linjc16/ctgov huggingface dataset:
Detection no Invasive of a Silent Myocardial Ischemia

Study Overview
=================
Brief Summary
-----------------
The pathophysiological features of myocardial diabetic subject combined with cardiac autonomic neuropathy were behind the quietness of myocardial ischemia, known as silent myocardial ischemia (IMS). These patients have the risk to remain asymptomatic until the sudden onset of a myocardial infarction, or even sudden death. That is why the investigators want to evaluate the contribution of non-invasive tools to stand in the diagnosis of IMS patients with diabetes type 2, asymptomatic heart on map: Technical myocardial speckle tracking in studying strains overall average left ventricular (longitudinal, circumferential and radial) measured in 2D and 3D at rest, compared to stress echocardiography with dobutamine (ESD)

Official Title
-----------------
Silent Myocardial Ischemia in Patients With Diabetes Type 2: Diagnostic Value of Myocardial Strains Left Ventricular Resting Echocardiography 2D and 3D, Compared to Stress Echocardiography

Conditions
-----------------
Silent Myocardial Ischemia, Type 2 Diabetes

Intervention / Treatment
-----------------
* Device: echography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With at least two cardiovascular risk factors including: hypertension, dyslipidemia, smoking active or interrupted for less than 3 years, family history (relatives of the 1st degree) Accident major CV before 60. Or whatever the level of risk factors: peripheral artery disease and / or carotid atherosclerosis, or proteinuria Exclusion Criteria: Valvular heart disease (severe to moderate valvular ) , hypertrophic , dilated , chronic lung History of cardiotoxic chemotherapy Atrioventricular blocks of degree Asthma Recent stroke within a month Bilateral carotid stenosis tight Glaucoma untreated narrow angle Subject to exclusion period (determined by a previous study or in progress) Inability to give informed about information patient under judicial protection patient guardianship or curatorship Current pregnancy (women of childbearing age ) Breastfeeding

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: echography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic of the silent myocardial ischemia |  | 80 minutes |
KTP (Potassium-titanyl-phosphate) Laser Versus TUR-P (Transurethral Resection of Prostate)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to TUR-P.

Official Title
-----------------
The Effect of KTP Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia (BPH), a Prospective Randomized Study

Conditions
-----------------
BPH (Benign Prostatic Hyperplasia)

Intervention / Treatment
-----------------
* Device: Green light Laser
* Device: Transurethral Resection of the Prostate (TURP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men undergoing surgery for BPH Exclusion Criteria: Previous prostate surgery Carcinoma of the prostate Neurogenic bladder Bladder carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Green Light Laser<br> | Device: Green light Laser<br>* Laser vs TURP<br>Device: Transurethral Resection of the Prostate (TURP)<br>* Laser vs TURP<br>|
| Active Comparator: TURP<br>Transurethral Resection of the Prostate | Device: Green light Laser<br>* Laser vs TURP<br>Device: Transurethral Resection of the Prostate (TURP)<br>* Laser vs TURP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS (International Prostate Symptom Score) | symptom | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAN-PSS (Danish Prostate Symptom Score) | symptom | 3, 6 and 12 months | 
| Maximum flow rate (Qmax) |  | 3, 6 and 12 months | 
| Residual urine |  | 3, 6 and 12 months | 
| Length of catheterization |  | Postoperative recovery | 
| Length of hospital stay |  | Postoperative recovery | 
| Perioperative bleeding |  | Time of operation | 
| IIEF (International Index of Erectile Function questionnaire) | Erectile Dysfunction | 12 months | 
| TRUS (transrectal ultrasound) | Measurement of prostate size | 12 months |
A Usability Study of External Neuromodulation With iTEAR100 Generation 2

Study Overview
=================
Brief Summary
-----------------
A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment.

Detailed Description
-----------------
A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment. Subjects sign a consent form and are sent a device. After downloading a mobile app, they can access the device and download a prescription. At 7 days, an official telehealth visit evaluates their success in the set up and training. At 30 days, the trial ends, A usability survey and symptom evaluation survey are used to determine success.

Official Title
-----------------
A Usability Study of External Neuromodulation With iTEAR100 Generation 2

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Device: iTEAR100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to sign English language consent form and over age 18 and reside in the U.S. - Exclusion Criteria: -

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Open Label Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: iTEAR100 Therapy<br>Treatment Arm. Assessment of usability of generation 2 connected devices | Device: iTEAR100<br>* Controlled Stimulation External Nasal Nerve to stimulate tear production<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | Subjects rate the device usability similar to daily mobile applications and home devices using a scale from -3 to +3 with 0 being same as every day devices such as bank application, restaurant application, etc. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Scores | OSDI and SPEED standard symptom scores | 30 days | 
| Adverse Events | Skin Damage, Headache, Dizziness, Sneezing | 30 days | 
| Symptom Score | SPEED standard symptom score | 30 Days |
Smoking Treatment in HIV Clinical Care Settings

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate and compare the efficacy and cost effectiveness of 3 smoking cessation treatments with HIV-positive cigarette smokers. The treatments include face-to-face individual counseling, a computer-Internet-based self-help treatment and a self-help manual treatment.

Conditions
-----------------
Nicotine Dependence

Intervention / Treatment
-----------------
* Behavioral: Internet-based smoking treatment
* Behavioral: Individual Counseling
* Behavioral: self-help


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive 18 years or older smoking most days during the past month must be able to read English Exclusion Criteria: any contraindications for over-the-counter nicotine replacement treatment active psychotic symptoms severe cognitive deficits/dementia

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet<br>Individual counseling + nicotine replacement. 6 sessions across a 3 month period. | Behavioral: Internet-based smoking treatment<br>* All participants have access to an Internet-based self-help intervention that includes social support through message boards. All participants have access to 10 weeks of nicotine replacement treatment.<br>|
| Experimental: Counseling<br>Individual counseling plus nicotine replacement treatment. | Behavioral: Individual Counseling<br>* Six individual counseling sessions are provided over a 12 week treatment period. Participants also have access to a 10-week nicotine replacement treatment.<br>|
| Active Comparator: Self-Help<br>Self-help Manual plus nicotine replacment treatment. | Behavioral: self-help<br>* Participants receive a self-help manual and have access to a 10 nicotine replacement treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 day point prevalence biochemically verified abstinence rates |  | 3, 6, 9, and 12 months following treatment initiation |
Psycho-Social Well Being Following Stroke

Study Overview
=================
Brief Summary
-----------------
Multicenter randomized controlled trial (RCT) testing the effect of a dialogue-based psychosocial intervention for stroke acute survivors in primary care one to six months poststroke. Primary outcome is psycho-social health and wellbeing, measured by GHQ28 (primary outcome) and SAQoL (secondary outcome). 400 stroke survivors are randomized into intervention group or control group. Patients are followed up for 12 months.

Official Title
-----------------
Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Dialogue-based psychosocial rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being adults (over 18 years old), suffered an acute stroke within the last month, medically stable, sufficient cognitive functioning to participate (assessed by their physician/stroke team and acceptable Raven's score (see below), interested in participating, able to understand and speak Norwegian, and able to give informed consent. Exclusion Criteria: moderate to severe dementia or other serious disease. Persons with aphasia will be examined by a speech therapist and excluded if they have significant impressive aphasia or severe expressive aphasia inconsistent with participating in the dialogues.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dialogue-based psychosocial intervention<br>Participants receive six individual meetings with trained health care professional in additional to usual rehabilitation and care. Dialogues focus on individual psychosocial challenges and needs and provide emotional and informational support to encourage and facilitate coping. | Behavioral: Dialogue-based psychosocial rehabilitation<br> <br> |
| No Intervention: Usual care Control group<br>Participants receive usual rehabilitation and care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Health Questionnaire (GHQ 28) | 28 item general scale measuring emotional distress. Four subscales (somatic symptoms, anxiety/insomnia, social dysfunction and serious depression | T2 (6 months poststroke) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Stroke and Aphasia Quality of Life scale (SAQOL-39) | Disease-specific quality of life scale, measures patient's perspective of stroke's impact on 'physical', 'psychosocial' and 'communication' domains. | T2 (6 months poststroke) |
Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)

Study Overview
=================
Brief Summary
-----------------
Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its outcome has not been improved despite the knowledge on inflammatory processes; a reason for these lack of results may lay on the lack of data on the precise dynamics of inflammatory and anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring of the inflammatory process on a small group of non-immunocompromised patients. Our goal is to obtain quality data, repeated over time, by limiting the technical variability.

Detailed Description
-----------------
The aim is to obtain precise data on the dynamics of cytokines, oxydative stress and hormonal response on immunocompetent adults during septic shock.

Official Title
-----------------
Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)

Conditions
-----------------
Immunocompetent Patient on Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years admitted in ICU. Clinical evidence of infection, suspected or proved, during the 48hrs following the hospital entry. Systemic inflammatory response syndrome. Shock defined as arterial hypotension (<90mmHg)not responding to adequated filling. Exclusion Criteria: Minors Patient under guardianship or trusteeship Pregnant or lactating women Not affiliated to the social security Deprived of liberty by court decision Patients hospitalised without their approval Shock related to another cause than infection Long term corticothérapy On-going chemiothérapy, AIDS Bedridden patient

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 |
| --- | --- | --- |
| Evolutive profile of the inflammatory response during septic shock |  | Hospitalisation in ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Research for early prognosis factors |  | Hospitalisation in ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Septic shock, Inflammatory process, Cytokines, Hormonal response, Oxydative stress
Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial was conducted in Russian Federation. This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.

Official Title
-----------------
Effect of Biphasic Insulin Aspart 30 on Glycaemic Control in Subjects With Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes, currently treated with one or more oral hypoglycemic agent HbA1c: At least 8.0% Exclusion Criteria: Impaired hepatic, renal or cardiac function

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 16 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-measured 7-point capillary plasma glucose profile |  |  | 
| Change in body weight |  |  | 
| Incidence of hypoglycaemic episodes and adverse events |  |  | 
| Quality of Life |  |  |
PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
We are evaluating the effect of methylene blue and visible light activation on the microbiome of the skin.

Detailed Description
-----------------
Antiseptics are routinely utilized to prevent infections of vascular catheters. We are evaluating the addition of methylene blue and light activation on skin to determine whether this inexpensive and non-toxic treatment can decrease skin pathogens and prevent blood stream infections of long-term vascular catheters. This is a pilot study of normal volunteers to determine the effect on the microbiome of the addition of methylene blue and light activation on antiseptic-treated skin.

Official Title
-----------------
PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Normal Volunteers

Conditions
-----------------
Light; Therapy, Complications

Intervention / Treatment
-----------------
* Procedure: Methylene blue and light treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal individuals without skin problems Exclusion Criteria: Smokers Diabetics Atopic dermatitis G-6-PD deficiency Eczema Other skin conditions Allergies to methylene blue or chlorhexadine

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Chloroprep and biopatch<br>Both arms are cleaned with chloroprep and a biopatch is placed on each arm. | |
| Experimental: Methylene blue and light treatment<br>Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals. | Procedure: Methylene blue and light treatment<br>* Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the skin microbiome after methylene blue treatment | We compared the two arms of each subject --one arm treated with chloraprep and a biopatch [routine treatment of skin] to the routine treatment with the addition of methylene blue spray and light activation. The microbiome of both skin areas were assessed before and after the routine treatment and the treatment with the addition of methylene blue therapy; | 1 week |
The Development of Pancreatic Injury in the Course of Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Study Overview
=================
Brief Summary
-----------------
Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common. In this study, it was aimed retrospective analysis of clinical and laboratory data of patients who developed pancreatic injury in the course of COVID 19 disease.

Official Title
-----------------
Pancreatic Injury in Patients With COVID-19 Disease

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Other: biochemical analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with amylase and lipase levels measured during covid-19 disease with or without pneumonia Exclusion Criteria: Patients with pregnancy Patients whose amylase and lipase levels were not measured during covid 19 disease Patients with known solid organ malignacy Patients with known hematologic malignacy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| patients with pancreatic injury<br>patients with higher amylase and lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection | Other: biochemical analysis<br>* cRP, d-dimer levels and lymphocyte counts will be compared<br>|
| patients without pancreatic injury<br>patients with normal amylase and lipase levels in the course of SARS-CoV-2 infection | Other: biochemical analysis<br>* cRP, d-dimer levels and lymphocyte counts will be compared<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare presence of fever in patients with and without pancreatic injury | To evaluate the frequency of presence of fever in patients with and without pancreatic injury | 3 month | 
| to compare presence of dyspnea in patients with and without pancreatic injury | To evaluate the frequency of presence of dyspnea in patients with and without pancreatic injury | 3 month | 
| To compare cRP levels in patients with and without pancreatic injury | CRP levels will be compared in patients with and without pancreatic injury | 3 month | 
| To compare d-dimer levels in patients with and without pancreatic injury | D-Dimer levels will be compared in patients with and without pancreatic injury | 3 month |