linjc16/ctgov huggingface dataset:
Evaluation of Pharmacokinetic and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics and safety of NVP-1705 and NVP-1705-R.

Detailed Description
-----------------
Evaluate the pharmacokinetics and safety of NVP-1705 compared to NVP-1705-R

Official Title
-----------------
A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: NVP-1705
* Drug: NVP-1705-R


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subject, 19 years of age or older Subjects who signed informed consent Body mass index(BMI) of 18 to 30.0 kg/㎡ Exclusion Criteria: Subject who has clinically significant medical history Inadequate subject for the clinical trial by the investigator's decision Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Interventional Model Description: single-dose, crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVP-1705<br>Tablet formulation for oral administration, single dose of NVP-1705 at Day 1 | Drug: NVP-1705<br>* NVP-1705<br>|
| Active Comparator: NVP-1705-R<br>Tablet formulation for oral administration, single dose of NVP-1705-R at Day 1 | Drug: NVP-1705-R<br>* NVP-1705-R<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Area under the plasma drug concentration-time curve(AUCt) | Pharmacokinetics parameter derived from plasma | 0   48 hours | 
| Evaluation of Maximum observed plasma concentration(Cmax) | Pharmacokinetics parameter derived from plasma | 0   48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation pf Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) | Pharmacokinetics parameter derived from plasma | 0   48 hours | 
| Evaluation of AUCt/AUC∞ | Pharmacokinetics parameter derived from plasma | 0   48 hours | 
| Evaluation of Time of peak concentration(Tmax) | Pharmacokinetics parameter derived from plasma | 0   48 hours | 
| Evaluation of Terminal phase of Half-life(t1/2) | Pharmacokinetics parameter derived from plasma | 0   48 hours |
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Official Title
-----------------
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients successfully completing study CLAF237A2303 are eligible Written informed consent Ability to comply with all study requirements Exclusion Criteria: Premature discontinuation from CLAF237A2303 Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 Years

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

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: vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of vildagliptin in combination with metformin during 52 weeks of treatment |  |  | 
| Change from baseline in HbA1c at 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c between 24 weeks and 52 weeks |  |  | 
| Change from baseline in fasting plasma glucose at 52 weeks |  |  | 
| Change in fasting plasma glucose between 24 weeks and 52 weeks |  |  | 
| Change from baseline in HOMA B at 52 weeks |  |  | 
| Change from baseline in HOMA IR at 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Evaluation of Diffusion MRI as a Tool in Planning Deep Brain Stimulation (DBS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the relationship between deep brain stimulation implantation site and DTI (diffusion tensor imaging) derived measures for the region and later compare this to the clinical treatment outcomes.

Official Title
-----------------
Evaluation of MRI Based Fiber Tracking as a Tool in Deep Brain Stimulation for Movement Disorders

Conditions
-----------------
Movement Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deep Brian Stimulation surgery Exclusion Criteria: DBS treatment stopped before 12 month followup
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 |
| --- | --- | --- |
| UPDRS (unified parkinson disease rating scale) score |  | patients will be followed from pre-surgical evaluation to 1 year after surgery, roughly 13-14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive scores on neuropsychological exam |  | patients will be followed from per-surgical evaluation to 1 year after surgery, roughly 13-14 months |
A Study Of The Taste Of Different Oral Liquid Preparations Of CP-690,550 In Trained Adult Product Testers

Study Overview
=================
Brief Summary
-----------------
This study will test the palatability of several different CP-690,550 oral preparations in trained product tester healthy volunteers.

Detailed Description
-----------------
To develop a palatable pediatric oral solution dosage form of CP-690,550.

Official Title
-----------------
A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of CP-690,550 Oral Solution

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: CP 690,550 oral solutions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trained healthy non-pregnant product testers, age 18-75 Exclusion Criteria: Severe acute or chronic medical conditions, including hepatitis or tuberculosis infections or clinically significant laboratory abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label<br> | Drug: CP 690,550 oral solutions<br>* flavored and unflavored prototype CP-690,550 formulations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A complete description of the sensory attributes of products (eg, aroma, flavor, texture, and mouthfeel). |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
taste study open label investigational drug oral therapy
Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease.

Official Title
-----------------
An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: dimebon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer's disease On donepezil (Aricept) Caregiver who cares for the patient at least 5 days per week Exclusion Criteria: Unstable medical illnesses or significant hepatic or renal disease Other primary psychiatric or neurological disorders

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Experimental: Dimebon<br>20 mg by mouth 3 times a day | Drug: dimebon<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of Dimebon in combination with donepezil (Aricept) |  | week 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation |
Breast Ultrasonography and Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
The results of the evaluation of breast ultrasonography results of patients with polycystic ovary syndrome diagnosis over 30 years of age will be evaluated. Patients admitted to the outpatient clinic and rotterdam criteria according to laboratory data and polycystic ovary syndrome patients diagnosed by the same radiologist the next day after the end of menstrual breast ultrasonography. The aim of this study is to show the association of polycystic ovary syndrome and fibrocystic breast.

Official Title
-----------------
Breast Ultrasonography Findings in Patients Over 30 Years With Polycystic Ovary Syndrome

Conditions
-----------------
Breast Diseases, Polycystic Ovary

Intervention / Treatment
-----------------
* Procedure: Breast ultrasonography findings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 30 years diagnosed with polycystic ovary syndrome according to rotterdam criteria no previous history of breast disease female patients Exclusion Criteria: Under 30 years polycystic ovary syndrome patients with a previously known history of breast disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Breast ultrasonography findings|Breast ultrasonography findings in patients over 30 years of age diagnosed with polycystic ovary syndrome.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast ultrasonography findings | Breast ultrasonography findings in patients over 30 years of age diagnosed with polycystic ovary syndrome. THE PRESENCE OF FIBROCISTIC DISEASE WILL BE EVALUATED FOR FIBROADENOMA OR OTHER BREAST DISEASE. YES OR NO ; WILL BE REGISTERED. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast diseases, fibrocystic breast, polycystic ovari syndrome, fibroadenoma
A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.

Official Title
-----------------
A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes

Conditions
-----------------
Hyperlipidemia, Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: ETC-1002
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes meeting all of the following: Minimum 6 month history of diabetes prior to screening visit; Fasting C-peptide ≥ 0.8 ng/mL at screening visit; HbA1C at screening visit 7-10%; Fasting glucose from 140-270 mg/dL on Day -7 following washout of all glucose regulating drugs and supplements. BMI at screening visit from 25-35 kg/m2; LDL-C at screening ≥ 100 mg/dL

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ETC-1002<br>ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day | Drug: ETC-1002<br>* ETC-1002 Daily for 4 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo daily 4 weeks | Drug: Placebo<br>* Placebo Daily for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes | evaluate the change in LDL-C from baseline to various time points | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin | evaluate the change in glucose and insulin from baseline to various time points | 4 weeks | 
| assess the effect of ETC-1002 versus placebo on measures of insulin sensitivity in subjects with type 2 diabetes | evaluate the change in HOMA-IR from baseline to various time points | 4 weeks | 
| assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters | evaluate any changes in safety parameters during the course of the study. | 4 weeks |
Efficacity of Incentive Spirometry in Elderly People

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficiency of incentive spirometry in elderly. Outcomes are lung function and chest expansion.

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

Intervention / Treatment
-----------------
* Device: Incentive spirometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Pulmonary disease Cognitive disorders

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spiro<br>Incentive spirometry | Device: Incentive spirometry<br> <br> * Other names: Coach;|
| No Intervention: Control<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung function will be measured by spirometry |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest expansion will be measured by a tape measure |  | One month |
Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have never received anti-HIV therapy. This study will look at the effectiveness of this drug combination and side effects.

Detailed Description
-----------------
Patients entering this study initiate antiretroviral therapy. For 24 weeks patients receive daily dosages of IDV, RTV, 3TC, and d4T. Patients are seen at Day 1 and at Weeks 2, 4, 8, 12, 16, 20, and 24 for physical examinations, pregnancy testing, and blood sampling to monitor CD4 count and viral load. On Day 14, blood is drawn frequently for 24 hours for IDV and RTV pharmacokinetic sampling. The incidence of serious and drug-related adverse events and of adverse events leading to study discontinuation is tabulated.

Official Title
-----------------
A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Activity of Indinavir Sulfate 1200 Mg q.d. and Ritonavir 200 Mg q.d. in Combination With Stavudine and Lamivudine in Treatment Naive HIV-1 Infected Patients

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

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Ritonavir
* Drug: Lamivudine
* Drug: Stavudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Are at least 18 years old. Have a viral load of 5,000 copies/ml or greater. Have a CD4 count of at least 50 cells/mm3. Exclusion Criteria Patients will not be eligible for this study if they: Have taken any antiretroviral (anti-HIV) agent. Are pregnant.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Ritonavir|nan|
|Drug: Lamivudine|nan|
|Drug: Stavudine|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
-----------------
Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Ritonavir, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Effect of Turmeric on Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether turmeric is effective in improvement of diabetic nephropathy and in decrease in the amount of proteinuria and cytokine levels.

Detailed Description
-----------------
Diabetic nephropathy is leading cause of ESRF that many therapy recommended for it. In this study, we investigate effect of turmeric on diabetic nephropathy, thus we selected diabetic nephropathy patients and divided them into 2 groups. One group received turmeric + ACE inhibitor + Angiotensin II receptor blocker (ARB) and the second group received only ACE inhibitor + ARB.

Conditions
-----------------
Diabetic Nephropathy, Proteinuria

Intervention / Treatment
-----------------
* Drug: Turmeric extract
* Drug: Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic nephropathy more than 300 mg proteinuria/day age more than 18 years old Exclusion Criteria: DM type 1

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Turmeric<br>diabetic nephropathy patient more than 300 mg/proteinuria | Drug: Turmeric extract<br>* turmeric 500 mg TID for 45 days<br>* Other names: turmeric;|
| Active Comparator: ACE inhibitor + ATI blocker<br>diabetic nephropathy more than 300 mg/day proteinuria | Drug: Turmeric extract<br>* turmeric 500 mg TID for 45 days<br>* Other names: turmeric;Drug: Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker<br>* maximum dosage as patient tolerated for 45 days<br>* Other names: losartan;|

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
-----------------
diabetes, nephropathy, turmeric, serum IL8, serum TGFb, serumINF, urinary IL8, urine TGFb