linjc16/ctgov huggingface dataset:
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced or recurrent esophageal cancer who have completed the previous Phase 2 study (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating investigator(s). To evaluate the severity of observed adverse reactions in treated subjects for assessment of long-term safety.

Official Title
-----------------
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects with advanced or recurrent esophageal cancer who have completed the previous late Phase 2 study (CA139-540) and for who continued therapy with paclitaxel would be beneficial as deemed by the investigator(s).
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel<br>One hour intravenous infusion on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consists of 49 days. Day 1 dose same level as last dose of original Study CA139-540 (100mg/m2, 80 mg/m2, or 60 mg/m2). Treatment to continue until disease progression or unacceptable toxicity apparent. | Drug: Paclitaxel<br> <br> * Other names: BMS-181339;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) Per Participant | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. | Weekly Day 1 to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Response to Tumor | Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552). | Every 7 weeks Day 1 to 4 years |
Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand

Study Overview
=================
Brief Summary
-----------------
Study clinical characteristics and phenotypes of patients diagnosed with NSAID sensitivity in Thailand

Official Title
-----------------
Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand

Conditions
-----------------
Aspirin Sensitivity, Aspirin-exacerbated Respiratory Disease, Aspirin-Induced Angioedema-Urticaria, Aspirin Allergy, NSAID-Induced Asthma, NSAID-Induced Angioedema-Urticaria, NSAID-Induced Anaphylactoid Reaction, Aspirin-Induced Anaphylactoid Reaction

Intervention / Treatment
-----------------
* Drug: aspirin, NSAIDs, paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thai patients with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs visiting King Chulalongkorn memorial Hospital Exclusion Criteria: None

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 |
| --- | --- |
| NSAID sensitivity<br>Patients diagnosed with an immediate reaction to aspirin/NSAIDs/or paracetamol | Drug: aspirin, NSAIDs, paracetamol<br>* Perform skin test and/or provocation test with aspirin, paracetmol, or suspected NSAIDs in questionable cases<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of skin test/provocation test | Positive, negative, or equivocal | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotypes of allergic reactions |  | 4 years | 
| Urine leukotriene E4 |  | 4 years |
Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesis is that there will be improvement in FEV1 in patients with severe asthma. This is a retrospective data study that reviews preexisting medical records; no patients will be enrolled.

Detailed Description
-----------------
The investigators plan is to retrospectively evaluate spirometry on patients with severe asthma who have undergone bronchial thermoplasty. The procedure will have been done according to the recommended protocol of three separate sessions. For each patient all available spirometric data obtained before and after thermoplasty will be used. Data will be collected from two centers, OU Medical Center and St. Francis Hospital in Tulsa, OK. All procedures done at St. Francis have been performed by a single physician and he is providing their spirometric data for the investigators study. The following data will be collected for all participants undergoing bronchial thermoplasty: Age, height, sex, weight, medical history, smoking history, baseline spirometry before and after bronchodilators, post thermoplasty spirometry before and after bronchodilators.

Official Title
-----------------
Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age severe asthma diagnosis decreased FEV1 Exclusion Criteria: < 18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Past Bronchial Thermoplasty data<br>Data will be collected from records of patients who, in the past, have undergone bronchial thermoplasty. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoints are improvements in prebronchodilator FEV1 and FVC. | The primary endpoints are improvements in prebronchodilator FEV1 and FVC by 12% predicted. | 1 year after thermoplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness. | Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness by 12% predicted. | 1 year after thermoplasty | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, thermoplasty
Exercise Capability and Training Effects in Diabetic Patients With Neuropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to investigate the effects of training on the exercise capability, balance performance, and microcirculation. Furthermore, to search the possible underlying mechanisms.

Official Title
-----------------
Exercise Capability and Training Effects in Diabetic Patients With Neuropathy

Conditions
-----------------
Diabetes Mellitus, Peripheral Neuropathy

Intervention / Treatment
-----------------
* Behavioral: exercise training
* Behavioral: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes with neuropathy. Exclusion Criteria: Central nerve system dysfunction, hemiparesis, motion tremor, other musculoskeletal disease that might effect the outcome measurements.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Training<br>aerobic exercise training | Behavioral: exercise training<br> <br> |
| Active Comparator: Control<br> | Behavioral: usual care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | oxygen consumption | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal oxygen pulse | maximal oxygen content in blood of each heart beat | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Peripheral neuropathy, Exercise, Balance performance
Diet and Activity Promotion Among Older Working Adults

Study Overview
=================
Brief Summary
-----------------
The trial will test whether the Alive email-delivered health behavior program can improve subjects' physical activity, fruits and vegetables and saturated/trans fats and added sugars.

Official Title
-----------------
Diet and Activity Promotion Among Older Working Adults

Conditions
-----------------
Cardiovascular Disease, Diabetes, Obesity, Aging

Intervention / Treatment
-----------------
* Behavioral: Physical Activity and Diet Intervention via Alive2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 50+ currently employed access to email/web Exclusion Criteria: angina

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alive2<br>Lifestyle Intervention delivered via email and web | Behavioral: Physical Activity and Diet Intervention via Alive2<br>* Weekly email/web goal-setting intervention to improve physical activity and diet, with and without additional phone and mail support.<br>|
| Experimental: Alive2 plus automated phone/print<br>All of Arm 1 components, plus biweekly tailored automated phone coaching plus monthly tailored automated print materials. | Behavioral: Physical Activity and Diet Intervention via Alive2<br>* Weekly email/web goal-setting intervention to improve physical activity and diet, with and without additional phone and mail support.<br>|
| Placebo Comparator: Control<br>Monthly emailed newsletter on other aspects of wellness, excluding diet and physical activity | Behavioral: Physical Activity and Diet Intervention via Alive2<br>* Weekly email/web goal-setting intervention to improve physical activity and diet, with and without additional phone and mail support.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity | Change in physical activity as reported on questionnaire | 3, 6, 9, 12 months | 
| Change in Fruits and Vegetables | Change in fruits and vegetables as reported on questionnaire | 3, 6, 9, 12 months | 
| Change in saturated fats | Change in saturated fat intake as reported on questionnaire | 3, 6, 9, 12 months | 
| Change in added sugar | Change in added sugar as reported on questionnaire | 3, 6, 9, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
behavior change, physical activity, nutrition, fruits and vegetables, saturated fat, trans fat, added sugars, email, web, obesity, aging
Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial was to examine the independent effects of equivalent diet- or exercise-induced weight loss on obesity and related cardiovascular health risk factors. We hypothesized that exercise would result in greater reductions in obesity and health risk factors that equivalent diet (caloric restriction).

Official Title
-----------------
Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Diet Weight Loss
* Behavioral: Exercise Weight Loss
* Behavioral: Exercise Without Weight Loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men between 20 and 60 yrs Exclusion Criteria: Smokers and diabetics

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: C<br> | |
| Active Comparator: DWL<br>Diet Weight Loss | Behavioral: Diet Weight Loss<br> <br> |
| Active Comparator: EWL<br>Exercise Weight Loss | Behavioral: Exercise Weight Loss<br> <br> |
| Active Comparator: EWS<br>Exercise without weight loss | Behavioral: Exercise Without Weight Loss<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal obesity |  | 3 months | 
| Insulin Resistance |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, exercise, diet, insulin resistance
Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy

Study Overview
=================
Brief Summary
-----------------
Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients will be determined with using irregular increased human chorionic gonadotropin (beta-HCG) results and no embryo reported ultrasonography results. Plasma and cervical fluid samples will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase levels of samples will be compared between patients who have doubt for ectopic pregnancy and patients who have intrauterine pregnancy. Concentration of these proteins in samples will be evaluated. If any difference will be found between groups in favour of ectopic pregnancy, these results might be interpreted as these proteins useful for early detecting of the ectopic pregnancy.

Conditions
-----------------
Ectopic Pregnancy

Intervention / Treatment
-----------------
* Other: Collecting cervical liquid and sera samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Doubted ectopic pregnancy Without any finding about intrauterine pregnancy in ultrasonography results Without any vaginal bleeding Having irregular pregnancy test results Beta-HCG results should be at least upper than 100 milli-International unit (mIU/ml) Having fist trimester pregnancy for intrauterine pregnancy group Without any emergency findings Exclusion Criteria: Doubted incomplete abortion Having vaginal bleeding Having ultrasound results which include intrauterine embryo report Having lower than 100 mIU/ml beta-HCG results Without fetal heart rate in intrauterine pregnancy group Having older than fist trimester pregnancy for intrauterine pregnancy group Having emergency findings

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Doubt for ectopic pregnancy group<br>This group participants have doubt for ectopic pregnancy in terms of beta-HCG pregnancy follow-up results and ultrasonography results. | Other: Collecting cervical liquid and sera samples<br> <br> |
| Normal intrauterine pregnancy group<br>This groups participants have normal intrauterine pregnancy | Other: Collecting cervical liquid and sera samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Axonemal Dynein Heavy Chain 5 |  | 1 year | 
| Concentration of creatine kinase |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ectopic pregnancy, Axonemal Dynein Heavy Chain 5, Creatine Kinase, Cervical fluid
Quiet Eye Duration in Baseball

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the gaze movements of individuals as they watch videos of a baseball pitcher throwing pitches. The goal will be to determine whether there is an anticipatory movement to the location where the ball is released, and whether this anticipatory movement occurs in experienced baseball players more commonly than in inexperienced players.

Detailed Description
-----------------
20 subjects between 18 and 40 years of age (males and females) will participate. 10 subjects will be required to have experience in baseball or softball at the high school level or above within the last 10 years. A further 10 subjects will be recruited who did not have baseball experience at or above the high school level. Upon entering the laboratory, the experiment will be explained to the subjects. Subjects will be consented. Then, the subject's visual acuity and stereoacuity (depth perception) will be measured. If subjects continue on to the experiment, they will also be asked to complete a short survey on previous baseball experience. Subjects will stand in a batting stance facing a projector screen. They will then participate in trials in which they mimic batting a ball thrown by a pitcher. Six different pitch videos will be shown. The subjects will act as if they are batting the ball (no bat swing will occur) for each video. The movement of the subject's eye will be tracked using an eye tracker.

Official Title
-----------------
Quiet Eye Duration in Baseball

Conditions
-----------------
Gaze Tracking

Intervention / Treatment
-----------------
* Other: Gaze tracking - no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20/20 visual acuity in each eye Stereoacuity of 40 arc seconds are better Exclusion Criteria: 20/25 or worse visual acuity in either eye Stereoacuity less than 40 arc seconds

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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
Intervention Model: Single Group Assignment
Interventional Model Description: There is no intervention or treatment in this study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gaze tracking<br>No intervention. Monitor gaze as subjects watch a video | Other: Gaze tracking - no intervention<br>* Monitor gaze as subjects watch a video<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quiet eye duration | Duration over which the gaze remains stable | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sports
Capnography During Upper GI Endoscopy

Study Overview
=================
Brief Summary
-----------------
In this randomized controlled trial the utility of capnography and IPI gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.

Official Title
-----------------
Clinical Value of Advanced Patient Monitoring With Capnography and Analysis of the Integrated Pulmonary Index During Interventional Upper Gastrointestinale Endoscopy

Conditions
-----------------
Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Interventional Upper GI Endoscopy

Intervention / Treatment
-----------------
* Device: Capnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>=18 Scheduled for interventional upper GI endoscopy with midazolam and propofol sedation Exclusion Criteria: No informed consent ASA IV or V Emergency endoscopy Preexisting hypotension, bradycardia or hypoxemia

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention<br>Standard monitoring. | |
| Experimental: Capnography<br>Arm with capnographic monitoring | Device: Capnography<br>* Monitoring of the capnography curve for early detection of apnea<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia |  | From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further complications |  | From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoxemia, Capnography, Integrated pulmonary index, Sedation, Propofol, Safety