linjc16/ctgov huggingface dataset:
Macrolane Retrospective Study

Study Overview
=================
Brief Summary
-----------------
This is a retrospective, multicenter chart review of medical records on the use of Macrolane for female breast enhancement. The primary objective is to evaluate the safety profile of Macrolane Volume Restoration Factor 20 and Macrolane Volume Restoration Factor 30 when used for female breast enhancement in clinical practice.

Official Title
-----------------
A Multi-center Retrospective Chart Review of Medical Records on the Use of Macrolane Volume Restoration Factor for Breast Enhancement

Conditions
-----------------
Women Who Have Had Breast Enhancement With Macrolane VRF

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females treated with Macrolane Volume Restoration Factor 20 and/or Volume Restoration Factor 30 for breast enhancement. Signed Informed Consent Exclusion Criteria: Subjects that have actively asked not to be contacted by the clinic Subjects that have participated or participates in clinical studies with Macrolane for breast enhancement
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Macrolane<br>Women that have had breast enhancement with Macrolane Volume Restoration Factor. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Number of Adverse events reported during the study period | 01may2008 - 31dec2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macrolane, Retrospective
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS

Study Overview
=================
Brief Summary
-----------------
To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic characteristics.

Official Title
-----------------
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis

Conditions
-----------------
Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: BG00012
* Drug: BG00012


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 to 55 years old, inclusive, at the time of informed consent. Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4. Be ambulatory. Exclusion Criteria: Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS). History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, renal, oncologic, anaphylaxis or other major diseases, as determined by the Investigator. Current enrollment in any other drug, biologic, or device study or treatment with another investigational drug within 6 months or 5 half-lives of the investigational product, whichever time period is longer. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1. Pregnant or nursing women. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>240 mg (two 120 mg capsules) twice a day | Drug: BG00012<br>* 240 mg (two 120 mg capsules) orally twice a day<br>|
| Experimental: 2<br>240 mg (two 120 mg capsules) three times a day | Drug: BG00012<br>* 240 mg (two 120 mg capsules) orally three times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS |  | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012 |  | 24 Hours |
A Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ alone and whether the combination treatments are safe and well tolerated. The study aims to establish a dose response relationship for both monotherapies and the combinations. This study is being conducted in Japan.

Official Title
-----------------
A Multi-center, Factorial Study to Evaluate Efficacy & Safety of 8 Wks Treatment With VAH631 [Valsartan (40 & 80 mg) and Hydrochlorothiazide (6.25 & 12.5 mg) Combined & Alone in Essential Hypertensive Patients] - Double-blind Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Valsartan
* Drug: Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Essential hypertension measured by mercury sphygmomanometer Outpatients Exclusion Criteria: Secondary hypertension or suspected of having secondary hypertension. A history of malignant hypertension Severe hypertension Significant heart, renal, hepatic diseases or significant cerebrovascular disorder Gout Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valsartan|nan|
|Drug: Hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure after 8 weeks |  |  | 
| Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks |  |  | 
| Change from baseline in standing diastolic blood pressure after 8 weeks |  |  | 
| Change from baseline in standing systolic blood pressure after 8 weeks |  |  | 
| Adverse events and serious adverse events at each study visit for 8 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension,, Valsartan,, Hydrochlorothiazide
Analysis of Changes in Medication Prescriptions After Hospitalization for 4 Disciplines: Gerontology, Diabetology, Cardiology and Rheumatology: Medical, Pharmaceutical and Economic Aspects

Study Overview
=================
Brief Summary
-----------------
The modifications of the medicinal treatments secondary to the hospitalizations have multiple reasons: reassessment of the previous treatment (conciliation), new therapeutic necessities, potential risk of iatrogeny or of drug interaction, restrictions of the therapeutic booklet, classification in reserve or hospital prescription ... These modifications are potentially generating extra costs for the Health Insurance and are monitored under the terms of the Contract of Good Use. The aims of this analysis are to define the medical-pharmaceutical rationale of the treatment changes imposed by hospitalization in a university-hospital center, their influence on the security of the medical treatment of patients and their financial implications for healthcare organizations

Official Title
-----------------
Analysis of Changes in Medication Prescriptions After Hospitalization for 4 Disciplines: Gerontology, Diabetology, Cardiology and Rheumatology: Medical, Pharmaceutical and Economic Aspects

Conditions
-----------------
Diabetes, Cardiac Disease, Rheumatic Diseases

Intervention / Treatment
-----------------
* Other: collection of prescription data


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria Patient social insured Patient belonging to the general social security scheme Patient followed in cardiology, rheumatology, geriatrics or diabetology departments no exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diabetology<br> | Other: collection of prescription data<br>* collection of prescription data before and after a hospitalization<br>|
| cardiology<br> | Other: collection of prescription data<br>* collection of prescription data before and after a hospitalization<br>|
| rheumatology<br> | Other: collection of prescription data<br>* collection of prescription data before and after a hospitalization<br>|
| geriatrics<br> | Other: collection of prescription data<br>* collection of prescription data before and after a hospitalization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| entry orders before hospitalization |  | 15 months | 
| exit orders after hospitalization |  | 15 months |
Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome

Study Overview
=================
Brief Summary
-----------------
Clinical Objective : To improve the growth of these children Genetic objective : A study of the genetics of the syndrome

Official Title
-----------------
Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome

Conditions
-----------------
Noonan Syndrome

Intervention / Treatment
-----------------
* Drug: MAXOMAT ®, biosynthetic growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents with Noonan's syndrome with a height < -2 SD and no progressive cardiopathy Exclusion Criteria: Age < 3 years Height ≥ -2 SD The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 15 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: MAXOMAT ®, biosynthetic growth hormone|2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of height : gain in height and rate of growth |  | at each visit (every 3 months) or every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and laboratory test safety |  | every 6 months |
The Role of Genetic Factors in the Development of Breast Cancer in the Kazakh Population

Study Overview
=================
Brief Summary
-----------------
This is a GWAS study that aims to identify possible candidate genes associate to breast cancer by exploring single nucleotide polymorphism (SNP) in a group of breast cancer, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with breast cancer

Detailed Description
-----------------
A genome-wide association study (GWAS) is an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies.

Official Title
-----------------
Preventive and Personalized Medicine (2021-2023)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Genetic: DNA analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with a histologically confirmed diagnosis of breast cancer. The age of patients is from 18 to 60 years; Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs. Persons who are able and willing to provide written informed consent; Persons capable and willing to comply with the research protocol; Exclusion Criteria: Persons under 18 and over 60 years old; Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent; Pregnant or lactating women; Tuberculosis of any localization in the active phase and in history; Severe and decompensated diseases of the liver and kidneys, cardiovascular system; Severe and decompensated course of endocrine diseases; Lack of histological verification of breast tumor

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

Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group:<br>Patients with breast cancer | Genetic: DNA analysis<br>* GWAS<br>|
| Control group<br>Patients without breast cancer | Genetic: DNA analysis<br>* GWAS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of SNPs associated with breast cancer | Using GWAS to identify candidate genes associate with breast cancer | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GWAS
DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is: To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots) To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures) A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.

Official Title
-----------------
A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: calcitriol
* Drug: docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologically or cytologically proven adenocarcinoma of the prostate Documented metastatic prostate adenocarcinoma Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging Age >= 18 years Eastern Cooperative Oncology Group (ECOG) performance status <= 2 Adequate hematologic, renal and hepatic function Life expectancy >= 3 months Exclusion Criteria: Prior chemotherapy, except estramustine Prior chemotherapy with docetaxel Prior isotope therapy (e.g., strontium-89, samarium-153, etc.) One or more contraindications to the use of corticosteroids History of cancer-related hypercalcemia

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

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

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

| Intervention/Treatment |
| --- |
|Drug: calcitriol|nan|
|Drug: docetaxel|nan|

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
-----------------
Androgen-independent Prostate Cancer (AIPC), Prostate Cancer, DN-101, calcitriol, Taxotere, docetaxel
Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of the investigators' study is to determine whether the production of heat shock proteins has an effect on the development and the outcome of acute renal failure in children.

Detailed Description
-----------------
A prognostic factor for the development of acute renal failure (ANR) in children would be very valuable for therapy regulation. So-called chaperones out of the family of heat shock proteins (HSP) are promising candidates which are involved in the development of ANR as well. This could be a starting point for the development of new therapeutic approaches. ANR occurs in up to 50 percent of all critical ill patients and has a high rate of morbidity and mortality despite advances in symptomatic therapy. Following severe sepsis, septic shock or other shocks, combined with multiple organ failure, the ANR is an autonomous prognosis worsening factor. Should the results of our study show a correlation between the production of HSP and the outcome of children with ANR, further studies would be required, to examine the pathophysiological relevance of HSP in ANR. We would then be able to determine a high risk population for ANR. A modulation of ANR therapy might be a result of further studies.

Official Title
-----------------
Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)

Conditions
-----------------
Kidney Failure, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 0 and 18 years of age. Either severe sepsis, shock of any origin or asphyxia. Operated patients with operative or post-operative transfusion requirement of at least 0.5 x 80 ml/kg body weight of erythrocyte concentrate. Exclusion Criteria: Existing affection of the kidney. Kidney transplantation. Missing written consent of the parents or guardian (if applicable).

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- | --- |
| Acute renal failure. |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Failure, Acute, Acute Renal Failure, Kidney Failure, Heat-Shock Proteins, Children
Respiratory and Quadriceps Muscle Fatigability After an ICU Acquired Weakness

Study Overview
=================
Brief Summary
-----------------
Muscle dysfunction can be lead to poor outcomes moreover ICU muscle weakness recovery are not correctly described. The investigators aimed to assess the ability for quadriceps or respiratory muscles to repeat an effort at a maximal loading.

Official Title
-----------------
Comparison Between Respiratory and Quadriceps Muscle Fatigability During a Maximal Loading for ICU Weakness Patients

Conditions
-----------------
ICU Acquired Weakness

Intervention / Treatment
-----------------
* Diagnostic Test: Muscle evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated at least at 24 Hours Maximal inspiratory pressure < 30 centimeter of water MRC score < 48/60 Exclusion Criteria: Age < 18 years Patients with neurological pathology or pre existing neuromuscular dysfunction Patient unable to walk 50 meters before ICU admission Patient with a thoracic or abdominal surgery Inability to carry out maximal voluntary contraction

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Muscle evaluation|Repeated maximal voluntary contraction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Respiratory muscle strength | Respiratory muscle strength will be assessed by Maximal Inspiratory pressure in centimeter of water. The measure will carry out by an electronical manometer | One day | 
| Change in quadriceps muscle strength | Quadriceps muscle strength will be assessed by Maximal Voluntary contraction of the quadriceps in Newton. The measure will carry out by an electronical dynamometer | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU acquired weakness, Muscle strength, fatigability, respiratory muscle, Quadriceps muscle