linjc16/ctgov huggingface dataset:
Circulating microRNAs as Disease Markers in Pediatric Cancers

Study Overview
=================
Brief Summary
-----------------
MicroRNAs are small molecules which have recently been discovered in cells. They are known to be responsible for the normal development of cells and when they are disrupted can contribute to the development of cancer. Many previous studies have been done evaluating the expression of microRNAs in normal tissues as well as a wide variety of cancers. Recently, microRNAs from tumor cells have been detected circulating in the blood of patients with cancer. This presents a novel opportunity to use microRNAs in the blood as an early predictor of cancer as well as a marker of response to therapy. No previous studies have been performed evaluating microRNAs in the blood or cerebrospinal fluid of patients with childhood cancers. We propose a feasibility study to evaluate the presence of microRNAs in the blood and cerebrospinal fluid of patients with central nervous system tumors, leukemia and lymphoma who are currently on chemotherapy and undergoing blood draws, lumbar punctures and/or reservoir taps for routine clinical care. If we're able to identify circulating microRNAs in this population of pediatric patients, we will build upon this data in proposing a future study.

Official Title
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A Feasibility Study of Circulating microRNAs as Disease Markers in Pediatric Cancers

Conditions
-----------------
Leukemia, Lymphoma, Central Nervous System

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors age: greater than 3 years and less than or equal to 21 years of age Patients must be in a phase of their treatment during which routine blood draws, lumbar punctures or CSF sampling from Ommaya reservoirs are required for treatment of their cancers. Exclusion Criteria: Patients who have completed treatment and do not require routine blood draws and/or lumbar punctures Patients who are considered too ill to participate as determined by their treating physician Patients with a known genetic condition that predisposed them to the development of cancer.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 21 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<br>All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors between 3 years and 21 years of age | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if miRNAs are present in the blood of patients with pediatric cancers |  | 1 year | 
| Determine if miRNAs are detectable in the CSF of patients with pediatric cancers. |  | 1 year |
Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers

Study Overview
=================
Brief Summary
-----------------
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.

Official Title
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Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS): RADARS® System Surveillance Protocol

Conditions
-----------------
Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse

Intervention / Treatment
-----------------
* Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with data in the RADARS system Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intentional exposures among adolescents and adults<br> | Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion<br> <br> |
| Unintentional exposures among infants and children<br> | Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups |  | Review over period from January 2010 to December 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group |  | Review over period from January 2010 to December 2016 |
The Effects of Social Role Participation on Life Quality

Study Overview
=================
Brief Summary
-----------------
The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA patients were compared with 95 healthy volunteer control group. Participants were asked to complete interview based questionnaires regarding pain, life quality, and social role participation to obtain additional information during the interview to participate in the study in 20 min.

Detailed Description
-----------------
The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA patients were compared with 95 healthy volunteer control group. Healthy volunteers were recruited from the partners next to the patients who came to our outpatient clinic for examination. The same physician carried out the physical examinations on all participations and conducted a interview, acquiring information on age, gender, body mass index (BMI), marriage status, living alone, working, and education. Participants were asked to complete interview based questionnaires regarding pain, life quality, and social role participation to obtain additional information during the interview to participate in the study in 20 min. Examinations took place at the our outpatient clinic. This study did not include all participants who had accompanying of other rheumatic diseases, musculoskeletal diseases, the presence of another chronic disease, cancer.

Official Title
-----------------
The Effects of Social Role Participation on Life Quality in Rheumatoid Arthritis Patients

Conditions
-----------------
Social Interaction

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:The study was carried out among RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic - Exclusion Criteria:This study did not include all participants who had accompanying of other rheumatic diseases, musculoskeletal diseases, the presence of another chronic disease, cancer. -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>100 rheumatoid arthritis patients (age from 20 to 70 years) | Other: Observational<br>* Physical examination and questionnaires<br>|
| Control<br>95 healthy volunteer | Other: Observational<br>* Physical examination and questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social role participation | Social role participation questionnaire | 4 months |
A Device Designed to Protect the Perineum During Labor

Study Overview
=================
Brief Summary
-----------------
Objective: To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth. Design: A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal. Main outcome measures: The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.

Detailed Description
-----------------
Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.

Official Title
-----------------
Study of Perineal Protection Device

Conditions
-----------------
Perineal Tear

Intervention / Treatment
-----------------
* Device: Perineal protection device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vaginal delivery Exclusion Criteria: Age below 18 years and no understanding of written and oral information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Perineal device used<br>Use of the perineal device during delivery | Device: Perineal protection device<br>* Use of the device during delivery and inspection afterwards to see the tears.<br>* Other names: Manufacturer; Calle Gejde AB, 234 21 Lomma, Sweden;|
| No Intervention: No intervention<br>Controls, delivered as normal | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade I and II rupture during delivery | Number and extension of perineal tears during delivery | time at the delivery department (up to 12 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delivery rupture, perineal protection device, reduce perineal tears
Prediction of Pain After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Despite improvements in treatment, a significant part of patients have severe pain following knee arthroplasty. Preoperative identification of high-risk patients would allow for an intensive individualized analgesic treatment pre- and postoperatively and thus potentially in reduced pain acute and chronically.

Official Title
-----------------
Prospective Descriptive Study of Nociceptive and Psychological Prediction of Pain After Total Knee Arthroplasty (TKA)

Conditions
-----------------
Knee Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary unilateral TKA caucasian 50 - 80 years osteoarthritis Exclusion Criteria: deficient written or spoken danish impairment from psychological og neurological disease expected discharged to rehabilitation facility anticoagulant therapy allergies to analgesic treatment hypertension (systolic > 160 / diastolic > 100) ASA class ≥ 4

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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 |
| --- | --- | --- |
| Pain | Pain intensity on a NRS from 0 to 10 upon ambulation 24 hours following surgery | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain intensity on a NRS (numeric rank scale) from 0 to 10 upon ambulation 48 hours following surgery | 48 hours postoperatively | 
| Pain | Daily diary reported pain intensity on a NRS (numeric rank scale) from 0 to 10 in average and when worse the first two weeks following knee arthroplasty. | From day 1 to day 14 following surgery |
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease. The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated. Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.

Detailed Description
-----------------
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease. Subjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Image Guided Programming (IGP) when used as a planning tool for programming of patients is also evaluated.

Official Title
-----------------
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation (DBS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Meets criteria established in locally applicable Vercise System Direction for Use At least 18 years old Key Exclusion Criteria: Meets any contraindication in the Vercise System locally applicable Directions for Use Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.

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 |
| --- | --- |
| Parkinson's disease<br>Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation. | Device: Deep Brain Stimulation (DBS)<br>* Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their Parkinson's disease symptoms will be offered participation in this registry.<br>* Other names: Boston Scientific;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in patient's quality of life (QoL) during the study as compared with baseline | Change in quality of life assessments during the study as compared with baseline | up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vercise, Deep brain stimulation, Parkinson's disease
To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Insulin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of insulin.

Official Title
-----------------
A Randomized, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Subjects With T2DM Treated With Insulin

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: AZD1656
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female with non child-bearing potential Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start. HbA1c below or equal to 11 % at screening (HbA1c value according to international DCCT standard) Exclusion Criteria: Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD1656<br>* Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Dosing to match AZD1656<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG) |  | Blood samples taken repeatedly during 24 hours on study day sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | Blood samples taken repeatedly during 24 hours on study day sessions | 
| Pharmacodynamic variables |  | Blood samples taken repeatedly during 24 hours on study day sessions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

Study Overview
=================
Brief Summary
-----------------
In this study, a system will be developed to guide patients with chronic obstructive pulmonary disease (COPD) to complete a mindful breathing practice at home. COPD is the third leading cause of death in the United States and no cure exists. Shortness of breath is the most common disabling symptom. Pursed lips breathing is a type of breathing practice that has demonstrated effectiveness for patients with COPD. It requires practice to maintain and there is currently no home system to provide the needed feedback and support to maintain PLB. Additionally, syncing breathing and heart rate variation offers patients additional benefits. The proposed project explores the use of biofeedback to guide COPD patients in a breathing practice and to provide data for health coaching to monitor and support the practice.

Official Title
-----------------
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

Conditions
-----------------
COPD, Emphysema

Intervention / Treatment
-----------------
* Behavioral: mindful breathing application
* Device: application on a computer tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients eligible for Pulmonary Rehabilitation will be recruited for this study.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 99 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
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot Study<br>Participants will be shown how to use a mindful breathing software application. The software will be used for 1 week. At the end of the week, participants will evaluate the software. | Behavioral: mindful breathing application<br>* Participants will use a mindful breathing application on a computer tablet.<br>Device: application on a computer tablet<br>* a computer tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the feasibility of a mindful breathing application for COPD patients | Mindful Breathing Application on a computer tablet for COPD patients | About 1 week |