louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01354327: Effects of Limicol on LDL-cholesterol
Official title: Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesteremia
Keywords: Delivery of Health Care
Cholesterol
LDL-cholesterol
Coronary artery disease
Red yeast rice
Plants extract
Cholesterol excess
Lead sponsor: Lescuyer Laboratory
Sponsor class: INDUSTRY
Collaborators: name: CIC Hôpital de la Conception - Marseille
name: Aix Marseille Université
First posted: 2011-05-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The principal objective of this study is to investigate the effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* About 18 to 55 years (inclusive)
* Subject has a stable weight for at least three months before the start of the study
* Subject able and willing to comply with the protocol and agreeing to give their consent in writing
* Subject affiliated with a social security scheme
* Subject willing to be included in the national register of volunteers who lend themselves to biomedical research

Primary outcomes:
measure: Change from Baseline in blood LDL-cholesterol levels at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months
timeFrame: 4 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Morange
Study officials:
affiliation: Lescuyer Laboratory
name: Sébastien Peltier, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06880627: Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis
Official title: Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scleroderma
Keywords: Cognitive issues
Memory or Focus problems
Internet connected devices
Online group sessions
Online brain games
Surveys
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Scleroderma Foundation
First posted: 2025-03-18
Enrollment: 66
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: The purpose of this study is to examine whether an 8-week online educational group-based program tailored to people with systemic sclerosis can help improve cognitive function and well-being.

The study team hypothesize that participants that receive the intervention will have better improvements immediately after treatment at week 8 in all cognitive function measures, non-cognitive symptoms, and self-management compared to those in the waitlist control.


Eligibility criteria: Inclusion Criteria:

* Have physician-diagnosis of Systemic sclerosis (SSc) (any subtype)
* A score of ≥ 10 on the Perceived Deficits Questionnaire
* A score of ≤ 7 on the 6-Item Cognitive Impairment Test
* Have access to a reliable, internet-connected device (e.g. computer, smartphone, tablet)
* Visual acuity with correction sufficient to work on a computer, smartphone, tablet or screen
* Be able to read, speak, and understand English

Exclusion Criteria:

* Diagnosis of dementia or head injury
* Other neurological disorders that might impact cognition
* Have major psychiatric disorder such as major depression and schizophrenia
* Complex, unstable health issues that would preclude full participation in the study (like a planned surgery or active cancer treatment)

Primary outcomes:
measure: Change in objective cognitive function from baseline to week 8
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in perceived cognitive function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function ability 4a short form
timeFrame: Baseline, 8 weeks
measure: Change in pain will be measured using the PROMIS pain interference short form
timeFrame: Baseline, 8 weeks
measure: Change in fatigue will be measured using the PROMIS fatigue short form
timeFrame: Baseline, 8 weeks
measure: Change in depressed mood will be measured using the PROMIS depression short form
timeFrame: Baseline, 8 weeks
measure: Change in self-management will be evaluated using the Patient Activation Measure (PAM)
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Yen Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06105827: Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy
Official title: A Multicenter, Prospective, Randomized, Controlled Clinical Study of Ningmitai Capsule to Promote the Passage of Residual Fragments After Ureteroscopic Lithotripsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ureteral Calculi
Keywords: Ureteral calculi
Lithotripsy of ureteral calculi
Ningmitai capsule
Residual fragments
Lead sponsor: Xintian Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 251
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To observe the effect of Ningmitai capsule on ureteral calculi after lithotripsy and evaluate the safety of treatment.

Study Design: A multicenter, prospective, randomized, controlled clinical study design was adopted

Interventions:

control group: Give antibiotics or diclofenac sodium suppository as needed. Ningmitai group: Oral Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day.

combination group (Ningmitai plus tamsulosin).: Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group.

Detailed description: Sample size: 230

Eligibility criteria: Inclusion Criteria:

1. Diagnosed as upper urinary calculi by B-ultrasound, kidney and upper bladder (KUB), intravenous urogram (IVU) or computerized tomography (CT) before surgery with the ages between 20 and 70 years.
2. Having ureteral residual fragments post URL and the diameter more than 5mm.
3. The lithotripsy went smoothly with expected outcomes and without any ureteral perforation, mucous exfoliation, kidney or bladder injury, serious bleeding or any other complications.
4. Willing and able to participate in this study and comply with all scheduled visits, treatment plans and complete the clinical observations.

Exclusion Criteria:

1. Pregnancy, severe diabetes, or renal insufficiency.
2. Ureteral stricture and lower urinary tract obstruction.
3. Concomitant treatment with α1-receptor antagonists, or Chinese traditional medicines who can be used to relieve stranguria and expel stone, or any other treatment that might interference the efficacy evaluation.
4. Unwilling or unable to comply with the administration regimen described in the protocol, or having an incomplete profile, hence their efficacy and safety couldn't be evaluated.
5. Severe adverse events and need to withdraw from the study.

Primary outcomes:
measure: the stone expulsion time, stone-free time
timeFrame: From baseline to 12 weeks of treatment
Secondary outcomes:
measure: the stone expulsion rate and stone-free rate.
timeFrame: From baseline to 12 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan First Hospital
name: Yuan Jingdong, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05843227: Description of the Organizational Measures Framing Surgery for Idiopathic Scoliosis in Children and Adolescents - Practice Survey
Official title: Description of the Organizational Measures Framing Surgery for Idiopathic Scoliosis in Children and Adolescents - Practice Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Practice Scope
Keywords: pediatric orthopaedic surgeon
Idiopathic Scoliosis
Pediatric
Enhanced Rehabilitation After Surgery (ERAS)
posterior vertebral arthrodesis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 39
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: Paediatric orthopaedic surgeons in the national territory who routinely treat idiopathic scoliosis in children and adolescents and who are members of the Société Française d'Orthopédie Pédiatrique (SoFOP) will be included.

Brief summary: The pediatric orthopaedic surgeon treats idiopathic scoliosis in children and adolescents using the posterior vertebral arthrodesis technique. This surgery is considered "heavy" by the child and families while it is intended for a healthy population. Through this study to take stock of the measures governing idiopathic scoliosis surgery (pre-operative, intra-operative and post-operative) within the various pediatric orthopedic surgery departments on the French national territory.

Detailed description: The goal is to measure the interest of harmonizing the preparation of orthopedic surgery for idiopathic scoliosis in children and adolescents by implementing a ERAS (Enhanced Rehabilitation After Surgery) protocol nationwide.

Eligibility criteria: Inclusion Criteria:

* Paediatric orthopaedic surgeons in the national territory who routinely treat idiopathic scoliosis in children and adolescents and who are members of the Société Française d'Orthopédie Pédiatrique (SoFOP)

Exclusion Criteria:

* Refusal

Primary outcomes:
measure: practices currently in force for the preparation of posterior vertebral arthrodesis
timeFrame: Month: 3
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Vincent Gautheron, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05206227: Histamine as a Molecular Transducer of Adaptation to Exercise
Official title: Histamine as a Molecular Transducer of Adaptation to Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Postexercise Hypotension
Keywords: Histamine
Mast cell
Exercise
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a series of Basic Experimental Studies with Humans (BESH, as defined by PA-20-184). Subjects are enrolled (non-randomized) in different arms of the overall study.
Primary purpose: BASIC_SCIENCE

Brief summary: This study is investigating the role of histamine in generating adaptation to exercise

Detailed description: Exercise promotes and maintains healthy cardiovascular, musculoskeletal, and metabolic function, but the signals and mechanisms which transduce these effects are poorly understood. Histamine plays a role in some of the positive benefits of exercise. The goal of this study is to determine the factors that regulate exercise's effects on endothelial and vascular function, with a focus on histamine released from mast cells in skeletal muscle. Participants will perform exercise or participate in interventions like heating that may replicate some of the effects of exercise. During most experiments, investigators will insert an intravenous catheter in an arm vein and microdialysis probes in the leg, collect dialysate from the microdialysis probe and blood from the vein, record noninvasive measures, and have the participants perform exercise or undergo heating.

Eligibility criteria: Inclusion Criteria:

* Age 18 -40

Exclusion Criteria:

* Systolic ≥ 120
* Diastolic ≥ 80
* Body mass index (BMI) ˃ 28 kg/m2
* Prior diagnosis of cardiovascular disease, diabetes, autonomic disorders, or asthma
* Smoking or nicotine use
* Ongoing medical therapy (other than birth control)
* Ongoing use of over-the-counter or prescription antihistamines
* Allergies or hypersensitivities to drugs, local anesthetics, skin disinfectants, adhesives, or latex
* Pregnant, breastfeeding subjects, or planning to become pregnant in the next 12 months
* Mobility restrictions that interfere with physical activity
* High physical activity based on International Physical Activity Questionaire (IPAQ1)
* Non-English speaking

Primary outcomes:
measure: Percentage of mast cell degranulation
timeFrame: One hour
measure: Histamine concentration
timeFrame: One hour
measure: Histamine metabolites
timeFrame: 24 hours
measure: Muscle perfusion
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: John R Halliwill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02699827: Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia
Official title: Adding Magnesium Sulphate to Epidural Levobupivacaine in Elective Caesarian Section for Patients With Preeclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preeclampsia
Keywords: Levobupivacaine
Magnesium
Preeclampsia
Epidural
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims at evaluating the effect of adding magnesium sulphate epidurally as an adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in patients with preeclampsia undergoing elective caesarian section (CS).

Detailed description: Pregnant women with preeclampsia undergoing elective CS in will be included in the study. All patients participating in the study will be randomly divided into two groups; magnesium sulphate group (study group) and placebo group (control group). Patients in the study group will receive epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml magnesium sulphate 10% (500 mg) while patients in the control group will received epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml saline 0.9%.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with preeclampsia undergoing elective CS.

Exclusion Criteria:

* Age \< 20 or \> 35 years.
* Height \< 150 or \> 180 cm.
* Body mass index (BMI) \> 35 kg/m2.
* Active labor.
* Multifetal pregnancy.
* Fetal distress.
* Medical conditions complicating pregnancy.
* HELLP syndrome.
* Thrombocytopenia.
* Hepatic or renal impairment.
* Pulmonary edema or cyanosis.
* Placenta previa.
* Vaginal bleeding or placental abruption.
* Contraindication for central neuraxial block.
* History of adverse reaction to any study medication.
* History of analgesic use.
* Magnesium therapy.
* Chronic pain syndrome.
* Presence of communication difficulties preventing reliable assessment.
* Refusal to undergo regional anesthesia.

Primary outcomes:
measure: Pain-free period
timeFrame: 24 hours after the epidural anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Tamer Elmetwally, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Reem A Elsharkawy, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Waleed El-refaie, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Alaa Wageeh, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Salwa S Hays, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT06112327: Long-term Follow-up of Participants Dosed with an Investigational Gene Editing Therapy for Cardiovascular Disease
Official title: Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants with or At High Risk for Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Atherosclerotic Cardiovascular Disease
Heterozygous Familial Hypercholesterolemia
Hypercholesterolemia
Keywords: LTF-001
Cardiovascular Disease
Gene Editing
Familial Hypercholesterolemia
Base Editing
Lead sponsor: Verve Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who received an investigational gene-editing therapy developed by the sponsor.

Brief summary: LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy. Participants will be followed for a total of 15 years after the first administration of the gene-editing therapy.


Eligibility criteria: Inclusion Criteria

1. A participant has completed or discontinued from a Verve sponsored clinical study in which they received at least one dose of study drug.
2. A participant has provided informed consent for LTF-001.

Exclusion Criteria: N/A

Primary outcomes:
measure: Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and other events of interest using CTCAE 5.0 to assess the long-term safety of gene-editing therapies.
timeFrame: up to 15 years
Secondary outcomes:
measure: Percent and absolute change from baseline of lipid concentrations over time after administration of a gene-editing therapy.
timeFrame: up to 15 years
measure: Percent and absolute change from baseline of target biomarkers over time after administration of a gene-editing therapy.
timeFrame: up to 15 years
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Clinical Study Center
city: Christchurch
country: New Zealand
facility: Clinical Study Center
city: London
country: United Kingdom
facility: Clinical Study Center
Study officials:
References:
Clinical trial NCT04123327: Symptom Preoccupation in Atrial Fibrillation (AF) and Its Role in AF-related Disability
Official title: The Prevalence of Symptom Preoccupation and Its Role in AF-related Disability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Symptom preoccupation
Atrial fibrillation
Quality of Life
Cardiac anxiety
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients above 18 years of age and diagnosed with AF (paroxysmal, persistant or chronic)

Brief summary: A cross-sectional study (N=400) will investigate the prevalence of symptom preoccupation and its role in AF-related disability. Subjectively-rated assessments will be gathered from 400 AF patients.

Detailed description: In the present study we aim to investigate symptom preoccupation in patients with atrial fibrillation (AF) to further improve the understanding of the role of psychological factors in AF-related disability. A cross-sectional study (N=400) will investigate the prevalence of symptom preoccupation and its role in AF-related disability. Subjectively-rated assessments will be gathered from 400 AF patients.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Diagnoses with AF
* Able to read Swedish and access to computer

Exclusion Criteria:

-

Primary outcomes:
measure: [Time Frame: From baseline to 12 weeks] Atrial Fibrillation Effect on Quality-of-Life (AFEQT)
timeFrame: Baseline
Secondary outcomes:
measure: Cardiac Anxiety Questionnaire (CAQ)
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: The Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline
measure: Anxiety Sensitivity Index (ASI)
timeFrame: Baseline
measure: Bodily Sensation Questionnaire (BSQ)
timeFrame: Baseline
measure: The University of Toronto Atrial Fibrillation Severity Scale (AFSS)
timeFrame: Baseline
measure: The Symptoms Checklist, Frequency and Severity Scale (SCL)
timeFrame: Baseline
measure: Perceived Stress Scale (PSS-4)
timeFrame: Baseline
measure: World Health Organization Disability Assessment Schedule (WHODAS)
timeFrame: Baseline
measure: AF behaviors
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
measure: Medical history
timeFrame: Baseline
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Clinical Neuroscience, Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Brjánn Ljótsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01418027: Combined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)
Official title: Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
Keywords: NAFLD
exercise
hepatic triglycerides
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 220
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase of physical activity are recommended as an effective approach for the prevention and treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In the present study we aim to compare the effect of intensive and conventional exercise interventions on NAFLD.


Eligibility criteria: 1. Subjects with NAFLD determined by MRS ;
2. Age 40-65 years old;
3. Waist circumference\> 90cm for men and \> 85cm for women.

Primary outcomes:
measure: Change of intrahepatic triglyceride contents
timeFrame: 12 months
Secondary outcomes:
measure: Change of body weight
timeFrame: 12 months
measure: Change of waist circumference
timeFrame: 12 months
measure: Change of body fat
timeFrame: 12 months
measure: Change of abdominal fat
timeFrame: 12 montshs
measure: Change of carotid intima-media thickness
timeFrame: 12 months
measure: Change of cardiovascular risk factors (Blood pressure, lipids, glucose)
timeFrame: 12 months
measure: Change of insulin resistance
timeFrame: 12 months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Hospital Affiliated to Xiamen University
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Xiaoying Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang HJ, He J, Pan LL, Ma ZM, Han CK, Chen CS, Chen Z, Han HW, Chen S, Sun Q, Zhang JF, Li ZB, Yang SY, Li XJ, Li XY. Effects of Moderate and Vigorous Exercise on Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. JAMA Intern Med. 2016 Aug 1;176(8):1074-82. doi: 10.1001/jamainternmed.2016.3202.