linjc16/ctgov huggingface dataset:
A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule

Study Overview
=================
Brief Summary
-----------------
This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.

Official Title
-----------------
A Multicenter, Comparative, Open Label, Prospective Observational Study on Discontinuation of Medication Due to Gastrointestinal Adverse Effects for the Patients Being Treated for Osteoarthritis With Anti-inflammatory Analgesic Drug

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum 20- year-old patients diagnosed with osteoarthritis Within 2 weeks prior to participation, not taken anti-inflammatory analgesic drug such as the Shinbaro Capsule, Celecoxib Capsule and NSAIDs(non-steroidal anti-inflammatory drugs) Written consent form voluntarity Exclusion Criteria: Diagnosed with disease that may affect measurement of efficacy clinically Diagnosed with clinically significant phycological disorder, and taking medication Participated in a clinical trial within 4 weeks Pregnant or lactating woman History of malignant disease within the previous 5 years Patients who seem not to participate in the study at investigator's discretion

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 |
| --- | --- |
| Shinbaro (only)<br> | |
| Celecoxib (only)<br> | |
| Shinbaro + NSAIDs<br> | |
| Shinbaro + Celecoxib<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discontinuation rate due to gastrointestinal adverse effects |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of medication discontinuation recorded as lack of efficacy | Number of participants discontinued from medication due to lack of efficacy | up to 12 weeks | 
| Rate of medication discontinuation | Number of participants discontinued from medication | up to 12 weeks | 
| Discontinuation rate due to adverse events |  | up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shinbaro Capsule, Celecoxib, Osteoarthritis, GCSB-5, Discontinuation rate, Gastrointestinal adverse event, NSAIDs, OASIS
Echocardiographic Examination Performed by Nurses in Cardiac Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: To study the clinical usefulness of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit. To study reproducibility of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit. To study which ultrasound measure that best correlate with the amount of pleural effusion.

Detailed Description
-----------------
For a period of 1 year patients in our cardiac intensive care unit will be recruited to nurse-drive ultrasound and echocardiographic examinations, after informed consent. Nurses underwent a training programme and their skills are approved by cardiologist. Our department does not always have a cardiologist on duty and indication for nurse-driven ultrasound examination is decided by the doctor responsible for the treatment, who not always are trained in echocardiography/ultrasound. We aim to study the described hypothesis.

Official Title
-----------------
Echocardiographic Examination Performed by Nurses in Cardiac Intensive Care Unit. Is it Clinical Useful?

Conditions
-----------------
Heart Failure, Myocardial Infarction, Pleural Effusion

Intervention / Treatment
-----------------
* Procedure: Ultrasound performed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient at Cardiac intensive care unit, Levanger Hospital Doctor responsible for treatment finds echocardiographic/ultrasound examination indicated. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Ultrasound performed<br>Single arm study. | Procedure: Ultrasound performed<br>* Nurse-driven ultrasound performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of diagnosis |  | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of treatment |  | 6-12 months | 
| Quantification of pleural effusion |  | 6-12 months | 
| Reproducibility of nurse-performed examinations |  | 6-12 months |
Incidence & Predictors of Mechanical Abnormalities of QuickSite® and QuickFlex® Left Ventricular Pacing Leads

Study Overview
=================
Brief Summary
-----------------
On April 2, 2012 the manufacturer of the Quicksite® and Quickflex® leads, St. Jude Medical, released a voluntary medical device advisory regarding these leads' potential for problems with the silicone insulation covering one end of the lead, where it meets another section of the lead which is coated with a different insulating material (polyurethane). There has been a voluntary suspension of sales of these leads. There are approximately 179,000 of the above leads implanted worldwide with an estimated 101,000 leads currently in service (59,000 in US). There have been 39 confirmed cases of the conductor portion of the lead becoming exposed from the silicone insulation (externalization), and the rate of occurrence of this type of problem is conservatively estimated at less than one percent. However, a review done by St. Jude Medical of returned Quicksite® and Quickflex® leads and available X-ray and fluoroscopic (x-ray movie) images of patients with these leads (from 1,219 patients) revealed a higher rate of 3-4%. It is presumed that there are patients whose leads have not yet been affected by this problem, but whose leads may show signs of structural changes on x-ray or fluoroscopy. This study seeks to determine what structural changes may be occurring in these leads, what signs might predict these changes, and what impact these changes may have on the lead and its performance.

Official Title
-----------------
Incidence & Predictors of Mechanical Abnormalities of QuickSite® and QuickFlex® Left Ventricular Pacing Leads: Impact on Electrophysiological Profile

Conditions
-----------------
Left Ventricular Pacing Leads

Intervention / Treatment
-----------------
* Device: Quicksite
* Device: Quickflex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient that received Quicksite or Quickflex lead at the University of Kansas Hospital Exclusion Criteria: Not willing to consent to data collection

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 |
| --- | --- |
| Quicksite and Quickflex<br>Patients who have received the leads affected by the medical product advisory | Device: Quicksite<br>* St. Jude Medical produced lead called Quicksite<br>Device: Quickflex<br>* St. Jude Medical produced lead called Quickflex<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the mechanical/structural abnormalities in implanted St Jude Medical QuickSite® and QuickFlex® left ventricular (LV) pacing leads |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quicksite, Quickflex, St. Jude Medical
SAM: Discharge Based on the Use of a MUAC-based Criterion to

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of routine program data of children aged 6 to 59 months admitted to the MSF therapeutic feeding program with MUAC ≤ 118 mm in Yako and Titao districts of Burkina Faso from 2007-2011.

Detailed Description
-----------------
Comparison of patient characteristics and treatment outcomes was conducted between two groups: 1) children discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission (Period A); and 2) children discharged as recovered from April 2009 to December 2011 with MUAC ≥ 124 mm (Period B). A total of 50,841 children were admitted with MUAC ≤ 118 mm to the MSF therapeutic feeding program and were included in this analysis: 24,792 children in Period A (2007-2009) and 26,049 children in Period B (2009-2011). Overall, 89% of admissions were directly into outpatient care and the majority (53%) entered with a MUAC 116-118mm; 48% of children were male and 80% of children < 2 years of age (Table 1). Compared to children admitted in Period A, children admitted in Period B were statistically more likely to be female, younger, and of better anthropometric status (e.g. higher mean MUAC, WHZ and HAZ). There was a greater proportion of children admitted directly to inpatient care in Period B than in Period A (10.6% vs 8.0%).

Official Title
-----------------
Discharge From Community-based Management of Severe Acute Malnutrition Using Mid Upper Arm Circumference

Conditions
-----------------
Severe Acute Malnutrition

Intervention / Treatment
-----------------
* Other: Discharge from community-based management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 to 59 months old presence of bipedal pitting edema or MUAC ≤ 118 mm Exclusion Criteria: < 6 months old or > 59 months old absence of bipedal pitting edema or MUAC ≥ 118 mm

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Period A<br>Children discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission | Other: Discharge from community-based management<br>* Comparison of patient characteristics and treatment outcomes between two groups<br>|
| Period B<br>Children discharged as recovered from April 2009 to December 2011 with Children discharged as recovered from September 2007-March 2009 with MUAC ≥ 124 mm | Other: Discharge from community-based management<br>* Comparison of patient characteristics and treatment outcomes between two groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MUAC based criterion | Use of a discharge criterion of MUAC ≥ 124 mm | 52 months |
Sargramostim for Myeloid Dendritic Cell Deficiency

Study Overview
=================
Brief Summary
-----------------
Previous studies have demonstrated a deficiency of blood dendritic cells in patients with kidney disease that is associated with the development of viral infections after kidney transplantation. We plan to test the ability of sargramostim to increase blood dendritic cell levels in patients with kidney disease in the hopes of developing new therapies to prevent viral infections after kidney transplantation.

Official Title
-----------------
Sargramostim for Myeloid Dendritic Cell Deficiency - Phase I

Conditions
-----------------
Dendritic Cell Deficiency

Intervention / Treatment
-----------------
* Drug: Sargramostim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years < 80 years with diagnosis of end stage renal disease and currently undergoing outpatient hemodialysis (HD) at one of the Johns Hopkins University-affiliated HD units Exclusion Criteria: Age<18or>80years History of non-adherence to prescribed HD treatment Active drug or heavy alcohol use (defined as > 4 drinks/day) Pregnancy or breast feeding Active infection (bacterial or viral) or clinically significant infections within the past three months (e.g. those requiring hospitalization, or as judged by the PI) Active malignancy (with the exception of excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or adequately treated pre- invasive cervical cancer in situ) Unstable cardiovascular status (angina, arrhythmias, congestive heart failure etc...) History of liver disease (as defined by a diagnosis of uncompensated cirrhosis) • History of lung disease (including moderate-severe chronic obstructive pulmonary disease, interstitial lung disease, or asthma) Known hypersensitivity to yeast-derived products Hemoglobin < 10 g/dL and hematocrit < 30%. Abnormal white blood cell (WBC) count at baseline (< 3 or > 12 x 10 cells/mm ) Treatment with WBC growth factors (G-CSF or GM-CSF) or immunosuppressive medications (tacrolimus, cyclosporine, mycophenolate, azathioprine, corticosteroids, chlorambucil, cyclophosphamide) within 4 weeks of study (erythropoiesis-stimulating agents will be allowed) Treatment with lithium within 4 weeks of study

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sargramostim administration<br>Subjects will receive sargramostim. | Drug: Sargramostim<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target blood myeloid dendritic cell level of > 2.0 x 10<4>/mL |  | 2-4 weeks |
Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents

Study Overview
=================
Brief Summary
-----------------
In this multicenter cluster randomized controlled trial stratified by school baseline prevalence of smoking will be randomly allocated to the control or intervention group. Control schools will receive normal smoking education and intrvention schools will receive a four year class-based curriculum intervention (22 Classroom lessons), reinforcement of smoke-free school policy, smoking cessation in parents, pupils, and teachers and information and annual meeting with parents. Study participants will be children aged 12 to 15 years old ; they will be followed to 2 years after high school. External evaluator and analyst will be blinded to school allocation. The aim of this study is to analyze the effectiveness of a complex intervention to reduce the prevalence of smoking at 3º ESO (14-15 yrs-old) and 2 years after high school (17-18 yrs-old) .

Official Title
-----------------
Effectiveness of a Complex Intervention on Reducing the Prevalence of Smoking Among Adolescents: a Cluster Randomized Control Trial

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: School intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children at first of Secondary education. Adolescents and parents accept and sign informed consent Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 11 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: School-based intervention<br> | Behavioral: School intervention<br>* The ITACA intervention is a cognitive and social-influences approach to prevent tobacco consumption. The intervention is integrated in the curricula of the school, also schools are reinforced to follow a smoke-free school and strictly follow legislation about smoking in schools. The community component include annual meeting with adolescents parents and parents and teachers intensive group for smoking cessation.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking prevalence of adolescents in each group | We will compare the smoking prevalence of adolescents in each group at six years against the usual null hypothesis of no difference between groups. We will use the Chi-squared test, taking into account the variance inflation factor of the adolescent cluster and intraclass correlation coefficient. | six years |
Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

Study Overview
=================
Brief Summary
-----------------
Fluid management study in patients with type 2 diabetes and autonomic neuropathy.

Official Title
-----------------
A 16-week, Randomised, Double-blind, Placebo-controlled, Single-centre Study to Investigate Fluid Retention in Insulin-treated Subjects With Type 2 Diabetes Mellitus and Varying Degrees of Autonomic Neuropathy When Administered Rosiglitazone 4mg Twice Daily

Conditions
-----------------
Neuropathy, Diabetic

Intervention / Treatment
-----------------
* Drug: rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects with Type 2 Diabetes (T2DM) as defined by the 1999 WHO criteria [World Health Organisation , 1988/NCD/NCS/99.2] with stable FPG of = 7.0 and = 15.0 mmol/l who have been established on insulin therapy for at least 6 months BMI = 40 kg.m2 Subject who is willing and able to provide a signed and dated written informed consent. Exclusion Criteria: Subjects with an HbA1c level > 12% Subjects taking oral hypoglycaemic agents other than metformin Subjects on insulin dosage > 200 units/day

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: rosiglitazone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in transcapillary escape rate of L125 albumin following 16 weeks treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluid retention, Autonomic Neuropathy
Non-interventional Study on Time to Response and Quality of Life in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide in Second Line

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantify the burden of treatment in relapsed or refractory multiple myeloma in patients receiving lenalidomide after one prior treatment for myeloma.

Official Title
-----------------
Phase IV Study on QoL in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age Have a confirmed diagnosis of MM Starting lenalidomide treatment for MM (due to relapsed or refractory disease) after one prior treatment. Have personally signed and dated a legally effective written informed consent form prior to admission to the study. Must be willing and able to understand and comply with the study requirements. Exclusion Criteria: Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening. Individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsed and Refractory Multiple Myeloma