linjc16/ctgov huggingface dataset:
A Multi-centre Survey on Tramadol Abuse in Singapore

Study Overview
=================
Brief Summary
-----------------
The rampant prescription of opioid has in part contributed to the ongoing worldwide opioid crisis. In the United States of America, it is estimated that death from the use of opioids outnumber death from motor vehicle accident deaths by more than 40%. Consequently, many countries such as America and Canada have drawn up guidelines pertaining to safe opioid prescribing. Tramadol is often used by pain physicians to treat chronic pain. As it is a weak opioid and unscheduled in many countries, it is often considered to have a lower addiction potential compared to strong opioids. Despite this, the literature does reveal evidence of abuse, addiction and withdrawal - although the incidence of this is unclear. In this study, the investigators aim to determine the prevalence of tramadol misuse in a pain clinic population. The investigators also aim to determine the real-life compliance of physicians to guidelines provided by International regulatory bodies (CDC) and the modifiable risk factors associated with tramadol misuse.

Official Title
-----------------
A Multi-centre Survey on Tramadol Abuse in Singapore

Conditions
-----------------
Opioid Abuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients attending pain clinic in Singapore General Hospital, Seng Kang General Hospital and Changi General Hospital Exclusion Criteria: -
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 |
| --- | --- | --- |
| Current Opioid Misuse Measure (COMM) | The primary outcome is the prevalence of Current Opioid Misuse (defined as a COMM score of 9 or greater) in the patients included in the cross-sectional study (ie patients who are on tramadol) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 measures depression with scores of 5-9, 10-14,15-19 and 20 or higher representing mild, moderate , moderate to severe and severe depression. PHQ-9 scores will be performed on all patients to determine the level of depression among patients prescribed tramadol. | Baseline | 
| General Anxiety Disorder-7 (GAD-7) | GAD-7 measures anxiety with scores of 5, 10 and 15 representing mild, moderate and severe anxiety. GAD-7 scores will be performed on all patients to determine the level of anxiety among patients prescribed tramadol. | Baseline | 
| Opioid Risk Tool (ORT) | ORT measures the risk of future opioid abuse. A score of equal or less than 3 correlates with a low risk of opioid abuse. Scores of 4 to 7 indicates moderate risk and scores above 8 represents high risk.ORT scores will be performed on all patients to determine the risk of future opioid misuse among patients prescribed tramadol. | Baseline |
Management of Cardiovascular Risk Factors

Study Overview
=================
Brief Summary
-----------------
This practical experience should report a retrospective collection of data regarding cardiovascular risk factors of cardiovascular diseases. The goal is an evaluation of the development of the risk profile of cardiovascular patients with simultaneous treatment of hypertension and hyperlipidemia

Official Title
-----------------
Management of Cardiovascular Risk Factors

Conditions
-----------------
Cardiovascular Risk Factors, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients received a anti-hypertension treatment in addition to cholesterol lowering treatment during the observation period Patients received a cholesterol lowering treatment in addition to hypertension treatment during the observation period Patients received during the observation time new cholesterol lowering and hypertension treatment Exclusion Criteria: Patients received during the observation time only cholesterol lowering or only anti-hypertension treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with hypertension and hyperlipidemia and other CV risk factors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The goal is an evaluation of the development of the risk profile of cardiovascular patients with simultaneous treatment of hypertension and hyperlipidemia. |  | Inclusion visit, 6 to 9 months before inclusion visit and / or 12 to 15 months before inclusion visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, hyperlipidemia
Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (BVS) system in patients with coronary artery disease

Detailed Description
-----------------
Patients with coronary artery disease receive bioabsorbable vascular scaffolds. Patients are clinically followed during a period of 10 years.

Official Title
-----------------
Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold

Conditions
-----------------
Coronary Artery Disease, Ischemic Heart Disease, Stable Angina, Unstable Angina, Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: use of bioresorbable vascular scaffolds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary artery disease implantation of at least one bioresorbable vascular scaffold Exclusion Criteria: no written informed consent

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: use of bioresorbable vascular scaffolds<br>Implantation of bioresorbable vascular scaffold for coronary artery disease. | Device: use of bioresorbable vascular scaffolds<br>* Implantation of bioresorbable vascular scaffolds for coronary artery disease.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events |  | 10 years |
Language Localization Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Epilepsy

Study Overview
=================
Brief Summary
-----------------
Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately detailed localization of language functions in the brain. We propose to test the ability of rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in patients with temporal lobe epilepsy before and after surgical resections. The study is expected to yield information on the organization of language in the temporal lobes and how unilateral temporal lobe lesions and lobectomy cause relocation of language mechanisms in the lesioned and in the other hemisphere. It will also be a preliminary step in the development of a clinically useful procedure for locating critical language areas in potential surgical candidates.

Detailed Description
-----------------
Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately detailed localization of language functions in the brain. We propose to test the ability of rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in patients with temporal lobe epilepsy before and after surgical resections. The study is expected to yield information on the organization of language in the temporal lobes and how unilateral temporal lobe lesions and lobectomy cause relocation of language mechanisms in the lesioned and in the other hemisphere. It will also be a preliminary step in the development of a clinically useful procedure for locating critical language areas in potential surgical candidates.

Official Title
-----------------
Language Localization Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Epilepsy

Conditions
-----------------
Epilepsy, Temporal Lobe

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients will be drawn from among those referred to the NINDS Epilepsy Research Branch. No patients with evidence for a progressive neurological disorder. No subjects with metal hardware in the cranial cavity, cardiac pacemakers, indwelling medication pumps, cochlear implants, intracardiac lines, significant intracranial masses or evidence of increased intracranial pressure. Women must not be pregnant.
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
-----------------
Brain Mapping, Cognition, Noninvasive, Temporal Lobe, Visual Naming
Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose

Study Overview
=================
Brief Summary
-----------------
Mothers are given the medication oxytocin after birth to help the uterus (womb) contract and therefore reduce blood loss. In Canada, oxytocin is given either into the muscle of the thigh or into a vein. However, it is not known which route is better.This study will test which dose and route of oxytocin is best in reducing blood loss following vaginal delivery.

Official Title
-----------------
Intramuscular Versus Intravascular Oxytocin for the Third Stage of Labour

Conditions
-----------------
Third Stage of Labour

Intervention / Treatment
-----------------
* Drug: oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women 19 years and older singleton pregnancy 32 weeks gestation spontaneous vaginal delivery Exclusion Criteria: previous postpartum hemorrhage placenta previa grand multiparity (>4) anticoagulation therapy delivery prior to 32 weeks gestation operative vaginal delivery antepartum hemorrhage > 20 weeks hemoglobin <10g/dL multiple gestation intrauterine death

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group B<br>women in group B will receive 10 uts oxytocin IM | Drug: oxytocin<br> <br> |
| Active Comparator: group C<br>women in group C will receive oxytocin 5 uts IV | Drug: oxytocin<br> <br> |
| Active Comparator: group A<br>women in group A will receive oxytocin 5 uts IM | Drug: oxytocin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in hematocrit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated blood loss |  |  | 
| postpartum hemorrhage (estimated blood loss > 500cc) |  |  | 
| severe postpartum hemorrhage (estimated blood loss > 1000cc) |  |  | 
| incidence of hypotension |  |  | 
| length of third stage of labour |  |  | 
| need for blood transfusion |  |  | 
| incidence of retained placenta |  |  | 
| need for dilatation and curettage |  |  | 
| need for hysterectomy |  |  | 
| need for additional oxytocics after delivery |  |  | 
| postpartum antibiotic use |  |  | 
| maternal satisfaction |  |  | 
| bleeding needing readmission |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxytocin, third stage, dose, route, blood loss
Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
The impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose and insulin have already been study in the past. The aim of the current study is to evaluate the long term effect of the probiotic bilberry drink on glucose tolerance and insulin resistance in healthy adults and in comparison to a control drink.

Official Title
-----------------
The Long Term Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance as Compared to a Control.

Conditions
-----------------
Insulin Resistance

Intervention / Treatment
-----------------
* Other: Bilberry
* Other: beverage without bilberries or probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults with a BMI between 20-30 Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Billberry<br>A bilberry-based probiotic beverage | Other: Bilberry<br>* A bilberry based probiotic beverage<br>|
| Active Comparator: Control<br>A control beverage without bilberries or probiotics | Other: beverage without bilberries or probiotics<br>* A control beverage without bilberries or probiotics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The long term effect of a bilberry-based probiotic beverage on postprandial levels of serum insulin | The incremental area under the curve (AUC) will be measured for the levels of postprandial serum insuling from 0 min to 120 min following ingestion of the product (included intermediate measuring time points are 30, 60 and 90 min) | Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product |
Collection and Storage of Human Biospecimens for Research Into Rare Diseases and Medical Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this protocol is to enable collection of biospecimens to facilitate current and future multidisciplinary research in rare genetic disorders and medical conditions.

Official Title
-----------------
Collection and Storage of Human Biospecimens for Research Into Rare Diseases and Medical Conditions

Conditions
-----------------
Rare Genetic Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide written, signed informed consent Willing and able to comply with all study procedures Exclusion Criteria: Use of any investigational product or investigational medical device within 30 days prior to screening, except as part of a BioMarin-sponsored study Concurrent disease or condition that would interfere with study participation or safety.
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 |
| --- | --- | --- |
| continuous collection of donated study subject samples |  | unknown, continuous sample collection |
Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.

Official Title
-----------------
A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.

Conditions
-----------------
Non-metastatic Prostate Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer in the early stage of disease Prostate removed and/or radiation therapy to the prostate area Exclusion Criteria: Previous systemic therapy for prostate cancer Previous history of another form of cancer (not prostate) within 5 years of study start.

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

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

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 |
| --- | --- |
| Experimental: 1<br> | Drug: Bicalutamide<br>* 150mg daily<br>* Other names: Casodex™;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical progression |  | Throughout study period | 
| Overall patient survival |  | Throughout study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure |  | Throughout study period | 
| Serum prostate-specific antigen |  | Initial study period up to 2006 amended protocol | 
| Tolerability in terms of adverse events and laboratory parameters |  | Throughout study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
androgen antagonists, prostate neoplasms
Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical efficacy of the extended release formulation of tacrolimus (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with cyclosporine A because of side effects and/or non-responsiveness.

Official Title
-----------------
Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Extended release tacrolimus (Advagraf®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with severe atopic dermatitis, uncontrolled by topical treatment (indication for oral immunosuppressive drugs), who are unresponsive to Cyclosporin A, or in which treatment was discontinued because of side effects. Exclusion Criteria: Concomitant use of other oral immunosuppressive drugs and/or UV light therapy Preexisting abnormalities in liver function, kidney function or haematological abnormalities History of malignancy within the last 5 years Uncontrolled hypertension Pregnancy or lactation; wish for pregnancy during the treatment period Infections requiring continued therapy Known positivity for HIV Evidence of drug and/or alcohol abuse

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Extended release tacrolimus (Advagraf®)<br> | Drug: Extended release tacrolimus (Advagraf®)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Scoring Atopic Dermatitis (SCORAD) | Clinical eczema scores | Every 4 weeks up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-Oriented Eczema Measure (POEM) | Self administered eczema score | Every 4 weeks up to one year | 
| Change in Thymus and Activation-Regulated Chemokine in serum (TARC) | Biomarker atopic dermatitis | Every 4 weeks up to one year |
Chemoprevention of Oral Premalignant Lesions

Study Overview
=================
Brief Summary
-----------------
Reduction in size and number of oral premalignant lesions

Official Title
-----------------
Clinical Protocol For A Phase II Double-Blind, Placebo-Controlled, Randomized Study Of Celecoxib (Sc-58635) In Oral Premalignant Lesions, Investigator IND

Conditions
-----------------
Precancerous Conditions

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 8mm oral premalignant lesion that has not been biopsied in the past 6 months Exclusion Criteria: Taking >100mg daily dose of NSAIDS (Non-steroidal anti-inflammatory drugs)

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

| Intervention/Treatment |
| --- |
|Drug: Celecoxib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL) |  |  | 
| by both clinical response (reduction in size of all lesions, |  |  | 
| prevention of growth in the index lesion and of any new lesions) |  |  | 
| and histological response (change in histological grade). |  |  | 
| To evaluate the safety of chronic multiple dosing of celecoxib in this patient population. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the treatment effects in modulating the expression of genomic and proliferative markers after 12 weeks of treatment with study drug, followed by 12 weeks off study drug. |  |  |