linjc16/ctgov huggingface dataset:
Genetic Variation in the Transporters and Hypoglycemic Agents

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes have become a major global health problem. Currently, metformin is used as first-line therapy in combination with lifestyle changes, and sitagliptin can be added to metformin in case of insufficient glycemic control by metformin alone, and fixed-dose combination of sitagliptin and metformin is available. In clinical practice, inter-individual variations in response to sitagliptin and metformin treatment are commonly found, which may reflect inter-patient differences in disposition of these medications. Sitagliptin and metformin are known as substrates of some transporters (P-gp, OAT3, OCT1 and OCT2) and some functional variations of these transporters were reported. This study is designed to clarify the effect of these transporter variants on response to sitagliptin and metformin in type 2 DM patients.

Official Title
-----------------
Effect of Genetic Variation in the Transporters on Glycemic Response and Pharmacokinetics of Sitagliptin and Metformin

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly Diagnosed Type 2 Diabetes Patients 20-80 years old Taking sitagliptin and metformin for more than 3 months Exclusion Criteria: Taking other oral hypoglycemic agents Taking medications can induce or inhibit transporters

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| differences of sitagliptin and metformin trough concentration according to genetic variations of transporters |  | After 3 months of sitagliptin and metformin treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences of HbA1c change according to genetic variations of transporters |  | Baseline and after 3 months of sitagliptin and metformin treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Newly diagnosed type 2 diabetes patients
INSIGHTS ICD Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias in order to better understand how to improve the clinical care of patients and effectiveness of ICD therapies.

Official Title
-----------------
Investigating Significant ICD Heart Therapies Registry Study (INSIGHTS ICD Registry)

Conditions
-----------------
Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
-----------------
* Device: ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older. Patients or legal guardians who are willing and able to sign a Permission for Access to and Use of Health Information in a Registry Form and, if required by an Institution's IRB, an Informed Consent. New or replacement implants of Medtronic market released single, dual or triple chamber ICDs including: GEM VR, GEM DR, GEM III AT, Marquis VR, Marquis DR, Maximo DR, Maximo VR, InSync ICD, InSync Marquis ICD and InSync II Marquis ICD. Exclusion Criteria: Patients enrolled in a device study which effects programming and or treatment.

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

| Intervention/Treatment |
| --- |
|Device: ICD|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
-----------------
ICD, Registry, Ventricular tachycardia, Ventricular Fibrillation
The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome

Study Overview
=================
Brief Summary
-----------------
The use of ActiveCare+S.F.T 3rd generation (an Intermittent Pneumatic Compression Device) will improve quality of life in patients suffering from Post Thrombotic Syndrome compared to compression stockings which is the current gold standard of care.

Official Title
-----------------
The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome

Conditions
-----------------
Post Thrombotic Syndrome

Intervention / Treatment
-----------------
* Device: ActiveCare+S.F.T 3rd generation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have developed post Thrombotic leg symptoms after a deep vein thrombosis event. Exclusion Criteria: admitted patients Patients who suffer from peripheral artery disease. Patients with an acute deep vein thrombosis. s/p leg skin transplant Patients with an active leg infection Patients who aren't capable of operating the device.

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: Supportive Care
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ActiveCare+S.F.T 3rd generation|Intermittent Pneumatic Compression Device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (Veins-QOL) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Villalta Scale | The scale consists of five patient-rated venous symptoms (pain, cramps, heaviness, paresthesia, pruritus) and six clinician-rated physical signs (pretibial edema, skin induration, hyperpigmentation,pain during calf compression, venous ectasia, redness),which are each rated on a four-point scale (0 = none,1 = mild, 2 = moderate, 3 = severe). Points are summed to produce a total score (range: 0-33). Subjects are classified as having Post Thrombotic Syndrome if the score is 5 or more, or if a venous ulcer is present, in a leg with previous DVT. | 1 month |
Effects of Packed Red Blood Cell Storage Duration on Pediatric Living Donor Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The patients assigned to either short-storage leukoreduced RBCs group (stored for ≤ 14 days) or longer-term storage leukoreduced RBCs group(stored for ≥21 days).When the hemoglobin concentration fell below 7.0 g per deciliter, PRBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0/dL. The primary outcome : Death from all causes in1-year after randomization. Secondary outcomes included: Intraoperative blood transfusion, Postoperative blood transfusion, Postoperative inflammatory reaction, Mechanical ventilation time in the intensive care unit, Lengths of stay in the intensive care unit and the hospital were also recorded.

Official Title
-----------------
Effects of Packed Red Blood Cell Storage Duration on Pediatric Living Donor Liver

Conditions
-----------------
Transfusion Related Complication

Intervention / Treatment
-----------------
* Procedure: RBC transfustion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Our study included pediatric patients (6 months< the moon's age <36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital. Exclusion Criteria: The exclu¬sion criteria of the study were a congenital sufferer from heart, lung, kidney, nervous system or blood disease,active Lung infection，a history of liver transplantation，Multivisceral transplantation , refused to participate the study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 36 Months

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: Short-term storage RBCs (stored for ≤ 14 days)<br>patients in this group were transfused with short-term storage RBCs (stored for ≤ 14 days). | Procedure: RBC transfustion<br>* When the hemoglobin concentration fell below 7.0 g per deciliter, RBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0g /dL<br>|
| Active Comparator: Longer-term storage RBCs (stored for ≥21 days)<br>patients in this group were transfused with longer-term storage RBCs (stored for ≥21 days). | Procedure: RBC transfustion<br>* When the hemoglobin concentration fell below 7.0 g per deciliter, RBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0g /dL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality in in1-year after randomization | Death from all causes in1-year after randomization. | 1-year after randomization. |
Association of Hb F Level With Clinical Severity of Beta Thalassemia

Study Overview
=================
Brief Summary
-----------------
The production of Hb F after birth is an important factor in modifying the clinical severity of beta thalassemia because an increased gamma-globin level will bind the additional a-globin and form Hb F. The objective of this project is to evaluate the association of Hb F level with phenotypic diversity of patients with beta thalassemia.

Official Title
-----------------
Association of Hb F Level With Clinical Severity of Beta Thalassemia

Conditions
-----------------
Beta Thalassemia

Intervention / Treatment
-----------------
* Diagnostic Test: Hematological Phenotype Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with beta-thalassemia Exclusion Criteria: Iron Deficiency Anemia
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| beta thalassemia patients<br> | Diagnostic Test: Hematological Phenotype Analysis<br>* Hematological parameters were determined with an automated hematology analyzer (Sysmex, Japan), and hemoglobin analysis was performed with either high-performance liquid chromatography (Bio- Rad, USA) or capillary electrophoresis (Sebia, France and Helena, USA).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb F level and severity of anemia | Observational study that analyzed association of Hb F level and anemia severity in patients | 3 years |
Open Trial of Miglitol in Type 1 Diabetic Patients With Insulin Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in patients with Type1 Diabetes Mellitus treated with insulin.

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Miglitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type1 Diabetes Criteria of postprandial glucose and HbA1c are met Exclusion Criteria: Type2 Diabetes Patients with antidiabetic drugs The other exclusion criteria are met

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Miglitol|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
-----------------
alpha-glucosidase inhibitor,Insulin
Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
There are no investigations so far whether an application of positive pressure during non-invasive ventilation might be a therapeutic option for transudative pleural effusion in patients with heart failure. In view of the pathophysiological process with pleural effusion resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation might provide an improvement. The aim of the present study is to investigate whether an additional non-invasive ventilation therapy leads to an improved suppression of pleural effusion in heart failure patients.

Official Title
-----------------
Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure

Conditions
-----------------
Pleural Effusion, Heart Failure

Intervention / Treatment
-----------------
* Device: Non-invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to our hospital on a routine or emergency basis Patients with heart failure according to the current ESC guidelines and chronic pleural effusion with clinical indication for pleurocentesis Non-invasively determined cardiac index of < 2.5 l/min/m² BNP > 300 pg/ml Transudative pleural effusion according to Light criteria Effective pleurocentesis with residual effusion on the side affected of < 500 ml Tolerance of non-invasive ventilation without subjective or objective hemodynamic impairment as verified during a test ventilation No change in drug or other therapy for the duration of the study (5 days) Exclusion Criteria: Psychological or neurological concomitant disease making an informed consent impossible Pregnancy Pneumothorax or pneumomediastinum Pathologically low blood pressure, particularly associated with intravascular volume depletion Liquor discharge, recent head surgery or trauma Severe bullous lung disease Dehydration Current ventilation therapy Bilateral pleural effusion > 500 ml at the time of enrolment Exudative pleural effusion

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 |
| --- | --- |
| Treatment group<br>Non-invasive ventilation after pleurocentesis | Device: Non-invasive ventilation<br>* Non-invasive Ventilation for a Minimum of 8 h per day after pleurocentesis<br>|
| Control group<br>Oxygen Administration via nasal tube | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of pleural effusion |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nt-Pro-BNP |  | 5 days | 
| Cardiac output |  | 5 days | 
| NYHA class |  | 5 days |
Venetoclax Registry

Study Overview
=================
Brief Summary
-----------------
Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax

Detailed Description
-----------------
The aim of this study is to document all patients with AML who are treated with the BCL2 inhibitor Venetoclax outside a clinical trial in all hospitals participating in this registry study in a standardised manner. Data is collected retrospectively and multi-centric. It is neither a therapy study nor is the therapy influenced by this study. Systematic and uniform collection and documentation of all patients treated with the BCL2 inhibitor Venetoclax. Collection and integrative analysis of clinical data of included patients. Mutation analysis of available patient samples and correlation with clinical parameters.

Official Title
-----------------
Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax: The Venetoclax Registry

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Venetoclax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: relapsed/refractory AML Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Venetoclax|Registry study observing clinical and biological characteristics of patients with acute myeloid leukemia who are treated with Venetoclax.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate of Venetoclax treatment. | Overall response rate of Venetoclax treatment (complete remission, complete remission with incomplete regeneration, partial remission) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival during Venetoclax treatment | Event-free survival of patients with relapsed/refractory AML receiving Venetoclax | 5 years | 
| Relapse-free survival during Venetoclax treatment | Relapse-free survival of patients with relapsed/refractory AML receiving Venetoclax | 5 years | 
| Overall survival during Venetoclax treatment | Overall survival of patients with relapsed/refractory AML receiving Venetoclax | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsed/refractory adult acute myeloid leukemia (AML)
Physical Actitvity and Blood Pressure Among Ambulance Personnel During Work and Leisure

Study Overview
=================
Brief Summary
-----------------
The aim is to describe physical activity and blood pressure during work and leisure time among Swedish ambulance personnel, and to relate this to work- and lifestyle factors.

Detailed Description
-----------------
The work environment for ambulance personnel consists of several factors that might have negative effect on health, for example shift work, long working hours, stress and physical demanding work. Associations between these work-related factors and increased risk of disease, for example cardiovascular- and musculoskeletal disease, have been observed in several studies. However, few studies have specifically been focusing on ambulance personnel. There is lack of knowledge regarding how work environment factors affect physical activity during work and leisure time among ambulance personnel. Further, the knowledge about blood pressure during work and leisure time is limited for this group.

Official Title
-----------------
Physical Actitvity and Blood Pressure Among Ambulance Personnel During Work and Leisure

Conditions
-----------------
Blood Pressure, Work-Related Condition

Intervention / Treatment
-----------------
* Other: Blood pressure, physical activity, health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Employed in the ambulance organisation at the time for data collection Exclusion Criteria: Managers and administrative personnel in the ambulance organisation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 68 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood pressure, physical activity, health|Observational study of work environment, leisure time, blood pressure, physical activity and health|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Ambulatory blood pressure, Objectively measured | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Objectively measured with accelerometry | 7 days | 
| Recovery | Self-reported | baseline, pre-intervention/procedure/surgery | 
| Health | Subjective overall health | baseline, pre-intervention/procedure/surgery |
Postoperative Recovery Index, Patient Expectations and Satisfaction With Prenatal Care Instrument in Pregnant Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to provide optimum care to postoperative patients diagnosed with COVID-19 (after cesarean) and to help them with recovery, to determine and assist the expectation and satisfaction of pregnant women with COVID-19 regarding prenatal care.

Official Title
-----------------
Evaluation of Pregnant Women Diagnosed With COVID-19 With Post-operative Recovery Index and Prenatal Care Satisfaction and Patient Expectations Scale

Conditions
-----------------
COVID-19, Prenatal Care, Postoperative Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant patients with COVID-19 Exclusion Criteria: Patient giving Preterm Labor

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pregnant women diagnosed with COVID-19 with Post-operative Recovery Index and Prenatal Care Satisfaction and Patient Expectations Scale | The benefit we expect from the study is to be able to provide optimum care to postoperative patients (after cesarean) diagnosed with COVID-19 and to help them with recovery, to identify and assist the expectation and satisfaction of pregnant women with COVID-19 regarding prenatal care. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pregnant women diagnosed with COVID-19 with Post-operative Recovery Index and Prenatal Care Satisfaction and Patient Expectations Scale | To determine the differences between healthy pregnant women in the control group and pregnant women diagnosed with COVID-19 in the study group in terms of postoperative care and prenatal care expectations. | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Prenatal Care, Postoperative Care