacrolimus",
"Tacrolimus, anhydrous",
"FR900506",
"Astagraf XL",
"FR 900506",
"Tacrolimus",
"Prograft",
"FK506",
"Anhydrous, Tacrolimus",
"FR-900506",
"Advagraf",
"Tacrolimus Anhydrous",
"Protopic",
"Prograf",
"FK-506",
"Tacrolimus, Anhydrous",
"Anhydrous tacrolimus",
"FK 506",
"Tacrolimus anhydrous"
],
"medline_plus_id": "a602020",
"generic_names": [
"Tacrolimus"
],
"mesh_id": "D065095",
"drugbank_id": "DB00864",
"wikipedia_url": "https://en.wikipedia.org/wiki/Tacrolimus"
}
],
"Total Body Irradiation": [
{
"intervention_type": "RADIATION"
}
],
"Busulfan": [
{
"intervention_type": "DRUG",
"description": "Busulfan",
"name": "Busulfan",
"synonyms": [
"n-Butane-1,3-di(methylsulfonate)",
"1,4-Dimethanesulfonoxybutane",
"Myl\u00e9ran",
"1,4-Dimesyloxybutane",
"Busulfano",
"Glyzophrol",
"Busulfex",
"Busulphan",
"Wellcome, Busulfan",
"Mylecytan",
"1,4-Butanediol dimethanesulfonate",
"Busulfan",
"Myelosan",
"Busulfanum",
"Busulfan Wellcome",
"Tetramethylene bis(methanesulfonate)",
"Myleran",
"1,4-Bis(methanesulfonoxy)butane"
],
"medline_plus_id": "a611033",
"generic_names": [
"Busulfan"
],
"mesh_id": "D019653",
"drugbank_id": "DB01008"
}
],
"Fludarabine": [
{
"intervention_type": "DRUG",
"description": "Fludarabine",
"name": "Fludarabine",
"synonyms": [
"Fludara",
"Fludarabina",
"Fludarabine",
"2-Fluoro-ara-A Monophosphate, 2-Fluoro-ara AMP, FAMP",
"Fludarabinum",
"2-fluoro ARA-A",
"2-F-ARAA"
],
"medline_plus_id": "a692003",
"generic_names": [
"Fludarabine"
],
"drugbank_id": "DB01073"
}
],
"Second Allogeneic Bone Marrow Transplantation": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT01418287 | Characterization of Influenza-like Illness in Mexico | https://clinicaltrials.gov/study/NCT01418287 | null | COMPLETED | A study to characterize children and adults with influenza like symptoms and to determine risk factors for severe disease and death among those with H1N1. | NO | Influenza-like Illness | null | Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses, Characterize demographics, co-morbid conditions, prior influenza vaccination, the use of antivirals, and clinical course and treatment, 5 years | Death, For all participants, to estimate the percentage who die, 5 years|Hospitalization, For all participants, to estimate the percentages who require hospitalization due to severe influenza, 5 years|Risk factors, For all participants, to determine risk factors for severe disease, 5 years|Repository of oropharyngeal and nasal samples, Establish a repository of oropharyngeal and nasal samples to determine a precise diagnosis, to molecularly characterize the virus, 5 years|Repository of serum and PBMC, Establish a repository of serum and PBMC to study biomarkers that predispose and correlate with severe influenza, 5 years | null | Mexican Emerging Infectious Diseases Clinical Research Network | National Institute of Allergy and Infectious Diseases (NIAID)|Secretaria de Salud, Mexico|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|Instituto Nacional de Enfermedades Respiratorias|National Institute of Pediatrics, Mexico|Hospital General Dr. Manuel Gea González|Hospital Infantil de Mexico Federico Gomez|Hospital Central Dr. Ignacio Morones Prieto | ALL | CHILD, ADULT, OLDER_ADULT | null | 5,819 | NETWORK | OBSERVATIONAL | Observational Model: |Time Perspective: p | ILI002|HHSN272200900003I | 2010-04 | 2014-05 | 2014-05 | 2011-08-17 | null | 2014-09-11 | Instituto Nacional de Pediatría (INP), México City, México, CP 04530, Mexico|Hospital Infantil de México Federico Gómez (HIM), México City, México, CP 06720, Mexico|Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), México City, México, CP 14000, Mexico|Hospital General y de Alta Especialidad Dr. Manuel Gea González, México City, México, CP 14080, Mexico|Instituto Nacional de Enfermedades Respiratorias (INER), México City, México, CP 14080, Mexico|San Luis Potosí (SLP):Hospital Central Dr. Ignacio Morones Prieto/Universidad Autónoma de San Luis Potosí, San Luis Potosí, CP 78240, Mexico | null | {} |
NCT01604187 | Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients | https://clinicaltrials.gov/study/NCT01604187 | Abstral | COMPLETED | Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the patient. The pain associated with the procedure is not caused by the insertion of the scope but from inflating of the colon in order to do the inspection. It has been shown that colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients feel discomfort during the procedure. Factors predicting a painful colonoscopy are female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy (Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or analgesia are achieved by administering a benzodiazepine or a combination of a benzodiazepine and an opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine (Dere et al. 2009) or by using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol as monotherapy did not significantly decrease pain intensity or endoscopist s evaluation of colonoscopy (Grossi et al. 2004). Currently, intravenous midazolam is the drug used most commonly to introduce some sedation for colonoscopy. Intravenous sedation definitely increases the cost of procedure; drug administration, need for pulse oximetry monitoring and the need for follow-up after the procedure make colonoscopy sometimes expensive and troublesome. It has also been shown, that low-dose midazolam neither relieves discomfort nor makes patients forget it (Elphick et al. 2009).
Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal sublingual formulation of fentanyl has been developed to further improve the management of pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by the body through the mucous membrane. After administration of buccal fentanyl maximum plasma drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl concentrations versus time following buccal and sublingual administration are very similar (Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under the tongue at the deepest part. Sublingual administration is an easy and non-invasive method of pain treatment for the patient coming to colonoscopy done as an office based procedure. Other advantages compared to invasive methods are improved comfort of patients and no need for intravenous access because of pain relief. Before, it has been used in the management of breakthrough pain in cancer patients. Sublingual fentanyl is shown to be effective and well-tolerated for the treatment of breakthrough cancer pain (Uberall et al. 2011). The use of transmucosal tablet for colonoscopy patients is a quite new approach. | NO | Colonoscopy|Pain | DRUG: Fentanyl|DRUG: Placebo | Efficacy of fentanyl transmucosal tablet to placebo in patients having colonoscopy., Anxiety will be measured using NRS (0 = no anxiety, 10=maximal anxiety). Pain will be monitored by using numercal rating scale NRS (0-10), sedation by using NRS (0-10, 0= not sedated at all, 10=no response) . Nurse s and surgeon s satisfaction with the procedure will be evaluated using NRS (0-10). Adverse effects of opioids will be evaluated by patients using NRS (0-10)) for the following items: drowsiness (alert / very drowsy), pleasantness (very unpleasant / very pleasant feeling) and nausea/vomiting (no nausea / very strong nausea). In addition, all other adverse effects will be recorded. | The safety of fentanyl transmucosal tablet to placebo in patients having colonoscopy., SpO2 and breath rate will be followed throughout the procedure. If the peripheral arterial oxygen saturation decreases below 90 % or breath rate falls below 8 per min, additional oxygen will be given. In case of excess opioid effects, naloxon 0.1mg iv will will be given.
The patients will be interviewed by telephone on the first day after the procedure approximately 24 hours later and. | null | Turku University Hospital | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 158 | OTHER_GOV | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE | Abstral | 2012-04 | 2019-04-22 | 2019-04-30 | 2012-05-23 | null | 2019-09-11 | Turku University Hospital, Turku, 20521, Finland | null | {
"Fentanyl": [
{
"intervention_type": "DRUG",
"description": "Fentanyl",
"name": "Fentanyl",
"synonyms": [
"Fentanyl CII",
"Abstral",
"R 4263",
"Fentanilo",
"Phentanyl",
"N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)propanamide",
"Fentora",
"1-Phenethyl-4-(N-phenylpropionamido)piperidine",
"Durogesic",
"1-phenethyl-4-N-propionylanilinopiperidine",
"Fentanyl",
"R-4263",
"R4263",
"Transmucosal Oral Fentanyl Citrate",
"N-(1-Phenethyl-piperidin-4-yl)-N-phenyl-propionamide",
"N-(1-phenethyl-4-piperidyl)propionanilide",
"N-(1-phenethyl-4-piperidinyl)-N-phenylpropionamide",
"N-(1-phenethylpiperidin-4-yl)-N-phenylpropionamide",
"Lazanda",
"Fentanil",
"Fentanyl Citrate",
"N-phenethyl-4-(N-propionylanilino)piperidine",
"Sublimaze",
"Fentanila",
"Duragesic",
"Fentanest",
"Fentanylum",
"Fentanyl Patch",
"Duragesic",
"Fentanyl Patch",
"Duragesic"
],
"medline_plus_id": "a612015",
"generic_names": [
"Fentanyl",
"Fentanyl Patch",
"Fentanyl Patch"
],
"nhs_url": "https://www.nhs.uk/medicines/fentanyl",
"mesh_id": "D018686",
"drugbank_id": "DB00813"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03385187 | Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test | https://clinicaltrials.gov/study/NCT03385187 | null | UNKNOWN | Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to a traditional Type I and a Type IV sleep monitor. | NO | Sleep Apnea | DEVICE: NightOwl HSAT | Apnea-Hypopnea Index (AHI), Comparison of the AHI derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors, At the time of the diagnostic night | Sleep-wake discrimination, Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors, At time of the diagnostic night | null | Ectosense NV | Ziekenhuis Oost-Limburg | ALL | ADULT, OLDER_ADULT | null | 450 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | 17/034U | 2017-06-29 | 2019-09-15 | 2019-12-15 | 2017-12-28 | null | 2019-03-21 | Ziekenhuis Oost-Limburg, Genk, Limburg, 3600, Belgium | null | {
"NightOwl HSAT": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04357587 | Safety and Feasibility of PD-1 Blockade in the Treatment of dMMR or MSI-H Rectal Cancer | https://clinicaltrials.gov/study/NCT04357587 | null | COMPLETED | Colorectal cancer is the third most common cancer worldwide and the second leading cause of cancer mortality in the United States. The current standard of care (SOC) for locally advanced rectal cancer includes neoadjuvant chemotherapy and radiation followed by surgery. However, great variability exists in patient s response to neoadjuvant chemoradiotherapy with only about 20-25% of patients achieving a complete response while other patients achieve a partial or no treatment response. The purpose of this study is to test the investigational agent, Pembrolizumab, in combination with SOC radiation and Capecitabine (or 5-Fluorouacil) in treatment of patients with mismatch repair deficient locally advanced rectal cancer. | NO | Rectal Neoplasms | DRUG: Pembrolizumab|RADIATION: External beam radiation|DRUG: Capecitabine | Rate of adverse events (AEs) as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Safety endpoint will be defined by rate of AEs as defined by the CTCAE v5.0, 30 days after intervention|Proportion of participants able to complete planned neoadjuvant treatment protocol, Tolerability as defined by proportion of participants that are able to complete the planned neoadjuvant treatment protocol, 45 days after intervention|Feasibility as defined by proportion of participants with any delay in planned surgery of more than 30 days, Feasibility as defined by proportion of participants with any delay in the planned surgery of more than 30 days, 115 days after intervention|Treatment response as measured by AJCC tumor regression grade (TRG), Treatment response as measured by pathologic assessment of treatment response using the AJCC TRG following surgical resection.
AJCC TRG grading ranges from 0-3:
0 (complete response): no viable cancer cells
1. (near complete response): single cells or rare small groups of cancer cells
2. (partial response): residual cancer with evident tumor regression but more than single cells or rare small groups of cancer cells
3. (poor or no response): extensive residual cancer with no evident tumor regression., at time of surgical resection, an average of 10 weeks after radiation|Treatment response as measured by MRI tumor regression grade, Treatment response as measured by MRI tumor regression grade.
The MRI tumor regression grade uses the following scale:
1. No/minimal fibrosis visible (tiny linear scar) and no tumor signal
2. Dense fibrotic scar (low signal intensity) but no macroscopic tumor signal (indicates no or microscopic tumor)
3. Fibrosis predominates but obvious measurable areas of tumor signal visible
4. Tumor signal predominates with little/minimal fibrosis
5. Tumor signal only: no fibrosis, includes progression of tumor, 4-6 weeks before intervention|Treatment response as measured by Carcinoembryonic antigen (CEA) blood test, Treatment response as measured by CEA levels, 4-6 weeks before intervention | null | null | Case Comprehensive Cancer Center | null | ALL | ADULT, OLDER_ADULT | PHASE1 | 6 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | CASE1220 | 2020-08-06 | 2023-09-25 | 2023-09-25 | 2020-04-22 | null | 2024-05-29 | Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, 44122, United States | 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"
}
],
"External beam radiation": [
{
"intervention_type": "RADIATION"
}
],
"Capecitabine": [
{
"intervention_type": "DRUG",
"description": "Capecitabine",
"name": "Capecitabine",
"synonyms": [
"Capecitabinum",
"Xeloda",
"(1-(5-Deoxy-beta-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinyl)-carbamic acid pentyl ester",
"pentyl 1-(5-deoxy-\u03b2-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate",
"Cap\u00e9citabine",
"Capecitabina",
"N(4)-pentyloxycarbonyl-5'-deoxy-5-fluorocytidine",
"Capecitabine",
"Pentyl [1-(5-deoxy-\u03b2-D-ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]carbamate",
"Capecitabin"
],
"medline_plus_id": "a699003",
"generic_names": [
"Capecitabine"
],
"mesh_id": "D000964",
"drugbank_id": "DB01101"
}
]
} |
NCT04404387 | Lessening Organ Dysfunction With VITamin C in Septic ARDS | https://clinicaltrials.gov/study/NCT04404387 | LOVIT ARDS | RECRUITING | The primary objective of the study aims to compare the effect of high-dose intravenous vitamin C vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 28 days on intensive care unit (ICU) patients.
As secondary objectives, the study aims:
* To compare the effect of high-dose intravenous vitamin C vs. placebo on:
1. 6-month mortality;
2. 6-month HRQoL;
3. organ function (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU);
4. global tissue dysoxia (at baseline);
5. oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU, and if still intubated);
6. occurrence of stage 3 acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global Outcomes) criteria20;
7. acute hemolysis as defined by:
* clinician judgment of hemolysis, as recorded in the chart, or
* hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:
* reticulocyte count >2 times upper limit of normal at clinical site lab;
* haptoglobin < lower limit of normal at clinical site lab;
* indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
* lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.
Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells;
8. hypoglycemia as defined as core lab-validated glucose levels of less than < 3.8 mmol/L.
* To assess baseline vitamin C levels in study participants (before the first dose of investigational product). | NO | Septic|Acute Respiratory Distress Syndrome | DRUG: Administration of vitamin C|DRUG: Administration of placebo | Number of deceased participants or with persistent organ dysfunction, Defined as death or persistent organ dysfunction: continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors., Both assessed at 28 days | Vital statue at 6 months, Mortality at 6 months, at 6 months|Quality of life assessement: EQ-5D-5L, Quality of life of patients will be assessed by the questionnaire EQ-5D-5L.
The questionnaire EQ-5D-5L essentially consists of 2 pages:
- page1: the EQ-5D-5L descriptive system:
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box (1-digit number) next to the most appropriate statement in each of the five dimensions.
- page 2: the EQ visual analogue scale (VAS): the EQ VAS records the patient s self-rated health on a vertical visual analogue scale.
The 2 parts of the questionnaire can not be assessed seperately., at 6 months|Daily organ function, Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, and 28);, Days 1, 2, 3, 4, 7, 10, 14, 28|Global tissue dysoxia, Global tissue dysoxia: assessed by serum lactate concentration, At baseline and days 1, 3, 7|Occurrence of stage 3 acute kidney injury, Occurrence of stage 3 acute kidney injury as defined by KDIGO criteria, Up to day 28|Acute hemolysis, Acute hemolysis as defined by:
* clinician judgment of hemolysis, as recorded in the chart, OR
* hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:
* reticulocyte count >2 times upper limit of normal at clinical site lab;
* haptoglobin < lower limit of normal at clinical site lab;
* indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
* LDH >2 times upper limit of normal at clinical site lab.
Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells., Up to day 28|Hypoglycemia, Hypoglycemia as defined by core lab-validated glucose levels of less than < 3.8 mmol/L., During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose | null | Assistance Publique - Hôpitaux de Paris | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 800 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | APHP200019|2019-003350-80|2020-003923-40 | 2022-07-22 | 2024-07 | 2024-07 | 2020-05-27 | null | 2024-01-31 | Department Intensive Care Unit, Hospital Raymond Poincaré - APHP, Garches, 92100, France | null | {
"Administration of vitamin C": [
{
"intervention_type": "DRUG"
}
],
"Administration of placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT04971187 | Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer | https://clinicaltrials.gov/study/NCT04971187 | null | TERMINATED | This phase II trial studies the effect of bintrafusp alfa with pemetrexed and platinum-based chemotherapy (carboplatin or cisplatin) in treating patients with EGFR mutant non-small cell lung cancer that have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic) and cannot be removed by surgery, and remains despite treatment with tyrosine kinase inhibitors (Resistant). Immunotherapy with bintrafusp alfa, a bifunctional fusion protein composed of the monoclonal antibody anti-PD-L1 and TGF-beta, may help the body s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bintrafusp alfa with pemetrexed and platinum-based chemotherapy may help to control the disease. | YES | Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma|Metastatic Lung Non-Squamous Non-Small Cell Carcinoma|Stage III Lung Cancer AJCC v8|Stage IIIA Lung Cancer AJCC v8|Stage IIIB Lung Cancer AJCC v8|Stage IIIC Lung Cancer AJCC v8|Stage IV Lung Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8|Unresectable Lung Non-Squamous Non-Small Cell Carcinoma | DRUG: Bintrafusp Alfa|DRUG: Pemetrexed|DRUG: Carboplatin|DRUG: Cisplatin | Best Objective Response Rate (ORR) Within 6 Months, Objective response was assessed by RECIST 1.1. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started)., Within 6 months since initiation of treatment|Progression Free Survival (PFS) at 18 Weeks, PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per Response evaluation criteria in solid tumors (RECIST) version 1.1 at 18 weeks., 18 weeks | Safety and Tolerability, Safety and tolerability as measured by all adverse events (AEs). Safety and tolerability will be described using frequency of AEs and AEs of Common Terminology Criteria for Adverse Events (CTCAE 5.0). Safety analyses will include all patients who have received at least one dose of study drug and will be evaluated descriptively., Up to 30 days post-treatment|Progression Free Survival (PFS), PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per Response evaluation criteria in solid tumors (RECIST) version 1.1., Up to 1 year|Disease Control Rate (DCR), DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD). According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1, Up to 1 year|Duration of Response (DoR), The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation), Up to 1 year|Overall Survival (OS), Overall Survival (OS) is defined as the time from treatment to death due to any cause, or censored at date last known alive., Up to 1 year | null | M.D. Anderson Cancer Center | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 3 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 2020-1266|NCI-2021-07070 | 2021-06-30 | 2022-02-21 | 2022-02-21 | 2021-07-21 | 2023-08-01 | 2023-08-01 | M D Anderson Cancer Center, Houston, Texas, 77030, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT04971187/Prot_SAP_000.pdf | {
"Bintrafusp alfa": [
{
"intervention_type": "DRUG",
"description": "Bintrafusp Alfa",
"name": "Bintrafusp alfa",
"synonyms": [
"Bintrafusp alfa"
],
"drugbank_id": "DB15387",
"generic_names": [
"Bintrafusp alfa"
]
}
],
"Pemetrexed": [
{
"intervention_type": "DRUG",
"description": "Pemetrexed",
"name": "Pemetrexed",
"synonyms": [
"LY-231,514",
"Pemetrexed",
"LY 231514",
"LY231514",
"LY-231514",
"Alimta",
"231,514, LY",
"Disodium, Pemetrexed",
"LY 231,514",
"MTA",
"Pemetrexed Disodium",
"231514, LY",
"N-(4-(2-(2-amino-3,4-dihydro-4-oxo-7H-pyrrolo(2,3-d)pyrimdin-5-yl)ethyl)benzoyl)glutamic acid",
"5-Methylthioadenosine",
"5'-Deoxy-5'-(methylthio)adenosine",
"S-Methyl-5'-thioadenosine",
"Methylthioadenosine",
"5'-S-methyl-5'-thioadenosine",
"Thiomethyladenosine",
"9-(5-S-methyl-5-thio-\u03b2-D-ribofuranosyl)-9H-purin-6-amine",
"MTA",
"5'-Methylthioadenosine"
],
"medline_plus_id": "a607043",
"generic_names": [
"Pemetrexed",
"5'-S-methyl-5'-thioadenosine"
],
"mesh_id": "D019384",
"drugbank_id": "DB00642"
}
],
"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"
}
],
"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"
}
]
} |
NCT03867487 | SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease | https://clinicaltrials.gov/study/NCT03867487 | SLIDE | NOT_YET_RECRUITING | This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity. | NO | Non-Alcoholic Fatty Liver Disease|NAFLD|Pediatric NAFLD | DRUG: Empagliflozin 10 MG|DRUG: Placebo Oral Tablet | Efficacy as Measured by Change in Hepatic Fat Fraction (HFF), HFF is measured by MRI via 1H- magnetic resonance spectroscopy (MRS). HFF will be measured with single-voxel 1H-MRS on a 3.0 T Trio whole body MRI scanner, using the software package provided by the vendor. The MR elastography measurement will consist of a phase-contrast 2D GRE scan (TR/TE = 50/25 ms, matrix 256 x 90, GRAPPA R=3, slice thickness 7mm) with motion encoding in the z-direction, and acoustic excitation at 60 Hz. Four axial slices will be acquired, each with a single breath-hold. Manual ROIs covering the liver will be drawn on the stiffness maps (in kPa units) generated by the system software. Fibrosis staging will be determined following previously published guidelines., Baseline to 26 weeks | Change in Body Measurements: Body mass index (BMI), Height and weight will be measured using a calibrated, wall-mounted stadiometer and an electronic scale, respectively. Three consecutive height and weight measurements will be obtained and averaged. BMI will be calculated as the weight in kilograms divided by the height in meters, squared., Baseline to 26 weeks|Change in Body Measurements: Body Fat %, Total percent body fat mass and lean muscle mass will be determined by dual energy x-ray absorptiometry (iDXA, GE Healthcare). Body fat percentage is calculated by body fat mass divided by the sum of fat and lean masses., Baseline to 26 weeks|Change in Body Measurements: Visceral Fat %, Total body fat mass and visceral fat mass will be determined by dual energy x-ray absorptiometry (iDXA, GE Healthcare). Visceral fat percentage of total body mass is calculated by visceral fat mass divided by the sum of total fat and lean masses. Visceral fat percentage of total fat mass is calculated by visceral fat mass divided by total fat mass., Baseline to 26 weeks|Change in Biomarkers of NAFLD: Alanine transaminase (ALT), Fasting (≥12 hours) blood will be collected for the measurement of ALT at Fairview Diagnostics Laboratories, Fairview-University Medical Center, Minneapolis, MN - a Center for Disease Control and Prevention certified laboratory., Baseline to 26 weeks|Change in Biomarkers of NAFLD: Cytokeratin (CK)-18, Fasting plasma samples will be used to measure CK-18 via Luminex Multiplex platform (Millipore, St. Louis, MO)., Baseline to 26 weeks|Change in Blood Pressure, Blood pressure measurements will be obtained manually on the same arm using the same cuff size and equipment. Standardized procedures will be employed as described in previously published standards. Individual cuff size will be determined by measuring the arm circumference midway between the acromial process and the bony olecranon. Sitting blood pressure and heart rate will be measured after the participant has been resting quietly without legs crossed for 10 minutes. Measurements will be made three consecutive times (3-minute intervals). The final two of three independent measurements will be averaged., Baseline to 26 weeks|Change in Arterial Stiffness, Carotid- and femoral artery augmentation index and carotid-femoral pulse wave velocity (PWV) will be measured by the SphygmoCor® MM3 system (AtCor Medical, Sydney, Australia). Augmentation index is a measure of the relative magnitude of the reflected (or retrograde) pulse wave early in the cardiac cycle. Higher values of augmentation index represent increased arterial stiffening. PWV will be calculated as distance divided by transit time. Since pulse wave transit time decreases in stiffer arterial segments, higher values of pulse wave velocity represent increased arterial stiffness., Baseline to 26 weeks|Change in Glycemic Control, After fasting measures are completed, we will perform a 2-hour oral glucose tolerance test with fasting (-15 and 0-min) and serial postprandial (15-, 30-, 45-, 60-, 90-, and 120-minutes) plasma concentrations of glucose (glucose oxidase, YSI INC., Yellow Sprigs, OH) and insulin (ELISA, ALPCO Diagnostics, Windham, NH) measured after administration of a 75g glucose challenge. Samples will be batched and a stored for analysis at the completion of the study. Insulin sensitivity will be estimated by the whole-body insulin sensitivity index (WBISI) using plasma glucose and insulin concentrations., Baseline to 26 weeks|Change in Proton Density Fat Fraction (PDFF) from MRI, A proton density fat fraction (PDFF) image will be acquired using LiverLab s qdixon imaging acquisition (3D gradient echo, TR=9ms, flip angle=4°, TE=1.15, 2.46, 3.69, 4.92, 6.15, 7.38 ms, 2x2x3.5mm resolution, one 17s breath-hold). The MRS measurement of HFF will be used as the primary metric. As a secondary endpoint we will use PDFF which has shown promise as a measure of fibrosis staging compared to liver biopsy in children., Baseline to 26 weeks | null | Ann & Robert H Lurie Children s Hospital of Chicago | null | ALL | CHILD | PHASE2 | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | IRB 2023-6034 | 2024-05-01 | 2029-12-31 | 2029-12-31 | 2019-03-08 | null | 2024-04-09 | University of Minnesota, Minneapolis, Minnesota, 55455, United States | null | {
"Empagliflozin": [
{
"intervention_type": "DRUG",
"description": "Empagliflozin 10 MG",
"name": "Empagliflozin",
"synonyms": [
"Empagliflozinum",
"Empagliflozine",
"Empagliflozina",
"Sciampa.M",
"Empagliflozin",
"1-chloro-4-(glucopyranos-1-yl)-2-(4-(tetrahydrofuran-3-yloxy)benzyl)benzene",
"Synjardy",
"Jardiance",
"(1S)-1,5-anhydro-1-(4-chloro-3-{4-[(3S)-tetrahydrofuran-3-yloxy]benzyl}phenyl)-D-glucitol",
"Empagliflozin/metformin",
"Synjardy",
"Jardiamet",
"Empagliflozin/metformin",
"Synjardy",
"Jardiamet"
],
"medline_plus_id": "a614043",
"generic_names": [
"Empagliflozin"
],
"nhs_url": "https://www.nhs.uk/medicines/empagliflozin",
"drugbank_id": "DB09038",
"wikipedia_url": "https://en.wikipedia.org/wiki/Empagliflozin"
}
],
"Placebo Oral Tablet": [
{
"intervention_type": "DRUG"
}
]
} |
NCT00765687 | Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates | https://clinicaltrials.gov/study/NCT00765687 | BLEST | COMPLETED | A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china. | NO | Non-small Cell Lung Cancer|Bone Metastases | DRUG: bisphosphates | Skeleton-related event, 24 months | overall survival, 24 months | null | Sun Yat-sen University | Novartis | ALL | ADULT, OLDER_ADULT | PHASE4 | 432 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | CZOL446ECN07 | 2008-08 | 2012-05 | 2012-05 | 2008-10-03 | null | 2013-12-10 | SunYat-senU, GuangZhou, Guangdong, China | null | {
"bisphosphates": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03901287 | Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension | https://clinicaltrials.gov/study/NCT03901287 | DECTPH | COMPLETED | Pathophysiological mechanisms leading to pulmonary hypertension (PH) are complex. Quantitative computed tomography (QCT) can help us to study morphological alterations in patients with PH. These CT morphometrics are useful to predict the degree of PH severity at least in PH secondary to chronic obstructive pulmonary disease (COPD). We hypothesized that assessing lung perfusion using dual energy CT (DECT) can refine our knowledge on PH pathophysiology and help to predict PH severity irrespective of its etiology | NO | Pulmonary Hypertension | OTHER: dual energy CT scans | stence and the severity of PH, Prediction of the existence and the severity of PH using a qCT score combining morphometric parameters (WT(mm), CSA(mm2) and/or VSA(mm3)) and functional parameters (PVB(HU)), Baseline | kappa coefficient, Good kappa coefficient (>0.6) for topographic evaluation of pulmonary artery segmentation, baseline|Dice coefficient, Good Dice coefficient (>0.8) for overlap and similarity between manual (ground truth) and automatic segmentations, Baseline | null | University Hospital, Bordeaux | null | ALL | ADULT, OLDER_ADULT | null | 60 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | CHUBX 2018/59 | 2019-08-02 | 2021-01-15 | 2021-01-15 | 2019-04-03 | null | 2021-03-26 | CHU Bordeaux, Bordeaux, France | null | {
"dual energy CT scans": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05550987 | The Use of Modern Technologies in Neurorehabilitation | https://clinicaltrials.gov/study/NCT05550987 | null | NOT_YET_RECRUITING | Early conventional rehabilitation improves the functioning of patients with neurological diseases. However, recovery is not always satisfactory. These needs are met by the constantly developing modern technologies supporting the process of neurorehabilitation. The main goal of the research project is to evaluate the use of modern technologies in the rehabilitation of patients with neurological diseases (after stroke, craniocerebral trauma, spinal cord injury, cerebral palsy and multiple sclerosis). According to the research hypothesis, intensive rehabilitation with the use of modern technologies will improve the functional efficiency of patients with neurological diseases. | NO | Neurorehabilitation|Nervous System Diseases|Biomedical Enhancement|Physical Activity | OTHER: Rehabilitation program with the use of mechanical vibration using the Vibramoov device and conventional physiotherapy|OTHER: Rehabilitation program with gait training using the Ekso GT exoskeleton and conventional physiotherapy|OTHER: Rehabilitation program with the use of gait training with the use of a RoboGait stationary robot and conventional physiotherapy.|OTHER: Rehabilitation program with the use of gait training with the use of the ZEBRIS treadmill and conventional physiotherapy|OTHER: Rehabilitation program with the use of upper limb function training with the use of the PABLO device and conventional physiotherapy|OTHER: Control Group | An assessment of static and dynamic balance using Berg Balance Scale (BBS), Assessment of static and dynamic balance based on 14 types of movement in the standing and sitting position of the patient. Each task of the test is scored using a four-point scale. A maximum score of 56 points is possible. Patients with a score below 20 pts indicate high risk of fall and the need of using wheelchairs., at baseline, immediately after treatment|An assessment of locomotor stages after Spinal Cord Injury using LOSSCI Scale, The LOSSCI is a five-stage scale result of applying and adapting to spinal cord injury the original Vojta s 10 specific locomotor stages. Each LOSSCI stage should be evaluated in ascending order and the grading is determined by the highest stage the person can accomplish: orienting to and touching or grasping an object in supine position, trunk uprighting in prone position, creeping, crawling or walking support for the upper limbs, independent bipedal locomotion. The person s highest stage is reached when at least one item in a stage is achieved., at baseline, immediately after treatment completion|An assessment of trunk movement using The Trunk Control Test for Motor Impairment After Stroke (TCT), The TCT examines four axial movements: rolling from a supine position to the weak side and to the strong side, sitting up from a lying-down position, and sitting in a balanced position on the edge of the bed with feet off the ground for 30 seconds. The scoring is as follows: 0, unable to perform movement without assistance; 12, able to perform movement but in an abnormal manner; and 25, able to complete movement normally. The TCT score is the sum of the scores obtained on the four tests (range, 0 to 100)., at baseline, immediately after treatment completion|An assessment of fall risk using Timed Up and Go Test (TUG), Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down., at baseline, immediately after treatment completion|An assessment of motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale, Fugl-Meyer Motor Assessment Scale for Upper Extremity is a comprehensive tool enabling measurement of motor function; it comprises 33 motor tasks, designed to assess general movements, precision movements, grip, coordination and speed. It is also possible to perform H subgroup tests - assessing superficial and deep sensibility, and J subgroup tests - for range of passive motion and pain induced by such movements. Individual tasks are assessed on a scale 0-2 0 - impossible task. The higher the score, the better., at baseline, immediately after treatment completion | An assessment of muscle tone using modified Tardieu Scale, The scale takes into account the tension depending on the bending speed of the limb. It includes an assessment of the extent of passive motion when a muscle is stretched at a very slow pace, an assessment of the quality of the muscle s response during rapid stretching, and a measurement of the angle at which the muscle first responds to overactive stretching., at baseline, immediately after treatment completion|An assessment of the parameters describing the center of pressure of the feet for measurements with eyes open and closed carried out on the stabilometric platform ALFA, The balance will be conducted using the Alfa platform. The board platform will be set up in parallel, 2 m from the walls of the room, where a tag will be placed to focus vision with open eyes during the trials. The measuring device will be calibrated before each test. The study will consist of two 30-s trials performed with open and closed eyes. The participant will be asked to conduct the test without shoes, in a relaxed standing position, with arms down by the sides., at baseline, immediately after treatment completion|An assessment of strength and quality of grips carried out on the Pablo, Assessment of the strength of a cylindrical grip and extension as well as grips: pincer, lateral, two-point, three-point measured in kilograms and the force control index (0-100 points). The force control index is determined on the basis of: force reaction time, release time, force value exceeding, bending and extension time control., at baseline, immediately after treatment completion|Analysis of gait spatiotemporal parameters carried out on Zebris, The Zebris FDM-T is fitted with an electronic mat of 10,240 miniature force sensors, each approximately 0.85 × 0.85 cm embedded underneath the belt. The treadmill s contact surface measures 150 × 50 cm and its speed can be adjusted from 0.2 to 22 km/h, at intervals of 0.1 km/h. When the subject will stands/walks on the treadmill, the force will be exerted by his feet (the so-called reactive-normal force) and recorded by the sensors at a sampling rate of 120 Hz. Dedicated software will be integrated the force signals and provides 2D/3D graphic representation of major spatiotemporal parameters., at baseline, immediately after treatment completion|Analysis of isometric muscle strength carried out on RoboGait, Based on the gait analysis carried out with the RoboGait, the isometric muscle strength will be obtained., at baseline, immediately after treatment completion|Analysis of gait carried out on Ekso Skeleton, The EksoGT powered robotic exoskeleton will be used to provide the experimental intervention for this study. The number of steps during training will be assessed., at baseline, immediately after treatment completion|An assessment of manual skills using Box and Blocks Test, The test uses a wooden box, divided into two equal parts by a partition, as well as 150 blocks. The subject moves as many blocks as possible from one part of the box to the other during 60 seconds, at baseline, immediately after treatment completion|An assessment of handgrip function using Franchay scale, The scale consists of 7 tasks (pass/fail grading); the patient is awarded 1 point for each activity performed successfully, or 0 points for a failure to perform. The maximum score of seven points may be achieved for the performance of the tasks. Higher score corresponds to better manual skills. The scale measures the proximal control of the upper limb and the manual skills, at baseline, immediately after treatment completion|An assessment of ability to perform basic activities of daily living using Barthel Index, Barthel Index is a scale for ADL (Activities of Daily Living) measurement, with lower scores indicating greater dependency in ADL. The score value ranges between 0 and 100 points. The assessment of the total score is as follows: 0-20 completely dependent; 21-61 almost completely dependent; 62-85 dependent; 91-100 - independent, at baseline, immediately after treatment completion|An assessment of body composition using subjected to bioelectrical impedancy analysis - Tanita 780, The TANITA is an 8-contact electrode system capable of acquiring segmental body composition analysis without the need for gel electrodes. Measurements using the TAN segmental body composition analyzer were recorded following a standardized 10-min standing period to minimize acute shifts in fluid distribution. Subject details were entered into the TAN, including information on clothing weight, gender, age, and height. When prompted, subjects stepped onto the footpads and grasped the handles. Analysis took approximately 10 sec during which time the subjects remained still and relaxed. Measurements were recorded in the standard mode., at baseline, immediately after treatment completion|An assessment of quality of life using The World Health Organization quality of life (WHOQOL) - BREF, The WHOQOL-Bref questionnaire was used to assess the quality of life, which allows to obtain a profile of quality of life on the basis of the analysis of the last 14 days in four domains: physical, psychological, social and environmental. Answers to the questions asked are classified in a five-point scale, and the interpretation of the obtained results has a positive direction. This means that the greater the number of points scored in each of the assessed domains, the better the quality of life of the subject., at baseline, immediately after treatment completion|An assessment of level of disability using The World Health Organization Disability Assessment Schedule (WHODAS 2.0), The questionnaire enables the assessment of the functioning of people in the last 30 days in six domains of life: understanding and communicating, getting around, self-care, getting along with people, life activities and participation in society. Answers to the questions were classified in a five-point scale in which, along with the increase in the score obtained, the severity of the problem increases (no problem - 1 point, extremely big problem - 5 points). After summing up the results obtained in each of six domains and converting them to the 0-100 point range, it is also possible to assess the overall disability level, in which 0 points means no disability and 100 points - total disability, at baseline, immediately after treatment completion|An assessment of Lung Capacity assessment using a peak expiratory flow (PEV) measurement, Lung Capacity was measured based on peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) using Peak flow meter (Peak Flow Meter Microlife PF 100, measuring range: 50-900 l/min and FEV1 0,01-9,99 l). Participants take a deep breath and blow air into the meter as fast as they can. For PEF and FEV1, at least three measurements were performed until the best values was selected, at baseline, immediately after treatment completion|An assessment of walking speed using the 10 meter walk test (10MTW), The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance., at baseline, immediately after treatment completion | An assessment of cognitive state using The abbreviated mental test score (AMTS), The Abbreviated Mental Test Score (AMTS) is a tool designed for the assessment of cognitive functions, such as episodic memory, semantic memory and working memory, to screen for potential problems in cognitive functioning. AMTS is a 10-item questionnaire comprising questions and simple tasks for the patient. It takes only several minutes to perform, is simple, and no professional knowledge or equipment are needed., at baseline, immediately after treatment completion|An assessment of anxiety and depression using Hospital Anxiety and Depression Scale (HADS), The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for both scales, scores of less than 7 indicate non-cases., at baseline, immediately after treatment completion | University of Rzeszow | Donum Corde Rehabilitation Center | ALL | ADULT, OLDER_ADULT | null | 120 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | Neurorehabilitation | 2022-11-01 | 2025-10-01 | 2025-12-31 | 2022-09-22 | null | 2022-11-08 | null | null | {
"Rehabilitation program with the use of mechanical vibration using the Vibramoov device and conventional physiotherapy": [
{
"intervention_type": "OTHER"
}
],
"Rehabilitation program with gait training using the Ekso GT exoskeleton and conventional physiotherapy": [
{
"intervention_type": "OTHER"
}
],
"Rehabilitation program with the use of gait training with the use of a RoboGait stationary robot and conventional physiotherapy.": [
{
"intervention_type": "OTHER"
}
],
"Rehabilitation program with the use of gait training with the use of the ZEBRIS treadmill and conventional physiotherapy": [
{
"intervention_type": "OTHER"
}
],
"Rehabilitation program with the use of upper limb function training with the use of the PABLO device and conventional physiotherapy": [
{
"intervention_type": "OTHER"
}
],
"Control Group": [
{
"intervention_type": "OTHER"
}
]
} |
NCT00005387 | Genetics of Hypertension in Blacks | https://clinicaltrials.gov/study/NCT00005387 | null | COMPLETED | To investigate the genetic determinants of hypertension in three populations of the African diaspora, with a major focus on clarifying the role of genes that code for the renin-angiotensin system (RAS). | NO | Cardiovascular Diseases|Heart Diseases|Hypertension | null | null | null | null | National Heart, Lung, and Blood Institute (NHLBI) | null | ALL | CHILD, ADULT, OLDER_ADULT | null | null | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 4293|R01HL053353 | 1995-09 | 2008-12 | 2008-12 | 2000-05-26 | null | 2016-07-12 | null | null | {} |
NCT01331187 | Influence of Routinely Adding Ultrasound Screening in Medical Department | https://clinicaltrials.gov/study/NCT01331187 | null | COMPLETED | Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia, hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic tool in these diagnosis, and on early diagnosis is crucial with respect to the patients well-being and inpatients workflow.
1. The aim is to study the clinical use of pocket-size US as a screening diagnostic tool in an medical department with respect to inpatients workflow and diagnostics.
Method: Patients admitted (in certain preset periods) to Department of medicine will be randomized to routinely adding an ultrasound examination with pocket-size device by residents on call. Time to definitive diagnosis, time to definitive treatment and time to discard will be recorded. US findings will be validated against standard echocardiography, or standard US/CT/MRI performed at the Radiological department. | NO | Heart Disease|Dyspnea|Aortic Disease|Kidney Disease|Liver Disease | PROCEDURE: Pocket-size ultrasonography|OTHER: Usual care | Time to definitive diagnosis, Time from admittance to definitive diagnosis, 3 months | Test-retest reproducibility, Pocket-sized ultrasound recordings by residents will be validated against reference methods (echocardiography and radiologic examinations by sepcialists)to assess sensitivity, specificity, positive and negative predictive values of pocket-size ultrasound., 3 months|Diagnostic outcome of additional ultrasound examination according to educational level of the performer, Study the diagnostic outcome of ultrasound screening related to the educational level and skills of the user, 3 months|Time to definitive treatment, Time from admittance to definitive treatment, 3 months|Time to discharge, Time from patients admittance to discharge from hospital, 3 months | null | Helse Nord-Trøndelag HF | Norwegian University of Science and Technology | ALL | CHILD, ADULT, OLDER_ADULT | null | 600 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | LH-2011-1 | 2011-04-01 | 2011-06 | 2011-06 | 2011-04-07 | null | 2021-11-09 | Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust, Levanger, 7600, Norway | null | {
"Pocket-size ultrasonography": [
{
"intervention_type": "PROCEDURE"
}
],
"Usual care": [
{
"intervention_type": "OTHER"
}
]
} |
NCT04546087 | Impact of Labor and Delivery on Ultrasound Measured Cricothyroid Membrane Depth and Height | https://clinicaltrials.gov/study/NCT04546087 | null | COMPLETED | The cricothyroid membrane acts as a route through which the upper airway can be accessed to provide oxygen and ventilation to patients. Anesthesiologists need to deliver oxygen and ventilation to patients under general anesthesia, where patients may lose the ability to breath for themselves. Access through this membrane to provide oxygen and ventilation is critical in emergency situations where other traditional means to access the airway (e.g. through endotracheal ventilation, supraglottic airway devices or face mask ventilation) have failed. It is known, from previous studies, that due to the physiological changes that occur in labour, the upper airway of the body undergoes changes that can make accessing the airway through traditional means more difficult, specifically during the period of labor, delivery, and just after delivery. Ultrasound is becoming increasingly popular due to its ability both to identify the cricothyroid membrane and to improve success in accessing the airway through the cricothyroid membrane. What is not known, and has not been studied to date, is specifically how the anatomy (i.e. its height and its depth) specifically changes during the period of labour, delivery and just after delivery.
The aim of this study would be to scan (using ultrasound) pregnant women s necks once at the very start of their labour, and once within 4 hours of delivery of their baby, to identify how the size and depth of the cricothyroid membrane changes. This information would improve the understanding of how to best approach accessing this membrane in laboring pregnant women.
The investigators hypothesize that in labouring third trimester patient, that the depth to the cricothyroid membrane will increase, and there will be no change in the cricothyroid membrane height. | NO | Airway Complication of Anesthesia | DEVICE: Ultrasound | Cricothyroid membrane position change, Difference between the depth from the skin to the cricothyroid membrane- tracheal interface change ultrasound between the onset of established labor and following delivery of the baby and placenta., 24 hours | Cricothyroid membrane size change, Difference between the height of the cricothyroid membrane (CTM) at the onset of established labor and the height of CTM following delivery of the baby., 24 hours | null | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | null | FEMALE | ADULT | null | 50 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | 20-01 | 2020-09-01 | 2022-11-02 | 2022-11-02 | 2020-09-11 | null | 2024-03-19 | Mount Sinai Hospital, Toronto, Ontario, M5G1X5, Canada | null | {
"Ultrasound": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04872387 | A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the Nose | https://clinicaltrials.gov/study/NCT04872387 | null | COMPLETED | BAY2586116 is a new drug in development for the treatment of obstructive sleep apnea. This is a condition that causes breathing to repeatedly stop and start during sleep due to blocked upper airways.
This is a study to learn more how safe BAY2586116 is, how it affects the body, how it moves into, through and out of the body in healthy Japanese male participants.
The participants will be randomly chosen to receive 1 of 3 different doses of BAY2586116 or to receive a placebo. A placebo looks like a treatment but does not have any medicine in it. The participants will receive their study treatment either 1 single time or once a day for 5 days through a nasal spray.
The participants will be in the study for a total of about 12 weeks. They will stay at their study site for either 5 or 9 days, depending on which study treatment they receive. During this time, the doctors will take blood and urine samples and check the participants health. About 6 to 8 days after the participants receive their last treatment, the researchers will check the participants health again.
The main aim of this study is to learn more about how safe BAY2586116 is compared to the placebo. To answer this question, the researchers will count the number of participants who have medical problems that may or may not be related to the study treatment. These medical problems are also known as adverse events while they are in the study. | NO | Obstructive Sleep Apnea | DRUG: BAY2586116|DRUG: Placebo | Number of participants with adverse events, From first administration up to 8 days after last dose (follow-up visit) | Cmax of BAY2586116, Cmax: maximum observed drug concentration in measured matrix after single dose administration., Day 1|Cmax/D of BAY2586116, Cmax/d: Cmax divided by dose., Day 1|AUC of BAY2586116, AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose., Day 1|AUC/D of BAY2586116, AUC/D: AUC divided by dose., Day 1|Cmax,md of BAY2586116, Only for Dose step 3., Day 5|Cmax,md/D of BAY2586116, Only for Dose step 3., Day 5|AUCτ,md of BAY2586116, Only for Dose step 3. AUCτ,md: AUC during any planned dose interval after multiple dose., Day 5|AUCτ,md/D of BAY2586116, Only for Dose step 3. AUCτ,md/D: AUCτ,md divided by dose., Day 5 | null | Bayer | null | MALE | ADULT | PHASE1 | 36 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE | 20906 | 2021-05-11 | 2021-08-04 | 2021-08-26 | 2021-05-04 | null | 2023-03-01 | SOUSEIKAI Fukuoka Mirai Hospital, Fukuoka, 813-0017, Japan | null | {
"BAY2586116": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT05263687 | Exercise Testing in Diseases and Health | https://clinicaltrials.gov/study/NCT05263687 | null | RECRUITING | Cardiopulmonary exercise test (CPET) is a helpful tool for evaluation of aerobic exercise capacity and tolerance for variety of population. CPET provides a full assessment of the physiologic responses of the pulmonary, cardiovascular, muscular, and cellular oxidative systems to exercise. The test progression include a incremental stepwise (on treadmill) or ramp control protocol (on bike ergometer ) to exhaustion. Measurement of respiratory gas exchange i.e. oxygen uptake, carbon dioxide, minute ventilation, other variables while monitoring ECG, blood pressure, pulse oximetry and exertion perceived (Borg Scale) during an incremental test .
Aim: To compere exercise responses for maximal exercise testing with different population. | NO | Exercise Test | DIAGNOSTIC_TEST: Maximal exercise test | Maximal Oxygen consumption, the maximum amount of oxygen that an individual can utilize during intense or maximal exercise., through study completion, an average of 1 year|Maximal Heart rate, the maximum heart rate achieved during intense or maximal exercise., through study completion, an average of 1 year|Maximal Blood pressure, the blood pressure in the end of intense or maximal exercise., through study completion, an average of 1 year | Ventilation Anaerobic Threshold, Ventilatory Threshold (VT) describes the inflection point for ventilation during an incremental exercise test., through study completion, an average of 1 year | null | The Baruch Padeh Medical Center, Poriya | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 1,000 | OTHER_GOV | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | 0033-17-POR | 2017-08-30 | 2025-03-19 | 2025-12-30 | 2022-03-02 | null | 2022-03-21 | The BARUCH PADEH Medical Center, Poriya, Teverya, The Lower Galilee, 15208, Israel | null | {
"Maximal exercise test": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
]
} |
NCT01179087 | Sleep Disordered Breathing and Lung Transplantation | https://clinicaltrials.gov/study/NCT01179087 | null | UNKNOWN | The purpose of the study is to investigate the prevalence, clinical predictors and consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung transplant recipients. | NO | Sleep Disordered Breathing|Lung Transplantation | null | Prevalence of sleep disordered breathing, Polysomnography will be performed at discharge from the hospital (1 month average), 1 month after lung transplantation|Prevalence of sleep disordered breathing, Polysomnographic evaluation, 1 year after lung transplantation | Pulmonary function, Effect of SDB on pulmonary function/BOS, 1 year after lung transplantation|Investigate possible relationship between SDB and patient medical history, 1 year after lung transplantation | null | KU Leuven | null | ALL | ADULT, OLDER_ADULT | null | 40 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | B32220109109 | 2010-08 | 2014-09 | 2014-09 | 2010-08-11 | null | 2013-08-07 | Katholieke Universiteit Leuven, Leuven, 3000, Belgium | null | {} |
NCT00789087 | Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion | https://clinicaltrials.gov/study/NCT00789087 | null | COMPLETED | The purpose of this study is to analyze and compare radiological lung expansion after talc pleurodesis performed either by videothoracoscopy or chest tube and correlate it with clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of life and survival. | NO | Recurrent Malignant Pleural Effusion. | PROCEDURE: Videothoracoscopic talc poudrage (VT).|PROCEDURE: Talc slurry through a chest tube (DT). | Radiological lung expansion after talc pleurodesis and clinical outcome, 6 months | Clinical efficacy, safety, quality of life and survival., 6 months | null | University of Sao Paulo | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 1105/04 | 2005-01 | 2008-01 | 2008-01 | 2008-11-11 | null | 2008-11-11 | University of São Paulo Medical School, São Paulo, 01246903, Brazil | null | {
"Videothoracoscopic talc poudrage (VT).": [
{
"intervention_type": "PROCEDURE"
}
],
"Talc slurry through a chest tube (DT).": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT04750187 | Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain | https://clinicaltrials.gov/study/NCT04750187 | null | COMPLETED | The purpose of this study will be to assess the effects of an 8-week hypo-pressive abdominal exercise program on Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability in patients with non-specific chronic low back pain. A randomized clinical trial will be carried out. A total sample of 40 patients with non-specific chronic low back pain will be recruited and divided into 2 groups including an experimental group (n=20) which will receive an 8-week hypo-pressive abdominal exercise program and a control group (n=20) which will not receive any training program. Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability will be assessed. | NO | Low Back Pain | OTHER: Hypo-pressive abdominal exercise intervention | Inspiratory muscle strength, Inspiratory muscle strength will be measured in % by a POWER-breathe device, Change from baseline inspiratory muscle strength at 8 weeks | Diaphragm muscle thickness, Diaphragm muscle thickness will be measured in mm by an ultrasound device, Change from baseline diaphragm muscle thickness at 8 weeks|Pressure pain threshold, Pressure pain threshold will be measured in kg/cm2 by an algometer, Change from baseline pressure pain threshold at 8 weeks|Disability, Pain-related disability score will be measured by the Roland-Morris Disability Questionnaire. Total score ranges from 0 to 24. Higher scores represent higher levels of pain-related disability., Change from baseline disability at 8 weeks | null | Universidad Complutense de Madrid | null | ALL | ADULT, OLDER_ADULT | null | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | UFV_1/2021 | 2021-02-15 | 2021-05-15 | 2021-05-18 | 2021-02-11 | null | 2021-05-19 | Universidad Francisco de Vitoria, Pozuelo De Alarcón, Madrid, 28223, Spain | null | {
"Hypo-pressive abdominal exercise intervention": [
{
"intervention_type": "OTHER"
}
]
} |
NCT02297087 | Next-generation Sequencing of Small Cell Lung Cancer to Identify Actionable Targets for Treatment | https://clinicaltrials.gov/study/NCT02297087 | null | TERMINATED | Aim 1 - Launch Pilot Study. In this aim, the investigators seek to launch a pilot study and enroll 12 eligible patients with advanced small cell lung cancer (SCLC) and to obtain the necessary tumor biopsies to yield sufficient DNA and RNA for Genome-Wide Sequencing (GWS).
Aim 2 - Treatment Selection. Completion of this study aim will provide a new clinical paradigm in the treatment of SCLC such that each individual patient would be treated with a single-agent or combination therapy of commercially available agents that relates to particular target(s) that have been identified via GWS. | NO | Small Cell Lung Cancer | GENETIC: Standard of care based on target(s) identified via GWS. | amount of DNA and RNA obtained from tumor biopsies and if can perform Genome-Wide Sequencing (GWS)., 28 Days | null | null | Western Regional Medical Center | null | ALL | ADULT, OLDER_ADULT | null | 12 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | gweiss 13-007 | 2014-10 | 2017-10 | 2017-10 | 2014-11-21 | null | 2017-11-09 | Cancer Treatment Center of America @ Western Regional Medical Center, Goodyear, Arizona, 85338, United States | null | {
"Standard of care based on target(s) identified via GWS.": [
{
"intervention_type": "GENETIC"
}
]
} |
NCT02424487 | Intracuff Pressure During One-lung Ventilation in Infants and Children | https://clinicaltrials.gov/study/NCT02424487 | null | COMPLETED | The purpose of this study is to evaluate the initial pressure and changes of the intracuff pressure during one-lung ventilation (OLV) in infants and children during thoracic surgery. | NO | One-lung Ventilation (OLV) | PROCEDURE: Intracuff pressure measurement in one-lung ventilation during thoracic surgery | Intracuff pressure during OLV, Evaluate changes in intracuff pressure with OLV during thoracic surgery., intraoperative | null | null | Joseph D. Tobias | null | ALL | CHILD, ADULT | null | 30 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | IRB14-00826 | 2015-05 | 2018-02-23 | 2018-02-23 | 2015-04-23 | null | 2019-01-18 | Nationwide Children s Hospital, Columbus, Ohio, 43205, United States | null | {
"Intracuff pressure measurement in one-lung ventilation during thoracic surgery": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT04118387 | Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment | https://clinicaltrials.gov/study/NCT04118387 | CSA | RECRUITING | Central sleep apnea (CSA) is common in patients with heart failure and those using opioid analgesics. Unfortunately, effective treatment of central apnea remains elusive, pressure therapy given the modest efficiency of positive airway pressure therapy. The focus of this proposal is to identify mechanistic pathways to guide future therapeutic interventions for central sleep apnea based on the strong premise that multi-modality therapy will normalize respiration and hence mitigate adverse long-term consequences of CSA. The investigators proposed studies will test combination therapies, including positive airway pressure (PAP) plus a pharmacological agent who have heart failure or are using opioid analgesics. The investigators anticipate that findings will inform future clinical trials to improve care and quality of life among Veterans suffering from central sleep apnea, which remains difficult to treat using existing approaches. | NO | Sleep Disordered Breathing|Able Bodied | DRUG: Acetazolamide + supplemental oxygen + PAP therapy|DRUG: Zolpidem + PAP therapy|DRUG: Buspirone + PAP therapy | CO2 reserve, CO2 reserve is the requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative., 120 days|Central apnea indices, Central apnea indices is used to indicate the severity of central sleep apnea, 120 days | Controller gain, Controller gain is a ventilatory response to changes in end-tidal PCO2, 120 days|Plant gain, Plant gain is blood gas response to a change in ventilation. This measure represents the effectiveness of the plant in eliminating CO2., 120 days|Carotid body function, This measure represents the activity of the carotid bodies. It is measured by the decrease in ventilation in response to a single breath of 100% oxygen., 120 days|Peripheral chemoreflex sensitivity, Peripheral chemoreflex sensitivity is measured either via brief hypoxia or a single breath of CO2., 120 days|Respiratory arousal threshold, The nadir pressure in the upper airway (supra-glottic pressure) prior to the occurrence of an arousal., 120 days|% stable breathing, To assess breathing stability, the investigators will measure % stable breathing using minute ventilation (VE) and tidal volume (VT) coefficient of variation as indices of breathing instability., 120 days | null | VA Office of Research and Development | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 200 | FED | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | NURR-001-19S|I01CX001944 | 2021-01-07 | 2025-06-30 | 2025-12-31 | 2019-10-08 | null | 2024-05-02 | John D. Dingell VA Medical Center, Detroit, MI, Detroit, Michigan, 48201-1916, United States | null | {
"Acetazolamide": [
{
"intervention_type": "DRUG",
"description": "Acetazolamide + supplemental oxygen + PAP therapy",
"name": "Acetazolamide",
"synonyms": [
"Apo Acetazolamide",
"Acetazolamide",
"Ak Zol",
"Apo-Acetazolamide",
"Acetazolamide Sodium, (Sterile)",
"Diacarb",
"Acetazolamidum",
"Acetazolamid",
"Huma-Zolamide",
"HumaZolamide",
"N-[5-(aminosulfonyl)-1,3,5-thiadiazol-2-yl]acetamide",
"Edemox",
"5-acetylamino-1,3,4-thiadiazole-2-sulfonamide",
"N-[5-(aminosulfonyl)-1,3,4-thiadiazol-2-yl]acetamide",
"Acetazolamida",
"Acetadiazol",
"ApoAcetazolamide",
"5-acetamido-1,3,4-thiadiazole-2-sulfonamide",
"Glauconox",
"Huma Zolamide",
"Ac\u00e9tazolamide",
"AkZol",
"Diamox",
"Diuramide",
"Ak-Zol",
"Acetazolam",
"Acetazolamide, Monosodium Salt",
"Glaupax",
"D\u00e9filtran",
"2-acetylamino-1,3,4-thiadiazole-5-sulfonamide"
],
"medline_plus_id": "a682756",
"generic_names": [
"Acetazolamide"
],
"mesh_id": "D004232",
"drugbank_id": "DB00819"
}
],
"Zolpidem": [
{
"intervention_type": "DRUG",
"description": "Zolpidem + PAP therapy",
"name": "Zolpidem",
"synonyms": [
"Zolirin",
"Bikalm",
"SL-800750-23-N",
"Zodormdura",
"Zolpidem AbZ",
"Zolpidem Tartrate",
"Zoldem",
"Zolpi-Lich",
"N,N,6-Trimethyl-2-(4-methylphenyl)imidazo(1,2-a)pyridine-3-acetamide",
"SL 80.0750",
"Zolpimist",
"Stilnox",
"SL 800750 23 N",
"N,N,6-Trimethyl-2-(4-methylphenyl)imidazo(1,2a)pyridine-3-acetamide hemitartrate",
"Zolpi Lich",
"Zolpidem 1A Pharma",
"Amsic",
"Stilnoct",
"Zolpinox",
"Zolpidemum",
"Ambien",
"Imidazo(1,2-a)pyridine-3-acetamide, N,N,6-trimethyl-2-(4-methylphenyl)-",
"Zolpidem",
"Dalparan",
"Edluar",
"Zolpidem Hemitartrate"
],
"medline_plus_id": "a693025",
"generic_names": [
"Zolpidem"
],
"nhs_url": "https://www.nhs.uk/medicines/zolpidem",
"mesh_id": "D000068776",
"drugbank_id": "DB00425",
"wikipedia_url": "https://en.wikipedia.org/wiki/Zolpidem"
}
],
"Buspirone": [
{
"intervention_type": "DRUG",
"description": "Buspirone + PAP therapy",
"name": "Buspirone",
"synonyms": [
"8-(4-(4-(2-Pyrimidinyl)-1-piperizinyl)butyl)-8-azaspiro(4,5)decane-7,9-dione",
"Buspirona",
"Buspiron",
"Buspironum",
"Buspirone",
"BuSpar"
],
"medline_plus_id": "a688005",
"generic_names": [
"Buspirone"
],
"drugbank_id": "DB00490"
}
]
} |
NCT01536587 | Effects of Salmeterol on Autonomic Nervous System | https://clinicaltrials.gov/study/NCT01536587 | ESAN | COMPLETED | This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects with Chronic Obstructive Pulmonary Disease (COPD) Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II or III with the aim to demonstrate that inhaled therapy with salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32 subjects is planned to be enrolled. | YES | Pulmonary Disease, Chronic Obstructive | DRUG: Salmeterol | Change in Muscle Sympathetic Nerve Activity (MSNA) at 2 Hours (Week 0), Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per 100 heart beats [bursts/100 heart beats]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1)., Baseline and 2 hours (Week 0) | Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/100 Heart Beats) at Week 4, Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per 100 heart beats (bursts/100 heart beats). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline and Week 4|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at 2 Hours (Week 0), Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per minute [bursts/minute]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1)., Baseline and 2 hours (Week 0)|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at Week 4, Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per minute (bursts/minute). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline and Week 4|Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT Population), Heart rate variability (HRV) refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population), HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT Population), HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population), HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population), HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline were calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population), HRV refers to the complex beat-to-beat (N-N) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation), respectively., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population), HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population), HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population), HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power-VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population), HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power-VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population), HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power-VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency Power (HF) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population), HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power-VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT Population), Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population), Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT Population), BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population), BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT Population), Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population), Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4, Systolic and diastolic BP was manually measured. Change in BP after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Respiratory Rate at 2 Hours (Week 0) and at Week 4, Respiratory rate is defined as the number of breaths taken within a set amount of time (typically within 60 seconds). Change in respiratory rate after salmeterol inhalation is expressed in terms of respiratory rate (breaths) per minute (min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Tidal Volume at 2 Hours (Week 0) and at Week 4, Tidal volume is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 milliliters or 7 milliliters per kilogram of body weight). Change in tidal volume after salmeterol inhalation is expressed in terms of milliliters (mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Respiratory Minute Volume at 2 Hours (Week 0) and at Week 4, Respiratory minute volume is defined as the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person s lungs per minute. Change in respiratory minute volume after salmeterol inhalation is expressed in terms of milliliters per minute (mL/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Catecholamines (Plasma Norepinephrine) at 2 Hours (Week 0) and at Week 4, Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma norepinephrine) after salmeterol inhalation is expressed in terms of nanogramms per liter (ng/L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Catecholamines (Plasma Epinephrine) at 2 Hours (Week 0) and at Week 4, Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma epinephrine) after salmeterol inhalation is expressed in terms of nanograms per milliliter (ng/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Catecholamines (Brain Natriuretic Peptide [BNP]) at 2 Hours (Week 0) and at Week 4, Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (BNP) after salmeterol inhalation is expressed in terms of picograms per milliliter (pg/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry (SpO2) at 2 Hours (Week 0) and at Week 4, Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. Change in SpO2 after salmeterol inhalation is expressed in terms of percent. Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Change From Baseline in Transcutaneous Carbon Dioxide (tCO2) at 2 Hours (Week 0) and at Week 4, Transcutaneous carbon dioxide monitoring is a noninvasive way of continuously measuring the tension of these gases in the skin. This methodology provides a continuous noninvasive estimation of the arterial CO2 value. Change in tCO2 after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation)., Baseline, 2 hours (Week 0), and Week 4|Lung Function (Forced Vital Capacity [FVC], Functional Residual Capacity [FRC; Body and Helium], Total Lung Capacity [TLC], and Residual Volume [RV]) at Baseline (Week 0) and at Week 4, FVC is defined as the volume of air that can be forcibly blown out from the lungs after a full inspiration. FRC is defined as the volume of air present in the lungs, specifically the parenchyma tissues, at the end of a passive expiration. TLC is defined as the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to VC plus the RV and is approximately 5800 milliliters. RV is defined as the amount of gas remaining in the lungs at the end of a maximal exhalation. All parameters describing lung function are expressed in terms of liters (L). Lung function (FVC, FRC [body and helium], TLC, and RV) was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation)., Baseline and Week 4|Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4, Diastolic dysfunction refers to the decline in performance of one (usually the left ventricle) or both (left and right) ventricles during diastole. The number of participants with diastolic dysfunction on echocardiography was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation)., Baseline and Week 4|Arterial Stiffness at Baseline (Week 0) and at Week 4, Arterial stiffness occurs as a consequence of age and arteriosclerosis. Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. PWV was evaluated in terms of meters per second (m/s). PWV after salmeterol inhalation at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after inhalation of salmeterol) was assessed., Baseline and Week 4 | null | GlaxoSmithKline | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 32 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | 114520 | 2012-07 | 2012-11 | 2012-11 | 2012-02-22 | 2014-02-04 | 2014-04-11 | GSK Investigational Site, Goettingen, Niedersachsen, 37075, Germany | null | {
"Salmeterol": [
{
"intervention_type": "DRUG",
"description": "Salmeterol",
"name": "Salmeterol",
"synonyms": [
"Salmeterolum",
"Serevent",
"Aeromax",
"Salmaterol",
"Salmeterol"
],
"medline_plus_id": "a695001",
"generic_names": [
"Salmeterol"
],
"drugbank_id": "DB00938",
"wikipedia_url": "https://en.wikipedia.org/wiki/Salmeterol"
}
]
} |
NCT05618587 | Effect of Lithium Therapy on Long COVID Symptoms | https://clinicaltrials.gov/study/NCT05618587 | null | COMPLETED | This study will assess low-dose lithium s effects on several different symptoms experienced by long COVID patients. | NO | Long COVID | DRUG: Lithium|DRUG: Placebo | Fatigue Severity Scale, 7-item questionnaire assessing fatigue severity, Change from baseline to day 21|Brain Fog Severity Scale, 7-item questionnaire assessing brain fog severity, Change from baseline to day 21 | Patient Global Impression of Change (PGIC), Change in symptoms on 7-point scale, Day 21|Well-Being Scale, Sense of well-being over past week on 10-point scale, Change from baseline to day 21|Short Form-12 Health Survey (1-week modification), Quality of life assessment over past week, Change from baseline to day 21|Desire to Continue Therapy, Single Yes/No question, Day 21|Generalized Anxiety Disorder-2 Scale, 2-item questionnaire assessing anxiety frequency over the past week, Change from baseline to day 21|Headache and Body Pain Bother Scale, 2-item questionnaire assessing frequency of headaches and body pain over the past week, Change from baseline to day 21|Insomnia Severity Index, 7-item questionnaire assessing insomnia severity over the past week, Change from baseline to day 21|Sense of Smell and Taste Change Scale, Subjective change from baseline on a 7-point scale, Day 21|Digit Symbol Substitution Test, Validated cognitive test, Change from baseline to day 21|Delayed Recall Test, Validated cognitive test, Change from baseline to day 21 | null | State University of New York at Buffalo | National Center for Advancing Translational Sciences (NCATS) | ALL | ADULT, OLDER_ADULT | PHASE2 | 50 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | STUDY00006678|UL1TR001412 | 2022-11-28 | 2023-07-21 | 2023-07-21 | 2022-11-16 | null | 2023-10-25 | University at Buffalo, Williamsville, New York, 14221, United States | null | {
"Lithium": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03123887 | Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients With B-precursor ALL | https://clinicaltrials.gov/study/NCT03123887 | BLING | COMPLETED | Although the response rate by first-line treatment has been improved, most adult patients with relapsed or refractory ALL will eventually relapse with poor outcomes regardless of treatments. To further understand current status of the treatment of adult patients with relapsed or refractory ALL in China, the study retrospectively collected diagnosis and treatment data from ALL patients in 14 centers in China. Primary objective: to estimate the proportion of patients in overall response rate (ORR) for early relapsed or primary refractory Philadelphia chromosome negative (Ph-) B-precursor ALL patients following salvage treatment (i.e., proportion of patients in hematological complete remission [CR] and CR with partial recovery of blood cells [CRh*]); Secondary objectives included: to estimate the proportion of patients in CR, CRh* and CRi(CR/CRh*/CRi) and the duration of CR/CRh*/CRi, overall survival, duration of CR/CRh*and the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) for early relapsed/primary refractory Ph-B-precursor ALL patients following salvage treatment; Exploratory objectives included: to estimate the efficacy in late relapsed Ph- B-precursor ALL (first remission duration > 12 months) patients and in Ph+ B-precursor ALL patients and specific subgroup patients following salvage treatment. | NO | B-precursor Acute Lymphoblastic Leukemia | OTHER: salvage therapy | overall response rate, overall response rate after the last salvage therapy, i.e., CR/CRh*. CR is generally defined as no blasts in peripheral blood, absence of extramedullary leukemia, full recovery of peripheral blood counts, ≤ 5% blasts in the bone marrow, ANC > 1.0×109/L, PLT > 100×109/L, no relapse within 4 weeks. CRh* was CR with partial recovery of peripheral blood counts, ANC > 0.5×109/L, PLT > 50×109/L, with other conditions meeting the criteria for CR, up to 3 years | proportion of patients in CR, CRh* or CRi, the proportion of patients in CR, CRh* or CRi for early relapsed/primary refractory Ph- B-precursor ALL patients following last salvage treatment, up to 3 years|overall survival, overall survival (OS) for early relapsed/primary refractory Ph- B-precursor ALL patients after CR or CRh* achieved, up to 3 years|duration of remission (CR/CRh*, CR/CRh*/CRi), duration of remission (CR/CRh*, CR/CRh*/CRi) for early relapsed/primary refractory Ph- B-precursor ALL patients after CR or CRh* achieved, up to 3 years|proportion of patients receiving allogeneic hematopoietic stem cell transplantation, the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) among early relapsed/primary refractory Ph- B-precursor ALL patients following salvage treatment, up to 3 years|overall survival, overall survival (OS) among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy, up to 3 years|duration of CR/CRh*/CRi, duration of CR/CRh* among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy, up to 3 years|the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT), the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) after CR or CRh* achieved among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy, up to 3 years|Complete Response, Complete Response among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy, up to 3 years|Complete Response with incomplete recovery of blood cells, Complete Response with incomplete recovery of blood cells among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy, up to 3 years|Complete Response with partial recovery of blood cells, Complete Response with partial recovery of blood cells among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy, up to 3 years|duration of CR/CRh*, duration of CR/CRh* with partial recovery of blood cells among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy, up to 3 years | null | Harbin Hematology and Oncology Institute | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 632 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | TA-ALL-150182 | 2015-07-10 | 2016-06-03 | 2016-10-10 | 2017-04-21 | null | 2017-04-21 | Institute of Harbin Hematology Oncology, Harbin, Heilongjiang, 150000, China | null | {
"salvage therapy": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05951387 | Dexmedetomidine Versus Dexmedetomidine With Ketamine in Mechanically Ventilated ARDS Patients | https://clinicaltrials.gov/study/NCT05951387 | ARDS | RECRUITING | The goal of this clinical trial study is to compare dexmedetomidine versus the combination of dexmedetomidine with ketamine in hemodynamic changes and sedative effects in ARDS patients who are in need of mechanical ventilation. The main question[s] it aims to answer are:
* [question 1]: Which dose that get the target in sedation, single and combined drugs?
* [question 2]: In which drug group that hemodynamic did not affect Participants will be patients with ARDS that will be divided into two group the first ont will receive dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h and the second one will receive dexmedetomidine at 0.5 µg/kg/h infusion only. In both the groups, studied drugs will be titrated to achieve target sedation. | NO | Haemodynamic Instability | DRUG: dexmedetomidine plus ketamine|DRUG: Dexmedetomidine | oxygenation parameter, change of PaO2/FiO2, 24-27 hours|positive end expiratory pressure (PEEP), change of PEEP parameter that need to maintain oxygen saturation above 88%, 24-27 hours | serum level of C-reactive protein (CRP), change of serum level of CRP (mg/dl), 24-72 hours | null | Benha University | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | RC 37-5-2023 | 2023-06-01 | 2024-06-01 | 2024-06 | 2023-07-19 | null | 2023-08-01 | Benha university, Banhā, Qalubia, 13511, Egypt | null | {
"Dexmedetomidine": [
{
"intervention_type": "DRUG",
"description": "dexmedetomidine plus ketamine",
"name": "Dexmedetomidine",
"synonyms": [
"Hydrochloride, D",
"Dexmedetomidinum",
"exmedetomidine",
"Igalmi",
"Dexmedetomidine Hydrochloride",
"Sedadex",
"Sileo",
"MPV 1440",
"Dexm\u00e9d\u00e9tomidine",
"Dexdomitor",
"Cepedex",
"MPV1440",
"Dexmedetomidina",
"Precedex",
"Dexmedetomidine",
"(+)-4-((S)-alpha,2,3-Trimethylbenzyl)imidazole",
"Dexmedetomidin",
"(+)-4-((S)-\u03b1,2,3-trimethylbenzyl)imidazole",
"Dexdor",
"MPV-1440"
],
"mesh_id": "D058647",
"generic_names": [
"Dexmedetomidine"
],
"drugbank_id": "DB00633"
},
{
"intervention_type": "DRUG",
"description": "Dexmedetomidine",
"name": "Dexmedetomidine",
"synonyms": [
"Hydrochloride, D",
"Dexmedetomidinum",
"exmedetomidine",
"Igalmi",
"Dexmedetomidine Hydrochloride",
"Sedadex",
"Sileo",
"MPV 1440",
"Dexm\u00e9d\u00e9tomidine",
"Dexdomitor",
"Cepedex",
"MPV1440",
"Dexmedetomidina",
"Precedex",
"Dexmedetomidine",
"(+)-4-((S)-alpha,2,3-Trimethylbenzyl)imidazole",
"Dexmedetomidin",
"(+)-4-((S)-\u03b1,2,3-trimethylbenzyl)imidazole",
"Dexdor",
"MPV-1440"
],
"mesh_id": "D058647",
"generic_names": [
"Dexmedetomidine"
],
"drugbank_id": "DB00633"
}
],
"Ketamine": [
{
"intervention_type": "DRUG",
"description": "dexmedetomidine plus ketamine",
"name": "Ketamine",
"synonyms": [
"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"
],
"mesh_id": "D018691",
"generic_names": [
"Ketamine"
],
"drugbank_id": "DB01221"
}
]
} |
NCT05452187 | Evaluation of the Safety and Effectiveness of Direct-acting Antiviral Drugs in the Treatment of Hepatitis C in Patients With Inflammatory Bowel Disease: National Multicenter Study | https://clinicaltrials.gov/study/NCT05452187 | MIC project | COMPLETED | The prevalence of hepatitis C virus infection (HCV) in patients with inflammatory bowel disease (IBD) ranges from 1-6%. Direct-acting antivirals (DAAs), with cure rates >90%, represent a radical change from interferon-based therapies. The ECCO (European Crohn s and Colitis Organisation) guidelines (Kucharzik T, Ellul P, Greuter T, et al. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohn s Colitis. 2021;15(6):879-913) warns about the risk of IBD reactivation due to the effect of DAAs, but HCV management in this situation is uncertain given the lack of evidence.
The project is proposed as the largest retrospective multicenter descriptive study carried out to evaluate the use of DAAs for HCV eradication in patients with IBD. The Eneida database (Zabana Y, Panés J, Nos P, et al. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring, and functions. Gastroenterol y Hepatol. 2020;43(9):551-8.) of the Spanish Working Group on Crohn s Disease and Ulcerative Colitis (GETECCU) is an adequate registry to identify patients with HCV infection. The serological status of the infection is frequently recorded in the ENEIDA database, and it is generally evaluated at the time of IBD diagnosis, before starting immunosuppressive treatment. The ENEIDA registry has the advantage over large population studies that researchers have access to relevant details of the clinical history, which can respond to the controversies raised.
This multicenter retrospective descriptive study will provide useful information to be able to give evidence-based recommendations regarding treatment of HCV in patients with IBD. | NO | Inflammatory Bowel Diseases|Hepatitis C Virus Infection | DRUG: Assess the effectiveness and safety of DAAs in patients with IBD.|DRUG: Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.|OTHER: Assessment of the impact of DAAs on the course of IBD. | Percentage of sustained viral response (effectiveness) in patients with IBD and HCV infection treated with DAAs., 8 weeks|Number and description of adverse events (safety) and possible interactions of DAAs with IBD drugs, particularly immunosuppressants and/or biologics., 8 weeks | Compare the clinical Crohn s disease activity (measured by Harvey Bradshaw Index) before and during the treatment with DAAs, to assess the impact of DAAs on the course of IBD., Harvey Bradshaw Index (HBI) for Crohn s disease (CD): The minimum score obtainable is 0, which indicates the absence of disease. The maximum attainable score depends on the number of stools the patient identifies per day, however, it is in the range of 18.
HBI score interpretation: < 5 remission, 5-7 points (mild activity), 8-16 points (moderate activity), > 16 points (severe activity)., 8 weeks|Compare the clinical ulcerative colitis activity (measured by Partial Mayo Score) before and during the treatment with DAAs, to assess the impact of DAAs on the course of IBD., Partial Mayo Score in ulcerative colitis (UC): The minimum score obtainable is 0, which indicates the absence of disease. The maximum attainable score is 9.
Partial Mayo score interpretation: < 2 remission, 2-4 points (mild activity), 5-7 points (moderate activity), >7 points (severe activity)., 8 weeks | null | Hospital Mutua de Terrassa | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 79 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | MIC2020 | 2021-03-12 | 2021-07-30 | 2021-12-20 | 2022-07-11 | null | 2022-07-11 | Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, 08221, Spain | null | {
"Assess the effectiveness and safety of DAAs in patients with IBD.": [
{
"intervention_type": "DRUG"
}
],
"Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.": [
{
"intervention_type": "DRUG"
}
],
"Assessment of the impact of DAAs on the course of IBD.": [
{
"intervention_type": "OTHER"
}
]
} |
NCT04778787 | Sodium-glucose Cotransporter Type 2 Inhibitors for Acute Cardiorenal Syndrome Prevention | https://clinicaltrials.gov/study/NCT04778787 | null | COMPLETED | The effect of sodium-glucose cotransporter type 2 inhibitors (SGLT2i) on the parameters of renal function in acute decompensation of chronic heart failure (ADHF) compared to standard therapy will be analyzed. Based on the dynamics of the clinical condition, the duration of hospitalization, and blood biochemical parameters (creatinine, urea, uric acid, potassium, sodium, N-terminal pro-brain natriuretic peptide - NT-proBNP) conclusions will be drawn about the possibility of using SGLT2i in this group of patients. | NO | Congestive Heart Failure | DRUG: Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596) | death due to heart failure, Death during hospitalization, through study completion, an average of 5 days | deterioration of renal function (increase in blood creatinine by 0.3 mg / dl within 48 hours), By deterioration of kidney function is meant an increase in blood creatinine by 0.3 mg / dl within 48 hours. The maximum creatinine at hospitalization, the maximum uric acid at hospitalization, an episode of hyponatremia (sodium less than 136), an episode of oligoanuria (diuresis less than 300 ml per day) will also be taken into account. Renal function will be determined at the date of inclusion and randomisation, 3-4 days of hospitalization (second visit) and the date of discharge (third visit)., through study completion, an average of 5 days|development of resistance to diuretics, The need to increase the daily dose of loop diuretics by more than 2 times compared to the initial one, or the need to add another class of diuretic drugs to the therapy. (Muthiah Vaduganathan et al. Unsolved challenges in diuretic therapy for acute heart
failure: a focus on diuretic response.Expert Review of Cardiovascular Therapy/ Volume 13, 2015 -Issue 10. Pages 1075-1078)., through study completion, an average of 5 days|re-hospitalization about decompensation of chronic heart failure within 30 days after discharge from the hospital, 30 days after discharge, patients will be called to find out whether there are repeated hospitalizations for heart failure, up to 30 days | weight loss during hospitalization, weight loss from the moment of randomization to the day of discharge, through study completion, an average of 5 days|admission to the intensive care unit due to worsening heart failure during the current hospitalization, admission to an intensive care unit (because of hemodynamic instability, systolic blood pressure less than 90 millimeters of mercury (mm Hg.St.), severe (progressive) shortness of breath with use of additional respiratory muscles, breathing frequency more than 25\min, need for intubation, lung ventilation, the presence of symptoms of hypoperfusion, oxygen saturation less than 90% (despite oxygen therapy), brady - and tachyarrhythmias with heart rate <40 or >130 beats/min, respectively, high-
grade atrioventricular block, life-threatening condition: acute coronary syndrome, mechanical complications of acute insufficiency of the heart valves, chest trauma, pulmonary thromboembolism, aorta dissection), through study completion, an average of 5 days | I.M. Sechenov First Moscow State Medical University | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 370 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | 10773100889666 | 2021-01-01 | 2022-08-01 | 2022-08-01 | 2021-03-03 | null | 2022-12-07 | University Clinical Hospital number 1, Moscow, Russian Federation|Сity Сlinical Нospital number 7, Moscow, Russian Federation | null | {
"Dapagliflozin": [
{
"intervention_type": "DRUG",
"description": "Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596)",
"name": "Dapagliflozin",
"synonyms": [
"(2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol",
"Edistride",
"Dapagliflozina",
"Forxiga",
"Dapagliflozin",
"Farxiga"
],
"medline_plus_id": "a614015",
"generic_names": [
"Dapagliflozin"
],
"nhs_url": "https://www.nhs.uk/medicines/dapagliflozin",
"drugbank_id": "DB06292",
"wikipedia_url": "https://en.wikipedia.org/wiki/Dapagliflozin"
}
]
} |
NCT02980887 | Pulmonary Vascular Disease Phenomics Program PVDOMICS | https://clinicaltrials.gov/study/NCT02980887 | PVDOMICS | ACTIVE_NOT_RECRUITING | It is recognized that patients with various forms of heart and lung disease exhibit varying degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular dysfunction. The genetic, molecular, and cellular processes driving these phenomena are not well understood. Rapid advances in high throughput omic methodology, combined with powerful bioinformatics and network biology capability, have created the opportunity to conduct studies that broadly search for homologies and differences across the spectrum of disease states associated with pulmonary hypertension, and determinants of the spectrum of right ventricular compensation that accompanies these conditions | NO | Pulmonary Arterial Hypertension | OTHER: No Intervention | Precision based definitions of pulmonary vascular diseases (PVD), OMICs analyses will be used to assign new class of PVD, Over 5 years | Identification of biomarkers for PVD, OMICs and other measures of disease, 5 years | null | The Cleveland Clinic | Brigham and Women s Hospital|Columbia University|Weill Medical College of Cornell University|Johns Hopkins University|Mayo Clinic|University of Arizona|Vanderbilt University | ALL | ADULT, OLDER_ADULT | null | 1,195 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 16-860 | 2016-11 | 2029-12-31 | 2029-12-31 | 2016-12-02 | null | 2024-01-18 | University of Arizona Health Sciences Center, Tucson, Arizona, 85721, United States|Johns Hopkins University School of Medicine, Baltimore, Maryland, 21287, United States|Brigham and Women s Hospital, Boston, Massachusetts, 02115, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Columbia University School of Medicine, New York, New York, 10032, United States|Weill Cornell Medicine, New York, New York, 10065, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States | null | {
"No Intervention": [
{
"intervention_type": "OTHER"
}
]
} |
NCT06098287 | Residential Ventilation Systems and Filtration for Asthma Control in Adults | https://clinicaltrials.gov/study/NCT06098287 | null | COMPLETED | The goal of this study was to investigate the effectiveness of three common approaches to upgrading residential mechanical ventilation systems in existing homes for improving asthma-related health outcomes, reducing indoor pollutants of both indoor and outdoor origin, and maintaining adequate environmental conditions and ventilation rates in a cohort of adult asthmatics in existing homes in Chicago, IL. | NO | Asthma|Pollution; Exposure | DEVICE: Residential mechanical ventilation system (Exhaust)|DEVICE: Residential mechanical ventilation system (CFIS) and air filtration upgrades|DEVICE: Residential mechanical ventilation system (ERV) and air filtration upgrades | Asthma Control, Asthma Control Test (ACT) is a 5-item clinically validated survey, which is designed to measure the multi-dimensional nature of asthma control, including asthma symptoms, utilization of rescue medications, and the impact of asthma on daily functioning. The ACT score ranges from 5 ( poor control of asthma ) to 25 ( complete control of asthma ), Each month throughout the study completion, an average of 2 years (24 months) | Health-Related Quality of Life, 12-Item Short Form Survey (SF-12) measures eight concepts commonly represented in widely used surveys: general health, physical functioning, bodily pain, vitality (energy/fatigue), social functioning, role limitations due to physical and emotional problems, and mental health (psychological distress and psychological well-being). Both the SF-12 physical (PCS) and mental (MCS) component summary scales use norm-based scoring, 0-100, with higher scores indicating better physical and mental health functioning., Baseline (July 2017) and end-line (March 2020, end of study completion)|Stress, Perceived Stress Scale (PSS) is a 10-item psychological assessment to understand how unpredictable, uncontrollable, and overloaded participants find their lives. The PSS score ranges from 0 to 40 with higher scores indicating higher perceived stress, and scores ranging from 0 to 13, from 14 to 26, and from 27 to 40 are considered low, moderate, and high perceived stress, respectively., Baseline (July 2017) and end-line (March 2020, end of study completion)|Asthma medications, Asthma medications via survey, Baseline (July 2017) and end-line (March 2020, end of study completion)|Comorbidities, Comorbidities via survey, Baseline (July 2017) and end-line (March 2020, end of study completion) | null | Illinois Institute of Technology | Elevate | ALL | ADULT, OLDER_ADULT | null | 51 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | IIT IRB2019-001|ILHHU0031-16|P-0136 | 2017-01-01 | 2020-11-30 | 2020-11-30 | 2023-10-24 | null | 2023-10-24 | Illinois Institute of Technology, Chicago, Illinois, 60616, United States | null | {
"Residential mechanical ventilation system (Exhaust)": [
{
"intervention_type": "DEVICE"
}
],
"Residential mechanical ventilation system (CFIS) and air filtration upgrades": [
{
"intervention_type": "DEVICE"
}
],
"Residential mechanical ventilation system (ERV) and air filtration upgrades": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04367987 | Variability of Heart Rate as a Marker of Complication of Colorectal Surgery | https://clinicaltrials.gov/study/NCT04367987 | VFC COLORECTAL | UNKNOWN | Heart rate variability reflects the autonomic nervous system on the intrinsic activity of sinus node cells. Sympathetic hyperactivity is an adaptation to stress, while parasympathetic hyperactivity is present at rest. Thus, any variability in the heart frequency rate reflects variations in sympathetic and parasympathetic components in the autonomic nervous system. Failure to return to normal or a reduction in the variability of the heart rate in the postoperative period is correlated with complications in colorectal surgery. | NO | Surgery--Complications | DIAGNOSTIC_TEST: Heart Rate Variability | Rate of variability of the heart rate between Day-1 to Day 7, Measured by power spectral density; ratio of the high to low frequencies, Day 7|Correlation between the rate of variability of the heart rate between Day-1 to Day 7and anastomotic fistula diagnosed according to Center for Diseases Control criteria after scheduled colorectal surgery, Abdominal-pelvic imagery, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and peri-anastomotic fluid collections after scheduled colorectal surgery, Abdominal-pelvic imagery, Hospital discharge (maximum Day 7) | Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal abscess, diagnosed on CT-scan, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of gut wall abscess, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pneumonia, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of urinary tract infection, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of central venous catheter infection, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal hematoma, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of hemorrhagic shock, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and death rate, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of deep vein thrombosis, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pulmonary embolism, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of acute pulmonary edema, Hospital discharge (maximum Day 7)|Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of heart disease, Hospital discharge (maximum Day 7) | null | Centre Hospitalier Universitaire de Nīmes | null | ALL | ADULT, OLDER_ADULT | null | 117 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | Local/2018/MB-01 | 2020-06-17 | 2024-06 | 2024-06 | 2020-04-29 | null | 2022-03-21 | CHU de Nimes, Nîmes, France | null | {
"Heart Rate Variability": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
]
} |
NCT03075787 | Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea | https://clinicaltrials.gov/study/NCT03075787 | OSAS | UNKNOWN | Obstructive sleep apnea is often associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between obstructive sleep apnea severity, age, gender and heart rate response associated with obstructive sleep apnea. Drug-free patients diagnosed with obstructive sleep apneas were included. Clinical data and 24-h polysomnography recordings were analyzed. | NO | Sleep Apnea, Obstructive | DEVICE: standard 24-h ambulatory polysomnography | Amplitude of heart rate response associated with obstructive sleep apneas, standard 24-h ambulatory ad libitum polysomnography, At diagnosis | Other Heart rate variability indices: Ptot, standard 24-h ambulatory ad libitum polysomnography, At diagnosis|Other Heart rate variability indices: very-low-frequency (VLF), low frequency (LF), low frequency normalized units (LFnu), high-frequency normalized units (HFnu), standard 24-h ambulatory ad libitum polysomnography, At diagnosis|Other Heart rate variability indices: LF/HF, standard 24-h ambulatory ad libitum polysomnography, At diagnosis | null | Centre Hospitalier Universitaire de Saint Etienne | null | ALL | ADULT, OLDER_ADULT | null | 60 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1700176 | 2016-09-01 | 2017-10 | 2017-10 | 2017-03-09 | null | 2017-07-06 | Chu Saint-Etienne, Saint Etienne, 42055, France | null | {
"standard 24-h ambulatory polysomnography": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT03184987 | A Long-term Safety Study of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Subjects With Asthma | https://clinicaltrials.gov/study/NCT03184987 | null | COMPLETED | Despite availability of treatments and published guidelines, subjects may have asthma that is inadequately controlled. GlaxoSmithKline is currently developing a once-daily closed triple therapy of an Inhaled Corticosteroids/Long-Acting Beta-2-Agonists/Long-Acting Muscarinic Antagonist (ICS/LAMA/LABA) combination (Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate [FF/UMEC/VI]) in a single device, with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. This study has 3 study periods: Run-in, Treatment period and a Follow-up period. Eligible subjects who meet the pre-defined criteria at screening (Visit 1) will enter into a 2-week run-in period. Subjects will continue their pre-screening inhaled medications for asthma (ICS+LABA or ICS+LABA+LAMA) without any change in regimen/dosage until day before Visit 2. At Visit 2 subjects will be allocated to either FF/UMEC/VI 100/62.5/25 or FF/UMEC/VI 200/62.5/25 micrograms (mcg) treatment depending on the asthma control status for 52 weeks. Switching medication from FF/UMEC/VI 100/62.5/25 to FF/UMEC/VI 200/62.5/25 will be permitted in accordance with the control status of the subject assessed by Asthma Control Questionnaire (ACQ)-7 at Week 24 of the treatment period. A follow-up visit will be conducted for approximately 1 week. Subjects will be provided with salbutamol as a rescue medication throughout the study. | YES | Asthma | DRUG: FF/UMEC/VI 100/62.5/25 mcg|DRUG: FF/UMEC/VI 200/62.5/25 mcg|DRUG: Salbutamol|OTHER: ACQ-7 | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs), An adverse event (AE) is any untoward medical occurrence in clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect, other important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcome mentioned before. Intent-To-Treat (ITT) Population comprised of all participants who received at least one dose of study treatment in the treatment period., Up to Week 52 | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 4, 12, 24, 36 and 52|Change From Baseline in Pulse Rate, Pulse rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 4, 12, 24, 36 and 52|Change From Baseline in PR Interval and QT Interval Corrected for Heart Rate According to Fridericia s Formula (QTcF), Single 12-lead electrocardiograms (ECG) were obtained using an automated ECG machine that measured PR Interval and QTcF Interval. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 4, 24 and 52|Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin, Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume, Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Hematology Parameter: Erythrocytes, Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Hematology Parameter: Hematocrit, Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Hematology Parameter: Hemoglobin, Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Hematology Parameter: Platelet Count, Blood samples were collected to analyze the hematology parameter: platelet count. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Hematology Parameter: Basophils/Leukocytes, Blood samples were collected to analyze the hematology parameter: Basophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes, Blood samples were collected to analyze the hematology parameter: Eosinophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes, Blood samples were collected to analyze the hematology parameter: Lymphocytes/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Hematology Parameter: Monocytes/Leukocytes, Blood samples were collected to analyze the hematology parameter: Monocytes/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes, Blood samples were collected to analyze the hematology parameter: Neutrophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Blood samples were collected to analyze the chemistry parameters: alanine aminotransferase, alkaline phosphatase and aspartate aminotransferase. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Chemistry Parameters: Albumin, Protein, Blood samples were collected to analyze the chemistry parameters: albumin and protein. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin, Blood samples were collected to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea, Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and urea. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value., Baseline (Day 1), Weeks 12, 24 and 52|Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline, Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as Trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits., Baseline (Day 1) and up to Week 52 | null | GlaxoSmithKline | York Bioanalytical Solution|BI Medical.Inc|SRL Mediserch.Inc|Parexel International Japan|Q2 Solutions | ALL | ADULT, OLDER_ADULT | PHASE3 | 111 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 207236 | 2017-06-22 | 2019-06-25 | 2019-06-25 | 2017-06-14 | 2020-05-29 | 2020-05-29 | GSK Investigational Site, Gifu, 509-6134, Japan|GSK Investigational Site, Gunma, 372-0831, Japan|GSK Investigational Site, Gunma, 373-0807, Japan|GSK Investigational Site, Hiroshima, 732-0052, Japan|GSK Investigational Site, Kagawa, 762-8550, Japan|GSK Investigational Site, Kanagawa, 236-0004, Japan|GSK Investigational Site, Kyoto, 607-8062, Japan|GSK Investigational Site, Okinawa, 901-2121, Japan|GSK Investigational Site, Tokyo, 103-0027, Japan|GSK Investigational Site, Tokyo, 134-0083, Japan|GSK Investigational Site, Tokyo, 157-0066, Japan|GSK Investigational Site, Tokyo, 169-0073, Japan|GSK Investigational Site, Toyama, 937-0042, Japan | Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03184987/SAP_000.pdf|Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT03184987/Prot_001.pdf | {
"FF/UMEC/VI 100/62.5/25 mcg": [
{
"intervention_type": "DRUG"
}
],
"FF/UMEC/VI 200/62.5/25 mcg": [
{
"intervention_type": "DRUG"
}
],
"Albuterol": [
{
"intervention_type": "DRUG",
"description": "Salbutamol",
"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"
}
],
"ACQ-7": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01684787 | Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients | https://clinicaltrials.gov/study/NCT01684787 | CONTRA | COMPLETED | In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis.
Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients.
The investigators have not data concerning the evolution and response to the treatment in co-infected patients with normal ALT.
In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it assumes a behavior similar between mono and co-infected patients and the results are different.
In the case of normal ALT the investigators do not know if the natural history in co-infected patients is similar than the mono-infected patients, and also the response of the treatment.
This study prospective and controls is the answer of this question. The main hypothesis is if the response of treatment in co-infected patients is not inferior than mono-infected patients.
The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning genotype, gender and hospital. | NO | Chronic Hepatitis C | DRUG: Peginterferon alfa-2a + ribavirin in normal ALT|DRUG: Peginterferon alfa-2a + ribavirin in elevated ALT | % patients with RNA-HCV negative, 24 weeks after treatment | null | null | Miguel Santin | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 80 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | Miguel Santín | 2006-09 | 2011-05 | 2011-06 | 2012-09-13 | null | 2012-09-13 | Hospital de Txagorritxu, Vitoria, Alava, 01009, Spain|Consorci Sanitari Integral, Hospitalet, Barcelona, 08907, Spain|Hospital Universitari of Bellvitge, Hospitalet, Barcelona, 08907, Spain|Hospital General de Mataró, Mataró, Barcelona, 08304, Spain|Consorci Sanitari de Terrassa, Terrassa, Barcelona, 08227, Spain|Hospital de Donostia, San Sebastián, Guipúzcoa, 20014, Spain|Hospital Xeral-Cíes, Vigo, Pontevedra, 36204, Spain|Hospital de Cruces, Baracaldo, Vizcaya, 48903, Spain|Hospital del Mar, Barcelona, 08003, Spain|Hospital Santa Creu i Sant Pau, Barcelona, 08025, Spain|Hospital Clinic, Barcelona, 08036, Spain|Hospital San Jorge, Huesca, 22004, Spain|Hospital de la Princesa, Madrid, 28006, Spain|Hospital Ramón y Cajal, Madrid, 28034, Spain|Hospital Clínico San Carlos, Madrid, 28040, Spain|Hospital 12 de Octubre, Madrid, 28041, Spain|Hospital Joan XXIII, Tarragona, 43007, Spain|Hospital Clínico Lozano Blesa, Zaragoza, 50009, Spain | null | {
"Peginterferon alfa-2a": [
{
"intervention_type": "DRUG",
"description": "Peginterferon alfa-2a + ribavirin in normal ALT",
"name": "Peginterferon alfa-2a",
"synonyms": [
"Peginterferon alfa-2a",
"PEG-IFN alfa-2A",
"Pegasys",
"Pegylated Interfeaon alfa-2A",
"Pegylated interferon alpha-2a",
"Pegylated-interferon alfa 2a",
"Pegylated interferon alfa-2a",
"PEG-Interferon alfa-2A",
"Pegasys",
"Peginterferon Alfa-2a",
"Pegasys",
"Peginterferon Alfa-2a",
"Pegasys",
"Peginterferon Alfa-2a"
],
"drugbank_id": "DB00008",
"generic_names": [
"Peginterferon alfa-2a",
"Peginterferon Alfa-2a",
"Peginterferon Alfa-2a",
"Peginterferon Alfa-2a"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Peginterferon%20alfa-2a"
},
{
"intervention_type": "DRUG",
"description": "Peginterferon alfa-2a + ribavirin in elevated ALT",
"name": "Peginterferon alfa-2a",
"synonyms": [
"Peginterferon alfa-2a",
"PEG-IFN alfa-2A",
"Pegasys",
"Pegylated Interfeaon alfa-2A",
"Pegylated interferon alpha-2a",
"Pegylated-interferon alfa 2a",
"Pegylated interferon alfa-2a",
"PEG-Interferon alfa-2A",
"Pegasys",
"Peginterferon Alfa-2a",
"Pegasys",
"Peginterferon Alfa-2a",
"Pegasys",
"Peginterferon Alfa-2a"
],
"drugbank_id": "DB00008",
"generic_names": [
"Peginterferon alfa-2a",
"Peginterferon Alfa-2a",
"Peginterferon Alfa-2a",
"Peginterferon Alfa-2a"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Peginterferon%20alfa-2a"
}
],
"Ribavirin": [
{
"intervention_type": "DRUG",
"description": "Peginterferon alfa-2a + ribavirin in normal ALT",
"name": "Ribavirin",
"synonyms": [
"Copegus",
"Ribamide",
"Ribovirin",
"Ribavirinum",
"Virazole",
"Vilona",
"Tribavirin",
"Virazide",
"tribavirin",
"Viramide",
"Ribamidil",
"RBV",
"1-beta-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide",
"Ribavirin",
"ICN-1229",
"Ribamidyl",
"Ribavirine",
"Rebetol",
"Ribavirina",
"ICN1229",
"ICN 1229",
"Ribasphere",
"1-beta-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide"
],
"medline_plus_id": "a605018",
"generic_names": [
"Ribavirin"
],
"mesh_id": "D000998",
"drugbank_id": "DB00811"
},
{
"intervention_type": "DRUG",
"description": "Peginterferon alfa-2a + ribavirin in elevated ALT",
"name": "Ribavirin",
"synonyms": [
"Copegus",
"Ribamide",
"Ribovirin",
"Ribavirinum",
"Virazole",
"Vilona",
"Tribavirin",
"Virazide",
"tribavirin",
"Viramide",
"Ribamidil",
"RBV",
"1-beta-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide",
"Ribavirin",
"ICN-1229",
"Ribamidyl",
"Ribavirine",
"Rebetol",
"Ribavirina",
"ICN1229",
"ICN 1229",
"Ribasphere",
"1-beta-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide"
],
"medline_plus_id": "a605018",
"generic_names": [
"Ribavirin"
],
"mesh_id": "D000998",
"drugbank_id": "DB00811"
}
]
} |
NCT04627987 | Mechanisms of Excess Risk in Aortic Stenosis | https://clinicaltrials.gov/study/NCT04627987 | MASTER | RECRUITING | Aortic stenosis (AS) is caused by narrowing of one of the main heart valves. Replacing the valve is the only treatment to prevent the heart from failing or death. The timing of replacement is currently often too late - half of patients are left with permanent scarring and a quarter die within 3.5 years.
Studies are underway to see if earlier replacement makes a difference. But for those with scarring of the heart, there is currently no tailored treatment. I want to change this by understanding why and how patients with scar are dying and what the investigators can do to prevent this.
In this study, the investigators will use a heart scan (MRI) to detect scarring before valve replacement. After replacement, patients will receive a tiny monitor (paper clip size), which the investigators inject underneath the skin. This monitor continuously checks the heartbeat and can detect increased body fluid due to heart failure. The investigators will monitor patients for an average of 3 years to see if scarring is linked to abnormal heart rhythms and heart failure.
Once the investigators know how and why, the investigators can target patients with available medications and design studies using specialised treatments, eg defibrillator implantation, to protect patients with scar from dying. | NO | Aortic Stenosis|Non-Sustained VT|Heart Failure | DIAGNOSTIC_TEST: Cardiac MRI scan|DIAGNOSTIC_TEST: Serum biomarkers (High sensitivity troponin, NT-proBNP|PROCEDURE: Implantable Loop Recorder|DIAGNOSTIC_TEST: 6 minute walk test|DIAGNOSTIC_TEST: Echocardiogram | Heart failure death or hospitalisation for heart failure., 5 years after aortic valve replacement|Burden of non-sustained VT, As assessed on implantable cardiac monitor (approximate battery life 2.5 years), 2.5 years after aortic valve replacement. | All-cause mortality (all-cause and cardiovascular via NHS spine/death registration), 5 years after aortic valve replacement|change in functional capacity (6-minute walk test), At 6 weeks and 12 months after aortic valve replacement.|Heart failure symptoms, New York Heart Association (NYHA) functional classification (NYHA 1 least symptomatic, 4 most symptomatic), At 6 weeks and 12 months post aortic valve surgery|Heart failure symptoms, World Health Organisation Disability Assessment Schedule 2.0 (Higher score indicates greater disability), At 6 weeks and 12 months post aortic valve surgery|Burden of other serious arrhythmias requiring change in management, Participants with complete heart block, Mobitz 2 AV block, new onset atrial fibrillation, 2.5 years after aortic valve replacement | null | University College, London | Barts & The London NHS Trust | ALL | ADULT, OLDER_ADULT | null | 192 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 125312 | 2021-03-23 | 2025-12-01 | 2025-12-01 | 2020-11-13 | null | 2021-04-30 | Barts Heart Centre, London, EC1A 7BE, United Kingdom | null | {
"Cardiac MRI scan": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
],
"Serum biomarkers (High sensitivity troponin, NT-proBNP": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
],
"Implantable Loop Recorder": [
{
"intervention_type": "PROCEDURE"
}
],
"6 minute walk test": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
],
"Echocardiogram": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
]
} |
NCT00581087 | Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults | https://clinicaltrials.gov/study/NCT00581087 | DHEA-HTAP | UNKNOWN | DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomization either 200 mg oral DHEA or placebo over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomized, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.
Eight patients with pulmonary hypertension (New York Heart Association functional class III or IV) associated with COPD were included in a pilot study between 2004 and 2005. Inclusion criteria were: COPD was defined by FEV1/FVC < 70% of reference values; resting mean pulmonary artery pressure (assessment by right pulmonary catheterization) ≥ 25mmHg with mean pulmonary capillary wedge pressure ≤ 15mmHg, PaO2 ≤ 60mmHg at rest or PaO2 ≥ 60mmHg associated with significant fall in O2 saturation with exercise; oxygen treatment initiated more than six months previously. Exclusion criteria were: clinical or respiratory instability during the three months before the inclusion in the study; corticosteroids therapy (> 0.5mg/kg/day of prednisolone or as equivalent); hepatic (prothrombin time < 50%) or renal (creatininemia > 130µmol/L) failure; diabetes; left ventricular dysfunction; PSA (prostatic antigens > 2,5ng/ml) and past history or diagnosis of cancer. The study was conducted in accordance with the Good Clinical Practices Guidelines. The study protocol was approved by the ethics review board of the University Hospital of Bordeaux (France). Written informed consent was obtained for all patients and investigations were conducted according to the institutional guidelines and to the Helsinki principles. This trial conducted enrollment between 2004 and 2005, but had not been registered in ClinicalTrials.gov because it preceded this policy.(Study design: The dose of oral DHEA administered was 200 mg once daily for three months. At baseline and after three months of treatment, clinical evaluation included 6MWT, Borg dyspnea index, systolic and diastolic blood pressure, right heart catheterisation, lung function testing and serum DHEA levels were performed.) | NO | Chronic Obstructive Pulmonary Disease|Hypertension, Pulmonary | DRUG: DHEA treatment|DRUG: Placebo | six-minute walk test, inclusion and one year of treatment | Pulmonary and systemic arterial pressures (mean, systolic and diastolic), Inclusion and one after year of treatment|Pulmonary vascular resistances, Inclusion and after one year of treatment|Safety, along one year of treatment|Compliance, Along one year of treatment | null | University Hospital, Bordeaux | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | Dromer|AFSSAPS 040479 | 2007-01 | 2015-06 | 2015-06 | 2007-12-27 | null | 2015-01-14 | University Hospital, Bordeaux, Bordeaux, France|APHP hospital Antoine Béclère GHU sud, Clamart, 92141, France|University Hospital, Limoges, Limoges, France|University Hospital, Strasbourg, Strasbourg, France|University Hospital, Toulouse, Toulouse, France | null | {
"Dehydroepiandrosterone": [
{
"intervention_type": "DRUG",
"description": "DHEA treatment",
"name": "Dehydroepiandrosterone",
"synonyms": [
"Dehydroandrosterone",
"Prasterone",
"5-Androsten-3-ol-17-one",
"3-beta-hydroxy-5-androsten-17-one",
"5 Androsten 3 ol 17 one",
"Dehydroisoandrosterone",
"Androstenolone",
"5 Androsten 3 beta hydroxy 17 one",
"Dehydroepiandrosterone",
"3beta-hydroxyandrost-5-en-17-one",
"3\u03b2-hydroxyandrost-5-en-17-one",
"DHEA",
"5-Androsten-3-beta-hydroxy-17-one",
"Prasterone, 3 alpha Isomer",
"Prasterone, 3 alpha-Isomer"
],
"mesh_id": "D000276",
"generic_names": [
"Prasterone",
"Dehydroepiandrosterone"
],
"drugbank_id": "DB01708"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT01229787 | The Relation Between Obesity, Adipose Tissue Content of Fatty Acids and Systemic and Airway Inflammation | https://clinicaltrials.gov/study/NCT01229787 | null | COMPLETED | Obesity has been recognized as a risk factors for developing asthma. In a cohort of 5384 children aged 15-17, we aim to:
1. To investigate the association of asthma prevalence at age 15-17 with body mass index (BMI) at age 15-17 and BMI at age 11-12 years Part II
2. To investigate the association of BMI in adolescence and BMI at age 11-12 years with:
1. Prevalence of allergic sensitization
2. Lung function
3. Levels of airway inflammation at age 16-18 years
4. Severity of asthma
Secondly, to assess diet and physical activity involvement as effect modifiers in these possible associations. | NO | Asthma, Allergies and Obesity | null | The association between asthma prevalence in adolescence and obsity in adolescence and in childhood, To investigate the association of asthma prevalence at age 15-17 with body mass index (BMI) at age 15-17 and at age 11-12 years | Association of BMI in adolescence and in childhood with allergic sensitization and lung function, To investigate the association of BMI in adolescence and BMI at age 11-12 years with:
1. Prevalence of allergic sensitization
2. Lung function
3. Levels of airway inflammation at age 16-18 years
4. Severity of asthma | null | Cyprus International Institute for Environment and Public Health | Merck Sharp & Dohme LLC | ALL | CHILD | null | 5,384 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | CIIRespiratory1 | 2007-01 | null | 2009-12 | 2010-10-28 | null | 2010-10-28 | Cyprus International insitute, Nicosia, Cyprus | null | {} |
NCT02961387 | A Clinical Trial on Effectiveness and Safety of Hydrogen Generator to Treat Dyspnea for the Patients With Tracheal Stenosis: A Randomized, Double-blind and Single-center Clinical Study | https://clinicaltrials.gov/study/NCT02961387 | null | UNKNOWN | Investigators aim to study the effectiveness and safety of inhaling hydrogen-oxygen which produced by a hydrogen generator with nebulizer to decreases inspiratory effort for the patients with tracheal stenosis. | NO | Tracheal Stenosis | DEVICE: Hydrogen generator treatment|DEVICE: Oxygen-making machine treatment | Change in sRMSdi/para/sc, RMSdi, Pdi& MIP from baseline after inhalation by bench study., sRMSdi/para/sc: root-mean-square of diaphragm/parasternal/sternocleidomastoid surface electromyography; RMSdi: root-mean-square of diaphragm electromyography; Pdi: Transdiaphragmatic pressure; MIP:maximal inspiratory pressure., Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min | Change in Borg score for dyspnea after inhalation., Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min|Change in symptom of dyspnea from baseline after inhalation., Changes in comfort with each gas mixture were evaluated by a simple questionnaire, Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min|Change in signs(BR, HR, BP, el) from baseline after inhalation, Change in signs include breath rate， heart rate， blood pressure，Three Depression Sign and so on., Baseline, 10min, 20min, 30min, 40min, 50min, 90min and 150min|Change in PaO2, PaCO2, PH& HCO3- after inhalation, Change in Arterial blood gases., Baseline and 150min|FEV1 & FVC, Forced expiratory volume in one second & Forced vital capacity., Baseline|Change in impulse oscillometry variables(R5,R20,X5,AX,RF) as change from baseline when inhaling., R5 - Resistance at 5Hz, R20 - Resistance at 20Hz, X5 - Reactance at 5Hz, RF - Frequency of resonance, AX - Area under reactance curve, Baseline and inhaling|Change in cough waves from baseline when inhaling, Cough waves will be recorded by a voice recorder., Baseline, Inhaling.|Grades of airway stenosis by bronchoscopy, baseline | null | Guangzhou Institute of Respiratory Disease | null | ALL | ADULT, OLDER_ADULT | null | 50 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT | TS20160801 | 2016-11 | 2018-06 | 2018-06 | 2016-11-11 | null | 2016-11-11 | Guangzhou Institute of Respiratory Disease, Guangzhou, Guangdong, 510120, China | null | {
"Hydrogen generator treatment": [
{
"intervention_type": "DEVICE"
}
],
"Oxygen-making machine treatment": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04032587 | Modification of Pavlovian and Instrumental Learning in Human Addiction | https://clinicaltrials.gov/study/NCT04032587 | null | COMPLETED | The project aims at investigating modifications of environmental factors (i.e. cues and stress) relevant for learning mechanisms in addictive disorders. | NO | Healthy|Alcohol Use Disorder (Mild vs. Moderate to Heavy) | BEHAVIORAL: Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011)|BEHAVIORAL: Mindfulness-based interventions (e.g. body scan) | Blood Oxygen Level Dependent especially within the ventral striatum and the amygdala (fMRI), 2 consecutive days|Rate of Pavlovian-to-instrumental-Transfer (instrumental responding, i.e.number of button presses, in dependence of Pavlovian Stimuli), 2 consecutive days|Rate of goal-directed decision-making/habitual decision making, 2 consecutive days | null | null | Charite University, Berlin, Germany | null | ALL | ADULT, OLDER_ADULT | null | 80 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | TRR265 C02 | 2019-10-01 | 2023-06-30 | 2023-06-30 | 2019-07-25 | null | 2024-01-26 | Dept. of Psychiatry, CCM, Charite Universitätsmedizin Berlin, Berlin, 10117, Germany | null | {
"Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011)": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Mindfulness-based interventions (e.g. body scan)": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT03365687 | Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers | https://clinicaltrials.gov/study/NCT03365687 | DIVA | ACTIVE_NOT_RECRUITING | In this 7-month randomized controlled trial, children aged 1 to less than 6 years, with recurrent asthma attacks triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5 months during their usual clinic visit, and a daily supplement of vitamin D or a placebo. This study will test whether children in vitamin D group have less frequent and less severe asthma exacerbations compared with those receiving placebo.The study will also document the safety profile of this strategy. | NO | Asthma | DIETARY_SUPPLEMENT: Vitamin D|DIETARY_SUPPLEMENT: Placebo | Number of asthma exacerbations per child treated with rescue oral corticosteroids, Group difference in the mean number of exacerbations treated with rescue oral corticosteroids/child, 7 months | Laboratory-confirmed respiratory infections, Group difference in mean number of laboratory-confirmed respiratory infections during asthma exacerbations, 7 months|Severity of asthma symptoms during asthma exacerbations, Group difference in the mean severity of asthma symptoms documented on the Asthma Flare-up Diary for Young Children , 7 months|Duration of asthma symptoms during asthma exacerbations, Group difference in the mean duration of asthma symptoms documented on the validated Asthma Flare-up Diary for Young Children , 7 months|Intensity of use of rescue β2-agonists during asthma exacerbations, Group difference in the mean cumulative use of rescue β2-agonists during exacerbations documented on the validated Asthma Flare-up Diary for Young Children , 7 months|Parents functional status during asthma exacerbations, Group difference in the mean parents functional status during exacerbation as documented on the validated Effect of a child s asthma flare-up on parents questionnaire , 7 months|Mean number of ED visits for asthma exacerbations, Group difference in mean number of ED visits for asthma exacerbations, 7 months|De-intensification of preventive asthma therapy, Group difference in proportion of children with de-intensification of preventive asthma therapy, 7 months|Intervention cost-effectiveness, Cost of intervention vs. cost (family expenses and health care) of exacerbations, 7 months | Hypercalciuria, Group difference in the proportion of children with ≥1 occurrence of hypercalciuria (urinary calcium: creatinine ratio >1.38 mmol/mmol for children aged 1-<2 years, or >1.1 mmol/mmol for children aged 2-<5 years, or >0.77 mmol/mmol for children aged ≥5 years), 7 months|Hypercalcemia, Group difference in the proportion of children with clinically significant hypercalcemia (>2.63 mmol/L), 7 months|Elevated serum 25-hydroxyvitamin D, Group difference in the proportion of children with ≥1 occurrence of elevated serum 25OHD (greater than 250 nmol/L), 7 months|Adverse Health Events, Group difference in the distribution of adverse health events, 7 months|Gene expression, Group difference in the change in gene expression levels (between baseline and 3.5 months) in blood peripherical mononuclear cells, adjusted for cell distribution estimated from lymphocyte differentiation in a subset of patients, 3.5 months | Professor Francine Ducharme | Canadian Institutes of Health Research (CIHR)|EURO-PHARM International Canada, Inc. | ALL | CHILD | PHASE3 | 323 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | MP-21-2018-1657 | 2018-10-01 | 2024-12 | 2024-12 | 2017-12-07 | null | 2024-05-21 | British Columbia Children s Hospital, Vancouver, British Columbia, V6H 3V4, Canada|Children s Hospital of London Health Sciences Centre, London, Ontario, N6A 2V5, Canada|Children s Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada|The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|Montreal Children s Hospital, Montreal, Quebec, H3H 1P3, Canada|CHU Sainte Justine, Montreal, Quebec, H3T1C5, Canada|Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada|CHU de Québec-Université Laval, Québec, Quebec, G1V 4G2, Canada|CHU de Sherbrooke, Sherbrooke, Quebec, J1G 2E8, Canada | null | {
"Vitamin D": [
{
"intervention_type": "DIETARY_SUPPLEMENT"
}
],
"Placebo": [
{
"intervention_type": "DIETARY_SUPPLEMENT"
}
]
} |
NCT02922387 | Smoking Cessation Intervention in Respiratory Inpatients | https://clinicaltrials.gov/study/NCT02922387 | null | COMPLETED | Prospective, open-label, parallel-group, 52-week trial comparing varenicline in combination with behavioral support with one session of behavioral support alone.
Eligible patients were smokers hospitalized due to a) acute exacerbation of chronic obstructive pulmonary disease (COPD), or b) bronchial asthma attack, or c) community-acquired pneumonia (CAP).
The primary outcome was the success rate (%) at week 52. Secondary outcomes were quality of life (QoL) alterations on the domains of the 36-Item Short Form Health Survey (SF36) and investigation of possible predictors for smoking abstinence. | NO | Pulmonary Disease, Chronic Obstructive|Asthma|Community Acquired Pneumonia | DRUG: Varenicline|BEHAVIORAL: Behavioral support | Smoking Cessation Rate at week 52, 12 months follow up | Quality of life changes following smoking cessation, Quality of life (QoL) was assessed, in both groups, with the Short Form SF36 questionnaire at baseline and at the end of the followup period, week 52., 12 months follow up | null | General Hospital of Kavala | University of Thessaly | ALL | ADULT, OLDER_ADULT | PHASE4 | 101 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | VTBSQOL-52-CAC | 2012-05 | 2015-05 | 2015-05 | 2016-10-04 | null | 2016-10-04 | null | null | {
"Varenicline": [
{
"intervention_type": "DRUG",
"description": "Varenicline",
"name": "Varenicline",
"synonyms": [
"6,7,8,9-Tetrahydro-6,10-methano-6H-pyrazino(2,3-h)benzazepine",
"see Champix",
"varenicline",
"Varenicline Tartrate",
"Champix",
"Vareniclina",
"Vareniclinum",
"Chantix",
"Varenicline",
"Tyrvaya"
],
"medline_plus_id": "a621057",
"generic_names": [
"Varenicline"
],
"nhs_url": "https://www.nhs.uk/medicines/champix-varenicline",
"mesh_id": "D000077444",
"drugbank_id": "DB01273",
"wikipedia_url": "https://en.wikipedia.org/wiki/Varenicline"
}
],
"Behavioral support": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT05185687 | Public Support for COVID-19 Test Allocation | https://clinicaltrials.gov/study/NCT05185687 | null | COMPLETED | In a randomized survey experiment, investigators will assess public support or opposition towards one of three potential government plans for allocating at-home coronavirus disease 2019 (COVID-19) tests to United States residents: 1) first come, first served; 2) a random draw; or 3) a random draw with 20% of tests reserved for disadvantaged areas. Investigators will also examine public attitudes surrounding other logistical and equity-related aspects of these allocation plans. | NO | Health Equity|COVID-19 | BEHAVIORAL: First Come, First Served|BEHAVIORAL: Random|BEHAVIORAL: Disadvantaged Priority & Random | Support for allocation plan, Self-reported degree of support for the plan, measured on a 5-point Likert scale ( strongly oppose to strongly support ) that will be collapsed into 3 response categories ( oppose, neutral, and support ) for analysis., 5 minutes | Household-level test allocation preference, Preferred way of sending tests to households, measured as a binary choice between a fixed or variable (based on household size) number of tests per household., 5 minutes|Tests allocated to disadvantaged areas, Self-reported percentage of tests wanted to be sent to disadvantaged areas, measured as a continuous variable on a slider from 0% to 100% with increments of 0.1%. This outcome will only be measured for respondents in the Disadvantaged Priority & Random condition., 5 minutes | null | University of Pennsylvania | null | ALL | ADULT, OLDER_ADULT | null | 2,019 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH | 848725|#84525 | 2022-01-04 | 2022-01-06 | 2022-01-06 | 2022-01-11 | null | 2022-01-11 | Harris Insights & Analytics, Washington, District of Columbia, 20006, United States | null | {
"First Come, First Served": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Random": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Disadvantaged Priority & Random": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT05016687 | First-in-human Clinical Trial Evaluating CUR-N399 in Healthy Volunteers. | https://clinicaltrials.gov/study/NCT05016687 | null | COMPLETED | The purpose of the trial is to evaluate CUR-N399, a PI4KB inhibitor, in a first-in-human trial to evaluate the safety, tolerability and pharmacokinetics profile of single and multiple ascending doses in healthy adults.
In the SAD part of the trial, single oral doses of CUR-N399 will be administered in 5 sequential cohorts. In all cohorts, safety and PK will be assessed before and after dose. Exploratory nasopharyngeal swab for assessment of airway infectants will be performed before dose and in the morning of Day 3.
In SAD part Cohort 4: A urine sample will be taken from the first morning void on Day 1 and urine will be collected for potential quantification of CUR-N399 (and metabolites) during the first 24 hours post-dose.
The MAD part of the trial will explore multiple ascending dosing of CUR-N399. The initial dose, dose escalation and dosing schedule will be based on emerging knowledge of safety, tolerability and PK of CUR-N399 observed in the SAD part of the trial. CUR-N399 will be administered in 3 sequential cohorts. An additional MAD cohort will evaluate CUR-N399 in older adults ≥65 years.
All SAD and MAD cohorts will evaluate 8 subjects. Within each cohort, subjects will be randomised in a 3:1 ratio to receive CUR-N399 (n=6) or placebo (n=2) in a blinded fashion. | NO | Pulmonary Disease, Chronic Obstructive|Enterovirus Infections|Rhinovirus | DRUG: CUR-N399|DRUG: Placebo | All Parts: Adverse events (AE), • Incidence (frequency, intensity and seriousness) of AEs, From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)|All Parts: Clinically significant changes in electrocardiograms (ECGs), • Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. HR and PR, QRS, QT and QTcF intervals will be recorded., From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)|All Parts: Clinically significant changes in vital signs (pulse), • Pulse will be recorded., From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)|All Parts: Clinically significant changes in vital signs (blood pressure), • Blood pressure will be recorded., From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)|All Parts: Clinically significant changes in safety laboratory parameters (clinical chemistry), • Blood samples for analysis of clinical chemistry parameters:
* Alanine aminotransferase (ALT)
* Albumin
* Alkaline phosphatase (ALP)
* Aspartate aminotransferase (AST)
* Bilirubin (total and conjugated)
* Calcium
* Cholesterol (HDL, LDL, total)
* Creatinine (estimated Glomerular Filtration Rate [eGFR] included)
* C-reactive protein (CRP)
* Glucose
* Lactate dehydrogenase (LD)
* Phosphate
* Potassium
* Sodium
* Triglycerides
* Urea
will be collected and sent to the certified clinical chemistry laboratory and analysed by routine analytical methods., From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)|All Parts: Clinically significant changes in safety laboratory parameters (heamatology), • Blood samples for analysis of haematology parameters:
* Haematocrit
* Haemoglobin (Hb)
* Platelet count
* Red blood cell (RBC) count
* White blood cell (WBC) count with differential count
will be collected and sent to the certified clinical chemistry laboratory and analysed by routine analytical methods., From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)|All Parts: Clinically significant changes in safety laboratory parameters (coagulation), • Blood samples for analysis of coagulation parameters:
* Activated Partial Thromboplastin Time (APTT)
* Prothrombin Complex International Normalised Ratio (PK[INR])
will be collected and sent to the certified clinical chemistry laboratory and analysed by routine analytical methods., From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)|All Parts: Clinically significant changes in physical examinations, • Routine physical examinations will be performed. Incidence of clinically significant changes will be recorded., From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD) | All Parts: Pharmacokinetics (PK) of CUR-N399 (AUC0-t), Area under the curve (AUC) from time 0 to time t (AUC0-t), Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)|All Parts: Pharmacokinetics (PK) of CUR-N399 (AUC0-∞), AUC from time 0 to infinity (AUC0-∞), Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)|All Parts: Pharmacokinetics (PK) of CUR-N399 (T½), Terminal half-life (T½), Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)|All Parts: Pharmacokinetics (PK) of CUR-N399 (Cmax), Observed maximum plasma concentration (Cmax), Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)|All Parts: Pharmacokinetics (PK) of CUR-N399 (Tmax), Time to Cmax (Tmax), Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)|All Parts: Pharmacokinetics (PK) of CUR-N399 (dose proportionality), Dose proportionality (based on AUC and Cmax), Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)|All Parts: Pharmacokinetics (PK) of CUR-N399 (CL/F), Apparent total body clearance following extravascular administration (CL/F), Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)|All Parts: Pharmacokinetics (PK) of CUR-N399 (Vz/F), Apparent volume of distribution following extravascular administration (Vz/F), Pre-dose Day 1 to 48 post last dose (Day 3 SAD and Day 9 MAD respectively)|Part II a+b: Pharmacokinetics (PK) of CUR-N399 (AUCtau) for MAD groups, AUC for the dosing interval (AUCtau), After first dose (Day 1) and up to 48 hours post last dose (Day 9)|Part II a+b: Pharmacokinetics (PK) of CUR-N399 (Ctrough) for MAD groups, Observed concentration at the end of a dosing interval (Ctrough), Pre-dose administration on Days 2 to 7|Part II a+b: Pharmacokinetics (PK) of CUR-N399 (Accumulation ratio) for MAD groups, Accumulation ratio, Day 1 to 48 hours post last dose (Day 9) | All parts: Nasopharyngeal swabs to evaluate airway infectants, Nasopharyngeal swab samples will be taken to evaluate the presence and levels of a panel of airway infectants:
* Respiratory syncytial virus
* Metapneumovirus
* Influenza a, b
* All 4 Coronaviruses
* Adenovirus
* Parainfluenza virus 1, 2, 3
* Mycoplasma
* Clostridium difficile
* Pneumococci, Pre-dose Day -1 to Day 3|Part I Cohort 4: CUR-N399 (and metabolites) in urine in SAD Cohort, Potential quantification of unchanged CUR-N399 and metabolites in urine, Pre-dose Day 1 to Day 3|Part II a+b: Metabolic profile of CUR-N399 in plasma in MAD groups, Potential future metabolite identification in plasma and possible comparison with metabolite exposure in pre-clinical safety studies (metabolites in safety testing [MIST]), Day 1 to Day 9|Part II a+b: To assess age-related differences in safety of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, To assess age related incidence (frequency and severity) of AEs, From Start of Treatment Day 1 to End of Study Day 14|Part II a+b: To assess age-related differences in pharmacokinetic (PK) profile (AUC0-t) of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, To assess age related differences in AUC0-t, Pre-dose to 48 hours after first dose (Day 3) and after last dose Day 7 to 48 hours post-dose (Day 9)y 1 to 24 hours post last dose Day 8|Part II a+b: To assess age-related differences in pharmacokinetic (PK) profile (AUCtau) of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, AUC for the dosing interval (AUCtau), Pre-dose Day 1 to 48 hours post last dose Day 9|Part II a+b: To assess age-related differences in pharmacokinetic (PK) profile (T½) of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, Terminal half-life (T½), After first dose Day 1 and up to 48 hours after last dose Day 9|Part II a+b: To assess age-related differences in pharmacokinetic (PK) profile (Tmax) of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, Time to Cmax (Tmax), Up to 48 hours after first dose Day 1 (Day 3) and last dose Day 7 (Day 9)|Part II a+b: To assess age-related differences in pharmacokinetic (PK) profile (Cmax) of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, Observed maximum plasma concentration (Cmax), Up to 48 hours after first dose Day 1 (Day 3) and last dose Day 7 (Day 9)|Part II a+b: To assess age-related differences in pharmacokinetic (PK) profile (Dose proportionality) of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, Dose proportionality (based on AUCtau and Cmax), Up to 48 hours after first dose Day 1 (Day 3) and last dose Day 7 (Day 9)|Part II a+b: To assess age-related differences in pharmacokinetic (PK) profile (Ctrough) of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, Observed concentration at the end of a dosing interval (Ctrough), Pre-dose of last dose Day 7|Part II a+b: To assess age-related differences in pharmacokinetic (PK) profile (CL/F) of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, Apparent total body clearance following extravascular administration (CL/F), Up to 48 hours post last dose Day 7 (Day 9)|Part II a+b: To assess age-related differences in pharmacokinetic (PK) profile (Vz/F) of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, Apparent volume of distribution following extravascular administration (Vz/F), Up to 48 hours post last dose Day 7 (Day 9)|Part II a+b: To assess age-related differences in pharmacokinetic (PK) profile (Accumulation ratio) of two age groups 18-55 vs ≥65 year in MAD Cohort with Older adults, Accumulation ratio, Up to 48 hours post last dose Day 7 (Day 9) | Curovir AB | CTC Clinical Trial Consultants AB | ALL | ADULT, OLDER_ADULT | PHASE1 | 74 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | CURCT-001 | 2021-07-22 | 2022-03-22 | 2022-03-22 | 2021-08-23 | null | 2022-03-23 | CTC Clinical Trial Consultants AB, Uppsala, SE-75185, Sweden | null | {
"CUR-N399": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT02572687 | A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic Malignancies | https://clinicaltrials.gov/study/NCT02572687 | null | COMPLETED | The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in participants with locally advanced and unresectable or metastatic gastrointestinal or thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC). | NO | Gastric Cancer|Gastroesophageal Junction Adenocarcinoma|Non-Small Cell Lung Cancer|Hepatocellular Carcinoma | DRUG: Ramucirumab|DRUG: MEDI4736 | Number of Participants with Dose Limiting Toxicities (DLTs), Cycle 1 (up to 28 days) | Percentage of Participants with a Best Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR), Baseline to Disease Progression (Approximately 22 Months)|Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR), Baseline to Disease Progression (Approximately 22 Months)|Duration of Response (DoR), Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 22 Months)|Time to First Response (TTR), Baseline to Date of CR or PR (Approximately 22 Months)|Progression Free Survival (PFS), Baseline to Progressive Disease or Death from Any Cause (Approximately 22 Months)|Overall Survival (OS), Baseline to Progressive Disease or Death from Any Cause (Approximately 32 Months)|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab and MEDI4736, Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)|PK: Minimum Concentration (Cmin) of Ramucirumab and MEDI4736, Predose Cycle 1 Day 1 through Follow up (Approximately 22 Months)|Number of Participants with Treatment Emergent Anti Ramucirumab Antibodies, Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)|Number of Participants with Treatment Emergent Anti MEDI4736 Antibodies, Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months) | null | Eli Lilly and Company | AstraZeneca | ALL | ADULT, OLDER_ADULT | PHASE1 | 85 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 16116|I4T-MC-JVDJ|2015-003013-14 | 2016-02-19 | 2018-03-27 | 2021-01-13 | 2015-10-09 | null | 2021-01-20 | UCLA Medical Center, Santa Monica, California, 90404, United States|Johns Hopkins University, Baltimore, Maryland, 21231, United States|Washington University Medical Center, Saint Louis, Missouri, 63110, United States|Carolinas Medical Center, Charlotte, North Carolina, 28204, United States|The Miriam Hospital, Providence, Rhode Island, 02906, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232-6307, United States|University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Besancon Cedex, 25030, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Marseille Cedex 5, 13385, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Montpellier Cedex 5, 34298, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Saint Etienne Cedex 2, 42055, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Großhansdorf, 22927, Germany|Hadassah Medical Center - Ein Karem, Jerusalem, 9112001, Israel|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ramat Gan, 5266202, Israel|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tel Aviv, 6423906, Israel|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Milano, 20133, Italy|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Rozzano, 20089, Italy|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Seoul, 03080, Korea, Republic of|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Seoul, 03722, Korea, Republic of|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Seoul, 05505, Korea, Republic of|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Seoul, 06351, Korea, Republic of|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Madrid, 28040, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Malaga, 29010, Spain|Hospital Virgen del Rocío, Sevilla, 41013, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tainan, 70403, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tainan, 704, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Tainan, 73657, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Taipei, 10048, Taiwan | null | {
"Ramucirumab": [
{
"intervention_type": "DRUG",
"description": "Ramucirumab",
"name": "Ramucirumab",
"synonyms": [
"IMC 1121B",
"1121B",
"LY3009806",
"IMC-1121B",
"Cyramza",
"Ramucirumab",
"IMC1121B"
],
"medline_plus_id": "a614026",
"generic_names": [
"Ramucirumab"
],
"mesh_id": "D020533",
"drugbank_id": "DB05578",
"wikipedia_url": "https://en.wikipedia.org/wiki/Ramucirumab"
}
],
"MEDI4736": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03461887 | Home-based Exercise Training for COPD Patients | https://clinicaltrials.gov/study/NCT03461887 | HOMEX-1 | COMPLETED | The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who have completed a pulmonary rehabilitation. | NO | Chronic Disease|Lung Diseases, Obstructive|Respiratory Disease | BEHAVIORAL: Exercise | Dyspnea, Dyspnea domain of the Chronic Respiratory Questionnaire (CRQ); 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea), Change from baseline to 12 months | Dyspnea, Dyspnea domain of the Chronic Respiratory Questionnaire (CRQ); 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea), Change from baseline to 3, 6 and 12 months|Exercise capacity, Six-Minute Walk Test (walk distance) and
1-min Sit-to-Stand Test (number of repetitions), Change from baseline to 12 months|Health-related quality of life, Chronic Respiratory Questionnaires (CRQ): Fatigue, emotional function, mastery domain and EuroQoL (EQ-5D-5L): 5 Dimensions - Mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item each with 5 levels, Change from baseline to 12 months|Health status, Visual analogue scale Feeling thermometer (0-100 scale; 0= worst health you can imagine ; 100= best health you can imagine ), Change from baseline to 12 months|Exacerbations, Event based, patient reported, During entire study, assessed at 12 months|Symptoms, Questionnaire, COPD Assessment Test, Change from baseline to 12 months | Compliance to the exercise training program, Percentage of fulfilled training sessions based on training diaries, Assessed daily by intervention group participants during 12 months|Satisfaction with the exercise training program, Questionnaire (Likert-Type scales), From baseline to 12 months|Experience with the exercise training program, Semi-structured interview, From baseline to 12 months (assessed at 12 months)|Health professionals feedback, Semi-structured interview, Assessed at 12 months|Cost effectiveness, Questionnaire: cost per quality-adjusted life year, From baseline to 12 months (assessed at 3, 6, 12 months) | University of Zurich | null | ALL | ADULT, OLDER_ADULT | null | 123 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER | HOMEX-1 | 2018-01-24 | 2020-03-20 | 2021-09-15 | 2018-03-12 | null | 2021-12-27 | Klinik Barmelweid, Barmelweid, 5017, Switzerland|Berner Reha Zentrum AG, Heiligenschwendi, 3625, Switzerland|Zürcher RehaZentren Wald, Wald, 8636, Switzerland|Kantonsspital Winterthur, Winterthur, 8401, Switzerland|University of Zurich, Zurich, 8001, Switzerland | null | {
"Exercise": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT01865487 | A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456) | https://clinicaltrials.gov/study/NCT01865487 | null | COMPLETED | This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is administered by IM injection. | YES | Latent Tuberculosis Bacteriology and Histology Unknown|Latent Tuberculosis | BIOLOGICAL: H56ug/IC31nmol|BIOLOGICAL: Placebo | Number and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination., Evaluation of unsolicited and solicited AEs was performed through 28 days after each study vaccination. Serious AEs were collected throughout the entire study period (i.e., 292 days). Evaluation of the safety profile of AERAS-456 was performed using data from all subjects who received at least one dose., Up to 10 months | Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-negative), LTBI: Latent TB Infection QFT: QuantiFERON-TB Gold Plus (QFT-Plus) is an in vitro diagnostic aid for detection of Mycobacterium tuberculosis infection Percent Antigen-specific T Cell DMSO-subtracted Cytokine Response Change from Baseline 13-color ICS assay using PBMCs T Cell: CD4+ Stimulation Antigen: Total Cytokine: Any, Day 292|Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-positive), Percent Antigen-specific T Cell DMSO-subtracted Cytokine Response Change from Baseline.
13-color ICS assay using PBMCs. T Cell: CD4+ Stimulation Antigen: Total Cytokine: Any, Day 292|Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - IFN-gamma ELISpot, DMSO-subtracted Antigen-specific IFN-gamma ELISpot Response (SFU - Background/10^6 PBMC) Change from Baseline LTBI Status at Baseline: Total Stimulation Antigen: Total, Day 292|Evaluate Kinetics of QuantiFERON®-TB Gold Test (QFT) Responses in LTBI-negative Participants, QFT results were summarized using subject count (percentage) for qualitative results.
Number of participants QFT-positive at any time point., Up to Study Day 292 | null | Aeras | Statens Serum Institut | ALL | ADULT | PHASE1|PHASE2 | 98 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | C-035-456 | 2013-08 | 2015-08 | 2015-11 | 2013-05-31 | 2019-12-19 | 2019-12-19 | eKhayavac TB Vaccine Trial, Khayelitsha, Cape Town, 7784, South Africa|SATVI Project Office, Brewelskloof Hospital, Worcester, 6850, South Africa | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT01865487/Prot_000.pdf | {
"H56ug/IC31nmol": [
{
"intervention_type": "BIOLOGICAL"
}
],
"Placebo": [
{
"intervention_type": "BIOLOGICAL"
}
]
} |
NCT05424887 | A Study to Evaluate the Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis | https://clinicaltrials.gov/study/NCT05424887 | null | NOT_YET_RECRUITING | This study is a randomized, double-blind, placebo-controlled, multi-center phase II clinical study conducted in China to compare the efficacy and safety of two different dose groups of AK3280 in IPF patients compared to the placebo control group. | NO | Idiopathic Pulmonary Fibrosis | DRUG: AK3280|DRUG: Placebo | After 24 weeks of continuous medication, the absolute decrease in percentage of the predicted FVC from baseline in the AK3280 treatment group compared to the placebo control group., Change in percentage of the predicted FVC from baseline, Up to 24 weeks | Assessment of whether AK3280 prolongs the progression-free survival of IPF subjects compared with the placebo control group within 24 weeks and 48 weeks of medication., Progression-free survival is defined as the time from randomization to the first occurrence of any of the following events:
* The percentage of FVC to the normal expected value (%FVC) achieves an absolute decrease of 10%, or
* The percentage of DLco to the normal expected value (%DLco) achieves an absolute decrease of 15%, or
* Non-elective hospitalization due to respiratory events
* Death, Main study: Up to 24 weeks; Extended study: Up to 48 weeks|The changes from baseline in %DLco， in the AK3280 treatment group compared to the placebo control group, - After hemoglobin correction, the absolute decrease in %DLco
* DLco will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively., Main study: Up to 24 weeks; Extended study: Up to 48 weeks|The proportion of subjects with a ≥15% absolute decrease in %DLco，in the AK3280 treatment group compared to the placebo control group, - After hemoglobin correction, the proportion of subjects with a ≥15% absolute decrease in %DLco
* DLco will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively., Main study: Up to 24 weeks; Extended study: Up to 48 weeks|The absolute decrease in forced vital capacity (FVC) from baseline ， in the AK3280 treatment group compared to the placebo control group, FVC will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively., Main study: Up to 24 weeks; Extended study: Up to 48 weeks|The proportion of patients with a percentage of decrease≥ 10%, ≥ 15% or ≥ 20% in FVC from baseline in each group, FVC will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively., Main study: Up to 24 weeks; Extended study: Up to 48 weeks|The time to the percentage of decrease in FVC reaching 10% from baseline, FVC will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively., Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Within 24 and 48 weeks of medication, the changes from baseline in the 6MWT（six-minute walk test） distance in the AK3280 treatment group compared to the placebo control group, The 6MWT distance will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively., Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Within 24 and 48 weeks of medication, the acute exacerbation of IPF subjects - The time from randomization to the first acute exacerbation - The proportion of subjects who experience at least one acute exacerbation, A subject needs to meet all 3 criteria below to be judged to have acute exacerbation of IPF:
* Acute worsening or progression of dyspnea occurs within 1 month (manifested as rapid decline in lung function, worsening of hypoxemia, worsening of irritating dry cough, and worsening of wheezing after exercise, etc.)
* Chest HRCT（high-resolution computed tomography） shows new diffuse ground glass opacities (GGO) and/or consolidation opacities in both lungs on the background of the original mesh opacities, honeycomb opacities and other manifestations of usual interstitial pneumonia (UIP)
* Heart failure or fluid overload is ruled out, Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Within 24 and 48 weeks of medication, the IPF-related mortality, all-cause mortality in IPF subjects, Main study: Up to 24 weeks; Extended study: Up to 48 weeks|The changes from baseline in the SGRQ（Saint George s Respiratory Questionnaire） total score in the AK3280 treatment group compared to the placebo control group, Saint George s Respiratory Questionnaire Part 1 : Symptoms component (frequency & severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.
Scores range from 0 to 100, with higher scores indicating more limitations., Main study: Up to 24 weeks; Extended study: Up to 48 weeks|The proportion of subjects with changes from baseline in the SGRQ ≥4 points from baseline, Scores range from 0 to 100, with higher scores indicating more limitations., Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Within 24 and 48 weeks of medication, the proportion of patients who have dose adjustments due to AEs in the AK3280 treatment group and the placebo control group, Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Within 24 and 48 weeks of medication, the proportion of subjects who discontinue the medication due to adverse events (AE) in the AK3280 treatment group and the placebo control group, Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Assessment of adverse events, Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Assessment of serious adverse events (SAEs), Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Number of participants with abnormal vital signs, Vital signs: include pulse, respiration, body temperature and blood pressure, Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Number of participants with abnormal Physical examination findings, Physical examination ： include height, weight, skin, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites, Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Number of participants with abnormal 12-lead ECG readings, Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Number of participants with abnormal laboratory test results, Laboratory tests：include blood routine examination， blood biochemistry ，urine routine test, Main study: Up to 24 weeks; Extended study: Up to 48 weeks|Pharmacokinetic endpoint：The maximum plasma drug concentration (Cmax) of AK3280 and AK3280 M2, Day 1 and Day 7|Pharmacokinetic endpoint：Time to peak (Tmax) of AK3280 and AK3280 M2, Day 1 and Day 7|Pharmacokinetic endpoint：Area under the plasma drug concentration-time curve from 0 hour to 12 hours (AUC0-12h) of AK3280 and AK3280 M2, Day 1 and Day 7|Pharmacokinetic endpoint：Area under the plasma drug concentration-time curve extrapolated from 0 hour to infinity (AUC0-∞） of AK3280 and AK3280 M2, Day 1 and Day 7|Pharmacokinetic endpoint：Oral clearance (CL/F) of AK3280 and AK3280 M2, Day 1 and Day 7|Pharmacokinetic endpoint：Oral volume of distribution (Vd/F) of AK3280 and AK3280 M2, Day 1 and Day 7|Pharmacokinetic endpoint：Terminal half-life (t1/2) of AK3280 and AK3280 M2, Day 1 and Day 7|Pharmacokinetic endpoint：Accumulation coefficient of AK3280 and AK3280 M2, Day 1 and Day 7 | null | Shanghai Ark Biopharmaceutical Co., Ltd. | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 105 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT | AK3280-2002 | 2022-07 | 2024-07 | 2024-10 | 2022-06-21 | null | 2022-07-20 | China-Japan Friendship Hospital, Beijing, Beijing, 100029, China | null | {
"AK3280": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT04564287 | An Observational Study of Neurologic Function After COVID-19 Infection | https://clinicaltrials.gov/study/NCT04564287 | null | COMPLETED | Background:
COVID-19 is an infection caused by a coronavirus. It can affect different parts of the body. For most people, it causes fevers or trouble breathing. Some people can have symptoms long after they recover. Researchers want to learn if there are signs of changes in the nervous system that may be related to COVID-19.
Objective:
To test the nervous system (the brain and nerves) in people who have had COVID-19 yet still have certain symptoms even after recovering.
Eligibility:
People age 18 and older who had COVID-19 and still have neurologic symptoms after they recovered from the initial infection.
Design:
Participants will be screened with a medical record review.
Participants will have a neurological exam. They will complete pen-and-paper tests of their memory and thinking. They will complete a smell test with scratch-and-sniff booklets.
They will give blood samples.
Participants will have magnetic resonance imaging (MRI) of the brain. Soft padding or a coil will be placed around their head. They will lie on a table that slides in and out of the MRI scanner. They will get a contrast dye through an intravenous (IV) catheter.
Participants blood pressure, blood flow, skin temperature, sweating, and breathing will be monitored.
Participants will have an electrocardiogram to measure heart function.
Participants will blow into a mouthpiece for several seconds.
Participants will lie on a table that has a motor. The motor tilts the table. Participants will have blood drawn through an IV as the table tilts.
Participants will have a lumbar puncture. A small needle will be inserted into the spinal canal to obtain fluid.
Participants may repeat some tests 8 weeks to 1 year later. | NO | COVID-19 | null | MRI brain, The number and character of brain MRI abnormalities on a dedicated research MRI protocol optimized to detect Covid-19-associated disease., NIH Clinical Center Visit | Neurological Examination, Neurologic examination: The number and character of abnormalities associated with both central and peripheral nervous system disease., NIH Clinical Center Visit|Autonomic Testing, Autonomic testing: The number and character of test results indicating autonomic nervous system disease as evidenced by abnormal heart rate and blood pressure responses during tilt table testing., NIH Clinical Center Visit | null | National Institute of Neurological Disorders and Stroke (NINDS) | null | ALL | ADULT, OLDER_ADULT | null | 13 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 10000094|000094-N | 2020-10-28 | 2023-04-12 | 2023-04-12 | 2020-09-25 | null | 2023-12-19 | National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States | null | {} |
NCT05125887 | Remote Assessment of Outpatient With Severe Acute Respiratory Syndrome (SARS-CoV-2) | https://clinicaltrials.gov/study/NCT05125887 | EVIDENCE | UNKNOWN | Outpatient management of patients with a milder form of COVID may be associated to an unfavorable initial or deferred course in relation to the pathology.. Outpatients represent the bulk of patients with COVID-19. To know their evolution, their secondary complications and identifying a profile of at risk patients is essential for the prevention and care of future non-hospitalized patients, in an epidemic context still active.
This study could make it possible to redefine the follow-up of outpatients. The study consists of a simple questionnaire and possibly a teleconsultation. | NO | SARS-CoV2 Infection | OTHER: Questionnaire | Medical procedures, number of medical procedures, At month 24 | null | null | University Hospital, Limoges | null | ALL | ADULT, OLDER_ADULT | null | 400 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 87RI21_0033/Evidence | 2022-02-01 | 2022-12-12 | 2023-06-12 | 2021-11-18 | null | 2022-05-04 | Médecine Interne A, Limoges, 87000, France | null | {
"Questionnaire": [
{
"intervention_type": "OTHER"
}
]
} |
NCT06063187 | Technology-based Fall Risk Assessments for Older Adults in Low-income Settings | https://clinicaltrials.gov/study/NCT06063187 | null | COMPLETED | The goal of this observational study is to examine the associations among fall risk appraisal, body composition, and physical activity in older adults in low-income settings.
The main questions it aims to answer are:
* What is the feasibility of recruitment (e.g., how many older adults need to be screened to recruit the sample?), especially during the COVID-19 pandemic, and acceptability of technologies and procedures for use among older adults in low-income settings?
* What are the the dynamic relationships between fall risk appraisal, body composition, physical activity, and behavioral changes related to fear of falling?
Participants will:
* complete questionnaires about their characteristics, socio-demographic, medical history, cognition, depressive symptoms, anxiety, and fear of falling.
* participate in static and dynamic balance tests, body composition measurement and handgrip strength test.
* wear an accelerometer for physical activity assessment for 7 consecutive days. | NO | Fall|Physical Inactivity|Sedentary Behavior | null | Feasibility of recruitment of low-income older adults, The investigators will assess the ability to recruit the participants by tracking the number of days and time spent to recruit the sample., Through study completion, an average of 2 years|Acceptability of using technologies in low-income older adults, The acceptability of the technologies and procedures will be examined based on an evaluation form (e.g., what the participants thought about the questionnaires and technology) and participants recommendations., Through study completion, an average of 2 years|Maladaptive fall risk appraisal, A condition in which there is a discrepancy between perceived fall risk (levels of fear of falling) and physiological fall risk (balance performance). Fear of falling will be assessed using the Short Fall Efficacy Scale International (short FES-I) with 7 items and balance performance will be assessed using the BTrackS Balance test. Maladaptive fall risk will be plotted on a electronic graph as the interaction between balance performance on the X-axis and fear of falling on the Y-axis., Once at baseline, an average of 5 minutes|Time spent in each physical activity intensity domain, Participants will wear the ActiGraph GT9X Link wireless activity monitor (ActiGraph LLC.), a tri-axial accelerometer, on the non-dominant wrist for 7 consecutive days.This device will assess the time (minutes) spent in light, moderate, and vigorous physical activity domains throughout the 7-day assessment period., 7 days|Body Composition, Body composition will be assessed using a direct segmental multi-frequency bioelectrical impedance analysis (BIA): InBody s10 device., Once at baseline, an average of 2 minutes|Balance Performance, Balance performance will be assessed using the BTrackS Balance test., Once at baseline, an average of 4 minutes|Fear of Falling, Fear of falling will be assessed using the Short Fall Efficacy Scale International (short FES-I) with 7 items.The minimum score possible is 7 and the maximum possible score is 28. Scores of 7-8 indicate low concern, scores of 9-13 indicate moderate concern, and scores of 14-28 indicate high concern. , Once at baseline, an average of 10 minutes | Depression, Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The minimum possible score is 0 and the maximum possible score is 27. Scores of 0-4 indicate minimal depression, scores of 5-9 indicate mild depression, scores of 10-14 indicate moderate depression, scores of 15-19 indicate moderately severe depression, and scores of 20-27 indicate severe depression. , Once at baseline, an average of 10 minutes | null | University of Central Florida | National Institute on Aging (NIA) | ALL | ADULT, OLDER_ADULT | null | 124 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | STUDY00002473|R03AG069799 | 2020-09-30 | 2022-06-30 | 2023-07-01 | 2023-10-02 | null | 2023-10-02 | University of Central Florida, Orlando, Florida, 32816, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT06063187/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/87/NCT06063187/ICF_001.pdf | {} |
NCT00127387 | Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia | https://clinicaltrials.gov/study/NCT00127387 | null | TERMINATED | Patients who receive radiation therapy often have fatigue or a decrease in feeling well causing a wasting away. For patients with advanced disease of lung cancer, prostate cancer, or cancer that has spread to the bone, it is hoped that this drug may decrease this. If patients feel better during treatments they can complete the therapy without any breaks in treatment. For treatment to be most effective, it should be given in the amount needed, on a particular schedule. | NO | Lung Cancer|Prostate Cancer|Neoplasm Metastasis|Bone Cancer | DRUG: Enbrel | Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo | Safety profile for enbrel taken by this group of individuals | null | The University of Texas Health Science Center at San Antonio | Sanchez Cancer Center | ALL | ADULT, OLDER_ADULT | PHASE2|PHASE3 | 54 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: DIAGNOSTIC | 001-0015-211 | 2001-05 | 2005-09 | 2005-11 | 2005-08-05 | null | 2012-06-26 | University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States | null | {
"Etanercept": [
{
"intervention_type": "DRUG",
"description": "Enbrel",
"name": "Etanercept",
"synonyms": [
"TNFR Fc Fusion Protein",
"Benepali",
"TNR 001",
"TNFR-Immunoadhesin",
"Fusion Protein, TNFR-Fc",
"TNR001",
"TNR-001",
"TNF Receptor Type II IgG Fusion Protein",
"etanercept-szzs",
"TNT Receptor Fusion Protein",
"Erelzi",
"rhu-TNFR:Fc",
"TNTR-Fc",
"Enbrel",
"Recombinant human TNF",
"etanercept-ykro",
"TNF Receptor Type II-IgG Fusion Protein",
"Etanercept",
"Recombinant Human Dimeric TNF Receptor Type II-IgG Fusion Protein",
"Recombinant Human Dimeric TNF Receptor Type II IgG Fusion Protein",
"rhu TNFR:Fc",
"TNFR-Fc Fusion Protein",
"Etanercept-szzs"
],
"medline_plus_id": "a602013",
"generic_names": [
"Etanercept"
],
"mesh_id": "D018501",
"drugbank_id": "DB00005",
"wikipedia_url": "https://en.wikipedia.org/wiki/Etanercept"
}
]
} |
NCT05179187 | Non-invasive Brain Mapping of Movement Facilitation in Parkinson s Disease | https://clinicaltrials.gov/study/NCT05179187 | null | RECRUITING | Several strategies or contexts help patients with Parkinson s disease to move more quickly or normally, however the brain mechanisms underlying these phenomena are poorly understood. The proposed studies use complimentary brain mapping techniques to understand the brain mechanisms supporting improved movements elicited by external cues. The central hypothesis is that distinct networks are involved in movement improvement depending on characteristics of the facilitating stimulus. Participants will perform movement tasks during recording of brain activity with EEG and MRI. The identified biomarkers may provide targets for future neuromodulation therapies to improve symptoms that are refractory to current treatments, such as freezing of gait. | NO | Parkinson Disease | BEHAVIORAL: Movement task | EEG recordings, EEG power in the beta band, baseline|BOLD fMRI: functional brain connectivity, Blood oxygen level dependent (BOLD) resting state network activity as a function of behavioral benefits from external cues, up to 4 weeks|Diffusion tractography imaging (MRI): structural brain connectivity, Diffusion tensor fractional anisotropy as a function of behavioral benefits from external cues, up to 4 weeks | null | null | University of California, Los Angeles | National Institute of Neurological Disorders and Stroke (NINDS) | ALL | ADULT, OLDER_ADULT | null | 90 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 19-002135|1K23NS119568 | 2022-07-06 | 2026-09 | 2026-09 | 2022-01-05 | null | 2023-12-18 | University of California Los Angeles, Los Angeles, California, 90095, United States | null | {
"Movement task": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT02385487 | Inflammation in Type 2 Myocardial Infarction | https://clinicaltrials.gov/study/NCT02385487 | null | WITHDRAWN | Type 2 myocardial infarction (MI) is defined as myocardial necrosis that results from an imbalance of myocardial oxygen supply and demand. Although type 2 MI is highly prevalent in patients with critical illness and strongly associated with mortality, the pathophysiology remains poorly understood. Inflammation is central to the development of atherosclerosis, plaque rupture, and other subtypes of MI, but the role of inflammation in type 2 MI and myocardial necrosis has not been defined. The investigators aim to to delineate the mechanistic role of inflammation in myocardial necrosis and type 2 MI complicating critical medical illness. | NO | Myocardial Infarction|Inflammation|Critical Illness | null | Leukocyte-platelet aggregates, Day 1 | Leukocyte-platelet aggregates, Participants will be followed for the duration of hospital stay, an expected average of 10 days., Day 10|Monocyte-platelet aggregates, Day 1|Monocyte-platelet aggregates, Participants will be followed for the duration of hospital stay, an expected average of 10 days., Day 10|Neutrophil-platelet aggregates, Day 1|Neutrophil-platelet aggregates, Participants will be followed for the duration of hospital stay, an expected average of 10 days., Day 10 | EndoPAT score, Day 1|EndoPAT score, Participants will be followed for the duration of hospital stay, an expected average of 10 days., Day 10|surface L-selectin, Day 1|surface L-selectin, Participants will be followed for the duration of hospital stay, an expected average of 10 days., Day 10|soluble L-selectin, Day 1|soluble L-selectin, Participants will be followed for the duration of hospital stay, an expected average of 10 days., Day 10|surface CD11b, Day 1|surface CD11b, Participants will be followed for the duration of hospital stay, an expected average of 10 days., Day 1 | NYU Langone Health | null | ALL | ADULT, OLDER_ADULT | null | 0 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | S14-01349 | 2015-03 | 2015-12 | 2016-03 | 2015-03-11 | null | 2015-07-03 | Bellevue Hospital Center, New York, New York, 10016, United States | null | {} |
NCT04703387 | Left Ventricular Diastolic Dysfunction as a Predictor of Weaning Failure From Mechanical Ventilation | https://clinicaltrials.gov/study/NCT04703387 | null | COMPLETED | Both premature and delayed extubation prolong the duration of mechanical ventilation and the intensive care unit (ICU) length of stay and increase morbidity and mortality. Therefore, accurate prediction of postextubation distress and the early diagnosis of the causes responsible for failure of a trial of pressure support ventilation are of paramount importance to improve the outcome of mechanically ventilated patients in the ICU.
This observational study is designed to test the ability of cardiac and diaphragm function assessed by bedside ultrasound to predict extubation failure within 48 h and re-intubation within 1 week after extubation. | NO | Left Ventricular Diastolic Dysfunction|Weaning Failure|Mechanical Ventilation Complication|Diaphragmatic Disorder | DIAGNOSTIC_TEST: transthoracic echocardiography | Weaning failure, Weaning failure predicted by diastolic dysfunction assessed by E/Ea., within 48 hours after extubation | Weaning failure, Weaning failure predicted by Diaphragmatic function assessment, within 48 hours after extubation | null | Tanta University | null | ALL | ADULT, OLDER_ADULT | null | 48 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 33855/6/20 | 2020-08-01 | 2022-12-31 | 2022-12-31 | 2021-01-11 | null | 2023-02-27 | Tanta University, Tanta, Gharbia, 31111, Egypt | null | {
"transthoracic echocardiography": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
]
} |
NCT00241787 | Progression of Sub-Clinical Atherosclerosis | https://clinicaltrials.gov/study/NCT00241787 | null | COMPLETED | To determine the rate of progression of sub-clinical cardiovascular disease as measured in carotid intimal medial thickness over a period of 8 to 10 years. | NO | Atherosclerosis|Cardiovascular Diseases|Heart Diseases|Carotid Artery Diseases | null | Cardiovascular Morbidity, Longitudinal follow-up of community based cohort, Longitudinal follow-up | null | null | Tufts Medical Center | National Heart, Lung, and Blood Institute (NHLBI) | ALL | ADULT, OLDER_ADULT | null | 2,900 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1314|R01HL081352 | 2005-09 | 2011-08 | 2011-08 | 2005-10-19 | null | 2015-12-02 | null | null | {} |
NCT05710887 | N2O for Acute Suicidality and Depression in the ED | https://clinicaltrials.gov/study/NCT05710887 | null | NOT_YET_RECRUITING | Investigators are conducting this double-blind, randomized control trial (RCT), to compare inhaled N2O+ treatment as usual (TAU) versus inhaled placebo+TAU; demonstrating the feasibility and tolerability of the intervention in an emergency department (ED) setting on an acutely suicidal population. | NO | Suicidal Ideation|Major Depressive Disorder|Treatment Resistant Depression | DRUG: Nitrous oxide gas for inhalation|DRUG: Placebo | Treatment Response Based on Changes in Computerized Adaptive Testing Scores, Monitor changes in Computerized Adaptive Testing Mental Health (CAT-MH) scores relating to suicide, depression, and anxiety; to determine whether a single 45-minute inhalation of nitrous oxide vs placebo reduces symptoms.
The CAT-MH is a validated self-reporting electronic diagnostic that adaptively selects a small optimal set of items from a large bank of approximately 1,500 items, targeted to individuals current or historical level of severity and likelihood of suicide , depression , and anxiety .
Generated scores include severity and liklihood percentile:
* suicide = (%) low, intermediate, high
* depression = (%) normal, mild, moderate, severe
* anxiety = (%) normal, mild, moderate, severe, Up to 24-hours from baseline | Treatment Compliance, Evaluate compliance of an acutely suicidal population in an Emergency Department (ED) setting, to complete a single 45-minute inhalation of nitrous oxide vs placebo.
Determined by ability , inability , or refusal to complete the entire 45-minute inhalation session (nitrous oxide vs placebo)., Intervention completion, 45-minutes|Treatment Response Correlation to Lifetime Predictors Associated with Suicide, Evaluate if lifetime predictors (e.g., personal/family history of suicide attempts or suicide, history of alcohol dependence, and worst lifetime suicidal ideation) of eventual suicide correlate with the acute reduction in symptom severity following treatment.
Lifetime predictors will be determined by medical and social history, and family history related to mental health.
Symptom reduction is determined by changes in CAT-MH scores, over 24-hours from baseline.
The CAT-MH is a validated self-reporting electronic diagnostic that adaptively selects a small optimal set of items from a large bank of approximately 1,500 items, targeted to individuals current or historical level of severity and likelihood of suicide , depression , and anxiety .
Generated scores include severity and liklihood percentile:
* suicide = (%) low, intermediate, high
* depression = (%) normal, mild, moderate, severe
* anxiety = (%) normal, mild, moderate, severe, Up to 24-hours from baseline|Rapid Treatment Response, Evaluate any acute reduction in symptoms.
Based on changes in CAT-MH scores (suicide, depression, anxiety) at 30-minutes to 1-hour following treatment. Study patients ability to complete self-administered CAT-MH following inhalation may impact time-point.
The CAT-MH is a validated self-reporting electronic diagnostic that adaptively selects a small optimal set of items from a large bank of approximately 1,500 items, targeted to individuals current or historical level of severity and likelihood of suicide , depression , and anxiety .
Generated scores include severity and liklihood percentile:
* suicide = (%) low, intermediate, high
* depression = (%) normal, mild, moderate, severe
* anxiety = (%) normal, mild, moderate, severe, At 30-minutes to 1-hour from intervention conclusion|Sustained Treatment Response, Evaluation of sustained response based on changes in CAT-MH scores at several time-points or until the patient is transferred or discharged from the ED.
The CAT-MH is a validated self-reporting electronic diagnostic that adaptively selects a small optimal set of items from a large bank of approximately 1,500 items, targeted to individuals current or historical level of severity and likelihood of suicide , depression , and anxiety .
Generated scores include severity and liklihood percentile:
* suicide = (%) low, intermediate, high
* depression = (%) normal, mild, moderate, severe
* anxiety = (%) normal, mild, moderate, severe, Up to 24-hours from intervention conclusion | Adverse Events, Monitor adverse events and severity associated with study participation, including nausea and vomiting; or other symptoms determined probably , possibly , unrelated , or related to the study intervention. This includes any unplanned escalation of care including pharmacological therapy for nausea, vomiting.
Study patient safety is monitored by the investigators (MD) with experience in critical care anesthesia, as well as an experienced clinical research team responsible for data collection and reporting of events., Through study completion, an average of 1-week | University of Chicago | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 50 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | IRB18-1083 | 2024-10-01 | 2025-10-01 | 2025-12-01 | 2023-02-02 | null | 2024-05-08 | University of Chicago Medicine, Chicago, Illinois, 60637, United States | null | {
"Nitrous oxide": [
{
"intervention_type": "DRUG",
"description": "Nitrous oxide gas for inhalation",
"name": "Nitrous oxide",
"synonyms": [
"Dinitrogen oxide",
"Nitrious oxide",
"Nitrous oxide",
"\u00f3xido nitroso",
"N2O"
],
"drugbank_id": "DB06690",
"generic_names": [
"Nitrous oxide"
]
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT04430387 | Dental Isolation Methods in Pediatric Patients | https://clinicaltrials.gov/study/NCT04430387 | null | WITHDRAWN | The purpose of this study is to collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry, to compare the effectiveness of aerosol reduction between these methods, to identify the most effective way to manage aerosol during dental prophylaxis for pediatric patients and to provide clinical evidence to facilitate practice guidelines in dentistry related to COVID-19. | NO | Dental Plaque|Calculus, Dental|Aerosol Disease | DEVICE: The saliva ejector|DEVICE: The high-volume evacuator|DEVICE: The DryShield | To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry, The image of the spots of fluorescence from the spatter collected will be captured using a digital camera (Nikon D3100, Nikon, Tokyo, Japan) with an amber-colored lens cover. The image will be processed by a digital imaging software, ImageJ (National Institutes of Health, the Laboratory for Optical and Computational Instrumentation, University of Wisconsin) to get the number of the spots on each mask and film. The number of fluorescent spots is recorded to determine the amount of spatter produced., Through case completion, an average a year | null | null | The University of Texas Health Science Center, Houston | null | ALL | CHILD | null | 0 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | HSC-DB-20-0381 | 2021-11-01 | 2022-11 | 2022-11 | 2020-06-12 | null | 2021-10-29 | null | null | {
"The saliva ejector": [
{
"intervention_type": "DEVICE"
}
],
"The high-volume evacuator": [
{
"intervention_type": "DEVICE"
}
],
"The DryShield": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT00629187 | Safety Study of High Dose Temozolomide to Treat Relapsed/Refractory Central Nervous System (CNS) Malignancy | https://clinicaltrials.gov/study/NCT00629187 | CN-306 | TERMINATED | The goal of this study is to find the maximum dose of a drug, temozolomide, that can safely be given to subjects with brain tumors. Past studies showed that the maximum dose of temozolomide was limited by low blood counts. The investigators will use blood stem cells collected from bone marrow to help subjects recover their blood counts, a procedure called autologous stem cell transplant or stem cell rescue. This way, the investigators expect to be able to safely deliver very high doses of temozolomide. This study is only available at Tufts Medical Center. | NO | Central Nervous System Neoplasms|Neoplasm Metastasis | DRUG: Temozolomide | Determine the maximum tolerated dose of temozolomide with hematopoietic stem cell rescue in patients with recurrent CNS malignancy, 5 years | Estimate the response rate, response duration and survival according to established response definitions, 5 years|Determine the pharmacokinetics of high daily dosing of temozolomide in the transplant setting, 5 years | null | Tufts Medical Center | null | ALL | ADULT, OLDER_ADULT | PHASE1 | 2 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | CN-306 | 2004-04 | 2012-04 | 2012-04 | 2008-03-05 | null | 2012-04-27 | Tufts Medical Center, Boston, Massachusetts, 02111, United States | null | {
"Temozolomide": [
{
"intervention_type": "DRUG",
"description": "Temozolomide",
"name": "Temozolomide",
"synonyms": [
"Temozolomide",
"Temodar",
"Methazolastone",
"3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-as-tetrazine-8-carboxamide",
"Temozolomida",
"CCRG 81045",
"Temozolomidum",
"Temcad",
"TMZA-HE",
"3-methyl-4-oxo-3,4-dihydroimidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide",
"8-Carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3H)-one",
"B-39831",
"Temozolodida",
"3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-1,2,3,5-tetrazine-8-carboxamide",
"(S)-perillyl alcohol temozolomide",
"T\u00e9mozolomide",
"TMZ",
"Temodal",
"Temozolomid",
"8-carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3H)-one"
],
"medline_plus_id": "a613002",
"generic_names": [
"Temozolomide"
],
"mesh_id": "D018906",
"drugbank_id": "DB00853",
"wikipedia_url": "https://en.wikipedia.org/wiki/Temozolomide"
}
]
} |
NCT02579187 | MicroRNA and MicroRNA Inhibitors Socket Study, Pilot Clinical Trial | https://clinicaltrials.gov/study/NCT02579187 | null | WITHDRAWN | To evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAs, and/or microRNA inhibitors, in the promotion of osteogenesis and modulation of the inflammatory response on the basis of different clinical, radiographic, histologic and biomolecular outcomes in post-extraction socket defects in humans. | NO | Tooth Extraction Status Nos | PROCEDURE: tooth extraction|RADIATION: CBCT scan|DRUG: Anesthesia|OTHER: clinical measurements|DRUG: Biodegradable sponge (type I bovine collagen)|DRUG: 10µg of pSil-miR200c|PROCEDURE: cross mattress suture|DRUG: 10µg of PMIS miR200a plasmids|DRUG: 5µg of pSil-miR200c and 5µg of PMIS miR200a|PROCEDURE: Blood|OTHER: Photos/videos|PROCEDURE: Wound fluid|PROCEDURE: saliva|RADIATION: periapical xray|OTHER: PVS impression | Percent of mineralized tissue upon histomorphometric analysis of bone core biopsies, compared using exact Wilcoxon rank sum tests, at 16 weeks postoperatively | Bucco-lingual width changes of the alveolar ridge (in mm), Fisher s exact tests will be used to compare the treatment groups, up to 16 weeks postoperatively|Mid-buccal height changes of the alveolar ridge (in mm), compared using exact Wilcoxon rank sum tests, up to 16 weeks postoperatively|Mid-lingual height changes of the alveolar ridge (in mm), compared using exact Wilcoxon rank sum tests, up to 16 weeks postoperatively|Volumetric reduction of the alveolar ridge (in cc) via CBCT scan analyses, compared using exact Wilcoxon rank sum tests, at 16 weeks postoperatively|Expression of different biomarkers (VEGF, PDGF, TGF-b, IL-1b, TNF-a) in wound fluid expressed in pg/ml, compared using exact Wilcoxon rank sum tests, up to 4 weeks postoperatively | null | Gustavo Avila-Ortiz DDS, MS, PhD | null | ALL | ADULT, OLDER_ADULT | PHASE1 | 0 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH | 201607780 | 2025-12-31 | 2030-09 | 2030-09 | 2015-10-19 | null | 2019-07-17 | UIowa, Iowa City, Iowa, 52242, United States | null | {
"tooth extraction": [
{
"intervention_type": "PROCEDURE"
}
],
"CBCT scan": [
{
"intervention_type": "RADIATION"
}
],
"Anesthesia": [
{
"intervention_type": "DRUG"
}
],
"clinical measurements": [
{
"intervention_type": "OTHER"
}
],
"Biodegradable sponge (type I bovine collagen)": [
{
"intervention_type": "DRUG"
}
],
"10\u00b5g of pSil-miR200c": [
{
"intervention_type": "DRUG"
}
],
"cross mattress suture": [
{
"intervention_type": "PROCEDURE"
}
],
"10\u00b5g of PMIS miR200a plasmids": [
{
"intervention_type": "DRUG"
}
],
"5\u00b5g of pSil-miR200c and 5\u00b5g of PMIS miR200a": [
{
"intervention_type": "DRUG"
}
],
"Blood": [
{
"intervention_type": "PROCEDURE"
}
],
"Photos/videos": [
{
"intervention_type": "OTHER"
}
],
"Wound fluid": [
{
"intervention_type": "PROCEDURE"
}
],
"saliva": [
{
"intervention_type": "PROCEDURE"
}
],
"periapical xray": [
{
"intervention_type": "RADIATION"
}
],
"PVS impression": [
{
"intervention_type": "OTHER"
}
]
} |
NCT00587587 | A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids | https://clinicaltrials.gov/study/NCT00587587 | null | COMPLETED | This pilot study will assess the safety and efficacy of Apligraf in the healing and recurrence of keloids post surgical shave excision in patients with clinically diagnosed keloids. | YES | Keloid | DEVICE: Apligraf|OTHER: Standard dressing regimen | The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented., Summary of all reported adverse events (AE) in the intent to treat (ITT) population.
AE was defined as any adverse change in the subject s medical status compared with the subject s baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject s pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study., 52 weeks | Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS), Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported.
BSS is a composite score where the individual scores from the following categories are summed:
Color (rated 1[perfect]-4[gross mismatch]), Shine (1/Matte or 2/Shiny), Contour (rated 1[flush with surrounding skin]-4[keloid]), Distortion (rated 1[None]-4[severe]), Texture (rated 1[normal]-4[hard]), and Overall Assessment on a 10cm visual analog scale (rated 0[excellent scar]-10 [poor scar]).
Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar)., Baseline to Week 52 or Last Visit|Cumulative Incidence of Keloid Recurrence at Week 52, Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome., 52 weeks|Degree of Recurrence (Scar Firmness), Scar firmness measured by Cutometer in millimeters., Week 52 or Last Visit|Degree of Recurrence (Scar Thickness), Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin., Week 52 or Last visit|Physician Global Assessment, Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor), Week 52 or Last Visit|Subject Global Assessment, Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor), Week 52 or Last Visit|Decreased Utilization of Intralesional Steroid Intervention, The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome., 52 weeks | null | Organogenesis | null | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 30 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 06-KEL-001-AG | 2007-12 | 2010-03 | 2010-03 | 2008-01-07 | 2011-08-19 | 2011-08-19 | University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology, Miami Beach, Florida, 33140, United States | null | {
"Apligraf": [
{
"intervention_type": "DEVICE"
}
],
"Standard dressing regimen": [
{
"intervention_type": "OTHER"
}
]
} |
NCT03580187 | Nebulized Morphine in Chest Trauma Patients: A Prospective Study | https://clinicaltrials.gov/study/NCT03580187 | null | COMPLETED | This is a prospective study carried out from 2018 to 2020 including patients aged ≥ 18 years, admitted for isolated chest trauma. Each patient received a nebulization of 10 mg morphine. If Visual Analog Score (VAS) assessed after 10 minutes still> 4, nebulization was repeated every 10 minutes until pain relief. At 30 minutes, VAS> 4 means failure. | NO | Blunt Injury of Thorax | DRUG: Morphine (+) | analgesia evaluated with visual scale, morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization, 30 minuts | null | null | University Hospital, Mahdia | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 75 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | NMCT/1 | 2018-06-14 | 2020-04-15 | 2020-04-15 | 2018-07-09 | null | 2022-09-23 | Mahdia Hospital, Mahdia, 5180, Tunisia | null | {
"Morphine": [
{
"intervention_type": "DRUG",
"description": "Morphine (+)",
"name": "Morphine",
"synonyms": [
"Anhydrous morphine",
"Morphium",
"MXL",
"Morphine Chloride",
"SDZ 202250",
"Arymo",
"Morphin",
"(5\u03b1,6\u03b1)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol",
"Contin, MS",
"Morfina",
"SDZ 202 250",
"(5R,6S,9R,13S,14R)-4,5-epoxy-N-methyl-7-morphinen-3,6-diol",
"(7R,7AS,12bs)-3-methyl-2,3,4,4a,7,7a-hexahydro-1H-4,12-methano[1]benzofuro[3,2-e]isoquinoline-7,9-diol",
"(5\u03b1,6\u03b1)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol",
"Sevredol",
"Oramorph",
"SDZ202-250",
"Morphine Sulfate (2:1), Anhydrous",
"Chloride, Morphine",
"Morphine",
"Roxanol-T",
"Morphgesic",
"Oramorph SR",
"Morphine Sulfate",
"Morphia",
"Astramorph",
"Zomorph",
"(5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol",
"Infumorph",
"MS Contin",
"Sulfate, Morphine",
"Morphine Sulfate (2:1), Pentahydrate",
"Morphinum",
"RMS",
"MST",
"Kadian",
"Duramorph",
"SDZ 202-250",
"SDZ202250",
"SDZ202 250",
"(5alpha,6alpha)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol",
"(\u2212)-morphine"
],
"medline_plus_id": "a606006",
"generic_names": [
"Morphine"
],
"nhs_url": "https://www.nhs.uk/medicines/morphine",
"mesh_id": "D009294",
"drugbank_id": "DB00295"
}
]
} |
NCT05514587 | Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC) | https://clinicaltrials.gov/study/NCT05514587 | MSVCAC | COMPLETED | Suicide is the highest mortality risk in psychiatry and about the only life-threatening risk associated with the evolution of mental illness. Worldwide, more than 800,000 people die by suicide each year. Although the number of deaths by suicide has decreased in France (from 11,000 in the 1990s to 9,000 today), suicide is still a major public health problem (the French rate is one of the highest in Europe).
The World Health Organisation (WHO) has declared a state of emergency and is pushing each country to develop a global multisectoral strategy for effective suicide prevention. To this end, suicide risk assessment tools have been developed for predictive purposes. However, diagnosis remains difficult and the risk of recidivism remains the fear of the psychiatrist. Questioning the subjects about their vision of their existence and the meaning they give to their life would perhaps help to better understand the psychology of the suicidal person. In recent decades, there has been research on meaning and suicide, and more recently a few studies have attempted to quantitatively investigate meaning as a protective factor. More recently, the COVID epidemic has brought the issue of meaning and suicide prevention to the forefront. | NO | Suicide|Mental Suffering|Meaning of Life|Questionnaire | BEHAVIORAL: Meaning of Life Questionnaire (MLQ) | Psychometric validation of the French translation of Steger s Meaning in Life Questionnaire (MLQ) in adult patients admitted to the Crisis Centre (CAC), The Meaning of Life Questionnaire (MLQ) measures the presence of meaning in life, that is the subjective sense that one s life is meaningful, and the search for meaning in life, reflecting one s drive and orientation toward finding such meaning., 3 months | Convergent validity of MLQ with Beck s hopelessness scale (BHS) in adult patients admitted to the Crisis Centre (CAC), Beck s hopelessness scale (BHS) : 20 items, self-report scale, assesses current mental state with regard to thoughts about the future, motivation and expectations., 3 months|Convergent validity of MLQ with Beck Suicide Intent Scale (BSI) in adult patients admitted to the Crisis Centre (CAC), Beck Suicide Intent Scale (BSI): 20 items, assesses suicidal intent of the most recent episode of self-harm, 3 months|Convergent validity of MLQ with Satisfaction with Life Scale (SWLS) in adult patients admitted to the Crisis Centre (CAC), The Satisfaction with Life Scale (SWLS) is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one s life. The scale usually requires only about one minute of a respondent s time., 3 months|Convergent validity of MLQ with Satisfaction with Beck Depression Inventory Short Form (BDI-SF) in adult patients admitted to the Crisis Centre (CAC), The Beck Depression Inventory Short Form (BDI-SF, BDI-13) consists of 13 items assessing the severity of depression symptoms., 3 months | null | Centre Hospitalier Régional Metz-Thionville | null | ALL | ADULT, OLDER_ADULT | null | 119 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2022-01Obs-CHRMT | 2022-09-29 | 2023-06-15 | 2023-09-15 | 2022-08-24 | null | 2023-11-07 | Centre Hospitalier Jury, Metz, 57073, France|CHR Metz-Thionville/Hopital de Mercy, Metz, 57085, France | null | {
"Meaning of Life Questionnaire (MLQ)": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT06366087 | Sublingual Atropine Bioequivalence by Route of Administration (SABER) | https://clinicaltrials.gov/study/NCT06366087 | SABER | NOT_YET_RECRUITING | A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult volunteers. | NO | Atropine Bioequivalence | DRUG: Atropine Sulfate Ophthalmic Solution USP, 1%|DRUG: Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL) | The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to infinity (AUCinf)., Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and route using noncompartmental analysis (NCA) methods. AUCinf is summarized by route of administration as the geometric mean and coefficient of variation of the geometric mean for all evaluable participants and expressed as min*ng/mL. Geometric ratios of least-square means and associated 90% confidence intervals are reported from a linear mixed model. Bioequivalence will be considered met if the 90% CI of the ratio for AUCinf lies within 80.00 to 125.00%., Pre-dose through 8 hours post-dose at Days 1 and 8|The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to time of last quantifiable data point (AUCt)., Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and route using noncompartmental analysis (NCA) methods. AUCt is summarized by route of administration as the geometric mean and coefficient of variation of the geometric mean for all evaluable participants and expressed as min*ng/mL. Geometric ratios of least-square means and associated 90% confidence intervals are reported from a linear mixed model. Bioequivalence will be considered met if the 90% CI of the ratio for AUCt lies within 80.00 to 125.00%., Pre-dose through 8 hours post-dose at Days 1 and 8 | The relative bioavailability of atropine sulfate administered SL versus IM as measured by area under the analyte concentration versus time curve to time 45, 60, 90, 120, 150, and 240 minutes (AUC45, AUC60, AUC90, AUC120, AUC150, and AUC240, respectively), Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and period using noncompartmental analysis (NCA) methods.
AUC45, AUC60, AUC90, AUC120, AUC150, and AUC240 are summarized by route of administration as the geometric mean and coefficient of variation for the geometric mean for all evaluable participants expressed as min*ng/mL. Geometric ratios of least-square means and associated 90% confidence intervals are reported from a linear mixed model., Pre-dose through 8 hours post-dose at Days 1 and 8|The relative bioavailability of atropine sulfate administered SL versus IM as measured by maximum measured plasma concentration (Cmax), Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and period using noncompartmental analysis (NCA) methods. C_max is summarized by route of administration as the geometric mean and coefficient of variation of the geometric mean for all evaluable participants and expressed as ng/mL. Geometric ratios of least-square means and associated 90% confidence intervals are reported from a linear mixed model., Pre-dose through 8 hours post-dose at Days 1 and 8|The relative bioavailability of atropine sulfate administered SL versus IM as measured by time to Cmax (tmax), Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and period using noncompartmental analysis (NCA) methods. t_max is summarized by route of administration as the mean and standard deviation for all evaluable participants and expressed as minutes., Pre-dose through 8 hours post-dose at Days 1 and 8|The relative bioavailability of atropine sulfate administered SL versus IM as measured by apparent terminal elimination half-life (t1/2), Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and period using noncompartmental analysis (NCA) methods. t_1/2 is summarized by route of administration as the mean and standard deviation for all evaluable participants and expressed as minutes., Pre-dose through 8 hours post-dose at Days 1 and 8|The relative bioavailability of atropine sulfate administered SL versus IM as measured by terminal elimination rate constant (λz), Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and period using noncompartmental analysis (NCA) methods. λz is summarized by route of administration as the mean and standard deviation for all evaluable participants and expressed as 1/sec., Pre-dose through 8 hours post-dose at Days 1 and 8|The relative bioavailability of atropine sulfate administered SL versus IM as measured by volume of distribution (Vd/F), Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and period using noncompartmental analysis (NCA) methods. V_d/F is summarized by route of administration as the mean and standard deviation for all evaluable participants and expressed as liters., Pre-dose through 8 hours post-dose at Days 1 and 8|The relative bioavailability of atropine sulfate administered SL versus IM as measured by total body clearance (CL/F), Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and period using noncompartmental analysis (NCA) methods. CL/F is summarized by route of administration as the mean and standard deviation for all evaluable participants and expressed as mL/min., Pre-dose through 8 hours post-dose at Days 1 and 8|The relative bioavailability of atropine sulfate administered SL versus IM as measured by absorption rate constant (Ka), Blood samples to measure atropine plasma concentrations were collected during each dosing visit at the following time points: time 0 (predose), and postdose at 5, 10, 15, 20, 30, 45, 60, and 90 minutes, and 2, 2.5, 4, 6, and 8 hours. PK parameters were estimated for each subject and period using noncompartmental analysis (NCA) methods. Ka is summarized by route of administration as the mean and standard deviation for all evaluable participants and expressed 1/sec., Pre-dose through 8 hours post-dose at Days 1 and 8 | null | Biomedical Advanced Research and Development Authority | Rho Federal Systems Division, Inc.|Allucent | ALL | ADULT, OLDER_ADULT | PHASE1 | 46 | FED | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT | BP-C-24-001 | 2024-04-15 | 2024-05-24 | 2024-05-24 | 2024-04-15 | null | 2024-04-15 | Johnson County Clin-Trials (JCCT), Lenexa, Kansas, 66219, United States | null | {
"Atropine": [
{
"intervention_type": "DRUG",
"description": "Atropine Sulfate Ophthalmic Solution USP, 1%",
"name": "Atropine",
"synonyms": [
"Atropina",
"Augen\u00f6l, Atropin",
"Atropin Augen\u00f6l",
"(\u00b1)-atropine",
"Atropine Sulfate",
"Atropinol",
"Sulfate Anhydrous, Atropine",
"(\u00b1)-hyoscyamine",
"Atropinum",
"Atropine Care 1%",
"Atropine",
"Atropine Sulfate Anhydrous",
"dl-Hyoscyamine",
"dl-tropyltropate",
"Isopto",
"Tropine tropate",
"Anhydrous, Atropine Sulfate",
"Atropin",
"Sulfate, Atropine",
"AtroPen"
],
"medline_plus_id": "a682487",
"generic_names": [
"Atropine"
],
"mesh_id": "D018727",
"drugbank_id": "DB00572"
},
{
"intervention_type": "DRUG",
"description": "Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL)",
"name": "Atropine",
"synonyms": [
"Atropina",
"Augen\u00f6l, Atropin",
"Atropin Augen\u00f6l",
"(\u00b1)-atropine",
"Atropine Sulfate",
"Atropinol",
"Sulfate Anhydrous, Atropine",
"(\u00b1)-hyoscyamine",
"Atropinum",
"Atropine Care 1%",
"Atropine",
"Atropine Sulfate Anhydrous",
"dl-Hyoscyamine",
"dl-tropyltropate",
"Isopto",
"Tropine tropate",
"Anhydrous, Atropine Sulfate",
"Atropin",
"Sulfate, Atropine",
"AtroPen"
],
"medline_plus_id": "a682487",
"generic_names": [
"Atropine"
],
"mesh_id": "D018727",
"drugbank_id": "DB00572"
}
],
"Ranitidine": [
{
"intervention_type": "DRUG",
"description": "Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL)",
"name": "Ranitidine",
"synonyms": [
"Ranitidine",
"USP",
"Sostril",
"url=https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=379425",
"Hydrochloride, Ranitidine",
"Zantic",
"Tritec",
"date=28 June 2018",
"Ranisen",
"Zantac",
"access-date=18 February 2021}}</ref>",
"Ranitidina",
"<ref name="Zantac FDA label">{{cite web",
"Ranitidinum",
"Biotidin",
"Ranitidin",
"N (2-(((5-((Dimethylamino)methyl)-2-furanyl)methyl)thio)ethyl)-N'-methyl-2-nitro-1,1-ethenediamine",
"title=Zantac 150 (ranitidine hydrochloride) Tablets",
"AH-19065",
"AH 19065",
"USP Zantac 300 (ranitidine hydrochloride) Tablets",
"Ranitidine Hydrochloride",
"AH19065",
"website=DailyMed",
"Pylorid",
"Tritec",
"Ranitidine bismuth citrate",
"Pylorid",
"Tritec",
"Ranitidine bismuth citrate"
],
"medline_plus_id": "a601164",
"generic_names": [
"Ranitidine"
],
"nhs_url": "https://www.nhs.uk/medicines/ranitidine",
"mesh_id": "D006635",
"drugbank_id": "DB00863",
"wikipedia_url": "https://en.wikipedia.org/wiki/Ranitidine"
}
]
} |
NCT03060187 | Proposal and Clinical Evaluation of a Comprehensive Airway Exam Score | https://clinicaltrials.gov/study/NCT03060187 | null | COMPLETED | The purpose of this observational study is to evaluate the usefulness of Kansas University airway exam score ( KU score ) in predicting difficulty of placement of a breathing tube into the windpipe. | NO | Intubation | OTHER: KU Score | Correlation between KU score and intubation difficulty scale (IDS) measure, The measure is assessed during the time period between the start of preoperative examination on the day of surgery and completion of a standard tracheal intubation in the operating room. Correlation measured using the Spearman correlation coefficient., Time between preoperative exam to after intubation, up to 3 hours | null | null | University of Kansas Medical Center | null | ALL | ADULT, OLDER_ADULT | null | 2,000 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 12093 | 2010-02 | 2011-01 | 2011-01 | 2017-02-23 | null | 2017-02-23 | University of Kansas Medical Center, Kansas City, Kansas, 66160, United States | null | {
"KU Score": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01078987 | Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) | https://clinicaltrials.gov/study/NCT01078987 | NFD | TERMINATED | The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF). | NO | Nephrogenic Fibrosing Dermopathy|Nephrogenic Systemic Fibrosis | PROCEDURE: Plasmapheresis | Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin, Assessed two weeks after each monthly course of plasmapheresis | null | null | Loma Linda University | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 12 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 51018 | 2002-02 | 2012-03 | 2012-03 | 2010-03-02 | null | 2014-11-21 | Loma Linda University Medical Center, Loma Linda, California, 92354, United States | null | {
"Plasmapheresis": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT05362487 | Assessment of Health-related Quality of Life After Switching COPD Patients From a Dry Powder Inhaler to a Soft Mist Inhaler Remaining on the Same Inhalative Drug | https://clinicaltrials.gov/study/NCT05362487 | NIS PIRATE | TERMINATED | The objective of this non-interventional, observational study is to assess whether changing Chronic Obstructive Pulmonary Disease (COPD) patients from a dry powder inhaler (HandiHaler®) to a soft mist inhaler (Respimat®), without changing the pharmacological compound, will lead to an improvement in Clinical COPD Questionnaire (CCQ) score and in the scores of the three subdomains of CCQ score: symptoms (4 items), functional state (4 items) and mental state (2 items) during a study period of approximately 8 weeks. | NO | Pulmonary Disease, Chronic Obstructive | DEVICE: Spiriva® Respimat®|DEVICE: Spiriva® HandiHaler®|DRUG: Tiotropium bromide | 0.2 points decrease in the Clinical COPD Questionnaire (CCQ) score between baseline and visit 2 in patients with high CCQ baseline score (≥ 2), The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3); very instable-very severe limited (CCQ ≥ 3)., At baseline and up to 8 weeks (visit 2) from baseline. | 0.2 points decrease in the CCQ score between baseline and visit 2 in patients independently from CCQ baseline score, The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3); very instable-very severe limited (CCQ ≥ 3)., At baseline and up to 8 weeks (visit 2) from baseline.|Changes in clinical control: Mean change in the CCQ score and in the scores of the 3 CCQ subdomains symptom, mental state, and functional state domain, in all patients independently from CCQ baseline score, The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The symptom score is calculation of the sum of the 4 items (items 1, 2, 5, 6) divided by 4. The mental state score is a calculation of the sum of the 2 items (items 3, 4) divided by 2. The functional state score is a calculation of the sum of the 4 items (items 7, 8, 9, 10) divided by 4. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3);very instable-very severe limited (CCQ ≥ 3)., At baseline and up to 8 weeks from baseline.|Changes in clinical control: Mean change in the CCQ score and in the scores of the 3 CCQ subdomains symptom, mental state, and functional state domain, in patients with high CCQ baseline score (≥ 2), The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The symptom score is calculation of the sum of the 4 items (items 1, 2, 5, 6) divided by 4. The mental state score is a calculation of the sum of the 2 items (items 3, 4) divided by 2. The functional state score is a calculation of the sum of the 4 items (items 7, 8, 9, 10) divided by 4. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3);very instable-very severe limited (CCQ ≥ 3)., At baseline and up to 8 weeks from baseline.|Breathlessness of the patients, This outcome will be assessed using the Modified Medical Research Council (mMRC) Questionnaire for Assessing the Severity of Breathlessness which contains one question scored by the patient on a 5-point scale between 0 and 4, with higher scores indicating severe breathlessness., At baseline and up to 8 weeks from baseline.|Changes in breathlessness of the patients, This outcome will be assessed using the Modified Medical Research Council (mMRC) Questionnaire for Assessing the Severity of Breathlessness which contains one question scored by the patient on a 5-point scale between 0 and 4, with higher scores indicating severe breathlessness., At baseline and up to 8 weeks from baseline. | null | Boehringer Ingelheim | null | ALL | ADULT, OLDER_ADULT | null | 7 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | 0205-0549 | 2022-08-05 | 2023-01-18 | 2023-01-18 | 2022-05-05 | null | 2023-02-10 | Cantonal Hosp. Baselland,Univ.Med.Dept,Liestal, Liestal, 4410, Switzerland | null | {
"Spiriva\u00ae Respimat\u00ae": [
{
"intervention_type": "DEVICE"
}
],
"Spiriva\u00ae HandiHaler\u00ae": [
{
"intervention_type": "DEVICE"
}
],
"Tiotropium bromide": [
{
"intervention_type": "DRUG",
"description": "Tiotropium bromide",
"name": "Tiotropium bromide",
"synonyms": [
"Spiriva",
"Tiotropium bromide"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Tiotropium%20bromide",
"generic_names": []
}
]
} |
NCT01975987 | Characteristics to Predict Successful Intubation With the Bonfils Fiberscope | https://clinicaltrials.gov/study/NCT01975987 | null | COMPLETED | This study is designed to identify patients features predictive of successful intubation using the Bonfils fiberscope.
Our hypothesis is that some patients characteristics are predictors of successful intubation with the Bonfils fiberscope. | NO | Endotracheal Intubation | DEVICE: Bonfils fiberscope | Morphologic and morphometric predictors of successful tracheal intubation with the Bonfils fiberscope, This study will correlate patients morphometric and morphologic characteristics with the number of attempts and time needed for intubation using the Bonfils fiberscope., Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes | Time to successful intubation, Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes|Number of attempts to successful intubation, Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes|Score on the Intubation Difficulty Scale, To calculate the Intubation Difficulty Score the following variables will be collected: number of attempts, number of operators, necessity to use an alternative intubation technique, glottic visualization and effort needed to obtain optimal view of the glottis, necessity of external laryngeal pressure and vocal cords position during intubation., Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes | null | Centre hospitalier de l Université de Montréal (CHUM) | null | ALL | ADULT, OLDER_ADULT | null | 400 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | 13.182 | 2014-01 | 2014-07 | 2014-07 | 2013-11-05 | null | 2014-07-18 | Centre Hospitalier de l Université de Montréal (CHUM), Montreal, Quebec, H2L 4M1, Canada | null | {
"Bonfils fiberscope": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT05974787 | Potential Improvements in the Pre-emergency Department Care for Cancer Patients | https://clinicaltrials.gov/study/NCT05974787 | OVERSEE-I | RECRUITING | The goal of this single center prospective cross-sectional study is to identify the facilitators and barriers in the course of the disease that starts when symptoms first arise until patients with solid and hematologic malignancies arrive in the emergency department (ED). The main question it aims to answer are: Is there a potential relation between the lag-time and the ED length of stay (LOS) and the chance of admission. Participants will be asked to participate in a one-time interview, that focusses on the pre-admission process. | NO | Cancer|Emergencies | BEHAVIORAL: Emergency department cancer patients interview | Clusters of facilitators experienced by cancer patients., Different (sub)clusters of facilitators experienced by cancer patients visiting the emergency department (ED), Through study completion, an average of 6 months|clusters of barriers experienced by cancer patients., Different (sub)clusters of barriers experienced by cancer patients visiting the ED, Through study completion, an average of 6 months | Time-to-speak, The time between the first notice of symptoms and the first time these complaints were spoken out to the primary giver, Through study completion, an average of 6 months|Time-to-contact, The time between the first time complaints are spoken out and contact is made with a healthcare professional, Through study completion, an average of 6 months|Time-to-present, The time between the first contact with a healthcare professional and the presentation at the ED, Through study completion, an average of 6 months|Difference in group average lag-time between day, evening and night, Difference in group average lag-time between day, evening and night, Through study completion, an average of 6 months|Difference in group average lag-time between weekdays (Monday 08:00 till Friday 23:59) and weekend (Saturday 00:00 and Monday 7:59), Difference in group average lag-time between weekdays (Monday 08:00 till Friday 23:59) and weekend (Saturday 00:00 and Monday 7:59), Through study completion, an average of 6 months|Correlation between number of contacted healthcare providers before presentation at the ED and the lag- time., Correlation between number of contacted healthcare providers before presentation at the ED and the lag- time., Through study completion, an average of 6 months|Willingness to participate, the percentage of people that participated in this study in comparison to the people approached for this study., Through study completion, an average of 6 months|Lag-time, The time between the first onset of symptoms and a visit to the ED., Through study completion, an average of 6 months|ED length of stay (LOS), The time a patient spends in the ED, Through study completion, an average of 6 months|Disposition, The outcome of a visit to the ED, being either admission or home, Through study completion, an average of 6 months|Patient characteristics, Age, sex, type of cancer, type of complaint, triage category, number of prior visits, Through study completion, an average of 6 months|Correlation between lag-time and ED-LOS, Correlation between lag-time and ED-LOS, Through study completion, an average of 6 months|Correlation between lag-time and disposition, Correlation between lag-time and disposition, Through study completion, an average of 6 months|Correlation between lag-time and patient characteristics, Correlation between lag-time and patient characteristics, Through study completion, an average of 6 months|ED crowding, Measure of business of the ED, composed of the number of patients in the ED and the color coding used for crowding, Through study completion, an average of 6 months | null | Erasmus Medical Center | null | ALL | ADULT, OLDER_ADULT | null | 75 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 10841 | 2024-01-29 | 2024-05-01 | 2024-07-01 | 2023-08-03 | null | 2024-02-05 | Erasmus MC, Rotterdam, Zuid-Holland, 3015GD, Netherlands | null | {
"Emergency department cancer patients interview": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT05813587 | To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19 | https://clinicaltrials.gov/study/NCT05813587 | null | COMPLETED | This trial was a randomized, double-blind, placebo-controlled, loading phase III clinical study. | NO | Post-COVID-19 | BIOLOGICAL: Meplazumab for injection|OTHER: Normal saline | During the trial (28 days), the duration/degree of relief/recovery of four types of clinical symptoms of Post-COVID-19, The clinical symptoms of Post-COVID-19 mainly involved the nervous system and physical ability (insomnia, memory loss, olfactory changes, taste changes, fatigue or fatigue, headache, chest pain, muscle/joint pain), respiratory system (shortness of breath, cough), cardiovascular system (palpitation, arrhythmia), and aggravation of primary diseases. Clinical symptoms/restore definition: new crown sequela comprehensive score decline, and continue for at least 2 days. Patients with the above symptoms were evaluated according to the actual clinical symptoms, and the clinical symptoms that did not appear were evaluated as 0 (none) , Day28 | null | null | Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 121 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | MPZ-III-02 | 2023-03-23 | 2023-09-14 | 2023-10-26 | 2023-04-14 | null | 2024-05-28 | First Affiliated Hospital of the Air Force Medical University, Xi an, China | null | {
"Meplazumab": [
{
"intervention_type": "BIOLOGICAL",
"description": "Meplazumab for injection",
"name": "Meplazumab",
"synonyms": [
"",
"Meplazumab"
],
"drugbank_id": "DB16465",
"generic_names": [
"Meplazumab"
]
}
],
"Normal saline": [
{
"intervention_type": "OTHER"
}
]
} |
NCT02141087 | Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone | https://clinicaltrials.gov/study/NCT02141087 | null | APPROVED_FOR_MARKETING | This is an open label multi-center program to allow patients in the US with IPF access to treatment with pirfenidone. | NO | Idiopathic Pulmonary Fibrosis | DRUG: Pirfenidone | null | null | null | Genentech, Inc. | null | ALL | ADULT, OLDER_ADULT | null | null | INDUSTRY | EXPANDED_ACCESS | null | PIPF-031 | null | null | null | 2014-05-19 | null | 2015-07-13 | null | null | {
"Pirfenidone": [
{
"intervention_type": "DRUG",
"description": "Pirfenidone",
"name": "Pirfenidone",
"synonyms": [
"Etuary",
"Esbriet",
"Pirfenidona",
"Pirespa",
"Pirfenidone"
],
"medline_plus_id": "a615008",
"generic_names": [
"Pirfenidone"
],
"drugbank_id": "DB04951",
"wikipedia_url": "https://en.wikipedia.org/wiki/Pirfenidone"
}
]
} |