bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to determine whether daily dosing with NYX-2925 changes markers of
      central pain processing in subjects with fibromyalgia by evaluating changes in evoked pain,
      and visual stimulation, functional magnetic resonance imaging (fMRI), resting state function
      connectivity magnetic resonance imaging (rs-fcMRI) and proton magnetic resonance spectroscopy
      (H-MRS) in fibromyalgia subjects on active drug versus placebo.
    

Detailed description: 
      This is a single-blind, exploratory, placebo-controlled, pilot study to assess the efficacy
      and safety of daily oral NYX-2925 in fibromyalgia subjects. The study will include a
      screening period (up to 30 days), a placebo period, an active treatment period with, and a
      follow-up period as follows:

        -  Placebo PO Every Day (QD) for 2 weeks

        -  NYX-2925 PO QD for 2 weeks (2x)

        -  Follow-up for 1 week

      Eligible subjects will receive MRIs during the screening period, during the placebo period,
      during the NYX-2925 PO QD period. Safety assessments will be conducted and adverse events
      will be collected during the study. Daily pain scores and other fibromyalgia scales will be
      collected during the study. Daily pain scores and other fibromyalgia scales will be collected
      for exploratory analysis. During the follow-up period, an optional MRI will be completed for
      consenting subjects in order to evaluate duration of effect.
    

Intervention name(s): NYX-2925; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).; Matching placebo capsules.
Intervention model: Single Group Assignment
Intervention model description: All subjects will receive placebo, NYX-2925 20 mg QD, NYX-2925 200 mg QD for sequential 2 week treatment periods, then go into Follow-up for 1 week.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibromyalgia
Excision Size and Location on the Postoperative Pain After Nevi Excision in Children
Condition: Anesthesia, Endotracheal
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The primary purpose of this study is to investigate the effects of excised surface area/body
      surface area ratio and location of excision on the postoperative pain after nevi excision in
      children.

      The primary purpose of this study is to investigate the effects of excised surface area/body
      surface area ratio and location of excision on the emergence excitation after nevi excision
      in children.
    


Intervention name(s): nevi excision
Intervention type(s): Procedure
Intervention description(s): After general anesthesia, nevi excision in children is performed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children undergoing nevi excision on general anesthesia
Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
Condition: COVID-19; Outcome, Fatal; Tocilizumab; Interleukin 6; Critically Ill
MeSH terms: COVID-19; Critical Illness
Study type: Observational

Summary: 
      In a retrospective observational study, critically ill COVID-19 patients admitted to the ICU
      with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated (ethics
      application nr. 129/22 of the ethics commssion of the university Ulm.
    

Detailed description: 
      According to the recommendations, IgG seronegative SARSCoV2-Spike antibody (< 0,80 U/ml)
      COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg
      (600 mg of each). Patients with CRP > 75 mg/l or IL-6 > 75 ng/l were treated with one dose of
      intravenous tocilizumab 8 mg/kg body weight. 28-day mortality and 30-day time course of
      leukocyte counts and serum concentrations of C-reactive protein (CRP), procalcitonin (PCT),
      interleukin 6 (IL-6) and ferritin in 4 patient groups, i. e., treated without (N) or with
      casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T),
      were evaluated.
    

Intervention name(s): treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)
Intervention type(s): Drug
Intervention description(s): IgG seronegative SARSCoV2-Spike antibody (< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP > 75 mg/l or IL-6 > 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight
Other intervention name(s): casirivimab / imdevimab; tocilizumab
Intervention MeSH terms: Casirivimab and imdevimab drug combination
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        In a retrospective observational study, critically ill COVID-19 patients admitted to the
        ICU with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated. IgG
        seronegative SARSCoV2-Spike antibody (< 0,80 U/ml) COVID-19 patients were treated with 1
        dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP
        > 75 mg/l or IL-6 > 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg
        body weight.
      
Keywords: COVID-19; critically ill; ICU; casirivimab imdevimab; tocilizumab; interleukin 6; C-reactive protein; ferritin; procalcitonin; mortality
The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision
Condition: Phimosis; Adhesions
MeSH terms: Phimosis; Tissue Adhesions
Study type: Interventional

Summary: 
      The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive
      decreased the incidence of recurrent adhesions after circumcision. The investigators
      hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl
      cyanoacrylate skin adhesive.
    

Detailed description: 
      The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive
      decreased the incidence of recurrent adhesions after circumcision. The investigators
      hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl
      cyanoacrylate skin adhesive.

      Secondary Objective(s) To assess parent satisfaction and comfort level after circumcision
      with use of 2-octyl cyanoacrylate skin adhesive and compare to those undergoing circumcision
      without the use of 2-octyl cyanoacrylate skin adhesive.
    

Intervention name(s): stitches and skin adhesive; stitches only
Intervention type(s): Procedure; Procedure
Intervention description(s): In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.; standard of care
Other intervention name(s): skin adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: circumcision; 2 octyl cyanoacrylate; phimosis
Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of the protocol is to determine the maximum tolerated dose and to investigate
      the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.
    


Intervention name(s): Lanreotide PRF
Intervention type(s): Drug
Other intervention name(s): Lanreotide acetate
Intervention MeSH terms: Lanreotide; Somatostatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid
Condition: Bullous Pemphigoid
MeSH terms: Pemphigoid, Bullous
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess that it will be possible to control with a single cycle of
      rituximab patient with bullous pemphigoid.
    

Detailed description: 
      The objective of this study is to assess the efficacy and tolerance of a single cycle of
      rituximab in control of bullous pemphigoid.

      the main objects are :

        1. to assess that a single cycle of rituximab is able to control patient with
           corticosteroid-dependent bullous pemphigoid,

        2. to avoid the use of corticosteroid in long time,

        3. to evaluate duration of control disease and side effect with a single cycle of
           rituximab.
    

Intervention name(s): Mabthera
Intervention type(s): Drug
Intervention description(s): Two IV perfusions of 1000mg at 15 days intervals
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bullous pemphigoid; mabthera
Vitamin D for Established Type 2 Diabetes (DDM2)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This research study in adults with established type 2 diabetes will test whether daily
      vitamin D supplementation affects how the body processes glucose (sugar).
    


Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adherence With Iron Sprinkles Among High-Risk Infants
Condition: Anemia; Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children
      beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron
      deficiency.
    

Detailed description: 
      Iron deficiency is the most common known nutrient deficiency and cause of anemia in
      childhood. It is associated with numerous adverse health effects, particularly delayed mental
      and motor development, that may be irreversible. Despite advances of iron nutrition, the
      prevalence of iron deficiency remains high among low-income infants and toddlers. Previous
      studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles
      among children as tested in studies in less developed countries appears high.

      Comparison: Children randomized to ferrous sulfate drops will be compared with children
      randomized to ferrous fumarate sprinkles.
    

Intervention name(s): Ferrous sulphate drops with vitamins A, D, and C; Ferrous fumarate sprinkles with vitamins and minerals
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin D; Vitamins; Vitamin A; Ferrous fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adherence; Supplements; Iron; Iron deficiency; Anemia; Vitamins; Minerals
Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study to evaluate the excretion of radioactivity, the metabolic profile,
      pharmacokinetics, safety and tolerability following a single oral administration of [14C]
      SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study
      is to investigate how and how quickly SPD557 or its break down products are excreted by
      analysing blood, faeces and urine samples collected during the study.
    


Intervention name(s): Radiolabeled SPD557
Intervention type(s): Drug
Intervention description(s): A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Radiolabelled; AME
Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of two doses of the TB
      vaccine administered according to a 0, 1 month schedule. In, addition, blood samples
      collected at different time points after vaccination will be analysed to see when exactly
      genes are activated by the vaccine using an assay called mRNA expression profiling. The
      different methods for mRNA expression profiling using whole blood samples versus Peripheral
      Blood Mononuclear cell(s) (PBMCs), will also be compared.
    


Intervention name(s): GSK Biologicals' investigational TB vaccine GSK 692342
Intervention type(s): Biological
Intervention description(s): 2 doses administered intramuscularly according to a 0, 1 month schedule (Day 0 and Day 30), in the deltoid region of the arm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: adults; Tuberculosis vaccine; HIV negative; healthy; mRNA expression
Nasal Xylitol in the Prevention of Otitis Media
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      Acute otitis media (AOM) is one of the most prevalent and costly illnesses in children
      throughout the world. AOM can lead to chronic otitis media with effusion (OME) resulting in
      conductive hearing loss that can cause speech, language, academic, and social developmental
      delays.

      Complementary and alternative medicines are being widely used for prevention of AOM.

      Xylitol is a five carbon polyol (sugar alcohol) produced from natural plants and is used for
      preventing dental caries and AOM in children. It is commercially available in chewing gums,
      syrups and toothpastes washes, and other products. Xylitol was shown in several studies to
      prevent the culture of bacteria in the nasopharynx and oral cavity. It was proven to
      eliminate the ability of bacteria to attach to the mucosa of the upper respiratory system. It
      was proven to reduce the ability of bacteria to attach to the mucosa of the upper respiratory
      system. Previous study had shown that oral usage of Xylitol (as chewing gum or syrup) can
      reduce the incidence of rAOM by 30% as compared to placebo. But this treatment did not gain
      popularity since the initial clinical trial 30 years. There are several potential reasons for
      that. First, Xylitol should be administrated 5 times daily in order to be effective. Study
      that checked usage of oral Xylitol 3 times daily in children with rAOM did not find
      additional advantage as compared to placebo. Secondly, by using Xylitol orally we rely on the
      gut absorption and systemic distribution. Xylitol absorbs poorly in the gut and can cause
      some GI symptoms (like nausea and diarrhea) especially when used in a syrup (the preferred
      way in small children).

      In this study the investigators aim to test the yield of Xylitol nasal spray as a preventive
      treatment in children with rAOM. By using Xylitol as nasal spray we deliver the active
      compound directly to the action site (nasopharynx- the AOM reservoir) and avoid the GI side
      effects
    


Intervention name(s): Xylitol spray
Intervention type(s): Dietary Supplement
Intervention description(s): xylitol nasal spray will be administered to this arm three times daily for three months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Test How Different Doses of BI 456906 Are Tolerated in Japanese Men With a Body Mass Index (BMI) Between 23 and 40 kg/m2
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Main objectives are to investigate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of different dose escalation schemes of BI 456906 in healthy Japanese male
      subject with BMI 23-40 kg/m2 and to determine a dose escalation scheme for future studies.
    


Intervention name(s): BI 456906; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for injection; Solution for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Cognitive Effects of Treatment of Interictal Discharges
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The purpose of this study is to determine if levetiracetam (for patients with focal seizures)
      or lamotrigine (for patients with generalized seizures) reduces the occurrence of interictal
      discharges. The study investigates the possible correlation between reduction of interictal
      discharges and improved cognitive performance.
    

Detailed description: 
      Subjects with seizures will be studied with electroencephalography (EEG) and offered
      medication for prevention of recurrent seizures. Those with focal seizures will be treated
      with levetiracetam, and those with generalized seizures will be treated with lamotrigine.
      Subjects will undergo repeated EEG with concurrent cognitive testing before and after
      initiation of treatment. The proposed study tests 3 hypotheses: 1. that treatment with
      levetiracetam will reduce focal interictal epileptiform activity, 2. that treatment with
      lamotrigine will reduce generalized interictal epileptiform activity, and 3. that the extent
      of interictal epileptiform activity is inversely associated with performance on
      neuropsychological batteries and computerized cognitive testing. Repeated
      cognitive/neuropsychological testing obtained at steady state of the study drug and again
      after approximately 2 months on the final dosage will serve to evaluate the timecourse of
      potential cognitive benefits.
    

Intervention name(s): levetiracetam; Lamotrigine
Intervention type(s): Drug; Drug
Intervention description(s): The dosage of levetiracetam will begin at 500mg twice per day (bid) for the first 4 days, and increase by 500mg every 5 days thereafter until a goal of 1500mg bid is reached. The subject will then remain on levetiracetam at 1500mg bid for 8 weeks, until the conclusion of the study. Medication will be supplied in 500mg tablets, to be taken orally.; The drug will be supplied in 25, 100 and 150mg tablets, to be taken orally per the titration schedule below:
The regimen will begin at 25mg once per day for the first two weeks, and increase to 50mg once per day during weeks 3 and 4. In week 5, the subject will take 50mg twice per day (bid). The dosage will increase to 50mg in the morning and 100mg at night during week 6. During week 7 the subject will take 100mg bid. During week 8, the subject will take 100mg in the morning and 150mg at night. At week 9, the subject will reach the target dose of 150mg bid. The subject will then remain on lamotrigine at 150mg bid for 7 weeks, until the conclusion of the study.
Other intervention name(s): Keppra; Lamictal
Intervention MeSH terms: Lamotrigine; Levetiracetam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Cognition; Lamictal; Lamotrigine; Keppra; Levetiracetam
Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy volunteers of the next morning driving performance after
      middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid. The
      next morning driving performance will be measured by taking a standardized driving test.
    


Intervention name(s): zopiclone; zolpidem tartrate sublingual tablet; Placebo (sublingual tablet); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 7.5 mg tablet by mouth. Zopiclone is a commonly used hypnotic in Europe that is known to impair driving in the morning 9 hours after dosing.; 3.5 mg zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.; Placebo matching zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.; Placebo matching zopiclone
Other intervention name(s): non-benzodiazepine hypnotic agent; Zimovane; Imovane; Intermezzo®
Intervention MeSH terms: Zolpidem; Zopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insomnia
A Safety, Efficacy and Tolerability Study of SEP-225289
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major
      Depressive Disorder
    

Detailed description: 
      This is a randomized, placebo-controlled, double-dummy, multi-center study of the safety,
      efficacy and tolerability of SEP-225289 in male and female subjects with MDD. Subjects
      meeting DSM-IV criteria for Melancholic or Atypical Features specifier are eligible for
      participation. The study will consist of a screening period, which may last up to 2 weeks, an
      eight week (56 day) double-blind treatment period, a two week (14 day) wash-out, and a one
      week (7 day) follow up. Total subject participation will be approximately 91 days (13 weeks).
      This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired
      by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to
      Sunovion Pharmaceuticals Inc.
    

Intervention name(s): SEP-225289; SEP-225289; Venlafaxine; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.5 mg SEP-225289; 2.0 mg SEP-225289; 150 mg Venlafaxine; Placebo
Other intervention name(s): Effexor
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Depression; Mental Disorders; Mood Disorders; Depressive Disorder, Major; Dysthymic Disorder