linjc16/ctgov huggingface dataset:
Hormone Therapy Effects on CVD Risk Factors

Study Overview
=================
Brief Summary
-----------------
To conduct extended analysis of the Postmenopausal Estrogen/Progestins Intervention PEPI trial database to address questions related to cardiovascular disease risk factor response and the possible determinants of this response.

Detailed Description
-----------------
BACKGROUND: Cardiovascular disease is the leading cause of death among postmenopausal women. Growing evidence exists that hormone replacement therapy (HRT) may reduce cardiovascular disease and mortality. This has led to the use of postmenopausal HRT for primary prevention of heart disease, however it remains unresolved which women are likely to benefit most from this clinical approach. This is a complicated question because many potential mechanisms are involved by which hormone therapy (HRT) may confer cardioprotection. The Postmenopausal Estrogen/Progestins Intervention (PEPI) trial examined the relative impact of four regimens of hormone therapy on a range of cardiovascular disease risk factors (e.g. lipids, blood pressure, insulin/glucose, hemostasis factors). The trial was well conducted; its data have been thoroughly edited and have yielded a series of important publications. To date, however, publications have focused on average effects without a thorough exploration of the range of, and interplay among, the various effects across the 875 enrolled in the trial. DESIGN NARRATIVE: The study extended the analysis of PEPI data by: 1) characterizing the distributions of responses to hormone therapy with respect to risk factors for cardiovascular disease (lipids/lipoproteins, blood pressure, insulin/glucose, hemostasis factors); 2) examining the multivariate patterns of treatment effects among these cardiovascular risk factors and on other outcomes (symptomatology, bone, endometrial); 3) examining clinical and demographic factors that may affect these relationships and, in doing so, characterizing women who may vary with respect to their sensitivity to the separate effects of estrogen and progestin therapy; 4) examining closely patterns of adherence and their relationship to response. An experienced team of statisticians/epidemiologists conducted and planned to publish results from these analyses. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Postmenopause

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
99th Percentile Upper Reference Limit (URL) for the Meritas Troponin I Test

Study Overview
=================
Brief Summary
-----------------
Prospective multicenter sample collection and testing study.

Detailed Description
-----------------
Prospective multicenter sample collection and testing study. Approximately 750 apparently healthy subjects, including healthy subjects with stable co-morbidities, age, gender and ethnicity dispersed will be eligible for enrollment

Official Title
-----------------
Using Normal Volunteer Whole Blood or Plasma Samples to Establish the 99th Percentile Upper Reference Limit (URL) for the Meritas Troponin I Test

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female at least 21 years of age at the time of enrollment in the study. Subjects with no medications or no changes in their medications in the last 3 months. Subjects with and without chronic stable morbidities (i.e., renal insufficiency, hypertension, diabetes, hypercholesterolemia, pulmonary disorders, coronary disease, musculoskeletal disorders, etc.). Subjects able to understand and sign the informed consent and the patient questionnaire. Exclusion Criteria: Subjects with a history of heart failure and/or, having received treatment for heart failure. Subject with renal failure. Subjects with a history of unstable heart disease or angina complaints. Subjects with any change in their medication in the last 3 months (diabetics may have small variations in glucose medications but may not have unstable disease, or have suffered a diabetic crisis in the last 6 months). Any known acute infection in the last 30 days. Marathon runners or extreme athletes. Pregnant (self-reported).

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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 |
| --- | --- | --- |
| 99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population |  | 1 day |
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and effectiveness of an investigational glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution
* Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)
* Drug: Timolol 0.5% Ophthalmic Solution
* Other: Timolol Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older. Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pregnant History of chronic or recurrent severe inflammatory eye disease. History of ocular infection or ocular inflammation within the past three months in either eye. Other protocol-defined exclusion criteria may apply.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost/Timolol<br>One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) each evening at 8 p.m. for 3 months | Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution<br>* Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension<br>Other: Timolol Vehicle<br>* Placebo<br>|
| Active Comparator: Xalatan + Timolol 0.5%<br>One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months | Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)<br>* Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension<br>* Other names: XALATAN;Drug: Timolol 0.5% Ophthalmic Solution<br>* Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open-angle, glaucoma, ocular, hypertension
Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile X syndrome (FXS). The investigators will use the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills. Importantly, the investigators propose to examine the effects of this treatment probe on brain and behavior.

Official Title
-----------------
Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome

Conditions
-----------------
Fragile X Syndrome, Intellectual Disability

Intervention / Treatment
-----------------
* Behavioral: Social gaze training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys diagnosed with fragile X syndrome Boys with intellectual disability who do not have FXS or other known genetic disorder associated with intellectual disability Age 8 to 18 years inclusive Ability to travel to Stanford Vineland Adaptive Behavior Scales standard score between 50 and 75 points Exclusion Criteria: Sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease). Materials in body that would preclude an MRI scan (e.g., dental braces).

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social gaze training<br>Appropriate social gaze behavior will be reinforced using the principles of Applied Behavior Analysis. | Behavioral: Social gaze training<br>* Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.<br>|
| No Intervention: No Training<br>Appropriate social gaze behavior will not be reinforced. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of social gaze aversion recorded during the social challenge |  | 3 days | 
| Heart rate recorded during the social challenge |  | 3 days | 
| Total t-score on the Social Responsiveness Scale (SRS) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal responses and pauses in conversation observed during the social challenge |  | 3 days | 
| Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex |  | 3 days |
The Analysis of Factors Influencing the Vd of Imipenem in Septic Shock Patients

Study Overview
=================
Brief Summary
-----------------
The study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd

Detailed Description
-----------------
Severe sepsis and septic shock are major causes of mortality in intensive care unit(ICU) patients.Correct and adequate antibiotic coverage is essential but can be complex as a result of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on pharmacokinetics(PK).Such changes will significantly distort the normal anti-biotic PK profile, resulting in drug exposure that is markedly different from the 'healthy volunteer.'The apparent volume of distribution is one of important PK parameters.Vd determines the loading dose. This review article considers these issues in detail, summarizing the key changes in antibiotic Vd in the critically ill, and providing general suggestions how to optimization of antibiotic dosing to manage Vd challenges.50 patients who receives the theapy of imipenem are included in this study.Whether hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on Vd will be evaluted.

Official Title
-----------------
The Analysis of Factors Influencing the Apparent Volume of Distribution of Imipenem in Septic Shock Patients

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Drug: Imipenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 years old and 80 years old; Admitted to the ICU; Patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g q8h; Exclusion Criteria: Patient participated in another interventional trial before enrollment Allergy, hypersensitivity or a serious reaction to imipenem; Pregnancy. patients with ECMO and(or)CRRT. tumors.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| septic shock<br>Patients with septic shock treat with Imipenem | Drug: Imipenem<br>* Imipenem 1.0 q 8h<br>|
| non-septic shock<br>Patients with infection but not septic shock treat with Imipenem | Drug: Imipenem<br>* Imipenem 1.0 q 8h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the apparent volume of distribution | The imipenem plasma concentrations are measured at different time to calculate Vd | Day1, Day 3, Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock; imipenem; VD ;pharmacokinetics
Lead, Endocrine Disruption and Reproductive Outcomes

Study Overview
=================
Brief Summary
-----------------
This prospective cohort study of 400 lead exposed and 400 non-lead exposed women and their husbands assesses endocrine dysfunction and adverse reproductive outcomes. Residing in two study areas in Shenyang, China, the women are married, 20 and 34 years of age, never smokers, have obtained permission to have a child, and have attempted to become pregnant over the course of the study. Lead exposure is defined by lead levels in blood samples collected at the baseline survey (both women and their husbands), first and second trimesters, and at delivery (both maternal and cord blood). Endocrine dysfunction is monitored by urinary hormone metabolites including follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrone conjugates (E1C), and pregnanediol-3-glucuronide (PdG). Reproductive endpoints include menstrual disturbance, time to conception, spontaneous abortion, preterm delivery, and low birth weight.

Conditions
-----------------
Lead Poisoning, Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
married women who: currently reside in two study areas in Shenyang, China between 20 and 34 years of age never smokers have obtained permission to have a child are attempting to become pregnant over the course of the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 34 Years

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lead, endocrine dysfunction
Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the three dimensional root resorption after extraction space closure in two groups: two step retraction and en masse retraction. Th main aim of this study is to conclude which method is less damaging to the roots. Participants will be divided into two groups: En masse retraction (experimental) Two step retraction (control) Pre retraction and post retraction CBCT scans will be compared for both groups.

Official Title
-----------------
Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure Using Cone Beam Computed Tomography

Conditions
-----------------
Root Resorption

Intervention / Treatment
-----------------
* Procedure: retraction method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who signed the informed consent to be part of this study. Patients with Class I or Class II malocclusion. Patients requiring extractions of maxillary first premolars with absolute anchorage. Good periodontal status. Exclusion Criteria: Patients who are syndromic or have cleft lip and/or palate. Patients with severe root dilacerations or root canal treated incisors. Patients receiving drugs that alter tooth movement. Patients with systemic disease like endocrinological disorders, vit D excess or deficiency, thyroid or parathyroid problems. Patients with history of trauma to dentition or impacted teeth in anterior maxilla. Patients who have undergone previous orthodontic treatment.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Two step retraction<br>teeth will be retracted in two stages | Procedure: retraction method<br>* Three dimensional evaluation of root resorption using cone beam computed tomography<br>|
| Experimental: En masse retraction<br>teeth will be retracted in one stage | Procedure: retraction method<br>* Three dimensional evaluation of root resorption using cone beam computed tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root resorption | Amount of root resorption in three dimensions | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Two step retraction, En masse retraction, Cone Beam Computed Tomography
Efficacy and Safety Study of S-Amlodipine Gentisate Compared to Amlodipine Besylate to Treat Mild-to-Moderate Hypertension

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the antihypertensive effect and tolerability of S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate hypertension.

Official Title
-----------------
An 8 Weeks, Multi-Center, Randomized, Double Blinded, Comparative Phase 3 Clinical Trial to Assess the Efficacy and Safety of S-Amlodipine Gentisate Compared to Amlodipine Besylate in Patients With Mild-to-Moderate Hypertension

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

Intervention / Treatment
-----------------
* Drug: S-amlodipine gentisate
* Drug: Amlodipine besylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients are required to have a mean cuff sitting diastolic blood pressure of ≥90 and ≤109 mmHg after successful completion of the 2-week placebo run-in period Exclusion Criteria: any serious disorder that could limit the ability of the patient to participate in the study significant cardiovascular disease (angina, myocardial infarction, cerebrovascular disease, or significant arrhythmia in the preceding 6 months) uncontrolled diabetes mellitus (serum glucose level ≥140 mg/dl) insulin dependent diabetes mellitus (type I) secondary hypertension

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

| Intervention/Treatment |
| --- |
|Drug: S-amlodipine gentisate|nan|
|Drug: Amlodipine besylate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in mean changes from baseline in through sitting diastolic blood pressure after 8 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean changes in sitting systolic blood pressure; response rate (defined as the proportion of patients whose sDBP was ≤90mmHg or whose sDBP had decreased from baseline by ≥10 mmHg); changes in triglyceride and total cholesterol level of blood sample |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension
Safety and Efficacy of SPARC1203 in Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with allergic rhinitis

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: SPARC1203
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients aged 18 to 65 years (both inclusive) with history of seasonal allergic rhinitis and positive skin prick test Exclusion Criteria: History or presence of perennial allergic rhinitis Upper or lower respiratory tract infection 2 weeks before Visit 2 Significant pulmonary disease other than allergic rhinitis or mild asthma controlled by beta-2-agonists alone Immunizations or vaccinations within 4 weeks prior to Visit 1

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC1203 low dose<br> | Drug: SPARC1203<br>* Active<br>|
| Experimental: SPARC1203 mid dose<br> | Drug: SPARC1203<br>* Active<br>|
| Experimental: SPARC1203 high dose<br> | Drug: SPARC1203<br>* Active<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Nasal Symptom Score (TNSS) |  | Baseline and 2 weeks |