linjc16/ctgov huggingface dataset:
Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.

Official Title
-----------------
Phase3,Open-label,Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.

Conditions
-----------------
Wison's Disease

Intervention / Treatment
-----------------
* Drug: Zinc acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Wilson's disease(adult,infant,pregnant woman) Exclusion Criteria: acute hepatitis malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zinc acetate|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.

Official Title
-----------------
A Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Higher Multi Dose Regimens to Subjects Sensitised to Birch Pollen

Conditions
-----------------
Birch Pollen-Related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* Biological: Placebo
* Biological: rBet v 1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written consent Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years. Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) of at least Class 2 at screening. FEV1 at least of 80% of predicted values at screening. Exclusion Criteria: Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder…) or who plan to start desensitization treatment during this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo group | Biological: Placebo<br>* Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.<br>|
| Experimental: Active group<br>rBet v 1 tablets | Biological: rBet v 1<br>* Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 50 to 300 µg rBet v 1.<br>* Other names: rBet v 1.0101;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tolerability |  | Assessed every day over 2 weeks | 
| Global safety |  | Assessed every day over 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological markers (IgE and IgG4) |  | Between selection and follow-up visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rBet v 1, Birch pollen allergy, Sublingual Immunotherapy
A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children

Study Overview
=================
Brief Summary
-----------------
The three major Soil-Transmitted Helminths (STH), Ascaris lumbricoides, Necator americanus/Ancylostoma duodenal and Trichuris trichiura are among the most prevalent parasites worldwide. The objective of this multicentre international study is to define the efficacy of a single 400 milligram dose of albendazole (ALB) against these three STHs using a standardised protocol. The trial will be undertaken among school age children in seven countries - Brazil, Cameroon, Cambodia, Ethiopia, India, Tanzania (Zanzibar) and Vietnam - each with a different epidemiologic pattern of infection. A trial of this nature is urgently required because in spite of the wide usage of albendazole over the last 3 decades, there is still no key publication reporting the efficacy of the anthelmintic accurately, and to modern conventional standards, that can act as a central reference for the baseline efficacy. The latter is critically important because albendazole is now being used even more widely, as large scale mass treatment campaigns are being implemented in Africa and elsewhere, with the intention of reducing morbidity in children. Such large scale usage of a drug risks resistance developing, but resistance cannot be detected unless benchmark values for baseline efficacy are widely known.

Official Title
-----------------
A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children

Conditions
-----------------
Infections With Soil-Transmitted Helminths (STH)

Intervention / Treatment
-----------------
* Drug: Albendazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children should be infected with a minimum of 150 eggs/gram of any of the three species of STH (i.e. Ascaris or hookworms or Trichuris). Exclusion Criteria: Not willing to participate Unable to give samples for follow up Severe intercurrent medical condition Diarrhoea at first sampling

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albendazole<br>Treatment with albendazole | Drug: Albendazole<br>* Treatment with albendazole<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of albendazole | To determine the efficacy of albendazole, and this will be assessed by the reduction in parasite faecal egg counts between the pre- and post-intervention surveys. The latter will be conducted 14-30 days after treatment. | 14 to 30 days after treatment |
Simple Home-Based Exercise for Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Simple home-based standing balance training and isometric knee extension exercise for 4 weeks would improve functional ability and knee muscle strength of patients with knee osteoarthritis. The outcome of standing balance training is different from isometric knee extension exercise.

Official Title
-----------------
The Relationship of Knee Joint Osteoarthritis to Balance and Walking Ability.

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Behavioral: Standing balance exercise
* Behavioral: Isometric knee extension exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical criteria for knee osteoarthritis Exclusion Criteria: cardiovascular disease Parkinsonism osteoporosis inability to walk for 15 meters intra-articular injections

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G1<br>Standing balance and mini squat training | Behavioral: Standing balance exercise<br>* Standing balance and mini squat exercise performed 30 times/day/side, 5 days/week, for 4 weeks.<br>|
| Active Comparator: G2<br>Isometric knee extension exercise | Behavioral: Isometric knee extension exercise<br>* Isometric knee extension exercise performed 10 repetitions/set, 3 sets/day, 5 days/week for 4 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee osteoarthritis outcome scores (KOOS) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee muscle peak torque |  | 4 weeks | 
| Aggregate functional performance time |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, knee, exercise, balance
Negative Pressure Wound Therapy for Prevention of Groin Infection Following Vascular Surgery

Study Overview
=================
Brief Summary
-----------------
Surgical site infection in vascular surgery is a relatively common event with reported incidence as high as 43%. When considering the groin alone, the incidence is around 20% (30% when considering any wound complication). This complication may sometimes lead to heavier complication (leg amputation, longer hospital stay, high costs…) and affects the early postoperative quality of life of the patients.

Official Title
-----------------
Negative Pressure Wound Therapy for Prevention of Groin Infection Following Vascular Surgery in High Risk Patient: a Randomized Control Study

Conditions
-----------------
Infection Wound

Intervention / Treatment
-----------------
* Device: Standard cutiplast®
* Device: PICO®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every high-risk patient (meeting one of the criteria of table I) undergoing vascular surgery with groin incision (without ongoing infection) Exclusion Criteria: Patients who need a transverse incision before EndoVascular Aortic Repair procedure, considering that in our experience surgical site infection almost never occurs after these procedures and patients with mental incapacities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dressing-Cutiplast®<br> | Device: Standard cutiplast®<br>* Our standard dressing consists in a usual ready-to-use Smith and Nephew Cutiplast®. This dressing is open 48 hours after the operation (CDC recommendation) for the first time and then changed every day after wound disinfection.<br>|
| Experimental: Negative pressure wound therapy-PICO®<br> | Device: PICO®<br>* PICO® is a negative pressure wound therapy consisting in a 4 layers ready-to-use dressing connected to a small console, responsible for the aspiration. The system is canister free. The fluid drained from the wound is lost by evaporation for 80% of it and only 20% remains in the dressing. This permits to the dressing to be kept in place for maximum 7 days. The wound is not checked during the hospital stay, allowing the patient to leave the hospital earlier after the operation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of wound complications |  | at one year |
Couple and Spouse Caregiver in Huntington's Disease

Study Overview
=================
Brief Summary
-----------------
The objectives are to better document the psychosocial status and needs of caregiver of HD patients and understand the dyad functioning, facing the disease at various stages.

Official Title
-----------------
Couple and Spouse Caregiver in Huntington's Disease

Conditions
-----------------
Huntington Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For patient : HD, CAG > 36, motor UHDRS > 5 Being able to communicate with the investigator For both spouses : Living together since at least 5 years 30 to 60 years old Exclusion Criteria: For patient : - Other chronic neurologic disorder For both spouses : Psychiatric disease Unable to participate, incl read, understand and sign the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease | Qualitative assessment: Interpretative phenomenological analysis (IPA) by semi-structured interviews to explore families representations and strategies about the patients with Huntington's Disease | once time, Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease | Qualitative assessment : Thematic analysis by COAT (Carers Outcome Agreement Tool) during a semi-structured interviews to explore families representations and strategies about the patients with Huntington's Disease | once time, Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Huntington's disease, spouse caregiver, quality of life
Imaging Study of Neurovascular Coupling in Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate using fMRI methods, EEG and dedicated mathematical models, the potential alterations of neurovascular coupling in CADASIL.

Detailed Description
-----------------
Comparison study of parameters derived from mathematical models of neurovascular coupling and obtained using fMRI (Bold signal, ASL and EEG).

Official Title
-----------------
Etude Comparative en Imagerie Par résonnance magnétique et Par Enregistrement électroencéphalographique du Couplage Neurovasculaire Dans l'Angiopathie Cadasil

Conditions
-----------------
CADASIL

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CADASIL group: typical NOTCH3 mutation, age less than 60 years, rankin score at 0-1, active social insurance Exclusion Criteria: MRI contra-indications and use of any treatment known to interfere with neurovascular coupling, pregnancy, lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| model-derived parameters of neurovascular coupling |  | one time point |
Characterizing PAI-1 Modulation on Monocyte Adhesion

Study Overview
=================
Brief Summary
-----------------
To determine how altering the expression of a gene known as PAI-1 may affect the adhesive capacity of cells that play a critical role in the developement of human atherosclerosis.

Detailed Description
-----------------
The principal aim of this study is to determine if molecular regulation of the human gene PAI-1 alters the migratory properties of human myeloid and endothelial cells sufficiently enough to regulate entry and exit from the vascular space. Human monocyte become the key cellular orchestrators of human atherosclerotic plaque. We believe that a loss of PAI-1 activity may promote a pro-atherogenic effect in human vasculature thereby defining a novel atheroprotective effect for PAI-1 when expressed at normal levels in humans. By using RNA interference to achieve PAI-1 gene, we hope to elucidate the mechanistic basis of how PAI-1 regulation may affect human migration within the vasculature.

Official Title
-----------------
Characterizing the Effects of PAI-1 Modulation on Human Monocyte Function - The Effect of PAI-1 Post-transcriptional Regulation on Human Monocyte Adhesion

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-50 No current or past medical problems Exclusion Criteria: Patients taking prescription drugs (hormonal birth control or herbal supplements may be taken)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerosis, metabolic pathways, monocyte adhesion,
Risk Factors for Lower Extremity Overuse Injuries in Jump-landing Athletes

Study Overview
=================
Brief Summary
-----------------
In this prospective study, male jump-landing athletes (volleyball and basketball) will be screened pre-season and followed for one consecutive season. Pre-season screening consists of 3D biomechanical analysis of standardized (such as drop vertical jump) and sports-specific jumps (such as stop-jump) before and after a high-intensity, intermittent exercise protocol and clinical field tests (such as force measurements).

Official Title
-----------------
Biomechanical (Fatigue-related) Risk Factors for the Development of Lower Extremity Overuse Injuries in Jump-landing Athletes

Conditions
-----------------
Landing Biomechanics, Fatigue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volleyball and basketball players elite and non-elite male healthy Exclusion Criteria: symptoms or complaints of lower extremity acute of overuse injuries in the past 3 months history or surgery of the lower extremities history of fractures of the lower extremities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jump-landing biomechanics | Full-body (trunk, pelvis, hip, knee, ankle) jump-landing biomechanics (3D joint angles and moments) during drop vertical jumps, block jumps and spike jumps | 1 year | 
| Jump-landing biomechanics after fatigue | Full-body (trunk, pelvis, hip, knee, ankle) jump-landing biomechanics (3D joint angles and moments) during spike jumps during and after a fatigue protocol | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical tests - force | Force measurements of the quadriceps, hamstrings and gluteal muscles by means of hand-held dynamometry | 1 year | 
| Clinical tests - mobility | Flexibility of the quadriceps and hamstrings muscles, and ankle dorsiflexion angle during dynamic weight-bearing lunge | 1 year | 
| Clinical tests - foot posture | Navicular height and position of the calcaneal bone | 1 year | 
| Clinical tests - force endurance | Prone bridge until fatigue | 1 year | 
| Clinical tests - endurance | Intermittent yo-yo test (level 1) | 1 year |