linjc16/ctgov huggingface dataset:
IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex

Study Overview
=================
Brief Summary
-----------------
This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating health care practitioners, the patient registry program is an observational study monitoring the long-term safety of patients treated with Increlex® (mecasermin [rDNA origin] injection). The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the safety and efficacy of Increlex replacement therapy in children with growth failure.

Detailed Description
-----------------
The data collected for a patient will be those that exist in the patient's medical record as part of standard medical care. No additional patient procedures or activities are mandated by this study. The specific data to be collected at each visit and the schedule of data collection are listed in a schedule of assessments. The collection of safety events is considered essential to the Registry. The website will provide the opportunity to report the occurrence of targeted adverse events (AEs), other important events considered to be related to Increlex administration and serious adverse events (SAEs).

Official Title
-----------------
Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex

Conditions
-----------------
Primary Insulin-like Growth Factor-1 Deficiency

Intervention / Treatment
-----------------
* Biological: mecasermin [rDNA origin] injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate. Patients receiving Increlex® by a qualified practitioner may be enrolled Exclusion Criteria:
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Increlex patients<br>Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex. | Biological: mecasermin [rDNA origin] injection<br>* As prescribed by the physician.<br>* Other names: Increlex®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure |  | periodically assessed over the course of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth Hormone (GH) Insensitivity Syndrome, Insulin-like Growth Factor Deficiency (IGFD), Short Stature, Insulin-like Growth Factor (IGF-1), Growth
Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

Study Overview
=================
Brief Summary
-----------------
Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered breathing and chronic tonsillitis. Up to half of children having this procedure experience a perioperative respiratory adverse event. We tried to determine whether tulobuterol patch (transdermal bronchodilator) premedication decreases the risk of perioperative respiratory adverse events in children undergoing anesthesia for tonsillectomy.

Official Title
-----------------
Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies

Conditions
-----------------
Tonsillar Hypertrophy

Intervention / Treatment
-----------------
* Drug: Tulobuterol Hydrochloride
* Drug: Placebo transdermal patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients undergoing tonsillectomy Exclusion Criteria: recent upper respiratory infection (2weeks) Allergy to tulobuterol patch Patients receiving catecholamine (epinephrine, isoproterenol) hyperthyroidism hypertension cardiac disease Diabetes melitus atopic dermatitis Asthma

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tulobuterol patch<br> | Drug: Tulobuterol Hydrochloride<br>* The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo transdermal patch<br>* The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative respiratory complication | laryngospasm, bronchospasm, oxygen desaturation, airway obstruction, severe coughing, postoperative stridor | from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours |
Clinical Comparison of Electrocardiograms Collected Using an Ambulatory Holter

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to compare electrocardiograms using ambulatory holter monitor with dry electrodes in a harness versus using an ambulatory holter with standard sticky electrodes (Red Dot) on monitored patients within the hospital. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived.

Conditions
-----------------
Electrocardiography

Intervention / Treatment
-----------------
* Device: Electrocardiogram holter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient within the hospital either for procedure or for admission Exclusion Criteria: Patients who cannot wear a Holter monitor Patients undergoing an MRI or have other contraindications for wearing an ambulatory Holter monitor.

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 with Electrocardiograms<br>Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned. | Device: Electrocardiogram holter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrythmia | quality of data obtained between harness and holter. Subjective evaluation: -Quality of the data will be rated on a 0 - 10 scale with 0 being unreadable and 10 being excellent | 15 minutes |
Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients

Study Overview
=================
Brief Summary
-----------------
The Capnostream 20p monitor by Medtronic is FDA-cleared and consists of a monitor which measures real-time respiratory status based on respiratory rate, pulse rate, pulse oximetry (SpO2) and end tidal carbon dioxide (etCO2) with a disposable nasal canula. The integrated pulmonary index (IPI) is an algorithm driven parameter derived from non-invasive etCO2, respiratory rate, pulse rate and SpO2. Fuzzy logic is used to produce a value from 1-10 with 4 and under requiring intervention and 8-10 representing the normal range. The purpose of this observational study is to determine if the IPI is associated with complications in the immediate postoperative period. The study will enroll approximately 600 patients at 2 centers. Clinicians will be blinded to the IPI therefore this device will not be used to guide care in any way.

Official Title
-----------------
Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Device: Capnostream20p


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Planned to undergo general anesthesia for surgery Exclusion Criteria: Pregnant Inability to consent Mechanically ventilated prior to 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enrolled patients<br>Surgical patients meeting enrollment criteria | Device: Capnostream20p<br>* Observational study of patients connected to the Capnostream20p monitor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Respiratory Event | Respiratory complications occurring after surgery | Up to 2 hours |
Robot-Assisted or Laparoscopic Resection for Gastric Subepithelial Tumor With Hand-Sewn Repair, a Case Series

Study Overview
=================
Brief Summary
-----------------
There are a lot of surgical techniques in minimally-invasive surgery to remove gastric subepithelium tumor. Surgical approach depend on location and size of tumor. Usefully used Endostapler to cut stomach include lesion. For tumors in difficult locations some surgeons prefer laparoscopic and endoscopic cooperation or use the intragastric port technique to identify and remove the mass. But in complex procedures, gastotomy and hand sawn to identify and remove gastric subepithelium tumor is a simple technique and easy to apply. This study demonstrates the safety and effectiveness of this technique.

Detailed Description
-----------------
: A retrospective chart review was made of all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection at Ramathibodi Hospital during 2012-2018. Surgical outcomes and complication of gastotomy and hand-sewn repair were analyzed.

Official Title
-----------------
Robot-Assisted or Laparoscopic Resection for Gastric Subepithelial Tumor With Hand-Sewn Repair, a Case Series

Conditions
-----------------
Gastric Mass

Intervention / Treatment
-----------------
* Procedure: Hand-Sewn Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection at Ramathibodi Hospital during 2012-2018. Exclusion Criteria: conversion to open surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hand-Sewn Repair|gastotomy to identify and remove gastric subepithelium tumor and hand sawn repair|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative complication | anastomosis leak | 7 day | 
| Post operative compliction | wound infection | 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcome | Complete remove mass with out rupture | 7 day |
Sleep Enhancement Training Study for Novice Shiftworkers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in shiftwork-naive new nurse graduates.

Official Title
-----------------
Sleep Enhancement Training Study for Novice Shiftworkers

Conditions
-----------------
Shift-Work Sleep Disorder

Intervention / Treatment
-----------------
* Behavioral: Sleep Enhancement Training System
* Behavioral: NIOSH shiftwork booklet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking nurses scheduled to work at least 2 consecutive night shifts per week in the next 2 months Exclusion Criteria: > 6 months experience working night-shift current diagnosis of sleep disorder or affective illness

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NIOSH shiftwork booklet<br> | Behavioral: NIOSH shiftwork booklet<br>* weekly readings about coping with shiftwork<br>|
| Experimental: Sleep Enhancement Training System<br> | Behavioral: Sleep Enhancement Training System<br>* 4 week program of readings and relaxation programs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| actigraphy measures of sleep |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective measures of sleep and well-being |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shift-work, sleep, nurse, relaxation
Prospective Health Assessment of Cataract Patients' Ocular Surface

Study Overview
=================
Brief Summary
-----------------
This study will determine the incidence and severity of dry eye in patients undergoing cataract surgery as determined by grade on the International Task Force (ITF) scale.

Official Title
-----------------
Cataract and Dry Eye The PHACO Study (Prospective Health Assessment of Cataract Patients' Ocular Surface)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be at least 55 years old. Patients must be scheduled to undergo cataract surgery. Exclusion Criteria: No previous intraocular surgery in the previous 3 months in either eye. No previous Corneal laser vision correction in either eye within the last one year. No previous lid surgery within the past 3 months. Patients may not have used topical antibiotics, topical NSAIDs or topical steroid in either eye in the past month. Patients are not eligible if they have recently been started on Restasis solely as a perioperative treatment regimen. Patients presently using Restasis in either eye will not undergo any of the study testing but a questionnaire should be completed for these patients regarding use of these medications.

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| Severity of dry eye in patients undergoing cataract surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dry eye as evaluated by grade on ITF (International Task Force) level. |  | One study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBUT (tear break-up time), OSDI (Ocular surface disease index), corneal staining with fluorescein, conjunctival staining with lissamine, Schirmer's, and a patient questionnaire. These are all standard operations of care. |  | One study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, incidence and severity, cataract surgery
COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort

Study Overview
=================
Brief Summary
-----------------
The Radiologically Isolated Syndrome (RIS) is defined as incidental Magnetic Resonance Imaging (MRI) abnormalities fulfil the criteria for dissemination in space, suggestive of multiple sclerosis. Nowadays, mandatory vaccination in patients with multiple sclerosis (MS) is widely recommended. Regarding COVID19, the absence of specific warnings led to the proposal of vaccination in patients with inflammatory diseases of the central nervous system. We aimed to evaluate if COVID19 vaccination or infection increased the risk of clinical conversion to multiple sclerosis or evidence of disease activity (EDA) in a cohort of RIS subjects.

Official Title
-----------------
Impact of COVID 19 Vaccination or Infection on Disease Activity in Radiologically Isolated Syndrome Cohort: the VaxiRIS Study

Conditions
-----------------
Multiple Sclerosis, COVID-19

Intervention / Treatment
-----------------
* Other: NO intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients belong to the RISC cohort; totally vaccinated ou partially vaccinated patient vaccination status known Exclusion Criteria: presented a first clinical event before the COVID19 vaccination

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 |
| --- | --- |
| complete vaccination<br>Complete vaccination was defined as administering two doses of mRNA or AstraZeneca vaccine, administration of one dose of Jansen vaccine, or administration of one dose of any vaccine in patients with a history of COVID19 infection. | Other: NO intervention<br>* no intervention<br>|
| incomplete vaccination<br>Other cases were defined as incomplete or absent vaccination. | Other: NO intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID 19 vaccination and clinical conversion to multiple sclerosis risk | number of patients with a conversion to MS in each group | year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID 19 vaccination and evidence disease activity risk | number of patients with an evidence disease activity in each group | year 2 | 
| multiple sclerosis evolution and history of COVID 19 infection | number of patients with a conversion to MS in each group | year 2 |
Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area

Study Overview
=================
Brief Summary
-----------------
This trials examines the feasibility of GRID-therapy combined with biologically imaging based IMRT (BG-IMRT). Within this trial, the strict toxicity parameters of primary treatment of head and neck tumors are used. The GRID and BG-IMRT technique might be possible to reduce the total radiation dose 2 to 3 times.

Official Title
-----------------
Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area

Conditions
-----------------
Head and Neck Tumors

Intervention / Treatment
-----------------
* Radiation: GRID radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent or new head or neck tumor 18 years or older

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>GRID-radiotherapy followed by biological imaging guided IMRT | Radiation: GRID radiotherapy<br>* GRID-radiotherapy followed by biological imaging guided IMRT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose. |  | 3 months after end of treatment | 
| Superior local control with Grid 18F-FDG-PET BG-IMRT using previously obtained maximum tolerated dose. |  | 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrent head and neck tumors