bioihbjkbjnl/mcl2 huggingface dataset:
Paraurethral Transplantation of Autologous Muscle Derived Stem Cells for Treatment of Stress Incontinency
Condition: Stress Urine Incontinency
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to provide confirmation of efficacy of muscle derived stem cells
      (MDCs) for the treatment of SUI in women.
    

Detailed description: 
      The investigators will be assessed the 12-month potential efficacy of autologous muscle
      derived cells as therapy for stress urinary incontinence. A total of 20 women in whom stress
      urinary incontinence had not improved underwent intra-sphincter injection of low doses 50×106
      of autologous muscle derived cells, which will be derived from biopsies of their deltoid
      muscle. Assessments will be made at 1, 3, 6 and 12 months after cell injection. Changes in
      stress urinary incontinence severity were evaluated by pad test, diary of incontinence
      episodes and quality of life surveys.
    

Intervention name(s): paraurethral injection
Intervention type(s): Biological
Intervention description(s): Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous stress urinary incontinence muscle derived cells
Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
Condition: Fasciitis, Plantar
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as
      compared to the saline placebo injection in the treatment of plantar fasciitis
    

Detailed description: 
      Approximately 276 patients will be enrolled in this study. Each patient will receive 1
      injection and be evaluated for efficacy and safety during a 6-month observation period.
      Randomization will be 1:1. The study is expected to be completed within 34 months, inclusive
      of enrollment and follow-up of all subjects.
    

Intervention name(s): Micronized dHACM; Saline Injection
Intervention type(s): Other; Drug
Intervention description(s): 1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM); Injection of 1mL 0.9% Sodium Chloride Injection, USP
Other intervention name(s): dHACM; 0.9% NaCl; Normal Saline; Sodium Chloride Injection, USP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic plantar fasciitis; Heel pain
Progranulin and CTRP3 in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      Inflammation has been known to be a pivotal pathogenic mechanism of obesity-related disorders
      such as type 2 diabetes, metabolic syndrome and atherosclerosis. Adipose tissue functions as
      a major endocrine organ by adipokine mediated modulation of a number of signaling cascades in
      target tissues, that has pro-inflammatory or anti-inflammatory activities. Progranulin and
      CTRP3 are recently discovered novel adipokines. Therefore, the investigators tried to clarify
      the clinical meaning of these two adipokines in the subjects with or without metabolic
      syndrome
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The subjects who visited for a routine health check-up at the Health Promotion Center of
        Korea University Guro Hospital were enrolled using predefined inclusion and exclusion
        criteria.
Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the efficacy and safety of BoNT/a-DP in the treatment of
      glabellar lines in comparison with placebo, including efficacy after repeat treatments and
      long term safety.
    

Detailed description: 
      This multicenter Phase 3 study is comprised of two parts. The first part of the study is a
      randomized, double blind, placebo-controlled, phase which aims to demonstrate efficacy and
      safety of BoNT/A-DP compared with placebo. The second part is an open label extension phase
      to evaluate efficacy after repeat treatments and long term safety. Subjects can receive a
      maximum of four treatment cycles over the duration of the study, a single treatment in the
      first cycle compared with placebo, and up to three subsequent treatments in the open label
      extension study.
    

Intervention name(s): Botulinum Toxin A; Placebo; Botulinum Toxin A - Open Label
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injection, 20 Units divided in five 0.1mL i.m injections into the glabellar area; injection, sodium chloride 0.9% divided in five 0.1 mL i.m. injections into the glabellar area; Open Label Extension Phase with Experimental Drug; Injection, 20 Units divided in five 0.1mL i.m injections into the glabellar area
Other intervention name(s): BoNT/A-DP; sodium chloride 0.9 %; BoNT/A-DP
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_33
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Participants will complete a listening task in a simulated reverberant environment.
      Participants are seated and instructed to look at a fixation cross while a sentence is
      played. Sentences are varied with respect to their speech rate. While listening to the
      sentences participant's pupil dilation is measured by means of pupillometry which is a
      non-invasive physiological measurement. Participants are asked to repeat back the sentences
      loud. At fixed intervals, subjective ratings are collected by asking participants to move an
      on-screen slider using a game controller. Two hearing aid programs will be compared, one
      intended for speech perception in quiet and the other to reduce reverberation in reverberant
      environments. The study is designed as factorial, with 2 speech rates, 2 room simulations and
      2 hearing aid programs. The same conditions will be re-tested once after a minimum of one
      day. A pilot study will determine appropriate speech rates by applying a different factorial,
      with 4 speech rates, 2 room simulations and 1 hearing aid program. Participants complete all
      conditions (within-subjects) in one experimental sessions that lasts around 1 hour.
    


Intervention name(s): Hearing Aid without Reverberation Canceller (RevC).; Hearing Aid Reverberation Canceller enabled (RevC_1)
Intervention type(s): Device; Device
Intervention description(s): Each participant will be fitted with the 2 different Sound Changing principles on the same hearing aid, saved to 2 manual programs (ensures exact same hearing loss compensation for each intervention). Reverberation Canceller principle is a sound processing algorithm to remove reverberation from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is without Reverberation Canceller principle enabled.; Each participant will be fitted with the 2 different Sound Changing principles on the same hearing aid, saved to 2 manual programs (ensures exact same hearing loss compensation for each intervention). Reverberation Canceller principle is a sound processing algorithm to remove reverberation from a speech signal to improve the speech intelligibility and comfort. The experimental condition applies the Reverberation Canceller and is predicted to provide a benefit in reverberant room simulations.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
ATP in Alzheimer Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To Check whether systemic treatment with ATP alters the profile of cerebral metabolism in
      patients with Alzheimer's disease using MRS techniques (Magnetic Resonance Spectroscopy) and
      adjust the infusion (minimum effective dose) that promotes this metabolic change.
    


Intervention name(s): ADENOSINE TRIPHOSPHATE; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): Infusion of 2.5g of ATP in 500 mL of saline solution. (IV); Infusion of 500 mL of saline solution. (IV)
Other intervention name(s): ATP
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Alzheimer
PRebiotic to IMprovE Calcium Absorption
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Gastric bypass surgery is a highly effective treatment for obesity, but it has negative
      effects on skeletal health, due in part to a dramatic decline in intestinal calcium
      absorption capacity. Animal and human studies suggest that non-digestible fibers termed
      prebiotics, such as soluble corn fiber (SCF), augment calcium absorption in the lower
      intestine as they act as substrates for beneficial gut microbiota. This is a pilot randomized
      controlled trial of the effects of SCF vs. placebo on intestinal calcium absorption, bone
      turnover marker levels, and the gut microbiome in postmenopausal women who have previously
      undergone gastric bypass surgery.
    

Detailed description: 
      The study is a pilot randomized control trial (RCT) of the effects of the prebiotic SCF vs.
      placebo in 20 postmenopausal women who underwent Roux-en-Y gastric bypass surgery 2-6 years
      previously and thus have completed the postoperative period of rapid weight loss and
      metabolic and dietary change. A 24 g/day dose of SCF85 (which is approximately 20 g/day
      fiber) will be tested, as that dose was proven effective for calcium absorption/retention in
      healthy postmenopausal women and adolescents. The SCF and the maltodextrin placebo will be
      mixed in water and consumed in divided doses twice daily for 2 months, a duration exceeding
      other SCF trials but remaining feasible for a pilot. The primary outcome will be change in
      intestinal calcium absorption, which is the efficacy outcome about which the study must
      collect preliminary data and from which the investigators must refine power calculations for
      the anticipated future trial. Because the investigators hypothesize that an increase in
      calcium absorption will decrease bone turnover and ultimately increase bone mineral density
      (BMD), the study will measure biochemical markers of bone turnover in this pilot. Secondary
      outcomes will be gastrointestinal tolerability and acceptability. On an exploratory basis,
      the study will determine effects of the prebiotic on the gut microbiome. This pilot will
      yield critical experience about feasibility of recruitment and adherence to the intervention
      and measurements.
    

Intervention name(s): Prebiotic: soluble corn fiber; Placebo: maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): prebiotic; placebo
Other intervention name(s): PROMOTOR 85
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled pilot trial with a parallel-arm design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: gastric bypass; calcium absorption; postmenopausal women
Detecting Infections Rapidly and Easily for Candidemia Trial - Part 2 (direcT2 Study)
Condition: Candidemia
MeSH terms: Candidemia
Study type: Observational

Summary: 
      The purpose of this study is to validate clinical performance (i.e. estimated sensitivity and
      specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture results
      and/or known Candida positive status of prospectively collected and contrived (i.e.
      Candida-spiked) clinical specimens.
    

Detailed description: 
      This study will prospectively collect and analyze whole blood T2 clinical research specimens
      and concomitant blood culture specimens from patients who have been referred for a blood
      culture per routine standard of care. Additional analysis of blinded, contrived (i.e. Candida
      spiked and un-spiked whole blood) specimens will be completed by study sites to augment the
      analysis of Candida positive blood specimens prospectively obtained from the study
      population.

      The clinical performance of the T2 Candida test on the T2 Dx Instrument will be evaluated by
      calculating the:

        -  Estimated clinical specificity of the T2Candida test results compared to Candida
           negative blood culture results in prospectively collected specimens, and the

        -  Estimated sensitivity of the T2 Candida test results compared to the known Candida
           positive status or Candida positive blood culture status of contrived specimens that
           have been spiked at clinically relevant concentrations of the target organisms and,
           where detected, to Candida positive blood culture results in prospectively collected
           clinical specimens.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients who have had a blood culture ordered, per routine standard of care
      
Biospecimen description: 
      Whole blood specimens
    
Keywords: Candida; Candidemia; Blood culture; Diagnostics
Single Ascending Doses of HER-096 in Healthy Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety and tolerability of HER-096 in healthy volunteer subjects by
      comparing the effects of active study treatment HER-096 to placebo (0.9% physiological
      saline). In addition, the pharmacokinetic profile of HER-096 in humans will be investigated.
      The investigational medicinal products will be administered as a single dose by subcutaneous
      injection.
    

Detailed description: 
      This is a Phase I, double-blind, placebo-controlled, clinical study, in which safety,
      tolerability and pharmacokinetic profile of HER-096 will be investigated after a
      subcutaneously (s.c.) administered single ascending doses of HER-096 to healthy volunteer
      subjects (HVS).

      Altogether 60-64 HVS will be enrolled into the study and the study will be conducted in two
      parts, part 1 being randomised and part 2 being open-label. In part 1, up to 48 young male
      HVS will be randomised 6:2 either to receive HER-096 or placebo (0.9% physiological saline)
      solution. In part 1, up to 6 dosing cohorts have been planned with single ascending doses of
      HER-096. In part 2, 12-16 older and elderly HVS, both males and females, will be administered
      with single dose of HER-096 to evaluate the blood-brain-barrier penetration of HER-096. The
      investigational medicinal products (HER-096 or placebo solution) will be administered as a
      s.c. injection.

      The total duration of the study will be up to 36 days for each subject, consisting of
      screening and treatment period.
    

Intervention name(s): HER-096; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as a single dose via s.c. injection; Administered as a single dose via s.c. injection
Other intervention name(s): 0.9% physiological saline; Sodium chloride 9 mg/ml
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1: single ascending doses of up to six dosing cohorts Part 2: single dose defined based on the Part 1 data
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson Disease
C2-C4 Compartment Block Versus Block of Costagliola, in TEAC
Condition: Somatic Pain; Neuropathic Pain
MeSH terms: Neuralgia; Nociceptive Pain
Study type: Interventional

Summary: 
      C2-C4 compartment block compared to the Costaiola block, in the control of persistent
      postoperative pain (somatic and neuropathic) in patients undergoing carotid
      thromboendarterectomy
    

Detailed description: 
      A comparative analysis will assess the somatic pain (scores ≥4 on the NRS scale) and
      neurapathic pain (by the Lindblom roller and Von Frei hair tests) between group A (block
      group of the C2-C4 compartment ) and the control group B (block group according to
      Costagliola), during the 3 months after surgery.
    

Intervention name(s): C2-C4 compartment anesthetic block; Costagliola block
Intervention type(s): Procedure; Procedure
Intervention description(s): C2-C4 compartment anesthetic block is performed by injecting levobupivacaine 0.375% 20 mL between the posterior face of the middle scalenus muscle, the anterior face of the posterior scalene muscle and the lower plane of the sternoscleidomastoid muscle.; Costagliola block is performed by injected by injecting levobupivacaine 0.375% 20 mL along the anterior and the posterior border of sternocleidomastoid muscle
Other intervention name(s): Intermediate cervical plexus block; Superficial cervical plexus block
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Carotid thromboendarterectomy; Carotidodynia
Citicoline, Creatine, and Omega-3 Effects in Middle Age Women
Condition: Cognitive Benefits
Study type: Interventional

Summary: 
      The purpose of this study is to determine the functional effects of a citicoline, creatine,
      and omega-3 fatty acids combination when administered for a duration of four weeks (28 days)
      to non-psychiatric adult female participants.
    

Detailed description: 
      Standard clinical measures for mood and neuropsychological measures of attention, cognitive
      inhibition and memory will be applied before, during, and after a course of a daily
      supplementation of citicoline, creatine and omega-3 for 28 days to non-psychiatric adult
      female participants. We hypothesis that the combination of supplements will improve memory
      and attention in healthy adult women.
    

Intervention name(s): Citicoline, Omega-3 Fatty Acids and Creatine
Intervention type(s): Drug
Intervention description(s): Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days
Other intervention name(s): CDP-Citicoline; Creatine monohydrate
Intervention MeSH terms: Cytidine Diphosphate Choline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuropsychological testing; Dietary supplements
A Study of Whether 2 New Oral Formulations of a Strong Pain Killer Release the Same Amount of Drug Into the Body as the Marketed Medication
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine whether two new oral formulations of a strong pain killer release the drug into
      the body in a similar pattern as the already marketed reference capsule formulation with or
      without food.
    

Detailed description: 
      Comparisons will be made between two new oral formulations and an existing marketed reference
      capsule formulation to determine whether the release rates of the products are similar or
      equivalent in a fed or fasted state. Determination is by measurement of drug concentrations
      in the blood at serial collection time points pre-dose until 32 hours post-dose, following an
      administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the
      primary endpoints.
    

Intervention name(s): Active comparator MR2XXX; MRXXX; MR1XXX; MRXXX and MR1XXX
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): comparison of two new oral formulations with existing formulation; MRXXX; MRXXX and MR1XXX in fed and fasted state
Other intervention name(s): MR2XXX; Experimental capsule formulation compared to marketed reference product; MRXXX and MR1XXX in fed and fasted state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer; Pharmacokinetics; Bioequivalence
A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of aticaprant on QT/ QT interval corrected
      for heart rate (HR) (QTc) intervals and electrocardiogram (ECG) morphology at therapeutic and
      supratherapeutic exposures in healthy adult participants.
    


Intervention name(s): Aticaprant Supratherapeutic Dose; Aticaprant Therapeutic Dose; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Aticaprant supratherapeutic dose capsule will be administered orally.; Aticaprant therapeutic dose capsule will be administered orally.; Placebo will be administered orally.; Moxifloxacin capsule will be administered orally.
Other intervention name(s): JNJ-67953964; JNJ-67953964
Intervention MeSH terms: Moxifloxacin; Aticaprant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment