bioihbjkbjnl/mcl2 huggingface dataset:
Nursing and Nurturing Premature Infants
Condition: Infant Growth; Mothers' Parental Competence
MeSH terms: Premature Birth
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether systematic use of the Newborn
      Individualized Developmental Care Assessment Program (NIDCAP®) improves the neurologic
      development of children and the parental competence of mothers.
    

Detailed description: 
      Background: The unborn infant's brain is growing from the fifth month of fetal life which
      makes preterm babies sensitive to environmental influence. Therefore, to prevent
      developmental brain injury is an essential goal for neonatal nurses.

      Purpose: The study investigates whether systematic use of Newborn Individualized
      Developmental Care Assessment Program (NIDCAP®) improves the neurological development of
      preterm babies and the parental competence of mothers.

      Design: This study compares postnatal care of preterm babies in two neonatal units.

      Participants: Preterm infants born before 32 weeks' gestational age and their mothers.

      Instruments:

        -  Preterm babies' behaviour in intervention and control groups is observed every 7-12 days
           using scoring sheets.

        -  Questionnaires focusing on maternal self esteem when the baby is 4 weeks and again at 3
           and 18 months and 5 years.

      Expected outcomes:

        -  Infants: less time with treatment using CPAP and oxygen, growth, time of discharge and
           pattern of motor behaviour.

        -  Mothers: self reported experiences of self esteem.

      Analysis: t-test Expected implications: In a health promotion perspective the systematic
      NIDCAP program hopefully will constitute a more competent mother, knowledgeable in child care
      and parental management. The intervention NIDCAP®-care infant group is expected to increase
      in growth compared to the control group, their motor system will be more mature, and there
      will be an earlier discharge, all factors contributing positively to health economy.
    

Intervention name(s): NIDCAP
Intervention type(s): Behavioral
Intervention description(s): Systematic care, where the mother and the nurses organize the caring on behalf of the preterm infants' ressources and developmental capacity such as the infant avoid over stimulation and distress
Other intervention name(s): Newborn Individualized Developmental Care Assessment Program; Induvidualized Neonatal Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Preterm Infant;; NIDCAP;; Neonatal Care,; Intervention Study;; Growth and Development;; Maternal Self-esteem.; Maternal Social support; NICU
A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate
      the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to
      Humira® in subjects with moderate to severe RA despite MTX therapy.
    

Detailed description: 
      Investigational product: SB5 40 mg (0.8 mL of 50 mg/mL) Indication studied: Rheumatoid
      arthritis
    

Intervention name(s): Humira (adalimumab); SB5 (proposed biosimilar to adalimumab)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis, Adalimumab
Blue Blockers at Night and Insomnia Symptoms
Condition: Insomnia; Sleep
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Under entrained conditions, humans maintain a consolidated nocturnal sleep episode that
      coincides with environmental darkness and endogenous melatonin secretion. Various factors,
      such as artificial light, can compromise this temporal harmony, resulting in sleep
      disruption. Light is the strongest synchronizer of the circadian clock, with direct inputs
      via the retinohypothalamic tract to brain centers regulating sleep and circadian rhythms.
      Evening light exposure can suppress melatonin secretion and worsen sleep. This is critical,
      since most individuals routinely expose themselves to light before bedtime. The high
      sensitivity of the circadian system to blue wavelength light indicates that modern light
      sources such as light-emitting diodes (LED) may have particularly deleterious effects on
      sleep. It is possible to selectively filter out blue light while maintaining other visible
      spectra with blue-blocking (BB) lenses. Wearing BB lenses before bedtime may present a
      simple, affordable, and safe method to improve sleep. None have yet investigated the effects
      of BB lenses on subjective and objective sleep in insomnia patients, while simultaneously
      exploring the effects on melatonin secretion.
    

Detailed description: 
      This study seeks to investigate the impact of BB lenses on melatonin and sleep in insomnia
      patients using a randomized, placebo-controlled crossover study, with the aim of developing a
      novel non-pharmacological approach for the treatment of insomnia. 15 individuals with
      insomnia will wear either BB or placebo (clear) lenses for 2 hours preceding bedtime while at
      home, for 1 week in a cross-over design. Sleep quality will be documented while at home, at
      also melatonin secretion while in the laboratory. It is predicted that compared to placebo,
      wearing BB lenses for 2 hours preceding bedtime will attenuate bright light associated
      melatonin suppression and improve sleep.
    

Intervention name(s): Blue blocking (BB) lenses; Clear lenses
Intervention type(s): Device; Device
Intervention description(s): Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.; Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant
Condition: Hematologic Neoplasms
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus
      following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced
      intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease
      the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune
      reconstitution, thereby improving the safety of the procedure. The past experience with
      post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism,
      which the investigators hope will translate into improved disease control through the well
      documented graft-versus-malignancy effects of donor T cells.
    


Intervention name(s): Allogeneic Hematopoietic Stem Cell Transplantation
Intervention type(s): Procedure
Intervention description(s): Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Myelogenous Leukemia; Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Myelofibrosis; Acute Lymphocytic Leukemia; Acute Lymphoblastic Lymphoma; Chronic Lymphocytic Leukemia; Prolymphocytic Leukemia; Low-grade non-Hodgkin's Lymphoma; Mantle Cell Lymphoma; Hodgkin Lymphoma; Myeloma
Oxytocin Effects on the Prosocial Learning
Condition: Healthy
Study type: Interventional

Summary: 
      To investigate whether intranasal oxytocin (24 IU) treatment can influence prosocial learning
      behavior in males.
    

Detailed description: 
      In a double-blind, within-subject, placebo controlled design, investigators plan to
      investigate the effect of oxytocin treatment on prosocial learning. Before the
      self-administration, participants need to finish several questionnaires including IRI, AAS,
      BASBIS, SPSRQ, SES, PTM, STAI, BDI, ASQ and PNAS. They would finish the PANAS again before
      the scanning.

      Participants are informed that they perform the reward learning task either for themselves,
      another (unknown) person or no one (control). In the probabilistc reward learning task,
      associations with two stimuli with different reward probabilities are learned via monetary
      feedback (reward ￥1 or no reward ￥0). After the experiment, participants need to finish the
      PANAS.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intranasal administration of oxytocin (24 IU); intranasal administration of placebo (24 IU)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oxytocin; prosocial learning
Measurement by 2D Ultrasound of the Pennation Angle and Elasticity of Gastrocnemius Muscle
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Observational

Summary: 
      Hemiplegic adults after stroke (stroke), children and adolescents with cerebral palsy (CP)
      have both muscles spastic and paresis. These movement disorders are likely to cause muscle
      changes both structural and viscoelastic involved in the alteration of neuromotor functions
      such as walking. Therefore, it seems interesting to study the structure of these muscles with
      available imaging techniques. The medial gastrocnemius muscle presents architectural
      characteristics which allows easy evaluation 2D ultrasound. The literature lacks data on the
      reproducibility of the measurement, by 2D ultrasound, of the pennation angle and muscular
      thickness, particularly in children. In addition, the sonoelastometry by Supersonic ShearWave
      Imaging (SSI) is a new technique of ultrasound, non-invasive, dynamic, which allows the
      calculation of the modulus of elasticity within a muscle tissue. This allows to consider new
      perspectives evaluation of the viscoelastic properties of the muscle. No studies have
      evaluated the reproducibility of this method in adults/children/ adolescent after stroke and
      hemiplegia.
    

Detailed description: 
      A 1 week apart, an ultrasound examination will be conducted on the hemiplegic leg side, while
      lying on his stomach and on the back. The thickness, elasticity and the pennation angle of
      the medial gastrocnemius muscle will be measured.
    

Intervention name(s): Muscle elasticity measure
Intervention type(s): Device
Intervention description(s): an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hemiplegic adults/children/adolescent after stroke ,
      
Keywords: Vascular hemiplegia; 2D ultrasound; Muscle elasticity; Pennation angle
A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is
      at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms
      that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.
    


Intervention name(s): Vortioxetine (Lu AA21004); Agomelatine
Intervention type(s): Drug; Drug
Intervention description(s): encapsulated tablets, daily, orally; encapsulated tablets, daily, orally
Other intervention name(s): Brintellix®; Valdoxan®
Intervention MeSH terms: Vortioxetine; Agomelatine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Multimodal antidepressant
Incentive Spirometer and Inspiratory Muscle Trainer
Condition: Parkinson Disease
MeSH terms: Respiratory Aspiration; Parkinson Disease
Study type: Interventional

Summary: 
      Patients suffering from parkinsonism have respiratory function abnormalities. This study
      compared the effects of incentive spirometer and inspiratory muscle trainer on pulmonary
      functions in patients with parkinsonism.
    

Detailed description: 
      The participants were recruited according to the inclusion and exclusion criteria.
      Participants were divided into two groups - incentive spirometer and inspiratory muscle
      trainer. These trainings were performed for 6 weeks duration. Several outcome measures
      related to pulmonary function tests were measured before and after the intervention.
    

Intervention name(s): Inspiratory muscle training; Incentive Spirometry
Intervention type(s): Other; Other
Intervention description(s): Threshold inspiratory muscle training was performed for 6 weeks with device.; Incentive spirometry was performed for 6 weeks with device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson disease; Incentive spirometer; Inspiratory muscle trainer; Pulmonary functions
Bioequivalence Study of Baricitinib From Barcimiant 4 mg Film Coated Tablets (Horus Pharma, Egypt) and Olumiant 4 mg Film Coated Tablets (Eli Lilly Nederland B.V., The Netherlands)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, three-way, three-sequence, two treatment, partial
      replicate, crossover, open-label study to determine the bioequivalence of Baricitinib from
      Barcimiant 4 mg Film Coated Tablets (Horus Pharma, Egypt) and Olumiant 4 mg Film Coated
      Tablets (Eli Lilly Nederland B.V., The Netherlands)
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Barcimiant; Olumiant (first dose); Olumiant (second dose)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet contains 4 mg Barcitinib; 1 tablet contains 4 mg Barcitinib; 1 tablet contains 4 mg Barcitinib
Other intervention name(s): Olumiant; Olumiant; Olumiant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
PHAST: Physical Activity in Substitution Therapy
Condition: Substance-related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The aim is to examine the effect of exercise (EX) training on individuals currently receiving
      ST - either opiate replacement therapy (ORT) or heroin-assisted treatment (HAT) - for their
      opiate dependence. Main outcome variables will be: cardiovascular fitness; consumption of
      substances (e.g. "street heroin", cocaine, cannabis, alcohol, cigarettes) other than
      prescribed ST or other prescribed medications; substance craving; blood pressure; lung
      function; resting pulse; social interaction; self-control capacity; objective and subjective
      sleep; cortisol levels; quality adjusted life years (QALYs); depression; mood. Covariates are
      current substitution dose and psychiatric diagnoses.
    

Detailed description: 
      The investigators aim is to carry out a randomized controlled trial comparing exercise
      training group and a control group of patients receiving substitution therapy (ST). The
      specific goals of the study are:

        1. To understand the exercise preferences, barriers to participation, motivation,
           experiences and attitudes regarding exercise training in patients under ST.

        2. To examine whether a 12-week exercise programme affects the mental health, subjective
           and objective sleep, quality of life, self-control capacity, substance craving, hair
           cortisol levels, secondary consumption, cardiovascular fitness, blood pressure, lung
           function, resting pulse, and social interaction in patients receiving ST.

        3. To compare the effects of the EX and control conditions on the above-mentioned outcome
           variables.

        4. To examine to what degree the covariates of heroin substitution dose and psychiatric
           comorbidities affect outcome variables.

        5. To explore to what extent objective variables (cardiovascular fitness, pulse, blood
           pressure, lung function, cortisol, objective sleep-EEG-parameters) and
           subjective-psychological dimensions (subjective sleep, social interaction, symptoms of
           depression and anxiety, self-control, substance craving) are interrelated.
    

Intervention name(s): Sport; Non-sport activities
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: craving
A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)
Condition: AGA
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study ,the
      mean change from baseline in vertex target area hair count (TAHC) after treatment for 24
      weeks.
    


Intervention name(s): CU-40102 Spray
Intervention type(s): Drug
Intervention description(s): topical application, 1~4 sprays each time, once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Nitrate-rich Fruit and Vegetable Supplement on Blood Pressure
Condition: High Blood Pressure; Flow Mediated Dilation
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      It is hypothesized that the daily supplementation of a nitrate-rich, two-ounce fruit and
      vegetable energy supplement (Isagenix International LLC) by healthy young adults with a would
      increase circulating nitrates and improve cardiovascular parameters compared to a
      nitrate-deficient placebo (prune juice).
    

Detailed description: 
      Endothelial cells of the peripheral vasculature are key sources of vasoactive factors
      regulating healthy blood pressure. One of the primary vasodilatory factors released from
      these cells is nitric oxide (NO). Production of NO is stimulated both through
      enzymatic-dependent mechanisms via NO synthase, as well as from dietary intake of
      nitrate-containing foods or supplements that increase NO bioavailability. This study examined
      whether the daily consumption of a nitrate-rich, two-ounce fruit and vegetable energy
      supplement (Isagenix International LLC) would increase circulating nitrates and improve
      cardiovascular parameters compared to a nitrate-deficient placebo (prune juice). Healthy male
      adults aged 18-40y (n=45) were recruited to participate in this longitudinal double-blind,
      placebo-controlled, randomized clinical trial. Subjects maintained their typical diet and
      physical activity patterns during the study. Anthropometric and cardiovascular (blood
      pressure and flow-mediated dilation (FMD)) parameters, along with plasma nitrates and
      nitrites were measured at baseline and after one and two weeks of supplementation. Subjects
      also completed questionnaires on sleep quality and mood. It is hypothesized that the
      nitrate-rich FVS supplement will provide a good source of dietary nitrates and effectively
      reduced blood pressure in normotensive, healthy young males.
    

Intervention name(s): fruit and vegetable juice supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): FVS was provided by Isagenix International LLC in identically sealed bottles labeled labeled "B". Subjects were not told which supplement they received. Each bottle contained one serving (two ounces) of the supplement.; PRU was provided by Isagenix International LLC in identically sealed bottles labeled labeled "A". Subjects were not told which supplement they received. Each bottle contained one serving (two ounces) of the supplement.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were stratified by age, height, weight, BMI, blood pressure and athletic status and randomly assigned to consume daily either the fruit and vegetable rich juice supplement (B) or prune juice (A; control treatment).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: beetroot juice; nitrates and nitrites
Study to Assess the Safety, Tolerability and Pharmacokinetics of STI-1558 in Healthy Volunteers
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, two-part, randomized, double blind, placebo controlled, ascending dose
      study to evaluate the safety, tolerability, pharmacokinetics of STI-1558 administered orally
      to healthy volunteers.
    

Detailed description: 
      This is a Phase 1, two-part, randomized, double blind, placebo controlled, single ascending
      dose (Part 1) and multiple ascending dose (Part 2) study to evaluate the safety,
      tolerability, pharmacokinetics (PK) of STI-1558 administered orally to healthy volunteers.
      Part 1 of the study will also incorporate a single-cohort arm to investigate the effect of
      food on the PK of STI-1558. Dietary status of administration in part 2 (fasted or fed) will
      be determined by the PK data from Part 1. Part 2 may run in parallel with Part 1, providing
      that the total daily dose to be administered does not exceed a dose already shown to be safe
      and well-tolerated in Part 1.
    

Intervention name(s): STI-1558; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Orally available protease inhibitor capsule; Placebo product capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: covid19; COVID-19