linjc16/ctgov huggingface dataset:
Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors

Study Overview
=================
Brief Summary
-----------------
This project will pilot test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will reduce sunburns in melanoma survivors. The use of wearable technology devices has grown quickly over the last decade and studies using these devices to promote physical activity and weight loss have been promising. The investigators will pilot test the technology device versus a similar control device in 80 melanoma survivors and compare sunburns between the two groups after the three month intervention.

Official Title
-----------------
Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors

Conditions
-----------------
Melanoma (Skin)

Intervention / Treatment
-----------------
* Device: Microsoft Band 2 + UV messaging
* Device: Microsoft Band 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years old Diagnosed with stage I-III cutaneous invasive melanoma between 2009 and 2017 and treated at the University of Minnesota Able to read/write in English Own a smartphone Able to provide voluntary informed consent Exclusion Criteria: -Patients currently undergoing adjuvant therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Microsoft Band 2 application with UV messaging activated | Device: Microsoft Band 2 + UV messaging<br>* wearable device (wrist) and associated mobile application; UV sensor and messaging activated<br>|
| Active Comparator: Control<br>Microsoft Band 2 application (UV messaging not active) | Device: Microsoft Band 2<br>* wearable device (wrist) and associated mobile application; UV messaging not activated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sunburn | Self-report of a sunburn during study period | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sunburn, cancer prevention
Vitamine D in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial. They will randomly assigned to placebo or vitamin D treatment group. The total time of study is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU) vitamin D, while the other group will receive weekly placebo. The annual relapse rate and EDSS will be compared at baseline, month 6 and 12.

Official Title
-----------------
Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis

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

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI:18-30kg/m2 caucasian race Relapsing remitting multiple sclerosis treatment with interferon beta Exclusion Criteria: Recent vitamin D supplement therapy Restricted fat diet nephrolithiasis in recent 5 years Past history of hyperparathyroidism, sarcoidosis, cancer Past history of hepatic disease Past history of gastrointestinal disease Past history of mycobacterial infection Past history of hypercalcemia and hypercalciuria serum creatinine>1.5 Smoking, drug abuse and corticosteroid therapy in recent year treatment with thiazides or other drugs that inhibit vitamin D absorption Disease attack in recent 2 months Serum Ca>2.6mm0l/L Serum 25(OH)D>85mmol/L hypersensitivity to cholecalciferol Past history of heart disease Major depression Uncontrolled hypertension (BP>180/110) Immunosuppressive therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br>treatment with weekly 50000IU vitamin D | Drug: Vitamin D<br> <br> |
| Placebo Comparator: Placebo<br>Treatment with placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expanded disability state scale score (EDSS) |  | Changes in EDSS from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual relapse rate(ARR) |  | Changes in ARR from baseline to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARR, Multiple sclerosis, Vitamin D, EDSS
Peripheral Metabolic Effects of Ghrelin

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis.

Official Title
-----------------
Peripheral Metabolic Effects of Intra Arterial Ghrelin Infusion in Healthy Controls

Conditions
-----------------
Healthy Controls

Intervention / Treatment
-----------------
* Drug: Ghrelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI < 27 kg/m2 Written informed consent Non-smoker Exclusion Criteria: Any disease including epilepsy Any use of medications (excl. paracetamol) Present or previous malignancy Alcohol dependency Allergy to any trial medication

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

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ghrelin<br> | Drug: Ghrelin<br>* Solvent, cont. infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of glucose |  | During study day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin signaling |  | Study day | 
| Serum levels of fatty acids |  | Study day |
Genome-wide Association Study of Development of Collateral Circulation for Patients With Coronary or Peripheral Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the genome-wide association for the development of collateral circulation for patients with coronary or peripheral artery disease and to develop the molecular genetic treatment model based on genome-wide association data.

Official Title
-----------------
Genome-wide Association Study of Development of Collateral Circulation for Patients With Coronary or Peripheral Artery Disease

Conditions
-----------------
Coronary Disease, Peripheral Arterial Disease, Collateral Circulation, Any Site

Intervention / Treatment
-----------------
* Diagnostic Test: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 20 Chronic total occlusive lesion from the coronary or peripheral angiogram Exclusion Criteria: Renal dysfunction Hepatic dysfunction Thrombocythemia or thrombocythemia Planned major surgery in 1 year History of gastrointestinal haemorrhage Malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Coronary Artery Disease_collateral flow grade 2<br> | Diagnostic Test: Blood samples<br>* for evaluation of the genome-wide association study<br>|
| Coronary Artery Disease_collateral flow grade 0<br> | Diagnostic Test: Blood samples<br>* for evaluation of the genome-wide association study<br>|
| Peripheral Artery Disease_collateral flow grade 2<br> | Diagnostic Test: Blood samples<br>* for evaluation of the genome-wide association study<br>|
| Peripheral Artery Disease_collateral flow grade 0<br> | Diagnostic Test: Blood samples<br>* for evaluation of the genome-wide association study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between genome and collateral flow |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genome-wide association, Collateral circulation
Transversus Abdominis Muscle Release Versus Mesh Only Repair in the Treatment of Complex Ventral Wall Hernia

Study Overview
=================
Brief Summary
-----------------
This trial was designed as a prospective randomized, controlled, intervention, with two parallel groups, and a primary endpoint of recurrence during 12 months' follow-up after initial treatment, with the randomization, was performed by an online software a 1:1 allocation.

Detailed Description
-----------------
Eligibility Criteria both sexes aged between 18 and 65 years old presented complex ventral wall hernia or incisional hernia Exclusion pregnant patients on steroid therapy underwent their hernia repair on an emergency basis Interventions Eligible patients were randomized in equal proportions between Mesh Only Repair and Posterior Component Separation with Transversus Abdominis Muscle Release

Official Title
-----------------
Posterior Component Separation With Transversus Abdominis Muscle Release Versus Mesh Only Repair in the Treatment of Complex Ventral Wall Hernia: A Randomized Controlled Trial

Conditions
-----------------
Hernia, Ventral, Hernia Incisional, Hernia, Abdominal

Intervention / Treatment
-----------------
* Procedure: Posterior Component Separation with Transversus Abdominis Muscle Release
* Procedure: Mesh-only repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with complex ventral-wall and incisional hernia Exclusion Criteria: pregnant female steroid therapy emergency basis

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesh-only repair<br> | Procedure: Mesh-only repair<br>* The prosthetic mesh only repair was done as described by Wantz in 1991.<br>|
| Active Comparator: Transversus Abdominis Muscl<br> | Procedure: Posterior Component Separation with Transversus Abdominis Muscle Release<br>* The posterior component separation technique with transversus abdominis muscle release was done as prescribed in Novitsky et al in 2012.<br>* Other names: Transversus Abdominis Muscle Release;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence | Reappearance of symptoms or swelling | after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | postoperative morbidity | 30 days postoperative | 
| Mortality | Postoperative mortality | 30 days postoperative |
Prospective Study for Molecular Biomarkers of Normal Nasopharyngeal Tissue

Study Overview
=================
Brief Summary
-----------------
The investigators collect nasopharyngeal epithelium samples from healthy individuals and analyze for biomarkers compared with tumor tissues from another clinical research project. The goal of this study is to identify molecular biomarkers for prediction of nasopharyngeal carcinoma.

Official Title
-----------------
Prospective Study for Molecular Biomarkers of Normal Nasopharyngeal Tissue

Conditions
-----------------
Nasopharyngeal Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suspected of nasopharyngeal carcinoma but excluded by biopsy Exclusion Criteria: Diagnosed as nasopharyngeal carcinoma during the follow-up period
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 positive rate of risk signature in healthy individuals |  | 3 years |
Aspiration Device in Myocardial Infarction Trial

Study Overview
=================
Brief Summary
-----------------
Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation (STEMI). The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI population. Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique.

Detailed Description
-----------------
ADMIT-Randomized Single Center Study with two arms: Standard PCI versus Primary PCI, using thrombus aspiration device after ever step of the procedure. Issues to be examined are: Immediate angiographic differences between the study arms. By evaluation of: TIMI FLOW GRADE,TIMI FRAME COUNT,MYOCARDIAL BLUSH GRADE. No reflow phenomenae, Infarc size evaluated by serum markers and non invasive parameters In hospital major adverse cardiac events Major adverse cardiac events during 30& 180 days of follow up

Official Title
-----------------
Aspiration Device Myocardial Infarction Trial

Conditions
-----------------
Angioplasty

Intervention / Treatment
-----------------
* Device: repeated thrombus aspiration during primary PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with STEMI<12 from synptoms onset eligble for primary PCI regardless of initial TIMI flow grade. patients for rescue PCI after failed thrombolysis will also be included Exclusion Criteria: womwn with known pregnancy or who are lactating pts with allergy to aspirin, clopidogrel or heparin inability to obtain informed consent known existence of life threatening diseases with a life expectency less than 6 months

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: repeated thrombus aspiration during primary PCI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limitation of infarct size |  |  | 
| Early and follow up related (MACE)-major adverse cardiac events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of using aspiration device after every stage of Primary angiplasty |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW
Tedizolid Suppressive Antimicrobial Therapy in a Reference Center

Study Overview
=================
Brief Summary
-----------------
the aim of the study is to describe the management and outcome of patients having an osteo-articular infection treated by tedizolid as a suppressive antibiotic therapy.

Official Title
-----------------
Tedizolid Suppressive Antimicrobial Therapy

Conditions
-----------------
Bone and Joint Infection

Intervention / Treatment
-----------------
* Other: patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having an osteo-articular infection treated with tedizolid as a suppressive antibiotic therapy Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy<br> | Other: patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy<br>* description of osteo-articular infection managed with tedizolid as a suppressive antibiotic therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy | proportion of patients having tedizolid as a suppressive antibiotic therapy | between 2016 and 2021 | 
| rate of failure in patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic | proportion of patients having a failure under tedizolid as a suppressive antibiotic therapy | 2 years | 
| rate of adverse event in patients having had a BJI/PJI treated with tedizolid as a suppressive | proportion of patients having a adverse event under tedizolid as a suppressive antibiotic therapy | through study completion, an average of 1 year | 
| Description of patients having had a BJI/PJI treated with tedizolid as a suppressive | type of patients: age, CMI, comorbidities... | 2 years | 
| Description of BJI/PJI treated with tedizolid as a suppressive | implant or prothese or not, acute/ chronic, bacteriology | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone and joint infection, tedizolid, suppressive antibiotic therapy
Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy

Study Overview
=================
Brief Summary
-----------------
An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

Detailed Description
-----------------
An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

Official Title
-----------------
A Randomized, Controlled, Open-Label Parallel Group Study to Evaluate the Effect of Regularly Scheduled Neutralizing Antibody Testing on Treatment Patterns Versus Usual Care in High-Dose Interferon Treated Patients

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

Intervention / Treatment
-----------------
* Procedure: NAbs testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to provide informed consent. Male or female, 18 years of age or older, with a diagnosis of MS. Exclusion Criteria: Has been on oral or parenteral corticosteroid therapy within the two weeks prior to the Baseline Visit. Has been treated with immunoglobulins (IgG) or plasmapheresis within the last six months. Has any condition which the investigator or nurse feels may interfere with participation in the study or with assessments for the full duration of the study. Previously participated in this study. Has received an experimental drug in the last thirty (30) days.

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 |
| --- | --- |
| Regularly Scheduled NAb Testing Arm<br>Subjects will be scheduled for 5 study visits over the course of 12 months and any NAbs test results will be available to the investigator during the study. | Procedure: NAbs testing<br>* blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.<br>|
| Usual Care Arm<br>Subjects will be scheduled for 2 study visits over the course of 12 months and any NAbs test results will be unknown by the investigator until the conclusion of the subject's study participation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects whose high dose IFN therapy had changed in the regularly scheduled NAbs testing arm versus the Usual Care Arm |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The nature of any therapy/management change in each arm |  | 1 year | 
| Reason for change in therapy/management |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High-Dose Interferon, Neutralizing Antibodies