bioihbjkbjnl/mcl2 huggingface dataset:
Sorafenib Drug Drug Interaction Study in Healthy Male Subjects
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and
      elimination of sorafenib and safety in healthy male subjects
    


Intervention name(s): Sorafenib (Nexavar, BAY43-9006); Levothyroxine
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 400 mg orally on Period 1 Day 1 and Period 2 Day 11; Single dose of 300 mcq orally from Period 2 Day 1 to Period 2 Day 14
Intervention MeSH terms: Sorafenib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Sorafenib, levothyroxine, drug interaction, pharmacokinetics, healthy volunteer
Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg)
      versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the
      prevention of relapse in participants with MDD who responded to acute treatment with
      vortioxetine 10 mg.
    

Detailed description: 
      The drug being tested in this study is called vortioxetine. Vortioxetine is being tested for
      the prevention of relapse in adults with major depressive disorder (MDD) who respond to daily
      treatment with vortioxetine. This study will look at relapse rates of MDD in people who take
      vortioxetine.

      The study will enroll approximately 1100 participants. All participants will receive
      vortioxetine 10 mg open-label for the first 16 weeks of the study. Participants who meet the
      appropriate MDD response criteria from the Week 8 Visit through Week 16 Visit will be
      eligible for randomization into the double-blind treatment period. Participants will be
      randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which
      will remain undisclosed to the patient and study doctor during the study (unless there is an
      urgent medical need):

        -  Vortioxetine 5 mg

        -  Vortioxetine 10 mg

        -  Vortioxetine 20 mg

        -  Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has
           no active ingredient

      All participants will be asked to take one capsule at the same time each day throughout the
      study.

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 55 weeks. Participants will make 19 visits to the clinic,
      and will be contacted by telephone 4 weeks after last dose of study drug for a follow-up
      assessment.
    

Intervention name(s): Vortioxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vortioxetine capsules; Vortioxetine placebo-matching capsules
Other intervention name(s): LuAA21004
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of this study is to investigate brain response and connectivity changes evoked by
      video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in knee
      osteoarthritis patients to elucidate the underlying brain mechanisms of mind-body
      interaction, imagery, and acupuncture.
    


Intervention name(s): Acupuncture
Intervention type(s): Device
Intervention description(s): Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
Other intervention name(s): Video of Acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: fMRI; acupuncture; osteoarthritis
Effect of Intrapulmonary Recombinant Human Activated Protein C (APC) on Coagulation and Inflammation After Lipopolysaccharide (LPS)
Condition: Pneumonia; Lipopolysaccharides
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Recombinant human Activated Protein C (rhAPC) has been shown to reduce the mortality of
      patients with severe sepsis. The biological effects of APC are pleiotropic, and can be
      roughly divided in anticoagulant and cytoprotective effects. Lung infection and inflammation
      are associated with reduced bronchoalveolar levels of endogenous APC. Recent evidence derived
      from animal studies indicates that local administration of rAPC into the lungs exerts local
      anti-inflammatory and anticoagulant effects. In this study we propose to study the potential
      of locally administered APC, within a lung subsegment, to inhibit lipopolysaccharide (LPS)
      induced lung inflammation and coagulation in humans.
    


Intervention name(s): Drotrecogin alpha; Saline (NaCl 0.9%); Endotoxin; Bronchoscopy; Blood sampling
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): Drotrecogin alpha is given intrabronchially by bronchoscopy at t=0; Normal saline is given intrabronchially by bronchoscopy at t=0; Endotoxin (4 ng/kg body weight) is given intrabronchially in one subsegment at t=0; Bronchoscopies are performed at t=0 (for instillation of LPS and Drotrecogin alpha) and at t=6 (for performing a bronchoalveolar lavage); Blood sampling is done by venapuncture at t=0 and t=6
Intervention MeSH terms: Drotrecogin alfa activated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Activated Protein C; Lipopolysaccharides; Inflammation, Pulmonary
Optimal Dose of a Cognitive Control Training for Depression Vulnerability
Condition: Major Depression in Remission
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study aims to examine the dose-response relationship of an online adaptive cognitive
      control training on depressive symptomatology and rumination. Participants will be randomized
      over six groups, each receiving a different dose (0, 1, 5, 10, 15 or 20 sessions) of a
      cognitive control training in remitted depressed patients. An adaptive Paced Auditory Serial
      Addition Task will be used as cognitive control training.
    

Detailed description: 
      Depression is often associated with cognitive impairments and recent studies have found that
      for some people, these cognitive problems persist after remission of depression. These
      cognitive impairments could be a risk factor for recurrence of depressive episodes. Cognitive
      control training aims to address these cognitive impairments and decrease the risk of
      recurrence of depression.

      One promising operationalization of cognitive control training is the adaptive Paced Auditory
      Serial Addition Task, but currently, it's unclear how many sessions one should complete in
      order to obtain cognitive- and emotional transfer effects. By comparing multiple groups with
      a different number of sessions (0, 1, 5, 10, 15 and 20), with measures at post (one month
      after baseline) and two follow-up periods (at 3 months and 6 months after baseline), this
      study examines the effects of an online cognitive control training on depressive
      vulnerability factors.
    

Intervention name(s): Cognitive control training
Intervention type(s): Behavioral
Intervention description(s): The five intervention groups will receive either 1, 5, 10, 15 or 20 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Depression; Remission; Relapse prevention; Cognitive control training; Internet intervention
MagniXene MRI Use in Patients With Asthma and COPD to Assess Regional Lung Function by Delineating Ventilation Defects
Condition: Asthma; COPD; Healthy
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to demonstrate hyperpolarized xenon (HXe) as a medical
      imaging drug (agent) for Magnetic Resonance Imaging (MRI) of the human lung ventilation.
    

Detailed description: 
      HXe MRI provides a diversity of imaging techniques for interrogating pulmonary function and
      lung microstructure. The most mature of these techniques utilizes HXe spin-density MRI to
      depict regional lung ventilation. Prior work suggests that ventilation imaging has utility in
      all obstructive lung diseases. This is a Phase II clinical trial to assess HXe MRI capability
      of providing qualitative and quantitative clinical information regarding lung ventilation.
      Proton and xenon images will be acquired within single breath holds on 28 subjects per year,
      including healthy volunteers and patients with COPD and asthma. All studies will include
      repeat scans and Pulmonary Function Tests (PFT). Ventilation scans with Technetium-99m
      (Tc-99m) diethylene-triamine-pentaacetate (DTPA) aerosol scintigraphy will be acquired on
      lung patients.

      The primary goal of this aim is to validate the effectiveness of HXe ventilation MRI for
      delineating regions of normal and abnormal lung ventilation. To validate the regional
      depiction of ventilation, HXe MRI ventilation will be compared with nuclear medicine Tc-99m
      DTPA ventilation scintigraphy. The comparatively low spatial and temporal resolution of
      ventilation scintigraphy will limit this study to demonstrating only that HXe MRI ventilation
      is not inferior to the current clinical standard. Additionally, the concordance between
      measurements of the whole lung volume from both proton MRI and HXe MRI with PFT, the current
      clinical standard for lung volume measurement, will be assessed as a secondary outcome of the
      study.
    

Intervention name(s): HXe MRI lung ventilation
Intervention type(s): Drug
Intervention description(s): MagniXene (HXe) is an Investigational New Drug made of xenon noble gas. Through a physical process using alkali vapors and powerful lasers, xenon atoms have their nuclear spin preferentially aligned (hyperpolarized), thus offering a highly enhanced signal inside an MRI scanner. High-resolution images of the lung spaces are acquired within a short breath-hold after inhalation of HXe.
Other intervention name(s): Hyperpolarized Xenon; MagniXene; HXe
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hyperpolarized Xenon; HXe; MagniXene
Efficacy and Safety of Metoprolol Tartrate Tablets Combined With Chinese Traditional Medicine on Premature Ventricular Complex.
Condition: Premature Ventricular Contraction
MeSH terms: Premature Birth; Ventricular Premature Complexes
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: investigators investigated the effects of metoprolol tartrate plus Tongmai Yangxin
      Pill on premature ventricular complexes and cardiac function in patients with premature
      ventricular complex.

      Methods: In total, 584 participants with premature ventricular complex will be randomly
      assigned (at a 1:1 ratio) into two groups: study group (metoprolol tartrate [25 mg twice per
      day, orally] plus Tongmai Yangxin Pill [40 pills twice per day, orally]) and control group
      (metoprolol tartrate [25 mg twice per day, orally] plus placebo [40 simulated pills twice per
      day, orally]). The total treatment period is 8 weeks.

      Efficacy endpoints and safety assessment:

      Primary efficacy endpoints are as follows: change in 24-h number of PVCs after treatment and
      effective rate of 24-h number of PVCs after treatment. Secondary efficacy endpoints are as
      follows: change in New York Heart Association classification; total effective rate of
      comprehensive effect; change in high-sensitivity C-reactive protein level; and change in
      echocardiography parameters (i.e., left ventricular ejection fraction, left ventricular end
      diastolic dimension, E/A, cardiac index, cardiac output, and stroke volume).
    


Intervention name(s): Tongmai Yangxin Pill (TMYXP); metoprolol tartrate; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TMYXP is a Chinese patent medicine developed by many years of clinical practice experience. The ingredients of TMYXP are Radix Rehmanniae, Caulis Spatholobi, Polygonum Multiflorum, Colla Corii Asini, Ophiopogonis, Tortoise Shell (vinegar), Radix Codonopsis, Cassia Twig, Jujube, Schisandra Fruit, and Licorice Root. It has the effect of invigorating Qi, nourishing Yin, dredging the pulse, and relieving pain. It is used in treatment of Qi and Yin deficiency syndromes caused by coronary heart disease, angina pectoris, and arrhythmia.
Metoprolol tartrate (a heart-selective β-blocker) is a class II antiarrhythmic medication that decreases the ventricular rate of supraventricular tachyarrhythmias by inhibition of atrioventricular conduction.; metoprolol tartrate (a heart-selective β-blocker) is a class II antiarrhythmic medication that decreases the ventricular rate of supraventricular tachyarrhythmias by inhibition of atrioventricular conduction.; simulated pills
Other intervention name(s): metoprolol; betaloc
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Agonist Contract Relax Versus Antagonist Contract Relax in Chronic Stroke Patient.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      It will be a randomized control trial with 112 patients which will be divided into two groups
      of 56 patients in each group. Participants will recruit through convenient sampling
      techniques.

      Outcome measures are range of motion and spasticity. The protocol was implemented three days
      per week for eight consecutive weeks. Data will be collected at baseline and 8 th week after
      intervention.
    

Detailed description: 
      Objective of the study is to compare the effects of the agonist contract-relax technique
      versus the antagonist contract-relax technique on spasticity and range of motion in
      individuals with chronic stroke.

      Null hypothesis (H0):

      There are no comparative effects of agonist contact-relax technique and the antagonist
      contract-relax technique on spasticity and ankle range of motion in chronic patients.

      The alternate hypothesis (HA):

      There are comparative effects of agonist contract-relax technique and the antagonist
      contract-relax technique on spasticity and ankle range of motion in chronic stroke patients.

      The sample size came out to 94 (47 in each group) after adding 20% dropout the sample size
      was 47+9=56 in each group.
    

Intervention name(s): Routine physical therapy; antagonist contract relax; agonist contract relax
Intervention type(s): Other; Other; Other
Intervention description(s): Both groups received routine physical therapy, which encompasses various components such as electrotherapy, strength training for both lower and upper limbs, gait training, and occupational therapy.; antagonist contraction i used to improve spasticity and range of motion in stroke patients; agonist contraction is used to improve spasticity and range of motion in stroke patients
Other intervention name(s): agonist contraction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Agonist contract relax; antagonist contract relax; stretching; modified A
Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers
Condition: Anhidrotic Area; Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the anhidrotic area and safety of MEDITOXIN
    


Intervention name(s): Meditoxin; Botox
Intervention type(s): Drug; Drug
Intervention description(s): injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses; injection of Botox into the intradermal of each contralateral upper back in equal doses
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Efficiency of Electronic Multimedia Intervention With the Cardiac Implantable Electronic Device.
Condition: Cardiac Implantable Electronic Device
Study type: Interventional

Summary: 
      In this study, we aim to design a multi-media model through e-book for preoperative care of
      CIED intervention, which can enhance the knowledges of patients, reducing the stresses and
      uncertainties before the intervention. Therefore, patient may reduce the psychological
      internalization after CIED intervention, also needs to track the impact of emotional
      depression, psychological adaption and life quality status.
    

Detailed description: 
      Arrhythmia is defined an abnormality in the heart transmission system related to heartbeat or
      heart rhythm problem (Li et al., 2017). Most of arrhythmia could diagnosed and treated
      effectively, including medication, cardiac implantable electronic device (CIED) and
      operation. Many patients have uncertainty about the implantation process, the results and
      possible complications after CIED, the lack of understanding about further progress of their
      disease, the change of lifestyle and the accident of electronic shock. Those causes are the
      physical and mental negative impacts on patient which makes anxiety or depressed and turn
      affects the quality of life.

      At present, there are few clinical models for CIED utilizing electronic multi-media in
      Taiwan. The use of multi-media models may integrate clinical care and health education for
      helping patients to learn disease and care, also through vivid video and multi-media, we may
      make a clear education of disease causes, treatment and relevant care knowledges which are
      alleviate the uncertainty factors from patients (Hsueh et al., 2016). Therefore, the more
      overall understanding before CIED intervention, the more helpful to quality of living and
      psychological adjustment of the patient.

      In this study, we aim to design a multi-media model through e-book for preoperative care of
      CIED intervention, which can enhance the knowledges of patients, reducing the stresses and
      uncertainties before the intervention. Therefore, patient may reduce the psychological
      internalization after CIED intervention, also needs to track the impact of emotional
      depression, psychological adaption and life quality status.

      keywords：Cardiac Implantable Electronic Device、arrhythmia、electronic multimedia、quality of
      life、psychological adjustment、depression
    

Intervention name(s): e book; traditional education booklet
Intervention type(s): Other; Other
Intervention description(s): e book; traditional education booklet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: cardiac implantable electronic device; quality of life; electronic multimedia; psychological adjustment
InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
Condition: Heart Diseases; Left Ventricular Dysfunction
MeSH terms: Heart Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Left
Study type: Observational

Summary: 
      The primary reason the investigators are doing this study are to understand how the right
      side of the heart functions in heart failure patients with left ventricular assist devices
      (LVADs, or "mechanical hearts"). Second, the investigators are interested in understanding
      how different pacemaker settings influence function of the heart at rest and activity.
    

Detailed description: 
      Healthy individuals, as well as patients with advanced heart failure supported by LVADs,
      completed invasive hemodynamic analysis at rest and with exercise to characterize right-sided
      heart function at rest and with exercise during invasive cardiopulmonary exercise testing on
      upright cycle ergometry.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        15 patients with advanced HF who have already undergone CF-LVAD implantation.

        10 healthy individuals will serve as a control group to define normal RV function during
        exercise.
Canadian Hemophilia Prophylaxis Study
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary prophylaxis given less frequently initially, with the infusion frequency increased if
      needed (Escalating Dose Prophylaxis), is likely to be less expensive and associated with
      fewer complications than standard prophylaxis while reducing disability to a greater degree
      than intermittent therapy.
    

Detailed description: 
      There are 2 specific study objectives. The first is to estimate the incidence of target joint
      bleeding in patients with severe hemophilia A treated (for primary prophylaxis) with
      Escalating Dose Prophylactic factor replacement. The second objective is to obtain accurate
      estimates of the direct and indirect costs associated with this protocol for use in a
      cost-effectiveness model (comparing Escalating Dose with standard prophylaxis and with
      intermittent therapy).
    

Intervention name(s): Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS); Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)
Intervention type(s): Biological; Biological
Intervention description(s): escalating dose prophylaxis; escalating dose
Other intervention name(s): Recombinant Factor VIII (antihemophilic agent); recombinant factor VIII (antihemophilic agent)
Intervention MeSH terms: Factor VIII
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemophilia, prophylaxis, cost effectiveness
A Pharmacokinetic Interaction Study Between Apatinib and Rosuvastatin or Metformin in Solid Tumor Subjects.
Condition: Solid Tumor, Adult
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to assess investigate the pharmacokinetic effects of
      Apatinib on Rosuvastatin or Metformin.

      The secondary objective of the study was to assess the safety of Apatinib alone or
      Rosuvastatin/Metformin alone or concomitant medication.
    


Intervention name(s): Apatinib in arm1; Rosuvastatin; Apatinib in arm2; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Apatinib will be administered at a dose of 250 mg once daily from Day 4 to Day 9.; Rosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 7.; Apatinib will be administered at a dose of 250 mg once daily from Day 3 to Day 7.; Metformin will be administered as a single oral 500 mg on Day 1 and Day 6.
Intervention MeSH terms: Metformin; Apatinib; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arms Assignment
Masking: None (Open Label)
Primary purpose: Treatment