bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates the effects of Lithium treatment on signal transduction pathways,
      gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It
      is hypothesized that specific changes in these markers will correlate with lithium treatment
      responsiveness.
    

Detailed description: 
      This study investigates the effects of blinded lithium treatment longitudinally in patients
      with bipolar disorder. At baseline and at multiple time points following the initiation of
      lithium treatment over 4 or more weeks, measures of signal transduction pathways, gene
      expression and brain neurochemistry and structure were obtained. It is hypothesized that
      modulation of these measures will be predictive of lithium treatment responsiveness.
    

Intervention name(s): Lithium Carbonate
Intervention type(s): Drug
Intervention description(s): 300mg PO, three times daily with dose titrated to obtain a therapeutic plasma level of 0.8 to 1.2meq/L) over the first week of treatment. Total duration is a minimum of 3 weeks. Medication is dispensed in the form of blinded research capsules.
Other intervention name(s): Eskalith; Lithonate; Lithane; Lithotabs; Lithobid
Intervention MeSH terms: Lithium Carbonate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Lithium; Neuroprotection; Neurotrophic; bcl2; gsk3; pkc; MRI; myoinositol; MRS; Alzheimers Disease
Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-blind (blinded expert grader), randomized, half-face study being conducted
      at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products,
      antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral
      side of the face will remain non-treated to serve as a control. Approximately 25-30 male and
      female healthy subjects will be randomly assigned to each product
    

Detailed description: 
      This is a single-blind (blinded expert grader), parallel group, randomized, half-face study
      being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the
      2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene
      and the contra lateral side of the face will remain non-treated to serve as a control.
      Approximately 25-30 male and female healthy subjects will be randomly assigned to each
      product.

      The subjects will be entered into a 2-week treatment phase. The once-daily applications for
      the study medication will be supervised at the site, Monday through Friday of each week.
      Subjects will apply the study product at home on Saturdays and Sundays.

      A blinded expert grader will rate comparative product tolerance on each week day (excluding
      Saturdays and Sundays) during the study before study product is applied.

      Subject questionnaires will be completed along with collection of all adverse events.
    

Intervention name(s): Clindamycin and benzoyl peroxide; benzoyl peroxide 2.5% and adapalene 0.1% gel
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.; Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel
Other intervention name(s): Duac® Topical Gel (clindamycin and benzoyl peroxide.; benzoyl peroxide gel and adapalene gel
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne
A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single centre, randomised, open-label, single-dose, 5-period, 5-treatment,
      crossover study in healthy male and female subjects. This study is intended to assess the
      relative bioavailability between the fixed dose combination (FDC, i.e. verinurad/allopurinol
      FDC capsule 12/300 mg) and free combination formulations of verinurad (i.e. verinurad
      prolonged release Hydroxypropyl methylcellulose [HPMC] capsule 12 mg) and allopurinol (i.e.
      allopurinol table 300 mg) in fasted and fed conditions. The study will also assess the
      relative bioavailability between a formulation only containing verinurad (i.e. verinurad
      prolonged release gelatin capsule 12 mg) and the FDC capsule.
    

Detailed description: 
      The study comprises of:

        -  A Screening Period of maximum 28 days;

        -  Five treatment periods during which subjects will be resident from the morning of Day -2
           until at least 72 hours after dosing in Treatment Period 5; discharged on the morning of
           Day 4 of Treatment Period 5; and

        -  A Follow-up Visit 7 to 14 days after the last dosing.

      Each subject will receive 5 single dose treatments of verinurad and allopurinol or verinurad
      alone and subject will be involved in the study for 52 to 59 days.
    

Intervention name(s): Verinurad prolonged release HPMC capsule; Allopurinol Tablet; Verinurad/Allopurinol FDC Capsule; Verinurad prolonged release gelatin Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Randomized subjects will receive oral dose of verinurad HPMC capsule.; Randomized subjects will receive oral dose of allopurinol tablet.; Randomized subjects will receive oral dose of Verinurad/Allopurinol FDC capsule.; Randomized subjects will receive oral dose of Verinurad gelatin capsule.
Intervention MeSH terms: Allopurinol; Verinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 3-period; Crossover; URAT1 inhibitor; Xanthine oxidase inhibitor
Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol,
      and placebo in patients with painful gastric or intestinal spasms.
    


Intervention name(s): Buscopan® plus; Buscopan®; Paracetamol; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Acetaminophen; Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986166
      and of branebrutinib, each versus placebo, for the treatment of participants with moderate to
      severe atopic dermatitis.
    


Intervention name(s): BMS-986166; Branebrutinib; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): BMS-986195
Intervention MeSH terms: Branebrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; BMS-986166; BMS-986195; Branebrutinib
Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      Positive micro vascular invasion in early stage hepatocellular carcinoma(HCC) leads to early
      recurrence after surgery. Adjuvant external radiotherapy will be applied in those patients to
      see if disease free survival and overall survival could be approved.
    

Detailed description: 
      Hepatocellular carcinoma(HCC) ranks the 6th most common cancer and is the 2nd leading cause
      of cancer-related death globally. Surgical resection remains the most efficient therapy in
      early stage. Though an anatomical resection of tumor lead to an up to 70% 5-year overall
      survival, the existence of micro vascular invasion(MVI) caused early recurrence. Stereotactic
      body radiation therapy (SBRT) has been proved to be efficient in treating vascular tumor
      thrombosis. The investigators tried to implement this technique in adjuvant setting for HCC
      after surgery with MVI. Participants with early stage HCC whose tumor locates closely to the
      main intrahepatic vascular will be regarded as potentially-not-enough-surgical-margin
      candidates. Surgical resection will be carried out as scheduled and an additional silver clip
      will be put into the margin. Postoperative pathological examination will detect micro
      vascular invasion or daughter nodule. MVI-positive candidates will be eligible for
      enrollment. Eligible participants will be randomized to two groups, SBRT group and
      surgery-alone(SA) group with 1-to-1 ratio. Participants in SBRT group will receive a 35Gy
      limited resection margin parenchyma SBRT after surgery, while participants in SA group just
      get surgery. Radiation related adverse events (AE) or reaction will be recorded and
      intervened necessarily. All participants will be followed up by investigators every three
      months. DFS, OS, and AEs are end points in this study.
    

Intervention name(s): Stereotactic radiotherapy
Intervention type(s): Radiation
Intervention description(s): Radiation using stereotactic radiotherapy device.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adjuvant SBRT after surgery group vs. surgery alone group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stereotactic body radiotherapy; Micro vascular invasion; Narrow resection margin
Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was designed to determine the number of doses of CAIV-T required to effectively
      immunize children and adolescents in the 6 to 17 year age group.
    

Detailed description: 
      This was a phase II, prospective, open-label, multicenter, outpatient study designed to
      evaluate the safety, tolerability, and immunogenicity of one or two doses of CAIV-T in
      children and adolescents between 6 and 17 years of age. Subjects were allocated to one of
      three study groups according to age at the time of enrollment: study group one consisted of
      subjects between 6 and 9 years of age, group two of subjects 10 to 12 years of age, and group
      three of subjects 13 to 17 years of age.

      Approximately 450 subjects (ie, 150 subjects per age group) participated in the study and
      were scheduled to receive two intranasal doses of CAIV-T separated by 35 ± 7 days in an
      open-label manner.
    

Intervention name(s): CAIV-T
Intervention type(s): Biological
Intervention description(s): Each dose of the vaccine was formulated to contain approximately 1 x 10^7 TCID50 of each of three (two subtype A and one subtype B) reassortant 6:2 influenza strains, as described above, for a total of ~3 x 10^7 TCID50 per dose.
Other intervention name(s): FluMist
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women
Condition: Overweight; Obesity; Pregnancy
MeSH terms: Overweight; Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      Excessive weight gain during pregnancy, particularly in overweight and obese women,
      predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal
      health. With an inverse relationship between socioeconomic status and obesity, significant
      health disparities exist between obese and normal weight women. The Institute of Medicine
      (IOM) recently revised its gestational weight gain recommendations, targeted to pregravid
      body mass index (BMI), to minimize pregnancy complications. However, these recommendations
      are based on cross sectional observational studies and neither the ideal method to achieve
      weight gain goals nor whether perinatal outcome is optimized with active management of weight
      gain is known. The investigators propose to investigate a behavioral incentive-based
      intervention to improve compliance with IOM weight gain recommendations during pregnancy in
      low-income overweight and obese women. The investigators will evaluate if 1) gestational
      weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain
      management during pregnancy improves perinatal outcomes. Two study groups will be compared in
      a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those
      receiving behavioral weight management counseling plus financial incentives for achieving
      weight gain goals. The main outcome measure will be the percentage of women gaining within
      the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include
      fetal growth and body composition changes, birth weight and the rate of cesarean delivery.
      The investigators hypothesize that 1) the behavioral intervention with incentives will result
      in greater compliance to IOM guidelines for gestational weight gain than standard care and 2)
      targeting weight gain to the IOM guidelines will lead to a reduction in the rates of fetal
      macrosomia and cesarean delivery. Finally, cost effectiveness of treatment conditions will be
      examined. This intervention, if efficacious and cost-effective, has the potential to improve
      compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce
      health disparities.
    


Intervention name(s): Financial incentives
Intervention type(s): Behavioral
Intervention description(s): Participants receive a behavioral intervention and financial incentives for meeting gestational weight gain goals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Pregnancy
Comparison of Different Frames of Numerical Information in Cochrane Plain Language Summaries
Condition: Health Knowledge, Attitudes, Practice
Study type: Interventional

Summary: 
      Participants will be randomly given one of two formats containing descriptions of health
      interventions. In one format, participants will have to read short summaries where results of
      the intervention are presented as frequencies and the side effects of health intervention are
      presented as percentages, while in another format the frames will be reversed (results will
      be presented as percentages and side effects as frequencies). After reading, participants
      will be asked several questions about the content of the summary and its conclusions.
    


Intervention name(s): Frequencies; Percentages
Intervention type(s): Other; Other
Intervention description(s): Results are presented as natural frequencies (e.g. the drug was effective for 1 out of 10 people) while side effects are presented as percentages (e.g. 40% participants experienced severe side effects); Results are presented as percentages (e.g. the drug was effective for 10% of people) while side effects are presented as natural frequencies (e.g. 4 out of 10 participants experienced severe side effects)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effects of Resistant Potato Starch on the Gut Microbiota
Condition: Microbiota
Study type: Interventional

Summary: 
      This was a randomized, double-blind, three-arm, parallel group clinical trial, which assessed
      the shifts that occur in microbial populations after four weeks of supplementation with
      resistant potato starch (SolnulTM) at two different dosages, in comparison to a placebo in
      healthy adults.
    


Intervention name(s): Resistant Potato Starch; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Unmodified potato starch containing >60% resistant starch Type 2; Fully digestible corn starch
Other intervention name(s): Solnul; MSPrebiotic; AmiocaTM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Microbiota; Resistant Potato Starch; Bristol Stool Chart; Diarrhea; Constipation; Bloating; Abdominal Pain; Gas; Well-being
In Vitro Studies on Pharmacological Regulation and Genetic Risk Factors of Peripheral Human Nociceptors
Condition: Pain
Study type: Observational

Summary: 
      This protocol is for a number of in vitro studies using human surgical biopsies and
      evaluating the pharmacology and genetics of human nociceptors ("pain detecting") neurons
    

Detailed description: 
      Purpose/Objectives

      a. Specific Aims Specific Aim 1: Characterize in humans the effects of inflammation and
      neuronal degeneration on peripheral levels of NPY, and related Y receptors (Y1, Y2, Y5) in
      periradicular tissue.

      Specific Aim 2: Determine whether NPY inhibits neurosecretion from peripheral terminals of
      capsaicin-sensitive neurons innervating normal versus inflamed tissue.

      Specific Aim 3: Determine whether peripheral administration of NPY is analgesic and/or
      anti-allodynic in patients experiencing spontaneous pain and mechanical allodynia in a
      clinical model of inflammation with associated neuronal degeneration.

      Specific Aim 4: Evaluate whether population characteristics are associated with altered pain
      reports. First, we will determine whether patients with the C1128 single nucleotide
      polymorphism (SNP) of the PreProNPY gene, whose phenotype confers substantially augmented
      peripheral NPY neurosecretion, report less pain compared with patients without this genetic
      polymorphism. Second, we will determine whether ethnic/cultural factors associated with an
      underserved minority population (Hispanics in the San Antonio area) are associated with
      altered pain reports.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers between ages 16-90 y.o. presenting to the dental clinics within the
        University Health Science Center San Antonio for extraction of teeth.
      
Biospecimen description: 
      Whole blood, serum, sputum, oral mucosa tissue, teeth
    
Keywords: Pain in teeth
Investigating the Effects of Beta-Hydroxy-Beta-Methylbutyrate on Glucose Handling in Older and Younger Men.
Condition: Insulin Resistance; Age Problems
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This study intends to examine the effect of a commercially available nutritional supplement,
      Beta-hydroxy-beta-methylbutyrate(HMB) on whole-body responses to a sugar load.
    

Detailed description: 
      One change associated with human aging is a reduction in "fitness", both in terms of how far
      or quickly a person can run/cycle/swim and also in how well their blood vessels work.
      Additionally a person's metabolic fitness decreases; this is how well the body copes with
      nutrition and is why, for example, older people have a higher risk of diseases like type 2
      diabetes. Previous studies have shown that as people become less fit, they are at increased
      risk of suffering a complication whilst undergoing surgery. It has also been shown that
      measuring how fit someone is, is better at predicting the risk of a surgical complication
      than purely using a person's age alone. Lots of research has shown that exercise can
      potentially reverse some of the age-related declines in fitness, however most has used long
      sessions of continuous exercise over a long period of time. High-intensity interval training
      (HIT), whereby people cycle on an exercise bike very hard for a minute, followed by a short
      rest, repeated over the course of 15 minutes can rapidly improve a person's fitness. However
      not everyone will be able to, or indeed want to participate in exercise this strenuous;
      therefore this research seeks to explore whether other options, such as dietary supplements
      can improve aspects of fitness

      This study intends to examine the effect of giving a dietary supplement on the way a person's
      body handles the glucose (from carbohydrates/ sugars) in a meal. Previous work has shown that
      taking a beta-hydroxy beta-methyl butyrate (HMB) supplement may improve may improve a
      patient's response to glucose, however the evidence is not clear. HMB is a commercially
      available nutritional supplement providing a compound that the body produces each time
      protein is consumed, and is most commonly used by bodybuilders to help gain muscle.
    

Intervention name(s): Beta-Hydroxy-Beta-Methylbutyrate; Placebo
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): HMB
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention