linjc16/ctgov huggingface dataset:
Pathogenesis and Mechanisms of Mitral Annular Calcification

Study Overview
=================
Brief Summary
-----------------
Researchers are testing blood or mitral valve tissue to better understand the reasons why Mitral Annular Calcification (MAC) develops in patients with heart disease.

Detailed Description
-----------------
The aim is to test the hypothesis that Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) play a significant role in the process of Mitral Annular Calcification (MAC) as prognostic markers of calcific cardiac valves.

Official Title
-----------------
Pathogenesis and Mechanisms of Mitral Annular Calcification

Conditions
-----------------
Mitral Annulus Calcification

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of MAC and patients coming to the Valve Clinic without MAC diagnosis Patients who will undergo surgery, either standard surgical MVR or trans-atrial TMVR, with diagnosis of MAC or without diagnosis of MAC Exclusion Criteria: Subjects unwilling to participate or to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic markers of calcific cardiac valves | Measured by Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) in Mitral Annular Calcification (MAC) | Baseline |
Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.

Official Title
-----------------
VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Iloprost (Ventavis BAYQ6256)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The treating physician has chosen Ventavis as a suitable treatment for the patient Patient with PH and classified as NYHA functional class III or IV and WHO group 1 Exclusion Criteria: Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis patient package insert).

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 |
| --- | --- |
| Group 1<br> | Drug: Iloprost (Ventavis BAYQ6256)<br>* Patients with pulmonary arterial hypertension, classified as New York Heart Association functional class III or IV where the treating physician has chosen Ventavis as a suitable treatment prior to inclusion into this non-interventional study. Patients should not have received prior treatment with Ventavis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is 6-minute walking distance |  | At baseline and month 1,3,6 for an observational period of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New York Heart Association functional class |  | Baseline, month 1,3,6 | 
| PH-related symptoms and change of concomitant medication |  | Baseline, month 1,3,6 | 
| Hemodynamic parameters |  | If applicable ( at any time during Ventavis treatment) | 
| Adverse Event collection |  | If applicable (during the study period) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Hypertension
Genetic Polymorphisms Associated With Cigarette Smoking and Risk of Graves' Disease

Study Overview
=================
Brief Summary
-----------------
Cigarette smoking is a well-recognized risk factor of Graves' disease and, particularly, Graves' ophthalmopathy. Hence, germline polymorphisms of detoxification genes and genes belonging to the major DNA repair/apoptosis pathways might have an important role in disease susceptibility. In addition, as some of these genes are regulated by thyroid hormones, they could affect the outcome of these patients. Our objective was to assess the influence of the GST, CYP and TP53 gene polymorphisms in the risk of Graves' disease and its outcome.

Detailed Description
-----------------
Although the role of many polymorphisms of genes related to toxins' metabolism has been extensively investigated regarding the susceptibility to thyroid cancer, their influence in thyroid autoimmune diseases risk is still largely unknown. Hence, this study was designed to assess the influence of GSTT1, GSTM1, GSTP1, CYP1A1 and 72TP53 polymorphic inheritance on the susceptibility to Graves' disease and to its response to the treatment.

Official Title
-----------------
Study of the Influence of the GST, CYP and TP53 Gene Polymorphisms in the Risk of Graves' Disease and Its Outcome.

Conditions
-----------------
Graves' Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Graves' disease patients

Ages Eligible for Study
-----------------
Minimum Age: 2 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
-----------------
susceptibility, genes, environment, ophthalmopathy, outcome
Impact of Smoking, Benzodiazepine (BZD) Use and Obesity on Severe Obstructive Sleep Apnea (sOSA)

Study Overview
=================
Brief Summary
-----------------
In this study the investigators will analyze the influence of smoking, benzodizepine use, and obesity among patients with severe Obstructive Sleep Apnea (sOSA).

Detailed Description
-----------------
This study is a retrospective study. Patients enrolled: all patients with a PSG (polysomnography) between 1st January 2014 and 30th June 2015. First analysis: influence of smoking, benzodiazepine use, and obesity on the AHI (Apnea Hypopnea Index: the number of apnea and hypopnea per hour of sleep). Second analysis: only among patients with sOSA: influence of smoking, benzodiazepine use, and obesity on sleep fragmentation and night oximetry.

Official Title
-----------------
Impact of Smoking, BZD and Obesity on Severe Obstructive Sleep Apnea (sOSA)

Conditions
-----------------
Obstructive Sleep Apnea, Obesity, Smoking

Intervention / Treatment
-----------------
* Other: Smoking
* Other: Obesity
* Other: Benzodiazepine use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients registered for an overnight PSG at Clinique Saint-Luc of Bouge Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Smoking|Influence of smoking on parameters derived from overnight PSG|
|Other: Obesity|Influence of obesity on parameters derived from overnight PSG|
|Other: Benzodiazepine use|Influence of benzodiazepine use on parameters derived from overnight PSG|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index | Apnea Hypopnea Index (AHI) is defined as the number of apnea and hypopnea per hour of sleep. It is the major determinant of the severity of OSA. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep fragmentation defined by the percentage of time spent in each of the four stades of sleep (Stade 1, Stade 2, Slow wave sleep and Rapid Eye Movements) | Are smoking and/or obesity a risk factor for sleep fragmentation? | 1 day | 
| Time spent under 90% of SpO2 during the night | Are smoking and/or obesity a risk factor for oxygen desaturation (< 90% SpO2) during the night? | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
All patients registered for A PSG, polysomnography
Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis

Study Overview
=================
Brief Summary
-----------------
Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and the Photopill capsule was developed for this purpose. An open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative Proctitis. Primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition. Furthermore clinical and biochemical parameters are monitored during the study.

Official Title
-----------------
Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis

Conditions
-----------------
Ulcerative Colitis, Proctitis

Intervention / Treatment
-----------------
* Device: Photopill treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Ulcerative Proctitis (Mayo grade 1/2) Exclusion Criteria: Symptomatic hemorrhoids Pregnant or lactating females Patients that have used any experimental treatment within 8 weeks prior to Day 0 Patient that have used any biologics therapies or immunomodulation agents and/or steroids 4 weeks prior to Day 0 Rectal therapy 2 weeks prior to Day 0

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photopill treatment<br> | Device: Photopill treatment<br> <br> * Other names: Photopill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Any adverse events reported by subjects | day 0-42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers | serum CRP, serum Hb/Ht, fecal Calprotectin | day 0,14,28,42 | 
| Clinical Questionnaires | Simple Clinical Colitis Activity Index Partial Mayo score | day 0,14,28,42 | 
| Mucosal appearance at sigmoidoscopy | endoscopic disease activity Mayo score and possible damage by device | week 0,14,28.42 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative Colitis, Ulcerative Proctitis, Low Level Light Therapy, Safety, Efficacy
Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03826)

Study Overview
=================
Brief Summary
-----------------
This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.

Detailed Description
-----------------
This study is a cross-over study design.

Official Title
-----------------
A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications

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

Intervention / Treatment
-----------------
* Drug: Desloratadine (Clarinex)
* Drug: Cetirizine (Zyrtec)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be: Between 6 and 11 years of age in good general health Premenarcheal if female Exclusion Criteria: Subjects who: Have known allergies or sensitivities to either of the drug formulations Have a medical condition that may interfere with the subject's ability to discriminate between tastes Have used any antihistamines within 24 hours prior to dosing Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs Were involved in another clinical or market research study within the past 30 days

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desloratadine and Cetirizine Crossover<br>To compare the preference in taste between desloratadine and cetirizine. | Drug: Desloratadine (Clarinex)<br>* Each subject received 5 mL of desloratadine syrup one time<br>* Other names: SCH 034117, Clarinex;Drug: Cetirizine (Zyrtec)<br>* Each subject received 5 mL of cetirizine syrup<br>* Other names: Zyrtec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face). |  | During the only study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste flavor preference between bubble-gum, banana-grape, or grape flavors |  | During the only study visit | 
| Adverse Events |  | During the only study visit |
Telemedicine in Pregnant Women With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Hypothesize that co-managing pregnant type 1 diabetics with telemedicine will have at least equivalent outcomes to those managed with standard care. Comparison of outcomes between pregnant type 1 diabetics being co-managed with telemedicine compared to those receiving conventional care will help identify unanswered clinical questions and areas for improvement in regard to standards of care for pregnant type 1 diabetics. The data generated from this analysis will help determine whether telemedicine can be an effective additional means of care for pregnant type 1 diabetic patients.

Detailed Description
-----------------
Few studies have researched the use of telemedicine in the management of type 1 diabetes during pregnancy. These studies are additionally limited due to the number of patients as well as several secondary outcomes reported. Therefore, this study will enroll 100 participants to reach a power of 81.8% with HbA1c as a primary outcome and secondary outcomes related to diabetic management such as frequency of hypoglycemia, antenatal hospital stay (percentage requiring admission, length of stay), miscarriage, cesarean section rates, induction of labor, fetal birth weight, gestational age at birth or preterm birth (<34 weeks, <37 weeks), frequency of neonatal hypoglycemia, shoulder dystocia, neonatal death, major and minor anomalies, and neonatal intensive care admission.

Official Title
-----------------
Effect of Telemedicine on Outcomes in Pregnant Women With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes, Pregnancy in Diabetic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 diabetics who are at or less than 16 weeks in their pregnancy 18 years of age or more Voluntary participation Exclusion Criteria: <18 years of age Not Type I diabetic

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

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

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 |
| --- | --- | --- |
| HbA1c, maternal glycemic control | maternal glycemic control during pregnancy as measured by HbA1c | first trimester in pregnancy through 6 weeks postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telemedicine, Type 1 diabetes in pregnancy
Dialysis Clinical Outcomes Revisited (DCOR) Trial

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder. Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.

Official Title
-----------------
A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Sevelamer hydrochloride
* Drug: Calcium-based phosphate binder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients must be 18 years of age or older, on dialysis for more than 3 months, require phosphate binder therapy, have Medicare as their primary insurance. Exclusion Criteria: dysphagia, swallowing disorders, severe gastrointestinal motility disorders, bowel obstruction.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sevelamer hydrochloride|nan|
|Drug: Calcium-based phosphate binder|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be evaluated based on a comparison of the association of Renagel use versus calcium-based phosphate binder use on all-cause mortality, cause-specific mortality (cardiovascular, infection, other), and all-cause hospitalization. |  |  | 
| Safety will be assessed based on an evaluation of related serious adverse events. |  |  |
Epidemiological Study to Describe Non-small-cell Lung Carcinoma (NSCLC) Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA

Study Overview
=================
Brief Summary
-----------------
The study is to provide accurate, reliable information on NSCLC clinical management across MENA (Middle East North Africa) countries in order to detect unmet medical needs of this disease, it is a purely observational study; therefore patients are not assigned to a particular therapeutic strategy beforehand by a protocol. Treatment will be according to current clinical practice.

Official Title
-----------------
Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA

Conditions
-----------------
NSCLC Patient Characteristics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed NSCLC diagnosis (e.g. bronchoscope or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between April 1st 2011 and March 31 2012, for PRO sub-sample: ability to read and write since they will be asked to participate in the PRO part of the study. Selection will not be based on the disease stage of each patient, in order to avoid a selection bias Exclusion Criteria: According to the study design there will not be any exclusion criteria in order to provide a high validity and to obtain the most accurate real daily practice information.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient outcomes