linjc16/ctgov huggingface dataset:
Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
A phase 3 study to evaluate efficacy and safety of AGSAVI

Detailed Description
-----------------
A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of AGSAVI for Inadequately Controlled with AGLS

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS

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

Intervention / Treatment
-----------------
* Drug: AGSAVI
* Drug: AGLS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension patient who satisfied below condition at Visit 1. patient who takes antihypertensive drug 140mmHg <= sitSBP <= 200mmHg patient who doesn't take antihypertensive drug 160mmHg <= sitSBP <= 200mmHg Hypertension patient who satisfied below condition at Visit 2. 140mmHg <= sitSBP <= 200mmHg at Visit 2 130mmHg <= sitSBP <= 200mmHg at Visit 2(In high-risk patients) Exclusion Criteria: Patient who have received 4 or more antihypertensive drug Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 2 times of BP measuring at Visit 1 Patient with sitDBP >= 120mmHg at Visit 1 or 2 Patient with secondary hypertension

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment<br>AGSAVI | Drug: AGSAVI<br>* S-amlodipine, Valsartan, Indapamide<br>* Other names: S-amlodipine, Valsartan, Indapamide;|
| Active Comparator: Reference<br>AGLS | Drug: AGLS<br>* S-amlodipine, Valsartan<br>* Other names: S-amlodipine, Valsartan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitSBP at week 10 |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting diastolic blood pressure at week 4 and week 10 |  | week 4 and week 10 | 
| Change from baseline in sitting systolic blood pressure at week 4 |  | week 4 | 
| •Proportion of subjects achieving Blood Pressure control |  | week 4 and week 10 |
Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which of the following drugs: enoxaparin, dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).

Official Title
-----------------
Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.

Conditions
-----------------
Hip Osteoarthritis, Blood Loss

Intervention / Treatment
-----------------
* Drug: Enoxaparin
* Drug: rivaroxaban
* Drug: dabigatran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary, end-stage hip osteoarthritis requiring total hip arthroplasty Exclusion Criteria: inflammatory arthropathies liver disorders neoplastic conditions clotting disorders

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enoxaparin<br>enoxaparin 40mg 1x1 s.c. daily, once preoperatively and then daily for 28 days | Drug: Enoxaparin<br> <br> |
| Experimental: rivaroxaban<br>rivaroxaban 10 mg 1x1 p.o. daily for 28 days after the surgery | Drug: rivaroxaban<br> <br> |
| Experimental: dabigatran<br>dabigatran 110 mg 1x1 p.o. postoperatively and then 1x2 p.o. for 27 days after the surgery | Drug: dabigatran<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood loss by the 3rd postoperative day | Measured for each individual. Measured according to the formula described by Nadler, Hidalgo and Bloch (Prediction of blood volume in normal human adults. Surgery 1962;51:224-32). | 3rd day postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop in the haemoglobin value between 3rd day postop and preoperative | Difference between haemoglobin on the 3rd postopertive day and day before operation | 3rd day postopertively | 
| Wound healing disturbances according to the definition of Centers for Disease Control and Prevention | Wound healing disturbances - diagnosis to be made according to the definition of Centers for Disease Control and Prevention (Mangram, Horan, Pearson, Silver and Jarvis. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78) | 3 months postoperatively |
Physiological Responses in Tobacco Chippers

Study Overview
=================
Brief Summary
-----------------
This study will analyze a series of biological and behavioral markers in different populations of smokers. The study groups will differ in their cigarette consumption and level of nicotine dependence. This analysis will help to identify factors that might be important for smoking behavior and nicotine addiction. The results from this study will contribute to improve campaigns for smoking prevention and treatments for smoking cessation.

Official Title
-----------------
Physiological Responses in Tobacco Chippers (Non Nicotine-dependent Light Smokers)

Conditions
-----------------
Smoking, Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults age 25-55 Exclusion Criteria: alcohol or drug addiction unstable significant medical problems neurologic disease medications known to affect CNS function or impact physiologic parameters measured in the study significant visual impairment breath carbon monoxide (BCO) level of less than 10 ppm for smokers breath carbon monoxide (BCO) level of more than 5 ppm for non-smokers for heavy regular smokers: erratic smoking history (i.e. they must have smoked an average of 15 cigarettes daily for at least one year)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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 |
| --- | --- |
| Heavy smokers, 15 or more cigarettes/day<br>Nicotine dependent. | |
| Light smokers (chippers)<br>Less than 2 cigarettes/day, at least 2 days/week. Non nicotine-dependent. | |
| Non smokers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography | Electroencephalography will be measured during performance on a hard cognitive task. | Changes from baseline during a hard cognitive task | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary cortisol | Salivary cortisol will be measured at baseline, during a hard cognitive task and 30 minutes after the cognitive task. | Changes from baseline during performance on a hard cognitive task |
A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes Who Are Not Achieving Glycemic Targets

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

Intervention / Treatment
-----------------
* Drug: pramlintide acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has HbA1c >7.0% and <=10.5% Has a body mass index (BMI) >=25 kg/m2 and <=45 kg/m2 Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start If taking oral antidiabetic agents, has been on a stable dose for at least 2 months Exclusion Criteria: Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study) Has received any investigational drug within 1 month of screening

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pramlintide<br> | Drug: pramlintide acetate<br>* Clear, colorless, sterile solution for SC injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes. |  | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes on markers of cardiovascular risk, fasting serum lipids, fasting plasma glucose, waist circumference, and patient-reported outcomes. |  | 16 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pramlintide, diabetes, Amylin, Symlin, insulin glargine
Swiss National Registry of Grown up Congenital Heart Disease Patients

Study Overview
=================
Brief Summary
-----------------
Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of the children with congenital heart disease reach adult age.This results in an increasing number of adults or grown-ups with congenital heart disease (ACHD or GUCH patients) that require special health care organization and training programmes. Long term complications of these GUCH patients and optimum treatment strategies are still poorly known. The aim of this registry is to collect quantitative and qualitative data regarding GUCH patients treated in specialised centres in Switzerland.

Detailed Description
-----------------
The SWISS GUCH registry will capture epidemiologic data, diagnosis, type of earlier treatment / intervention and cardiac complications. Following each visit, the cardiac complications will be captured as well as the mortality. Every GUCH patient coming for a visit in one of the specialized organisation participating to the registry will be asked to participate. After signing the informed consent form, the patient data will be coded and captured in a web-based data base (secuTrial®). Pooling the data from the different centres will enable a nation wide register to be established. More robust data on the size and composition of the GUCH population will be obtained. Also long term prognosis of specific patient group will be derived.

Official Title
-----------------
Swiss National Registry of Grown up Congenital Heart Disease (GUCH) Patients

Conditions
-----------------
Congenital Heart Disease, Congenital Heart Defect

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (above 18 years of age) with congenital heart disease, treated in one of the Swiss centre with specialized organisation for GUCH patients. Signed informed consent. Patients with trisomy 21: the parents or legal guardian will have to give the consent. Exclusion Criteria: None

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 |
| --- | --- | --- |
| Mortality |  | 1 year and yearly up to 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardial complications | Requiring in-patient hospitalisation, strokes, re-intervention | 1 year and yearly up to 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult, Registry, Grown-up congenital heart disease
Meta-analysis - Eltrombopag

Study Overview
=================
Brief Summary
-----------------
The purpose of the meta-analysis was to explore the efficacy of eltrombopag versus placebo (standard of care)

Detailed Description
-----------------
Meta-analysis of three studies: Bussell 2007 & Bussell 2009 & RAISE (TRA102537).

Official Title
-----------------
Systematic Review of the Clinical and Cost Effectiveness of Treatments for Idiopathic (Immune) Thrombocytopenic Purpura (ITP): Direct Meta Analysis

Conditions
-----------------
Thrombocytopaenia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with ITP Received a pre-specified treatment Prospective clinical studies with at least 10 patients Exclusion Criteria: Subjects with ITP due to other causes

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 |
| --- | --- |
| Eltrombopag & standard of care<br> | Drug: Eltrombopag<br>* Eltrombopag 50mg & standard of care<br>|
| Standard of care<br> | Drug: Placebo<br>* Placebo + standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| >=50 Gi/L platelet count to <400 Gi/L |  | 43 days |
Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy.

Study Overview
=================
Brief Summary
-----------------
Proof of concept study for the prediction of ongoing pregnancy in women undergoing In-Vitro Fertilization (IVF), using hyperglycosylated human chorionic gonadotropin (hhCG), early after In-Vitro Fertilization and fresh Embryo Transfer (IVF-ET).

Official Title
-----------------
Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy After In-vitro Fertilization and Embryo Transfer.

Conditions
-----------------
Pregnancy Test

Intervention / Treatment
-----------------
* Diagnostic Test: Pregnancy test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Written informed consent Patients undergoing their first or second IVF-ET cycle Age 18-45 years Use of Ovitrelle for final follicular maturation and luteinization Fresh or Frozen day-5 blastocysts transrer (Autologus or Egg donation) Exclusion criteria: Gestational surrogacy (patient's eggs used for pregnancy in a surrogate mother) Canceled IVF cycles GnRH agonist triggering cycles in the case of fresh ET.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All the patients will undergo 3 blood samples for analyses to determine pregnancy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. | Diagnostic Test: Pregnancy test<br>* Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Early Detection of Pregnancy | Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer) | One month |
Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.

Study Overview
=================
Brief Summary
-----------------
The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox. The two populations are followed up prospectively as regarding blood loss and need for blood transfusions, as well as adverse events at 30 days after surgery.

Conditions
-----------------
Hemostasis

Intervention / Treatment
-----------------
* Drug: Omni-stat Celox
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing heart surgery Exclusion Criteria: None
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: Control<br>Traditional best-practice surgical hemostasis | Drug: Control<br>* Traditional surgical Hemostasis<br>|
| Experimental: Omni-stat Celox<br>Administration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis | Drug: Omni-stat Celox<br>* Topical administration of 6 gr of Omnistat Celox<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blood units transfused to the patients after surgery till discharge |  | 30 days | 
| Percentage of acute bleeding controlled by Hemostasis Tool (surgical technique or Omnistat application) in the defined time frame of 10 minutes |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood volume collected in chest drains expressed in milliliters, with partial totals 3, 6 and 12 hours after surgery and final total 24 hours after surgery. |  | 3, 6, 12, 24 hours | 
| Time needed to achieve Hemostasis using Omnistat as regarding to defined time frames of 1,2,3,5,7,10 minutes |  | 1,2,3,5,7,10 minutes after application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ability of topical drug to reduce acute and overall bleeding as well as blood transfusions
Testing Spread and Implementation of Novel Methicillin Resistant Staphylococcal Aureus (MRSA)-Reducing Practices

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to implement strategies for improved efficiency and waste reduction (Toyota Lean) and positive deviance, a social behavioral change process, utilizing frontline healthcare personnel to reduce infection bloodstream infection and MRSA infection in outpatient dialysis care. In two outpatient dialysis units, dialysis unit healthcare staff will be educated in Toyota lean techniques and conduct periodic discovery and action dialogues to identify and implement care process changes to reduce infection. Outcomes to be monitored will include incidence of bloodstream infections and MRSA infections of all types. Data will be assessed at quarterly intervals using interrupted time series analysis.

Official Title
-----------------
Testing Spread and Implementation of Novel MRSA-Reducing Practices

Conditions
-----------------
Blood Stream Infections, MRSA Infections

Intervention / Treatment
-----------------
* Behavioral: healthcare staff processes for infection prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all hemodialysis patients at two outpatient dialysis units Exclusion Criteria:peritoneal dialysis patients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prevalent hemodialysis patients<br>These patients are observed in two outpatient dialysis units with a combined census of approximately 175 patients | Behavioral: healthcare staff processes for infection prevention<br>* Toyota lean and positive deviance discovery and action dialogues to facilitate process improvement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bloodstream infections |  | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MRSA infections |  | 14 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRSA, bloodstream infections, hemodialysis