linjc16/ctgov huggingface dataset:
Telehealth Following Orthopaedic Procedures

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the quality of care provided by a home-based teleheath program as a safe and acceptable alternative to an in-person office visit as determined by satisfaction with the program and the amount of further medical management required by the patients.

Official Title
-----------------
Evaluation of Telehealth Follow-up Appointments Following Orthopaedic Surgery

Conditions
-----------------
Post-Op Complication

Intervention / Treatment
-----------------
* Procedure: In-person office visit
* Procedure: Teleheath visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Subjects over 18 and under 75 years of age undergoing elective primary orthopaedic surgery at Thomas Jefferson University Hospital, Rothman Orthopaedic Specialty Hospital or Methodist Hospital who have the capability to utilize a telecommunications platform (computer, tablet or similar device at home with a webcam, microphone and access to high-speed internet). Exclusion Criteria: Subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion Subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them Subjects with workman's compensation or automotive claims or other ongoing litigation Subjects that are unable or unwilling to consent for enrollment Patients under the age of 18 years Pregnant or breastfeeding women Patients undergoing surgery for tumor, trauma or infection or who require revision or staged procedures Patients without English-language proficiency Patients with unforeseen intra-operative or perioperative complications

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person office visit<br> | Procedure: In-person office visit<br>* Post-operative visit to occur in-person with provider<br>|
| Active Comparator: Telehealth visit with provider<br> | Procedure: Teleheath visit<br>* Post-operative visit to occur via telehealth software platform with provider<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction: Likert Score | Likert Score self-reported patient satisfaction | 2 mont post-operative period following surgery |
Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)

Study Overview
=================
Brief Summary
-----------------
Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.

Official Title
-----------------
Quality of Life With Arcoxia in Women With Dysmenorrhea

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women older than 18 years old and younger than 25 years old Voluntary agreement to participate in the study and signature of informed consent Women with clinical diagnosis of dysmenorrhea Exclusion Criteria: Diagnosis of secondary dysmenorrhea due to: endometriosis, adenomyosis, malformations of Muller's conducts, uterine fibromyomas, ovarian cystic, pelvic varicocoele, inflammatory pelvic disease, adherences, intrauterine devices, cervical channel stenosis, etc. Patients with diagnosis of acute inflammatory abdomen Patients with diagnosis of congestive heart disease, stroke (1 year), unstable angina, and history of myocardial infarction Women auto prescribing rescue medication for dysmenorrheal pain during the study Women with a diagnosis of mild dysmenorrhea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of menstrual pain, through the analog verbal scale during three days. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measures during three days. |  |  |
Pain Expression in the Perioperative Period of Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Patients having cataract extraction in the second eye under topical anesthesia with monitored anesthesia care often report increased pain and awareness relative to the first surgery in the fellow eye, despite similar operative and anesthetic conditions. The purpose of this study is to investigate the pathogenesis of this phenomenon.

Official Title
-----------------
Pain Expression in the Perioperative Period of Cataract Surgery

Conditions
-----------------
Cataract, Surgery, Eye Pain

Intervention / Treatment
-----------------
* Procedure: First eye (FE)
* Procedure: Second eye (SE)
* Drug: Steroids eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age-related cataract patients aged 50 years or older able to give informed consent undergoing cataract surgery; Pupil dilation ≧7 mm after mydrisis; VA prognosis ≧6/12 Exclusion Criteria: Unable to give informed consent; Patients with history of ocular pathology or diabetic retinopathy; Patients with traumatic, subluxated and posterior polar cataract; Patients had other ocular surgery (not cataract surgery) in the past 6 months; Patients with significant intra-operative complications

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First eye (FE)<br>Phacoemulsification cataract extraction surgery of first eye | Procedure: First eye (FE)<br>* Phacoemulsification cataract extraction surgery<br>Drug: Steroids eye drops<br>* Use steroids eye drops to decrease the pain.<br>|
| Active Comparator: Second eye (SE)<br>Phacoemulsification cataract extraction surgery of second eye | Procedure: Second eye (SE)<br>* Phacoemulsification cataract extraction surgery<br>Drug: Steroids eye drops<br>* Use steroids eye drops to decrease the pain.<br>|
| Experimental: Steroids eye drops<br>Dexamethasone eye drop, 1 drop, qid, for 3 days before surgery | Procedure: First eye (FE)<br>* Phacoemulsification cataract extraction surgery<br>Procedure: Second eye (SE)<br>* Phacoemulsification cataract extraction surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain level | Post operative pain level recorded on a VAS (0-10) at rest for the first three days after cataract surgery. | 3 days |
Cannabinoids, Neural Synchrony, and Information Processing

Study Overview
=================
Brief Summary
-----------------
The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active ingredient of cannabis, on neural synchrony. Neural synchrony is studied using electroencephalography (EEG).

Official Title
-----------------
Cannabinoids, Psychosis, Neural Synchrony, and Information Processing

Conditions
-----------------
Cannabis, Psychotic Disorders

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18 and 55 years (extremes included) on the day of the first dosing. Exposed to cannabis at least once. Exclusion Criteria: Cannabis naïve Positive pregnancy screen during screening Hearing deficits

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: THC<br>Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes. Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or joint. Administered intravenously over 10 minutes. Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or joint. Administered intravenously over 10 minutes. | Drug: THC<br>* Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes. Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or joint. Administered intravenously over 10 minutes. Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or joint. Administered intravenously over 10 minutes.<br>|
| Placebo Comparator: Placebo<br>• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes | Drug: Placebo<br>* • Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG |  | +30 | 
| Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale |  | Baseline, +10, +80 |
Provigil (Modafinil) Study by Taiwan Biotech Co.

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness associated with narcolepsy. Both of the subjective and objective sleepiness of the patients were assessed in the experiment by repeat measures.

Official Title
-----------------
A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy

Conditions
-----------------
Narcolepsy, Cataplexy, Sleep Disorders, Hypersomnolence, Excessive Sleepiness

Intervention / Treatment
-----------------
* Drug: Modafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Polysomnographic findings of shortened sleep latency less than 5 minutes average of Multiple Sleep Latency Test, and two or more SOREM should be fulfilled. Age of 12 y/o to 55 y/o. The liver and kidney functions are within normal limits. Meeting the strict criteria of narcolepsy described above. Wash out any medications which might enhance wakefulness or affect nocturnal sleep two weeks prior to the experiments. Willingness to comply with the protocol and signed the written Informed Consent. Exclusion Criteria: Patients whose hypersomnia was caused by severely sleep deprived, phase delayed, or suspected long sleeper. Patients with concomitant neurological disorder and psychiatric disorders. Patients with sleep-related breathing disorders whose apnea/hypopnea index (AHI) was 5 pauses per hour above. Patients with Restless Leg Syndrome & Periodic Limbs Movements whose index was more than 5 per hour. Patients who are pregnant or breast-feeding.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in the sleep latency. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's assessment of general level of daytime sleepiness on ESS. |  |  | 
| Patient's cognitive function assessed by psychomotor function test (Trail making test, and Digit Symbol Substitution Test). |  |  | 
| Patient's sleep quality evaluated by PSQI. |  |  | 
| Safety would be evaluated by tabulating and summarizing all adverse events reported. |  |  |
Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot

Study Overview
=================
Brief Summary
-----------------
This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and/or palpitations) as well as changes in right heart structure in patients with Tetralogy of Fallot (TOF).

Official Title
-----------------
Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot

Conditions
-----------------
Tetralogy of Fallot

Intervention / Treatment
-----------------
* Diagnostic Test: Remote Heart Rhythm Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate (or greater) PR based on quantitative Doppler echocardiography. Repaired TOF Exclusion Criteria: Pregnant Women Unable to undergo CMRI

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 |
| --- |
|Diagnostic Test: Remote Heart Rhythm Monitoring|We will be looking to see if remote heart rhythm monitoring for 3 months at baseline, 12, and 24 months, helps for early identification of adverse cardiac events.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right Heart Remodeling | Right Heart Remodeling measured via right atrial reservoir strain (%). | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident arrhythmias | Incident of atrial flutter, atrial fibrillation, atrial tachycardia, and/or ventricular tachycardia. | 24 Months | 
| Aerobic Capacity | Aerobic Capacity measured as maximal oxygen consumption (ml/kg/min). | 24 Months |
Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to check whether development of depression as a side effect of interferon alpha treatment in chronic carriers of hepatitis C can be prevented by omega-3 fatty acids.

Detailed Description
-----------------
Omega-3 fatty acids are known as an alternative treatment for different conditions, including mental conditions, such as depression. We assume that combining omega-3 with the treatment by interferon alpha may prevent the development of depression, which is quite a common side effect of the interferon alpha.

Official Title
-----------------
Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: omega-3 fatty acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic carriers of hepatitis C who start a course of interferon alpha treatment, and are treated in the liver clinic of Bnai Zion hospital. Exclusion Criteria: Disagreement to participation in trial. Diagnosed and active mental illness. Encephalopathic patients. Patients with limited ability to understand the questionnaires or the informed consent process.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: omega-3 fatty acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly |  |  | 
| with the BDI questionnaire which estimates the level of depression of the patient and |  |  | 
| the SF36 questionnaire which provides information about the overall influence of a disease upon a patient's daily life and mental status. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of: |  |  | 
| albumin |  |  | 
| bilirubin |  |  | 
| ALT |  |  | 
| CRP |  |  | 
| hemoglobin |  |  | 
| WBC |  |  | 
| platelets |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interferon alpha, depression, omega 3
Study of CEP-701 in Treatment of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.

Detailed Description
-----------------
A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.

Official Title
-----------------
An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: CEP-701


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 yrs of age diagnosis of adenocarcinoma of the prostate no detectable metastatic disease as assessed by bone and CT scans has increasing serum PSA concentrations life expectancy of at least 3 months ECOG of 0 or 1 has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period Exclusion Criteria: has asymptomatic disease has active GI ulceration or bleeding has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit bilirubin >2x ULN or ALT or AST >2xULN or serum creatinine >1.5mg/dL hemoglobin <9g/dL or platelets below 100,000/uL or ANC below 1500/uL receiving treatment for HIV with protease inhibitors has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin has used investigational drug with previous one month

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CEP-701|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
-----------------
prostate cancer, prostate specific antigen, PSA
Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

Official Title
-----------------
Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: perflutren lipid microsphere


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Measurable focal neurological deficit (National Institutes of Health Stroke Scale [NIHSS] score > 4 points) tPA eligible Occlusion of the middle cerebral artery Exclusion Criteria: Right to left cardiac shunt Uncontrolled hypertension Absent temporal windows

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: perflutren lipid microsphere|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic intracranial hemorrhage |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete recanalization of the occluded artery (TIBI 4-5) |  | End of treatment | 
| NIHSS score of 0-2 |  | 24 hours | 
| Favorable outcome (modified Rankin Scale or NIHSS 0-1) |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren