linjc16/ctgov huggingface dataset:
Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to test the safety of HPV Vaccine in Women

Official Title
-----------------
Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease

Conditions
-----------------
Cervical Cancer, Genital Warts

Intervention / Treatment
-----------------
* Biological: V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years
* Biological: Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females age 16 to 23 years old Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit Exclusion Criteria: History of vaccination with an HPV vaccine History of hepatitis B infection History of vaccination with hepatitis B vaccine History of genital warts or treatment for genital warts

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 23 Years

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years|nan|
|Biological: Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV vaccine is well tolerated in 16-23 year old females. |  |  |
Can Methods From Computational Psychology be Used to Phenotype Individuals Most Likely to be Non-adherent to Fitness Goals?

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal study combining objective sensor data, with decision-making games and contextual personality traits to identify patterns in exercise decay. The data generated will be used to build computational models to predict digital personas, and help identify those individuals most likely to abandon exercise goals.

Detailed Description
-----------------
Interested individuals to be recruited on social media and invited to download the study app. The plain language statement and informed consent are embedded in the app. Once e-consent is obtained, individuals will share their Fitbit data and complete the following questionnaires; Type D Personality, Goal Setting, and Self-Efficacy questionnaire and a decision-making game based on the IGT. After a 6 month time period, they will be requested to retake the questionnaires and decision-making game.

Official Title
-----------------
Can Methods From Computational Psychology be Used to Phenotype Individuals Most Likely to be Non-adherent to Fitness Goals?

Conditions
-----------------
Lifestyle, Sedentary

Intervention / Treatment
-----------------
* Other: App


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals who have a Fitbit Exclusion Criteria: Individuals under the age of 18 years of age.

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

| Intervention/Treatment |
| --- |
|Other: App|An application to deliver a series of behavioral questionnaires and decision-making game|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity measured by an increase in weekly steps measured by Fitbit. | Fitbit is a physical activity tracker worn on the wrist and objectively measures steps taken. | Week 1 and 6 months |
Outcome Evaluation of Patients After Percutaneous Tracheostomy Due to Respiratory Failure in an Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
To determine the morbidity and mortality of patients who have undergone percutaneous tracheostomy due to respiratory failure in the critical care unit and after intensive care in the internal medicine department, including follow-up of quality of life of these patients.

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Procedure: Tracheostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated critical care patients Exclusion Criteria: All others

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tracheostomy Patients<br>Critical care patients with respiratory failure who were mechanically ventilated and who underwent tracheostomy | Procedure: Tracheostomy<br> <br> |
| Non-Tracheostomy Patients<br>Critical care patients with respiratory failure who were mechanically ventilated but did not undergo tracheostomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with tracheostomy due to respiratory failure who died | Retrospective review of charts showing increase in morbidity in patients with respiratory failure with tracheostomy taking place 2 weeks after admission to critical care | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tracheostomy
Airway Alkalinization and Nasal Colonization

Study Overview
=================
Brief Summary
-----------------
The study will be a randomized, cross-over study of THAM followed by saline or saline followed by THAM in human non-CF and CF subjects to assess nasal colonization

Detailed Description
-----------------
16 subjects per group will be randomized to receive study drug or saline followed by a wash out period and cross-over to the other treatment, three times daily for 4 days. Nasal swab will be done at baseline and after both study treatment and saline treatment for assessment of airway colonization.

Official Title
-----------------
Airway Alkalinization and Nasal Colonization

Conditions
-----------------
Healthy Subjects, Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Tham
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy subjects: Inclusion Criteria: 16 subjects, aged 16-80, clinically stable with no significant changes in health status for 14 days prior to Day 1, written informed consent obtained fom subject. Exclusion Criteria: Pregnant or lactating Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to screening, smoked in the last 6 months. CF subjects: Inclusion Criteria: FEV1% >35%, O2 saturation >90% on room air, clinically stable with no significant changes in health status for 14 days prior to Day 1, written informed consent obtained from subject. Exclusion Criteria: Same as for healthy subjects.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline<br>normal saline | Drug: Saline<br>* Placebo<br>|
| Experimental: treatment<br>tham | Drug: Tham<br>* alkalinizer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal bacterial colonization | Culture | Day 5 of placebo or Tham intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment questionnaire | Questionnaire for local side effects | Day 5 of placebo or Tham intervention |
Microcurrent Stimulation for Dry Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.

Detailed Description
-----------------
Multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.

Official Title
-----------------
Microcurrent Stimulation Therapy for Dry Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Double-masked, Clinical Device Trial

Conditions
-----------------
Dry Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Device: i-Lumen AMD
* Device: i-Lumen AMD Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria - Study Eye: Dry AMD diagnosis. Key Exclusion Criteria - Study Eye: Wet AMD

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: i-Lumen AMD Active<br> | Device: i-Lumen AMD<br>* Microcurrent stimulator<br>|
| Sham Comparator: i-Lumen AMD Sham<br> | Device: i-Lumen AMD Sham<br>* Sham microcurrent stimulator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint. |  | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected distance visual acuity (CDVA) response rate at 1 month visit. |  | 1 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, Dry AMD
Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment

Study Overview
=================
Brief Summary
-----------------
The purpose of the evaluation is to confirm operability and usability of the SL-D301 Slit Lamp and the DC-4 digital camera attachment by conducting a usability evaluation and subsequently submitting a questionnaire and hold an interview with the operator. Of special interest for the study is to confirm whether the illumination level of SL-D301 is enough to perform an eye exam since the maximum illumination level on the SL-D301 is lower than other existing Topcon digital ready slit lamps due to regulations that limit the maximum light intensity on the human eye. The SL-D301 will be compared against the predicate device SL-3G.

Detailed Description
-----------------
An eye care professional familiar with the use of slit lamps and experienced with other Topcon and other manufacturer's slit lamps will evaluate operability and usability of SL-D301 and DC-4 digital camera attachment instrument performing routine eye examinations and image capture on volunteer subjects using above mentioned instruments. Similar evaluations will be performed with the SL-3G Slit Lamp and a comparative evaluation will be drawn between the two instruments. At the end of the evaluation, the evaluator will be presented with a questionnaire on specific points regarding the performance and features of the instruments and interviewed. The responses will then be evaluated by Topcon.

Official Title
-----------------
Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment

Conditions
-----------------
Ocular Images

Intervention / Treatment
-----------------
* Device: SL-D301
* Device: DC-4
* Device: SL-3G


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any Willing Subject Exclusion Criteria: Subjects unwilling to participate

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 |
| --- | --- |
| Any Willing and Able Person for Ocular Imaging<br>Any Willing and Able Person for Ocular Imaging | Device: SL-D301<br>* Slit Lamp<br>Device: DC-4<br>* Digital Camera Attachment<br>Device: SL-3G<br>* Slit Lamp<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Comparison of DC-4 to the SL-D301 |  | 1 Hour |
Study Of GW679769 In Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy and Safety of GW679769 in Subjects With Major Depressive Disorder.

Conditions
-----------------
Depressive Disorder, Major, Major Depressive Disorder (MDD)

Intervention / Treatment
-----------------
* Drug: GW679769


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects must have the ability to comprehend the key components of the consent form. Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit. If female, subjects must be practicing an acceptable method of birth control. Subjects must have rating scores as outlined. Exclusion criteria: Subjects whose symptoms of the MDE are better accounted for by another diagnosis. Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder. Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months. Subjects with an unstable medical disorder. If female, pregnant or lactating. Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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

| Intervention/Treatment |
| --- |
|Drug: GW679769|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder, Major Depression, Mood Disorders, Major Depressive Episode
Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early

Study Overview
=================
Brief Summary
-----------------
Observational retrospective study that included all patients meeting the inclusion criteria from 1st January 2014 to 31st December 2015. The objective of the study is to describe and compare two populations of patients with severe traumatic head injury arriving under sedation in the Department in whom the sedation was not continued.

Official Title
-----------------
Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early

Conditions
-----------------
Traumatic Head Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with traumatic head injuring arriving in the Neurosurgery and Traumatologic Intensive Care Unit under sedation Exclusion Criteria: Brain death within the 48h following admission, Stroke leading to the traumatic head injury, Death within the 24h following admission, Patients not under sedation on admission to the unit, Non-sedated patients transferred directly to the operating theatre Traumatic brain injury in patients presenting chronic sub-dural haematoma, Continued sedation (> 15h) in the ICU.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Motor score |  | At baseline |
Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the rate of osteoporosis among patients with advanced prostate cancer. to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis.

Detailed Description
-----------------
Patients with advanced prostate cancer are included at the initiating of androgen deprivation therapy. The patients are followed for 2 years after inclusion with blood sampling, DXA-scan, questionnaire, bone scintigraphy.

Official Title
-----------------
Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer: Symptoms, Risc Factors, and Prevention

Conditions
-----------------
Prostate Cancer, Androgen Deprivation Therapy, Osteoporosis

Intervention / Treatment
-----------------
* Procedure: blood sampling, DXA-scan, bone scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer Initiation of androgen deprivation therapy Oral and written informed consent Exclusion Criteria: They withdraw their consent Treatment for osteoporosis within the last year Other malignancy Other bone disease, bedbound, use of steroid
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood sampling, DXA-scan, bone scintigraphy|Blood sampling 5 times DXA-scan 5 times Bone scintigraphy 3 times|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoporosis, either T-score < -2,5 or osteoporosis fracture |  | 2½ years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, androgen deprivation therapy, osteoporosis
Rifampin Drug-Drug Interaction Study With Lurasidone HCl

Study Overview
=================
Brief Summary
-----------------
The effect of rifampin on the pharmacokinetics of lurasidone

Detailed Description
-----------------
by performing an open-label, 2-period, sequential study in healthy subjects. All subjects (N=20) will be assigned to the same treatment sequence, 40 mg po dosing.

Conditions
-----------------
Male, Healthy Normal Subjects

Intervention / Treatment
-----------------
* Drug: Lurasidone HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects must be of nonchildbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year) with follicle stimulating hormone [FSH] > 40 U/L). Subjects with partners of child-bearing potential must agree to use barrier contraception during the study and for 90 days after discharge. Volunteers must agree to not donate sperm during the study and for 90 days after discharge. Exclusion Criteria: Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs. Use of concomitant medications that prolong the QT/QTc interval from 14 days prior to day - 2 to discharge. Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to study Day -2 Use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever was longer) prior to Screening. Previous exposure to lurasidone (SM-13496).

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rifampin/Lurasidone<br>Healthy Normal Subject | Drug: Lurasidone HCl<br>* 40mg, Single-dose of lurasidone 40 mg (one 40 mg tablet) on Day 1. Daily dosing of rifampin 600 mg (two 300 mg capsules) on Days 1-8. On Day 8, subjects will also receive a single-dose of lurasidone 40 mg (one 40 mg tablet).<br>|

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
-----------------
Rifampin DDI with Lurasidone HCl