linjc16/ctgov huggingface dataset:
Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France

Study Overview
=================
Brief Summary
-----------------
Evaluation of the following prognostic factors in France, based on national quotation data: volume per center, patient age, geographic distance from a clinical center, delay for chemotherapy,Upfront surgery.

Official Title
-----------------
Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France: Surgical Thresholds, Geographical Distance, Age and Therapeutic Sequence

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Diagnosic of Ovarian or Tubal Cancer C56 et C570 +/- Carcinose péritonéale C786 Tumueur maligne secondaire de la plèvre C782, Tumueur maligne secondaire des ganglions C770 à C779, Tumueur maligne secondaire du foie C787, Tumueur maligne secondaire du péritoine C786 Exclusion criteria: autres causes de : Carcinose péritonéale C786 Tumueur maligne secondaire de la plèvre C782, Tumueur maligne secondaire des ganglions C770 à C779, Tumueur maligne secondaire du foie C787, Tumueur maligne secondaire du péritoine C786

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 |
| --- | --- | --- |
| To study the prognostic effect of the volume of activity | To study the prognostic effect of the volume of activity per center on the risk of recurrence | at 5 years | 
| Verify that the therapeutic sequence | Verify that the therapeutic sequence of primary surgery and secondary chemotherapy is a good prognostic factor for overall and specific survival at 5 years | at 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify that delay in initiation of chemotherapy beyond 4 weeks | Verify that delay in initiation of chemotherapy beyond 4 weeks after surgery is a poor prognostic element on overall and specific survival at 5 years | at 5 years | 
| Verify that age is a poor prognostic element | Verify that age is a poor prognostic element for overall and specific survival at 5 years | at 5 years | 
| Verify that geographic distance | Verify that geographic distance from a clinical center is a poor prognostic element for overall and specific survival at 5 years | at 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian or Tubal Cancer, Upfront surgery, surgical thresholds
Predictive Role of Urodynamics on Mid-urethral Sling Failure

Study Overview
=================
Brief Summary
-----------------
Purpose The aim of this study is to investigate the contribution of preoperative urodynamics to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and easily accessible tools Methods Women with stress urinary incontinence and who desired surgical correction of their incontinence were included in the study. The selection of the procedure was according to an algorithm used in an institution developed by a chief of urogynecology department who had 25 years of urogynecology experience. Urodynamic and baseline factors that may be associated with surgery failure were analyzed in MUS failure.

Official Title
-----------------
Do Urodynamics Superior to 25 Years of Clinical Expertise Predict Mid-Urethral Sling Failure?

Conditions
-----------------
Urinary Incontinence, Stress

Intervention / Treatment
-----------------
* Device: Midurethral sling mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented pure or predominant SUI symptoms for at least 3 months, along with a positive standardized urinary stress test Exclusion Criteria: prior incontinence surgery, post-void residual volumes of greater than 100 ml, a history of chronic inguinal or vulvar abscess, hidradenitis suppurativa, genitourinary fistula or urethral diverticulum, reversible cause of incontinence (i.e., drug effect), or any contraindication to surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Midurethral sling mesh|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mid urethral sling surgery failure |  | after june 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urodynamics, Midurethral sling, Transobturator tape (TOT), Tension free vaginal tape (TVT)
Pilonidal Excision Versus Endoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Compare clinical outcomes of endoscopic pilonidal sinus treatment (EPSiT) with excision treatment with a randomised clinical trial.

Detailed Description
-----------------
Primary outcome: complication rate Secondary outcomes: Quality of life, recurrence rate, length of stay, post operative pain (NRS), return to work time, time to complete wound healing, resource use. Allocation ratio 2:1

Official Title
-----------------
Pilonidal Excision Versus Endoscopic Surgery

Conditions
-----------------
Pilonidal Sinus

Intervention / Treatment
-----------------
* Procedure: EPSiT
* Procedure: Excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II Pilonidal disease <3 previous treatments Previous incision and drainage allowed Over 16 years Exclusion Criteria: Co-morbidity >ASA II Unable to consent themselves Under 16 years Vulnerable adults

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental - EPSiT<br>Endoscopic Pilonidal Sinus Treatment | Procedure: EPSiT<br>* Specialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation.<br>* Other names: Endoscopic Pilonidal Sinus Treatment;|
| Active Comparator: Control - excision<br>Excision treatment | Procedure: Excision<br>* Surgery to remove all affected tissue, followed by wound closure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | As described by Dindo et al 2004 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QoL) | QoL utilising validated tool | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic Pilonidal Sinus Treatment (EPSiT)
Early Urinary Continence After Radical Prostatectomy: Surgical Procedure and Anatomic Landmarks

Study Overview
=================
Brief Summary
-----------------
This study describes how to perform a correct prostatic apex and membranous urethra in order to preserve all anatomical elements that are necessary to achieve a very fast urinary continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical margins at this level.

Detailed Description
-----------------
This study describes a simple technical variation, aimed at the sparing of the muscle systems and neurovascular bundles in order to achieve high rates of urinary continence in the early postoperative period ( the first two months after surgery) in prostate cancer patients undergoing radical prostatectomy.

Official Title
-----------------
Complete Puborectalis, Puboperinealis Muscle and Urethral Rhabdomyosphincter Preservation in Laparoscopic Radical Prostatectomy: Anatomic Landmarks to Achieving Early Urinary Continence

Conditions
-----------------
Prostatic Cancer, Surgical Procedure, Unspecified, Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 40 and 75 years A Body Mass Index lower than 35 Hg/m2 Patients with organ-confined prostate cancer Signed informed consent Exclusion Criteria: Contraindications for Laparoscopy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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 |
| --- | --- | --- |
| change in the proportion of patients with of urinary incontinence | Assessment of the proportion of patients with urinary incontinence after laparoscopic radical prostatectomy | The follow-up was at 2 weeks, 4 weeks and 8 weeks after removal of the urethral catheter (one week after surgery), and, thereafter, once a month over the first year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the proportion of patients with recovery of the erectile function | assessment of the recovery of the erectile function after surgery | every month during the first year after surgery | 
| number of patients with overall positive surgical margins | postoperative assessment of positive surgical margins | immediate postoperative period | 
| biochemical recurrence rate |  | until the completion of the study, with a mean follow-up of 72 months |
TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x 500 mg mesalazine in the treatment of patients with acute ulcerative colitis

Official Title
-----------------
Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative Colitis

Conditions
-----------------
Active Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Mesalazine - TID 1000 mg
* Drug: Mesalazine - TID 2x 500 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Men or women aged 18 to 75 years Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology Exclusion Criteria: Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis) Toxic megacolon Screening stool positive for germs causing bowel disease Malabsorption syndromes Celiac disease Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhoea or gastrointestinal bleeding

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Mesalazine - TID 1000 mg<br> <br> |
| Active Comparator: B<br> | Drug: Mesalazine - TID 2x 500 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission | Proportion of patients with clinical remission at week 8 compared to baseline. Clinical remission includes normalisation of stool frequency and absence of blood in stools | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of stools per week |  | 8 weeks | 
| Number of bloody stools per week |  | 8 weeks | 
| Time to first resolution of clinical symptoms | Times to first resolution of symptoms defined as the periods from the day of first administration of trial medication , until the First of at least 3 consecutive days each with =< 3 stools/day First of at least 3 consecutive days each with no bloody stools/day, First of at least 3 consecutive days each with =< 3 stools/day, all without blood | 8 weeks |
Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fed Conditions

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: Zolpidem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Zolpidem or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |
Physical Activity and Inactivity in Lung Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn how often lung cancer survivors exercise. We also want to learn what helps people to be active or prevents them from being active. Learning this will help us to expand services for lung cancer survivors.

Detailed Description
-----------------
Despite the potential benefits of physical activity, particularly for cancer survivors with comorbid pulmonary and cardiac conditions, no previous research has examined the physical activity levels of lung cancer survivors, an underrepresented subpopulation in cancer survivorship research. We address this research gap in the current study, in which a random sample of 200 lung cancer survivors will complete a comprehensive telephone interview or use self-report to complete a questionnaire focusing on physical activity, related covariates, and preferences regarding physical activity counseling and interventions. We estimate the total time for the completion of the interview or self-report questionnaire to be 45-60 minutes. This study will be conducted with survivors of primary lung cancer who are from 1 to 5 years posttreatment and were treated at Memorial Sloan-Kettering Cancer Center (MSKCC).

Official Title
-----------------
Physical Activity and Inactivity in Lung Cancer Survivors

Conditions
-----------------
Lung Cancer Survivors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary Stage IA or IB NSCLC; Underwent surgical resection for NSCLC at MSKCC; From 1 to 5 years post-treatment for NSCLC prior to study recruitment; No evidence of disease (NED) at the time of recruitment; Can be reached by telephone; Able to provide informed consent. Exclusion Criteria: Undergoing active antineoplastic treatment; Major psychopathology or cognitive impairment likely in the judgment of the investigator to interfere with participation and compliance with the protocol.
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 |
| --- | --- | --- |
| The primary outcomes of this study are physical activity levels and preferences regarding physical activity counseling and interventions |  | 45-60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer, Survivor, Lung
Independence Stairs Climbing Ability Prediction During the Sub-acute Rehabilitation Phase of People After Stroke

Study Overview
=================
Brief Summary
-----------------
Independence stairs climbing ability prediction during the sub-acute rehabilitation phase of people after stroke

Official Title
-----------------
Independence Stairs Climbing Ability Prediction During the Sub-acute Rehabilitation Phase of People After Stroke

Conditions
-----------------
CVA

Intervention / Treatment
-----------------
* Other: Follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First cerebro vascular accident (CVA) diagnosis Basic cognitive and communicative abilities Exclusion Criteria: Traumatic brain injury (TBI) Confusion state and lack of cooperation due to brain lesion Unstable cardiovascular status Independently climbing stairs ability at entrance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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 |
| --- | --- |
| Cohort patients post stroke<br> | Other: Follow up<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independently climbing stairs ability | Yes / No | Through study completion, an average of 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time post stroke | Days | Through study completion, an average of 1-2 years | 
| Time for ascending and descending staircase | Seconds | Through study completion, an average of 1-2 years | 
| Stairs climbing tipe | Step over / Step to, use of handrail | Through study completion, an average of 1-2 years |
EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes (LN)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle aspiration (EBUS-TBNA).

Detailed Description
-----------------
NSCLC is a common cancer. Accurate and early staging has a significant impact on outcome. EBUS-TBNA of involved mediastinal lymph nodes is critical. Molecular markers could improve mediastinal staging.

Official Title
-----------------
EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: EBUS_TBNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Samples are collected before surgery or before any therapy ECOG 0 or 1 Clinical stage I-II, T1-2, N0-1, M0) Surgically respectable Patient with enlarged med. lymphnodes (control group) Exclusion Criteria: Previous RT/CHT Previous or current cancer of other entity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non small cell lung cancer<br>cancer patients | Procedure: EBUS_TBNA<br>* EBUS during bronchoscopy<br>* Other names: EBUS-TBNA scope, Olympus Medical;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |