linjc16/ctgov huggingface dataset:
Phase II Study Using Thalidomide for the Treatment of ALS

Study Overview
=================
Brief Summary
-----------------
The use of Thalidomide in patients with ALS who have disease progression.

Detailed Description
-----------------
Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of disease progression.

Official Title
-----------------
Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis, ALS

Intervention / Treatment
-----------------
* Drug: Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically proven ALS Disease duration less than or equal to 5 years ALSFRS-R score equal to or greater then 30 Exclusion Criteria: Patients with known deep venous thrombosis or hyper coagulable state will be excluded Patients with FVC less than 80%

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thalidomide|Thalidomide will start at a dose of 100mg/day, dose escalated every 2 weeks by 100mg/day to a target dose of 400mg/day.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of Thalidomide in the rate of progression in ALS at 9 months and hence determine preliminary efficacy in the treatment of ALS |  | Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate 1) toxicity 2) quality of life 3) cytokine profile 4) PFT's 5) sleep questionnaire and 6) survival of thalidomide in the treatment of ALS |  | survival and progression free suvival will be assessed from the date of initial therapy on study to date od death. Survival and progresion free survival wil be analyzed using the Kaplan Meier method | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALS
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.

Official Title
-----------------
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: ONO-8025 (KRP-197)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 20 years old or over with overactive bladder Total number of urinary incontinence episodes per week is 5 or over Mean number of micturition per day is 8 or over Mean number of urinary urgency episodes per day is 1 or over Other inclusion criteria as specified in the study protocol Exclusion Criteria: Patients with genuine stress incontinence Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study Patients suffering from complications for which anticholinergics are contraindicated Other exlcusion criteria as specified in the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ONO-8025 (KRP-197)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of urinary incontinence episodes per week |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-8025, KRP-197, overactive bladder, antimuscarinic
Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)

Study Overview
=================
Brief Summary
-----------------
Evaluate sleep disordered breathing before and after orthopedic surgery utilizing a FDA cleared to market (510k) home sleep study device (Nexan Inc., ClearPath System) Compare Berlin Questionnaire and Epworth Sleep Scale questionnaires to the home sleep study device results. Evaluate effectiveness of the home sleep study testing in the orthopedic presurgical population.

Official Title
-----------------
Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing knee or hip total joint replacement Answer Yes to any PROSPECT health history questions and/or score Positive on the sleep questionnaires Exclusion Criteria: Tape Allergy Previous Diagnosis Of Obstructive Sleep Apnea

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Perioperative | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of objective sleep data to standardized sleep questionnaires |  | Pre and Post Operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Pre and Post Operative Objective sleep data |  | Pre and post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perioperative, Obstructive Sleep Apnea, Screening, Home Sleep Testing
Treatment of Acetabular Fractures in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
This retrospective study investigates surgical treatment of acetabular fractures in elderly patients (>60 years of age), either undergoing joint-preserving surgery or joint- replacement. 1 year- outcome with regard to mobility and autonomy is assessed.

Official Title
-----------------
Treatment of Acetabular Fractures in Elderly Patients

Conditions
-----------------
Acetabular Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgical treatment of acetabular fracture between 2009 and 2018 Exclusion Criteria: pathological fractures due to neoplasm or metastasis status after implantation of an endoprosthesis

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in living arrangements | preservation of autonomy investigated by assessment of living arrangements: at home (by oneself, with a partner, with professional support), residential home for the elderly with occasional support, nursing home) | at baseline (right after surgery) and 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of rehospitalisations | number of rehospitalisations | single time point assessment 1 year after surgery | 
| number of re-surgeries | number of re-surgeries | single time point assessment 1 year after surgery | 
| mortality | number of deaths | single time point assessment 1 year after surgery | 
| infections | number and type of infections | single time point assessment 1 year after surgery | 
| Change in leg length difference | radiological leg length difference (mm) | at baseline (right after surgery) and 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip joint replacement, hip joint preserving surgery
Study to Demonstrate Equivalence of Formoterol 12 and 24 µg Delivered Via Two Types of Single Dose Dry Powder Inhalers (Concept1 and Aerolizer)

Study Overview
=================
Brief Summary
-----------------
This study is designed to demonstrate that formoterol 12µg and 24µg delivered by a new inhalation device (Concept1) are equivalent to the corresponding dose of formoterol delivered by the Aerolizer device in terms of efficacy, in patients with persistent asthma.

Official Title
-----------------
A Randomized, Multi-centre, Double-blind, Double Dummy Placebo Controlled Single-dose Cross-over Study to Demonstrate That 12 and 24 µg of Formoterol Delivered by Concept1 Has a Bronchodilator Efficacy Which is Equivalent to the Same Dose of Formoterol Delivered by Aerolizer in Adult Patients With Persistent Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: formoterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of asthma attacks Forced expiratory volume in 1 second (measure of how well the lungs are working) is greater than 60% of the predicted value Exclusion Criteria: Asthma is not stable: patients were admitted to hospital or received emergency room treatment Patients whose asthma drugs need changing within the month prior to the start of the study

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: formoterol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Efficacy assessed by 12 hour Area Under the Curve (AUC) of FEV1 (forced expiratory volume in 1 second, is a measure of how well the lungs are working) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Efficacy assessed by forced expiratory volume in 1 second at pre-dose, 15, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours post dose |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, adults, B2 agonist, formoterol
Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

Study Overview
=================
Brief Summary
-----------------
D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.

Official Title
-----------------
Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

Conditions
-----------------
Diarrhea

Intervention / Treatment
-----------------
* Other: Stool sampling and sequencing of gut microbiota.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for symptomatic group: male/female aged at least of 18 years subject with abdominal pain, diarrhea, bloating no other known intestinal disease Inclusion Criteria for asymptomatic group: male/female aged at least of 18 years no known intestinal disease Exclusion Criteria of symptomatic and asymptomatic groups: chronic intestinal diseases such as IBD, IBS … intake of antibiotic or probiotic within the 2 last months subject in exclusion period subject unable to understand information for a free consent to the study subject in safeguarding justice or guardianship

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic subjects<br>Subjects with intestinal symptoms | Other: Stool sampling and sequencing of gut microbiota.<br> <br> |
| Asymptomatic subjects<br>Subjects without intestinal symptoms | Other: Stool sampling and sequencing of gut microbiota.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16SrRNA copy numbers |  | Within the 2 days following inclusion |
Regional Central Database Recording of Chronic Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.

Detailed Description
-----------------
Given the complexity and evolution of recommendations and to harmonize these, it appears necessary to establish a central database for recording , monitoring patients with CML supported by the participating centers the region and evaluation of care practices in use . Indeed , the main purpose of this database is to provide diagnostic and therapeutic management of reported cases of chronic myeloid leukemia and to study the prognostic factors . The main objective is to improve significantly the percentage of patients treated adequately load in the region, in the initial stages of the disease and during its evolution.

Official Title
-----------------
Regional Central Database Recording of Chronic Myeloid Leukemia

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Other: Practices evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic myeloid leukemia Diagnosis (CML) in chronic phase , accelerated or blast male or female patient aged 18 years or more Cases transmitted by referring hematologist , one of the 6 participating centers after patient's oral information Clinical record presented Concertation Meeting LMC Multidisciplinary coordinated by the Institute Bergonié Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Practices evaluation|Practices evaluation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance of the management of patients with chronic myeloid leukemia compared to the guidelines |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic myeloid leukemia, practices evaluation
Is Recombinant Growth Hormone Therapy Associated With Increased Intraoccular Pressure?

Study Overview
=================
Brief Summary
-----------------
Recombinant growth hormone is a common therapy in the pediatric population. A number of associated side effects have been described. Several years ago, a case report was published concerning a child that was treated with RGH and developed acute glaucoma. To date no study has evaluated the connection.

Conditions
-----------------
Growth Hormone Treatment, Glaucoma

Intervention / Treatment
-----------------
* Other: Measuring intraoccular pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6-18 years treatment with recombinant growth hormone Exclusion Criteria: Underlying Chronic diseases Family history of eye diseases elevated occular pressure prior to starting treatment

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RGH treated<br> | Other: Measuring intraoccular pressure<br>* Measurement of intraoccular pressure by tonometry<br>|
| Starting treatment with RGH<br> | Other: Measuring intraoccular pressure<br>* Measurement of intraoccular pressure by tonometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoccular pressure in children treated with RGH |  | 2 years |
Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome.

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled, Multicenter, 12-week Phase 3 Study to Evaluate Efficacy and Safety of ALS-L1023 Tablet in Patients With Abdominal Obesity of Metabolic Syndrome

Conditions
-----------------
Abdominal Obesity Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: ALS-L1023
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 20 and 64 years(Both genders) more than 2 among components of the metabolic syndrome Triglyceride >= 150mg/dL HDL-D: Women < 50mg/dL or Men < 40mg/dL Hypertension: Systolic blood pressure >= 130mmHg or Diastolic blood pressure >= 85mmHg Hyperglycemia: fasting plasma glucose >= 100 mg/dL Informed consent awarding Exclusion Criteria: Alcohol or any drug abuse Any investigational medication during the preceding 3 months

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test arm<br>ALS-L1023 300mg in two tablets | Drug: ALS-L1023<br>* daily twice for 12 weeks<br>|
| Placebo Comparator: Comparator arm<br>placebo in two tablets | Drug: placebo<br>* daily twice for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 12 week in visceral fat area measured by CT |  | baseline and 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of metabolic profile |  | baseline and 12 week | 
| change of insulin resistance |  | baseline and 12 week | 
| change of BMI |  | baseline and 12 week |
Effect of Creatine and L-Arginine on Endothelial Function

Study Overview
=================
Brief Summary
-----------------
The study is a double blind 2x2 factorial study. Patients with coronary disease will be randomly be assigned to L-arginine (9 g/day), creatine 21 g/d, both, or neither dietary supplement. The function of the endothelium will be tested using ultrasound before and after each treatment. These studies will help us understand why the endothelium is abnormal in patients with coronary artery disease and how L-arginine is acting on endothelial function.

Official Title
-----------------
Effect of Creatine and L-Arginine on Endothelial Function in Patients With Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Creatine
* Dietary Supplement: L-arginine and creatine
* Dietary Supplement: l-arginine
* Dietary Supplement: placebo, double


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery disease Exclusion Criteria: Pregnancy Creatine use within one month of study L-arginine use within one month of study Change in dose or initiation of lipid lowering therapy, aspirin therapy, or angiotensin converting enzyme therapy within one month of study

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: Creatine<br>* Creatine 21 g daily<br>|
| Experimental: 2<br> | Dietary Supplement: l-arginine<br>* l-arginine 9 g daily<br>|
| Experimental: 3<br> | Dietary Supplement: L-arginine and creatine<br>* L-arginine<br>|
| Placebo Comparator: 4<br> | Dietary Supplement: placebo, double<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery flow-mediated dilation |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum arginine, creatine, creatinine, homocysteine |  | 5 days |