bioihbjkbjnl/mcl2 huggingface dataset:
Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the addition of daratumumab to
      lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants
      achieving stringent complete response (sCR), as defined by the International Myeloma Working
      Group (IMWG) criteria, by the time of completion of post autologous stem cell transplantation
      (ASCT) consolidation treatment, compared with RVd alone.
    


Intervention name(s): Lenalidomide; Bortezomib; Dexamethasone; Daratumumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cycles 1 through 6: lenalidomide 25 (milligram) mg orally on Days 1 through 14 and each cycle is of 21-days followed by maintenance treatment with lenalidomide 10 mg on days 1-21 throughout each 28-day cycle on Cycles 7 through 9. Beginning at Cycle 10, the lenalidomide dose will be increased to 15 mg unless there is a tolerability concern.; Bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 4, 8, and 11 during Cycles 1-6.; Dexamethasone 40 mg orally every week (20 mg on Days 1, 2, 8, 9, 15, and 16).; Daratumumab intravenously at a dose of 16 milligram per kilogram (mg/kg) weekly during induction treatment (Days 1, 8, and 15 of Cycles 1 through 4), and every 3 weeks during consolidation treatment (Day 1 of Cycles 5 and 6), followed by maintenance treatment with daratumumab every 4 or 8 weeks.
Intervention MeSH terms: Dexamethasone; Lenalidomide; Bortezomib; Daratumumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of ABT-806 in Subjects With Advanced Solid Tumor Types
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and
      evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.
    


Intervention name(s): ABT-806
Intervention type(s): Drug
Intervention description(s): ABT-806 will be administered by intravenous infusion.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Incretin Effect and Use After Clinical Islet Transplantation
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      We aim to study if the administration of medications to increase the secretion of hormones
      from the intestines can improve glycemic control, reduce insulin use and promote β-cell
      regeneration/expansion in subjects with type 1 diabetes following islet transplantation who
      are back using small doses of insulin because of early graft dysfunction. We believe that the
      results will enable us to understand whether these drugs could be useful in islet transplant
      recipients, particularly if glycemic control deteriorates.
    

Detailed description: 
      This is a single centre non-randomized pilot study. Subjects will be recruited from the
      current cohort of islet transplant recipients at the University of Alberta.

      The primary objective of the study is to evaluate whether the combination of sitagliptin and
      pantoprazole can restore insulin independence in previously insulin independent islet
      transplant recipients experiencing early graft dysfunction. The study will also evaluate the
      safety of the combination drug therapy.
    

Intervention name(s): Pantoprazole; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.; Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.
Other intervention name(s): Pantoloc; Januvia
Intervention MeSH terms: Sitagliptin Phosphate; Pantoprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Intra-articular Injections vs Placebo in Patients With Pain From Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the effectiveness and safety of a combined Traumeel® /
      Zeel® injection against placebo (saline) in patients with moderate-to-severe pain associated
      with osteoarthritis of the knee.
    

Detailed description: 
      The primary objective is to demonstrate the superiority of Traumeel® and Zeel®
      co-administered intra-articular (IA) injections vs placebo IA injections on the change in
      knee pain in patients with moderate to severe knee pain associated with osteoarthritis.

      The secondary objectives are to evaluate reduction of pain and stiffness and change in
      physical function.

      Safety is evaluated by the incidence of treatment emergent adverse events during the
      treatment period and follow up period for all randomized patients.
    

Intervention name(s): Traumeel® / Zeel® Injectable Solution; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injection volume is 4.2 mL for active study medication (2.0 mL Zeel plus 2.2 mL Traumeel in one IA injection) on treatment days 1, 8 and 15.; Placebo is an injection of Saline
Other intervention name(s): Traumeel; Zeel; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dobutamine on the Cardiac Conduction System
Condition: Arrhythmias, Cardiac
MeSH terms: Arrhythmias, Cardiac; Cardiac Conduction System Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Our hypothesis is that Dobutamine will act in a similar fashion to Isoproterenol with respect
      to cardiac conduction. Our goal is to study the effects of Dobutamine on cardiac conduction
      and refractoriness during an Electrophysiology study (EPS). At the end of most EPS
      Isoproterenol is commonly administered in an effort to change the conduction properties of
      the heart. In our practice we have been using Dobutamine for this purpose for many years.
      Dobutamine has never been rigorously studied for this indication however. We designed this
      study to systematically study the effect of various doses of Dobutamine on the parameters of
      cardiac conduction and refractoriness that are commonly measured during an EPS. We are
      specifically looking to compare the effect that Dobutamine has on the sinus node with the
      effect it has on the atrioventricular node. Patients undergoing an EPS at Long Island Jewish
      Hospital will be recruited and consented. Measurements of various conduction parameters will
      be taken at baseline as is standard protocol for an EPS. Dobutamine will then be administered
      at doses of 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min. At each of these
      dosages the same conduction parameters will be measured. A comparison will then be made
      between the conduction parameters at baseline and when the Dobutamine is administered.
    


Intervention name(s): Dobutamine
Intervention type(s): Drug
Intervention description(s): Dobutamine will then be administered at doses of 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min.
Intervention MeSH terms: Dobutamine
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT
Condition: Mechanical Ventilation
Study type: Observational

Summary: 
      To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation
    

Detailed description: 
      53 patients who ready to wean from mechanical ventilation were included in this study. The
      changes of lung tidal distribution during SBT with mechanical ventilation by EIT were
      recorded. Whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation?
    

Intervention name(s): Assessment of Lung Tidal Distribution With EIT
Intervention type(s): Diagnostic Test
Intervention description(s): Changes of lung tidal distribution during SBT with mechanical ventilation were recorded by EIT can be used to predict weaning success or failure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with mechanical ventilation admitted to ICU of Zhongda hospital
      
Keywords: Weaning; Mechanical ventilation; Electrical impedance tomography; Tidal distribution
Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an 8-week, single centre, randomized, parallel-group, double-blind,
      placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific
      insulin sensitivity in patients with Type 2 diabetes mellitus
    


Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks; Matching placebo to Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks
Other intervention name(s): Forxiga, Farxiga
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Dapagliflozin; Placebo; Insulin resistance; Insulin sensitivity
Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?
Condition: Shoulder Pain; Post-operative Pain
MeSH terms: Shoulder Pain; Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy of parecoxib with placebo on the
      incidence and severity of postthoracotomy shoulder pain, the amount of analgesic requirement
      for relieving severity of postthoracotomy shoulder pain and adverse events associated with
      treatment.
    

Detailed description: 
      The incidence of Post-operative Ipsilateral Shoulder Pain (PISP) varies from 21-97% after
      thoracic surgery, despite receiving effective thoracic epidural analgesia. This pain has been
      described as constant, aching in quality, unrelated to position change or respiration.
      Possible causes of shoulder pain includes injury of the phrenic nerve, the lateral decubitus
      position, transection of major bronchus or preexisting arthritis condition. The possibilities
      of prevention and management of PISP are taken into consideration. Thoracic epidural block
      will be performed in all patients before general anesthesia.
    

Intervention name(s): Parecoxib; Control
Intervention type(s): Drug; Other
Intervention description(s): Parecoxib 40 mg intravenous before surgery and every 12 hours for two days.; NSS 2 ml intravenous before surgery and every 12 hours for two days.
Other intervention name(s): Dynastat
Intervention MeSH terms: Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this Phase I exploratory study is to determine the effects of
      mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density
      lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period,
      a 1-week Run-in Period to establish a stable diet, an approximate 11-week Treatment Period
      with Placebo or Mipomersen, and a 25-week Post-Treatment Follow-up Period. The total duration
      of any given subject's participation will be approximately 40 weeks.
    


Intervention name(s): mipomersen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): mipomersen 200mg subcutaneously (SC) once weekly; Placebo administered subcutaneously (SC) once weekly
Intervention MeSH terms: Mipomersen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: ApoB (Apolipoprotein B); LDL (low density lipoprotein); mipomersen
Impact of Patient-Prosthesis-Mismatch on Coronary Flow Reserve
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Complete normalization of CFR following AVR for aortic stenosis was observed only for
      stentless valves. Besides the superior hemodynamic performance this might explain the
      excellent long term results of this valve design.
    


Observational model: Natural History
Time perspective: Prospective
Keywords: Coronary artery disease; Coronary flow reserve; Heart failure; prospective randomised
A Study to Evaluate the Effect of Turmeric in Healthy Participants
Condition: Healthy
Study type: Interventional

Summary: 
      Turmeric is recognized as a bioactive compound with potential benefits for human health. This
      study compares the pharmacokinetic profile of the Turmeric test product to a comparator.
    

Detailed description: 
      This randomized, double-blinded, comparator-controlled, crossover study will compare the
      pharmacokinetic profile of the Turmeric test product to a comparator.
    

Intervention name(s): Turmeric test product; Turmeric comparator
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules of 490 mg Turmeric are taken with water once; 2 capsules of 200 mg Turmeric are taken with water once
Other intervention name(s): Turmeric Supreme Extra Strength; Renew Actives Turmeric Curcumin
Intervention MeSH terms: Curcumin; Turmeric extract
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomization at 1:1 ratio for test product or comparator
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Turmeric; Curcumin
Acamprosate in the Treatment of Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see whether acamprosate (Campral) will curb the desire to
      gamble in people with pathological gambling disorder.
    

Detailed description: 
      Because the opiate antagonists appear to be effective in the treatment of pathological
      gambling (PG), it is reasonable to ask whether acamprosate (calcium acetylhomotaurine;
      Campral), also FDA approved for the treatment of alcoholism, can be used effectively to treat
      PG. Acamprosate is not an opioid antagonist; rather, it is assumed that its therapeutic
      effects are due to actions on GABA receptors. Acamprosate is structurally related to
      1-glutamic, which is an excitatory neurotransmitter. It has been proposed that acamprosate
      decreases the effects of the naturally-occuring excitatory neurotransmitter glutamate in the
      body. Because chronic alcohol consumption disrupts this system, and the changes last many
      months after alcohol ingestion is stopped, it is possible that acamprosate restores the
      glutamate system towards normal. Regardless, acamprosate decreases the pleasant "high"
      associated with alcohol consumption, and thus decreases the frequency of relapse during
      abstinence. We hypothesize that acamprosate will have similar actions in persons with PG.
    

Intervention name(s): acamprosate
Intervention type(s): Drug
Intervention description(s): Two 333mg tablets taken three times daily.
Other intervention name(s): Campral
Intervention MeSH terms: Acamprosate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acamprosate, impulse-control disorders
The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease
Condition: Coronary Microvascular Dysfunction; Obstructive Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      The study was designed to evaluate the left ventricular longitudinal strain and strain rate
      assessed by 2D-STI in patients with coronary microvascular dysfunction (CMD) or obstructive
      coronary artery disease (CAD) , to investigate the effect of different types of ischemic
      heart disease on the LV systolic function, and to explore the value of LS on the diagnosis of
      coronary microvascular dysfunction.
    

Detailed description: 
      A total of 175 patients with chest pain, without wall motion abnormality and without
      significant coronary artery stenosis (<50%) assessed by coronary angiography or coronary
      computed tomography were enrolled from July 2011 to December 2017. Coronary flow reserve
      (CFR) of these patients were detected by transthoracic Doppler echocardiography. The patients
      were divided into coronary microvascular dysfunction group ( CFR≤2.5, n=67) and control group
      (CFR>2.5, n=108). At the same time, 67 age-matched patients with any major coronary arteries
      stenosis≥50% and without wall motion abnormality were involved into the obstructive coronary
      artery disease group. Parameters of global longitudinal strain (LS) and strain rate,
      subendocardial LS and subepicardial LS were quantified by 2D-STI, the differences of these
      parameters among three groups were analyzed，correlation analysis、univariate and multivariate
      analysis and receiver operating characteristic curve were used.
    

Intervention name(s): Two dimensional speckle tracking imaging
Intervention type(s): Diagnostic Test
Intervention description(s): lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 242 patients were enrolled, including 102 males (42.1%) and 140 females (57.9%).
        Their ages ranged from 44 to 81 years, with an average age of (62.6 + 8.3) years.
      
Keywords: two-dimensional speckle tracking imaging; strain; coronary microvascular dysfunction
Mitophagy and Autophagy in Elderly Subjects
Condition: Aging; Frailty; Mitophagy
MeSH terms: Frailty
Study type: Observational

Summary: 
      In recent years, evidence has shown that mitochondrial dysfunction plays an important role in
      the development of age-related muscle decline that may lead to frailty.

      During aging, there is a progressive reduction in the cell's capacity to eliminate its
      dysfunctional elements by autophagy, as evidenced by the accumulation of oxidative damage and
      mutations in mitochondria and by the decrease in autophagic flux. In fact, it has been
      demonstrated that dysfunctional mitochondria can be specifically targeted for elimination by
      autophagy, a process that has been termed mitophagy.

      A major challenge in the clinic today is in the lack of validated tools, including
      biomarkers, to assess the decline in mitochondrial health associated with an impairment in
      muscle function. In the present study, the investigators will employ a battery of established
      and exploratory tests (clinical, physiological and molecular) to assess in vivo mitochondrial
      function and more specifically, the levels of mitophagy and autophagy, in the muscle of
      healthy and pre-frail elderly.

      It is anticipated that the results of this study will facilitate the rapid translation of
      interventions targeting mitophagy and autophagy for the improvement of muscle function.
    


Intervention name(s): Muscle Biopsy
Intervention type(s): Procedure
Intervention description(s): Muscle Biopsy
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  10 active, healthy elderly, >61 years of age

          -  10 sedentary, pre-frail elderly, >61 years of age
      
Biospecimen description: 
      Muscle, Peripheral blood mononuclear cells (PBMC)
6-week Safety and PD Study in Adults With NAFLD
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY,
      SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS
      WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
    


Intervention name(s): Placebo; PF-06835919 Low Dose; PF-06835919 High Dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0 mg; 75 mg once daily; 300 mg once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Graphic Messages to Prevent E-Cigarette Use Among Black and Latino Adolescents
Condition: Vaping
Study type: Interventional

Summary: 
      The aim of this study is to determine if graphic messages prevent future vaping use among
      African American and Latino adolescents. The images have been developed in a user-design
      model and include four main themes: health reward, financial reward, self-efficacy, and
      social norms. We will assess pre- and post-exposure reactions on likelihood of future vaping
      among African American and Latino adolescents.
    


Intervention name(s): Financial reward graphic message; Health reward graphic message; Self-efficacy graphic message; Social norms graphic message
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Vaping leads to nothing. Don't let your money vaporize away.; Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Dying for a vape? It hurts more than you know.; Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Vaping companies are targeting Black and Latino teens. Your life matters. Don't let them take it away.; Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Just because vaping is common, doesn't mean it's cool. Stay woke. Don't smoke.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention