louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04753632: Status of People With Cerebral Palsy and Their Caregivers During COVID-19 Pandemic
Official title: Assessment of the Biopsychosocial Status of People With Cerebral Palsy and Related Diseases and Their Caregivers During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cerebral palsy patients and their caregivers

Brief summary: COVID-19, as well as the collateral situations that it entails, has been causing panic, anguish and anxiety that has generated biopsychosocial problems in society affecting not only the physical and social level but also the mental health and well-being.

The main objective of this research project is to assess the biopsychosocial status of people with cerebral palsy and related diseases and their caregivers during the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* Cerebral palsy patients and their caregivers

Exclusion Criteria:

* Patients or caregivers with Cognitive impairment

Primary outcomes:
measure: Questionnaire of Knowledge, attitudes and practice towards COVID-19
timeFrame: Baseline
measure: Caregiver COVID-19 limitation scale
timeFrame: Baseline
measure: Fear of Coronavirus-19 Scale
timeFrame: Baseline
measure: Covid-19 Stress Scale (CSS)
timeFrame: Baseline
measure: Coronavirus Anxiety Scale (CAS)
timeFrame: Baseline
measure: Connor-Davidson Resilience Scale-10
timeFrame: Baseline
measure: COPE
timeFrame: Baseline
measure: Medical Outcomes Study-Social Support Survey
timeFrame: Baseline
measure: Zarit Burden Inventory
timeFrame: Baseline
Secondary outcomes:
measure: Euroqol-5D
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: International Physical Activity Questionnaire
timeFrame: Baseline
measure: Functional independence measure
timeFrame: Baseline
measure: Gross motor function classification system
timeFrame: Baseline
measure: Manual Agility Classification System
timeFrame: Baseline
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
References:
Clinical trial NCT06333132: Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat)
Official title: Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Diabetes Mellitus Type 2 in Obese
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission.

Detailed description: Participants will undergo an intensive, individualized dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn. Before and after the intervention, the patients will undergo:

* measurement of fasting glucose and glycated hemoglobin
* Indirect calorimetry
* oral glucose tolerance test
* intravenous glucose tolerance test
* quality of life and diet-related questionnaires
* 72-hour food records

At the end of the protocol, subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse.

Eligibility criteria: Inclusion Criteria:

* T2D for less than 6 years;
* age 18-65 years;
* both genders;
* BMI 27-45 kg/m2;
* HbA1c 48-108 mmol/mol (43-108 mmol/mol if on glucose-lowering drugs).

Exclusion Criteria:

* type 1 or secondary/genetic diabetes;
* treatment with insulin, Glucagon-Like Peptide-1 agonists, Gastric Inhibitory Peptide/GLP-1 co-agonists, or pioglitazone;
* weight loss \>5% within the previous 6 months;
* eGFR \<30 ml/min/1.73m2;
* myocardial infarction within the previous 6 months;
* severe heart failure (NYHA III-IV); eating disorder; substance abuse;
* severe depression;
* known cancer;
* pregnancy.

Primary outcomes:
measure: Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
affiliation: University of Pisa
name: Domenico Tricò, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06565832: Reproducibility of Virtual Exercise Assessments Versus Face-to-face Exercise Testing in Adults With Cystic Fibrosis
Official title: Reproducibility of Virtual Exercise Assessments Versus Face-to-face Exercise Testing in Adults With Cystic Fibrosis - a Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Exercise testing
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2024-08-22
Enrollment: 19
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: RExA-CF is investing if results from exercise tests (the Chester Step Test and the One-Minute Sit-to-Stand test) completed face to face are comparable to results of the same tests completed via a virtual teleconferencing platform. The study involves two exercise testing sessions (one face-to-face and one via a video link), with participants being randomised to complete the two exercise tests (the 1-minute sit-to-stand test and the Chester Step test). The two testing sessions will be completed within three weeks of each other, the order of which will be randomly allocated. One session will be completed face-to-face during a pre-arranged visit to the hospital, the other test session will be completed through a video call at a time convenient to the participants. After the second testing session participants will be asked some questions about the face-to-face and video tests to get their views about the two formats.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cystic fibrosis (as confirmed by standard criteria)
* Sixteen years of age or over
* Home internet access
* Stable CF disease as judged by the medical team
* Registered with the Royal Brompton Hospital adult CF team

Exclusion Criteria:

* Inability to give consent for treatment or measurement
* Current participation in another interventional study
* Current moderate haemoptysis (greater than streaking in the sputum)
* Pregnancy
* Forced expiratory volume in 1 second (FEV1) below 30% predicted
* Dependency upon oxygen therapy (with home oxygen concentrators or portable oxygen cylinders) or non-invasive ventilation (NIV)
* Current neurological or musculoskeletal injury which would prevent completion of exercise tests
* Inability to complete the second set of exercise tests within three weeks

Primary outcomes:
measure: Aerobic Capacity from the Chester Step test
timeFrame: Completed at week 0 and within 2 weeks of first test
measure: Number of sit to stands completed during One-Minute Sit-to-Stand test
timeFrame: Completed at week 0 and within 2 weeks of first test
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital, Guy's and St Thomas's NHS Foundation Trust
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Gemma E Stanford
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04091932: Treatment of PD-1 Inhibitor in AIDS-associated PML
Official title: The Effect and Safety of Programmed Cell Death Protein 1 (PD-1) Inhibitor on AIDS Patients With Progressive Multifocal Leukoencephalopathy (PML): A One-center, Single-arm and Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Progressive Multifocal Leukoencephalopathy
AIDS
Keywords: PD-1 inhibitor
Pembrolizumab
Progressive Multifocal Leukoencephalopathy
AIDS
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PD-1 inhibitor （Pembrolizumab, 2mg/kg weight, once per 4 weeks and 3 times of medication usage）treatment on AIDS patients with progressive multifocal leukoencephalopathy.

Detailed description: This is a one-center, single-arm and prospective study, planing recruiting 10 AIDS-associated PML patients. All patients will receive PD-1 inhibitor (Pembrolizumab) for 12 weeks, and the dose for each time is 2 mg per kg/weight, and the frequency is once per 4 weeks. The effect and safety of Pembrolizumab on AIDS-associated PML will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Age: 18-65
2. Diagnosed of HIV by lab confirmation
3. Diagnosed of PML by diplomatic radiologists through brain MRI or by brain biopsy once there are some concerns on radiologic diagnosis.
4. agree to sign the consent
5. agree to use contraception measures during 4 weeks before to 6 months after this study

Exclusion Criteria:

1. Pregnancy or lactating women or planing birth during this study
2. Anticipated bad treatment compliance
3. Within 6 months before joining this study, receive other immunosuppressors, immunomodulators or cytotoxic drugs (glucocorticoid is allowed)；
4. With neutrophil\<1000/mm3 or platelet\<75000/mm3 or allergic to PD-1 inhibitor 5）With severe basic diseases in heart, brain, lung, liver, kidney

6) disagree to sign the consent

Primary outcomes:
measure: the rate of non-progressors and recovers of AIDS patients with PML in 6 months after receiving PD-1 inhibitor
timeFrame: 6 months
measure: the rate of non-progressors and recovers of AIDS patients with PML in 12 months after receiving PD-1 inhibitor
timeFrame: 12 months
Secondary outcomes:
measure: the negative conversion rate of John Cunningham virus (JCV) in cerebrospinal fluid，blood and urine in patients receiving Pembrolizumab.
timeFrame: 3 months
measure: Side effects associated with Pembrolizumab
timeFrame: 12 months
measure: The rate of patients with decreased HIV viral reservoir
timeFrame: 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the first affiliated hospital of Zhejiang university school of medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Biao Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03322332: Adipokines of Epicardial Adipose Tissue and Atherosclerosis of Coronary Arteries
Official title: The Role of Adipokines Secreted by Epicardial Adipose Tissue in the Atherosclerosis of Coronary Arteries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Atherosclerosis
Adipokines
Keywords: adiponectin
omentin-1
resistin
RBP4
epicardial fat
Coronary artery disease
Lead sponsor: University Hospital, Ioannina
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals undergoing cardiac surgery will be recruited in this study.

Brief summary: The aim of the study is to investigate whether the expression and production of adipokines secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis.

Detailed description: The aim of the study is to investigate whether the expression and production of four adipokines \[adiponectin, omenin-1, resistin and retinol binding protein-4 (RBP4)\] secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis. Specifically, this study aims to investigate whether the expression and production of these adipokines is different between two sites of the heart, that are perfused by coronary arteries with different degrees of stenosis.

Eligibility criteria: Inclusion Criteria:

1) Individuals undergoing cardiac surgery

Exclusion Criteria:

* Age \< 18 years
* HbA1c \> 7.0%
* Any change of antidiabetic medication the previous 3 months before the surgery
* GFR \< 60 mL/min/1.73 m2
* Liver disease
* Cancer
* Non-treated hyperthyroidism or hypothyroidism
* Autoimmune disease
* Infection
* Any change in body weight at least 5% the previous 3 months before surgery
* Significant dehydration.
* Taking any of the following drugs the previous 3 months before surgery: hormones, antiobesity drugs

Primary outcomes:
measure: Association between coronary artery disease and epicardial adipokines
timeFrame: Baseline measurement
Secondary outcomes:
measure: Impact of diabetes on epicardial adipokines
timeFrame: Baseline measurement
Other outcomes:
Locations:
city: Ioánnina
country: Greece
facility: University Hospital of Ioannina
Study officials:
affiliation: University Hospital, Ioannina
name: Eustratios Apostolakis, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03645837: Rapid Clamp Release Post Trans-radial Cardiac Catheterization
Official title: Reducing Compression Duration Post Trans Radial Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Catheterization
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare different short durations of radial clamp application following an angiogram via a trans-radial approach.

Detailed description: This is a single-center, prospective, randomized study that will enroll patients that are referred for an angiogram and will compare 3 different durations of radial clamp applications. Patients will be randomly assigned to either 10, 20 or 30-minute clamp applications. The clamps will be gradually released at the end of the assigned durations and participants will be assessed for the radial artery occlusion, hematoma, and other bleeding events.

Eligibility criteria: Inclusion Criteria:

1. Diagnostic catheterization
2. 5 F slender sheath
3. Normal ulno-palmar circulation

Exclusion Criteria:

1. Abnormal ulno-palmar circulation type D
2. Ad hoc percutaneous coronary intervention
3. Heparin or other anticoagulation

Primary outcomes:
measure: Hematoma
timeFrame: 1 hour
measure: Radial artery occlusion
timeFrame: 1 hour
Secondary outcomes:
measure: Bleeding - any
timeFrame: 1 hour
Other outcomes:
measure: Comparison to prior study results
timeFrame: 1 hour
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sceinces Centre
name: Shahar Lavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavi S, Cheema A, Yadegari A, Israeli Z, Levi Y, Wall S, Alemayehu M, Parviz Y, Murariu BD, McPherson T, Syed J, Bagur R. Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention. J Am Heart Assoc. 2017 Feb 3;6(2):e005029. doi: 10.1161/JAHA.116.005029.
Clinical trial NCT01724437: Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
Official title: Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Catheter Ablation Strategies
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2012-11-09
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to assess the near-term (12 months) efficacy of pulmonary vein isolation.

Detailed description: The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* age \> 18 years
* paroxysmal atrial fibrillation

Exclusion Criteria:

* structural heart disease
* intracardiac thrombus
* reversible causes of atrial fibrillation
* inability to take warfarin

Primary outcomes:
measure: time to AF and AT recurrence
timeFrame: 12 months
Secondary outcomes:
measure: procedure duration
timeFrame: completed (15 months)
measure: procedure safety
timeFrame: up to three days after the procedure
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg
Study officials:
affiliation: Universitäres Herzzentrum Hamburg GmbH
name: Stephan Willems
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steven D, Sultan A, Reddy V, Luker J, Altenburg M, Hoffmann B, Rostock T, Servatius H, Stevenson WG, Willems S, Michaud GF. Benefit of pulmonary vein isolation guided by loss of pace capture on the ablation line: results from a prospective 2-center randomized trial. J Am Coll Cardiol. 2013 Jul 2;62(1):44-50. doi: 10.1016/j.jacc.2013.03.059. Epub 2013 May 1.
Clinical trial NCT06995937: Medical Marijuana and Open Road Driving Task
Official title: An Open Road Driving Performance Task to Examine Long-term Medical Marijuana Use and Prescription Opioid Positivity in Adults 50 and Older
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Medical Cannabis
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: University of Florida
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-30
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biological men and women in the state of Florida aged 50 and older

Brief summary: Medical marijuana use among adults 50 and older has more than doubled in the past decade with exponential increases projected in this demographic by 2050, and prescription opioids are one of the most common treatments for pain management in this population. To date, no studies systematically assess driving performance in a rigorous and ecologically valid manner accounting for long-term medical marijuana use and/or the combined effect of prescription opioid use in adults 50 and older who endorse chronic or severe non-malignant pain. Further, studies examining how older adults self-regulate prescription medication use and driving behavior is limited, with none rigorously examining medical marijuana.


Eligibility criteria: Inclusion Criteria:

* Age 50 and older who endorse chronic or severe non-malignant pain
* Resident of Florida with an active and valid Florida Drivers License
* Can communicate in English
* Willing and able to complete study procedures
* Have active medical marijuana card for \>12 months issued by the state of Florida (MMG group) OR are race-sex match who has not used marijuana in the past 10 years with no history of daily use (NMG group)

Exclusion Criteria:

* Have active psychosis
* Have lost or revoked driving privileges
* Score of below the cut 24 (out of 30) on the Montreal Cognitive Assessment (MoCA)
* Are a control participant who urine test positive for marijuana use and/or reports any marijuana use in past 10 years

Primary outcomes:
measure: Sum of Maneuvers Score (SMS)
timeFrame: One Day
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tallahassee
country: United States
facility: Florida State University, Center for Translational Behavioral Science
state: Florida
Study officials:
References:
Clinical trial NCT06080737: Long Term Effects of Awake Prone Positioning in COVID-19 ICU Patients
Official title: Effects of Awake Prone Positioning on Long-term Quality of Life in Patients Managed in the ICU Under Nasal High Flow for SARS-CoV2 Pneumonia, a Cohort Study Nested Within a Randomized Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SARS-CoV 2 Pneumonia
Keywords: long-term quality of life
awake prone positioning
acute respiratory distress syndrome
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in France in the randomized study "High Prone Covid" alive at day 28 (NCT04358939).

Brief summary: Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939)

Detailed description: All patients included in the initial trial who survived and were not lost to follow up at 28 days will be invited for a telephone interview to collect data on long term quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients included in the randomized meta-trial evaluating awake prone position versus control among COVID-19 patients on high-flow nasal oxygen therapy (Ehrmann 2021).
* Patients alive at D28
* No opposition to participate in the research which evaluates mortality and quality of life by telephone interview.

Exclusion Criteria:

* Patients lost to follow-up after 28 days.
* Withdrawal of consent from randomized meta-trial by patient
* Vulnerable person: safeguard of justice, curatorship, or guardianship
* Patients refusing to answer telephone questionnaire.

Primary outcomes:
measure: EURO QoL 5D 5L quality-of-life score
timeFrame: 2 years after randomization
Secondary outcomes:
measure: Mortality at last follow-up time beyond 2 years after randomization
timeFrame: an average of 2 years follow up
measure: Assessment of autonomy
timeFrame: an average of 2 years follow up
measure: Assessment of mobility
timeFrame: an average of 2 years follow up
measure: Assessment of performance of daily activities
timeFrame: an average of 2 years follow up
measure: Assessment of pain and discomfort
timeFrame: an average of 2 years follow up
measure: Assessment of anxiety and depression
timeFrame: an average of 2 years follow up
measure: Number of points on the visual analog scale
timeFrame: an average of 2 years follow up
measure: Hospitalisations
timeFrame: an average of 2 years follow up
measure: Family situation
timeFrame: before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up.
measure: Employment status
timeFrame: before hospitalization, then at 12, 24 months and at final follow-up.
measure: Subgroup analysis:
timeFrame: an average of 2 years follow up
Other outcomes:
Locations:
city: Tours
country: France
facility: university hospital Tours
Study officials:
References: