linjc16/ctgov huggingface dataset:
Curcumin Supplement in Nonalcoholic Fatty Liver Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of curcumin supplement on metabolic factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes. Subjects will participate in 3 month, two group, randomized intervention, where one group (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare differences in outcomes between the two groups.

Official Title
-----------------
The Effect of Curcumin Supplement on Metabolic Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Patients

Conditions
-----------------
Type 2 Diabetes, Nonalcoholic Fatty Liver

Intervention / Treatment
-----------------
* Dietary Supplement: curcumin
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed with type 2 diabetes based on ADA definition or who only take oral antidiabetic drug; CAP score >263. Exclusion Criteria: Taking any kind of antibiotics two weeks before recruitment; History of alcohol consumption; pregnancy or lactation; Professional athletes; Other liver disease (viral/etc); High dose synthetic estrogens, methotrexate, amiodarone, steroids, chloroquine, immunosuppressive drugs; A history of Cardiovascular disease; Renal disease, Celiac disease, Cirrhosis; History of Upper GI surgery; A history of hypothyroidism or Cushing's syndrome; History of drug dependence; Body mass index (BMI) ≥35 kg/m2; A restrictive diet or weight change ≥ 5 kg during the 3months prior to study; Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study; Use of weight loss medications.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: curcumin<br>curcumin | Dietary Supplement: curcumin<br>* 1500 mg 1 capsule / day for 12 weeks<br>|
| Placebo Comparator: placebo<br> | Dietary Supplement: placebo<br>* 1500 mg 1 capsule / day for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic steatosis | measured by CAP score using Fibroscan | [12 weeks] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose |  | [12 weeks] | 
| HBA1C |  | [12 weeks] | 
| ALT |  | [12 weeks] | 
| AST |  | [12 weeks] |
Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the production of mucin in GERD/RE subjects before and after 8 weeks of treatment with rabeprazole.

Detailed Description
-----------------
Enrolled patients will undergo collection of salivary and esophageal secretions. Subsequently, all patients will receive rabeprazole (20mg QD) for 8 weeks and will be re-endoscoped to confirm complete healing of reflux esophagitis. In patients with completely healed reflux esophagitis the second collection of salivary and esophageal secretion will be implemented. In both secretions, adequately coded for the laboratory Research Fellow (blinded in terms of which sample is collected before and which after treatment with rabeprazole) the content of mucin will be measured using commercially available assay and its secretion expressed in units per minute of collection time.

Official Title
-----------------
Esophagoprotection by Rabeprazole Mediated by Restoration of an Impairment in Esophageal Mucin Production: Its Potential Therapeutic Benefit in Patients With Gastroesophageal Reflux Disease (GERD)

Conditions
-----------------
Esophageal Reflux

Intervention / Treatment
-----------------
* Drug: Rabeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 24 patients with endoscopically confirmed reflux esophagitis (Grades A-D according to LA classification) in patients with chronic symptoms of GERD (heartburn with or without regurgitation) between the age of 19 and 79, 12M & 12F, will be included. Exclusion criteria: History of GI surgery, primary esophageal motor disorders, any systemic disease, history of drug or alcohol abuse, pregnancy or nursing, allergy to the same drug class as rabeprazole, the need for any concurrent therapy that affects salivary secretion (causing so-called dry mouth syndrome).

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of concentration and output of esophageal mucus in esophageal secretion before and after 8 weeks of therapy with rabeprazole |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal mucin measurement comparisons on samples collected before and after rabeprazole therapy |  |  |
System Accuracy of the Blood Glucose Monitor for Personal Use JT100

Study Overview
=================
Brief Summary
-----------------
This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

Detailed Description
-----------------
This study assesses the system accuracy the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines

Official Title
-----------------
Evaluierung Der Systemgenauigkeit Des JT100 Blood Glucose Monitoring Systems Der Firma Tyson Bioresearch Inc. gemäß DIN EN ISO 15197:2015

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use
* Diagnostic Test: blood glucose measurement, laboratory reference device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients with clinical indication for blood glucose testing Signed form of consent Minimum age of 18 years Subjects are legally competent and capable to understand character, meaning and consequences of the study Exclusion Criteria: Pregnancy or lactation Severe acute disease (at study physician's discretion) Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion) Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197) Being unable to give informed consent Age younger than 18 years Legally incompetent

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject glucometer measurement<br>Blood glucose measurement BGM for personal use | Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use<br>* measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)<br>* Other names: measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100);Diagnostic Test: blood glucose measurement, laboratory reference device<br>* measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of system accuracy based on DIN EN ISO 15197 | Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197 | day 1 |
Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs

Study Overview
=================
Brief Summary
-----------------
In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes.

Official Title
-----------------
Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Upper Trapezius Myofascial Trigger Points- a Randomized Intervention Study

Conditions
-----------------
Myofascial Pain Syndrome

Intervention / Treatment
-----------------
* Procedure: Dry needling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinically relevant MFTrP of the upper Trapezius musculature Self-reported pain of ≥3 on an eleven-point numerical pain rating scale (NRS-101). BMI less than 31 Exclusion Criteria: a history of chronic, systemic pathology (e.g. hemophilia) pre-existing neck/shoulder pathology/surgical procedures, clinical depression health-related legal action pregnant anti-inflammatory and/or chronic pain medication had received dry needling for a shoulder/neck disorder within 6 months prior to the study (to raise the level of patient naiveté) suffered from needle phobia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 46 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry needling (deep)<br>Subjects receive dry needle insertion deeper than 1,5cm below the skin of the Trapezius. | Procedure: Dry needling<br>* Insertion of acupuncture needle into a myofascial trigger point.<br>* Other names: Acupuncture;|
| Active Comparator: Dry needling (superficial)<br>Insertion of dry needle less than 1cm. | Procedure: Dry needling<br>* Insertion of acupuncture needle into a myofascial trigger point.<br>* Other names: Acupuncture;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle contractility | Measurements of maximal isometric muscle force (Fmax), and rate of force development (RDF) | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pressure-pain threshold | Algometer measurement of pressure-pain perception | 60 seconds | 
| NRS-101 | Self-reported pain | 60 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TP, Myofascial pain
Ex Vivo Exploratory Analysis in Healthy Full-term Infants

Study Overview
=================
Brief Summary
-----------------
Exploratory analyses of the immune response in a ex vivo culture system Characterization of the composition of maternal milk and infant urine

Official Title
-----------------
Ex Vivo Exploratory Analysis in Healthy Full-term Infants

Conditions
-----------------
Healthy Infant and Mother Pairs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Infant or infant-mother pair in good health Infant or infant-mother pair is from smoke-free home Infant is a singleton, full term birth weight was > 2490 g Between 0 and 17 days of age at enrollment Human milk fed infants must have been exclusively human milk-fed since birth; formula fed infants must have received Similac Advance or Similac Sensitive since birth Parents confirm their intention not to administer vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D), solid foods or juices to their infant from enrollment throughout the study Exclusion Criteria: An adverse maternal, fetal or infant medical history, including gestational diabetes that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. Infant has been treated with antibiotics Participation in another study -

Ages Eligible for Study
-----------------
Maximum Age: 17 Days

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 |
| --- | --- | --- |
| Viral load in cell cultures |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in viral load and cytokine profiles |  | 14 days |
Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation

Study Overview
=================
Brief Summary
-----------------
Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs following cataract surgery. However, no data is available regarding endothelial changes after cataract surgery with IOL implantation in pediatric eyes. The aim of this study is to prospectively observe changes in endothelial cell density, coefficient of variation and hexagonality following cataract surgery with IOL implantation in pediatric eyes.

Official Title
-----------------
Corneal Endothelial Morphologic Assessment in Pediatric Cataract Surgery With IOL Implantation: Comparison of Preoperative and Early Postoperative Specular Microscopy

Conditions
-----------------
Congenital Cataract Surgery, IOL Implantation, Change in Corneal Endothelial Cell Morphology

Intervention / Treatment
-----------------
* Procedure: Congenital Cataract Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eyes undergoing pediatric cataract surgery with IOL implantation at Iladevi Cataract & IOL Research Center, Ahmedabad, India. Children older than 4 years undergoing cataract surgery with IOL implantation were included. Exclusion Criteria: Exclusion criteria were as follows: eyes with traumatic or subluxated cataract and inability to get preoperative specular. Intraoperatively, sulcus fixated IOLs, and eyes with no IOL implantation were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 15 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 |
| --- | --- |
| Congenital cataract surgery with IOL implantation<br>Congenital cataract surgery was performed with or without anterior vitrectomy, followed by in the bag IOL implantation | Procedure: Congenital Cataract Surgery<br>* Congenital cataract surgery with IOL implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal endothelial morphology | Change in corneal endothelial cell density, (CD), coefficient of variation (CV) and % of hexagonality (6A) were studied from preoperatively to 3 months postoperatively | preoperatively to 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central corneal thickness | Change in central corneal thickness from preop to 3 months postop was studied | preoperatively to 3 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
corneal endothelium, congenital cataract surgery, IOL implantation
The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19

Study Overview
=================
Brief Summary
-----------------
COVID is a major health problem causing massive capacity problems at hospitals. Rapid and accurate diagnostic workflow is of paramount importance. Access to radiological diagnostics tools such as x-ray or computed tomography of the chest are limited even in high-resource settings. Focused lung ultrasound, FLUS, is a point-of-care diagnostic tool that allows rapid and on-site assessment of lung abnormalities. No transportation of the patient is required thus lowering risk of spreading SAR-CoV- inside the hospital. This study aims to explore the diagnostic value of FLUS in the COVID-19 pandemic and to explore if FLUS findings can predict risk of respiratory failure.

Official Title
-----------------
The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical suspicion of COVID-19 requiring contact to a hospital. Exclusion Criteria: Age less than 18 years Previous enrollment in this study.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLUS findings and respiratory failure | Analysis of FLUS related to risk of development of respiratory failure. | Up to 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLUS findings and chest x-ray. | Analysis of FLUS related to risk of result of chest x-ray | Up to 3 months. | 
| FLUS findings and admission to intensive care. | Analysis of FLUS related to risk of intensive care admission | Up to 3 months. | 
| FLUS findings and SAR-CoV-2 PCR-test result. | Analysis of FLUS related to result from SAR-CoV-2 PCR-test | Up to 3 months. |
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.

Official Title
-----------------
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Negative Pressure Wound Therapy System for Treatment of Non-responding Venous Stasis and Diabetic Lower Extremity Ulcers

Conditions
-----------------
Diabetic Foot Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Wound < 10 cm in greatest diameter Wound age > 4 weeks and patient shows < 50% wound area healing after 4 weeks of treatment Patient > 18 years of age Patient is willing and able to sign consent Patient is willing and able to complete study visits and comply with study dressing protocols Exclusion Criteria: Wound size reduction of > 50% in last 4 weeks of treatment Patients with active wound infections, including cellulitis and osteomyelitis Patients with wounds not able to have eschar debrided ABI < 0.65 or SPP < 30mmHg Patients with wounds in anatomic areas which preclude achieving an airtight seal for NPWT Ulcers due to inflammatory conditions such as rheumatoid arthritis, lupus, scleroderma, vasculitis, calciphylaxis, etc. Patients with allergy to or intolerance of any of the wound dressing materials expected to be used during the trial. Pregnant patients Patients unable to tolerate NPWT Patients with dialysis dependent ESRD Index ulcer is on the plantar surface of the foot

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 |
| --- | --- | --- |
| Percentage of wounds closed |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Wounds, Ulcers
Long Non Coding RNA in Complications of Systemic Lupus

Study Overview
=================
Brief Summary
-----------------
the precise role of RNA in setting of this complication in systemic lupus erythematosus (SLE) is largely unknown

Official Title
-----------------
Long Non Coding RNA IN Systemic Lupus

Conditions
-----------------
Complication in Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with systemic lupus Exclusion Criteria: vasculitis

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SLE group<br> | Other: blood sampling<br>* blood sampling<br>|
| Other: control group<br> | Other: blood sampling<br>* blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non coding RNA expression by real time PCR | non coding RNA expression by real time PCR to evaluate thier role in lupus | 1 year |