linjc16/ctgov huggingface dataset:
Functional Capacity in Institutionalized Elders

Study Overview
=================
Brief Summary
-----------------
Getting old is a process of transformation of the body that occurs along the vital cycle in a universal and progressive way causing functional restrictions in the human being. The aim of this work was to identify, analyze and quantify the limitations of the functional capacity of the institutionalized elderly who are not provided with physiotherapic assistance.

Detailed Description
-----------------
A descriptive, qualitative, quantitative and transverse field research was made, based on an evaluation of the activities of daily living (ADL) using the Katz Index, with 62 institutionalized elderly people from Casa do Pobre de Maceió, Alagoas, both genders, average age of 77.03 years old and different levels of functions. Activities related to the self care were emphasized. At first, people were classified as independent, partially dependent and totally dependent. According to the Katz Index score, they were classified regarding their functional dependency, which varies from level 0 (a totally independent person) to level 6 (a totally dependent person in the six evaluated functions).

Official Title
-----------------
Evaluation of the Functional Capacity in Institutionalized Elders Who Do Not Receive Physiotherapic Assistance

Conditions
-----------------
Elderly

Intervention / Treatment
-----------------
* Other: Evaluation of the functional capacity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be elderly and a resident of Casa do Pobre de Maceió Exclusion Criteria: Individuals under the age of 60 years and over 90, or received private care or physical therapy who refused to participate in the evaluation

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 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 |
| --- | --- |
| Old-aged people<br> | Other: Evaluation of the functional capacity<br>* An evaluation (questionnaire) was performed by the Katz Index of individuals in this group, including personal issues (sex and age) and different levels of functional independence for the elderly in their basic activities of daily living (ABVD's) such as: bathe, dress, use the bathroom for withdrawals, transfers perform, has control of the sphincters and the food itself. Subject themselves, if capable of responding to the issues of consistency index, did. The answers were given to the auxiliary nurse responsible for care to residents.<br>* Other names: Elderly;|

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
-----------------
Physiotherapy, Aged, Functionality, Physiotherapic assistance, Functional capacity
Rasagiline Tablets Special Drug Use-Results Survey Survey on Long-term Safety

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to evaluate the long-term safety of Rasagiline (AZILECT) in patients with Parkinson's disease in daily clinical practice and also collect efficacy information.

Detailed Description
-----------------
The drug being tested in this survey is called rasagiline tablet. This tablet is being tested to treat people with Parkinson's disease. This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the rasagiline tablet in the routine clinical setting. The planned number of observed patients will be approximately 1000. This multi-center observational trial will be conducted in Japan.

Official Title
-----------------
AZILECT Tablets Special Drug Use-Results Survey Survey on Long-term Safety

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Rasagiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with Parkinson's disease should be surveyed. Exclusion Criteria: -Participants who have contraindications on package insert of rasagiline.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rasagiline 1 mg<br>Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care. | Drug: Rasagiline<br>* Rasagiline Tablets<br>* Other names: AZILECT Tablets (AZILECT is a registered trademark of Teva Pharmaceutical Industries Ltd.);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Had One or More Adverse Events |  | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | UPDRS retains the four-scale structure with a reorganization of the various subscales; (Part I) Mentation, behavior and mood (4 items), (Part II) Activities of daily living (13 items), (Part III) Motor (14 items), and (Part IV) Complications (11 items). Each item on Part III have 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe, some items will be scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome). | Baseline, Up to Month 24 |
Study of Post-operative Oxygen Consumption Following Vascular Surgery

Study Overview
=================
Brief Summary
-----------------
To define any changes in whole body oxygen consumption that occur following major vascular surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and infra-inguinal lower limb revascularisation procedures).

Official Title
-----------------
Study of Post-operative Oxygen Consumption Following Vascular Surgery

Conditions
-----------------
Oxygen Consumption, Aortic Aneurysm, Peripheral Arterial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh Exclusion Criteria: Patient refusal
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open aortic aneurysm repair<br> | |
| Endovascular aortic aneurysm repair<br> | |
| Infra-inguinal lower limb revascularisation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole body oxygen consumption |  | post-operative day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxygen consumption, Aortic Aneurysm, Peripheral Arterial Disease
The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Detailed Description
-----------------
Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Official Title
-----------------
The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer

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

Intervention / Treatment
-----------------
* Procedure: MRI Prostate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prostate cancer Exclusion Criteria: contraindication to MRI

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MRI Prostate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
First in Men Study of Single Oral Doses of ASP1941 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether the intake of food had an effect on the PK of ASP1941 (Part B).

Detailed Description
-----------------
This study consists of two parts. Part A is a double-blind, placebo controlled single dose escalation study to evaluate the safety and tolerability of single ascending doses of ASP1941. Part B is an open label, crossover design food-effect study to evaluate the effect of fed conditions on the PK of ASP1941.

Official Title
-----------------
A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food-effect of Single Oral Doses of ASP1941 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ASP1941
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight between 60-100 kg, body mass index (BMI) between 20-30 kg/m2, inclusive Exclusion Criteria: Fasting Plasma Glucose (FPG) > 6.4 mmol/l HbA1c > 6.2% Pulse <40 or >90 beats per minute; Systolic Blood Pressure (SBP) <90 or >140 mmHg; Diastolic Blood Pressure (DBP) <40 or >95mmHg

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ASP1941|Oral|
|Drug: Placebo|Oral|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests |  | Up to 2 weeks after each administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics calculated by ASP1941 plasma concentration change |  | Up to 72 hours | 
| Pharmacodynamics assessed by ASP1941 glucose concentration changes in blood and urine |  | Up to 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1941, Diabetes Mellitus, First in Men
Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man

Study Overview
=================
Brief Summary
-----------------
Sexual steroids administered to supra-physiological doses are likely to change the carbohydrate and lipid metabolism. Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by the reference method of the hyperinsulinemic euglycemic clamp.

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Biological: Estradiol (Insulin sensitivity)
* Biological: Testosterone (Insulin sensitivity)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypogonadism hypogonadotropic or hypergonadotropic Man aged 18-60 years BMI between 18 and 27. Exclusion Criteria: Other ante-pituitary deficiency Chronic treatment modifying carbohydrate metabolism (thiazides, beta 2 mimetics, steroids ...) Diabetes Obesity diffuse or android Hemochromatosis osteoporosis chronic diseases neoplasia High blood pressure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estradiol<br>dosage used in the study: 1 patch / 3-4 days dosed at 25, 37.5 or 50 mg / 24h titration according to the plasma level, with the objective of a physiological level of estradiol (25-40 pg / ml ) - During 4 weeks | Biological: Estradiol (Insulin sensitivity)<br> <br> |
| Experimental: Testosterone<br>dosage used : from 25 to 75 mg / day of testosterone (ie 2.5 to 7.5 g / day transdermal gel) according to the plasma level, with the goal of a physiological level of testosterone (5-8 ng / ml) - During 4 weeks | Biological: Testosterone (Insulin sensitivity)<br> <br> |
| Experimental: Testosterone + Estradiol<br>Testosterone + Estradiol During 4 weeks | Biological: Estradiol (Insulin sensitivity)<br> <br> Biological: Testosterone (Insulin sensitivity)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp |  | change between baseline and after 4 weeks of treatments |
Safe Traction During Ongoing Lead Extraction Procedure (STOP)

Study Overview
=================
Brief Summary
-----------------
The study will evaluate (in-vitro) the forces that are typically used for the extraction of pacemaker or defibrillator electrodes.

Official Title
-----------------
Safe Traction During Ongoing Lead Extraction Procedure

Conditions
-----------------
Electrode Malfunction, Infections of Cardiac Electronic Implantable Devices

Intervention / Treatment
-----------------
* Other: simulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experience in pacemaker and defibrillator lead extraction Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Physicians experienced in lead extraction<br>Physicians experienced in lead extraction | Other: simulator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forces used for lead extraction |  | 10 Minutes |
Social Behavior in Depression

Study Overview
=================
Brief Summary
-----------------
In the project, investigators basically plan to test the difference in social behavior and social cognition between depressive patients and healthy individuals. To test this, investigators plan to use traditional or novel behavioral experiment paradigms to target various behaviors.

Official Title
-----------------
Social Behavior in Depression

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range between 18 and 60 Education experience above high school Score for Hamilton's Depression Scale >=17 Diagnosis of depression through Scid Exclusion Criteria: Undergoing electric shock treatment in 3 months Excluding those who with bipolar disorder Excluding those who with postpartum depression Excluding those who with hysteria

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosocial behavior | The prosocial behavior will be assessed by conventional economic games, including dictator game, message game, and ultimatum game. | Baseline | 
| Cognitive flexibility | Cognitive flexibility will be assessed by psychological cognitive paradigm, i.e. reversal learning paradigm. The participants will be asked to choose the item with high probability to win reward. | Baseline | 
| Valuation of social information | The valuation of social information was measured by psychological paradigm, developed from animal studies, called pay-per-view. The participants will be asked make decision about more social information or more monetary reward. | Baseline | 
| Optimism bias | Participants will complete two sessions of life event estimation, i.e. estimating their likelihood of experiencing each event on a self-paced basis. | Baseline | 
| Emotion recognition | After viewing a video, participants will be asked to judge the person's attitude in the video. Through this paradigm, investigators could test emotional bias in social interaction in depressive patients. | Baseline | 
| Model-free & model-based tendency | Participants will be asked to complete a two-stage task, by choosing the stimuli with high probability to obtain reward. | Baseline |
The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia

Study Overview
=================
Brief Summary
-----------------
We aimed to determine the prevalence of HAI in medical Tunisian ICUs. Secondary endpoints were to identify the predominant infecting microorganisms and evaluate independent risk factors of HAIs.

Detailed Description
-----------------
In Tunisia, there is no national or regional monitoring system of HAI. It is worth noting that HCAIs in intensive care unit (ICU) are more common and life threatening than in general ward because of the frequent use of invasive procedures and multiple therapies. Controlling this fatal scourge should begin with greater awareness of HAI frequency and ICU ecology. That is why conducting multi-center Tunisian studies is necessary to guide control measurements against HAI and to improve surveillance and infection-control practices. NOSOREA1 study (Tunis Med. 2018 Oct-Nov;96(10-11):731-736) was conducted in 2017 and showed that HAI prevalence within Tunisian ICUs was 25.2% CI 95% [15-35]. Five years later, it is high time to update our finding.

Official Title
-----------------
The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia: NOSOREA2 Study

Conditions
-----------------
Cross Infection, Prevalence, Epidemiology, Critical Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients occupying an ICU bed over a 48-hour period Age >=18 years Exclusion Criteria: no criteria

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 |
| --- | --- | --- |
| Determine the prevalence of healthcare-associated infection in medical Tunisian ICUs | The number of infected patients divided by the total number of patients at the day of the study | September 27th, 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify independent risk factors of HAIs. | Multivariate logistic regression model | September 27th, 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iatrogenic Disease, Cross Infection, Intensive Care Units, Prevalence, Risk Factors, Critical Care