bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Iron Supplementation on Pediatric Vaccine Response
Condition: Iron-deficiency; Iron Deficiency Anemia; Vaccination; Pediatric ALL
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      ID/IDA affects many young children in Africa. Vaccines provide tremendous benefits in LMIC;
      however, they currently fail to reach their full potential. We need to better understand the
      causes of vaccine failure, in order to develop new strategies to improve vaccine
      immunogenicity.

      This study will contribute to children's health by: (1) providing updated guidelines to
      better define the prevalence of ID/IDA in early infancy, and its safe and effective control
      using iron; and (2) providing a new approach to improve response to pediatric vaccines in
      LMIC, by ensuring adequate iron status at time of vaccination.
    

Detailed description: 
      Two major pediatric public health goals in LMIC are increasing immunization effectiveness and
      reducing ID/IDA in children. ID/IDA affects many young children in Africa. Current guidelines
      do not recommend routine testing of hemoglobin in early infancy, as it is generally believed
      that most infants are born with adequate iron stores to last 6 months. However, many African
      infants are born with low iron stores and ID/IDA may develop earlier than generally
      appreciated, within 2-3 months after birth. Vaccines provide tremendous benefits in LMIC;
      however, they currently fail to reach their full potential. We need to better understand the
      causes of vaccine failure, in order to develop new strategies to improve vaccine
      immunogenicity. Despite lower efficacy in LMIC, these vaccines provide a major benefit
      because the disease burden is so high; however, if approaches can be found to improve
      immunogenicity, these vaccines would be even more powerful.

      For this study, 6 weeks old infants will be randomly assigned to two study groups. Group 1
      will receive iron at time of pediatric vaccinations from age 6-24 weeks. Group 2 will receive
      no iron at time of pediatric vaccinations. All infants will receive a multivitamin syrup from
      age 6-24 weeks. All infants remaining ID/IDA at age 24 weeks will receive iron. Infants will
      be followed-up until age 52 weeks.
    

Intervention name(s): Iron syrup; Multivitamin syrup
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily supplementation with iron; Daily supplementation with multivitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Phase 1, Open-Label, Single-photon Emission Computed Tomography (SPECT) Study to Evaluate Serotonin and Dopamine Transporter Occupancy After Multiple Dose Administration of SEP-228432 to Achieve Steady State in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study investigating the relationship between SEP-228432 and SEP-228431
      (the active metabolite of SEP-228432) plasma concentrations, SERT occupancy, and DAT
      occupancy, both measured by SPECT imaging.
    

Detailed description: 
      This is an open-label study investigating the relationship between SEP-228432 and SEP-228431
      (the active metabolite of SEP-228432) plasma concentrations, SERT occupancy, and DAT
      occupancy, both measured by SPECT imaging using [123I]-2β-carbomethoxy-3β-(4-iodophenyl)
      tropane ([123I] β -CIT). Up to 3 sequential cohorts of 8 subjects each will have multiple
      dose administrations of SEP-228432. The target dose for the first cohort will be 200 mg. Dose
      selection for the remaining cohorts will be based on preliminary review of all available
      relevant data from prior dosing cohort(s).
    

Intervention name(s): SEP-228432; SEP-228432
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg, orally, once daily for 3 days followed by 200 mg orally, once daily for 5 days; 40 mg orally once daily for 3 days followed by ≤ 300mg, orally once daily for 5 days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Single-photon Emission Computed Tomography; Healthy Volunteers; Tomography
Cytokines in Femtosecond Laser-assisted Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The investigators performed the current study to compare: 1) the pain scores by Visual
      Analogue Scale; 2) the cytokines concentrations in aqueous humor by human cytokine antibody
      array; 3) the prostaglandin E2 (PGE2) concentrations by enzyme linked immunosorbent assay
      (ELISA); 4) the pupil behaviors by Image J between first-eye and second-eye in bilateral
      cataract patients undergoing sequential femtosecond laser-assisted cataract surgery (FLACS).
      To our knowledge, this is the first intraindividual study investigating contralateral effect
      in FLACS. The findings from the current study may broaden our understanding on the mechanism
      of sympathetic reaction, help to improve clinical performances, and provide strong clinical
      guidance for cataract surgeons.
    


Intervention name(s): aqueous humor collection
Intervention type(s): Other
Intervention description(s): Once the laser procedures were finished, the patient was transported to another surgery operating bed. Before the eyeball was opened, 100-200 μL of aqueous humor was obtained from the anterior chamber via an ultra-thin needle through the paracentesis site of cornea.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cataract; cytokine; pain; miosis
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg
      tablet with Xanax® 1 mg tablet under fed conditions.
    

Detailed description: 
      The study is a phase I, open, randomised, crossover, single dose pharmacokinetic study
      performed in a single centre. The study consists of 2 treatment periods, during which the
      study subjects will receive the test product and the reference product in a randomised order.
      During both treatment periods, the study subjects will receive 1 mg of alprazolam as a single
      oral dose administered after a high-calorie, high-fat meal. Following an overnight fast of at
      least 10 hours, the study subjects will eat the standardised meal 30 minutes prior to
      administration of the study treatments. Blood samples will be drawn during both treatment
      periods.

      The duration of the study per subject will be approximately 5 weeks and at most 9 weeks
      including a screening visit, 2 treatment periods with a wash-out between the study treatment
      administrations and a post-treatment period.
    

Intervention name(s): Alprazolam; Xanax
Intervention type(s): Drug; Drug
Intervention description(s): Alprazolam 1 mg tablet; Xanax 1 mg tablet
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Alprazolam; Bioequivalence
Ablative Fractional Lasers to Treat Peri-orbital Rhytides
Condition: Peri-orbital Rhytides
Study type: Interventional
Phase: Phase 4

Summary: 
      Ablative fractional lasers were introduced for treating facial rhytides in an attempt to
      achieve results comparable to traditional ablative resurfacing but with fewer side effects.
      However, there is conflicting evidence on how well this goal has generally been achieved as
      well as on the comparative value of fractional CO2 and Er:YAG lasers. The present study
      compares these modalities in a randomized controlled blinded split-face study design:

      28 patients were enrolled and completed the entire study. Patients were randomly assigned to
      receive a single treatment on each side of the peri-orbital region, one with a fractional CO2
      and one with a fractional Er:YAG laser. The evaluation included Fitzpatrick wrinkle score,
      profilometric measurement of wrinkle depth (both before and 3 months after treatment) as well
      as assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after
      treatment).
    


Intervention name(s): Fractional carbon dioxide laser treatment; Fractional erbium:YAG laser treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): The CO2 laser (Fraxel Re:pair, Solta Medical Inc., Hayward, CA) employs disposable tips with a diameter of 7 mm and 15 mm, the smaller being used for the peri-orbital region. The laser beam is delivered through multiple deflective and refractive elements and focused to a spot size of approximately 120 µm in diameter at incidence to the skin to deposit an array of laser beams across the surface. Pulse energy varies from 5 to 70 mJ and density from 5 to 70 %. The pulse duration is 10 msec. In the present study, patients received two passes at 15 mJ (1st pass) and 20 mJ (2nd pass), respectively, with a total density of 20 %.; The Er:YAG laser used in this study has a fractional handpiece (MCL 30 Dermablate, Asclepion Laser Technologies GmbH, Jena, Germany). By means of a microlens array the laser beam is divided into 13 x 13 small spots with 250 µm diameter each, spread over an area of 13 x 13 mm. A coverage of 5 % of the skin is achieved with a single pass. The pulse duration is 400 μsec. In this trial, we performed 4 passes (resulting in coverage of 20 % of the treated skin) with a total fluence of 60 J/cm² and pulse stacking (6 stacked pulses) to optimize thermal exposure.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: skin aging; laser surgery; fractional photothermolysis; comparative study; Ablative fractional treatment of peri-orbital rhytides
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
Condition: HIV
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a
      regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse
      transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.
    


Intervention name(s): Atazanavir Sulphate; Ritonavir
Intervention type(s): Drug; Drug
Other intervention name(s): Reyataz; BMS-232632; Norvir
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric
Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
Condition: Malignant Glioma; Glioblastoma Multiforme
MeSH terms: Glioblastoma; Glioma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of
      ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health
      Organization (WHO) grade III or IV malignant glioma.
    


Intervention name(s): Whole Brain Radiation; Temozolomide; ABT-414
Intervention type(s): Radiation; Drug; Drug
Intervention description(s): Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.; Temozolomide will be administered per label.; ABT-414 will be administered by intravenous infusion
Other intervention name(s): Depatuxizumab; Mafodotin
Intervention MeSH terms: Temozolomide; ABT-414
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: WHO grade III; WHO grade IV; Glioblastoma
Pre-mapping Networks for Brain Stimulation 2
Condition: Depressive Episode; Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The investigators compare the primary and secondary outcome measures using accelerated
      intermittent theta burst stimulation (aiTBS, 20 sessions active and 20 sessions sham in a
      counterbalanced crossover design) to treat depressive symptoms with 2 parallel arms of
      intervention: personalized (stimulation position based on participants' brain networks) vs
      conventional (stimulation in F3 position of the 10-20 EEG cap) aiTBS.
    


Intervention name(s): Neuronavigated aiTBS
Intervention type(s): Device
Intervention description(s): Accelerated intermittent theta burst stimulation (aiTBS, 4 sessions per day with at least 20 minutes pause between sessions) in the left dorsolateral prefrontal cortex (DLPFC)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The investigators compare study outcomes using aiTBS in personalized stimulation targets vs conventional F3 stimulation targets in parallel arms, each arm controlled by its respective sham stimulation in a counterbalanced crossover design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy
Condition: HIV; Contraception
Study type: Interventional

Summary: 
      The purpose of The Quatro Study is to assess the acceptability, preferences, user experience
      and effect on sexual behavior of four different vaginal microbicide or multi-purpose
      technology (MPT) delivery forms, using placebo products in 18-30 year old African women:
      rapidly disintegrating vaginal insert, intravaginal ring (IVR), film and gel. The study also
      examines adherence to the dosage forms through objective markers, developed for each dosage
      form prior to the commencement of the study.
    


Intervention name(s): HEC Placebo Gel; Placebo Vaginal Insert; Placebo Vaginal Film; Placebo Intravaginal ring (IVR)
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV; DCE; MPT; Microbicide
A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity
Condition: Spasticity, Post-Stroke
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a multicenter, open-label study to evaluate the safety and efficacy of
      GSK1358820 for treatment in post-stroke subjects with focal wrist, finger and in some cases,
      thumb spasticity. Qualified patients who complete GSK double-blind study 112958 will be
      enrolled. Subjects will receive a single treatment session of intramuscular GSK1358820 "200U
      or 240U (if thumb spasticity is present)". The subjects will be observed until 12 weeks post
      injection. Outcome measures include changes from baseline at every post injection visit as
      measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global
      Assessment Scale. Safety parameters will be measured including adverse events, vital signs
      (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and
      urinanalysis).
    

Detailed description: 
      This trial is a multicenter, open-label study to evaluate the safety and efficacy of
      GSK1358820 for the treatment of patients with focal wrist, finger and in some cases, thumb
      spasticity post-stroke. Qualified patients will be eligible for enrollment upon completion of
      double-blind study 112958. Patients will receive a single treatment session with
      intramuscular injections of GSK1358820 "200U or 240U (if thumb spasticity is present)".The
      subjects will be observed for 12 weeks post injection.

      Each completed subject will attend 4 clinic visits. The maximum study duration is 13 weeks.
      The study includes a 1 week pretreatment period, during which the screening visit (visit 1
      could be the last visit of previous double-blind study 112958 or any time within 3 months
      after completion of previous study) is to take place. Only one upper limb (meeting
      inclusion/exclusion criteria) will be evaluated and treated in the study. Subjects will
      receive a single intramuscular treatment with investigated drug at day 0 (visit 2). There
      will be two post-injection follow-up visits at week 6 and 12 (visits 3 to 4).
    

Intervention name(s): Botulinum toxin type A
Intervention type(s): Drug
Intervention description(s): Botulinum toxin type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK1358820; upper limb; spasticity; post-stroke
The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in
      reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain,
      sleep, general activity, mood, and quality of life, and the use of rescue medication to treat
      pain will be assessed.
    

Detailed description: 
      The overall post-Baseline duration of treatment was 13 weeks. The trial consisted of a 4-week
      Titration Phase, an 8-week Maintenance Phase, a 1-week De-escalation Phase, and a 2-week
      Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to
      receive rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo during the Maintenance
      Phase. During the 4-week Titration Phase, subjects assigned to rotigotine were titrated at
      weekly intervals of 2 mg/24 hrs until they reached 4 mg/24 hrs or 8 mg/24 hrs. All subjects
      who completed the 4-week Titration Phase entered an 8-week Maintenance Phase and were
      maintained at their randomized dose (rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or
      placebo). No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase
      was defined as the combined Titration and Maintenance Phases.
    

Intervention name(s): Rotigotine; Rotigotine; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch); Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches); Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.
Other intervention name(s): Neupro; Neupro
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia Syndrome; Rotigotine; Neupro
A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are:

      i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on
      exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced
      expiratory volume in 1 second (FEV1) after exercise challenge

      ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg
      of ONO-6950 in asthmatic patients.

      The secondary objectives of this study are:

      i. to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus
      montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise
      challenge

      ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200 mg)
      single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.
    

Detailed description: 
      The study will examine if ONO-6950 could alleviate EIB in asthmatic patients. Eligible
      patients will complete a randomized, double-blind, four-way crossover study. During each of
      four evaluation periods, patients will be administered a single dose of either 20 or 200 mg
      ONO-6950, 10 mg Montelukast, or placebo. Each evaluation period include various assessments
      following exercise challenge in an ambulatory setting.
    

Intervention name(s): ONO-6950; ONO-6950; Montelukast; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200 mg QD, single dose; 20 mg QD, single dose; 10 mg Montelukast, QD single dose; Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; Adult
GSK1349572 Drug Interaction With Tenofovir
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy volunteers to determine whether there is a drug interaction between
      GSK1349572 and tenofovir
    


Intervention name(s): GSK1349572 and tenofovir
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir; Dolutegravir
Allocation: Non-Randomized
Primary purpose: Treatment
Keywords: healthy volunteer; pharmacokinetics; GSK1349572; integrase
Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety, tolerability, and bioeffects (how the body reacts to the
      drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in
      hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will
      be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3
      study drug injections over 16 clinic visits, which will include 3 overnight stays(study
      duration 148 days, not including the screening period). Patients on atorvastatin will take
      their daily dose in the morning for the duration of the study. Patients will be monitored by
      the study staff for side effects and the body's response to the study drug. Vital signs(blood
      pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples
      will be collected at some or all visits.
    


Intervention name(s): REGN727(SAR236553)
Intervention type(s): Drug
Intervention description(s): subcutaneous
Intervention MeSH terms: Alirocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment