linjc16/ctgov huggingface dataset:
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.

Official Title
-----------------
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial

Conditions
-----------------
Pediatric Disorder, Hypospadias, Congenital Hypospadia, Urologic Diseases

Intervention / Treatment
-----------------
* Procedure: Hypospadias repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 6 months. Distal, mid-shaft penile hypospadias. Exclusion Criteria: Glanular hypospadias. Penoscrotal, Scrotal & Perineal hypospadias. Recurrent cases.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dartos Fascia<br>Dartos flap is used as a covering layer for urethra during repair of hypospadias | Procedure: Hypospadias repair<br>* surgical repair of hypospadias<br>|
| Active Comparator: Tunica Vaginalis<br>Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias | Procedure: Hypospadias repair<br>* surgical repair of hypospadias<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula | Fistula prevalence will be recorded as a complication after surgery | Within the first three months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome | Patients' parents reported cosmetic outcomes will be evaluated using The Pediatric Penile Perception Score (PPPS). | Within the first three months after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypospadias repair, Fistula, Tunica Vaginalis Flap, Dartos Fascia
Study of MK0677 for the Treatment of Alzheimer's Disease (0677-030)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
An investigational drug (MK0677) will be studied to determine whether it helps the memory and cognition of patients with Alzheimer's Disease.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-0677 25 mg in Slowing the Progression of Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: MK0677


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients must have probable Alzheimer's disease of mild or moderate severity. A brain scan and laboratory results must be consistent with Alzheimer's disease. The patient must be otherwise medically healthy.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0677|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function over 12 month period; safety and tolerability |  | over 12 month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AD symptoms over a 6 month and 12 month period measured by the CIBIC + and the ADAS-Cog. |  | over a 6 month and 12 month period |
Quality-of-Life Study of Patients With Previously Treated Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Quality-of-life assessment of patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment in patients with cancer. PURPOSE: This clinical trial studies the quality of life in patients with previously treated ovarian cancer.

Detailed Description
-----------------
OBJECTIVES: I. Compare quality of life in terms of health status, sexual functioning, psychological/emotional well being, and social functioning in ovarian germ cell cancer survivors vs a matched healthy control group. II. Predict quality of life in these patients through the additive effects of cancer diagnosis and treatment, sociodemographic characteristics, other stressors, and social network variables. OUTLINE: Patients identify up to 3 healthy acquaintance controls within 3 years of the same age. Patients and controls complete a written questionnaire, which takes about 30 minutes, and a telephone interview, which takes about 1 hour, to assess quality of life. PROJECTED ACCRUAL: A total of 190 patients and 190 healthy controls will be accrued for this study within 2 years.

Official Title
-----------------
Quality of Life in Ovarian Germ Cell Cancer Survivors

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: History of early or advanced ovarian germ cell tumors Continuously disease free for at least 2 years prior to study Must have been enrolled on GOG protocols 45, 78, 90, and 116 or similar protocols of cisplatin-based chemotherapy at M.D. Anderson Cancer Center PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be able to complete a written questionnaire and telephone interview in English PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|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
-----------------
stage I ovarian germ cell tumor, stage II ovarian germ cell tumor, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor
Recovery at the Post Anaesthetic Care Unit After Hip and Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately after fast-track hip and knee arthroplasty.

Detailed Description
-----------------
In this prospective, consecutive, observational cohort study we examine: Patient related problems in the PACU after hip and knee arthroplasty simply to answer the question Why in PACU?, using a modified version of the national guidelines for patient observation in PACU. The time spent in PACU with the modified version of the national guidelines for patient observation in PACU. If the modified version of the national guidelines for patient observation in PACU results in patient related problems in the ward afterwards.

Official Title
-----------------
Recovery at the Post Anaesthetic Care Unit After Fast-track Hip and Knee Arthroplasty

Conditions
-----------------
PACU Stay After THA Under Spinal Anaesthesia, PACU Stay After TKA Under Spinal Anaesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary, unilateral, total hip or knee arthroplasty by one of three surgeons using the same technique, and under spinal anaesthesia Exclusion Criteria: Bilateral arthroplasty Revision arthroplasty General anaesthesia

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 |
| --- | --- |
| Patients undergoing arthroplasty<br>Patients undergoing primary, unilateral, total hip or knee arthroplasty under spinal anaesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to meet PACU discharge criteria |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual discharge time from PACU |  | 3 hours | 
| Clinical and logistic factors detaining patients in PACU |  | 3 hours | 
| Potential complications at the surgical ward |  | 24 hours |
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Industrial Workers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of specific resistance training on neck/shoulder pain in industrial workers.

Official Title
-----------------
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Industrial Workers

Conditions
-----------------
Non-specific Pain of the Neck and Shoulder

Intervention / Treatment
-----------------
* Other: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: industrial worker Exclusion Criteria: trauma, life threatening diseases, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Specific resistance training<br>3 x 20 min a week of specific resistance training for 20 weeks | Other: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck<br>* Participants will be randomized at the cluster level to a control group or 20 weeks of specific resistance training for 3 x 20 min a week<br>|
| No Intervention: Control<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain of the neck and shoulders |  | At week 0 (baseline) and week 20 (follow-up) | 
| Pain in the arm/hand |  | At week 0 (baseline) and week 20 (follow-up) |
Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days postoperatively.

Official Title
-----------------
Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

Conditions
-----------------
Patient Under Going Colorectal and Stomach Cancer Surgery

Intervention / Treatment
-----------------
* Procedure: Guardix
* Procedure: Seprafilm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of GI cancer Operable Exclusion Criteria: Withdrew consent Pregnant Ascites Distant metastasis Liver dysfunction (serum total bilirubin >2.0 mg/dL) Renal failure (serum creatinine >1.5 mg/dL) A past history of small bowel obstruction.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Guardix<br>6g per body | Procedure: Guardix<br>* Applying 6g of guardix during abdominal surgery<br>* Other names: Seprafilm;Procedure: Seprafilm<br>* Applying 1 sheet of seprafilm during abdominal surgery<br>|
| Active Comparator: Seprafilm<br>1 sheet per body | Procedure: Guardix<br>* Applying 6g of guardix during abdominal surgery<br>* Other names: Seprafilm;Procedure: Seprafilm<br>* Applying 1 sheet of seprafilm during abdominal surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ileus rate | Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations | within 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effect rate |  | within 60 days |
Factors Associated With Gynecological Consultation by General Practitioner

Study Overview
=================
Brief Summary
-----------------
Because of the shortage of doctors in France, notably gynaecologist, general practitioners are definitely an essential partner women's health. However, few of them regularly practice gynecological acts. A lot of studies have studied why general doctors not practice gynecological acts but it would necessary to include the women's perspective.

Detailed Description
-----------------
The aim of the study will be identify women's factors associated with gynaecological consultation by the general practitioner.

Official Title
-----------------
Factors Associated With Gynecological Consultation by General Practitioner

Conditions
-----------------
Adult Daughters

Intervention / Treatment
-----------------
* Other:  women group 


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged more than 18 years old woman agreeing to participate to the study Exclusion Criteria: women aged less than 18 years old woman not agreeing to participate to the study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other:  women group |women aged more than 18 years old|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of gynecological consultation with a general practitioner | would the woman agree to consult a general practitioner for a gynecological reason ? (Yes or No) | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Women's knowledge of general practitioner gynecology competences | Does woman know that a general practitioner is able to perform gynecological acts? (Yes or No) | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult women, gynecological acts, general practitioners
Application of the Apsara Thermal Wand System

Study Overview
=================
Brief Summary
-----------------
The purpose of this feasibility study is to gain an initial assessment of the acute safety and performance of the Apsara Thermal Wand System in human facial tissue.

Official Title
-----------------
TP-1013 Pilot 1: Application of the Apsara Thermal Wand System

Conditions
-----------------
Tightening of Skin Laxity

Intervention / Treatment
-----------------
* Device: Apsara Thermal Wand System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nonsmoker Glogau class 1-3 Previously chosen to undergo facelift Exclusion Criteria: Pregnant, nursing Implanted electro-mechanical device Allergy to anesthesia or device metals Collagen vascular disease History of keloid or hypertrophic scar formation Uncontrolled diabetes Long term steroid or other immunologic inhibitor use Previous treatment to target area Does not consent to study Does not consent to photography or histological evaluation

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: Apsara Thermal Wand System<br>* Single radiofrequency cycle to dermal tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | Number of Serious Adverse Events | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin laxity, wrinkles, rhytids
Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using PHQ-9 as a Screening Tool

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to complete a retrospective chart review of subjects who were treated at the Wound Care Clinic at Methodist Dallas Medical Center, presented for treatment between June 2018 and February 2019, and were administered the PHQ-9. The study aims to measure the prevalence of depression in this sample, feasibility of using PHQ-9 in this patient population, and identifying variables and functional impairment associated with clinically significant depression.

Detailed Description
-----------------
The study will review medical records of new patients who presented to the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019. These patients were all administered PHQ-9 as part of a quality improvement project. The medical records included for analysis will be from male and female patients aged 18 years or older. The medical records will be reviewed for the following information: general demographics, information including age, sex, ethnicity, race, PHQ-9 score (total and individual items), medical conditions, wound history, past medical history, general symptoms, abuse and suicide risk, activities of daily living, motivation assessment, mental status, and pain ratings. This information will be used to measure the prevalence of clinically significant depression in the sample, which is the primary aim. We will also use the data to establish factors and variables correlated with the presence and severity of clinically significant depression.

Official Title
-----------------
Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using PHQ-9 as a Screening Tool

Conditions
-----------------
Wound

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Received care at the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019 Completed a PHQ-9 form at the time of initial evaluation/examination Exclusion Criteria: 1. Patients less than 18 years of age will be excluded from 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-9 score | to measure the prevalence of clinically significant depression defined as a PHQ-9 score of equal to or greater than 10. | Through study completion, an average of 1 year |
Efficacy Study of the Embryo Transfer Catheter

Study Overview
=================
Brief Summary
-----------------
A prospective randomized trial comparing Cook K-SOFT-5100 and Frydman classical catheter 4.5 for embryo transfer in human IVF/ICSI was performed. Three experienced operators participated in the trial, using a fixed distance transfer protocol. Primary endpoint was clinical pregnancy rate, secondary endpoints were rates of difficult transfer and of catheter failure. Patients were randomized by a computer program immediately prior to embryo transfer.

Official Title
-----------------
The Efficacy of the Embryo Transfer Catheter in IVF and ICSI is Operator-Dependent: a Randomized Clinical Trial

Conditions
-----------------
Infertility (IVF Patients)

Intervention / Treatment
-----------------
* Device: Cook K-SOFT-5100 catheter
* Device: Frydman classical catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing embryo transfer in our IVF program between 2000 and 2005 Exclusion Criteria: patients not giving consent were excluded

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cook K-SOFT-5100 catheter | Device: Cook K-SOFT-5100 catheter<br>* A Cook K-SOFT-5100 catheter was used for embryo transfer in human IVF/ICSI<br>|
| Active Comparator: 2<br>Frydman classical catheter | Device: Frydman classical catheter<br>* A Frydman classical catheter was used for embryo transfer in human IVF/ICSI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rates |  | End of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of difficult transfer |  | End of study | 
| Catheter failure rate |  | End of study |