bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for
      preventing postoperative nausea and vomiting in highly susceptible patients following spine
      surgery.
    


Intervention name(s): ramosetron with saline; ramosetron with dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Group A : saline 1 ml, ramosetron 6μg/kg; Group B : dexamethasone 4 mg, ramosetron 6μg/kg
Intervention MeSH terms: Dexamethasone; Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: highly susceptible patients following spine surgery
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease
Condition: Covid 19 Disease
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigator will select participants with moderate to severe covid 19 disease admitted
      in Fatima memorial hospital. The investigator will divide them in two groups according to
      convenience sampling. Group 1 will be given dexamethasone 8mg/day and group 2 will be given
      methylprednisolone 1mg/kg/day IV for 5 days. The investigator will compare the improvement in
      temperature, oxygen requirement and CRP level at day zero and day 5 in both the groups.
    

Detailed description: 
      The investigators enrolled first 100 participants admitted in covid unit of Fatima memorial
      hospital who fulfilled the inclusion criteria and signed informed consent. Baseline oxygen
      saturation and clinical findings were noted. Chest x-ray was done on admission. Baseline labs
      were sent, initial level of CRP (C-reactive protein) was noted down.

      Patients with oxygen saturation < 94% on room air with normal chest x-ray and CRP between 30
      - 50, were labelled as having moderate covid 19 disease. Patients with CRP> 50 and having
      infiltrates on chest x-ray at the time of admission were considered having severe covid 19
      disease. Intravenous methylprednisolone in a dose of 1 mg/kg/day in 2 divided doses or
      dexamethasone 8 mg/day IV was given to alternate patients for 5 days. After 5 days, the
      investigator again recorded the oxygen saturation, CRP level and repeat chest x-ray findings.

      Patients were given tocilizumab and convalescent plasma as and when indicated. Oxygen was
      given by nasal cannula and face mask. Patient was shifted to ICU if clinical condition
      deteriorated and/or mechanical ventilation is needed.

      The investigator noted the improvement in clinical, radiological and biochemical parameters
      of the patient on day 0 that is admission day and later on day 5 after giving steroids
      (methylprednisolone or dexamethasone) for 5 days.

      Data was analyzed using SPSS version 25.0. Descriptive statistics like frequency and means
      were calculated. Paired sample t-test was applied for comparison of the two groups.
    

Intervention name(s): Dexamethasone 2 MG/ML; Methylprednisolone Injection
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants; methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants
Other intervention name(s): decadron; solumedrol
Intervention MeSH terms: Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: covid19; dexamethasone; methlprednisolone; corticosteroids
TMC207-TiDP13-C110: Interaction Study With Lopinavir/Ritonavir in Healthy Volunteer
Condition: Tuberculosis; HIV
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase I, open-label, randomized crossover trial is to investigate the
      pharmacokinetic interaction between steady-state lopinavir/ritonavir and single-dose TMC207
      in healthy volunteers.
    

Detailed description: 
      TMC207 is being investigated for the treatment of MDR-TB infection. This is a Phase I,
      open-label, randomized crossover trial in healthy volunteers to investigate the potential
      interaction between steady-state lopinavir/ritonavir (LPV/rtv) 400/100 mg twice daily and a
      single dose of 400 mg TMC207. The trial population will consist of 16 healthy volunteers.
      During 2 sessions, each participant will receive 2 treatments (Treatments A and B) in a
      randomized order. This means it will be decided by chance if subjects will receive first
      treatment A, then B or first treatment B, then A.

      In Treatment A, participants will receive a single dose of TMC207 400 mg on Day 1. In
      Treatment B, participants will receive LPV/rtv 400/100 mg twice daily on Days 1 to 24, while
      on Day 11 a single dose of TMC207 400 mg will be co-administered. The two single doses of
      TMC207 will be administered 4 weeks apart. Consequently, Treatment B should start 4 days
      after completion of Treatment A, and Treatment A should start 14 days after completion of
      Treatment B (counting from the day the last PK sample has been collected). Pharmacokinetic
      profiles over 336 hours will be determined for TMC207 and its N-monodesmethyl metabolite (M2)
      after administration of TMC207 400 mg alone (Day 1 of Treatment A), and in combination with
      steady-state LPV/rtv (Day 11 of Treatment B). Morning predose concentrations of lopinavir and
      ritonavir will be determined at several time points. Safety and tolerability will be
      evaluated throughout the trial. Day 1 of Treatment A and on Day 11 of Treatment B, 400 mg
      TMC207 (1 tablet) will be taken orally in the morning within 10 mins. after completion of a
      meal. Days 1 to 24 of Treatment B, 2 tablets of Lopinavir/Ritonavir (LPV/rtv = 400 mg
      lopinavir and 100 mg ritonavir) will be taken in the morning and evening. When LPV/rtv is
      administered alone, it can be taken with or without food. When co-administered simultaneously
      with TMC207, LPV/rtv intake will be within 10 mins. after completion of a meal.
    

Intervention name(s): TMC207
Intervention type(s): Drug
Intervention MeSH terms: Bedaquiline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC207-TiDP13-C110; TMC207-C110; TMC207; Drug-drug interaction; Tuberculosis; HIV; Kaletra; Lopinavir; Ritonavir; Open-label; HIV Infections
Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The lack of clear guidelines and studies addressing the proper response to the pneumococcal
      vaccine (Pneumovax ®) has hampered our ability to diagnosis and care for our immunodeficiency
      patients. Should an age matched normal response range to the Pneumovax ® be established, it
      would have a profound impact in the diagnosis, safety and care of immunodeficiency patients.
      Moreover, characterizing the B cell compartments response to the Pneumovax ® may better
      delineate the mechanism of protective immunity from Pneumovax ® and provide an additional
      tool for the diagnosis and care for immunodeficiency patients.
    

Detailed description: 
      The ability to respond to a polysaccharide vaccine antigen is an integral part of evaluating
      a patient with immunodeficiency. The pneumococcal vaccine (Pneumovax ®) remains the only
      readily available and the most widely used unconjugated polysaccharide vaccine. Although the
      pneumococcal vaccine is widely used test the immune systems response to a polysaccharide
      antigen, no clear guidelines or studies exist to what is considered a proper response to the
      Pneumovax ®. Immunoglobulin M (IgM) memory B cells are thought to play an important role in
      protection against pneumococcal disease. It is not known to what extent the ability of B
      cells to be activated in response to pneumococcal vaccination contributes to protective
      immunity. To address these issues, the following two specific aims are proposed:

      Specific Aim 1. Assess Immunoglobulin G (IgG) antibodies to pneumococcus pre- and
      post-pneumococcal immunization in healthy controls Specific Aim 2. Analysis of B cell subsets
      in blood of healthy controls pre-and post-pneumococcal immunization to identify changes in
      memory B cell, class switched and activated B cells.
    

Intervention name(s): pneumococcal vaccination (Pneumovax)
Intervention type(s): Biological
Intervention description(s): pneumovax was given
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pneumococcal vaccine; normal response; immunodeficiency; Healthy patients; Healthy Volunteers
Topical 3% Amphotericin B Cream for the Treatment of Cutaneous Leishmaniasis in Colombia
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The proposed study encompasses a two-step approach. The first aiming to determine the safety
      of Topical 3% Amphotericin B Cream when applied three or two times per day for 4 weeks in
      subjects with un-complicated Cutaneous leishmaniasis (CL) whilst the second focusing in
      having and indication of the efficacy of the two above mentioned regimens of Topical 3%
      Amphotericin B Cream

      For the first step, 30 subjects will be randomly assigned to receive direct observed
      treatment (DOT) with Topical 3% Amphotericin B Cream applied either three or two times per
      day for 4 weeks. Enrolment will be temporarily halted until all 30 subjects (15 in each
      group) have been enrolled and completed the 28 day treatment course. An interim analysis of
      all safety (Adverse Events, including local reactions and lab parameters) and
      pharmacokinetics collected on subjects who were randomized will be performed by data safety
      monitoring board. If no serious adverse events (SAEs) related to the study drug are
      identified on the first 30 subjects by the end of the treatment course, 50 additional
      subjects will be randomly allocated to receive Topical 3% Amphotericin B Cream either three
      or two times per day for 28 days

      Subjects will have a follow-up visit at the end of therapy, on Day 45± 5 days, Day 63± 5 days
      and on Days 90± 14 days and on Day 180, minus 14d, plus 4 weeks to assess efficacy, as
      measured by the number of subjects who fulfil the cure criteria: 100% re-epithelialization of
      the lesion(s) by Day 90 and no relapse by Day 180. All subjects will be followed up to Day
      180 for final analysis of efficacy.
    


Intervention name(s): Topical Amphotericin B at 3%
Intervention type(s): Drug
Other intervention name(s): Anfoleish
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cutaneous leishmaniasis; Topical treatment; Colombia
GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose
Condition: Physiology; Gastroenterology; Endocrinology
Study type: Interventional
Phase: Phase 1

Summary: 
      Academic phase 1 study which investigates the effects of the two incretin hormones
      glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying,
      appetite, insulin release and glucose disposal in the body. The hypothesis is that incretin
      hormones not only stimulate insulin release but also inhibits gastric emptying. This effect
      can be utilized for further drug development.
    

Detailed description: 
      Effects of GIP and GLP-1 on gastric emptying, appetite control and insulin release in
      relation to glucose levels in the bloodstream. Infusions of GIP and GLP-1 are given under
      simultaneous gastric emptying study and appetite questionnaires and blood sampling for
      analysis of insulin, glucose, and other gut hormones such as glucagon, ghrelin, and PYY, as
      well as those administered, GIP and GLP-1.
    

Intervention name(s): Glucose-insulinotropic peptide, Glucagon-like peptide-1
Intervention type(s): Other
Intervention description(s): GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min
Other intervention name(s): GIP; GLP-1; Saline
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Incretin hormones; Glucose-insulinotropic peptide; Glucagon-like peptide-1; Gastric emptying; Appetite; Glucose disposal; Gut hormones
Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a
      previous study (whose objectives & outcome measures are presented in a separate protocol
      posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation
      technology.

      These subjects will be compared to subjects vaccinated with the new vaccine, but who were not
      previously vaccinated with a meningococcal polysaccharide vaccine.
    

Detailed description: 
      GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate
      vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5
      years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal
      polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for
      serogroup C, and a recent publication suggest the same may be true for other serogroups.

      This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory
      immune response for the serogroups it contains across subjects 4.5 through 34 years of age
      who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30
      years. A non-randomised age-strata matched group of subjects, who have not previously
      received (or not received within the preceding 10 years) any meningococcal vaccine, will also
      be administered the GSK134612 vaccine for comparison.
    

Intervention name(s): Meningococcal vaccine GSK134612 (Nimenrix)
Intervention type(s): Biological
Intervention description(s): one dose, as intramuscular injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Booster vaccination; Meningococcal vaccine; Meningococcal disease; Safety; immunogenicity
A Study to Evaluate the Safety and Tolerability of ILB-202
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to
      Evaluate the Safety and Tolerability of ILB-202 Administered Intravenously as Single
      Ascending Doses to Healthy Participants. Male or female subjects aged 18 to 50 years
      (inclusive) who fulfill the inclusion/exclusion criteria will be enrolled in this study.
    

Detailed description: 
      ILB-202 is an engineered exosome loaded with super-repressor IκBα. This is Phase I,
      Single-center, Randomized, Double-blind, Placebo-controlled Study.

      Healthy volunteers, 18-55 years of age, selected from healthy participants fulfilling the
      inclusion/exclusion criteria.

      18 subjects will participate in the study. Doses of investigational product (IP) will be
      administered intravenously on Day 1. During the Screening Period (within the 28 days) each
      subject will be assessed for eligibility. Each subject must sign and date an informed consent
      form (ICF) prior to undergoing any study-related procedures.

      All dosed subject samples will be analyzed and their data will be included in the final study
      report.
    

Intervention name(s): ILB-202; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single i.v. infusion; Single i.v. infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Vascular and Metabolic Effects of Vytorin vs Simvastatin
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that vytorin will improve insulin resistance compared with
      simvastatin
    


Intervention name(s): placebo; vytorin; simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Simvastatin; Ezetimibe, Simvastatin Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: insulin resistance
A Study to Evaluate and Compare the Efficacy and Pharmacokinetics of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022)
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a within-participant comparison study to investigate the efficacy of a 28-day regimen
      of MK-0873 2% cream twice a day (b.i.d.) compared to MK-0873 vehicle (matching placebo)
      b.i.d. as well as to a positive control comparator calcitriol 0.0003% (3 µg/g) in
      participants with plaque psoriasis. In order to be enrolled in the study, patients need to
      have at least two pairs (lesions AB and CD) of approximately similar plaque lesions in
      severity and size of surface area involved and located in approximately symmetric regions
      such as the trunk or limbs of the body. Participants will be randomly assigned to apply
      either MK-0873 or MK-0873 vehicle to plaque A or B and will be randomly assigned to apply
      MK-0873 or calcitriol to plaque C or D. It is hypothesized that MK-0873 cream formulation
      administered to participants with psoriasis by the topical route will result in a
      statistically greater percent target lesion severity (TLS) reduction in plaque lesion than
      will MK-0873 Vehicle on Day 29.
    


Intervention name(s): MK-0873 2% Cream; MK-0873 vehicle (placebo) Cream; Calcitriol Cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Approximately 3 to 5 mg of MK-0873 2% cream per cm^2 of body area in 2 divided applications per day for 28 days. The maximum area for one treatment will be approximately 5% of body surface area.; Approximately 3 to 5 mg matching placebo to MK-0873 2% cream per cm^2 of body area in 2 divided applications per day for 28 days. The maximum area for one treatment will be approximately 5% of body surface area.; Approximately 3 to 5 mg of Calcitriol 0.0003% (3 µg/g) per cm^2 of body area once daily for 28 days. The maximum area for one treatment will be approximately 5% of body surface area
Intervention MeSH terms: Calcitriol; MK 0873
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Reading Problems Associated With Central Nervous System (CNS) Pathologies.
Condition: Injury Brain; Eye Abnormalities; Multiple Sclerosis; Parkinson Disease; Ataxia, Cerebellar
MeSH terms: Parkinson Disease; Multiple Sclerosis; Ataxia; Cerebellar Ataxia; Eye Abnormalities
Study type: Observational

Summary: 
      This project aims to analyse eye movements, their alterations and influence in reading
      performance in patients with acquired CNS diseases and compare them with people of the same
      age, without neurological or ocular pathology and with normal reading speed and pattern.

      The exploration is focused on the oculomotor system in patients with CNS diseases, even
      without involvement of the primary visual pathway, and reveals more involvement than the one
      obtained by a simple ophthalmological examination.
    

Detailed description: 
      The following protocol will be applied:

      Neuropsychological function Clock Test- Clock Drawing, whose score corresponds to a scale of
      1 to 6, from perfect organization to severe disorder respectively, with a cognitive deficit
      being a result greater than 3. This test is used to detect signs of heminegligence in
      addition to the Line Bisection Test. It will consider the displacement of the central mark to
      the right side as a positive sign.

      Mini-Cognitive Exam, whose cut-off score corresponds to 23 out of the 30 total, equal to or
      less than this figure, would indicate the presence of a cognitive deficit.

      Far and near Best corrected visual acuity Primary gaze position Cover test (far and near)
      Extrinsic ocular motility Nystagmus presence Intrinsic ocular motility Biomicroscopy of the
      anterior pole Computerized visual field 30-2 Intraocular pressure Ocular fundus examination
      Records with Tobii Pro Nano Hardware Package eye-tracking system and Tobii Pro Lab - Full
      Edition software.

      Reading performance assessment: International Reading Speed Texts (IReST) Attentional
      questionnaire based on the IReST, two simple answer questions (one word) will be formulated
      for each text, at the end of the reading to check the reading comprehension of the patient
      Evaluation of the speed and quality of horizontal and vertical reading: Test DEM
      (Developmental Eye Movement).

      Eye-tracking test: with an animation of a moving circle.
    

Intervention name(s): eye tracking
Intervention type(s): Diagnostic Test
Intervention description(s): Eye tracker will be used to evaluate study parameters
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal population (no pathology) and people with neurological pathologies such as multiple
        sclerosis, Parkinson, tumours, or stroke, cerebellum ataxia and other miscellaneous
        neurological disorders.
      
Keywords: eye tracking