bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Evaluate the Impact of aKwa Skincare System on Skin Health
Condition: Sin Health; Skin Hydration; Skin Wrinkles; Skin Porphyrins; Facial Skin Red Spots; Facial Skin Red Vasculature
MeSH terms: Erythema; Facies
Study type: Interventional

Summary: 
      The purpose of the study was to evaluate the effectiveness of the äKwä 6-step skincare system
      by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and
      red vasculature counts over a 30-day period.
    

Detailed description: 
      The äKwä 6-step skincare system is comprised of various skincare products intended to be
      applied both morning and night. Some of the notable ingredients included in the product
      formulas are fermented green tea water, other ferments, niacinamide, antioxidants, and a
      variety of natural plant extracts. The purpose of the study was to evaluate the effectiveness
      of the äKwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles,
      porphyrin count, red spots, and red vasculature counts over a 30-day period.
    

Intervention name(s): äKwä skincare system products; competitor products (control)
Intervention type(s): Other; Other
Intervention description(s): The skincare product system tested in this study was äKwä 6-step skincare system from 4Life Research USA, LLC ( https://www.4life.com/6613461/page/äKwä). Product directions state to use the following products morning and night in sequential order: First Wave Oil-to-Foam Cleanser, Glacier Glow Four-Way Toner, Precious Pool Vitamin Essence, Ripple Refine Eye Cream, and RainBurst Moisture Cream.; Participants use whatever their normal daily routine of skincare products, which are commercially available competitor products from the marketplace.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One Active group and one Control group
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the
      safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18
      years with type 2 diabetes mellitus.
    


Intervention name(s): empagliflozin medium dose; empagliflozin high dose; empagliflozin low dose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Additional Effects of Vagus Nerve Stimulation on Motor Functions of Upper-limb in Stroke
Condition: Stroke (CVA) or TIA
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The study aims to determine the additional effects of vagus nerve stimulation with
      task-oriented training on motor functions of upper-limb in stroke
    

Detailed description: 
      Stroke is a clinical syndrome characterized by rapidly developing clinical signs of focal (or
      global) disturbance of cerebral function lasting more than 24 hours or leading to death with
      no apparent cause. Nerve stimulation paired with rehabilitation is a novel potential
      treatment option for people with long-term moderate-to-severe arm impairment after stroke.
      The study aims to determine the additional effects of vagus nerve stimulation with
      task-oriented training on motor functions of upper-limb in stroke. The idea of stimulating
      the vagus nerve to modify central brain activity has been pursued. Vagus nerve stimulation
      (VNS) paired with rehabilitative training enhances recovery of function in models of stroke
      and is currently under investigation for use in chronic stroke patients. Compared to
      traditional stimulation, noninvasive VNS seems to be safer and more tolerable.
    

Intervention name(s): Vagus nerve stimulation with task oriented training; Task oriented training
Intervention type(s): Other; Other
Intervention description(s): VNS Group will receive non-invasive vagus nerve stimulation at left auricle of ear for 30 mins during the task-oriented training. Subjects will receive protocol 3 days per week for 12 weeks.; Task oriented group will receive task oriented training and placebo effect with vagus nerve stimulator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Impairement; Stroke; Task oriented; Upper limb; Vagus nerve
A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential
      drug-drug interactions between darunavir and danoprevir when administered together with
      low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive
      either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all
      subjects will receive darunavir plus danoprevir together with ritonavir for 10 days.
      Anticipated time on study treatment is 20 days.
    


Intervention name(s): danoprevir; darunavir; ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg q12h; 600 mg q12h; 100 mg q12h
Intervention MeSH terms: Ritonavir; Darunavir
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study of Subcutaneous Doses of HIP2B in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      HIP2B is the stabilized form of the Human proIslet Peptide (HIP). Human proIslet Peptide is
      the human homolog of Islet Neogenesis Associated Protein (INGAP) peptide, which has shown
      signals of efficacy in type 1 and type 2 diabetes mellitus. In a mouse model of diabetes,
      repeat dose treatment with HIP results in new islet formation and improvement in blood
      glucose measurements.

      HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.

      The present clinical trial protocol proposes the first administration of HIP2B to humans with
      the goal of exploring the tolerability, safety and PK of HIP2B following subcutaneous single
      ascending doses.
    

Detailed description: 
      Primary Outcome:

      To assess the tolerability and safety after subcutaneous single ascending doses of HIP2B in
      healthy male subjects. Adverse events including local injection site reactions/pain will be
      assessed during the study. Ongoing adverse events will be followed to resolution or for 30
      days (whichever is sooner). Clinical laboratory evaluations including amylase and lipase will
      be reviewed. Vital signs and ECGs will be used to evaluate subject safety.

      Secondary Outcome:

      To assess the pharmacokinetics (including Cmax, AUClast, AUC0-∞, tmax, t1/2, tlag) in healthy
      male subjects after subcutaneous single ascending doses of HIP2B.
    

Intervention name(s): HIP2B; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Total daily doses of 60, 120, 240, 480, and 720 mg are planned in five separate dosing cohorts. Single or split dose (depending on dose volume) will be given by subcutaneous injection in the abdomen to six subjects per dosing cohort.; Equal volumes of placebo will be given by subcutaneous injection in the abdomen to 2 randomized subjects per dosing cohort.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy male volunteers
Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
Condition: Dengue Fever; Dengue Hemorrhagic Fever; Dengue Virus; Dengue Diseases
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objectives:

        -  To evaluate safety after each CYD Dengue vaccination in terms of injection site and
           systemic reactogenicity.

        -  To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period.

        -  To evaluate the humoral immune response to each CYD Dengue serotype after each
           vaccination in a subset of participants.

      Secondary Objectives:

        -  To evaluate the persistence of the humoral immune response during 4 years after the last
           vaccination in a subset of participants.
    

Detailed description: 
      This was a multicenter trial involving three vaccinations one each at 0, 6 and 12 months over
      a period of 1 year, and a 4-year follow-up following the last vaccination.
    

Intervention name(s): CYD Dengue vaccine; NaCl + influenza virus or hepatitis A vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous on Day 0, Months 6 and 12; 0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)
Other intervention name(s): Sanofi Pasteur's CYD Dengue Vaccine; NaCl 0.9%; Vaxigrip®; Havrix® pediatric formulation
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue virus; Dengue fever; Dengue Hemorrhagic fever; Dengue diseases; Sanofi Pasteur's CYD Dengue Vaccine
Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition
Condition: Physical Medicine
Study type: Interventional

Summary: 
      This study will incorporate the use of wearable actigraphy devices (Fitbit) on research
      participants admitted to medicine inpatient units at Tisch Hospital and/or NYU Brooklyn. The
      investigator's sample size will be 600 randomized into two groups, with basic inclusion
      criteria including age greater than 65 years and pre-hospital ambulatory status. While both
      groups will be monitored in terms of their activity (specifically pedometer data), the
      intervention group will have twice daily encouragement of ambulation. Once a subject is
      enrolled, data will be collected daily and at time of discharge.
    


Intervention name(s): Ambulation; Standard of Care
Intervention type(s): Behavioral; Other
Intervention description(s): This group will be encouraged twice daily to ambulate; Care as usual at inpatient NYU Langone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
An Open Label Study to Evaluate the Impact of Duration of Subcutaneous Infusion of a Novel, pH Neutral Formulation of Furosemide (Furoscix®) on Safety and Local Skin Tolerability
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to evaluate the safety and tolerability of shortened subcutaneous
      infusions of Furoscix.
    

Detailed description: 
      Furoscix 80 mg will be administered as a subcutaneous infusion following a step-wise decrease
      in infusion times starting with a 5 hour infusion time. Subsequent cohorts will enroll
      following a safety assessment of the prior cohort. While maintaining the 80 mg dose, infusion
      time will ultimately be reduced to 30 minutes.
    

Intervention name(s): Furosemide 80 mg (8 mg/mL)
Intervention type(s): Drug
Intervention description(s): Furoscix will be administered as a subcutaneous infusion.
Intervention MeSH terms: Furosemide
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The initial cohort (Cohort 1) will receive 80 mg (10 mL) with a bi-phasic delivery profile over 5 hours.
Cohort 2a will evaluate a 2-hour infusion and Cohort 2b will be a bi-phasic delivery over 2 hours.
Cohorts 3 and 4 will deliver the Furoscix over one hour and 30 minutes, respectively.
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy Registry of Yinyi Stent
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and
      delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from
      a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may
      prevent these complications.
    


Intervention name(s): Yinyi stent
Intervention type(s): Device
Intervention description(s): subjects with Yinyi stent implantation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Weight Gain Prevention
Condition: Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional

Summary: 
      The specific aim of the proposed project is to test two separate self-regulation
      interventions to prevent weight gain in young adults, one based on making sustained small
      changes in behavior to prevent weight gain and the other on making periodic larger behavior
      changes resulting in weight loss.
    


Intervention name(s): large changes in eating and activity; small changes in eating and activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral self-regulation interventions to prevent weight gain in young adults.; Behavioral self-regulation interventions to prevent weight gain in young adults.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: overweight; prevention of weight gain; young adults; self-regulation; daily weighing; weight gain prevention
Evaluation of Ultrasound (US) Assistance for Anesthesia Trainees for Caesarean Section Spinal Placement
Condition: Pregnancy
Study type: Interventional

Summary: 
      Parturients receiving spinal anesthetic for Cesarean section will be randomized to have/not
      have pre-spinal ultrasound examination of their back.
    

Detailed description: 
      Parturients receiving spinal anesthetic for elective Cesarean section will be randomized to
      have/not have pre-spinal ultrasound examination of their back, prior to spinal insertion by
      anesthesia trainees.

      The hypothesis is that ultrasound visualization of the patient spinal spaces will allow
      junior residents to correctly place the spinal needle with fewer attempts.

      The null hypothesis is that there is no difference in the primary outcome (number of
      attempts). i.e. the investigators hypothesize that the number of attempts is not affected by
      ultrasound assistance. The control group will undergo spinal anesthesia with manual
      palpation, the standard of care.
    

Intervention name(s): Ultrasound examination
Intervention type(s): Device
Intervention description(s): Trainees will receive pre-procedure U/S guided examination of the parturient's back.
Other intervention name(s): M-turbo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: pregnancy; Caesarian; section; spinal
Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed
      drug in pediatric subjects with migraines.

      After completion of a portion of the study (Panels A and B), a regulatory agency issued an
      amended request that the 12-17 year old age group studied should include a similar number of
      male and female subjects. Therefore, the study was amended to add an additional panel of
      subjects (Panel C) to ensure gender balance specifically in this age group.
    


Intervention name(s): rizatriptan benzoate (5 mg); rizatriptan benzoate (10 mg); Rizatriptan 5 mg Placebo; Rizatriptan 10 mg Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single dose of rizatriptan 5 mg administered on Day 1.; A single dose of rizatriptan 10 mg administered on Day 1.; A single dose of rizatriptan 5 mg placebo administered on Day 1.; A single dose of rizatriptan 10 mg placebo administered on Day 1.
Other intervention name(s): MAXALT®; MK0462; MAXALT®; MK0462
Intervention MeSH terms: Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP)
      injection in the treatment of diabetic peripheral neuropathy compared to traditional medical
      treatment.
    

Detailed description: 
      Background: Neuropathy is a common complication of diabetes mellitus (DM) with a wide
      clinical spectrum that encompasses generalized to focal and multifocal forms not only leads
      to an impaired quality of life, but also to an increased morbidity and mortality . Till now
      there is no available effective therapy for the treatment of diabetic peripheral neuropathy
      (DPN). Autologous platelet-rich plasma is easy and cost-effective method as it provides
      necessary growth factors that promote wound healing/growth, angiogenesis, and axon
      regeneration .

      Objective: To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma
      (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional
      medical treatment.

      Method : Prospective double blinded randomized controlled trial was conducted . All included
      patients had type 2 DM selected from Endocrinology unit Department of Internal medicine,
      Assuit university Hospital, Egypt . DPN of at least 5 years duration of symptoms . Patients
      with other causes of neuropathy like hereditary neuropathies , entrapment neuropathies
      ,connective tissue diseases , vertebral diseases ,thyroid disorders and end organ failure
      were excluded . Neuropathy was assessed by the modified Toronto Clinical Neuropathy Score
      (mTCNS) 2001 (3) , Baseline pain and nerve conduction studies were done. Then they were
      double blindly divided into two groups, Group I underwent PRP preineural injection under
      ultrasound guidance plus medical treatment . Group װreceived medical treatment only( control
      group) . Blood glucose was strictly controlled in both groups . Patients were followed every
      month for 3 months by mTCNS and by nerve conduction studies. Results were expressed as means
      ± standard deviation or frequencies. Independent Student's t test was done for comparison
      between groups
    

Intervention name(s): PRP injection; traditional medical treatment
Intervention type(s): Drug; Other
Intervention description(s): peri-neural injection of platelet rich plasma; traditional medical treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Maternal Oxygen Administration for Fetal Distress II
Condition: Oxygen Inhalation Therapy; Labour; Fetal Distress
MeSH terms: Fetal Distress
Study type: Interventional

Summary: 
      Supplementary oxygen is routinely administered to patients, even those with adequate oxygen
      saturations, in the belief that it increases oxygen delivery. However, oxygen delivery
      depends not just on arterial oxygen content but also on perfusion.

      Maternal oxygen administration has been used in an attempt to lessen fetal distress by
      increasing the available oxygen from the mother. However, the effect of supplemental maternal
      oxygen therapy on fetal acid base status has been debated for more than seven decades.

      The investigators found the use of 2 L/min maternal oxygen during the second stage of labor
      did not adversely affect either the umbilical artery pH value or the fetal heart rate (FHR)
      pattern distribution.
    


Intervention name(s): tight-fitting simple facemask
Intervention type(s): Device
Intervention description(s): Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia
    

Detailed description: 
      To compare the hypnotic efficacy and safety of different dose levels of gaboxadol with
      placebo in non-elderly patients with primary insomnia over two weeks of treatment
    

Intervention name(s): Gaboxadol
Intervention type(s): Drug
Intervention MeSH terms: Gaboxadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Primary insomnia
Treatment of Multiple Sclerosis Using Over the Counter Inosine
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether raising low levels of the natural
      antioxidant uric acid by the administration of a precursor, inosine, has any therapeutic
      effect on the progression of Relapsing Remitting Multiple Sclerosis (RRMS) and secondary
      progressive Multiple Sclerosis (MS).
    

Detailed description: 
      Uric acid is a natural inhibitor of certain chemistries associated with peroxynitrite, a
      product of inflammation. In animal models of multiple sclerosis (MS), these chemical
      reactions have been associated with breakdown of the blood-brain barrier and CNS tissue
      damage. In addition, MS patients have serum uric acid levels that are lower than age- and
      sex- matched healthy individuals. The primary purpose of this study to determine whether
      raising low serum uric acid levels by daily oral administration of its precursor inosine has
      an effect on the cumulative number of newly active lesions on magnetic resonance imaging
      (MRI) and to evaluate the safety and tolerability of inosine in patients diagnosed with
      relapsing remitting and secondary progressive MS.
    

Intervention name(s): Inosine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Relapsing remitting multiple sclerosis; Multiple sclerosis; Peroxynitrite; Uric acid; Inosine