linjc16/ctgov huggingface dataset:
Effect of Aerobic Exercises and Nutrition In Adolescent Girls With Anorexia

Study Overview
=================
Brief Summary
-----------------
Randomized control study used to identify the effect of aerobic exercises on the activity of daily living and estradiol serum level in young girls with anorexia

Detailed Description
-----------------
Control group will receive diet program while the study group received the same diet program given to control group in addition to AEROBIC exercise program. Inclusive criteria Thirty girls with anorexia BMI ≤ 18 kg/m2 Age ranged from (14-17 years). Exclusive criteria: Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone. Exclude any other eating disorders Data analysis and statistical design: The collected data will be statistically treated using: Descriptive statistics. Inferential statistics using: Paired t-test.

Official Title
-----------------
Effect of Aerobic Exercises and Nutrition on The Activities of Daily Living and Estrogen Level in Adolescent Girls With Anorexia

Conditions
-----------------
Anorexia in Adolescence

Intervention / Treatment
-----------------
* Other: aerobic exercises + Diet
* Other: diet proram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thirty girls with anorexia BMI ≤ 18 kg/m2 Age ranged from (14-17 years). Exclusion Criteria: Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>DIET PROGRAM IN ADDITION TO AEROBIC EXRCISES | Other: aerobic exercises + Diet<br>* Frequency 5-6 days per week Intensity To perform moderate intensity for weight-bearing aerobic exercise Time Goal of 20-30 min per session of moderate-intensity aerobic activity per week<br>|
| Other: Group B<br>DIET PROGRAM | Other: diet proram<br>* diet program for anorexic adolescent girls<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estradiol level | blood test | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anorexia, adolescent girls, areobic exercises
Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Cancer is second leading cause of death worldwide. The psychological issues are related to all stages of the disease affecting outcome of treatment and overall quality of life. The study evaluated the effectiveness of yoga counselling among prostate cancer patients on their quality of life and psychological outcomes.

Official Title
-----------------
Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients: Randomized Control Trial

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Counselling based on yoga
* Drug: Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of Prostate Cancer Sign a consent form allowing related information to be included in this research. Exclusion Criteria: Have pre-existing diagnosed psychiatric conditions Currently taking psychotropic medications Have been diagnosed with cancer other than prostate cancer Evidence of active substance abuse.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Counselling Group<br>Yoga based psychological counselling delivered individually and in group along with conventional care | Behavioral: Counselling based on yoga<br>* Counseling sessions were given as one-on-one and group to patients based on yoga philosophy and therapy.<br>Drug: Chemotherapy<br>* Usual Care group had standard chemotherapy regimens<br>|
| Active Comparator: Usual Care Group<br>Usual care provided to patients | Drug: Chemotherapy<br>* Usual Care group had standard chemotherapy regimens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and Depression | Depression and anxiety as assessed by Hospital Anxiety Depression Scale | Change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life as assessed by WHO quality of life-BREF | Change from baseline to 12 weeks |
Vivatmo proTM EU-study: FeNO Monitoring in Asthmatic Patients Responding to ICS Treatment

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.

Detailed Description
-----------------
Subjects will be screened, enrolled and tested at Study Visit #1 and then prescribed inhaled corticosteroid (ICS) treatment as per routine clinical care. Subjects will return for Study Visit #2 in two weeks and repeat fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro,

Official Title
-----------------
Clinical Study of the Vivatmo proTM for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Diagnostic Test: FeNO measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 7 to 80 years of age. Has asthma Has been identified as a candidate for inhaled corticosteroid (ICS) treatment Is willing and able to perform Vivatmo pro™ testing Exclusion Criteria: Subject has used corticosteroids prior to enrollment. Subject has other current serious medical conditions Subject has not been clinically stable for at least 2 weeks prior to the study Subject is unwilling or unable to perform Vivatmo pro testing

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children 7 to 17<br>Children with asthma | Diagnostic Test: FeNO measurement<br>* FeNO measurement at each visit<br>|
| Adults 18 to 80<br>Adults with asthma | Diagnostic Test: FeNO measurement<br>* FeNO measurement at each visit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FeNO Value [Time Frame: 14 days] | Change in FeNO value before and after inhaled corticosteroid treatment | 14 days |
AKIN Criteria: Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft (CABG)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump CABG.

Detailed Description
-----------------
Eight hundred and seventeen patients was enrolled in this series and divided into to groups: Group AKI (-) - patients without acute kidney injury after on-pump CABG. Group AKI (+) - patients with acute kidney injury after on-pump CABG. AKI was defined as an absolute increase in serum creatinine (SCr) of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l) or a percentage increase in SCr of more than or equal to 50% (1.5-fold from baseline). The change in SCr concentration was defined as the difference between immediate postoperative concentration and the highest concentration during the stay in ICU. Clinical Outcomes and 30-day mortality was evaluate in this patients.

Official Title
-----------------
AKIN (Acute Kidney Injury Network): Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft Surgery

Conditions
-----------------
Kidney Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent on-pump coronary artery bypass grafting Patients with at least two serum creatinine values within 48 hours. Exclusion Criteria: Patients with end-stage kidney disease requiring renal replacement therapy.

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 |
| --- | --- |
| AKI (-)<br>Patients without acute kidney injury after on-pump CABG | |
| AKI (+)<br>Patients with acute kidney injury after on-pump CABG | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the hypothesis that patients with acute kidney injury after on-pump CABG have higher 30-day mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare clinical outcomes in patients with and without acute kidney injury after on-pump CABG |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Kidney failure, Clinical outcomes, On-pump, Coronary artery bypass grafting, Morbidity, Mortality
Initiation and Titration of Amaryl

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To describe the conditions of initiation and titration of Amaryl M, according to previous treatment: initial dose titration scheme efficacy after 4 months assessed by HbA1C tolerability (number and severity of hypoglycaemia) Secondary Objective: Fasting Plasma Glucose Weight evolution

Official Title
-----------------
AMIT Study - Amaryl M Initiation and Titration Study

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: GLIMEPIRIDE + METFORMIN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with Type 2 diabetes who have been treated with a stable dose (any dose) of : sulfonylurea monotherapy or metformin monotherapy or free combination of glimepiride and metformin with a stable dose (any dose) Body Mass Index (BMI) between 20 and 40 kg/m2 HbA1c superior or egal to 7.5% FPG superior or egal 7 mmol/l Exclusion criteria: Secondary or insulin-dependant diabetes Any severe chronic disease (hepatic, renal impairments) History of major cardiovascular event in the last 6 months Acute conditions with the potential to alter renal function such as: dehydratation, severe infection, shock, IV administration of iodinated contrast agents Allergy to sulfonylurea, metformin Drug or alcohol abuse Pregnancy, lactation 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: 35 Years
Maximum Age: 75 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: Single arm Glimepiride+metformin<br>Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks. | Drug: GLIMEPIRIDE + METFORMIN<br>* Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycolysated Haemoglobin (HbA1c) |  | From baseline to Month 4 | 
| Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% |  | Month 4 | 
| Evolution of Fasting Plasma Glucose (FPG) |  | From baseline to Months 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Prandial Plasma Glucose (PPPG) |  | Month 4 | 
| Number of patients for each start dose |  | At baseline | 
| Number of patients with different final doses |  | Month 4 | 
| Rate of Symptomatic Hypoglycemia |  | During treatment period (4 months) | 
| Change in Weight |  | Month 4 |
Regorafenib Treatment Patterns and Survival Outcomes in Advanced Colorectal Cancer: A Real-world Study

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, retrospective, real-world study. The purpose of this study is to observe the effectiveness and safety of regorafenib in Chinese advanced colorectal cancer patients. The main observational goals include overall survival(OS), 6 month OS rate, 1 year OS rate, and treatment time failure (TTF), other study goals include objective response rate( ORR)、Disease control rate（DCR）and adverse event(AE) of regorafenib.

Official Title
-----------------
Regorafenib Treatment Patterns and Survival Outcomes in Advanced Colorectal Cancer: A Real-world Study

Conditions
-----------------
Advanced Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with colorectal cancer confirmed by pathological tissue or cytology； The pathological type of colorectal tumor was adenocarcinoma； Patients with recurrent or metastatic, unresectable advanced colorectal cancer； Patients who received regorafenib at least one period treatment. Exclusion Criteria: Patients participating in other interventional clinical studies while taking regorafenib; Patients with other malignant tumors within 5 years before regorafenib treatment, except for cured cervical carcinoma in situ, skin squamous cell carcinoma or basal cell carcinoma, early papillary thyroid carcinoma, etc.; The investigator deems that there are other factors that are not suitable for patients who participate in this study.

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 |
| --- | --- | --- |
| 6-month Overall Survival rate | 6 months OS rate of patients who received regorafenib treatment. | 6 month | 
| 1 year Overall Survival rate | 1 year OS rate of patients who received regorafenib treatment. | 1 year | 
| overall survival | overall survival of patients who received regorafenib treatment. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | Investigator assessed according to RECIST v1.1 | 1 year | 
| Disease control rate | Investigator assessed according to RECIST v1.1 | 1 year | 
| Incidence of Adverse Events (AEs) | Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0. | 1 year |
Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study)

Study Overview
=================
Brief Summary
-----------------
This study is designed to provide long-term safety and efficacy data for the combination doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350 patients (approximately) who have successfully finished the core trial CVAH631B1303 and signed consent for the extension will be enrolled into this study.

Official Title
-----------------
A 52-week Extension to the Factorial Study to Evaluate the Efficacy and Safety of VAH631 (Valsartan and Hydrochlorothiazide Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study) -

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Valsartan + Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who successfully complete the core study (Protocol 1303) Outpatients Exclusion Criteria: Presence of crucial protocol violation in Protocol 1303 Patients who experienced any adverse events considered serious and drug related in Protocol 1303.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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 |
| --- |
|Drug: Valsartan + Hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in average sitting diastolic blood pressure after 52 weeks |  |  | 
| Change from baseline in average sitting systolic blood pressure after 52 weeks |  |  | 
| Change from baseline in average standing diastolic blood pressure after 52 weeks |  |  | 
| Change from baseline in average standing systolic blood pressure after 52 weeks |  |  | 
| Laboratory abnormalities after 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Valsartan, Hydrochlorothiazide
Mitral Valve Reconstruction in Chronic Heart Failure (CHF): Identification of Predictors for a Successful Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients with secondary mitral insufficiency and CHF. Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients. Collection of clinical factors for the assessment of the postoperative course after mitral valve reconstruction in CHF patient.

Official Title
-----------------
Mitral Valve Reconstruction in Patients With Chronic Heart Failure and Secondary Mitral Insufficiency: Identification of Predictors for a Successful Therapy

Conditions
-----------------
Mitral Insufficiency, Chronic Heart Failure

Intervention / Treatment
-----------------
* Procedure: mitral valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Dilatative Cardiomyopathy with LVEF < 35% NYHA III oder IV under maximal medical treatment Angiographic and hemodynamic MI > II° (LAP- mean pressure > 15-20 mmHg; LA v-wave-oder PCWP v-wave > 35 mmHg under exercise) Echocardiographic MI > II° At least 1 hospitalization for heart failure before OP Exclusion Criteria: Secondary Cardiomyopathy by vitium cordis Planned secondary procedure like CABG, aortic valve surgery, surgery of the tricuspid valve etc Inclusion in another trial Euro-Score > 30% Former valve operation or CABG

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Surgical mitral valve reconstruction | Procedure: mitral valve repair<br>* surgical mitral valve repair<br>|
| No Intervention: 2<br>conservative treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of clinical factors for the postoperative outcome |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHF, mitral insufficiency, conductance catheter, mitral valve repair
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fed conditions.

Official Title
-----------------
Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions

Conditions
-----------------
Bioavailability

Intervention / Treatment
-----------------
* Drug: Famotidine Tablets, 40 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men or women 18 years of age or older body mass index below 30.0 kg/m2 willing to participate and sin a copy of the informed consent form Exclusion Criteria: recent history of drug or alcohol addiction or abuse pregnant or lactating women history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant smoking more than 25 cigarettes per day

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Drug<br> | Drug: Famotidine Tablets, 40 mg<br> <br> |
| Active Comparator: Reference Drug<br> | Drug: Famotidine Tablets, 40 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioavailability, famotidine