linjc16/ctgov huggingface dataset:
Prospective Cohort Study of the Body Constitution Among Type II Diabetes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
By analyzing the relationship between the body constitution and the progression of Type II diabetes mellitus, its morbidities, mortality and the impact of the life quality, we try to provide an useful tool, body constitution, to stratify the patients accordingly for individualized health care.

Detailed Description
-----------------
The study participants are recruited from the Diabetes Shared Care Network of the Taichung Veterans General Hospital (Taichung, Taiwan)

Official Title
-----------------
Prospective Cohort Study of the Body Constitution Among Type II Diabetes Mellitus Patients

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient diagnosed as Type II diabetes mellitus by Endocrinology specialist. aged from 20 to 75 years old. clear conscious, willing to join the program. Exclusion Criteria: Severe mental illness, which lead to unable to fulfill the questionaire Major surgical intervention,medical events (such as acute myocardial infarction, cerebral vascular accident...et al.,), chemotherapy or radiation therapy within past one month , which made body constitution measurement unavailable.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Type II DM body constitution<br>Type II diabetes mellitus, body constitution | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body constitution of type II diabetes mellitus patients |  | Two years follow up after being recruited | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality of type II diabetes mellitus patients |  | Two years follow up after being recruited | 
| Life quality of diabetes mellitus patients |  | Two years follow up after being recruited | 
| Diabetic retinopathy of type II diabetes mellitus patients |  | Two years follow up after being recruited | 
| Diabetic nephropathy of type II diabetes mellitus patients |  | Two years follow up after being recruited | 
| Diabetic neuropathy of type II diabetes mellitus patients |  | Two years follow up after being recruited | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Body constitution
Ergometer Training in Patients With OSA

Study Overview
=================
Brief Summary
-----------------
Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard bike ergometer which is additionally equipped with a system to gather training data and the ability to send daily training time to an internet server to which the physician has access. Training time of two groups is compared. Group one is not motivated while group two benefits from telephone feedback when training time declines. It is presumed that training time increases with better information and response to training behaviour.

Official Title
-----------------
Telemedizinisches Trainings-Monitoring Von Patienten Mit Obstruktivem Schlafapnoesyndrom

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

Intervention / Treatment
-----------------
* Behavioral: Motivation by Telephone Call


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected OSA Capable of giving consent Exclusion Criteria: Symptomatic cardial infarction Decompensated cardiac insufficiency Hemodynamically effective cardiac arrhythmias Hemodynamically significant Vitia (heart disease) Insufficiently regulated arterial hypertension Global respiratory insufficiency Significant partial insufficiency (PAO2 <50mmHg or SaO2 < 80% at rest) State after decompensation of Cor Pulmonale Right ventricular strain at pulmonary hypertension at rest (pulmonary arterial pressure > 20 mmHg) Severe osteoporosis Higher degree of lung functional restriction: FEV1 <50% oder >60% of nominal value after bronchospasmolysis Working performance on ergometer < 50% Unstable bronchial asthma Exacerbated COPD Heavily overweight (BMI >40 or weight >140kg)

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Motivation<br>Patients are asked to complete a telemonitored Ergometer training for 4 Weeks, at least 30 minutes per day, no more intervention is done. | |
| Other: Motivation<br>Patients are asked to complete a telemonitored Ergometer training for 4 Weeks, at least 30 minutes every day. If training time declines to less than 20 minutes per day for one week, a motivation phone call will take place once a week. | Behavioral: Motivation by Telephone Call<br>* Telephone call not exceeding 10 minutes according to a protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training time |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ergometer, training, motivation, telemonitoring, sleep apnea
Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.

Conditions
-----------------
Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity

Intervention / Treatment
-----------------
* Procedure: intravitreal injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion Exclusion Criteria: previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders neovascularization on the disc or elsewhere or rubeosis

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bevacizumab<br>intravitreal bevacizumab or triamcinolone determined by single physician | Procedure: intravitreal injection<br>* intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection<br>|
| Active Comparator: triamcinolone<br> | Procedure: intravitreal injection<br>* intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best corrected visual acuity |  | baseline, 1 month, 2 months, 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central macular thickness by optical coherence tomography |  | baseline, 1 month, 2 months, 3 months, 6 months 12months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab,triamcinolone, intravitreal injection
Statins and Risk of Myocardial Infarction in Real Life in France

Study Overview
=================
Brief Summary
-----------------
The main objective of this case-referent study is to assess the impact of statins usage on the risk of having a first myocardial infarction (MI) in a real life situation in France

Official Title
-----------------
Statins and Risk of Myocardial Infarction in Real Life in France

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients can speak French or English Patients can be interviewed by telephone Place of usual residence in the area of recruitment Exclusion Criteria: Patients refusing to participate in the study Patients who cannot be reached by telephone Previous history of myocardial infarction

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 |
| --- | --- |
| 1<br>Cases : Patients with a first myocardial infarction | |
| 2<br>Referents : Patients recruited by a GP during a routine consultation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the impact of the different statins (molecules) usage on the risk of having a first myocardial infarction in a real life situation in France |  | in 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the interaction between statin treatment and risk factors such as cholesterol, age, gender, tobacco, alcohol, co-prescriptions, co-morbidities |  | in 2011 | 
| Assess the populational impact of statins usage on the risk of having a first myocardial infarction |  | in 2011 | 
| Assess the risk of having a first myocardial infarction according to high and low dosages of statins |  | in 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
statins, myocardial infarction, case-referent study, France
National Cohort of Children Born to HIV-positive Mothers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide a surveillance system to monitor changes in the rate of mother to child HIV transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.

Detailed Description
-----------------
The goal of the CO11 national cohort is to provide with CO1 a wider surveillance system to monitor changes in the rate of mother to child transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs. The CO11 EPF enrolle HIV infected women who delivery in maternity generally smaller than CO1 maternity (15 sites in Paris area, 35 in mainland France and 4 in the DOM). Maternal clinical, biological and therapeutic data before and during pregnancy were collected at delivery, with simplified questionnaires. The children are examined clinically and biologically at birth, 6, 12 and 24 months.

Official Title
-----------------
ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers

Conditions
-----------------
Mother to Child Transmission of HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women >= 18 years infected with HIV1 and/or HIV2 Exclusion Criteria: guardianship or judicial or administrative detention

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

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

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 |
| --- | --- | --- |
| Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV | Number of infected children (HIV RNA >50c/mL or Positive serology) reported on the total number of children | At birth up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immuno-virological response during pregnancy | HIV ARN <50c/mL, CD4 cells count>500 cells/mL | At inclusion up to childbirth | 
| Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy | incidence of pathologies during pregnancy | At inclusion up to childbirth | 
| Impact of different kind of MTCT prophylaxis on childbirth | Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section) | At delivery | 
| Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children | Clinical abnormalities (occurrence of adverse events) | At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Pregnancy, Prevention of mother-to-child transmission
Treating Heart Failure With Enhanced External Counterpulsation (EECP)

Study Overview
=================
Brief Summary
-----------------
Enhanced external counterpulsation (EECP) is an outpatient coronary artery disease (CAD) therapy that involves the cyclical inflation/deflation of cuffs wrapped around the lower extremities. However, the possible benefits of EECP in patients with heart failure (HF) (New York Heart Association [NYHA] classes II to IV) and cardiomyopathy are unclear.

Official Title
-----------------
Treating Heart Failure With Enhanced External Counterpulsation (EECP): Prospective, Multi-centric Observational Cohort Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with heart failure (NYHA II-IV) with optimal medical therapy caused by ischemic or non-ischemic cardiomyopathy EECP-Therapy and Treatment in the Cardio Centrum Berlin or Charité - University Medicine Berlin Aged 18 to 100 years Offered patient information and written informed consent Exclusion Criteria: Participation in another interventional trial Acute coronary syndrome < 4 weeks prior to enrollment Operation < 4 weeks prior to enrollment Stroke < 4 weeks prior to enrollment Clinically significant disease with hospitalization Aortic valvular heart disease ≥ moderate Aortic aneurysm clinically relevant severe cardiopulmonal diseases Resting RR > 160/90mmHg Thrombose, Thrombophlebitis < 8 weeks prior to enrollment Peripheral artery occlusive disease ≥ Stadium II Acute Heart failure Pathological bleeding tendency Arrhythmias, which interfere with Triggering of the EECP Other diseases, that inhibit EECP-Treatment (e.g. Spinal disc herniation) Accommodation in an institution due to an official or judicial order Women: pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Systolic and diastolic heart function |  | A period of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ergometric power increase | Ergometric power increase will be measured by individuals' performance in ergometric work load. Scale is Watt. | A period of 1 year | 
| Subjective health Status - Mental Health Composite Score | Sf-12-questionnaire: value of the Mental Health Composite Score | A period of 1 year | 
| Subjective health Status - Physical Health Composite Score | Sf-12-questionnaire: value of the Physical Health Composite Score | A period of 1 year | 
| Organ complications | Relevant laboratory parameters | A period of 1 year |
Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes

Study Overview
=================
Brief Summary
-----------------
In a setting of acute cholecystitis (AC) one of the treatment option is percutaneous transhepatic cholangiography (PTHC) drainage. The goal of current study is to evaluate some radiology aspects and correlate with clinical patient outcomes in patients with acute cholecystitis severity grade III (presented as acute cholecystitis with organ dysfunction).

Official Title
-----------------
Percutaneous Drainage in a Setting of Acute Cholecystitis Severity Grade III and Correlation With Clinical Outcomes

Conditions
-----------------
Cholecystitis, Acute, Elderly Infection, Drain Abscess

Intervention / Treatment
-----------------
* Procedure: Percutaneous cholecystostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical markers of acute cholecystitis diagnosis confirmed with some imaging technique: computed tomography (CT), ultrasound (US). Exclusion Criteria: clinical diagnosis was not confirmed with imaging.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients older than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC). | Procedure: Percutaneous cholecystostomy<br>* Placement of drainage catheter into gallbladder lumen in order to evacuate inflamed content.<br>|
| Group 2<br>Patients younger than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC). | Procedure: Percutaneous cholecystostomy<br>* Placement of drainage catheter into gallbladder lumen in order to evacuate inflamed content.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein (CRP) | C-reactive protein (CRP) is a protein found in blood plasma, whose levels rise in response to inflammation. | Up to 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drainage duration (expressed in days) | The drain which is placed in gallbladder during Percutaneous transhepatic cholangiography (PTHC) remains there until resolving clinical parameters of acute cholecystitis. | Up to 16 weeks. | 
| White blood cells (WBCs) count | White blood cells (WBCs) are the cells of the immune system. During inflammation White blood cell level rise. | Up to 8 weeks. |
Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.

Official Title
-----------------
Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

Conditions
-----------------
Ischemic Stroke, Intracranial Hematoma

Intervention / Treatment
-----------------
* Other: Mechanical thrombectomy
* Other: Minimally invasive surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 Years of Age Frontline treatment with: Penumbra System for ischemic stroke patients eligible for mechanical thrombectomy or Artemis Neuro Evacuation device for intracranial hematoma evacuation in patients eligible for minimally invasive surgery (MIS) Extracted thrombus/embolus Informed consent is obtained from either the patient or legally authorized representative (LAR) Exclusion Criteria: Pregnancy or positive pregnancy test according to site routine practice (only required for women of child bearing potential; serum or urine acceptable) Currently participating in an investigational drug or device clinical trial that may confound the ability to capture clot and/or influence clot composition. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible

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 |
| --- | --- |
| Patients with ischemic stroke<br> | Other: Mechanical thrombectomy<br>* Clot specimen collection Extracranial blood collection<br>|
| Patients with intracranial hematoma<br> | Other: Minimally invasive surgery<br>* Clot specimen collection Arterial blood collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clot specimen histology | Numbers of clot specimen for histology analysis | Clot specimen obtained during procedure | 
| Blood and clot specimen transcriptomics | Numbers of blood and clot for RNA sequency | Blood and clot specimen obtained during procedure | 
| Blood and clot specimen proteomics | Numbers of blood and clot specimen for proteomic analysis | Blood and clot specimen obtained during procedure | 
| Blood and clot specimen genomics | Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs) | Blood and clot specimen obtained during procedure |