louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06591507: Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation
Official title: Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation: a Clinical Multicenter Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Transplantation
Sarcopenia
Keywords: Liver transplantation
Sarcopenia
Branched-chain amino acids
Muscle rehabilitation
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing liver transplantation frequently experience a reduction in skeletal muscle mass, malnutrition, and decreased levels of physical activity. These complications can adversely affect early postoperative recovery and the therapeutic effect of the transplant. This clinical study aims to investigate the effects of nutritional supplementation and rehabilitation therapy on sarcopenia associated with liver transplantation in adults. The goal is to establish a comprehensive perioperative intervention strategy to reduce the incidence of postoperative sarcopenia and improve transplantation outcomes.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 70 years.
2. Patients with end-stage liver disease who meet the criteria for liver transplantation (for liver cancer cases, only recipients meeting specific standards are included).
3. Complete clinical information, including documented pre-transplant muscle status (e.g., preoperative CT scans and handgrip strength tests).
4. High compliance with treatment, fully capable of independent action or having at least one assistant.
5. No contraindications to the planned interventions.

Exclusion Criteria:

1. Presence of musculoskeletal disorders before transplantation, such as myositis, idiopathic muscle atrophy, or history of hip surgery within the past three months.
2. Coexisting severe cardiovascular or cerebrovascular diseases, infectious diseases, or epilepsy.
3. Liver transplantation due to autoimmune liver disease or drug-induced liver failure.
4. Re-transplantation, multi-organ transplantation, living donor liver transplantation, split liver transplantation, or pediatric liver transplantation.
5. ABO-incompatible liver transplantation.
6. Incomplete clinical information.
7. Difficulty in follow-up.

Primary outcomes:
measure: 2-year overall survival
timeFrame: From enrollment to the end of follow-up at 2 years
Secondary outcomes:
measure: Muscle mass
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02753907: Impact of an 8-week Linoleic Acid Intake in Soy Oil on Lp-PLA2 Activity in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Subjects
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Self-reported healthy participants (n=150) aged 30-65 years with 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2 were randomly assigned into three groups: a low linoleic acid (LA, 18:2n-6) group (n=50) replaced 10 mL soy oil with one apple; a medium LA group (control group, n=50) maintained usual food intake; a high LA group (n=50) reduced 1/3 cup of cooked refined rice and consumed 9.9g of soy oil capsules daily as a supplement. Plasma fatty acids and lipoprotein-associated phospholipase A2 (Lp-PLA2) activity were measured at baseline and 8 week alongside other cardiovascular disease risk factors.


Eligibility criteria: Inclusion Criteria:

* Age 30 to 65 years at beginning of study
* Subjects with BMI 18.5 to 30 kg/m\^2

Exclusion Criteria:

* Use of any medication or supplements that alter lipid metabolism.
* Presence of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, chronic disease of the gastrointestinal tract, cerebrovascular disease, pancreatitis or cancer.
* Women who pregnant or lactating.
* Drug or alcohol abuse.

Primary outcomes:
measure: Change in Lp-PLA2 activity (nmol/mL/min)
timeFrame: At baseline and end of each 8-week diet period
Secondary outcomes:
measure: Change in total cholesterol (mg/dL)
timeFrame: At baseline and end of each 8-week diet period
measure: Change in LDL cholesterol (mg/dL)
timeFrame: At baseline and end of each 8-week diet period
measure: Change in HDL cholesterol (mg/dL)
timeFrame: At baseline and end of each 8-week diet period
measure: Change in triglyceride (mg/dL)
timeFrame: At baseline and end of each 8-week diet period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Study officials:
References:
citation: Kim M, Kim M, Lee A, Yoo HJ, Her JS, Jee SH, Lee JH. Impact of 8-week linoleic acid intake in soy oil on Lp-PLA2 activity in healthy adults. Nutr Metab (Lond). 2017 May 8;14:32. doi: 10.1186/s12986-017-0186-2. eCollection 2017.
Clinical trial NCT03327207: Exploring Interactions Between Growth Hormone and the Microbiome
Official title: Exploring Interactions Between Growth Hormone and the Microbiome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Growth Hormone Deficiency
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Weizmann Institute of Science
First posted: 2017-10-31
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with GH deficiency

Brief summary: The goal of this study is to characterize the microbiome and metabolomics of children with Growth Hormone (GH) deficiency, prior GH treatment initiation and compare it to healthy children


Eligibility criteria: Inclusion Criteria:

* Children with GH deficiency

Exclusion Criteria:

* Turner syndrome
* End state renal disease (ESRD)
* Prader-Willi syndrome
* Systemic illness
* Antibiotics/Antifungal in the last 3m

Primary outcomes:
measure: Changes in the microbiome population following Growth hormone treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Pediatric endocrinology unit rambam medical center
Study officials:
References:
Clinical trial NCT00681707: Retrospective Treatment Pattern Survey for the Patients With Hypertension and Stroke
Official title: A Retrospective, Multi Centre, Non-Interventional, Observational Study to Investigate Treatment Pattern of Blood Pressure in the Post Stroke Patients With Hypertension.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Post stroke
JNC7
2007 ESH-ESC guidelines
survey
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with history of stroke, receiving hypertension medication during at least 1 year.

Brief summary: This study will address the treatment rate and control rate of hypertension, treatment pattern and factors that affect BP control by examining retrospective medical records of hypertension patients recovering from stroke, among outpatients coming to the Neurology Department in 10 university hospitals nationwide.


Eligibility criteria: Inclusion Criteria:

* Patients had been hospitalized as a acute stroke in 2006
* Patient with history of stroke receiving hypertension medication during at least 1 year.

Exclusion Criteria:

* Secondary hypertension patients
* Patients not receiving hypertension medication

Primary outcomes:
measure: Attainment rate to the target blood pressure
timeFrame: After collecting all Patient Record Form.
Secondary outcomes:
measure: Dropout rate will be estimated during the follow-up period after the hypertension treatment. Attainment to the target blood pressure will be investigated according to concomitant diseases.
timeFrame: After collecting all Patient Record Form.
measure: Change in DBP/SBP value during the follow-up period will be addressed. Change in the DBP/SBP value will be investigated according to the risk factors and concurrent disease.
timeFrame: After collecting all Patient Record Form.
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Research Site
state: Gyeonggi
city: Sungnam
country: Korea, Republic of
facility: Research Site
state: Gyeonggi
city: Wonju
country: Korea, Republic of
facility: Research Site
state: Kangwon
city: Busan
country: Korea, Republic of
facility: Research Site
city: Deagu
country: Korea, Republic of
facility: Research Site
city: Deajeon
country: Korea, Republic of
facility: Research Site
city: Kwangju
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Astrazenca Korea medical dept.
name: Joon Woo Bahn
role: STUDY_DIRECTOR
References:
Clinical trial NCT05595707: Expert-Guided Early Tracheostomy Pathway
Official title: Page 1/27 Effectiveness of an Expert-Guided Early Tracheostomy Pathway for Mechanically Ventilated Critically Ill Adults in Jordan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Tracheostomy Complication
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Denver Health Medical Center
First posted: 2022-10-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The optimal timing of tracheostomy insertion remains uncertain. We hypothesized that a clinical pathway including expert-informed risk assessment regarding predicted duration of mechanical (MV) would enhance the effectiveness of early percutaneous dilatational tracheostomy (PDT) for patients with anticipated prolonged durations of MV, as reflected by duration of ventilation, complications, and patient-centered outcomes.

Detailed description: three-year prospective observational study (2018-2020) at a tertiary care level 1 trauma center (King Hussein Medical Center) in Amman Jordan and 4 affiliated subspecialty hospitals. The study sequentially enrolled all adult patients (\>18yo) with critical illness receiving MV in an intensive care unit for 48 hours or longer. Institutional ethical committee clearance for the study was secured.

Eligibility criteria: Inclusion Criteria:

Patients undergoing continued MV for 48 or more hours for whom continuation of life-prolonging therapy was indicated

Exclusion Criteria:

Patients at imminent risk of death were included

Primary outcomes:
measure: Duration of hospitalization from admission to ventilator independent discharge
timeFrame: Hospital stay up to 90 days
Secondary outcomes:
measure: Easy or Moderately Easy to Wean
timeFrame: Hospital stay up to 90 days
measure: Days of ventilation requiring administration of NMB
timeFrame: Hospital stay up to 90 days
measure: Difference in average and total morphine equivalent dose
timeFrame: Hospital stay up to 90 days
measure: 90 day survival
timeFrame: 90 days
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: King Hussein Medical Center
Study officials:
References:
Clinical trial NCT04467307: Comparison of Patients With and Without Foreign Body Aspiration After Bronchoscopy.
Official title: Comparison of Symptoms and Findings and Short-term Results After Bronchoscopy in Patients With and Without the Foreign Body in Children Under 5 Years Old Who Underwent Bronchoscopy With Suspicion of Foreign Body Aspiration. A Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Foreign Body Aspiration, Blood Gas, Bronchoscopy
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 80
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results.

Detailed description: Foreign body aspiration in children is a serious cause of mortality and morbidity. It is a preventable and treatable disease. Difficulties in diagnosis arise in non-radiopaque foreign body aspirations. Recently, when there is a suspicious history, bronchoscopy is recommended. Bronchoscopy is used to both diagnose and treat foreign body aspiration. Bronchoscopy seems to continue to be performed in suspicious cases until a method to establish a definitive diagnosis of foreign body aspirations before the operation is invented. In our study, to compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results.

Eligibility criteria: Inclusion Criteria:

Suspected foreign body aspiration

Exclusion Criteria:

infection, trauma

Primary outcomes:
measure: Foreign body aspiration
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University
state: Onikisubat
Study officials:
References:
Clinical trial NCT06387407: Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran
Official title: Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters
Lead sponsor: The Affiliated Hospital Of Guizhou Medical University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects in the dabigatran etexilate bioequivalence study; patients with nonvalvular atrial fibrillation (NVAF).

Brief summary: According to published studies, the effects of genetic polymorphisms in the ABCB1 and CES1 genes on the blood concentration of dabigatran are controversial, and it is not clear whether dabigatran dosage and dosing intervals need to be adjusted according to genotype or other covariates in Chinese subjects. For these purposes, we will include patient demographics, genetic polymorphisms, and PK data based on a population pharmacokinetic study of dabigatran ester in healthy Chinese subjects to analyze the effect on dabigatran pharmacokinetics.

The aim of this study was to develop a population pharmacokinetic model to understand the relationship between dabigatran-related genes and dabigatran plasma levels after a single oral dose in healthy Chinese subjects and patients, and to analyze the effects of genetic variation on the efficacy and safety of dabigatran etexilate.


Eligibility criteria: Inclusion and exclusion criteria for healthy subjects were consistent with bioequivalence studies.

Inclusion Criteria:

1. Age 18-89 years;
2. ECG meeting the diagnostic criteria for atrial fibrillation;
3. Provide at least one valid blood sample for SNP testing;
4. no contraindication to anticoagulation, blood counts and coagulation times within normal reference values, and negative urine and stool occult blood;
5. not have had any stroke in the 6 months prior to enrollment.

Exclusion Criteria:

1. Cardiac ultrasound suggestive of moderate-to-severe mitral stenosis or after mechanical valve replacement;
2. severe hepatic injury or renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 mL/(min\*1.73m2))
3. History of stroke or peripheral arterial embolism during dosing;
4. patients at high risk of bleeding, such as history of bleeding, hematologic disorders, other disorders requiring anticoagulant therapy, peptic ulcer and other bleeding, and blood pressure \>180/110 mmHg;
5. Combination of other serious diseases, such as malignant tumors, severe hepatic and renal insufficiency;
6. history of allergy to dabigatran and warfarin.

Primary outcomes:
measure: Plasma drug concentration
timeFrame: 3 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07016607: Vital Peripheral Intravenous Catheter Feasibility
Official title: Feasibility Study to Assess the Safety and Efficacy of the ViTal Peripheral Intravenous Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization, Peripheral Venous
Lead sponsor: Embrace Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to assess the safety and efficacy of ViTal, a peripheral intravenous catheter with a glide-on-contact design of the plastic canula tip, in peripheral intravenous catheterization in individuals requiring intravenous therapy or blood sampling. The main question it aims to answer is:

What is the first attempt success rate of the peripheral intravenous catheterization done using the study device?

Participants will be asked to grade the pain they experienced when attempts were made to insert the study device into their peripheral vein.


Eligibility criteria: Inclusion Criteria:

1. Male or female age ≥ 18.
2. Requiring blood sample collection (roll-in subjects) or planned for PIVC (analyzable subjects)
3. Signed informed consent.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement).
3. Previous venous grafts or surgery at the target vessel access site.

Primary outcomes:
measure: First attempt success rate
timeFrame: Periprocedural
Secondary outcomes:
measure: Device- and procedure-related adverse events
timeFrame: Periprocedural
Other outcomes:
Locations:
city: La Romana
country: Dominican Republic
facility: Clinica Canela
Study officials:
References:
Clinical trial NCT00610207: Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft
Official title: Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (SurgiSIS AFP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anal Fistula
Crohn's Disease
Keywords: Anal fistula
fistula in ano
anorectal fistula
Crohn's Disease
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Cook Biotech Incorporated
First posted: 2008-02-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Healing anal fistulas in Crohn's patients with an anal fistula plug.

Detailed description: The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.

Eligibility criteria: Inclusion Criteria:

* Patient is diagnosed with Crohn's Disease
* Patient has a chronically draining anal fistula of Crohn's origin
* Patient is 18 years old or older
* Patient has signed an informed consent

Exclusion Criteria:

* Patient is pregnant or lactating
* Patient has peri-anal drainage with originates from outside the anorectal tract

Primary outcomes:
measure: Fistula Closure (Patient Based)
timeFrame: 12 months
measure: Fistula Closure (Tract Based)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cleveland
country: United States
facility: Univeristy Hospitals Medical Center
state: Ohio
Study officials:
affiliation: Colon & Rectal Surgeons of Southern California, Mt. Sinai
name: Beth Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05143307: Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101
Official title: Long-Term Follow-Up Study of HIV-1 Infected Adults Exiting a Parent Study Where EBT-101 Was Administered
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: HIV-1-infection
Keywords: CRISPR
Gene Therapy
adeno-associated virus serotype 9 (AAV9)
Lead sponsor: Excision BioTherapeutics
Sponsor class: INDUSTRY
First posted: 2021-12-03
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Long term follow up of participants who received EBT-101
Primary purpose: OTHER

Brief summary: Participants who receive EBT-101 in a parent protocol will be eligible to participate in this long-term follow-up (LTFU) study (EBT-101-002).

Detailed description: Participants who receive EBT-101 in a parent protocol will be eligible to participate in this LTFU study (EBT-101-002). All participants will have follow-up visits every six months until Year 5 post EBT-101. Thereafter, all participants will have follow-up visits annually on the anniversary of EBT-101 administration until study completion at Year 15.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written, signed informed consent
* Participants who received the investigational study intervention EBT-101 in a parent study

Exclusion Criteria:

• Participants who did not receive EBT-101 in a parent study

Primary outcomes:
measure: Long-term safety of EBT-101
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Camden
country: United States
facility: Cooper Health
state: New Jersey
Study officials:
affiliation: Excision BioTherapeutics
name: William Kennedy, MD
role: STUDY_DIRECTOR
References: