bioihbjkbjnl/mcl2 huggingface dataset:
Metabolism and Pharmacokinetics of [14C]-BI 44370 BS Administered as an Oral Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the basic pharmacokinetics of BI 44370 BS, its metabolite CD 10419 BS,
      and 14C-radioactivity including mass balance, excretion pathways, and metabolism following a
      single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers and to
      evaluate safety and tolerability following a single oral administration of 200 mg [14C]BI
      44370 BS to healthy male volunteers
    


Intervention name(s): BI 44370 BS
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure
Condition: Ischemic Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, randomized, placebo-controlled clinical trial designed to assess
      feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells
      (MSCs) and c-kit+ cells both alone and in combination (Combo), compared to placebo (cell-free
      Plasmalyte-A medium) as well as each other, administered by transendocardial injection in
      subjects with ischemic cardiomyopathy.
    

Detailed description: 
      This is a randomized, placebo-controlled clinical trial designed to evaluate the feasibility,
      safety, and effect of Combo, MSCs alone, and c-kit+ cells alone compared with placebo as well
      as each other in subjects with heart failure of ischemic etiology. Following a successful
      lead-in phase, a total of one hundred forty-four (144) subjects will be randomized (1:1:1:1)
      to receive Combo, MSCs, c-kit+ cells, or placebo. After randomization, baseline imaging,
      relevant harvest procedures, and study product injection, subjects will be followed up at 1
      day, 1 week, 1 month, 3 months, 6 months and 12 months post study product injection. All
      subjects will receive study product injection (cells or placebo) using the NOGA® XP Mapping
      and Navigation System. Subjects will have delayed-enhanced magnetic resonance imaging (DEMRI)
      scans to assess scar size and LV function and structure at baseline and at 6 and 12 months
      post study product administration. All endpoints will be assessed at the 6 and 12 month
      visits which will occur 180 ±30 days and 365 ±30 days respectively from the day of study
      product injection (Day 0). For the purpose of the endpoint analysis and safety evaluations,
      the Investigators will utilize an "intention-to-treat" study population, however an as
      treated analysis will also be conducted.
    

Intervention name(s): Mesenchymal Stem Cells (MSC); c-kit+ cells; Placebo (Plasmalyte A)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 15 transendocardial injections of 0.4ml MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure); 15 transendocardial injections of 0.4ml c-kit+ cells administered to the left ventricle via NOGA Myostar injection catheter (single procedure); 15 transendocardial injections of 0.4ml placebo administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
Other intervention name(s): Plasmalyte A
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Ischemia; Autologous Stem Cells; LV dysfunction; Mesenchymal Stem Cells; c-kit+ Cells; Combination Cell Therapy; LV function; Functional status
Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to generate data on immunogenicity and safety of Purified Vero
      Rabies Vaccine - Serum Free (VRVg) in comparison with Imovax® Rabies in order to support the
      registration of VRVg in the USA.

      Primary Objectives:

        -  To demonstrate that VRVg is non inferior to Imovax® Rabies in terms of proportion of
           subjects achieving an rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day
           42.

        -  To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5
           IU/mL at Day 42 is at least 99%, with a 95% lower confidence limit of at least 97%.

      Secondary Objectives:

        -  To assess the clinical safety of VRVg each vaccine after each vaccine injection when
           administered in a pre-exposure schedule.

        -  To describe the immune response induced by each vaccine 21 days after two vaccinations
           (Day 28) in a randomized subset of subjects and 14 days after the last vaccination of
           the primary vaccination series.

        -  To describe antibody persistence at 6 and 12 months after the first vaccination in all
           subjects, and at 18 and 24 months in a subset of subjects.
    

Detailed description: 
      The vaccination will be given in three injections, at Day 0, Day 7, and Day 28, respectively,
      based on the Advisory Committee on Immunization Practice (ACIP) and the World Health
      Organization (WHO) recommendations for pre-exposure regimen. A booster dose will be
      administered 1 year after the first vaccine injection in a randomized subset of participants.

      Safety will be assessed in all participants up to 28 days after vaccination, as applicable,
      in terms of occurrence of adverse events (AEs), and serious adverse events (SAEs) and adverse
      events of special interest (AESIs) up to Month 12.
    

Intervention name(s): Purified Vero Rabies Vaccine (VRVg) - Serum Free; Imovax® Rabies: inactivated rabies vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 1.0 mL, Intramuscular
Other intervention name(s): Imovax® Rabies
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rabies; Human Diploid Cell Vaccine; Imovax® Rabies
Oral Dexmedetomidine vs Midazoam For Premedication
Condition: Premedication
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and
      0.5 mg/kg dormicum as premedication among children undergoing dental procedures.
    

Detailed description: 
      The study involved 52 children between 3-7 years of age, ASA I , who underwent full-mouth
      dental rehabilitation. The DEX group (n=26) received 2 µg/kg DEX in apple juice, and the
      control group (n=26) received 0.5 mg/kg midazolam in apple juice.

      The patients' scores on the Ramsey sedation scale (RSS), parental separation anxiety scale,
      mask acceptance scale, post-anesthesia emergence delirium scale (PAEDS), and hemodynamic
      parameters were recorded. The data were analyzed using chi-square test, Fisher's exact test,
      student t test, and analysis of variance in SPSS.
    

Intervention name(s): Precedex; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): 2 µg/kg oral; 0.5 mg/kg
Other intervention name(s): Dexmedetomidine; Dormicum
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Retrospective clinical trial
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: premedication
Povidone-iodine Versus Normal Saline Solution in Vaginal Cleansing in Laparoscopy
Condition: Postoperative Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      Laparoscopy is a minimally invasive method used for diagnostic and therapeutic purposes. It
      allows surgeons to take a look on the abdominal and pelvic organs. Diagnostic laparoscopy is
      usually done in an operating room under general anesthesia. The procedure takes about 25
      minutes and the patients usually discharged in the same day. The laparoscopy can diagnose
      pelvic pathological conditions in approximately 50% of the cases. However, the laparoscopy
      has some complications, such as infections, hemorrhage and injuries of visceral organs.

      A preoperative vaginal preparation is important to prevent the bacteria colonization in a
      trial to avoid postoperative infection after laparoscopic surgery. The povidone-iodine (PI)
      is normally used as a skin and vaginal disinfectant to prevent postoperative infections,
      however; it can be the cause of significant postoperative irritation.

      There are many reports in the literature proved that the mechanical cleansing of the vagina,
      not the use of an antiseptic solution, is responsible for the efficacy of vaginal
      preparations. In the field of assisted reproductive technology; A study in 1992 concluded
      that the infection rates with normal saline solution are comparable to PI.

      Another proved that, a normal saline solution can be effective in prevention of preventing
      postoperative infections after vaginal surgery.

      The most recent study by Lewis et al has been shown that the Baby shampoo is preferable than
      PI in vaginal cleansing before gynecologic procedures because it has minimal vaginal
      irritation and cheaper than PI.

      So the optimal vaginal antiseptic solution is unknown, the investigators want to conduct a
      randomized trial comparing 2 commonly used vaginal antiseptic solutions: PI and the saline
      solution before the laparoscopic surgery.

      The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning
      wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike
      many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.
    


Intervention name(s): Povidone-iodine solution; Normal saline solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Povidone-Iodine; Povidone; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Protein Quality to Support Increased Muscle Protein Synthesis
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The age-related decline in muscle mass and strength is collectively referred to as
      sarcopenia. Canadian recommended daily allowance (RDA) for protein intake (0.8 g/kg/d),
      however, many expert groups have advocated that older persons should increase their daily
      intake to ~1.2 g/kg/d to support the preservation of muscle mass. The use of plant-based
      proteins in food formulation has recently become of interest. This study will examine the
      impact of consuming higher- versus lower-quality protein supplements on muscle protein
      synthesis in healthy older men.
    

Detailed description: 
      This study will examine the impact of consuming higher- versus lower-quality protein
      supplements on the integrated rates of muscle protein synthesis in healthy older men.
      Briefly, participants will consume dietary protein at the RDA for the entire duration of the
      protocol (2 weeks). Participants will be randomized to consuming collagen (control - CON),
      whey (WHEY), or pea (PEA) protein supplements twice daily for one week. We will examine the
      ability of different qualities of protein supplements to stimulate integrated rates of muscle
      protein synthesis.
    

Intervention name(s): Protein Supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will continue to ingest the standardized diet; however, supplements will be consumed twice daily (25g per serving x 2 servings/day or 50g supplemental protein/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be a double blind, randomized parallel group controlled trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sarcopenia; Muscle; Aging; Muscle Protein Synthesis
Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV
Condition: Bacterial Vaginoses
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosec™
      (Secnidazole) in adolescent girls with BV
    

Detailed description: 
      This is a multi-center, open-label study to evaluate the safety of Solosec in adolescent
      girls with bacterial vaginosis. Approximately 40 patients will be enrolled. Patients
      determined to be eligible at the Baseline Visit (Day 1) will receive a single oral dose of
      Solosec™ granules (containing 2 grams of secnidazole) on Day 1. Patients will return to the
      site once between Days 7-14 for a "test of cure" (TOC) Visit. A follow-up telephone call will
      be performed at Days 21-30 to assess the continued clinical response to treatment and adverse
      events.
    

Intervention name(s): Secnidazole
Intervention type(s): Drug
Intervention description(s): One dose
Other intervention name(s): Solosec™
Intervention MeSH terms: Secnidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Vaginal fishy smell; Vaginal itching; off-white milky vaginal discharge
Accelerated Brain Volume Loss in People With Multiple Sclerosis
Condition: Retrospective Study
MeSH terms: Multiple Sclerosis
Study type: Observational [Patient Registry]

Summary: 
      To explore whether brain volume loss (BVL) in people with multiple sclerosis (MS), assessed
      on magnetic imaging (MRI) data obtained during routine medical follow-up (and thus outside a
      standardized research environment), differs from that of healthy controls and correlates with
      measures of physical and/or cognitive disability, the latter also gathered during regular
      clinical practice.
    

Detailed description: 
      This project will not be the first study on real-world data in an existing MS cohort. A NMSC
      research group has already reported on the contribution of a single brain volumetric
      assessment to the prediction of MS-related disability10 - with distinct patterns for the
      Expanded Disability Status Scale (EDSS) as a measure of physical disability11, and Symbol
      Digit Modalities Test (SDMT) as a measure of cognitive disability12 - and found a threshold
      effect for the lowest brain volumes with regard to SDMT worsening over time10. Ghione and
      co-workers, in turn, have demonstrated a positive correlation between annualized BVL and EDSS
      progression based on the EDSS in a very large sample containing nearly 2,000 individuals13.
      The novelty of this new study lies in the fact that the investigators want to explore the
      correlations between BVL and changes in an expanded set of routinely collected clinical
      variables in our center - in addition to the EDSS score - such as Timed 25-Feet Walk Test
      (T25FWT)14, 9-Hole Peg Test (9HPT)15 and SDMT.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Multiple Sclerosis
A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density
Condition: Healthy; Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Up to 20 subjects will receive an injection with [11C]-UCB-J followed by a PET scan on Days 1
      and 28
    

Detailed description: 
      After assessing eligibility during a 4-week screening period, approximately 20 subjects will
      participate in the PET acquisition phase of the study. Drop-outs or unevaluable subjects will
      be replaced for a target sample size of 20 completed and evaluable subjects.

      During the screening period, a 3D T1-weighted MRI must be acquired and reviewed for exclusion
      criteria and acquisition quality.

      On the day of radioligand administration (Day 1), subjects will come to the study center for
      an ambulatory visit (Visit 1). After re-confirming eligibility, all subjects will receive an
      injection with [11C]-UCB-J followed by a PET scan.

      Using an arterial line and manual sampling, blood samples will be collected up to 90 minutes
      after radioligand injection in order to quantify radioactivity concentration in whole blood
      and plasma as well as parent fraction over time.

      Subjects will return to the clinic for one more ambulatory visit on Day 28 ± 3 (Visit 2). The
      same procedures will be performed as on Day 1.

      PET scanning duration will be initially set to 90 minutes. After a minimum of 4 subjects have
      completed baseline and Day 28 scans, 90 minute and 60 minute scan data will be analyzed.
      Based on this analysis, and at the discretion of the investigator, it will be decided whether
      the remaining subjects will require 60 or 90 minute scans.

      Adverse events will be recorded throughout the study.
    

Intervention name(s): [11C]-UCB-J
Intervention type(s): Other
Intervention description(s): IV radioligand given prior to and during positron emission tomography (PET) scan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: evaluate the kinetics and test-retest repeatability and reproducibility of the radioligand [11C]-UCB-J for imaging synaptic density in up to10 healthy subjects and then mild to moderate Alzheimer's Disease patients
Masking: None (Open Label)
Primary purpose: Other
A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
Condition: Chronic Renal Failure; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC)
      Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels
      and study drug dose requirements in patients treated for anemia associated with chronic renal
      failure and on hemodialysis.
    


Intervention name(s): Epoetin Hospira; Epogen Amgen
Intervention type(s): Biological; Biological
Intervention description(s): Variable dose; Variable dose
Other intervention name(s): Epoetin Alfa
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya
Condition: Multiple Sclerosis; Cognitive Deficits; Gilenya Modifying Therapy for MS
MeSH terms: Multiple Sclerosis; Sclerosis; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study is investigating the efficacy of computer-based cognitive exercises as a means of
      cognitive remediation in patients with Multiple Sclerosis (MS) who are beginning the disease
      modifying pharmacotherapy Gileyna.
    

Detailed description: 
      Gilenya represents the most recent advance in MS disease-modification therapy (DMT) and shows
      promise for neuroprotection, a feature relevant to the progressive neurologic damage
      associated with the disease. Cognitive impairment accompanies MS in 40-60% of cases and when
      present, additional symptomatic treatment combined with DMT is required. To date no
      symptomatic pharmacologic therapy has shown a consistent benefit on MS associated cognitive
      dysfunction. However, non-pharmacologic approaches show promise. With recent technical and
      scientific advances, cognitive training is rapidly evolving to become the most effective
      intervention for the cognitive impairments associated with a wide range of neurological
      conditions. However, these training programs have not yet been studied in MS.

      This study will be a randomized open-label clinical pilot trial to compare a plasticity-based
      and adaptive cognitive remediation (PACR) program to an active control (ordinary computer
      games) in 20 adults with multiple sclerosis (MS) starting Gilenya therapy. Primary outcome
      measures will be used as preliminary indicators of effect, with improvements on program
      task-related measures and changes in cognitive measures. Secondary outcome measures will
      determine the feasibility of the use of these programs in patients with MS, as indicated by
      compliance and patient-reported experience.
    

Intervention name(s): plasticity-based computerized cognitive remediation program; Gileyna
Intervention type(s): Other; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Cognition; Cognitive Remediation; Gilenya; Computerized Cognitive Exercise
Night Time Use of Thiazide Diuretics for Improved Reduction in Stone Risk in Stone Formers With Elevated Urine Calcium
Condition: Kidney Stones
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi; Hypercalciuria
Study type: Interventional

Summary: 
      Thiazide diuretics will be more effective in lowering urine calcium excretion if taken at
      night as compared to the daytime. It will therefore be more effective in reducing kidney
      stone recurrence in nephrolithiasis patients with elevated urine calcium who are known to
      have increased risk of kidney stones at night time.
    

Detailed description: 
      The study will be divided into three phases for every single patient, investigators will
      study 15-20 stone formers who have previously documented elevated urine calcium excretion,
      with a plan to measure their urine chemistries at baseline (if they currently use thiazide
      diuretics, they will come off of their respective thiazide for a 7-day washout period).
      Investigators will ask them to collect urine samples in two 12-hour intervals: on awakening,
      the 1st sample starts to before supper; 2nd sample begins after dinner and extends overnight
      with fasting after dinner, These measurements will be used as controls. Then patients will be
      started back on diuretics (25mg of chlorthalidone for the primary study; pending the results
      this may be repeated with 25mg of hydrochlorothiazide as a second substudy) which they will
      take in the daytime; after a 6-day acclimation period, two 12-hour urine samples will be
      collected as in the washout period. For the third study period, the patients will then begin
      taking the thiazide after dinner. After a 6-day acclimation period, the third set of urine
      collections will be done.
    

Intervention name(s): chlorthalidone; Hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Chlorthalidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: nephrolithiasis; calcium stones; kidney stones; hypercalciuria; thiazide