linjc16/ctgov huggingface dataset:
Obesity Effect on Stroke and Cardiovascular Events

Study Overview
=================
Brief Summary
-----------------
The relation between obesity and stroke recurrence is still under debate. In this study it has been sought whether baseline obesity is associated with recurrent stroke and major cardiovascular events in a long-time period.

Detailed Description
-----------------
Five-years follow-up data of Ege Stroke Registry for stroke recurrence and cardiovascular events regarding to obesity were analyzed. Data include age, gender, stroke severity, neuroimaging studies, cardiovascular risk factors. Within the inclusion period, all of the included patients were followed until censoring (10th of December 2011) or readmission because of recurrent stroke, cardiovascular event or death, whichever came first. The Kaplan-Meier method was used for survival analysis. Cox proportional hazard model was applied to identify predictors of recurrent vascular events.

Official Title
-----------------
OBESITY ASSOCIATION WITH RECURRENT STROKE AND CARDIOVASCULAR EVENTS

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Diagnostic Test: Obesity assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive stroke patients. Exclusion Criteria: Incomplete baseline information, other factors making them unsuitable for follow-up,undetermined stroke, subarachnoid hemorrhage.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 obesity<br>Obesity in those with BMI ≥30 kg/m2 | Diagnostic Test: Obesity assessment<br>* Body mass index (BMI (kg/m2) was calculated from measurements of weight to the nearest kg and height<br>|
| Patients without obesity<br>Normal weight was considered in the patients with BMI <30 kg/m2 | Diagnostic Test: Obesity assessment<br>* Body mass index (BMI (kg/m2) was calculated from measurements of weight to the nearest kg and height<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke recurrence | Ischemic or hemorrhagic stroke | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, recurrent stroke, ischemic stroke, hemorrhagic stroke, cardiovascular events, vascular death
Risk Factors Analysis for Acute Myocardial Infarction Patients

Study Overview
=================
Brief Summary
-----------------
ECMO has been used to save the lives of many critically ill patients with cardiorespiratory dysfunction as important rescue therapy. Though the proportion of ECMO applied to this population has been increasing year by year, clinical outcomes of AMI remain poor with high in-hospital mortality. Thus, it is necessary to characterize clinical features and investigate potentially modifiable factors contributing to outcomes of AMI patients who received ECMO treatment.

Official Title
-----------------
Clinical Features and Risk Factors Analysis for Acute Myocardial Infarction Patients Received ECMO

Conditions
-----------------
AMI - Acute Mesenteric Ischemia, Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment
-----------------
* Other: Not application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Alzheimer's Disease Age more than 18 Exclusion Criteria: Life expectancy <1 year Prolonged cardiac arrest before VA-ECMO therapy (>60 min) Iatrogenic myocardial infarction secondary to a percutaneous coronary intervention VA-ECMO implanted in another center before admission

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survival<br> | Other: Not application<br>* Not application<br>|
| Death<br> | Other: Not application<br>* Not application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Survival information from ICU entry to ICU exit | 1 month |
Study of Antenatal Model to Prevent Preterm Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether antenatal model in vaginosis are effective in preventing vaginal infection and preterm delivery

Detailed Description
-----------------
The standard antenatal care nowadays can not answer for preterm delivery problems. Thus, comprehensive and proactive approach is needed for preventing preterm delivery. This antenatal model is consisted of midwife training, early detection of bacterial vaginosis, pregnant women campaign and self administered pH check

Official Title
-----------------
Study of Antenatal Model to Prevent Preterm Delivery: Early Detection and Treatment of Bacterial Vaginosis

Conditions
-----------------
Preterm Delivery, Pregnant Women, Antenatal Care Model

Intervention / Treatment
-----------------
* Behavioral: antenatal model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14- 18 week gestation pregnant women with or without any vaginal discharge singleton pregnancy, without any fetal or uterine anomaly Exclusion Criteria: Any complication in pregnancy Any history of disease in pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Antenatal model<br> | Behavioral: antenatal model<br>* Antenatal model is consisted of integrated efforts to lower preterm delivery rate through early detection and bacterial vaginal infection treatment: Midwife training Pregnant women campaigning Early detection with self pH detection Treatment of bacterial vaginosis<br>* Other names: antenatal care model;|
| Experimental: Antenatal Model<br> | Behavioral: antenatal model<br>* Antenatal model is consisted of integrated efforts to lower preterm delivery rate through early detection and bacterial vaginal infection treatment: Midwife training Pregnant women campaigning Early detection with self pH detection Treatment of bacterial vaginosis<br>* Other names: antenatal care model;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all preterm delivery |  | 37 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge of midwife about preterm |  | one year |
Study of Tomotherapy in Patients With Benign Brain Tumour

Study Overview
=================
Brief Summary
-----------------
Although malignant brain tumors are the most common type of primary brain tumor, there are a number of other benign brain tumors that exist. Many difficulties exist with treating these tumors that have led to controversies in the best treatment. A common issue among these brain tumors is the risk of long term side effects from treatment. What limits the use of curative radiation therapy is the ability to deliver a maximal dose to the tumor while minimizing the amount of radiation to the normal structures in the brain. A new method of delivering radiation, called tomotherapy, has been acquired at the Cross Cancer Institute (CCI) and will be used in this study. It has the ability to deliver a high dose of radiation to the tumor while minimizing the amount of radiation to normal brain structures. This study will use this method of radiation therapy to deliver radiation and see if the long term side effects from radiation therapy can be reduced.

Official Title
-----------------
A Phase I Study of Tomotherapy in Patients With Benign Brain Tumour

Conditions
-----------------
Brain Neoplasms

Intervention / Treatment
-----------------
* Procedure: Tomotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologically confirmed newly diagnosed base of skull benign tumour Karnofsky Performance Status (KPS) equal to or greater than 70 Exclusion Criteria: Brain metastases or recurrent tumour Prior radiotherapy (RT) to head or neck No prior chemotherapy or radiosensitizer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- |
|Procedure: Tomotherapy|3T MRS scans (3T magnetic resonance spectroscopy)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and adverse effects |  | Trial Completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy and survival |  | Trial completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiotherapy, brain
Observational Study to Evaluate Safety, Efficacy and Convenience of Using NovoMix® 30 FlexPen® in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to evaluate safety, efficacy and convenience in using NovoMix® 30 FlexPen® in type 2 diabetes under normal clinical practice conditions.

Official Title
-----------------
A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix® 30 FlexPen® as Monotherapy, or in Combination With OHA, in Treatment of Type 2 Diabetic Patients in Routine Clinical Practice: A Post-Marketing Surveillance Study

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with type 2 diabetes, not adequately controlled on their current therapy, who were prescribed NovoMix® 30 FlexPen® as monotherapy, or in combination with OHA, in accordance with the approved labeling, are eligible for the survey.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* No intervention is done. For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation<br>* Other names: NovoMix® 30;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | after 12 weeks of therapy | 
| Change in post-prandial glucose (PPG) |  | after 12 weeks of therapy | 
| Change in fasting plasma glucose (FPG) |  | after 12 weeks of therapy | 
| Change in prandial glucose increment (PGI) |  | after 12 weeks of therapy | 
| Incidence of hypoglycaemia and other adverse drug reaction |  | after 12 weeks of therapy | 
| Patient and doctor's convenience |  | after 12 weeks of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of different patient profiles to NovoMix 30 therapy and patient profiles considered eligible for insulin treatment in physicians' routine clinical practice |  | For the duration of the study | 
| Patient satisfaction on devices |  | after 12 weeks of treatment |
Anti-Mullerian Hormone Changes After Laparoscopic Ovarian Cystectomy for Endometrioma Compared With the Non-ovarian Conditions

Study Overview
=================
Brief Summary
-----------------
This aim of the study is to evaluate the impact of endometrioma and laparoscopic cystectomy on ovarian reserve as measured by serum antimullerian hormone and to study the different effects of levels of serum antimullerian hormone between laparoscopic cystectomy and the non-ovarian pelvic surgery.

Conditions
-----------------
Ovarian Reserve

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Participants must be between the ages of 18 - 45 during enter the study . Every participants have to completely understand the process of this study and have written informed consent . Having regular menstrual cycles (21-35 days) at the time of operation no evidence of any other endocrine disorders such as diabetes mellitus, thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, or adrenal insufficiency. undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery for benign pelvic disease No previous history of adnexal surgery No any suspicious findings of malignant ovarian diseases Never taking any medication such as oral pill and hormonal drugs within 3 months before the enrollment. pathological diagnosis of excised ovarian tissue confirm as endometriotic cyst in study group and other benign pelvic disease in control group Exclusion Criteria: polycystic ovarian syndrome according to the Rotterdam criteria pathological report as the malignant diseases have operation conversion to open-laparotomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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 |
| --- | --- |
| laparoscopic ovarian cystectomy<br>the group who laparoscopic ovarian cystectomy are performed for endometrioma | |
| laparoscopic non- ovarian pelvic surgery<br>the group whom laparoscopic non- ovarian pelvic surgery are performed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum AMH levels |  | 6 months |
An Evaluation of a Marketed Lubricated Eye Drop in Soft Contact Lens Wearers Who Experience Ocular Dryness

Study Overview
=================
Brief Summary
-----------------
Study to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.

Detailed Description
-----------------
The objective of this study is to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.

Official Title
-----------------
An Evaluation of a Marketed Lubricated Eye Drop in Soft Contact Lens Wearers Who Experience Ocular Dryness

Conditions
-----------------
Contact Lens Wear

Intervention / Treatment
-----------------
* Other: FID 112903


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal eyes Exclusion Criteria: Topical ocular medication use Unstable or active ocular issues

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 FID 112903<br>FID 112903 | Other: FID 112903<br>* lubricant eye drop FID 112903<br>* Other names: Systane Ultra;|
| No Intervention: No Intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp |  | 14 Days | 
| Visual Acuity |  | 14 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact lens wear, lubricant eye drops
Comparative Bioavailability Study of UDCA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.

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

Intervention / Treatment
-----------------
* Drug: Ursodiol
* Drug: URSO Forte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≥ 19.0 and ≤ 30.0 kg/m2. No clinically significant findings in a 12-lead electrocardiogram (ECG) Be informed of the nature of the study and give written consent prior to any study procedure Exclusion Criteria: Known history or presence of any clinically significant medical condition Participated in a clinical trial which involved administration of an investigational medicinal product within 30 days prior to drug administration, or recently participated in a clinical investigation that, in the opinion of the investigator, would jeopardize subject safety or the integrity of the study results

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AB<br>Ursodiol followed by URSO Forte | Drug: Ursodiol<br> <br> Drug: URSO Forte<br> <br> |
| Experimental: BA<br>URSO Forte followed by Ursodiol | Drug: Ursodiol<br> <br> Drug: URSO Forte<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | 72 hours | 
| Cmax |  | 72 hours |
Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

Study Overview
=================
Brief Summary
-----------------
The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.

Official Title
-----------------
Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

Conditions
-----------------
Stoma Ileostomy

Intervention / Treatment
-----------------
* Other: test patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have intact skin on the area used in the evaluation Have an abdominal area accessible for application of test product (assessed by investigator) Negative pregnancy test for fertile women Signed document claiming use of safe contraceptives for fertile women Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemo-therapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peristomal- or abdominal area (assessed by investigator) Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test patch<br>two adhesive patches are applied to the abdominal area | Other: test patch<br>* the test patch consists of an adhesive patch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance (Moisture in the adhesive) | moisture in adhesive is measured using a measurement probe | 3 days |