bioihbjkbjnl/mcl2 huggingface dataset:
Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants
Condition: HIV-1-infection
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and behavior in the body of the experimental drug TMB-365
      in people with HIV-1 infection. This will be the first test of TMB-365 in humans. One dose of
      the study drug is given to each participant, followed by 10 weeks of monitoring for safety
      and levels of the drug in the blood. The first group of participants will receive the lowest
      dose (400 mg). If no safety concerns are seen, the next group will begin at a higher dose
      (800 mg). If no safety concerns are seen in the second group, the third group will begin at
      the highest dose in this study (1600 mg).
    

Detailed description: 
      This phase 1, randomized, double-blinded, placebo-controlled, sequential single dose
      escalation study will evaluate the safety, tolerability and pharmacokinetic (PK) parameters
      of TMB-365 administered via intravenous infusion (IV) to HIV-1 infected participants at one
      of three successively increasing dose levels: 400 mg, 800 mg, and 1600 mg. Each participant
      will be monitored for 10 weeks post-administration. All participants will be expected to
      participate in PK sampling during Weeks 1, 4, 5, and 6.

      Beginning with the lowest dosage group, a Data Monitoring Committee (DMC) will review
      available data after four participants have completed two weeks of post-dose follow-up to
      determine if dosing of the next dosage group may proceed.

      If no dose limiting toxicities (DLTs) emerge, defined as a single Grade 4 or two of the same
      Grade 3 clinical or laboratory adverse events deemed possibly, probably or definitely related
      to the study drug, or a serious adverse event deemed possibly, probably or definitely related
      to the study drug as graded by the DAIDS Table for Grading Severity of Adult and Pediatric
      Adverse Events Version 2.1, then dosing of the next higher dose group will be permitted.

      Dosing in the highest dose group will begin after four of the eight participants in second
      group have successfully completed the scheduled study drug administration and two weeks of
      follow-up, and those data, along with all available data from the initial dose group have
      been reviewed by the DMC and no DLTs or SAEs as defined above are identified.

      All participants may initiate standard combination antiretroviral therapy six weeks after
      receiving the study drug.
    

Intervention name(s): TMB-365
Intervention type(s): Biological
Intervention description(s): An IgG1 monoclonal antibody targeting domain 2 of the CD4 receptor for treatment of HIV-1 infection
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single dose escalation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to asses the efficacy, safety and tolerability of repeat doses
      of IRL201104 in Adult Participants with Active Eosinophilic Esophagitis (EoE)
    


Intervention name(s): IRL201104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): lyophilised powder for reconstitution for IV dosing; Matching placebo for IRL201104
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: EoE
Hyaluronic Acid in Counteracting Aphthous Stomatitis
Condition: Aphthous Stomatitis
MeSH terms: Stomatitis; Stomatitis, Aphthous
Study type: Observational

Summary: 
      Oral mucosal ulcers can determine a real worsening of the quality of life. Conventional
      therapy usually lasts not less than 2-3 weeks, and carries a high risk of serious side
      effects; furthermore, ulcers often recur. The use of hyaluronic acid applied as an adhesive
      gel over the lesions seems to have potential in terms of efficacy and the avoidance of side
      effects. Of course, hyaluronic acid-based formulations show different effects and
      tolerability. In this retrospective observational study, the results obtained using a
      hyaluronic-acid based medical device applied for 14 days to counteract ulcers in adults will
      be reported.
    


Intervention name(s): Hyaluronic acid-based gel; Chlorhexidine Gluconate
Intervention type(s): Device; Drug
Intervention description(s): Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks; Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Hyaluronic Acid
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult subjects without ethnic limitations, of both sexes and between the ages of 18 and 65,
        with a diagnosis of aphthous stomatitis, but considered otherwise healthy.
      
Keywords: mucositis; oral ulcers; chlorhexidine; aloe barbadensis; rosa damascena
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
Condition: Rotavirus Infections; Gastroenteritis
MeSH terms: Rotavirus Infections; Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to
      rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing
      the safety or immunogenicity of either vaccine.
    


Intervention name(s): Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: Oral Poliovirus Vaccine (OPV); Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.; Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.; Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of ADSTEM Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate safety, tolerance, and efficacy in subjects with over moderately
      subacute and chronic atopic dermatitis after an intravenous injection of autologous
      mesenchymal stem cells. The study is composed of two steps. Step 1 is to determine clinically
      proper dose capacity of the ADSTEM Inj. and step 2 is to evaluate exploratory efficacy of the
      ADSTEM Inj. at the proper dose.
    

Detailed description: 
      Atopic dermatitis (AD) is a type of inflammation of the skin. It results in itchy, swollen,
      red, and cracked skin. The symptoms typically start in childhood with changing severity over
      the years. The pathogenesis of AD is characterized by excessive type 2 helper T cell mediated
      inflammatory responses, resulting in B lymphocyte mediated increase in serum level of
      immunoglobulin E (IgE). Subsequent degranulation of mast cells by IgE releases various
      inflammatory mediators, which recruit the lymphocytes and eosinophils into the lesion.

      Current clinical management of AD includes topical corticosteroids and systemic
      immunosuppressants. However, these drugs have been reported to carry the risk of side-effects
      and severe.

      Several recent studies including ours have demonstrated that mesenchymal stem cells (MSCs)
      could suppress allergic responses in AD. MSCs have been known to interact with cell types of
      both innate and adaptive immune systems, which results in the suppressive effect on
      proliferation, differentiation, and activation of immune cells including T cells, B cells,
      dendritic cells, and natural killer cells. Indeed, a number of studies have reported that the
      immunomodulatory ability of MSCs can be usefully applied for the treatment of autoimmune and
      inflammation-related diseases such as asthma, rhinitis, and dermatitis. Therefore, MSCs has
      possibility as a new drug for AD.
    

Intervention name(s): ADSTEM Inj. (Adult human mesenchymal stem cells)
Intervention type(s): Drug
Intervention description(s): Comparison of different dosages of the drug in the aspect of safety and efficacy.
Other intervention name(s): ADSTEM Inj.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic dermatitis; Mesenchymal stem cells
Miromatrix Biological Mesh for Hiatal Hernia Repair
Condition: Hiatal Hernia
MeSH terms: Hernia; Hernia, Hiatal
Study type: Interventional

Summary: 
      Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived
      from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an
      indication for reinforcement of soft tissue on March 31, 2014 under K134033. This study will
      serve to provide clinicians with high-quality clinical data in order to provide them with a
      higher degree of confidence when selecting MIROMESH for hiatal hernia repair.
    


Intervention name(s): MIROMESH
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Combined EMS and RF Treatments
Condition: Non-invasive Circumference Reduction
Study type: Interventional

Summary: 
      The objective of this trial is to evaluate the safety and efficacy of the Evolve device
      utilizing the Ti10 and Tone applicators for abdominal non-invasive circumference reduction
      and skin tightening
    


Intervention name(s): Treatment with Evolve System
Intervention type(s): Device
Intervention description(s): EMS and RF Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BCAA's in Concussion
Condition: Brain Concussion
MeSH terms: Brain Concussion
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory
      clinical trial of branched chain amino acids (BCAA's) in the treatment of concussion. The aim
      of the study is to determine whether, compared to placebo treatment, administration of
      BCAA's, at one or more doses, after a concussion improves neurocognitive recovery at one or
      more time-periods post concussion.
    

Detailed description: 
      Annually, between 100,000 to 140,000 children present to the emergency department for
      concussion in the United States.1 The Centers for Disease Control now estimates that 1.6 -
      3.8 million sports related concussions occur each year in the United States. A large
      proportion of these patients have enduring cognitive and neurobehavioral problems. Concussion
      is a heterogeneous insult to the brain that precipitates a complex pathophysiological process
      that can result in a cascade of deleterious side effects. At present, there are no proven
      therapies to mitigate or prevent the neurocognitive and neurobehavioral consequences of
      concussions. The limbic hippocampus, a brain structure crucial for learning and memory, is
      often damaged in concussion. In preclinical studies in our laboratory, analysis of
      ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated
      that only the concentrations of the three BCAA's (valine, isoleucine, and leucine) were
      significantly altered (reduced) after injury. When these brain-injured animals received
      dietary supplementation with BCAA's, the concentrations of these amino acids were restored in
      the injured hippocampus and the injured animals demonstrated significant cognitive
      improvement to levels comparable to those obtained in non-injured control animals. In light
      of these results and the increasing awareness and morbidity associated with concussion, we
      are proposing a pilot therapeutic exploratory clinical trial to determine the effects of
      BCAA's in reducing the neurocognitive side effects of concussion injury.
    

Intervention name(s): Branched Chain Amino Acids; Placebo solution
Intervention type(s): Drug; Drug
Intervention description(s): The three BCAA's will be combined together and dissolved in a flavored solution.; The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Concussion; Branched chain amino acids; BCAA; HIT HEADS
Discontinuation of Lens Wear in New Ortho-k Children (DOEE2)
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study aims at investigating the efficacy of myopic control using ortho-k in younger and
      older children.
    

Detailed description: 
      Children wearing ortho-k have been shown to have slower rate of myopic progression than those
      wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009).
      Younger myopic children (aged 6-10 years old) may have the faster increase in myopia than old
      myopic children (aged 11-15 years old), i.e. the rate of myopic progression may be different
      in different age groups and in children with different refractive status (Edwards 1999; Fan
      et al. 2004; Cheng et al. 2007). Although the refractive correction with ortho-k has been
      well documented, it is unknown whether the efficiency and reversibility of ortho-k for myopic
      reduction as well as myopic control are similar in children of different age and refractive
      groups.

      In this 14-month study, the eyeball length in 45 younger (6-10 years old) and 45 older (11-15
      years old) myopic children before and after ortho-k will be evaluated. Eyeball elongation
      will be determined for the first 7 months when single-vision glasses will be prescribed
      (Phase I) and the next 7 months when ortho-k will be prescribed (Phase I). Rate of myopic
      progression will be determined and compared between the two groups of children in the two
      phases.
    

Intervention name(s): single-vision glasses; ortho-k lenses
Intervention type(s): Device; Device
Intervention description(s): Daily wear of glasses to correct vision in the first seven months of the study; Nightly wear of lenses to correct vision in day time in the second seven months of the study
Other intervention name(s): CR-39 lenses; orthokeratology; corneal reshaping therapy; Menicon Z Night lenses; Menicon Z Night Toric lenses
Intervention model: Single Group Assignment
Intervention model description: All subjects were prescribed with a pair of glasses for seven months and switched to orthokeratology for another seven months
Masking: Single
Primary purpose: Treatment
Keywords: children; corneal reshaping; myopia; myopia progression; orthokeratology
Flexible Catheter for Insulin in Diabetes
Condition: Diabetic Ketoacidosis
MeSH terms: Ketosis; Diabetic Ketoacidosis
Study type: Interventional

Summary: 
      Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the
      usual treatment with a metal needle.
    

Detailed description: 
      Assess whether the use of a flexible subcutaneous catheter improves comfort in patients with
      DKA compared to the usual treatment with a metal needle.

      Compare the metabolic evolution of patients with DKA using a flexible subcutaneous catheter
      for insulin administration vs. a metal needle.
    

Intervention name(s): FLEXIBLE CATHETER; hourly rigid needle puncture
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
Condition: Edema, Cardiac
MeSH terms: Heart Failure; Edema, Cardiac; Edema
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg
      or placebo in congestive heart failure (CHF) patients with extracellular volume expansion
      despite the use of a conventional diuretic.
    


Intervention name(s): OPC-41061(Tolvaptan)
Intervention type(s): Drug
Intervention description(s): 0, 15mg of OPC-41061 per day for 7days p.o. administration
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac edema; OPC-41061; Vasopressin antagonist
Safety and Feasibility of the EyeControl Device
Condition: ALS (Amyotrophic Lateral Sclerosis)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional

Summary: 
      The EyeControl device is an eye movement-based communication device in the form of wearable
      glasses with connected infrared cam-era that tracks the pupil and translates blinks and
      movements into commands.This study is aimed to demonstrate the safety and feasibility of the
      EyeControl device in healthy volunteers, and ALS patients in early stages.
    


Intervention name(s): EyeControl device
Intervention type(s): Device
Intervention description(s): Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Sampling of Human Microbiota in Order to Test, on a Mouse Model, Individualized Intervention Strategies During Aging
Condition: Healthy Volunteers; Frail Volunteers
Study type: Interventional

Summary: 
      Human microbial flora transfer studies in rodent models have clearly identified that
      age-associated microbiota dysbiosis can play a decisive role with respect to pathologies or
      complications linked to aging: increased intestinal permeability, in place of systemic
      inflammation, dysfunction of immune cells and insulin resistance.

      This trial therefore aims to validate the process of ex vivo transfer to the rat of human
      microbiota selected from three categories of male individuals: young adults, healthy older
      adults and frail older adults, with the evaluation of the bacterial population of stool by
      analysis of the 16S rRNA gene.
    

Detailed description: 
      This is a pilot study to validate a process of ex vivo stool transfer from humans to rats.
      Single-center intervention research with minimal risks and constraints.

      Exploration of the bacterial composition of the intestinal microbiota in healthy adult
      volunteers, healthy elderly and frail elderly. The evaluation of the bacterial population of
      the stool will be done by analysis of the 16S rRNA gene.

      The secondary objectives will evaluate the muscular functional abilities the body composition
      measurement, at Day 0 (visit 2) and the inflammatory status at Day -7 (visit 1).

      Seconds parameters are the following :

      seated, standing, walking, and direction changes, a balance test, a walking speed test and a
      chair lift test, the maximum voluntary force of manual gripping, the maximum muscle strength
      of the quadriceps and the level of autonomy

      This protocol includes 3 visits :

        -  Visit 1 : Day -7 (allowed until Day-14) = inclusion

        -  Visit 2 : Day 0 = tests and questionnaires

        -  Visit 3 : Day +7 (allowed from Day+1) = stool collect
    

Intervention name(s): Stool collection
Intervention type(s): Genetic
Intervention description(s): The volunteer will receive the stool collection kit as well as the procedure to follow for this collection.
Treatment of stool after collection:
The stool will be treated according to the following two procedures:
i) part of the stool will be sequenced and will be stored as quickly as possible (4 hours maximum) at -80 ° C, 3 separate aliquots of 1 g; ii) the other part will be intended for implantation in rats and must be homogenized in a final concentration of 20% glycerol (2 hours maximum) and then stored at -80 ° C, 3 aliquots of 1 g.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Genetic; Elderly; Microbiota
A Clinical Trial to Evaluate the Efficacy and Safety of YMC026 in Respiratory Disease Patients
Condition: Respiratory Disease
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase 4, randomized, double-blind, multicenter clinical trial to evaluate the
      efficacy and safety of YMC026 in respiratory disease patients with cough and sputum as the
      main symptoms
    

Detailed description: 
      The study has planned 4 visits during 2 weeks period (1 week of screening period, 1 week of
      treatment period). All subjects who agree to participate in the study and voluntarily give
      written informed consent are assessed by inclusion and exclusion criteria at the screening
      visit. After the screening period, the final eligibility of the subjects will be assessed at
      the randomization visit. Subjects who are determined to be appropriate for this study will be
      allocated to experimental group(YMC026) or control group(placebo) randomly in a 1:1 ratio.
      Subject will be administered the investigational product daily for 6 days. The safety for the
      subjects will be assessed at Day 3 and Day 6 visit, and the efficacy evaluation will be
      assessed at Day 6 visit.
    

Intervention name(s): YMC026; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): YMC026 20mL TID; Placebo 20mL TID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment