bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants
Condition: Infant Development
Study type: Interventional

Summary: 
      A goal of infant formula development is to mimic human milk (HM) both in nutrient composition
      as well as physiologic outcomes. investigators have developed an infant formula for term
      infants that more closely resembles the composition of human milk. The purpose of this study
      is to demonstrate that this formulation meets nutritional requirements and supports age
      appropriate growth of healthy term infants.
    

Detailed description: 
      This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF)
      infants. FF infants will be randomized to receive either a experimental infant formula,
      formulated for healthy term infants (BBN) or a commercially available infant formula for
      healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks;
      infant growth, serum markers for inflammation and tolerance to the formulas will be assessed
      throughout the study.
    

Intervention name(s): BBN; Brand
Intervention type(s): Other; Other
Intervention description(s): BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.; Brand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks
Other intervention name(s): BBN-102; Enfamil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Formula feed infants will be randomized to receive either a new infant formula formulated for healthy term infants (BBN) or a commercially available infant formula for healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir Study
Condition: Bioequivalence Study
Study type: Interventional
Phase: Phase 1

Summary: 
      In a phase 1, open-label, crossover study to evaluate the relative bioavailability of a
      tablet formulation of ravidasvir (test) versus the capsule formulation of ravidasvir
      (reference) in 24 healthy adult volunteers (PPI-668-104 study), relatively high intra-subject
      coefficients of variation were observed for both Cmax and AUC0-t.

      A two-sequence, four-period replicate design will be used to allow the possibility to scale
      the acceptance range for Cmax if the observed intra-subject coefficient of variation for the
      reference formulation is greater than 30%
    

Detailed description: 
      During the course of development, a new batch of ravidasvir tablets has been prepared by the
      proposed commercial manufacturer (Doppel Farmaceutici, Italy). Tablets manufactured by Doppel
      Farmaceutici are intended to be used in subsequent clinical trials and be registered as the
      commercial product. The purpose of this Phase 1, Open-Label, Four-Period, Two-Sequence,
      Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study is to assess if
      ravidasvir 200 mg tablets supplied by European Egyptian Pharmaceutical Industries (EEPI) and
      tablets from Doppel Farmaceutici are bioequivalent.

      Primary objectives:

      To compare the rate and extent of absorption for ravidasvir (RDV) when administered as a
      single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel
      Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy
      volunteers, under fasted conditions.

      Secondary objectives To evaluate the safety and tolerability of single oral doses of RDV in
      healthy volunteers.
    

Intervention name(s): Ravidasvir test formulation produced by Doppel; Ravidasvir reference formulation produced by EEPI
Intervention type(s): Drug; Drug
Intervention description(s): To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions.; To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study
Masking: None (Open Label)
Primary purpose: Treatment
Molecular Epidemiology of Clostridium Difficile Infections in Children
Condition: Clostridium Difficile Infections
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Study type: Observational

Summary: 
      Objectives:

        1. Describe the molecular epidemiology of Clostridium Difficile infection in children in
           the Chicago area.

        2. Determine the clinical spectrum and risk factors for Clostridium Difficile infection
           secondary to particular endemic strains in children.

        3. Define the risk factors for recurrent and community-associated Clostridium Difficile
           infection in children.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children with Clostridium Difficile infection
The Effect of Mandala Activity-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Maternal-Infant Attachment of Primiparous Mothers
Condition: Breastfeeding; ART; Self Efficacy; Maternal-Fetal Relations
Study type: Interventional

Summary: 
      This study will be conducted to determine the effect of breastfeeding program integrated with
      art therapy such as mandala painting on postpartum breastfeeding self-efficacy, breastfeeding
      rates, and mother-infant attachment of primiparous mothers.

      Training on breastfeeding and mother-baby bonding and mandala drawings supporting the
      training will be sent online to primiparous pregnant women who are at 32-36 weeks of
      gestation and agree to participate in the study. Telephone follow-up and counseling will
      continue in the postpartum period. In the postpartum period, follow-up and counseling will
      continue until the second month.
    

Detailed description: 
      In this study, a mandala-based breastfeeding program will be applied to primiparous mothers
      at 32-36 weeks of gestation. The study will be conducted to determine the effect of
      mandala-based breastfeeding programs on postpartum breastfeeding self-efficacy, breastfeeding
      rates, and maternal-infant attachment of primiparous mothers. Training on breastfeeding and
      mother-baby bonding and mandala drawings supporting training will be sent online to
      primiparous pregnant women who are at 32-36 weeks of gestation and agree to participate in
      the study. The study is planned to be conducted with 72 pregnant women (intervention
      group=36, control group=36). Telephone follow-up and counseling will continue in the
      postpartum period. In the postpartum period, follow-up and counseling will continue until the
      second month.
    

Intervention name(s): "Mandala Activity-Based Breastfeeding Program"
Intervention type(s): Other
Intervention description(s): Training modules for breastfeeding and Maternal -infant attachment will be implemented with pregnant women in the study group at 32-36 weeks of gestation. The training will be explained by the researchers by shooting a video. In addition, for each week, mandala drawings will be videotaped by the researcher who received mindfulness-based art therapy training and will be sent to the Whatsapp accounts of the pregnant women. t 36 weeks of gestation, the Prenatal Attachment Scale and Spielberger State Anxiety Inventories will be sent to mothers as Google forms. The mother will be called 24 hours after the birth and the situation of having a problem with breastfeeding will be determined. In the first week, in the first and second months after the birth, questionnaire forms and online questionnaires will be applied to the mothers, apart from the follow-up and counseling in the postpartum 2nd month, the posttests of the scales
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Antimicrobial Stewardship in Community Pharmacy
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      Acute otitis media (AOM) is the most common indication for antibiotics for Canadian
      paediatric patients. As the gatekeepers of safe and effective prescription pharmacotherapy,
      community pharmacists are well positioned to influence and optimize antibiotic use. The
      purpose of this project is to develop, implement, and evaluate an antimicrobial stewardship
      program in the community pharmacy setting that aims to optimize antibiotic use for AOM. This
      nonrandomized pre-post study includes children aged 6 months to 12 years presenting with an
      antibiotic prescription for AOM at two community pharmacies in Toronto, Ontario. Participants
      are excluded if they exhibit signs/symptoms of mastoiditis, have an additional indication for
      systemic antibiotics, or parents/guardians cannot consent in English. The multifaceted AMS
      intervention includes pharmacist education, a clinical decision support tool, a
      parent/guardian questionnaire, and individualized monthly audit and feedback with each
      pharmacist. Prescriptions are reviewed and adapted by the pharmacist to optimize congruence
      with 2016 Canadian Paediatric Society AOM guidelines. The primary outcome is the percentage
      change in guideline congruence attributable to pharmacist intervention. This study will
      provide insight into the opportunities and barriers of developing large-scale antimicrobial
      stewardship programs for community pharmacies.
    


Intervention name(s): Antimicrobial stewardship; Comparator (no intervention)
Intervention type(s): Behavioral; Other
Intervention description(s): The multifaceted AMS intervention includes pharmacist education, a clinical decision support tool, a parent/guardian questionnaire, and individualized monthly audit and feedback with each pharmacist.; No active intervention
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Pre-post intervention study model
Masking: None (Open Label)
Primary purpose: Other
Keywords: antimicrobial stewardship; pharmacies; community pharmacy services; anti-infective agents; drug utilization
A Nutrition Intervention to Lower Blood Pressure in Adolescents
Condition: Hypertension
MeSH terms: Hypertension; Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a 12-week, clinic-based, behavioral
      nutrition intervention emphasizing fruits, vegetables, and low fat dairy compared to routine
      nutrition care on changing diet quality and blood pressure post-treatment and at short-term
      follow-up in adolescents with hypertension.
    

Detailed description: 
      Among youth, hypertension is no longer a rare disease, affecting about 7 million children and
      adolescents. Numbers are increasing with the evolving pediatric obesity epidemic in the US.
      More adolescents than children have primary hypertension, which tracks into adulthood and has
      been linked with preclinical indicators of adverse cardiovascular events in adults. Early
      prevention and intervention efforts are needed to address this increasing public and
      individual health problem. The purpose of this project is to evaluate the immediate and
      sustained impact of a 3-month clinic-based behavioral nutrition intervention emphasizing a
      diet high in fruits, vegetables, and low fat dairy, and low in fat and sodium (the DASH
      intervention) versus routine nutrition care on changing diet quality and blood pressure in
      adolescents with pre-hypertension or hypertension. The DASH intervention will include a
      printed participant manual, 1 individual counseling session with a dietitian, 4 mailings and
      10 telephone calls on behavioral strategies to promote dietary change. Routine care will
      include 1 individual counseling session with a dietitian on dietary guidelines consistent
      with those of the National High Blood Pressure Education Program. Adolescents with
      prehypertension or hypertension will be randomly assigned to the DASH intervention or routine
      nutrition care after pre-treatment assessment. Post-treatment and at 3-month follow-up,
      outcome measures will be assessed including dietary intake and blood pressure. Our
      expectations are that the DASH intervention will significantly improve dietary quality and
      blood pressure in adolescents with elevated blood pressure compared to that observed as a
      result of routine nutrition care. The findings from this study are expected to improve the
      manner in which hypertension among adolescents is being treated in the clinical setting and
      contribute to the enhancement of the cardiovascular health of the target population.
    

Intervention name(s): diet high in fruits, vegetables, and dairy; Routine nutrition care
Intervention type(s): Behavioral; Other
Other intervention name(s): DASH dietary pattern; Routine Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: nutrition; adolescent nutrition; blood pressure; hypertension; diet therapy; patient education
Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)
Condition: Intermittent Claudication; Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to establish the safety profile of

      Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects
      comprising of 4 treatment groups:

        1. Double treatment of PLX-PAD low dose

        2. Double treatment of PLX-PAD high dose

        3. Double treatment of Placebo

        4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will
           receive the assigned treatment twice to the affected leg, within 12-weeks interval
           between each treatment.

      The study will be comprised of 5 stages:

      Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by
      additional injection after 12 weeks and with follow-up of 12 months post second injection
    


Intervention name(s): PLX-PAD Low dose; PLX-PAD high doses; Double Placebo; high dose +Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride
Condition: Elevated Triglycerides
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, a lipase -sourced from a nonpyrogenic yeast, Candida rugosa, will be
      investigated to establish optimal TG levels in adults in a 12-week supplementation period.
      The investigational product provides a lipase formulation that is stable and active in acidic
      and neutral pH environments, while also fully digesting TGs into free fatty acids and
      glycerol which is beyond the scope of pancreatic lipase (Schuler et al. 2012). This will be a
      novel study investigating the effects of C. rugosa lipase on adults with slightly elevated TG
      levels.
    


Intervention name(s): GFA-918; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants will be instructed to take one GFA-918 (125000 FIP Units of Lipase AY) capsule twice per day with their morning and evening meals for 12 weeks.; Participants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
Condition: Mycoses; Candidiasis, Invasive; Candidemia
MeSH terms: Mycoses; Candidiasis; Candidemia; Candidiasis, Invasive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral
      SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the
      treatment of invasive candidiasis.
    

Detailed description: 
      Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are
      eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or
      standard-of-care.
    

Intervention name(s): SCY-078; Fluconazole; Micafungin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fluconazole; Micafungin; Ibrexafungerp
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Invasive Candidiasis; Invasive Candida infections; Candidemia; SCY-078; Micafungin; Fluconazole; Echinocandin
Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      TJ-100, a Japanese herbal medicine, is clinically effective in postoperative ileus. So it may
      activate bowel movement. This study will test the efficacy and safety of TJ-100 in the
      treatment of patients with chronic constipation.
    


Intervention name(s): TJ-100
Intervention type(s): Drug
Intervention description(s): TJ-100 2.5g three times per day for 6 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: constipation
Gabapentin for Bipolar & Cannabis Use Disorders
Condition: Bipolar I Disorder; Bipolar II Disorder; Cannabis Use Disorder; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and
      manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and
      neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with
      cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown
      to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate
      medication-related changes in response inhibition (go no-go) and cannabis cue reactivity
      functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms
      (including anxiety and sleep), and impulsivity in individuals with CUD+BD.
    

Detailed description: 
      Bipolar disorder (BD) is the Axis I condition most strongly associated with cannabis use
      disorder (CUD); there is a six-fold increase in the prevalence of CUD in individuals with BD
      relative to the general population. Individuals with co-occurring CUD and BD (CUD+BD) have
      substantially worse clinical outcomes than those with either BD or CUD alone. Response to
      mood stabilizing medications appears to be poor, yet little is known about optimal treatment
      for CUD+BD, as there have been no randomized medication trials for CUD+BD to date. Convergent
      evidence supports dysregulated brain γ-Aminobutyric acid (GABA)/glutamate homeostasis as a
      candidate target for pharmacological intervention in CUD+BD. Preclinical and clinical studies
      have demonstrated that CUD and BD are each associated with prefrontal GABA and glutamate
      disturbances and that impulsivity, a core neurobehavioral feature of both CUD and BD and a
      key Research Domain Criteria (RDoC) construct, is causally related to GABAergic/glutamatergic
      functioning. Gabapentin has been consistently shown in preclinical research to modulate GABA
      and glutamate transmission. In human Proton Magnetic Resonance Spectroscopy (1H-MRS) studies,
      both acute and chronic gabapentin dosing have been shown to increase brain GABA levels,
      however, few studies have investigated gabapentin effects on glutamate levels. Researchers
      propose that gabapentin may impact clinical outcomes in CUD+BD individuals both directly and
      indirectly through their impact on impulsivity.
    

Intervention name(s): Gabapentin; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): 5 day trial of gabapentin with titration to 1,200mg; 5 day trial of matched placebo
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Serum 1,25-dihydroxyvitamin D Levels in Type 2 Diabetes Mellitus Patients With Different Levels of Albuminuria
Condition: Type 2 Diabetes Mellitus With Diabetic Nephropathy
MeSH terms: Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Diabetic nephropathy(DN)is a major microvascular complication of diabetes.Renal injury may be
      presented with the characteristics of albuminuria, and its main pathological change is
      glomerular sclerosis. However, both glomerular lesions such as glomerulosclerosis, glomerular
      basement membrane thickness and tubulointerstitial fibrosis have been found in both type 1
      and type 2 diabetic patients with normal urinary albumin excretion rate, moreover the tubular
      injury may be the primary pathological change in diabetic renal injury not only the secondary
      change brought on by glomerular injury. Thus, if overt urinary albumin exists in T2DM
      patients, the tubular injury may be severe already. An index which is predominant, sensitive
      and convenient to be measured should be purposed.It is predicted that insufficient renal
      1-alpha hydroxylase may play a critical role in diabetic nephropathy. Then the investigators
      present the presumption that the activity of renal 1-alpha hydroxylase could reflect the
      degrees of tubulointerstitial injury, using serum 1,25-dihydroxyvitamin D level as an index.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with T2DM were recruited from the general hospital of Tianjin Medical University
        in China .
      
Biospecimen description: 
      Blood samples were collected after an overnight fast to evaluate glycosylated hemoglobin
      A1c（HbA1c）, hemoglobin (Hb), serum albumin (ALB), serum creatinine (SCR), serum urea nitrogen
      (BUN), uric acid (UA), serum calcium (Ca), serum phosphate (P), serum alanine transferase
      (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), serum
      25-hydroxyvitamin D and 1,25-dihydroxyvitamin D. Urine albumin, calcium and phosphate of 24
      hour were also evaluated.