linjc16/ctgov huggingface dataset:
A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge

Study Overview
=================
Brief Summary
-----------------
Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine

Detailed Description
-----------------
This is a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to determine the effect of 200 mg oral TR-701 FA on SBP response when administered with tyramine in healthy adult male and female volunteers.

Official Title
-----------------
A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: TR-701 FA with Tyramine
* Drug: Placebo-controlled withTyramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects between 18 to 45 years of age, inclusive Body mass index between 19 kg/m2 and 31 kg/m2, inclusive Healthy subjects with no clinically significant abnormalities identified by a detailed medical history, Exclusion Criteria: Systolic blood pressure >130 mmHg or <90 mmHg measured after 10 minutes in the supine position at Screening or at admission to the study center Heart rate >90 bpm or <45 bpm measured after 10 minutes in the supine position Electrocardiogram (ECG) finding of QTc interval >500 msec, or other clinically significant ECG abnormality at the Screening Visit

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TR-701 FA with Tyramine<br>TR-701 FA 200 oral with Tyramine | Drug: TR-701 FA with Tyramine<br>* TR-701 FA 200 mg oral and Tyramine<br>* Other names: Tedizolid Phosphate;|
| Placebo Comparator: Placebo-controlled with Tyramine<br>Placebo-controlled with Tyramine | Drug: Placebo-controlled withTyramine<br>* Placebo-controlled and Tyramine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure | 14 days |
Risperidone Treatment in Dually-Diagnosed Individuals - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of risperidone for cocaine dependence in individuals with schizophrenia/schizoaffective illness.

Official Title
-----------------
Risperidone Treatment in Dually-Diagnosed Individuals

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Risperidone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 
| Craving |  |  | 
| Drug use |  |  | 
| Psychiatric symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Assessing Fatiguability of Tongue Muscles in MS

Study Overview
=================
Brief Summary
-----------------
Multiple Sclerosis (MS) patients with subjective dysphagia will be tested for tongue strength fatigue using a strictly defined fatigue paradigm. A maximum of 40 sets will be performed, each set consisting of 5 repetitions of 80% of maximum isometric pressure (MIP) at the anterior tongue, followed by a MIP at the anterior tongue. Cut-off criteria are a MIP <50% of the baseline MIP, pronounced subjective discomfort and/or exceeding the allocated test time of 30 minutes.

Detailed Description
-----------------
Eligibility is Mini-Mental State Exam-score (MMSE) > 23, a Eating Assessment Tool-score (EAT-10) > 3, or a Functional Oral Intake Scale-score (FOIS) < 7, or failing the Yale Swallow Protocol.

Official Title
-----------------
Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis

Conditions
-----------------
Muscle Weakness, Fatigue, Multiple Sclerosis, Deglutition Disorders, Exertion; Excess

Intervention / Treatment
-----------------
* Device: Iowa Oral Performance Instrument (IOPI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proven MS subjective dysphagia Exclusion Criteria: MMSE < 23 major head and neck surgery history of cancer

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iowa Oral Performance Instrument (IOPI)<br>All MS patients will be included in this arm to compare with a historical control arm. Iowa Oral Performance Instrument (IOPI). | Device: Iowa Oral Performance Instrument (IOPI)<br>* Using biofeedback to attain repetitions of 80% of baseline MIP.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successful repetitions | The number of repetitions where the target force was developed. | 30 minutes | 
| Evolution of MIP during subsequent repetitions | The change in MIP after each 5 repetitions. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline MIP as predictor for number of repetitions | Does baseline MIP predict the number of successful repetitions. | 30 minutes |
CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).

Official Title
-----------------
Phase III Evaluation of the Safety and Efficacy of CLONICEL (Clonidine HCl Sustained Release) as Add-on to Psychostimulant Medication vs. Psychostimulant Medication Alone in Children and Adolescents With ADHD

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: CLONICEL (clonidine HCl sustained release)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6-17 years, inclusive Diagnosis of ADHD Currently on a stable psychostimulant regimen for ADHD Lack of adequate response to stable psychostimulant regimen Ability to swallow tablets Exclusion Criteria: Clinically significant illnesses or abnormalities upon evaluation Conduct Disorder Intolerance to clonidine History of seizures or syncope

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: 1<br> | Drug: CLONICEL (clonidine HCl sustained release)<br>* Flexible Dose (0.1 - 0.4 mg)<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Matching placebo tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHDRS-IV Total Score |  | Week 5 | 
| Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs |  | Throughout Treatment and Follow-up Period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, ADD, Attention Deficit Hyperactivity Disorder, Attention Deficit, Clonidine, CLONICEL, Addrenex
A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence

Study Overview
=================
Brief Summary
-----------------
This study will enroll completers of a prior 24 week MEMS cap study of Kaletra adherence, conducted in 2005 - 2006, and repeat the MEMS monitoring for an additional 24 weeks in 2008/2009 on the current antiretroviral anchor drug. The goals of the study are to correlate long-term adherence with virologic outcome, and to explore the stability of MEMS cap adherence measurements over time.

Official Title
-----------------
A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Other: MEMS cap monitoring
* Other: MEMS cap monitoring
* Other: MEMS cap monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the prior Kaletra MEMS cap study Exclusion Criteria: Not receiving antiretroviral therapy, refusal to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Intervention/Treatment |
| --- |
|Other: MEMS cap monitoring|Electronic monitoring of medication adherence using MEMS caps|
|Other: MEMS cap monitoring|Adherence to antiretroviral medications will be measured using electronic bottle caps (MEMS caps) that record the time signature of each bottle opening.|
|Other: MEMS cap monitoring|Adherence to antiretroviral medications will be measured using electronic bottle caps (MEMS caps) that record the time/date signature of each bottle opening.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion with virologic suppression |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Adherence, MEMS
A Study to Evaluate LY3154207 on the Brain of Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about how LY3154207 affects the brain of healthy participants by using magnetic resonance imaging. The study will last up to about nine weeks for each participant and may include up to four visits to the study center.

Official Title
-----------------
A Single-Dose Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of LY3154207 in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: LY3154207
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Overtly healthy males and non-childbearing females, as determined through medical history and physical examination Exclusion Criteria: Have known or ongoing psychiatric disorders Have contraindications to magnetic resonance imaging (MRI)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3154207<br>LY3154207 administered orally in one of two study periods. | Drug: LY3154207<br>* LY3154207 administered orally.<br>|
| Placebo Comparator: Placebo<br>Placebo administered orally in one of two study periods. | Drug: Placebo<br>* Placebo administered orally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Intrinsic Functional Connectivity Among Resting-State Networks of the Brain | Mean Connectivity and Mean Component Weight Between LY3154207 and Placebo in the Dorsal Attention Network (DAN), Frontoparietal Network (FPN), and Executive Control Network (ECN). | Day 1, Approximately Day 28 |
Observational Study of Methoxy Polyethylene Glycol Epoetin Beta Daily Use in Participants on Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
This non-interventional, observational study investigates the efficacy, safety and usability of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis. Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and who meet the selection criteria were to be enrolled and documented in this study for a period of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect to efficacy, safety and usability.

Official Title
-----------------
Non-Interventional Observation Trial to Investigate the Efficacy, Safety and Usability of Mircera in PD Patients in Daily Use

Conditions
-----------------
Renal Impairment, Renal Anemia of Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Methoxy polyethylene glycol epoetin beta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants on peritoneal dialysis Need for Erythropoiesis Stimulating Agent (ESA) therapy Prescription of methoxy polyethylene glycol epoetin beta by the doctor Exclusion Criteria: N/A

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 |
| --- | --- |
| Peritoneal Dialysis participants<br>Participants who are on peritoneal dialysis and have been prescribed with methoxy polyethylene glycol were observed for a period of 9 months. | Drug: Methoxy polyethylene glycol epoetin beta<br>* Methoxy polyethylene glycol epoetin beta is prescribed as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC).<br>* Other names: Mircera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) |  | Month 7 to Month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) |  | Month 7 to Month 9 | 
| Average Duration in Days Mircera Was Administered at a Stable Dose |  | Up to 9 months |
Comparison of Predictive Factors Related to Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
In Taiwan, heart disease and cerebrovascular disease ranked the second and third of ten leading causes of death in female in 2007; half of these deaths is due to coronary artery disease (CAD). Postmenopausal status is an independent risk factor for CAD. Early assessment and proper management of risk factors may reduce the prevalence rate of CAD. In the past decade, despite increased attention to CAD in women, most studies focused on certain menopausal status instead of all phases of menopause or on risk factors limited to related metabolic syndrome. Because the prevalence of risk factors related to CAD is influenced by various physiological and lifestyle status in different menopausal statuses, the purpose of this study, at the first stage, is to explore respectively the risk factors of CAD among middle-aged women in three menopausal statuses. At the second stage, the influence of a lifestyle management program on risk factors modification among pre-menopausal women is examined in this study.

Official Title
-----------------
Comparison of Predictive Factors Related to Coronary Artery Disease Among Different Menopausal Status and Effect of a Life Style Management Program on Risk Factors Modification Among Middle-aged Women

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: lifestyle modified project


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of CAD by coroangiography LVEF >30% Exclusion Criteria: impairment of physical activity history of psychiatric disorder, vital arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifestyle modified project<br>education, counseling | Other: lifestyle modified project<br>* education, counseling<br>|
| No Intervention: control<br>waiting list control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lifestyle | physical activity, dietary, depression, anxiety |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic | blood pressure, lipid profile, blood sugar, obesity | 6 months | 
| biomarkers | hsCRP, homocysteine, leptin |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
middle age, women, risk factor
Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
Today the minimal invasive access is used for a lot of different operations. This technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection). Especially patients under immunosuppressive therapy could benefit from this technique. First results in minimally invasive kidney transplantation indicate that it may be performed quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical complications. Another retrospective study showed lower rates of hernia, abdominal wall relaxations, and a better postoperative cosmetic. The aim of this study is to compare the classic hockey stick incision with a minimal invasive incision in a randomized clinical trial.

Official Title
-----------------
Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Procedure: Short Transverse Incision
* Procedure: Hockey Stick Incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal or over 18 years Sole kidney transplantation Consent form

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Short Transverse Incision | Procedure: Short Transverse Incision<br>* Short Transverse Incision for kidney transplantation<br>|
| Active Comparator: 2<br>Hockey Stick Incision | Procedure: Hockey Stick Incision<br>* Hockey Stick Incision for kidney transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoR (Quality of Recovery) - Score |  | preoperative, day 1/3/5/7 postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life by SF (Short Form) 36 |  | preoperative, day 7, week 4, month 6 postoperative | 
| Operation time |  | intraoperative | 
| Warm ischemic time |  | intraoperative | 
| Postoperative pain measured by VAS (visual analog scale) and amount of analgesia |  | day 1/2/3/4/5/6/7 postoperative | 
| Surgical complications |  | day 7, week 4, month 6, month 12 postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney, transplantation, minimal invasive, short transverse, hockey stick, incision, quality of life, planned kidney transplantation