louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03548974: Internet-based MOTOmed Exercise to Reduce Spasticity and Improve Physical Function in Persons With Multiple Sclerosis
Official title: Internet-based Physical Activity Promotion Using the MOTOmed Movement Trainer to Reduce Spasticity and Improve Physical Function in Moderately to Severely Affected Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Spasticity
MOTOmed training
internet
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: Fa. Reck MOTOmed
First posted: 2018-06-07
Enrollment: 57
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: In an RCT, the effect of the MOTOmed movement trainer (Reck, Germany) on spasticity and physical function in pwMS with EDSS score between 4,5 and 7 is investigated. All subjects exercise at home and are supervised and supported by an exercise therapist via an online platform.

We compare the effect of a 12 week passive, motor-driven movement therapy (VG1) to an intermittent active and passive training (VG2). After 12 weeks, VG1 continues with an active training including strengthening exercises for another 12 weeks. VG2 does not receive any intervention in the second study phase.


Eligibility criteria: Inclusion Criteria:

diagnosed Multiple Sclerosis (McDonald criteria) EDSS score between 5,5 and 7 diagnosed spasticity access to the internet

Exclusion Criteria:

lack of medical certificate for physical activity cognitive impairment clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases

Primary outcomes:
measure: Change in spasticity: MSSS-88
timeFrame: Assessments took place at baseline, at 3 and 6 months
measure: Change in sSpasticity: Modified Tardieu scale
timeFrame: Assessments took place at baseline, at 3 and 6 months
Secondary outcomes:
measure: Change in function: 5-Chair-Rise
timeFrame: Assessments took place at baseline, at 3 and 6 months
measure: Change in function: 25foot-walk-test
timeFrame: Assessments took place at baseline, at 3 and 6 months
measure: Change in function: 2min-walk
timeFrame: Assessments took place at baseline, at 3 and 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01051674: A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss
Official title: A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss in Obese Individuals With or Without Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Type 2 Diabetes
Keywords: Obesity
Type 2 diabetes
Fiber
Dietary fiber
Low-carbohydrate diet
High protein diet
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Lifestyle Center of America
First posted: 2010-01-18
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Using a 2x2 complete factorial design, approximately 140 obese men and women who may or may not have type 2 diabetes will be randomized to one of two conditions (70 in each condition): (a) a high fiber diet, or (b) a low-carbohydrate diet. Participants will be instructed to follow their assigned diets for 1 year. Outcome measures of interest will include participants' BMI, waist circumference, blood lipids (total, HDL, and LDL cholesterol, and triglycerides), C-reactive protein, and gastrointestinal peptides. Participants will be recruited from the Loma Linda and San Bernardino city area in southern California.


Eligibility criteria: Inclusion Criteria:

* BMI 30.0-42.0 kg/m2
* English-speaking

Exclusion Criteria:

* Pregnancy
* Lactation
* Acute or chronic infection
* Type 1 diabetes
* Participation in another trial
* Active cancers
* Currently using Byetta
* Currently on weight loss medication
* Weight loss of more than 4 lbs. within the last 3 months
* Vegan
* Active eating disorder
* Gastrointestinal problems that may be worsened by a high fiber intake

Primary outcomes:
measure: Weight
timeFrame: 1 year
Secondary outcomes:
measure: Lipid profiles
timeFrame: 1 year
measure: Gastrointestinal hormones
timeFrame: 1 year
measure: Waist circumference
timeFrame: 1 year
measure: C-reactive protein
timeFrame: 1 year
measure: Blood glucose
timeFrame: 1 year
measure: Serum insulin
timeFrame: 1 year
measure: Hemoglobin A1c
timeFrame: 1 year
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda U Medical Center Diabetes Treatment Center
state: California
Study officials:
affiliation: Loma Linda University
name: Serena Tonstad, MD, PhD, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT00396474: Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height
Official title: Long-Term Metabolic Risk In Small for Gestational Age (SGA) Patients After Growth Hormone Treatment Compared To Matched, Untreated Controls
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infant, Small for Gestational Age
Keywords: Small for gestational age, Insulin Sensitivity Index, growth hormone treatment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-07
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SGA Subjects treated or untreated with growth hormone

Brief summary: The purpose of this study is to demonstrate that insulin sensitivity is not different between growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort of subjects matched by gender and body mass index (BMI) who are not treated with growth hormone (GH) and who remain short at final height.

Detailed description: case-control

Eligibility criteria: Inclusion Criteria:

* Patients with SGA treated with growth hormone in one of the following Genotropin studies (89-041, 89-070/071, 90-079, 90-080/98-8122-011) for at least 3 years and after having stopped GH treatment for 5-10 years
* Untreated SGA (based on birth weight and/or length below -2 standard deviations \[SDs\] for gestational age) matched to treated SGA by body mass index (+ or = 10%) and gender:

  * Subjects born SGA with normal final height (within +/- 1.3 SD of their target height); or
  * Subjects born SGA with short stature (height SDs \> 1.3 below target at final height).

Exclusion Criteria:

* Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2
* Familial dyslipidemia

Primary outcomes:
measure: To demonstrate, that the Insulin Sensitivity Index is not different between GH treated SGA and SGA cohort matched by gender and BMI and not treated with GH that remained short at final height
timeFrame: 90 days
Secondary outcomes:
measure: To demonstrate that blood pressure and lipid profile are not different between GH treated SGA subjects and an SGA cohort matched by gender and BMI and not treated with GH
timeFrame: 90 days
measure: To demonstrate that the ISI is not different between GH treated SGA subjects and an SGA cohort matched by gender and BMI and not treated with GH that achieved normal final height
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04036474: Development, Implementation, and Evaluation of School-based Smoking Prevention Education Program Among Non-smoking Adolescents
Official title: Development, Implementation, and Evaluation of School-based Smoking Prevention Education Program Among Non-smoking Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Behaviors
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 145
Sex: ALL
Minimum age (years): 11
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preventing smoking among adolescents is critical to end the epidemic of smoking in Malaysia. Despite the implementation of several smoking prevention programs, the prevalence of adolescent smoking and experimenting with tobacco in Malaysia is still increasing. Therefore, the purpose of this quasi-experimental study was to evaluate the effectiveness of Smoking Prevention Education Programs (SPEP) in preventing the smoking initiation among non-smoker adolescents based on their smoking status on follow-up and smoking intention, which includes; attitude, subjective norms, and perceived behavioural control as described by the Theory of Planned Behaviour. A total of 140 Primary five students (non- smokers) were involved in this study. Four schools in Kuantan district were randomly assigned to intervention and control groups. The intervention schools received a lecture on the hazards of smoking and SPEP intervention whereas the control schools received just a lecture on the hazards of smoking. The questionnaires and exhale carbon monoxide levels were first assessed at baseline and then again after three months.


Eligibility criteria: Inclusion Criteria:

* Primary school students (standard 5)
* 11years' old
* Non- smoker (CO level less than 4ppm) to maintain baseline never- smoker
* Both genders
* Consented by parent

Exclusion Criteria:

* Ex-smoker (self- reporting) and smoker (CO level more than 4ppm)
* Students unable to understand and read the national language (Bahasa Malaysia)
* Children with special needs

Primary outcomes:
measure: Number of students who smoke
timeFrame: 3 months
Secondary outcomes:
measure: Mean score of students' intention to smoke
timeFrame: 3 months
measure: Mean score of students' attitudes towards smoking
timeFrame: 3 months
measure: Mean score of students' perception of subjective norms
timeFrame: 3months
measure: Mean score of students' perceived behavioural control
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01929174: Diffuse Myocardial Fibrosis in Fontan Patients
Official title: Heart Failure and Fibrosis in Adult Congenital Heart Patients With a Single Ventricle and Prior Fontan Operation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Single Ventricle
Myocardial Fibrosis
Keywords: Congenital heart disease
Myocardial fibrosis
Diastolic dysfunction
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a single ventricle palliated with a Fontan procedure

Brief summary: The purpose of this protocol is to measure the relaxation of the heart in subjects with single ventricles who have undergone the surgical Fontan procedure. We will do this by measuring relaxation with MRI, echocardiography, and cardiac catheterization and compare to blood levels that measure heart scarring. We will also measure relaxation before and after boluses of intravenous (IV) fluids to see if the relaxation changes when there is more fluid in the heart. Measurements of heart relaxation will be obtained from the MRI, echocardiogram, and cardiac catheterization for each patient and compared to blood markers of heart scarring. We aim to compare all of these measurements to see if we can accurately identify heart scarring and, if present, how much it correlates with impaired heart relaxation.


Eligibility criteria: Inclusion criteria: adult patients (age ≥18) with a previous Fontan procedure (including all variants) referred for catheterization. This includes individuals with tricuspid atresia, double inlet left ventricle, unbalanced atrioventricular septal defect, and pulmonary atresia with intact septum. Control subjects will be selected from individuals referred to the lab for evaluation/closure of a patent foramen ovale (PFO). All subjects must be willing to participate in all portions of the study and provide written informed consent.

Exclusion criteria: contraindications to MRI such as ferromagnetic objects in the chest, claustrophobia, or contraindication to gadolinium contrast (estimated creatinine clearance \< 30 ml/min/1.73m2). Fontan patients with a morphologic right ventricle (namely hypoplastic left heart after a Norwood palliation) will be excluded, because of the disproportionate risk of systolic dysfunction in the morphologic right ventricle.33 Control patients with hypertension, diabetes, coronary disease, or reduced systolic function will be excluded.

Primary outcomes:
measure: Myocardial fibrosis measured by the extracellular volume fraction
timeFrame: 1 day of single observation
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science Univ.
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Craig Broberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01562574: Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
Official title: A Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombi-nant Factor VIIa (rFVIIa/ NovoSeven®) With Standard Haemostatic Replacement Therapy, and Standard Haemostatic Replacement Ther-apy Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 82
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent obtained from parent or legal guardian before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject
* Children with complex congenital heart disease requiring corrective surgery with cardiopulmonary bypass (CPB)

Exclusion Criteria:

* Congenital heart disease that does not require CPB surgery

Primary outcomes:
measure: Time from reversal of heparin with protamine sulphate to chest closure
Secondary outcomes:
measure: Number of units/volume of fresh frozen plasma (FFP) and/or platelets and/or red-cell concentrates transfused during surgery and in the post-surgery period
measure: Blood loss
measure: Adverse events
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Ekert H, Brizard C, Eyers R, Cochrane A, Henning R. Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: a randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy. Blood Coagul Fibrinolysis. 2006 Jul;17(5):389-95. doi: 10.1097/01.mbc.0000233369.03358.c1.
Clinical trial NCT04934774: Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
Official title: Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: T-cell Acute Lymphoblastic Leukemia
T-cell Acute Lymphoblastic Lymphoma
T-cell Non-Hodgkin Lymphoma
Keywords: Anti-CD7 CAR
CD7CAR
T cell leukoma/lymphoma
T-ALL
T-cell acute lymphoblastic leukemia
T-cell acute lymphoblastic lymphoma
Lead sponsor: iCell Gene Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: iCAR Bio Therapeutics Ltd.
name: Peking University Shenzhen Hospital
First posted: 2021-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia

Detailed description: Anti-CD7 CAR is a chimeric antigen receptor immunotherapy treatment designed to treat leukemia/lymphoma expressing CD7 antigen. T-cell acute lymphoblastic leukemia, T-acute lymphoblastic lymphoma and T-cell non-Hodgkin lymphoma are a subset of leukemias and lymphomas that are positive for the surface protein CD7. The purpose of this study is to evaluate the efficacy and safety of anti-CD7 CAR T cells.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent; Patients volunteer to participate in the research
2. Diagnosis is mainly based on the World Health Organization (WHO) 2008
3. Patients have exhausted standard therapeutic options
4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
5. Female must be not pregnant during the study

Exclusion Criteria:

1. Patients declining to consent for treatment
2. Prior solid organ transplantation
3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
4. Any drug used for GVHD must be stopped \>1 week

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: The first 28 days after infusion
measure: Type of dose-limiting toxicity (DLT)
timeFrame: The first 28 days after infusion
measure: Adverse event by severity
timeFrame: 2 years
Secondary outcomes:
measure: Overall response rate of ant-CD7 CAR
timeFrame: 1 year
measure: Progression-free survival (PFS)
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
Study officials:
affiliation: Peking University Shenzhen Hospital, China
name: Hongyu Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00600574: Ai Chi Versus Stretching in Fibromyalgia Management
Official title: A Randomized Controlled Trial Comparing the Efficay and Tolerability of Ai Chi Versus Stretching in Fibromyalgia Management: a Six Months Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: fibromyalgia
physical therapies
stretching
Ai Chi
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 94
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 the study is to compare the efficacy and tolerability of Ai Chi, an adaptation of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.

Detailed description: Physical therapies have shown to be effective in the treatment of fibromyalgia and It is generally assumed that a multidisciplinary approach, combining both pharmacologic and non-pharmacologic measures, is probably the optimal treatment approach for most fibromyalgia patients. As these patients are usually physically deconditioned, low-intensity exercise has been recommended at least as initial treatment. At this respect, exercise in warm water is considered a good option as both temperature and water buoyancy minimize body weight's stress and help patients to minimize pain. In a previous study comparing short term physiotherapy with stretching and Ai Chi we found that Ai Chi was at least as effective as stretching and induced a significant reduction in fibromyalgia core symptomatology and in sleep parameters. The objective of the present randomized controlled study is to compare both physiotherapy techniques in a long term basis.

Eligibility criteria: Inclusion Criteria:

* diagnosis of fibromyalgia according to the ACR criteria
* 18 years or older
* written informed consent to participate

Exclusion Criteria:

* unable to tolerate warm chlorinated water
* associated medical condition contraindicating exercise in warm water

Primary outcomes:
measure: Fibromialgya Impact Questionnaire
timeFrame: baseline, 6 months, 1 year
Secondary outcomes:
measure: Pittsbugh Sleep Quality Index
timeFrame: baseline, 6 months, 12 months
measure: Hospital Anxiety and Depression Scale
timeFrame: baseline, 6 months, 12 months
measure: SF-36 Health Survey
timeFrame: baseline, 6 months, 12 months
measure: Brief Pain Inventory
timeFrame: baseline, 6 months, 12 months
measure: Adverse reaction recording
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario "Virgen de las Nieves"
Study officials:
affiliation: Universidad de Granada
name: Elena P. Calandre, M.D.
role: STUDY_DIRECTOR
References:
citation: Gowans SE, deHueck A. Pool exercise for individuals with fibromyalgia. Curr Opin Rheumatol. 2007 Mar;19(2):168-73. doi: 10.1097/BOR.0b013e3280327944.