linjc16/ctgov huggingface dataset:
Sleep Quality and Presence of Sleep Disordered Breathing

Study Overview
=================
Brief Summary
-----------------
The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older. Hypothesis: African-American HIV infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.

Detailed Description
-----------------
The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older. A secondary objective is to investigate possible relationships between sleep quality and aspects of a patient's medical history including BMI, CD4 count, HIV viral load, history of substance abuse, psychiatric disorders, concurrent medical conditions, current HIV medications and HIV medication compliance. Hypothesis: African-American HIV infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.

Official Title
-----------------
Sleep Quality and Presence of Sleep Disordered Breathing In An Inner City African American HIV Infected Population Aged 50 Years and Older

Conditions
-----------------
HIV Infections, Sleep

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American Aged 50 years and older HIV infected Receiving HIV care at the Boulevard Comprehensive Care Clinic, Duval County Health Department Exclusion Criteria: Patients refusing to fill out the questionnaires Patients less than 50 years old Non-African Americans Persons not receiving care at the Boulevard Comprehensive Care Clinic

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older. |  | 10-20 minutes to complete surveys | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate possible relationships between sleep quality and aspects of a patient's medical history |  | a single chart review | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Sleep Quality, Sleep apnea, Berlin Questionnaire, Pittsburgh Sleep Quality Index
Randomized Controlled Trial Comparing Different Closure Methods for Laparoscopic Port Sites

Study Overview
=================
Brief Summary
-----------------
This study wishes to compare patient satisfaction and cosmesis of two different closure methods of laparoscopic ports. One method uses tissue adhesive (Dermabond) with a deep sub-cutaneous stitch and a Band-Aid dressing. The comparison method uses a 3.o undyed vicryl transcutaneous stitch, with a Bacitracin and Tegaderm dressing.

Official Title
-----------------
Randomized Controlled Trial Comparing Two Different Methods of Laparoscopy Port Closure

Conditions
-----------------
Laparoscopic Cosmesis

Intervention / Treatment
-----------------
* Procedure: Tissue adhesive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gynecologic laparoscopy patients Exclusion Criteria: known sensitivity to tissue adhesive, antibiotic ointment

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tissue adhesive|nan|

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
-----------------
laparoscopy, port site, closure, Dermabond
Inspiratory Effort in COVID-19

Study Overview
=================
Brief Summary
-----------------
This study aims at assessing esophageal pressure in patients with acute respiratory failure due to COVID-19 undergoing non invasive respiratory support.

Official Title
-----------------
Inspiratory Effort Assessment in Patients With COVID-19 Pneumonia Undergoing Non Invasive Respiratory Support

Conditions
-----------------
Acute Respiratory Failure, Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 Acute respiratory failure undergoing non-invasive respiratory support Exclusion Criteria: Need for immediate endotracheal intubation Chronic respiratory diseases

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory effort quantification | Esophageal pressure assessment through dedicated esophageal pressure transducer | 24 hours from admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non invasive respiratory support failure | Reaching of the criteria for endotracheal intubation | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute respiratory failure, Esophageal pressure, Non invasive respiratory support, COVID-19
Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance

Study Overview
=================
Brief Summary
-----------------
Determine the force required to occlude the esophagus with a left paratracheal pressure

Official Title
-----------------
Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance

Conditions
-----------------
Oesophageal Reflux

Intervention / Treatment
-----------------
* Device: Left paratracheal pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physical status score 1 or 2 No contre indication to Left Paratracheal pressure Exclusion Criteria: Obese patients Physical status score 3, 4 or 5 Contre indication to Left Paratracheal pressure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: 1 , Left paratracheal pressure<br>50 male | Device: Left paratracheal pressure<br>* Applying Left Paratracheal pressure and testing its effectiveness using gastric tube . in addition , by using the dynamometer , the CP 50 is defined.<br>|
| Active Comparator: 2, Left paratracheal pressure<br>50 female | Device: Left paratracheal pressure<br>* Applying Left Paratracheal pressure and testing its effectiveness using gastric tube . in addition , by using the dynamometer , the CP 50 is defined.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Necessary force of Left paratracheal pressure to occlude the esophagus in female versus male . an up and down method will define the CP 50 in each gender. A comparison between CP50 in both sex will define exactly our outcome |  | 24 hours |
Further Validation of the Memory Orientation Screening Test (MOST):A 5-minute Screening Test for Dementia in Primary Care Practice

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to apply a recently developed screening test for dementia, the Memory Orientation Screening Test (MOST) to two additional groups. Group one is composed of 150 elders who do not have dementia and are residing in the community so that we can determine what is a normal MOST score. These subjects will also be individually administered a one-hour battery composed of other commonly used tests of memory and information processing. Group two is composed of 150 elders who are administered the MOST by a nurse as part of their regular visit to the primary care doctor's office, and their scores will be compared against a rating of their cognitive ability made independently by the doctor or another nurse. Their scores will also be compared with a list of their medical problems and medications. Our hypothesis for the first group is that the MOST scores will be higher in the normal group than in the previous clinical groups and that MOST scores will correlate significantly with other neurocognitive tests. Our hypothesis for the second group is that the MOST can be administered quickly and easily by briefly trained nurses, that it will compare highly with doctor opinions, and that patients with known medical conditions related to dementia, such as hypertension or diabetes, will have lower MOST scores than patients in better health.

Official Title
-----------------
Further Validation of the Memory Orientation Screening Test (MOST): A 5-minute Screening Test for Dementia in Primary Care Practice

Conditions
-----------------
Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 or older Exclusion Criteria: Younger than 65, diagnosed with dementia, blind, non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Normal community dwelling elders<br>Individuals age 65 and older who live in the community | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory Orientation Screening Test score |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other neuropsychological test scores and doctor ratings |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Screening Tests, Cognition, Memory, MOST
Effect of Vestibular Rehabilitation - a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess if early supported vestibular rehabilitation can reduce dizziness and improve daily life activities in patients with acute vestibular injury. The study question is: Does early supported vestibular rehabilitation have an additional effect on dizziness symptoms and daily life functions compared to standard treatment?

Official Title
-----------------
Effects of Vestibular Rehabilitation in the Treatment of Patients With Acute Vestibular Loss. - A Randomized Controlled Trial

Conditions
-----------------
Dizziness, Nausea, Nystagmus, Vestibular Diseases

Intervention / Treatment
-----------------
* Behavioral: Vestibular rehabilitation
* Other: standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute symptoms of dizziness, nausea and nystagmus diagnosed by videonystagmography (at least 25% reduced caloric response in one ear) age 18-70 years inclusion within one week after symptom debut Exclusion Criteria: chronic dizziness psychiatric diagnosis that might interfere with participation

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestibular rehabilitation<br>early supported vestibular rehabilitation | Behavioral: Vestibular rehabilitation<br>* Daily home training (4-6 specific exercises) 2-3 times per day. Group training led by a physiotherapist twice per week during the first 10 weeks and once per week from 10 weeks to 12 months or to symptoms are cured.<br>|
| Active Comparator: standard<br>standard treatment | Other: standard treatment<br>* treatment as usual<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vertigo | Vertigo symptom scale (VSS) | at inclusion, 10-12 weeks, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness | Dizziness Handicap Inventory (DHI), University of California Los Angeles Dizziness Questionnaire (UCLA-DQ), Three questions regarding dizziness on VAS-scale, | At inclusion, 10-12 weeks, 12 months | 
| Movement provoked dizziness | Rombergs test and advanced Rombergs test | at inclusion, 10-12 weeks, 12 months | 
| return of symptoms |  | 12 months | 
| sick leave |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vestibular rehabilitation, acute vestibular injury, Dizziness, Nausea, Nystagmus, Daily life activities, Balance, physiotherapy
PCORI-CER-1306-03385 Lung Cancer Screening Readiness Study

Study Overview
=================
Brief Summary
-----------------
Investigators will administer a brief, anonymous survey at the Texas Academy of Family Physicians (TAFP) annual Primary Care Summit to better understand the readiness of primary care physicians in Texas to implement lung cancer screening programs in their practice settings.

Detailed Description
-----------------
For this project there will be up to 1000 participants. Physicians attending the annual CME event at the Texas Academy of Family Physicians event will be asked to fill out an anonymous survey to better understand their readiness to implement lung cancer screening programs in their practice settings. The surveys will be administered to physicians attending the TAFP education events in Houston, Texas, October 17-19, 2014 and in Dallas, Texas, November 7-9, 2014.

Official Title
-----------------
Promoting Informed Decisions About Lung Cancer Screening: Lung Cancer Screening Readiness Study

Conditions
-----------------
Lung Cancer Screening

Intervention / Treatment
-----------------
* Behavioral: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Physicians attending the TAFP education events in Houston, Texas, October 17-19, 2014 and in Dallas, Texas, November 7-9, 2014. Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Physicians - Texas Academy of Family Physicians<br>Physicians attending Texas Academy of Family Physicians event asked to fill out an anonymous survey to better understand their readiness to implement lung cancer screening programs in their practice settings. Surveys administered to physicians attending the TAFP education events in Houston, Texas, October 17-19, 2014 and in Dallas, Texas, November 7-9, 2014. | Behavioral: Survey<br>* Physicians complete survey to better understand their readiness to implement lung cancer screening programs in their practice settings. Surveys administered to physicians attending the TAFP education events in Houston, Texas, October 17-19, 2014 and in Dallas, Texas, November 7-9, 2014.<br>* Other names: Questionnaire;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Cancer Screening Program Readiness | Descriptive statistics (eg, rates) used to describe the readiness of primary care physicians to support lung cancer screening programs in their practices. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer Screening, LCS, Survey, Questionnaire, Texas Academy of Family Physicians
Gastrectomy Study: Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate BMI and the nutritional parameters of Creon (pancreatin) versus placebo after a total or subtotal gastrectomy.

Official Title
-----------------
Double-Blind, Multicenter, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy

Conditions
-----------------
Gastrectomy

Intervention / Treatment
-----------------
* Drug: Pancreatin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Males or females Age >= 18 years Total or subtotal gastrectomy Females having negative pregnancy test or being surgically sterile or 1 year postmenopausal; women of childbearing age must use effective birth control. Exclusion Criteria: Diseases or conditions limiting the participation in, or completion of, the study Progressive tumors/metastasis Complications leading to insufficient peroral nutrition Known allergy to pancreatin Known exocrine insufficiency Experimental drug intake

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Pancreatin<br>* 2 capsules Pancreatin with 25 000 lipase units per main meal (3 meals) and 1 capsule per snack (2-3 snacks)<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline-adjusted body mass index (BMI) after 6 months therapy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on body composition, on stool fat, on the coefficient of fat absorption, stool weight, quality of life (Qol), clinical symptoms (gastrointestinal), data from the diary, Elastase |  | 6 months |
Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion

Study Overview
=================
Brief Summary
-----------------
Larotrectinib expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion, who are ineligible for an ongoing larotrectinib clinical trial or have other considerations that prevent access to larotrectinib through an existing clinical trial. Gene fusion occurs when a gene is made by joining parts of two different genes. NTRK gene fusion can lead to the development of solid tumors in a variety of tissue types. The study drug larotrectinib blocks the action of the NTRK gene fusion. Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion who are unresponsive to current standard treatment for their condition and also are unable to participate in ongoing clinical trials.

Official Title
-----------------
Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion

Conditions
-----------------
Tumors Harboring NTRK Fusion

Intervention / Treatment
-----------------
* Drug: Larotrectinib (Vitrakvi, BAY2757556)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cancer with a NTRK1, NTRK2, or NTRK3 gene fusion Subjects are unable to participate in an ongoing larotrectinib clinical trial Medically suitable for treatment with larotrectinib Exclusion Criteria: Currently enrolled in an ongoing clinical study of larotrectinib or another TRK inhibitor
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Larotrectinib (Vitrakvi, BAY2757556)|Larotrectinib will be administered orally as capsule or liquid solution as specified by the treating physician.|

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
-----------------
Neurotrophic tyrosine receptor kinase (NTRK), NTRK1, NTRK2, NTRK3, Fusion Positive