linjc16/ctgov huggingface dataset:
Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that very lenient rate control is not inferior to strict or lenient rate control assessed by implantable continuous ECG monitor for preventing cardiovascular hospitalization and mortality in patients with long-standing persistent or permanent atrial fibrillation

Official Title
-----------------
Rate Ventricular Control Therapy by Implantable Continuous Monitor in Patients With Permanent Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: implantable continuous monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Long-standing persistent or permanent atrial fibrillation Mean resting heart rate > 80 beats per minute with or without rate control medication Age < 70 years old Constant use of anticoagulation therapy Exclusion Criteria: Paroxysmal or persistent atrial fibrillation Non-stable heart failure or > III NYHA FC Indications for IPG/CRT/ICD Thyroid dysfunction Inability to walk or bike.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Group 2 (Lenient control <120bpm)<br> | Device: implantable continuous monitor<br>* The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.<br>* Other names: implantable loop recorder;|
| Active Comparator: Group 1 (Strict control <80 bpm)<br> | Device: implantable continuous monitor<br>* The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.<br>* Other names: implantable loop recorder;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for all cardio-vascular events |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 12 months | 
| stroke |  | 12 months | 
| life-threatening arrhythmic and drugs adverse events |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rate control, ILR
The Effect of Endometrial Scratching on Patients With Endometriosis

Study Overview
=================
Brief Summary
-----------------
We aimed to investigate whether endometrial scratching could improve IVF outcomes by enhancing endometrial receptivity in patients with endometriosis.

Official Title
-----------------
The Effect of Endometrial Scratching on Patients With Endometriosis Undergoing IVF Treatment

Conditions
-----------------
Endometriosis, IVF

Intervention / Treatment
-----------------
* Procedure: Endometrial scratching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Endometriosis that surgery or pathology confirmed; 2. normal ovarian reserve; 3. at least one implantation failure history Exclusion Criteria: 1. hydrosalpinx; 2.ademomyosis; 3.endocrine or self-immune disease; 4.serious medical condition; 5.Contraindications of intrauterine operation

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 40 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial scratching group<br> | Procedure: Endometrial scratching<br>* An intrauterine procedure that causes mild endometrial injury<br>|
| No Intervention: Non-scratching group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | pregnancy sacs confirmed by ultrasound | 6-7 weeks of gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis, Endometrial scratching, Endometrial receptivity, IVF, Pregnancy rates
Circulating P3NP and Cardiovascular Events in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates whether circulating levels of aminoterminal propeptide of type III procollagen (PIIINP) can predict the cardiovascular events in hemodialysis patients.

Detailed Description
-----------------
Type III collagen abundantly exists in the cardiovascular system including the aorta and heart. The aminoterminal propeptide of type III procollagen (PIIINP) is an extension peptide of type III procollagen, which is cleaved off stoichiometrically during conversion from type III procollagen to type III collagen and liberated to serum. Elevated serum concentrations of PIIINP are considered a marker of higher collagen turnover and tissue fibrosis including the heart and vascular system. In this study, the investigators prospectively examined whether serum levels of PIIINP could be a biomarker for predicting cardiovascular events in hemodialysis patients.

Official Title
-----------------
Involvement of Circulating Aminoterminal Propeptide of Type 3 Procollagen in Cardiovascular Events in Patients on Hemodialysis

Conditions
-----------------
Cardiovascular Events, Cardiac Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End-stage kidney disease patients who had been undergoing maintenance hemodialysis over one year in Toujinkai Hospital at the point of January 1, 2005 Exclusion Criteria: Histories of coronary events and/or interventions Congestive heart failure of New York Heart Association grades III to IV Moderate or worse valvular heart disease Permanent pacemaker implantation Idiopathic cardiomyopathy Chronic obstructive pulmonary disease Malignancy Acute hepatitis, chronic hepatitis, or liver cirrhosis including carrier of hepatitis virus
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 |
| --- | --- | --- |
| Cardiovascular events | Cardiac deaths, non-fatal acute myocardial infarction, obstructive coronary artery disease needing intervention, vasospastic angina identified by angiography, heart failure needing hospitalization, bradycardia needing pacemaker implantation, dissecting aortic aneurysm, cardiac valvular disease needing valve replacement, peripheral artery disease needing bypass surgery or leg amputation. | January 1, 2005 to January 31, 2011 |
Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma

Study Overview
=================
Brief Summary
-----------------
Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of different workplaces, and is even found in homes. The endotoxin used for this study is obtained from the National Institutes of Health, and is called Clinical Center Reference Endotoxin, or CCRE. The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in your sputum cell samples that the scientists can measure. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation. Eventually, with these types of studies we will be able to examine why some people are more sensitive to endotoxin. Scientists at other universities have found that while most people do not have a considerable lung response to endotoxin at doses as high as 60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our study is designed to identify if using a dose of 20,000 EU causes changes in the lung cells but does not cause symptoms in our study subjects. In our previous studies in our lab, using an endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with asthma with no major problems, and we have used 10,000 EUs of CCRE in subjects with allergies and asthma without problems. We have used 20,000 EUs of CCRE in healthy individuals with no major problems.

Official Title
-----------------
Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma

Conditions
-----------------
Mild Allergic Rhinitis, Mild Allergic Rhinitis With Mild Asthma

Intervention / Treatment
-----------------
* Biological: Clinical Center Reference Endotoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild allergic rhinitis Mild allergic asthma Normal lung function No other chronic illness Exclusion Criteria: Use of inhaled or oral steroids Emergency treatment of asthma in last year Inhaled tobacco use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Clinical Center Reference Endotoxin|single inhalation challenge|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased sputum neutrophils with no adverse events |  | 6 hours post challenge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mild asthma, mild allergies
Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

Study Overview
=================
Brief Summary
-----------------
Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing

Official Title
-----------------
A Randomised, Parallel-group, Double-blind, Placebo-controlled, Multicentre Phase III Trial Assessing the Pharmacodynamic Efficacy and Safety of an Intra-seasonal Short-time Updosing Schedule for Alutard SQ

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: Allergy vaccination (Alutard SQ)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of grass pollen induced allergic rhinoconjunctivitis positive skin prick test Exclusion Criteria: uncontrolled severe bronchial asthma previous treatment with immunotherapy within the previous 5 years contraindication for specific immunotherapy

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allergy vaccination<br>Allergy vaccination by 6 subcutaneous injections to 10,000 SQ-U with 1-3 days intervals, continuation by 2 injections with 10,000 SQ-U with 2-4 weeks intervals | Biological: Allergy vaccination (Alutard SQ)<br>* Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days<br>|
| Placebo Comparator: Subcutaneous injections<br>Placebo injections | Biological: Allergy vaccination (Alutard SQ)<br>* Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Immuno globuline E (IgE)-blocking factor |  | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  | 9 weeks |
Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study

Study Overview
=================
Brief Summary
-----------------
The treatment of Growth Hormone deficiency (GHD) patients with GH, often induce fluid retention; this effect is dose dependent and temporary. The symptoms are swelling of soft tissue and joint stiffness. The objective of this study is to create bioelectric impedance/arm muscle area (BIA/AMA) reference data, as a measurement of hydration status, of healthy persons of both genders in the age 20-70 years.

Detailed Description
-----------------
The treatment of Growth Hormone deficiency (GHD) patients with GH, has since 1994 been approved in several countries. The approval is based on studies that show positive effect on body composition, physiology, lipid profile, bone density and life quality. One often observed side effect is fluid retention; this effect is dose dependent and temporary. The symptoms are swelling of soft tissue and joint stiffness. By comparing the body bioelectric impedance (BIA) with an Arm Muscle Area (AMA) measurement, it is possible to determine the hydrations status of a person. This measurement is a simple and non invasive method to evaluate the GH dosages applied in the treatment of GHD persons. The objective of this study is to create BIA/AMA reference data of healthy persons of both genders in the age 20-70 years.

Official Title
-----------------
Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study

Conditions
-----------------
Growth Hormone Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy persons, Age 20- 70 years. Exclusion Criteria: Cardiac implanter (pacemaker), Heart insufficiency, chronic venuos insufficiency, Use of diuretics, desmopressin, neuroleptica, antidepressants, corticosteroids, fludrocotidon, Obesity (BMI > 30), Knowledge of changes in electrolyte or water homeostasis.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male<br> | |
| Female<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Foveal Cone Outer Segment Tips Line Defect in Macular Pseudohole

Study Overview
=================
Brief Summary
-----------------
Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after surgery for macular pseudohole

Official Title
-----------------
Correlation Between Foveal Cone Outer Segment Tips Line Defect and Visual Acuity After Surgery for Macular Pseudohole

Conditions
-----------------
Macular Psudohole

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patienst with macular pseudo hole Exclusion Criteria: The patients with follow-up less than 6 months

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 95 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vitrectomy<br>Vitrectomy for macular pseudo hole | Procedure: Vitrectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical coherence tomography | Anatomical recovery detected with optical coherence tomography after surgery | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Visual recovery after surgery | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular pseudohole, Cone outer segment tips line
The Effect of Radiation on Semen Quality and Fertility in Men With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Many younger men are diagnosed with prostate cancer. These patients are often choosing radiation therapy as their primary treatment. The effect of this therapy on fertility will have a direct impact on their decision about therapeutic options and fertility preservation. The researchers hypothesize that when patients are treated with radiation for localized prostate cancer, infertility can occur due to direct damage to seminiferous tubules affecting sperm quality.

Detailed Description
-----------------
Prostate cancer is the most common malignant disease among men. Many young men are diagnosed with localized prostate cancer. Some of these men are choosing to manage their prostate cancer with radiation therapy. The radiation therapy delivers minimal dose exposure to adjacent organs. We hypothesize that when patients are treated with radiation therapy for localized prostate cancer, decreased fertility can occur due to damage of seminiferous tubules, which may affect sperm quality. This study will assess the impact of radiation therapy on semen and seminal fluid.

Official Title
-----------------
The Effect of Radiation on Semen Quality and Fertility in Men Treated With External Beam Radiation or Brachytherapy for Early Stage Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with histologically confirmed low risk to moderate stage prostate cancer (Gleason 6 - 7) treated with brachytherapy or external beam radiation > 12 months ago Exclusion Criteria: Subjects with a prior history of infertility Subjects who have undergone vasectomy Subjects who have received LHRH therapy for prostate cancer < 6 months ago Subjects who have received anti-androgens < 3 months ago Subjects using alpha blockers within 7 days of specimen provision Subjects who have taken finasteride or dutasteride within the previous 4 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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
-----------------
Prostate, cancer, brachytherapy, radiation, semen, fertility
Mobile Application and Pregnant Patient Knowledge

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial to investigate the impact of a pregnancy-specific mobile phone application on the knowledge of specific pregnancy topics and guidelines.

Official Title
-----------------
Impact of Mobile Application on Patient Knowledge of Pregnancy Topics

Conditions
-----------------
Pregnancy, Mobile Application

Intervention / Treatment
-----------------
* Behavioral: Mobile Phone Application Educational Resources
* Behavioral: Mobile Phone Application GWG Tracker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older at time of consent (or 16-17 years of age with guardian present) Singleton gestation Exclusion Criteria: Inadequate knowledge of English language Inability to read at or above 8th grade level Prior diagnosis of eating disorder

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study<br> | Behavioral: Mobile Phone Application Educational Resources<br>* Mobile Phone Application Educational Resources<br>Behavioral: Mobile Phone Application GWG Tracker<br>* Mobile Phone Application GWG Tracker<br>|
| Sham Comparator: Control<br> | Behavioral: Mobile Phone Application Educational Resources<br>* Mobile Phone Application Educational Resources<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy-specific topic/guideline questionnaire | Number of participants who correctly answer | Outcome assessed up to 23 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy-specific questionnaire | Description of general patient population knowledge of pregnancy-specific topics and guidelines. | Outcome assessed up to 23 weeks gestation | 
| Gestational weight gain quantification | Quantify total gestational weight gain with and without intervention from final documented weight during pregnancy. | Outcome assessed through study completion, an average of 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Mobile Phone Application