linjc16/ctgov huggingface dataset:
RecoverLINK Technology Pilot for HF Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective is to examine feasibility of incorporating RecoverLINK into the standard of care as a function of (i) user engagement, (ii) user satisfaction, and (iii) workflow efficiency. As secondary objectives, the investigators will collect preliminary data to examine the association between patient engagement with the RecoverLINK app and (i) changes in patient knowledge and behavior, and (ii) hospital readmission(s) at 30, 60, and 90-day time periods post-enrollment.

Official Title
-----------------
Pilot to Assess Feasibility of Using RecoverLINK Technology to Supplement Outpatient Care for Heart Failure Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: RecoverLINK technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart failure (HF) patients with a rapid follow up appointment scheduled at the Mount Sinai HF clinic English-speaking With either access to (i) an iOS smart device or (ii) wifi at-home Exclusion Criteria: Patients meeting any of the following criteria: A heart transplant A mechanical circulatory support (MCS) device An altered mental status Serious co-morbidities (as identified by Mount Sinai team) Cognitive impairments (as identified by Mount Sinai team) Inability to use technology (as identified by Mount Sinai team)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RecoverLINK technology<br>RecoverLINK is a two-part mHealth technology designed to supplement traditional care transitional programs for heart failure (HF) patients. | Other: RecoverLINK technology<br>* HF patients will receive the RecoverLINK app upon study enrollment for 30-days. The Mount Sinai HF care team will interact with patients via the RecoverLINK cloud-based system during this period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User engagement: # symptom surveys completed/30 days |  | 30 days | 
| User satisfaction: Percent patients report satisfied via post-program survey |  | 30 days | 
| Workflow efficiency: mean/median time to resolution of patient alerts |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in pre/post SCHIFI score |  | 30 days | 
| Hospital admission |  | 30, 60, 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, mHealth
Montefiore Opioid and Pain Study

Study Overview
=================
Brief Summary
-----------------
This study will determine pain and opioid outcomes 3 & 6 months after an emergency department visit for acute pain. This is an observational study. Patients are enrolled during an ED visit and followed by telephone 3 & 6 months later. Opioid databases will also be reviewed.

Official Title
-----------------
Montefiore Opioid and Pain Study

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Drug: Any oral opioid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults seen in the emergency department for acute, new-onset pain, defined as: 1)localized pain duration < 10 days and 2) prior to the acute episode, the patient has not had this type of pain in the preceding six months Upon emergency department discharge, the patients is prescribed an opioid for pain Exclusion Criteria: Any prescribed opioid use within the previous six months including methadone and buprenorphine Frequent use of any analgesic medication (Use of any analgesic >10 days per month prior to the onset of acute pain) Not available for follow-up

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 |
| --- |
|Drug: Any oral opioid|Emergency department patients who receive a prescription for an oral opioid|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subsequent opioid prescription | All participants in this study received an opioid prescription at the time of discharge from the emergency department. Using a review of a prescription monitoring database, this study will determine whether participants received a subsequent prescription for an opioid medication. | 6 months | 
| Chronic pain in the affected body part | An affirmative response to the following question: its been about 180 days since you left the ER. Have you had pain on more than 50% of these days? | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 item PEG score | This is a validated pain questionnaire with 3 questions | 3 months and 6 months after ED discharge | 
| Pain description | Severe, moderate, mild or no pain | 3 months and 6 months after ED discharge |
HUDDLE: Heart Health: Understanding & Diagnosing Disease by Leveraging Echocardiograms

Study Overview
=================
Brief Summary
-----------------
This study will screen for the presence of cardiovascular disease and provide education about the signs and symptoms of cardiovascular disease and heart disease.

Official Title
-----------------
HUDDLE: Heart Health: Understanding & Diagnosing Disease by Leveraging Echocardiograms

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Eligibility Criteria: at least 50 years of age on the day of the screening event informed of the nature of the study, agrees to its provisions, and has provided written informed consent does not have any conditions that would interfere with obtaining an echocardiogram of the heart

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal structural heart findings | The number of patients with abnormal structural heart findings as identified by echocardiography | 30 days | 
| Abnormal electrocardiography findings | The number of patients with abnormal electrocardiography findings such as rhythm disturbances, bundle branch or fascicular block, or other conduction delays | 30 days | 
| Risk factors associated with cardiovascular disease | Risk factors associated with cardiovascular disease including obesity (BMI and BSA calculations using height and weight) and blood pressure, along with personal and familial medical history. | 30 days |
Effect of Partial Sleep Deprivation on Cognition and Cytokines in Individuals With Major Depression

Study Overview
=================
Brief Summary
-----------------
40 patients with the diagnosis of major depression are included. There are two interventions: partial sleep deprivation (PSD) and normal night sleep (CTRL). Patients are randomly assigned to PSD-(2 undisturbed nights)-CTRL or CTRL-(2 undisturbed nights)-PSD. Cytokine-status, neuropsychological and psychopathometric status are assessed pre and post each interventional and control condition.

Official Title
-----------------
Phase 4 Study on the Effect of Partial Sleep Deprivation on Cognition and the IL-6-gp130-System in Individuals With Major Depression

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Behavioral: partial sleep deprivation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major depression Informed consent Exclusion Criteria: Known epilepsy or previous unexplained loss of consciousness after sleep deprivation Bipolar disorder Acute or chronic inflammatory diseases Psychosis Suicidal tendency Pregnancy or nursing

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: partial sleep deprivation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognition |  |  | 
| cytokine concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical improvement |  |  |
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

Study Overview
=================
Brief Summary
-----------------
Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes

Detailed Description
-----------------
In this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.

Official Title
-----------------
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

Conditions
-----------------
Neuropathic Foot Ulceration in Individuals With Diabetes

Intervention / Treatment
-----------------
* Device: cast vs. shoe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diabetes neuropathic ulcer grade 1/2 (wagner scale) confirmed sensory neuropathy Exclusion Criteria: osteomyelitis patients unable to walk life threatening co-morbidity ankle/brachial index , 0.4

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: cast vs. shoe|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound surface area reduction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to wound healing (days) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading
Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode

Study Overview
=================
Brief Summary
-----------------
Observational study on long PR interval using the SafeR mode in bradycardia patients.

Detailed Description
-----------------
This observational trial aims to study the evolution of the PR interval in patients implanted with a dual chamber pacemaker with the SafeR mode. The investigators will assess the prevalence and the incidence of PR lengthening and the investigators will study the long PR interval management by physicians, depending on the data embedded in the pacemaker.

Official Title
-----------------
Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation

Conditions
-----------------
Sinus Node Dysfunction, Atrioventricular Block

Intervention / Treatment
-----------------
* Device: dual chamber pacemaker with SafeR algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient implanted (primo-implant, replacement, upgrade) with a Sorin Group™ dual chamber pacemaker according to current available guidelines and IFU from less than three months. Since implantation, the device is programmed in SafeR mode Patient agreed to participate, after having received the appropriate and mandatory information Exclusion Criteria: Patient contraindicated for cardiac pacing, according to current available guidelines Permanent atrial fibrillation Permanent high-degree AV block Patient not available for routine follow-up visits Patient already included in another clinical study Inability to understand the purpose of the study / refusal to cooperate minor age Pregnancy Life expectancy less than 12 months Under guardianship

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 |
| --- |
|Device: dual chamber pacemaker with SafeR algorithm|SafeR is an AVB management algorithm: it provides AAI pacing while continuously monitoring AV conduction, it switches to DDD when detecting AVB I, II or III, according to the following criteria: (1) AVB I: 6 long PR intervals, (2) AVB II: 3 blocked atrial events/12 cycles, (3) AVB III: 2 consecutive blocked atrial events. It switches back to AAI mode when needed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of clinical AVB1) | This incidence will be measured using PR/AR histograms stored in the device memory | at 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bradycardia
Effect of Anesthesia on Force Application During Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.

Detailed Description
-----------------
Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.

Official Title
-----------------
Effect of Anesthesia on Force Application During Colonoscopy

Conditions
-----------------
Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases

Intervention / Treatment
-----------------
* Device: Colonoscopy Force Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age: 30-75 years ASA Class I or II All ethnic and racial groups will be included Exclusion Criteria: Colonic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor. Specific pathology that would limit the extent of examination ASA class 3 or greater Pregnancy Monitored anesthesia using propofol for sedation. Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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 |
| --- | --- |
| Patients undergoing colonoscopy<br>Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases. | Device: Colonoscopy Force Monitor<br>* Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.<br>* Other names: CFM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak push force is increased in patients receiving propofol as compared to conscious sedation. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, Force, Monitor, Endoscopist, Conscious, Sedation, Propofol
Dynamic Stabilization Versus Fusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease.

Detailed Description
-----------------
Two strategies for treatment of degenerative lumbar instability are in frequent clinical use: fusion versus dynamic stabilization. Up to now it is not clear whether fusion (Gold-standard) or the non-fusion technique is superior. Nevertheless some data are available that dynamic stabilization as a less invasive technique can achieve similar or better results concerning patient satisfaction and re-OP rate compared with fusion as the standard therapy.

Official Title
-----------------
Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease

Conditions
-----------------
Degeneration of Lumbar Intervertebral Disc

Intervention / Treatment
-----------------
* Procedure: standard
* Procedure: new


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Mono- or bisegmental symptomatic lumbar degenerative disease with or without stenosis Indication for fusion with (i) spondylolisthesis of at least 5mm or segmental vertebral motion of at least 3mm or 10º on flexion/extension radiographs, (ii) predominant low back pain in combination with Modic changes Failure of adequate conservative measures for more than 3 months Correctly signed informed consent form Exclusion Criteria: Olisthesis more than grade I, spondylolisthesis vera, spondylolysis without olisthesis or spinal deformity (i.e. scoliosis of more than 20°, sagittal imbalance) Significant comorbidity impeding with surgical success (e.g. osteoporosis, rheumatoid arthritis, mental illness) Previous fusion or stabilization surgery

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 |
| --- | --- |
| Active Comparator: A<br>A - Fusion | Procedure: standard<br>* fusion<br>|
| Active Comparator: B<br>B - Dynamic (new) | Procedure: new<br>* dynamic stabilization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention |  | 2 years after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumbar degenerative disease
Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture.

Official Title
-----------------
Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers

Conditions
-----------------
Methodology Study

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: zolpidem
* Drug: zolpidem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-55 BMI 18-30 kg/m2 body weight > 50 kg Exclusion Criteria: no history of sleep disorder no concurrent medications no alcohol use no medical issues no smoking

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>groups of 3-4 subjects for overnight polysomnography assessments | Drug: placebo<br>* single oral dose placebo<br>|
| Experimental: Low dose Zolpidem<br> | Drug: zolpidem<br>* single oral dose, 5 mg zolpidem<br>|
| Experimental: High dose zolpidem<br> | Drug: zolpidem<br>* single oral dose, 10 mg zolpidem<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset to persistent sleep |  | minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| awakenings after sleep onset |  | minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mobile actigraphy inpatient polysomnography actigraphy ambien