linjc16/ctgov huggingface dataset:
Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young Women Soldiers and Effect on Activity

Study Overview
=================
Brief Summary
-----------------
As combat women soldiers are required to more intensive daily activity the investigators believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as characterized by, anemia iron deficiency and reduced quality of life)) on personal performance will be more significant in combat women soldiers compared to non-combat women soldiers. Using cohorts from the same environment will enable the investigators to better study the effect of menorrhagia and dysmenorrhea eliminating other uncontrolled factors, such as nutrition. The study does not include any intervention.

Official Title
-----------------
Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young Women Soldiers

Conditions
-----------------
Menorrhagia, Dysmenorrhea, Iron Deficiency Anemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women soldiers in the participating units Exclusion Criteria: Lack of consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- |
| Combat women soldiers<br>Women soldiers in combat units | Other: no intervention<br> <br> |
| Non combat women soldiers<br>Women soldiers in non-combat units | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menorrhagia and dysmenorrhea | The prevalence of menorrhagia and dysmenorrhea and association with quality of life will be assessed | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron deficiency | The prevalence of iron deficiency and iron deficiency anemia will be assessed by laboratory tests. | one year |
Re-hospitalized Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The predictors of re-hospitalization of patients with history of acute coronary syndrome

Detailed Description
-----------------
The aim of this retrospective multicenter study is to evaluate the demographic, clinical characteristics and medications of re-hospitalized for new cardiac event in patients with history of acute coronary syndrome within in 12 months.

Official Title
-----------------
Demographic, Clinical Characteristics and Medications of Re-hospitalized Patients for Acute Coronary Syndrome

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age >18 years who had hospitalized for acute coronary syndrome within 12 months Exclusion Criteria: Patients whose previous hospitalizations data are not available Myocardial Infarction, type 2 patients

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 |
| --- | --- | --- |
| Clinical and demographics characteristics of patients re-admitted with acute coronary syndrome | The demographics and clinical characteristics of study population Admissions with an 'I'-group ICD-10 code | Up to 1 year | 
| Cardiovascular Hospitalization | Predictive factors for patients re-admitted with acute coronary | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarction, Hospitalization, Coronary artery disease, Retrospective, Cohort study
Impact of Dairy Products on Postprandial Inflammation

Study Overview
=================
Brief Summary
-----------------
The study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic response to the ingestion of three different meals in obese subjects. The administered meals will differ in the proportion of dairy products. Postprandial response will be monitored during 6 hours after meal consumption.

Official Title
-----------------
The Impact of Dairy Products on Postprandial Inflammation in Obese Males

Conditions
-----------------
Inflammation, Obesity, Nutritional Intervention

Intervention / Treatment
-----------------
* Other: consumption of test meal based on dairy products
* Other: consumption of high fat test meal without dairy products
* Other: consumption of high fat test meal with dairy products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male BMI ≥ 20 kg/m2 age 25-55 y informed consent Exclusion Criteria: Physiological or psychological diseases Allergies to food or intolerance to high-fat meal Vegetarians Chronic intake of drugs Smokers Diabetes mellitus Type I and II Debilitating kidney diseases Debilitating liver diseases Clinically established coronary heart diseases Ingestion of vitamins or dietary supplements during the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high fat meal without dairy products<br>high fat meal without dairy products | Other: consumption of high fat test meal without dairy products<br> <br> |
| Experimental: high fat meal with additional milk<br>high fat meal with additional milk | Other: consumption of high fat test meal with dairy products<br> <br> |
| Experimental: dairy product meal<br>dairy product meal | Other: consumption of test meal based on dairy products<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation markers in blood plasma (IL-6, TNF-alpha) |  | 0,6h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers in blood (serum insulin, plasma glucose, GLP-1, lipids) |  | 0,1,2,4,6h | 
| Endotoxin in blood serum |  | 0,6h |
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Pravastatin for at Least 4 Weeks.

Study Overview
=================
Brief Summary
-----------------
Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least 4 weeks.

Official Title
-----------------
Efficacy of WelChol as an Add-on to Pravastatin Therapy

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: pravastatin tablets and Welchol tablets
* Drug: pravastatin tablets and Welchol placebo tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female > or = to 18 years of age On a stable dose of pravastatin LDL-C > or = to 100 mg/dL and < or = 250 mg/dL Triglycerides < or = to 300 mg/dL Women are not pregnant or breast-feeding or planning to become pregnant Women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control as specified in the protocol Exclusion Criteria: BMI > 40 kg/m2 History of allergic or toxic reaction to colesevelam HCL History of swallowing disorder Any serious condition that would interfere with the conduct of the study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>pravastatin tablets and Welchol tablets | Drug: pravastatin tablets and Welchol tablets<br>* pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks<br>|
| Placebo Comparator: 2<br>pravastatin tablets and Welchol placebo tablets | Drug: pravastatin tablets and Welchol placebo tablets<br>* pravastatin tablets, 1 tablet/day; Welchol placebo tablets, 6 tablets/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy parameter was the percent change in LDL-C from baseline to endpoint. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute change in LDL-C from baseline to endpoint. |  | 6 weeks | 
| The absolute change and % change of total cholesterol from baseline to endpoint |  | 6 Weeks | 
| The absolute change and % change of triglycerides from baseline to endpoint |  | 6 Weeks | 
| The absolute change and % change of HDL-C from baseline to endpoint |  | 6 Weeks | 
| The absolute change and % change of c-reactive protein from baseline to endpoint |  | 6 weeks |
Impact of SARS-CoV-2 Pandemic on Psychological State of Health Care Workers

Study Overview
=================
Brief Summary
-----------------
In COVID-19 pandemic, many health-care workers (HCWs) have worked in high-pressure environments. They have been exposed to and faced moral dilemmas in addition to infection exposure risk are increasing the risk of mental health disorders.

Detailed Description
-----------------
Throughout the SARS-CoV-2 pandemic, many HCWs have worked in high-pressure environments. Moreover, they may have been exposed to trauma and/or faced moral dilemmas relating to challenges in the delivery of high-quality care, possibly due to a lack of experience or equipment, or as a result of low staffing levels. These unfavorable circumstances and exposure risk to infection are likely to increase the risk of mental health disorders such as post-traumatic stress disorder (PTSD) or depression, other anxiety disorders, substance misuse and suicide In the present study, This study aimed to assess the psychological state of HCWs who were facing challenges of SARS-CoV-2pandemic comparing them to non medical staff group based on use of the Hamilton Anxiety and Depression Rating Scale.

Official Title
-----------------
Impact of SARS-CoV-2 Pandemic on Psychological State of Health Care Workers

Conditions
-----------------
SARS-CoV-2

Intervention / Treatment
-----------------
* Other: other


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All health workers team Exclusion Criteria: no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 25 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

| Intervention/Treatment |
| --- |
|Other: other|questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire to assess the psychological impacts of SARS-CoV-2 on health care workers | Impact of SARS-CoV-2 on the Psychology of health care workers | 4 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, SARS-CoV-2, Depression
Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.

Official Title
-----------------
Efficacy of Agomelatine 25mg/Day (With Possible Increase to 50mg/Day After 8 Weeks of Treatment) Given Orally During 16 Weeks in Patients With Obsessive-Compulsive Disorder. A Randomised, Double-blind, Placebo-controlled, Parallel Groups, International Study

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: Agomelatine A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obsessive Compulsive Disorder (OCD) according to Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR), Y-BOCS total score ≥ 20, duration of OCD symptoms of at least one year. Exclusion Criteria: Bipolar disorder, Schizophrenic or Psychotic Disorder Severe or uncontrolled organic diseases Neurological disorder Women of childbearing potential who are not using effective contraception

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 |
| --- | --- |
| Experimental: Agomelatine A<br> | Drug: Agomelatine A<br>* Agomelatine 25 mg film-coated tablet Agomelatine 2x25mg film-coated tablet<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Y-BOCS total score | Yale-Brown Obsessive Compulsive scale (Y-BOCS) total score. This scale measures the severity of obsessive and compulsive symptoms from baseline to W16. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIMH-OC score | National Institute for Mental Health- Obsessive Compulsive scale (NIMH-OC) Total Score. This scale measures the severity of obsessive and compulsive symptoms from baseline to week 16. | 16 weeks | 
| MADRS total score | Montgomery and Asberg Depression rating scale (MADRS) Total score. This scale measures the severity of depressive symptoms from baseline to week 16. | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obsessive Compulsive Disorder, Agomelatine
18790 - Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor (SPF) efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment-Darkening Dose (MPPD)

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY 987516)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurnace Portability and Accountability Act) Form An unbmbiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been dianoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: BAY 987516<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY 987516)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment DArkening Dose (MPPD) |  | Up to 15 minutes |
Metamizol for the Treatment of Neoplastic Chronic Pain

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the efficacy of metamizole in reducing morphine requirements in patients with moderate to severe chronic cancer pain in comparison to administration of placebo or diclofenac.

Official Title
-----------------
Analgesic Effect of a New Metamizol Oral Pharmaceutical Form for the Treatment of the Neoplastic Chronic Pain: Randomized, Double-blind Crossover Clinical Trial Between Metamizol, Diclofenac and Placebo

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Metamizole
* Drug: Diclofenac
* Drug: Diclofenac placebo
* Drug: Metamizole placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with neoplastic chronic pain requiring morphine treatment Exclusion Criteria: Karnofsky index less than 30%

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metamizole - Diclofenac<br>metamizole followed by diclofenac | Drug: Metamizole<br> <br> Drug: Diclofenac<br> <br> Drug: Diclofenac placebo<br> <br> Drug: Metamizole placebo<br> <br> |
| Experimental: Diclofenac - Metamizole<br>diclofenac followed by metamizole | Drug: Metamizole<br> <br> Drug: Diclofenac<br> <br> Drug: Diclofenac placebo<br> <br> Drug: Metamizole placebo<br> <br> |
| Experimental: Metamizole - Placebo<br>metamizole followed by placebo | Drug: Metamizole<br> <br> Drug: Diclofenac placebo<br> <br> Drug: Metamizole placebo<br> <br> |
| Experimental: Placebo - Metamizole<br>placebo followed by metamizole | Drug: Metamizole<br> <br> Drug: Diclofenac placebo<br> <br> Drug: Metamizole placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in morphine requirement |  | Baseline, 9 days |
Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)

Study Overview
=================
Brief Summary
-----------------
This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune Diabetes in Adult (LADA).

Official Title
-----------------
A Placebo-Controlled Study to Investigate the Impact of Diamyd® on the Diabetes Status of Patients With LADA (Latent Autoimmune Diabetes in Adult)

Conditions
-----------------
Latent Autoimmune Diabetes in Adult (LADA)

Intervention / Treatment
-----------------
* Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Male and female patients between 30-70 years of age diagnosed with type 2 diabetes within 5 years Presence of GAD65 antibodies Detectable C-peptide level Patients requiring treatment with diet and/or oral hypoglycaemic agents (OHA) Written informed Consent Key Exclusion Criteria: Treatment with insulin Intolerance to OHA Secondary diabetes mellitus History of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma, neurological disease, alcohol or drug abuse, HIV, hepatitis) Treatment with any vaccine within one month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose Participation in other clinical trials with a new chemical entity within the previous 3 months Pregnancy (or planned pregnancy within one year after 2nd administration) Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study Significant illness other than diabetes within 2 weeks prior to first dosing Unwillingness to comply with the provisions of the protocol Clinically significant history of acute reaction to drugs in the past Treatment with immunosuppressants

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)|20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The development over time of safety variables, i.e. injection site discomfort, vital signs, laboratory values and AEs/SAEs as well as development of diabetes status, i.e. HbA1c, C-peptide, blood glucose and insulin requirement. |  | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, LADA, Latent Autoimmune Diabetes in Adult, Autoimmunity, HbA1c, C-peptide