linjc16/ctgov huggingface dataset:
Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in the treatment of moderate to severe Dry Eye Syndrome.

Official Title
-----------------
Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Device: T2762
* Device: Optive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent. Male or female aged ≥ 18 years old. Diagnosis of moderate to severe dry eye syndrome Exclusion Criteria: Pregnancy, lactation. Childbearing potential woman who is not using a reliable method of contraception and is not surgically sterilised. Inability of patient to understand the study procedures and thus inability to give informed consent. Non-compliant patient Participation in another clinical study at the same time as the present study. Participation to the present study during the exclusion period of another clinical study. Already included once in this study. Ward of court. Patient not covered by government health care scheme

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: T2762<br>One drop of T2762 in each eye 3 to 6 times daily | Device: T2762<br>* One drop in each eye 3 to 6 times daily<br>|
| Active Comparator: Optive<br>One drop of Optive in each eye 3 to 6 times daily | Device: Optive<br>* One drop in each eye 3 to 6 times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the symptomatology evaluation on a Visual Analogic Scale |  | Day 28 |
Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Non-adherence to the treatment regimen is a common problem associated with injectable drugs (e.g. Betaferon) that are used in multiple sclerosis patients. Certain patients omit single injections or even totally discontinue therapy that normally should be long-term. It is therefore crucial to identify the factors which have the most significant effect on regularity of administration of Betaferon and the risk of premature discontinuation of treatment in order to undertake appropriate preventive measures. This study is conducted in routine practice setting and aims to identify those risks. Pre-defined risk factors associated with technical aspects of the treatment, support provided to the patient, stage of the disease and possible adverse effects of the medication are checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of the prescribed medication (Betaferon) is carried out by the study nurse.

Official Title
-----------------
Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaseron, BAY86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsing-remitting multiple sclerosis Age >/= 18 years Start of treatment with Betaferon not earlier than 60 days prior to inclusion Exclusion Criteria: Synonymous with contraindications to Betaferon

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under the routine practice setting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of discontinuation of Betaferon |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of missed doses of Betaferon |  | 24 months | 
| Depression score as measured by CES-D questionnaire |  | 24 months | 
| Neurological disability score as measured by EDSS scale |  | 24 months | 
| Overall tolerability of treatment as measured by rate of adverse events |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple sclerosis, Interferon beta-1b, Compliance to treatment, Premature treatment discontinuation
Advance Care Planning GuideTailored for Primary Care Patients

Study Overview
=================
Brief Summary
-----------------
this project seeks to: validate results of ACP framework pilot study in a larger randomized controlled trial (rates and quality of ACP documentation) prior to using participatory design to develop an Electronic Health Record (EHR)-tethered patient portal delivered ACP communication guide, tailored for use in busy primary care settings, incorporating patients, caregivers, and primary care providers

Official Title
-----------------
Validation of a Novel EHR Patient Portal Advance Care Planning Delivery System

Conditions
-----------------
Advance Care Planning, Chronic Disease, Communication Research

Intervention / Treatment
-----------------
* Other: Patient Centered Medical Home Based Electronic Framework for Advance Care Planning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must have an activated patient portal account over 50 years of age scheduled for a well visit appointment or chronic visit follow up English speaking Exclusion Criteria: under 50 inactive patient portal account

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>The investigators seek to conduct a pragmatic trial including 2 sister clinical sites to test an innovation using a patient portal framework for Advance Care Planning. The intervention site implemented the intervention (secure patient portal delivered pre-visit planning framework for Advance Care Planning communication). The presence of ACP and the quality of documentation will be assessed through post-intervention chart review. Practice level enrollment was sought for the trial, and the framework will be delivered to all patients during a period of roll out. About 250 patients will receive the intervention. | Other: Patient Centered Medical Home Based Electronic Framework for Advance Care Planning<br>* The intervention tested a pre-visit ACP workflow centered around a framework sent via secure Electronic Health Record (EHR)-linked patient portal in a real world clinical setting. The primary objectives were to determine its impact on frequency and quality of ACP documentation.<br>* Other names: Secure patient portal delivered pre-visit planning for advance care planning;|
| control<br>The control site delivered usual care during the same period of roll out. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Advance Care Planning (ACP) documentation as noted in description | Presence of Electronic Health Record problem list based ACP documentation or presence of Electronic Health Record scanned completed Advance Directive document | 4 weeks post-intervention |
Timing of Morning Rounds for Postpartum Hospitalized Women

Study Overview
=================
Brief Summary
-----------------
In postpartum hospitalized women, does delayed morning rounding improve patient satisfaction?

Detailed Description
-----------------
OBJECTIVE To investigate the timing of physician rounds on patient satisfaction STUDY DESIGN Randomized, controlled, quality improvement trial OUTCOMES Primary: score on Hospital Consumer Assessment of Healthcare Provers and Systems (HCAPS) survey Secondary: score on Edinburgh Postnatal Depression Scale

Official Title
-----------------
Timing of Morning Rounds for Postpartum Hospitalized Women: A Randomized Controlled Quality Improvement Trial

Conditions
-----------------
Physician Rounds, Postpartum

Intervention / Treatment
-----------------
* Behavioral: Delayed rounds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Delivered between 0600 and 0000 Admitted to Memorial Hermann postpartum unit Patient managed by the University of Texas Physicians Group and/or obstetrics-gynecology residents Exclusion Criteria: - None
Sexes Eligible for Study
-----------------
Female

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Postpartum patients that receive physician rounding at current time | |
| Experimental: Delayed rounding<br>Postpartum patients that receive physician rounding at a delayed time | Behavioral: Delayed rounds<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score on Hospital Consumer Assessment of Healthcare Provers and Systems (HCAPS) survey | Patient will be give a modified version of the validated HCAPS survey at discharge from the hospital to assess patient satisfaction and the scores will be compared between the 2 groups. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score on Edinburgh Postnatal Depression Scale | Patient will be given this questionnaire at discharge from the hospital to assess risk for postpartum depression and the scores will be compared between the 2 groups. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
timing
Cancer Control Following Polypectomy

Study Overview
=================
Brief Summary
-----------------
This study evaluates strategies for the surveillance of post-polypectomy patients for the control of bladder cancer

Official Title
-----------------
Cancer Control Following Polypectomy

Conditions
-----------------
Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referral for colonoscopy or referral for proctoscopy or for a complete colonoscopy after a proctoscopy or flexible sigmoidoscopy Exclusion Criteria: prior history of colon cancer, unrelated polypectomy, inflammatory bowel disease, family history of familial polyposis
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 |
| --- | --- |
| A<br>Barium enema and colonoscopy at one and three years after entry. | |
| B<br>Barium enema and colonoscopy at three years only after entry. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate strategies for the surveillance of post-polypectomy patients |  | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
large bowel cancer, polyps, colorectal cancer
Etiology of Motor Developmental Delay in Children

Study Overview
=================
Brief Summary
-----------------
This study aims to identify the etiology of children with motor developmental delay, in association with the results of magnetic resonance imaging and genetic analysis.

Detailed Description
-----------------
Results of other available assessments including Gross Motor Function Measurements and Bayley Scale of Infant Development, second edition, modified Ashworth Scale, IQ score and developmental language assessments are to be collected.

Official Title
-----------------
Etiology of Motor Developmental Delay in Children

Conditions
-----------------
Delayed;Development;Physical, Delayed; Development, Intellectual

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of motor developmental delay available results of functional assessments at ages older than 18 months Functional measures include either GMFM or BSID_II Exclusion Criteria: single domain delay other than motor (e.g., speech delay)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| developmental delay<br>Children who visited tertiary rehabilitation clinic for delayed motor development were all included. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Gross Motor Function Classification System from baseline at 6 months | To avoid variation in each individual the exact date of evaluation for every outcome is included to estimate the exact time from birth | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain MRI findings | the first brain MRI taken after the event causative to developmental delay, read by radiology specialists | From the date of the first documented developmental delay until the date of last documentation or date of death from any cause, whichever came first, assessed up to 100 months | 
| Mental quotient | BSID-II mental month estimated/actual age in month times 100 | From the date of the first documented developmental delay until the date of last documentation or date of death from any cause, whichever came first, assessed up to 100 months |
ALTERRA Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting

Detailed Description
-----------------
This is a single arm, prospective, multicenter post-approval study.

Official Title
-----------------
Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent

Conditions
-----------------
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation, RVOT Anomaly

Intervention / Treatment
-----------------
* Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Native or surgically-repaired RVOT with severe PR Clinically indicated for pulmonary valve replacement Planned for treatment with the Alterra prestent and SAPIEN 3 THV Exclusion Criteria: Inability to tolerate an anticoagulation/antiplatelet regimen Active bacterial endocarditis or other active infections
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TPVR<br>Transcatheter Pulmonary Valve Replacement | Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System<br>* The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular right ventricular outflow tracts (RVOTs) and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 transcatheter heart valve (THV).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Device Success | Acute Device Success, defined as a non-hierarchical composite of: Single Alterra deployed in the desired location Single THV implanted in the desired location within Alterra Right ventricle-pulmonary artery peak-to-peak gradient < 35 mmHg post-THV implantation Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation | 24 hours post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alterra prestent, SAPIEN 3, Pulmonic Delivery System, Transcatheter pulmonary valve replacement, Transcatheter pulmonary valve implantation
Conservation of Red Cell Mass , Oxygen Supply and Demand in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Fifty patients will be enrolled into the study. The purpose of the study is to investigate the relevance of Hct levels in determining need for transfusion during operations employing bypass as well as to test the hypothesis that, while HCt levels may decrease during surgery , red blood cell mass and tissue oxygenation remain fairly constant.

Detailed Description
-----------------
Fifty adults( male or female-nonpregnant) whose weight is between 55-85 kg and are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass for CABG or primary valve repair or replacement will be eligible. Patients with any history of abnormal bleeding disorders, urgent or emergent need for surgery, and combination surgeries will be excluded. Blood volume analysis will be performed with the DAXOR Blood Volume Analyzer BVA-100 System and the Volumex HSA I-131 radiopharmaceutical for use for determining circulating volume. Multiple timed sample points will be obtained. The DAXOR blood volume analyzer will batch samples and with input of patients height, weight, gender, time of draw, and corresponding Hct, calculate circulating total blood volume. We hypothesize that Total red cell mass is relatively well conserved( <20% decrease) during and immediately after surgery as long as major bleeding does not occur. We hypothesize that decrease in Hct during surgery are related to changes in circulating plasma volume. Total red cell O2 carrying capacity and O2 economics will be measured and it is also hypothesized that lowered Hct values, even as low as 15%, do not independently signal a tissue or whole body O2 deficit.

Official Title
-----------------
Conservation of Red Cell Mass, Oxygen Supply and Demand in Cardiac Surgery

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled to undergo elective Cabg or primary repair/replacement on bypass pump. Age 18 yrs or older Male or non pregnant female Weight between 55-85 kg. Exclusion Criteria: Any known bleeding risks; Urgent or emergent surgery; Combined aortic and major vascular surgery; Pregnant women If participating in another study within last 90 days.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Transfusion regulation
Alternate Day Buprenorphine Administration, Phase IX - 14

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if four times a subjects' daily maintenance dose will hold for 120 hours without changes in agonist and antagonist effects.

Official Title
-----------------
Alternate Day Buprenorphine Administration, Phase IX

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 51 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Opioid withdrawal |  |  | 
| Opioid agonist effects |  |  | 
| Dose identification |  |  | 
| Pupil diameter |  |  |