linjc16/ctgov huggingface dataset:
Correlation Between Vitamin D and B Regulatory Cell in Pregnancy

Study Overview
=================
Brief Summary
-----------------
During pregnancy , the maternal immune system is always confronted with fetal alloantigens. the immunological mechanisms that prevent the rejection of the fetus are still not under understood.

Detailed Description
-----------------
During pregnancy , the maternal immune system is always confronted with fetal alloantigens. the immunological mechanisms that prevent the rejection of the fetus are still not under understood.the fetus is normally accepted by the maternal immune system despite despite the expression of paternal alloantigens. Normally, the fetus grows and develops very well with ongoing pregnancy. B regulatory cells are increased in pregnant women compared to non-pregnant women.

Official Title
-----------------
Correlation Between B Regulatory Cell and Vitamin D Status in Term and Preterm Labor

Conditions
-----------------
Labor, Premature

Intervention / Treatment
-----------------
* Dietary Supplement: Investigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy female according to the required groups Exclusion Criteria: patient with infectious disease , tuberculosis ,tumor ,hematologic disease,metabolic bone disease or any other connective tissue diseases were excluded. Patient with viral hepatitis. serological evidence of HIV infection.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Full term labor<br>Measured by flow cytometry and ELUSA | Dietary Supplement: Investigation<br>* Cross sectional intervention<br>|
| Preterm labor<br>Measured by flow cytometry and ELISA | Dietary Supplement: Investigation<br>* Cross sectional intervention<br>|
| Control<br>For comparison | Dietary Supplement: Investigation<br>* Cross sectional intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in number of B regulatory cell in pregnant woman | Immune system immunosuppressed to maintain fetus | 9 months |
Genetic and Environmental Characteristics of Primary Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to identify the modifying genes and environmental features that regulate the clinical expression of mutations in bone morphogenetic protein receptor 2 (BMPR2); to develop the understanding of how BMPR2 mutations result in disease; and to identify the undiscovered genetic mutations that cause primary pulmonary hypertension (PPH).

Detailed Description
-----------------
BACKGROUND: PPH is a progressive disease that causes obstruction of the smallest arteries in the lungs, which often leads to heart failure. It threatens the lives of thousands of individuals. PPH affects both genders at any age, although females are affected twice as often as males. In a recent important advance, mutations in BMPR2 were associated with both familial and sporadic PPH. Because only 20% of people with a BMPR2 mutation ever develop PPH, other genes or modifying biologic events must contribute to the clinical development of the disease. PPH was recently renamed Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension. DESIGN NARRATIVE: This study will utilize a database and specimen bank developed from 100 families affected by PPH across the United States. In families with genetic mutations not yet identified, changes in the BMPR2 gene will be studied, including in the promoter and intronic regions, and chance recombination events that could confirm another locus near 2q33 will be examined. New methods will look for modifier genes in large families with known mutations; examine kindreds for mitochondrial DNA haplotypes; and test candidate genes, including NOS-1, NOS-3, and the serotonin transporter. This study will determine the functional mechanisms by which variations found in the BMPR2 alleles alter BMP signal transduction by defining the biochemical effects of the mutant proteins on signaling pathways. In addition, the study will examine the perceived risks and benefits of clinical genetic testing and counseling in individuals from families at high risk for PPH and will determine how this new information might be most helpful to these individuals and their families.

Official Title
-----------------
Genetic and Environmental Pathogenesis of PPH

Conditions
-----------------
Lung Diseases, Hypertension, Pulmonary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PPH, or family members of individuals diagnosed with PPH, for inclusion in the database and specimen bank

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
| New development of pulmonary arterial hypertension (penetrance), age of onset, and survival |  | Measured through genetic analysis |
Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

Study Overview
=================
Brief Summary
-----------------
Primary objective: To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in hypertensive patients with diabetes and microalbuminuria. Secondary objectives: To determine how well irbesartan 300mg is tolerated versus 150mg To determine the percentage of patients reaching the blood pressure target of 130/80 mmHg

Official Title
-----------------
A Study of Irbesartan 150mg Verses 300mg in Chinese Hypertensive Patients With Diabetes and Microalbuminuria

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

Intervention / Treatment
-----------------
* Drug: Irbesartan
* Drug: Irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive patients, treated or untreated, with type 2 diabetes and urinary albumin excretion rate 20-200ug/min. Blood pressure of < 180/110mmHg at baseline Normal serum creatinine Exclusion Criteria: Type 1 diabetes Use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers in the 5 weeks before recruitment Pregnant or lactating women Severe hypertension Overt nephropathy Allergy to study drug 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: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Irbesartan 150mg | Drug: Irbesartan<br>* Administration throughout the study period<br>|
| Experimental: 2<br>Irbesartan 300mg | Drug: Irbesartan<br>* Administration throughout the study period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of urinary albumin excretion rate change |  | at week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching target BP of 130/80mmHg |  | At week 24 | 
| Adverse events |  | From the beginning to the end of the study |
High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone

Study Overview
=================
Brief Summary
-----------------
Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%. This study aims to study the effects of fenofibrate on HDL and subfractions in women taking tibolone.

Detailed Description
-----------------
Tibolone decreases plasma concentrations of HDL cholesterol and HDL-apoA1 and pre-beta HDL, consistent with a pro-atherogenic effect. The mechanism of tibolone on HDL cholesterol has been suggested to result from an acceleration of the catabolism of HDL by stimulation of hepatic lipase with no effect on cellular cholesterol efflux. PPAR-a agonists, in particular fenofibrate, improve HDL metabolism by increasing the expression and hepatic secretion of HDL apoAI and apoAII. We hypothesise that fenofibrate will rectify the perturbations on HDL metabolism wrought by tibolone.

Official Title
-----------------
Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women

Conditions
-----------------
HDL Cholesterol

Intervention / Treatment
-----------------
* Drug: fenofibrate and tibolone
* Drug: tibolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal women More than 6 months of amenorrhoea Raised FSH and low oestradiol level If hysterectomised, raised FSH and low oestradiol level Exclusion Criteria: Diabetes Renal failure Proteinuria High alcohol intake Regular endurance exercise Active weight loss of dieting Smokers Agents known to influence lipid metabolism Major systemic illness Intolerance to tibolone and fenofibrate Cholelithiasis CK and ALT > 2ULN Bleeding disorders Peptic ulcer disease.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>fenofibrate and tibolone | Drug: fenofibrate and tibolone<br>* fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks<br>* Other names: Livial;|
| Sham Comparator: 2<br>tibolone | Drug: tibolone<br>* tibolone 2.5 mg daily 23 weeks<br>* Other names: Livial;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL subpopulation analysis |  | August 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in HDL subpopulations |  | December 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause, menopausal symptoms, tibolone, HDL-C, fenofibrate
Comparison of ACT Between Hemochron Jr and ACT Plus

Study Overview
=================
Brief Summary
-----------------
This study aimed to compare 2 activated clotting time analysers (Hemochron Jr vs. ACT Plus).

Detailed Description
-----------------
Measurement of activated clotting time (ACT) is a standard method for anticoagulation monitoring. Especially in cardiac surgery, heparin is usually used as anticoagulant and protamine is used to reverse anticoagulation effect at the end of surgery. ACT method defines the time until a clot is formed in a test tube after triggering of internal pathway coagulation using blood activating agents (eg. kaolin). Acute normovolemic hemodilution (ANH) consists of withdrawing patient's blood volume early in the operative period and concurrent infusion of crystalloid or colloid to maintain intravascular volume, and is used in cardiac surgery. ANH is known to affect hemostasis in some studies. Assuming that accurate monitoring of coagulation therapy is important to prevent both thrombotic and hemorrhagic complications, we compared ACT results from 2 analysers (Hemochron Jr and ACT Plus) in patients undergoing cardiac surgery using ANH.

Official Title
-----------------
Comparison of Activated Coagulation Time Between Hemochron Jr and ACT Plus During Cardiac Surgery for Patient Using Acute Normovolemic Hemodilution

Conditions
-----------------
Cardiac Disease

Intervention / Treatment
-----------------
* Device: Hemochron
* Device: ACT Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent cardiac surgery with heparin administration. Exclusion Criteria: Preoperative hemoglobin under 11g/dL Weight under 40kg Preoperative coagulopathy

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient<br>Patients were checked activated coagulation time by both Hemochron Jr and ACT Plus during cardiac surgery with heparin administration. | Device: Hemochron<br>* Activated coagulation time was checked serially by Hemochron Jr.<br>Device: ACT Plus<br>* Activated coagulation time was checked serially by ACT Plus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of activated coagulation time between Hemochron Jr and ACT Plus |  | During cardiac surgeris (within 8 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Whole Blood Coagulation Time, cardiac surgery
Safety and Tolerability of Lu AG06479 in Healthy Young Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.

Detailed Description
-----------------
Part A: randomized, sequential Part B: open-label, cross-over

Official Title
-----------------
Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Lu AG06479
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit. Other in- and exclusion criteria may apply

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Single dose of Lu AG06479 or Placebo<br> | Drug: Lu AG06479<br>* capsules, orally (Part A and B)<br>* Other names: ABX-1762;Drug: Placebos<br>* Placebo - capsules, orally (Part A only)<br>|
| Experimental: Part B: Repeated dose of Lu AG06479 and Food interaction<br>Sequence B1: Fed - Fasting - Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed | Drug: Lu AG06479<br>* capsules, orally (Part A and B)<br>* Other names: ABX-1762;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment emergent adverse events (Safety and Tolerability) | Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters) | From baseline to Day 9 (Part A and B) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (0-inf) of Lu AG06479 | Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf) | From pre-dose to Day 5 (Part A and B) | 
| CL/F Lu AG06479 | Oral clearance of Lu AG06479 | From pre-dose to Day 5 (Part A and B) | 
| Cmax Lu AG06479 | Maximum observed plasma concentration for Lu AG06479 | From pre-dose to Day 5 (Part A and B) |
Evaluation of the Accuracy of the Masimo Pulse-Hemoglobin-Meter Monitor in Surgical Patients

Study Overview
=================
Brief Summary
-----------------
This is a retrospective comparison of hemoglobin measurements obtained by arterial blood gas analysis and the Masimo Continuous Hemoglobin Monitor

Detailed Description
-----------------
The chief objective of this study is to internally validate the accuracy of the Masimo SpHb (TM) technology as compared to our laboratory measurement of Hb. We have been using the Masimo SpHb monitor on patients who underwent open heart surgery, hepatic resection, kidney transplant and aortic aneurysm repair since January 2009. These patients also had hemoglobin concentration measurements as part of the arterial blood gas analysis performed by our laboratory to evaluate intraoperative ventilation and electrolyte changes. We will collate the laboratory measurements with the Masimo SpHb values documented in the anesthetic records.

Official Title
-----------------
Evaluation of the Accuracy of the Masimo Pulse-Hemoglobin-Meter Monitor in Surgical Patients

Conditions
-----------------
Accuracy of Non-invasive Hemoglobin Monitor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had indwelling arterial catheters placed for surgeries that involved major blood loss and who had serial hemoglobin concentration measurements for their surgeries, since January 2009. This will represent approximately 50 patients. Exclusion Criteria: Inclusion criteria are patients undergoing major surgery from January 2009 - April 2009, who had continuous hemoglobin pulse oximetry readings form the Masimo SpHb monitor and serial hemoglobin concentration measurement from the lab. Patient who did not have these studies will be excluded.
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 |
| --- | --- | --- |
| Accuracy of Masimo Monitor | 365 Days | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-invasive, hemoglobin
Platelet Inhibition by Aspirin, Acetaminophen and NSAID

Study Overview
=================
Brief Summary
-----------------
Nonsteroidal antiinflammatory drugs such as diclofenac or naproxen may interfere with the inhibition of platelet aggregation by aspirin, because they all interact with the platelet cyclooxygenase.This may be of great clinical importance because of an increased cardiovascular event rate (myocardial infarction, stroke). The present randomized, controlled study analyses in vitro platelet aggregation under a combined treatment of healthy volunteers with aspirin and either acetaminophen, diclofenac, naproxen, or placebo.

Detailed Description
-----------------
An in vivo study on healthy volunteers with combinations of well established drugs

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

Intervention / Treatment
-----------------
* Drug: Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Administration of drugs affecting platelets History of bleeding Gastrointestinal disorders Hypersensitivity to aspirin and/or NSAID Pregnancy and breast feeding
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1, 2, 3, 4<br>acetylsalicylic acid 100 mg/po,acetaminophen 3x1g/po acetylsalicylic acid 100 mg/po,diclofenac 3x50mg/po acetylsalicylic acid 100 mg/po,naproxen 3x250mg/po acetylsalicylic acid 100 mg/po,placebo 3x1/po | Drug: Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo<br>* Acetylsalicylic acid 100mg/po and acetaminophen 3x1g/po for 4 days Acetylsalicylic acid 100mg/po and diclofenac 3x50mg/po for 4 days Acetylsalicylic acid 100mg/po and naproxen 3x250mg/po for 4 days Acetylsalicylic acid 100mg/po and placebo 3x1/po for 4 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet aggregation |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet, aggregation, aspirin
Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of Fexofenadine (Telfast®) 30mg pediatric tablets on Filipino children aged 6 to 11 for the relief of symptoms associated with perennial and intermittent allergic rhinitis.

Official Title
-----------------
A Monitored Release Study On The Efficacy And Safety of Fexofenadine (Telfast®) 30mg Pediatric Tablets On Filipino Children Aged 6 To 11 for The Relief of Perennial And Intermittent Allergic Rhinitis.

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: Fexofenadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who manifest allergic rhinitis symptoms such as sneezing, rhinorrhea, itchy nose/palate/throat and/or itchy/watery/red eyes.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 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: 1<br>Fexofenadine | Drug: Fexofenadine<br>* Fexofenadine: One 30 mg Tablet once daily for two weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's assessment of symptoms and drug activity (Total symptom scores) |  | At baseline, D 7 and D 14 | 
| Physician's assessment of symptoms and drug activity (Total symptom scores) |  | At D 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE and SAE collection |  | From the signature of the informed consent up to the end of the study |