linjc16/ctgov huggingface dataset:
Single Blind Randomized Study to Determine the Sensitivity and Specificity of 2 Non-invasive Markers of Early Coronary Disease

Study Overview
=================
Brief Summary
-----------------
Diagonal ear lobe crease and microcirculatory disorder in the conjunctiva are both non invasive methods documented in the literature as early signs of coronary artery disease. We wish to study the sensitivity and specificity of both signs by conducting a single blind study involving patients with documented presence or absence of coronary artery disease via angiogram.

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 20 to 70 years old angiogram within past 12 weeks stable during post angio period willing to provide informed consent Exclusion Criteria: previous eye surgery including cataract surgery previous ophthalmologic disorders previous surgeries involving ears or ear lobes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Presence of coronary disease<br>All patients with or without coronary disease who are followed in coronary clinics or wards | |
| coronary disease<br>Is coronary disease associated with tortuosity of vessels Patients seen in cardiology clinics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of tortuosity of conjunctival vessels |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD, microangiopathy, patients, more likely, to have tortuosity, of conjunctival vessels
Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life. To date, the effect of systemic lupus on quality of life has only been described using generic questionnaires. Among the specific questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows interesting psychometric properties. The determinants of quality of life specifically related to the disease are still unknown and could be studied using a longitudinal cohort thanks to the French version of the LupusQol.

Conditions
-----------------
Lupus Erythematosus

Intervention / Treatment
-----------------
* Other: Questionnaire about quality of life and satisfaction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients meeting ACR 1997 classification criteria for systemic lupus erythematosus. Patients able to understand written and spoken French. Patients aged from 18 to 75 years Patients who have received written and oral information about the research. Exclusion Criteria: - Patients aged less than 18 years Patients aged more than 75 years Severe mental retardation Any impairment of abilities to understand that make self-evaluation impossible

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lupus erythematosus<br> | Other: Questionnaire about quality of life and satisfaction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| data for quality of life and satisfaction | Quality of life and satisfaction will be evaluate by questionnaire as Questionnaire SLEQOL, QUESTIONNAIRE LUPUSQOL, QUESTIONNAIRE MFI-20 | participants will be followed for the duration of hospital stay, an expected average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical data | Question about any recent hospitalization pregnancy contraception Compliance score of Girerd Fatigue score MFI-20 tobacco consumption Score of CES-D depression Score stress response WCC | participants will be followed for the duration of hospital stay, an expected average of 3 months |
Fibromyalgia in Rheumatiod and Psoriatic Patients

Study Overview
=================
Brief Summary
-----------------
the study based on investigate for fibromyalgia among rheumatiod arthritis patient and psoriatic arthritis.....and to what extent gibromyalgia affect disease activity indices ....and its relation to serum Vitamin D level in those patients

Official Title
-----------------
Fibromyalgia in Rheumatiod and Psoriatic Arthritis Patients:Relationshipwith Disease Activity and Serum Vitamin Dlevel

Conditions
-----------------
Fibromyalgia, Secondary

Intervention / Treatment
-----------------
* Diagnostic Test: Serum vitaminDlevel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - adult onset disease any patient diagnosed as rheumatiod arthritis and psoriatic arthritis above18years old Exclusion Criteria: any other autoimmune diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Rheumatiod arthritis patients<br> | Diagnostic Test: Serum vitaminDlevel<br>* Investigate about fibromyalgia in psoiaritic and rheumatiod arthritis patients ...and assesment of seum vitamin D level<br>|
| Psoaritic arthritis<br> | Diagnostic Test: Serum vitaminDlevel<br>* Investigate about fibromyalgia in psoiaritic and rheumatiod arthritis patients ...and assesment of seum vitamin D level<br>|
| Control group<br> | Diagnostic Test: Serum vitaminDlevel<br>* Investigate about fibromyalgia in psoiaritic and rheumatiod arthritis patients ...and assesment of seum vitamin D level<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum vitamin D level | Blood test to asses hypovitaminosis in these patients | One year |
The Role of Narrow-Band Imaging Endoscopy in Diagnosing Gastric Intestinal Metaplasia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if endoscope with NBI(narrow banding imaging)can detect intestinal metaplasia( consider pre malignant condition) and use a targeting biopsy in case of suspected intestinal metaplasia

Detailed Description
-----------------
To detect intestinal metaplasia which consider pre malignant condition and use a targeting biopsy in case of suspected intestinal metaplasia which allowed us to better follow-up those patients.

Official Title
-----------------
Observational: Studies in Human Beings Health Outcomes

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Procedure: Gastric mucosal biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dyspepsia Exclusion Criteria: Pregnancy, Upper gastrointestinal bleeding, Previous gastric operation, Known gastric malignancy' Non cooperative patients

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Seventy dyspeptic consecutive patients that going upper gastrointestinal endoscopy | Procedure: Gastric mucosal biopsy<br>* Using upper gastrointestinal endoscopy with targeting biopsy in patients with dyspepsia<br>* Other names: patients ith dyspepsia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if endoscope with NBI can detect intestinal metaplasia |  | In one week (the time from biopsy till the histology assement) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NBI, gastroscopy, biopsy, intestinal metaplasia
Endometriosis, Food Consumption and Fertility

Study Overview
=================
Brief Summary
-----------------
To investigate parameters related to fertility in women with endometriosis in relation to food items.

Detailed Description
-----------------
The study has been reviewed and accepted by the legal registrations in Denmark (The Regional Committee on Biomedical Research Ethics and The Danish Dataprotection Agency). The data will be anonymous and kept as described by the Danish register law.

Official Title
-----------------
A Study on the Differences in Inflammatory Markers Between Women With Endometriosis and Women Without in Relation to Fertility and Food Consumption.

Conditions
-----------------
Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fertility patients Exclusion Criteria: mental challenges

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 41 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fertility patients<br>Women with endometriosis compared to women without endometriosis. Different samples will be collected (blood, follicular fluid, cells from the uterus) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of Free Fatty Acid in follicular fluid will be different in women with endometriosis compared to controls |  | The fluid will be collected, frozen and tested december 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| methylation pattern of specific genes in the endometrium | The cells will be collected from infertile women with or without endometriosis, frozen and tested later. | Collecting of cells and testing december 2014 |
Switching to Duloxetine From Other Antidepressants

Study Overview
=================
Brief Summary
-----------------
A multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression. The study compares outcomes associated with two methods of switching from current antidepressant to duloxetine

Official Title
-----------------
Switching to Duloxetine From Other Antidepressants: A Regional Multicentre Trial Comparing Two Switching Techniques

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female outpatients of at least 18 years of age, who meet criteria for Major Depressive Disorder (MDD) Currently non- or only partially-responsive to an SSRI antidepressant after at least 5 weeks of treatment Exclusion Criteria include: Current primary Axis I disorder other than MDD Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders Patients judged to be at serious suicidal risk. Serious medical illness

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: Duloxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy, health outcomes, safety and tolerability associated with the above two switching methods, as measured by HAMD17, CGI-S, PGI-I, SF-36, spontaneously reported adverse events , vital signs and other measures. |  |  |
Genetic Studies in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the specific genetic alterations associated with breast cancer. This will leat to a better understanding of the genetic causes of breast cancer.

Detailed Description
-----------------
It is estimated that 175,000 new breast cancer cases and 44,5000 cancer deaths will result from female breast cancer in 1991. One of the most important risk factors is a family history of breast cancer. A susceptibility allele which accounts for a large proportion of familial breast cancer has been localized to chromosome 17q and attempts to clone the susceptibility are proceeding rapidly. The existence of recognized susceptibility loci and the awareness of a significan proportion of genetic predisposition and the associated penetrances remain unknown and are impossible to estimate without bias from previous studies. This study is designed to estimate heterogeniety and prenetrance in a series of unslected families, identify additional breast cancer susceptibility locs, as well as provide resources for gene isolation and mutation analysis studies.

Official Title
-----------------
Genetic Studies in Breast Cancer

Conditions
-----------------
Breast Cancer, Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with breast cancer under age 41 patient with bilateral breast cancer 41-50 years old or 41-50 years old with a first degree relative (mother, sister, daughter) with breast cancer diagnosed under age 50 patient with ovarian cancer with first degree relative with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 60 patient any age with either ovarian or breast cancer who have 2 first degree rleatives with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 50 relatives of any of the above patients will be included in this trial if a genetic abnormality is found in the patient's blood sample Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
Female

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
-----------------
Breast Cancer, Ovarian Cancer, Family History, Genetic Studies
Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, placebo-controlled, randomized study lasting 8 weeks. Purpose of the study is two-fold: first, to use a pharmacological agent to treat symptoms of PTSD, and second, to explore neurobiological mechanisms of action of guanfacine.

Detailed Description
-----------------
Subject population is comprised of 100 persons with PTSD. 50 patients will receive guanfacine and 50 patients will receive a placebo. Guanfacine is prescribed at 1 mg/day and may be increased to 2 mg/day. Samples of plasma MHPG will be collected weekly. Clinical ratings of PTSD anxiety and depression, as well as vital signs, will be assessed weekly. Repeated measures analysis of variance will assess significance of main effect of drug, time, and drug by time.

Official Title
-----------------
Guanfacine for the Treatment of PTSD

Conditions
-----------------
Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Drug: guanfacine


Participation Criteria
=================
Eligibility Criteria
-----------------
Males and females, age 18-65 Diagnosis of PTSD from combat or civilian trauma No major medical problems such as diabetes, cardiovascular disease Taking no psychiatric medication, or taking only one SSRI antidepressant

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

| Intervention/Treatment |
| --- |
|Drug: guanfacine|nan|

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
-----------------
PTSD
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

Study Overview
=================
Brief Summary
-----------------
To determine if fBT+sRT is superior to standard care in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL

Detailed Description
-----------------
In this Phase IIR trial investigators primarily seek to determine if fBT boost (15Gy) to SBRT (35Gy/5) can be shown to be superior to standard care (whole-gland BT boost 15Gy to RT 37.5Gy/15) in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL as measured by ePRO (EPIC-26) at 12 and 24 months post completion of therapy.

Official Title
-----------------
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

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

Intervention / Treatment
-----------------
* Radiation: focal brachytherapy boost to SBRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of prostate cancer planned for curative-intent HDR brachytherapy boost to external beam radiotherapy to the prostate gland. ECOG 0-1 Charlson Comorbidity Index ≤ 4 Imaging visible disease encompassing < 50% of the prostate gland and consistent with biopsy findings. Exclusion - none
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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: focal brachytherapy boost to SBRT|As above|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Quality of Life | EPIC | 12-24 months |
Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).

Official Title
-----------------
A Randomised, Open-Label Phase 3 Trial Comparing Amrubicin Versus Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: Amrubicin hydrocloride
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) 1 or 2 prior chemotherapy regimen including 1 platinum-based chemotherapy 20 or older but younger than 75 years of age Exclusion Criteria: Symptomatic brain metastasis Interstitial pneumonia or pulmonary fibrosis Abnormal cardiac function or myocardial infraction within 6 months before study enrollment Active infection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 AMR<br> | Drug: Amrubicin hydrocloride<br>* AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.<br>|
| Active Comparator: 2 DOC<br> | Drug: Docetaxel<br>* DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 3.3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 12 months | 
| response rate (RECIST) |  | 3 months | 
| Number of Participants with Adverse Events |  | 4 months |