linjc16/ctgov huggingface dataset:
Study of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death

Study Overview
=================
Brief Summary
-----------------
As an ancillary study to the KEEPS study (see ClinicalTrials.gov Identifier: NCT00154180), the primary purpose is to measure effects of estrogen vs. placebo in menopausal women, on autonomic function and repolarization; both measured non-invasively via holter monitoring.

Detailed Description
-----------------
The parent study KEEPS, will be a randomized, placebo-controlled double blinded, prospective trial with two active groups and one placebo group. Only patients enrolled in KEEPS will be invited to participate in this ancillary study.Duration of the KEEPS study will be for 4 years after randomization for each study subject, with assessment of the primary endpoint, carotid CIMT, twice at baseline, 12, 24, 36 and 48 months. Ancillary to the KEEPS study, patients will undergo holter monitoring at baseline, 24 and 48 months.Data will be analyzed after 24 and 48 months (corresponding to data analysis of the primary endpoints.) Holter monitors will be put on during the scheduled KEEPS visits, will be worn for 24 hours and will be returned the following day. Effects of estrogen on heart rate variability (HRV) and repolarization parameters will be evaluated, and also correlated with clinical, quality of life, sleep and mood information gathered through the parent study. Anticipated enrollment from the parent study at this site is 90 study subjects. This ancillary does not involve the use of drugs or investigational devices.

Official Title
-----------------
Effects of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death: Autonomic Function and Ventricular Repolarization Heterogeneity ( A KEEPS Ancillary Study)

Conditions
-----------------
Menopausal Women

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participant of the KEEPS parent study: ClinicalTrials.gov Identifier NCT00154180 Exclusion Criteria: non-participants of parent study

Ages Eligible for Study
-----------------
Minimum Age: 42 Years
Maximum Age: 58 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 |
| --- | --- |
| Placebo<br>Observing heart rate variability in placebo and active estrogen preparations | |
| Active estogen<br>Observing heart rate variability in placebo and active estrogen preparations | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability |  | 48 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repolarization parameters |  | 48 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause, Hormone Replacement Therapy, Sudden Cardiac Death
The Relation Between Uric Acid Level and Endothelial Dysfunction in Patients With Polycystic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
There are substantial data demonstrating increased endothelial dysfunction, inflammation and oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the association between serum uric acid level and endothelial dysfunction has not been elucidated yet in these patients. Therefore, in this study, the investigators aimed to examine the relationship between the uric acid level and the ED in normotensive ADPKD patients with preserved renal function.

Detailed Description
-----------------
This is the first study to evaluate the relationship between uric acid and endothelial dysfunction in patients with early stage ADPKD

Official Title
-----------------
Endothelial Dysfunction in Patients With Polycystic Kidney Disease

Conditions
-----------------
Polycystic Kidney, Autosomal Dominant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADPKD patients with normal renal function, Normotensive ADPKD patients Exclusion Criteria: Patients with impaired kidney function, Atherosclerotic disorders, Diagnosis of hypertension, gout, diabetes, Using of insulin, thiazide, allopurinol or uricosuric drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| polycystic kidney ,no hypertension<br>The study evaluated the association of serum uric acid levels with endothelial dysfunction in early ADPKD patients with normal renal function | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of asymmetric dimethylarginine (ADMA) and flow mediated dilatation (FMD) | ADMA,FMD and uric acid measurements were performed to determine endothelial dysfunction in ADPKD patients | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uric acid, polycystic kidney disease
Measuring Sensitivity to Nonignorability

Study Overview
=================
Brief Summary
-----------------
To develop a new statistical index that measures sensitivity to non-ignorability (index of sensitivity to nonignorability, or ISNI) for model-based inferences.

Detailed Description
-----------------
BACKGROUND: Despite a considerable number of recent developments, missing data and associated methodology continues to be an important topic of research in biostatistics, medicine and public health. As investigators begin to understand the limitations of model-based inferences under the assumption of non-ignorable missingness, recent attention has turned to the formulation and implementation of sensitivity analyses. Having a general-purpose index to assess sensitivity to departures from ignorability would be extremely useful to researchers in a variety of fields in the health sciences. This is especially true if the index is relatively easy to compute and interpret. DESIGN NARRATIVE: It would be useful to have a general, easily computed diagnostic that characterizes data sets with respect to their potential for sensitivity to nonignorability. The investigators have developed a diagnostic that measures the effect of small perturbations from ignorability on coefficient estimates in the univariate linear model with missing observations.They will extend their analysis in a number of directions: i) They will develop a general class of diagnostics for Bayes and direct- likelihood inferences, and demonstrate its application to a number of important special cases. ii) They will develop an analogous theory for sensitivity to nonignorability in frequentist estimation and testing. iii) They will develop a general form of the diagnostic for the coarse-date model, a generalization of missing data that includes censoring and rounding as special cases. iv) They will analyze a number of real- world data sets that represent important cases where nonignorability is of interest, including dropout in longitudinal data, censored survival data, and cross-over in clinical trials.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

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 |
| --- | --- | --- |
Plasma GLP1 and Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the predicting role of plasma GLP1 level on major adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo percutaneous coronary intervention.

Detailed Description
-----------------
Acute myocardial infarction (AMI) is associated with high mortality and its prognosis differed among patients. Primary percutaneous coronary intervention (pPCI) is an effective method to treat AMI. To accurately predict adverse outcomes following pPCI in patients with AMI will help doctors develop precise therapeutic strategy in advance. At present how to predict adverse events before pPCI is still controversial. In our previous studies, the investigators found that glucagon like peptide -1 (GLP-1) can improve cardiac function in patients with AMI after PCI, other studies have reported that plasma GLP-1 levels is negatively correlated with CK-MB in patients with AMI, but the relationship between plasma GLP1 and prognosis of AMI patients after PCI has not been reported, the investigators hypothesized that plasma levels of GLP1 is associated with major adverse cardiovascular events (MACE) after pPCI. The investigators planned to evaluate the predicting role of plasma GLP1 level on major adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo percutaneous coronary intervention.

Official Title
-----------------
The Association of Plasma Levels of GLP1 With Prognosis of Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

Conditions
-----------------
Coronary Angiography, Glucagon-Like Peptide 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were eligible if they were 18 years or older and presented within 12 h from the onset of symptoms and signs of acute myocardial infarction to the catheterization laboratory. Exclusion Criteria: Taking drugs of GLP-1 analogue and DPP4 inhibitor Cancer patients

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 |
| --- | --- | --- |
| major adverse cardiovascular events (MACE) after 6 months |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection fractions | measured by transthoracic echocardiography at 3 months . | at 3 months |
PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS

Study Overview
=================
Brief Summary
-----------------
Patients will be randomly assigned into 2 groups: Group A: (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months. Group B: (20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.

Official Title
-----------------
NARROW BAND UVB PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY PRURITIS IN END STAGE RENAL DISEASE PATIENTS

Conditions
-----------------
Refractory Uremic Pruritis

Intervention / Treatment
-----------------
* Device: NB UVB phototherapy
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 20-60 years. End stage renal disease (the last stage(stage 5) of chronic disease which means kidneys are only functioning at 10 to 15 percent of their normal capacity and dialysis or kidney transplant is necessary to stay alive). Refractory uremic pruritis. Exclusion Criteria: Other causes of pruritis (Dermatological or systemic) e.g. atopic, cholestatic liver disease. Photosensitivity. Contraindication or allergy to pregabalin. Patients on antipruritic drugs e.g. antihistamines, steroids, emollients, opioid agonists.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: NB UVB phototherapy<br>(20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months. | Device: NB UVB phototherapy<br>* ultraviolet phototherapy sessions<br>|
| Active Comparator: pregabalin<br>20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months. | Drug: Pregabalin<br>* oral medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 D-itching scale | assessment of degree, duration, direction, disability and distribution of itching | two month |
Paula Method of Exercises in Patients With LARS Syndrome

Study Overview
=================
Brief Summary
-----------------
Sphincter sparing rectal resection surgery, either total mesorectal excision (TME) with a temporary loop ileostomy or partial mesorectal excision (PME), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of Low anterior resection syndrome (LARS). This syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. There is no gold standard therapy designed to treat the root cause of the problems associated with LARS. Paula Method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. The purpose of this study is to evaluate the feasibility of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.

Official Title
-----------------
Paula Method Muscle Exercises in Patients With Low Anterior Resection Syndrome After Sphincter Sparing Rectal Resection: A Feasibility Study

Conditions
-----------------
Low Anterior Resection Syndrome

Intervention / Treatment
-----------------
* Other: Paula Method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over age 18 LARS syndrome (LARS score of 21 or higher) up to 24 months post sphincter sparing rectal resection Able to read, understand and communicate in Hebrew Exclusion Criteria: Pregnancy Actively undergoing Chemotherapy or Radiation Other causes of anal incontinence or bowel dysfunction (ex: Irritable Bowel Syndrome) Concurrent performance of other exercise methods Unable or unwilling to perform the Paula exercises

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paula Method<br> | Other: Paula Method<br>* 12 weeks of Paula Method of Exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in LARS (Low Anterior Resection Syndrome) Score | Decrease of in the LARS Score from baseline measurement to the end of the study measurement. The scale is based on a score of 0-42 . A score of 0-20 indicates the absence of LARS, 21-29- Minor LARS, and 30-42- Major LARS. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paula Method, Sphincter sparing rectal resection, Anal incontinence
Follow-up of Patients With Talocalcaneal Coalitions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to develop a new classification system based on the articular facets involved to cover all coalitions and guide operative planning.

Detailed Description
-----------------
Patients were diagnosed with talocalcaneal coalition using a CT scan, between January 2009 and February 2021. We classified the coalition into four main types according to the shape and nature of the coalition: I, inferiorly overgrown talus or superiorly overgrown calcaneus; II, both talus and calcaneus overgrew; III, coalition with an accessory ossicle; (I-III types are non-osseous coalition) IV, complete osseous coalition. Then each type was further divided into three subtypes according to the articular facets involved. A, the coalition involving the anterior facets; M, the coalition involving the middle facets, and P, the coalition involving the posterior facets.

Official Title
-----------------
Follow-up of Patients With Talocalcaneal Coalitions

Conditions
-----------------
Talocalcaneal Coalition

Intervention / Treatment
-----------------
* Other: talocalcaneal coalition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as talocalcaneal coalition by CT or MRI at the outpatient Underwent arthroscopic talocalcaneal coalition resection due to failure of conservative treatment Exclusion Criteria: The affected side underwent other foot and ankle operations Combined with other ankle diseases Refused to participate in the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: talocalcaneal coalition|patients with talocalcaneal coalition|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT | computerized tomography scan | pre-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI | magnetic resonance imaging | pre-surgery | 
| AFOAS | he American Orthopaedic Foot & Ankle Society score | pre-surgery, one year after sugery | 
| Tegner | the Tegner score | pre-surgery, one year after sugery |
Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

Study Overview
=================
Brief Summary
-----------------
The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.

Detailed Description
-----------------
Epidemic keratoconjunctivitis is a very common disease, some patients developed a complication after the infection wich is corneal infiltration. Topical treatment sometimes helps to avoid loss of visual acuity. Therefore recurrence of the opacities after topical drops is observed. When corneal fibrosis occur is difficult to achieve visual rehabilitation with topical approach. This study evaluate pre and postoperative data of patients with subepithelial fibrosis caused by adenoviral infiltrates submitted to phototherapeutic keratectomy (PTK) using mitomycin C.

Official Title
-----------------
Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates

Conditions
-----------------
Keratitis, Corneal Opacity

Intervention / Treatment
-----------------
* Procedure: PTK with mitomycin in Adenoviral Opacities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: visual acuity worse than 20/40, caused by central subepithelial fibrosis Exclusion Criteria: pregnancy, age less than 18 years-old or more than 80 years-old. diabetes, autoimmune diseases, corneal thickness less tha 400 micron.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PTK with mitomycin in Adenoviral Opacities|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wavefront analysis, anterior segment tomography data, corneal biomechanics data. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTK, corneal opacity, mitomycin
Mapping COVID-19 Spread in a Tertiary Hospital

Study Overview
=================
Brief Summary
-----------------
One of the major problems in suppressing the spreading of an epidemic resides in understanding and monitoring its propagation patterns, and in evaluating how these are modified by enforced policies. The standard solution requires detailed information at the microscopic scales, e.g. how infected people have moved and whom they came in contact with, which is hardly ever available. The researchers propose a novel approach to the study of the propagation of COVID-19, in which a proxy of this information is derived at macroscopic scales. This will be based on two ingredients: the spatiotemporal study in shiny with mathematical models with aggregated or non aggregated data and the reconstruction of functional networks of spreading patterns, and the development of a supporting software.

Official Title
-----------------
Evaluation of the Response of COVID-19 Spread With a Spatiotemporal Analysis in a Tertiary Hospital

Conditions
-----------------
Covid19, Spatial Visualization, Neural Network, Respiratory Disease, Pandemic, Disease Spread

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive test (PCR or serology) for SARS-CoV-2 outpatient follow-up Exclusion Criteria: hospitalisation in ward or ICU

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|just descriptive analysis of clinical data|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spatiotemporal spread | spatiotemporal spread of COVID-19 patient in our hospital | February 1, 2020 to September 30, 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| classification score | risk classification score of each patients with clinical and analytical variables | February 1, 2020 to September 30, 2020 |