bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, and Pharmacokinetics of Modified and Immediate Release Anatabine Citrate Formulations
Condition: Pharmacokinetics of Anatabine
Study type: Interventional
Phase: Phase 1

Summary: 
      Parts 1 and 2:

      Subjects take 1 dose of various formulations of the study product, and provide samples for
      pharmacokinetic (PK) analysis after each, with at least 7 days between doses.

      Part 3:

      Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and
      provides samples for PK analysis.
    

Detailed description: 
      Parts 1 and 2:

      Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast
      overnight and receive the study product in the morning of Day 1 in a non-randomized manner.
      Subjects will remain onsite until 24 h post-dose and will return to the clinical unit at 36
      and 48 h post-dose to provide a sample for PK analysis.

      There will be at least a 7-day washout between regimens. Subject will be telephoned 3-5 days
      after the final dose to ensure his/her ongoing well-being.

      Part 3:

      Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast
      overnight (for Day 1 and Day 7) and receive the study product or placebo on a once, twice, or
      three times a day regimen in a randomized, double-blind manner. Subjects will remain onsite
      until 24 h after the final dose (Day 7), leaving the clinic on the morning of Day 8 and
      returning at 36 and 48 h post last-dose to provide a sample for PK analysis.

      Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing
      well-being.
    

Intervention name(s): Modified Release Formulation x (MRx)
Intervention type(s): Drug
Intervention description(s): Subject receives 1 dose of a MRx and is followed. 7-day washout before dosing with another formulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Biological Risk Factors for Onset of Binge Eating and Compensatory Behaviors
Condition: Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders
Study type: Observational

Summary: 
      The purpose of this proposed project is to test whether several biological factors (such as
      elevated brain reward region and attention region response to high-calorie foods, weaker
      inhibitory region response to high-calorie foods, habitual caloric deprivation, and elevated
      limbic region responsivity) increase the risk of problematic eating (bingeing and purging) in
      female adolescents.
    

Detailed description: 
      Participants will be adolescent girls aged 13-16, some of whom will have parental history of
      eating pathology. Participants will be recruited from the general population but their age,
      gender, and the presence of parental lifetime eating pathology will create a high-risk
      sample. The goals of the proposed project are to (1) conduct a prospective high-risk study to
      test whether proposed biological risk factors predict the future onset of core ED symptoms
      (e.g., binge eating, compensatory behaviors); (2) test hypotheses regarding how these
      biological risk factors and established self-report ED risk factors may work together to
      predict ED behavior onset; (3) examine if certain biological factors account for the effects
      of certain established self-reported ED risk factors (e.g., elevated brain response to thin
      models accounts for the effect of questionnaire-measured thin-ideal internalization). The
      participants will complete a baseline assessment and then follow-ups assessments over a span
      of three years. In addition, participants will complete one fMRI scan after the first
      assessment.

      During the COVID-19 shelter-at-home order, the investigators will not measure in person only
      outcomes including fMRI scans, height and weight measurement for BMI calculation nor IAT
      computer paradigms for all participants that have assessments due during this order.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Keywords: fMRI; Eating disorder; adolescent
Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A cross-over, polysomnography study to test the safety, tolerability and effectiveness of
      different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.
    


Intervention name(s): Suvorexant; Dose-matched Placebo to Suvorexant
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet taken before bedtime; Dose-matched placebo to suvorexant taken before bedtime (oral tablet)
Other intervention name(s): MK-4305
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CARTOON: CoronAviRus (COVID-19) educaTional prOgram fOr childreN
Condition: Covid19; Pediatric Psychiatric Disorder; Psychological Stress
MeSH terms: COVID-19; Mental Disorders; Problem Behavior; Stress, Psychological
Study type: Interventional

Summary: 
      Our study aims to investigate whether our CoronAviRus educaTional prOgram fOr children
      (CARTOON) facilitates the adherence to hygiene measures and is feasible to dispel fear in
      preschool children (3-6 years old) during the pandemic.
    

Detailed description: 
      This prospective randomized controlled trial will be performed at four kindergartens in
      Vienna, Austria. About 60 children between three and six years of age attending kindergarten
      will be included in the study. Prior inclusion in the study eligible adults have to sign a
      parental consent form. We will randomly assign 30 children to the intervention group (n=30)
      and 30 children to the control group (n=30). Depending on the randomization (intervention
      group vs. control group), children either receive our CARTOON (intervention group) or no
      educational training (control group).
    

Intervention name(s): Educational Program (CARTOON)
Intervention type(s): Other
Intervention description(s): CARTOON is an interdisciplinary psychoeducational intervention program. It consists of five teaching sessions: 1) hand hygiene, not grasping the face, 2) sneezing etiquette, 3) wearing a mask, 4) social distancing, and 5) theoretical knowledge about the coronavirus. Using special exercises and games, information about the coronavirus is conveyed in a child friendly manner.
Other intervention name(s): Education; Psycho-educational intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Educational Program; education
Dietary Requirement for Vitamin D in Adolescents Aged 14-18 Years
Condition: Serum 25-hydroxyvitamin D Concentrations (25OHD)
Study type: Interventional

Summary: 
      It is known that low vitamin D status is a very common problem in the UK. It is also known
      that a lack of vitamin D availability has potentially serious health implications, especially
      with respect to bone and muscle function. Much research has recently taken place to establish
      the vitamin D requirements of key population groups (i.e. pregnant women, the elderly, ethnic
      minorities). However few data are available describing the vitamin D requirements for male
      and female adolescents. The period of adolescence is a key stage of growth and development -
      poor nutrition during this time can have detrimental health consequences for a lifetime.

      No intervention studies have comprehensively investigated the vitamin D requirements of
      adolescents. The proposed ODIN Study will enable a better understanding of how adolescents
      respond to vitamin D supplementation and the most effective daily amount that will raise and
      maintain vitamin D status in adolescents during the winter-time. In addition, investigations
      into the mechanisms of action with respect to any differences observed across the doses of
      vitamin D and between the genders of the participants will also provide key information.
      Mechanisms of action will focus on genetic differences as well as differences in vitamin D
      metabolising enzymes.

      The results obtained from this significant study will not only inform the European Food
      Standards Agency (EFSA) with respect to their imminent deliberations regarding vitamin D
      recommendations. The ODIN Study will also inform the UK Department of Health's Scientific
      Advisory Committee on Nutrition (SACN), the wider scientific community and be a critical
      resource for key stakeholders (i.e. food industry, government health agencies) to collaborate
      in determining future public health strategies, thus potentially positively impacting on the
      health of the population for years to come.

      The investigators propose that the daily supplementation of 10µg/day (400 IU) and 20µg/day
      (800 IU) of vitamin D3 for five months will meet the vitamin D requirements of males and
      females aged 14-18 year and will be sufficient to maintain winter-time 25OHD levels above a
      range of thresholds between 30 and 50nmol/l.
    


Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; Serum 25-hydroxyvitamin D (25OHD); Adolescents
Open-label V565 Target Engagement Study
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and
      reduces inflammation after oral dosing to patients with IBD.
    

Detailed description: 
      Single-site, open-label study in up to 6 patients treated for up to 7 days with sigmoidoscopy
      and biopsies before and after treatment period to determine biological activity.
    

Intervention name(s): V565
Intervention type(s): Biological
Intervention description(s): Capsules for oral administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Fatty Liver and Ectopic Fat in Overweight and Obese Patients
Condition: Steatohepatitis
MeSH terms: Fatty Liver; Cardiac Complexes, Premature; Overweight
Study type: Interventional

Summary: 
      The aim of the study is to find new clinico-biological and medical imaging parameters
      associated with non alcoholic steatohepatitis in overweight and obese patients.
    

Detailed description: 
      Non invasive assessment of liver fibrosis and liver inflammation and steatosis is clinically
      relevant in patients exposed to non alcoholic fatty liver diseases.

      The aim of the study is to find new clinico-biological and medical imaging parameters
      associated with non alcoholic steatohepatitis in overweight and obese patients.

      Fatty liver and ectopic fat accumulation will be particularly assessed.
    

Intervention name(s): liver biopsy
Intervention type(s): Procedure
Intervention description(s): liver biopsy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: overweight; obesity; steatohepatitis; ectopic fat
The Endocrine Secretome After Gastric Bypass Surgery
Condition: Obesity, Morbid; Type2 Diabetes
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Examination of the molecular phenotype and composition of endocrine cells in the
      gastrointestinal tract correlated to analyses of blood for hormones/analytes before and after
      Roux-en-Y gastric bypass surgery in morbidly obese individuals both with and without type 2
      diabetes
    

Detailed description: 
      Enteroscopy was conducted during sedation with Propofol®. The pre-surgical sampling included
      biopsies retrieved from the stomach and at the expected site of anastomosis. During RYGB
      surgery, a ~1 cm gut tissue sample was removed at the site of anastomosis. The post-surgical
      enteroscopy ~3 months after RYGB surgery included biopsies taken from the gastric pouch, the
      alimentary limb, the biliopancreatic limb and common channel. One sample from each location
      was immersion-fixated in formalin for subsequent histological analyses and one sample was
      placed in a tube with RNA-preserving media for mRNA expression analysis. Remaining samples
      were snap-frozen and stored at -80°C until further processing.

      Enteroendocrine cells were identified and isolated from biopsies obtained at several sites in
      the small intestine by using immunohistochemistry and laser capture technology. Isolated
      individual enteroendocrine cells were extensively characterised by next generation sequencing
      (Illumina NGS).

      The participants also went through four mixed meal tests with blood sampling performed:
      before an 8 % diet-induced weight loss was initiated and one week before/one week after/3
      months after RYGB surgery. Blood was sampled at several specific time points.

      The plasma, serum and urine collected from study participants before and after RYGB surgery
      will be analysed for biomarkers/analytes and correlated with clinical data (weight, BMI,
      waist/hip ratio, blood pressure) and molecular phenotype found in gut samples.

      To study changes in gut bacteria (microbiota) composition stool samples were collected during
      the study and will be analysed for microbiota composition by means of bacterial DNA
      sequencing.
    

Intervention name(s): Enteroscopy with biopsy sampling and mixed meal test
Intervention type(s): Other
Intervention description(s): Enteroscopies with biopsy retrieval and mixed meal tests with blood sampling before and after Roux-en-Y gastric bypass surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Combination of Rituximab and NK Immunotherapy for B Lymphoma
Condition: B-cell Lymphoma Recurrent
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of Rituximab plus NK immunotherapy to
      recurrent B lymphoma.
    

Detailed description: 
      By enrolling patients with B lymphoma adapted to enrolled criteria, this study will document
      for the first time the safety and the short and long term efficacy of the combined therapy
      using Rituximab and natural killer (NK) cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Rituximab; NK immunotherapy
Intervention type(s): Drug; Biological
Intervention description(s): Each time 10 billion cells, 4 times in all,i.v.
Other intervention name(s): IDEC-C2B8 or Rituxan; natural killer cell
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B lymphoma; Rituximab; NK immunotherapy
A Pilot Study of Kaletra and Intelence Tablets in Naive Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if using a combination of other drug classes, like the
      ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your
      blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so
      their use in this study is experimental.
    


Intervention name(s): Kaletra and Intelence Tablets
Intervention type(s): Drug
Intervention description(s): Kaletra 400 mg twice a day and Intelence Tablets 200mg twice a day.
Intervention MeSH terms: Etravirine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Treatment Naive
A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A single centre, open, randomized, placebo controlled, 3 period cross-over study to evaluate
      the effects of single oral doses of pioglitazone 45mg, rosiglitazone 8mg and placebo on
      urinary sodium excretion in 12 healthy male volunteers
    


Intervention name(s): pioglitazone/rosiglitazone/placebo; rosiglitazone/pioglitazone/placebo; placebo/pioglitazone/rosiglitazone; pioglitazone/placebo/rosiglitazone; rosiglitazone/placebo/pioglitazone; placebo/rosiglitazone/pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo; single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo; single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg; single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg; single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg; single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg
Intervention MeSH terms: Pioglitazone; Rosiglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: urinary sodium excretion; Pioglitazone; Rosiglitazone; Methodological study
Overweight Adults--Ethnic, SES and Behavioral Influences
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To examine the effects of ethnicity, socioeconomic status (SES) and behavior in overweight
      adults.
    

Detailed description: 
      BACKGROUND:

      In 1999, more than 55 percent of United States adults were overweight, an increase of 8
      percent in fifteen years. Because overweight is associated with cardiovascular disease (CVD)
      morbidity and mortality, the alarming increase in overweight underscored the need for
      innovative and effective weight-loss interventions. Tailored interventions specifically
      designed for high-risk subgroups can compliment existing population-based approaches.
      However, before designing such interventions, sociodemographic characteristics of those at
      high risk must be identified.. Although past studies have shown that ethnicity is associated
      with overweight, these studies suffered from potential confounding from SES because ethnic
      minority groups are disproportionately poor. Past studies have been compromised by limited
      sample size at the extremes of SES such as higher SES Mexican-Americans or Blacks, and/or
      lower SES Whites.

      Weight loss is affected by multiple perceptions and behaviors, such as perceptions of
      overweight, physical activity, dietary habits, smoking, and alcohol use. Although past
      epidemiological research has investigated the independent effects of such influences on
      weight, research to date has not identified whether distinct clusters of weight perceptions
      and behaviors exist among overweight adults. Given that such clusters may differ by
      sociodemographic characteristics, identifying clusters may contribute to the design of
      innovative and tailored weight-loss interventions that address the presence of multiple
      influences on weight loss and increase the likelihood of successful interventions.

      DESIGN NARRATIVE:

      The study had four specific aims: (1) to identify subgroups at high risk of overweight based
      on sociodemographic characteristics (e.g., ethnicity and SES): (2a) to determine whether
      distinct clusters of weight perceptions and behaviors exist among overweight adults and (2b)
      to determine whether the clusters differ by sociodemographic characteristics; (3) to
      determine whether clusters in the overweight sample exist among normal-weight adults, and (4)
      to propose tailored weight-loss interventions to be tested empirically in the future. Data
      were analyzed, by gender, for 3203 Black, 2989 Mexican-American, and 3761 white men and
      women, ages 25-64, who participated in the third National Health and Nutrition Examination
      Survey (NHANES III), 1988-1994). This national survey of the United States population
      over-sampled by the two largest ethnic minorities, Blacks and Mexican-Americans, and provided
      sufficient sample sizes at the extremes of SES.