linjc16/ctgov huggingface dataset:
Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the bioequivalence of a potential generic 6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol® (mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the fasted state.

Official Title
-----------------
A Pharmacokinetic Study to Assess the Single-Dose Bioequivalence of a Potential Generic Formulation of a 6-Mercaptopurine 50 mg Tablet Compared to a Marketed 6-Mercaptopurine 50 mg Tablet, Purinethol®, When Administered to Healthy Male Subjects, in the Fasted State

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: 6-Mercaptopurine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on physical examination, medical history, or clinical laboratory results. Must voluntarily consent. Exclusion Criteria: Must not have a known history of thiopurine methyltransferase deficiency or family history. Must not have a history of elevated uric acid or gout. Must not be currently using allopurinol.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 6-Mercaptopurine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, two period, 3 day washout |
Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The bipolar depression patients of 18-55 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological, neurobiological and genetic data was collected. After the completion of the baseline assessment and examination, the patients were given lithium carbonate or lithium carbonate combined with SSRI antidepressant treatment. Clinical evaluation was performed at 2 and 8 weeks after treatment, including the therapeutic efficacy and adverse drug reactions, and monitoring of serum lithium concentration. The patients further receive the fMRI scans after treatment for 8 weeks. Through above work, this study aimed to provide some guidance for the use of antidepressants in patients with bipolar depression.

Official Title
-----------------
Clinical Psychopharmacology Division Institute of Mental Health, Peking University

Conditions
-----------------
the Use of Antidepressants in Patients With Bipolar Depression

Intervention / Treatment
-----------------
* Drug: Lithium Carbonate
* Drug: lithium carbonate combined with SSRI antidepressant treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-55 years old, bipolar depression Exclusion Criteria: other mental illness, serious somatic illnesses, MRI contradictions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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 |
| --- | --- |
| Experimental: lithium carbonate<br>recieve lithium carbonate | Drug: Lithium Carbonate<br>* bipolar depression recieve lithium Carbonate treatment<br>|
| Experimental: lithium carbonate combined with SSRI antidepressant treatment<br>recieve lithium carbonate combined with SSRI antidepressant treatment | Drug: lithium carbonate combined with SSRI antidepressant treatment<br>* lithium carbonate combined with SSRI antidepressant treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRSD reduction ratio | HRSD reduction ratio | 8 weeks |
A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis

Official Title
-----------------
A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation: the ELICOPTER Trial

Conditions
-----------------
Myocardial Ischemia

Intervention / Treatment
-----------------
* Device: DEB+BMS
* Device: POBA+DES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 18 years angina or stress test positive for ischemia de novo coronary stenosis>50% Exclusion Criteria: recent myocardial infarction (<72h) severe chronic kidney disease allergy to Paclitaxel contraindication for combined antiplatelet treatment life expectancy <1 year hypersensitivity or contraindication to one of the study drugs lack of 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEB+BMS<br>drug-eluting balloon predilation and bare metal stent implantation | Device: DEB+BMS<br>* drug-eluting balloon predilation and bare metal stent implantation<br>|
| Active Comparator: POBA+DES<br>conventional balloon predilation and drug-eluting stent implantation | Device: POBA+DES<br>* conventional balloon predilation and drug-eluting stent implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic binary re-restenosis | incidence of angiographic binary re-restenosis | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late luminal loss | incidence of late luminal loss assessed by angiography | 9 months | 
| major adverse cardiac events | incidence of major adverse cardiac events | 12 months |
Impact of Balanced Slat Colloid HES 130/0.42 on Coagulation Profiles in Patients Undergoing Spinal Cord Tumor Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of study is to compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery.

Conditions
-----------------
Coagulation

Intervention / Treatment
-----------------
* Other: Valanced salt colloid
* Other: Valanced salt crystalloid group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients over the age of 20 scheduled for spinal tumor removal and fixation Exclusion Criteria: 1. Renal failure 2. Preexisting congestive heart failure(NYHA III   IV) 3. Anemia 4. Coagulopathy 5. Abnormal liver function 6. Anti coagulation/Anti platelet ,edication 7. Foreigner, illiterate 8. Disabled person,

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valanced salt colloid group<br> | Other: Valanced salt colloid<br>* Maximum dose : 30ml/kg, IV, The infusion of valanced salt colloid is started at bleeding and continued until reach at maximum dose<br>|
| Active Comparator: Valanced salt crystalloid group<br> | Other: Valanced salt crystalloid group<br>* Maximum dose : 30ml/kg, IV, The infusion of valanced salt crystalloid is started at bleeding and continued until reach at maximum dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery. | ROTEM, CBC, PT/aPTT,ABGA, Lactic acid, electrolyte | up to 24hrs after anesthesia induction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
balanced salt colloid, coagulation profiles, spinal cord tumor
Electronic Medical Records and Genomics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a biobank containing samples of 2,000 patients treated in a tertiary cardiology hospital containing electronic medical records and genetic data in genome-wide scale for performing genetic association studies for validation and development of medical decision routines that help the clinical management of heart failure patients.

Detailed Description
-----------------
Patients between 18 and 80 years old with heart failure diagnosis of different etiologies and left ventricular ejection fraction < 50% in the past 2 years will be eligible for enrollment on the cohort. After consent, patients will be submitted to clinical baseline, echocardiographic, cardiography impedance and biochemical evaluation. Study data will be collected and managed using Research Electronic Data Capture (REDCap) tools. The follow up will take place every 6 months to assess cardiovascular outcomes (all-cause mortality, cardiovascular mortality, hospitalization for worsening heart failure and current medication use). Initial analytical strategy will focus on the establishment of the accuracy of electronic medical records extraction protocols for main predictor factors of morbidity and mortality in heart failure.

Official Title
-----------------
Genetic and Electronic Medical Records to Predict Outcomes in Heart Failure Patients

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 80 years old Heart failure diagnosis of different etiologies Left ventricular ejection fraction < 50% in the past 2 years Exclusion Criteria: Patients with impaired cognition due to advanced dementia syndrome or severe psychiatric disorder Patients without telephone access Patients that refused to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| all cause mortality | Deaths for all causes after 6 months of inclusion. Deaths for all causes after 12 months of inclusion | six and twelve months after inclusion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular mortality | Deaths for cardiovascular cause after 6 months of inclusion. Deaths for cardiovascular cause after 12 months of inclusion. | six and twelve months after inclusion. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Electronic medical records, Genomics, Biobank
Metformin as Adjuvant to Insulin Therapy in Insulin-resistant Diabetes Mellitus With Pregnancy

Study Overview
=================
Brief Summary
-----------------
Adding metformin to insulin therapy in pregnant women with diabetes mellitus who show insulin resistance may be equivalently effective to further raising the insulin dose

Official Title
-----------------
The Role of Adding Metformin in Insulin-Resistant Diabetic Pregnant Women - a Randomized Controlled Trial

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Humulin Insulin Mixtard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women with insulin-resistant diabetes mellitus Exclusion Criteria: type-1 diabetes mellitus secondary diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin<br>metformin was added without raising the insulin dose | Drug: Metformin<br> <br> * Other names: Cidophage;|
| Active Comparator: Raising Insulin<br>insulin dose is raised | Drug: Humulin Insulin Mixtard<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proper Glycemic Control |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Pregnancy, Insulin, Metformin
Modulation of Cognitive Control by Transcranial Direct Current Stimulation

Study Overview
=================
Brief Summary
-----------------
Insufficient cognitive control over emotional distracters is characteristic for major depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is associated with this deficit. In this study the investigators assess the effect of an enhancement of dlPFC activity in MDD patients by anodal transcranial direct current stimulation (tDCS) on cognitive control. In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators determine the effect of a single-session tDCS to the left dlPFC on cognitive control in MDD patients and healthy controls. To assess the cognitive control the investigators use a delayed response working memory (DWM) task with pictures of varying valence presented during the delay period.

Official Title
-----------------
Modulation of Cognitive Control in Healthy and Depressed Subjects by Transcranial Direct Current Stimulation

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Device: Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 informed consent in the patients group: Major depressive disorder, no antidepressant medication or stability over 1 week Exclusion Criteria: seizures cardiac pacemaker deep brain stimulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anodal transcranial direct current stimulation<br>Anodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus | Device: Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)<br> <br> |
| Sham Comparator: Sham transcranial direct current stimulation<br>Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus | Device: Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correctness of response |  | The primary outcome measure is obtained during the intervention (20min tDCS or sham stimulation). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time |  | The secondary outcome measure is obtained during the intervention (20min tDCS or sham stimulation). |
Myocardial Inflammation in Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
The goal is to assess for myocardial edema on cardiac MRI during SLE flare to assess for myocardial inflammation.

Detailed Description
-----------------
The over-arching goal of this work is to further the understanding of myocardial damage in systemic lupus erythematosus (SLE) using state of the art CV imaging to investigate a novel potential mechanism of CV injury in SLE, subclinical myocardial inflammation. Aim 1: Investigate an alternative pathway for CV morbidity in SLE by measuring myocardial edema at time of moderate to severe flare and compare values to post-flare studies and historical healthy controls. Hypothesis 1: Myocardial edema, measured quantitatively with T2 CMR mapping during moderate to severe SLE flare will be significantly increased compared to 1) historical controls and 2) in SLE patients after resolution of flare. Aim 2: Perform exploratory analyses investigating relationships between myocardial edema on CMR and markers of SLE disease activity and CV risk factors. Hypothesis 2: Markers of disease activity including inflammatory makers (ESR and high sensitivity c-reactive protein), complement and autoantibody levels will predict the presence of T2 CMR detected myocardial edema during flare.

Official Title
-----------------
Myocardial Inflammation in Systemic Lupus Erythematosus

Conditions
-----------------
SLE

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Diagnosis of SLE by American College of Rheumatology Classification Criteria [21] Active SLE Flare defined by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)[22] > 6 or British Isles Lupus Assessment Group (BILAG) Index A or B.[23] Exclusion Criteria: Pregnant Allergy to gadolinium Severe claustrophobia Renal replacement therapy or glomerular filtration rate (GFR) < 30 mL/min/1.75m² Medically unstable for transportation to Ross MRI scanner. Stability will be defined as: not on mechanical ventilation, HR < 120 BPM, MAP > 65 mmHg. The treating providers' input on the patient's stability will also be considered in addition to these criteria Weight > 500 pounds MR incompatible implanted devices such as neurostimulator pacemakers and implantable defibrillators, presence of intracranial metal or any metal not compatible with CMR

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SLE active flare<br>Patients who are having an active flare of their lupus confirmed by labs | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T2 edema on Cardiac MRI | Compare T2 edema at flare and 3 months later | 3 months |
Probiotic Formula and Infant Growth

Study Overview
=================
Brief Summary
-----------------
This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.

Official Title
-----------------
ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Control infant formula
* Other: Test infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy newborn infant Full-term Birth weight > 2500 and < 4500 g 14±3 days of age on enrollment Exclusively formula-fed, singleton birth Having obtained his/her legal representative's informed consent Exclusion Criteria: Known or suspected cow-milk allergy Congenital illness or malformation that may affect infant feeding and/or growth Significant prenatal and/or postnatal disease Any readmission to hospital prior to enrollment Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements Has received intravenous antibiotic therapy or oral probiotic in the last 7 days Currently participating in another clinical study Cannot be expected to comply with treatment

Ages Eligible for Study
-----------------
Minimum Age: 11 Days
Maximum Age: 17 Days

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 |
| --- | --- |
| Active Comparator: control infant formula<br>partially hydrolyzed whey infant formula | Other: Control infant formula<br>* partially hydrolyzed whey infant formula consumed ad libitum throughout study<br>|
| Experimental: test infant formula<br>partially hydrolyzed whey infant formula with probiotic | Other: Test infant formula<br>* partially hydrolyzed whey formula with probiotic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth | weight gain assessed monthly | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other growth | Length, head circumference will be measured at monthly visits | 4 months | 
| adverse events | all adverse events will be documented throughout the study | 4 months | 
| stool characteristics | stool frequency, color, consistency | throughout study | 
| spit-up | frequency of spit-up as reported by caregivers | throughout study | 
| vomit | frequency of vomitting as reported by caregivers | throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
full-term, formula-fed infants