linjc16/ctgov huggingface dataset:
ATX-101 Abdominoplasty

Study Overview
=================
Brief Summary
-----------------
Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty

Official Title
-----------------
Phase 1, Open-label Study of the Safety, Tolerability, and Histological Effect of Single Doses of ATX-101 (Sodium Deoxycholate for Injection) Administered in Abdominal Fat in Subjects Undergoing Abdominoplasty

Conditions
-----------------
Characteristics of Subcutaneous Fat

Intervention / Treatment
-----------------
* Drug: ATX-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects undergoing planned abdominoplasty Exclusion Criteria: History of interventions in the abdominal area

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATX-101<br> | Drug: ATX-101<br>* ATX-101 single doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, laboratory test results, physical examinations |  | 1 - 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathology |  | 1 - 28 Days |
Safety and Efficacy of Distending Media Infusion by Manual Syringe Method for Hysteroscopic Procedures

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures.

Detailed Description
-----------------
In order to minimize the amount of distending media infused during hysteroscopic procedures, investigators used manual syringe method for delivering of distending media during hysteroscopic procedures from June 2010 to November 2013 in our institute. The aim of this study was to evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures. The medical records of all women who received hysteroscopic procedures by manual fluid-infusion method or convention pump fluid infusion method between June 2010 and November 2013 will be reviewed. In order to reveal the superiority/inferiority of clinical outcome of women receiving manual fluid infusion method, perioperative outcomes will be compared.

Official Title
-----------------
Safety and Efficacy of Distending Media Infusion by Manual Syringe Method for Hysteroscopic Procedures

Conditions
-----------------
Hysteroscopic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma. Patients had hysteroscopic procedures for either diagnostic or therapeutic purpose from June 2010 to November 2013 in Department of Obstetrics & Gynecology in Far Eastern Memorial Hospital. Exclusion Criteria: Female patients of less than twenty years-old.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Hysteroscopic surgery<br>Women who received hysteroscopic surgeries or examinations | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of manual fluid-distension methods for hysteroscopic procedures | The complications (such as hyponatremia, abdominal pain) related to manual fluid-distension methods for hysteroscopic procedures. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of manual fluid-infusion methods for hysteroscopic procedures | The perioperative data, including operation time, estimated blood loss, completion operation rate of hysteroscopic procedure by using manual fluid-infusion methods | 1 week |
Analysis of Palliative Surgery in View of Quality of Life and Prognosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define if palliative surgery in patients with cancer improves quality of life and prognosis.

Detailed Description
-----------------
The purpose of this study is to find out if palliative surgery in patients with cancer improves quality of life and prognosis. There will be a scheduled assessment of quality of life and assessment of postoperative complications. prognostic scoring will be performed before surgical intervention.

Official Title
-----------------
Analysis of Palliative Surgery in View of Quality of Life and Prognosis

Conditions
-----------------
Cancer, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of inoperable cancer planned surgery able to give interview written informed consent Exclusion Criteria: unconsciousness psychiatric disorder not able to communicate in German
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical observation<br>patients with cancer in a palliative setting and in need of surgical interventions | |

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
-----------------
surgery, prognostic, palliation
Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 75 mg and 150 mg Doses of ERB-041 on the Reduction of Symptoms Associated With Endometriosis During Treatment and Post Treatment in Reproductive-Aged Women

Conditions
-----------------
Dysmenorrhea, Dyspareunia, Endometriosis, Pelvic Pain

Intervention / Treatment
-----------------
* Drug: ERB-041


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical diagnosis of endometriosis within the last 10 years Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception Exclusion Criteria: Conditions requiring the use of chronic pain therapy Prophylactic use of analgesics to avoid endometriosis-related pain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ERB-041|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment |  |  | 
| change in rescue medication use |  |  | 
| change in health related quality of life questionnaires |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis, Dysmenorrhea, Pelvic pain, Dyspareunia
Assessment of the 90-day Mortality Risk Score After VATS Lobectomy

Study Overview
=================
Brief Summary
-----------------
A five classes (A-E) aggregate risk score predicting 90-day mortality after video-assisted thoracoscopic lobectomy for lung cancer, including as independent factors male sex (3 points), carbon monoxide lung diffusion capacity <60% (1 point) and operative time >150 minutes (1 point), has been recently published. This study aims to assess the effectiveness and reliability of this risk model in a large, independent cohort of patients, in order to confirm its generalizability.

Detailed Description
-----------------
From the Italian VATS Group Database, we selected patients who underwent video-assisted thoracoscopic lobectomy for non-small cell lung cancer. We calculated the aggregate risk score and the corresponding class of 90-day mortality risk for each patient. The correlation between risk classes and mortality rates was tested by Spearman's rho-test. Model calibration was evaluated by Hosmer-Lemeshow goodness-of-fit test.

Official Title
-----------------
Assessment of the 90-day Mortality Risk Score After Video-assisted Thoracoscopic Lobectomy in the Italian VATS Group Cohort

Conditions
-----------------
Lung Cancer, Surgery--Complications, Morality

Intervention / Treatment
-----------------
* Procedure: VATS lobectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients undergoing VATS lobectomy for non-small cell lung cancer Exclusion Criteria: Incomplete data for risk score calculation Tumor size >5 cm Follow-up <3 months Patients undergoing neoadjuvant treatment Patients undergoing extended resection
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: VATS lobectomy|VATS lobectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day postoperative mortality | Alive/Death (cause of death) | 90 day post surgical procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-small cell lung cancer, VATS lobectomy, 90-day postoperative mortality, risk score, validation
Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

Study Overview
=================
Brief Summary
-----------------
The investigators propose to study intensively the bacteriology of feces in C. difficile associated diarrheal disease, using a variety of conventional and very up-to-date techniques.

Detailed Description
-----------------
Clostridium difficile associated colitis is an increasing problem in hospitals throughout the developed world; the number of cases has increased, and the failure to respond to conventional therapy has become far more common. The investigators have recently documented in the medical literature (Clin Infect Dis, June, 2005; Lancet Infect Dis, August, 2005). Possible reasons for failure of treatment include persistence of C. difficile and/or imbalance of other bacterial flora in the colon. The bacteriology of fecal flora in C. difficile associated diarrhea has not been studied.

Official Title
-----------------
Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

Conditions
-----------------
Enterocolitis, Pseudomembranous Colitis, Antibiotic-Associated Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with antibiotic-associated diarrhea with a positive assay for C. difficile toxin Patients with antibiotic-associated diarrhea with 3 negative assays for C. difficile toxin Patients with antibiotic-associated diarrhea that has failed to respond to conventional therapy Hospitalized patients who have received >2 antibiotics and who have no symptoms of diarrhea or abdominal discomfort Exclusion Criteria: none

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clostridium difficile associated diarrhea
Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Study Overview
=================
Brief Summary
-----------------
Strabismus surgery for children is a very common procedure, with a high incidence of emergence delirium in the recovery room. Pain is often implicated in delirium. The primary aim of this study is to determine whether a single, intraoperative dose of methadone for outpatient ambulatory pediatric strabismus surgery reduces postoperative delirium.

Official Title
-----------------
Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Conditions
-----------------
Emergence Delirium, Strabismus

Intervention / Treatment
-----------------
* Drug: Methadone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I/II children undergoing outpatient strabismus surgery Exclusion Criteria: anything not meeting the above

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study<br>pediatric patients undergoing outpatient strabismus surgery, and receiving methadone | Drug: Methadone<br>* see desc above<br>|
| control<br>pediatric patients undergoing outpatient strabismus surgery, and not receiving methadone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Anesthesia Emergence Delirium scale scores | A low total score would indicate less emergence delirium | measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wong-baker or numeric pain scores, depending on age | A low total score would indicate less pain | measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours. | 
| discharge time | time the patient is actually discharged from recovery room | 24 hours |
Safety Validation of EndoSWIR Device

Study Overview
=================
Brief Summary
-----------------
Head and neck cancer has an incidence of 600,000 cases per year worldwide (6th among cancers) and cause 380,000 death per year. Surgical resection is guided by the surgeon's inspection and palpation of the tumor. The prognosis of patients depends on the quality of the lesion's resection. The ENDOSWIR dispositive developed by engineers of Atomic Energy Comity of Grenoble allows for reliable and accurate analysis of tumor margins. The camera provides a spectral analysis of the tissues according to their composition. We want to show that the prognosis of patients is improved by the use of this device. For that we need to prove first that it is not toxic for tissue analysis.

Detailed Description
-----------------
ENDOSWIR dispositive is a InGaAs (Indium Gallium Arsenide) camera working at ambient temperature. The light is a quartz-tungstene-halogeno (QTH) source and the collected beam is filtered to illuminate in different precise wavelength bands in the short wave domain. We will use it on tonsil tissue just after tonsillectomy and just before the histological analysis.

Official Title
-----------------
Evaluation of the Medical Device ex Vivo ENDOSWIR in Patient Operated for a Tonsillectomy : a Preliminary Cohort Study Proof of Concept (ENDOSWIR-AMYG)

Conditions
-----------------
Optical Guided Surgery

Intervention / Treatment
-----------------
* Device: EndoSWIR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tonsillectomy Exclusion Criteria: suspicion of Head-and neck cancer

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 |
| --- | --- |
| Patient's tissues exposed<br>Tonsil of each patient will be imaged using the medical device | Device: EndoSWIR<br>* Exposition of the respected tissues to the camera<br>|
| Patient's tissues not exposed<br>Tonsil of each patient will not be imaged using the medical device | Device: EndoSWIR<br>* Exposition of the respected tissues to the camera<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue integrity | Histological score : evaluation of cellular cohesion and denaturation of epithelial cells and conjunctive support tissue | 1 day |
CoStar Catheter System Evaluation

Study Overview
=================
Brief Summary
-----------------
To evaluate product performance and safety of the Catheter Design for the treatment of a single coronary lesion.

Conditions
-----------------
Symptomatic Ischemic Heart Disease

Intervention / Treatment
-----------------
* Device: Costar Coronary Stent Delivery System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is ≥18 years of age. Eligible for percutaneous coronary intervention (PCI). Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification [CCS] 1, 2, 3, or 4), documented ischemia, or documented silent ischemia. Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks. Acceptable candidate for coronary artery bypass graft surgery (CABG). Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed. Willing to comply with all specified follow-up evaluations. Inclusion Criteria (Angiographic): A single de novo lesion per study subject may be treated with the study device. Each target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent. Cumulative target lesion length per vessel is ≤24 mm based on a visual estimate. RVD of ≥2.5 mm to ≤3.0 mm based on a visual estimate. Target lesion diameter stenosis ≥50% and <100% based on a visual estimate. Target vessel has not undergone prior revascularization within the preceding 6 months. Target lesion must be a minimum of 10 mm distance from any previously treated segment of the target vessel Exclusion Criteria: Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: PLGA. Planned treatment with any other PCI device in the target vessel(s). Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q wave, or creatinine kinase (CK) >2 times the laboratory upper limits of normal and elevated MB. The patient is in cardiogenic shock. Cerebrovascular Accident (CVA) within the past 6 months. Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/L). Contraindication to ASA or to clopidogrel. Thrombocytopenia (platelet count <100, 000/mm3). Active gastrointestinal (GI) bleeding within the past three months. Any prior true anaphylactic reaction to contrast agents.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTW Catheter System<br> | Device: Costar Coronary Stent Delivery System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Goal Setting in SCS Patients: a Qualitative Review

Study Overview
=================
Brief Summary
-----------------
This is a prospective study in which the investigators will describe individual goals of patients with Failed Back Surgery Syndrome, who will be treated with spinal cord stimulation.

Official Title
-----------------
Goal Setting in SCS Patients: a Qualitative Review (LEISURE)

Conditions
-----------------
Failed Back Surgery Syndrome

Intervention / Treatment
-----------------
* Other: interview regarding goals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS) FBSS patients suitable for SCS Age > 18 years Native Dutch or French speeking patients Exclusion Criteria: Expected inability of patients to receive or properly operate the spinal cord stimulation system History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew Active malignancy Addiction to any of the following drugs, alcohol (5E/day) and/or medication Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator Immune deficiency (HIV positive, immunosuppressiva, etc.) Life expectancy < 1 year Local infection or other skin disorder at site of incision Pregnancy Other implanted active medical device

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 |
| --- | --- |
| FBSS patients<br>patients with Failed Back Surgery Syndrome, eligible for SCS | Other: interview regarding goals<br>* interview regarding goals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goals and expectations towards spinal cord stimulation | Individual goals and expectations regarding the treatment with spinal cord stimulation will be explored during an interview | Before spinal cord stimulation implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord stimulation, interview