linjc16/ctgov huggingface dataset:
Energy Homeostasis Under Treatment With Atypical Antipsychotics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of different atypical antipsychotics on weight changes, energy homeostasis, metabolism, energy intake as well as activity. Patients with schizophrenia or schizoaffective disorders will be randomly assigned to be treated with ziprasidone or olanzapine for 24 weeks. Primary outcome parameter are the weight changes after 24 weeks.

Official Title
-----------------
Energy Homeostasis and Metabolism in Patients With Schizophrenic Disorders Under Treatment With Atypical Antipsychotics

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: olanzapine
* Drug: Ziprasidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia or related disorders(DSM-IV) Indication for long-term treatment with antipsychotics BMI between 20 to 30 Weight changes less than 3kg in the last 3 months before inclusion Informed consent Exclusion Criteria: Psychiatric comorbidity Depot antipsychotic in the last 2 months Antipsychotics in the last 2 weeks Treatment with olanzapine, clozapine or ziprasidone in teh last 3 months Treatment with drugs, that may lead to weight changes Significant endocrine, neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests Female subjects during pregnancy and breastfeeding Female subjects within childbearing years who were not using adequate birth control Patients who are judged by the investigator to be at serious suicide risk

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Active Comparator: Olanzapine<br> | Drug: olanzapine<br>* treatment with either Olanzapine or Ziprasidone<br>* Other names: Zyprexa;|
| Active Comparator: Zpirasidone<br> | Drug: Ziprasidone<br>* treatment with either Olanzapine or Ziprasidone<br>* Other names: Zeldox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment |  | during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in energy homeostasis, food intake, metabolism |  | during and after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight gain, schizophrenia, atypical antipsychotics
Effect of Mantra on Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Mantras are specialized energized sound or words, which are defined most important sound therapy in Vedic healing. Present study was undertaken to evaluate the immediate effect of specialized Mantra chant on cardiovascular parameters in high blood pressure patients.

Official Title
-----------------
Immediate Effect of Mantra Chikitsa on Cardiovascular Parameters in Hypertensive Patients

Conditions
-----------------
High Blood Pressure

Intervention / Treatment
-----------------
* Other: Mantra Chikitsa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed and stable hypertension on regular medication Exclusion Criteria: Individuals diagnosed with another lung disease, Have psychiatric, musculoskeletal or cardiovascular diseases, Being smokers Being pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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: Mantra Chikitsa<br>Mantra chanting for 15 mins | Other: Mantra Chikitsa<br>* Specific Mantra were given to chants for 15 mins and resting in the impact of chants for following 15 mins.<br>* Other names: Mantra therapy;|
| No Intervention: Wait list control<br>Rest for 15 Mins | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure |  | Change from baseline to half an hour | 
| Diastolic Blood Pressure |  | Change from baseline to half an hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supine heart rate (HR) |  | Change from baseline to half an hour |
Study of Comparison Between Pentacam and locs3

Study Overview
=================
Brief Summary
-----------------
Hypothesis: There is no difference between pentacam scheimpflug system and locs3 in grading of cataract. Major aims: research the efficiency of pentacam scheimpflug system in lens density measurment. To compare the pentacam with the locs3 in grading of cataract.

Official Title
-----------------
Comparison Between Pentacam Scheimpflug System and locs3 in Grading of Cataract

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cataract patient age>18 Exclusion Criteria: pregnant women any disease of the eye except for cataract patients who are ineligible by law to take decisions by themselves.patients who have a custodian.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, locs3, pentacam
Cross Linking for Treatment of Corneal Infection

Study Overview
=================
Brief Summary
-----------------
This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.

Official Title
-----------------
A Prospective Randomized Double-masked Evaluation of Treatment Duration of the UVX System for Treating Infectious Keratitis

Conditions
-----------------
Infectious Keratitis

Intervention / Treatment
-----------------
* Drug: riboflavin
* Device: UVX Light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of infectious keratitis Exclusion Criteria: corneal ulcer that has perforated corneal ulcer that has produced a descemetocele women who are pregnant or breastfeeding patients who are immunocompromised or unwilling or unable to comply with a medication regimen

Ages Eligible for Study
-----------------
Minimum Age: 14 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 30 minute light duration<br>30 minute treatment with UVX light | Drug: riboflavin<br>* riboflavin 0.1% is applied every 2 minutes for 30 minutes<br>Device: UVX Light<br>* UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%<br>|
| Active Comparator: 45 minute light duration<br>45 minute treatment with UVX light | Device: UVX Light<br>* UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Re-epithelialization |  | Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Resolution of Stromal Infiltration |  | day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infectious keratitis, cross linking, corneal ulcer, corneal infection, collagen cross linking
Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.

Official Title
-----------------
An Open-label, Long-term Extension Study of Lanthanum Carbonate 750 to 2,250 mg in Hyperphosphatemia in Patients With Chronic Kidney Disease Not on Dialysis (52 Weeks Extension From Study 14817)

Conditions
-----------------
Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study). Exclusion Criteria: Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)<br>* Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events |  | baseline to Week 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long-term study in Chronic Kidney Disease, Lanthanum Carbonate
The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes

Official Title
-----------------
The Role of Aldosterone in Diabetes Related Vascular Disease, a New Therapeutic Target?

Conditions
-----------------
Endothelial Dysfunction, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: Eplerenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed diabetic < 5 Yrs. BMI < 32 kg/m2 Non-smoking Blood pressure < 140/90 mmHg (treatment with maximum of two antihypertensive drugs) Exclusion Criteria: Insulin treatment Hypertension (>140/90 mmHg) Sequelae to diabetes Smoking Known chronic diseases Pregnancy or birth within 3 month Alcohol misuse

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Type 2 Diabetes<br>8 weeks of treatment with Aldosterone blocker Eplerenone | Drug: Eplerenone<br> <br> |
| Experimental: Healthy<br>8 weeks of treatment with Aldosterone blocker Eplerenone | Drug: Eplerenone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function | Femoral arterial blood flow in response to femoral arterially infused ACh | 8 weeks | 
| Insulin sensitivity measured by a insulin clamp | Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function | Microperfusion performed on blood vessels in vitro obtained from muscle biopsies | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endothelial dysfunction, Insulin resistance, Type 2 diabetes, Mineralocorticoid blocker
Effects of Somatostatin on ADPKD Heart

Study Overview
=================
Brief Summary
-----------------
Autosomal dominant polycystic kidney disease (ADPKD) is associated with early onset hypertension and left ventricular (LV) hypertrophy. Since LV hypertrophy is associated with LV diastolic function impairment, we aimed to assess the changes over time of LV diastolic function in ADPKD patients and whether they were affected by the treatment with the somatostatin analogue, octreotide. 35 ADPKD patients (14 males) aged 34±8 years (mean glomerular filtration rate 82±26 mL/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and echocardiography parameters were evaluated at baseline and study end. LV mass (M) and ejection fraction (EF) were calculated according to Devereux formula and biplane Simpson's algorithm, respectively. LV filling was assessed by mitral and pulmonary vein flow velocity curves and mitral annulus early diastolic velocity peak (Ea) by tissue Doppler imaging.

Official Title
-----------------
EFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDY

Conditions
-----------------
Autosomal Dominant Polycystic Kidney Disease, Glomerular Filtration Rate > 40 ml/Min

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of autosomal dominant polycystic kidney disease glomerular filtration rate grater than 40 ml/min Exclusion Criteria: diabetes mellitus proteinuria greater than 1 g/24 hours significant glomerular disease urinary tract lithiasis and infections symptomatic gallstones biliary sludge cancer pregnant women lactanting women

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCTEOTRIDE<br>Octeotride, 20 mg monthly intramuscular injection for 3 years | Drug: Octeotride<br> <br> |
| Placebo Comparator: PLACEBO<br>Placebo (salin soluction), intramuscular injection monthly for 3 years | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION | To assess the changes over time of left ventricular dyastolic function in ADPKD patients and whether they were affected by the treatment with the somatostatin analogue, octreotide | 3 years |
When and How to Administer Oxytocin for Active Management of Third Stage of Labour

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).

Detailed Description
-----------------
Our objective is to determine the most efficient route and timing of oxytocin administration by measuring the duration of third stage of labour, quantitative blood during the first hour after delivery and comparing haemoglobin and haematocrit changes and the need for additional interventions in patients who had either a spontaneous labour or received labour augmentation with oxytocin.

Official Title
-----------------
When and How to Administer Oxytocin for Active Management of Third Stage of Labour

Conditions
-----------------
Postpartum Bleeding

Intervention / Treatment
-----------------
* Drug: intravenous & intramuscular oxytocin
* Procedure: after delivery of the fetus & when anterior shoulder seen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having a singleton pregnancy above 37th gestational week normal live vaginal delivery with cephalic presentation being in active labor Exclusion Criteria: Fetal demise multiple pregnancy known coagulation disorder presentation anomalies placental pathology liver disease thrombocytopenia hypertension or being currently on anticoagulants having a cesarean section, operative delivery or deep vaginal tear chorioamnionitis developing HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count) or DIC (disseminated intravascular coagulation) before delivery
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous & intramuscular oxytocin<br>intravenous or intramuscular 10 iu oxytocin | Procedure: after delivery of the fetus & when anterior shoulder seen<br>* oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered<br>|
| Active Comparator: after delivery & when anterior shoulder seen<br>oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered | Drug: intravenous & intramuscular oxytocin<br>* intravenous or intramuscular 10 iu oxytocin<br>* Other names: Postuitrin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postpartum bleeding in the third stage of labour |  | participants will be followed for the duration of hospital stay, an expected average of 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxytocin, Active Management of Third Stage of Labour
German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany

Study Overview
=================
Brief Summary
-----------------
The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany

Detailed Description
-----------------
The aim of this retrospective, multi-center analysis is to use individual patient data to determine the extent of the variability in LDL-C reduction in response to inclisiran administration in a real-world setting.

Official Title
-----------------
German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany

Conditions
-----------------
Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with elevated LDL-C levels (hypercholesterolemia) on stable lipid-lowering drugs for at least one month prior to the application of the siRNA Inclisiran patients 18 years and older Exclusion Criteria: - patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.
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 elevated LDL-cholesterol (hypercholesterolemia)<br>Application of si RNA Inclisiran to reduce serum LDL-cholesterol levels. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C change | LDL-C change in mg/dL / mmol/L | 3 months, 6 months, 12 months, 24 months |