linjc16/ctgov huggingface dataset:
RehaSleep Register - Prevalence of Sleep Apnea in Cardiac Rehabilitation

Study Overview
=================
Brief Summary
-----------------
Prevalence of sleep-related breath disturbance in patients in cardiac rehabilitation. The aim of the register is to enable a better diagnosis and early treatment initiation in the context of secondary prevention. In addition to the prevalence, the further course of the patients shall be documented after hospital discharge to verify any gaps (sleep laboratory, therapy introduction) and emphasize the importance of rehabilitation and to examine the possibility of initiating therapy in rehabilitation.

Official Title
-----------------
RehaSleep Register - Prevalence of Sleep Apnea in Cardiac Rehabilitation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: terminal cardiac treatment in cardiac rehabilitation facility for example: Myocardial infarction, bypass surgery, stent implantation, valve replacement, ICD, CRT, pacemakers, heart failure Exclusion Criteria: no informed consent form signed limited consent capacity (Dementia, addiction, psychosis) pregnancy

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 |
| --- | --- |
| Quality of Life (SF12), 2-channel Polygraphy<br>cardiological treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiological treatment | all Patients who are admitted under a terminal cardiac treatment (myocardial infarction, bypass surgery, stent implantation, valve replacement, ICD, CRT) in a cardiac rehabilitation faciliy | April 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep Apnea, cardiological treatment
Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator

Study Overview
=================
Brief Summary
-----------------
Angular deformities around the knee are one of the common cause of presentation at pediatric orthopedic clinic. Although these conditions are commonly benign and self-limiting. The mechanical axis of the lower extremity is a straight line extending from the center of the femoral head to the center of the ankle. The horizontal distance in millimeters from the center of the knee joint to the mechanical axis is the deviation of the mechanical axis. The goal of treatment is to correct malalignment of the lower extremity and perhaps to prevent or delay the onset of osteoarthritis by normalizing the mechanical axis

Official Title
-----------------
Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator

Conditions
-----------------
Deformities Around the Knee in Pedietrics

Intervention / Treatment
-----------------
* Procedure: correction of deformities around the knee with external fixator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genu valgus having tibio-femoral angle more than 15 degrees. Genu varus having metaphyseal-diaphyseal angle of more than 11 degrees More than one plane defirmity Age 10 - 16 yrs Range of motion: Full extension More than 100 in flextion Exclusion Criteria: Genu recurvatum. Flexion deformity. Pathological conditions (e.g: bone softening diseases Dysplasia Limb length discrepancy

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 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: study group<br> | Procedure: correction of deformities around the knee with external fixator<br>* minimally invasive surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thoresen scoring system | Malaligment varus/valgus procurvatum/retrocurvatum internal/external rotation Range of motion flextion extension deficit pain and swelling | one year |
Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Detailed Description
-----------------
This study will also evaluate the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP

Official Title
-----------------
A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

Conditions
-----------------
Generalized Pustular Psoriasis

Intervention / Treatment
-----------------
* Biological: Imsidolimab
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment Exclusion Criteria: Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV +SC Imsidolimab<br>IV loading dose followed by subcutaneous Imsidolimab | Biological: Imsidolimab<br>* Solution for infusion Solution for injection<br>* Other names: ANB019;|
| Active Comparator: SC Imsidolimab<br>Subcutaneous Imsidolimab | Biological: Imsidolimab<br>* Solution for infusion Solution for injection<br>* Other names: ANB019;|
| Placebo Comparator: SC Placebo<br>Subcutaneous Placebo | Other: Placebo<br>* Solution for injection<br>|
| No Intervention: Standard of Care<br>Any available therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Incidence of adverse events | Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IL-36 receptor, Interluekin 36, Imsidolimab
Autonomous Syncope Onset Prediction and Prevention

Study Overview
=================
Brief Summary
-----------------
syncope prediction on tilt table

Detailed Description
-----------------
A tilt table is used to provoke syncope. syncope prediction is achieved through sensor measurements (ECG, ICG, SpO2, breathing rate, BP, NIRS, GSR, oculography).

Official Title
-----------------
Autonomous Syncope Onset Prediction and Prevention An Open-label, One-centre Pilot Study on Healthy Subjects With the Erigo Tilt Table

Conditions
-----------------
Syncope

Intervention / Treatment
-----------------
* Device: tilt table Erigo®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years


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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tilt table Erigo®<br>observation of physiological parameters, tilting table with onset of syncope | Device: tilt table Erigo®<br>* tilting table with onset of syncope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical sign of syncope | as diagnosed by the medical staff | 1 session of 90 minutes duration |
Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to non-inflammatory cytokines in women suffering from habitual abortion treated with dydrogesterone (Duphaston).

Official Title
-----------------
Oral Dydrogesterone Treatment During the First Trimester of Pregnancy in Women With Recurrent Miscarriage: A Double-Blind, Prospectively Randomized, Placebo-Controlled, Parallel Group Trial

Conditions
-----------------
Recurrent Miscarriage

Intervention / Treatment
-----------------
* Drug: Dydrogesterone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Women with a history of idiopathic recurrent miscarriage, based on a documented history of at least three spontaneous consecutive miscarriages before 20 weeks gestation with the same partner Exclusion Criteria Any verifiable cause of the recurrent miscarriages apart from luteal phase defect (e.g. systemic lupus erythematosus [SLE], infections with chlamydia or mycoplasma) Any gynecological neoplasias or anatomical abnormalities that oppose pregnancy Concurrent infertility treatment/superovulation protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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 |
| --- | --- |
| Experimental: 1<br> | Drug: Dydrogesterone<br>* 20 mg/day, oral<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine ratio IFN/IL-10 |  | 14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone |  | First trimester of pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Immunology, Unexplained recurrent miscarriage
Dermacyd Tina Gel Sweet Flower - Photo Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Sweet Flower.

Official Title
-----------------
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Tina Gel Sweet Flower.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototype Skin II and III Integral skin test in the region Exclusion Criteria: Lactation or gestation Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection Diseases which can cause immunity decrease, such as HIV, diabetes Use of drug photosensitizer History of sensitivity or irritation for topic products Active cutaneous disease which can change the study results History or photodermatosis active Family or personal antecedent of cutaneous photoinduced neoplasias Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium Intense solar exposure in the study area Use of new drugs or cosmetics during the study 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: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lactic acid (Dermacid)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type. |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hygiene
Pharmacological Modulation of Cocaine Effects - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct human laboratory studies of possible cocaine interactions with various potential treatment medications.

Official Title
-----------------
Pharmacological Modulation of Cocaine Effects

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Selegiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Selegiline|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
-----------------
cocaine dependence
Study Evaluating LXR-623 in Healthy Japanese Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of LXR-623 in healthy Japanese subjects.

Official Title
-----------------
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LXR-623 Administered Orally to Healthy Japanese Male Subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: LXR-623


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, Japanese Males aged 20-45 years Exclusion Criteria: A history or active presence of clinically important medical disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LXR-623|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  |
Characteristics of Adult Patients With Recessive Dystrophic Epidermolysis Bullosa

Study Overview
=================
Brief Summary
-----------------
Recessive dystrophic epidermolysis bullosa (RDEB) is a severe inherited blistering disease caused by the absence of type VII collagen. Patients with RDEB develop large, severely painful blisters and open wounds from minor trauma to their skin. We are screening RDEB subjects to determine additional characteristics of patients who survive to adulthood.

Official Title
-----------------
Characteristics of Adult Patients With Recessive Dystrophic Epidermolysis Bullosa

Conditions
-----------------
Epidermolysis Bullosa Dystrophica

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Clinical diagnosis of RDEB by local dermatologist. 2. 18 years of age or more and willing to give consent. Exclusion Criteria:1. Medical instability limiting ability to travel to Stanford University Medical Center.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
Inhibitors of the type 2 sodium-glucose co-transporter (iSGLT2) may improve the metabolic and hemodynamic profile in patients with DM2 and heart failure.

Official Title
-----------------
Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure. GLUCOSUR-IC Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: iSGTL2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes HbA1c> 6.5% Estimated GF> 45 ml / min BMI: ≥25 Kg / m2 Stable pharmacological treatment of Heart Failure in the last 3 months Exclusion Criteria: Diabetes type 1 or type LADA (presence of antibodies against GAD and/or IA-2 positive) DM2 with C-peptide <1 ng / mL GEF <45 ml / min Recurrent urinary tract infections

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 |
| --- | --- |
| Treatment<br>Patients with diabetes and heart failure that are treated with iSGLT2 | Drug: iSGTL2<br>* Treatment with empaglifozine 10 mg/day (may be also dapaglifozine 10mg/day depending on clinical trial results)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac biomarkers | Changes in cardiac biomarkers: NTproBNP, CA125 and ST2 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life: EuroQol-5D questionnaire (EuroQol five dimension questionnaire) | Changes in patient's quaility of life by 5Q questionnaire (EuroQol standardised, non-disease-specific instrument for health-related quality of life with 2 parts: first one score from 3-3-3-3 (worst) to 1-1-1-1 (best) and second one which a visual scale scores form 0 (worst)-100 (best). EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208. El EuroQol-5D: una alternativa sencilla para la medición de la calidad de vida relacionada con la salud en atención primaria. Aten Primaria 2001; 28:425-429.) | 12 months | 
| Improvement of pulmonary congestion | Changes in pulmonary congestion by pulmonary echocardiography | 12 months | 
| Improve in the 6-minute walk | Changes in functional capacity by the 6 minute-walk | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Diabetes, iSGLT2
Multinational Survey of Epidemiology, Morbidity, and Outcomes in Intracerebral Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The aim of this project is development of a comprehensive, prospective, multinational, multicenter, hospital-based, data repository for patients with intracerebral hemorrhage.

Detailed Description
-----------------
MNEMONICH is a disease-specific registry of prospectively collected data obtained from the integration and harmonization of preexisting single-center data sets. It was formed to provide clinician-scientists around the world a comprehensive database to direct future studies toward better understanding of ICH. MNEMONICH will help examine global variability in the prevalence of ICH and identify research priorities. New data for MNEMONICH will be prospectively collected on a wide range of features including demographics, medical history, dates and times of symptom onset, presentation symptoms, hemodynamic signs, initial and chronic medical therapy, diagnostic imaging, laboratory and genetic analyses, pathological data, and surgical and medical management. Future research will be based upon ad hoc analysis of this data.

Official Title
-----------------
Multinational Survey of Epidemiology, Morbidity, and Outcomes in Intracerebral Hemorrhage (MNEMONICH)

Conditions
-----------------
Intracerebral Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of spontaneous intracerebral hemorrhage (ICH) met by clinical and imaging criteria Age 18 and above Able to consent Exclusion Criteria: ICH due to trauma ICH due to vascular malformation or aneurysm ICH due to brain tumor ICH due to underlying infectious lesion (e.g., abscess)

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Modified Rankin Scale score |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intracerebral hemorrhage, Hemorrhagic stroke, Intraparenchymal hemorrhage, Cerebrovascular disease, Stroke