bioihbjkbjnl/mcl2 huggingface dataset:
Plasma Appearance of Xanthohumol in Healthy Adults
Condition: Plasmakinetics of Xanthohumol
Study type: Interventional

Summary: 
      The aim of this study is to investigate the rate and extend of the plasma appearance of
      native Xanthohumol and Xanthohumol integrated into micelles in healthy men and women.
      Therefore, participants consume capsules with either 86 or 172 mg of native Xanthohumol or
      Xanthohumol integrated into micelles. In an observation period of 24 hours, Xanthohumol and
      its major metabolites are analyzed in plasma.
    

Detailed description: 
      In a crossover design, 6 healthy young men and 6 healthy young women participate in 4
      Xanthohumol interventions with either 86 or 172 mg native or micellar solubilized
      Xanthohumol. During an observation period of 24 hours, Xanthohumol and its major metabolites
      Isoxanthohumol, 8- and 6-Prenylnaringenin are analyzed in plasma. Each intervention will be
      separated by a wash-out period of 14 days. Typical plasmakinetic analyses (Cmax, tmax, AUC,
      t1/2, bioavailability) will be conducted.
    

Intervention name(s): solubilized Xanthohumol low dose; solubilized Xanthohumol high dose; native Xanthohumol low dose; native Xanthohumol high dose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): single administration of 2 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol and 2 soft gelatine capsules containing only micelles; single administration of 4 soft gelatine capsules each containing 43 mg micellar solubilized Xanthohumol; single administration of 2 hard gelatine capsules each containing 43 mg native Xanthohumol and 2 hard gelatine capsules containing silicon dioxide; single administration of 4 hard gelatine capsules each containing 43 mg native Xanthohumol
Intervention MeSH terms: Xanthohumol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Isoxanthohumol; 6-Prenylnaringenin; 8-Prenylnaringenin; Polyphenols; Hops; Bioavailability
Rehabilitation Gaming System for Cerebral Palsy
Condition: Cerebral Palsy; Movement Disorder
MeSH terms: Cerebral Palsy; Movement Disorders
Study type: Interventional

Summary: 
      In this study the investigators evaluate the effectivity of Virtual Reality-based
      rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.
    


Intervention name(s): VR-based motor training; Conventional Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color.; Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Hemiparesis; Functional independence; Virtual Rehabilitation
Effect of Consumption of Yogurt Fortified in Calcium and Vit. D on Circulating Levels of 25OHD in Postmenopausal Women
Condition: Menopause; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of daily consumption of one or two CALIN+
      pot(s) versus no intake of product, after 4, 8, 12 and 16 weeks, on the evolution of the
      serum concentration of 25-hydroxy vitamin D (25OHD) (D2 + D3) in postmenopausal women.
    

Detailed description: 
      The active form of vitamin D is produced by skin when it is exposed to ultraviolet-B (UVB)
      rays. However, because of our sedentary lifestyle and to the low sun exposure during winter,
      the vitamin D status is most frequently deficient. Hence the consumption of enriched food
      could be an efficient strategy to improve vitamin D status.

      The current recommendation for vitamin D intake is 20 µg per day for adults (19-50 yo) and
      between 25 and 37.5 µg per day for people over 50 years old according to the French National
      Medicine Academy. However, the recommended daily allowance (RDA) in France for vitamin D is
      limited to 5 µg corresponding to the maximum enrichment allowed in a food product. The
      current study is designed to evaluate if a daily consumption of two CALIN+ yogurts enriched
      with 5µg of vitamin D is sufficient to improve the vitamin D status in postmenopausal women.
    

Intervention name(s): CALIN+; CALIN+
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.; Consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product intake during 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Menopause; Osteoporosis; Hip fractures; vitamin D deficiency
TAK-020 Relative Bioavailability and Food Effect Study in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability of solid oral
      formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation
      and to evaluate the food effect and potentially the dose proportionality of the optimal oral
      solid formulation.
    

Detailed description: 
      TAK-020 is being developed for the potential treatment of autoimmune diseases including
      rheumatoid arthritis. Currently TAK-020 is available as an oral solution. This study is to
      develop an oral tablet formulation. There are three parts to this study. Part 1 will compare
      different tablet formulations of TAK-020 compared to a reference oral solution to identify
      the best tablet formulation to use in Parts 2 and 3. Part 2 will look at the effect food has
      on TAK-020. Part 3 is optional; its implementation will be decided upon using data from Part
      2. It will evaluate whether increased doses of TAK-020 produce an expected proportional
      increase in the plasma concentration of TAK-020.

      In Part 1 participants will receive a single dose of the following:

      Period 1: TAK-020 Oral Solution Period 2: TAK-020 Co-Crystal Tablet Period 3: TAK-020 Solid
      Dispersion Tablet Period 4: TAK-020 Immediate Release Tablet

      In Part 2 participants will be split into two groups; one will receive the chosen formulation
      of TAK-020 in the fasted state followed by the fed state and the other group will receive it
      in the fed state followed by the fasted state. The dose used in Part 2 will be based upon
      data from Part 1 and previous studies.

      Participants in Part 3 of the study will be split into 2 cohorts. Each cohort will be
      administered, in the fasted state, a single dose of the tablet selected as optimal from
      previous study parts. The dose used will be based upon data from Parts 1 and 2 and previous
      studies.

      Part 1 will assess the relative bioavailability of TAK-020 by using analysis of variance
      (ANOVA) on tmax, and the natural logarithms of AUCs, and Cmax. Part 2 will assess the food
      effect of TAK-020, also using ANOVA on tmax, and the natural logarithms of AUCs, and Cmax.
      The power model will be used to assess dose proportionality of single doses of the solid
      formulations in the fasted state from Parts 2 and 3.
    

Intervention name(s): TAK-020 Captisol Oral Solution; TAK-020 CCT; TAK-020 SDT; TAK-020 IRT; TAK-020 CCT; TAK-020 Solid Formulation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): TAK-020 solution.; TAK-020 co-crystal tablet; TAK-020 Solid dispersion tablet.; TAK-020 immediate release tablet.; TAK-020 co-crystal tablet.; TAK-020 solid formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject
Condition: Drug Use
Study type: Interventional

Summary: 
      The objective of this present study was to asses the pharmacokinetic properties of acyclovir
      tablet from new product formulation (PT. Kimia Farma (Persero) Tbk) to its innovator product,
      Zovirax® tablet (Glaxo Wellcome S.A., Aranda, Spain)
    

Detailed description: 
      Twenty-eight healty subjects were given a single dose of acyclovir tablet or Zovirax® in
      dosage form 200 mg and 400mg with 240 mL of water. Then the blood samples for acyclovir was
      drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for
      pharmacokinetic evaluation
    

Intervention name(s): Acyclovir 200 MG; Acyclovir 400 MG; Zovirax 200 MG Tablet; Zovirax 400 MG Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered with 240 mL of water; Administered with 240 mL of water; Administered with 240 mL of water; Administered with 240 mL of water
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, single blind, single dose, 2-periods, cross-over design study with one week washout period between each treatment in 28 healthy subjects under fasting condition
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: bioequivalence; pharmacokinetics; Indonesian healthy subject; Acyclovir
Pix2pix Networks for Scheimpflug Corneal Tomography Image Generation
Condition: Eye Diseases
MeSH terms: Eye Diseases
Study type: Observational

Summary: 
      Computer-aided medical image analysis has advantages, but requires large amounts of training
      data, which are scarce and costly to obtain, are subject to privacy concerns, and are often
      highly imbalanced, with over-representation of common conditions and poor representation of
      rare conditions. Consequently, some methods have been proposed to generate artificial medical
      images using generative adversarial networks (GANs). Computer aided diagnosis of keratoconus
      is an emerging research field that may benefit greatly from medical image synthesis, which
      can affordably provide an arbitrary number of sufficiently diverse synthetic images that
      mimic real Pentacam images. A new conditional GAN, the pix2pix cGAN, has not been used in
      this context to date. Here, investigators will assess the efficacy of a cGAN implementing
      pix2pix image translation for image synthesis of color-coded Pentacam 4-map refractive
      displays of clinical and subclinical keratoconus as well as normal corneas.
    


Intervention name(s): Scheimpflug Camera Corneal Tomography
Intervention type(s): Diagnostic Test
Intervention description(s): Pentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterior and posterior surfaces of the cornea to obtain corneal tomographic maps.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Refractive surgery candidates with unilateral, bilateral, or forme fruste keratoconus,
        obtained between July 2014 and March 2019 at private eye center, Assiut, Egypt.
      
Keywords: Cornea; Imaging
Acetyl-L-Carnitine Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin
Condition: Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis; Fatigue in Workers With Chronic C Hepatitis; Fatigue
MeSH terms: Hepatitis A; Hepatitis; Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the effects of Acetyl-L-Carnitine administration on work productivity, daily
      activity, and fatigue in subjects with chronic hepatitis C treated with
      Pegylated-Interferon-α2b and Ribavirin.
    


Intervention name(s): Acetylcarnitine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): (sugar pill)
Intervention MeSH terms: Acetylcarnitine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Characterization of Methylation Patterns in Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      In this study the investigators will collect Blood,sputum and saliva samples for
      Characterization of Methylation Patterns in lung Cancer.
    

Detailed description: 
      Lots of information about the relationship between changes in methylation patterns and
      various diseases are accumulated in recent years. Characterization of methylation changes
      that occur in cancer may contribute to the development of methods for early detection of
      cancer by detecting cancer cells in liquids. Early detection of such changes and their
      correlation examining different cancers may lead to a diagnostic tool for the early detection
      of cancers and improve the treatment of these patients. Detection by molecular analysis can
      be a sensitive method and non-invasive early diagnosis of the disease In this study the
      investigators will collect Blood,sputum and saliva samples for Characterization of
      Methylation Patterns in lung Cancer.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants who come to the medical center for the diagnosis of lung cancer.
      
Biospecimen description: 
      1. Blood samples

        2. Sputum samples

        3. saliva samples
A Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy
      adult subjects. The purpose of this study is to characterize the effect of orally
      administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac
      repolarization as measured by the corrected QT interval (QTc) duration, compared with placebo
      and moxifloxacin. Moxifloxacin (Avelox) is a drug with a known potential to create a mild QTc
      interval prolongation; therefore, it will serve as a positive control to validate the ability
      of this study to detect a change in the QTc interval. All subjects will participate in 4
      study periods separated by a minimum washout period of 5 days. Each subject will receive one
      of 4 regimens (A = Losmapimod 7.5 milligram [mg] Twice daily [BID] x 5 days, B = Losmapimod
      20 mg Once daily [QD] x 5 days, C = moxifloxacin 400 mg on Day 5, D = Losmapimod matched
      placebo and moxifloxacin placebo x 5 days) in each of the 4 planned study periods in a
      randomized, cross-over fashion. Subjects will be assigned to one of four treatment sequences
      following a Williams design (ABDC, BCAD, CDBA, DACB). Follow-up visit will occur 10 to 14
      days after end of Period 4
    


Intervention name(s): Losmapimod; Moxifloxacin; Losmapimod matched Placebo; Moxifloxacin Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Wet granulation formulation, Film coated white, 7 mm round, biconvex, plain faced Tablet of 7.5 mg or 10 mg unit dose strength. Taken orally 7.5 mg BID / 20 mg QD for 5 days in one of the 4 study periods; 17.2mm x 7.1 mm capsule shaped pink biconvex tablet of 400 mg unit dose strength. Taken orally 400 mg on Day 5 in one of the 4 study periods; Direct compression formulation (visually matched to GW856553), Film coated white, 7 mm round, biconvex, plain faced Tablet. Taken orally for 5 days in one of the 4 study periods; 16 mm x 8 mm capsule shaped to white film coated tablet. Taken orally for 5 days in one of the 4 study periods
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: QTc,; GW856553 .; P38,
Tolerability of ALK Grass Tablet in Children
Condition: Allergy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use
      in children aged 5-12 years
    


Intervention name(s): ALK Grass tablet
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
Condition: Idiopathic Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The aims of the trial are to assess the safety and the efficacy of SPM 962 following
      once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese
      patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum
      treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week,
      double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003).
      The trial is also for an exploratory investigation of incidence of augmentation, the most
      problematic complications in dopaminergic treatment.
    


Intervention name(s): SPM 962
Intervention type(s): Drug
Intervention description(s): Tansdermal patch
Other intervention name(s): rotigotine
Intervention MeSH terms: Rotigotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether Rebamipide facilitate the healing of
      inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).
    

Detailed description: 
      1. To evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant
           regimen in erosive reflux esophagitis patients

        2. To evaluate the safety of rebamipide as an adjuvant regimen in erosive reflux
           esophagitis (ERE)
    

Intervention name(s): Lansoprazole; Rebamipide; Rebamipide-placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast; Oral administration of Mucosta (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch, and dinner; Oral administration of Mucosta®-placebo, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
Other intervention name(s): Lanston; Mucosta; Mucosta-placebo
Intervention MeSH terms: Lansoprazole; Dexlansoprazole; Rebamipide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rebamipide
Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The purpose of this study is to determine safety and patients' satisfaction when using Tears
      Again to treat Dry Eye Symptoms.
    


Intervention name(s): Tears Again
Intervention type(s): Drug
Intervention description(s): Liposome Eye Spray
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dry Eye Syndrome
OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a
      multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with
      pain.It will be a single center, open label, randomized, oral administration study.
    

Detailed description: 
      Single dose: The subjects will be randomized to receive a single dose of OxyNorm®
      immediate-release capsules 5, 10, and 20mg.

      Multiple dose: The subjects will take 3 days OxyNorm® capsule 10mg, once every 6 hours, 10mg
      per dose. In the morning of the 4th day, the subjects will take single dose of OxyNorm®
      capsule 10mg. On the 5th day, all the subjects complete the study.
    

Intervention name(s): Oxycodone hydrochloride
Intervention type(s): Drug
Intervention description(s): The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.
Other intervention name(s): OxyNorm® Capsules
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nesiritide and Vo2 Max in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study, funded by Scios, Inc., and conducted by the Cardiology Division of the
      Department of Medicine at the University of Rochester School of Medicine and Dentistry
      investigates the potential benefit of nesiritide (brand name is Natrecor(TM))in improving
      exercise capacity in patients with heart failure (HF). Previous studies have shown beneficial
      hemodynamic and neurohumoral effects of nesiritide infusion in the therapy of decompensated
      heart failure. Other studies have demonstrated increases in endogenous BNP levels (normalized
      for exercise workload) in HF patients during and after exercise. However, trials involving
      the measurement of exercise capacity in this population following BNP administration are
      lacking. This is an experimental prospective, non-blinded, pilot study with a sample size of
      20 patients, all serving as their own controls. This study involves off-label use of the drug
      nesiritide (indicated for IV treatment of NYHA Class II and III patients, and this study is
      enrolling Class II and III patients) and has received FDA approval, and an IND. Subjects are
      recruited from the population of referrals to the Strong Memorial Hospital Heart Failure and
      Transplantation clinical service, who meet all the inclusion criteria and none of the
      exclusion criteria may participate in the study. Enrolled study subjects perform an exercise
      VO2 max test, receive a 24 hour infusion of nesiritide and perform a second exercise VO2 max
      test.
    

Detailed description: 
      See above comments.
    

Intervention name(s): nesiritide (Natrecor(TM))
Intervention type(s): Drug
Intervention description(s): administration of IV nesiritide
Intervention MeSH terms: Natriuretic Peptide, Brain
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment