bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout
Condition: Hyperuricemia; Gout
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to
      placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in
      patients with gout.
    


Intervention name(s): Arhalofenate; Arhalofenate; Placebo comparator; Colchicine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Arhalofenate 400 mg once daily for 4 weeks; Arhalofenate 600 mg once daily for 4 weeks; Matching placebo once daily for 4 weeks; 0.6 mg colchicine daily for flare prophylaxis
Other intervention name(s): MBX-102; MBX-102
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Evaluation of Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of JPI-289 in Healthy Male Volunteers
Condition: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      Double blind, randomized, placebo control, multiple dose, dose escalation study
    

Detailed description: 
      A phase I clinical study, randomized, double-blind, placebo-controlled, multiple doses, dose
      escalation study of the safety, tolerability and pharmacokinetics/pharmacodynamics of JPI-289
      in healthy male volunteers.
    

Intervention name(s): JPI-289; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PARP-1 inhibitor; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Topical Application of Highly Concentrated Water-in-oil Emulsions
Condition: Skin Physiology; Dermal Administration; Emulsions
Study type: Interventional

Summary: 
      The purpose of this study is to I. determine the effect of repetitive application of newly
      developed silicone based formulations (placebo water-in-oil emulsions) on transepidermal
      water loss and other physiological skin parameters and II. investigate the skin penetration
      of the model drug fluorescein sodium in tape stripping studies to determine the in vivo
      penetration profile from the water-in-oil emulsions.
    

Detailed description: 
      Water-in-oil emulsions will be applied daily for a period of 4 weeks on the non-dominant
      volar forearm of voluntary participants. Several physiological skin parameters will be
      monitored in weekly intervals during the application period. Additional measurements will be
      carried out immediately before the start of the application and after a treatment-free
      recovery period of 2 weeks. The untreated forearm will be used as a reference.

      Subsequent to the observational study, tape stripping experiments with fluorescein
      sodium-loaded formulations will be conducted on the non-dominant forearm of the participants.
    

Intervention name(s): Application of emulsion; Measurement of physiological skin parameters; Tape stripping
Intervention type(s): Other; Procedure; Procedure
Intervention description(s): Daily application of the assigned formulation on the non-dominant volar forearm for 4 weeks; Weekly measurement of physiological skin parameters using confocal Raman spectroscopy, Corneometer® CM 825, Sebumeter®, Skin-pH-Meter®, AquaFlux® and Epsilon®; Removal of 40 adhesive strips after application of a model drug-loaded emulsion and determination of the transepidermal water loss
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Water-in-oil emulsion; Confocal Raman spectroscopy; Skin parameters; Tape stripping
Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial
Condition: HIV-1
Study type: Observational

Summary: 
      This protocol will study the clinical course of HIV-infection among volunteers who have
      received either a placebo injection or the experimental vaccine combination of ALVAC-HIV and
      AIDSVAX B/E prior to HIV-1 infection in reference to study NCT00223080 RV144. The study will
      assess whether those who received the experimental vaccine combination have a slower
      progression of HIV disease compared to those who received the placebo injection.
    

Detailed description: 
      Prospective cohort study of the clinical course of HIV-1 infection occurring after candidate
      HIV-1 vaccination (breakthrough infection) with ALVAC-HIV (vcP1521) and AIDSVAX B/E in
      reference to study NCT00223080 RV144. This study will enroll volunteers who become
      HIV-infected during the course of follow up in a phase III preventive HIV vaccine trial
      conducted in Rayong and Chon Buri, Thailand. Volunteers will be enrolled in this protocol to
      provide additional long-term follow up to establish whether differences in viral load after
      infection (comparing vaccine to placebo) are associated with altered disease outcomes, as
      well as provide more detailed immunologic and virologic assessment of these volunteers.

      After enrollment in RV152, follow-up visits were scheduled at 0, 1, 3, and 6 months, and
      every 3 months thereafter. After month 12, CD4+ T cell counts and viral load were obtained at
      6-month intervals until the CD4+ T cell count declined to <350/ul or highly-active
      antiretroviral therapy (HAART) was initiated, at which time CD4+ T cell counts and viral load
      were obtained every 3 months. Peripartum antiretroviral drugs given for prevention of
      mother-to-child-transmission was not considered a study endpoint, however HAART initiated
      during pregnancy and continued post-partum was counted. After a single CD4+ T-cell count <
      350/ul a second sample was requested about 2 weeks later, and if the confirmatory measurement
      was >350/ul, a study endpoint was not registered and the volunteer resumed a normal visit
      schedule. A single genital fluid collection for viral load was obtained at the first RV152
      visit. Clinical and laboratory data from RV144, including CD4+ T-cell and HIV-1 plasma viral
      load measurements, were linked to RV152 to inform primary and secondary protocol analyses as
      well as volunteer care and treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All individuals who became HIV-infected after receiving experimental vaccine or placebo in
        the RV144 clinical trial if they received at least one injection
      
Keywords: HIV-1; Natural History; HIV vaccine; Thailand
Investigation of Serotonin Receptor Binding in the Migraine Brain Using Positron Emission Tomography
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura
Study type: Observational

Summary: 
      Migraine affects 16% of the world population and is one of the most disabling of all
      disorders. It is a complex brain disorder characterized primarily by recurrent headache
      attacks. The signaling molecule serotonin (5-hydroxytryptamine, 5-HT) has for decades been
      thought to play a central role in migraine pathophysiology. The most effective class of
      abortive migraine drugs, the triptans, act on 5-HT receptors. However, the migraine-specific
      actions of serotonin and the mechanisms of triptans are still unknown. In this project the
      investigators will use high-resolution positron emission tomography and specific radioligands
      to investigate the significance of serotonin in migraine. Two newly developed radioligands
      that are specific for the 5-HT1B and 5-HT4 receptor, respectively, will be applied. To
      investigate the level and distribution of serotonin in the migraine brain the investigators
      will compare the binding of these ligands in episodic migraine patients with healthy
      controls. In addition, the investigators will include chronic migraine patients to evaluate
      the relation between the level of serotonin in the brain and the frequency of migraine
      attacks. To investigate the changes in the serotonin level during a migraine attack and the
      effects of triptans on the central nervous system the investigators will repeat the scans
      using the 5-HT1B specific ligand during induced migraine attacks and following treatment with
      sumatriptan. The results from this study will shed light on the role of serotonin in the
      migraine brain and elucidate the migraine-specific action of triptans. This will improve our
      understanding of the migraine pathophysiology and, potentially, facilitate the development of
      more efficient treatment of migraine.
    


Intervention name(s): PET scan with 5-HT receptor ligands
Intervention type(s): Other
Intervention description(s): Interictal episodic migraine patients and healthy controls will be scanned with a 5-HT1B and a 5-HT4 receptor radioligand. Episodic migraine patients will further be scanned during a cilostazol induced migraine attack and after treatment with sumatriptan. Chronic migraine patients will be scanned with only the 5-HT4 receptor radioligand.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Migraine patients and healthy controls.
A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in participants with type 1 diabetes mellitus on continuous
      subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014
      (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate
      reduction and following a test meal compared to insulin lispro (Humalog). The study may last
      up to approximately 10 weeks and may include up to 7 visits.
    


Intervention name(s): Lyumjev; Humalog
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Other intervention name(s): LY900014; Insulin Lispro
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Lyumjev; Humalog®; Insulin lispro; Exercise; Continuous Subcutaneous Insulin Infusion; Glycemic control; Hypoglycemia; Type 1 Diabetes
The Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will assess the safety and efficacy and tolerability of TADIOS compared to placebo
      in patients with mild to moderate COVID-19.
    

Detailed description: 
      100 patients diagnosed with COVID-19 by RT-PCR were randomized in a ratio of 1:1 into TADIOS
      group and placebo group to evaluate efficacy and safety after intake over 10 days.
    

Intervention name(s): TADIOS; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TADIOS is a combination extract which composed of three herbs, and each herbal medicine has been traditionally used as a food or a herbal medicine treating various respiratory diseases in Asia; Combination of the following Lactose hydrate, Microcrystalline cellulose, Colloidal silicone dioxide, Povidone, Croscarmellose sodium, Magnesium stearate, Tabshield(79O245)
Other intervention name(s): Herbs; Lactose hydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: COVID-19; Antioxidative biomarker; Inflammatory biomarker; TADIOS
SSRI Effects on Semen Parameters in Men
Condition: Healthy
Study type: Observational

Summary: 
      According to the National Institute of Mental Health, depressive disorders afflict over six
      million U.S. men annually. Most cases of moderate or severe depression are treated with
      antidepressants, including monoamine oxidase inhibitors, tricyclic antidepressants, and, more
      recently, selective serotonin reuptake inhibitors (SSRIs) and antidepressants with modest
      serotonin and norepinephrine reuptake inhibition but unknown mechanism-of-action. Over the
      past two years, prescribing data show a steady increase in antidepressant dispensing rates
      (especially including serotonin reuptake inhibitors) for adults. SSRIs are known to have an
      effect on ejaculatory function and are therapeutically used for treatment of premature
      (rapid) ejaculation. However, few studies have evaluated the potential impact of
      antidepressant medications on male fertility, and no studies have been published with respect
      to the impact of newer antidepressants, such as SSRIs, on male fertility. In the high-volume
      male infertility practice at New York Hospital-Cornell Medical Center, several patients have
      presented who have had a clear temporal association between SSRI use and impairment in sperm
      motility and/or sperm transport (emission). These men have shown improvement in sperm counts
      and motility after discontinuation of antidepressant medications.
    

Detailed description: 
      We propose a crossover pilot study of normal healthy males to ascertain possible effects of
      SSRIs on semen parameters. After initial screening semen analyses, subjects will take the
      SSRI paroxetine for five weeks. Serial semen analyses will be obtained while on medication
      and one month after discontinuation of medication. Comparisons between semen parameters on
      and off medication will be used to evaluate the frequency and significance of semen analysis
      changes during SSRI treatment.
    

Intervention name(s): paroxetine
Intervention type(s): Drug
Intervention description(s): paroxetine 10-40mg daily x 5 weeks
Other intervention name(s): Selective Serotonin Reuptake Inhibitor (SSRI)
Intervention MeSH terms: Paroxetine; Selective Serotonin Reuptake Inhibitors; Serotonin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      Serum samples Semen samples
    
Keywords: Human volunteers
Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Anthracycline-containing regimens are recommended as adjuvant treatment for women with node
      positive breast cancer. In at least three large randomized clinical trials the addition or
      sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based
      regimen resulted in superior clinical outcome for women with node positive early breast
      cancer. In two large randomized studies the dose dense administration with G-CSF support of
      anthracycline-based and paclitaxel combination was superior to the same regimen administered
      every three weeks without growth factors as adjuvant therapy in women with axillary node
      positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel
      in women with metastatic breast cancer
    

Detailed description: 
      This trial will compare the dose dense, G-CSF supported sequential administration of 4 cycles
      of 5-Fluoruracil (F) plus Epirubicin (E 75mg/m2) plus Cyclofosfamide (C) followed by 4 cycles
      of docetaxel versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary
      lymph node positive breast cancer
    

Intervention name(s): Docetaxel; Paclitaxel; Epirubicin; Cyclophosphamide; 5-fluoruracil; Granulocyte-colony stimulating growth factor
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles; Paclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles; Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles; Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks; 5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks; rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other intervention name(s): Taxotere; Taxol; Farmorubicin; Endoxan; 5-FU; Granocyte; Neulasta
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Epirubicin; Fluorouracil; Lenograstim; Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Early breast cancer; Axillary node positive; Adjuvant chemotherapy; Dose dense; Docetaxel; Paclitaxel; FEC
Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects
Condition: Healthy Subjects; Pharmacokinetics; Drug-Drug Interaction (DDI)
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady state solifenacin and
      mirabegron on the pharmacokinetics of co-administered steady state digoxin. This study will
      also evaluate the safety and tolerability of the combined steady state administration of
      solifenacin, mirabegron and digoxin.
    

Detailed description: 
      This study is comprised of two study sequences with 2 investigational periods in each
      sequence. There will be a wash-out period between each investigational period. Patients will
      be admitted to the clinic until discharged after each investigational period.
    

Intervention name(s): Mirabegron; Solifenacin; Digoxin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Other intervention name(s): Myrbetriq; Betmiga; Betamis; solifenacin succinate; Vesikur; Vesicare; Lenoxin
Intervention MeSH terms: Digoxin; Mirabegron; Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy subjects; Mirabegron; Solifenacin; Digoxin
A Pilot Study of Topiramate in Childhood Absence Epilepsy
Condition: Epilepsy, Absence
MeSH terms: Epilepsy; Epilepsy, Absence
Study type: Interventional
Phase: Phase 2

Summary: 
      Limited data exist on the effectiveness of antiepileptic drugs for treatment of childhood
      absence epilepsy. Preliminary data suggest that topiramate may be an effective drug for this
      condition. The present study is designed to provide further evidence of the potential
      effectiveness of topiramate for childhood absence epilepsy, as well as preliminary
      information about a potential target dose for future study.
    

Detailed description: 
      Childhood Absence Epilepsy (CAE) affects 2-11% of all children with epilepsy. CAE occurs most
      frequently in children between the ages of 4 and 10 years. Children with CAE have brief
      seizures (usually several seconds in duration) that typically involve staring and loss of
      awareness; twitching movement of the face or other areas of the body may also occur. Absence
      seizures are provoked by deep breathing for several minutes ("hyperventilation"). Topiramate
      is known to be effective in several types of seizures in children. Preliminary data from
      studies on other types of epilepsy, as well as case reports, suggest that it may also be
      effective in the type of seizures that occur in CAE. The objective of the study is to gather
      additional preliminary data on the effectiveness and the potential target dose of topiramate
      in CAE. Because CAE is not expected to resolve spontaneously in the age group being studied,
      no control group will be included. Patients in the study will receive increasing doses of
      topiramate, with the starting dose and dose increases at weekly intervals. The starting dose
      and dosage increases will be based on the child's weight. At each visit, hyperventilation
      will be used to determine if seizures can be provoked. If seizures occur, the dose will be
      further increased to the maximum dose for the study. If seizures do not occur with
      hyperventilation, an electroencephalogram (EEG) will be performed to confirm that the
      seizures are not occurring. If the EEG confirms that no seizures are occurring, topiramate
      dose will be maintained for 12 weeks. Topiramate will be given in the form of "sprinkles"
      contained within capsules that may be opened and the drug sprinkled onto food. Starting dose
      will depend on the child's weight, then increased to a maximum dose: 9
      milligrams/kilogram/day or 400 milligrams/day, whichever is less for up to 162 days
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: childhood absence epilepsy; epilepsy; seizures; absence seizures
Wholegrain Cereal Diet and Insulin Sensitivity
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Study type: Interventional

Summary: 
      A diet with the multiple beneficial characteristics of whole grains and, more in general, of
      "healthy cereals" favorably influences glucose and insulin metabolism in subjects with
      metabolic syndrome. Therefore, the aim of the study is to evaluate the long term effects of a
      diet containing "healthy cereals" versus a control diet, on glucose and insulin metabolism in
      subjects with metabolic syndrome.
    


Intervention name(s): Wholegrain cereal diet; Refined cereal diet
Intervention type(s): Other; Other
Intervention description(s): Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules.; Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wholegrain cereals; glycemic index; metabolic syndrome; insulin sensitivity