linjc16/ctgov huggingface dataset:
Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder

Conditions
-----------------
Body Weight Change, Schizophrenia, Schizoaffective Disorder, Psychotic Disorder

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aripiprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of metabolic laboratory measures |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient weight change, changes in metabolic status
Evening Primrose Oil Efficacy in Second Trimester Abortion

Study Overview
=================
Brief Summary
-----------------
efficacy of evening primrose oil in shortening the duration of induction in 2nd trimesteric missed abortion

Official Title
-----------------
Effect of Adding Evening Primrose Oil to Misoprostol in Second Trimester Abortion

Conditions
-----------------
Missed Abortion

Intervention / Treatment
-----------------
* Drug: Evening primrose oil(EPO)
* Drug: Placebo - Cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparous women Exclusion Criteria: Previous uterine incision( Cs, myomectomy,) Contraindications to medical or surgical uterine evacuations (eg, hemodynamically unstable, coagulopathy) Evidence of intra-uterine infection Rupture of fetal membranes. Intrauterine device in place. Allergy to prostaglandins or EPO

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Evening primrose oil<br> | Drug: Evening primrose oil(EPO)<br>* primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of EPO( 1000mg) in addition to misopristol<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo - Cap<br>* primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of placebo in addition to misopristol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of medical induction of abortion | time needed for complete expulsion of fetus and placenta | up to 1 week |
Hip Prosthesis Components Position

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is

Official Title
-----------------
Influence of Use of Intraoperative Fluoroscopy on the Hip Prosthesis Components Position

Conditions
-----------------
Hip Arthrosis

Intervention / Treatment
-----------------
* Diagnostic Test: Intraoperative fluoroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for hip replacement surgery Exclusion Criteria: pregnancy abnormal anatomy (hip dysplasia, fracture) previous srgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hip Prosthesis with intraoperative fluoroscopy<br> | Diagnostic Test: Intraoperative fluoroscopy<br>* Impantation of hip prosthesis with intraoperative fluoroscopy<br>|
| No Intervention: Hip Prosthesis without intraoperative fluoroscopy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthesis cup position | inclination, anteversion, centre of rotation of the prosthesis cup. Measurement will be made on post x-rays | Day 1 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthesis steam position | Leg length, total offset of the hip prosthesis. Measurement will be made on post x-rays | Day 1 after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip prosthesis, center of rotation, offset
Comparison Study of BNP and Thoracic Impedance Measurements on Arrhythmias

Study Overview
=================
Brief Summary
-----------------
It is hypothesized that elevated BNP level correlate with an elevated thoracic impedance/fluid index as measured separately by CRT-D devices and external impedance cardiography. Ultimately, it is also hypothesized that both BNP and thoracic impedance/fluid index measurements are predictive of atrial and ventricular arrhythmias.

Detailed Description
-----------------
The primary aim of this study: To assess the correlation between elevated brain natriuretic peptide levels and elevated thoracic impedance/body fluid index as measured by selective biventricular resynchronization devices and an external impedance cardiography device. Correlate impedance measurements and brain natriuretic levels with occurrence of atrial and ventricular arrhythmias as assessed by interrogation of biventricular devices.

Official Title
-----------------
Does Elevated Brain Natriuretic Peptide (BNP) Reflect Changes in Thoracic Impedance Levels and Affect Occurrence of Atrial and Ventricular Arrhythmias?

Conditions
-----------------
Heart Failure, Arrhythmias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between 18 to 85 years of age. All patients with biventricular implantable cardio-defibrillators(manufacturer: Medtronic/ model: InSync 7299/7297 or newer). LVEF <35% NYHA III/IV QRS >120 msec Pt willing and able to sign informed consent. Conventional heart failure therapy Clinically stable for six months. Exclusion Criteria: age less than 18 years of age age greater than 85 years of age Creatinine > 2.5 mg/dl. End stage liver disease complicated by ascites as determined by electronic medical record review. women who are pregnant, lactating, or plan to become pregnant during the course of the study. Patients who are heart transplant candidates with expected transplantation within the next six months. Life expectancy due to non-cardiac cause less than one year. Anticipated problem with compliance. Critical valvular stenoses/insufficiencies. Morbidly obese patients(>300 lbs.) In patients whom impedance cardiography was not able to be performed because of inability to place sensors. Planned or known need for revascularization procedures within three months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHF, CRT, Atrial Arrhythmias, Ventricular Arrhythmias, BioZ, Optivol
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively evaluate a scoring system to predict a mild course of disease in patients newly diagnosed with Crohn's disease.

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Other: This study will evaluate a new clinical scoring system in patients receiving routine treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with Crohn's disease who have been newly diagnosed (initial diagnosis not more than 6 weeks previously) and are as yet untreated (permitted medications are a maximum of 10 days of 5-aminosalicylates (5-ASA) or glucocorticosteroids and antibiotics for non-intestinal indications) and have consented to the documentation of their patient data and agree to the up to 5-year documentation of the course of disease Exclusion Criteria: Pre-treatment with 5-ASA > 10 days Treatment with steroids > 10 days Treatment with antibiotics, immunosuppressants or biological agents > 10 days

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 newly diagnosed with Crohn's disease<br>This study will evaluate a new clinical scoring system in patients receiving routine treatment | Other: This study will evaluate a new clinical scoring system in patients receiving routine treatment<br>* Treatment for Crohn's disease will be performed routinely based on the treating physicians clinical determination and patients' needs.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of a Crohn's scoring system | Measured as percentage of patients with a low score at initial diagnosis having a mild course of disease during the 5 year follow-up period. | Up to 5 years |
Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?

Study Overview
=================
Brief Summary
-----------------
Does pre-operative administration of Sildenafil (Viagra, Pfizer) reduce the lung injury associated with cardiopulmonary bypass in children undergoing corrective surgical repair of congenital heart disease.

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study of the Pre-Operative Effect of Sildenafil Citrate on Pulmonary Related Complications Following Cardiopulmonary Bypass in Children Undergoing Cardiac Surgical Repair.

Conditions
-----------------
Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Drug: Sildenafil Citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paediatric patients undergoing open heart surgery utilising cardiopulmonary bypass to correct acyanotic congenital heart disease. Age > 3 months Parents that show a good understanding of their child's condition and are happy for their child to participate in the study. Exclusion Criteria: Patients with known organ dysfunction prior to surgery (pulmonary, renal or hepatic) Communication barrier resulting in poor basic comprehension of the proposed study (e.g. language barrier) Patients with cyanotic heart disease Patients undergoing heart surgery without the use of cardiopulmonary bypass Patients who do not tolerate oral Sildenafil (e.g. Vomiting) or whose surgery is subsequently cancelled.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 5 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sildenafil Citrate|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
-----------------
Sildenafil Citrate, Cardiopulmonary bypass, Open heart surgery
Provider and Peer Delivered Youth Smoking Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents.

Detailed Description
-----------------
The majority of adolescent smokers are interested in quitting and have attempted to stop with limited success. A recent review of cessation trials for adolescents has concluded that there are no proven programs to help teens stop smoking, but suggested interventions based on cognitive behavioral therapy and sensitive to stages of change appear promising. The American Academy of Pediatrics suggests that pediatricians are well-positioned to intervene with adolescent smokers, as well as with nonsmokers to prevent initiation. A comprehensive, practice-based smoking prevention and cessation intervention for adolescents delivered by pediatric providers and peer counselors in the context of routine care has the potential for assisting nonsmoking adolescents in remaining smoke-free and smoking adolescents to quit.

Official Title
-----------------
Provider and Peer Delivered Youth Smoking Intervention

Conditions
-----------------
Tobacco Dependence

Intervention / Treatment
-----------------
* Behavioral: Pediatric Practice-Based Smoking Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 13 to 17, regardless of smoking status Scheduled for routine or acute care office visit Parental consent and youth assent Exclusion Criteria: Unable to complete study requirements

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

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

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Pediatric Practice-Based Smoking Intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence from smoking in the past 30 days at 6 months and 1 year |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric practice, Smoking cessation, Smoking prevention, Adolescents
Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial ﬁbrillation can reduce atrial ﬁbrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.

Official Title
-----------------
Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation

Conditions
-----------------
Persistent or Long-standing Persistent Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Control intervention
* Procedure: Experimental intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained >7 days or >12 months, respectively) Age ≥18 and ≤80 years Indication for AF ablation as per current guidelines Exclusion Criteria: Missing informed consent LAA diameter >25mm 10mm distant from circumflex artery assessed by TEE Paroxysmal atrial ﬁbrillation Long-standing persistent atrial ﬁbrillation with a continuous AF duration of >4 years Previous pulmonary vein isolation or MAZE surgery Previous led atrial appendage closure or surgical excision Left atrial diameter >60 mm at baseline Left atrial thrombus at baseline

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone | Procedure: Control intervention<br>* patients treated with balloon-based ablation of AF by PVI<br>* Other names: Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone;|
| Experimental: Group 2<br>Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation | Procedure: Experimental intervention<br>* patients treated with balloon-based ablation of AF by PVI<br>* Other names: Experimental: Group 2 Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until any documented episode of ATa | Time until any documented episode of atrial tachyarrhythmia (ATa: atrial fibrillation or atrial tachycardia) lasting longer than 30 seconds within 3-12 months after index ablation without antiarrhythmic therapy | 3 - 12 months |
The Investigation of the Mechanism of Cachexia Occurrence for Patients With Gastrointestinal Cancer

Study Overview
=================
Brief Summary
-----------------
The study is going to recruit patients with gastrointestinal cancer, collect clinical data and peripheral blood sample and possible fat samples. The expression of SIRT-6 in peripheral blood will be tested and connect with different status of cachexia of the patients. A mathematical model of the relationship between cachexia classification and SIRT-6 expression is going to constructed as anticipated.

Detailed Description
-----------------
At the start of cancer develop, not all patients with gastrointestinal cancer manifest cachexia, it may be associated with SIRT-6 expression. This study will collect and test the peripheral blood sample of patients, use it as an important indicator of the degree of cachexia, and provide references for clinical drug intervention, prognosis and dietary intervention for cachexia patients. If possible, fat sample of the patients will be collected during surgery, and the adipose progenitor cells will be cultured to find the key target proteins by detecting differences in protein expression, changes in protein modification levels, and protein interactions.

Official Title
-----------------
The Investigation of the Mechanism of Cachexia Occurrence for Patients With Gastrointestinal Cancer

Conditions
-----------------
Cachexia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 90 years old, unlimited gender; Patients who are diagnosed with gastrointestinal cancer for the first time and are planning to undergo further treatment; Volunteer to participate and sign the informed consent form. Exclusion Criteria: Women who are pregnant or lactate; Patients with severe metabolic diseases; combined with cardiac function, liver and kidney dysfunction, acute myocardial infarction and acute stroke in the past 3 months , COPD acute onset respiratory failure and other serious medical diseases and patients who need hormone therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| cachexia<br>patients suffering from cachexia recently | |
| no cachexia<br>patients are not suffering from cachexia recently | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIRT-6 expression | SIRT-6 expression tested by ELISA | 4 months |