bioihbjkbjnl/mcl2 huggingface dataset:
Brief Behavioral Treatment for Sleep Problems in IBS Study
Condition: Irritable Bowel Syndrome; Sleep Disturbance
MeSH terms: Irritable Bowel Syndrome; Dyssomnias; Parasomnias; Syndrome
Study type: Interventional

Summary: 
      Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances
      compared to their healthy counterparts and compared to patients with other GI disorders. This
      pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia
      (BBT-I) in Irritable Bowel Syndrome. 40 participants will be recruited; 20 will receive 4
      weeks of BBT and 20 will be assigned to a wait list control group (WLC). The primary aim of
      the current project is to assess feasibility of administering BBT-I to a sample of patients
      with IBS. Because behavioral sleep treatment has not yet been studied in IBS or any other GI
      population, this project will provide information about treatment adherence, recruitment, and
      effect sizes. Secondary aims include evaluating the impact of BBT-I on sleep quality and IBS
      symptom severity.
    


Intervention name(s): Brief Behavioral Treatment for Sleep
Intervention type(s): Behavioral
Intervention description(s): The BBT arm will consist of 2 in-person treatment visits and 2 telephone check-in visits. Treatment will involve psychoeducation about sleep hygiene and stimulus control as well as sleep schedule modification and sleep restriction. The treatment manual is attached for clarification. This manual is used solely to guide clinical decision making and will not be provided to participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Repeated Doses of Foliglurax on Drug Metabolizing Enzymes in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to help determine which types of drugs that may interact with
      foliglurax
    

Detailed description: 
      This study is designed to evaluate the PK of caffeine, montelukast and midazolam following
      multiple doses of foliglurax in healthy subjects. The study is divided into four periods:

        -  Period 1: investigation of the CYP450 probe substrates (caffeine, montelukast,
           midazolam) alone followed by a 2-day washout before start of Period 2.

        -  Period 2: administration of foliglurax for 7 days to reach steady state.

        -  Period 3: administration of the CYP450 probe substrates in combination with foliglurax
           followed by a 7-day washout before start of Period 4.

        -  Period 4: investigation of the effects of foliglurax on the PK of the CYP450 probe
           substrates following washout of foliglurax.
    

Intervention name(s): Drug Cocktail; Foliglurax; midazolam iv
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of the cocktail probe substrates (caffeine 200 mg, montelukast 10 mg, midazolam 4 mg); Foliglurax; Single intravenous (iv) dose of midazolam 0.025 mg/kg
Intervention MeSH terms: Midazolam
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Serotonergic System and Violent Video Games
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Aggressive behavior (AB) is a major burden to society with severe socio-economic
      consequences. Genetic studies suggest a high heritability of AB; in particular, the low
      expressing allele of the MAOA gene (MAOA-L) has been associated with increased AB. Recent
      neural aggression models have suggested a dysfunctional emotion regulation circuit including
      amygdala, orbitofrontal, and anterior cingulate cortex. Dysregulated serotonergic (5-HT)
      projections from the anterior cingulate cortex to the amygdala have been suggested to promote
      aggressive behavior. This finding is well in line with the observation that the MAOA-L allele
      leads to a reduced expression of monoamine oxidase A and thus to an overflow of 5-HT in
      serotonergic cortico-amygdalar projections. However, due to methodological and ethical
      constraints, the neural substrates of AB are difficult to assess. A possible solution is the
      use of virtual violence which permits AB against virtual characters without direct
      consequences for any real person and can be easily applied in functional imaging experiments.
      There is evidence that virtual and real aggression share common neural substrates. AB in
      violent video games inhibits rostral anterior cingulate cortex (ACC) and amygdala in line
      with the suggested neurophysiological circuits underlying real-life AB.
    

Detailed description: 
      Our study plan comprises the assessment of brain activation patterns during virtual AB in a
      violent video game with functional magnetic resonance imaging under three experimental
      conditions in randomized, double-blind fashion:

        1. Increase of synaptic 5-HT with a selective serotonin reuptake inhibitor (SSRI, Cipralex
           ®);

        2. reduction of synaptic 5-HT with the Rapid Tryptophan Depletion Test (RTD); and 3)
           Placebo.

      A blood sample genotyping will assess the allelic expression of the MAOA gene. We hypothesize

        1. a modification of the ACC-amygdala system by the serotonergic intervention and

        2. an interaction with the genotype concerning the MAOA gene. The results of this study
           will give valuable insights into the neurogenetic biology underlying aggression which
           will open new perspectives for therapeutical and pharmacological intervention.
    

Intervention name(s): cipralex
Intervention type(s): Drug
Intervention description(s): one time 10 mg, tablet
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: violent video games; serotonergic system
Optimal Dose of Early Intervention to Prevent PTSD
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The overall aim of this study is to determine the optimal dose, 3-session exposure
      intervention versus 1-session exposure intervention compared to no treatment, for the
      delivery of exposure therapy in the immediate aftermath of trauma for preventing the
      development of posttraumatic stress disorder.
    

Detailed description: 
      The precipitant for adult posttraumatic stress disorder (PTSD) is a known event, which allows
      for immediate intervention and presents the potential to prevent the occurrence of this
      serious condition. However, there currently are no accepted interventions for the early
      intervention and prevention of PTSD in the immediate aftermath of trauma. This study will
      determine whether providing exposure therapy to people who have recently experienced trauma
      will significantly reduce the severity of PTSD symptoms post-trauma and if delivery of three
      exposure sessions will result in larger reductions in the symptoms of PTSD post-trauma than
      one exposure session. This study will also examine predictors for treatment response.

      Participation in this study will last 12 months. Participants will first undergo an
      evaluation session that will include an interview and questionnaires. They will then be
      randomly assigned to one of the following three conditions: 1-session exposure therapy,
      3-session exposure therapy, or assessment only. Participants receiving 1-session exposure
      therapy will complete one treatment session in the emergency department (ED). Participants
      receiving 3-session exposure therapy will complete three weekly treatment sessions, with the
      first occurring in the ED. Treatment will involve reviewing memories of a recent trauma out
      loud with a therapist and audio-recording these discussions for review at home. All
      participants will undergo assessments 1, 3, 6, and 12 months after the initial evaluation
      session.
    

Intervention name(s): 1-Session Exposure Therapy; 3-Session Exposure Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): One exposure therapy session lasting one hour; Three exposure therapy sessions lasting one hour each, delivered one week apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: PTSD
Effect of Sweetness Intensity of a Sucrose Solution on Blood Glucose Regulation and Energy Intake
Condition: Blood Glucose, Low; Hunger
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of the present study is to investigate the influence of the modulation of the
      sweetness intensity of a carbohydrate (sucrose)-containing solution on metabolic effects, in
      particular the regulation of blood glucose concentration and regulation of hunger & satiety.
    

Detailed description: 
      The study is designed as a randomised cross-over intervention study with four interventions.
      The study investigates the influence of sweetness modulation by Rebaudioside M (sweetness
      enhancement) and Lactisol (sweetness inhibition) of a 10% sucrose solution, corresponding to
      the concentration of a regular soft drink, on blood glucose regulation (blood glucose
      concentration and regulating hormones) in healthy male volunteers. Furthermore, the study
      assesses ad libitum energy intake, individual feelings of hunger and satiety, metabolic
      responses to the interventions, and preference for sweet-tasting foods such as sugar and
      sweeteners. In addition, the participants' individual thresholds for sweet taste, as well as
      morphological markers for taste sensitivity and body composition will be recorded as
      potential influencing factors.
    

Intervention name(s): Lactisole; Rebaudioside M; Sucrose
Intervention type(s): Drug; Drug; Other
Intervention description(s): sweet taste inhibitor (decreases sweetness); Sweetener (increases sweetness); 10% Sucrose corresponding to a regular soft drink
Other intervention name(s): 2-(4-methoxyphenoxy)propionic acid; CAS Number: 150436-68-3; CAS Number: 1220616-44-3; table sugar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Cognitive Skills Training for Homeless Youth
Condition: Affective Disorders; Anxiety Disorders; Attention Deficit Disorder; Substance Abuse
MeSH terms: Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity; Anxiety Disorders; Mood Disorders
Study type: Interventional

Summary: 
      Many young people who are homeless have cognitive deficits which impede their ability to
      secure and maintain employment. This study looks to see if targeting cognitive deficits can
      improve cognition and vocational outcome.
    

Detailed description: 
      The aim of this research is to conduct a controlled study of cognitive remediation, to
      provide feasibility data on adapting an established empirically-based cognitive intervention
      for homeless youth to help them attain vocational goals. The ultimate purpose is that youth
      will improve in cognitive functioning and have better functional outcomes including jobs to
      sustain independent living.

      The results of this study will inform a larger trial on the efficacy of cognitive remediation
      in homeless youth to improve cognition and vocational outcomes. Hypotheses are that, compared
      to those in an active control group receiving computerized work-skills training, individuals
      who receive cognitive remediation will show greater cognitive benefits on proximal measures
      of neurocognition and evidence better vocational outcome as defined by greater number of
      hours worked. This study will address the service gap in the use of integrated psychosocial
      interventions for homeless populations as the first investigation of cognitive remediation in
      homeless youth.
    

Intervention name(s): Cognitive Remediation; Computer Skills Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Neuropsychological Educational Approach to Remediation (NEAR) is an evidence based, manualized cognitive remediation program that targets cognitive deficits (eg memory, processing speed, executive functioning, working memory and attention) with the intent of improving daily functioning.NEAR is conducted in a small group setting, allowing for supportive social interaction while participants work at their own computer station on engaging computerized activities that are selected to address their unique profile of cognitive deficits. Then, as a group they discuss how their respective cognitive activities will help them achieve their vocational goals.; Participants utilize an interactive software program that delivers tutorials, lessons, and practice sessions to develop computer skills for office based employment. During the learning activities, the clinician offers coaching and assistance in setting up computerized training exercises as needed.
Other intervention name(s): NEAR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
OVERWEIGHT AND OBESITY ADVERSELY AFFECT IVF OUTCOMES IN WOMEN WITH PCOS
Condition: Polycystic Ovary Syndrome IVF
MeSH terms: Polycystic Ovary Syndrome; Obesity; Overweight; Syndrome
Study type: Observational

Summary: 
      The effect of overweight and obesity on IVF outcomes is still questionable. The purpose of
      this study was to determine if overweight/obesity in women with PCOS were associated with an
      adverse IVF outcome compared to those with normal weight.

      Design: Retrospective cohort study.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This is a retrospective study to evaluate the impact of obesity on ivf outcomes.
      
Keywords: OBESITY; In Vitro Fertilization (IVF); Polycystic ovary syndrome (PCOS)
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety & immunogenicity of a potential vaccine against meningococcal B
      disease
    


Intervention name(s): MnB rLP2086
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines; Healthy Adults; Health; Adult; Meningococcal Vaccines
Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional

Summary: 
      Premature infants frequently have trouble breathing after birth. If the respiratory disorder
      is caused by surfactant deficiency or dysfunction, the disease is treated with a medication
      called surfactant that is given to the infant through a tube inserted into the windpipe. This
      study will compare the safety of two of the commonly used surfactants, poractant and
      calfactant,in the United States. Poractant has added chemicals called phospholipids which are
      known to cause inflammation and irritation in the body of premature infants. The
      investigators will compare this to another similar surfactant that does not contain these
      chemicals by looking at samples from the windpipe, while the tube is in place, and from blood
      tests in the first few days of life.

      The investigators are hoping to learn whether calfactant is a safer therapeutic agent to
      treat respiratory distress syndrome in preterm infants compared to poractant.
    

Detailed description: 
      30 infants were randomized to receive either poractant or calfactant for Respiratory Distress
      Syndrome.

      Tracheal aspirates were obtained to look for increase in macrophage and blood samples were
      drawn to look for markers of inflammation.
    

Intervention name(s): Poractant alfa; calfactant
Intervention type(s): Drug; Drug
Intervention description(s): Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.; Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist
Other intervention name(s): Curosurf; Infasurf
Intervention MeSH terms: Poractant alfa; Calfactant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: surfactant; respiratory distress syndrome; inflammation; c-reactive protein; lipid peroxidation
Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).
Condition: Menopause
Study type: Interventional
Phase: Phase 3

Summary: 
      The study has been designed to look at the transfer from using LNG IUS for contraception
      only, in reproductive age to using it for endometrial protection in menopausal age. The main
      area of interest in the study is the pattern of any vaginal bleeding that occurs.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the
      trial.
    

Intervention name(s): LNG IUS
Intervention type(s): Drug
Intervention description(s): LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D, C-reactive Protein and Insulin Resistance
Condition: Diabetes; Low-intensity Chronic Inflammation; Insulin Resistance
MeSH terms: Insulin Resistance; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation
      (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes
      mellitus.

      The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein
      (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM).

      The trial was conducted from March to October 2008 at the Hospital of the Mexican Social
      Security in Cuernavaca, Mexico.
    

Detailed description: 
      Methods. Randomized, double blind, placebo-controlled clinical trial. We selected 104
      postmenopausal women, ages 45 to 65, with uncomplicated T2DM and BMI ≥25. Women with history
      of kidney or liver disease, BMI>40, autoimmune disease or cancer were not included in the
      study.

      Participants were randomly assigned to receive either a capsule containing 4,000 IU of
      vitamin D3 (cholecalciferol, n=52) or placebo (n=52), once a day during 6 months.

      Outcome variables were serum CRP, measured with a high-sensitivity assay (nephelometry), and
      HOMA-IR. Serum vitamin D (25-OH-D) was measured by HPLC. Outcome variables were measured at
      baseline, and 3 and 6 months thereafter. All participants received diet and physical activity
      counseling, and visited the clinic for medical check-up once a month.

      Baseline Results. Mean age was 56.8 ± 5.1 y. Baseline BMI was 30.7 ± 3.9. Median CRP
      concentration was 5.0 mg/L (Interquartile range: 1.0, 8.5). HOMA index at baseline was 7.13 ±
      3.8. Serum 25-OH-D concentration at baseline was 54.5 ± 15.7 nmol/L (~22 ng/mL). Almost 94%
      of patients had baseline serum 25-OH-D levels <80 nmol/L, and 25% were below 40 nmol/L. No
      one had levels <20 nmol/L. There were no statistical differences on important variables by
      treatment group at the onset of study.
    

Intervention name(s): cholecalciferol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4,000 IU per day during 6 months. Capsule form.; no active principles given.
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D; diabetes; C-reactive protein; insulin resistance
Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab
Condition: Acquired Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose:

      To evaluate the efficacy when administering steroid combined with single dose rituximab to
      eliminate the antibody in acquired hemophilia A patients compared to treatment using steroid
      with cyclophosphamide.

      The study will test the hypothesis that steroid combined with small dose rituximab is as
      effective as steroid combined with cyclophosphamide for FVIII inhibitor eradication in
      Chinese patients with acquired hemophilia A.

      Study design Allocation: Randomized Intervention Model: Parallel Assignment Masking: None
      (Open Label) Primary Purpose: Treatment
    

Detailed description: 
      This is a prospective randomized multi-center controlled pilot trial comparing the regimen of
      steroid with rituximab and steroid with cyclophosphamide to eradicate anti-factor VIII
      antibodies in Chinese patients with acquired hemophilia A.

      Patients will be randomized to two regimens: methylprednisolone 0.8mg/kg/day (or equivalent
      corticosteroid doses) for 3 weeks (then tapering gradually,8 weeks in total) with rituximab
      (375mg/m2 for one dose) or methylprednisolone 0.8mg/kg/day (or equivalent corticosteroid
      doses) for 3 weeks (then tapering gradually,8 weeks in total) with cyclophosphamide
      2mg/kg/day until inhibitor negative(no longer than five weeks).

      Patients will be randomized to the treatment cohorts according to the biostatistical methods.
    

Intervention name(s): Steroid; Rituximab; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Methylprednisolone 0.8 mg/kg/day (or equivalent corticosteroid doses) for 3 weeks（then tapering gradually, 8 weeks in total）; 375mg/m2 for one dose; cyclophosphamide 2 mg/kg/day until inhibitor negative (no longer than five weeks)
Other intervention name(s): Corticosteroid
Intervention MeSH terms: Cyclophosphamide; Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acquired hemophilia A; Cyclophosphamide; Rituximab; Steroid