louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01457690: Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention
Official title: Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypobetalipoproteinemias
Keywords: Vitamin E pegylated
chylomicron retention
Familial Hypocholesterolemia
Hypobetalipoproteinemias
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the kinetics of intestinal absorption of vitamin E water-soluble form from the classical lipid-soluble form in a population of patients with intestinal malabsorption (hypocholesterolemias family by retention of chylomicrons).


Eligibility criteria: Inclusion Criteria:

* Patient suffering from familial hypocholesterolemia by retention of chylomicrons
* Systematically followed in the department of Gastroenterology and Paediatric Nutrition in Women Mother Child's Hospital or in the endocrinology department of GHE (Louis Pradel Hospital);
* During treatment with oral vitamin E;
* over the age of 3 years and weighing over 16 kg at the time of inclusion
* For which there is a signed informed consent from the patient or parents / guardians in the case of a minor patient, and benefit from social security coverage.

Exclusion Criteria:

* Patient with encephalopathy
* Hypersensitivity to the active substance or the excipients of Vedrop
* A suspected allergy to local anaesthetics (including xylocaine)
* Patients who may not be compliant to treatment (psychiatric);
* In case of refusal to participate in the study from the patient and / or parents or legal guardian;
* Patients unable to consent (if patients with encephalopathy)

Primary outcomes:
measure: Measurement the area under the curve of absorption of vitamin E according to its dosage form (fat-soluble versus water-soluble) in the beginning of each treatment period. versus water-soluble) in the beginning of each treatment period.
timeFrame: 12 months
Secondary outcomes:
measure: Measurement of serum (membranes erythrocytic) of vitamin E at the beginning and after each treatment.
timeFrame: 12 months
measure: Measurement of tissue (subcutaneous adipose tissue) of vitamin E at the beginning and after each treatment.
timeFrame: 12 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mere Enfant-Hospices Civils de Lyon
Study officials:
affiliation: Hopital Femme Mere Enfant, Hospices Civils de Lyon
name: Noel PERETTI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00343590: Whole Body Vibration Therapy in a Participant With Multiple Sclerosis Related Balance Deficits - A Case Study
Official title: Whole Body Vibration Therapy in a Participant With Multiple Sclerosis Related Balance Deficits - A Case Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2006-06-23
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy (WBV) on balance in a participant with multiple sclerosis (MS) related balance deficits as measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke Expanded Disability Status Scale (EDSS) and the Berg Balance Score.


Eligibility criteria: Inclusion Criteria:

Logan student, staff, or faculty or general public with a minimal of 2 year history of diagnosed Multiple Sclerosis (MS)

Exclusion Criteria:

1)visual or vestibular condition that would affect balance; 2) Non-Ms related systemic illness that would have an adverse effect on balance; 3) Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes; 4) Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates; 5) Acute thrombosis; 6) Severe migraine, epilepsy; 7) Serious cardiovascular disease, wearing a pacemaker; Any Spinal manipulation within 48 hours; 8) Acute disc herniation, discopathy or spondylolysis; 9) Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance; 10) Any implanted device or prosthesis or intrauterine IUD type of device; 11) Pregnancy

Primary outcomes:
measure: NeuroCom Balance Master
measure: SF-EMG Nerve conduction velocity test
measure: Berg balance score
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
city: Chesterfield
country: United States
facility: Logan College of Chirpractic
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic
name: Dennis Enix, DC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romberg A, Virtanen A, Ruutiainen J, Aunola S, Karppi SL, Vaara M, Surakka J, Pohjolainen T, Seppanen A. Effects of a 6-month exercise program on patients with multiple sclerosis: a randomized study. Neurology. 2004 Dec 14;63(11):2034-8. doi: 10.1212/01.wnl.0000145761.38400.65.
citation: Griffin JW. Use of proprioceptive stimuli in therapeutic exercise. Phys Ther. 1974 Oct;54(10):1072-9. doi: 10.1093/ptj/54.10.1072. No abstract available.
Clinical trial NCT02404090: Impact of the Excess Weight Loss on Mineralization Patterns of the Knee After Bariatric Operations
Official title: Impact of the Excess Weight Loss on Mineralization Patterns of the Knee After Bariatric Operations - a Prospective CT-osteoabsorptiometry-based Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Weight Loss
Knee Osteoarthritis
Keywords: Obesity
Weight Loss
Knee Osteoarthritis
Subchondral Mineralization
Lead sponsor: Spital Limmattal Schlieren
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bariatric patients with BMI \> 35 kg/m2 with knee pain (VAS \> 2).

Brief summary: Evaluation of the subchondral mineralization plate after excess weight loss in patientes undergoing bariatric operation by means of CT-osteoabsorptiometry.


Eligibility criteria: Inclusion Criteria:

* BMI \> 35
* need for bariatric operation
* knee pain (VAS \> 2)

Exclusion Criteria:

* malignancy
* poor compliance
* previous bariatric operation
* pregnancy
* lack of knee pain (VAC \< 2)
* previous knee operation

Primary outcomes:
measure: Mineralization changes after excess weight loss?
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Spital Limmattal Schlieren
name: Urs Zingg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02569190: Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients
Official title: Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Veterans Health Service Medical Center, Seoul, Korea
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients.

Detailed description: This study designed an interventional pre-post compared clinical study. The subjects received conventional physical therapy with Walkbot training (3 sessions per week for 7 weeks, 20 session). Before and after intervention all subjects evaluated using diffusion tensor imaging and clinical outcome measurements.

Eligibility criteria: Inclusion Criteria:

* First stroke attack
* Within 3 months after stroke onset
* Supratentorial stroke
* Unilateral stroke

Exclusion Criteria:

* Bilateral stroke
* infratentorial stroke
* Cognitive disabilities or serious psychiatric illness.
* Difficulty in walking due to orthopedic problems.

Primary outcomes:
measure: Change from baseline fraction anisotropy of corticoreticular tract in Diffusion tensor imaging 8 weeks after the first day of intervention
timeFrame: at the first day of intervention and 8 weeks after the first day
Secondary outcomes:
measure: Functional ambulation category
timeFrame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
measure: Fugl-meyer assessment
timeFrame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
measure: Medical research council
timeFrame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
measure: Trunk control test
timeFrame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Veterans Health Service Medical Center
state: Gangdong-gu
Study officials:
affiliation: Veterans hospital, Seoul, Republic of Korea
name: Dae Hyun Kim, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06890390: TSPO PET in the Evaluation of Neuroinflammation in Patients with Multiple System Atrophy
Official title: TSPO PET in the Evaluation of Neuroinflammation in Patients with Multiple System Atrophy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple System Atrophy - Cerebellar Subtype (MSA-C)
Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
Keywords: Multiple System Atrophy
PETCT
TSPO
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People who came to Third Xiangya Hospital of Central South University for consultation or online questionnaire recruitment

Brief summary: The aim of this study was to apply PET/MR techniques targeting TSPO to explore the temporal and spatial alterations characterizing neuroinflammation in MSA patients, and to assess its value as a biomarker for diagnostic typing, disease severity, and prognosis of MSA disease.


Eligibility criteria: Inclusion Criteria:

* Age\> 35 years old, gender is not limited;
* Clinically confirmed MSA and clinically probable MSA according to the 2022 MDS MSA diagnostic criteria;
* all patients had been ruled out of polyQ disease by genetic testing;
* Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

* pregnancy or breastfeeding;
* contraindications to MRI examination or inability to cooperate in completing neuroimaging examination;
* previous history of other neurological disorders or presence of other organic intracranial lesions on neuroimaging that cannot be interpreted by MSA, such as epilepsy, trauma, tumors, or high-grade cerebral white matter degeneration (Fazekas grade 2 and above);
* History of alcohol or drug abuse

Primary outcomes:
measure: Standard uptake value ratio(SUVR)
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: UMSARS
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: H-Y stage
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: SCOPA-AUT
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Wexner score
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Frontal Assessment Battery
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: MoCA score
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: TSPO Single nucleotide polymorphism genotyping
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Hunan
country: China
facility: Third Xiangya Hospital of Central South University
state: Changsha
Study officials:
References:
Clinical trial NCT00153790: LEAN Project: Weight Loss and Appetite Suppression
Official title: The Effect of Soy Lecithin-derived N-oleoyl-phosphatidyl-ethanolamine (NOPE) and Green Tea-derived Epigallocatechin Gallate (EGCG) on Indices of Weight Loss and Appetite Suppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Weight Loss
Keywords: green tea
weight
women
Lead sponsor: The Cooper Institute
Sponsor class: OTHER
Collaborators: name: Chemi Nutra
First posted: 2005-09-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim is to examine whether the intake of PhosphoLEAN is effective in aiding a cohort of women in losing weight. Participants taking the supplement will have significantly greater improvement in study outcomes than those taking the placebo.

Detailed description: Participants will be randomized to either a control or treatment group taking the dietary supplement containing a soy lecithin-derived N-oleoyl-phosphatidyl-ethanolamine (NOPE) and caffeine free Green Tea-derived epigallocathchin gallate (EGCG) whose trade name is PhosphoLean. The outcome is to determine the effects on indices of weight loss and appetite suppression. Participants will return at 6, 12, and 16 weeks for clinical measures.

Eligibility criteria: Inclusion Criteria:

* 30-45 years, women, overweight or obese class I, premenopausal, maintain current diet and exercise regimen

Exclusion Criteria:

* pregnant or planning to become pregnant, currently have or history of cancer, heart disease, anemia, diabetes, depression

Primary outcomes:
measure: Weight Loss
measure: Appetite Suppression
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The Cooper Institute
state: Texas
Study officials:
affiliation: The Cooper Institute
name: Conrad Earnest, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00434590: Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
Official title: Controlled, Randomized, Parallel Group Study to Assess Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Kidney Transplantation
Mycophenolic Acid
Immunosuppression
Cyclosporine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will evaluate kidney graft function in maintenance renal transplant patients.


Eligibility criteria: Inclusion criteria:

* Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years
* Age \> 18 yrs
* Adequate and stable renal function
* Informed consent.

Exclusion criteria:

* Kidney transplant combined with other organs;
* Significant proteinuria
* Severe ongoing infections;
* Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;
* Relapse of the end-stage renal disease on the transplanted kidney;
* Leucopenia, thrombocytopenia or severe anemia;

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Creatinine Clearance at 12 Months
timeFrame: 12 months
measure: Serum Creatinine at 12 Months
timeFrame: 12 months
measure: Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months
timeFrame: 12 months
measure: Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months
timeFrame: 12 months
measure: Chronic Rejection as Confirmed by Renal Biopsy at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT06097390: A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III
Official title: A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants - Oral Formulation III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-10-24
Enrollment: 121
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. Participants will receive one tablet version for 10 days (first treatment period) and the other version for 10 days (second treatment period). The treatment arm participants will be assigned to is decided by chance. The study will last for about 23 weeks for each participant. The study will enroll healthy male participants.


Eligibility criteria: Key inclusion criteria:

* Body mass index (BMI) between 22.0 and 31.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Key exclusion criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days before screening.

Primary outcomes:
measure: Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve
timeFrame: From 0 to 24 hours after dosing on day 80 and 90
Secondary outcomes:
measure: Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration
timeFrame: From 0 to 24 hours after dosing on day 80 and 90
measure: Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration
timeFrame: From 0 to 24 hours after dosing on day 80 and 90
measure: t½,sema; the terminal half-life of semaglutide
timeFrame: From 0 to 840 hours after dosing on day 90
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Altasciences Clinical Company, Inc
state: Quebec
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02054390: Angiotensin Converting Enzyme Inhibitors and Periprocedural Myocardial Infarction
Official title: Angiotensin Converting Enzyme Inhibitor Therapy and Periprocedural Myocardial Infarction in Patients With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Coronary Artery Disease
Keywords: Angiotensin converting enzyme inhibitor
inflammation
metabolic syndrome
myonecrosis
percutaneous coronary intervention
periprocedural myocardial injury
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metabolic syndorme (MS) was defined as the presence of 3 or more of these components:

1. high fasting glucose (fasting serum glucose ≥100 mg/dl or drug treatment for elevated blood glucose)
2. abdominal obesity (given as waist circumference \>102 cm in men and \>88 cm in women)
3. high blood pressure (\>130/\>85 mmHg or drug treatment for hypertension)
4. hypertriglyceridemia (serum triglycerides ≥150 mg/dl)
5. low high-density lipoprotein (HDL) cholesterol (\<40 mg/dl in men and \<50 mg/dl in women).

Brief summary: Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of the present cohort study is to investigate whether ACEi therapy reduces the rate of periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention (PCI) among patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

1. metabolic syndrome
2. elective percutaneous coronary intervention with angiographically successful stent implantation

Exclusion Criteria:

1. acute coronary events
2. renal failure
3. needed the use of IV glycoprotein IIb/IIIa receptor inhibitors were excluded
4. left main coronary artery disease
5. chronic total occlusion
6. high levels of baseline CKMB or troponin
7. any contraindication of aspirin, clopidogrel or ACEi treatment

Primary outcomes:
measure: Periprocedural myocardial injury (MI)
timeFrame: 24 hours after (percutaneous coroary intervention) PCI
Secondary outcomes:
measure: Periprocedural myonecrosis
timeFrame: 24 hours after PCI
Other outcomes:
measure: inflammatory marker
timeFrame: 24 hours after PCI
Locations:
city: Ankara
country: Turkey
facility: Ankara University School Of Medicine, Department of Cardiology
Study officials:
References: