bioihbjkbjnl/mcl2 huggingface dataset:
Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether an inhaled corticosteroid (fluticasone)
      alters the expression of any gene expressed in the lining of the airways of asthmatics. The
      study uses high density gene chips which allow the study investigators to measures all gene
      in the human genome. We hypothesize that this approach will identify novel genes that are
      affected by steroids in asthmatics.
    

Detailed description: 
      This is a 10 week, randomized, double blind, prospective study comparing the effects of
      inhaled fluticasone or inhaled placebo on measures of airway function, airway remodeling and
      airway gene expression in asthmatic subjects. Enrollment has been completed as have all study
      visits. We are now in the data analysis phase. The study design was as follows: Following a
      one-week run-in/characterization period, subjects were randomized to receive 2 puffs BID of
      fluticasone (250µg/puff) or matching placebo for 8 weeks. Beginning with the run-in period,
      subjects recordes in a daily diary their peak flow measurements twice daily, (symptoms of
      cough, sputum production, wheeze, dyspnea, and chest tightness. They visited the laboratory
      for an interval diary review and spirometry and for medication dispensing. Bronchoscopy was
      performed at baseline (week 1 of the run-in), and 1 week after starting the study drug Weekly
      telephone contact will be made during the treatment period to monitor subject well being and
      to ensure compliance with study medication. There was a one-week run-out to allow monitoring
      of subjects after discontinuation of the study drug.
    

Intervention name(s): Inhaled fluticasone 500 ug BID for 8 weeks
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Corticosteroid; Gene expression
Effect of Ambient Light on the Parameters of the Pupillary Light Reflex
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      The purpose of this study is to determine the effects of varying luminescent levels on the
      pupillary response.
    

Detailed description: 
      Evaluation of the pupillary response is an underemphasized aspect of the assessment of visual
      function. The pupillary light reflex is one of the few objective indicators of afferent input
      from the retina and optic nerve. Since the pupillary light reflex is processed through the
      retina, it may be used to assess visual integrity (1). Pupillometry is a reliable technology
      capable of providing repetitive data on quantitative pupillary function in states of health
      and disease (2). Amplitude, latency, maximum constriction velocity, mean constriction
      velocity, and dilation velocity are measured using the Neuroleptics pupillometer. The effects
      of varying levels of ambient light on these parameters of the pupillary response have not
      been extensively studied. The purpose of this investigation is to determine the effects of
      varying luminescent levels on the pupillary response.
    

Intervention name(s): Pupillometry
Intervention type(s): Other
Intervention description(s): Pupillometry readings will be taken at low, intermediate and high ambient light
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volinteers
      
Keywords: a light flash in each eye for a total of 48 measurements
Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis
Condition: Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Secondary Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study
      designed to evaluate the safety, tolerability and activity of ibudilast administered twice
      daily over a 96 week period in subjects with primary or secondary progressive multiple
      sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or
      who are receiving either glatiramer acetate (GA) or interferon beta-1, any formulation
      (IFNβ-1A [Avonex, Rebif] or IFNβ-1B [Betaseron, Extavia]). Study drug or placebo will be
      administered to a total of 250 male and female subjects from 21 to 65 years old, inclusive,
      in two treatment groups. Randomization of subjects will be stratified by disease status
      (primary progressive multiple sclerosis or secondary progressive multiple sclerosis) and
      immunomodulating therapy status: current use of immunomodulating therapy or no current use of
      immunomodulating therapy.

      The study will consist of a screening phase (up to 30 days) followed by a treatment phase (96
      weeks) and a follow-up visit (1 month post Week 96 visit). Following the screening phase,
      subjects who continue to meet entry criteria will be randomly assigned to 1 of 2 treatment
      groups: doses up to ibudilast 100 mg/day or matching-placebo in a 1:1 ratio. Study drug will
      be administered twice daily (BID), e.g., ibudilast 50 mg or placebo taken in the morning and
      evening).
    


Intervention name(s): ibudilast; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.; Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
Other intervention name(s): MN-166
Intervention MeSH terms: Ibudilast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients
Condition: Hepatitis C; Evidence of Liver Transplantation
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I pilot study to determine the safety and preliminary efficacy of a novel
      hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing
      liver transplantation.
    

Detailed description: 
      Hepatitis C virus (HCV) infection is common and treatment options at present are limited.
      Recurrence of HCV infection after liver transplantation is inevitable and disease progression
      is rapid when compared with disease in the non-transplanted liver.

      Studies of ITX 5061 in vitro have shown it to be a potent inhibitor of HCV entry into
      hepatocytes, through blocking the interaction of the virus with scavenger receptor BI
      suggesting it may reduce graft re-infection rates after liver transplant.

      There are no studies of treatments to block host receptors for HCV and the investigators
      hypothesize that ITX 5061 will modulate HCV kinetics in the early phase post liver
      transplant.
    

Intervention name(s): ITX 5061
Intervention type(s): Drug
Intervention description(s): ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C virus; Entry; Scavenger receptor-BI; High density lipoprotein; Liver transplantation
Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to determine if cryopreservation at the blastocyst stage
      followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear
      oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer. Effectiveness
      will be measured by the rate of ongoing pregnancy at 10 weeks gestation.
    

Detailed description: 
      Subjects will be randomized to one of two study groups during their cycles of in vitro
      fertilization (IVF). In one group, the subjects will have all of their embryos cryopreserved
      at the blastocyst stage, followed by thaw and transfer in a subsequent cycle. In the other
      group, subjects will have all of their embryos cryopreserved at the bipronuclear oocyte
      stage, followed by thaw, extended culture, and transfer in a subsequent cycle.
    

Intervention name(s): Blastocyst cryopreservation; Bipronuclear oocyte cryopreservation
Intervention type(s): Procedure; Procedure
Intervention description(s): Embryos cryopreserved at the blastocyst stage; Bipronuclear oocyte cryopreservation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF, assisted reproduction, embryo transfer
Evaluation of Wear Experience With Daily Contact Lenses
Condition: Contact Lens
Study type: Interventional

Summary: 
      To evaluate the wear experience of current monthly replacement contact lens wearers after
      they have been fit into a daily disposable contact lens.
    


Intervention name(s): Precision1® Daily Disposable Contact Lens
Intervention type(s): Device
Intervention description(s): Soft, spherical contact lens used to correct distance vision.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants
Condition: Prevention
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the acceptability and preliminary efficacy of a
      universal prevention program delivered by psychologists in conjunction with pediatric primary
      care well-child visits.
    

Detailed description: 
      Integrated behavioral health has emerged as an effective approach to addressing emotional and
      behavioral health needs of children in the pediatric setting, yet there is little evidence
      for a standardized model of care for providing universal preventive services in pediatric
      primary care. Current models are typically loosely constructed, inconsistently applied, and
      unspecified. Our aim is to evaluate a model of care developed to address these gaps.
      Integrated Behavioral Health-Prevention (IBH-P) is a collection of clinical strategies and
      structured approaches designed to promote emotional and behavioral health. IBH-P is delivered
      by psychologists in the pediatric setting as part of scheduled well-child visits. The overall
      objective of this study is to evaluate the efficacy of the intervention in promoting infant
      self-regulation. Maternal experience and satisfaction, adherence to well-child visits and
      immunizations will also be examined.
    

Intervention name(s): Integrated Behavioral Health - Prevention; Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): IBH-P consists of 15-30 minute visits with mothers as part of the 1, 2, 4, and 6 month well-child visits. The intervention is delivered by doctoral level pediatric psychologists that are an integrated member of the primary care team.; Bright Futures curriculum will be delivered by the pediatrician as part of the 1, 2, 4 and 6 month well-child visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Behavioral Health; Integrated Behavioral Health; Infant Self-Regulation; Parenting Skills
The Effect of Breakfast Size Prior to Morning Exercise on Cognition, Mood and Appetite in Habitually Active Women
Condition: Alteration of Cognitive Function
Study type: Interventional

Summary: 
      Both regular exercise and breakfast consumption have well known health benefits. Consuming
      breakfast prior to morning exercise may influence appetite, mood and cognitive function later
      in the day. The purpose of this study is to test whether the amount of food consumed at
      breakfast prior to exercise influences these parameters in active women.
    


Intervention name(s): Cereal; No breakfast
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Breakfast cereal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Breakfast size; Exercise; Cognitive performance; Mood; Appetite; Active women
Phase Ib/II Study of Chiauranib in Patients With Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases
      involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory
      microenvironment.
    

Detailed description: 
      Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the
      angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3, PDGFRa and c-Kit), mitosis-related
      kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with
      the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high
      selectivity in the kinase inhibition profile with little activity on off-target non-receptor
      kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms
      of clinical relevance.

      Because of its broad preclinical anti-tumor efficacy and the potential to improve
      conventional TKI kinase inhibitor therapy in various cancer indications,Chiauranib has now
      entered phase Ib clinical trials.

      This clinical trial is studying the efficacy and safety of chiauranib works in treating
      patients with relapsed or refractory small cell lung cancer, in the meantime, exploreing the
      latent biomarkers accompany with chiauranib, as well as the relevancy of which and clinical
      benefit.
    

Intervention name(s): Chiauranib
Intervention type(s): Drug
Intervention description(s): CS2164
Intervention MeSH terms: Chiauranib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Moxibustion-Induced Thermal Transport Effect Between The Heart And Lung Meridians
Condition: Meridians
Study type: Interventional

Summary: 
      Although some important progresses were made in the field of the meridian research, no
      breakthroughs have been achieved. Besides,there are some problems in meridian researches.
      Particularly, previous research of meridian phenomenon involved lots of subjective elements
      and outcomes. Researches that use modern scientific techniques to investigate the biological
      characteristics of meridian phenomenon are urgently needed. Therefore, this study was
      designed to assess the heat transport characteristics of meridian phenomenon for the Heart
      and Lung meridians by using infrared thermography. Thus, the biological characteristics of
      meridian phenomenon could be presented objectively in a scientific methodology.
    

Detailed description: 
      80 eligible subjects were finally included. Among them, 40 participants were assigned to the
      lung meridian intervention group, and 40 participants were assigned to the heart meridian
      intervention group. All 80 participants completed the trial.
    

Intervention name(s): Moxibustion
Intervention type(s): Procedure
Intervention description(s): In this study, suspended moxibustion was performed by holding an ignited moxa stick at a certain distance (about 3-4 cm) over the skin surface, keeping the moxibustion Site warm without burning the skin.
In the heart meridian intervention group, moxibustion was applied over Site 4 (HT3) of the heart meridian.
In the lung meridian intervention group, moxibustion was performed over Site 1 (LU5) of the lung meridian.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: heart and lung meridians; site specificity; infrared thermography; moxibustion; thermal transport
Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Fasting Conditions
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200
      capsules and Rebetol 200 mg capsules in females under fasting conditions.
    


Intervention name(s): Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.); Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy
Condition: Hypoxic-Ischemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypothermia; Hypoxia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and
      mortality in term and preterm neonates. Birth asphyxia accounts for 23% of neonatal deaths
      globally and survivors suffer from long term neurological disability and impairment. Although
      many neuroprotective strategies appeared promising in animal models, most of them were not
      feasible and effective in human newborns. However, hypothermia was reported not to be
      effective if introduced beyond and thus should be introduced within 6 hrs after
      birth.Applying this selection criterion naturally would deprive many patients of the
      opportunity of hypothermia treatment.
    

Detailed description: 
      Hypoxic-ischemic encephalopathy of the newborn infant remains a significant socio-economic
      health problem worldwide. Moderate to severe HIE of newborn infants is associated with a high
      rate of death or long-term disabilities. Historically, treatment has been purely supportive
      including stabilizing cardio-respiratory functions and treating convulsions. Recent
      multi-center trials assessing the effects of hypothermia demonstrated improved outcome in
      term neonates with moderate hypoxic-ischemic encephalopathy (HIE). However, hypothermia was
      not effective beyond 6 hrs after brain injury. The aim of this study was to investigate
      whether systemic hypothermia induced up to 10 hrs after birth would improve the
      neurodevelopmental outcome at 18 months in infants with moderate or severe HIE.
    

Intervention name(s): hypothermia
Intervention type(s): Device
Intervention description(s): For the systemic hypothermia treatment (TS Med 200, Germany), the infants were nursed under an open unit, covered only by a diaper and a thin linen, loosing heat to the environment and to a cooling mat¬tress which was perfused by circulating liquid at a variable temperature. The rectal temperature was targeted at 33.5 °C (range of 33 to 34 °C) and was meant to be achieved within 60 min. The body temperature was checked every 10 min during induction hypothermia and every hour during the remaining period of cooling. The duration of hypothermia was 72 hrs. Rewarming was started by stopping the cooling system. The infant was meant to reach a 36.5°C rectal temperature in 6 hrs after stopping cooling to prevent rebound hyperthermia.
Other intervention name(s): TS Med 200, Germany
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: asphyxia; hypothermia; hypoxic-ischemic encephalopathy; neonates
Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis
Condition: Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      Primary localized hyperhidrosis is a dermatological disorder that involves excessive sweat
      production without an underlying cause. The disease usually affects the axillae but can also
      involve palms, soles of the feet or face and causes major problems in many social situations
      with a negative impact on quality of life and mental health.

      In this study, the investigators want to investigate the effect of microwave therapy
      (MiraDry®) on self-rated sweating, quality of life and anxiety in participants with severe
      axillary hyperhidrosis. The study also aims to evaluate the safety (side effects) of the
      method and long term effects over 1 year of follow upp.
    

Detailed description: 
      The study is conducted during several visits or telephone follow-ups at the clinic over a
      period of 12 months and each patient receives a maximum of two treatments with MiraDry® (at
      3-month intervals). 100 participants are planned to participate in the study.

      The primary objective is to evaluate the effectiveness of the miraDry ® treatment measured by
      Hyperhidrosis Disease Severity Scale(HDSS).

      Secondary objectives are to evaluate the side effects and the quality of Life by assessment
      of The Dermatology life Quality Index, The Hyperhidrosis Quality of Life Index, and Hospital
      Anxiety and Depression Scale.
    

Intervention name(s): miraDry®
Intervention type(s): Device
Intervention description(s): MiraDry is a noninvasive method that uses microwave technology to destroy sweat glands.
In this study we evaluate a higher energy level with a newer generation device, in respect with side effects and number of treatments (one or two interventions).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperhidrosis; hyperhidrosis disease severity scale (HDSS); Hospital Anxiety and Depression Scale (HADS); DLQI; HYPERHIDROSIS QUALITY OF LIFE INDEX (HidroQoL); microwave