linjc16/ctgov huggingface dataset:
Active Symptom Control Alone Or In Combination With Oral Topotecan In Patients With Relapsed Resistant Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if giving oral HYCAMTIN to patients with relapsed small cell lung cancer benefits them. The study will compare how long patients live when they are given therapy to make them feel better (active symptom control) to the length of time patients live when they are also receiving oral HYCAMTIN.

Official Title
-----------------
An Open-Label, Multicentre, Randomised, Phase III Comparator Study of Active Symptom Control Alone or in Combination With Oral Topotecan in Patients With Relapsed Resistant SCLC

Conditions
-----------------
Lung Cancer, Small Cell

Intervention / Treatment
-----------------
* Drug: topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received one prior chemotherapy regimen only. Documented partial or complete response to first-line therapy. Documented relapse of limited or extensive SCLC at least 45 days after the cessation of first-line chemotherapy. Not considered suitable for further intravenous chemotherapy. Considered to have adequate bone marrow reserve. Performance Status of 0, 1 or 2. Exclusion Criteria: Pregnant or lactating. Received more than one prior regimen of chemotherapy. Uncontrolled vomiting. Brain metastases. Active uncontrolled infection. Received previous treatment with HYCAMTIN. Received an investigational product within 30 days.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to response, response rate, time to disease progression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapsed, lung cancer, resistant, small cel, topotecan (HYCAMTIN)
Cognitive Profile of Patients at the Sagol Center for Hyperbaric Medicine and Research

Study Overview
=================
Brief Summary
-----------------
In the investigator's institute there is ongoing treatment of different patients with cognitive deficits using Hyperbaric oxygen therapy (HBOT). These patients undergo neuro-cognitive function computerized tests before and after treatment. The aim of this study was to retrospectively evaluate the cognitive changes before and after HBOT in different patients populations.

Detailed Description
-----------------
Retrospective analysis of patients suffering from chronic neuro-cognitive deficits due to different conditions, treated at Sagol center for hyperbaric medicine and research, Shamir (Assaf Harofeh) Medical Center, Israel Patients included if they had at least two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). The study was approved by the institutional review board of the hospital. Patients were treated with 40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.

Official Title
-----------------
The Profile of Cognitive Function of Patients Who Had Neurocognitive Evaluation at the Sagol Center for Hyperbaric Medicine and Research

Conditions
-----------------
TBI (Traumatic Brain Injury), Stroke, Fibromyalgia, Aging

Intervention / Treatment
-----------------
* Other: Hyperbaric Oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included if they completed at least two neuro-cognitive computerized tests, before and after HBOT Exclusion Criteria: Patients who were not able to complete two cognitive tests

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 |
| --- | --- |
| HBOT<br>Patients with chronic brain injury or cognitive complaints that have been treated with Hyperbaric oxygen therapy and underwent computerized cognitive tests before and after the treatment | Other: Hyperbaric Oxygen<br>* 40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neurocognitive scores | change in scores in a computerized neuro-cognitive test, IQ-scale score, normalized for age and education, with mean=100 and SD=15 points in healthy population, higher score implies better results. | baseline and 12 weeks |
Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of diagnosing breast cancer. PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in diagnosing breast masses in women with a breast mass or breast cancer.

Detailed Description
-----------------
OBJECTIVES: To study in vivo detection of breast masses by vibro-acoustography (VA) imaging. To evaluate the performance of VA imaging in differentiating between benign and malignant breast masses identified as BI-RADS 4 or 5. OUTLINE: Patients undergo clinical mammography of the breast, followed by vibro-acoustography (VA) imaging using ultrasonography over 90 minutes. Patients may also undergo further imaging using clinical ultrasonography.

Official Title
-----------------
Identification and Differentiation of Breast Masses by Vibro-Acoustography

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

Intervention / Treatment
-----------------
* Other: breast imaging study


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Suspiciuos breast lesions identified as BI-RADS 4 or 5 and 3 Hormone receptor status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified Not pregnant No condition that does not allow proper use of study imaging devices PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: breast imaging study<br> | Other: breast imaging study<br>* 1. A set of vibro-acoustography (VA) scans will be taken of the breast by an experimental vibro-acoustography device that uses ultrasound for imaging. 2- An ultrasound scan (sonography) of the breast using a clinical ultrasound machine may be taken during the procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection and differentiation of breast masses with an estimated specificity of ≥ 70% using vibro-acoustography (VA) imaging |  | 25 minutes for Breast VA imaging | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
Impact of HMGB1 on Diastolic Dysfunction in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluated the association between HMGB1 and diastolic dysfunction in hypertensive patients. HMGB1 level were tested in all patients, and diastolic function determined by echocardiographic.

Official Title
-----------------
Impact of HMGB1 on Diastolic Dysfunction in Hypertensive Patients

Conditions
-----------------
Hypertension, Diastolic Dysfunction, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All of the hypertensive patients in both diastolic dysfunction and control groups were either newly diagnosed or were aware of hypertension without using any pharmacotherapy. - Exclusion Criteria: Individuals already under treatment for hypertension were not include. -

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Differences of HMGB1 levels between hypertensive patients with and without diastolic dysfunction | Blood samples of all individuals are collected on the day of admission and HMGB1 levels are tested. Echocardiographic assessment is performed with echocardiography device by using 2.5-3.5 Mega Hertz(MHz) transducer in the lateral decubitis position. | on the day of admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences of HMGB1 levels between grades of diastolic dysfunction | Blood samples of all individuals are collected on the day of admission and HMGB1 levels are tested. Echocardiographic assessment is performed with echocardiography device by using 2.5-3.5 Mega Hertz(MHz) transducer in the lateral decubitis position. | on the day of admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diastolic Dysfunction, Hypertension, HMGB1
Outcomes From Treatment Liver and Bile Duct Diseases

Study Overview
=================
Brief Summary
-----------------
It is reported in the literature that the treatment of any liver and bile duct disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with adenocarcinoma continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome measurements but with much more room for improvement. Our goal is to continue to review our treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity. The main aim of this study is to evaluate and compare the outcomes from our multiple treatments of benign or malignant liver and bile duct diseases.

Detailed Description
-----------------
The study will be a retrospective chart review of patients who have been diagnosed with benign or malignant liver and bile duct disease under the practices of Rohan Jeyarajah, M.D., Houssam Osman, M.D., F.A.C.S., Edward Cho, M.D., Sc.M at Methodist Health System Hospital in Richardson, T.X. We plan to conduct an analysis of patients meeting the inclusion criteria form 2005 to present (up to the day before this study receives IRB approval). Charts will also be reviewed by the PI. Sub-I, Fellows, Office Staff, Clinical Research Coordinator who are delegated to do so by the PI. Data will be obtained from a national database. Data will be analyzed primarily by the study conductors.

Official Title
-----------------
Evaluation of Outcomes From Treatment of Benign or Malignant Liver and Bile Duct Diseases

Conditions
-----------------
Benign or Malignant Liver and Bile Duct Disease

Intervention / Treatment
-----------------
* Other: Treatment of Benign or Malignant Liver and Bile Duct Diseases


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients diagnosed and treated for liver and bile duct disease benign or malignant from 2005 to present (up to the day before this study receives IRB approval) Age > 18 years Exclusion Criteria: Patients that are not diagnosed with or treated for liver and bile duct disease Age < 18 years

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: Treatment of Benign or Malignant Liver and Bile Duct Diseases|Available treatment of Benign or Malignant Liver and Bile Duct Diseases|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality from Treatment of Benign or Malignant Liver and Bile Duct Diseases | Mortality | 2005 to 2019 | 
| Morbidity from Treatment of Benign or Malignant Liver and Bile Duct Diseases | Morbidity | 2005 to 2019 |
Oxytocin, Couple Interaction and Wound Healing

Study Overview
=================
Brief Summary
-----------------
effects of intranasal oxytocin and couple interaction on wound healing. Trial with medicinal product

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Syntocinon (Oxytocin) nasal spray
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: healthy heterosexual couples in a stable relationship since > 1 year Exclusion criteria: pregnancy breast feeding heavy smoking (> 5 cigarettes/d) extensive skin disease artificial UV irradiation during < 3 months before study inclusion

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nasal spray<br> | Drug: Syntocinon (Oxytocin) nasal spray<br>* two-times daily self-administration of nasal spray containing active substance (oxytocin) during five days after wounding.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* two-times daily self-administration of nasal spray containing placebo during five days after wounding.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound size | wound healing process within seven days after wounding | seven days |
An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.

Detailed Description
-----------------
The total duration per patient will be approximately 22 months including a 18-month double-blind treatment period.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Type 2 Diabetic Patients With Nonalcoholic Steatohepatitis (NASH).

Conditions
-----------------
Fatty Liver

Intervention / Treatment
-----------------
* Drug: Rimonabant
* Drug: Placebo (for Rimonabant)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 2 diabetes mellitus and a diagnosis of NASH Exclusion Criteria: Excessive alcohol use Presence of Type 1 diabetes mellitus Other chronic liver disease Previous or current hepatocellular carcinoma Use of medication known to cause steatosis Previous bariatric surgery Pregnancy or breastfeeding Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimonabant<br>Rimonabant 20 mg once daily. | Drug: Rimonabant<br>* Tablet, oral administration<br>* Other names: Acomplia;|
| Placebo Comparator: Placebo<br>Placebo (for Rimonabant) once daily. | Drug: Placebo (for Rimonabant)<br>* Tablet, oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS) |  | Baseline to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hepatic fibrosis score |  | Baseline to 18 months | 
| Change from baseline in serum hyaluronate and hepatic transaminases (AST/ALT) |  | Baseline to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NASH, chronic liver disease
A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With Oral Inhalation From Dry Powder Inhalers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.

Official Title
-----------------
An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C
* Drug: Treatment D
* Drug: Treatment E
* Drug: Treatment F
* Drug: Treatment G


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Pregnant or nursing females. A positive urine drug screen.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: Treatment A<br>* PF-00241939 300 ug using inhaler A<br>|
| Experimental: Treatment B<br> | Drug: Treatment B<br>* PF-00241939 300 ug using inhaler A<br>|
| Experimental: Treatment C<br> | Drug: Treatment C<br>* PF-00241939 300 ug using inhaler A<br>|
| Active Comparator: Treatment D<br> | Drug: Treatment D<br>* PF-00241939 300 ug using inhaler B<br>|
| Active Comparator: Treatment E<br> | Drug: Treatment E<br>* PF-00241939 300 ug using inhaler B<br>|
| Active Comparator: Treatment F<br> | Drug: Treatment F<br>* PF-00241939 300 ug using inhaler B<br>|
| Active Comparator: Treatment G<br> | Drug: Treatment G<br>* PF-00241939 300 ug using inhaler B<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: AUClast and Cmax. |  | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: AUC24, AUCinf, Tmax and half-life. |  | 36 hours |
Emergency Surgery Following Pediatric Catheterization

Study Overview
=================
Brief Summary
-----------------
We study the outcome and prequesties of emergency surgeries that were necessary following accidents in the pediatric cardiac catheterization lab

Official Title
-----------------
Emergency Surgery Following Pediatric Cardiac Catheterization

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Procedure: Surgery following catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients presenting for diagnostic or therapeutic pediatric cardiac catheterization Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 9 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Surgery following catheterization|Emergency surgery following pediatric cardiac catheterization|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge from ICU |  | A 2 years study |