linjc16/ctgov huggingface dataset:
Effects of Curcumin Supplementation on Lipid Profile and Inflammatory Markers of Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation on serum levels of lipid profile and inflammatory markers in patients with type 2 diabetes

Official Title
-----------------
Curcumin Supplementation and Type 2 Diabetes

Conditions
-----------------
Non Insulin Dependent Diabetes

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tendency to participate Age range of 40-65 Suffering from diabetes type 2 ( between 1 to 10 yeares) BMI 18/5-30 Patients with diabetes who administer oral hypoglycemic agents and do not use Exclusion Criteria: patients with liver diseases patients with kidney diseases patients with inflammatory diseases patients with liver diseases Administering herbal agents Administering multivitamins and minerals in past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention<br>500 mg curcumin capsule | Dietary Supplement: curcumin<br> <br> |
| Placebo Comparator: placebo<br>500 mg placebo | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Reactive Protein |  | 12 weeks |
The Association of G9a Protein and Outcome of Patients With Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
Tumor invasion and metastasis are the major causes of cancer-related death. Some studies have found that histone methyltransferases, such as EZH2, specifically affect metastasis in breast, gastric and prostate cancer. The functional roles of other members of the HMT family such as G9a in cancer remain obscure. Therefore, the investigators will investigate whether G9a have a role in recurrence/metastasis of endometrial cancer.

Conditions
-----------------
Outcome of Endometrial Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cases with endometrial cancer underwent staging operation Exclusion Criteria: nil

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: endometrial cancer<br> | Other: no drug<br>* The role of G9a protein in patients with endometrial cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The role of G9a protein in endometrial cancer | We will correlate the G9a protein and outcome of endometrial cancer | overall survial, disease-free survival |
Study to Evaluate the Effect of ALNA® (Tamsulosin) on the Primary Symptoms of Benign Prostatic Hyperplasia

Study Overview
=================
Brief Summary
-----------------
The aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Additionally to obtain relevant information for the 5-year report of experience with this product according to the requirements in § 49, para 6 of the German Medicines Act.

Official Title
-----------------
Effect of ALNA® (Tamsulosin) on the Primary Symptoms of BPH (Benign Prostatic Hyperplasia) Syndrome

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: ALNA®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from symptomatic benign prostatic hyperplasia (BPH) symptoms and receiving ALNA® treatment are to be included in the observation according to the prescribing information Exclusion Criteria: No exclusion criteria is defined, prescribing information is to be considered
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with symptomatic of benign prostatic hyperplasia<br> | Drug: ALNA®<br> <br> * Other names: tamsulosin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in obstructive BPH symptoms |  | up to 12 weeks | 
| Change in irritative BPH symptoms |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Residual Urine volume |  | up to 12 weeks | 
| Number of patients with adverse events |  | up to 12 weeks | 
| Assessment of the number of days on sick leave |  | up to 12 weeks | 
| Global assessment of efficacy by investigator on a 4-point scale |  | after 12 weeks | 
| Change in Quality-of-Life Index |  | up to 12 weeks | 
| Global assessment of tolerability by investigator on a 4-point scale |  | after 12 weeks | 
| Changes in urinary flow rate |  | up to 12 weeks |
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.

Official Title
-----------------
A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects

Conditions
-----------------
Kawasaki Disease

Intervention / Treatment
-----------------
* Drug: Technetium Tc99m Sestamibi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been scheduled to undergo a clinically indicated rest or stress CARDIOLITE® MPI scan. Be able to comply with imaging requirements permitting completion of rest or stress CARDIOLITE® whole-body scans and SPECT imaging procedures without the use of sedation. Exclusion Criteria: Have a terminal illness where expected survival is ≤6 months Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 Years

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

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 |
| --- |
|Drug: Technetium Tc99m Sestamibi|Rest and/or stress SPECT imaging study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the absorbed radiation dose of Sestamibi in subjects will be evaluated at the end of the study through measurements of PK (blood and urine) up to 8 hours, dosimetry for 8 hours and image biodistribution for up to 8 hours |  | Following administration of Technetium Tc99m Sestamibi | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A determination of the safety of Sestamibi will be evaluated at the end of the study through adverse and serious adverse events reported and evaluating vital signs, ECGs, physical exams and laboratory tests for each subject |  | Following administration of Technetium Tc99m Sestamibi |
Comparing Pain Relief Between Exparel® Injection vs. On-Q Catheter as the Postsurgical Analgesia Following Total Knee Arthroplasty (TKA)

Study Overview
=================
Brief Summary
-----------------
The goal of this research project is to evaluate the effectiveness of a novel treatment to control pain after Total Knee Arthroplasty (TKA). The proposed approach to manage pain and eliminate risks associated with catheters is the use of Exparel injection into the joint at the time of surgery.

Conditions
-----------------
Osteoarthritis: Joint Replacement Surgery

Intervention / Treatment
-----------------
* Drug: Exparel
* Drug: On-Q pain intra-articular catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults scheduled to undergo primary total knee replacement Willing and able to provide informed consent

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exparel Injection<br> | Drug: Exparel<br> <br> |
| Active Comparator: On-Q intraarthicual catheter placement<br> | Drug: On-Q pain intra-articular catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Morphine and morphine equivalent consumption |  | 96 hours post-op |
FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in Bolivian Subjects

Study Overview
=================
Brief Summary
-----------------
Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population

Detailed Description
-----------------
The data of consecutive adult smoker patients, referred to the Clínica del Pulmón (Santa Cruz, Bolivia), between May 2018 and June 2018, will be analyzed. All the patients are current or ex-smokers, complaining of dyspnea, cough or expectorations. Spirometry measurements will be performed with a Medisoft Body Box 5500 by one highly trained and experienced pulmonologist according to the guidelines of the ATS/ERS. The criteria used to detect airway obstruction are either the fixed cut-off points according to GOLD recommendations (FEV1/FVC<0.70) or the lower limit of normal (FEV1/FVC<LLN). These indices will be compared to a fixed cut-off FEV1/FEV6 <0.73 as proposed by Vandevoorde et al. or to a FEV1/FV6 ration < LLN. Reference equations used are those of Caucasians from the NHANES III survey. Statistical tests will be done using IBM SPSS 24 software. Cohen's κ will be used to determine if there is an agreement between the definitions of airway obstruction.

Official Title
-----------------
FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in the Detection of Airway Obstruction in a Small Group of Bolivian Subjects

Conditions
-----------------
Copd

Intervention / Treatment
-----------------
* Diagnostic Test: FEV6 spirometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult smoker suspected of COPD Exclusion Criteria: unable to perform spirometry

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 |
| --- | --- |
| COPD<br>FEV1/FVC and FEV1/FEV6 will be compared within the same cohort of COPD patients | Diagnostic Test: FEV6 spirometry<br>* During the same spirometry, to compare the relative value of FVC and FEV6<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim of this preliminary study is to determine if the criteria of airway obstruction using FEV6 as a surrogate of FVC are transposable to a non-selected Bolivian population | see above | one measurement lasts 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spirometry
Prevalence and Risk Factors of Pressure Ulcers in Beni Suef Governorate of Egypt

Study Overview
=================
Brief Summary
-----------------
the study aims at examining the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt

Detailed Description
-----------------
pressure ulcers are defined as localized damage to the skin as well as underlying soft tissue, usually occuring over a bony prominence or to medical devices. immobility and friction are important risk factors for pressure ulcers, Malnutrition and body mass index are associated with pressure injury prevalence, the days in hospital, skin moisture and other neurological factors are significant risk factors for pressure ulcer development. Beni-Suef is one of the upper Egypt governorates located about 120 Km south of cairo, according to population estimates from 2019, the majority of residents in the governorate live in rural areas, with an urbanization rate of only 23.2%, Due to greater reliance on federal and state payers, low volume and complxity of services provided, rural residents often encounter barriers to healthcare that limit their ability to obtain the care they need

Official Title
-----------------
Prevalence and Risk Factors of Pressure Ulcers in Hospitalized Patients in Beni Suef Governorate of Egypt

Conditions
-----------------
Pressure Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized patients will be selected from ICU and CCU both sexes males and females their age ranges between 25-65 years old patients who have peripheral arterial disease their body mass index (class II and class III obesity) diabetic patients more than 5 years old Exclusion Criteria: medically unstable patients un cooperative patients semi- conscious or unconscious patients according to glascow coma scale

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| examine the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt | correlate between the prevalence and risk factors of pressure ulcers by using : sociodemographic variables, Braden risk scale assessment, clinical charactristics of the patient illness amd physical examination to assess the grade of pressure ulcer | baseline |
An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml

Study Overview
=================
Brief Summary
-----------------
To provide product through an expanded access program to HIV-infected patients with CD4 counts less than 300 cells/ml.

Official Title
-----------------
An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Biological: HIV-1 Immunogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV-1 seropositivity. CD4 counts < 300 cells/ml. NOTE: If a patient's CD4 count is 275 to 300 cells/ml, the patient must either rescreen for Study 806 or wait 6 months before entering the expanded access program. Patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies. Patient must not meet inclusion criteria for other Remune trials. Patient must have laboratory tests within specified limits. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Clinically significant cardiac, hepatic, renal, or gastrointestinal dysfunction. Current participation in a Remune study. Concurrent Medication: Excluded: Use of any immune-modulating drugs. Induction therapy or initiation of new treatment regimen for an AIDS-defining condition. Patients with any of the following prior conditions are excluded: Previous participation in a Remune study. Prior Medication: Excluded: Use of any immune-modulating drugs within 3 months of Day 1 visit. Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 visit.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HIV-1 Immunogen|nan|

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
-----------------
Acquired Immunodeficiency Syndrome, AIDS Vaccines, CD4 Lymphocyte Count, Salk HIV Immunogen
Lantus in Prediabetes

Study Overview
=================
Brief Summary
-----------------
To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).

Official Title
-----------------
Assessment of Safety and Tolerability of Lantus® (Insulin Glargine) in Subjects With Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)

Conditions
-----------------
Hyperglycemia, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Lantus® (insulin glargine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes) HbA1c < 7.0% BMI < 40kg/m2 Able to perform moderate stationary bicycle exercise Exclusion Criteria: Chronic pharmacologic treatment for hyperglycemia, past or present CAD serum creatinine > 2.0mg/dL BP > 180/105 History of hypoglycemia unawareness

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lantus® (insulin glargine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: 8-point blood glucose measurements. |  |  | 
| Safety / tolerability: hypoglycemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose in response to exercise. |  |  | 
| Fasting supine levels of counterregulatory hormones |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glargine, prediabetes, impaired glucose tolerance, impaired fasting glucose
Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography

Study Overview
=================
Brief Summary
-----------------
To reduce As Low As Diagnostically Acceptable (ALADA) the X ray exposure of pediatric radiology by using a new post treatment processing algorithm (S-Vue, Samsung table GC85A).

Detailed Description
-----------------
The study will investigate the minimum dose required to obtain acceptable image quality for different pediatric localizations (abdomen, thorax, pelvis, spine) by using a simulation tool of different dose levels. Three different radiologists blinded to the simulated dose level will score the images independently by using a dedicated image quality scoring grid.

Official Title
-----------------
Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography

Conditions
-----------------
Pediatric Radiology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged under 18 years and under 80 kg; Prior radiography perfomed within 6 months before the beginning of the study. Exclusion Criteria: - Refusal of parents to participate to the study.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Assesment of image quality by radiologists blinded to the simulated dose level | Three different radiologists will score the images of localizations of abdomen, thorax, pelvis, spine independently by using a dedicated image quality scoring grid. | through study completion, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALADA, IQ, Pediatric Radiology