bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study of Suvorexant for Insomnia in Parkinson Disease
Condition: Insomnia
MeSH terms: Parkinson Disease; Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if the study drug, suvorexant, is safe and effective in
      treating symptoms of insomnia in people with Parkinson's Disease. It is anticipated that a
      total of 20 subjects, 30 to 80 years of age, with Parkinson's Disease and symptoms of
      insomnia will participate in the study at this site
    

Detailed description: 
      The proposed study is a randomized, double-blind, placebo-controlled, cross-over trial to
      assess the safety, tolerability, and efficacy of suvorexant specifically in a cohort of 20
      Parkinson's Disease patients between the ages of 30 and 80 (inclusive) who have a complaint
      of insomnia. After informed consent is given, potential subjects will be screened to ensure
      they meet eligibility criteria. This will include an overnight polysomnogram, which will
      serve both as a baseline and a screening polysomnogram. Active drug will be suvorexant 10 mg
      orally at bed time with an optional up-titration to 15 mg orally at bedtime after 2 weeks.
      The first treatment period will be 4 weeks long, in which subjects will be randomized 1:1 to
      receive active drug or matching placebo. At the end of treatment period 1, subjects will
      undergo efficacy assessment with repeat polysomnogram and clinical scales. This will be
      followed by a 2-week washout period with placebo; this period only will be single-blinded, as
      subjects only will be blinded to treatment. Subjects will then be crossed over into the
      alternate treatment group, which will once again be double-blinded; those on active treatment
      for period 1 will be switched to placebo, and those on placebo in period 1 will be switched
      to active treatment. Treatment period 2 will also be 4 weeks long, and at the end of this,
      subjects will undergo final assessment with polysomnogram and clinical scales.
    

Intervention name(s): Suvorexant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg Suvorexant or matching Placebo orally at bedtime with optional up-titration to 15 mg Suvorexant or matching Placebo orally at bedtime after 2 weeks.; 10 mg Suvorexant or matching Placebo orally at bedtime with optional up-titration to 15 mg Suvorexant or matching Placebo orally at bedtime after 2 weeks.
Other intervention name(s): Belsomra; Sugar Pill
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Community Salt Testing and Relation of Iodine Intake to Visual Information Processing of Ethiopian Infants
Condition: Iodine Deficiency Goiter; Infant Development
MeSH terms: Goiter
Study type: Interventional

Summary: 
      This study evaluated efficacy of iodized salt for mothers and their six-month-old infants'
      thyroid hormones and visual information processing. Half of the participants received 450 g
      iodized salt for the household each week, while the other half received 225 ug iodine daily
      as a potassium iodide capsule.
    

Detailed description: 
      Iodine is essential for the synthesis of thyroid hormones, and thyroid hormones regulate the
      metabolic processes of most cells and play important roles in human growth and development.
      Iodine deficiency disorders can have serious consequences on brain and physical development.
      In neonates iodine deficiency and hence insufficient supply of thyroid hormones could cause
      neonatal goiter, neonatal hypothyroidism, and endemic mental retardation.

      Iodine deficiency disorders can be prevented and controlled by providing iodine and iodine
      can be provided in different ways. However, the United Nations Children's Fund and the World
      Health Organization jointly recommended salt iodization where iodized salt is accessible.
      Iodized salt is a safe, cost effective and sustainable strategy to ensure sufficient intake
      of iodine by all individuals and to improve maternal and infant health. However, although the
      effect of iodine on human health is well established efficacy of iodized salt has not been
      studied.
    

Intervention name(s): Iodine capsule; Iodized Salt
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 225 µg of iodine daily as a capsule of potassium iodide; 450 g iodized salt provided for the household weekly. Salt iodine content was 30 to 40 mg iodine /kg salt as KIO3
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The mother-child dyads were randomly assigned either to receive iodine capsule (n = 53) or iodized salt (n = 53). The iodine capsule group received 225 µg of iodine daily as potassium iodide for 6 months.The iodized salt group was provided with iodized salt (30 to 40 mg iodine/kg as KIO3). One packet of salt (450 g) per household was provided starting within one week of delivery for 6 months.
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Black Raspberry Phytochemicals on Oral Microbiome in Current Smokers and Non-smokers
Condition: Healthy Subject; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This randomized clinical trial studies the effects of black raspberry compounds
      (phytochemicals) on the bacteria in the mouth (oral microbiome) of current smokers and
      non-smokers. The oral microbiome protects the body from pathogenic bacteria. Smoking alters
      the oral microbiome and may increase the susceptibility to cancer by modulating normal
      host-bacteria interactions. Black raspberry phytochemicals may protect the oral microbiome of
      smokers and may lower their risk of developing oral cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the effect of black raspberry phytochemicals on community dynamics within oral
      biofilms.

      II. Examine the effect of oral bacterial communities on metabolism of black raspberry
      phytochemicals in current and never smokers.

      III. Evaluate the efficacy of black raspberry phytochemicals and their metabolites in
      reversing the effect of smoking on oral host-microbial interactions.

      OUTLINE: Participants are randomized to 1 of 2 arms.

      ARM I: Participants receive bioactivity of black raspberry phytochemical-rich delivery
      vehicle (BRB nectar) orally (PO) once daily (QD) for 12 weeks.

      ARM II: Participants receive placebo nectar PO QD for 12 weeks.
    

Intervention name(s): Laboratory Biomarker Analysis; Phytochemical; Placebo; Screening Questionnaire Administration
Intervention type(s): Other; Dietary Supplement; Other; Other
Intervention description(s): Correlative studies; Given black raspberry (BRB) nectar per oral (PO); Given PO; Ancillary studies
Other intervention name(s): Phytonutrients; placebo therapy; PLCB; sham therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Implicit Messaging by Cigarette Pack Color on Smoking Behaviors
Condition: Cigarette Smoking Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of changes in cigarette package color and
      warning label features on smoking behaviors and beliefs about cigarette risks.
    

Detailed description: 
      This project will recruit 360, current daily Marlboro, non-menthol, red (n=180) or gold
      (n=180) cigarette smokers to a 50-day protocol using a randomized factorial design with two
      factors: (1) cigarette pack color manipulation (within subject: red, gold, plain packaging)
      and (2) warning label manipulation (between subject: graphic vs. standard text). The
      randomization will be stratified by own brand cigarette. To evaluate effects of changes in
      cigarette package coloring, participants will smoke commercially available cigarettes that
      may or may not be similar to their preferred brand of cigarettes throughout the study, but in
      different colored packages during three 15-day study periods (i.e., one period will be
      Marlboro plain (tan-olive) packs, one will be Marlboro gold packs and one will be Marlboro
      red packs; order counterbalanced). Participants will visit the Center every 5 days to
      complete assessments (11 total sessions).
    

Intervention name(s): Graphic Warning Label; Text Warning Label
Intervention type(s): Other; Other
Intervention description(s): All packs provided will include FDA-approved graphic warning labels; All packs provided will include standard text warning labels
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Other
Optimal Length of Pre-inserted ETT for Nasal Fiber Optic Intubation
Condition: Nasal Fiberoptic Intubation
Study type: Observational

Summary: 
      This study is intended to find the optimal length of pre-inserted ETT for nasal fiberoptic
      intubation and the equation to predict it.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled to undergo an elective oral and maxillofacial surgery requiring a nasal
        intubation of ETT for general anesthesia
      
Keywords: Airway management; Fiber optic technology; Intubation
Psychosocial Needs of YMSM
Condition: HIV+ YMSM
Study type: Observational

Summary: 
      The proposed study will use both qualitative and quantitative research methods (mixed
      methods) to gather data that will support the eventual development of interventions for young
      men who have sex with men (YMSM) living with behaviorally acquired HIV infection. The overall
      goal of the study is to gain an understanding of the psychosocial/developmental needs of YMSM
      by focusing on two critical developmental issues-identity development and future life goals.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male, HIV+ participants from ages 16-24 who have had sex with another male in the past year
        and accquired HIV behaviorally.
      
Keywords: HIV positive; YMSM; risk factors; coping; identity development; psychosocial needs
Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
Condition: Schizophrenia Patients
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of
      paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients
      and to compare the PK of LY03010 P1 and P2 with that of INVEGA SUSTENNA® following a single
      IM injection of 156 mg dosage level.
    

Detailed description: 
      This is a randomized, open-label, parallel-group, single-dose study. Patients will undergo
      screening evaluations to determine eligibility within 28 days prior to study drug
      administration. About 36 patients will be randomized in a 1:1:1 ratio to 1 of 3 treatment
      groups. Patients will be admitted to the clinical facility the day before dosing (Day 0) and
      will be receiving an IM injection of study drug and completing the assigned study activity
      including PK sample collection on Day 1. Patients will be discharged on Day 2 after PK
      collection. All patients will return to the clinical site at designated study days for PK
      sample collections and assigned clinical procedures. End of study evaluation will be
      completed on Day 120.

      Pharmacokinetics of the study medication will be assessed as primary outcome. Participants'
      safety will be monitored throughout the study.
    

Intervention name(s): Paliperidone Palmitate
Intervention type(s): Drug
Intervention description(s): A long acting extended release injectable suspension intended for monthly intramuscular administration
Other intervention name(s): Paliperidone Injectable Product
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single dose study in three parallel dosing groups of schizophrenia patients
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295)
Condition: Asthma; Common Cold; Picornavirus Infection; Rhinovirus
MeSH terms: Common Cold; Picornaviridae Infections; Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the
      efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms
      in asthmatic participants exposed to picornavirus respiratory infections. Participants will
      be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses).
      Participants will be followed for an additional 14 days.
    


Intervention name(s): Pleconaril; Placebo to Pleconaril
Intervention type(s): Drug; Drug
Intervention description(s): Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril.; Placebo nasal suspension
Other intervention name(s): SCH 900819
Intervention MeSH terms: Pleconaril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy of Azithromycin in MSAF Cases to Improve Maternal and Neonatal Outcomes
Condition: Meconium Stained; Azithromycin; Postpartum Endometritis
MeSH terms: Endometritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Meconium stained amniotic fluid increases the risk of maternal complications (e.g., dystocia,
      operative delivery, and postpartum endometritis) and neonatal complications (e.g., sepsis,
      admission to the neonatal intensive care unit [NICU], and meconium aspiration syndrome). The
      goal of the study is to compare between Azithromycin vs Placebo in cases of meconium stained
      amniotic fluid during the first stage of labor in multigravida women and their effect on
      maternal and neonatal outcomes.
    

Detailed description: 
      Meconium stained amniotic fluid, a troublesome situation both for obstetrician and
      pediatrician, it is associated with high rates of caesarean section, perinatal morbidity and
      mortality. The rate of meconium-stained amniotic fluid varies from 12 to 20%.It is higher in
      underdeveloped countries.Our study design would be a prospective randomized trial. Consented,
      eligible pregnant women presenting during the first stage of labor at or more than 37 weeks
      of gestation with meconium stained amniotic fluid will be randomized to receive Azithromycin
      capsule (Zithromax, Pfizer) (250 mg / 12hrs on empty stomach for 3 days)(Group 1).Group 2
      will be offered placebo capsules (manufactured in pharmacy department with the same shape,
      color and consistency as Azithromycin capsule for 3 days).
    

Intervention name(s): Azithromycin capsule (Zithromax, Pfizer) (250 mg); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Azithromycin, a second generation macrolide, broad-spectrum antibacterial that stops bacterial growth by inhibiting protein synthesis and translation, treating bacterial infections Azithromycin has additional immunomodulatory effects and has been used in chronic respiratory inflammatory diseases for this purpose. .Azithromycin has been beneficial in the treatment of influenza and Middle East respiratory syndrome coronavirus (MERS-CoV) and recently has shown to be effective against severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) when used in combination with hydroxychloroquine or chloroquine.; A treatment that has no active properties
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participant will be allocated to one of two groups :
Group 1 will be offered Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12 hrs on empty stomach for 3 days).
Group 2 will be offered placebo capsules (manufactured in pharmacy department with the same shape, colour and consistency as Azithromycin capsule for 3 days). A single pharmacist will be responsible for manufacturing of placebo capsules and packing all medications into sterile boxes and labelling of them as 1 or 2.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Azithromycin; Placebo; Postpartum Endometritis
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the safety and effectiveness of an investigational study drug (called
      CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
    


Intervention name(s): CTP-543 matching placebo; CTP-543; CTP-543
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as tablets.; Administered as tablets.; Administered as tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alopecia; Hair loss; Hair disease; CTP-543
Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma
Condition: Diffuse Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, double-blind, randomized study comparing the efficacy,
      pharmacokinetics (PK)/pharmacodynamics (PD), safety and immunogenicity profile of RTXM83
      (rituximab biosimilar) vs reference rituximab (MabThera®), both with CHOP, as first-line
      treatment of Diffuse-Large-B-Cell-Lymphoma (DLBCL).

      Rituximab biosimilar and MabThera® were both administered intravenously on Day 1 of each
      3-week cycle with CHOP chemotherapy for six cycles. Two additional cycles of treatment were
      permitted at the Investigator's discretion. Patients were followed up for 9 months after last
      study dose.
    

Detailed description: 
      The primary endpoint of the investigation is to determine if the response rate obtained with
      RTXM83 combined with CHOP is non inferior to the response rate obtained with reference
      rituximab combined with CHOP.

      The present study is a non inferiority trial and the study hypothesis is the following: H0:
      pc ≥ pe + δ vs. H1: pc < pe + δ where, pe: proportion of successes in the experimental group
      (RTXM83+CHOP) pc: proportion of successes in the control group (Reference Rituximab+CHOP)
      Type I error: the difference pc-pe is less than δ when in fact the difference is greater than
      or equal to δ ie, the investigators choose the experimental treatment when the control
      treatment is actually substantially better.

      Type II error: the difference -pe is greater than or equal to δ when it is actually lest than
      δ ie, the investigators choose the control treatment when the experimental treatment is
      essentially just as good.
    

Intervention name(s): RTXM83; Mabthera
Intervention type(s): Biological; Biological
Intervention description(s): Rituximab biosimilar (RTXM83) will be administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles, although the administration of 2 additional cycles may be allowed.; Mabthera will be administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles, although the administration of 2 additional cycles may be allowed.
Other intervention name(s): Rituximab Biosimilar; Reference rituximab
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Non-Hodgkin Lymphoma; DLBCL; Diffuse large b-cell lymphoma
Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the absence of photoirritation and photosensitization potential of the product
      Dermacyd Femina (Lactic Acid) Pocket BR.
    


Intervention name(s): Lactic Acid
Intervention type(s): Drug
Intervention description(s): Drug: Lactic Acid (Dermacyd Femina)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Sacral nerve stimulation (SNS) has become a well-established treatment for patients with
      fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood
      but recent studies have shown changes in both colonic motility and rectal sensibility. We
      have previously shown IBS patients to benefit from sacral nerves stimulation. With the
      present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as
      suprasensory sacral nerve stimulation.
    

Detailed description: 
      Twenty four patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled
      in the study.

      Having meet inclusion criteria, the patients are randomised to receive either OFF-subsensory
      or subsensory-OFF stimulation in a 2+2-week period followed by 2 weeks of suprasensory
      stimulation. Hereby rendering a percutaneous nerve evaluation (PNE) test of a total of 6
      weeks.

      During the PNE test the effect of the stimulation is evaluated by specific IBS symptom and
      quality of life questionnaires (GSRS-IBS and IBS-IS) and bowel habit diaries.
    

Intervention name(s): Subsensory; OFF; Suprasensory
Intervention type(s): Device; Device; Drug
Intervention description(s): The stimulation is here set to 90% of the sensory threshold; The stimulation is here turned OFF; The stimulation is here set suprasensory
Other intervention name(s): Device: External pacemaker, model 3625, Medtronic Inc.; Device: External pacemaker, model 3625, Medtronic Inc.; Device: External pacemaker, model 3625, Medtronic Inc.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Sacral Nerve Stimulation; Symptoms; Quality of Life; Bowel habits