bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance
Condition: Hypertension; Type 2 Diabetes Mellitus
MeSH terms: Hypertension; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin
      Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the
      cardiac- and reno-protective effects of these drugs. However, these recommendations could not
      be extrapolated to Japanese patients, because Japan has been known as a country with a low
      incidence of coronary artery disease and a high incidence of cerebrovascular disease.
      Furthermore, calcium channel blockers (CCBs) also were protective against renal function as
      well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test
      whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.
    


Intervention name(s): Valsartan; Amlodipine
Intervention type(s): Drug; Drug
Intervention description(s): valsartan 80 to 160 mg daily; Amlodipine 5 to 10 mg daily.
Intervention MeSH terms: Amlodipine; Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cardiovascular disease; rennin-angiotensin system; calcium channel blocker; impaired glucose tolerance
Late Cardiac Evaluation of the Three Arm Belgian Trial Involving Node-positive Early Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial involving
      node-positive early breast cancer patients with a long median follow-up (~ 15 years)

      OBJECTIFS

      Primary:

      • To compare the incidence of late cardiac events between anthracycline and non-anthracycline
      chemotherapy given to node-positive breast cancer patients in the Belgian three arm
      randomized clinical trial

      Secondary:

        -  To compare the late incidence of cardiac events between higher and lower dose
           anthracycline treated node-positive breast cancer patients;

        -  To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy
           for:

        -  left ventricular diastolic function assessed by Echo

        -  exercise capacity assessed by 6-minute walk test (6MWT)

        -  cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI

        -  serum cardiac biomarkers (BNP and TNT)

        -  patient-reported cardiac symptoms

        -  patient-reported cardiac symptoms assessed by QOL questionnaires are associated with
           subclinical findings on LVEF assessment

        -  cognitive function, functional autonomy, and psychological distress
    

Detailed description: 
      The primary objective of this study is to compare the incidence of cardiac events [(defined
      as asymptomatic systolic dysfunction (LVEF < 50%, asymptomatic NYHA I) or symptomatic heart
      failure NYHA class II-IV either by Echo and/or by clinical exam (LVEF < 50% and heart failure
      symptoms)] between anthracycline and non-anthracycline chemotherapy treated node-positive
      breast cancer patients in a long-term follow-up. We will define a binary status for each
      patient: no cardiac event / one or more cardiac events. Analysis of the primary endpoint will
      involve a comparison of the CMF-treated patients versus the pooled anthracycline treated
      patients (EC and HEC). If a significant difference is detected, all paired comparisons will
      also be performed for the primary endpoint (CMF versus EC, CMF versus HEC, EC versus HEC).
    

Intervention name(s): cardiac MRI
Intervention type(s): Other
Intervention description(s): Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CMF; HEC; EC; node positive; breast cancer
Early Goal-Directed Therapy Utilizing Transpulmonary Thermodilution and Severe Burn Injury
Condition: Burns
MeSH terms: Burns
Study type: Observational

Summary: 
      This study aimed to optimize fluid resuscitation with transpulmonary thermodilution
      (TPTD)-guided protocol and to lower the mortality rate of the severely burned.
    


Intervention name(s): Control group: Patients being admitted when The advancement of transpulmonary thermodilution(TPTD) device was unavailable.; Study group: TPTD device was implemented for monitoring.
Intervention type(s): Other; Other
Intervention description(s): The control group included patients being admitted when TPTD device was unavailable; and relatively stable patients without the need for TPTD. The adequacy of fluid resuscitation in the control group was monitored by traditional monitoring parameters including vital signs and hourly urine output.; TPTD device was implemented for monitoring; the inclusion criteria included patients suffering from 2nd degree burn greater than 40% TBSA; a combined 2nd to 3rd degree burn greater than 30% TBSA; or patients with inhalation injury despite the burned surface area.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From January 2011 to June 2019, all adult patients (age > 18 years) suffered from major
        burn,23 defined as total burned surface area (TBSA) > 20% with at least second degree burn
        depth were admitted to the intensive care unit (ICU) of the Burn Center at a tertiary
        medical center were retrospectively reviewed.
Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary
      pulmonary hypertension.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
      Patients are stratified according to center and etiology of disease.

      Patients receive conventional oral therapy plus a continuous subcutaneous infusion of either
      UT-15 or placebo for 12 weeks.

      After completing 12 weeks of treatment, patients may continue therapy with open label UT-15.
      Patients who received placebo cross over to receive UT-15.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): UT-15
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: cardiovascular and respiratory diseases; hypertensive disorder; primary pulmonary hypertension; rare disease
The Effect of Core Stability Training on Deep Stabilizing Muscles.
Condition: Low Back Pain, Mechanical; Low Back Pain; Low Back Pain, Postural
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Non-specific low back pain is the most cause of adult disability throughout life. Its
      prevalence widens in young adults. Background of this pathology can be multifactorial. One of
      the most common is poor core stability and overloading of the local tissues as a result.

      Among treatment methods stabilizing training is commonly used with good effects. This form of
      therapy affects the transverse abdomen and multifidus muscles. To assess these structures
      several methods can be applied, e.g. sonofeedback.

      Our hypothesis claims that the core muscles morphology will change over the training process
      duration, in result, the analgesic effect will be achieved.
    

Detailed description: 
      Non-specific low back pain is the most cause of adult disability throughout life. Its
      prevalence widens in young adults. Background of this pathology can be multifactorial. One of
      the most common is poor core stability and overloading of the local tissues as a result.

      Among treatment methods stabilizing training is commonly used with good effects. This form of
      therapy affects the transverse abdomen (TrA) and multifidus (MF) muscles. To assess these
      structures several methods can be applied, e.g. sonofeedback.

      All participants will be randomly divided into two groups:

        1. Training group (TG)

        2. Control group (CG)

      Outcome measure:

      Pre- and post-therapy outcome measure will be done. It will include:

        -  ultrasound (sonofeedback) of the TrA and MF

        -  Oswestry Disability Index questionnaire (ODI)

        -  subjective pain scale - Numeric Rating Scale (NRS)

      Intervention:

      Core stability training including 4 exercise positions, each of 15 repetitions, 4 sets. Once
      a day, 5 times a week, 20 sessions in total (4 weeks).

      Our hypothesis claims that the core muscles morphology will change over the training process
      duration, in result, the analgesic effect will be achieved.
    

Intervention name(s): Core stability training
Intervention type(s): Other
Intervention description(s): 20 sessions of specific core stability exercise with no external loading.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: low back pain; ultrasound; sonofeedback; core stability; lumbar spine; transverse abdomen; multifidus
Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa
      pharmacokinetics
    

Detailed description: 
      Single centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4
      groups of healthy subjects
    

Intervention name(s): BIA 9-1067; Placebo; levodopa/carbidopa; levodopa/benserazide
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): OPC, Opicapone; PLC, Placebo; Sinemet® 100/25; Prolopa® 100/25
Intervention MeSH terms: Levodopa; Carbidopa; Opicapone; Benserazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson Disease; BIA 9-1067
Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
Condition: Chronic Viral Hepatitis B With Delta-agent
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in
      Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with
      Chronic Viral Hepatitis B with Delta-agent
    

Detailed description: 
      This is a multicenter, open-label, randomised, comparative, active-controlled parallel-arm
      phase II study.

      The study will be conducted in Russia. The aim of this study is to explore the safety and
      efficacy of treatment with Myrcludex B used as a monotherapy and in combination with PEG-IFNα
      and Tenofovir compared to monotherapy with PEG-IFNα in patients with chronic viral hepatitis
      B with delta-agent, based on the achievement of undetectable viral load at the end of the
      follow-up period 6 months (24 weeks) after the end of treatment. The study is also aimed at
      investigating immunogenicity of Myrcludex B and the drug pharmacokinetics when used in
      combination with PEG IFN alfa-2a and with Tenofovir.

      It is planned to screen 110 patients, and 90 patients will be randomised in equal numbers
      into six treatment arms.

        -  Arm A (n=15): PEG IFN alfa-2a 180 µg for 48 weeks

        -  Arm B (n=15): Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks

        -  Arm C (n=15): Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks

        -  Arm D (n=15): Myrcludex B 2 mg for 48 weeks

        -  Arm E (n=15): Myrcludex B 10 mg (10 mg once a day)+ PEG IFN alfa-2a 180 µg for 48 weeks

        -  Arm F (n=15): Myrcludex B 10 mg (5 mg twice a day)+ Tenofovir for 48 weeks
    

Intervention name(s): Myrcludex B; PEG IFN alfa-2a; Tenofovir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lyophilised powder for solution for subcutaneous injection; solution for subcutaneous injection, once per week; Film-coated tablets, 300 mg, per os, once daily
Other intervention name(s): Bulevirtide; Pegasys; Viread
Intervention MeSH terms: Tenofovir; Peginterferon alfa-2a; Interferon alpha-2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, Open-label, Randomized, Comparative, parallel-arm phase II study
Masking: None (Open Label)
Primary purpose: Treatment
Magnesium and Vascular Stiffness
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Observational epidemiologic studies have observed an inverse relationship between daily
      dietary magnesium intake and blood pressure (BP). Except for BP, magnesium may also
      beneficially affect other cardiovascular risk markers. Whether all these effects translate
      into improved vascular function is not known. Different vascular function markers at various
      stages on the pathway between diet and disease exist. One of these markers, vascular
      stiffness, is closely related to the process of atherosclerosis, an independent
      cardiovascular risk factor, and predictive of future cardiovascular events and mortality. To
      examine the integrated effects of interventions on cardiovascular risk, vascular stiffness
      may therefore serve as a marker at the later stage of cardiovascular disease development.

      Therefore, it is imperative to examine in a 24-week, randomized, double-blind,
      placebo-controlled, two-way parallel-group human intervention study, the effect of magnesium
      on vascular stiffness. Focus will be on carotid-femoral pulse wave velocity (PWV), the gold
      standard for the evaluation of vascular elasticity, to quantify vascular stiffness. Urinary
      excretion of magnesium will be used to assess dietary magnesium uptake. Furthermore, time
      courses of an increased magnesium intake on changes in BP, other markers reflecting vascular
      function, and plasma biomarkers related to low-grade inflammation and vascular activity will
      be measured to unravel possible cause-effect relationships.
    


Intervention name(s): Magnesium Citrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One capsule thrice daily that contains magnesium citrate (total daily dose: 350 mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks; One capsule thrice daily that contains placebo at breakfast, lunch and dinner for 24 weeks
Intervention MeSH terms: Magnesium citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Metabolic Syndrome; Obesity; Magnesium Supplementation; Vascular Stiffness; Vascular Function
Stress, Anxiety and Type A Personality and Analgesics
Condition: Postoperative; Dysfunction Following Cardiac Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients scheduled for elective cardiac surgery are preoperative evaluated using different
      personality type, stress and anxiety tests.

      Patient are randomized to receive the investigators' standard moderate dose sufentanil (bolus
      1microgram/kg and propofol 0.03 mg/kg/min) or low dose sufentanil (bolus 0.5 microgram/kg and
      propofol 0.06 mg/kg/min).
    

Detailed description: 
      Patients randomized and the type of induction informed to the anaesthetist 30 minutes before
      surgery.

      Patients are monitored before induction of anesthesia. Propofol is started on the randomized
      infusion rate. Sufentanil bolus are given according to randomization. BIS level is followed.
      Time to reach BIS < 50 is monitored. BIS after 30, 60 and 90 minutes are registered. Lowest
      BIS during surgery are registered. Total amounts of sufentanil and propofol recorded.
    

Intervention name(s): Sufentanil I; Sufentanil II; Propofol I; Propofol II
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): bolus dose of sufentanil 1 microgram/kg; bolus dose of sufentanil 0.5 microgram/kg; Continued dose of propofol 0.03 mg/kg/min; Continued dose of propofol 0.06 mg/kg/min
Other intervention name(s): Sufenta; Sufenta; Propofol; Propofol
Intervention MeSH terms: Sufentanil; Dsuvia; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: sufentanil; propofol; personality/stress test; fast-track
Comparison of Effect-site Concentration of Remifentanil for Preventing Cough Against Endotracheal Tube During Anesthetic Emergence According to Anesthetics (Sevoflurane, Desflurane, and Propofol)
Condition: Female Patients Undergoing Thyroidectomy
Study type: Interventional

Summary: 
      It has been reported that target-controlled infusion of remifentanil can reduce cough against
      endotracheal tube during emergence from general anesthesia. We hypothesized that effective
      concentration of remifentanil for preventing cough during anesthetic emergence varies
      depending on the type of main anesthetic agents which is administered with remifentanil
      during general anesthesia. The purpose of this study is to evaluate the effective
      concentrations of remifentanil to prevent coughing during emergence from general anesthesia
      according to main anesthetic agent (sevoflurane, desflurane, and propofol).
    


Intervention name(s): up-and-down method to find out effective concentration of remifentanil for preventing cough
Intervention type(s): Drug
Intervention description(s): During the emergence from anesthesia, if the patient did not cough, the extubation was defined as smooth emergence and the predetermined effect site concentration of remifentanil for the subsequent patient was decreased by 0.5 ng/mL. Likewise, if the patient coughed anytime around extubation, it was considered a failed smooth emergence and the predetermined effect site concentration for the next patient was increased by 0.5 ng/mL. This up-and-down method was conducted independently for each of the three groups. EC50 of the remifentanil of each group was obtained using the Dixon's method.
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Walking Meditation Exercise in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study is to evaluate the effects of Walking Meditation on vascular function in breast
      cancer patients receiving Anthracyclines chemotherapy
    

Detailed description: 
      Walking Meditation program will be based on aerobic walking exercise combined with Buddhist
      meditation. The subjects will perform walking while listening to the sound "Budd" and "Dha"
      and squeeze rubber balls according to the sound in order to practice mindfulness while
      walking. In phase 1 (week 1-6), Walking Meditation will be conducted at initial moderate
      intensity (41-50% heart rate reserve) 3 sets, 10 minutes per set and rest 3 minutes between
      set In phase 2 (week 7-12), the training intensity will be increased to ultimate moderate
      intensity (51-60% heart rate reserve) 3 sets, 15 minutes per set and rest 3 minutes between
      set. In both phases of the training, the frequency of Walking Meditation training is three
      times a week.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Walking meditation exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Walking Meditation; Vascular Function; Flow-mediated dilatation; Breast Cancer Patients; Anthracyclines Chemotherapy
Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its Impact on Morbidity and Mortality
Condition: Diastolic Dysfunction; Chronic Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with
      cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of
      complications in liver disease. The purpose of this prospective, randomized controlled trial
      is to determine whether carvedilol can revert cardiac dysfunction i.e. left ventricular
      diastolic dysfunction secondary to cirrhosis, and prevent complications (renal dysfunction,
      worsening cardiac function, and mortality).
    


Intervention name(s): Carvedilol; Ivabradine; Endoscopic Variceal Ligation
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure> 90 mmHg.; Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure> 90 mmHg.
If carvedilol is not tolerated,Ivabradine is added in a dose starting 2.5 mg BD to a maximum of 15 mg/day to ensure targeted heart rate reduction
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon
Condition: Raynaud Phenomenon
MeSH terms: Raynaud Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin
      discoloration, is 5-10% in general population. Often conventional measures such as warming up
      or minimizing exposure to cold are not enough and many patients require treatment with a
      vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil,
      a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.

      Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5
      inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment
      of secondary RP in Korean patients.
    


Intervention name(s): Udenafil or Amlodipine
Intervention type(s): Drug
Intervention description(s): Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily
Intervention MeSH terms: Amlodipine; Udenafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pathological Conditions; Signs and Symptoms; Blood circulation