linjc16/ctgov huggingface dataset:
Early Range of Motion Following Arthroscopic Rotator Cuff Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether there is a difference in the quality of life, ability to return to functioning (back to everyday life), the amount of experienced pain in patients who immediately move their shoulder versus patient who delay moving their shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a difference in the healing rates between these two groups.

Official Title
-----------------
The Effect of Early Range of Motion on Clinical Outcomes, Patient Satisfaction, and Cuff Integrity Following Arthroscopic Rotator Cuff Repair. A Prospective Randomized Study.

Conditions
-----------------
Rotator Cuff Disease

Intervention / Treatment
-----------------
* Other: Early motion
* Other: Standard motion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are between 18 years and 70 years of age full thickness rotator cuff tear on ultrasound and MRI failed conservative management Exclusion Criteria: concomitant pathology including massive rotator cuff tears that extend into the subscapularis or the teres minor and all co-existing labral pathology history of neuromuscular or degenerative disease

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Early motion<br> | Other: Early motion<br>* Early referral to physical therapy for range of motion (2 days post)<br>|
| Other: Standard motion<br> | Other: Standard motion<br>* Standard referral to physical therapy for range of motion (4 weeks post)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Rotator Cuff Index (WORC) |  | 6 month post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rotator cuff, rehabilitation, range of motion
Eliquis Regulatory Post Marketing Surveillance (rPMS)

Study Overview
=================
Brief Summary
-----------------
The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the safety and effectiveness information about Eliquis in general practice

Official Title
-----------------
Eliquis (Apixaban) Regulatory Post Marketing Surveillance in Clinical Practice for Venous Thromboembolism (VTE) Prevention

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: Apixaban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed data release Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty Exclusion Criteria: Being treated for an indication not approved for the use of Eliquis® in Korea Is contraindicated for the use of Eliquis® as described in the Korean label

Ages Eligible for Study
-----------------
Minimum Age: 19 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 with risk of VTE<br>Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release | Drug: Apixaban<br> <br> * Other names: Eliquis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) and serious AEs |  | Up to 30 days after last study drug dose |
PREMIUM, Observational Study

Study Overview
=================
Brief Summary
-----------------
PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective cohort study and with independent investigators. The purpose is to compare PFS in real life with PFS clinical trials and to determine factors impacting efficacy and compliance to cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.

Detailed Description
-----------------
Retrospective studies have shown the influence of some factors on the efficacy of treatment with cetuximab (nicotine, magnesium etc..). No randomized study has compared the mode of administration of weekly and biweekly cetuximab. What are the factors influencing patient compliance? Adverse events, the relation between doctor and patient. PREMIUM will attempt to explore and assess the variables associated with efficacy and compliance to treatment and study practices in France for clinical management.

Official Title
-----------------
Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer

Conditions
-----------------
First Line WT KRAS mCRC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients > 18 years old diagnosed with mCRC patients naïve for CT excepted for adjuvant setting or trated max 2 cycles CT in first line mCRC with or without cetuximab all patients receiving cetuximab in first line treatment associated or not with CT patients relapsed < 6 months after an adjuvant therapy Exclusion Criteria: patients participating to clinical trials

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 |
| --- | --- |
| First line WT KRAS mCRC<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR at 1 year (ITT and subgroup analysis) |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cetuximab, nicotine, magnesium
A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients

Study Overview
=================
Brief Summary
-----------------
A long term observational study in sickle cell disease will enhance the understanding of the disease patterns, current transfusion practices, treatments and outcomes in sickle cell disease.

Official Title
-----------------
A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease Patients

Conditions
-----------------
Sickle Cell Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients with HbSS, HbS/beta-thalassemia and HbSC Age > 2 years old. Written informed consent by the patient or legal guardians, and pediatric assent where indicated. Exclusion Criteria: Patients with Sickle Cell trait (HbAS) are not eligible for the study Patient or legal guardians unable or unwilling to give consent, or pediatric assent where indicated.

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| No treatment<br>Patients aged 2 to less than 12 | |
| No treatment patients aged 12 to less than 18<br>Patients aged 12 to less than 18 | |
| No treatment Patients greater than 18 years<br>patients greater than 18 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document current treatment patterns, natural history and outcomes in patients with sickle cell disease |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection | Collection of the following data:Current therapies used for the treatment of SCD Current transfusion practices, Difference in treatments between pediatric and adult patients, Use of chelation therapies, Frequency and types of crises including Frequency of hospitalizations, Incidence of end organ damage (caridac, renal, pulmonary,liver), Quality of life assessed by PedsQL TM Pediatric Quality of Life Inventory for patients 2- <18 years old and SF-36® Health Survey for patients 18 years old and older | up to 5 years | 
| Measure Sickle cell crisis and hospitalizations | To evaluate whether patients on regular transfusion protocol have fewer crisis and hospitalizations | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sickle cell disease, iron over load
Cardiac Output Monitoring in Critically Ill Patient Undergoing Intubation

Study Overview
=================
Brief Summary
-----------------
Collect hemodynamic data, such as heart rate, blood pressure, and cardiac output to help understand the effect of pre and post intubation.

Detailed Description
-----------------
A Non-invasive physiologic monitor, Non-Invasive Cardiac Output Monitor (NICOM), will be utilized for this study. This is the first completely non-invasive hemodynamic device approved by the FDA and available for clinical use produced by Cheetah Medical and utilizes Bioreactance (Tel Aviv, Israel). It performs accurately and with precision in all patient's studied and requires only 4 adhesive gel pads on the skin to measure continuous cardiac output and to calculate Stroke Volume Variation (SVV). Other physiologic data (blood pressure, total peripheral resistance (TPR), stroke volume (SV), and heart rate) will be analyzed in real time and recorded on the device and downloaded into an excel database. The data on the device will be downloaded weekly onto the excel database and deleted on the device. The Study personnel will be trained in its use prior to study initiation.

Official Title
-----------------
Non-invasive Cardiac Output Monitoring (NICOM) in Critically Ill Patient Undergoing Endotracheal Intubation in ICU

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Device: NICOM (Non invasive cardiac output monitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring endotracheal intubation in the intensive care unit. Exclusion Criteria: Patients previously enrolled in this study. Patients requiring intubation outside of the intensive care unit.

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 |
| --- | --- |
| Patients undergoing intubation<br>Adhesive gel pads will be placed on patient to measure continuous cardiac output and to calculate stroke volume variation. Other physiologic data will be analyzed in real time using the NICOM (Non invasive cardiac output monitor) device. | Device: NICOM (Non invasive cardiac output monitor)<br>* Non invasive hemodynamic device utilizing bioreactance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac output in critically ill patients undergoing endotracheal intubation | change in cardiac output as measured in liters/minute | 10 minutes pre intubation,10 minutes post intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intubation
Disaster Preparedness Among Families Caring for Children With Diabetes

Study Overview
=================
Brief Summary
-----------------
The primary aim of the survey is to ascertain the emergency preparedness among our families with diabetes mellitus and to obtain a percentage of unprepared to the ones who are prepared. The secondary aim is to demonstrate the relationship between disaster preparedness and factors like socio-economic status, parent's marital status, ethnicity and those who had prior experience of a disaster to those who have not experienced a disaster.

Detailed Description
-----------------
This is a cross-sectional study. The subjects are the parent/parents/legal guardian, who will be coming to the clinic for their routine appointment for diabetes management. During the time in which the subject is waiting for the doctor or after their check-up, a research team member will approach the family and ask for their permission to administer the survey. The survey consists of a series of questions designed to ascertain the awareness towards emergency preparedness among families. After they have completed the questionnaire they would be given and/or mailed handouts to enhance their awareness towards disaster preparedness. Potential Benefits: This study will help to increase awareness regarding disaster preparedness among the surveyed families. Subjects and families will gain valuable information about caring for diabetes in the event of a disaster. The potential benefit to the society is that through this study we can ascertain the primary caregiver's awareness of disaster preparedness in regard to a family member with a chronic illness. We will suggest measures to improve their competency towards dealing with disasters. We will be providing educational literature to the primary care givers in the form of handouts at the end of the survey.

Official Title
-----------------
Pre-hurricane Disaster Preparedness: A Survey in Pediatric Type 1 Diabetes

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects include families of children with type 1 and type 2 diabetes mellitus attending the Diabetes/ Endocrine Clinic at Texas Children Hospital. Exclusion Criteria: Subjects excluded are families of Children with illnesses other than type 1 and type 2 diabetes mellitus attending the Diabetes/ Endocrine Clinic at Texas Children Hospital.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| The primary aim is to ascertain the emergency preparedness among our families with diabetes mellitus and to obtain a percentage of unprepared to the ones who are prepared. |  | September 2008 |
Effect of Exercise on Metabolic Health

Study Overview
=================
Brief Summary
-----------------
One of the main objectives of this study will be to assess potential differences in important risk factors associated with Metabolic Syndrome in overweight adults who do not participate in a regular exercise program compared with overweight individuals who do exercise regularly. In addition, we will determine the effects of a single, modest session of exercise on the body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults vs. obese adults who live a physically active lifestyle. Our study focuses on identifying mechanisms responsible for improved insulin action related to regular exercise and to provide novel targets for preventing and treating type 2 diabetes.

Official Title
-----------------
Effect of Exercise on Novel Insulin Signaling Events in Human Muscle

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index [BMI] = 30-45 kg/m2, fasting blood glucose concentration must be < or = to125 mg/dl, Hematocrit > or = to 34%, all women must be pre-menopausal Exclusion Criteria: pregnancy or actively breastfeeding, weight instability (> or = to ± 5 lbs in the past month) evidence of cardiovascular or metabolic diseases, taking medications know to affect lipid and/or glucose metabolism.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br> | Other: Exercise<br>* single session of exercise<br>|
| No Intervention: Sedentary Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity | A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity. Insulin sensitivity will be calculated from the clamp data as the rate of glucose infusion during the steady state period of the clamp - divided by the plasma insulin concentration at this time (units: mg/uU/ml/min) | 2-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Metabolic Rate |  | 20-30 min | 
| Meal Tolerance Test |  | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin Sensitivity, Exercise, Metabolism
Emergence Agitation in Pediatric Strabismus Surgery

Study Overview
=================
Brief Summary
-----------------
This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.

Official Title
-----------------
The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery

Conditions
-----------------
Emergence Agitation

Intervention / Treatment
-----------------
* Drug: fentanyl group
* Drug: remifentanil group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective subumbilical surgery, physical status was American Society of Anesthesiologists (ASA) class 1 or 2 Exclusion Criteria: history of airway problem, upper respiratory tract infection within 2 weeks, developmental delay, neurological or psychological disease, history of allergy to the drugs in our protocol were excluded in this study.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 8 Years

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fentanyl<br>A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction | Drug: fentanyl group<br>* fentanyl 2 μg/kg<br>|
| Active Comparator: remifentanil<br>Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery | Drug: remifentanil group<br>* remifentanil 0.2 μg/kg/min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative agitation | 0=none; 1=occur | 5 minutes in the recovery room | 
| incidence of postoperative agitation | 0=none; 1=occur | 30 minutes in the recovery room | 
| severity of postoperative agitation | Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented) | 5 minutes in the recovery room | 
| severity of postoperative agitation | Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented) | 30 minutes in the recovery room | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergence Agitation, fentanyl, remifentanil, children
A Trial of Skin Care Protocols for Facial Resurfacing

Study Overview
=================
Brief Summary
-----------------
The aims of the Skin Product Assessment Research study were to (1) develop an infrastructure and process for industry-sponsored, Plastic Surgery Educational Foundation (PSEF) research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System (ODNS) and conventional therapy as treatment adjuncts in ablative facial resurfacing.

Official Title
-----------------
A Double-Blind, Randomized, Controlled Trial to Assess the Effects of the Obagi Nu-Derm System on Re-Epithelialization After Chemical Peel or Ablative Laser Resurfacing.

Conditions
-----------------
Facial Photo Damage, Periocular Fine Wrinkles, Perioral Fine Wrinkles

Intervention / Treatment
-----------------
* Other: Obagi New-Derm System
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with moderate to severe photo damage and rhytids, undergoing full or partial face resurfacing with chemical peel or ablative laser. Fitzpatrick I-IV skin types Exclusion Criteria: patients unable to complete the regimen or who had used topical prescription steroids, retinoids, depigmentation products or other products containing hydroquinone and polyhydroxy acids within 8 weeks of enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Obagi Nu-Derm System (ONDS)<br> | Other: Obagi New-Derm System<br> <br> |
| Active Comparator: Standard of Care<br> | Other: Standard of Care<br> <br> |

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
-----------------
Moderate to severe facial photo damage, Periocular or perioral fine wrinkles