bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      D-ribose, a natural occurring pentose carbohydrate, has repeatedly shown to enhance
      high-energy phosphates and improve function following ischemia, states of congestive heart
      failure, and recently in subjects with lung disease. An initial preliminary, open label pilot
      study demonstrated a positive benefit of D-ribose in "Baby-Boomer" subjects aged 50 to 65
      years old complaining of persistent fatigue. The objective of this study will build on the
      previously collected data to evaluate oral D-ribose vs. dextrose (administered as a
      supplement) in relatively healthy, yet fatigued subjects with a goal of improving their state
      of fatigue.
    


Intervention name(s): D-ribose; Dextrose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A 6 gm/day (3 gm/bid) dose of D-ribose in water. Each subject will consume oral D-ribose, dissolved in 8 fl. oz of water (1 serving) twice daily, for 2 weeks.; A 6 gm/day (3 gm/bid) dose of dextrose in water. Each subject will consume oral dextrose, dissolved in 8 fl. oz of water (1 serving) twice daily, for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields
Condition: Knee Osteoarthritis; Knee Arthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study is a randomized controlled clinical trial using a blind evaluator. Fifty-one
      volunteers were selected from 50 years to 70 years, obeying the following criteria: diagnosis
      of knee OA grade II and III through the radiographic classification of Kellgreen and Lawrence
      1955, Body mass index (BMI) less than 40 kg / m², volunteers should have had knee pain for at
      least six months. All are from the Rehabilitation Sector of Santa Casa de Misericórdia de São
      Paulo (ISCMSP). The subjects were evaluated through a questionnaire developed by the authors
      of the study (Annex I), the Visual Analogue Scale (EVA) (Annex II), then applied to the Lower
      Extremity Functional Scale LEFS (Appendix III) and the Activities of daily living scale ADLs
      (Annex IV). In addition, the evaluation of muscular strength was through dynamometry using
      the Lafayete dynamometer model 01163, which was performed by a blind evaluator regarding the
      group that will belong to each candidate. The muscles tested were: quadriceps, ischiostibial
      and gluteus maximus. The randomization was through 60 brown envelopes divided into A, B, C
      and D, designating the randomness of the sample.

      In addition to the initial evaluation, an evaluation was performed at the end of the tenth
      session and after 3 months of treatment.

      The volunteers underwent a five-week treatment program, totaling 10 sessions, divided into
      four groups, group A - Intervention (INT) underwent knee and hip muscle strengthening
      exercises and electromagnetic field therapy with (Meditea - ARG) using the coplanar
      technique, group B - Exercises (EXE) carried out exercises to strengthen the hip and knee
      muscles in the C - Placebo group (PLA). hip and knee and electromagnetic field therapy with
      the Magnetron® coplanar technique, but with the device switched off and group D - Apparatus
      (APA) only use electromagnetic field therapy with the magnetron® coplanar technique. In the
      present study, there were no significant differences between groups regarding pain, function
      and muscle strength. However, group A obtained better results in the evaluated criteria,
      tending that the combination PEMF and exercises, is an indicated treatment for OA knee.
    


Intervention name(s): Exercises; Electromagnetic field therapy
Intervention type(s): Other; Other
Intervention description(s): Muscle strengthening exercises of the hip and knee muscles; Electromagnetic field therapy with Magnetron®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Staccato Alprazolam Single Dose PK
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      We are developing Staccato Alprazolam for the acute treatment of panic attacks associated
      with panic disorder.
    


Intervention name(s): Alprazolam thermal aerosol
Intervention type(s): Drug
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Panic attacks, Staccato® Alprazolam
Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objectives:

        -  To determine the response rate, measurable and non measurable, to Taxotere® in the
           second line setting.

      Secondary objectives:

        -  To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as
           second line therapy in HRPC

        -  To evaluate PSA response (PSA: Prostate Specific Antigen)

        -  To evaluate symptomatic response

        -  To evaluate Quality of life

        -  To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.
    


Intervention name(s): docetaxel
Intervention type(s): Drug
Intervention MeSH terms: Docetaxel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study
Condition: Infant, Very Low Birth Weight
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      In Canada, the leading cause of long-term disability in children is being born at very low
      birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant
      care. Mother's milk is the optimal way to feed VLBW infants; however, many need a supplement
      of donor milk or preterm formula as not enough mother's milk is available. As the ideal
      supplement for prolonged feeding and its long-term effects is currently unknown, this study
      is a prospective follow-up of infants born VLBW who were fed mother's own milk or pasteurized
      donor breastmilk nutrient enriched with a human milk-based fortifier or a bovine
      protein-based fortifier. Intakes of donor milk, fortifier type, macronutrients and fatty
      acids will be explored. Areas of development to be assessed include: cognition, language,
      motor skills, and body composition. This study will also cross-sectionally examine aspects of
      eating behaviours, food parenting and the home environment (e.g., stress, home chaos, family
      functioning) with a term-born comparison. A DNA biorepository will also be created.
    


Intervention name(s): VLBW; Term-born Comparison
Intervention type(s): Other; Other
Intervention description(s): Participants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study; Children born >=37 weeks gestation and weighing more than 2500g
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Very low birth weight infants previously enrolled in the Bovine vs. Human Milk-Based
        Fortifier Study (NCT02137473) and a comparison group of children born full-term (>=37 weeks
        gestation) and weighing >2500g.
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in
      adults with moderate to severe active systemic lupus erythematosus (SLE).
    

Detailed description: 
      This is an open-label extension study to evaluate long-term safety and tolerability of
      intravenous (IV) anifrolumab in adult participants with moderately-to-severely active SLE.
      Participants must have completed the qualifying Phase 2 study and meet this study criteria in
      order to be eligible.
    

Intervention name(s): Anifrolumab
Intervention type(s): Biological
Intervention description(s): Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
Other intervention name(s): MEDI-546
Intervention model: Single Group Assignment
Intervention model description: This is an Open Label Extension study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus
Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects
Condition: Cicatrix; Wound Healing
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal
      avotermin (Juvista) in young females.
    

Detailed description: 
      Subjects were to receive two 1cm incisions on the upper, inner aspect of each arm (four
      wounds per subject).

      On Day 0 all subjects received intradermal Juvista at a concentration of 50ng/100ul to one
      incision site on Arm 1 and 5ng/100ul to one incision site on Arm 2. The other incision sites
      were injected with placebo. Following injection, 1cm incision wounds were made at each site.

      On Day 1 all subjects were re-injected with 100ul/cm intradermal Juvista or placebo to each
      side of the wound (200ul per incision) at the same concentration as for Day 0 (50 or
      5ng/100ul).

      At month 6 all incision sites were excised for histological analysis and all excision sites
      injected with Juvista. Both sites on Arm 1 received 50ng/100ul/linear cm wound margin and
      both sites on Arm 2 received 5ng/100ul/linear cm wound margin. No excision sites received
      placebo.

      The appearance of excision scars was then assessed after 2, 4 and 6 months of healing i.e at
      months 8, 10 and 12 of the study.
    

Intervention name(s): Avotermin; Avotermin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6; Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6; Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1
Other intervention name(s): TGFbeta 3; Juvista; TGFbeta 3; Juvista
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cicatrix; Scar; Wound healing; Avotermin; TGF beta 3; Juvista; RN1001
Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the safety of the gynaecological formulation in normal
      conditions of use.
    


Intervention name(s): Dermacyd Femina Pocket BR (Lactic Acid)
Intervention type(s): Drug
Intervention description(s): Dermacyd Femina Pocket BR (Lactic Acid) during 21 consecutive days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to evaluate the metabolic effects of concomitant use of three
      consecutive doses of recombinant human growth hormone over three days and exercise during
      continuous nutrient infusion in chronic hemodialysis patients. We would also like to evaluate
      the metabolic effects of nutritional supplementation alone without the additional anabolic
      strategies.
    


Intervention name(s): nutritional supplement; recombinant human growth hormone (rcGH); exercise
Intervention type(s): Dietary Supplement; Drug; Behavioral
Intervention description(s): either oral nutritional formula (Nepro) or intravenous IDPN solution will be administered during hemodialysis; Nepro has a total calorie amount as well as protein, carbohydrate and fat content that are comparable to that of IDPN, and will be provided at four equal amounts with 1-hour intervals throughout the study (150 ml for a total of 600 ml over 4 hours of hemodialysis); IDPN consists of 225 ml of amino acids at a concentration of 15%, 112.5 ml of dextrose at 50% and 112.5 ml of lipids at 20%, will be given at a rate of 150 ml/hr, and will provide 209 kcal/hr; subcutaneous administration of 75 micrograms/kg/day of rcGH for 3 consecutive days; either dual leg press (3 sets of 8-12 repetitions) beginning 30 minutes prior to hemodialysis, or modified stepper (minimum of 15 minutes up to a maximum of 90 minutes, depending upon the patient's tolerance) beginning 15 minutes post initiation of hemodialysis
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
Condition: Bioavailability; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy males to assess bioavailability of 4 different fostamatinib tablets
    


Intervention name(s): Fostamatinib; Fostamatinib; Fostamatinib; Fostamatinib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral tablets, 50 mg x 2, single dose; Oral tablets, 100 mg Batch 1, single dose; Oral tablets, 100 mg Batch 2, single dose; Oral tablets, 100 mg Batch 3, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy; pharmacokinetics; Fostamatinib
Carbohydrates and Related Biomarkers
Condition: Healthy; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study is designed to investigate associations of low- and high-glycemic load diets with
      biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for
      cancer risk.
    

Detailed description: 
      This is a randomized, crossover feeding study conducted in normal weight and overweight
      individuals. Participants will be given all their food to eat and drink (except water) for
      two 28-day feeding periods (a total of 56 days). The diets will be carefully controlled and
      energy intake will be regulated to maintain weight stability for each participant. The two
      feeding periods will be separated by a 28 day "washout" period when participants will eat
      their own food. Dinner will be eaten at the Hutchinson Center Monday through Friday. Each
      evening, breakfast, lunch and snacks will be brought home for the next day. On Friday
      evenings all the food will be taken home for the weekend.

      Samples of blood will be collected after an overnight fast at the beginning and the end of
      each feeding period. All urine will be collected for 24 hours at the end of each feeding
      period. A number of questionnaires will also be completed during each diet period. A small
      stool sample will be collected in your own home, before the first feeding period, and once
      during each feeding period. The stool sample collection is optional. One can decide not to
      provide a stool sample and still participate in the study.
    

Intervention name(s): Low Glycemic Load Diet; High Glycemic Load Diet
Intervention type(s): Other; Other
Intervention description(s): consume both high and low glycemic load diets for 28 days each; consume both high and low glycemic load diets for 28 days each
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Glycemic response; Glycemic index; Obesity; Carbohydrates; Insulin; Blood glucose
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      This study explored the prevalence of DDEs in a chronic pain population with cLBP and
      associated healthcare utilization and costs using a healthcare claims database.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        chronic low back pain patients
      
Keywords: retrospective chronic low back pain
Phase II, Randomized, Placebo-controlled Trial in Patients With Charcot-marie-tooth Disease Type 1A
Condition: Charcot-Marie-Tooth Disease; Hereditary Neuropathy With Liability to Pressure Palsies; Genetic Disorders
MeSH terms: Tooth Diseases; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy; Genetic Diseases, Inborn
Study type: Interventional
Phase: Phase 2

Summary: 
      The present trial is a randomized, placebo-controlled study evaluating 3 different doses of
      PXT3003 in patients with CMT1A disease.
    

Detailed description: 
      In addition to the safety and tolerability of the treatment, clinical, electrophysiological
      and biological endpoints (PMP22 mRNA, skin biopsy histology and plasma biomarkers) will be
      assessed. Standard laboratory tests and drug plasma concentrations will also be measured.
      Because of the slow progression of the disease and the nature of the observed symptoms, a
      minimum duration of 12 months of treatment is required in order to observe a potential
      improvement in any of the efficacy parameters.
    

Intervention name(s): PXT3003 Low dose; PXT3003 Intermediate Dose; PXT3003 High Dose; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Liquid,5 ml, twice a day, 12-month treatment; Liquid,5 ml, twice a day, 12-month treatment; Liquid,5 ml, twice a day, 12-month treatment; Liquid,5 ml, twice a day, 12-month treatment
Other intervention name(s): Pleocompound PXT3003; Pleocompound PXT3003; Pleocompound PXT3003; Pleocompound PXT3003
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PXT3003; Charcot-Marie-Tooth Disease; Hereditary Motor and Sensory Neuropathies
UCB Stem Cells for Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose. The goals of the study are to assess the safety of the intravenous infusion of
      umbilical cord blood (UCB) cells in patients with autism and to confirm changes in social/
      communicative skills and cognitive functioning after four infusions of ABO/Rh-matched UCB
      stem cells.

      Material and methods. The sample comprises 30 patients (27 males, 3 females) aged between 3
      and 11 years with ASD under the care of the National Medical Research Center for Psychiatry
      and Neurology (Saint-Petersburg, Russia). Participants are randomly assigned to either the
      control group (14 males, 1 female) or the experimental group (13 males, 2 females). The
      experimental group receives intravenous injections of UCB cells four times with a two-week
      gap between injections. The control group receives standard therapy.

      The dynamic of cognitive functions and social/communicative skills assess with Checklist for
      autism spectrum disorders (CASD), Autism treatment evaluation checklist (ATEC), subscales of
      Wechsler Intelligence Scale for Children (WISC) - "Digit Span", "Picture completion", "Block
      design", "Coding".
    


Intervention name(s): umbilical cord blood mononuclear stem cells
Intervention type(s): Other
Intervention description(s): UCB samples (70-130 ml of initial volume) were aseptically drained in blood-collection bags with 35 mL of citrate phosphate dextrose (CPDA-1) anticoagulant. Red blood cell-depleted/plasma-reduced nucleated cells were isolated by sedimentation in dextran-40, resuspended in autologous plasma with 10% dimethylsulfoxide and 1% dextran-40, and aliquoted in 3.8 ml vials with target doses of 3.0±0.2 x 10⁶ cells per vial. Vials were cooled to -90⁰C, quarantined in the vapor phase of liquid nitrogen. Tested for HIV-1/2, hepatitis B and C, HTLV-1/2, HSV-1 and -2, CMV, syphilis, and sterility. Characterized by AB0/Rh, CD34/CD45-positive cell content. Before injection sample thaws in the water bath at +37⁰C and washes from an excess amount of DMSO in 40 mL of physiological saline containing 2.5% human serum albumin and 5% dextran-40. After centrifugation and supernatant withdrawal, the UCB resuspends in 40 ml of the same solution at a target dose of 250±10 x 10⁶ viable cells per sample.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction
Condition: Biological Availability
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of
      BAY1841788 (ODM-201)
    


Intervention name(s): BAY1841788 (ODM-201); Itraconazole; Rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In Period 1, 600 mg single dose administered as 2x300 mg tablets on Study Day 1, In Period 2, 600 mg single dose administered as 2x300 mg tablets on Study Day 5, In Period 3, 600 mg single dose administered as 2x300 mg tablets at Study Day 8.; 200 mg twice daily (BID) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Day 1, 200 mg once daily (QD) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Days 2 to 7.; 600 mg QD administered as 1 x 600 mg tablet per dose in treatment period 3 on Study Days 1 to 10.
Intervention MeSH terms: Itraconazole; Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other