bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin,
      ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic
      Resonance Spectroscopy
    

Detailed description: 
      The goal within the current development program and this study is to investigate whether
      lower doses of AEGR-733 can result in significant reductions in LDL-C and TGs while providing
      fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies
      with higher doses. The potential for atorvastatin, ezetimibe or the PPAR-alpha agonist
      (fenofibrate) to ameliorate any hepatic fat accumulation will also be investigated. The
      twelve week dosing schedule allows us to demonstrate the longer term effects of lower doses
      of MTP-I on hepatic fat accumulation.
    

Intervention name(s): AEGR-733; placebo; AEGR-733; AEGR-733; AEGR-733; AEGR-733 and atorvastatin; AEGR-733 and fenofibrate; AEGR-733 and ezetimibe
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period
Intervention MeSH terms: Atorvastatin; Ezetimibe; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: LDL; hepatic fat
Comparison of Two Formulations of Proellex for Vaginal Administration
Condition: Comparison of 2 Different Formulations of 12 mg Proellex Vaginal Capsules
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a double-blind crossover study in female healthy volunteers to compare the
      pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations
      of Proellex for vaginal administration. Each formulation will be designated as either
      Treatment A or Treatment B. A total of 8 subjects who meet the eligibility criteria will be
      randomized to receive either Treatment A or Treatment B as their first assigned treatment.
      Subjects will receive a single dose of Treatment A or daily dosing with Treatment B for 6
      days. After a 7-day washout period subjects will receive the alternative treatment. On the
      day of treatment with Treatment A and on the first and last days of treatment with Treatment
      B subjects will remain in the clinic overnight and undergo 32-hour pharmacokinetic assessment
      at the following time points: 0, 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28 and 32 hours after
      administration of study drug. For Treatment B study drug will be administered in the clinic
      each day after a trough blood sample has been drawn.
    


Intervention name(s): Proellex Formulation A; Proellex Formulation B
Intervention type(s): Drug; Drug
Other intervention name(s): telepristone acetate; telepristone acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Changes of Coping With Stressful Events Among Adolescents Under the COVID-19 Pandemic.
Condition: Coping Behavior; Mental Health Issue
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This study aims to describe the changes in coping strategies used by adolescents for
      stressful life events under the background of epidemic normalization; and explore the causes
      of coping strategy changes of stressful life events under the background of normalization of
      the epidemic situation among adolescents.
    

Detailed description: 
      Under the special background of normalization of the epidemic situation, this paper describes
      and discusses the subjective feelings, changes in coping strategies, and causes of adolescent
      stressful life events, and puts forward a coping mechanism model of stressful adolescent
      events, which reflects the psychological changes of adolescent groups in the era of the
      epidemic situation and provides the basis for subsequent intervention measures.
    

Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): Participants will be asked to respond to the demographic information sheet, Adolescent Self-Rating Life Events Check List, Coping Inventory For Stressful Situations, Social Skills Rating System, brief-symptom-inventory, and Wong and Law EI Scale.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        General adolescents
      
Keywords: adolescent; pandemic; coping behavior; mental health; stressful life event
Effects of Yoga, Strength Training and Aerobic Exercise on Cognition in Adult Cancer Survivors
Condition: Cancer; Cancer-related Problem/Condition; Exercise
Study type: Interventional

Summary: 
      The investigators propose to compare the effects of a 12-week, supervised, site-based group
      yoga intervention on cognitive function, functional fitness, and well-being in middle-aged
      cancer survivors. Subjects will be randomly assigned to one of three exercise conditions: a
      yoga group, an aerobic walking group or a strength training group. All sessions (2-3 times
      per week) will be led by a trained exercise leader for a total of 150 minutes of exercise
      each week for the 12-week intervention.
    


Intervention name(s): Yoga; Stretching and Toning; Aerobic Walking
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 12 weeks, total of 150 minutes of exercise per week.; 12 weeks, total of 150 minutes of exercise per week.; 12 weeks, total of 150 minutes of exercise per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose
      of tezepelumab in children aged ≥ 5 to 11 years with asthma.
    


Intervention name(s): Tezepelumab
Intervention type(s): Biological
Intervention description(s): Single dose subcutaneous injection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mild asthma; Moderate asthma; Severe asthma
Zinc Bioavailability From Amaranth-enriched Maize Tortillas
Condition: Nutritional Deficiency
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets
      and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common.
      Supplementation of Zn to children during diarrhea episodes has been shown to diminish
      duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this
      diet might play a role in these processes. Supplementation of this micronutrient in the diet
      might be beneficial. The investigators will compare absorption of Zn from white maize
      tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool
      children in Guatemala.
    

Detailed description: 
      This is a randomized cross-over study of zinc absorption in young children living in the
      Western Highlands of Guatemala. Absorption of zinc will be measured from maize tortillas and
      maize tortillas fortified with 20% amaranth as the major food staple which provides at least
      70% energy and at least 90% zinc and phytate of the diet. Participants will be randomized as
      to which type of tortilla they receive on the first and second day. Fractional absorption of
      zinc (FAZ) from all meals in one day for one type of tortilla and one day for the other will
      be measured by extrinsic labeling with stable isotopes of zinc. FAZ will be measured by a
      dual isotope tracer ratio (DITR) technique based on ratio of urine enrichment of orally
      versus intravenously administered zinc stable isotopes. Measurement of total zinc in
      duplicate diets on test days allow for determination of quantities of this micronutrient
      absorbed.
    

Intervention name(s): Day 1: Maize Tortillas with 20% Amaranth; Day 2 Maize Tortillas without 20% Amaranth
Intervention type(s): Other; Other
Intervention description(s): Subjects received Maize tortillas with 20% Amaranth added.; Maize tortillas without Amaranth.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Keywords: Zinc Absorption; Maize; Amaranth; Guatemala; Stable isotopes of Zn
A Study to Investigate the Pharmacokinetics and Safety of Beclomethasone Dipropionate Administered by Breath-Actuated Inhaler and Metered-Dose Inhaler in Healthy Adults
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to compare the systemic exposure of orally inhaled beclomethasone
      dipropionate inhalation aerosol delivered via BAI to that delivered via MDI.
    


Intervention name(s): Beclomethasone dipropionate BAI; Beclomethasone dipropionate MDI
Intervention type(s): Drug; Drug
Intervention description(s): Breath Activated Inhaler (BAI); Metered Dose Inhaler (MDI)
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Young Adults' Reactions to Low Nicotine Cigarette Advertising
Condition: Smoking
Study type: Interventional

Summary: 
      Reducing the nicotine content in combustible cigarettes to non-addictive levels has
      demonstrated promise as a safe and effective public health strategy for decreasing
      tobacco-caused morbidity and mortality. Little data are available, however, assessing how the
      marketing of low nicotine content (LNC) cigarettes could dampen their potential population
      health benefit. This study will examine LNC cigarette advertising content effects on message
      recall, viewing patterns, product perceptions, and use behaviors. Young adults (N = 340; 170
      smokers, 170 non-smokers) will complete a single-session laboratory study using a 2 x 2
      between-subject design to manipulate advertisement messaging accuracy (true vs.
      false/misleading) and content (implicit vs. explicit). Findings may be used to guide public
      health policy decisions related to regulating cigarette nicotine content and marketing.
    


Intervention name(s): Advertisement content (explicit vs. implicit); Advertisement content (true vs. misleading)
Intervention type(s): Other; Other
Intervention description(s): Participants will be randomly assigned to view an advertisement with either implicit or explicit harm messaging content; Participants will be randomly assigned to view an advertisement with either true or misleading messaging content
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: low nicotine
The Nutritional Health for the Elderly Reference Centre Study (NHERC Study)
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      Elderly are at greater risk of dietary insufficiency due to age-related increases in nutrient
      requirements concomitant with a reduction in energy requirements, decreases in appetite and
      energy intake. Currently there is a gap in knowledge of the factors that are associated with
      malnutrition in the elderly in Singapore. In addition, there is no "reference" database on
      anthropometric measurements and biochemical indices for elderly with a range of nutrition
      status in Singapore. Thus, the objectives of this cross-sectional study are to examine
      factors influencing nutritional status and to determine the reference values for
      anthropometric and biochemical measurements related to nutritional status for
      community-dwelling elderly in Singapore.
    

Detailed description: 
      This is a cross-sectional study. Measurements will be taken at baseline for elderly with
      normal nutrition (n = 400) and elderly who are at risk of under nutrition (n = 800).. These
      measurements will be used to examine factors influencing nutritional status and to create a
      "reference" database for anthropometric and biochemical measurements related to nutritional
      status for use in clinical practice.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This cross-sectional study will include 400 elderly with normal nutrition (MUST score: 0)
        and 800 elderly who are at risk of undernutrition (MUST score ≥ 1). Community-dwelling
        elderly recently discharged from the hospital as well as those who recently visited
        polyclinics in Singapore will be recruited for the study.
Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations
Condition: Cardiac Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and
      analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are
      associated with respiratory depression and hypotension. The aim of this study was to compare
      the effect of remifentanil and dexmedetomidine, which exerts sedative and analgesic effect
      without serious respiratory depression, with conventional midazolam/remifentanil combination
      on sedative and analgesic levels in patients undergoing endocardial ablation.
    


Intervention name(s): dexmedetomidine-remifentanil; midazolam-remifentanil
Intervention type(s): Drug; Drug
Intervention MeSH terms: Midazolam; Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cardiac ablation
Role of BP1.3656 on Alcohol Responses
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The current study will determine whether a novel pharmacotherapy, BP1. 3656, affects
      laboratory alcohol self-administration in participants with alcohol use disorder (AUD).
    

Detailed description: 
      The current study employs BP1.3656, a novel investigational compound with a track record for
      safety and tolerability in phase I clinical trials. When administered to mice, BP1.3656 was
      associated with increased metabolism of histamine and elevated brain dopamine and
      acetylcholine, suggestive of utility in psychiatric disorders including Alcohol Use Disorder
      (AUD).

      This study is a Phase II laboratory-based trial of BP1 .3656 for AUD. 40 non-treatment
      seeking participants with AUD will be recruited. Participants will be randomly assigned to
      intervention with BP1 .3656 or placebo in a within-subject, crossover design. During each
      intervention period, outcome measures relating to alcohol motivation and self-administration
      will be assessed in the laboratory. It is hypothesized that relative to placebo, alcohol
      self-administration will be decreased by BP1 .3656.
    

Intervention name(s): BP1.3656; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BP1.3656 will be administered in tablet form once daily at a dose of 30 µg/day for the first 4 days of the intervention phase, followed by a dose increase to 60 µg/day for the remaining 10 days. If the highest dose is not tolerated, it will be lowered to 30 µg.; Administered once daily in tablet form.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a within-subjects, counterbalanced, crossover trial with a washout period. Participants will receive either placebo or the interventional drug BP1.3656 during the initial 14-day phase of the study and receive the other intervention during the second 14-day phase of the study. The washout period will last a minimum of 14 days.
Participants will come in to the laboratory on two separate days near the end of each intervention phase to complete alcohol self-administration sessions.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Ethanol; Alcohol; Self administration; BP1.3656B; Alcohol Use Disorder; Alcoholism; Alcohol Drinking; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders
Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma
Condition: Malignant Glioma; Glioblastoma Multiforme
MeSH terms: Glioblastoma; Glioma
Study type: Interventional
Phase: Phase 1

Summary: 
      Despite the marginal improvements in survival of patients suffering from malignant glioma
      treated with gene therapy vectors, the clinical trials conducted so far using viral vectors,
      in particular adenoviral vectors, have proven that the use of adenoviral vectors is a safe
      therapeutic approach, even in large, multicenter, phase 3 clinical trials. Treatment of
      malignant glioma using gene transfer modalities typically consists of surgical debulking of
      the tumor mass followed by the administration of the viral vectors into the brain tissue
      surrounding the tumor cavity. This study will combine direct tumor cell killing (TK) and
      immune-mediated stimulatory (Flt3L) gene transfer approaches delivered by first generation
      adenoviral vectors.
    

Detailed description: 
      This is a Phase 1, multiple center open label, dose escalation safety study of Ad-hCMV-TK and
      Ad-hCMV-Flt3L delivered to the peritumoral region after tumor resection. This study will
      combine direct tumor cell killing (TK) and immune-mediated stimulatory (Flt3L) gene transfer
      approaches delivered by first generation adenoviral vectors. Treatment with HSV1-TK is
      expected to kill transduced brain cells, thus exposing tumor antigen. Treatment with Flt3L, a
      cytokine known to cause proliferation of dendritic cells, should cause the migration of
      dendritic cells to the peritumoral brain and remaining tumor. There, they will be exposed to
      tumor antigens released from dying glioma cells through TK + valacyclovir-induced glioma cell
      death, and thus mediate a specific anti-malignant glioma immune response against remaining
      malignant glioma cells.
    

Intervention name(s): Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L
Intervention type(s): Biological
Intervention description(s): Two adenoviral vectors will be used, each to deliver one of the therapeutic genes. Both vectors are human serotype 5, replication-defective, first generation adenoviral vectors deleted in E1a and E3 viral encoding regions. Each vector will constitutively express their respective therapeutic transgene (i.e. HSV1-TK or Flt3L) under the control of the human cytomegalovirus promoter (hCMV). Valacyclovir treatment will begin 1-3 days after vector administration at a dose of 2 grams given orally 3X per day for 14 days. A second course of valacyclovir will be given beginning Week 10.
Radiation and chemotherapy will be administered as per standard of care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
Condition: Infantile Colic
MeSH terms: Colic
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind,
      placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and
      safety of Nepadutant given at two oral doses once daily for seven days in comparison to
      placebo in the treatment of infantile colic.
    

Detailed description: 
      Infant colic is a functional gastrointestinal disorders which affects up to the 30% of the
      infant population; it is primarily characterised by excessive inconsolable crying starting
      without any apparent cause and lasting for several hours per day.

      Current non pharmacological interventions (e.g. message, restriction in maternal diet in
      breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs)
      are largely unsatisfactory.

      In animal models, Nepadutant reverse the exaggerated intestinal motility and sensitivity,
      induced by different stimuli, without producing inhibitory effects on these functions at
      baseline, suggesting that Nepadutant could have a therapeutic effect with no interference on
      physiological gastrointestinal transit.

      This phase IIa study is designed to evaluate the efficacy of Nepadutant paediatric oral
      solution given once daily at two doses in comparison to placebo.

      The experimental clinical phase encompasses the following periods:

        -  Screening period (no study medication) to be done 7 to 4 days prior to randomisation

        -  Treatment period, lasting seven days with once daily administration

        -  Post treatment period, lasting seven days A safety follow-up visit will be performed
           approximately 1 month after the first administered dose.
    

Intervention name(s): Nepadutant oral solution; Nepadutant oral solution; Placebo matching Nepadutant oral solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration once daily for 7 days; Oral administration once daily for 7 days; Oral administration once daily for 7 days
Intervention MeSH terms: Pharmaceutical Solutions; MEN 11420
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infantile Colic; tachykinin antagonist; Nepadutant