linjc16/ctgov huggingface dataset:
KERatoconus and Metalloproteinases InvesTigation

Study Overview
=================
Brief Summary
-----------------
Corneal stromal thinning observed in keratoconic eyes could result from an increased synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by an overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and Galectin-3 by epithelial cells. A differential expression of EMMPRIN, Galectin-3 and metalloproteinases (MMP) may be observed between the apex of the keratoconus and the peripheral cornea. Highlighting the implication of EMMPRIN and Galectin-3 could lead to the development of specific inhibitors to slow or to stop keratoconus evolution.

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Other: immuno-histo-chemical analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old Patient with keratoconus undergoing corneal collagen cross-linking (epithelium-off methods) Patient with keratoconus undergoing his first corneal graft for optical indication (control) Exclusion Criteria: Patient with keratoconus undergoing corneal graft for tectonic indication Patient undergoing corneal refractive surgery (refractive photokeratectomy) with a normal topography, a normal slit lamp examination and no previous ophthalmic condition (control) pregnant or breast feeding patient patient under judiciary protection patient opposition to participate in 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgery for keratoconus<br> | Other: immuno-histo-chemical analysis<br>* in vitro immuno-histo-chemical analysis of corneal epithelium<br>|
| refractive surgery (control patients)<br> | Other: immuno-histo-chemical analysis<br>* in vitro immuno-histo-chemical analysis of corneal epithelium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells |  | baseline |
Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.

Official Title
-----------------
Adjunctive Lisdexamfetamine in Bipolar Depression

Conditions
-----------------
Bipolar Depression

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, through the ages of 18 and 55 years, inclusive. Exclusion Criteria: Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. Subjects who are displaying clinically significant homicidality or suicidality Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lisdexamfetamine<br>Drug | Drug: Lisdexamfetamine<br>* oral; 20-70mg/day<br>|
| Placebo Comparator: Placebo<br>Drug | Drug: Placebo<br>* oral; 20-70mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Montgomery-Asberg Depression Rating Scale | Efficacy will be assessed by measuring the baseline-to-endpoint change in the Montgomery-Asberg Depression Rating Scale (MADRS) | 30-36 months |
The Influence of Wedge Insoles After Partial Meniscectomy

Study Overview
=================
Brief Summary
-----------------
Research on the implications of orthotic devices and the recovery after knee arthroscopy are widely known. But only a handful of specific issues have been studied to date. However, the effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. To our best knowledge, there are no studies that deal with the treatment of partial medial or lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this study is to find out if using wedge inserts or knee orthoses improve the outcomes after partial meniscectomy. We therefore verify the following hypothesis: In patients with partial meniscectomy can be by the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a significantly better clinical outcome than without specific treatment.

Official Title
-----------------
Effect of Orthotic Devices in the Recovery After Partial Meniscectomy

Conditions
-----------------
Partial Meniscectomy

Intervention / Treatment
-----------------
* Device: Wedge Insole 5mm
* Device: Knee Brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: full leg x-ray to measure the leg axis undersigned Informed Consent Form Exclusion Criteria: at the same time conducted or within one year subsequent corrective osteotomies of the leg axis medial meniscectomy combination and valgus combination of lateral meniscectomy and varus psychiatric or neurological comorbidities that produce a poor compliance forth degree cartilage lesions or evident osteoarthritis concomitant lesion of the collateral ligaments insufficient knowledge of the study language

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No specific treatment<br>No specific treatment after partial meniscectomy | |
| Other: Wedge Insole with 5mm wedge angel<br>Participants wear a wedge insole after partial meniscectomy | Device: Wedge Insole 5mm<br> <br> |
| Other: Knee Brace<br>Participants wear a knee brace after partial meniscectomy | Device: Knee Brace<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee-specific questionnaires which combine an activity and a quality of life score. |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wedge insoles,, knee brace,, orthotic device, goal
Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses

Study Overview
=================
Brief Summary
-----------------
To determine the safety, tolerability, and drug absorption profile of multiple IV doses of BLI 489 in healthy subjects.

Official Title
-----------------
Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: BLI-489
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of non-childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening; Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg.; Healthy as determined by the investigator on the basis of screening evaluations; Calculated creatinine clearance within normal limits using the Cockcroft-Gault formula; Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history, and if a smoker must be able to abstain from smoking during the inpatient stay; Have a high probability for compliance with and completion of the study. Exclusion Criteria: Presence or history of any disorder that may prevent the successful completion of the study; Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease; Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the investigational product; Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1; History of drug abuse within 1 year before study day 1; Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BLI-489 | Drug: BLI-489<br> <br> |
| Placebo Comparator: 2<br>placebo | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety of drug given to healthy subjects by evaluating any reported adverse events (AEs), scheduled physical examinations, vital sign measurements, 12-lead ECGs, and clinical laboratory test results. |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects
Comparison of Photorefraction With Cycloautorefraction and Cycloretinoscopy at Emam Hosein Medical Centre in 2008-2009

Study Overview
=================
Brief Summary
-----------------
Screening of refractory defect is one of major reason for amblyopy. Photorefraction is a new method with some advantages in treatment of this problem. In this study the investigators are going to compare the results of this surgery in children between 1 to 10 years old with cycloautorefraction in children above 3 years old.

Official Title
-----------------
Comparison of Photorefraction With Cycloautorefraction and Cycloretinoscopy at Emam Hosein Medical Centre in 2008-2009

Conditions
-----------------
Amblyopia

Intervention / Treatment
-----------------
* Device: photorefraction,cycloautorefraction,cycloretinoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amblyopy Children between 1 to 10 years old

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: photorefraction<br> | Device: photorefraction,cycloautorefraction,cycloretinoscopy<br> <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
-----------------
children between 1 to 10 years old, amblyopy
A Study to Observe the Treatment Patterns and Outcomes of Patients in Japan With Kidney Cancer That is Unable to be Removed by Surgery or That Has Spread

Study Overview
=================
Brief Summary
-----------------
A medical review chart study in Japan to describe the treatment patterns and outcomes of patients with kidney cancer that is unable to be removed by surgery or that has spread. The clinical data is to be abstracted using electronic data capture (eDC) from patient medical records in Japan.

Official Title
-----------------
Treatment Patterns and Outcomes in Unresectable or Metastatic Renal Cell Carcinoma (mRCC) Patients in Japan

Conditions
-----------------
Renal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Adults 20 years and older at the time of initial diagnosis of mRCC Alive or deceased as of the date of data collection Diagnosis of mRCC between 01-Jan-2012 and 31-Aug-2015 Exclusion Criteria: Previously and/or currently enrolled in RCC clinical trials Patients have primary cancer other than renal cell cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Unresectable or metastatic renal cell carcinoma (mRCC)<br>Medical records will be reviewed for treatment patterns and outcomes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment patterns | measured by retrospective data collection of treatment regimen and duration (including rate of permanent and temporary discontinuation) | Approximately 5 years | 
| Overall survival | measured by data collection in years | Approximately 2 years | 
| Reason for terminating or switching treatment | measured by data collection information available in retrospective analysis, if disclosed | Approximately 5 years | 
| Adverse Events | measured by data collection | Approximately 5 years |
An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients

Official Title
-----------------
Efficacy and Safety of a Novel Silicone Wound Dressing for the Management of Atrophic Vaginitis

Conditions
-----------------
Atrophic Vaginitis

Intervention / Treatment
-----------------
* Device: Film forming silicone gel (7-0940)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide informed consent Diagnosed acute or chronic Atrophic Vaginitis Controlled disease, or uncontrolled disease that did not respond to standard therapy with HRT Exclusion Criteria: Unable to provide informed consent Patient unable to apply topical device Allergy or intolerance to ingredients or excipients of the formulation of studied products Currently on HRT (orally or topically) Currently on corticosteroid treatment
Sexes Eligible for Study
-----------------
Female

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Patients apply 7-0940 at least 2 times daily for 3 months. | Device: Film forming silicone gel (7-0940)<br>* Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas. Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel. Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue. Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported Vulvar Quality of Life | Vulvar Quality of Life Index | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported symptoms | Likert scales to measure: Pruritus/itchiness Tender/sore Swelling Dryness Burning of skin Dyspareunia Stinging with urination/clothes Defecating pain/burning | 3 months | 
| Severity of overall condition | Clinician-rated severity of atrophic vaginitis | 3 months | 
| Product rating | Likert scale for product rating by the patient | 3 months |
A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients with mild and moderate hepatic impairment. Patients with type 2 diabetes, and with normal hepatic function, or mild or moderate hepatic impairment, will receive a single dose of GK Activator (2) 100mg po before breakfast, for assessment of pharmacokinetic, pharmacodynamic and safety parameters. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Nonrandomized, Open Label Study to Examine the Effect of Hepatic Impairment on the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.'

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: GK Activator (2)
* Drug: Ethanol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-75 years of age; type 2 diabetes; normal hepatic function, or mild or moderate hepatic impairment. Exclusion Criteria: type 1 diabetes, or latent autoimmune diabetes in adults; diabetic neuropathy, retinopathy or nephropathy; treatment with insulin or PPAR gamma agonist within 6 weeks of screening; clinically significant cardiovascular disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: GK Activator (2)<br>* 100mg po<br>|
| Experimental: 2<br> | Drug: Ethanol<br>* 40g po<br>|
| Experimental: 3<br> | Drug: GK Activator (2)<br>* 100mg po<br>Drug: Ethanol<br>* 40g po<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCo-inf and Cmax of plasma and urine GK Activator (2) and M4. AUC0-6 of plasma glucose. |  | Days 1, 8 and 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax, AUC0-6, AUC0-last, t1/2, CL/F, Ac, CL for GK Activator (2) and M4. Cmin, Cmax, tmax and tmin of plasma glucose. |  | Days 1, 8 and 15 | 
| AEs, laboratory parameters. |  | Throughout study |
Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants

Study Overview
=================
Brief Summary
-----------------
An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231

Official Title
-----------------
Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants

Conditions
-----------------
Heart Decompensation, Acute

Intervention / Treatment
-----------------
* Drug: BMS-986231


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2. Exclusion Criteria: History of chronic illness Chronic headaches Recurrent dizziness Personal or family history of heart disease Personal history of bleeding diathesis Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986231 Intravenous Infusion<br>A single continuous intravenous infusion of BMS-986231 | Drug: BMS-986231<br>* BMS-986231<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) | Measured by plasma concentrations | Up to 8 days | 
| Percent of Total Radioactivity Recovered in All Excreta (% total) | Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts | Up to 8 days | 
| Half-Life (T-HALF) | Measured by plasma concentrations | Up to 8 days | 
| Total Body Clearance (CLT) | Measured by plasma concentrations | Up to 8 days | 
| Volume of Distribution during Terminal Elimination Phase (Vz/F) | Measured by plasma concentrations | Up to 8 days | 
| Time to Maximum Observed Concentration (Tmax) | Measured by plasma concentrations | Up to 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) | Measured by investigator assessment | Up to 8 days | 
| Results of electrocardiogram tests (ECGs) | Measured by investigator assessment | Up to 8 days | 
| Results of vital sign measurements | Measured by investigator assessment | Up to 8 days | 
| Results of clinical laboratory tests | Measured by investigator assessment | Up to 8 days |