linjc16/ctgov huggingface dataset:
Hydrotherapy CP and Lying Down to Sitting Position

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of a very specific hydrotherapy programm on the movement from lying down to sitting position for children with CP

Detailed Description
-----------------
40 children aged 5-11 years with cerebral palsy and difficulty in the transfer activity from lying down to sitting position were randomly divided into 2 groups of 20 children, a land group and a water group. The children of the land attended a neurodevelopmental treatment program and the water group a very specific program in hydrotherapy on combined rotation at all levels. The water program was implemented by specialized physiotherapists in hydrotherapy. The duration of the program for both groups was 3 months. On the first and last day of the intervention, an evaluation of all children was performed using the GMFM and PBS evaluation tests of the evaluation parameters of the transfer from the lying position to the sitting position.

Official Title
-----------------
The Effect of a Specific Hydrotherapy Program on the Movement From Lying Down to Sitting Position for Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Hydrotherapy programm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral palsy DIfficulties from lying down to sitting posistion Exclusion Criteria: Surgery or injection of botilium toxin in the last year. Scheduled surgery or injection of botilium toxin. Uncontrolled seizures. Do not run elementary commands or play a test representation. Autism. Syndromes without OP. Serious vision problem. Absence from the treatment program for more than a week.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 equal groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water Group<br>Neurodevelopmental treatment | Other: Hydrotherapy programm<br>* Treatment<br>* Other names: Neurodevelomental treatment;|
| Experimental: Land Group<br>Lonqitudinal, transversal and compined rotation in a hydrotherapy programm | Other: Hydrotherapy programm<br>* Treatment<br>* Other names: Neurodevelomental treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMFM | Gross Motor Function Measurement | 3 months | 
| PBS | Paediatric Balance test | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral palsy, hydrotherapy, Neurodevelopmental treatment, Lying down, Sitting
Carotid Ultrasound Study

Study Overview
=================
Brief Summary
-----------------
To use carotid ultrasound to screen 20-30 patients with longstanding or resistant hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and will give insight into the prevalence and specific location of carotid plaque at the bifurcation in this patient population.

Official Title
-----------------
Carotid Ultrasound Study

Conditions
-----------------
Resistant Hypertension

Intervention / Treatment
-----------------
* Other: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years old Uncontrolled hypertension on 3 or more medications or longstanding controlled hypertension on 4 or more medications. Exclusion Criteria: Previous stroke Carotid endarterectomy or carotid stent procedure >50% stenosis anywhere in carotid arteries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Resistant hypertension<br> | Other: Ultrasonography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific location of carotid plaque at the bifurcation |  | Baseline |
The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of transfusion of allogeneic (homologous) red cells on the immunologic parameters such as T-cells as well as natural killer cell count/function, various interleukins, TNF alpha and other immunologic relevant parameters on postoperative day 1,3 and 5-7 in patients undergoing spine surgery.

Official Title
-----------------
The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

Conditions
-----------------
Infection After Transfusion

Intervention / Treatment
-----------------
* Other: Blood transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 - < 60 years Patients underwent elective spine surgery ASA classification 1-3 Exclusion Criteria: Patients who have the concomitant condition Cancer History of heart disease including, heart failure, coronary artery disease, hypertension treated with more than one medicament. Serum creatinine > 1.5 mg/dL Stroke, neurologic and mental deficits, epilepsy General or local infection (site of surgery), Coagulation disorders. Intraoperative massive bleeding Infection of the spine Rheumatoid arthritis Patients who had either of the following drug (aspirin, methotrexate, cyclosporine, qualaquin)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood transfusion<br>Patients receive blood transfusion during operation | Other: Blood transfusion<br>* Intraoperative blood transfusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunologic parameters | Blood level of the following parameters on preoperative, postoperative day 1, 3, 5-7. IL-1beta, IL-1ra, IL-2, IL-4, IL-5, IL-6, Il-7, IL-8, Il-9, Il-10, Il-12, Il-13, IL-15, Il-17,basic FGF (Fibroblast growth factors). Cell Analytics - (mononuclear) T-Cells incl. killer cells, CD2, CD3, CD4, CD8, CD25, CD30, CD19, CD20, CD138, CD56, CD56, CD303, CD304, NK cytotoxicity (non-radioisotope), CTL cytotoxicity (non-radioisotope), T cell proliferation, B cell, T cell. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of red cell transfusion on clinical relevant outcome parameters, such as myocardial infarction, infection rate, and length of hospital stay. |  | 1 month |
Patients Undergoing Strokes Admitted in Intensive Care Requiring Neurosurgical ICU Crossing: Patient Profile and Prognosis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the population of patients admitted to the ICU in neurosurgery for stroke requiring secondary care in intensive care and their future.

Detailed Description
-----------------
Methodology : DESIGN: Retrospective observational study single center, non-interventional Term study over 2 years, retrospectively Acquisition of data: Study of computer file: report available on DxCare hospital and Cora Collection of data as excel spreadsheet Statistical analysis: local management Anonymity of data: For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data for this study is single center on the site GHPSJ. Development of the study: Procedure: Series includable patients from the PMSI data Select folders according the inclusion criteria Collecting information from files on Excel spreadsheet by the internal charge of data collection (Sylvain CHAWKI) Statistical Analysis Writing Article Expected duration of patient recruitment: Retrospective of 2 and a half years from January 1, 2013 to April 31, 2015

Official Title
-----------------
Patients Undergoing Strokes Admitted in Intensive Care Requiring Neurosurgical ICU Crossing: Patient Profile and Prognosis

Conditions
-----------------
Cerebral Stroke

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted USINV for ischemic or hemorrhagic stroke Admitted secondarily in ICU Exclusion Criteria: Admission in ICU in first Administrative Admission in Intensive Care Requiring Neurosurgical within the thrombolysis alert regulated by the neurovascular guard but going directly to ICU imaging waning Subarachnoid hemorrhage

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: No intervention|No intervention. It's a study on retrospective Data|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death event |  | Day 1 after hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurosurgical, Intensive Care
18572 - Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose.

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987521)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: BAY987521<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987521)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: Y49-103)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Short Message System (SMS) Monitoring Intended for the Suicidal Patients

Study Overview
=================
Brief Summary
-----------------
The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.

Official Title
-----------------
Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency

Conditions
-----------------
Patients Having Realized a Suicide Attempt

Intervention / Treatment
-----------------
* Device: SMS contact with patient after discharge in intervention group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Surviving a suicide attempt Leaving directly the emergency department or hospitalized less than 7 days Being able to be joined by telephone mobile Exclusion Criteria: under guardianship Patient who are not able to provide a consent

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS<br>The patients of the test group receive a first SMS 48 hours after their discharge from the hospital then a total of 10 messages distributed over six months: 48 hours, S1, S2, M1, M2, M3, M4, M5, M6 and M13. | Device: SMS contact with patient after discharge in intervention group<br> <br> |
| No Intervention: Without SMS<br>The patients of the group benefit from the usual care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of suicide reattempts in every group |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of suicide reattempts in every group |  | 13 months | 
| Total number of suicidal second recurrences in every group |  | 6 months | 
| Total number of suicidal second recurrences in every group |  | 13 months | 
| Number of deaths by suicide |  | 6 months and 13 months | 
| Score in the scale C-SSRS |  | inclusion, 6 months and 13 months | 
| Presence of a disorder in the MINI: characterization of the comorbidity |  | 6 months and 13 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suicide attempt, SMS monitoring, recurrence, phone, prevention control, tertiary healthcare
Prostatic Hyperplasia Treatment and Cancer Prevention

Study Overview
=================
Brief Summary
-----------------
Treatment of patients with prostatic hyperplasia with topical papaverine.

Detailed Description
-----------------
Patients with obstructive voiding and high PSA to be studied for the regression of symptoms and declining PSA.

Official Title
-----------------
Treatment of Prostatic Hyperplasia With Topical Papaverine

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Other: Placebo
* Drug: papaverine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with symptoms e.g. obstructive voiding, hyperplasia and high PSA Exclusion Criteria: patients on chemotherapy abnormal lab values e.g. liver function, GFR and CAD

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Drug free base as placebo | Other: Placebo<br>* observation of skin changes if any<br>* Other names: drug free base;|
| Experimental: group two- papaverine arm<br>papaverine in a suitable base | Drug: papaverine<br>* observation of symptoms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory tests to measure regression of symptoms | patients follow-up on regular intervals | every 4 weeks up to 16 weeks |
Effects of Black Cohosh on Menopausal Hot Flashes

Study Overview
=================
Brief Summary
-----------------
This study will assess whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes. In addition, this study will determine whether or not black cohosh reduces the frequency of other menopausal symptoms and improves quality of life.

Detailed Description
-----------------
Most American women will spend the last third of their lives post-menopause. During this time, chronically low levels of steroidal estrogens may lead to a number of short and long-term medical sequelae such as hot flashes, vaginal dryness, heart disease, and osteoporosis. While some physicians believe that demonstrated beneficial effects of estrogen, particularly on the cardiovascular and skeletal systems, warrant the taking of hormone therapy from menopause on, many women choose not to take estrogen replacement therapy (ERT) and are increasingly exploring alternative approaches to ERT. For centuries, black cohosh (Cimicifuga racemosa) has been used worldwide for women's health. Despite its long-standing use, studies of black cohosh have yielded conflicting data, in part because of lack in study design rigor and the short duration of studies to date. The primary aim of this study is to correct past shortcomings in study design to determine whether treatment with black cohosh is effective in treating menopausal symptoms. Participants in this study will be given black cohosh for a 12-month period. Potential mechanisms of action of black cohosh will be examined by quantifying the levels of sex hormones, including estradiol, estrone, FSH, and LH. Because black cohosh may act as an estrogenic agent, the effect on endometrium will be evaluated by sonogram and by monitoring the incidence of adverse events and compliance with the study.

Official Title
-----------------
Effects of Black Cohosh on Menopausal Hot Flashes

Conditions
-----------------
Postmenopause, Hot Flashes, Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: Black Cohosh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident of the New York Metro Area Postmenopausal Weight within 90% to 120% of ideal body weight

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Black Cohosh|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
-----------------
Menopause, Hot Flashes, Osteoporosis, Postmenopausal
Safety and Efficacy of Hunterase

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the safety and efficacy of once weekly dosing of idursulfase-beta 0.5mg/kg administered by intravenous(IV) infusion for Hunter syndrome patients < 6 years old.

Official Title
-----------------
To Evaluate the Safety and Efficacy of Hunterase(Idursulfase-beta) in Hunter Syndrome Patients < 6 Years of Age Receiving Idursulfase Enzyme Replacement Therapy

Conditions
-----------------
Hunter Syndrome

Intervention / Treatment
-----------------
* Biological: Hunterase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has a diagnosis of Hunter syndrome based upon biochemical criteria: as measured in plasma, leukocytes, or fibroblasts, a deficiency in iduronate-2-sulfatase (I2S) enzyme activity of ≤ 10 % of the lower limit of the normal range That corresponds to one or more of the following: a normal enzyme activity level of one other sulfatase Confirmed as MPS2 by genetic test results shows clinical symptoms/ visible signs of MPS2 < 6 years old and male Patients who are able to comply with the study requirements The patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study Exclusion Criteria: The patient has had a tracheostomy The patient has known severe hypersensitivity or shock to any of the components of idursulfase The patient has received treatment with another investigational therapy within 30 days prior to enrollment History of a stem cell transplant The patient has known severe hypersensitivity or shock to any of the components of test drug(excipient etc)

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

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

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: Test drug<br>Idursulfase-beta | Biological: Hunterase<br>* once weekly, 0.5mg/kg IV infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of anti-idursulfase-beta antibody status |  | baseline and one year | 
| Percent Change of Urine GAG |  | baseline to 53 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hunter syndrome, idursulfase-beta, Hunterase, GC1111