linjc16/ctgov huggingface dataset:
Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Study Overview
=================
Brief Summary
-----------------
This is a randomized clinical trial in U.S. Veterans to evaluate the impact of treatment for obstructive sleep apnea (OSA) on the effectiveness of cardiac rehabilitation, including impact on exercise capacity, disability, and quality of life.

Detailed Description
-----------------
Obstructive sleep apnea (OSA) is a highly prevalent condition in patients with coronary heart disease and is associated with impaired exercise performance, functional limitation and reduced health-related quality of life. The investigators hypothesize that identification and treatment of OSA in patients undergoing cardiac rehabilitation will improve the response to rehabilitation. The proposed study will test this hypothesis using a parallel group, randomized, clinical trial comparing OSA treatment with continuous positive airway pressure (CPAP) to an educational control group in patients undergoing cardiac rehabilitation who screen positive for previously undiagnosed OSA.

Official Title
-----------------
Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Conditions
-----------------
Obstructive Sleep Apnea, Coronary Heart Disease

Intervention / Treatment
-----------------
* Device: CPAP
* Behavioral: HLSE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veterans referred for cardiac rehabilitation at the VA Boston Healthcare System. Moderate to severe OSA (AHI >15) on home sleep testing. Exclusion Criteria: Dangerous levels of sleepiness (Epworth Sleepiness Scale score >16 or a report of falling asleep at the wheel of a car within the past 2 years). Physical limitation precluding exercise testing.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Positive Airway Pressure (CPAP)<br>Continuous positive airway pressure | Device: CPAP<br>* Continuous positive airway pressure<br>|
| Sham Comparator: Healthy Lifestyle and Sleep Education (HLSE)<br>Healthy living and sleep education | Behavioral: HLSE<br>* Healthy living and sleep education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO Disability Assessment Scale 2 Scores | Functional status as measured by the World Health Organization Disability Assessment Scale 2.0. Score range 0-48 (higher scores indicate more disability). | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive sleep apnea, Coronary heart disease, Cardiac rehabilitation, Cardiopulmonary exercise testing
Can Tailored Patient Letters Improve The Quality Of Diabetic Patient Care?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if tailored letters sent to diabetic patients will improve care of diabetes.

Detailed Description
-----------------
Diabetes care in the US is less than optimal. Some authors have found that targeted patient letters are also an effective tool to improve outcomes when they are part of a comprehensive disease management plan. Local patient satisfaction surveys had revealed that many patients had sub-optimal understanding of diabetes measures and of the importance of controlling these measures to reduce diabetic complications. We wondered if tailored patient letters and enclosed lab orders when due might increase patient awareness of diabetes measures and increase patient engagement.We hypothesized that the addition of targeted patient letters with enclosed lab orders to an ongoing performance improvement program would further improve diabetes care. We conducted a randomized controlled study of tailored patient letters and diabetes lab orders at our two resident-based clinics.

Official Title
-----------------
Can Tailored Patient Letters Improve The Quality Of Diabetic Patient Care?

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Tailored letter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All active patients age 18 to 75 years with a diagnosis of diabetes mellitus were eligible. An active patient was defined as one having an ICD-9 code on the active problem list identifying the patient as diabetic, and a progress note in the EMR associated with an office visit within the prior 12 months. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored letter<br>Patients in the tailored letter group received by mail a tailored letter detailing their diabetes measures, together with enclosed orders for lab tests when due, and reminder of or scheduling for an office appointment. | Other: Tailored letter<br> <br> |
| Active Comparator: Usual Care<br>Patients in the usual care group were part of a practice wide quality improvement process. | Other: Tailored letter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes summary quality measure |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus targeted mailing
Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Hypoxic Pulmonary Vasoconstriction

Study Overview
=================
Brief Summary
-----------------
It has been shown, that subjects susceptible to high altitude pulmonary edema (HAPE)are characterized by an abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia. This abnormal rise of pulmonary artery pressure has also been observed in about 10 % of otherwise healthy subjects without prior altitude exposure. The aim of the study is to investigate the susceptibility to HAPE in unacclimatized subjects with abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia after rapid ascent to high altitude (4559 m).

Official Title
-----------------
Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Pulmonary Artery Pressure During Exercise in Normoxia and at Rest in Hypoxia

Conditions
-----------------
High Altitude Pulmonary Edema

Intervention / Treatment
-----------------
* Other: Altitude Exposure:


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia ability to climb Margherita Hut Exclusion Criteria: Birth at or above 1500 m altitude any cardiovascular or pulmonary disease Infection disease Intake of drugs, in particular Acetazolamide, Nifedipine, corticosteroids or PDE-5-inhibitors. Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>high altitude exposure without prior acclimatization | Other: Altitude Exposure:<br>* rapid ascent to Margherita Hut (4559 m) within 24 h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of HAPE after rapid ascent to 4559 m |  | during the 48 h stay at altitude | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of pulmonary artery pressure |  | during the 48 h stay at altitude | 
| Assessment of right ventricular function by echocardiography |  | during the 48 h stay at altitude | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high altitude pulmonary edema, hypoxic pulmonary vasoconstriction, right ventricular function, hypoxia
Blood Management Program in the Post - Operative Period.

Study Overview
=================
Brief Summary
-----------------
A care path in the field of transfusion medicine was creates at ASMN - IRCCS addressed to patients undergoing complex surgical procedures.

Detailed Description
-----------------
This pathway is called Blood Management Program (BMP). The implementation of this process should improve transfusion therapy in the peri-operative period in order to: correct the transfusional approach to surgical patients optimize the management of transfusional resources (red blood cells, plasma, platelets) optimize the management of plasma derivatives, drugs and techniques designed to limit the use of homologous blood

Official Title
-----------------
Blood Management Program: Appropriateness of Transfusion Therapy in the Post - Operative Period.

Conditions
-----------------
Excessive Amount of Blood / Fluid Transfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -All patients undergoing complex surgical procedures Exclusion Criteria:

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 |
| --- | --- | --- |
| Evaluation of therapeutic appropriateness for Red Cells - Plasma - Platelets transfusion: comparison between prospective vs. retrospective data in ASMN ,Reggio Emilia (Italy) |  | 24 months |
PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients

Study Overview
=================
Brief Summary
-----------------
The reports on relationship of obesity and biochemical or clinical recurrence of prostate cancer are controversial. Several reports have shown that obesity is associated with increased risk of biochemical or clinical failure after radical prostatectomy. Other prospective studies have shown no adverse effect of obesity on long-term outcomes after prostatectomy. Limited reports are available on the impact of obesity on prostate cancer progression after radiotherapy. Primary: to assess percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy. Secondary: to determine the Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire

Official Title
-----------------
PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients Assessment of the Correlation Between Body Mass Index and Recurrence Among Zoladex Treated Prostate Cancer Patients

Conditions
-----------------
Prostate Cancer, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven prostate cancer patients being on adjuvant Zoladex treatment after primary therapy or on adjuvant therapy without primary curative therapy Exclusion Criteria: -Prostate cancer patients refractory to hormonal therapy, not agreeing to participate, allergy against treatment

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

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

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 |
| --- | --- | --- |
| Percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy. |  | Every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire |  | Every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMI, Prostate cancer, Recurrence
Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses

Study Overview
=================
Brief Summary
-----------------
Local anesthesia used for incision and drainage of abscesses is known to be painful. We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage (I&D) of skin abscesses. Local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine patch during I&D of skin abscesses in the Emergency Department. Pain at presentation and following the procedure was similar in both groups.

Official Title
-----------------
Injectable Lidocaine Provides Similar Analgesia Compared to Transdermal Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses: A Randomized Controlled Trial

Conditions
-----------------
Cutaneous Abscess, Pain

Intervention / Treatment
-----------------
* Drug: Lidocaine/tetracaine patch
* Drug: 1% lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years Skin abscess in need of incision and drainage (judged by treating physician) Exclusion Criteria: Allergy to lidocaine or tetracaine Non-intact skin Unable/unwilling to provide informed consent

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine Injection<br>Incision and drainage performed after patient received placebo patch with injection of 1% lidocaine into the site of the abscess. | Drug: 1% lidocaine<br> <br> |
| Experimental: Lidocaine/tetracaine patch<br>Incision and drainage performed after patient received active lidocaine/tetracaine patch and injection of 10cc of saline into site of abscess | Drug: Lidocaine/tetracaine patch<br> <br> * Other names: Synera patch;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS pain score over time | VAS measured at each of the 3 time points noted above. | Immediately prior to starting I&D (Time 0); 2-5 minutes after start of I&D (Time 1); within 1 minute of completion of I&D (Time 2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
local anesthetic, incision and drainage, pain, cutaneous abscess
Quality and Outcome Measurements of Urological Patients

Study Overview
=================
Brief Summary
-----------------
Prospectively, all available parameters of urologic patients treated at the study sites will be acquired and stored in multilayered databases. Upon a given samples size, neuronal networks will be trained to define clinical endpoints. Beside uro-oncological patients also patients with other urological diseases will be enrolled.

Official Title
-----------------
Quality and Outcome Measurements of Urological Patients

Conditions
-----------------
Urologic Diseases

Intervention / Treatment
-----------------
* Other: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated at the study sites, signed informed consent Exclusion Criteria: No consent to record medical history

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: Standard of care|Patients are treated according to the standard of care for each individual disease.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease specific primary endpoint | Neuronal networks will be trained to define the respective endpoints for the diseases | 4-5 years |
Expanded Access for Fixed-Dose Combination of Nivolumab Plus Relatlimab

Study Overview
=================
Brief Summary
-----------------
This is an expanded access designed to provide access to fixed-dose combination of nivolumab plus relatlimab for eligible participants.

Intervention / Treatment
-----------------
* Biological: Nivolumab plus Relatlimab FDC


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Nivolumab plus Relatlimab FDC|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Microcirculation of Patients With Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
This study measures the sublingual microcirculation of patients with kidney transplant using MicroScan. The data will be compared with data of health volunteers and end stage renal disease patients on hemodialysis.

Detailed Description
-----------------
This study measures the sublingual microcirculation of patients with kidney transplant using MicroScan. The data will be compared with data of health volunteers and end stage renal disease patients on hemodialysis. The microcirculation date includes total small vessel density, perfused small vessel density, proportion of perfused vessels, microvascular flow index, and heterogeneity index.

Official Title
-----------------
Sublingual Microcirculation Data of Patients With Kidney Transplant

Conditions
-----------------
Microcirculation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with kidney transplant for more than one month Exclusion Criteria: Body mass index (BMI) < 18.5 or > 30 diagnosis of sepsis or trauma, or admitted to intensive care unit within one month before enrollment body temperature < 35.5 or > 37.5 Celsius patients with tongue resection non-native speaker

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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 |
| --- | --- | --- |
| Total small vessel density |  | 6 hours | 
| Perfused small vessel density |  | 6 hours |
NIRS Monitoring During Intracranial Interventions

Study Overview
=================
Brief Summary
-----------------
Near infrared spectroscopy is a valuable tool to monitor cerebral oxygenation during intracranial interventions. However, it yields artificial results when the dye indocyanine green (ICG) is applied, which is routinely done for intraoperative angiography. The investigators examine, to what extent and which duration NIRS is disturbed following ICG application.

Conditions
-----------------
Subarachnoid Hemorrhage, Intracranial Arteriovenous Malformation

Intervention / Treatment
-----------------
* Other: near infrared spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for aneurysm clipping or av-malformation removal Exclusion Criteria: pregnancy

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: near infrared spectroscopy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of rSO2 - change [%] induced by ICG-application | Cerebral oxygenation (rSO2) may be quantified using NIRS. The dye ICG, that is used intraoperatively, affects NIRS, since it changes rSO2 without modifying cerebral oxygenation. The amount, by which rSO2 is altered will be assessed | 1 hour |