linjc16/ctgov huggingface dataset:
Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189

Study Overview
=================
Brief Summary
-----------------
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.

Conditions
-----------------
Hyperuricemia, Gout

Intervention / Treatment
-----------------
* Drug: LC350189


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects between the ages of 20 and 50 years at screening Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). ☞ BMI (kg/m2) = body weight (kg)/ {height (m)}2. Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures. Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Experimental: LC350189<br> | Drug: LC350189<br>* Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg<br>|
| Active Comparator: Febuxostat<br> | Drug: LC350189<br>* Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg<br>|
| Placebo Comparator: Placebo<br> | Drug: LC350189<br>* Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events of LC350189 |  | 7 days(plus or minus 1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 3 days | 
| AUC |  | 3days | 
| Tmax |  | 3days |
Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.

Official Title
-----------------
A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age

Conditions
-----------------
Hypertension, Chronic Kidney Disease, Nephrotic Syndrome

Intervention / Treatment
-----------------
* Drug: Valsartan (VAL489)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome Exclusion Criteria: GFR < 30 mL/min/1.73 m2 Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion. Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes). Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 Years

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

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 |
| --- | --- |
| Experimental: Valsartan 20 mg or 40 mg<br> | Drug: Valsartan (VAL489)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of valsartan in plasma |  | Up to 24 hours post-dose | 
| Cmax of valsartan in plasma |  | Up to 24 hours post-dose | 
| Tmax of valsartan in plasma |  | Up to 24 hours post-dose | 
| T1/2 of valsartan in plasma |  | Up to 24 hours post-dose | 
| CL/F of valsartan in plasma |  | Up to 24 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG evaluations |  | 24 hours post-dose | 
| Standard clinical laboratory evaluations |  | 24 hours post-dose | 
| Vital signs |  | 2, 4, and 24 hours post-dose | 
| Physical examination |  | 24 hours post-dose | 
| Number and severity of adverse events |  | Up to 24 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, chronic kidney disease, nephrotic syndrome, pharmacokinetics
Vitamin D Supplement Study for Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if 14-19 year old African American adolescents are able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.

Detailed Description
-----------------
To determine the feasibility of African American teenagers taking a daily vitamin D supplement over a 4 month period in terms of compliance and practical implementation. To determine the differences in response in blood 25-OH D level between those randomly assigned to taking a 400 IU supplement versus 2000 IU per day and to determine if there are differences in blood 25-OH D level response depending on subject gender and overweight/obese versus healthy-weight status.

Official Title
-----------------
V.I.P. Feasibility Study (Vitamin D Intake Project)

Conditions
-----------------
Vitamin D Deficiency, Overweight, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: 2000 IU Vitamin D3 daily supplement
* Dietary Supplement: 400 IU Vitamin D3 supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy African American Adolescents Exclusion Criteria: Hypertension Pregnancy Medications that affect study outcome measures Use of other vitamin and/or mineral supplement or herbal supplements Individuals of other races

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily 2000 IU vitamin D supplement<br> | Dietary Supplement: 2000 IU Vitamin D3 daily supplement<br>* 2000 IU vitamin D3 supplement to be taken once daily over 4 months<br>* Other names: NatureMade Maximum Strength D Vitamin 2000 IU List NO. 2516;|
| Active Comparator: Daily Vitamin D supplement 400 IU<br> | Dietary Supplement: 400 IU Vitamin D3 supplement<br>* 400 IU Vitamin D3 supplement to be taken daily over 4 months<br>* Other names: NatureMade D Vitamin 400 IU List No. 1688;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma 25-OH D level |  | 3-4 months from baseline to post-testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 3-4 months from baseline to post-testing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D deficiency, Adolescents, African Americans, Overweight, Obesity
FirstWIND: Weight Loss Interventions After Delivery

Study Overview
=================
Brief Summary
-----------------
This a pilot intervention study in which postpartum women will be randomized to receive a 6-month postpartum weight loss intervention or usual care.

Detailed Description
-----------------
Overweight and obesity affect over 15 million adult women in the United States. Postpartum weight retention has been shown to be one factor contributing to weight retention, obesity and possible development of type 2 diabetes. African-American women and other minority women are at especially high risk for the development of obesity and type 2 diabetes. We propose to pilot a six-month postpartum-specific lifestyle intervention among urban-based, postpartum African-American women.

Official Title
-----------------
FirstWIND: Weight Loss Interventions After Delivery

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: lifestyle intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postpartum women with a pre-pregnancy or first trimester body mass index of 28 or greater or a history of gestational diabetes in the most recent pregnancy. Exclusion Criteria: Current cardiac disease or serious chronic disease, including cancer.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifestyle<br>participants receive lifestyle intervention | Behavioral: lifestyle intervention<br>* Lifestyle modification including individual sessions with an interventionist to discuss dietary intake and exercise. Group sessions with other participants randomized to the lifestyle intervention to discuss lifestyle modification and group exercise.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | baseline, 3 months, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health status |  | baseline and six months | 
| body mass index |  | baseline, 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight loss, postpartum, weight retention
Understanding the Efficacy of Mobile Apps as Intervention for Depression in Adults When Deployed as Part of Primary Care.

Study Overview
=================
Brief Summary
-----------------
The clinical study is meant to optimize the mobile intervention, to develop a robust implementation plan for the mobile intervention within primary care, and to conduct an effectiveness trial, randomizing 128 participants in order to understand effect on severity of depression and anxiety symptoms, cost-effectiveness, and usability of mobile apps.

Official Title
-----------------
Implementing an Innovative Suite of Mobile Applications for Depression and Anxiety

Conditions
-----------------
Depression, Anxiety, Primary Health Care

Intervention / Treatment
-----------------
* Behavioral: IntelliCare


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive screen on PHQ-9 Exclusion Criteria: Does not own or use a mobile smart phone

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waitlist Control<br>8 weeks of treatment as usual followed by 8 weeks of IntelliCare treatment. | |
| Experimental: Experimental<br>8 weeks of IntelliCare treatment followed by 8 weeks of treatment as usual. | Behavioral: IntelliCare<br>* A suite of mobile apps that use principles of computerized therapy to decrease symptoms of depression.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of depression | Using the PHQ-9 screener | 8 weeks |
Long-term Caloric Restriction and Cellular Aging Markers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether people who have restricted the number of calories they eat for a long period of time, compared to normal-eating and obese people, have markers of cellular aging that look younger.

Official Title
-----------------
Caloric Restriction With Optimal Nutrition and Aging Study

Conditions
-----------------
Aging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Calorie restricting group: Self-reported caloric restriction for at least two years Calorie restriction group: BMI below 23 Normal eating control: Normal eating (no history of caloric restriction) for two years Normal eating control: BMI below 30 Obese comparison group: BMI above 30 Obese comparison group: Normal eating (no history of caloric restriction) for two years Exclusion Criteria: Regular smoker for the past six months

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Calorie Restricting Group<br> | |
| Normal-eating controls<br> | |
| Obese comparison group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telomere Length | This study is not a clinical trial, but the UCSF Committee on Human Research requires registration with clinicaltrials.gov. It is a ONE TIME POINT study, where we get a simple blood draw from people from three groups - calorie restricting, normal eating, and obese. Therefore, there IS NO FOLLOW UP/time frame. The outcome measure is assessed on the day of the study. Telomere length is a marker of cellular aging and is used to understand how the cells are aging. We will investigate whether long-term caloric restriction is associated cross-sectionally with longer telomere length (less aging). | One day |
Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach

Study Overview
=================
Brief Summary
-----------------
This proposal is for the pilot study that will inform the conduct of a larger prospective randomized controlled trial to guide perioperative work up and the cost/utility of CTCA (high definition CT coronary angiography.)

Detailed Description
-----------------
This proposal is for a pilot study that will inform the conduct of a prospective, blinded randomized controlled trial designed to determine the cost effectiveness of an algorithm for pre operative cardiac risk stratification that uses coronary CT angiography. In addition perioperative and long-term cardiac event rate will be recorded to determine if there is any difference in these rates between the 2 groups.

Official Title
-----------------
Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach

Conditions
-----------------
Complex Aortic Surgery

Intervention / Treatment
-----------------
* Other: contrast CTA of the CAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis Exclusion Criteria: Patients with contraindications to undergoing CT coronary angiography coronary revascularization within the last six months renal dysfunction in whom the treating physician has decided a contrast enhanced CT scan is not warranted as part of the routine clinical work up

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 |
| --- | --- |
| contrast CTA of the CAP<br>All patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis will be includedRaw data from CT coronary angiography will be available from all patients. | Other: contrast CTA of the CAP<br>* CT coronary angiography results will be reported for all patients by adjudicators blinded to their inclusion in the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome for the pilot study will be to assess feasibility of processes as set out in the specific aims. |  | 6 months |
SunRISe Study - Stroke Rehabilitation In Suriname

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the effect of a supervised home-based physical fitness program on the aerobic capacity, quality of gait and health related quality of life in people with chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term lifestyle change will be investigated.

Official Title
-----------------
The Effect of a Tele-supervised Home Based Rehabilitation Program on Physical Fitness, Quality of Gait, Upper Limb Disability and Quality of Life in People After Chronic Stroke in a Urban Setting in Suriname. Randomised Controlled Trial.

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

Intervention / Treatment
-----------------
* Behavioral: Home base stroke rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ability to give informed consent ability to understand measurement procedures defined as MMSE >24 last stroke >6 months ago mild to moderate stroke deficit defined by Fugl Meyer test score of 27 to 90 for upper and lower extremities FAC ≥3 medical clearance to participate in a moderate exercise program living at home and having a minimum of 5 stairs at home Exclusion Criteria: serious cardiac condition other serious end organ damage other neurological deficits leading to disability uncontrolled blood pressure (systolic pressure >140, diastolic pressure >90)
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 |
| --- | --- |
| Experimental: Intervention group<br>Stroke patients from the intervention group will be, on top of usual care, offered a holistic home based and semi-supervised stroke rehabilitation program followed by a period of tele-supervision. | Behavioral: Home base stroke rehabilitation<br>* The intervention consists of physiotherapy exercises targeting functional and physical capacity.<br>|
| No Intervention: Control group<br>The participants in the control group will only receive usual care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak oxygen uptake |  | 4 weeks, 8 weeks and 5 months after start of rehabilitation |
Drug Use-results Survey in Patients Infected With Hepatitis C Virus Genotype 1

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily practice in Japan.

Official Title
-----------------
Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1

Conditions
-----------------
Chronic Hepatitis C Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV genotype 1 patients treated with paritaprevir/ritonavir/ombitasvir in daily practice Exclusion Criteria: Patients who have been previously treated with paritaprevir/ritonavir/ombitasvir

Ages Eligible for Study
-----------------
Maximum Age: 120 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 |
| --- | --- |
| Chronic infection of hepatitis C virus (HCV) Genotype 1 (GT1)<br>Participants with confirmed chronic hepatitis C genotype 1, receiving paritaprevir/ritonavir/ombitasvir according to standard of care and in line with the current local label | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Sustained Virologic Response (SVR12) | Hepatitis C virus ribonucleic acid less than the lower limit of quantification 12 weeks after the last dose of study drug. | 12 weeks after the last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Virologic Failure After Treatment | Confirmed quantifiable hepatitis C virus ribonucleic acid (HCV RNA) at the end of 12 week treatment but subsequent viremia with HCV RNA greater than or equal to the lower limit of quantitation during follow-up period of 24 weeks after treatment. | Post-treatment 24 weeks | 
| Percentage of Participants with Sustained Virologic Response (SVR24) | Hepatitis C virus ribonucleic acid less than the lower limit of quantification 24 weeks after the last dose of study drug. | 24 weeks after the last dose of study drug | 
| Percentage of Participants with Virologic Failure During Treatment | HCV RNA levels reach less than the lower limit of quantitation (LLOQ), then increase to greater than or equal to the LLOQ at any point during treatment. | Up to Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C Virus (HCV), Paritaprevir, Ombitasvir, Ritonavir, Genotype 1