bioihbjkbjnl/mcl2 huggingface dataset:
Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, open-label, crossover study to assess the bioequivalence of 1
      risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral
      dose. Approximately 320 subjects will be enrolled from 4 study centers in the U.S.
    

Detailed description: 
      The data to support the interchangeability of one risedronate 150 mg tablet versus two
      risedronate 75 mg tablets as monthly dose forms is primarily based on the similarity of in
      vitro dissolution and an in vivo study, which showed risedronate absorption is not
      dissolution rate limited. These results suggest that monthly dosing of risedronate may be
      accomplished by administration of either one risedronate 150 mg tablet or two risedronate 75
      mg tablets. The purpose of this study is to provide additional clinical data to support the
      interchangeability of these 2 dose regimens.
    

Intervention name(s): Risedronate; Risedronate
Intervention type(s): Drug; Drug
Intervention description(s): 1 risedronate 150 mg tablet administered orally; 2 risedronate 75 mg tablets administered as a single oral dose
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Soluble Corn Fiber Supplementation for Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Studies of the importance of the human microbiome have demonstrated that microbial
      metabolites of fermentation of our dietary products (e.g. dietary fiber) have a multitude of
      health benefits. The investigators aim to determine whether supplementation of asthmatic
      children with soluble corn fiber alongside standard of care reduces airway inflammation
      driven by the gut microbial metabolites acetate, propionate, or butyrate (short chain fatty
      acids).
    

Detailed description: 
      Asthma is a complex inflammatory disease of the airways that is estimated to affect 300
      million people worldwide. Incidence of asthma is steadily increasing in Western populations;
      an additional 100 million asthma diagnoses are anticipated by the year 2025. Asthma is a
      multifactorial disease affected by genetic and environmental factors. One major and
      potentially modifiable environmental factor is the Western diet. The Western diet influences
      the microbiome, which in turn, may influence inflammatory airway diseases via a gut
      microbiome-airway connection. The investigators hypothesize that prebiotic dietary fiber
      supplementation leads to increased circulating short chain fatty acid production and
      improvement in asthma disease activity. The investigators will recruit 20 children, ages 6-17
      years old, with asthma from the Severe Asthma Clinic or General Pulmonary Clinic at Phoenix
      Children's Hospital. Participants will be randomly assigned (1:1) using a random number
      generator to ingest PROMOTIR soluble corn fiber (85% fiber, 12 g/day) in a fruit-flavored
      beverage or placebo (malodextrin in a similar fruit-flavored beverage) as previously
      described. Participants will be asked to consume the prebiotic soluble corn fiber (or
      placebo) for 4 weeks alongside their normal diet and normal asthma treatments. Blood will be
      collected pre- and post-fiber intervention to measure baseline and post-intervention
      circulating SCFAs. Stool samples and nasal wash will be collected for microbiome and immune
      analysis pre- and post- fiber consumption. Nasal washes will be collected pre- and post-fiber
      consumption to measure inflammatory patterns.
    

Intervention name(s): Soluble Corn Fiber
Intervention type(s): Drug
Intervention description(s): Fiber or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
GRC 27864 First in Man, Single Ascending Dose Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single Dose Study of GRC 27864 in Healthy Volunteers.
    

Detailed description: 
      This is a phase I study of GRC 27864 in healthy volunteers. The purposes of this study are to
      look at safety, how well the study drug is tolerated, how much of the study drug gets into
      the blood stream, and how long it takes the body to get rid of it when given to humans.
      Information about any side effects that may occur will also be collected. Participants will
      remain in the study for approximately 3 months. This study is for research purposes only and
      is not intended to treat any medical condition.
    

Intervention name(s): GRC 27864; Celecoxib; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional

Summary: 
      The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on
      time to doubling of serum creatinine or the onset of end stage renal disease in patients with
      advanced IgA nephropathy who are treated with the maximal tolerated daily dose of
      losartan.The study will also assess the effects of MMF compared with losartan alone on the
      changes of urine albumin excretion and the changes in estimated glomerular filtration rate.
    


Intervention name(s): Mycophenolate mofetil; Losartan
Intervention type(s): Drug; Drug
Intervention description(s): Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan; Maximum tolerated labeled dose of Losartan
Intervention MeSH terms: Mycophenolic Acid; Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect Kinesio Taping on Acute-onset Muscle Soreness and Calf Muscle Extensibility Among Endurance Athletes
Condition: Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      In recent years, athletes have frequently utilized Kinesio tape (KT) to enhance their
      performance. Despite widespread use, data regarding its efficacy and mechanism of action is
      lacking among healthy endurance athletes. This study aims to determine the effect of KT
      application on acute-onset muscle soreness and the extensibility of the calf muscles in
      endurance athletes.
    

Detailed description: 
      The study followed a single-blinded one-arm crossover repeated-measures randomized controlled
      design and included fifty-five endurance athletes (mean age, 16.40±2.69) from different
      stadia in Delhi, India. Outcome measures, including the ankle dorsiflexion range of motion
      (ADFROM), were measured using a universal goniometer before, immediately after application of
      either KT or Sham tape, and after treadmill running. However, the pain due to acute-onset
      muscle soreness was measured using a numeric pain rating scale (NPRS) immediately, 10 min,
      and 30 min after treadmill running.
    

Intervention name(s): Kinesio Taping; Sham Taping
Intervention type(s): Other; Other
Intervention description(s): Kinesio tape was applied over the calf muscle of either leg.; The sham tape was applied over the calf muscle of either leg.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Kinesio tape; Sham tape; Ankle dorsiflexion; Range of motion; Pain; Muscle soreness
Effect of Calcium Supplement Particle Size and Vitamin D Supplement on Calcium Retention in Adolescent Girls
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      This study has two research arms:

      The purpose of the 1st is to determine if a smaller particle size calcium carbonate
      supplement (than that which is now commercially available) improves calcium absorption and
      retention in adolescents girls.

      The purpose of the 2nd is to determine if vitamin D supplementation improves calcium
      absorption and retention in adolescents girls.
    

Detailed description: 
      An important strategy to reducing the risk for osteoporosis and fracture in later life is to
      optimize the development of peak bone mass during adolescence. Because calcium is the main
      mineral component of bone, maximizing calcium absorption and retention during adolescence is
      important to maximize peak bone mass.

      Our two research arms address two different mechanisms by which calcium absorption and
      retention may be increased:

        1. We hypothesize that a smaller particle size calcium carbonate supplement (than that
           which is now commercially available) may be better absorbed and lead to higher calcium
           retention in adolescents.

        2. We hypothesize that vitamin D supplementation will increased calcium absorption and
           retention in adolescents.

      Subjects will be assigned to one of the two research arms.

      1)Small and large particle size calcium supplements or placebo or 2) calcium supplements with
      or without vitamin D supplements will be given to subjects during two 3-week study periods in
      which subjects live on-site.

      Calcium absorption will be measured by parathyroid hormone suppression after a calcium load
      and by stable calcium isotope in some subjects.

      Calcium retention will be measured by calcium intake minus calcium excretion.
    

Intervention name(s): Small Particle Size Calcium Carbonate Supplement; Large Particle Size Calcium Carbonate Supplement; Vitamin D; Calcium Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.; Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.; Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.; Placebo tablets identical to the large and small particle size calcium carbonate tablets.
Given twice daily.
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Calcium; Vitamin D; Particle Size; Adolescents; Bone; Osteoporosis
Precursors of CVD Risk Factors--Project Heartbeat
Condition: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia; Hypertension
MeSH terms: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia
Study type: Observational

Summary: 
      To elucidate the changes in body size, composition, and configuration occurring in
      adolescence, because these are important precursors of change in blood pressure and blood
      lipids.
    

Detailed description: 
      BACKGROUND:

      Project HeartBeat! was uniquely designed to investigate the course of change in
      cardiovascular disease risk factors and several categories of covariates, including the
      anthropometric indicators addressed in this study. The data pertained to the 678 participants
      who entered the Project in 1991-93 at ages 8, 11 or 14 years of age, of whom 49.1 percent
      were female and 20.1 percent were black. Of the 395 participants who became eligible for 10
      or more 4-monthly examinations, 349 (88.4 percent) completed at least 10 occasions; 538
      participants of 556 who were eligible for seven or more examinations (96.8 percent) completed
      at least seven. Multi-level (MLn) analytic methods previously tested with other data were
      utilized for this analysis.

      DESIGN NARRATIVE:

      Data from Project Heartbeat were analyzed. Hypotheses tested included: (1) the time patterns
      of change in several indicators of body size, composition and configuration over the period
      of observation; (2) the relations between the time patterns of change in these indicators and
      the corresponding patterns for change in selected endocrine factors; and (3) the explanatory
      contributions of energy intake and expenditure to variation between individuals in their
      observed time patterns of change in these indicators. The anthropometric indicators addressed
      were: weight (total mass), height, body mass index (BMI, wt/ht2), fat-free mass, fat mass,
      per cent body fat, and fat distribution (waist/hip ratio). Each of these indicators were
      examined first separately and then in relation to selected endocrinologic measures
      (testosterone, estradiol, and DHEAS) and to energy intake and expenditure (from interview
      histories of diet and physical activity). Existing data from up to twelve 4-monthly
      examinations over the age range from 8-17 years conducted in Project HeartBeat! were
      analyzed.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy,
      3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice
      daily [BID]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary
      Disease (COPD) patients.
    

Detailed description: 
      Treatments are described as follows:

      Treatment A: Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg
      matching placebo tablet) will be administered approximately every 12 hours under fasting
      conditions for 55 consecutive days. Only the morning dose will be administered on Day 56.

      Treatment B: Multiple oral YPL-001 160 mg doses (2 x 80 mg tablets) will be administered
      approximately every 12 hours under fasting conditions for 55 consecutive days. Only the
      morning dose will be administered on Day 56.

      Treatment C: Multiple oral matching placebo (2 x 1 YPL-001 80 mg matching placebo tablets)
      will be administered approximately every 12 hours under fasting conditions for 55 consecutive
      days. Only the morning dose will be administered on Day 56. In all treatments, one tiotropium
      (Spiriva® HandiHaler®) 18 μg capsule will also be administered QD every morning prior to
      study drugs administration. Albuterol will be administered on an as needed basis. Each dose
      of Treatments A, B and C will be administered orally with approximately 240 mL of water.
    

Intervention name(s): YPL-001 80 mg; YPL-001 160 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): twice daily [BID]; twice daily [BID]; twice daily [BID]
Other intervention name(s): Treatment A; Treatment B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Minimally Invasive Surgery: Using Natural Orfices
Condition: Appendicitis; Cholelithiasis; Gallstones
MeSH terms: Appendicitis; Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Observational

Summary: 
      This is an observational study of pain and outcomes from females undergoing transvaginal
      NOTES removal of their appendix or gallbladder. Female subjects who elect to have a
      transvaginal NOTES removal of their appendix or gallbladder and agree to be in this study
      (through signature on the informed consent form) will be followed per standard of care, with
      additional follow-up for data collection including the following:

        -  Subjects will complete a 7 day pain/temperature log after surgery

        -  Subjects will complete a standardized sexual function questionnaire (Female Sexual
           Function Index) prior to surgery and 6 months after surgery

        -  Subjects will receive a phone call at 6 months and at 1 year after surgery to capture
           data related to safety, adverse events, hospitalizations and patient satisfaction

      Additional data related to pain and outcomes will be collected at baseline/screening and at
      follow-up as necessary.
    


Intervention name(s): Transvaginal Appendectomy; Transvaginal Cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): The appendix will be removed via an incision in the vagina.; The gallbladder will be removed via an incision in the vagina.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group #1: NOTES Appendectomy - Transvaginal approach:

        Subjects will be female between the ages of 18-75 who present to the emergency room and are
        subsequently diagnosed with acute appendicitis. Following diagnosis, investigators will
        determine if the procedure can be completed via the transvaginal approach. If the patient
        satisfies the listed criteria then researchers will present study information and offer
        participation.

        Group # 2: NOTES Cholecystectomy - Transvaginal approach:

        Female subjects, between the ages of 18-75 who present in the UCSD surgery clinic for
        elective cholecystectomy will be offered participation in this study.
      
Keywords: appendicitis; cholelithiasis; Gallstones
Exploring the Role of the GABAergic Modulation in Pain Transmission in Human
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      Neuropathic pain affects about 7% of the general population in European countries.
      Meta-analyses indicate that only a minority of neuropathic pain patients has adequate
      response to drug therapy and management of neuropathic pain is still an unmet medical need.
      New insights into the contribution of defined subtypes of GABAA receptors (GABAARs) to the
      different clinical effects of benzodiazepines, including analgesia, have suggested that
      α1-sparing selective benzodiazepines, such as N-desmethylclobazam (NDMC), may be a new
      realistic alternative for the treatment of neuropathic pain. Results from our previous study
      in healthy volunteers assessing the antihyperalgesic and sedative effects of benzodiazepines
      on a UVB-induced pain model of central sensitization showed that, at the time of maximum
      effect, clobazam and clonazepam antihyperalgesic effect was greater than placebo by
      respectively 15.7% (95% CI 0.8 - 30.5) and 28.6% (95% CI 4.5 - 52.6), p<0.05. Moreover
      difference in sedation (VAS), as compared to placebo, was only significant for clonazepam
      26.3mm (95%CI 15.0-37.7), p<0.001. Our preclinical data also demonstrate that, in recombinant
      receptors, NDMC has a better α2- over α1GABAARs activity ratio than clobazam and diazepam.
      And, unlike diazepam, NDMC caused no or modest sedation at antihyperalgesic doses in two
      strains of wild-type mice. In addition NDMC α2/α1 in vitro activity profile and long term
      clinical experience from its marketed parent compound (clobazam) make it an advisable
      clinical candidate for further proof-of-concept assessments in human. Therefore the Geneva
      University Hospitals have manufactured a new chemical entity and initiated a drug development
      program for NDMC starting with this proof-of-concept phase 1b randomized double-blind
      crossover (4 arms) study that will assess the analgesic and sedative effects of NDMC 20mg and
      60mg compared to clonazepam 1.5 mg or placebo on a UVB-induced erythema pain model in healthy
      volunteers.
    


Intervention name(s): NDMC 20mg; NDMC60mg; Clonazepam 1.5mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration of one NDMC 20mg capsule and two Placebo capsules; Oral administration of three NDMC 20mg capsules; Oral administration of three clonazepam 0.5mg capsules; Oral administration of three Placebo capsules
Intervention MeSH terms: Clonazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic pain; Benzodiazepine; Central sensitization; Selective compound; GABAA receptors; Antihyperalgesia; RCT
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Condition: Secondary Hyperparathyroidism; Chronic Kidney Disease
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is
      not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels
      by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary
      hyperparathyroidism (SHPT) who require management with hemodialysis.
    


Intervention name(s): Etelcalcetide; Cinacalcet; Oral Placebo; Intravenous Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.; Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.; Administered orally once a day.; Administered intravenously (IV) three times per week.
Other intervention name(s): AMG 416; Sensipar®, Mimpara®
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Secondary Hyperparathyroidism, renal, kidney, kidneys, dialysis, hemodialysis, chronic kidney disease, CKD, SHPT