linjc16/ctgov huggingface dataset:
The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: Bathing in sweet or mineral water can induce significant physiological changes in several body systems including the endocrine system. To date, there have only been a small number of reports that balneology can reduce blood sugar Levels in patients with type 2 diabetes mellitus (DM]. OBJECTIVE: To compare the effects of a immersion in sweet or mineral water on blood glucose levels in patients with type 2 DM. METHODS: Forty patients with type 2 DM will immerse in either sweet or mineral water twice daily. In both cases the water will be warmed to a temperature of 35 degrees C and the bath continue for 20 minutes.

Official Title
-----------------
The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients

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

Intervention / Treatment
-----------------
* Procedure: Dead Sea water
* Procedure: Pool water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uncontrolled type 2 diabetes mellitus patients(HbA1c levels between 7.5-10) Ages 18-65 Signed Informed Consent Exclusion Criteria: Peripheral neuropathy Diabetic ulcers or damaged skin PVD Diabetes diagnosis for over 20 years Orthostatic Hypotension

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dead Sea Water<br> | Procedure: Dead Sea water<br>* Subjects will immerse in mineral (dead sea) waters for twenty minutes twice daily for a period of 10 days<br>|
| Sham Comparator: Pool Water<br> | Procedure: Pool water<br>* Subjects will immerse in sweet(pool)waters for twenty minutes twice daily for a period of 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Levels |  | participants will be followed for the duration of hotel stay, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels |  | three months afer intervention |
Optimal Multimodal Analgesia in Abdominal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).

Detailed Description
-----------------
Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups, for patients admitted for planned abdominal hysterectomy with or without BSO: A: standard of care (SOC) receiving paracetamol, celecoxib, epidural analgesia, dexamethasone, ondansetron and droperidol, and general anaesthesia with propofol, remifentanil and cisatracurium B: SOC with sham epidural analgesia, preoperative gabapentin, intraoperative lidocaine, s-ketamine and sufentanil

Conditions
-----------------
Planned Abdominal Hysterectomy

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: Lidocaine
* Drug: S-ketamine
* Procedure: Epidural analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned abdominal hysterectomy with or without BSO Age above 18 years Written informed consent American Society of Anesthesiologists (ASA) class I-III Exclusion Criteria: Planned vaginal or laparoscopic hysterectomy Hysterectomy as part of other surgery Allergy to part of the treatment regimen Previous reactions to opioids (nausea, cognition) Previous inability to place correct epidural catheter Severe state anxiety according to the OCAP or STAI ASA class IV Dependency on alcohol, opioids or central stimulants Chronic pain condition Hemorrhagic diathesis Participation in another study

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

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

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: Gabapentin|nan|
|Drug: Lidocaine|nan|
|Drug: S-ketamine|nan|
|Procedure: Epidural analgesia|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative abilities over time |  |  | 
| Discharge time from PACU according to fixed criteria |  |  | 
| Consumption of analgesics and antiemetics in the PACU |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of nursing requirements at the PACU |  |  | 
| General tolerability of the regimes |  |  | 
| Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively |  |  |
The Impact of COVID-19 Pandemic to Trauma Patients in Emergency Department: A Multicenter Experience of Istanbul

Study Overview
=================
Brief Summary
-----------------
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.

Detailed Description
-----------------
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The investigators hypothesize that since the number of hospital applications expected to be decreased due to trauma during the COVID-19 period, the level of hospital trauma applications changed. Thus, the aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.

Official Title
-----------------
The Impact of COVID-19 Pandemic to Trauma Patients in Emergency Department: A Multicenter Experience of Istanbul

Conditions
-----------------
Trauma, Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: COVID-19 PCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: accepted to participate with an informed consent trauma patients who admitted to the study centers Exclusion Criteria: lack of informed consent lack of data

Ages Eligible for Study
-----------------
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: COVID-19 PCR|Nasopharyngeal samples were analyzed by PCR for the detection of Novel Coronavirus 2019 DNA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trauma admissions | within the study period, trauma patients who admitted to any of the seven study centers will be recorded. | 3 months |
Psychiatric Day Hospital Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to compare the effectiveness of acute psychiatric day care to conventional inpatient care within a cross-national multi-site randomised controlled trial.

Conditions
-----------------
Depressive Disorders, Schizophrenia, Anxiety Disorders, Personality Disorders, Adjustment Disorders

Intervention / Treatment
-----------------
* Behavioral: acute psychiatric day care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have presented with a mental disorder with current symptoms that had either led to at least a moderate disturbance in performance in more than one area of daily living or had jeopardized the residential, financial or occupational status of the patient or his family Treatments other than inpatient or day hospital care must have been inadequate or not sufficiently effective for the patient's current mental state Exclusion Criteria: Temporary admission for diagnostic purposes or for other reasons Under 18 or over 65 years Admission without consent of the patient (according to country-specific legal regulations) One-way journey to hospital longer than 60 minutes Suicidal risk Risk to others Degree of severity of the disorder requires measures restrictive of the patient's freedom on the day of admission, or a 1:1 supervision, or deems such probable Acute intoxication Main clinical diagnosis: addictive disorder Presence of a somatic disorder requiring inpatient care Direct transfer from a different hospital Homelessness Need for constant pick-up and delivery service Inability to give informed consent with respect to participating in the study

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: acute psychiatric day care|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of MEDI-575 in Patients With Advanced Solid Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).

Official Title
-----------------
A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies

Conditions
-----------------
Advanced Solid Malignancies

Intervention / Treatment
-----------------
* Drug: MEDI-575


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having advanced solid malignancy for which no curative or standard therapies exist Karnofsky performance status of ≥60 Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part) Exclusion Criteria: Inadequate bone marrow reserve or organ function Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MEDI-575<br>* MEDI-575 will be administered weekly or every 3 weeks as IV infusion as part of a 21-day treatment cycle. One or two doses will be selected for expansion part<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign |  | 30 days after the last dose of MEDI-575 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion |  | 30 days after last dose of study drug | 
| To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies |  | 3 months after last dose of study drug | 
| Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST) |  | 3 months after last dose of study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, tumor, hepatocellular carcinoma
GORE® Septal Occluder European Union Clinical Evaluation

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen Ovale (PFO).

Official Title
-----------------
GORE® Septal Occluder EU Clinical Evaluation: A Study to Evaluate Clinical Success and Performance in the Treatment of Transcatheter Closure of Patent Foramen Ovale (PFO)

Conditions
-----------------
Closure; Foramen Ovale

Intervention / Treatment
-----------------
* Device: Closure, Foramen Ovale


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects with a PFO less than or equal to 17mm

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Closure, Foramen Ovale<br>Patients undergoing device closure of PFO | Device: Closure, Foramen Ovale<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO | The primary endpoint for the study is composite Clinical Success evaluated at 6 months post-index procedure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Clinical Success evaluated during the procedure and 6 months post-procedure | Technical Success, Procedure Success, Closure Success | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PFO, closure
Oral Berotralstat Expanded Access Program

Study Overview
=================
Brief Summary
-----------------
This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.

Detailed Description
-----------------
Physicians may request access to berotralstat for eligible participants with unmet medical need Physicians can send email inquiries to access.us@inceptua.com or call 1-888-225-8677 Patients who may be interested should contact their physician about participation Berotralstat (BCX7353) will be available through this expanded access program until it is commercially available

Official Title
-----------------
Expanded Access Program With Oral Berotralstat for the Prevention of Attacks in Patients With Hereditary Angioedema

Conditions
-----------------
Hereditary Angioedema, HAE, Prophylaxis

Intervention / Treatment
-----------------
* Drug: Berotralstat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must meet all of the following inclusion criteria to be eligible for participation in this program: At least 12 years of age Able to provide written, informed consent or assent Patients with a clinical diagnosis of HAE Type I or II who, in the opinion of their treating physician, are expected to benefit from an oral treatment for the prevention of angioedema attacks, and who are not eligible or able to access a berotralstat clinical trial Females must use acceptable effective contraception Exclusion Criteria Patients must meet none of the below exclusion criteria to be eligible for participation in this program: Pregnancy or breast-feeding Any clinically significant medical condition or medical history that, in the opinion of the treating physician, would interfere with the patient's safety Current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Berotralstat|One 150mg capsule administered orally once daily|

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
-----------------
Berotralstat, BCX7353, Hereditary Angioedema, HAE
Blind vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
To compare relative efficacy of intraarticular steroid injection using anatomic landmarks vs. fluoroscopy guided technique in decreasing knee osteoarthritis pain 1 month after the procedure.

Official Title
-----------------
Prospective Randomized-Controlled Two-Arm Study of Blind vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Other: Fluoroscopy guided steroid injection
* Other: Blind Steroid Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adults with knee OA clinically deemed to qualify for steroid injection Exclusion Criteria: - Children Non-English Speakers Pregnant

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blind Steroid Injection<br>Blind Steroid Injection for patients with OA deemed qualified for it clinically | Other: Blind Steroid Injection<br>* Want to compare it to fluoroscopy guided, with assumption that it will be less effective in reducing pain<br>|
| Active Comparator: Fluoroscopy guided steroid injection<br>Fluoroscopy guided Steroid Injection for patients with OA deemed qualified for it clinically. We want to see which one is better. | Other: Fluoroscopy guided steroid injection<br>* We want to compare if there is a difference between the two arms, with the assumption that with fluoroscopy will deliver the steroid more accurately and see better outcomes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (pain) | Decrease in pain from baseline at one month | 1 month |
Genetic Polymorphisms of Interleukin-10 and TNF-α on Outcome of HCV-Related Chronic Liver Disease

Study Overview
=================
Brief Summary
-----------------
The prognosis of chronic hepatitis C virus (HCV)infeciton varies from minimal progressive disease to cirrhosis or hepatocellular carcinoma. Host genetic factors contribute to disease severity. It is known that cytokine gene (including tumor necrosis factor-alpha (TNF-alpha) and interleukin-10 (IL-10) polymorphism affect disease prognosis.This study aims to assess the effect of TNF-alpha and IL-10, and their interaction,on prognosis of HCV-related chronic liver disease

Conditions
-----------------
Hepatitis C Virus Infection, Chronic Liver Disease

Intervention / Treatment
-----------------
* Genetic: TNF-alpha and IL-10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anti-HCV-positive patients Exclusion Criteria: Anti-HCV-negative patients
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: TNF-alpha and IL-10|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine gene polymorphism |  | years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine gene polymorphism on severity of disease |  | years |