linjc16/ctgov huggingface dataset:
Study of Medication and Placebo Response in Major Depression

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the research study is to use recordings of brain electrical activity (through electroencephalogram, or EEG) and symptom measurements to determine whether patients are likely to show a response to medication or placebo treatment during a treatment trial for depression.

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: sertraline (Zoloft)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnosis of Unipolar Major Depression Exclusion Criteria: Substance Abuse, Psychotic Disorder, History of Severe Head Trauma

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sertraline (Zoloft)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depressive symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain electrical activity (EEG) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, EEG, QEEG, cordance, Zoloft, sertraline, placebo, electroencephalogram, brain, antidepressants
Duchenne Muscular Dystrophy < 18y in Norway: Genotype/Phenotype, Growth, Puberty, Bone Health and Quality of Life.

Study Overview
=================
Brief Summary
-----------------
The study will give a consent based epidemiological overview of Norwegian patients with Duchenne muscular dystrophy younger than 18 years of age. Genotype of the population will be described. Longitudinal development of growth, bone health, and , when applicable, puberty over a two year period will be studied. Questionnaires regarding quality of life will also be an important part of the study.

Detailed Description
-----------------
The participants who are not regularly seen at our regional hospital, are recruited via their local neuropediatrician. Patients who do not come to our region hospital will be seen at their local hospital.Each participant will be seen up to three times with one year between each visit. The visits include clinical examination, DXA scan, x-ray for bone age, and blood tests including several parameters related to bone health, growth and puberty. Standardized questionnaires regarding quality of life (patients and parents) will be used, and certain questions regarding the importance of achieving normal height and puberty will be added. Additional anamnestic data will be retrieved from the patients' medical records.

Official Title
-----------------
Duchenne Muscular Dystrophy in Norway. Genotype/Phenotype in Patients Younger Than 18 Years, With a Main Focus on Growth, Puberty, Bone Health and Quality of Life.

Conditions
-----------------
Duchenne Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Duchenne muscular dystrophy Age under 18 years Residing in Norway Exclusion Criteria: -

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

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

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 |
| --- | --- | --- |
| Genotype | Specific description of mutation | 1 day (At first visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genotype/phenotype correlations, Growth, Bone health, Puberty, Quality of life
Best Possible Medication History at USB

Study Overview
=================
Brief Summary
-----------------
This pilot project investigates the use of a structured medication history (Best Possible Medication History, BPMH) in patients (primarily admitted at the emergency department of University Hospital Basel) after transfer to a medical ward. Unintentional medication discrepancies are analyzed comparing outpatient and inpatient medication therapy.

Official Title
-----------------
Best Possible Medication History at Universitätsspital Basel (USB)

Conditions
-----------------
Best Possible Medication History

Intervention / Treatment
-----------------
* Other: BPMH structured interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to Emergency Department of University Hospital Basel and transfer to medical ward Exclusion Criteria: medication history taken at Emergency Department of University Hospital Basel not present

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

| Intervention/Treatment |
| --- |
|Other: BPMH structured interview|creating a standardized medication list by interviewing patient and/ or relatives according to Best Possible Medication History (BPMH) after patient transfer to medical ward|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unintended medication discrepancy | number of unintended medication discrepancies comparing medication history taken when admitted to emergency department and BPMH after transfer to medical ward | single time point (1 day after admission to hospital) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorisation ( Class1, Class2, Class3) for clinical relevance of unintended medication discrepancy | expert panel classifies each unintended medication discrepancy in 1 of 3 classes for its potential to cause patient harm. Class 1 discrepancies are those unlikely to cause patient discomfort or clinical deterioration. Class 2 discrepancies could potentially result in moderate discomfort or clinical deterioration. Class 3 discrepancies could potentially result in severe discomfort or clinical deterioration. | during 7 days after admission to hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse Drug Events (ADEs), Medication Accuracy, Medication Discrepancy
Bioimpedance Spectroscopy Compared to CardioMEMS™

Study Overview
=================
Brief Summary
-----------------
Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.

Detailed Description
-----------------
This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll ten participants from the Scripps Clinic. Participants will be monitored 3 times a week for a period of 4 weeks. At each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's vital signs and weight will also be taken at each monitoring visit.

Official Title
-----------------
Bioimpedance Spectroscopy Compared to CardioMEMS™ Determined Pulmonary Artery Pressure Measurements

Conditions
-----------------
NYHA Class III Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient: has an CardioMEMs device implanted has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA) is able to give informed consent Exclusion Criteria: Patient: has pacemaker/ICD is pregnant or breastfeeding is an amputee has been diagnosed with multiple medical conditions that would make participation burdensome not able to co-operate with impedance measurements

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 |
| --- | --- | --- |
| Change from baseline in bioimpedance measurement at 4 weeks | Change in impedance values will be tracked from baseline for 4 weeks and compared to CardioMEMS measures | Baseline and 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioimpedance spectroscopy
Review on Minimally Invasive Skin Incision in Vanguard PS Artificial Knee Joint System

Study Overview
=================
Brief Summary
-----------------
This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in Vanguard PS artificial knee joint total replacement observational period before and during surgery.

Official Title
-----------------
Efficacy and Safety of Vanguard PS Knee Joint System Using MIS Technique

Conditions
-----------------
Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

Intervention / Treatment
-----------------
* Procedure: Incision technique
* Procedure: Incision technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who need artificial knee joint replacement in ordinary medical consultation are selected as the subjects. Exclusion Criteria: Patients with infections such as osteomyelitis, or sepsis (Because the affected part is lesioned, excellent surgical results cannot be obtained.)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tri-Vector Approach<br> | Procedure: Incision technique<br>* Tri-Vector Approach retains the majority of 3 vectors of quadriceps.<br>|
| Experimental: Mini Mid-Vastus Approach<br> | Procedure: Incision technique<br>* Mini Mid-Vastus Approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force from femoral and tibial side to retract and bring visual field into view |  | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision length |  | intraoperatively | 
| Visual determination of the extension and flexion gap |  | intraoperatively |
A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet

Study Overview
=================
Brief Summary
-----------------
An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual Tablets in Healthy Adult Volunteers

Conditions
-----------------
Gastric Ulcer

Intervention / Treatment
-----------------
* Drug: BRI-1501
* Drug: Lafutidine
* Drug: Irsogladine maleate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subject, aged 19- 50 years Exclusion Criteria: History of clinically significant and active disease History of gastrointestinal disease History of clinically significant hypersensitivity to study drug, any other drug Laboratory test serum AST or ALT > 1.25 times of upper normal range serum total bilirubin > 1.5 times of upper normal range eGFR < 60 ml/min/1.73m² serological test(HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin) positive Hypotension or hypertension Pregnant or nursing women Participation in any other study within 90 days

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)<br>Subjects of Arm A take Lafutidine and Irsogladine maleate Individual tablets at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm A take a BRI-1501 tablet at 36th day | Drug: BRI-1501<br> <br> Drug: Lafutidine<br> <br> Drug: Irsogladine maleate<br> <br> |
| Other: Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)<br>Subjects of Arm B take a BRI-1501 tablet at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm B take Lafutidine and Irsogladine maleate Individual tablets at 36th day | Drug: BRI-1501<br> <br> Drug: Lafutidine<br> <br> Drug: Irsogladine maleate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate |  | 0 36 hour after medication | 
| Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate |  | 0 36 hour after medication |
A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies

Official Title
-----------------
A Phase I Single Arm,Open-label,Multiple Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies

Conditions
-----------------
Relapsed or Refractory B-cell Hematologic Malignancies

Intervention / Treatment
-----------------
* Drug: HEC89736


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age is over 18 years old Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies ECOG performance status (PS) 0   1 Expected survival of > or = 3 months Exclusion Criteria: The use of PI3Ks as the target of anti-tumor drugs progress (due to intolerance group) Received any other anti-cancer treatment within 4 weeks Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption Allergy, or known to have a history of allergy to the drug components

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: HEC89736 treatment<br>HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle | Drug: HEC89736<br>* HEC89736 tablets QD every 28 days for each cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose | Incidence of dose limited toxicities and associated dose of HEC89736 | Dosing started until the 28th day | 
| Adverse events evaluated by NCI CTCAE 5.0 | Incidence of adverse events and associated dose of HEC89736 | From the frst dose to within 30 days after the last dose |
Computer-Assisted Quantification of the Synovial Perfusion in Patients With Arthritis Using Two-Dimensional and Three-Dimensional Power Doppler Ultrasonography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the data obtained by computer-aided quantification of the synovial perfusion in patients with arthritis using two-dimensional and three-dimensional power Doppler ultrasonography and the clinical data used to represent the degree of joint inflammation. Intra- and inter-observer reliability of this method will also be determined.

Official Title
-----------------
Computer-Assisted Quantification of the Synovial Perfusion in Patients With Arthritis Using Two-Dimensional and Three-Dimensional Power Doppler Ultrasonography

Conditions
-----------------
Synovitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with at least one painful swollen peripheral joint observed by a rheumatologist, including: shoulder joints elbow joints wrist joints metacarpophalangeal (MCP) AND proximal interphalangeal (PIP) joints of hands, ankle joints, subtalar joints, mid-tarsal joints, MTP and PIP joints of feet Exclusion Criteria: patients with active infection patients with concurrent malignant disease patients with a history of traumatic, septic, or cystal arthritis previous joint surgery, or isotopic synovectomy within the past 12 months before the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>RA patients with at least one active synovitis | |
| 2<br>Non-RA patients with at least one active synovitis | |

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
-----------------
active synovitis
Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

Study Overview
=================
Brief Summary
-----------------
This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.

Detailed Description
-----------------
This open-label feasibility study seeks to examine the potential of 400μg sublingual misoprostol for the treatment of incomplete abortion provided at tertiary hospitals.

Official Title
-----------------
Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

Conditions
-----------------
Incomplete Abortion

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed incomplete abortion No known contraindications to the study drug Uterine size no larger than 12 weeks at time of presentation for care No signs of severe infection, defined as at least two of the following: foul smelling discharge, fever > 38 degrees C, 100 degrees Fahrenheit uterine tenderness. No hemodynamic disturbances (pulse >110/min and systolic bp <100) General good health Agree to comply with study procedures including return for follow up visit Live or work within one hour from a study site Willing and able to sign consent forms Exclusion Criteria: 1. Inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 55 Years

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

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

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 |
| --- | --- |
| Other: Miso<br>Misoprostol 400 s/l | Drug: Misoprostol<br>* 400 mcg sublingual misoprostol<br>* Other names: cytotec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women with complete uterine evacuation with study medication alone. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women experiencing side effects | occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain. | 7-14 days | 
| Level of self-reported acceptability of treatment | Woman's satisfaction with the treatment, woman's likelihood to use the treatment in the future, woman's likelihood of recommending the treatment to a friend, providers' satisfaction with the treatment, likelihood provider would recommend the treatment in a similar situation. | 7-14 days |