linjc16/ctgov huggingface dataset:
Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation of Female Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The investigators performed a prospective analysis of 450 women with stress, urge and mixed incontinence in order to assess the health-related quality of life (Contilife® questionnaire) and the objective cure rate after two months of electrical stimulation (Keat® stimulator). Management of urinary incontinence with the Keat® stimulator could given an improvement in the quality of life and a good rate of satisfaction without side effect. Objective cure is as good as subjective improvement especially in urinary stress incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the bew first-line non surgical treatment for female urinary incontinence.

Official Title
-----------------
Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Device: KEAT stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women age > 18 years stress, urge or mixed incontinence with indication of perineal reeducation follow in gynecology Exclusion Criteria: incontinence due to neurological disorders younger than 18 years old pregnancy patient with pace-maker patient with gynecological cancer patient who don't understand the electrical stimulation procedure

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>women with urinary incontinence | Device: KEAT stimulator<br>* electrical stimulation with KEAT stimulator : 4 times per week during 2 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of quality of life after electrostimulation | Change from baseline in quality of life after 2 months of electrostimulation Measurement of health-related quality of life with contilife questionnaire | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of urinary handicap after electrostimulation | Change from baseline in urinary handicap after 2 months of electr-st-imulation. Measurement of urinary handicap with MHU questionnaire | 2 months | 
| satisfaction after electrostimulation | description of patient's satifaction 2 months after electrostimulation by satisfaction questionaire | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Incontinence, Urinary stress incontinence, Urinary urge incontinence, Women, electrical stimulation, KEAT stimulator, quality of life
Non Traumatic Neuro-Vascular Diseases Critical Complications : a Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational epidemiological study is to investigate the management and the complications associated with Non Traumatic Neuro-Vascular Diseases. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Detailed Description
-----------------
Anonymous data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.

Official Title
-----------------
Prospective Cohort of Patients Hospitalized in West French Intensive Care Units.

Conditions
-----------------
Non Traumatic Acute Brain Injury

Intervention / Treatment
-----------------
* Other: Collection of medical data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non Traumatic Neuro-Vascular Diseases Exclusion Criteria: Consent withdrawal

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| ICU patients<br>Patients with Non Traumatic Neuro-Vascular Diseases. Medical data concerning ICU stay will be collected. | Other: Collection of medical data<br>* A code will be applied to each patient included. Medical data such as demography, Simplified Acute Physiological Score II (SAPS II), Sequential Organ Failure Assessment (SOFA), procedures and complications during ICU stay will be collected.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in ICU stay complications | Hospital acquired infections (epidemiology, risk factors, antibiotic susceptibility of pathogens), Organ failures (incidence, risks factors), Bleeding, Hemorrhage Intra-Cranial Hypertension, Brain Ischemia, Mechanical ventilation weaning, Extubation failure | Within the first 28 days after ICU admission date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration in mechanical ventilation |  | in ICU (up to 90 days) | 
| ICU length of stay |  | in ICU (up to 90 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non traumatic acute brain injury
Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis

Study Overview
=================
Brief Summary
-----------------
Purpose: To describe a novel configuration of venous access for the performance of intermittent apheresis. Participants: 20 participants at UNC who were referred for change from a vortex port to a powerflow port. Procedures (methods): Placement of one of two configurations of the powerflow port and follow up visits between January 1, 2019 and December 31, 2023.

Official Title
-----------------
Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis

Conditions
-----------------
Apheresis

Intervention / Treatment
-----------------
* Device: PowerPort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over the age of 18 years of age. Referred for change from a vortex port to a powerflow port. Previously placed or scheduled placement of one of two configurations of the PowerFlow port Exclusion Criteria: Unable to read and understand English. Unable to provide informed consent.

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 |
| --- | --- |
| PowerPort Subjects<br>This study will involve a chart review of patients at UNC who were referred for change from a vortex port to a powerflow port. | Device: PowerPort<br>* The study will compare pheresis sessions with the old system versus pheresis sessions with one of two new configurations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flow Rate | The study will compare mean change flow rate for pheresis sessions with the old system versus pheresis sessions with one of two new configurations by averaging the flow rate for up to 5 sessions using the new port configuration. | 1 year following new port configuration placement | 
| Change in Procedure Time | The study will compare mean change in procedure time for pheresis sessions with the old system versus pheresis sessions with one of two new configurations. | 1 year following new port configuration placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Use of Tissue Plasminogen Activator | The study will compare mean change in use of tissue plasminogen activator for pheresis sessions with the old system versus pheresis sessions with one of two new configurations. | 1 year following new port configuration placement |
Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE)

Study Overview
=================
Brief Summary
-----------------
Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med 2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the radiotherapy we will use 5 FU continue infusion as previously reported. The global design of adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue then four FOLFIRI.

Official Title
-----------------
Feasibility Study of 2 Parallel Phases II Pre or Postgastrectomy in Patients With Gastric Cancer (FOLFIRI-radiotherapy Plus 5 Fluorouracil-surgery or Surgery-FOLFIRI-radiotherapy Plus 5 Fluorouracil)

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: association chemotherapy and radiochemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gastric adenocarcinoma histologically confirmed tumor T3 or N+ at the pretherapeutic staging (Scanner and endoscopic ultrasound) performance status WHO<2 serum albumin >30 gr/l weight loss < 10% in the next 6 months signed informed consent form Exclusion Criteria: metastatic disease prior abdominal radiotherapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative chemoradiotherapy<br> | Procedure: association chemotherapy and radiochemotherapy<br> <br> |
| Experimental: Postoperative chemoradiotherapy<br> | Procedure: association chemotherapy and radiochemotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of treatment |  | at the end of the treatment |
Drug Interaction Study Between Erdosteine and Bepotastine Besilate in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and Bepotastine besilate in healthy adult volunteers.

Official Title
-----------------
A Randomized, Open-label, Single Dose, Three-treatment, Three-period, Six-sequence Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Erdosteine and Bepotastine Besilate After Oral Administration in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Erdos
* Drug: Talion
* Drug: Erdos, Talion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects aged 20 - 45 years A body mass index in the range 18.5 - 25 kg/m2 Willingness to participate during the entire study period Written informed consent after being fully informed about the study procedures Exclusion Criteria: Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease History of clinically significant drug hypersensitivity Use of medication within 7 days before the first dose Heavy drinker/smoker Whole blood donation during 60 days before the study Judged not eligible for study participation by investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erdosteine 300mg<br> | Drug: Erdos<br>* capsule, 300mg<br>|
| Experimental: Bepotastine besilate 10mg<br> | Drug: Talion<br>* tablet, 10mg<br>|
| Experimental: Erdosteine 300mg + Bepotastine besilate 10mg<br> | Drug: Erdos, Talion<br>* capsule 300mg and tablet 10mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment | 
| AUClast |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment |
Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum

Study Overview
=================
Brief Summary
-----------------
To examine retrospectively whether transcatheter closure of the interatrial septum leads to myocardial injury and to determine the mechanism.

Detailed Description
-----------------
In a prospective study in adults troponin T (TnT) serum concentrations were determined before and the day after transcatheter closure of an atrial septal defect (ASD) or patent foramen ovale (PFO).

Official Title
-----------------
Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Device: Transcatheter closure of an atrial septal defect or patent foramen ovale.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: transcatheter ASD and PFO closure at the University Hospital of Lund, Sweden Exclusion Criteria: missing TnT values

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

| Intervention/Treatment |
| --- |
|Device: Transcatheter closure of an atrial septal defect or patent foramen ovale.|In a prospective study in adults troponin T (TnT) serum concentrations were determined before and the day after transcatheter closure of an atrial septal defect (ASD) or patent foramen ovale (PFO).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TnT changes |  | Blood samples for TnT were taken one day before intervention and one day after intervention. |
One-or Two Person Technique and Quality Performance of Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Colonoscopy can be performed by a one-operator technique with endoscopist personally advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant doing the physical insertion and withdrawal of the scope directed by the endoscopist. Uncontrolled data report that 1 operator technique is associated with a higher adenoma detection rate, although it is also characterized by a lowwer cecal intubation rate and longer intubation time. The aim of present randomized controlled study was to assess whether one technique is better than the other one in terms of colonoscopy quality performances.

Conditions
-----------------
Colonoscopy Techniques

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult outpatients colonoscopy for screening or surveillance indications Exclusion Criteria: previous colonic surgery poor bowel prep inability to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| one-operator technique<br> | |
| two-operator technique<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cecal intubation time |  | 4 months |
Endoangel Withdrawal Overspeed Analysis

Study Overview
=================
Brief Summary
-----------------
Exploring the relationship between the percentage of overspeed of colonoscopy withdrawal and the rate of adenoma detection.

Official Title
-----------------
Explore the Relationship Between the Percentage of Overspeed of Colonoscopy Withdrawal and the Rate of Adenoma Detection:a Prospective、Multicenter、Observational Study

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Other: Endoangel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females who are over 18 years old (inclusive); Enteroscopy and related examinations are needed to further clarify the characteristics of digestive tract diseases; Able to read, understand and sign the informed consent form; The researcher believes that the subject can understand the process of the clinical research, is willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures. Exclusion Criteria: Participated in other clinical trials, signed an informed consent form and within the follow-up period of other clinical trials; Abuse of drugs or alcohol or mental disorders in the last 5 years; Women during pregnancy or breastfeeding; Subjects with previous history of bowel surgery; The investigator believes that the subject is not suitable for enteroscopy and related examinations; The investigator believes that the subject is not suitable for high-risk diseases or other special circumstances to participate in clinical trials. Patients with gastrointestinal bleeding; Known or highly suspected allergy to any ingredient of bowel cleansing agent; Restricted activities or any mental or physical condition impairs their ability to drink intestinal cleansing preparations; Known or suspected intestinal obstruction or perforation, toxic megacolon, most colectomy, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure or end, renal insufficiency, etc.

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

| Intervention/Treatment |
| --- |
|Other: Endoangel|Collecting the colonoscopy videos and analyzing the correlation between withdrawal overspeed proportion and adenoma detection rate.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of withdrawal overspeed |  | 3 months |
A Study of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies.

Official Title
-----------------
A Phase 1, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies

Conditions
-----------------
Lymphoid Malignancies

Intervention / Treatment
-----------------
* Drug: HGS1029


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed relapsed/refractory lymphoid malignancies Previously treated with at least 2 therapeutic regimens ECOG performance < 2. Life expectancy of at least 3 months Adequate renal function Adequate hematologic status Adequate liver function Transfusion independent Exclusion Criteria: Received other therapy (biological or drug) to treat cancer within 4 weeks prior to starting treatment with HGS1029 or who exhibit persistent clinical evidence of cancer treatment toxicity The use of systemic corticosteroids within 1 week of starting treatment with HGS1029 Evidence of active bacterial, viral or fungal infection within 2 weeks before starting treatment with HGS1029 Known HIV infection Positive for hepatitis B surface antigen or positive hepatitis C antibody Grade 2 or greater neuropathy Pregnant female or nursing mother Males or females who do not agree to use effective contraception during the study and through at least 30 days after the last dose of HGS1029

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HGS1029<br> | Drug: HGS1029<br>* HGS1029 will be given as a 15-minute IV infusion (in the vein) once weekly for 3 consecutive weeks, followed by 1 week off.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, frequency and severity of adverse events |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure pharmacokinetic profile |  | 1st two months of the study | 
| Evaluation of pharmacodynamics |  | 1st two months of the study | 
| Evaluation of possible anti-tumor activity |  | Every 2 months while on study |