bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive
      Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild
      to Moderate Essential Hypertension
    

Detailed description: 
      After subjects have signed informed consent voluntarily, when they are taking hypertension
      medication, they go through screening period for 7 days including wash-out period.

      After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days),
      and evaluate their suitability to Inclusion and Exclusion criteria.

      Patients, who evaluated the proper subject for this clinical trial, are allocated to
      experimental group (Fimasartan 30mg) or Control group (Placebo group) or Reference group
      (Valsartan 80mg) randomly at a ratio 2:2:1 and their investigational drugs will be
      administered daily for the study period (8 weeks). Subjects visit their investigators twice
      during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.

      The placebo period will be single-blinded and the treatment allocation in this study will be
      double-blinded.
    

Intervention name(s): Placebo; Valsartan; Fimasartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; Valsartan 80mg; Fimasartan 30mg
Other intervention name(s): Diovan; Kanarb
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fimasartan
A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of multiple doses of carbamazepine
      (a strong inducer of cytochrome P450 [CYP]3A4 and a weak inducer of CYP2C9) on the
      pharmacokinetics of a single oral dose of erdafitinib in healthy adult participants.
    


Intervention name(s): Erdafitinib; Carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single oral dose of erdafitinib tablets on Day 1 in Period 1 and on Day 28 in Period 2.; Participants will receive an oral dose of carbamazepine tablets from Day 15 to 35 in Period 2.
Other intervention name(s): JNJ-42756493
Intervention MeSH terms: Carbamazepine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
Condition: Liver Transplant Rejection
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to investigate the safety, efficacy, pharmacokinetics (PK) and
      pharmacodynamics (PD) of two CFZ533 dose regimens in liver transplant recipients.
    

Detailed description: 
      This study allowed assessment of the ability of CFZ533 to replace Calcineurin inhibitors
      (CNIs) in terms of anti-rejection efficacy, while providing potentially better renal function
      with an expected similar safety and tolerability profile. Results of this study will inform
      the CFZ533 dose and regimen selection for investigation in later phases of clinical
      development.
    

Intervention name(s): CFZ533; Tacrolimus - MMF - corticosteroids
Intervention type(s): Biological; Drug
Intervention description(s): Comparison with standard of care immunosuppression; Standard of care immunosupprevive regimen
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study CCFZ533A2202 is a randomized, 12-month, active-controlled, multicenter, dose range finding study to evaluate the efficacy, safety, tolerability, PK and PD of CFZ533, as compared to standard of care comprised of tacrolimus, MMF and corticosteroids, with a 12-month additional follow up.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver transplantation; de novo recipients; deceased donor; CFZ533; CNI-free immunosuppression; Transplant rejection
The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity(DH)
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This single centre, comparative design study will be used to investigate the efficacy of an
      experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity
      (DH) after short term use compared with a standard fluoride dentifrice.
    


Intervention name(s): Stannous Fluoride dentifice; Sodium Monofluorophosphate dentifrice
Intervention type(s): Device; Other
Intervention description(s): Experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm); Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effect of Auditory Distractions on Pediatric Postoperative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of the study was to determine the effect of different auditorial methods of attention
      distraction on postoperative pain and anxiety in children. Three group pre and post-test
      randomized clinical trial.The data were collected using the Socio-demographic Data Form for
      Child and Parent, Visual Analogue Scale, Wong-Baker Faces Pain Scale and State-Trait Anxiety
      Inventory for Children. The investigators found that listening to classical music, Turkish
      music and audiobook methods played an effective role in decreasing postoperative pain and
      anxiety state in children in the three groups in the study. As a result, investigators showed
      that different auditorial attention distraction methods had a decreasing effect on
      postoperative pain and anxiety in children.
    


Intervention name(s): music and audiobook listening
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes, Youth Onset
MeSH terms: Alzheimer Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational [Patient Registry]

Summary: 
      The goal of the study is to characterize preclinical Alzheimer's Disease and related
      dementias (AD/ADRD) neuropathology in a selected group of young adults with youth-onset
      diabetes, and an age-similar group of young adults without diabetes.
    

Detailed description: 
      The goal of the current proof-of-concept study is to characterize brain structural,
      functional, and molecular imaging biomarkers of preclinical Alzheimer's Disease and related
      dementias (AD/ADRD) neuropathology in a selected group of young adults with youth-onset
      diabetes (Y-DM; type 1 diabetes [T1D], n=5; type 2 diabetes [T2D], n=5) from the SEARCH for
      Diabetes in Youth study cohort, and an age-similar group of young adults without diabetes
      (n=5). This study will quantify structural and functional imaging biomarkers of AD/ADRD
      neuropathology via magnetic resonance imaging by assessing gray matter (GM) volume/cortical
      thickness, as well as GM and white matter (WM) microstructure, resting state functional
      network connectivity (rsfMRI), and cerebral blood flow (CBF) and WM hyperintensity volume.
      This study will additionally quantify brain tau density via positron emission tomography as
      the gold-standard measure of preclinical AD/ADRD neuropathology.
    

Intervention name(s): PI-2620 tracer
Intervention type(s): Drug
Intervention description(s): Following published manufacturer guidelines for Flutemetamol (VizamylTM), Flortaucipir (TauvidTM) and PI-2620 tracer administration162, all participants will be given a 370 MBq (10 mCi) single intravenous bolus (total volume 10mL) of the radiotracer, followed with an intravenous flush of 0.9% sodium chloride injection. Radiotracer administration and participant monitoring will be conducted by trained personnel from the CU-RIC.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of young adults with youth-onset type 1 diabetes and type
        2 diabetes from the SEARCH for Diabetes in Youth study cohort, and an age-similar group of
        young adults (18-40 years old) without diabetes.
      
Keywords: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes, Youth Onset; Magnetic Resonance Imaging; Positron Emission Tomography Imaging
Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      A randomized double-blind controlled trial will be carried out in which young, nulliparous
      (having never given birth) women will be randomly assigned to receive weekly supplementation
      with either iron and folic acid or folic acid alone. Women will be followed-up weekly up to
      18 months. Women who become pregnant will be followed-up until delivery. Malaria risk in both
      groups will be compared by assessing the prevalence of peripheral parasitaemia at the first
      antenatal clinic visit for pregnant women and at the end of the first malaria transmission
      season for non-pregnant women. The incidence of clinical malaria will be assessed by active
      and passive case detection throughout the follow-up period.
    


Intervention name(s): Folic Acid; Folic Acid and Iron
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2.8mg; 60mg Iron and 2.8mg Folic Acid
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pregnancy; Iron deficiency; Iron supplementation; Burkina Faso
A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in
      healthy male subjects.
    


Intervention name(s): Donepezil patch; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the
      effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the
      drugs.

      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and dexamethasone
      with oblimersen in treating patients who have relapsed or refractory multiple myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the clinical efficacy of oblimersen, thalidomide, and dexamethasone, in terms
           of complete and partial response rates, in patients with relapsed or refractory multiple
           myeloma.

        -  Determine the time to progression and duration of response in patients treated with this
           regimen.

        -  Determine the toxicity of this regimen in these patients.

        -  Correlate disease response (clinical outcome) with changes in Bcl-2 levels in patients
           treated with this regimen.

        -  Determine the disease-free and overall survival of patients treated with this regimen.

      OUTLINE: Patients receive induction therapy comprising oblimersen IV continuously on days
      1-7, 22-28, and 43-49, oral dexamethasone on days 4-7, 25-28, and 46-49, and oral thalidomide
      daily beginning on day 4. Treatment continues in the absence of disease progression or
      unacceptable toxicity.

      Patients with stable disease after induction therapy receive maintenance therapy comprising
      oblimersen IV continuously on days 1-7, oral dexamethasone on days 4-7, and oral thalidomide
      daily. Courses repeat every 35 days for up to 2 years in the absence of disease progression
      or unacceptable toxicity.

      Patients are followed for 3 years.

      PROJECTED ACCRUAL: A total of 10-46 patients will be accrued for this study within 10 months.
    

Intervention name(s): oblimersen sodium; dexamethasone; thalidomide
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Thalidomide; Dexamethasone; Oblimersen
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory multiple myeloma
Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Montelukast Sodium Oral Granules 4mg of Dr. Reddy's
      Laboratories Limited, India comparing with that of SINGULAIR® (Montelukast sodium) 4mg oral
      granules of Merck Sharp & Dohme Ltd., USA in healthy, adult, human subjects under fasting
      conditions.
    

Intervention name(s): Montelukast sodium
Intervention type(s): Drug
Intervention description(s): Montelukast Sodium Oral Granules 4mg
Other intervention name(s): SINGULAIR
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Montelukast Sodium; crossover
Comparing the Quality of Life Between LADG and TLDG for Gastric Cancer_KLASS07 (CKLASS01)).
Condition: Quality of Life; Gastric Cancer; Surgery; Surgical Complication
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The present randomized study is designed to compare the quality of life between the patients
      undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric
      cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy
      to laparoscopy-assisted distal gastrectomy.
    

Detailed description: 
      The primary endpoint of this trial is the early postoperative morbidity, that is defined as
      complications that occur within 30 days after surgery.

      Early postoperative morbidity is classified as follows:

      (1) wound morbidity (2) surgical site morbidity: anastomosis bleeding or leakage, duodenal
      stump leakage, postoperative bleeding, afferent loop or efferent loop obstruction, etc.; (3)
      lung morbidity: atelectasis, pleural effusion, empyema, pneumothorax, etc.; (4) intestinal
      obstruction morbidity (5) urinary tract morbidity (6) intra-abadominal abscess (7)
      postoperative pancreatitis (8) pancreatic fistula (9) intestinal fistula 10) others:
      lymphorrhea, diarrhea, etc.

      The secondary end point is the questionnaire score regarding QOL. This is assessed by the
      Korean versions of the EORTC QLQ-C30 (version 3.0) and STO22 questionnaires.
    

Intervention name(s): TLDG arm; LADG arm
Intervention type(s): Procedure; Procedure
Intervention description(s): After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG); After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, multi-center trial that comparing surgical complications and Quality of Life between "Totally laparoscopic distal gastrectomy" and "Laparoscopy-assisted distal gastrectomy" in Korea.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Remote Care for CIED Patients in Korea
Condition: Arrhythmias, Cardiac
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      This trial is for monitoring the quality and satisfaction of CIED patients who are naive with
      remote device monitoring.
    

Detailed description: 
      Patient satisfaction (using questionnaire) before and after wireless/wired monitoring and
      outpatient treatment time, variables in heart transplantation devices for wireless/wired
      monitoring, presence of heart failure, cardiovascular events such as arrhythmia, myocardial
      infarction or cerebral infarction, thromboembolism and admission related to cardiovascular
      cause. The questionnaire was adopted and modified from modified Korean version of HoMASQ (by
      YouMi Hwang,2021 from HoMASQ; Europace (2010))
    

Intervention name(s): remote monitoring
Intervention type(s): Device
Intervention description(s): CIED monitoiring with remote monitoring device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study includes Biotronic CIED implanted patients in St. Vincent's Hospital, Catholic
        University of Korea, Republic of Korea. Study population are included if they are more than
        20year old, followed up at outpatient clinic > 6 months after CIED implantation, and are
        literate and have perceptibility on questionnaire.
      
Keywords: pacemaker; Implantable Cardioverter Defbrillator; Cardiac resynchronization therapy
Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory
Condition: Body Constitution
Study type: Observational

Summary: 
      Background: Different people are classified into different physiological constitution types
      in the Traditional Chinese Medicine (TCM) theory. Two instruments, the Body Constitution
      Questionnaire (BCQ) and the Constitution in Chinese Medicine Questionnaire (CCMQ), have been
      developed in Taiwan and Mainland China respectively to measure constitution. They were
      adapted and pilot tested in primary care Chinese patients in Hong Kong, which showed
      acceptable validity and reliability. These instruments have potential applications for
      epidemiological studies on body constitution.

      Aim and objectives: The aim of this study is to establish the prevalence and epidemiology of
      body constitution classified by the Traditional Chinese Medicine Theory in the Chinese
      population in Hong Kong. It would also determine whether the prevalence of constitution types
      change with seasons and whether it is associated with socio-demographic factors, place of
      origin or residence, life style, or quality of life.

      Design and subjects: Two cross-sectional telephone surveys of the Hong Kong (HK) general
      Chinese population, one in Summer and one in Winter, will be carried out. Sample size for
      each survey is 3200 subjects.

      Methods: Residential-telephone-owning households will be contacted through random dialing by
      the Social Science and Research Centre of the University of Hong Kong using the
      Computer-Assisted Telephone Interviewing (CATI) system that covers 95% households in Hong
      Kong. A member, aged 18 or above, of the contacted household who last had his/her birthday
      will be invited to the study to answer either the BCQ or the CCMQ and a structured
      questionnaire on socio-demographics, place of origin, place of residence, health service
      utilization, life style and quality of life.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Methods: Residential-telephone-owning households will be contacted through random dialing
        by the Social Science and Research Centre of the University of Hong Kong using the CATI
        system that covers 95% households in Hong Kong. A member, aged 18 or above, of the
        contacted household who last had his/her birthday will be invited to the study to answer
        either the BCQ or the CCMQ and a structured questionnaire on socio-demographics, place of
        origin, place of residence, health service utilization, life style and quality of life.
      
Keywords: Body constitution; Chinese Medicine; Validation
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3
Condition: Still's Disease, Adult-Onset
MeSH terms: Still's Disease, Adult-Onset
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind,
      Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and
      Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants.
    

Detailed description: 
      Primary objective of this study will be to evaluate the safety and tolerability of APB-R3
      following intravenous (IV) administration of single ascending dose in healthy participants.

      The study will consist of 5 planned cohorts (1 cohort per dose level) for a total of up to 31
      participants. Cohorts 1 and 2 will include 5 participants each (3 participants receiving the
      active and 2 participants receiving the placebo). Cohort 3 to Cohort 5 will include 7
      participants each (5 participants receiving the active and 2 participants receiving the
      placebo).
    

Intervention name(s): APB-R3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): APB-R3 is formulated as a sterile solution containing APB-R3 as the active substance administered intravenously.; 0.90% Normal Saline only
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment