bioihbjkbjnl/mcl2 huggingface dataset:
Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The overarching aim of this trial is to evaluate naltrexone's efficacy in light of genetic
      variation and brain response to alcohol cues utilizing a neuroimaging paradigm. This trial
      has four specific aims. First, this trial will evaluate whether the presence of the OPRM1
      Asp40 allele substitution is associated with improved treatment response to naltrexone in
      treatment-seeking alcoholics. Second, it will evaluate whether there is a difference in the
      naltrexone dampening of the alcohol cue-induced brain activation dependent on OPRM1 genotype.
      Third, it will explore whether alcohol cue-induced brain activation dampening by naltrexone
      might be a mediating factor in the treatment effects of naltrexone, the OPRM1 gene, or their
      interaction that might be observed in the first aim. Finally, this trial will evaluate the
      effect of medication compliance, or adverse effects, on the observed medication by genotype
      treatment response. A secondary aim will measure medication compliance and side effects based
      on OPRM1 genotype.
    


Intervention name(s): Naltrexone 50 Mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Naltrexone 25 or 50 mg per titration schedule; placebo
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcohol Dependence; Alcoholism; Naltrexone; Substance Abuse; Genetics
Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      This is an observational study to determine the prevalence of moderate to severe Crohn's
      disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a
      standard clinical practice.
    


Intervention name(s): Physician standard-of-care
Intervention type(s): Drug
Intervention description(s): Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with diagnosed active Crohn's Disease who are inadequately controlled with
        their current therapy
      
Keywords: Crohn's disease; standard-of-care; Crohn Disease; Active Crohn's Disease
Observational Study to Assess the Frequency of Lidocaine Ineffectiveness in Hard-to-treat ADHD
Condition: ADHD
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This work will assess the prevalence in hard-to-treat ADHD of the ineffectiveness of the
      anesthetic Lidocaine.
    

Detailed description: 
      Using a non-invasive, pain-free, taste-based approach to assess lidocaine effectiveness, the
      study will assess the frequency of ineffectiveness in the target population.
    

Intervention name(s): Lidocaine gel
Intervention type(s): Drug
Intervention description(s): Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg
Other intervention name(s): Intervention
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Intervention model description: Using a taste-based test before and after the application of lidocaine gel to the tongue, we will assess the degree to which lidocaine is effective at blocking taste in those with hard-to-treat ADHD
Masking: None (Open Label)
Primary purpose: Health Services Research
Community Pediatric Acceptability Study (CPAS)
Condition: Otitis
MeSH terms: Otitis
Study type: Interventional

Summary: 
      Ear infections, or otitis media, are a leading cause of health expenditures and antimicrobial
      prescriptions in children. Diagnosis of otitis media requires the ability to view the
      tympanic membrane. An instrument called an otoscope with a light source and a magnifying lens
      with a plastic tip that conforms to the ear canal is currently the standard of care for
      examining the tympanic membrane. Interpretation of otoscopic examinations is
      operator-dependent and cannot be seen by anyone other than the person holding the otoscope. A
      pocket size attachment that uses the technology and light source of a smartphone to capture
      images of the ear canal and tympanic membrane facilitates image documentation of the otic
      examination. In previous studies with the device, the investigators have shown that image
      quality of photographs of the tympanic membrane taken with the smartphone otoscope are
      equivalent to those taken with a camera-fitted conventional otoscope.

      In this study, the Community Provider Assessment Study (CPAS), the investigators will perform
      a cross-sectional study in which they will randomly assign 3-4 pediatricians to use a
      smartphone otoscope as the standard of care device for all ear examinations and 3-4
      pediatricians to use a conventional otoscope for alternating 1 month periods for 6 months.
      The parents of children examined during the study period with both devices will be invited to
      participate in 3 telephone surveys assessing parental satisfaction with the device and
      antimicrobial use by their child for the otic complaint. The results of this study have the
      potential to improve diagnosis and management of otitis media, thus improving patient care,
      reducing costs, and decreasing the opportunity for the development of antimicrobial
      resistance.
    


Intervention name(s): Conventional otoscope; Smartphone otoscope
Intervention type(s): Other; Other
Intervention description(s): The conventional analogue otoscope will be used to provide a two-dimensional view of the ear canal. Clinicians will use this for one month periods for a total of 3 months.; The smartphone otoscope is a pocket size smartphone attachment that uses technology and light source of a smartphone to capture reproducible images of the middle ear and tympanic membrane. Images and videos can be transmitted via real-time communication software from the device to another smartphone. Clinicians will use this for one month periods for a total of 3 months.
Other intervention name(s): CellScope-Oto
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of Oral RO7020531 in Chinese Healthy Participants.
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of single and multiple ascending doses of oral
      RO7020531 in Chinese healthy participants.
    


Intervention name(s): RO7020531; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.; Placebo hard capsules will be administered orally as per the dosing schedules described above.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on
      symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects
      exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.
    


Intervention name(s): Placebo; Prasterone (DHEA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vulvovaginal atrophy (VVA); Vaginal atrophy; Atrophic vaginitis; prasterone; DHEA; Intrarosa
Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis
Condition: Spondylarthropathies; Magnetic Resonance Imaging
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Spondylarthropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      Axial Spondyloarthritis (SpA) is a kind of inflammatory arthritis which includes ankylosing
      spondylitis. Common symptoms of axial SpA are inflammatory back pain, morning stiffness,
      peripheral arthritis, enthesitis. Controlling aforementioned symptoms are one of the goal in
      treatment, and another goal is preventing bony ankylosis of axial skeleton such as spine.
      Ankylosis can limit range of motion and lower the quality of life.

      Non-steroidal antiinflammatory drug (NSAID) and Tumor necrosis factor (TNF)-a inhibitor are
      the current treatment options for axial SpA. These medications can improve pain and stiffness
      of axial SpA patients, however preventing bony ankylosis is not proven. Current study showed
      attenuating inflammation at early stage could prevent further bony destruction and ankylosis
      in axial SpA. Present study is designed to discover the therapeutic effect of NSAID whether
      NSAID could recover the early inflammatory bony change (bone marrow edema at MRI) and prevent
      further bony change.
    


Intervention name(s): Celecoxib
Intervention type(s): Drug
Intervention description(s): Continue celecoxib 400mg/day for 3months in axial spondyloarthritis patients.
Intervention MeSH terms: Celecoxib
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-drug Interaction Study of Eltrombopag and Cyclosporine in Healthy Subjects
Condition: Purpura, Thrombocytopenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      A drug-drug interaction study between eltrombopag and cyclosporine is being conducted to
      support the use of these drugs together in subjects, such as those with severe aplastic
      anemia or immune thrombocytopenia purpura. The primary objective of the study is to evaluate
      the effect of cyclosporine on the pharmacokinetics of eltrombopag. This is a Phase I,
      open-label, randomized, three-period cross-over study in healthy adult subjects. The study
      consists of a screening visit and three treatment periods. All subjects will be randomized to
      receive one of the three treatments in each treatment period separated by washout periods of
      3-10 days. The total duration of a subject's participation in the study from screening to
      final discharge is up to approximately 6 weeks (assuming 3 day washouts between treatment
      periods). Approximately 39 healthy subjects will be enrolled with the goal of completing at
      least 10 subjects per sequence (total 30).
    


Intervention name(s): Eltrombopag; Cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): White to off white bi-convex round tablets containing eltrombopag 50 mg for oral administration; Soft gelatine capsule containing cyclosporine 100 mg for oral administration. Cyclosporine will be administered at the doses of 200 mg (2 x 100 mg capsules) or 600 mg (6 x 100 mg capsules)
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cyclosporine; drug-drug interaction; pharmacokinetics; eltrombopag; SB-497115
A Safety Study of LY3526318 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about how the drug is absorbed in to the
      blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318
      will also be evaluated when given by mouth either by single or multiple doses to healthy
      participants. The study will have two parts. Each participant will enroll in only one part.
      For each participant, Part A will last up to 44 days and Part B will last up to 50 days,
      including screening and follow-up.
    


Intervention name(s): LY3526318; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluation of [18F]PI-2620 as a Potential Positron Emission Computed Tomography Radioligand for Imaging Tau Protein in the Brain
Condition: Healthy Volunteer; Alzheimer Disease; Frontotemporal Dementia; Parkinson Disease
MeSH terms: Parkinson Disease; Alzheimer Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall goal of this imaging trial is to evaluate [18F]PI-2620, a tau targeted positron
      emission computed tomography radioligand, in individuals with tauopathies and healthy
      volunteers (HV).
    


Intervention name(s): [18F]PI-2620
Intervention type(s): Drug
Intervention description(s): Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other intervention name(s): FluoroTau
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: [18F]PI-2620, tauopathy, positron emission computed tomography
Intravenous Lidocaine in Open Lung Resection Surgery
Condition: Lidocaine; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Management of postoperative pain in 2020 remains a challenge for anesthesiologists in the
      perioperative period. Lidocaine is an amide local anesthetic, it is one of the oldest
      adjuvant analgesics and is known to possess analgesic, anti-hyperalgesic and
      anti-inflammatory properties. Lidocaine is proven to be as effective as epidural analgesia in
      colorectal surgery.

      However, no study has evaluated the effect of a continuous lidocaine infusion for open lung
      resection in the post-operative period. The present study aims to evaluate the influence of
      IV lidocaine given during and 24 hours after surgery, on pain scores, opioid consumption, and
      possible benefits on patient outcome via the opioid-sparing effect in open thoracic surgery
    


Intervention name(s): Lidocaine Iv; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the Lidocaine group received a bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery; Patients in Group Placebo received an equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Safety Study of a Topical Treatment for Dry Age Related Macular Degeneration
Condition: Nonexudative Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the safety and tolerability of MC-1101, a potential topical treatment for
      non-edxudative age Related Macular Degeneration (AMD) in medically stable individuals.
    

Detailed description: 
      MC-1101 is a topical version of a previously approved anti-hypertensive drug that is intended
      to increase choroidal blood flow.

        -  A reduction of choroidal blood flow has been identified in patients with AMD

        -  This study will evaluate 0.5% and 1.0% potencies of MC-1101 delivered 2X per day.
    

Intervention name(s): MC-1101, Placebo
Intervention type(s): Drug
Intervention description(s): One drop 0.5%; MC-1101; One drop 1.0% MC-1101, One drop Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Non-exudative, dry AMD
Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This randomized, double-blind, placebo controlled, parallel and multiple dose study provided
      safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and
      BMS-224818 in subjects with RA
    


Intervention name(s): Belatacept; Abatacept
Intervention type(s): Drug; Drug
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state
      pharmacokinetics (PK) of sotagliflozin.

      Secondary Objectives:

        -  To assess the safety and tolerability of multiple-dose sotagliflozin with and without
           co-administration of multiple-dose HCTZ

        -  To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ

        -  To assess the effects of multiple-dose HCTZ on the steady-state PK of
           sotagliflozin-3-O-glucuronide
    

Detailed description: 
      Duration of the study for each subject will be between 33 to 77 days, including screening up
      to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment
      Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal
      Product (IMP) in Period 2.
    

Intervention name(s): Sotagliflozin (SAR439954); Hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Tablet
Route of administration: Oral; Pharmaceutical form: Tablet
Route of administration: Oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Hydrochlorothiazide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Predicting Analgesic Response to Acupuncture: A Practical Approach
Condition: Chronic Low Back Pain; Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      In this placebo controlled, patient and assessor blinded clinical trial, the investigators
      will administer electroacupuncture vs sham electroacupuncture to patients suffering from
      chronic low back pain, and monitor their symptoms as well as collecting objective outcome
      measures. The investigators objective is to identify predictors of pain reduction and
      functional improvement with electroacupuncture vs placebo.
    


Intervention name(s): Real Acupuncture with Electrical Stimulation; Simulated Acupuncture with Electrical Stimulation
Intervention type(s): Other; Other
Intervention description(s): Acupuncture is a therapy commonly used in East Asian countries, where the practitioner insert thin needles at specific body sites in order to relieve pain and illnesses. Recent studies found low frequency electricity applied through acupuncture needles can lead to profound pain relief by increasing endorphin levels in the central nervous system. Electroacupuncture will thus be used as the active intervention to treat chronic low back pain in this clinical study.; This intervention serves as the placebo control of the active intervention. Sterile acupuncture needles and the ITO electrical stimulators will be used in this intervention. But special care will be taken to have this intervention mimic the real treatment yet remaining as physiologically inert as possible.
Other intervention name(s): Verum Electroacupuncture; Traditional acupuncture needles; ITO® ES-130® electrical stimulator; Sham Electroacupuncture / Placebo Electroacupuncture; Sterile Acupuncture Needles; ITO® ES-130® electrical stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Back Pain; Chronic Pain
Obesity, Oral Contraception, and Ovarian Suppression
Condition: Ovarian Suppression
MeSH terms: Vision Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study proposes a double blind randomized clinical trial to include normal weight and
      obese women who have normal ovulatory function at baseline; the investigators will randomize
      women to 2 widely used OCs and evaluate ovarian follicle development and circulating
      progesterone to assess ovarian suppression during OC use.
    

Detailed description: 
      There is a large gap between lowest expected failure rates of about 1.5% and typical use
      failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral
      contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC
      failure among heavier women, particularly those using the lowest doses. The prevalence of
      obesity in the US population has recently increased to about 23% in women aged 20-29, peak
      years for OC use. OC physiology and effectiveness have not been evaluated in obese women.
    

Intervention name(s): Low dose formulation; High dose formulation
Intervention type(s): Drug; Drug
Intervention description(s): Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use.
Dose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonorgestrel (LN) per tablet.; Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use.
Dose formula contains 30 ug of ethinyl estradiol (EE) and 150 ug of levonorgestrel (LN) per tablet.
Other intervention name(s): Low dose; High dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ovarian Suppression; Oral Contraceptives; Obese and Normal BMI