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NCT05391373

Effect of Laughter Therapy on Perceived Stress and Quality of Life

https://clinicaltrials.gov/study/NCT05391373

COMPLETED

Breast cancer is the most common type of cancer seen in women worldwide and ranks first. Chemotherapy is one of the commonly used methods of treatment in breast cancer. Physiological and psychological symptoms that occur due to chemotherapy treatment affect women negatively and reduce their quality of life. For this reason, there is a need for an intervention that could decrease psychological symptoms such as stress and improve quality of life in women with breast cancer. In the literature, it is stated that laughter therapy which is one of the non-pharmacological methods, can be an effective nursing intervention to decrease stress and improve the quality of life in women with breast cancer.

NO

Laughter Therapy

BEHAVIORAL: Laughter therapy

Perceived Stress Scale, The scale consists of 14 items in total and was designed to measure how stressful the changing situations in the individual s life are perceived.The scale is a 5-point Likert-type scale with each item ranging from never (0) to very often (4) . 7 of the scale items with positive expressions are scored in reverse and the total score that can be obtained from the scale ranges from 0 to 56. Eskin et al. performed the validity and reliability study of the Turkish version of Perceived Stress Scale and the internal consistency of the scale was determined to be 0.82., The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.

Quality of Life Scale (SF-12), The scale evaluates the quality of life of individuals.The scale consists of 12 items and two sub-dimensions in total.While the items related to physical and emotional role were answered as yes or no, the other items had likert type options ranging between 3 and 6. While the Physical Component Summary-12 (PCS-12) score was obtained from the sub-dimensions of general health, physical functionality, physical role and body pain; The Mental Component Summary-12 (MCS-12) score was obtained from the sub-dimensions of social functionality, emotional role, mental health and energy. Both the PCS-12 and MCS-12 scores range from 0 to 100, with the higher score representing better health.Soylu et al. performed the validity and reliability study of the Turkish version of Quality of Life Scale (SF-12) and the internal consistency of the scale was determined to be 0.73., The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.

Izmir Bakircay University

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE

2021/271

2022-02-17

2022-05-31

2022-06-12

2022-05-25

2022-06-30

Izmir Bakircay University Health Sciences Faculty, Izmir, 35560, Turkey

{ "Laughter therapy": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04902573

A Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Out-comes

https://clinicaltrials.gov/study/NCT04902573

TriMaximize

ACTIVE_NOT_RECRUITING

TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).

NO

Asthma

OTHER: Non-interventional

To describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice, Descriptive analysis of patient demographics, 12 months

Assess asthma control (ACT), Change from baseline in ACT scores, 12 months|Assess quality of life, Change from baseline in Mini-AQLQ scores, 12 months|Assess treatment adherence, Change from baseline in TAI scores, 12 months|Analyse parameters of lung function using spirometry, Change from baseline in FEV1, 12 months|Analyse parameters of small airways disease, Change from baseline in small airway function measured by pre-dose AUCAX (Area under the curve of reactance) using available oscillometry system, 12 months|Analyse parameters of asthma-related airway inflammation, Change from baseline in percentage of patients with a fraction of exhaled nitric oxide (FeNO) below or above 20 ppb, 12 months|Analyse parameters of persistent airflow limitation, Change from baseline in percentage of patients with persistent airflow limitation (PAL); PAL defined as post-BD FEV1 <80% predicted and post-BD FEV1/FVC Ratio < 0.7, 12 months|Analyse the incidence of asthma exacerbations, Number of exacerbations 12 months prior to baseline and during study, 12 months|Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations, Severity of exacerbations, defined according to the ATS/ERS classification of asthma exacerbations, will be analysed 12 months prior to baseline and during study, 12 months|Analyse use of rescue medication, Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit, 12 months|Analyse use of systemic corticosteroids, Use of any systemic corticosteroids 12 months prior to baseline and during study, 12 months|Assess adverse events associated with use of Trimbow, Assessment of the number and type of adverse events, 12 months|Assess retention rate with Trimbow, Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12, 12 months

Chiesi UK

Gesellschaft für Therapieforschung mbH

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

548_TriMaximize|NIS 005 Pn|294788

2021-06-17

2024-06

2024-06

2021-05-26

2023-08-02

The Haven Surgery, The Haven, Burnhope,, Durham, County Durham, DH7 0BD, United Kingdom

{ "Non-interventional": [ { "intervention_type": "OTHER" } ] }

NCT02177773

GA-68 DOTA-TOC of Somatostatin Positive Malignancies

https://clinicaltrials.gov/study/NCT02177773

DOTA-TOC

TERMINATED

This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.

YES

Neuroendocrine Tumor|Paraganglioma|Carcinoid Tumors|Neuroblastoma

PROCEDURE: Computed Tomography (CT)|DRUG: Gallium Ga 68-Edotreotide|PROCEDURE: Magnetic Resonance Imaging (MRI)|PROCEDURE: Positron Emission Tomography (PET)

Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging, The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT, 1 day|Standardized Uptake Value Maximum (SUVmax), The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded., 1 day|Inter-reader Variability, Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values., 1 day

Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging, Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both Change in stage with a 95% confidence interval determined., Up to 2 weeks

University of California, San Francisco

Peterson Family Foundation

ALL

CHILD, ADULT, OLDER_ADULT

PHASE1|PHASE2

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC

14453-HDFCCC|NCI-2017-00451

2014-06-23

2017-08-07

2017-08-07

2014-06-30

2019-11-12

2019-11-12

University of California, San Francisco, San Francisco, California, 94143, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT02177773/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/73/NCT02177773/ICF_001.pdf

{ "Computed Tomography (CT)": [ { "intervention_type": "PROCEDURE" } ], "Gallium Ga 68-Edotreotide": [ { "intervention_type": "DRUG" } ], "Magnetic Resonance Imaging (MRI)": [ { "intervention_type": "PROCEDURE" } ], "Positron Emission Tomography (PET)": [ { "intervention_type": "PROCEDURE" } ] }

NCT05899673

An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease

https://clinicaltrials.gov/study/NCT05899673

ENROLLING_BY_INVITATION

The main aim of this study is to learn if fazirsiran is safe during long-term use in people with liver disease caused by the abnormal Z-alpha-1 antitrypsin (Z-AAT) protein. People who are currently taking part in or have completed previous fazirsiran studies (AROAAT2001 [NCT03945292] or AROAAT2002 [NCT03946449]) can continue to receive fazirsiran in this study. Participants will receive fazirsiran every 3 months for almost 2 years and will then be followed for an additional 6 months. The study may also provide information on whether fazirsiran has a long-term effect in reducing liver fibrosis or slowing down the progression of liver fibrosis in people with liver disease due to the abnormal Z-AAT protein.

NO

Alpha1-Antitrypsin Deficiency

DRUG: Fazirsiran Injection

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs), An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not it is considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study intervention. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, suspected transmission of any infectious agent, an important medical event. AEs and SAEs including any pulmonary AEs or SAEs indicative of worsening pulmonary condition (example, pulmonary exacerbation, respiratory infection, significant pulmonary function test decline) will be reported., From start of study drug administration (in current study) up to End of study (EOS) (current study [up to Week 120])|Number of Participants With Clinically Significant Changes From Baseline in Pulmonary Function Parameters, Standard pulmonary function parameters measured will be used to study lung function. Clinical significance of pulmonary function parameters will be determined at the investigator s discretion., Baseline (current study), Weeks 12, 24, 36, 48, 60, 72, 84, 96, EOS (current study [Week 120])|Number of Participants With Clinically Significant Changes in Vital Signs, Vital signs include body temperature, respiratory rate, sitting blood pressure (systolic and diastolic, resting more than 5 minutes), pulse, oxygen saturation. Clinical significance of vital signs will be determined at the investigator s discretion., From start of study drug administration (in current study) up to EOS (current study [up to Week 120])|Number of Participants With Clinically Significant Changes in Laboratory Parameters, Laboratory parameters include hematology, biochemistry including liver tests, coagulation, and urinalysis. Clinical significance of laboratory parameters will be determined at the investigator s discretion., From start of study drug administration (in current study) up to EOS (current study [up to Week 120])

Number of Participants With no Progression from Baseline of At least 1 Stage of Histologic Fibrosis on Liver Biopsy at Week 102, Number of participants with no progression from baseline of at least 1 stage of histologic fibrosis (by Meta-Analysis of Histological Data in Viral Hepatitis [METAVIR] staging) on liver biopsy at Week 102 will be reported., At Week 102 (current study)|Number of Participants With Reduction from Baseline of At least 1 Stage of Histologic Fibrosis on Liver Biopsy at Week 102, Number of participants with baseline fibrosis of F1 or higher, a decrease from baseline of at least 1 stage of histologic fibrosis (by METAVIR staging) on liver biopsy at Week 102 will be reported., At Week 102 (current study)|Change from Baseline in Intrahepatic Z-AAT Protein Polymer Burden Assessed by Periodic Acid Schiff Plus Diastase (PAS+D) Staining in Liver Biopsy at Week 102, Change from baseline in intrahepatic Z-AAT protein polymer burden assessed by PAS+D staining in liver biopsy will be assessed., Baseline (current study), Week 102 (current study)|Change from Baseline in Intrahepatic Portal Inflammation Score at Week 102 in Liver Biopsy, Change in portal inflammation score in liver biopsy, based on pathology slide reads. Inflammation will be assessed on a scale of 0-3, with higher scores showing more severe inflammation., Baseline (current study), Week 102 (current study)|Change from Baseline in Hepatic Stiffness Assessed by Magnetic Resonance Elastography (MRE) at Weeks 48 and 96, Change from baseline in MRE-derived liver stiffness will be assessed., Baseline (current study), Weeks 48 and 96 (current study)|Change from Baseline in Vibration-Controlled Transient Elastography (VCTE) at 48 Week Intervals Through Week 102, Change from baseline in VCTE-derived liver stiffness will be assessed., Baseline (current study), at 48 Week intervals through Week 102

Takeda

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

TAK-999-3003|2023-503497-21

2023-08-08

2026-05-29

2026-05-29

2023-06-12

2024-03-15

UAB Hospital Clinical Research Unit, Birmingham, Alabama, 35233-1900, United States|UCSD Altman Clinical and Translational Research Institute, La Jolla, California, 92037-1337, United States|Stanford Medicine Outpatient Center, Redwood City, California, 94063, United States|UF Clinical and Translational Science Institute, Gainesville, Florida, 32610-3010, United States|University Of Iowa Hospitals And Clinics, Iowa City, Iowa, 52242-1009, United States|Columbia University Medical Center, New York, New York, 10032-3725, United States|Medical University of South Carolina - Hollings Cancer Center - PPDS, Charleston, South Carolina, 29425-8900, United States|Medizinische Universitat Wien (Medical University of Vienna), Vienna, A-1090, Austria|Universitätsklinikum der RWTH Aachen, Aachen, Nordrhein-Westfalen, 52074, Germany|Hospital Nélio Mendonça, Funchal, 9000-168, Portugal|Addenbrooke s Hospital, Cambridge, CB2 0QQ, United Kingdom|Royal Infirmary of Edinburgh - PPDS, Edinburgh, EH16 4SA, United Kingdom

{ "Fazirsiran": [ { "intervention_type": "DRUG", "description": "Fazirsiran Injection", "name": "Fazirsiran", "synonyms": [ "Ads-001 free acid", "TAK-999", "ARO-AAT", "Fazirsiran", "Double stranded oligomer ADS-001 RNA interference-based liver targeted therapeutic", "RNA, ((1'-DE(6-AMINO-9H-PURIN-9-YL))DA-(5'->5')-SP-AM-GM-CM-GM-UM-UM- UM-AM-(2'-DEOXY-2'-FLUORO)G-(2'-DEOXY-2'-FLUORO)G-(2'-DEOXY-2'-FLUORO)C-AM- UM-GM-UM-UM-UM-AM-AM-CM-AM-(3'->3')-SP-(1'-DE(6-AMINO-9H-PURIN-9- YL))DA), 3'-(O-(CIS-4-((3S,8S)-17-((2-(ACE" ], "drugbank_id": "DB17891", "generic_names": [ "Fazirsiran" ] } ] }

NCT06216873

Collecting the Results of Multiple Trauma Patients and Find the Correlation of Morality and Mobility

https://clinicaltrials.gov/study/NCT06216873

trauma

RECRUITING

Collect data about physiological examination values, blood test values and radiological examination results of patients admitted to the hospital for major trauma. There are different causes of mortality in multiple trauma patients. In this study, review the multiple symptoms and parameters of major trauma patients. We hope to understand and develop one feasible assessment model for emergency departments for enable rapid diagnosis and treatment evaluation about major trauma patients occurrence.

NO

Multiple Trauma/Injuries

OTHER: multiple trauma

The Survey of Mortality and Mobility on Multiple Trauma Patients, Analyze and evaluate the effectiveness of this operative model to increase the possibility of correct diagnosis and timely medical examination major trauma patients and improve the hospital s manpower deployment plan., 20100101 till 20241231

St. Martin De Porress Hospital

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

23B-021

2023-12-29

2024-12-28

2025-01-31

2024-01-22

2024-01-22

St. Martin De Porres Hospital, Chiayi City, 600046, Taiwan|St. Martin De Porres Hospital, Chiayi City, 60069, Taiwan

{ "multiple trauma": [ { "intervention_type": "OTHER" } ] }

NCT04767373

Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

https://clinicaltrials.gov/study/NCT04767373

ACTIVE_NOT_RECRUITING

The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.

NO

Respiratory Syncytial Virus Infection

BIOLOGICAL: Clesrovimab|DRUG: Placebo

Percentage of participants with RSV-associated MALRI, Outpatient and inpatient MALRI is defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample., From Day 1 (postdose) to Day 150|Percentage of participants with solicited injection-site adverse events (AEs), An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs (i.e., redness/erythema, swelling, and pain/tenderness) will be reported., From Day 1 (postdose) to Day 5|Percentage of participants with fever, Fever is defined as as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). The percentage of participants with fever will be reported., From Day 1 (postdose) to Day 5|Percentage of participants with solicited systemic AEs, An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs (i.e., irritability, drowsiness, and appetite lost) will be reported., From Day 1 (postdose) to Day 5|Percentage of participants with anaphylaxis/hypersensitivity AE of special interest (AESI), An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with anaphylaxis/hypersensitivity will be reported., From Day 1 (postdose) to Day 42|Percentage of participants with rash AESI, An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with rash will be reported., From Day 1 (postdose) to Day 42|Percentage of participants with ≥1 nonserious AE, An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., From Day 1 (postdose) to Day 42|Percentage of participants with serious adverse events (SAEs), An SAE is any untoward medical occurrence that results in death; is life-threatening; required inpatient hospitalization/prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with SAEs will be reported., Up to Day 515

Percentage of participants with RSV-associated hospitalization, RSV-associated hospitalization is defined as a hospital admission for respiratory illness AND RSV-positive RT-PCR nasopharyngeal sample., From Day 1 (postdose) to Day 150|Percentage of participants with RSV-associated MALRI, Outpatient and inpatient MALRI is defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration; AND 3) RSV-positive RT-PCR nasopharyngeal sample., From Day 1 (postdose) to Day 180

Merck Sharp & Dohme LLC

ALL

CHILD

PHASE2|PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION

1654-004|MK-1654-004|jRCT2051210019|PHRR210706-003684|2022-500350-42-00|2020-002405-26

2021-04-07

2024-08-15

2024-08-15

2021-02-23

2023-07-17

Southeastern Pediatric Associates, P.A. ( Site 0008), Dothan, Alabama, 36303, United States|Northwest Arkansas Pediatric Clinic ( Site 0050), Fayetteville, Arkansas, 72703, United States|Children s Clinic of Jonesboro, PA ( Site 0058), Jonesboro, Arkansas, 72401, United States|Long Beach Memorial Medical Center ( Site 0014), Long Beach, California, 90806, United States|Madera Family Medical Group ( Site 0046), Madera, California, 93637, United States|Orange County Research Institute ( Site 0057), Ontario, California, 91762, United States|Children s Hospital Colorado ( Site 0066), Aurora, Colorado, 80045, United States|Optumcare Colorado Springs, LLC ( Site 0022), Colorado Springs, Colorado, 80922, United States|Children s National Hospital ( Site 0076), Washington, District of Columbia, 20010, United States|MedStar Georgetown Pediatrics ( Site 0047), Washington, District of Columbia, 20016, United States|Next Phase Research Alliance, LLC ( Site 0071), Homestead, Florida, 33030, United States|Acevedo Clinical Research Associates ( Site 0002), Miami, Florida, 33142, United States|Tekton Research ( Site 0080), Chamblee, Georgia, 30341, United States|Meridian Clinical Research, LLC ( Site 0083), Macon, Georgia, 31210, United States|Clinical Research Prime ( Site 0075), Idaho Falls, Idaho, 83404, United States|Saltzer Medical Group ( Site 0004), Nampa, Idaho, 83686, United States|Cotton-O Neil Clinical Research Center PediatricCare ( Site 0061), Topeka, Kansas, 66604, United States|ACC Pediatric Research ( Site 0067), Haughton, Louisiana, 71037, United States|Meridian Clinical Research, LLC ( Site 0082), Hastings, Nebraska, 68901, United States|Midwest Children s Health Research Institute, LLC ( Site 0044), Lincoln, Nebraska, 68504, United States|Dartmouth-Hitchcock Medical Center ( Site 0031), Lebanon, New Hampshire, 03756, United States|Rutgers University-Pediatric Clinical Research Center ( Site 0055), New Brunswick, New Jersey, 08901, United States|Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093), Winston-Salem, North Carolina, 27103, United States|Senders Pediatrics ( Site 0062), Cleveland, Ohio, 44121, United States|Ohio Pediatric Research Association ( Site 0063), Dayton, Ohio, 45414, United States|CCP- Kid s Way ( Site 0017), Hermitage, Pennsylvania, 16148, United States|UPMC Children s Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043), Pittsburgh, Pennsylvania, 15213, United States|Coastal Pediatric Research ( Site 0013), Charleston, South Carolina, 29414, United States|Tribe Clinical Research, LLC ( Site 0015), Greenville, South Carolina, 29607, United States|Holston Medical Group ( Site 0040), Kingsport, Tennessee, 37660, United States|Javara - Privia Medical Group North Texas - Frisco ( Site 0086), Frisco, Texas, 75035, United States|University of Texas Medical Branch at Galveston ( Site 0059), Galveston, Texas, 77555, United States|DM Clinical Research ( Site 0005), Houston, Texas, 77065, United States|FMC Science - Lampasas ( Site 0011), Lampasas, Texas, 76550, United States|DCOL Center for Clinical Research ( Site 0042), Longview, Texas, 75605, United States|University Health System- San Antonio ( Site 0048), San Antonio, Texas, 78229, United States|Private Practice - Dr. Etokhana ( Site 0089), San Antonio, Texas, 78244, United States|Road Runner Research, Ltd ( Site 0049), San Antonio, Texas, 78249, United States|Alliance for Multispecialty Research, LLC ( Site 0092), Kaysville, Utah, 84037, United States|Wee Care Pediatrics ( Site 0077), Layton, Utah, 84041, United States|Cottonwood Pediatrics ( Site 0032), Murray, Utah, 84107, United States|Wee Care Pediatrics-Roy ( Site 0053), Roy, Utah, 84067, United States|University of Utah School of Medicine ( Site 0006), Salt Lake City, Utah, 84108, United States|Copperview Medical Center ( Site 0078), South Jordan, Utah, 84095, United States|Wee Care Pediatrics ( Site 0065), Syracuse, Utah, 84075, United States|Pediatric Research of Charlottesville, LLC ( Site 0073), Charlottesville, Virginia, 22902, United States|MultiCare Rockwood Cheney Clinic ( Site 0068), Cheney, Washington, 99004, United States|Multicare Health System Institute for Research and Innovation ( Site 0025), Spokane, Washington, 99202, United States|Multicare Institute For Research And Innovation ( Site 0045), Tacoma, Washington, 98405, United States|Marshall University School of Medicine and Medical Center ( Site 0064), Huntington, West Virginia, 25701, United States|Marshfield Clinic ( Site 0054), Marshfield, Wisconsin, 54449, United States|Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001), Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426BOS, Argentina|Clinica del Nino y la Madre ( Site 1005), Mar De La Plata, Buenos Aires, B7600FYH, Argentina|SANATORIO DEL SALVADOR-Pediatria ( Site 1008), Córdoba, Cordoba, 5004, Argentina|SANATORIO MATER DEI ( Site 1010), Buenos Aires, C1425DND, Argentina|Clinica Privada del Sol S.A ( Site 1013), Cordoba, X5000IIH, Argentina|Universitair Ziekenhuis Antwerpen ( Site 2001), Edegem, Antwerpen, 2650, Belgium|Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003), Brussels, Bruxelles-Capitale, Region De, 1000, Belgium|Cliniques Universitaires Saint-Luc ( Site 2005), Bruxelles, Bruxelles-Capitale, Region De, 1200, Belgium|Cabinet Médical Demeulemeester ( Site 2002), Gozée, Wallonne, Region, 6534, Belgium|AZ Delta ( Site 2004), Roeselare, West-Vlaanderen, 8800, Belgium|University of Calgary - Alberta Children Hospital ( Site 0504), Calgary, Alberta, T3B 6A8, Canada|BC Women s Hospital and Health Centre ( Site 0506), Vancouver, British Columbia, V6H 3N1, Canada|Canadian Center for Vaccinology ( Site 0503), Halifax, Nova Scotia, B3K 6R8, Canada|Hamilton Medical Research Group ( Site 0509), Hamilton, Ontario, L8M 1K7, Canada|CHU Sainte Justine ( Site 0502), Montreal, Quebec, H3T 1C5, Canada|McGill University Health Centre - Vaccine Study Centre ( Site 0500), Pierrefonds, Quebec, H9H 4Y6, Canada|CHU de Quebec Universite de Laval ( Site 0501), Quebec, G1E 7G9, Canada|Hospital La Florida ( Site 1104), Santiago, Region M. De Santiago, 8242238, Chile|Hospital Roberto del Rio ( Site 1106), Santiago, Region M. De Santiago, 8380418, Chile|Facultad Medicina Universidad de Chile ( Site 1105), Santiago, Region M. De Santiago, 8380453, Chile|Hospital Padre Hurtado ( Site 1101), Santiago, Region M. De Santiago, 8880465, Chile|Peking University Third Hospital ( Site 3339), Beijing, Beijing, 100091, China|The Children s Hospital of Chongqing Medical University ( Site 3333), Chongqing, Chongqing, 400065, China|Jiangjin District Central Hospital ( Site 3319), Chongqing, Chongqing, 402260, China|Xiamen Maternity and Child Health Care Hospital ( Site 3351), Xiamen, Fujian, 361003, China|Guangdong Provincial People s Hospital ( Site 3341), Guangzhou, Guangdong, 510080, China|The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348), Guangzhou, Guangdong, 510150, China|Guangdong Maternity and Child Health Care Hospital ( Site 3340), Guangzhou, Guangdong, 511400, China|Liuzhou People s Hospital ( Site 3364), Liuzhou, Guangxi, 545006, China|Hebei Petro China Central Hospital ( Site 3365), Langfang, Hebei, 065000, China|Fourth Hospital of Hebei Medical University ( Site 3366), Shijiazhuang, Hebei, 050035, China|Sanmenxia Central Hospital ( Site 3360), Sanmenxia, Henan, 472000, China|Wuhan Children s Hospital ( Site 3329), Wuhan, Hubei, 430000, China|Renmin Hospital of Wuhan University ( Site 3316), Wuhan, Hubei, 430060, China|Changde First People s Hospital ( Site 3311), Changde, Hunan, 415000, China|The Maternal and Child Health Hospital of Hunan Province ( Site 3334), Changsha, Hunan, 410000, China|Hunan Provincial People s Hospital ( Site 3355), Changsha, Hunan, 410005, China|Xiangya Hospital Central South University ( Site 3347), Changsha, Hunan, 410008, China|Hunan Shaoyang No.1 People s Hospital ( Site 3345), Shaoyang, Hunan, 422000, China|Zhongda Hospital Southeast University ( Site 3353), Nanjing, Jiangsu, 210009, China|Jiangxi Provincial Children s Hospital ( Site 3313), Nanchang, Jiangxi, 330006, China|The Third Hospital of Nanchang ( Site 3325), Nanchang, Jiangxi, 330009, China|Jiangxi Pingxiang People s Hospital ( Site 3312), Pingxiang, Jiangxi, 337000, China|Dalian Women and Children Medical Treatment Center(Hope Square Children s Branch Hospital) ( Site 33, Dalian, Liaoning, 116012, China|Children s Hospital of Fudan University ( Site 3361), Shanghai, Shanghai, 201102, China|Linfen Central Hospital ( Site 3368), Linfen, Shanxi, 041000, China|Linfen People s Hospital ( Site 3363), Linfen, Shanxi, 041081, China|Yuncheng Central Hospital - Eastern Hospital ( Site 3318), Yuncheng Shi, Shanxi, 044000, China|Chengdu Women and Children Center Hospital ( Site 3332), Chengdu, Sichuan, 610091, China|The First People s Hospital of Hangzhou ( Site 3342), Hangzhou, Zhejiang, 310006, China|Ningbo Women and Children s Hospital ( Site 3314), Ningbo, Zhejiang, 315012, China|Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154), Medellin, Antioquia, 050036, Colombia|Sociedad Medica de Rionegro SOMER S.A. ( Site 1157), Rionegro, Antioquia, 054040, Colombia|Clinica de la Costa S.A.S. ( Site 1152), Barranquilla, Atlantico, 080020, Colombia|Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155), Chía, Cundinamarca, 250001, Colombia|Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159), Cali, Valle Del Cauca, 760001, Colombia|Regionshospitalet Herning ( Site 2105), Herning, Midtjylland, 7400, Denmark|Aalborg Universitetshospital, Nord-Børne- og Ungeafdelingen ( Site 2100), Aalborg, Nordjylland, 9000, Denmark|Regionshospitalet Nordjylland ( Site 2102), Hjoerring, Nordjylland, 9800, Denmark|Odense University Hospital ( Site 2107), Odense, Syddanmark, 5000, Denmark|FVR, Kokkolan rokotetutkimusklinikka ( Site 2157), Kokkola, Mellersta Osterbotten, 67100, Finland|Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160), Tampere, Pirkanmaa, 33100, Finland|FVR, Oulun rokotetutkimusklinikka ( Site 2158), Oulu, Pohjois-Pohjanmaa, 90220, Finland|FVR, Porin rokotetutkimusklinikka ( Site 2156), Pori, Satakunta, 28100, Finland|FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155), Seinajoki, Sodra Osterbotten, 60100, Finland|FVR, Espoon rokotetutkimusklinikka ( Site 2152), Espoo, Uusimaa, 02230, Finland|FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159), Helsinki, Uusimaa, 00100, Finland|FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 2153), Helsinki, Uusimaa, 00930, Finland|FVR, Järvenpään rokotetutkimusklinikka ( Site 2154), Järvenpää, Uusimaa, 04400, Finland|FVR, Turun rokotetutkimusklinikka ( Site 2151), Turku, Varsinais-Suomi, 20520, Finland|CHU Caen ( Site 2212), Caen, Calvados, 14033, France|Groupe Hospitalier Pellegrin ( Site 2218), Bordeaux, Gironde, 33000, France|Centre Hospitalier de Versailles ( Site 2206), Le Chesnay, Yvelines, 78150, France|Soroka University Medical Center Ramot Family health center ( Site 2354), Be er Sheva, 8471844, Israel|Soroka Medical Center ( Site 2351), Beer-Sheva, 8410101, Israel|Rambam Medical Center ( Site 2352), Haifa, 3525408, Israel|Soroka University Medical Center Rahat Family health center ( Site 2355), Rahat, 8535700, Israel|Chaim Sheba Medical Center ( Site 2353), Ramat Gan, 5265601, Israel|Policlinico Universitario Gemelli ( Site 2301), Rome, Roma, 00168, Italy|A.O.Universitaria Meyer ( Site 2306), Firenze, Toscana, 50139, Italy|Universita degli studi di Padova Patologia e TIN ( Site 2305), Padova, Veneto, 35128, Italy|A.O. Policlinico Consorziale di Bari ( Site 2309), Bari, 70124, Italy|Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310), Milano, 20122, Italy|Maebashi Red Cross Hospital ( Site 3057), Maebashi, Gunma, 371-0811, Japan|St. Marianna University School of Medicine Hospital ( Site 3060), Kawasaki, Kanagawa, 216-8511, Japan|JOHAS Yokohama Rosai Hospital ( Site 3058), Yokohama, Kanagawa, 222-0036, Japan|National Hospital Organization Beppu Medical Center ( Site 3063), Beppu, Oita, Japan|Ageo Central General Hospital ( Site 3051), Ageo, Saitama, 362-8588, Japan|Tottori University Hospital ( Site 3053), Yonago, Tottori, 683-8504, Japan|Fukui Aiiku Hospital ( Site 3056), Fukui, 910-0833, Japan|Fukui-ken Saiseikai Hospital ( Site 3064), Fukui, 918-8503, Japan|Saitama City Hospital ( Site 3055), Saitama, 336-8522, Japan|Shizuoka City Shimizu Hospital ( Site 3061), Shizuoka, 424-8636, Japan|St.Luke s International Hospital ( Site 3062), Tokyo, 104-8560, Japan|Showa University Hospital ( Site 3059), Tokyo, 142-8666, Japan|The Catholic University of Korea, Incheon St. Mary s Hospital ( Site 3209), Bupyeong-gu, Incheon, 21431, Korea, Republic of|Jeonbuk National University Hospital ( Site 3210), Jeonju-si, Jeonrabugdo, 54907, Korea, Republic of|Korea University Ansan Hospital ( Site 3212), Ansan-si, Kyonggi-do, 15355, Korea, Republic of|Hallym University Sacred Heart Hospital ( Site 3207), Anyang, Kyonggi-do, 14068, Korea, Republic of|Seoul National University Bundang Hospital-Pediatrics ( Site 3204), Seongnam, Kyonggi-do, 13620, Korea, Republic of|Pusan National University Hospital ( Site 3206), Busan, Pusan-Kwangyokshi, 49241, Korea, Republic of|Chungang University Hospital ( Site 3211), Dongjak-gu, Seoul, 06973, Korea, Republic of|Seoul National University Hospital ( Site 3203), Seoul, 03080, Korea, Republic of|Severance Hospital Yonsei University Health System ( Site 3201), Seoul, 03722, Korea, Republic of|Samsung Medical Center ( Site 3202), Seoul, 06351, Korea, Republic of|The Catholic Univ. of Korea Seoul St. Mary s Hospital ( Site 3208), Seoul, 06591, Korea, Republic of|Hospital Raja Perempuan Zainab II ( Site 3106), Kota Bahru, Kelantan, 15586, Malaysia|Hospital Seri Manjung ( Site 3103), Seri Manjung, Perak, 32040, Malaysia|Hospital Taiping ( Site 3108), Taiping, Perak, 34000, Malaysia|Hospital Pulau Pinang ( Site 3104), Georgetown, Pulau Pinang, 10990, Malaysia|Hospital Seberang Jaya ( Site 3107), Seberang Jaya, Pulau Pinang, 13700, Malaysia|Sabah Womens & Childrens Hospital ( Site 3102), Kota Kinabalu, Sabah, 88996, Malaysia|Hospital Sibu ( Site 3101), Sibu, Sarawak, 96000, Malaysia|CAIMED Investigación en Salud S.A de C.V ( Site 1209), Mexico, Distrito Federal, 06760, Mexico|Centenario Hospital Miguel Hidalgo ( Site 1204), Aguascalientes, 20259, Mexico|Hospital Angeles Lomas ( Site 1207), Huixquilucan, 52763, Mexico|Instituto Nacional de Pediatria ( Site 1202), Mexico City, 04530, Mexico|Clinica Peruano Americana S.A. ( Site 1253), Trujillo, La Libertad, 13011, Peru|Asociacion Civil Selva Amazonica ( Site 1255), Iquitos, Loreto, 16001, Peru|Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251), Lima, 15001, Peru|Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252), Lima, LIMA 36, Peru|University of the Philippines-Philippine General Hospital ( Site 3152), Manila, National Capital Region, 1000, Philippines|Philippine Children s Medical Center ( Site 3154), Quezon City, National Capital Region, 1100, Philippines|Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153), Quezon City, National Capital Region, 1118, Philippines|Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409), Trzebnica, Dolnoslaskie, 55-100, Poland|Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440), Wrocław, Dolnoslaskie, 50-368, Poland|IN VIVO ( Site 2401), Bydgoszcz, Kujawsko-pomorskie, 85-048, Poland|Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423), Lodz, Lodzkie, 91-347, Poland|NZOZ Salmed ( Site 2433), Leczna, Lubelskie, 21-010, Poland|Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404), Lublin, Lubelskie, 20-093, Poland|Centrum Medyczne PROMED ( Site 2432), Krakow, Malopolskie, 31-411, Poland|Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403), Tarnow, Malopolskie, 33-100, Poland|WIP Warsaw IBD Point Profesor Kierkus ( Site 2441), Warsaw, Mazowieckie, 00-728, Poland|Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435), Warszawa, Mazowieckie, 00-315, Poland|Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425), Warszawa, Mazowieckie, 01-809, Poland|Centrum Medyczne Pratia Warszawa ( Site 2438), Warszawa, Mazowieckie, 01-868, Poland|Uniwersyteckie Centrum Kliniczne ( Site 2437), Gdansk, Pomorskie, 80-214, Poland|Szpital Miejski w Tychach ( Site 2442), Tychy, Slaskie, 43-100, Poland|Instytut Mikroekologii Sp. Z o.o. & Co. Sp. Komandytowa ( Site 2412), Poznan, Wielkopolskie, 60-129, Poland|MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426), Mazowieckie, 02-972, Poland|Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456), Brasov, 500063, Romania|Spitalul Clinic Filantropia Clinica Obstetrica-Ginecologie ( Site 2451), Bucuresti, 011171, Romania|Spitalul Clinic Judetean De Urgenta Constanta ( Site 2458), Constanta, 900591, Romania|Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452), Iasi, 700038, Romania|University Of The Orange Free State ( Site 2507), Bloemfontein, Free State, 9301, South Africa|Baragwanath Hospital ( Site 2501), Johannesburg, Gauteng, 2013, South Africa|Empilweni Services and Research Unit ( Site 2504), Johannesburg, Gauteng, 2093, South Africa|Steve Biko Academic Hospital ( Site 2505), Pretoria, Gauteng, 0002, South Africa|Enhancing Care Foundation-DICRS ( Site 2506), Durban, Kwazulu-Natal, 4013, South Africa|Tygerberg Hospital ( Site 2503), Cape Town, Western Cape, 7505, South Africa|MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 2502), Cape Town, Western Cape, 7700, South Africa|Srinagarind Hospital. Khon Kaen University ( Site 3253), Muang, Khon Kaen, 40002, Thailand|Chulalongkorn University-Pediatrics ( Site 3252), Bangkok, Krung Thep Maha Nakhon, 10330, Thailand|Siriraj Hospital ( Site 3251), Bangkok, Krung Thep Maha Nakhon, 10700, Thailand|Prince of Songkla University Faculty of Medicine ( Site 3255), Hat Yai, Songkhla, 90110, Thailand|Maharaj Nakorn Chiang Mai Hospital ( Site 3254), Chiang Mai, 50200, Thailand|Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555), Adana, 01330, Turkey|Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552), Ankara, 06560, Turkey|Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551), Ankara, 06590, Turkey|Ege University Medical Faculty ( Site 2553), Izmir, 35100, Turkey|Erciyes University Medical Faculty-pediatric infection ( Site 2554), Kayseri, 38039, Turkey|UH Bristol Education Centre ( Site 2607), Bristol, Bristol, City Of, BS2 8AE, United Kingdom|St. Georges University Hospital NHS Foundation Trust ( Site 2601), London, London, City Of, SW17 0QT, United Kingdom|Royal Maternity Hospital ( Site 2602), Belfast, Northern Ireland, BT12 6BB, United Kingdom|Oxford University Hospital NHS Foundation Trust ( Site 2604), Oxford, Oxfordshire, OX3 9DU, United Kingdom|Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606), Liverpool, L12 2AP, United Kingdom

{ "Clesrovimab": [ { "intervention_type": "BIOLOGICAL" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT01435473

Clinical Assessment of Thrombosis in Children After Heart Surgery

https://clinicaltrials.gov/study/NCT01435473

CATCH

COMPLETED

Thromboembolic complications (TCs) are important causes of morbidity and mortality after pediatric cardiac surgery, resulting in longer hospital stay, increased risk of early and late post-surgical complications, early reoperation, neurologic and organ damage, and potentially death. The true incidence of blood clots in pediatric surgical patients is unknown. The overarching objective of this study is to further our understanding of TCs, including quantification, characterization and risk stratification. This study will ultimately allow the development of effective tools for prevention and early identification of TCs, rather than focusing on treatment alone.

NO

Thrombosis

PROCEDURE: Cardiac Surgery

Incidence of Thromboembolic Complications (TC) after pediatric cardiac surgery, Thrombosis will be recorded through review of post-operative clinical assessments, targeted laboratory testing for blood abnormalities and echocardiographic/ultrasound evaluation., Outcome will be recorded throughout the duration of the participants hospital stay, an expected average of 10 days

Assessment of the patients coagulation, hemostatic and inflammatory system activity, Standard coagulation panel to assess the function of the coagulation system in order to identify the degree of maturity, potential for resistance to anticoagulation and overall activity of the coagulation system., Baseline|Genome-Wide Association Study (GWAS), To identify genetic polymorphisms associated with coagulation system activity, sensitivity and overall thrombotic risk., Baseline|Post-operative sign and symptoms of thrombosis, Daily clinical assessment of signs and symptoms of thrombosis, Up to 10 days after surgery|Post-thrombotic Syndrome (PTS) Evaluation, Assessment of upper and lower limbs based on the adaptation of the Khule scale. PTS will be classified as mild, moderate and severe., Up to 2 years after surgery|Neurodevelopment and functional health assessment, Subject will undergo Ages and Stages (ASQ, Child Health Questionnaires and PedsQL), Up to 2 years post- surgery|Response of the patients coagulation, hemostatic and inflammatory system activity to cardiopulmonary bypass, Repeat of complete blood count, inflammatory markers, coagulation and fibrolnolytic systems activity, Up to 10 days after surgery|Proportion of patients with thrombo-occlusive complications of thrombosis, Following events associated with thrombosis: * Death / cardiorespiratory arrest associated with thrombosis * Embolism (cardioembolic stroke, pulmonary embolism) * Obstruction (sinovenous stroke, SVC syndrome) * Unanticipated procedures directed at thrombosis or its clinical impact * Escalation of antithrombotic treatment, 18-24 months after surgery

The Hospital for Sick Children

ALL

CHILD, ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

1000020203

2011-07

2014-11

2015-12

2011-09-16

2016-02-01

The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada

{ "Cardiac Surgery": [ { "intervention_type": "PROCEDURE" } ] }

NCT00782873

Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients

https://clinicaltrials.gov/study/NCT00782873

COMPLETED

The purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper endoscopy. The investigators aim to test the hypothesis that it is safe to use balanced-propofol, gastroenterologist-administered sedation in obese patients.

NO

Obesity

A change in mean arterial pressure (MAP) of 20% or more from baseline, during upper endoscopy

Episodes of bradycardia - pulse less than 50, during upper endoscopy|ECG changes consistent with myocardial ischemia, during upper endoscopy|Decrease in respiratory rate - change of 20% or more from baseline, during upper endoscopy|Assess the dose of propofol, midazolam, and fentanyl necessary to achieve adequate sedation during upper endoscopy and compare the dose requirements of the obese and non-obese patient cohorts., after all patients completed|Compare the level of sedation between the obese and non-obese cohorts, after all patients completed|compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts, after all patients completed|Compare time to sedation in the obese and non-obese cohorts, after all patients completed|Oxygen desaturation, during upper endoscopy|Apneic episodes, during upper endoscopy

Research Associates of New York, LLP

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

424-02-08

2008-03

2008-08

2008-09

2008-10-31

2008-10-31

Research Associates of New York, New York, New York, 10075, United States

{}

NCT04686773

Open-label, Non-randomized, Non-comparative, Phase II Study of Safety and Immunogenicity of Combination of AZD1222 and rAd26-S for COVID-19 Prevention

https://clinicaltrials.gov/study/NCT04686773

COMPLETED

The purpose of the study is to assess safety and immunogenicity of heterologous booster vaccine containing combination of AZD1222 and rAd26-S (one of components of Gam-COVID-Vac vaccine) in adult subjects aged ≥ 18 years old to prevent COVID-19 spread.

NO

COVID-19

BIOLOGICAL: AZD1222|BIOLOGICAL: rAd26-S

Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the second vaccination., Antibody seroconversion rate (≥4-fold increase from baseline) to SARS CoV-2 Spike protein 29 days after the second vaccination., Day 57

Incidence of local and systemic solicited Adverse Events (AEs) for 7 days post each dose, Number of Participants Reporting local (Pain at the site of injection, Erythema/hyperemia at the site of injection, Tenderness, Induration/swelling at the site of injection) and systemic (Fever > 37.8°C, Chills, Muscle pains, Fatigue, Headache, Malaise, Nausea, Vomiting) Solicited Adverse Events for 7 days following each vaccination (Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination)., from Day 1 to Day 8 and From Day 29 to Day 36|Incidence of unsolicited AEs, serious adverse events (SAEs) and AEs of special interest, Number of Participants Reporting unsolicited AEs, SAEs and AESIs through 29 days post each vaccination (i.e. up to day 29 after the first vaccination and day 57 after second vaccination)., up to day 29, up to day 57|Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the first vaccination., The proportion of participants who have a post treatment seroresponse (defined as: ≥ 4 fold rise in titres from Day 1 baseline value) to the SARS CoV-2 Spike protein 29 days post first vaccination., day 29|Antibody seroconversion rate against receptor-binding domain antigen 29 days after each vaccination., The proportion of participants with post treatment seroresponse (defined as: ≥ 4-fold rise in titres from Day 1 baseline value) to receptor-binding domain antigen 29 days post each vaccination., day 29, 57|Change from baseline Geometric mean titre (GMT) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens, Сhange from baseline GMT values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens at day 15, 29, 57, 180., Day 1, 15, 29, 57, 180|Change from baseline Geometric mean fold rise (GMFR) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens, Сhange from baseline GMFR values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens at Day 15, 29, 57, 180., Day 1, 15, 29, 57, 180|Antibody seroconversion rate of neutralizing antibodies to SARS-CoV-2 antigen - 29 days after each vaccination, The proportion of participants with post treatment seroresponse (defined as: ≥ 4-fold rise in titres day from Day 1 baseline value to 29 days post each vaccination - Day 29 and Day 57), as measured by SARS-CoV-2 neutralising antibodies, day 29, 57|Change from baseline GMT values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2, Сhange from baseline GMT values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2 at Day 15, 29, 57, 180., Day 1, 15, 29, 57, 180|Change from baseline GMFR values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2, Сhange from baseline GMFR values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2 at Day 15, 29, 57, 180., Day 1, 15, 29, 57, 180

R-Pharm

AstraZeneca|Russian Direct Investment Fund|The Gamaleya National Center of Epidemiology & Microbiology

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION

CV03872092

2021-03-05

2021-10-30

2022-03-18

2020-12-29

2022-06-03

Public legal entity Baku Health Center , Baku, Azerbaijan

{ "AstraZeneca COVID-19 Vaccine": [ { "intervention_type": "BIOLOGICAL", "description": "AZD1222", "name": "AstraZeneca COVID-19 Vaccine", "synonyms": [ "Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19", "ChAdOx1-S [recombinant]", "AZD-1222", "Covishield", "AstraZeneca COVID-19 Vaccine", "AZD1222", "ChAdOx1 nCoV-19" ], "drugbank_id": "DB15656", "generic_names": [ "AstraZeneca COVID-19 Vaccine" ] } ], "rAd26-S": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT05263973

The Effect of Music on Pain, Comfort and Physiological Parameters During Prematurity Retinopathy Examination

https://clinicaltrials.gov/study/NCT05263973

COMPLETED

It is planned to determine the effect of music during Retinopathy of Prematurity (ROP) examination on pain, comfort and physiological parameters in preterm infants. This is single-center, randomized controlled trial, double blind, parallel. Hypotheses: H1: The music applied during the ROP examination has an effect on the Revised Premature Infant Pain Profile (PIPP-R) score of the preterm infant. H2: The music applied during the ROP examination has an effect on the Preterm Infant Comfort Scale (PMI) score of the preterm infant. H3: Music applied during the ROP examination has an effect on the physiological parameters (peak heart rate, O2 saturation) of the preterm infant. H4: The music applied during the ROP examination has an effect on the crying time of the preterm infant during the procedure. Method: The study will be performed with preterm infants (n=28) hospitalized in the neonatal intensive care unit of a tertiary hospital. Premature infants to be included in the study will be assigned to two study groups using the block randomization method created in the computer environment according to their gestational age, gender, birth weight. The data in the study were will be collected using the Questionaire Form for Preterm Newborns and Their Parents, Physiological Parameters Observation Form, Revised-Premature Infant Pain Profile (PIPP-R), Premature Infant Comfort Scale (PICS), Pulse Oximeter, Music CD, Music box, Video camera, decibel meter, tripod. Data will be collected by researcher ABÇ. Infants who meet the criteria for inclusion in the study will be selected from the infants who are planned to an ROP examination, and written and verbal consent will be obtained from the families by explaining the purpose of the study. Questionaire Form for Preterm Newborns and Their Parents will be obtained from the nurse observation form and patient files. Four minutes before the ROP, the infant will be monitored and physiological parameters will be recorded, and three minutes before the ROP, the experimental group will start to listen to music (Video recordings will be evaluated by three experts, PIPP-R and PICS). The music recording will continue to be played during the ROP examination for music group. No application will be made for the control group other than the clinical routines.

NO

ROP Examination

OTHER: Music

Premature Infant Comfort Scale (PBIC), According to the PICS, a score between 7-35 is obtained from the scale. A high score from the scale indicates a low level of comfort., The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.|Premature Baby Pain Profile Scale-Revised Form (PIPP-R), The PIPP-R is a Likert-type scale. In scoring the scale, items related to physiological and behavioral elements are scored as 0, 1, 2, 3, reflecting the difference between the values at baseline and during the procedure in each variable. Contextual items (behavioral status and CI) are scored as 3, 2, 1, 0 only at the beginning of the pain assessment (before touching the baby). According to the PIPP-R, the baby s pain is evaluated over the total score. Accordingly, the highest score that can be obtained from the PIPP-R scale for preterm newborns is 21 and 18 for term newborns., The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.|Physiological parameters- heart rate, Heart rate, The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.|Physiological parameters- oxygen saturation, Oxygen saturation, The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.|Physiological parameters- respiratory rate, Respiratory rate, The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.|Physiological parameters- crying time, Crying time, immediately after the ROP examination.

TC Erciyes University

ALL

CHILD

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE

2022/122

2022-03-10

2023-01-10

2023-01-10

2022-03-03

2023-10-12

Erciyes university, Kayseri, Turkey

{ "Music": [ { "intervention_type": "OTHER" } ] }

NCT04212273

Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC

https://clinicaltrials.gov/study/NCT04212273

RECRUITING

Hepatocellular carcinoma (HCC) is the fifth most common cancer. Patients with HCCs usually have a poor prognosis. Hepatocarcinogenesis is an intricate and multistep process. Detecting and staging early HCC in patients with liver cirrhosis are still challenging for imaging techniques. Contrast-enhanced ultrasonography (CEUS) and gadoxetic acid-enhanced magnetic resonance imaging (EOB-MRI) are widely used in clinical practice. EOB-MRI has advantages of high detecting rate for small lesions, high sensitivity of hepatobiliary phase and extensive image information. Sonazoid has the advantage of offering a unique post-vascular phase, also called the Kupffer phase. Therefore, malignant tumors with few or no Kupffer cells appear as contrast defects, with respect to the relatively well-enhanced surrounding liver in the postvascular phase. The diagnostic efficacies of these two imaging methods have not been well studied. Therefore, the purpose of this study is to compare the efficacies of Sonazoid-CEUS and EOB-MRI in patients with high risk of HCC, and to compare the detection ability for malignant tumors by Kupffer phase and hepatobiliary phase.

NO

Hepatocellular Cancer|Liver Cirrhoses|Diagnoses Disease

DIAGNOSTIC_TEST: Diagnostic Sonazoid-CEUS and EOB-MRI

The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI, The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI in the diagnosis for patients with high risk of HCC will be determined., 6 to 12 months

The detection rate of the additionally found HCC, The detection rate of the additionally found HCC on Sonazoid-CEUS and EOB-MRI will be determined ., 6 to 12 months

Tianjin Third Central Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC

drjingxiang001

2019-12-21

2022-12-24

2022-12-24

2019-12-26

2022-12-13

Tianjin Third Central Hospital, Tianjin, Tianjin, 300170, China

{ "Diagnostic Sonazoid-CEUS and EOB-MRI": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT05763173

Evaluation of Lung Metastases Based on Ultrashort Echo Time MRI

https://clinicaltrials.gov/study/NCT05763173

COMPLETED

Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma with chest CT as gold standard

NO

Hepatoblastoma|Radiology

UTE-MRI assessment of lung metastases with chest CT as gold standard, Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma., Baseline to 14 days

RenJi Hospital

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

LY2022-064-B

2023-01-01

2024-02-29

2024-02-29

2023-03-10

2024-04-18

Department of Radiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, Shanghai, 200127, China

{}

NCT05396573

A Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine Against COVID-19

https://clinicaltrials.gov/study/NCT05396573

UNKNOWN

This is a phase 1b, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013 in healthy adults primed with a two-dose inactivated vaccine 6-9 months earlier. The study vaccine is administered IM in the upper arm deltoid as single booster shot on day 0.

NO

COVID-19

BIOLOGICAL: RQ3013|BIOLOGICAL: Comirnaty

Immediate AEs within 30 minutes after booster vaccination, solicited local and systemic AEs for within 7 days and unsolicited AEs within 28 days following booster vaccination, within 28 days following booster vaccination

Live virus GMT, GMFR and seroconversion rate against Beta and Omicron strain in serum measured at pre booster dose and day 7, 14, 28 after booster dose, pre booster dose and day 7, 14, 28 after booster dose|Pseudovirus GMT, GMFR and seroconversion rate against SARS-CoV-2 Beta and Omicron strain in serum measured at pre booster dose and day 7, 14, 28 after booster dose, pre booster dose and day 7, 14, 28 after booster dose|GMT, GMFR and seroconversion rate of S-Protein Specific IgGs in serum measured at pre booster dose and day 7, 14, 28 after booster dose, pre booster dose and day 7, 14, 28 after booster dose|Live virus GMT, GMFR and seroconversion rate against Beta and Omicron strain in serum measured at 3, 6, 12 months after booster dose, 3, 6, 12 months after booster dose|Pseudovirus GMT, GMFR and seroconversion rate against SARS-CoV-2 Beta and Omicron strain in serum measured at 3, 6, 12 months after booster dose, 3, 6, 12 months after booster dose|GMT, GMFR and seroconversion rate of S-Protein Specific IgGs in serum measured at 3, 6, 12 months after booster dose, 3, 6, 12 months after booster dose|Changes of safety laboratory measures at day 4 following booster vaccination in comparison to pre-boosting levels, day 4 following booster vaccination|SAEs and AESIs throughout the study, 12 months after vaccination

Spike protein specific CD4+, CD8+, CD4+IFN-γ+, CD4+IL-2+, CD4+TNFα+, CD4+IL-4+, CD4+IL-13+, CD8+IFN-γ+, CD8+IL-2+, CD8+TNFα+ cytokine profiling (flow cytometry) by flow cytometry at baseline and day 7, 14 after booster, baseline and day 7, 14 after booster|Spike protein specific cytokine responses by enzyme-linked immunospot (ELISPOT) assay, IFN-γ, IL-2, IL-4 at baseline and day 7, 14 after booster, baseline and day 7, 14 after booster|Spike protein specific T memory cell responses: CD4+ and CD8+ TCM(CCR7+CD45RA-), TEM(CCR7-CD45RA-) and TSCM(CCR7+CD45RA+CD95+) at baseline and 28 days, 3, 6 months after booster, baseline and 28 days, 3, 6 months after booster

Walvax Biotechnology Co., Ltd.

Shanghai RNACure Biopharma Co., Ltd.

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION

RQ3013-005

2022-07

2022-08

2023-07

2022-05-31

2022-05-31

{ "RQ3013": [ { "intervention_type": "BIOLOGICAL" } ], "COVID-19 Vaccine, mRNA (Pfizer-BioNTech)": [ { "intervention_type": "BIOLOGICAL", "description": "Comirnaty", "name": "COVID-19 Vaccine, mRNA (Pfizer-BioNTech)", "synonyms": [ "COVID-19 Vaccine, mRNA (Pfizer-BioNTech)", "BNT162b2 mRNA", "Comirnaty", "SARS-CoV-2 (COVID-19) vaccine, mRNA spike protein", "mRNA COVID-19 vaccine", "Spikevax", "COVID-19 Vaccine, mRNA (Moderna)", "SARS-CoV-2 (COVID-19) vaccine, mRNA spike protein", "mRNA COVID-19 vaccine", "Spikevax", "COVID-19 Vaccine, mRNA (Moderna)", "SARS-CoV-2 (COVID-19) vaccine, mRNA spike protein" ], "medline_plus_id": "a621003", "generic_names": [ "COVID-19 Vaccine, mRNA (Pfizer-BioNTech)", "COVID-19 Vaccine, mRNA (Moderna)", "COVID-19 Vaccine, mRNA (Moderna)" ] } ] }

NCT06071273

Online Platform for Self-service of Patients With Chronic Cardiovascular Diseases

https://clinicaltrials.gov/study/NCT06071273

COMPLETED

The purpose of this study is to define the requirements and characteristics of the software that will be developed for the project Creation of a platform for self-service of people living with chronic cardiovascular diseases in an understandable, clear, complete, consistent and verifiable manner. The project concerns the design and implementation of a long-term program of therapeutic exercise and evaluation, by exercise and health professionals, of the anatomical and functional adaptations of exercise in patients and athletes with cardiovascular diseases. Essentially, it is a program of recording and monitoring cardiovascular rehabilitation in the form of systematic exercise of the patient both at home and in sports venues, which will contribute to the prevention of cardiovascular events in conditions of fatigue and at rest as well as to the gradual rehabilitation of the patient who performs a physical activity. Depending on the individual s functional capacity and health issues, combined with monitoring the patient s vital signs (such as blood pressure, heart rate, oxygen saturation, body temperature) the exercise professional will create an individualized, targeted exercise program with ultimate aiming at its rehabilitation with the help of physical activity and the improvement of its functional performance and by extension the quality of life of the individual. At the same time, the project will seek to motivate patients to remain committed to the physical activity program, with the aim of faster reintegration into their daily life.

NO

Cardiovascular Diseases

OTHER: Group A: online real-time home based exercise using the online platform|OTHER: Group B: supervised community based exercise intervention

Physical activity levels, Physical activity levels will be assessed by mean daily step count for all groups including the control group., 6 months

Cardiorespiratory fitness (CRF), CRF will be assessed by performing a peak oxygen uptake test at baseline and post-exercise intervention for all groups including the control group., 6 months|Percentage of body fat mass, Body composition analysis will be performed via bioelectrical impedance to assess the levels of fat (%) pre and the intervention for all groups, including the control group., 6 months|Body muscle mass, Body composition analysis will be performed via bioelectrical impedance to assess the levels of muscle mass (kg) pre and the intervention for all groups, including the control group., 6 months

Aristotle University Of Thessaloniki

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

ΚΜΡ6-0076626

2023-10-10

2024-04-30

2024-05-30

2023-10-06

2024-06-25

Aristotle University of Thessaloniki, Thessaloníki, Thermi, 57001, Greece

{ "Group A: online real-time home based exercise using the online platform": [ { "intervention_type": "OTHER" } ], "Group B: supervised community based exercise intervention": [ { "intervention_type": "OTHER" } ] }

NCT04749173

To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers.

https://clinicaltrials.gov/study/NCT04749173

COMPLETED

This Phase I study is a double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability and PK profile of single intramuscular doses of DWRX2003 in healthy volunteers.

NO

Covid19

DRUG: DWRX2003, 96mg|DRUG: DWRX2003, 432mg|DRUG: DWRX2003, 144mg|DRUG: DWRX2003, 144mg

Incidence of Treatment-Emergent Adverse Events, Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: follow-up 42 days after dosing ], follow-up 42 days after dosing

Daewoong Pharmaceutical Co. LTD.

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

DW_DWJ1516101

2020-11-21

2021-06-18

2021-06-18

2021-02-11

2021-12-13

Chungnam National university hospital, Daejeon, Korea, Republic of

{ "DWRX2003, 96mg": [ { "intervention_type": "DRUG" } ], "DWRX2003, 432mg": [ { "intervention_type": "DRUG" } ], "DWRX2003, 144mg": [ { "intervention_type": "DRUG" }, { "intervention_type": "DRUG" } ] }

NCT05427773

(In)Voluntary Assessed Quadriceps Muscle Endurance in COPD

https://clinicaltrials.gov/study/NCT05427773

Bionic

COMPLETED

The primary objective is to assess the relation between involuntary and voluntary assessed quadriceps muscle endurance in patients with COPD. We hypothesized a good correlation (>0.8) between the measurements.

NO

Pulmonary Disease, Chronic Obstructive

Electrically evoked fatigue resistance (%), Fatigue resistance (%) is the decline in muscle force generated using electrical stimulation., Performed in first week of pulmonary rehabilitation program|Voluntary isometric quadriceps endurance (time to fatigue)., Voluntary isometric quadriceps endurance (time to fatigue in seconds) is determined on the computerized dynamometer. The isometric endurance test protocol is performed by asking participants to maintain, for as long as possible, an isometric quadriceps contraction representing 60% of the individual isometric maximal voluntary contraction (MVC) force. The test will be ended if the force of the contraction was less than 50% of the MVC for three consecutive seconds., Performed in first week of pulmonary rehabilitation program|Voluntary isokinetic work fatigue index., Voluntary isokinetic work fatigue (%) is the decline in work over 30 repetitions determined on the computerized dynamometer. The isokinetic protocol consists of 30 contractions at an angular velocity of 90°/s with maximal effort during extension and passive (submaximal) flexion. Work fatigue index = *work first 5 repetitions - work last 5 repetitions) / work first 5 repetitions * 100%, Performed in first week of pulmonary rehabilitation program

Radboud University Medical Center

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

1132321

2022-07-05

2023-01-20

2023-01-20

2022-06-22

2023-02-03

Radboudumc, Nijmegen, Gelderland, 6525 GA, Netherlands

{}

NCT04632173

Head and Neck cancERs International cOviD-19 collabOraTion

https://clinicaltrials.gov/study/NCT04632173

UNKNOWN

To develop an International registry on head and neck cancer patients infected with COVID-19

NO

Head and Neck Cancer|Covid19

OTHER: non interventional study

Demographic features, age, performance status etc, Nov 1 2019 to January 31 2021|prevalence of comorbidities in head and neck cancer patients with COVID-19, Nov 1 2019 to January 31 2021|proportion of head and neck cancer patients experiencing severe adverse events, Nov 1 2019 to January 31 2021|proportion of head and neck cancer patients by COVID-19 clinical course severity, Nov 1 2019 to January 31 2021|proportion of head and neck cancer patients with COVID-19 who received chemotherapy, surgery, radiotherapy, immune check point inhibitors in the last 3 months before, as well as during, COVID-19 infection, Nov 1 2019 to January 31 2021|predictive factors of severe adverse events in head and neck cancer patients with COVID-19 including cancer-related treatment, Nov 1 2019 to January 31 2021|prognostic factors of head and neck cancer patients with COVID-19 including cancer related treatment including Human papilloma virus(HPV)., Nov 1 2019 to January 31 2021

Hellenic Cooperative Oncology Group

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|Grupo Español de Tratamiento de Tumores de Cabeza y Cuello|National Cancer Centre, Singapore|Emory University|University of Toronto|University of Birmingham|The University of Queensland

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

HERODOTUS

2021-05-03

2022-06-30

2022-12-30

2020-11-17

2022-03-17

Attikon University Hospital, Chaïdári, Athens, 12462, Greece|Lisa Licitra, Milano, 20133, Italy|National Cancer Centre (NCC)- Radiation Oncology Dept, Singapore, 169610, Singapore

{ "non interventional study": [ { "intervention_type": "OTHER" } ] }

NCT01556373

Effects of Acute Systemic Inflammation on Arterial Stiffness and Microcirculation.

https://clinicaltrials.gov/study/NCT01556373

IRIGA

COMPLETED

This study aims to assess the effect of acute inflammation on arterial stiffness and microcirculation. Patients with severe sepsis will be compared with age-, sex- and cardiovascular risk factors-matched controls. The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate, cardiac output, left ventricular ejection fraction, systemic vascular resistances), central hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index), thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen, C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).

NO

Severe Sepsis

OTHER: NA : non interventional study

Carotid-femoral pulse wave velocity, 1 day

Systemic hemodynamics, * Systolic, diastolic, mean, and pulse blood pressures, and heart rate * Cardiac output, left ventricular ejection fraction, systemic vascular resistances, 1 day|Central aortic hemodynamic, * Aortic systolic, diastolic, mean and pulse pressures, * Augmentation index, 1 day|Micro-circulation, Thenar tissue oxygen saturation, 1 day|Biological markers from plasma samples, * fibrinogen * C-reactiv protein * Interleukin-6 * matrix metalloproteinases -2, -9, and tissue inhibitor of metalloproteinase 1 * epinephrine and norepinephrine, 1 day

Rennes University Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2010-A00612-37

2012-02-23

2015-04-16

2015-04-16

2012-03-16

2019-12-27

Service de Réanimation Chirurgicale - Hôpital de Pontchaillou, Rennes, 35033, France|Unité d Investigation Clinique - Hôpital de Pontchaillou, Rennes, 35033, France

{ "NA : non interventional study": [ { "intervention_type": "OTHER" } ] }

NCT04126473

A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele

https://clinicaltrials.gov/study/NCT04126473

COMPLETED

This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 with and without ivacaftor in patients with CF with at least one G542X allele or phenotypically similar nonsense allele. Up to 16 patients will be enrolled in the trial; up 4 patients will be homozygotes to G542X, and the remaining patients will be compound heterozygotes with G542X or phenotypically similar nonsense mutation and any Class 1 or Class 2 mutation. Each patient will receive 5 escalating doses as follows: * 0.3 mg/kg per day SC * 0.75 mg/kg per day SC * 1.5 mg/kg per day SC * An individualized dose, as high as 3.0 mg/kg per day SC, based upon the patients observed safety and tolerability, PK at previous doses and the results of laboratory tests * ELX-02 1.5 mg/kg per day SC plus 150 mg ivacaftor every 12 bid

NO

Cystic Fibrosis

DRUG: ELX-02|DRUG: Ivacaftor

AEs associated with different dose levels of ELX-02, From the time of first dosing through the follow-up visit, an average of approximately 9 weeks|Area under the plasma concentration curve from time zero to 24 hours (AUC0-24), Full PK profile 8 blood samples up to 24 hours, Day 1 of treatment periods 1, 2, 3, and 4|Maximum observed plasma concentration (Cmax) on Day 1, Full PK profile 8 blood samples over 24 hours, Day 1 of treatment periods 1, 2, 3, and 4|Peak observed plasma concentration (Cpeak) over time, Days 1, 2 and 7 of treatment periods 1-3, Days 1, 2, 7, and 14 of treatment period 4, sparse sampling, blood sampling at 30 min and 1 hour post-dose|Trough observed plasma concentrations (Cpredose) over time, Days 1, 2 and 7 of treatment periods 1-3, Days 1, 2, 7 and 14 of treatment period 4, sparse blood sampling at pre-dose

Changes from baseline in sweat chloride concentration, From baseline to Day 7 of treatment periods 1-3, and Days 7 and 14 of treatment period 4|Changes from baseline in percent predicted forced expiratory volume (ppFEV1), From baseline to Day 7 of treatment periods 1-3, and Days 7 and 14 of treatment period 4|Changes from baseline in percent predicted forced vital capacity (ppFVC), From baseline to Day 7 of treatment periods 1-3, and Days 7 and 14 of treatment period 4|Changes from baseline in percent predicted forced expiratory flow at 25-75% (ppFEF25-75), From baseline to Day 7 of treatment periods 1-3, and Days 7 and 14 of treatment period 4

Eloxx Pharmaceuticals, Inc.

ALL

CHILD, ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

EL-004

2019-11-05

2022-04-06

2022-04-06

2019-10-15

2023-08-21

The Royal Prince Alfred Hospital, Camperdown, New South Whales, 2050, Australia|The Royal Adelaide Hospital, Adelaide, South Australia, Australia|The Alfred Hospital, Melbourne, Victoria, Australia|Universitätsmedizin Essen Ruhrlandklinik, Essen, North Rhine-Westphalia, 45239, Germany|Universitätsklinikum Frankfurt, Frankfurt, Germany|Carmel Medical Center, Haifa, Israel|Hadassah Medical Center, Jerusalem, Israel|Schneider Children s Medical Center, Petach Tikvah, Israel|Safra Children s Hospital - Chaim Sheba Medical Center, Ramat Gan, Israel

{ "ELX-02": [ { "intervention_type": "DRUG", "description": "ELX-02", "name": "ELX-02", "synonyms": [ "", "ELX-02" ], "drugbank_id": "DB15080", "generic_names": [ "ELX-02" ] } ], "Ivacaftor": [ { "intervention_type": "DRUG", "description": "Ivacaftor", "name": "Ivacaftor", "synonyms": [ "N-(2,4-di-tert-butyl-5-hydroxyphenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide", "Kalydeco", "Ivacaftor", "Ivacaftorum" ], "medline_plus_id": "a612012", "generic_names": [ "Ivacaftor" ], "drugbank_id": "DB08820", "wikipedia_url": "https://en.wikipedia.org/wiki/Ivacaftor" } ] }

NCT06084273

Investigation Of Two Different İnterventions İn Hemiplegic Patients

https://clinicaltrials.gov/study/NCT06084273

COMPLETED

Background: Our study aims to determine the effect of relaxation and breathing exercises in addition to the treatment procedure on depression level, sleep quality, and spasticity in hemiplegic patients. Methods: Thirty patients aged 40-70 years diagnosed with hemiplegia were included in the study. All patients received the same Bobath exercise three days a week for six weeks. Patients in Group 2 additionally received breathing and relaxation exercises. Sleep quality assessment by Pittsburgh Sleep Quality Index (PUKI), depression by Hospital Anxiety and Depression Scale (HADS), and spasticity by Modified Ashworth scale (MAS) were used. All assessments were made at baseline and six weeks after exercise treatments.

NO

Stroke|Physiotherapy and Rehabilitation

OTHER: Bobath Exercises|OTHER: Breathing Exercises,Breathing Exercises, Bobath Exercises

Sleep quality assessment, The subjective sleep questionnaire, the PUKI, is used to assess individuals sleep quality, sleep duration, presence of sleep problems, and the severity of sleep problems over the past month., 30 min|Depression assessment, The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale developed to determine the risk, level, and severity of anxiety and depression in individuals, 30 min|Spasticity assessment, Spasticity is a method used to determine the severity of spasticity. The assessment is based on the subjective rating of the resistance felt by the evaluator during the evaluation. It is divided into six degrees: 0 = Normal muscle tone, 1 = Slight increase in muscle tone with minimal resistance felt at the end of the range of motion, 1+ = Minimal resistance felt in less than half of the range of motion, 2 = more pronounced increase in muscle tone but affected parts can be moved without difficulty, 3 = Passive movement is complex and requires significant effort, with a noticeable increase in muscle tone, 4 = Affected parts are rigid in flexion and extension, with severe increase in tone., 15 min

Derya Azim

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

06.04/58

2021-11-01

2021-12-30

2021-12-30

2023-10-16

2023-10-16

Istanbul Aydın University, Istanbul, 34900, Turkey

{ "Bobath Exercises": [ { "intervention_type": "OTHER" } ], "Breathing Exercises,Breathing Exercises, Bobath Exercises": [ { "intervention_type": "OTHER" } ] }

NCT04196673

Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses

https://clinicaltrials.gov/study/NCT04196673

Acryvivi

COMPLETED

On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type. A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.

NO

Age Related Cataracts

DEVICE: Alcon SN60WF|DEVICE: Hoya Vivinex

PCO score, subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO), 3 years

Visual Acuity, UCDVA(uncorrected distance visual acuity), BCDVA (best corrected distance visual acuity), 3 years|Fibrosis, grade of fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis), 3 years|Subjective glistening score, neg, <10, 10-20, 20-30, 30-40, >40 uniform or localized, 3 years|YAG capsulotomy rate, described subjectively at the slitlamp: was a YAG capsulotomy performed yes/no, 3 years

Medical University of Vienna

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC

1560/2014

2015-09-01

2016-06-19

2019-08-23

2019-12-12

2019-12-12

{ "Alcon SN60WF": [ { "intervention_type": "DEVICE" } ], "Hoya Vivinex": [ { "intervention_type": "DEVICE" } ] }

NCT02895373

PGE1 as Additive Anticoagulant in ECMO-Therapy

https://clinicaltrials.gov/study/NCT02895373

ECMO_PGE1

TERMINATED

Bleeding complications and thromboembolic complications are frequent during extracorporeal membrane oxygenation (ECMO). Retrospective data suggest that platelet inhibition using prostaglandins, in this case PGE1, may reduce thromboembolic complications without increasing the bleeding risk. This randomized, double-blind trial aims to investigate the effects of PGE1 on bleeding risk, thromboembolic complications and the function of the ECMO.

NO

Respiratory Distress Syndrome, Adult|Extracorporeal Membrane Oxygenation

DRUG: Alprostadil|DRUG: 0.9% sodium chloride solution

Bleeding rate (quantified by the number of packed red blood cells transfused in relation to the duration of ECMO therapy), The bleeding rate will be quantified by the number of packed red blood cells in relation to the duration of ECMO therapy. This duration may vary and cannot be predicted. Thus, we will calculate the required number of packed red blood cells i.e. per week., up to 6 months

number of bleeding incidences and severity of bleeding (bleeding grades), type 0: no bleeding type1: bleeding that is not actionable type 2: any overt actionable sign of hemorrhage type3: a) overt bleeding plut hb drop of 3-5g/dl b) >5g/dl, cardiac tamponade, requiring surgical intervention, bleeding requiring vasoactive agents c)intracranial bleeding, type 5: fatal bleeding number and severity of bleeding relative to the duration of ECMO therapy, up to six months|Number of Clotting Events, * clinically noticeable thromboembolic events * cannulized veins (Duplex 24h after canula removal) * need of Membrane- changes,, macroscopic thrombus, discoloration * Global clotting tests (prothrombin time, activated partial thromboplastin time, Fibrinogen, D-Dimer) number of Clotting events in relation to the duration of ECMO therapy., up to six months|Function of the membrane oxygenator, The function of the membrane oxygenator will be assessed on a daily basis as part of clinical routine.This includes the capacity of oxygen transfer and carbon-dioxide (CO2) transfer., up to six months|Number of changes of the membrane oxygenator relative to the duration of ECMO therapy, Membrane oxygenators need to be changed due to loss of function (cause by clotting etc.)., up to six months|Inflammation specific biomarkers (i.e. C-reactive protein, blood counts, reticulated platelets, etc.), daily routine measurements and frozen plasma, Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months|Global Coagulation assays, Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months|Thromboelastometry, Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months|platelet function analyzer-100, Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months|Fibrinogen levels, Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months|whole blood aggregometry, Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months|D-Dimer levels, Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months|Catecholamines, need for and dose of catecholamines, Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months|cardiac output, Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months|blood pressure, Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months|mortality, by chart review or telephone call, Day 28/90, ICU mortality assessed at the discharge from the Intensive Care unit, this will be up to 12 months after inclusion into the study|number of platelet transfusions, fresh frozen plamsa, coagulation interventions etc., by chart review, number relative to the duration of ECMO therapy, up to six months|number of platelet transfusions, by chart review, number relative to the duration of ECMO therapy, up to six months|number of coagulation interventions, by chart review, number relative to the duration of ECMO therapy, up to six months

Thomas Staudinger

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

ECMO_PGE1_2.1

2016-07

2021-05

2021-07

2016-09-09

2022-02-09

Medical University of Vienna, Department of Medicine I, Intensive Care Unit, Vienna, 1090, Austria

{ "Alprostadil": [ { "intervention_type": "DRUG", "description": "Alprostadil", "name": "Alprostadil", "synonyms": [ "Prostaglandin E1alpha", "PGE1", "Alprostadil", "Alprostadilum", "Prostaglandin E1", "11\u03b1,15\u03b1-dihydroxy-9-oxo-13-trans-prostenoic acid", "(11\u03b1,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid", "(13E)-(15S)-11alpha,15-Dihydroxy-9-oxoprost-13-enoate", "PGE-1" ], "mesh_id": "D064804", "generic_names": [ "Alprostadil" ], "drugbank_id": "DB00770" } ], "Sodium chloride": [ { "intervention_type": "DRUG", "description": "0.9% sodium chloride solution", "name": "Sodium chloride", "synonyms": [ "Cloruro s\u00f3dico", "Sodium chloride", "Natrum muriaticum", "Natriumchlorid" ], "drugbank_id": "DB09153", "generic_names": [ "Sodium chloride" ] } ] }

NCT00489931

Phase I Open-Label Study of Recombinant DNA Plasmid Vaccine, VRC-AVIDNA036-00-VP, Encoding for Influenza Virus H5 Hemagglutinin Protein Given Intradermally

https://clinicaltrials.gov/study/NCT00489931

COMPLETED

This study will evaluate the safety and effectiveness of a vaccine to prevent avian influenza (bird flu). About 25 to 50 million cases of influenza occur a year in the U.S., leading to 150,000 hospitalizations and 30,000 to 40,000 deaths. Globally, a pandemic influenza may be 1 billion flu cases, with 3 to 5 million cases of severe illness and up to half a million deaths annually. There is potential threat of a pandemic from emerging virus strains for which the population has little or no preexisting immunity. Avian influenza A (H5N1) viruses causing serious disease have emerged recently, affecting domestic and wild bird populations. Patients ages 18 to 60 who are in good health and not pregnant or breast feeding may be eligible for this study. The study will be done at the NIH Clinical Center by staff of the Vaccine Research Center. It will last about 32 weeks for each person. A traditional needle or a needle-free device called Biojector 2000 will be used. Intramuscular (in the muscle) and subcutaneous (in fat below the skin) delivery of vaccine via Biojector is cleared for use by the Food and Drug Administration and is not considered investigational. Intradermal (in the skin) delivery of vaccine by Biojector in this study is deemed investigational but has been evaluated in humans before, and found safe and well tolerated in other trials. There will be about 10 clinic visits in this study, and it is important to stay on schedule. Visits are about 2 hours, though on injection days, visits are about 4 hours. Injections are given on day 0 and at weeks 4 and 8. The vaccine is given by injections in the skin on the upper arms. Clinic staff will observe patients for 30 minutes after each vaccination. One to 2 days after the first injection, there will be a clinic visit. One to 3 days after the second and third injections, patients need to telephone clinic staff to report on how they are doing. Patients will complete a diary card at home, recording temperature and symptoms, and looking at the injection site daily for 5 days. Patients should report any side effects to one of the study physicians or nurses as soon as possible. They will return to the clinic 2 weeks after each injection. A needle-free system uses the pressure of carbon dioxide, instead of a needle, to inject the vaccine into the skin. Discomfort can result from either the needle-free device or the needle. There may be stinging, pain, soreness, swelling, bruising, or a small cut in the skin.

NO

Influenza A Virus, H5N1 Subtype|Influenza A Virus|Influenzavirus A|Orthomyxovirdae|H5N1 Virus

DRUG: VRC-AVIDNA036-00-VP

Safety (local and systemic reactogenicity, lab tests, AEs)

Immunogenicity (cellular and humoral immune function assays)

National Institute of Allergy and Infectious Diseases (NIAID)

ALL

ADULT

PHASE1

NIH

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION

070172|07-I-0172

2007-06-18

2009-04-15

2007-06-21

2017-07-02

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States

{ "VRC-AVIDNA036-00-VP": [ { "intervention_type": "DRUG" } ] }

NCT01608373

The Effect of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation on Pain After Laparoscopic Cholecystectomy

https://clinicaltrials.gov/study/NCT01608373

UNKNOWN

This prospective randomized study aims to comparison the effectiveness of intravenous lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in patients undergoing laparoscopic cholecystectomy. A total of 83 patients will be randomized into one of three groups (group C or group I or group P) based on Excel number generation. Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr. Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg lidocaine and normal saline 100cc. Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 2, 4, 8, 12, 24, 48 hours postoperatively.

NO

Postoperative Pain

DRUG: Intravenous lidocaine injection|DRUG: Intraperitoneal lidocaine irrigation group|DRUG: Intravenous normal saline injection

Postoperative pain measuring using Visual analogue scale at postoperative 2hour, Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is No pain , right side end with 100 is Very severe pain . The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 2hour., Post op 2 hour

Visual analogue scale 4hour, Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is No pain , right side end with 100 is Very severe pain . The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 4hour., Post op 4 hour|Visual analogue scale 8hour, Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is No pain , right side end with 100 is Very severe pain . The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 8hour., Post op 8 hour|Visual analogue scale 12 hour, Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is No pain , right side end with 100 is Very severe pain . The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 12hour., Post op 12hour|visual analogue scale 24hour, Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is No pain , right side end with 100 is Very severe pain . The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 24hour., Post op 24hour|Visual analogue scale 48 hour, Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is No pain , right side end with 100 is Very severe pain . The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 48hour., Post op 48hour|Opioid consumption 2hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 2hour will be measured., Post op 2 hour|Opioid consumption 4 hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 4hour will be measured., Post op 4 hour|Opioid consumption 8 hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 8hour will be measured., Post op 8 hour|Opioid consumption 12 hout, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 12hour will be measured., Post op 12 hour|Opioid consumption 24 hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 24hour will be measured., Post op 24 hour|Opioid consumption 48hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 48hour will be measured., Post op 48 hour|FPB 2 hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 2 hour will be measured., Post op 2 hour|FPB 4 hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 4 hour will be measured., Post op 4 hour|FPB 8 hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 8 hour will be measured., Post op 8 hour|FPB 12 hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 12 hour will be measured., Post op 12 hour|FPB 24 hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 24 hour will be measured., Post op 24hour|FPB 48 hour, The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 48 hour will be measured., Post op 48 hour

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

ChungAngUH4

2011-07

2014-07

2014-07

2012-05-31

2013-08-02

Hyun Kang, Seoul, Korea, Republic of

{ "Lidocaine": [ { "intervention_type": "DRUG", "description": "Intravenous lidocaine injection", "name": "Lidocaine", "synonyms": [ "Boots Haemorrhoid", "2-(Diethylamino)-2',6'-acetoxylidide", "2-2EtN-2MePhAcN", "\u03b1-diethylamino-2,6-dimethylacetanilide", "Xylocaine", "Lidocaine Monohydrochloride, Monohydrate", "Lidocaine Carbonate", "Xyloneural", "2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide", "Ztlido", "EMLA", "Lidocaina", "Lidocaine", "2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide", "Covonia", "Xylopract", "Nulbia", "Lidoca\u00edna", "Octocaine", "Lidocainum", "LMX4", "Bonjela", "Lidocaine Hydrochloride", "Dalcaine", "Lidocaine Sulfate (1:1)", "Anbesol", "Perinal", "Anusol", "Lidocaine Monohydrochloride", "Germaloids", "Iglu", "Xylesthesin", "Lidocaine Monoacetate", "Lignocaine", "Calgel", "Lidocaine Carbonate (2:1)", "Denela", "Lidocaine Hydrocarbonate", "alpha-diethylamino-2,6-dimethylacetanilide", "Xylocitin", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Xylocaine", "Lidocaine Viscous", "Xylocaine", "Lidocaine Viscous", "Senstend", "Emla", "Fortacin", "Lidocaine/prilocaine", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort" ], "nhs_url": "https://www.nhs.uk/medicines/lidocaine-for-piles-and-itchy-bottom", "generic_names": [ "Lidocaine", "Lidocaine Patch", "Lidocaine Patch", "Lidocaine Viscous", "Lidocaine Viscous", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone" ], "mesh_id": "D061567", "drugbank_id": "DB00281", "wikipedia_url": "https://en.wikipedia.org/wiki/Lidocaine" }, { "intervention_type": "DRUG", "description": "Intraperitoneal lidocaine irrigation group", "name": "Lidocaine", "synonyms": [ "Boots Haemorrhoid", "2-(Diethylamino)-2',6'-acetoxylidide", "2-2EtN-2MePhAcN", "\u03b1-diethylamino-2,6-dimethylacetanilide", "Xylocaine", "Lidocaine Monohydrochloride, Monohydrate", "Lidocaine Carbonate", "Xyloneural", "2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide", "Ztlido", "EMLA", "Lidocaina", "Lidocaine", "2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide", "Covonia", "Xylopract", "Nulbia", "Lidoca\u00edna", "Octocaine", "Lidocainum", "LMX4", "Bonjela", "Lidocaine Hydrochloride", "Dalcaine", "Lidocaine Sulfate (1:1)", "Anbesol", "Perinal", "Anusol", "Lidocaine Monohydrochloride", "Germaloids", "Iglu", "Xylesthesin", "Lidocaine Monoacetate", "Lignocaine", "Calgel", "Lidocaine Carbonate (2:1)", "Denela", "Lidocaine Hydrocarbonate", "alpha-diethylamino-2,6-dimethylacetanilide", "Xylocitin", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Xylocaine", "Lidocaine Viscous", "Xylocaine", "Lidocaine Viscous", "Senstend", "Emla", "Fortacin", "Lidocaine/prilocaine", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort" ], "nhs_url": "https://www.nhs.uk/medicines/lidocaine-for-piles-and-itchy-bottom", "generic_names": [ "Lidocaine", "Lidocaine Patch", "Lidocaine Patch", "Lidocaine Viscous", "Lidocaine Viscous", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone" ], "mesh_id": "D061567", "drugbank_id": "DB00281", "wikipedia_url": "https://en.wikipedia.org/wiki/Lidocaine" } ], "Intravenous normal saline injection": [ { "intervention_type": "DRUG" } ] }

NCT04528173

Opioid-Free Anesthetic for Tonsillectomy

https://clinicaltrials.gov/study/NCT04528173

RECRUITING

Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic

NO

Anesthesia|Opioid Use|Tonsillitis|Sleep Disorder|Surgery

DRUG: Ketorolac|DRUG: Dexmedetomidine|DRUG: Morphine|DRUG: Fentanyl

Median Maximum Pain Score, Median Maximum Pain Score by investigational group in the recovery room, calculated by the blinded observer 15 and 30 minutes after awakening., up to 30 minutes

Frequency of nausea, vomiting, pruritis, Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30., up to post-op day 30|Frequency of readmission and of seeking unplanned medical attention (phone calls, office visits, ED visits), Chart review and questionnaires for readmission and medical reattendance, including calls to physician, up to 2 years|Frequency of non-artifactual percentage of oxygen saturation (SpO2)<90% (>30 seconds), Collected in recovery room and chart review, up to 2 years|Percentage of patients receiving rescue opioids, Questionnaires and chart review, up to 2 years|Family satisfaction with patient recovery based on seven-point Likert score, Follow-up questionnaire to family on post-op days 1, 5, and 30. Parents will be asked to rank how satisfied they are with their child s recovery by using these two prompts: I am satisfied with my child s recovery, and I am satisfied with my child s pain control at home. They will choose from the following options: Strongly agree = 1 , Agree = 2 , More or Less agree = 3 , Undecided = 4 , More or Less disagree = 5 , Disagree = 6 , Strongly Disagree =7. Minimum score is 1, Max is 7. Higher scores indicate worse outcomes., up to post-op day 30|Bleeding prevalence, Follow-up questionnaires and chart review, up to 2 years

Children s Hospital of Philadelphia

University of Pennsylvania|University of Tennessee

ALL

CHILD, ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

19-016618

2020-07-22

2023-10-30

2023-12-31

2020-08-27

2023-08-02

The Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|University of Tennessee Health Science Center; St. Jude Children s Research Hospital, Memphis, Tennessee, 38105, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT04528173/Prot_SAP_002.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/73/NCT04528173/ICF_003.pdf

{ "Ketorolac": [ { "intervention_type": "DRUG", "description": "Ketorolac", "name": "Ketorolac", "synonyms": [ "Ketorolac", "Toradol", "Acular", "Ketorolaco", "Ketorolacum", "rac-Ketorolac", "K\u00e9torolac", "Sprix" ], "medline_plus_id": "a601241", "generic_names": [ "Ketorolac" ], "mesh_id": "D016861", "drugbank_id": "DB00465" } ], "Dexmedetomidine": [ { "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" } ], "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" } ], "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" } ] }

NCT02522273

Evaluation of the SensPoint Lactate Meter in the Estimation of Foetal Scalp Blood and Umbilical Cord Blood Lactate

https://clinicaltrials.gov/study/NCT02522273

WITHDRAWN

A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a baby. An abnormal CTG may be a sign that a baby has low oxygen levels (hypoxia) and is becoming distressed. In this situation a blood test can be taken from the scalp of the baby. A high lactate level in the blood indicates that urgent delivery is required to prevent long-term harm to the newborn. SensPoint is a new medical device that measures lactate. It has several potential benefits over the current method of measuring lactate in that it is a portable hand-held device (allowing for use in the delivery room), requires a much smaller volume of blood and produces results more quickly than the current method of measuring lactate. Before a new device is adopted into clinical practice, it is important that it is first confirmed that it is accurate and reliable for its intended use. This study will evaluate the ability of the SensPoint device to accurately and reliably detect lactate in fetal and umbilical cord blood by comparing its performance to the reference device currently in use.

NO

Measurement of Fetal Blood Lactate

DEVICE: EKF Diagnostics SensPoint Lactate Meter

Comparison of lactate level in blood obtained from the fetal scalp measured using a Senspoint handheld lactate meter and the current gold standard., Foetal blood sampling will be undertaken as clinically indicated by National Intrapartum Guidance and serum lactate will be measured in the usual manner using the current gold standard. Once the serum lactate has been measured using the current gold standard (and the sample are no longer clinically useful and would normally be discarded) any blood remaining in the capillary tube will be handed to the research team. A member of the research team will then process the sample using the new Senspoint device. Lactate readings from (i) the reference machine and (ii) the Senspoint device will be compared using a Bland-Altman plot, a difference plot used in analytical chemistry and biostatistics to analyze the agreement between two different assays., Within 5 minutes of obtaining blood sample|Comparison of lactate level in blood obtained from the umbilical artery measured using a Senspoint handheld lactate meter and the current gold standard., Blood from the umbilical artery will be sampled as clinically indicated by National Intrapartum Guidance and serum lactate will be measured in the usual manner using the current gold standard. Once the serum lactate has been measured using the current gold standard (and the sample are no longer clinically useful and would normally be discarded) any blood remaining in the syringe will be handed to the research team. A member of the research team will then process the sample using the new Senspoint device. Lactate readings from (i) the reference machine and (ii) the Senspoint device will be compared using a Bland-Altman plot, a difference plot used in analytical chemistry and biostatistics to analyze the agreement between two different assays., Within 5 minutes of obtaining blood sample|Comparison of lactate level in blood obtained from the umbilical vein measured using a Senspoint handheld lactate meter and the current gold standard., Blood from the umbilical vein will be sampled as clinically indicated by National Intrapartum Guidance and serum lactate will be measured in the usual manner using the current gold standard. Once the serum lactate has been measured using the current gold standard (and the sample are no longer clinically useful and would normally be discarded) any blood remaining in the syringe will be handed to the research team. A member of the research team will then process the sample using the new Senspoint device. Lactate readings from (i) the reference machine and (ii) the Senspoint device will be compared using a Bland-Altman plot, a difference plot used in analytical chemistry and biostatistics to analyze the agreement between two different assays., Within 5 minutes of obtaining blood sample

North Bristol NHS Trust

EKF Diagnostics

FEMALE

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

3493

2015-10

2016-03

2015-08-13

2020-09-14

North Bristol NHS Trust, Bristol, BS10 5NB, United Kingdom

{ "EKF Diagnostics SensPoint Lactate Meter": [ { "intervention_type": "DEVICE" } ] }

NCT01578031

The Effects of Treating Obese and Lean Patients With Sleep Apnea

https://clinicaltrials.gov/study/NCT01578031

PISA

COMPLETED

The investigators overall goal is to compare the effect of CPAP treatment on intermediate cardiovascular risk measures in obese versus lean patients with obstructive sleep apnea (OSA). The overall hypothesis is that, adjusting for OSA severity and obtaining normative data from non-OSA subjects with comparable amounts of visceral adiposity, the two OSA groups will have comparable improvements in daytime sleepiness, but that the cardiovascular and metabolic improvements following CPAP therapy will be decreased in OSA patients with increased visceral adipose tissue. The investigators anticipate that, although there will be a greater absolute change in markers of sympathetic activity, inflammation and oxidative stress in obese compared to lean OSA patients following CPAP treatment, the levels will still be abnormally high in the obese patients resulting in the decreased improvements in insulin resistance, arterial blood pressure, and vascular health in obese versus lean OSA patients.

YES

Sleep Apnea|Obesity

DEVICE: Positive Airway Pressure During Sleep (ResMed S9 Elite)|OTHER: Usual Care

Change From Baseline in Mean Arterial Blood Pressure, Change in mean 24-hour ambulatory blood pressure from baseline following 4-months of PAP treatment, 4 months

Change From Baseline in Psychomotor Vigilance Task, Change from Baseline in Psychomotor Vigilance Task as measured by number of lapses during 10-minute Reaction time test., 4 months|Change From Baseline in Sympathetic Nervous System Activity, Change from Baseline in Sympathetic Nervous System Activity as measured by 24-hour urine collection for norepinephrine levels., 4 months|Change From Baseline in Circulating Inflammatory Biomarker, Change from Baseline in Circulating Inflammatory Biomarker: IL-6., 4 months|Change From Baseline in Oxidative Stress, Overnight urinary excretion of 8-isoprostane., 4 months

University of Pennsylvania

University of Iceland

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

NIH P02 HL094307-01

2009-03

2014-09

2014-09

2012-04-16

2017-05-18

2019-07-05

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

{ "Positive Airway Pressure During Sleep (ResMed S9 Elite)": [ { "intervention_type": "DEVICE" } ], "Usual Care": [ { "intervention_type": "OTHER" } ] }

NCT05226273

Occupational Exposure to Dust and the Relationship With the Respiratory Symptoms, Lung Function Among Construction Workers of the University of Malaysia Sabah (UMS)

https://clinicaltrials.gov/study/NCT05226273

COMPLETED

Background The respiratory tract often becomes the site of injury from occupational exposure. All construction sites generate high levels of dust, typically from concrete, silica, asbestos, cement, wood, stone, sand and therefore, the workers are exposed to this airborne dust and increased their risk of developing respiratory disorders. Limited studies have been conducted to assess the relationship between respiratory symptoms, lung function and occupational dust exposure among construction workers in Sabah. The objectives of this study are to determine the occupational exposure to dust and the relationship with the respiratory symptoms as well as lung function among construction workers in UMS Teaching Hospital. Materials and methods This cross-sectional study consisted of construction workers working in all sections in the development of UMS Teaching Hospital. A standard respiratory questionnaire was distributed to construction workers and lung function measurement was performed using Spirometry and the results of their respiratory status were compared between workers who were exposed and unexposed to dust. Occupational dust exposure was determined by the gravimetric method using an air sampler. The total duration of the collection was 8 hours and the filters with the dust samples were analyzed in the laboratory.

NO

Occupational Exposure

OTHER: no intervention

Number of participants with Occupational exposure to dust, Number of participants with Occupational exposure to dust and having respiratory symptoms, 2019-2020

Universiti Malaysia Sabah

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

JKEtika 3/18 (9).

2019-01-01

2019-10-01

2020-01-01

2022-02-07

2022-02-07

Universiti Malaysia Sabah, Kota Kinabalu, Sabah, 88400, Malaysia

{ "no intervention": [ { "intervention_type": "OTHER" } ] }

NCT05406531

The Effectiveness of Psychological Interventions in Psycho-neuroendocrine-immune Network in Breast Cancer Survivors

https://clinicaltrials.gov/study/NCT05406531

RECRUITING

In this study researchers will examine an influence of three different psychological interventions in the form of mobile application on psycho-neuroendocrine-immune system among breast cancer survivors.

NO

Breast Cancer Female|Breast Cancer Stage I|Breast Cancer Stage II|Breast Cancer Stage III

BEHAVIORAL: Mindfulness-Based Cognitive Therapy (MBCT-Ca) - online|BEHAVIORAL: Positive Psychology - online|BEHAVIORAL: Autogenic Training - online

Change in heart rate variability (HRV) using ECG, HRV will be obtained from ECG measured according to a protocol involving a standardized sequence of measurements taken at rest with uncontrolled and controlled breathing. The completion of questionnaire related to rumination and impact of the cancer event before the measurement of rest ECG will serve as the priming of distress. The obtained data will be processed using the Kubios HRV Premium program- time-domain HRV parameters - RMSSD, SDNN, pNN50 and Power Spectrum density HRV parameters - LF power, HF power, and LF/HF ratio., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in symptoms of individual stress level using the Perceived Stress Scale, The Perceived Stress Scale (PSS) is a classic stress assessment instrument. The questions in this scale ask about feelings and thoughts during the last month. Each question has five response options ranging in value from null to four (0=never; 1=almost never; 2=sometimes; 3=fairly often; 4=very often). To find the total raw score, sum the values of the response to each question (reverse code items 4, 5, 7a and 8). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in depression, anxiety and stres using the Depression, Anxiety and Stress Scale, The Depression, Anxiety and Stress Scale (DASS-21) is a 21 items scale designed to measure depression, anxiety, and stress. The instrument comprises three subscales: the emotional states of depression, anxiety, and stress. Each question has four response options ranging in value from null to four (0= did not apply to me at all; 1= applied to me to some degree, or some of the time; 2= applied to me a considerable degree or a good part of time; 3= applied to me very much or most of the time). To find the total raw score, sum the values of the response to each question for each of subscale (scores will need to be multiplied by 2 to calculate the final score). The lowest possible raw score is 0 and the highest possible raw score is 42 for each subscale. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in positive mental health using the Positive Mental Health Scale, The Positive Mental Health Scale (PMHS) is a nine-item scale designed to measure positive mental health (combination of emotional, psychological, and social aspects of well-being). Each item on the questionnaire is scored from 0 (do not agree) - 3 (agree). The lowest possible raw score is 0 and the highest possible raw score is 27. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in health-related quality of life using The Functional Assessment of Chronic Illness Therapy (FACIT)-Spiritual Well-Being (Sp), The Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT)-(Sp) is composed of the FACT-General (FACT-G) and a 12-item Spiritual Well-Being scale (FACIT-Sp-12).The FACT-G (Version 4) is a 27-item compilation of general questions divided into four primary QOL subscales: Physical Well-Being (PWB; 7-items), Social/Family Well-Being (SWB; 7-items), Emotional Well-Being (EWB; 6-items), and Functional Well-Being (FWB; 7-items).Each question has five response options ranging in value from null to four (0= not at all; 1= a little bit; 2=somewhat; 3= quite a bit; 4=very much). The total FACT-G score is obtained by summing individual subscale scores (PWB + EWB + SWB + FWB). The lowest possible raw score is 0 and the highest possible raw score is 48 in Spiritual Well-Being subscales. The lowest possible raw score is 0 and the highest possible raw score is 108 in FACT-G. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention

Change in relative and absolute counts of B-lymphocytes (CD19+), T-lymphocytes, T-helper lymphocytes (CD3+ CD4+), T-cytotoxic lymphocytes (CD3+ CD8+), NK-cells (CD16+ CD56+), NK-T-like cells (CD3+ CD56+) and monocytes (CD14+), The counts will be obtained by flow cytometric immunophenotyping. For immunophenotyping tests will be collected peripheral blood sample (2,6 ml of K3EDTA-blood) of patients., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in cytokine levels, Cytokine levels (IL-1β, IL-2, IL-6, IL-8, IL-12, IFN-γ, TNFα, IL-17, IL-1ra, IL-4, IL-5, IL-10, TGF-β) will be analysed using the Bioplex 200 multiplex system. For cytokines levels will be collected peripheral blood sample (7,5 ml of blood without anti-coagulants for serum separation). Units of measurement: pg/ml (ng/l)., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in serum cortisol level, Serum cortisol level will be determined by chemiluminescence-based immunoassay using the Cobas e 601 analyser (ROCHE Diagnostics). For serum cortisol level will be collected peripheral blood sample (7,5 ml of blood without anti-coagulants for serum separation ) between 9-11. a.m. Units of measurement: nmol / l., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in levels of C-reactive protein (CRP), Levels of C-reactive protein (CRP) will be determined through the turbidimetric method automated on the Cobas c 501 module . For CRP level will be collected peripheral blood sample (7,5 ml of blood without anti-coagulants for serum separation).Units of measurement: mg/l., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in current emotional state using the Self-Assessment Manikin, Current emotional state will be assessed three times per day using three short items (Self-Assessment Manikin) directly incorporated in the MOÚ MindCare Application. The Self-Assessment Manikin (SAM) measures pleasure, arousal, and dominance. It is a non-verbal pictorial assessment technique., every single morning during a whole 8 weeks of intervention; every single afternoon during a whole 8 weeks of intervention; every single evening during a whole 8 weeks of intervention|Adherence to/satisfaction with the MOÚ MindCare application and intervention programme using the MOÚ MindCare Feasibility Questionnaire, Mobile application will be monitoring completing tasks by participants. Satisfaction with the MOÚ MindCare application will be measured by the MOÚ MindCare Feasibility Questionnaire. Questions have two, three, four or five response options ranging in value from one to two, three, four or five. A few questions have open answers options. To find the total raw score, sum the values of the response to each question (reverse code item: 4). The lowest possible raw score is 8 and the highest possible raw score is 26. A higher score represents more of the concept being measured., week 9 from baseline|Change in emotion dysregulation using the Difficulties in Emotion Regulation Scale-SF, The Difficulties in Emotion Regulation Scale Short Form (DERS-SF) is a measure used to identify emotional regulation issues. The measure covers 4 dimensions of emotional regulation: awareness and understanding of emotions; acceptance of emotions; the ability to engage in goal-directed behaviour and refrain from impulsive behaviour when experiencing negative emotions; and access to emotion regulation strategies perceived as effective. Each question has five response options ranging in value from one to five (1=almost never; 2=sometimes; 3=about half of the time; 4=most of the time; 5=almost always). The lowest possible raw score is 18 and the highest possible raw score is 90. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Five Facet Mindfulness Questionnaire-15, The 15-item FFMQ (FFMQ-15) measures five facets: Observing, Describing, Acting with Awareness, Non-Judging of inner experience, and Nonreactivity to inner experience. Each question has five response options ranging in value from one to five (1=never or very rarely true; 2= rarely true; 3=sometimes true; 4=often true; 5=very often or always true). To find the total raw score, sum the values of the response to each question (reverse code items 3, 4, 7, 8, 9, 13 and 14). The lowest possible raw score is 15 and the highest possible raw score is 75. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Applied Mindfulness Process Scale, The Applied Mindfulness Process Scale (AMPS) measures the application of mindfulness practices in daily life among persons participating in mindfulness-based interventions. The measure covers three domains of applied mindfulness processes: decentering, positive emotional regulation, and negative emotional regulation. Each question has five response options ranging in value from null to four (0= never; 1= rarely; 2=sometimes; 3=often; 4=almost always). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 0 and the highest possible raw score is 60. A score ranging from 0-20 is obtained by summing each factor individually. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Self- Compassion Scale, The Self-compassion Scale (SCS) is a psychometrically measurement of self-compassion. The instrument comprises six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness and Over-identification. Each item on the questionnaire is scored from 1-5 (1=almost never, 5=almost always). To find the total raw score, sum the values of the response to each question for each of subscale (reverse code items 1, 2, 4, 6, 8, 13, 16, 18, 20, 21, 24 and 25). The lowest possible raw score is 26 and the highest possible raw score is 130. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Gratitude Questionnaire Six-Item Form, The Gratitude Questionnaire-Six-Item Form (GQ-6) is a self-report questionnaire measures individual differences in the proneness to experience gratitude in daily life. Each question has seven response options ranging in value from one to seven (1= strongly disagree; 2= disagree; 3= slightly disagree; 4= neutral; 5= slightly agree; 6= agree; 7= strongly agree). To find the total raw score, sum the values of the response to each question (reverse code items 3 and 6). The- Page 4 of 7 - lowest possible raw score is 6 and the highest possible raw score is 42. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Perceived Hope Scale, The Perceived Hope Scale (PHS) is self-report questionnaire measures individual judgment about one s experience and levels of hope. Each item on the questionnaire is scored from 0-5 (0= strongly disagree, 5= strongly agree). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 0 and the highest possible raw score is 30. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Basic personality traits using the Big Five Inventory BFI-10, The Big Five Inventory-10 (BFI-10) measures the Big Five personality traits: Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness. Each question has five response options ranging in value from one to five (1= disagree strongly; 2= disagree a little; 3= neither agree or disagree; 4= agree a little; 5= agree strongly). To find the total raw score, sum the values of the response to each question for each of subscale (reverse code items 1,3,4,5 and 7). The lowest possible raw score is 10 and the highest possible raw score is 50. A score ranging from 2-10 is obtained by summing each factor individually. A higher score represents more of the concept being measured., baseline|Change in rumination and reflection using the Rumination-Reflection Questionnaire, The Rumination Reflection Questionnaire (RRQ) measures an adaptive (self-focus) and maladaptive form (self- rumination) of self-focus or self-attention. The instrument comprises two subscales: Rumination and Reflection. Each question has five response options ranging in value from one to five (1= strongly disagree; 2= disagree; 3= neutral; 4= agree; 5= strongly agree). To find the total raw score, sum the values of the response to each question for each of subscale (reverse code items 6, 9, 10, 13, 14, 17, 20 and 24). The lowest possible raw score is 24 and the highest possible raw score is 120. A score ranging from 12-60 is obtained by summing each factor individually. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in impact of event using the Impact of Event Scale-Revised, The Impact of Event Scale - Revised (IES-R) measures impact of recent and specific events, and post-traumatic stress disorder symptoms. The instrument comprises three subscales: Intrusion; Avoidance and Hyperarousal. Each question has five response options ranging in value from null to four (0= not at all; 1= a little bit; 2= moderately; 3= quite a bit; 5= extremely). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 0 and the highest possible raw score is 88. A scores ranging from: 0-32; 0-32 and 0-24 are obtained by summing each factor individually. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in sleep quality using the Pittsburgh Sleep Quality Index, The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality and disturbances. The instrument comprises seven subscales: subjective sleep quality; sleep latency; sleep duration; habitual sleep efficiency; sleep disturbances; use of sleeping medication and daytime dysfunction. Questions have four response options ranging in value from null to three and a few questions with open answers options. To find the total raw score, sum the values of the response to each question and for each subscale separately. The sum of scores for components yields one global score. The lowest possible raw score is 0 and the highest possible raw score is 21. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in fatigue using the Fatigue Symptom Inventory, The Fatigue Symptom Inventory (FSI) measures multiple aspects of fatigue, including its perceived severity, frequency, and interference with daily functioning. Each item on the questionnaire is scored from 0-10 (0= not at all fatigued, 10= as fatigued as I could be). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 0 and the highest possible raw score is 130. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|The total amount of received health care using the medical documentation software (GreyFox), Number of PET, CT and MR imaging examinations, number of acute hospitalizations, the total cost of care, and the type and amount of anticancer treatment will be measured by using hospital database program called GreyFox ., month 9 post-intervention|Changes in severity of somatic symptoms using the Patient Health Questionnaire 15, The Patient Health Questionnaire (PHQ-15) measures common mental disorders and is used to assess somatic symptom severity and screen for the potential somatisation and somatoform disorders. Each question has three response options ranging in value from null to two (0= not bothered at all; 1= bothered a little; 2= bothered a lot). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 0 and the highest possible raw score is 30. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in pain medication use, The following variables about medication will be collected: name and strength of medication; number of days in the week the medication was taken (0-7), number of taken doses per the day (0-7 and more); regularity of a medication using (options: regularly/according to need)., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in psychiatric medication use, The following variables about medication will be collected: name and strength of medication; condition the medication is used for (options= sleep disorder/anxiety/depression/other); number of days in the week the medication was taken (0-7); number of taken doses per the day (0-7 and more); regularity of a medication using (options: regularly/according to need)., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in pain intensity using the Numerical Rating Scale of Pain Intensity, Pain intensity will be measured by the Numerical Rating Scale of Pain Intensity (NRS-I) consists of a range of numbers (0-10). The lowest number is null and represents no pain . The highest number is ten and represents an extreme level of pain . Respondents are asked to choose the number that best represents a level of pain intensity., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention|Change in dealing with pain using the Pain Self-Efficacy Questionnaire, The Pain Self-Efficacy Questionnaire is a 10-item scale designed to measure the confidence of people with ongoing pain to achieve different activities despite pain. Each item on the questionnaire is scored from 0 (not at all confident) to 6 (completely confident). The lowest possible raw score is 0 and the highest possible raw score is 60. A higher score represents more of the concept being measured., baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention

Socio-demographic variables, The following socio-demographic variables will be collected: gender, age, level of education, marital status, number of children (if any), employment status, any previous experience with autogenic training, psychotherapy, meditation, or another practice of self-development (how long/ how often is one practicing such activities)., baseline

Masaryk University

Masaryk Memorial Cancer Institute

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE

AZV2022

2022-06-06

2025-01

2025-06

2022-06-06

2023-10-19

Faculty of Medicine, Masaryk University, Brno, Bohunice, 62500, Czechia

{ "Mindfulness-Based Cognitive Therapy (MBCT-Ca) - online": [ { "intervention_type": "BEHAVIORAL" } ], "Positive Psychology - online": [ { "intervention_type": "BEHAVIORAL" } ], "Autogenic Training - online": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT01046331

Novel Influenza A (H1N1) Surveillance Registry

https://clinicaltrials.gov/study/NCT01046331

COMPLETED

The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden of disease and resource utilization of these patients remains largely unknown. The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.

NO

Novel Influenza A|H1N1|Influenza

National Heart, Lung, and Blood Institute (NHLBI)

ALL

CHILD, ADULT, OLDER_ADULT

NIH

OBSERVATIONAL

Observational Model: |Time Perspective: p

688|N01HR056179|HSN268200536179C

2009-10

2010-04

2010-10

2010-01-12

2016-04-14

Alaska Native Medical Center, Anchorage, Alaska, United States|The Children s Hospital at Providence, Anchorage, Alaska, United States|Phoenix Children s Hospital, Phoenix, Arizona, United States|Arkansas Children s Hiospital, Little Rock, Arkansas, United States|University of San Francisco-Fresno Medical Center, Fresno, California, United States|Children s Hospital Los Angeles, Los Angeles, California, United States|Children s Hospital and Research Center Oakland, Oakland, California, United States|Children s Hospital of Orange County, Orange, California, United States|University of California, Davis Medical Center, Sacramento, California, United States|UCSF Children s Medical Center, San Francisco, California, United States|UCSF-Moffitt Hospital, San Francisco, California, United States|UCSF-San Francisco General Hospital, San Francisco, California, United States|University of California, San Francisco (UCSF)-Moffitt Hospital, San Francisco, California, United States|Denver s Children Hospital, Aurora, Colorado, United States|Centura St. Anthony Central Hospital, Denver, Colorado, United States|Denver Health Medical Center, Denver, Colorado, United States|Rose Medical Center, Denver, Colorado, United States|University of Colorado Health Sciences Center, Denver, Colorado, United States|Connecticut Children s Medical Center, Hartford, Connecticut, United States|Yale-New Haven Children s Hospital, New Haven, Connecticut, United States|Washington Hospital Center, Washington DC, District of Columbia, United States|Children s National Medical Center, Washington, District of Columbia, United States|Mayo Clinic at Jacksonville, Jacksonville, Florida, United States|Holt z Children s Hospital, Miami, Florida, United States|Miami Children s Hospital, Miami, Florida, United States|Children s Healthcare of Atlanta at Egleston, Atlanta, Georgia, United States|Kapi olani Center for Women and Children, Honolulu, Hawaii, United States|Children s Memorial Hospital, Chicago, Illinois, United States|Kosair Children s Hospital, Louisville, Kentucky, United States|Earl K. Long Medical Center, Baton Rouge, Louisiana, United States|Our Lady of the Lake Regional Medical Center, Baton Rouge, Louisiana, United States|Medical Center of Louisiana, New Orleans, Louisiana, United States|Ochsner Clinic Foundation, New Orleans, Louisiana, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, United States|Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States|Johns Hopkins Children s Center, Baltimore, Maryland, United States|Johns Hopkins Hospital, Baltimore, Maryland, United States|Union Memorial Hospital, Baltimore, Maryland, United States|University of Maryland Shock Trauma Center, Baltimore, Maryland, United States|Boston Medical Center, Boston, Massachusetts, United States|Children s Hospital Boston, Boston, Massachusetts, United States|Baystate Medical Center, Springfield, Massachusetts, United States|Helen DeVos Children s Hospital, Grand Rapids, Michigan, United States|Children s Hospital and Clinics of Minnesota, Minneapolis, Minnesota, United States|University of Minnesota Children s Hospital, Minneapolis, Minnesota, United States|Rochester Methodist Hospital, Rochester, Minnesota, United States|St. Mary s Hospital, Mayo Clinic, Rochester, Minnesota, United States|SSM Cardinal Glennon Children s Medical Center, St. Louis, Missouri, United States|St. Louis Children s Hospital, St. Louis, Missouri, United States|Children s Hospital of Nebraska, Omaha, Nebraska, United States|Darthmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States|Children s Hospital of Montefiore, Bronx, New York, United States|University of Rochester Medical Center, Rocherster, New York, United States|University of North Carolina, Chapel Hill, North Carolina, United States|Duke University Children s Hospital, Durham, North Carolina, United States|Duke University Medical Center, Durham, North Carolina, United States|Durham Regional Medical Center, Durham, North Carolina, United States|Moses Cone Health System, Greensboro, North Carolina, United States|Wesley Long Community Hospital, Greensboro, North Carolina, United States|Wake Forest University Baptist Medical Center, Winston Salem, North Carolina, United States|Cleveland Clinic Foundation, Cleveland, Ohio, United States|MetroHealth Medical Center, Cleveland, Ohio, United States|University Hospitals of Cleveland, Cleveland, Ohio, United States|Nationwide Children Hospital, Columbus, Ohio, United States|Children s Hospital at St. Francis, Tulsa, Oklahoma, United States|Doernbecher Children s Hospital, Portland, Oregon, United States|Penn State Children s Hospital, Hershey, Pennsylvania, United States|The Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, United States|Monroe Carell Children s Hospital at Vanderbilt, Nashville, Tennessee, United States|Vanderbilt University Medical Center, Nashville, Tennessee, United States|Dell Children s Medical Center of Central Texas, Austin, Texas, United States|University of Texas Southwestern Children s Medical Center, Dallas, Texas, United States|Baylor College of Medicine, Houston, Texas, United States|Texas Children s Hospital, Houston, Texas, United States|Intermountain Medical Center, Murray, Utah, United States|McKay-Dee Hospital, Ogden, Utah, United States|Utah Valley Regional Medical Center, Provo, Utah, United States|LDS Hospital, Salt Lake City, Utah, United States|Primary Children s Medical Center, Salt Lake City, Utah, United States|University of Virginia Children s Medical Center, Charlottesville, Virginia, United States|University of Virginia Medical Center, Charlottesville, Virginia, United States|Providence Hospital, Everett, Washington, United States|Harborview Medical Center, Seattle, Washington, United States|Seattle Children s Hospital, Seattle, Washington, United States|University of Washington, Seattle, Washington, United States|Children s Hospital of Wisconsin, Milwaukee, Wisconsin, United States

{}

NCT00933231

Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts

https://clinicaltrials.gov/study/NCT00933231

COMPLETED

This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.

NO

Kidney Transplantation

DRUG: tacrolimus|DRUG: tacrolimus|BIOLOGICAL: Simulect|DRUG: Cellcept|DRUG: Corticosteroids|DRUG: Ramipril|DRUG: Irbesartan

Percentage of Participants with the Presence of Allograft Interstitial Fibrosis and Tubular Atrophy (IF/TA) as Assessed at a Central Pathology Lab, up to 24 months|Progression of IF/TA from Month 6 to Month 24, up to 24 months

Time to T-cell Banff Mediated Rejection as Assessed at a Central Pathology Lab, up to 24 months|Percentage of Participants in Each Category of Banff 2007 Diagnostic Classification of Renal Allograft Pathology, up to 24 months|Percentage of Participants with Humoral Rejections, up to 24 months|Percentage of Participants with Acute Rejections, up to 24 months|Time to First Any Acute Rejection, up to 24 months|Banff 2007 Individual Sub-scores, Banff 2007 sub-scores (AH = Arteriolar hyalinethickening score; AT = Tubulitis score; AV = Intimal arteritis score; AI = Interstitial inflammation score; AG = Glomerulitis score; CG = Glomerulopathy score; CI = Interstitial fibrosis score; CT = Tubularatrophy score; CV = Vascular fibrous intimal thickening score; MM = Mesangial matrix increase score; TI = Total interstitial inflammation score; PTC = Peritubulary capillaritis score) is measured on an ordinal scale of 0 - 3., up to 24 months|Change from Baseline in Chronic Allograft Damage Index, Baseline and 6, 24 months|Percentage of Participants with Circulating Anti-Donor Antibody, up to 5 years|Number of Participants with Cellular Immune Response (ELISPOT), up to 6 months|Urine Renal Biomarkers, up to 24 months|Graft Survival, up to 5 years|Patient Survival, up to 5 years|Renal Function as Measured by Glomerular Filtration Rate (GFR), up to 5 years|Renal Function as Measured by Serum Creatinine, up to 5 years|Renal Function as Measured by Ratio of Urine Protein and Creatinine Concentrations, up to 5 years|12-Item Short Form (SF-12) Health Survey: Physical Composite Score (PCS) and Mental Health Composite Score (MCS), The PCS and MCS are measured on a normalized 0-100 scale and computed using the corresponding subdomains from the SF-12 with 0 being the lowest level of health and 100 the highest., up to 24 months|Kidney Transplant Recipient Opinions of Immunosuppressive Medications Questionnaire, This questionnaire consists of 11 questions regarding immunosuppressive medications, where questions 1-3 ask about your experiences and opinions of transplant anti-rejection medications, questions 4 and 11 ask to rate each medication on the scale of 1-10, with 1 meaning disagree completely and 10 meaning agree completely, and questions 5-10 ask which medication satisfies the question., up to 24 months|Percentage of Participants with Polyomavirus Infection, up to 12 months

Astellas Pharma Inc

Astellas Pharma Canada, Inc.

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT

FKC-014

2009-08-17

2015-05-11

2018-04-03

2009-07-07

2019-04-05

Site CA133 Foothills Medical Centre, Calgary, Alberta, T2N 2T9, Canada|Site CA54 University of Alberta Hospital, Edmonton, Alberta, T6G 2B7, Canada|Site CA141 Health Sciences Centre, Winnipeg, Manitoba, R3A 1R9, Canada|Site CA114 Capital District Health Authority- QEII Health Sciences Centre, Halifax, Nova Scotia, B3H 1V7, Canada|Site CA150 St. Joseph s Healthcare, Hamilton, Ontario, L8N 4A6, Canada|Site CA27 London Health Sciences Centre, London, Ontario, N6A 5A5, Canada|Site CA165 St. Michael s Hospital, Toronto, Ontario, M5C 2T2, Canada|Site CA238 Hôpital Maisonneuve-Rosemont, Montreal, Quebec, H1T 2M4, Canada|Site CA172 Hôpital Notre-Dame du CHUM, Montreal, Quebec, H2L 4M1, Canada|Site CA144 McGill University Health Centre, Montreal, Quebec, H4A 3J1, Canada|Site CA116 Centre Hospitalier Universitaire de Sherbrooke- Hôpital Fleuirmont, Sherbrooke, Quebec, J1H 5N4, Canada|Site CA142 St. Paul s Hospital, Saskatoon, Saskatchewan, S7V 0Z9, Canada|Site CA64 Centre Hospitalier Universitaire de Québec- L Hôtel-dieu de Québec, Quebec, G1R 2J6, Canada

{ "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" }, { "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" } ], "Basiliximab": [ { "intervention_type": "BIOLOGICAL", "description": "Simulect", "name": "Basiliximab", "synonyms": [ "CHI 621", "SDZ CHI 621", "Simulect", "Basiliximab" ], "medline_plus_id": "a612013", "generic_names": [ "Basiliximab" ], "mesh_id": "D007166", "drugbank_id": "DB00074", "wikipedia_url": "https://en.wikipedia.org/wiki/Basiliximab" } ], "Mycophenolate": [ { "intervention_type": "DRUG", "description": "Cellcept", "name": "Mycophenolate", "synonyms": [ "Myfortic", "Mycophenolic acid", "Acidum mycophenolicum", "Acido micofenolico", "CellCept", "Mycophenolate", "Micofenolico acido", "(e)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acid", "Mycophenols\u00e4ure", "Acide mycophenolique" ], "medline_plus_id": "a601081", "generic_names": [ "Mycophenolic acid", "Mycophenolate" ], "drugbank_id": "DB01024", "wikipedia_url": "https://en.wikipedia.org/wiki/Mycophenolic%20acid" } ], "Corticosteroids": [ { "intervention_type": "DRUG" } ], "Ramipril": [ { "intervention_type": "DRUG", "description": "Ramipril", "name": "Ramipril", "synonyms": [ "Vesdil", "Tritace", "Ramipril", "(2S-(1(R*(R*)),2alpha,3abeta,6abeta))-1-(2-((1-(Ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)octahydrocyclopenta(b)pyrrole-2-carboxylic acid", "Carasel", "HOE-498", "Ramiprilum", "Triatec", "HOE 498", "Zabien", "Delix", "Altace", "Ramace", "HOE498", "Acovil" ], "medline_plus_id": "a692027", "generic_names": [ "Ramipril" ], "nhs_url": "https://www.nhs.uk/medicines/ramipril", "mesh_id": "D000959", "drugbank_id": "DB00178" } ], "Irbesartan": [ { "intervention_type": "DRUG", "description": "Irbesartan", "name": "Irbesartan", "synonyms": [ "Aprovel", "Irbesartan", "Avapro", "2-butyl-3-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one" ], "medline_plus_id": "a698009", "generic_names": [ "Irbesartan" ], "nhs_url": "https://www.nhs.uk/medicines/irbesartan", "drugbank_id": "DB01029", "wikipedia_url": "https://en.wikipedia.org/wiki/Irbesartan" } ] }

NCT05726331

Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care

https://clinicaltrials.gov/study/NCT05726331

RECRUITING

This feasibility project aims to evaluate the effectiveness of chiropractic care combined with Tai Chi (TC) training to reduce pain and disability in adults with chronic non-specific neck pain (CNNP).

NO

Neck Pain|Chronic Pain

OTHER: Chiropractic Care|OTHER: Tai Chi|OTHER: Enhanced Usual Care

Recruitment rate, Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial., Through study completion (an average of 18 months)|Retention rate, Retention rate will be quantified by the proportion of subjects who remain in the study to complete the 24-week visit., Through study completion (an average of 18 months)|Intervention adherence, Intervention adherence will be measured by collection of chiropractic visit attendance and Tai Chi class attendance data., Through study completion (an average of 18 months)

Pain intensity, Pain intensity over the past 7 days will be measured using an 11 point numerical rating scale with 0 indicating no neck pain at all and 10 indicating worst neck pain imaginable ., Baseline, 16-weeks, and 24-weeks|Pain on movement (POM), Pain on movement (POM) will be assessed using a previously validated and reliable protocol. Participants are asked to flex, extend, laterally flex, and laterally rotate their necks to the left and right. The evoked pain is measured on a 100mm visual analog scale (VAS), for each direction. An average POM score is then calculated from these data for each participant., Baseline, 16-weeks, and 24-weeks|Bothersomeness of pain, Bothersomeness of Pain (BOP) in the past 7 days will measured on a 0-10 scale (0 indicating neck pain not at all bothersome and 10 indicating neck pain extremely bothersome )., Baseline, 16-weeks, and 24-weeks|Disability, Functional neck-related disability will be measured using the Neck Disability Index. This validated and reliable 10-item questionnaire determines how participants see their neck pain affecting their daily activities. The maximum score is 50. Scores of ≤4 indicate no disability; 5 to 14 indicate mild disability, 15 to 24 moderate disability, and 25 to 34 severe disability. Scores >35 indicate complete perceived disability., Baseline, 16-weeks, and 24-weeks|Health-related quality of life, The (Profile Physical and Mental Health Summary Scores) PROMIS-29 will be used to characterize global health-related quality of life. This validated, reliable, and widely used instrument includes 7 key domains: Physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. All items except for a single question evaluating pain intensity are rated on a 5-point Likert scale. PROMIS-29 has excellent psychometric properties and offers the ability to compare scores across conditions and to general population norms., Baseline, 16-weeks, and 24-weeks|Self-efficacy, Self-efficacy will be measured using the General Self-Efficacy Scale (GSES). The GSES measures a participant s confidence in their ability to respond to environmental demands and challenges. The scale consists of 10 items with a 4-point Likert response scale ranging from 1 ( not at all true ) to 4 ( exactly true ). Higher summed scores indicate greater self efficacy (SE) to complete the task., Baseline, 16-weeks, and 24-weeks|Postural awareness, Postural awareness will be measured using the Postural Awareness Scale (PAS) which includes 12 items that describe the awareness of body posture and postural control. Higher scores indicate more awareness and control of one s posture., Baseline, 16-weeks, and 24-weeks|Pain Catastrophizing Scale, The Pain Catastrophizing Scale will be used to assess catastrophic thinking associated with pain. This instrument consists of 13 items that measure rumination, magnification, and helplessness related to pain. Higher scores correspond to higher levels of catastrophic thinking associated with pain., Baseline, 16-weeks, and 24-weeks|Fear of Movement, Fear of Movement will be measured using the Tampa Scale for Kinesiophobia. This instrument consists of 17 items that measure pain-related fear with higher scores indicating higher levels of kinesiophobia., Baseline, 16-weeks, and 24-weeks|Interoceptive Awareness, Interoceptive awareness, the sensitivity toward stimuli originating from within the body, will be measured using the Multidimensional Assessment of Interoceptive Awareness (MAIA) which consists of 40 items resulting in eight separate dimensions of interoceptive awareness; higher scores represent higher awareness., Baseline, 16-weeks, and 24-weeks|Perceptions of treatments, Qualitative interviews will be employed to further probe participants perceptions of chiropractic care with and without the addition of TC training focusing on: a) understanding facilitators and barriers to participation in a pragmatic trial utilizing community-based practitioners, and b) patient-centered experiences that might inform outcome measures to use in a future trial., Baseline and 16-weeks

Harvard University Faculty of Medicine

Brigham and Women s Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2021A014141

2023-10-25

2026-04-30

2026-12-31

2023-02-13

2024-01-19

Osher Clinical Center at Brigham and Women s Hospital, Chestnut Hill, Massachusetts, 02199, United States

{ "Chiropractic Care": [ { "intervention_type": "OTHER" } ], "Tai Chi": [ { "intervention_type": "OTHER" } ], "Enhanced Usual Care": [ { "intervention_type": "OTHER" } ] }

NCT00540631

Multicenter Trial of Immunotherapy With House Dust Mite Allergoid

https://clinicaltrials.gov/study/NCT00540631

ACRI

COMPLETED

Multicenter Immunotherapy House Dust Mite Allergoid

NO

Rhinoconjunctivitis

BIOLOGICAL: specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)

The primary endpoint is the change of the area under the curve (AUC)of the Symptom-Medication-Score (SMS)after 2 years of double-blind treatment to baseline, November 2007 - February 2010

Change of the AUC of the SMS after one year to baseline., 1 year|Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline, 2 years|Immunologic changes IgE, IgG1 and IgG4, 2 years|Tolerability and safety of treatments during the entire study period, 4 years

Allergopharma GmbH & Co. KG

ALL

ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

AL0106ac|2006-000934-11

2007-10

2010-08

2011-12

2007-10-08

2013-02-11

Allergopharma GmbH & Co. KG, Reinbek, 21465, Germany

{ "specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT05231031

Effect of Breathing and Relaxation Exercises on Serum Cortisol Levels in Type 2 Diabetic Patients

https://clinicaltrials.gov/study/NCT05231031

COMPLETED

Background: Diabetes is a fast-growing health problem in Egypt with a significant impact on morbidity, mortality, and health care resources. Aim of the study: To assess the effect of breathing and relaxation exercises on serum cortisol levels in type 2 diabetic patients. Subject and Methods: sixty, type 2 diabetic patients for more than 5 years were selected from the outpatient clinic of the Faculty of Physical Therapy, Cairo University. Their age ranged from 40 to 50 years. Serum cortisol and blood glucose tests were done before the start of the study and after 6 weeks. The patients were randomly assigned into two equal groups in number (30 patients for each group) performed 3 sessions/week for 6 weeks. Group A received aerobic exercise in the form of walking on a treadmill, breathing exercise, and mindfulness meditation, and group B received continuous aerobic exercise only in the form of walking on a treadmill. ( The exercise program included 45 minutes and consist of warming up phase of slow walking on the treadmill for 5 minutes, training phase 35 minutes, and cooling down for 5 minutes) .

NO

Diabetes Mellitus|Stress

BEHAVIORAL: Aerobic exercise|BEHAVIORAL: breathing exercise|BEHAVIORAL: Relaxation training

Fating blood glucose, blood sampling for blood glucose after 9 hours fasting, 6 weeks|Serum cortisol level, blood sampling for cortisol at 8 am, 6 weeks

The perceived stress score (PSS), Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived, 6 weeks

Cairo University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT

DM and Cortisol

2021-01-01

2021-08-15

2021-08-15

2022-02-09

2022-02-09

Alkasr Alaini hospitals, Cairo, Egypt

{ "Aerobic exercise": [ { "intervention_type": "BEHAVIORAL" } ], "breathing exercise": [ { "intervention_type": "BEHAVIORAL" } ], "Relaxation training": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT02085473

A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers

https://clinicaltrials.gov/study/NCT02085473

COMPLETED

The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.

YES

Asthma|Healthy Subjects or Volunteers

BIOLOGICAL: Tralokinumab 300 mg

Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]), AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero to infinite time, obtained from AUC (0 - t) plus AUC (t - infinity). Units are day*micrograms per millilitres = day*mcg/mL., Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|Maximum Observed Serum Concentration (Cmax), The Cmax is the maximum observed serum concentration of tralokinumab., Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|Time to Maximum Concentration (Tmax), Tmax is defined as actual sampling time to reach maximum observed tralokinumab concentration., Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]), AUC [0-t] is defined as area under the serum concentration-time curve from zero to last observed tralokinumab concentration., Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|Terminal Elimination Half-life (t1/2), Terminal elimination half-life is the time measured for the serum concentration to decrease by one half. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z)., Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|Apparent Systemic Clearance (CL/F) After Subcutaneous Dose, Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability)., Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|Apparent Terminal-Phase Volume of Distribution (Vz/F), Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug., Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose

Local Injection-Site Pain and Injection-Site Pruritus, Local injection-site pain and pruritus intensity was rated on 0 to 100 millimeter (mm) visual analogue scale (VAS) at various time points, where 0 = no pain/ no pruritus; 100 = most severe pain/ most severe pruritus. Injection site pruritus intensity was assessed by the blinded assessor. Higher the score indicated higher intensity of pain and pruritus. Local injection site pain and pruritus was assessed at below time-points: 1 and 6 minute (min) during investigational product administration (IPA); immediately post IPA, 10, 20, 30, and 60 min, 2, 4, 8, 24 and 72 hour (h) post IPA., During the injection until 72 hours post-injection for injection site-pain and immediately after administration of injection until 72 hours for injection-site pruritus|Number of Participants Reporting Local Injection-Site Reactions, The signs and/or symptoms of local injection-site reactions including erythema, hematoma or bleeding, local warmth, swelling, and/or rash occurring within 72 hours post-injection were assessed and recorded by a blinded assessor., 0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injection|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs), An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and important medical event. Treatment-emergent were events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state., From start of study drug administration up to Day 57|Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination, The treatment-emergent adverse events related to physical examination were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state., Day 1 to Day 57|Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs, Vital signs included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature. The treatment-emergent adverse events related to vital signs were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state., Day 1 to Day 57|Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters, Laboratory parameters included hematology, serum chemistry and urinalysis. The treatment-emergent adverse events in laboratory parameters were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state., Day 1 to Day 57|Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit, Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples., Pre-dose on Day 1 and Day 57

MedImmune LLC

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER

D2210C00011

2014-03-19

2014-07-10

2014-07-10

2014-03-12

2018-11-23

2018-12-31

Celerion, Lincoln, Nebraska, 68502, United States|Research Site, Lincoln, Nebraska, 68502, United States

{ "Tralokinumab": [ { "intervention_type": "BIOLOGICAL", "description": "Tralokinumab 300 mg", "name": "Tralokinumab", "synonyms": [ "Tralokinumab", "Adbry", "Adtralza", "Tralokinumab-ldrm injection", "Adbry", "Tralokinumab-ldrm injection", "Adbry" ], "drugbank_id": "DB12169", "generic_names": [ "Tralokinumab", "Tralokinumab-ldrm injection", "Tralokinumab-ldrm injection" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Tralokinumab" } ] }

NCT04454073

Investigation of Factors Associated With Preserved Cognitive Function in Bipolar Disorder

https://clinicaltrials.gov/study/NCT04454073

RECRUITING

Bipolar disorder (BD) ïs the fourth leading cause of disability worldwide among young people. Differences in demographic and clinical characteristics between patients do not influence educational achievement and receipt of disability pension, indicating that there are other factors such as neurocognitive function that are of importance for maintaining occupational and social function. Research has shown that at the group level, cognitive deficits are present in euthymic BD patients, while approximately 30%-50% of BD patients is not different from healthy controls when it comes to cognitive function. There is however little knowledge of risk and resilience factors for cognitive impairment in BD. Factors likely to contribute to cognitive and functional outcomes in BD, such as sleep, obesity, biological rhythms, comorbid medical and psychiatric conditions are also understudied. While it has been customary to focus research on factors related to the negative illness trajectories, the overarching aim of the current project is to explore factors associated with favourable outcomes. This shift in research focus is essential to elucidate factors related to more preserved function since this represents a clear gap in knowledge today.

NO

Bipolar Disorder

Assessment of cognitive function in bipolar patients, Memoro is a self-administered web-based neuropsychological test platform. All tests include both written and auditory instructions. The Memoro will be used to assess objective cognitive function. It contains measures of learning, storing, recalling and recognizing visual and verbal information, pattern separation, and verbal memory span, verbal working memory, processing speed, reaction time and cognitive control. Time frame: After examination of sleep and activity for a period of up to two weeks. Results from the test will be converted to z-scores., On day 7 after inclusion|Assessing change of cognitive function in bipolar patients, Memoro is a self-administered web-based neuropsychological test platform. All tests include both written and auditory instructions. It contains measures of learning, storing, recalling and recognizing visual and verbal information, pattern separation, and verbal memory span, verbal working memory, processing speed, reaction time and cognitive control. The Memoro will be used to assess stability or change in objective cognitive function., Up to 5 years after inclusion

Montgomery Åsberg Depression Rating Scale (MADRS), MADRS will be used to assess depressive symptoms. Range is 0-60. Higher score indicate more severe depressive symptoms., Day 1|Young Mania Rating Scale (YMRS), YMRS will be used to assess hypo-/manic symptoms. Range is 0 to 60. Higher score indicate more severe manic symptoms., Day 1|Insomnia Severity Index (ISI), A self-reported questionnaire of insomnia severity. Range is 08-28. Higher values represent higher levels of insomnia symptom severity., Day 1|Medication use, Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) prescribed per individual by the time of inclusion will be recorded., Day 1|Actigraph, Actigraph is a small device usually worn on the wrist that records the activity level of the body by sensing physical movement. The actigraph will be used to objectively assess sleep variables and daytime activity parameters., 1 week|Sleep diary, A self-reported record of the participants sleeping and waking times., 1 week|Oximetry, Oximetry is a measurement of the blood s oxygen saturation. It will be used to assess any indication of sleep apnea for one night during the period of sleep assessment, 1 day (1 night during period of sleep assessment)|The Functioning Assessment Short Test (FAST), FAST will be used to assess functional outcomes. Range is 0-72. Higher values indicate greater disability, 7 days after inclusion|Cognitive complaints in Bipolar disorder Rating Assessment (COBRA), COBRA is an assessment of subjective cognitive dysfunction. Range is 0-48 and higher scores indicate more cognitive complaints., 7 days after inclusion|The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN), BRIAN is an assessment of circadian rhythms disturbance. Range is 1 to 72 and higher score indicate more severe disturbance of circadian rhythms., 7 days after inclusion|Alcohol use disorders identification test (AUDIT), AUDIT is an assessment of the frequency and quantity of alcohol consumption where higher scores indicate higher levels of use., 7 days after inclusion|Drug use disorders identification test (DUDIT), DUDIT is an assessment of the frequency and quantity of drug consumption where higher scores indicate higher levels of use., 7 days after inclusion|Number of participants With Metabolic syndrome, The World Health Organisation criteria for the metabolic syndrome will be used in the dichotomisation of the metabolic factors: Systolic blood pressure will be dichotomised as ≤ 140 mmHg or >140 mmHg and diastolic blood pressure as ≤ 90 mmHg or > 90 mmHg. Triglycerides will be classified as < 1.7 mmol/l or ≥ 1.7mmol/l. HDL cholesterol will be categorised as ≥ 1 mmol/l or <1 mmol/l for women and ≥ 0.90 mmol/l or <0.90 mmol/l for men. Fasting glucose will be defined as elevated when the plasma glucose levels is ≥7.0 mmol/l and two dichotomous groups will be created; < 7.0 mmol/l or ≥ 7.0 mmol/l. Waist circumference will be measured at the level of the umbilicus, and the hip girth will be measured at the level of maximal protrusion of the gluteal muscles. Waist-to-hip ratio will be dichotomised as ≤ 0.85 or > 0.85 for women and ≤ 0.90 or > 0.90 for men. The waist circumference will be categorised as ≤ 88 cm or > 0.88 for women and ≤ 102 cm or >102 cm for men., 7 days after inclusion|Numbers of participants With disturbances of Thyroid function, Normal thyroid function is considered thyroid stimulating hormone (TSH) levels in the range from 0.24 to 3.78 mIU/l and T4 levels in the range of 13.5 to 21.2 pmol/l. Latent and subclinical biochemical hypothyroidism; with an elevation of TSH with T4 in the normal range. Overt biochemical hypothyroidism: elevated TSH and a decrease of T4 levels. Biochemical hyperthyroidism and latent biochemical hyperthyroidism: TSH levels below the normal range with and without elevated T4., 7 days after inclusion|Diagnostic evaluation With Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-5), This measure will be used to determine if participants meet the diagnostic criteria for Bipolar Disorder. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for bipolar type I or type II., Day 1

St. Olavs Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

67144

2021-10-29

2025-05

2025-05

2020-07-01

2023-11-28

Bipolar and sleep outpatient clinic, Department of Østmarka, Division of Mental Health Care, Trondheim, Norway

{}

NCT05897073

Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity

https://clinicaltrials.gov/study/NCT05897073

TEMPUS

RECRUITING

In Spain, overweight and obesity prevalence is reaching 70% in men and 50% in women. Excess of triglycerides are usually stored in the subcutaneous adipose tissue (SAT), until a point where SAT is unable to expand further. Therefore, lipids are deposited in visceral and other peripheral organs and tissues that are not otherwise designed for adipose storage such as the liver, pancreas or the skeletal muscle, a process known as ectopic fat deposition. Time-restricted eating (TRE) is a recently emerged intermittent fasting approach which has the potential to maximize the beneficial metabolic effects extensively reported for energy intake restriction. Furthermore, exercise reduces hepatic steatosis and improves cardiometabolic health in humans. However, whether the effects of TRE combined with exercise on reducing hepatic steatosis are superior to TRE or exercise intervention alone remains unknown. The TEMPUS study will investigate the effects of a 12-week TRE combined with supervised exercise intervention, as compared with TRE or exercise alone, and usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity; and to unveil the role of gut microbiota.

NO

Time Restricted Feeding|Exercise|Hepatic Steatosis|Cardiometabolic Syndrome|Obesity

BEHAVIORAL: Time-restricted eating intervention|BEHAVIORAL: Exercise intervention|BEHAVIORAL: Time-restricted eating plus exercise intervention

Change in hepatic fat content, Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI), Change from baseline to 12 weeks

Change in hepatic elasticity, Viscosity, fibrosis severity and steatosis will be assessed by US elastography, Change from baseline to 12 weeks|Change in values of alkaline phosphatase, Fasting blood samples will be used to asses alkaline phosphatase, Change from baseline to 12 weeks|Change in values of alanine transaminase, Fasting blood samples will be used to asses alanine transaminase, Change from baseline to 12 weeks|Change in values of gamma-glutamyl transferase, Fasting blood samples will be used to assess gamma-glutamyl transferase, Change from baseline to 12 weeks|Change in values of Vitamin D, Fasting blood samples will be used to assess Vitamin D, Change from baseline to 12 weeks|Change in values of Calcium, Fasting blood samples will be used to assess Calcium, Change from baseline to 12 weeks|Change in values of Bilrubin, Fasting blood samples will be used to assess Bilrubin, Change from baseline to 12 weeks|Change in values of glomerular filtration rate, Fasting blood samples will be used to assess glomerular filtration rate, Change from baseline to 12 weeks|Change in values of estradiol, Fasting blood samples will be used to assess estradiol, Change from baseline to 12 weeks|Change in values of progesterone, Fasting blood samples will be used to assess progesterone, Change from baseline to 12 weeks|Change in values of testosterone, Fasting blood samples will be used to assess testosterone, Change from baseline to 12 weeks|Change in values of follicle stimulating hormone, Fasting blood samples will be used to assess follicle stimulating hormone, Change from baseline to 12 weeks|Change in values of luteinizing hormone, Fasting blood samples will be used to assess luteinizing hormone, Change from baseline to 12 weeks|Change in values of thyrotropin, Fasting blood samples will be used to assess thyrotropin, Change from baseline to 12 weeks|Change in values of thyroxine, Fasting blood samples will be used to assess thyroxine, Change from baseline to 12 weeks|Change in values of triiodothyronine, Fasting blood samples will be used to assess triiodothyronine, Change from baseline to 12 weeks|Change in visceral adipose tissue, Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI), Change from baseline to 12 weeks|Change in abdominal subcutaneous adipose tissue, Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI), Change from baseline to 12 weeks|Change in visceral adipose tissue, Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI), Change from 12 weeks of intervention to 12 months|Change in abdominal subcutaneous adipose tissue, Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI), Change from 12 weeks of intervention to 12 months|Change in pancreatic fat content, Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI), Change from baseline to 12 weeks|Change in pancreatic fat content, Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI), Change from 12 weeks of intervention to 12 months|Change in intramuscular fat content, Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI), Change from baseline to 12 weeks|Change in intramuscular fat content, Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI), Change from 12 weeks of intervention to 12 months|Change in values of fasting glucose, Fasting blood samples will be used to assess glucose, Change from baseline to 12 weeks|Change in HOMA-IR index., Fasting blood samples will be used to assess glucose and insuline and HOMA index will be computed, Change from baseline to 12 weeks|Change in values of HbA1c, Fasting blood samples will be used to assess HbA1c, Change from baseline to 12 weeks|Change in values of fasting triglycerides, Fasting blood samples will be used to assess levels of triglycerides, Change from baseline to 12 weeks|Change in values of fasting high-density lipoprotein cholesterol, Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol, Change from baseline to 12 weeks|Change in values of fasting low-density lipoprotein cholesterol, Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol, Change from baseline to 12 weeks|Change in values of fasting total cholesterol, Fasting blood samples will be used to assess levels of total cholesterol, Change from baseline to 12 weeks|Change in values of C-reactive protein, Fasting blood samples will be used to assess levels of C-reactive protein, Change from baseline to 12 weeks|Change in values of interleukin 6, Fasting blood samples will be used to assess levels of interleukin 6, Change from baseline to 12 weeks|Change in values of creatinine, Fasting blood samples will be used to assess levels of creatinine, Change from baseline to 12 weeks|Change in values of creatine kinase, Fasting blood samples will be used to assess levels of creatine kinase, Change from baseline to 12 weeks|Change in values of iron, Fasting blood samples will be used to assess levels of iron, Change from baseline to 12 weeks|Change in values of ferritin, Fasting blood samples will be used to assess levels of ferritin, Change from baseline to 12 weeks|Change in values of folic acid, Fasting blood samples will be used to assess levels of folic acid, Change from baseline to 12 weeks|Change in values of apolipoprotein A1, Fasting blood samples will be used to assess levels of apolipoprotein A1, Change from baseline to 12 weeks|Change in values of apolipoprotein B, Fasting blood samples will be used to assess levels of apolipoprotein B, Change from baseline to 12 weeks|Change in levels of mean glucose (Continuous Glucose Monitoring), Men glucose over 14 days will be assessed by Continuous Glucose Monitoring during 2 weeks, Change from baseline to the last 2 weeks of intervention|Change in quantitative insulin-sensitivity check index, Quantitative insulin-sensitivity check index will be assessed by oral glucose tolerance test, Change from baseline to the last 2 weeks of intervention|Change in Body weight, Body weight will be measured by a digital scale, Change from baseline to 12 weeks|Change in Body weight, Body weight will be measured by a digital scale, Change from 12 weeks of intervention to 12 months|Change in Body height, Body height will be measured by a stadiometer, Change from baseline to 12 weeks|Change in Body height, Body height will be measured by a stadiometer, Change from 12 weeks of intervention to 12 months|Change in fat mass, Fat mass will be assessed by Dual-energy X-ray Absorptiometry (DXA), Change from baseline to 12 weeks|Change in fat free mass, Fat free mass will be assessed by Dual-energy X-ray Absorptiometry (DXA), Change from baseline to 12 weeks|Change in bone mineral density, Bone mineral density will be assessed by Dual-energy X-ray Absorptiometry (DXA), Change from baseline to 12 weeks|Change in fat mass, Fat mass will be assessed by Dual-energy X-ray Absorptiometry (DXA), Change from 12 weeks of intervention to 12 months|Change in fat free mass, Fat free mass will be assessed by Dual-energy X-ray Absorptiometry (DXA), Change from 12 weeks of intervention to 12 months|Change in bone mineral density, Bone mineral density will be assessed by Dual-energy X-ray Absorptiometry (DXA), Change from 12 weeks of intervention to 12 months|Change in waist circumference, Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry, Change from baseline to 12 weeks|Change in calf girth, Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry, Change from baseline to 12 weeks|Change in waist circumference, Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry, Change from 12 weeks of intervention to 12 months|Change in calf girth, Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry, Change from 12 weeks of intervention to 12 months|Change in hip circumference, Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry, Change from baseline to 12 weeks|Change in hip circumference, Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry, Change from 12 weeks of intervention to 12 months|Change in neck circumference, Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry, Change from baseline to 12 weeks|Change in neck circumference, Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry, Change from 12 weeks of intervention to 12 months|Change in systolic blood pressure, Systolic blood pressure will be assessed by blood pressure monitor, Change from baseline to 12 weeks|Change in systolic blood pressure, Systolic blood pressure will be assessed by blood pressure monitor, Change from 12 weeks of intervention to 12 months|Change in diastolic blood pressure, Diastolic blood pressure will be assessed by blood pressure monitor, Change from baseline to 12 weeks|Change in diastolic blood pressure, Diastolic blood pressure will be assessed by blood pressure monitor, Change from 12 weeks of intervention to 12 months|Change in energy intake, Energy intake (kcal/day) will be assessed by 24h recalls, Change from baseline to 12 weeks|Change in carbohydrates intake, Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls, Change from baseline to 12 weeks|Change in fat intake, Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls, Change from baseline to 12 weeks|Change in protein intake, Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls, Change from baseline to 12 weeks|Change in dietary habits, Dietary habits will be assessed by food frequency questionnaire (FFQ). Minimum value is 1 (never) and maximum value is 9 (more than 6 times per day). Higher values mean a more frequency of a certain food consumption., Change from baseline to 12 weeks|Change in Appetite traits, Appetite traits will be assessed by the Adult Eating Behavior Questionnaire (AEBQ). Minimum value is 1 (completely disagree) and maximum value is 5 (completely agree). Higher values mean a worse outcome., Change from baseline to 12 weeks|Change in Subjective sleep quality, Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). Minimum value is 0 (never) and maximum value is 3 (3 or more times per week). Higher values mean a worse outcome., Change from baseline to 12 weeks|Change in Objectively sleep quality, Objectively sleep quality will be assessed by accelerometry, Change from baseline to 12 weeks|Change in Chronotype, Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ)., Change from baseline to 12 weeks|Change in Morning-Evening type, Morning-Evening type will be assessed by the Morningness-Eveningness Questionnaire Self-Assessment Version. Define if a person is more morningness or eveningness based on daily times preferences., Change from baseline to 12 weeks|Change Objectively moderate to vigorous physical activity levels, Objectively physical activity levels will be assessed by accelerometry, Change from baseline to 12 weeks|Change in Depression aspects, Depression aspects will be assessed by the Beck Depression Inventory Fast Screen (BDI-FS). Values ranged from 0 to 63. Higher values mean worse outcome., Change from baseline to 12 weeks|Change in Stress aspects, Stress aspects will be assessed by the Perceived Stress Scale (PSS). Values ranged from 0 to 40. Higher values mean worse outcome., Change from baseline to 12 weeks|Change in Anxiety aspects, Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI). Values ranged from 0 to 60. Higher values mean worse outcome., Change from baseline to 12 weeks|Change in General health, General health will be assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L). Values ranged from 0 to 100. Higher values mean better outcome., Change from baseline to 12 weeks|Change in Quality of life, Quality of life will be assessed by the Rand Short Form 36 (SF-36). Values ranged from 0 to 100. Higher values mean better outcome., Change from baseline to 12 weeks|Change in Gut microbiota composition, DNA sequencing to determine gut microbiota composition (e.g., phylum and genera), Change from baseline to 12 weeks|Change in fecal microbiota diversity, DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha), Change from baseline to 12 weeks|Change in Cardiorespiratory Fitness, Cardiorespiratory fitness measured by maximum treadmill test, Change from baseline to 12 weeks|Change in Lower muscular strength, Lower body muscular strength measured by chair stand test., Change from baseline to 12 weeks|Change in Upper muscular strength, Upper body muscular strength measured by hand grip strength test., Change from baseline to 12 weeks|Change in walking speed., Walking speed measured by gait speed test. Higher values mean worse performance., Change from baseline to 12 weeks|Adherence to the time-restricted eating intervention, Adherence will be assessed by eating records through the mobile phone app., Change from baseline to 12 weeks|Adherence to the exercise intervention, Adherence will be assessed by number of completed exercise sessions., Change from baseline to 12 weeks|Change in hepatic fat content, Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI), Change from 12 weeks of intervention to 12 months

Universidad de Granada

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

TEMPUS

2023-05-02

2025-12

2025-12

2023-06-09

2023-12-19

University of Granada - Instituto Mixto Universitario Deporte y Salud, Granada, 18011, Spain|University of Granada, Granada, 18011, Spain

{ "Time-restricted eating intervention": [ { "intervention_type": "BEHAVIORAL" } ], "Exercise intervention": [ { "intervention_type": "BEHAVIORAL" } ], "Time-restricted eating plus exercise intervention": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT02408731

A Study to Determine the Safety, Tolerability and Pharmacokinetics of PMZ-2010 (Centhaquin) in Healthy Volunteers

https://clinicaltrials.gov/study/NCT02408731

COMPLETED

Shock is a condition of reduced tissue perfusion, resulting in the inadequate delivery of oxygen and nutrients that are necessary for cellular function. The current resuscitative agents can extend patient s life to a limited extent. Centhaquin (PMZ-2010) in very low doses reduced blood lactate levels, improved blood pressure, cardiac output, survival and proved to be a highly effective resuscitative agent. The investigators are conducting a phase I clinical study in humans to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of centhaquin citrate in normal healthy volunteers.

NO

Healthy

DRUG: PMZ-2010 (Centhaquin)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability, Measure blood pressure, heart rate, body temperature, ECG, laboratory parameters and clinical assessment.after single and multiple ascending doses of PMZ-2010., 7 days

Composite of pharmacokinetics of PMZ-2010 in plasma, Maximum concentration (Cmax), Time of maximum plasma concentration (Tmax), Area under the concentration-time curve (AUC) from time of dosing to the last quantifiable concentration (AUClast), Terminal elimination half-life (t½), Clearance (CL/F), Apparent volume of distribution during the terminal elimination phase (Vz/F) of PMZ-2010 in plasma after single ascending doses., 24 hours|Phamacodynamics profile of PMZ-2010, Change in systolic and diastolic blood pressure, pulse rate, heart rate, QTcF after single ascending dose and multiple ascending doses, 7 days

Pharmazz, Inc.

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT

CT-430-CENT-2012

2014-10

2015-04

2015-04

2015-04-03

2015-04-28

Jahangir Clinical Development Centre Pvt. Ltd., Pune, Maharastra, Pune 411001, India

{ "PMZ-2010 (Centhaquin)": [ { "intervention_type": "DRUG" } ] }

NCT02564731

Prognosis of Bronchiectasis in Children--A Multicenter Prospective Cohort Study

https://clinicaltrials.gov/study/NCT02564731

UNKNOWN

This prospective cohort study is designed to observe of the effect of intervention therapy on the long-term prognosis of children with bronchiectasis. The main purpose of the study was to evaluate the degree of deterioration of lung function, to observe and compare the quality of life, the time of pulmonary exacerbation, and the changes of lung image.

NO

Bronchiectasis

Change from baseline in lung function on the spirometry, forced expiratory volume at one second (FEV1) in Liter, 5 years

Baoping XU

Wuhan women and children s health care center|Children s Hospital of Chongqing Medical University|Yuying Children s Hospital of Wenzhou Medical University|Changchun Children s Hospital|Shenzhen Children s Hospital|Jiangxi Province Children s Hospital|Shanghai Children s Medical Center|First Affiliated Hospital of Guangxi Medical University|Tianjin Children s Hospital|The First Affiliated Hospital of Xiamen University|Children s Hospital of Fudan University|The Affiliated Hospital Of Guizhou Medical University|Shanxi Provincial Maternity and Children s Hospital

ALL

CHILD, ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

BCHlung003

2016-06

2022-03

2022-03

2015-10-01

2017-01-09

Beijing Children S Hospital, Beijing, Beijing, 100045, China

{}

NCT04473131

Immune Profiling of COVID19-patients Admitted to ICU

https://clinicaltrials.gov/study/NCT04473131

IMPROVISE

UNKNOWN

SARS-CoV-2 is the novel coronavirus responsible for COVID-19, coronavirus disease 2019. This new coronavirus was first detected in Wuhan, China in late December 2019. According to WHO, the incidence rate of COVID-19 is prominent among adults and elderly people, reaching so far >2 million cases globally. Meanwhile, confirmed death cases reached >126 thousands of reported cases in 185 countries and still increasing. We anticipate that immunological differences among COVID19-infected patients might be a reason behind the variation of patient outcomes. Therefore, we intend to investigate cellular and humoral immune responses of COVID19-positive patients, and we claim to discover new indicators of patients prognosis. Our target population includes three categories of patients staying at ICU, HMC (COVID19-positive vs. COVID19-negative vs. healthy control). Throughout their ICU stay, multiple blood samples will be screened for leukocytes surface markers, leukocytes production of certain molecules, and circulating cytokines/chemokines/checkpoint inhibitors. Their plasma/serum will be used as well for immune proteomics, metabolomics, and other serological tests. Such parameters can provide the more comprehensive status of COVID19-infected patients at infection onset, during treatment intake, and at recovery or relapse stage. Following analysis, the main prospective outcome of this study is to identify the most reflective markers of COVID19-positive patients outcomes.

NO

COVID-19

OTHER: No intervention

To create an immune profile for each COVID19-positive patient during their ICU stay, A descriptive analysis of the innate and adaptive immune cells (phenotypically and functionally), along with circulating pro- and anti-inflammatory cytokines, and the dynamic change of immune cells and cytokines throughout the first 4 weeks of the COVID-19 infection., 8 to 12 months|To correlate patients immune profile to disease severity and patient s outcome, A correlative analysis of the immune cells and cytokines levels with the COVID-19 severity and with the patient s outcome following their stay at the ICU. An attempt to identify markers associated with the disease severity and predictive measures to the patient s outcome., 4 to 6 months

Hamad Medical Corporation

Qatar University|Weill Cornell Medical College in Qatar

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

MRC-05-007

2020-04-27

2022-06

2022-06

2020-07-16

2020-07-16

Hamad Medical Corporation, Doha, Qatar

{ "No intervention": [ { "intervention_type": "OTHER" } ] }

NCT04107831

Physical Function in Patients With Chronic Obstructive Pulmonary Disease

https://clinicaltrials.gov/study/NCT04107831

ACTIVE_NOT_RECRUITING

The aims of the study are to examine the responsiveness of, and the correlation between field walk tests and physical performance test in patients with chronic obstructive pulmonary disease (COPD) after participating in pulmonary rehabilitation.

NO

COPD

OTHER: Pulmonary rehabilitation

6-minute walk test, Change from baseline to 6 weeks in 6 minute walk distance in meter is primary outcome, up to 6 weeks

Incremental Shuttle walk test, Change from baseline to 6 weeks in walk distance in meter is the outcome, up to 6 weeks|Endurance shuttle walk test, Change from baseline to 6 weeks in time in second is the outcome, up to 6 weeks|30 second sit to stand test, Change from baseline to in number of repetition is the outcome, up to 6 weeks|Stair test, Change from baseline to 6 weeks in time of the test is the outcome: 18 steps are walked up and down three times as fast as possible. Time in sec. is measured., Up to 6 weeks

Haukeland University Hospital

Norwegian Fund for Postgraduate Training in Physiotherapy|Western Norway University of Applied Sciences

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

HaukelandUH- 2019/852

2019-08-09

2024-12-31

2024-12-31

2019-09-27

2024-01-05

Bente Frisk, Sandsli, 5253, Norway

{ "Pulmonary rehabilitation": [ { "intervention_type": "OTHER" } ] }

NCT05518773

Mechanisms and Treatment of Exercise Intolerance and Persistent Fatigue in Spinal Muscular Atrophy

https://clinicaltrials.gov/study/NCT05518773

RECRUITING

This study will focus on the pathophysiological underpinnings of reduced exercise capacity and fatigue in ambulatory patients with spinal muscular atrophy (SMA). There has been laboratory evidence to suggest that the molecular mechanisms underlying mitochondrial biogenesis may be vulnerable to survival motor neuron (SMN) protein deficiency. This is an observational, single visit study including 34 ambulatory SMA patients treated with SMN repletion therapies (risdiplam or nusinersen) for at least 6 months at enrollment.

NO

Spinal Muscular Atrophy

Peak oxygen uptake, Participants will undergo an exercise tolerance test performed by a clinical exercise physiologist using an electronically-braked recumbent cycle ergometer to determine peak oxygen uptake (VO2 max)., Baseline

NIRS derived index of muscle oxygen extraction, Near Infrared Spectroscopy (NIRS) is a simple, non-invasive method to measure oxygen in muscle and other tissues in vivo., Baseline|Distance walked during the Six Minute Walk Test (6MWT), 6MWT is an objective evaluation of functional exercise capacity, measures the maximum distance a person can walk in six minutes over a 25-meter linear course., Baseline|Leg muscle composition, To characterize leg muscle composition, quality and architecture using MRI and ultrasound in individuals with SMA treated with agents that restore SMN either systemically (risdiplam) or to central nervous system alone (nusinersen)., Baseline

Relationship of muscle quality and function, Muscle quality and architecture will be assessed using MRI and muscle ultrasound of the lower body, and the relationship to strength, function, and fitness will be evaluated., Baseline

Columbia University

Genentech, Inc.

ALL

CHILD, ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

AAAT5811

2022-12-15

2025-06-30

2025-09-01

2022-08-29

2024-04-18

Columbia University Irving Medical Center, New York, New York, 10032, United States

{}

NCT03822273

Analgesic Effect of Acupuncture for Patients With Rib Fractures

https://clinicaltrials.gov/study/NCT03822273

COMPLETED

Traumatic rib fractures are common, resulting from significant forces impacting on the chest, and are associated with significant morbidity and mortality. Acute pain management in inpatients with traumatic rib fractures has been highly emphasized by practitioners. Inappropriate analgesia may cause respiratory complications, including pneumonia, atelectasis, acute respiratory distress syndrome, and prolonged hospital stay. These may be prevented or reduced by good analgesic therapy. This study is aimed to investigate the analgesic effect of acupuncture on traumatic rib fractures.

NO

Rib Fractures|Acute Pain|Analgesia

PROCEDURE: Traditional acupuncture (TA)|PROCEDURE: Laser acupuncture (LA)|PROCEDURE: Sham laser acupuncture (SLA)

Efficacy of pain relief, Maximal pain intensity (Numerical Rating Scale; NRS: 0-10) evaluated by participants themselves during deep breathing, coughing, and turning over in bed., The NRS will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. Primary outcome is the change of NRS score on DAY 1 pretreatment and DAY 3 post treatment.

Sustained maximal inspiration lung volumes, Sustained maximal inspiration lung volumes, The sustained maximal inspiration lung volumes will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.|Number of cases with pulmonary complications, Pulmonary complications including pneumonia, atelectasis, pleural effusion, acute respiratory distress syndrome, and respiratory failure., Follow-up for one month|Saliva cortisol level, Saliva cortisol level, The saliva cortisol level will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.|Heart rate variation, Heart rate variation, The heart rate variation will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.|The dose of narcotic and non-narcotic analgesics used, Record the use of narcotic and non narcotic analgesics based on chart reviews. Narcotic drugs include codeine, tramadol, and morphine. Non narcotic drugs include acetaminophen, ibuprofen, diclofenac, ketoprofen, mefenamic acid, and parecoxib., Record the medication use for 2 weeks after participant enrolled

Chang Gung Memorial Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

201701455A3

2018-03-01

2020-02-28

2020-12-31

2019-01-30

2021-04-14

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, 833, Taiwan

{ "Traditional acupuncture (TA)": [ { "intervention_type": "PROCEDURE" } ], "Laser acupuncture (LA)": [ { "intervention_type": "PROCEDURE" } ], "Sham laser acupuncture (SLA)": [ { "intervention_type": "PROCEDURE" } ] }

NCT04741373

Study on Pulmonary Rehabilitation for Stable Chronic Obstructive Pulmonary Disease(COPD) Patients

https://clinicaltrials.gov/study/NCT04741373

UNKNOWN

To compare the difference of effectiveness for stable COPD patients with poor nutritional status among three groups named health education, upper and lower limb exercises, and oral nutritional supplements. Then formulate the best pulmonary rehabilitation guidance strategy according to the result of this trial.

NO

Nutritional Support|Aerobic Exercise|Respiratory Function Tests|Body Composition|Muscle Strength

DIETARY_SUPPLEMENT: oral nutritional supplements|BEHAVIORAL: rehabilitation exercise|OTHER: health education

Weight, Anthropometry, three months|Fat free mass, Anthropometry, three months|Fat mass, Anthropometry, three months|Muscle mass, Anthropometry, three months

Grip strength, Muscle strength, three months|6MWD, Muscle endurance strength, three months

Fudan University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

Huadong Hospital to Fudan

2021-04-01

2021-06-01

2021-09-01

2021-02-05

2021-04-13

Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China

{ "oral nutritional supplements": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "rehabilitation exercise": [ { "intervention_type": "BEHAVIORAL" } ], "health education": [ { "intervention_type": "OTHER" } ] }

NCT04179773

Chemotherapy and Liver Cirrhosis in Frequently-associated Cancers

https://clinicaltrials.gov/study/NCT04179773

CHIMIOSE

RECRUITING

Cirrhosis and cancers of the upper digestive tract, colorectal and ENT share common risk factors. Liver cirrhosis can change the elimination of cancer drugs. Precise data on management and outcome of patients with liver cirrhosis undergoing chemotherapy are lacking. Most patients have been excluded from clinical trials evaluating conventional therapies. The study of tolerance, side effects, and outcome in patients with cirrhosis could help improve chemotherapy management for better tolerance and efficacy. The main objective is to estimate the frequency of liver cirrhosis among patients evaluated in CPR for ENT, upper digestive or colorectal cancer. Secondary objective includes the evaluation ofthe impact of cirrhosis on the management of chemotherapy by comparing cirrhotic patients outcomes with a control group of matched non-cirrhotic patients.

NO

Cirrhosis|Neoplasms

OTHER: Current care study

Frequency of patients with ENT, upper digestive-tract or colorectal cancer with a diagnosis of cirrhosis, before the chemotherapy initiation, within 45 days of multidisciplinary board

Percentage of patients receiving at least a first effective course of chemotherapy on all patients with a theoretical indication for chemotherapy, within 45 days of multidisciplinary board.|Survival time, Survival time defined as the difference between the date of initiation of chemotherapy,, the date of death, the date of last news or the point date (12 months).|Progression-free survival time, Progression-free survival time defined as the difference between the date of initiation of chemotherapy, the date of progression or death, the date of last news or the point date (12 months)., the date of initiation of chemotherapy, tthe date of progression or death, the date of last news or the point date (12 months).|Frequency of chemotherapy side effects according to CTCAE version 5.0 classification in cirrhotic patients who have received chemotherapy, Up to 5 years after chemotherapy

University Hospital, Lille

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

RNI2018_41|2018-A01781-54

2019-01-24

2025-01

2025-01

2019-11-27

2020-11-19

Centre Oscar Lambret, Lille, France|Hôpital Claude Huriez, CHU, Lille, France

{ "Current care study": [ { "intervention_type": "OTHER" } ] }

NCT05487573

Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure

https://clinicaltrials.gov/study/NCT05487573

PREDILACT

NOT_YET_RECRUITING

Extubation failure (EF) is independently associated with excess mortality of critically ill patients. To avoid EF, critically ill patients being weaned from invasive mechanical ventilation (IMV) perform spontaneous breathing trial (SBT), which is the litmus test for determining the ability to breathe without a ventilator. Thus, the performance of the SBT during weaning from IMV to predict successful extubation is crucial. The investigators hypothesize that patients with EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia. The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients.

NO

Extubation Failure

Evaluation of the variation in arterial lactate concentration, Evaluation of the variation in arterial lactate concentration measured before and after spontaneous ventilation trial in during weaning from invasive mechanical ventilation to predict extubation failure., 72 hours

Arterial lactate concentration before the spontaneous ventilation trial, Measurement of arterial lactate concentration (mmol/L) before the spontaneous ventilation trial., 30 minutes|Arterial lactate concentration after the spontaneous ventilation trial, Measurement of arterial lactate concentration (mmol/L) after the spontaneous ventilation trial and before reconnection to mechanical ventilation., 30 minutes|Diagnostic performance of the variation in arterial lactate concentration, Calculation of the area under the receiver operating characteristic curves (AUROC) for the variation in arterial lactate concentration measured before and after spontaneous ventilation trial., 72 hours

Assistance Publique - Hôpitaux de Paris

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2022-A00111-42

2022-09-15

2025-10-15

2025-10-15

2022-08-04

2022-08-15

Bichat - Claude-Bernard hospital, Paris, 75018, France

{}

NCT00206973

Bronchial Response to Mannitol and Inflammation in Steroid Naive Asthmatics.

https://clinicaltrials.gov/study/NCT00206973

UNKNOWN

Study on the relationship between the response of the airways to a bronchial provocation test with mannitol and the degree of airway inflammation in asthma patients.

NO

Asthma

PROCEDURE: mannitol test

Bispebjerg Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

7654 - man 05

2005-08

2005-09

2005-09-21

2005-09-21

Respiratory Research Unit, Med. Clinic I, Bispebjerg Hospital, Bispebjerg Bakke 23, Copenhagen, NV, 2400, Denmark

{ "mannitol test": [ { "intervention_type": "PROCEDURE" } ] }

NCT05865327

UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture

https://clinicaltrials.gov/study/NCT05865327

UNPIN

RECRUITING

Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They also often lead to serious complications, more time spent in hospital, and can even lead to death. Even after rib fractures have healed, they can lead to long-term pain and a lower quality of life. A technology called cryoneurolysis, which acts to freeze nerves causing pain using a small tool which can turn very cold, is a promising new way to manage rib fracture pain. This study is a test with a small number of people to see if it is feasible to use this technology for patients with rib fractures. If this is successful, we will recruit more people for a larger study to see if cryoneurolysis, along with standard pain control techniques, is better at stopping pain, compared to just the normal techniques alone. Participants in our study will be asked to rate their pain, and record pain medications that they take for 3 months after their pain procedure.

NO

Rib Fractures|Rib Fracture Multiple|Rib; Fracture, With Flail Chest|Pain|Pain, Acute|Pain, Chronic|Trauma|Trauma Injury

PROCEDURE: Cryoneurolysis|PROCEDURE: Sham Cryoneurolysis

Number of participants randomized over an 8 month period, Goal of 3 participants per month for 8 months, Entire pilot study (approximately 8 months)|Number of participants able to adhere to the protocol, Goal of > 90%, Entire pilot study (approximately 8 months + 3 month follow-up)|Number of participants able to adhere to the follow-up, Goal of > 90%, 3 month follow-up|Rate of Adverse events, Ensure no adverse events (short or long term) associated with CN, 3 month follow-up

Pain Severity during deep inspiration 24 hours post ESP catheter placement, Pain measured using Numeric Pain Rating Scale, 24 hours post placement of ESP catheter|Time to discontinuation of ESP catheter, Based on when patient has met criteria for APS discharge or pain is controlled such that PCRA use is < 2 boluses over 12 hrs and NRS < 3 with deep breathing and coughing, Until ESP catheter removal (usually < 7 days)|ESP catheter use, Cumulative volume of local anesthetic solution used via ESP catheter patient controlled reginal analgesia, Until ESP catheter removal (usually < 7 days)|Opioid consumption in hospital and after discharge, Determined from medical records (in-hospital) and via a daily pain diary (post-discharge). Calculated in Oral Morphine Equivalents., Daily for 90 days after block placement|Pain Intensity at 1 and 3 months, As measured using Numeric Pain Rating Scale (0-10) , at rest and during deep inspiration, 1 and 3 month follow-ups|Oxygen requirements, Room air oxygen saturation (SpO2) and requirement for supplementary O2 to maintain SpO2 > 92%, Pre-intervention, post intervention, then daily until discharge|Pulmonary Function Testing, FVC, Pre-intervention, post intervention, then daily until discharge|Pulmonary Function Testing, FEV1, Pre-intervention, post intervention, then daily until discharge|Pulmonary Function Testing, Peak Inspiratory flow, Pre-intervention, post intervention, then daily until discharge|Pulmonary Function Testing, Peak Expiratory Flow, Pre-intervention, post intervention, then daily until discharge|Length of Stay in hospital, Hospital discharge date, Date of admission to date discharge|Length of Stay on acute pain service (APS), Criteria include on oral meds without continuous regional analgesia or intravenous opioids, Date of admission to date of discharge from acute pain service|Time to achieve discharge criteria for isolated chest injury, Criteria include on oral meds without continuous regional analgesia, chest tube out and chest well evacuated (e.g. no evidence of retained hemothorax), and no supplemental O2, Date of admission until discharge criteria met|Patient satisfaction, Patient satisfaction assessed using Patients Global Impression of Change (PGIC) scale, 48 post block procedure, and 1 week, 1 month and 3 month follow-ups|Incidence of chronic rib fracture pain, As assessed using Brief Pain Inventory (BPI) questionnaire, 3 month follow-up|Adverse events, Adverse events to be recorded include: local anesthetic complications, catheter related complications (clotting, migration), procedural complications (pneumothorax, bleeding, infection), and neurological disturbances (dysesthesia, hyperalgesia, allodynia) in area of rib fracture, until 3 month follow-up

Pain Intensity, As measured using NRS-11, at rest and during deep inspiration, 1h and 48h, post block placement, daily in hospital, weekly post discharge and at 1 week follow-up

Sunnybrook Health Sciences Centre

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

5715

2023-10-23

2025-12

2025-12

2023-05-18

2023-12-15

Sunnybrook Health Sciences Centre, Toronto, Ontario, M4N3M5, Canada

{ "Cryoneurolysis": [ { "intervention_type": "PROCEDURE" } ], "Sham Cryoneurolysis": [ { "intervention_type": "PROCEDURE" } ] }

NCT01020227

Usefulness of Integrative Medicine Tools As Adjunctive Care for Women After Coronary Artery Bypass Grafting

https://clinicaltrials.gov/study/NCT01020227

COMPLETED

Background: This randomized controlled trial investigates the effectiveness of an Integrative Therapies (IT) health education intervention in improving physical and psychological functioning in female patients after coronary artery bypass graft (CABG). Methods: One hundred female cardiac surgery patients were assigned to either an intervention or standard care control group. Patients in the intervention group were given a cardiac yoga video, a guided imagery audiotape, instruction in diaphragmatic breathing, and an educational booklet outlining recommendations for dietary change. Patients were followed for 6 months by a health educator who provided ongoing education and encouragement and were assessed at 6 weeks and 6 months post surgery to determine between group differences on physical functioning and psychological distress using the SF-36 and the Profile of Mood States

NO

Cardiovascular Disease

BEHAVIORAL: Integrative Therapies Intervention

Self reported psychosocial adjustment, 6 weeks and 6 months post surgery

Self reported physical functioning and clinical cardiovascular outcomes, 6 weeks and 6 months post surgery

Columbia University

FEMALE

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE

AAAB1732

2004-02

2007-12

2009-11-25

2014-01-29

Columbia University Medical Center, New York, New York, 10032, United States

{ "Integrative Therapies Intervention": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT02872727

Nanoparticles Emitted by Aircraft Engines, Impact on the Respiratory Function:

https://clinicaltrials.gov/study/NCT02872727

NANOAF2

TERMINATED

The object of this new project is to proceed with investigations with the employees of the cohort for the first study so as to obtain a remote evolution (5 years) of their respiratory function while measuring their nanoparticle exposure. This will enable us to assess the possible link between exposure and respiratory function evolution in the employees

NO

Air France Company s Employees Working in the Marseilles and Paris Airports (Flightline and Administrative Employees)

OTHER: Respiratoy health, biological investigations

respiratory function, maximum expiratory volume per second (MEVS), 1 day (Day of inclusion (D0))

Exhaled CO measurement, Exhaled CO measurement, 1 day (Day of inclusion (D0))|Exhaled NO measurement, Exhaled NO measurement, 1 day (Day of inclusion (D0))|Exhaled air condensate, Exhaled air condensate, 1 day (Day of inclusion (D0))|oxidative stress marker (8 isoprostane), oxidative stress marker (8 isoprostane), 1 day (Day of inclusion (D0))|plasma mass spectrometry which allows the simultaneous assaying of 17 elements, plasma mass spectrometry which allows the simultaneous assaying of 17 elements (Zn, Al, Ti, Co, Cu, Zr, Ni, Cr, Ga, In, Mn, Fe, Se, Cd, Ge, Be), 1 day (Day of inclusion (D0))

University Hospital, Montpellier

Aix Marseille Université|LBM- Nanosecurity platform - CEA Grenoble|LR2N - Nanosecurity platform - CEA Grenoble

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

9637|2015-A01771-48

2017-12-13

2020-12-13

2021-06-13

2016-08-19

2021-12-30

Uhmontpellier, Montpellier, 34295, France

{ "Respiratoy health, biological investigations": [ { "intervention_type": "OTHER" } ] }

NCT00211627

Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.

https://clinicaltrials.gov/study/NCT00211627

UNKNOWN

Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.

NO

Snoring|Sleep Apnea Syndromes

DEVICE: KEEPASLEEP enhanced breathing device

Reduction/Elimination of snoring behavior

Miller, Chipp St. Kevin, M.D.

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

MILC - KEEPASLEEP - 0704

2004-06

2006-06

2005-09-21

2005-09-21

Chipp St. Kevin Miller M.D., Santa Monica, California, 90404, United States

{ "KEEPASLEEP enhanced breathing device": [ { "intervention_type": "DEVICE" } ] }

NCT05813873

The Use of Incentive Spirometry in Adult Patients Hospitalised in a Rehabilitation Center With Long-covid Syndrome

https://clinicaltrials.gov/study/NCT05813873

RECRUITING

The aim of this clinical trial is to investigate the efficacy of Triflow in the rehabilitation of patients with long covid syndrome hospitalised in a rehabilitation center. Participants will be divided into 2 groups and follow their exercise regime until the day they are discharged from the rehabilitation center. The intervention group will participate in a rehabilitation program which includes upper and lower limbs exercises, cycle ergometer, walking and the use of triflow. The control group will participate in the same program but without the Triflow.

NO

Long COVID

OTHER: Triflow|OTHER: Control

Barthel Index, Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living., on admission day|Barthel Index, Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living., on discharge day|Dyspnoea (Medical Research Council Dyspnoea Scale), Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is, on admission day|Dyspnoea (Medical Research Council Dyspnoea Scale), Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is, on discharge day|Peak Flow Meter, Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is, on admission day|Peak Flow Meter, Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is, on discharge day

Number of hospitalisation days, Number of days participants stay in the rehabilitation center, on discharge day|Muscle strength (Hand Grip), Assess muscle strength for the upper extremities via hand-held dynamometer, on admission day|Muscle strength (Hand Grip), Assess muscle strength for the upper extremities via hand-held dynamometer, on discharge day|Muscle strength and endurance (30 seconds Sit to stand), Assess muscle strength for the lower extremities and endurance via 30 seconds sit to stand. The participants will have to stand up from a chair without using their arms as many times as they can in 30 seconds. The more times the better their muscle strength and endurance, on admission day|Muscle strength and endurance (30 seconds Sit to stand), Assess muscle strength for the lower extremities and endurance via 30 seconds sit to stand. The participants will have to stand up from a chair without using their arms as many times as they can in 30 seconds. The more times the better their muscle strength and endurance, on discharge day|Balance (Berg Balance), Assess via Berg Balance Questionnaire, a total of 14 items that asess balance. from 0 to 56, the higher the score the better balance a person has and has a smaller risk for falls., on admission day|Balance (Berg Balance), Assess via Berg Balance Questionnaire, a total of 14 items that asess balance. from 0 to 56, the higher the score the better balance a person has and has a smaller risk for falls., on discharge day|Cardiorespiratory fitness (Six minutes walking test), Assess the cardiorespiratory fitness via 6 minutes walking test. The participants have to walk for 6 mins independently and the distance they cover is measured. The bigger the distance the better cardiorespiratory fitness., on admission day|Cardiorespiratory fitness (Six minutes walking test), Assess the cardiorespiratory fitness via 6 minutes walking test. The participants have to walk for 6 mins independently and the distance they cover is measured. The bigger the distance the better cardiorespiratory fitness., on discharge day|Quality of life (EQ-5D-5L), Assess via EQ-5D-5L questionnaire, it has 6 components (movement,self-care, everyday activities, pain/discomfort, stress/depression, and a scale from 0 to 100 for participants to score how they perceive their health on the day( 0 indicates worst heath and 100 best health), on admission day|Quality of life (EQ-5D-5L), Assess via EQ-5D-5L questionnaire, it has 6 components (movement,self-care, everyday activities, pain/discomfort, stress/depression, and a scale from 0 to 100 for participants to score how they perceive their health on the day( 0 indicates worst heath and 100 best health), on discharge day|Fatigue (Multidimensional fatigue inventory), Assess the feeling of fatigue via Multidimensional fatigue inventory. it has 20 questions with a scale from 1(yes that is true) to 5 (no that is not true), on admission day|Fatigue (Multidimensional fatigue inventory), Assess the feeling of fatigue via Multidimensional fatigue inventory. it has 20 questions with a scale from 1(yes that is true) to 5 (no that is not true), on discharge day|Timed up and Go, Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility, on admission day|Timed up and Go, Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility, on discharge day

European University Cyprus

Eden Resort Wellness Rehabilitation Center

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

Triflow

2022-12-21

2024-12-23

2025-12-31

2023-04-14

2024-02-20

Eden Resort Wellness Rehabilitation Center, Larnaca, 7562, Cyprus

{ "Triflow": [ { "intervention_type": "OTHER" } ], "Control": [ { "intervention_type": "OTHER" } ] }

NCT02146573

Pediatric Continuity Care Intensivist

https://clinicaltrials.gov/study/NCT02146573

CCI

COMPLETED

This study will implement and evaluate the effects of a pediatric continuity care intensivist program. This study will determine the impact of an additional pediatric intensive care unit (PICU) intensivist on outcomes at the patient and family level. It will also evaluate the training program to prepare the continuity care intensivist (CCI).

NO

Critical Illness

BEHAVIORAL: Continuity Care Intensivist Communication Training|BEHAVIORAL: Continuity Care Intensivist (CCI) Provider Program

Difference in patient length of stay in the PICU between usual care and intervention arm, Length of stay as measured by the Virtual PICU system (VPS) in the PICU., up to 600 days

Difference in number of new technological dependence patients acquire during hospitalization between usual care and intervention arms, We will measure new technology dependence like tracheostomy, gastrostomy tube, long term ventilation, bipap using VPS during the PICU hospitalization., up to 600 days|Difference in patient hospital-acquired conditions between usual care and intervention arm, Using VPS, investigators will track hospital acquired infections like catheter associated urinary tract infections and ventilator associated pneumonias, up to 600 days|Difference in patient length of time on sedation medicines between usual care and intervention arm, Investigators will track the length of time on sedation medications used during intubations and when there is other medical equipment like chest tubes that it is not safe for patients to be moving. These medications include midazolam and fentanyl among others., up to 600 days|Difference in patients new or progressive multiple organ dysfunction syndrome between usual care and intervention arm, Investigators will use the VPS designation of multiple organ dysfunction syndrome to characterize system failures like respiratory, renal, cardiac failure., up to 600 days|Difference in patient organ failure free days between usual care and intervention arm, Investigators will use the VPS designation of organ failure for systems like renal, respiratory and cardiac., up to 600 days|Difference in patient ventilator free days between usual care and intervention arm, Investigators will use the VPS designation for days up to 90 that the patient remains off of mechanical ventilation., up to 600 days|Difference in change in parent preferences for shared decision-making from baseline to patient discharge between usual care and intervention arm, A decision-analysis method will be used to administer and measure parental preferences for shared decision-making. Validation of the measure is completed but not yet published by the principal investigator., baseline, up to 600 days|Difference in change in parent preferences for control in decision-making from baseline to patient discharge between usual care and intervention arm, The Control Preferences Scale for Pediatrics (CPS-P), a validated tool, will be used to measure parent s preferences for control in decision-making., baseline, up to 600 days|Affects of Parent attachment style on communication preferences, The Relationship Questionnaire, a validated measure, will be used to measure parent relationship style, which is based on attachment theory., baseline|Difference in change in parental levels of anxiety and depression from baseline to patient discharge between usual care and intervention arm, Parental levels of hospital anxiety and depression will be measured using the Hospital Anxiety and Depression scale (HADS)., baseline, up to 600 days|Difference in change in parental levels of positive and negative affect from baseline to patient discharge between usual care and intervention arm, Parental levels of positive and negative affect will be measured using the Positive and Negative Affect Scale (PANAS), a validated tool., baseline, up to 600 days|Difference in change in parental levels of anger from baseline to patient discharge between usual care and intervention arm, Parent levels of anger will be measured using PROMIS bank v1.1- Anger scale., baseline, up to 600 days|Difference in change in parental levels of hope from baseline to patient discharge between usual care and intervention arm, Parental levels of hope will be measured using the Hope Scale, a validated tool., baseline, up to 600 days|Difference in change in Parent/family satisfaction with decision-making from baseline to patient discharge between usual care and intervention arm, Parent satisfaction with decision-making will measured through several question items designed to assess parent satisfaction with making decisions during their child s PICU visit. This measure was developed through extensive literature review and has been evaluated for face validity through cognitive interviewing and pilot testing with parents and families of children admitted to the ICU., baseline, up to 600 days|Difference in parent/family satisfaction with communication with their child s PICU physicians between usual care and intervention arm, The Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU), a validated tool, will be used to measure parent satisfaction with communication with their child s PICU physician., up to 600 days|Difference in change in parent self-report of medical communication competence from baseline to patient discharge between usual care and intervention arm, The Medical Communication Competence Scale, a partially validated tool, will be used to measure parent self-reported competency with communication., baseline, up to 600 days|Difference in change in parent assessment of physician communication competency from baseline to patient discharge between usual care and intervention arm, The Communication Assessment Tool (CAT), a validated tool, will be used to measure parent perceptions of physician competence in interpersonal and communication skills., baseline, up to 600 days|Comparison of physician burnout between intervention and control group from baseline up to 600 days, The Maslach Stress and Burnout Inventory, a validated tool, will be used to measure the three aspects of the burnout syndrome: emotional exhaustion, depersonalization, and lack of personal accomplishment., baseline, up to 600 days|Physician satisfaction with the communication training and with the CCI experience., Questions written for this study that have been written and piloted will assess the physicians satisfaction and perceived usefulness of the communication training., up to 600 days|Evaluation of CCI provider experience in role of CCI and its feasibility of larger implementation, Both open ended survey questions and focus groups will be qualitatively analyzed to determine the benefits and burdens for providers of serving in the CCI role., up to 600 days|Comparison of physician comfort with end-of-life communication between intervention and control group from baseline up to 600 days, Physician comfort with end-of-life communication will be measured through several question items developed to assess how physicians feel about engaging in end of life discussions. The measure was developed through extensive literature review and has been evaluated for face validity through cognitive interviewing and pilot testing with PICU physicians., baseline, up to 600 days|Difference in timing of patient s limitations of interventions to death between usual care and intervention arm, As measured by a chart review of timing of limitations of interventions including do not resuscitate (DNR)/ do not intubate (DNI) and other limitations like no escalation of care will be described and the time to event of death will be compared., up to 600 days|Frequency of palliative care consultation between usual care and intervention arm, Medical chart review to determine request for and consultation performed by Pediatric Advanced Care Team (palliative care consultation service) will be measured and compared., up to 600 days|Physician competency in communication with families via objective structured clinical examination (OSCE) evaluation, CCI providers will be evaluated using a simulated patient and scored using a validated tool for communication skills including empathy in an encounter in the end-of-life setting., up to 600 days|Comparison of physician self-reported communication competency between intervention and control group, The Medical Communication Competence Scale, a partially validated measure will be used to assess physician self-reported competency., baseline, up to 600 days|Correlation between amount of CCI contact and parent and patient level outcomes, Investigators will categorize the extent of CCI contact and then determine if there is a correlation between amount of contact and parent and patient level outcomes., baseline, up to 600 days

Children s Hospital of Philadelphia

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH

IRB 14-010987

2014-05

2017-12

2018-12

2014-05-26

2020-09-16

The Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States

{ "Continuity Care Intensivist Communication Training": [ { "intervention_type": "BEHAVIORAL" } ], "Continuity Care Intensivist (CCI) Provider Program": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT01196273

Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 5 Years Follow-up

https://clinicaltrials.gov/study/NCT01196273

COMPLETED

HIV-infection is associated not only with a reduced function of the immune system, but also linked with diseases of other organ systems, in particular with the heart. Heart conditions that have been described with HIV include * Pericarditis, * Pleural effusion * Pulmonary hypertension (Venedic classification typ II) * Dilated cardiomyopathy * Heart failure * Myocarditis * Bacterial endocarditis * Heart valve disorders In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians. Premature atherosclerosis of coronary arteries results in coronary calcification, angina pectoris, myocardial infarction and sudden death. HIV-positive patients are at greater risk for a variety of heart-related conditions, including coronary artery disease. It is assumed, that HIV infection doubles the risk of a heart attack, according to recent research. The reason for this link between HIV and heart-related conditions is unknown, but secondary infections that affect the heart muscle and coronary arteries have a greater chance of occurring in people with compromised immune systems. In addition, the HI-virus itself had been detected in the myocardium and might have an impact on the premature of cardiovascular diseases. Furthermore, some of the medications used to treat HIV patients (antiretroviral therapy, ART) are assumed to have heart-related side effects. Therefore, current treatment regimens for HIV infection have to be balanced against the marked benefits of antiretroviral treatment. Nevertheless, prevention of coronary heart disease should be integrated into current treatment procedures of HIV-infected patients. The link between the heart and HIV is well established but not well understood. Therefore, further results are needed for efficient guidelines for the prevention, diagnostic and therapy of HIV-associated cardiovascular diseases.

NO

Coronary Heart Disease|Heart Failure|HIV|AIDS|Metabolic Syndrome

OTHER: Comprehensive non invasive cardiovascular examination

Cardiovascular Diseases in HIV-infected Patients, The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease - in HIV-infected patients., Baseline up to 5 years follow-up

Cardiovascular Disorders in HIV-infected Patients HIV-HEART, The study also investigates the impact of established risk factors and new HIV-specific risk factors of coronary artery disease such as, age, gender, virus-load, CD4-cell count. The HIV-HEART study will focus on the impact of medication including cardiovascular medication and antiretroviral medication. Further secondary objectives will be examined, including economic costs and quality of life of subjects with and without cardiovascular diseases in this patient population., Baseline up to 5 years follow-up

University Hospital, Essen

HIV-HEART Study Investigative Group|German Heart Failure Network|German Competence Network for HIV/AIDS|German Federal Ministry of Education and Research|Bristol-Myers Squibb|ViiV Healthcare|GlaxoSmithKline|Abbott|Boehringer Ingelheim|Merck Sharp & Dohme LLC

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

09-4085

2009-12

2011-12

2011-12

2010-09-08

2012-06-28

University Hospital of Bochum, Department of Dermatology, Bochum, 44791, Germany|HIV Outpatient Department, Dortmund, 44137, Germany|University Hospital, Department of Dermatology and Venerology, Essen, 45122, Germany|University Hospital, West German Heart Center Essen, Essen, 45122, Germany|Clinical Coordinating Center Leipzig, Leipzig, 04107, Germany

{ "Comprehensive non invasive cardiovascular examination": [ { "intervention_type": "OTHER" } ] }

NCT00448773

REDucing Influenza Among University Students, University of California at Berkeley

https://clinicaltrials.gov/study/NCT00448773

REDI-US

COMPLETED

We will be testing the hypothesis whether online education for UC Berkeley students on respiratory hygiene, cough etiquette, hand hygiene/awareness, as well as face mask use (while ill) will reduce the acquisition and transmission of influenza-like illness. The study will be conducted during the flu seasons 2006-7 and 2007-8.

NO

Influenza-like Illness|Influenza

BEHAVIORAL: Online education

Occurrence of influenza-like illness

Centers for Disease Control and Prevention

University of California, Berkeley

ALL

CHILD, ADULT, OLDER_ADULT

PHASE4

FED

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION

CDC-NCID-20061243

2007-02

2008-04

2008-05

2007-03-19

2010-01-07

University of California, Berkeley, Berkeley, California, 94720, United States

{ "Online education": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT03347227

Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation

https://clinicaltrials.gov/study/NCT03347227

COAST-AF RCT

RECRUITING

A multicentre, parallel group, two arm, single-blinded randomized clinical trial, assessing the efficacy of a patient-tailored catheter ablation (CA) strategy guided by atrial scar mapping in addition to pulmonary vein isolation (PVI) when compared to PVI alone in patients with persistent atrial fibrillation (AF).

NO

Atrial Fibrillation

PROCEDURE: Catheter ablation

Rate of documented (>30s) AF, atrial flutter or atrial tachycardia occuring from day 91 to 18 months post ablation, Documented AF, Aflutter or AT by ECG, holter or external loop monitoring and has a duration of at least 30 seconds, day 91 post ablation to 18 months

AF burden, Documented amount of AF, At 12 months and 18 months|Need for repeat ablation procedure for AF, AFl or AT, Documented by ECG, holter or ECG loop recorder, Up to 18 months|Need for emergency room visits or hospitalization, Hospital admission for > 24 hours and emergency room admission, Up to 18 months|Incidence of any ECG documented AF with 90 days of ablation, Symptomatic or asymptomatic AF, up to 90 days|Time to first recurrence at 18 months according to sex and atrial scar extent, Recurrence of AF, AFl or AT, 18 months|Composite safety outcome, Procedure related complications at any time (stroke, PV stenosis, pericarditis, cardiac perforation, major bleeding) and/or death, Up to 18 months|Total ablation delivery time, RF ablation time, Day of ablation procedure|Total procedure duration, Start of ablation to end of ablation, Day of ablation procedure|Quality of life analyses, Using EQ-5D general quality of life score, and AF severity scale (symptoms and functionality), 18 months

Ottawa Heart Institute Research Corporation

Heart and Stroke Foundation of Canada

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT

20170

2018-08-24

2024-12

2024-12

2017-11-20

2024-05-08

Libin Cardiovascular Institute, Calgary, Alberta, Canada|Vancouver General Hospital, Vancouver, British Columbia, Canada|QEII Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, B3H 1V7, Canada|Hamilton General Hospital, Hamilton, Ontario, Canada|London Health Sciences Centre, London, Ontario, Canada|Southlake Regional Health Centre, Newmarket, Ontario, L3Y 2P9, Canada|University of Ottawa Heart Institute, Ottawa, Ontario, K1Y 4W7, Canada|St. Michael s Hospital, Toronto, Ontario, M5B 1W8, Canada|Rouge Valley Regional Heart Centre, Toronto, Ontario, Canada|Centre Hospitalier de l Universite de Montreal (CHUM), Montreal, Quebec, H2W 1T8, Canada|Sacre-Coeur Hospital, Montreal, Quebec, H4J 1C5, Canada|McGill University Health Centre, Montreal, Quebec, Canada|Montreal Heart Institute, Montreal, Quebec, Canada|Institute Universitaire de Cardiologie et Pneumologie du Quebec (IUCPQ), Quebec City, Quebec, G1V 4G5, Canada|CIUSSS de L Estrie-CHUS-Hopital Fleurimont, Sherbrooke, Quebec, J1H 5N4, Canada

{ "Catheter ablation": [ { "intervention_type": "PROCEDURE" } ] }

NCT02805127

Obstructive Airways Diseases in Emergency Department (OADED) Study

https://clinicaltrials.gov/study/NCT02805127

TERMINATED

This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both Chronic Obstructive Pulmonary Disease (COPD) and Asthma patients.

NO

Asthma|Chronic Obstructive Pulmonary Disease (COPD)

Correlation between capnography parameters and severity of asthma, Correlation between the airway obstruction severity calculation based on the capnography parameters and the clinical severity of asthma and COPD as defined by forced expiratory volume in 1 second (FEV1), in severe asthma and COPD patients, 1/2 hour to 48 hours from enrollment of subjects

Oridion

Hadassah Medical Organization

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

MDT17071

2016-12-22

2017-08-06

2017-08-06

2016-06-17

2017-12-08

{}

NCT01627327

Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease

https://clinicaltrials.gov/study/NCT01627327

COMPLETED

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease

YES

Pulmonary Disease, Chronic Obstructive

DRUG: fluticasone furoate/vilanterol 100/25mcg|DRUG: tiotropium bromide 18mcg

Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84, Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group., Baseline and Day 84

Time to Onset on Treatment Day 1, Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum., Baseline and Day 1|Change From Baseline in Trough FEV1 at Treatment Day 84, Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group., Baseline and Day 84

GlaxoSmithKline

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

115805

2012-04-01

2012-12-01

2012-12-21

2012-06-25

2013-11-01

2017-11-09

GSK Investigational Site, Newport Beach, California, 92663, United States|GSK Investigational Site, Coeur d Alene, Idaho, 83814, United States|GSK Investigational Site, Charlotte, North Carolina, 28207, United States|GSK Investigational Site, Cincinnati, Ohio, 45231, United States|GSK Investigational Site, Medford, Oregon, 97404, United States|GSK Investigational Site, Gaffney, South Carolina, 29340, United States|GSK Investigational Site, Greenville, South Carolina, 29615, United States|GSK Investigational Site, Seneca, South Carolina, 29678, United States|GSK Investigational Site, Spartanburg, South Carolina, 29303, United States|GSK Investigational Site, Union, South Carolina, 29379, United States|GSK Investigational Site, Newport News, Virginia, 23606, United States|GSK Investigational Site, Winnipeg, Manitoba, R2H 2A6, Canada|GSK Investigational Site, Truro, Nova Scotia, B2N 1L2, Canada|GSK Investigational Site, Toronto, Ontario, M5V 2T3, Canada|GSK Investigational Site, Montreal, Quebec, H2W 1T8, Canada|GSK Investigational Site, Montreal, Quebec, H4J 1C5, Canada|GSK Investigational Site, Montreal, Quebec, H4N 3C5, Canada|GSK Investigational Site, Sherbrooke, Quebec, J1H 1Z1, Canada|GSK Investigational Site, St-Charles-Borromée, Quebec, J6E 2B4, Canada|GSK Investigational Site, St-Romuald, Quebec, G6W 5M6, Canada|GSK Investigational Site, Kralupy nad Vltavou, 278 01, Czechia|GSK Investigational Site, Kromeriz, 767 55, Czechia|GSK Investigational Site, Teplice, 415 10, Czechia|GSK Investigational Site, Trebic, 674 01, Czechia|GSK Investigational Site, Zamberk, 564 01, Czechia|GSK Investigational Site, Cottbus, Brandenburg, 03050, Germany|GSK Investigational Site, Ruedersdorf, Brandenburg, 15562, Germany|GSK Investigational Site, Frankfurt, Hessen, 60596, Germany|GSK Investigational Site, Neu-Isenburg, Hessen, 63263, Germany|GSK Investigational Site, Schwerin, Mecklenburg-Vorpommern, 19055, Germany|GSK Investigational Site, Magdeburg, Sachsen-Anhalt, 39112, Germany|GSK Investigational Site, Dresden, Sachsen, 01069, Germany|GSK Investigational Site, Leipzg, Sachsen, 04109, Germany|GSK Investigational Site, Grosshansdorf, Schleswig-Holstein, 22927, Germany|GSK Investigational Site, Berlin, 10117, Germany|GSK Investigational Site, Berlin, 10717, Germany|GSK Investigational Site, Berlin, 10787, Germany|GSK Investigational Site, Berlin, 10789, Germany|GSK Investigational Site, Bialystok, Poland|GSK Investigational Site, Czestochowa, 42-200, Poland|GSK Investigational Site, Dzialdowo, 13-200, Poland|GSK Investigational Site, Krakow, 31-024, Poland|GSK Investigational Site, Piekary Slaskie, 41-940, Poland|GSK Investigational Site, Slupsk, 76-200, Poland|GSK Investigational Site, Tarnow, 33-100, Poland|GSK Investigational Site, Bucharest, 020125, Romania|GSK Investigational Site, Bucharest, 030317, Romania|GSK Investigational Site, Bucharest, 050159, Romania|GSK Investigational Site, Bucuresti, 70000, Romania|GSK Investigational Site, Cluj Napoca, 400371, Romania|GSK Investigational Site, Cluj-Napoca, 400371, Romania|GSK Investigational Site, Constanta, 900002, Romania|GSK Investigational Site, Iasi, 700115, Romania|GSK Investigational Site, Suceava, 720284, Romania|GSK Investigational Site, Timisoara, 300310, Romania

{ "Fluticasone furoate/vilanterol": [ { "intervention_type": "DRUG", "description": "fluticasone furoate/vilanterol 100/25mcg", "name": "Fluticasone furoate/vilanterol", "synonyms": [ "Fluticasone furoate/vilanterol", "Relvar Ellipta", "Breo Ellipta" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Fluticasone%20furoate/vilanterol", "generic_names": [] } ], "Tiotropium bromide": [ { "intervention_type": "DRUG", "description": "tiotropium bromide 18mcg", "name": "Tiotropium bromide", "synonyms": [ "Spiriva", "Tiotropium bromide" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Tiotropium%20bromide", "generic_names": [] } ] }

NCT02577627

Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC

https://clinicaltrials.gov/study/NCT02577627

UNKNOWN

This is a retrospective observational, open label study to evaluate and prospectively validate in a blind manner the accuracy of predicting treatment outcomes by PrediCare in individual patients with Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Castration-Resistant Prostate Cancer, Breast Cancer & Colon Cancer under the treatment with the mono- and combination drug protocols for the 1st and 2nd line treatment, approved to the market as a Standard of Care

NO

Non-Small Cell Lung Cancer|Small Cell Lung Cancer|Prostate Cancer|Breast Cancer|Colon Cancer

DEVICE: PrediCare

Primary endpoint in this study is Time To Progression of disease, 1 year

Optimata Ltd.

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

OPTI-006

2015-09

2018-01

2019-09

2015-10-16

2017-04-04

Optimata Ltd., Bene-Atarot, 60991, Israel

{ "PrediCare": [ { "intervention_type": "DEVICE" } ] }

NCT03052673

Ketamine for Pain Relief in Bariatric Surgery

https://clinicaltrials.gov/study/NCT03052673

COMPLETED

The surgical interventions for treating morbid obesity, i.e. bypass procedure and sleeve gastrectomy are collectively covered under the term bariatric surgery . The growth of bariatric surgery has seen consonant development of anaesthesia techniques so as to ensure patient safety and facilitate post-surgery outcome. Conventionally, balanced general anaesthesia techniques routinely use opioids peri-operatively for intra-operative haemodynamic homeostasis and postoperative pain relief. However, since the morbidly obese patients have high prevalence of obstructive sleep apnea(OSA) and other co-morbidities the same technique when employed in the morbidly obese patients hampers early and intermediate postoperative recovery due to the occurrence of side effects, such as, sedation, PONV, respiratory depression, depressed GI-mobility. The above stated side effects, have lead to increased propensity for postoperative cardiac and pulmonary complications. Obese patients are more vulnerable and sensitive to the narcotics and sedatives, these drugs need to be employed judiciously in these patients. On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimise opioid use and employ some other drugs which besides having analgesia, has a opioid-sparing effect also. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anaesthetic doses. When used in low dose (0.2mg/kg), it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance. On a conceptual basis, a key advantage of ketamine is that it can reduces post-operative pain and use of opioid when used per-operatively. Therefore, a regimen which avoid or minimise use of opioid is likely to decrease opioid-related postoperative morbidity in these patients undergoing bariatric surgery.In view of the above, a clinical research is highly desirable to study techniques to decrease the use of opioids in obese surgical patients.This prospective randomised two-arm study aims to assess the effect of low-dose ketamine on postoperative pain relief and opioid-sparing ability in obese patients undergoing bariatric surgery.

NO

Postoperative Pain

DRUG: Fentanyl|DRUG: ketamine

Efficacy of Postoperative Analgesia, will be assessed using visual analogue scale (VAS) score, From end of anaesthesia till 24-hours postoperatively|Postoperative Fentanyl Consumption in micrograms, Amount of fentanyl consumed using the IV-PCA pump will be calculated, From end of anaesthesia till 24-hours postoperatively

Time to eye opening in minutes, Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted, From end of anaesthesia till 20-minutes postoperatively|Time to extubation in minutes, Time taken for tracheal extubation after discontinuation of anaesthesia will be noted, From end of anaesthesia till 30-minutes postoperatively|Changes in intraoperative heart rate (beats per minute), Comparison of intraoperative heart rate between both the arms will be done, From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively|Changes in intraoperative blood pressure- systolic, diastolic, and mean (mmHg), Comparison of intraoperative blood pressure- systolic, diastolic, and mean between both the arms will be done, From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively|Postoperative Sedation, will be assessed using Modified Observer s assessment of alertness/sedation scale (OASS), From end of anaesthesia till 24-hours postoperatively|Postoperative Nausea and Vomiting, will be assessed using PONV Scale, From end of anaesthesia till 24-hours postoperatively

Sir Ganga Ram Hospital

ALL

ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

EC/01/17/1120

2017-02-20

2018-07-30

2018-07-30

2017-02-14

2018-08-31

Sir Ganga Ram Hospital, New Delhi, 110060, India

{ "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" } ], "Ketamine": [ { "intervention_type": "DRUG", "description": "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" } ] }

NCT03469973

Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction

https://clinicaltrials.gov/study/NCT03469973

UNKNOWN

The velopharyngeal valve is a tridimensional muscular valve that is located between the oral and nasal cavities. It consists of the lateral and posterior pharyngeal walls as well as the soft palate. The role of the velopharyngeal valve is to separate the oral and nasal cavities during speech and swallowing.

NO

Velopharyngeal Insufficiency|Velopharyngeal Incompetence Due to Cleft Palate

PROCEDURE: Partial adenoidectomy

40 patients diagnosed by velopharyngeal insufficiency will go for partial adenoidectomy completely visualised by 45 degrees, 4 mm nasal endoscope. The adenoid will be removed by using microdeprider., Up to 2 years

Assiut University

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

BASEMM

2018-06-01

2020-05-01

2020-09-01

2018-03-19

2018-03-20

{ "Partial adenoidectomy": [ { "intervention_type": "PROCEDURE" } ] }

NCT02582073

Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™

https://clinicaltrials.gov/study/NCT02582073

COMPLETED

There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. The current therapeutic dose regimen for Grass MATA MPL is a course of four injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU and 18200 SU are being developed to compare with the current dose. The study is designed to explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA (without MPL) and placebo.

NO

Seasonal Allergic Rhinitis

BIOLOGICAL: Placebo (0.5ml)|BIOLOGICAL: Placebo (1.0ml)|BIOLOGICAL: Grass MATA MPL (0.5ml) 5100SU|BIOLOGICAL: Grass MATA MPL (1.0ml) 10200SU|BIOLOGICAL: Grass MATA MPL (1.0ml) 18200SU|BIOLOGICAL: Grass MATA (0.5ml) 5100SU

Post-treatment TSS, The primary efficacy endpoint will be the mean average of the last three TSS measurements recorded in each of the four post-treatment Visits 12 15. TSS will be measured during the four post-treatment mEEC™ sessions conducted on consecutive days 12-15, and is defined as the sum of individual NSS (rhinorrhea, congestion, sneezing and itchiness) and NNSS (itchy/gritty eyes, tearing/watery eyes, red/burning eyes and ear/palate itching)., 21-28 days after the last injection

Frequency of local adverse events (AEs), A Local AE is located at the injection site of study medication, occurring within 24 hours after the injection., A Local AE is located at the injection site of study medication, occurring within 24 hours after the injection.|Frequency of systemic adverse events (AEs), A Systemic AE is allergic signs and symptoms (e.g., conjunctivitis, rhinitis, cough and generalized urticaria including anaphylaxis) associated with the injection of study medication, occurring within 24 hours after the injection., 24 hours following each injection|Frequency of other AEs, All post-treatment AEs that do not fall into local or systemic AEs, Up to 1 year following injections|Frequency of AEs of special interest (AESI), AESI includes New Onset Autoimmune Disorders and Neuro-inflammatory events., Up to 1 year following injections|Safety laboratory values, Change in serum chemistry and haematology from baseline to Visit 16, Up to 12 weeks|Specific IgE, Change in grass specific IgE from baseline to Visit 16, Up to 12 weeks

Allergy Therapeutics

ALL

ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

GrassMATAMPL204

2015-11-07

2016-05-05

2017-04-28

2015-10-21

2021-01-29

Inflamax Research Inc., Neptune, New Jersey, 07753, United States

{ "Placebo (0.5ml)": [ { "intervention_type": "BIOLOGICAL" } ], "Placebo (1.0ml)": [ { "intervention_type": "BIOLOGICAL" } ], "Grass MATA MPL (0.5ml) 5100SU": [ { "intervention_type": "BIOLOGICAL" } ], "Grass MATA MPL (1.0ml) 10200SU": [ { "intervention_type": "BIOLOGICAL" } ], "Grass MATA MPL (1.0ml) 18200SU": [ { "intervention_type": "BIOLOGICAL" } ], "Grass MATA (0.5ml) 5100SU": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT00691873

Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids

https://clinicaltrials.gov/study/NCT00691873

COMPLETED

In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab (administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

NO

Asthma

DRUG: Placebo|DRUG: Xolair

Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids, 2005-2007

University of Mississippi Medical Center

Novartis

ALL

ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

Marshall, Gailen 6 3 08

2006-05

2007-05

2007-10

2008-06-06

2008-06-06

University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States

{ "Placebo": [ { "intervention_type": "DRUG" } ], "Omalizumab": [ { "intervention_type": "DRUG", "description": "Xolair", "name": "Omalizumab", "synonyms": [ "Omalizumab", "Xolair" ], "medline_plus_id": "a603031", "generic_names": [ "Omalizumab" ], "mesh_id": "D018927", "drugbank_id": "DB00043", "wikipedia_url": "https://en.wikipedia.org/wiki/Omalizumab" } ] }

NCT02556073

ICS/LABA Combination With Integrated Dose Counter and Smartphone APP to Improve Asthma Control

https://clinicaltrials.gov/study/NCT02556073

UNKNOWN

Poor adherence to asthma controller medication may link to poor asthma outcome. A metered dose device with built-in dose counter helps physicians to monitor drug compliance in asthma patients. Mobile-phone based self management opens a window for better asthma control. The present study aims to investigate the relationship between the adherence to controller medication of combined inhaled corticosteroid/long acting beta2-agonists, assessing by integrated dose counter, and the level of airway inflammation and asthma control. Moreover, the investigators also use a new asthma self-management Apps to enhance drug compliance. With the application of the new, easily available tools, the investigator expect to increase adherence rates, and hence, to reduce airway inflammation and improve the level of asthma control.

NO

Asthma

OTHER: Smartphone action|DRUG: usual care

Changes of airway inflammation profile, measurement including exhaled NO, cell counts and mediator in induced sputum before (baseline, wk0) and after treatment (wk 24), Changes of airway inflammation profile from baseline at 24 weeks

changes of scores of asthma control questionnaire, scores of questionnaire of asthma control test (ACT), Changes of scores of asthma control questionnaire from baseline at 24 weeks|Changes of lung function parameters, Changes of lung function parameters (FEV1, FVC) from baseline at 24 weeks|Numbers of rescue medication use, Total numbers of rescue medication use during 24-week period

Taipei Veterans General Hospital, Taiwan

ALL

ADULT, OLDER_ADULT

OTHER_GOV

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

20140218

2014-08

2016-08

2016-12

2015-09-22

2015-09-22

Taipei Veterans General Hospital, Taipei City, 886, Taiwan

{ "Smartphone action": [ { "intervention_type": "OTHER" } ], "usual care": [ { "intervention_type": "DRUG" } ] }

NCT01631773

A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only

https://clinicaltrials.gov/study/NCT01631773

COMPLETED

We hypothesize that the miRNA expression in subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) differs from the miRNA expressed in subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD).

NO

Aspirin-exacerbated Respiratory Disease|Nasal Polyp

GENETIC: microRNA

Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA., 5 total groups, No time frame noted|Negative Group: MiRNAs are absent from both groups, 5 total groups, No time frame noted

University of South Florida

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Nasal Polyp Study & Aspirin

2011-08

2012-06

2012-06

2012-06-29

2014-10-07

USF Division of Allergy and Clinical Immunology Clinical Research Unit, Tampa, Florida, 33613, United States

{ "microRNA": [ { "intervention_type": "GENETIC" } ] }

NCT03748173

Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04

https://clinicaltrials.gov/study/NCT03748173

TERMINATED

Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.

NO

Bronchiolitis

COMBINATION_PRODUCT: Aerosolized Infasurf

Improvement in Respiratory Status, Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4., 24 hours post PICU admission

Need of Respiratory support, Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation, 24 hours post PICU admission

Dose as Measured as duration of the therapy, To determine the optimal dose/duration of aerosolized Infasurf® in infants with bronchiolitis by aerosolizing Infasurf at 35mg/ml at a rate of 1.8 to 2.2 mls per minute until therapeutic response is achieved or the maximum amount of a single dose is reached., 24 hours post PICU admission

ONY

ALL

CHILD

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

Aero-04

2019-01-12

2020-10-02

2020-10-21

2018-11-20

2020-10-23

Children s Hospital of Richmond at VCU, Richmond, Virginia, 23298, United States

{ "Calfactant": [ { "intervention_type": "COMBINATION_PRODUCT", "description": "Aerosolized Infasurf", "name": "Calfactant", "synonyms": [ "Calfactant", "Bovactant", "Infasurf", "SF-RI 1", "Calf lung surfactant extract (CLSE)", "Alveofact", "AeroFact" ], "drugbank_id": "DB06415", "generic_names": [ "Calfactant" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Calfactant" } ] }

NCT05975073

A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

https://clinicaltrials.gov/study/NCT05975073

RECRUITING

The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).

NO

MTAP-null Non-Small-Cell Lung Cancer|MTAP-null Solid Tumors

DRUG: AMG 193|DRUG: IDE397

Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs), Day 1 up to Day 21|Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events, Day 1 up to approximately 2.5 years|Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs), Day 1 up to approximately 2.5 years|Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, Day 1 up to approximately 2.5 years

Part 1 and 2: Maximal Plasma Concentration (Cmax) of AMG 193, Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)|Part 1 and 2: Cmax of IDE397, Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)|Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of AMG 193, Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)|Part 1 and 2: Tmax of IDE397, Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)|Parts 1 and 2: Area Under The Curve (AUC) After Single Dose of AMG 193, Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)|Parts 1 and 2: Area Under The Curve (AUC) After Multiple Doses of AMG 193, Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)|Parts 1 and 2: AUC After Single Dose of IDE397, Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)|Parts 1 and 2: AUC After Multiple Doses of IDE397, Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)|Parts 1: Overall Response per RECIST 1.1, Day 1 up to end-of-study (EOS) (approximately 2.5 years)|Parts 1 and 2: Disease Control Rate, Day 1 up to EOS (approximately 2.5 years)|Parts 1 and 2: Time to Response (TTR), Day 1 up to EOS (approximately 2.5 years)|Parts 1 and 2: Duration of Response (DOR), Day 1 up to EOS (approximately 2.5 years)|Parts 1 and 2: Duration of Stable Disease, Day 1 up to EOT (approximately 6 months)|Parts 1 and 2: Progression-free Survival (PFS), Day 1 up to EOS (approximately 2.5 years)|Parts 1 and 2: Overall Survival (OS), Day 1 up to EOS (approximately 2.5 years)|Part 2: Number of Participants Experiencing TEAEs, Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events, Day 1 up to approximately 2.5 years|Part 2: Number of Participants Experiencing SAEs, Day 1 up to approximately 2.5 years|Parts 1 and 2: Change From Baseline in Symmetric Dimethylation of Arginine (SDMA) in Blood, Baseline (Day 1) to EOT plus 30 days (approximately 7 months)

Amgen

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT

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