linjc16/ctgov huggingface dataset:
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.

Official Title
-----------------
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer

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

Intervention / Treatment
-----------------
* Drug: AR Antagonist (BMS-641988)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced castration-resistant prostate carcinoma with progressive disease At least 4 weeks must have elapsed from major surgery Patient must be available for follow-up Adequate liver and kidney function Adequate blood values Exclusion Criteria: Uncontrolled or significant heart disease History of seizures History of head injury, loss of consciousness, or stroke Patients undergoing alcohol withdrawal Any concurrent cancer A serious uncontrolled medical disorder or active infection Inability to swallow tablets

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AR Antagonist (BMS-641988)<br>* Tablets, Oral, 6 Patients will be randomized in a 1:1 ratio and in a double-blinded fashion to achieve a single dose of the study drug or Placebo on C1D1. Once daily, at least 3 cycles until the disease progresses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety and tolerability and to identify a dose for Phase II evaluation |  | during the dose escalation phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pharmacokinetics |  | throughout the study | 
| To describe preliminary evidence of anit-tumor activity |  | throughout the study |
Transvaginal Versus Transperineal Repair of Rectocele

Study Overview
=================
Brief Summary
-----------------
Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months

Official Title
-----------------
Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial

Conditions
-----------------
Rectocele

Intervention / Treatment
-----------------
* Procedure: Transvaginal repair
* Procedure: Transperineal repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult female patients with anterior rectocele Exclusion Criteria: Male patients. Combined rectocele with internal rectal prolapse. Anismus. Associated anorectal condition such as hemorrhoids and anal fissure. Pregnancy. Unwilling to participate in the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: Transvaginal repair<br>Repair of anterior rectocele via the vagina | Procedure: Transvaginal repair<br>* Vaginal incision through which plication of the rectovaginal septum is done<br>|
| Active Comparator: Transperineal repair<br>Repair of anterior rectocele via the perineum | Procedure: Transperineal repair<br>* Perineal incision through which plication of the rectovaginal septum is done<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in constipation | decrease in Wexner constipation score by 25% | 6 and 12 months after surgery |
Playtime Open Globe Injuries in Children

Study Overview
=================
Brief Summary
-----------------
This study investigated the epidemiology, aetiologies, and complications of playtime open-globe injuries in children at the Assiut University Hospital, Egypt, between January to July 2016.

Detailed Description
-----------------
This prospective study was conducted at the Department of Ophthalmology, Assiut University Hospital, which is the largest tertiary referral hospital in Upper Egypt and provides 24-hour ophthalmic emergency services for six governorates. The study included all children (age ≤18 years) admitted with open-globe injuries that occurred during playtime over a 6-month study period. Demographic information (age and sex), the site and mechanism of injury, the site of ocular laceration (corneal, scleral or corneoscleral) and associated complications were recorded and analysed.

Official Title
-----------------
Epidemiology, Aetiologies, and Complications of Playtime Open-globe Injuries in Children

Conditions
-----------------
Eye Trauma

Intervention / Treatment
-----------------
* Other: Repair of open globe injury


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all children (age ≤18 years) admitted with open-globe injuries that occurred during playtime over a 6-month study period (January-July 2016). Exclusion Criteria: Open globe injuries in patients olader than 18 years. Closed globe injuries

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Repair of open globe injury|repair of corneal, corneoscleral, or scleral wounds|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity (in Decimal using Snellen chart) after repair of open globe injury | measurement of corrected distant visual acuity after wound repair. | 1 day |
Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?

Study Overview
=================
Brief Summary
-----------------
AUS/FNAC allows the identification of tumors without axillary tumor involvement, or with low axillary tumor burden, many of which do not benefit from SLNB, in the staging of early breast cancer. Objective: To calculate the negative predictive value of AUS/FNAC in those patients with breast cancer who meet ACOSOG Z0011 criteria.

Official Title
-----------------
Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Tumors with ACOSOG Z0011 criteria, except positive SLNB (cT1-T2; cN0; breast-conserving surgery; Whole-Breast Radiotherapy) Axillary study with AUS/FNAC. SLNB/ALND (Gold-Standard). Exclusion Criteria: Tumors without confirmation of axillary histologic status (No Gold-Standard) Tumor in pregnancy or breastfeeding. Tumors in the male. Tumors treated with neoadjuvant chemotherapy Tumors that do not meet ACOSOG Z0011 criteria. Tumors without axillary study using AUS/FNAC

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

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

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 |
| --- | --- | --- |
| Detection of axillary tumor burden by axillary ultrasound | To calculate the negative predictive value of AUS/FNAC in those patients with breast cancer who meet ACOSOG Z0011 criteria. | Two weeks after the axillary surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Axillary ultrasound, Sentinel lymph node biopsy, Axillary management
A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
Study Design : randomized, open label, single-dose, 2-way cross-over design Phase : Phase I

Official Title
-----------------
A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers

Conditions
-----------------
Healthy Male Volunteer

Intervention / Treatment
-----------------
* Drug: Exforge®
* Drug: G-0081


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male volunteers between the ages of 20 to 50 years old within the range of ±20% of IBW(Ideal Body Weight) having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination doctor determines to be suitable as subjects within 4 weeks ago before administration Exclusion Criteria: Hypersensitivity(or history of hypersensitivity) to amlodipine and valsartan Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT Gastrointestinal diseases or surgeries that affect absorption of drug Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/day) Smoking over 10 cigarettes per day

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg)<br>Exforge® 10/160 | Drug: Exforge®<br> <br> |
| Experimental: G-0081 (Amlodipine orotate 10mg / Valsratan 160mg)<br>G-0081 | Drug: G-0081<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Cmax |  | Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf, Tmax, t1/2, % AUCextra | AUCinf = AUClast + Clast/λz %AUCextra = [ (AUCinf - AUClast) / AUCinf ] ×100 t1/2 = 0.693/λz | Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h |
N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

Study Overview
=================
Brief Summary
-----------------
Oxidative stress is associated with kidney damage in several different situations, including hypotension. In animal models it has been shown that the combination of n-acetylcysteine plus deferoxamine is superior to its isolate use in the treatment of several diseases. Thus the investigators aimed to determine if the administration of n-acetylcysteine plus deferoxamine could prevent renal failure in critical ill patients who develops hypotension.

Official Title
-----------------
Prospective, Randomized, Double-blinded, Placebo-controlled Study of N-acetylcysteine Plus Deferoxamine for Patients With Hypotension as Prophylaxis for Acute Renal Failure

Conditions
-----------------
Hypotension, Acute Renal Failure

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine and deferoxamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the ICU Presenting hypothesion (MAP < 60mm Hg or the needing to use vasoactive drugs) for at least 30 min in the last 12h before study inclusion Exclusion Criteria: Age lower than 18 years old Chronic renal failure A known history of allergy to any of the study drugs Using n-acetylcysteine to paracetamol overdose Pregnant women Patients who used iodinated contrast medium Hemoglobin less than 6.5 mg/dl Cancer patients

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine plus deferoxamine<br> | Drug: N-acetylcysteine and deferoxamine<br>* N-acetylcysteine bolus dose of 50mg/kg/4h, by a manutention of 100mg/kg/day during 2 days and deferoxamine single dose of 1g administered 15mg/kg/h.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of acute renal failure |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day-mortality |  | 28 days | 
| Decrease on plasma oxidative damage and inflammatory parameters |  | at the end of drug infusion |
Trichloroethylene (TCE) Exposure in an Industrial Population

Study Overview
=================
Brief Summary
-----------------
This study is to follow-up with workers from a local company that had exposure to TCE that may have symptoms of Parkinson's disease. We hope to learn more about TCE exposure and Parkinson's disease. Eligible participants will be those who participated in previous research study entitled Survey of Selected Exposures and Neurologic Symptoms in an Industrial Population

Official Title
-----------------
Evaluation of Parkinson Disease Symptoms in Trichloroethylene Exposed Patients in an Industrial Population

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participant in the research study entitled Survey of Selected Exposures and Neurologic Symptoms in an Industrial Population Exclusion Criteria: Not a participant in the research study entitled Survey of Selected Exposures and Neurologic Symptoms in an Industrial Population
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
-----------------
Parkinson's disease, Trichloroethylene
Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications

Study Overview
=================
Brief Summary
-----------------
The aim of this interventional study is to optimize the movements and discipline of surgical staff in order to improve the quality of care, the safety of the patient in the surgery and to prevent the postoperative complications in the broad sense and in particular the infection of the surgical site. The intervention will be carried out using tools of new technologies allowing the monitoring of the movements and the sound level associated with techniques of behavior change inspired by those used in the human and social sciences.

Official Title
-----------------
Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Other: Non interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient Patient agreeing to participate in the study Patient who will benefit from orthopedic surgery for hip or knee arthroplasty with prosthesis placement Non-Inclusion Criteria: Patient with previous history of surgical site infection

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non interventional study|None intervention will be conduct on patient. Only the operating room will be randomized to have an intervention or not (Bundle of measure for optimizing the discipline of personnel in the operating room)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of any major postoperative complications |  | Until 30 days after hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Behavior; Operational block; Monitoring; Social Sciences ; New technologies
Topical Treatment of Under Eye Dark Circles and Swelling

Study Overview
=================
Brief Summary
-----------------
This study examines topical treatment of under eye circles and swelling.

Detailed Description
-----------------
This study examines topical treatment of under eyes dark circles and under eye swelling.

Official Title
-----------------
A Pilot Randomized Double Blind Study to Assess the Safety and Efficacy of 1% Ibuprofen/ 1%Fexofenadine Topical Cream for the Treatment of Dark Circles Under the Eyes

Conditions
-----------------
Edema

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under eye dark circles and swelling Exclusion Criteria: Under age 18 Allergy to tested medicines

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fexofenadine left; placebo right<br>Topical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison. | Drug: Fexofenadine<br>* Fexofenadine 1%<br>* Other names: Topical fexofenadine;Drug: Placebo<br>* Placebo<br>* Other names: Topical placebo;|
| Experimental: Fexofenadine right; placebo left<br>Split face double blind | Drug: Fexofenadine<br>* Fexofenadine 1%<br>* Other names: Topical fexofenadine;Drug: Placebo<br>* Placebo<br>* Other names: Topical placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention | Efficacy was measured per intervention by assessing number of participants with improvement in under eye dark circles and swelling. Criteria used to assess under eye improvement and swelling was by a 5 point scale comparing each week's photographic appearance to the appearance at baseline: 1) fexofenadine right and placebo left, and 2) fexofenadine left and placebo right. The split face comparison was noted in efficacy measured changes in under eye swelling and dark circles relative to baseline. Participants were graded by 2 blinded dermatologists who reviewed photographs of all participants at entry and weekly until end of study plus one week, day 37. Total number of participants: 30. Placebo right and fexofenadine left 15 participants. Placebo left and fexofenadine right 15 participants. | Baseline, weekly, and end of study +7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Under eye dark circles, Under eye puffiness
Lesinurad and Allopurinol Combination Extension Study in Gout

Study Overview
=================
Brief Summary
-----------------
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.

Detailed Description
-----------------
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.

Official Title
-----------------
A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol

Conditions
-----------------
Gout

Intervention / Treatment
-----------------
* Drug: Lesinurad
* Drug: Lesinurad


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity. Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit. Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth Exclusion Criteria: Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lesinurad 200 mg + allopurinol<br> | Drug: Lesinurad<br>* Tablets, 200 mg QD<br>|
| Experimental: lesinurad 400 mg + allopurinol<br>Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015. | Drug: Lesinurad<br>* Tablets, 400 mg QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with an sUA level that is < 6.0 mg/dL |  | up to a total of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of at least 1 target tophi |  | Up to Month 12 | 

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