linjc16/ctgov huggingface dataset:
Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Nelfilcon A contact lens
* Device: Narafilcon B contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye. Able to wear study lenses in the available powers from -1.00D to -6.00D. Other protocol-defined inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury within twelve weeks of enrollment. History of corneal or refractive surgery. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in any clinical trial. Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses. Monovision correction during the study. Other protocol-defined inclusion/exclusion criteria may apply.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nelfilcon A / Narafilcon B<br>Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week. | Device: Nelfilcon A contact lens<br>* Commercially marketed, spherical contact lens for daily wear, daily disposable use<br>* Other names: DAILIES AquaComfort Plus;Device: Narafilcon B contact lens<br>* Commercially marketed (US), spherical contact lens for daily wear, daily disposable use<br>* Other names: 1-DAY ACUVUE TruEye;|
| Other: Narafilcon B / Nelfilcon A<br>Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week. | Device: Nelfilcon A contact lens<br>* Commercially marketed, spherical contact lens for daily wear, daily disposable use<br>* Other names: DAILIES AquaComfort Plus;Device: Narafilcon B contact lens<br>* Commercially marketed (US), spherical contact lens for daily wear, daily disposable use<br>* Other names: 1-DAY ACUVUE TruEye;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Vision Quality | Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week of wear |
A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.

Study Overview
=================
Brief Summary
-----------------
Objective of this study is to investigate the efficacy, safety and pharmacokinetics of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.

Official Title
-----------------
A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.

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

Intervention / Treatment
-----------------
* Drug: KDT-3594
* Drug: Pramipexole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese patients Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale Exclusion Criteria: Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score < 24 points

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KDT-3594<br> | Drug: KDT-3594<br>* oral administration, dose titration<br>|
| Other: Pramipexole<br>Reference drug | Drug: Pramipexole<br>* ER formulation, oral administration, dose titration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score | Change from baseline (Week 0) in MDS-UPDRS total score | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score | Change from baseline (Week 0) in PDQ-39 summary index score | 12 weeks | 
| Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score | Change from baseline (Week 0) in PDSS-2 total score | 12 weeks |
Lipid Efficacy Study (0524B-022)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Factorial Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Coadministered MK0524B Tablets in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

Conditions
-----------------
Primary Hypercholesterolemia, Mixed Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: niacin (+) laropiprant (+) simvastatin
* Drug: Comparator: niacin (+) laropiprant
* Drug: Comparator: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides </= 350 mg/dL. Exclusion Criteria: A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study Patients with <80% compliance Patients with certain medical conditions Patients taking certain concomitant medications and/or with unstable doses of medications Or those with a history of CHD/CHD equivalent or diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Drug: niacin (+) laropiprant (+) simvastatin|Duration of Treatment 12 Weeks|
|Drug: Comparator: niacin (+) laropiprant|Duration of Treatment 12 Weeks|
|Drug: Comparator: simvastatin|Duration of Treatment 12 Weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin. |  |  | 
| Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A. |  |  |
Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab

Study Overview
=================
Brief Summary
-----------------
Application for Compassionate Use of Tocilizumab in a Boy with Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) Unresponsive to All Licensed Medications.

Detailed Description
-----------------
This trial is for a single subject with juvenile idiopathic arthritis unresponsive to all licensed treatments for JIA, and some licensed only for rheumatoid arthritis. He is currently wheelchair bound and completely dependent for activities of daily living and self-care. He is in constant pain, has abundant warmth and swelling of nearly all joints including TMJs, neck, shoulders, elbows, wrists, MCP and finger joints (even some DIP joints), hips, knees, ankles, subtalar and intertarsal joints, MTP and IP joints of the toes. Drug at a dose of 8 mg/kg would be administered IV every 2 weeks, with close safety and monitoring studies. Treatment would be monitored every 2 weeks. Efficacy will be measured using the ACR Pedi 30, 50 and 90 definitions as previously published, based on: 1) physician global assessment of disease activity; 2) parent/patient assessment of overall well-being; 3) functional ability; 4) number of joints with active arthritis; 5) number of joints with limited range of motion; and 6) erythrocyte sedimentation rate.

Official Title
-----------------
Emergency IND for Provision of Tocilizumab

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Drug: Tocilizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject X, polyarticular JIA, not responding to any other drug Exclusion Criteria: Not identified subject

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tocilizumab|8 mg/kg would be administered IV every 2 weeks for six weeks.|

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
-----------------
juvenile idiopathic arthritis
Breathing After COVID-19

Study Overview
=================
Brief Summary
-----------------
This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19.

Detailed Description
-----------------
This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19. Individuals' sternal movements using motion analysis sensors; will be recorded in sitting position, standing, and walking. Sternal movement of the person; It will be recorded during relaxed breathing and deep breathing. They will also be asked to walk on the treadmill in such a way as to collect at least 500 steps.

Official Title
-----------------
Thoracal Motion After COVID-19 Disease

Conditions
-----------------
Gait, Covid19, Thorax Anomalies

Intervention / Treatment
-----------------
* Other: No intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to be voluntary. have COVID-19 illness history. No COVID-19 illness history. treated by a standard medical treatment (vitamins, blood thinners, anti-viral drugs) Exclusion Criteria: have another chronic disease such as systemic, orthopedic or neurologic.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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 |
| --- | --- |
| Individuals who have had COVID-19.<br>Individuals who have had COVID-19 and who treated by a standart medical treatment at home. | Other: No intervention.<br>* No intervention.<br>|
| Individuals who have not a COVID-19 illness history.<br>Individuals who have not a COVID-19 illness history. | Other: No intervention.<br>* No intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thoracal motion while normal breathing at sitting. | Sensor - based thoracal motion assesment while normal breathing at sitting will be utilized. | At first day. | 
| Thoracal motion while normal breathing at standing. | Sensor - based thoracal motion assesment while normal breathing at standing will be utilized. | At first day. | 
| Thoracal motion while deep breathing at sitting. | Sensor - based thoracal motion assesment while normal breathing at sitting will be utilized. | At first day. | 
| Thoracal motion while deep breathing at standing. | Sensor - based thoracal motion assesment while deep breathing at standing will be utilized. | At first day. | 
| Thoracal motion at walk. | Sensor - based thoracal motion assesment at walk will be utilized. | At first day. |
Gene Testing in Patients With Colon Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer. PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon cancer.

Detailed Description
-----------------
OBJECTIVES: Determine the relationship between disease free survival, overall survival, and tumor replication error status for patients who have received adjuvant chemotherapy for colon cancer on CALGB protocol 8896. Determine the prognostic and predictive values for response to this therapy in these patients.

Official Title
-----------------
Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Genetic: mutation analysis
* Genetic: tumor replication error analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Patients who received chemotherapy for colon cancer as part of CALGB protocol 8896 Underwent an initial resection for adenocarcinoma of the colon and were determined to have a high risk of tumor recurrence based upon nodal disease or local extension of tumor with obstruction or perforation due to tumor Surgical specimen blocks available, including tumor tissue and normal tissue
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Samples of tumor and normal tissue<br>Samples of tumor and normal tissue are obtained from CALGB 8896 patients. The samples are tested for somatic mutations and tumor replication error (RER) tumor status. Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. | Genetic: mutation analysis<br> <br> Genetic: tumor replication error analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | Up to 10 years | 
| tumor replication error status |  | Up to 10 years | 
| determine the prognostic and predictive values for response to this therapy |  | Up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage III colon cancer, adenocarcinoma of the colon
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium

Study Overview
=================
Brief Summary
-----------------
Approximately 36 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.

Official Title
-----------------
A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

Conditions
-----------------
HIV Infections, HIV-1

Intervention / Treatment
-----------------
* Drug: dapivirine (TMC120) vaginal gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-negative Willing to participate and sign an informed consent form Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group. Willing to use two forms of contraception during the study Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study. Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses Exclusion Criteria: Currently pregnant or breast-feeding Clinically detectable genital abnormality on the vulva, vaginal walls or cervix Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment. Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- |
|Drug: dapivirine (TMC120) vaginal gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systemic safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV seronegativity
Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.

Official Title
-----------------
Phase 2 Study of the Treatment of Antiretroviral Treatment-Experienced Subjects Comparing Ritonavir-Boosted GS-9137 (GS-9137/r) vs. a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination With Background ART.

Conditions
-----------------
HIV, HIV-1, Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Drug: GS-9137 - A Novel HIV-1 Integrase Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV RNA greater than or equal to 1000 c/mL. Failed/Failing protease inhibitor based antiretroviral therapy. Stable antiretroviral therapy for greater than or equal to 30 days prior to screening. Negative Serum Pregnancy Test. GFR by Cockcroft Gault greater than or equal to 80 mL/min. AST & ALT less than or equal to 2.5x ULN. Total Bilirubin less than or equal to 1.5 mg/dL. Albumin greater than 3.5 mg/dL. Prothrombin Time INR 1.0-1.4 Platelets greater than or equal to 50,000. Hemoglobin greater than or equal to 8.0 mg/dL. Absolute Neutrophil Count greater than or equal to 1000. Exclusion Criteria: New AIDS defining condition within 30 days of baseline. Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101). Ascites or encephalopathy. Breast Feeding. Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: GS-9137 - A Novel HIV-1 Integrase Inhibitor|nan|

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
-----------------
Phase 2, Phase II, Randomized, Controlled, Comparator, Partially Blind, Protease Inhibitors, Integrase Inhibitors, Antiviral Agents, Antiretroviral Agents, ART, ARV, Highly Activity Antiretroviral Therapy, HAART, Treatment Experienced