linjc16/ctgov huggingface dataset:
Protein Requirements In Active Female Populations

Study Overview
=================
Brief Summary
-----------------
Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA). Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity. Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data. The purpose of this study is to measure the protein requirement in active, young adult females using the IAAO technique in the presence of a variable intensity exercise stimulus.

Official Title
-----------------
Evaluation of Protein Requirements in Active, Young Adult Females

Conditions
-----------------
Increased Metabolic Requirement, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Amino acid intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, active, young adult females who regularly participate in moderate-vigorous activity 5x per week, for a minimum of 1 hour A minimum score of 10 on the Beep Test (a measure of aerobic fitness) Exclusion Criteria: Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+) Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption) Regular tobacco use Illicit drug use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active, Young Adult Famale<br>Participants will complete a bout of exercise and then consume a randomly assigned amino acid intake prior to measuring whole body 13CO2 excretion and phenylalanine oxidation. | Dietary Supplement: Amino acid intake<br>* Amino acid intakes will be varied at 0.2-2.6 g/kg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13CO2 (carbon dioxide) excretion (μmol/kg/h) |  | 4 hours / study day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13C-Phenylalanine Oxidation (μmol/kg/h) |  | 4 hours / study day |
A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.

Official Title
-----------------
A Single-center, Open-label, Randomized, Two Way Crossover Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: ACT-541468


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent prior to any study-mandated procedure Healthy male subjects aged between 18 and 45 years (inclusive) at Screening Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening No clinically relevant findings on the physical examination at Screening Exclusion Criteria: History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed) Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two way crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: ACT-541468 50 mg under fasted conditions<br>Single oral dose administered on Day 1 under fasted conditions. | Drug: ACT-541468<br>* ACT-541468 50 mg film-coated tablets<br>|
| Experimental: Treatment B: ACT-541468 50 mg under fed conditions<br>Single oral dose administered on Day 1 administered after food intake. | Drug: ACT-541468<br>* ACT-541468 50 mg film-coated tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic endpoint: AUC0-24 | Area under the plasma concentration-time curve (AUC) from time zero to 24 h | Multiple timepoints; duration: up to 48 hours in each treatment period |
Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous trans-hepatic biliary drainage (PTBD).

Official Title
-----------------
A Comparative Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage of Benign and Malignant Biliary Obstruction

Conditions
-----------------
Biliary Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with benign biliary obstruction Patients with malignant biliary obstruction Patients undergoing ERCP and/or PTBD Exclusion Criteria: Patients with gallstone disease Patients who will undergo ERCP who have previously underwent a PTBD Patients who will undergo PTBD who have previously underwent an ERCP Female patients who are pregnant Prisoners and other vulnerable populations

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 |
| --- | --- |
| ERCP<br>Subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) | |
| PTBD<br>Subjects with benign and malignant biliary obstruction who have or will undergo percutaneous trans-hepatic biliary drainage (PTBD). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in European Quality of Life-5 Dimensions questionnaire score | Measured using the European Quality of Life-5 Dimensions questionnaire that measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The Euro-QOL-5D score is derived from adding the scores from each of the five items. The best possible score is five (i.e., asymptomatic in each item) and the worst possible score is 15 (incapacitated in each item). | Baseline, 1 month, 3 months |
Saphenous Vein Allografts for Coronary Bypass

Study Overview
=================
Brief Summary
-----------------
The primary objective of this observational study is to evaluate the function (patency) of cryopreserved saphenous vein allografts used as coronary artery bypass grafts (CABG) for patients with occlusive coronary artery disease.

Detailed Description
-----------------
This Study is designed as a combination retrospective/prospective single center study in which all patients will be eligible for enrollment based on having a previous implant of CryoVein Saphenous Vein for CABG during the 2008-2010 time frame. A comprehensive chart review of former and previously implanted allograft patients will be performed for the retrospective portion of this Study. An effort will be made to include all patients from this site. Eligible patients will be consented into the Study for a single, prospective, observational imaging evaluation of their bypass conduits.

Official Title
-----------------
Single Center Evaluation of CryoVein Saphenous Vein Allografts for Coronary Artery Bypass Grafting

Conditions
-----------------
Coronary Artery Disease, Occlusion of Artery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient implanted with a CryoVein saphenous vein allograft for CABG during 2008 - 2010 time frame. Patients > 18 years of age at implant. Exclusion Criteria: • Patients < 18 years of age.

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 |
| --- | --- |
| Prior recipients of allografts for CABG<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Patency |  | 1 to 3 years as defined by the date of their incident operation (CABG surgery). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 1 to 3 years defined by the date of their incident operation (CABG surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allograft, coronary, patency, morbidity
The Role of Stress in Self-Control, Coping, and Emotion Regulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of stress on mental and physical health and behavior.

Official Title
-----------------
The Role of Stress in Self-Control, Coping and Emotion Regulation

Conditions
-----------------
Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-50 able to read and write Exclusion Criteria: Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation Pregnant women Inability to give informed consent Traumatic brain injury or loss of consciousness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Community sample<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress response and lifestyle behaviors | Study explores differences in measures of stress as they relate to self-control, coping, emotion regulation and lifestyle and health outcomes. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological stress responses |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress, self-control, emotion regulation, health
Efficacy and Safety of HL-040XC in Essential Hypertension and Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with essential hypertension and hyperlipidemia

Official Title
-----------------
A Phase 3, Randomized, Double- Blind, Multi-center, Double Dummy, Clinical Trial Comparing HL-040XC With Single Component Therapies(Atorvastatin, Losartan) to Assess the Efficacy and Safety of HL-040XC in Patients With Essential Hypertension and Hyperlipidemia

Conditions
-----------------
Essential Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Losartan
* Drug: Placebo
* Drug: HL-040XC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18 and 80 years History of essential hypertension and hyperlipidemia Able to sign informed consent Exclusion Criteria: At screening, SBP ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HL-040XC<br>Once daily, administered orally, 8 week | Drug: HL-040XC<br>* Once daily, administered orally, 8 week<br>|
| Active Comparator: Atorvastatin<br>Once daily, administered orally, 8 week | Drug: Atorvastatin<br>* Once daily, administered orally, 8 week<br>* Other names: Lipitor;|
| Active Comparator: Losartan<br>Once daily, administered orally, 8 week | Drug: Losartan<br>* Once daily, administered orally, 8 week<br>* Other names: Cozaar;|
| Placebo Comparator: Placebo<br>Once daily, administered orally, 8 week | Drug: Placebo<br>* Once daily, administered orally, 8 week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure) |  | Baseline and 8 week | 
| Percent change from baseline to 8 week in LDL-Cholesterol |  | Baseline and 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood Pressure Responder according to JNC VII Guideline. |  | Baseline and 4, 8 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atorvastatin, Losartan, Essential Hypertension, Hyperlipidemia
Impact of Melatonin on IVF/ICSI Outcomes in Prospective Poor Responders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the impact of melatonin administration on in vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders.

Detailed Description
-----------------
The prospective poor responders have been associated with lower number and poorer oocyte quality. Melatonin is suggested to have antioxidative effects which may contribute to improving the IVF/ICSI outcomes in this group of patients who expected to have poor outcomes. However, the expected beneficial effects of melatonin have not yet been investigated. The purpose of this study is to investigate the impact of melatonin administration on IVF/ICSI outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders. A randomized, double-blinded, placebo-controlled study is used to investigate the impact of melatonin on the IVF/ICSI outcomes.

Official Title
-----------------
Impact of Melatonin Adjuvant Therapy on IVF/ICSI Outcomes in Prospective Poor Responders: A Double-blind, Randomized, Placebo-controlled Trial

Conditions
-----------------
In Vitro Fertilization, Poor Ovarian Response

Intervention / Treatment
-----------------
* Drug: Melatonin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prospective poor responder with AMH < 1 ng/ml and AFC < 8 (in both ovaries). Exclusion Criteria: Severe male factor infertility.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 42 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>Melatonin 6 mg tablet once daily. | Drug: Melatonin<br>* Melatonin 6 mg tablet once daily<br>|
| Placebo Comparator: Placebo<br>Placebo tablet once daily | Other: Placebo<br>* one tablet once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of retrieved mature oocytes |  | On the day of oocyte retrieval procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melatonin, IVF/ICSI, Poor ovarian response
Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.

Official Title
-----------------
Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: Vercise Deep Brain Stimulation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implanted bilaterally in STN with a Vercise™ DBS system for Parkinson's disease for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks. Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. Be at least 18 years of age. Exclusion Criteria: Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator. Device must be implanted on label.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Novel Arm<br>Programming completed by a novel method | Device: Vercise Deep Brain Stimulation System<br> <br> |
| Other: Standard of Care Arm<br>Programming completed as Standard of care | Device: Vercise Deep Brain Stimulation System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in time to program between the two arms at Programming Visit |  | at least four months post implant |
Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.

Official Title
-----------------
National, Multicentre, Randomized, Double-blind, Triple-dummy Active-Controled Phase III Clinical Trial to Evaluate the Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction.

Conditions
-----------------
Postsurgical Pain, Third Molar Extraction

Intervention / Treatment
-----------------
* Drug: APSCTC
* Drug: Toragesic®
* Drug: Tramal®


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Males and Females aged 18 to 40 years; Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; Participants who require extraction of impacted mandibular third molar. Main Exclusion Criteria: Known hypersensitivity to the formula components used during the clinical trial; Previous history of alcohol or drugs abuse diagnosed by DSM-V; Previous history of renal failure from moderate to severe; Women who are pregnant, lactating, or positive for β - hCG urine test.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Experimental: APSCTC<br>Oral tablets every 6h for 3 days | Drug: APSCTC<br>* APSCTC + Toragesic® placebo + Tramal® placebo<br>|
| Active Comparator: Toragesic®<br>Oral tablets every 6h for 3 days | Drug: Toragesic®<br>* APSCTC placebo + Toragesic® + Tramal® placebo<br>|
| Active Comparator: Tramal®<br>Oral tablets every 6h for 3 days | Drug: Tramal®<br>* APSCTC placebo + Toragesic® placebo + Tramal®<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At least 50% of maximum pain relief score (TOTPARmax) |  | Change from Baseline to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events incidence and classification |  | During treatment |