linjc16/ctgov huggingface dataset:
Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.

Official Title
-----------------
Study to Evaluate the Effect of BMS-791325 on the Pharmacokinetics of the CYP3A4 Probe Midazolam Administered Orally in Healthy Subjects

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Midazolam
* Drug: BMS-791325


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects aged 18 to 49 years, with BMI of 18-32 kg/m² Women who are not of childbearing potential Exclusion Criteria: Women of childbearing potential Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control. Gastrointestinal disease that may impact the absorption of study drug History of any chronic respiratory disease (asthma, COPD)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam + BMS-791325<br> | Drug: Midazolam<br>* Syrup, Oral, 5 mg, Single dose, 2 days<br>Drug: BMS-791325<br>* Capsules, Oral, 300 mg, Every 12 hours, 8 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax) |  | Within 24 hours of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examination and clinical laboratory tests |  | On Days 1, 2, 4, 6, 8, 9, and 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human Volunteers
Quantification of Respiratory-induced Prostate Motion

Study Overview
=================
Brief Summary
-----------------
Patient anatomy and position during the course of radiation therapy can vary from those used for treatment planning; a function of patient movement, uncertainty in positioning system, and organ motion. Traditionally, treatment margins are designed to compensate for interfraction prostate setup variability. This approach has the potential to lower the overall effectiveness of treatment because the prostate gland is a continuously moving target whose motion cannot be accurately accounted for solely on the basis of interfraction movement. More recently, the dosimetric relevance of intra-fraction prostate motion has been recognized, and may be compensated for by continuous real-time adaptive radiation therapy afforded by the Calypso 4D Localization System™. In the current study, the investigators propose to characterize intrafraction prostate motion. The investigators hypothesize that intrafraction prostate motion is correlated with respiratory motion.

Official Title
-----------------
Pilot Study on the Quantification of Respiratory-induced Prostate Motion During Radiation Therapy Using Continuous Real-time Tracking

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed stage I-III adenocarcinoma of the prostate gland Age > 18 years. Males of all races and ethnic groups Scheduled to receive radiation for definitive therapy Three (3) electromagnetic transponders implanted into prostate gland Exclusion Criteria: Does not satisfy inclusion criteria

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

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

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 |
| --- | --- | --- |
| Motion amplitude | Measured at frequency of 10Hz | Continuously during radiation administration (generally 8 to 15 minutes in duration) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Motion, Respiration
Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

Study Overview
=================
Brief Summary
-----------------
The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system's response will be studied throughout the trial.

Official Title
-----------------
A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines Administered With the Biojector® 2000 Needle-Free System

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: VCL-IPM1
* Biological: VCL-IPM1
* Biological: VCL-IPT1
* Biological: PBS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 45 years of age Able to provide informed consent and be followed for 6 months Exclusion Criteria: No immunomodulatory therapy within the past 6 months No evidence of immunodeficiency or pregnancy No laboratory or evidence of clinically significant medical disease No history of previous pDNA immunization No influenza immunization within the past 30 days No blood donations within 30 days of screening visit No history of bleeding disorder No use of aspirin and/or anticoagulants within 2 weeks of the administration of the investigational vaccines

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: VCL-IPM1<br>* IM, 0.5 mg/mL, 2 injections, 0 and 21 days<br>|
| Experimental: 2<br> | Biological: VCL-IPM1<br>* IM, 1 mg/mL, 2 injections, 0 and 21 days<br>|
| Experimental: 3<br> | Biological: VCL-IPT1<br>* IM, 1 mg/mL, 2 injections, 0 and 21 days<br>|
| Placebo Comparator: 4<br> | Biological: PBS<br>* IM, 1 mL, 2 injections, 0 and 21 days<br>* Other names: Phosphate Buffered Saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pandemic Influenza, Avian Influenza, DNA Vaccines, Antibody, T Cells, HA/NP/M2, Biojector
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to to compare the clinical utility of two dosage tapering regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.

Official Title
-----------------
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females are not pregnant or lactating Subjects meet DSM-IV criteria for opiate dependence, are medically and psychiatrically stable, and do not have a current history of benzodiazepine dependence abuse, dependence, or treatment

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 99 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: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate abstinence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opiate dependence
Incidence and Prevalence of Juvenile Dermatomyositis

Study Overview
=================
Brief Summary
-----------------
This is a descriptive, retrospective, multi-center, cross-sectional and observational epidemiological study of incidence and prevalence of juvenile dermatomyositis in Alsace from 2000 to 2015. Alsace is a French region with a low migratory flow

Official Title
-----------------
Incidence and Prevalence of Juvenile Dermatomyositis in Alsace Between 2000 to 2015

Conditions
-----------------
Juvenile Dermatomyositis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age under 16 years Have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975 Exclusion Criteria: Refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 16 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify incident and prevalent cases of juvenile dermatomyositis according to Bohan and Peter's criteria at january 1st, 2016 via capture/recapture strategy |  | The period from from January 1st, 2000 to December 31st, 2015 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incidence, prevalence, epidemiology, juvenile dermatomyositis, inflammatory myopathy
Effect of Acu-Transcutaneous Electrical Nerve Stimulation (TENS) on Post-Exercise Expiratory Flow Rate in Subjects With Asthma

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the effectiveness of Acu-TENS (Transcutaneous electrical nerve stimulation applied on acupoints) on the post- exercise expiratory flow rate and exercise performance on the subjects with exercise.

Official Title
-----------------
Effect of Acu-TENS on Post-Exercise Expiratory Flow Rate in Subjects With Asthma- A Randomized Controlled Trial

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Device: Transcutaneous electrical nerve stimulation (TENS)
* Device: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis with asthma attending regular follow up at respiratory clinic Exclusion Criteria: Allergic to gel Suffered from other neurological or cardiovascular or musculoskeletal disorders that may affect their exercise performance Suffered from upper respiratory tract infection prior to the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Applied Acu-TENS prior to exercise | Device: Transcutaneous electrical nerve stimulation (TENS)<br>* Applied 45 minutes prior to exercise<br>|
| Experimental: Group 2<br>Applied Acu-TENS prior to and during exercise | Device: Transcutaneous electrical nerve stimulation (TENS)<br>* Applied 45 minutes prior to exercise<br>|
| Placebo Comparator: Group 3<br>Applied placebo TENS prior to exercise | Device: placebo<br>* placebo TENS applied prior to exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC) |  | measured before exercise, immediately after exercise and at 20, 40 and 60 minutes post exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RPE, Exercise duration |  | immediately post exercise | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Exercise training, TENS, Acupuncture, FEV1
Effect of Chrysanthemum Flower Oil and Its Dose-dependency on Hyperuricemia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum flower oil in suppressing serum uric acid.

Official Title
-----------------
A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Chrysanthemum Flower Oil and Its Dose-dependency in Subjects With Hyperuricemia

Conditions
-----------------
Hyperuricemia

Intervention / Treatment
-----------------
* Dietary Supplement: 200 mg of chrysanthemum flower oil
* Dietary Supplement: 300 mg of chrysanthemum flower oil
* Dietary Supplement: 400 mg of chrysanthemum flower oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum uric acid 6.8-8.9 mg/dL Exclusion Criteria: Taking anti-hyperuricemic drugs History of gouty attack Taking drugs or functional food that may affect serum uric acid level Hypertention, hyperlipidemia, or diabetes millitus Participation in any clinical trial within 90 days of the commencement of the trial Renal or hepatic dysfunction Heart disease History of severe disease and/or major surgery

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg CFO<br>200 mg of chrysanthemum flower oil | Dietary Supplement: 200 mg of chrysanthemum flower oil<br> <br> |
| Experimental: 300 mg CFO<br>300 mg of chrysanthemum flower oil | Dietary Supplement: 300 mg of chrysanthemum flower oil<br> <br> |
| Experimental: 400 mg CFO<br>400 mg of chrysanthemum flower oil | Dietary Supplement: 400 mg of chrysanthemum flower oil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum uric acid from baseline |  | Every 4 weeks (Overall 8 weeks) | 
| Change in uric acid clearance from baseline |  | Every 4 weeks (Overall 8 weeks) |
Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases

Study Overview
=================
Brief Summary
-----------------
Multicentric study, open label, uncontrolled phase IV in 140 patients with meibomian glands dysfunction . Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized. This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21. Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.

Official Title
-----------------
Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.

Conditions
-----------------
Eyelid Diseases

Intervention / Treatment
-----------------
* Device: Blephasteam


Participation Criteria
=================
Eligibility Criteria
-----------------
Signed and dated informed consent. Male or female up to 4 years old. Known and treated symptomatic Meibomian Gland Diseases, and/or Dry Eye related to MGDs stable since at least a month. Without any active pathology requiring a change in ocular treatments within the last month before inclusion. Best corrected far visual acuity (VA) > 1/10

Ages Eligible for Study
-----------------
Minimum Age: 4 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 |
| --- |
|Device: Blephasteam|Eye lid warming goggles|

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
-----------------
Meibomian Gland Dysfunction
Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation

Study Overview
=================
Brief Summary
-----------------
Ureteral stent placement is one of the most common procedures performed within urology. The stents are generally placed for relief of obstruction or to prevent obstruction following a urological procedure. Most patients with ureteral stents will eventually form stent encrustations. However, patients form these encrustations at dramatically different degrees and rates ranging from no encrustation at 1 year of stenting to severe encrustation in just a few weeks. The purpose of this study is to determine if the degree of encrustation on a stent for any given patient can be predicted based on 24 hour urine parameters prior to stent placement, with the stent in place and after stent removal. Patients who will be receiving stents for other urological reasons will have a 24 hour urine sample collected before stent placement, while the stent is in place and after the stent has been removed. The parameters examined in the 24 hour urine collected will then be compared to the amount of encrustation there is on the stent to see if there is any correlation between the two.

Official Title
-----------------
Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation

Conditions
-----------------
Kidney Stones

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient at UCI Scheduled to undergo surgery (standard of care) where ureteral stent will be placed Exclusion Criteria: minors

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ureteral Stent, Kidney Stones
Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

Study Overview
=================
Brief Summary
-----------------
Patients eligible for entry into the study have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature.The primary purpose of the study is to observe symptoms changes over 6 months in schizophrenia in patients treated with Seroquel; additionally disease severity and treatment compliance are followed

Official Title
-----------------
Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To assess at baseline and after treatment administration the severity of the illness in patients with schizophrenia, using the scores obtained after the application of the CGI scale To assess the changes in symptoms of patients treated with Seroquel for 24 weeks, using BPRS (Brief Psychiatry Rating Scale) as measuring tool Exclusion Criteria: All the patients who have a known hypersensitivity to Seroquel /quetiapine or any of its excipients will not be included in this study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Schizophrenia patients under Seroquel treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Psychiatric Rating Scale - BPRS |  | Monthly at every clinic visit- 7 times | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Severity of Illness |  | Monthly/ at every clinic visit-7 times | 
| CGI-S Clinical Global Impression Improvement CGI -I |  | Monthly/ at every clinic visit except first visit- 6 times | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia