bioihbjkbjnl/mcl2 huggingface dataset:
Vestibular Versus Sublingual Route of AIT Tablets
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the tolerability of the vestibular administration route of birch pollen, grass
      pollen, ragweed pollen, and house dust mite (HDM) AIT tablets compared with the sublingual
      route in adult subjects with allergic rhinitis/conjunctivitis (AR/C)
    

Detailed description: 
      This is a single-center randomised controlled pilot trial conducted in Canada. Subjects will
      be randomised (1:1) to receive vestibular or sublingual birch pollen, grass pollen, ragweed
      pollen, or HDM AIT in tablet form for 28±4 days, followed by 28±4 days of sublingual
      administration only. The ratio will be ~ 1:1:1:1 for tree-, grass-, ragweed-pollen and HDM
      AIT tablet treatments, with a minimum of 30 patients in each allergen group for a total of
      approximately 200 randomised subjects.

      Adults (18-65 years of age) who demonstrate birch, grass, ragweed, or HDM allergen skin prick
      test (SPT) positivity and with a history of birch pollen-, grass pollen-, ragweed pollen-, or
      HDM allergen-induced AR/C, with or without asthma are eligible for the trial.

      Data for the primary endpoint of severity of treatment-related AEs will be collected during
      the first 28±4 days of treatment. The trial consists of 3 trial periods: a screening period
      (up to 12 weeks), a randomised two-arm treatment period of 28±4 days, and a single-arm
      sublingual treatment follow-up period of 28±4 days.

      Screening period: Subjects will be evaluated based on eligibility criteria at visit 1 (V1).

      Treatment period: the randomisation visit will be performed (V2) and eligible subjects
      randomised in a 1:1 ratio to vestibular or sublingual AIT tablet with the appropriate
      allergen for their allergen sensitization. At day 28±4, a visit will be conducted (V3) for
      all subjects previously receiving vestibular AIT to be switched to sublingual AIT with the
      appropriate allergen for their allergen sensitization. Subjects previously receiving
      sublingual AIT will remain on their previous treatment. All subjects will discontinue
      treatment after 56±8 days on treatment (V4). Subjects who would like to continue the
      sublingual immunotherapy tablets will be permitted to do so based on physician judgment and
      own expense but will no longer be part of the study.
    

Intervention name(s): tree 12 SQ-Bet; GRASS 2800 BAU; RAGWEED 12 AMB A 1-U; HDM 12 SQ-HDM
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): DAILY DOSE OF AIT TABLET; DAILY DOSE OF AIT TABLET; DAILY DOSE OF AIT TABLET; DAILY DOSE OF AIT TABLET
Other intervention name(s): ITULATEK; GRASTEK; RAGWITEK; ACARIZAX
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: First month of treatment is taken the vestibular route and the following the sublingual
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's
      formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation
      (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fasting conditions and
      to assess the bioequivalence.
    

Detailed description: 
      An open label, balanced, randomized, two treatment, two sequence, two period, single-dose,
      crossover oral bioequivalence study of Clopidogrel Bisulfate 300 mg Tablets of Dr. Reddy's
      Laboratories Ltd., India and Plavix® (Clopidogrel Bisulfate) 300 mg Tablets of Bristol-Myers
      Squibb/Sanofi pharmaceuticals partnership Bridgewater, NJ 0880750086441, USA, in healthy,
      adult, human male subjects under fasting conditions.
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): Clopidogrel Tablets 300 mg
Other intervention name(s): Plavix
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Determine the Clinical Advantage of IV vs PO Acetaminophen
Condition: Inguinal Hernia
MeSH terms: Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      There is limited research on the clinical outcome differences between intravenous (IV)
      acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen
      sometimes being almost 100 times the cost of PO acetaminophen, it is not only important
      fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The
      proposed research study is to determine the clinical advantages of IV vs PO acetaminophen
      during the post-operative recovery time for ambulatory surgery patients by analyzing
      differences in time to first opioid delivery, pain scores, and patient satisfaction.
    

Detailed description: 
      In previous literature it has been shown that compared to placebo, IV acetaminophen can
      improve postoperative pain scores and reduce opioid requirements. In addition, IV
      acetaminophen has several pharmacokinetic properties that may be beneficial when compared to
      acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum
      plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative
      effectiveness trials of IV vs PO administration have not conclusively demonstrated improved
      clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be
      conducted to determine possible clinical advantages.
    

Intervention name(s): Acetaminophen IV Soln; Oral Acetaminophen; Placebo Pills; Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1000mg of IV acetaminophen; oral acetaminophen 975mg pills; placebo match to acetaminophen; Intravenous saline
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acetaminophen; Tylenol; Intravenous versus oral
Effects of Compression Stockings on Obstructive Sleep Apnea in Patients Under Hemodialysis
Condition: Renal Failure Chronic Requiring Dialysis; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      To study the effects of compression stockings on sleep apnea in hemodialysis patients with
      diagnosed obstructive sleep apnea. The rationale of this study consists in the fluid shift
      theory, which consists in the nocturnal rostral fluid shift from legs, which causes upper
      airways edema.

      The aim of this study is to evaluate if compression stockings could improve such nocturnal
      volume redistribution and, therefore, improve obstructive sleep apnea.
    

Detailed description: 
      Investigators will apply the following methods:

        -  Sleep study, performed through polysomnography

        -  Fluid redistribution, by bioimpedance analysis

        -  Autonomic nervous system evaluation, by spectral heart rate variability analysis.

      The study protocol comprises two moments: baseline evaluation (in patients with diagnosed
      sleep apnea) and after using compression stockings for a one-week period.
    

Intervention name(s): Compression Stockings
Intervention type(s): Device
Intervention description(s): To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis; Obstructive sleep apnea; Compression stockings
Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to
      placebo in increasing time from randomisation to an anxiety event in patients with
      generalised anxiety disorder (GAD).

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine SR
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Generalised Anxiety Disorder
Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The aim of this prospective study is to evaluate the clinical performance of fanfilcon A
      toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.
    

Detailed description: 
      The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality
      toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1
      month of wear in each pair.
    

Intervention name(s): Fanfilcon A toric lens; Lotrafilcon B toric lens
Intervention type(s): Device; Device
Intervention description(s): Contact lens; Contact lens
Other intervention name(s): Avaira Vitality toric lens; AIR OPTIX for Astigmatism
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Healthy Approach to weIght Management and Food in Eating Disorders (HAPIFED)
Condition: Binge Eating Disorder; Bulimia Nervosa; Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Study type: Interventional

Summary: 
      The investigators have developed a new integrated therapy, namely a Healthy Approach to
      weIght management and Food in Eating Disorders (HAPIFED). HAPIFED is an enhanced behavioral
      weight loss therapy integrated with CBT for the management of EDs. HAPIFED uses CBT to treat
      ED behaviors and body image distress, whilst simultaneously emphasize a healthy lifestyle,
      the role of food and physical activity in mood regulation, and revised but clinically
      meaningful goals for weight loss. The investigators propose a randomized controlled trial
      (RCT) that will compare HAPIFED to CBT-E in people with obesity and either BN or BED. The two
      main aims will be to reduce symptoms of ED and to improve weight management. The RCT will be
      conducted in Sydney and in São Paulo with a one year follow-up.
    

Detailed description: 
      In sum, a new approach in management of the increasing numbers of obese people with BN and
      BED is needed. The investigators propose a RCT that will compare a novel therapy HAPIFED with
      the current 'gold-standard' trans diagnostic treatment, CBT-E. HAPIFED has been developed by
      the CIs and is based on recent developments in psychological approaches to obesity in general
      (as highlighted in Casazza et al.'s (2013) paper on "Myths, presumptions and facts about
      obesity") and in people with co-morbid obesity and BN or BED. Unlike CBT-E, it allows reduced
      energy intake and education around specific food choices - a necessary element in weight
      loss.
    

Intervention name(s): HAPIFED; CBT-E
Intervention type(s): Behavioral; Behavioral
Intervention description(s): HAPIFED is adapted from CBT to promote a positive relationship with food, eating and activity, appetite awareness, and weight loss to be achieved over a longer and more intensive period of therapy, thus recognizing the importance of longer-term therapy in weight loss (Casazza et al., 2013). Notably, HAPIFED is also multidisciplinary. Clinical practice and consensus views are to utilize the special expertise of dietitians and other allied health professionals (Robinson, 2009).; CBT-E therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: BED; Binge Eating Disorer; BN; Bulimia Nervosa; Obesity
SB-742457 And Donepezil In Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it
      has on the symptoms of mild to moderate Alzheimer's Disease. SB-742457 is a new treatment
      which is thought to increase the levels of certain chemicals in the brain that are often
      decreased in patients with Alzheimer's Disease.
    


Intervention name(s): SB-742457; donepezil
Intervention type(s): Drug; Drug
Other intervention name(s): SB-742457
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alzheimer's Disease; cognition global functioning; symptomatic; SB-742457
Effect of Simethicone on Eustachian Tube Dysfunction
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to measure the effects of a chewable Simethicone tablet taken by mouth
      on middle-ear pressure in adults with a common cold and evidence of abnormal middle-ear
      pressure. In children and adults, middle-ear diseases such as otitis media (the buildup of
      fluid within the middle ear) and a form of temporary hearing loss occur if the Eustachian
      tube does not open, does not open often enough or is always open. Simethicone, available
      over-the-counter under several brand names including Gas-X, may help break up the bubbles
      that may block the opening of the Eustachian tube in the back of the nose during a cold,
      allowing air to pass between the nose and middle ear. This study requires a single visit to
      the Middle Ear Physiology Laboratory in the Oakland section of Pittsburgh. If eligible for
      the study, Eustachian tube function testing will be done; the Simethicone tablet or placebo
      (a tablet that looks and tastes like the Simethicone tablet but has no active ingredient)
      will be given and Eustachian tube function testing repeated.
    

Detailed description: 
      For the Eustachian tube function testing, the subject and a technician are seated comfortably
      within a pressure chamber, a room-like chamber in which the air pressure can be varied much
      like in an airplane or submarine. Middle ear pressure will be measured in each ear by
      tympanometry, a test done by inserting a small probe (an earplug attached to a rubber or
      plastic tube that measures ear pressure) half-way into the ear canal and changing the
      pressure in the probe. Then, microphones will be placed in the ear canals and a sound source
      placed into one nostril. The chamber pressure is then decreased and increased to various
      pressures and middle ear pressure is measured at these various pressures.
    

Intervention name(s): Simethicone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single 125 mg chewable tablet; chewable calcium tablet
Intervention MeSH terms: Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eustachian tube; otitis; middle-ear pressure; simethicone
Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.
Condition: Bipolar Depression; Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in
      animal models.

      This study is being conducted to obtain information regarding the safety, tolerability and
      pharmacokinetics of repeated doses of GSK1014802 administered for up to 28 days in healthy
      male or female subjects. In addition, the effect of food on the pharmacokinetics of
      GSK1014802 will be investigated.
    

Detailed description: 
      This study, previously posted by GlaxoSmithKline (GSK), was transitioned to Convergence
      Pharmaceuticals, Ltd., which spun off from GSK. Convergence Pharmaceuticals, Ltd., has now
      been acquired by Biogen.
    

Intervention name(s): Placebo; GSK1014802
Intervention type(s): Drug; Drug
Intervention description(s): Tablets to match GSK1014802; Sodium channel blocker
Other intervention name(s): BIIB074 and CNV1014802
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sodium channel blocker; bipolar disorder; repeat dose
A Randomized Phase II Clinical Trial on the Efficacy of Axitinib as a Monotherapy or in Combination With Lomustine for the Treatment of Patients With Recurrent Glioblastoma
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial will recruit patients diagnosed with glioblastoma at the time of
      recurrence or progression following prior treatment with surgery, radiation therapy and
      alkylating chemotherapy. Patients will be screened and if found eligible will be randomized
      to one of two treatment arms (1:1 randomization). Patients randomized to the Axitinib
      treatment-arm will be treated with Axitinib until progression (they can be treated after
      progression in the Axitinib plus lomustine arm), unacceptable treatment related toxicity, or
      patients refusal to continue study treatment. Patients randomized to the Axitinib plus
      Lomustine-arm will receive treatment until progression, unacceptable treatment related
      toxicity, or patients refusal to continue study treatment.
    


Intervention name(s): axitinib; Axitinib plus Lomustine
Intervention type(s): Drug; Drug
Intervention description(s): The starting dose of axitinib (AG-013736) is 5 mg BID administered orally with food.; Lomustine 90mg/m²
Other intervention name(s): Inlyta (TM); CCNU
Intervention MeSH terms: Axitinib; Lomustine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: axitinib; glioblastoma; recurrent
Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults
Condition: Hyperglycemia
MeSH terms: Insulin Resistance; Hyperglycemia
Study type: Interventional

Summary: 
      This study tested the effects of resistant starch type 4 on blood sugar and hunger in young
      adults with Type 2 diabetes.
    

Detailed description: 
      To measure the blood glucose response, after an overnight fast, blood samples were collected
      before eating and at 15, 30, 45, 60, 90, and 120 minutes after each each bar. The incremental
      area under the curve was used to calculate the glycemic index and insulin sensitivity via
      minimal model.
    

Intervention name(s): Resistant starch type 4 - raw; Resistant Starch Type 4 - Cooked; Dextrose; Puffed Wheat
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dose: 80g bar containing Resistant Starch Type 4 - raw; Dose: 80g bar containing Resistant Starch Type 4 - cooked; Dose: 7 oz of oral glucose tolerance beverage; Dose: 80g bar containing puffed wheat cereal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Diabetes; Diet; Fiber; Age
iSTART: A Campus & Community Initiative for Services in Tec-health
Condition: Substance Use; Binge Drinking; Marijuana Use; Alcohol Drinking; Prescription Opioid Misuse; Illicit Drug Use
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Binge Drinking; Alcohol Drinking; Marijuana Use
Study type: Interventional

Summary: 
      The iSTART intervention is a 30-day substance prevention web-app whereby students complete
      five weekly interactive modules using a smart device or computer. Each module is
      approximately 15 minutes long, and focuses on a select substance: (i) alcohol, (ii)
      marijuana, (iii) nicotine, (iv) prescription drugs, and (v) illicit drugs. The modules are
      based on key theoretical constructs, behavior change strategies, and practical module
      components: attitudes (knowledge), perceived susceptibility (risk perceptions), subjective
      norms (normative re-education), and self-efficacy (refusal skills). This intervention will be
      evaluated via a time series design using a sample of 600 students randomly assigned to either
      the intervention, comparison, or control condition at a public institution in southern
      California.
    


Intervention name(s): iSTART Web-app
Intervention type(s): Behavioral
Intervention description(s): 30-day substance prevention web-app for students at a Hispanic Serving Institution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Web-app; Module; mHealth
Cumulative Skin Irritation Potential of a New 25 mg Nicotine Patch
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      An investigation on the cumulative skin irritation potential of a newly developed 25 mg
      nicotine patch. Evaluation of skin irritation of a newly developed 25 mg nicotine transdermal
      patch
    

Detailed description: 
      Study on the cumulative skin irritation potential of a newly developed 25 mg nicotine
      transdermal therapeutic system. A double blind, randomized, repeat patch test, single center
      study in 42 healthy male and female subjects.
    

Intervention name(s): Nicotine Patch; Placebo Patch; SLS Comparator Patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days.; Placebo Patch applied on the lower back, according to treatment sequence, daily for 21 days.; 0.1% (w/v) SLS patch applied on the lower back, according to treatment sequence, daily for 21 days.
Other intervention name(s): Experimental Nicotine Patch; Placebo Paatch Comparator; SLS Comparator
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of
      multiple parallel doses of PF-00734200 following oral administration to adult human subjects
      with T2DM who currently are on a stable dose of metformin.
    


Intervention name(s): Placebo; PF-00734200 10 mg QD; PF-00734200 20 mg QD; PF-00734200 5 mg QD; PF-00734200 2 mg QD
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo QD; 10 mg QD; 20 mg QD; 5 mg QD; 2 mg QD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment