bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Iron Source on the Growth of Enteric Pathogens
Condition: Iron-deficiency; Iron Deficiency Anemia; Iron Deficiency Anemia Treatment
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

Summary: 
      The World Health Organization recommends daily iron supplementation for infants and children
      (6 months-12 years). Based on the low cost and high bioavailability and efficacy, ferrous
      sulfate is typically the first choice for supplementation and fortification. The recommended
      dose of iron is set high to deliver adequate absorbed iron due to low rates of dietary iron
      absorption, which is typically <10%. Thus, the majority of dietary iron is not absorbed and
      travels to the colon. Unabsorbed iron in the colon may select for enteric pathogens at the
      expense of beneficial commensal bacteria and increase infection risk, including the clinical
      incidence of diarrhea. The objective of this study is to compare the effects of iron as
      ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and
      virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool
      samples will be collected from children following ingestion of an iron supplement as either
      FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens and outcome
      measures will be determined following in vitro fecal fermentation.
    


Intervention name(s): FeSO4; Ao iron
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron); 2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Bioequivalence Study of Isosorbide-5-Mononitrate Extended-Release Tablets Under Fed Conditions in Healthy Subjects
Condition: Bioequivalence
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to compare the pharmacokinetic characteristics of two isosorbide
      -5 -mononitrate extended -release tablets 40 mg of Qilu Pharmaceutical Co., Ltd and ISMO
      Retard (isosorbide -5 -mononitrate extended -release tablet) 40 mg, distributed by RIEMSER
      Pharma GmbH.

      Primary endpoints are Cmax, AUC(0-t) and AUC(0-inf). Secondary endpoints are Tmax, t1/2 and
      λz.
    

Detailed description: 
      Objectives: Primary Objective: To compare the pharmacokinetic characteristics of two
      isosorbide -5 -mononitrate extended -release tablets 40 mg of Qilu Pharmaceutical Co., Ltd,
      China and ISMO Retard (isosorbide -5 -mononitrate extended -release tablet) 40 mg,
      distributed by RIEMSER Pharma GmbH. following a single oral dose administration in healthy
      Chinese subjects under fed condition.

      Secondary Objective: To monitor the safety profile of the subjects exposed to the
      Investigational Medicinal Product.

      Study Design: a randomized, open label, balanced, 3-way crossover, single dose study under
      fed conditions.12 subjects will be randomized to one of the 3 treatment sequences. Each
      treatment sequence will consist of 3 periods, separated by a washout period of at least 7
      days. For sequence 1, first reference drug, then test formulation 1 and test formulation 2
      will be administered. The order for sequence 2 is test formulation 2, reference drug and test
      formulation 1. The order for sequence 3 is test formulation 1, test formulation 2 and
      reference drug.
    

Intervention name(s): IS-5-MN R; IS-5-MN T1; IS-5-MN T2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single orally dose under fed conditions on day 1 of treatment period 1 for group 1, on day 1 of treatment period 2 for group 2, on day 1 of treatment period 3 for group 3.; single orally dose under fed conditions on day 1 of treatment period 2 for group 1, on day 1 of treatment period 3 for group 2, on day 1 of treatment period 1 for group 3.; single orally dose under fed conditions on day 1 of treatment period 3 for group 1, on day 1 of treatment period 1 for group 2, on day 1 of treatment period 2 for group 3.
Other intervention name(s): ISMO Retard; IS-5-MN; IS-5-MN; IS-5-MN
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Myo-inositol and Melatonin in Pre-menopausal Women
Condition: Pre-menopausal Irregular Cycles and Bleedings
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether myo-inositol and melatonin, or myo-inositol
      alone, or melatonin alone, are effective in normalizing irregular bleeding and anovulatory
      cycles in pre-menopausal women.
    

Detailed description: 
      Melatonin has produced a remarkable significant improvement of thyroid function, positive
      changes of gonadotropins towards reduced levels, and in some women a re-acquisition of normal
      menstrual cycle. Furthermore, an abrogation of menopause-related depression, amelioration of
      hot-flashes and improvement of quality and duration of sleep has been reported.

      Myo-inositol is involved in several aspects of human reproduction. Elevated concentrations of
      myo-inositol in human follicular fluids appear to play a positive function in follicular
      maturity and provide a marker of good quality oocytes. Nevertheless its positive role in PCOS
      women is a consequence of a defect in the insulin signalling pathway (inositol-containing
      phosphoglycan mediators) that seems to be primarily implicated in the pathogenesis of insulin
      resistance
    

Intervention name(s): melatonin; myo-inositol; melatonin plus myo-inositol
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months; 30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.; 30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months
Intervention MeSH terms: Inositol; Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pre-menopause; melatonin; myo-inositol
Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis
Condition: Ulcerative Colitis Chronic Mild; Inflammatory Bowel Diseases
MeSH terms: Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer
Study type: Interventional

Summary: 
      Ulcerative colitis (UC) is a chronic immune-mediated inflammatory bowel disease (IBD) that
      almost always affects the rectum and often extends to the more proximal colon. UC usually
      begins at a young age (15-30 years), most patients (~ 85%) have a mild or moderate activity,
      characterized by periods of exacerbation and remission. Considering the important
      pathogenetic role of gut dysbiosis, recently, as an additional method of treating UC, it is
      considered a modification of altered gut microbiota using various drug and non-drug methods.
      One such method is fecal microbiota transplantation (FMT), consisting of the simultaneous
      replacement of the gut microbiota of a sick recipient with fecal material from a healthy
      donor. Even though so far the only officially approved indication for FMT is recurrent
      Clostridium difficile infection, however, the effectiveness of FMT is currently being studied
      in the treatment of other gastrointestinal and non-gastrointestinal pathologies, including
      UC. To date, several controlled and uncontrolled studies have been conducted to study the
      effectiveness of FMT in UC, showing encouraging results. This study aimed to assess the
      clinical and microbiological efficacy, tolerability, and safety of FMT as add-on therapy to
      basic therapy, in patients with mild-to-moderate UC.
    


Intervention name(s): Mesalazine; Fecal transplantation
Intervention type(s): Drug; Biological
Intervention description(s): daily dose of 3 g (2 g orally + 1 g rectally); Preparation of fresh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of UC patient by colonoscopy after standard bowel preparation.
Other intervention name(s): Pentasa
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; fecal microbiota transplantation; gut microbiota; dysbiosis; inflammatory bowel disease
Kinetic Oscillation Stimulation (KOS) of Nasal Mucosa in Non-allergic Rhinitis: Investigation of Treatment Procedure
Condition: Non-allergic Rhinitis.
MeSH terms: Rhinitis; Common Cold
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation
      (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize
      any patient reported discomfort during treatment procedure.
    


Intervention name(s): PBASE system 1.1 (active treatment)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to investigate safety, tolerability, and
      pharmacokinetics of treatment with BI 661051 rising single doses administered as oral
      drinking solution (powder in bottle) in healthy male subjects.

      The primary objective is to investigate the safety and tolerability of treatment with BI
      661051.

      The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051,
      (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI
      661051 is administered as tablet at two dose levels compared to oral drinking solution and
      (4) to assess the effect on the bioavailability when BI 661051 is administered as oral
      drinking solution after intake of a high fat meal.

      Pharmacodynamic parameters will not be determined within this study.
    

Detailed description: 
      Purpose:
    

Intervention name(s): BI 661051; BI 661051; BI 661051; BI 661051; BI 661051; BI 661051; BI 661051; BI 661051; BI 661051; Placebo; BI 661051
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): medium dose solution for oral administration; medium dose solution for oral administration; medium dose solution for oral administration; low dose solution for oral administration; low dose solution for oral administration; low dose solution for oral administration; high dose solution for oral administration; high dose solution for oral administration; low dose tablet; solution for administration; medium dose tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome
Condition: Overweight
MeSH terms: Overweight; Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      Insoluble (1,3),(1,6)-beta-D-glucan from bakers yeast are indigestible polysaccharides.
      Previous studies indicate that the intake of insoluble dietary fiber is strongly associated
      with reduced risk of type 2 diabetes and cardiovascular disease. However, the mechanisms
      leading to this phenomenon are largely unknown.

      There are close relations between metabolic and inflammatory pathways, and a number of
      hormones, cytokines, signal proteins, bioactive lipids, and transcription factors have been
      shown to be involved in both systems.

      Beta-D-glucans have been suggested to play a role as so called biological response modifiers.
      Studies in animals indicate that even small doses of (1,3),(1,6)-beta-D-glucan may have
      beneficial effects on immune activity, i.e., by reducing the secretion of inflammatory
      factors.

      The investigators hypothesize that the intake of isolated (1,3), (1,6)-beta-D-glucan from
      bakers yeast improves inflammatory makers and insulin-sensitivity in overweight subjects with
      increased C-reactive protein concentrations at baseline.
    


Intervention name(s): Beta-D-Glucan; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1,5 g Beta-D-Glucan daily; 1.5 g waxy maize starch daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Increased non-specific inflammatory markers
Sedentary Behavior in Overweight Women
Condition: Sedentary Behavior; Overweight
MeSH terms: Overweight
Study type: Observational

Summary: 
      Objective activity data will be collected using accelerometry for a minimum of seven days on
      38 adult, female, women recruited from the metabolic Clinic at the University of Mississippi
      Medical Center. Following objective measurement of activity, participants will complete
      self-report and objective activity data, as well as the relationship between sedentary
      activities and food cravings will be examined. It is hypothesized that minutes of sedentary
      behavior, especially time spent in television viewing, will be significantly correlated with
      total and specific food cravings.
    


Intervention name(s): Behavioral
Intervention type(s): Other
Intervention description(s): Participants will be asked to wear an accelerometer
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Caucasian or African American women between the ages of 18 and 65.
      
Keywords: Female
Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion
Condition: Central Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare ranibizumab injection to hemodilution at the early
      phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both
      treatments may have a synergic effect.
    

Detailed description: 
      Patients with recent-onset CRVO (lasting for less than 1 month)are randomly assigned to one
      of 3 groups: hemodilution using erythrocytapheresis alone, 3 monthly injection of ranibizumab
      alone, or both.

      Patients are followed monthly during the 6-month study.
    

Intervention name(s): ranibizumab; hemodilution
Intervention type(s): Drug; Procedure
Intervention description(s): 3 monthly intravitreous injection as soon as possible after the inclusion; hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Personalized Blood Pressure Management
Condition: Blood Pressure; Intraoperative Hypotension; Postoperative Complications
MeSH terms: Hypotension; Postoperative Complications
Study type: Interventional

Summary: 
      The aim of this research project is to find out whether a personalized definition of the
      lower blood pressure threshold based on the individual blood pressure profile by means of
      preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney,
      heart) through reduced blood flow during surgery.
    


Intervention name(s): 24 hour blood pressure measurement, fluids, vasopressors; Standard of Care
Intervention type(s): Procedure; Procedure
Intervention description(s): Targeting individual blood blood pressure values during surgical procedures; Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf
Intervention MeSH terms: Vasoconstrictor Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI
Condition: Traumatic Brain Injury (TBI); Hazardous and Harmful Alcohol Use
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Alcohol Drinking
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of the proposed project is to improve the treatment of veterans with co-occurring
      traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators
      will conduct a pilot controlled clinical trial of topiramate for the treatment of these
      co-occurring disorders.
    


Intervention name(s): Medical Management Counseling; Topiramate; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Brief alcohol and medication counseling; Experimental medication; Placebo comparator
Other intervention name(s): Topamax
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TBI; hazardous and harmful alcohol use; veterans; co-occurring disorders; pharmacotherapy
Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study
Condition: Hemianopia; Stroke
MeSH terms: Stroke; Hemianopsia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this Study is to determine whether non-invasive transcranial direct current
      stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual
      Cortex.
    

Detailed description: 
      Visual field defects after posterior cerebral artery stroke can be improved by vision
      restoration training (VRT), but when combined with transcranial direct current stimulation
      (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic
      stage. Because it is possible that such therapy may be more effective during the early
      recovery phase after the stroke and can reach patients during the rehabilitation phase,
      investigators wished to explore the applicability, efficacy and safety of early intervention
      with a combined tDCS/VRT treatment.

      19 post-acute stroke homonymous hemianopia patients were randomly assigned to either 10
      sessions of combined rea-tDCS (2mA, 10 daily sessions of 15-20 min) and VRT, or sham-tDCS and
      VRT. The primary outcome criterion was the pre-post change in perimetric detection
      thresholds. Secondary outcome is neurophysiological changes in EEG measures (VEP,
      Connectivity, Spectral Power, ...)
    

Intervention name(s): verum tDCS; sham tDCS; VRT
Intervention type(s): Device; Device; Behavioral
Intervention description(s): real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes; sham transcranial direct current stimulation, 10 sessions, for 20 minutes; Vision restoration training, 10 sessions, 20 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oral Azithromycin Versus Doxycycline in Posterior Blepharitis
Condition: Posterior Blepharitis
MeSH terms: Blepharitis; Meibomian Gland Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      One hundred patients with the diagnosis of posterior blepharitis based on history taking and
      proper physical examinations by two experienced ophthalmologists will include in the study.

      Patients will diagnose with posterior blepharitis if they score at least one in two symptoms
      (based on a subjective grading scale) and two signs (based on an objective grading scale) of
      posterior blepharitis according to study criteria. Patients will exclude if they have the
      following criteria: age< 12 years old,history of previous ocular or lacrimal surgery,previous
      usage of contact lenses,any history of ocular allergy,history of systemic diseases with
      ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in
      the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity
      to cyclines.

      Qualified patients then randomly receive oral azithromycin (2 of 250 mg capsules for the
      first day and 250mg for the next 4 days) or oral doxycycline (100mg capsule every 12 hours
      for one month) in a double-blinded fashion. each patients in both treatment groups will
      accurately instruct to apply warm compress and eyelid scrubbing 2 times a day for 5 minutes
      each in the treatment period. Symptoms and signs were recorded for each patient in two
      treatment groups at baseline visit (before treatment) and then in the days 7, 31, 37 and 61
      after treatment.
    


Intervention name(s): Azithromycin; Doxycycline
Intervention type(s): Drug; Drug
Other intervention name(s): Azithromycin (Razak Co., Tehran); Doxycycline (Kimidarou Co., Tehran)
Intervention MeSH terms: Azithromycin; Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Azithromycin; Doxycycline; Posterior Blepharitis