linjc16/ctgov huggingface dataset:
School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if using school-based telemedicine for diabetes support and education in students with type 1 diabetes in grades K-8 can lead to improvement in control of diabetes and improved satisfaction of all caregivers.

Detailed Description
-----------------
Subjects, ages 5 to 14 years (grades kindergarten through eighth) were randomized to usual care (18 students; 13 schools) or intervention (23 students; 12 schools). Usual care included medical visits every 3 months and communication between school nurse and diabetes team as needed by phone. The intervention group received usual care plus a telemedicine unit in the school nurse office to videoconference between the school nurse, child, and diabetes team every month. Hemoglobin A1c and pediatric quality of life were measured every 3 months for 1 year. Analyses used multilevel modeling.

Official Title
-----------------
School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: telemedicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes under care of Joslin Diabetes Center in Syracuse NY Grade K-8 Age 5-14 at time of enrollment Consent of student, parent and school

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 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 |
| --- | --- |
| No Intervention: 1<br>Usual care of type 1 diabetes at the diabetes center | |
| Experimental: 2<br>Usual care at the diabetes center supplemented by a telemedicine intervention in the school involving school personnel, the child with diabetes and at least 1 parent of the child. The diabetes center NP conducts videovisits with the school nurse, patient (child) +/- parent monthly. | Other: telemedicine<br>* School telemedicine intervention involving school personnel, the child with type 1 diabetes and at least 1 parent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin A1c |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose levels, hypoglycemia, quality of life, satisfaction |  | 1 year |
Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Triptolide has been approve effective in animal model.

Detailed Description
-----------------
Randomized

Official Title
-----------------
Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Conditions
-----------------
Polycystic Kidney

Intervention / Treatment
-----------------
* Drug: tripterygium wilfordii
* Drug: Emodin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically established ADPKD eGFR>30ml/min. Chinese nationality Exclusion Criteria: Uncontrolled infections Non-ADPKD complications

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: emodin<br> | Drug: Emodin<br>* 100mg/d<br>* Other names: Frangula emodin,Frangulic acid;|
| Experimental: Triptolide Woldifii<br>TW60mg/d | Drug: tripterygium wilfordii<br>* TW，60mg/d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI calculated kidney volume, eGFR |  | Every 3-6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-stage kidney disease (ESRD) |  | every 2months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polycystic kidney disease, tripterygium wilfordii
Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

Study Overview
=================
Brief Summary
-----------------
Buprenorphine is an important alternative to methadone in the maintenance treatment of heroin addiction. Transfer from methadone to buprenorphine requires a reduction of daily methadone dosage below 30 mg to avoid withdrawal after the first buprenorphine intake. The study hypothesis states that the transfer from a daily methadone dosage between 60 mg and 100 mg to buprenorphine can be carried out without withdrawal using buprenorphine patches (35 micro grams per hour) within 12 to 48 hours after last methadone intake.

Official Title
-----------------
Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches: A Study on Practicability With Patients Maintained With Daily Dosages Between 60mg and 100mg Methadone.

Conditions
-----------------
Heroin Addiction

Intervention / Treatment
-----------------
* Drug: Buprenorphine patch and sublingual tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 60 years Methadone maintenance treatment for at least 3 months preceding the study Daily methadone dosage between 60mg amd 100mg Sufficient knowledge of German language Ability to give informed consent Exclusion Criteria: Daily methadone dosage below 60mg amd over 100mg Prescribed use of benzodiazepines over 30 mg equivalent to diazepam Misuse or dependence of alcohol and/or GHB/GBL Pregnant or breast-feeding women Known intolerance of buprenorphine Somatic diseases interfering with the study plan

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine patch and sublingual tablets|Buprenorphine patch: 35 micro grams per hour 12 to 48 hours after last methadone intake. Buprenorphine sublingual tablets: 2mg 48 and 60 hours after last methadone intake; 8mg 72 and 84 hours after last methadone intake; 8mg 96, 102 and 109 hours after last methadone intake.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Opiate Withdrawal Scale |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heroin use |  | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transfer methadone buprenorphine patch heroin addiction
Differential Metabolic Effects of Statins

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: statins (simvastatin, pravastatin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low-density lipoprotein cholesterol levels > 130 Exclusion Criteria: Overt liver disease, Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: statins (simvastatin, pravastatin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipophilic statins, Insulin resistance, simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.
Blood Collection Biorepository for Liver Disease Research

Study Overview
=================
Brief Summary
-----------------
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.

Detailed Description
-----------------
The Biorepository at the University at Buffalo has been established to collect biological samples from patients with various types of liver disease. The objectives of this biorepository are to stimulate collaboration between clinicians and researchers, to bolster training of junior investigators and to promote multidisciplinary integration to advance translational medicine and to improve the health of patients all over the country. The purpose of this biorepository is to support investigators and to provide them with high quality specimens to promote their efforts in new discoveries or perfecting treatment of patients with liver diseases caused by Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Human Immunodeficiency Virus (HIV). The goal is to obtain samples that represent patients seen in the clinics of medical centers in Western NY and from some of the rarer diseases encountered in these clinics. The ultimate goal is to develop the biorepository as Western New York's resource for clinically annotated human samples that can be used to conduct research that could lead to significant advances in patient care.

Official Title
-----------------
Virology, Immunology and Mechanisms of Liver Disease in Patients With Hepatitis C and Other Liver Diseases

Conditions
-----------------
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C, Hepatitis B, Fibrosis, Cirrhosis, Fatty Liver, Obesity, Childhood, Bariatric Surgery Candidate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This protocol is to establish a biobank of blood samples from individuals with or without liver diseases including viral hepatitis, liver cancer, NASH, and negative control samples. Children and teenagers will be special populations considered in this protocol. Exclusion Criteria: Vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study.

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- | --- |
| Number of samples collected | Total number of samples collected | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Disease, Obesity, Hepatitis, HIV, Hepatology
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial (Optilaryngo)

Study Overview
=================
Brief Summary
-----------------
Suspension laryngoscopy is realised during apnea. In effect, surgeons are in the mouth of the patient and we can't have access at the aiways. So investigators like to use a Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) to increase time of apnea and decrease the impact of oxygen desaturation.

Official Title
-----------------
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial

Conditions
-----------------
Apnea, Apnea, Postanesthetic, Desaturation of Blood, Anesthesia, Larynx Disease, Pharynx; Anomaly

Intervention / Treatment
-----------------
* Device: optiflow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspension laryngoscopy Exclusion Criteria: THRIVE contraindication: epistaxis undrained pneumothorax Recent gastroesophageal surgery (1months) Skull Fractures

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Allocation<br>apnea without oxygenation like usual traitement | |
| Experimental: oxygenation optiflow<br>optiflow oxygenation during apnea | Device: optiflow<br>* we use Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (thrive-optiflow) during general anesthesia for suspension laryngoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| desaturation defined as the number of patient who presented at least one desaturation during suspension laryngoscopy | the number of patient who presented at least one desaturation during suspension laryngoscopy. An oxygen desaturation define like SpO2<96% | Two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoxemia (decrease the number of Hypoxemia event define like SpO2<90%) | Decrease the number of Hypoxemia event define like SpO2<90% | 2 hours | 
| side effect | decrease the number of side effects | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Time of apnea, Optiflow, Thrive, Apnea oxygenation, Suspension laryngoscopy, General Anesthesia, Oxygenation apnea
Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, long term safety and efficacy follow up study for with insulin dependent diabetes 2 type who have been treated with ex vivo gene therapy product in Ukraine Association of Biobank bio-sponsored clinical studies. After completing the parent clinical study (2 years),eligible subjects will be followed for an additional 8 years for total 10 years post-drugproduct infusion. No investigation drug product will be administered in the study

Official Title
-----------------
Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell

Conditions
-----------------
Diabete Type 2, Mesenchymal Stem Cell

Intervention / Treatment
-----------------
* Other: Long term follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated with gene therapy of diabetes 2 type in a drug product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study Able to comply with study requirements Provision of written informed consent for this study by subjects or as applicable subject legal/parent guardian Exclusion Criteria: There are no exclusion criteria for this study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Long term follow up|Undergo long term follow up, including copy number measurement safety evaluations diseases specific product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival of subject with diabetes 2 type with gene therapy drug product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study |  | 10 years post-drug product infusion |
Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis

Study Overview
=================
Brief Summary
-----------------
It was conducted a prospective study with a series of 50 patients treated with PRP one-shot injection in patient affected by Supraspinatus Tendinosis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection). Constant Score, The Disabilites of the Arm,Shoulder and Hand Score (DASH) And Visual Analogue Scale (VAS) were administered at each evaluation.

Official Title
-----------------
Clinical Results Of Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis, Our Experience At Short-Term Follow Up

Conditions
-----------------
Supraspinatus Tendinitis

Intervention / Treatment
-----------------
* Procedure: one-shot PRP injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old; Supraspinatus tendinosis detected by MRI. Exclusion Criteria: Supraspinatus rupture; Previous shoulder surgery; Rotator cuff tears secondary to fracture; Hemoglobin <7 g/dL or Platelets < 30,000 microL; Active infection; Pregnant patients; Patients with hematologic and oncologic diseases.

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 treated by one-shot PRP injection<br> | Procedure: one-shot PRP injection<br>* A single injection of PRP (7% concentrate) ml 4 was made in the Supraspinatus tendon and in the Subacromial space under ultrasound guidance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogic Scale | The shoulder pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain). | Day 0; Month 1; Month 3; Month 6 (after the injection) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Supraspinatus tendinosis; PRP; Shoulder;
Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA

Study Overview
=================
Brief Summary
-----------------
This protocol is not an independent research study, but rather a means to aggregate Children's Cancer Group protocols that are closed to patient entry for the purpose of collecting current status information on those patients treated under those protocols.

Detailed Description
-----------------
Children's Cancer Group clinical trials are conducted to improve understanding of the biology and treatment of childhood cancers. Protocols are developed by expert committees and distributed from the Group Operations Center to the member institutions. Before a protocol can be opened to patient accrual at a CCG institution, the protocol, consent form and any activation amendments are reviewed and approved by the local Institutional Review Board QRB). Protocols remain open to patient accrual until sufficient evaluable patients have been entered to answer the study questions. During this time, the protocol and any new amendments are reviewed annually by the IRB. When the study has been closed to patient accrual it remains open solely for the purpose of collecting life status and occurrence of adverse events. The IRB must continue its annual review as long as a patient treated on the protocol is alive and follow-up data are being collected. The CCG Long Term Follow-up protocol (CCG-LTF1) is meant to allow continued collective review of all protocols that meet the following criteria: (a) It is closed to patient accrual, (b) all patients have completed treatment, and (c) there are patients who are alive and being followed. The protocols that meet these criteria will be listed as being aggregated under CCG-LTF1 such that an IRB review of CCG-LTF1 will constitute a review of that protocol.

Official Title
-----------------
CCG-LTFI: A Groupwide Protocol for Collecting Follow- up Data

Conditions
-----------------
Pediatric Cancers, Oncology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have completed anti-cancer treatment according to a CCG protocol, or must have been declared off protocol therapy, but not off study. The data to be collected on the patient must include only those data that are documented in the medical record or included on the follow-up forms. Exclusion Criteria: n/a
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facilitate reporting of adverse events for those who completed treatment; To establish a mechanism for regular annual approval; Decrease the number of active protocols; Develop a framework for future studies of long-term health related outcomes. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric Cancers, Oncology