bioihbjkbjnl/mcl2 huggingface dataset:
The Liver Health Study for Patients With NAFLD
Condition: Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis; Obesity
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The study will investigate whether the level of fat stored in the liver is related to the
      liver's ability to burn fat.
    

Detailed description: 
      The study has two phases. In Phase I, liver samples from patients undergoing bariatric
      surgery or a diagnostic liver biopsy will be tested for the ability to burn fatty acids. In
      Phase II, patients with nonalcoholic fatty liver disease will participate in either a
      nine-month lifestyle treatment program or undergo standard care. The goal is to determine how
      weight loss and exercise improve liver health.

      Inpatient comprehensive metabolic tests are performed before and after the nine-months.
    

Intervention name(s): Phase II: Lifestyle treatment; Phase II: Control treatment; Phase I: Observational studies
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Subjects will undergo energy restriction and exercise training over a 9 month period.; Subjects will receive dietary advice and receive information on a stretching program.; The liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will undergo in vitro assays to determine the capacity of the tissue to burn fat
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: In Phase I, liver samples derived from patients undergoing either bariatric surgery or a liver biopsy to diagnose nonalcoholic fatty liver disease, are tested one time in vitro. There is no treatment in Phase I.
In Phase II, only patients with nonalcoholic fatty liver disease (and not those who have had bariatric surgery) are eligible to go into a study in which they are randomly assigned to 1) a lifestyle treatment program or 2) a control group undergoing standard care. Allocation is 2:1 subjects in the treatment vs standard care groups.
Thus, the arms are:
Arm 1: Phase I studies with no treatment, only observational data generated in vitro from the liver samples Arm 2: Phase II lifestyle treatment Arm 3: Phase II control standard of care
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Nonalcoholic fatty liver; Exercise; Weight loss diet
Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Currently, topical antihistamines and corticosteroids are mainly used for itching relief.
      However, the over the counter antihistamines are not effective on all itch conditions.
      Acetaminophen is a popular and widely used OTC drug for pain relief. Although its mode of
      action is still unknown, recent studies have shown that acetaminophen indirectly activates
      cannabinoid CB1 receptors. Recent studies have shown that topical cannabinoid agonists are
      effective for itch relief, the efficacy of topical acetaminophen will be tested for
      non-histaminergic itch relief.
    

Detailed description: 
      This will be a single-blinded, vehicle-controlled randomized study in healthy controls to
      test the efficacy of the topical gel formulation with three differing concentrations of
      acetaminophen (APAP) for itch relief. To detect medium effects of the treatments with a given
      α of 0.5 and an error probability of 0.05, with a power of 0.95, the number of participants
      needed is 36 (10 within post hoc pairwise comparisons).
    

Intervention name(s): Acetaminophen; Carbomer 980
Intervention type(s): Drug; Drug
Intervention description(s): Topical acetaminophen gel; Topical vehicle gel
Other intervention name(s): Topical acetaminophen gel; Topical vehicle gel
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The antipruritic effect of 3 topical treatments of varying doses and 1 vehicle treatment will be explored in each subject. One study visit will consist of testing all topical formulations on histaminergic induced itch, and second study visit will test all topical formulations on non-histaminergic induced itch.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treatment for Caffeine Dependence
Condition: Caffeine Use Disorder (DSM-5 Condition for Further Study)
Study type: Interventional

Summary: 
      Recent research has shown that some individuals become addicted to or dependent on caffeine
      and are unable to quit or reduce caffeine consumption despite a persistent desire to do so.
      The aims of the current study are to characterize caffeine use among individuals with
      physical or psychological dependence on caffeine and evaluate a manual-based intervention to
      promote caffeine reduction and cessation.
    

Detailed description: 
      A large percentage of caffeine users in the general population (56%) report a persistent
      desire or unsuccessful efforts to stop or reduce caffeine consumption. The aim of Study 1 is
      to recruit and identify individuals who are interested in receiving treatment to reduce or
      quit caffeine consumption. Individuals will be recruited from Baltimore, MD and surrounding
      communities via flyers and newspaper and radio advertisements. Those who are eligible will be
      invited to come to the Behavioral Pharmacology Research Unit located on the Johns Hopkins
      Bayview Medical Center campus in Baltimore, MD. After consent is obtained at intake (consent
      form A), a series of questionnaires will be completed (e.g., demographics, caffeine history,
      medical and psychiatric history, mood), followed by a structured clinical interview that will
      assess caffeine use and dependence. Individuals who meet eligibility criteria will be offered
      the opportunity to receive assistance to reduce or quit caffeine. Those who consent (consent
      form B) to enroll in the second phase of the project will be randomly assigned to one of two
      conditions: 1) immediate treatment or 2) delayed treatment. The conditions will be identical
      with the exception of a 6 week delay for the delayed treatment group. Participants will
      receive a caffeine reduction and cessation treatment manual during a brief treatment session
      at week 1. Treatment progress will be assessed during a study session approximately 7 weeks
      post-treatment, during a telephone interview approximately 8 weeks post-treatment, and during
      a follow-up telephone call approximately 27 weeks after the treatment session. Progress will
      be assessed via questionnaires, food diaries, and salivary caffeine measures.
    

Intervention name(s): Manual-based treatment for caffeine dependence
Intervention type(s): Behavioral
Intervention description(s): Participants will meet with a counselor to discuss plans for caffeine reduction or cessation, and they will receive a manual-based treatment to help guide them through caffeine reduction or cessation.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: caffeine dependence; caffeine withdrawal; caffeine use disorder
Benefits of Cycling Wheelchair Training for Elderly With Physical Disability
Condition: Aged; Disable; Exercise; Rehabilitation; Wheelchair
Study type: Interventional

Summary: 
      To investigate the feasibility of cycling wheelchair training as an exercise for elderly
      disabled patients, and to determine its effects on cognition, quality of life, aerobic
      capacity and physiological markers. We measure SF-12. Other outcome measures included the
      Mini-Mental State Examination, Aero bike workload test, resting blood pressure (systolic and
      diastolic), and heart rate.
    


Intervention name(s): Cycling wheelchair
Intervention type(s): Device
Intervention description(s): Apply the mechanical principle of pedaling on a bicycle to a conventional wheelchair
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of the Gut Hormone Analogue G3215 in Adult Subjects
Condition: Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomised, placebo controlled Phase I study to investigate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of G3215 in adult subjects.
    

Detailed description: 
      Objectives:

      Primary Objective

        -  To investigate the safety and tolerability of single doses of G3215 in overweight but
           otherwise healthy male subjects.

        -  To investigate the safety and tolerability of multiple doses of G3215 in overweight male
           subjects with mild stable Type 2 diabetes or prediabetes.

      Secondary Objectives • To assess the pharmacokinetic (PK) profile of single and multiple
      ascending doses of G3215 in overweight but otherwise healthy male subjects or overweight /
      obese male subjects with mild stable Type 2 diabetes or prediabetes.

      Exploratory Objective

      • To investigate the effects of multiple doses of G3215 on food consumption, body weight,
      enteropancreatic hormone changes and glucose tolerance in overweight male subjects with mild
      Type 2 diabetes or prediabetes.
    

Intervention name(s): G3215; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Gut hormone analogue; 0.9% saline
Other intervention name(s): Saline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: obesity; diabetes mellitus; glucagon-like peptide-1
Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP)
      versus varenicline.
    

Detailed description: 
      This component builds directly upon the results of the previously funded project in
      systematically investigating the impact of short-term ovarian hormone fluctuation on females
      as they try to quit smoking with the aid of either transdermal nicotine patch (TNP) or
      varenicline. Each participant will receive a standardized impulsivity evaluation and a
      laboratory-based cue reactivity assessment before the initiation of smoking cessation.
      Progesterone and estrogen levels will be measured at each of nine visits, thereby providing
      an index of reproductive hormone variation over the course of each participant's quit
      attempt. This novel approach of integrating a human laboratory cue reactivity paradigm
      directly with a treatment outcome study will permit us to assess whether or not smoking cue
      reactivity has predictive utility with respect to cessation outcome. Subjects will be
      randomized to receive one of two active pharmacotherapeutic interventions for smoking
      cessation: TNP vs. varenicline in a randomized, single-blind, double dummy design. While TNP
      has demonstrated modest efficacy in improving smoking cessation outcomes, there is some
      evidence that its efficacy may be more robust in men as compared to women. This project will
      provide important information about a) the impact of ovarian hormone levels on smoking
      cessation outcomes, b) the relationship between smoking cue reactivity and smoking cessation,
      and c) comparison between a new pharmacotherapeutic agent and TNP in women.
    

Intervention name(s): varenicline; transdermal nicotine patch
Intervention type(s): Drug; Device
Intervention description(s): Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID
Varenicline is taken for a duration of 4 weeks in this study.; Weeks 0-3: 21mg patch
Transdermal nicotine patch is used for a duration of 3 weeks in this study.
Other intervention name(s): Chantix; Nicoderm CQ
Intervention MeSH terms: Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Menstrual Cycle effects; Cue Reactivity; Smoking Cessation; Impulsivity
An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      An international, multi-centre, prospective, non-controlled, open, single-group, 8-week trial
      in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.
    

Detailed description: 
      A phase 2 trial evaluating the safety and efficacy of once daily use of LEO 80185 gel
      containing calcipotriol 50 mcg/g plus betamethasone 0.5mg/g (as dipropionate) in adolescent
      subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.
    

Intervention name(s): LEO 80185 gel
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      HIV infected children and adolescents who have taken many anti-HIV drugs may have limited
      treatment options and are at high risk for progressing to AIDS. The purpose of this study is
      to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2
      nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4
      NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV
      treatment.
    

Detailed description: 
      HIV infected children and adolescents on anti-HIV treatment regimens have traditionally had
      more difficulty with non-adherence and drug resistance than adults, often resulting in
      virologic failure. Additionally, HIV infected children with extensive exposure to
      antiretrovirals (ARVs) are likely to have fewer therapeutic options for salvage therapy, and
      their physicians find it difficult to choose regimens that will keep the HIV infection under
      control. This study will compare the efficacy of three 4-drug ARV salvage regimens in
      treatment-experienced, HIV infected children and adolescents who have experienced virologic
      failure.

      This study will last at least 96 weeks. Participants will be randomly assigned to one of
      three groups. Group 1A will receive a dual-PI based regimen of lopinavir/ritonavir (LPV/r),
      saquinavir (SQV), and the NRTIs emtricitabine (FTC) and abacavir sulfate (ABC). Group 1B will
      receive a dual-PI based regimen of LPV/r, SQV, FTC, and tenofovir disoproxil fumarate (TDF).
      Group 2 will receive an NRTI-only regimen of ABC, lamivudine, zidovudine, and TDF.

      There will be 11 study visits during Step I of this study. Medical history, a physical exam,
      and blood collection will occur at all visits. Dual-energy x-ray absorptiometry (DEXA) scans
      will occur at study entry and at Weeks 24, 48, 72, and 96. Urine collection will occur at
      most visits; participants will also take part in adherence modules at most visits.
      Participants will be asked to complete a pill count form at Weeks 4 and 24. Additionally,
      some study participants will be asked to participate in an intensive pharmacokinetics study
      at Week 4.
    

Intervention name(s): Abacavir sulfate; Emtricitabine; Lamivudine; Lopinavir/ritonavir; Saquinavir; Tenofovir disoproxil fumarate; Zidovudine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Lopinavir; Saquinavir; Tenofovir; Lamivudine; Emtricitabine; Zidovudine; Abacavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment Experienced; Child
Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers
Condition: Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered
      intravenously in escalating dose levels in comparison to placebo.
    

Detailed description: 
      NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of
      this drug class are hypothesized to be beneficial in a number of central nervous system
      disorders, including brain ischemia associated with subarachnoid hemorrhage, severe pain,
      major depression and substance abuse disorders. This study uses a double blind, adaptive
      design approach to evaluate the safety, tolerability and pharmacokinetics of a single dose of
      NP10679 when delivered intravenously in up to six escalating dose levels in comparison to
      placebo.
    

Intervention name(s): Placebo; NP10679
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous vehicle; NP10679
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Adaptive design of placebo and up to six escalating doses of NP10679
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Test of Chamber Pressure to Divers and Chamber Attendants
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      SCUBA divers and chamber inside attendants will undergo a brief hyperbaric chamber excursion
      and will be asked to what chamber pressure they were compressed and what gas they breathed.
    

Detailed description: 
      In clinical trials evaluating hyperbaric oxygen, blinding can be challenging. Options for
      participant blinding include offering regular air at a lower pressure than the hyperbaric
      oxygen intervention, or compressing all participants to the same pressure but providing
      different gas mixes to the active and sham arms.

      In some trials of hyperbaric oxygen for brain injury, investigators offer a sham chamber
      session (regular air at 1.2 atmospheres absolute [atm abs]) compared to the active
      intervention, hyperbaric oxygen (100% oxygen at 1.5 atm abs). It is unknown whether
      individuals familiar with pressure changes, such as divers and hyperbaric chamber inside
      attendants, could discern the difference between these pressures and thereby become unblinded
      to study allocation.

      In this study, 80 experienced divers and chamber inside attendants will be enrolled and
      randomly assigned to one of four possible chamber pressures and one of two breathing gases.
      After a brief hyperbaric chamber excursion, they will be asked to what chamber pressure they
      were compressed and what gas they breathed. If participants can accurately report chamber
      pressure or breathing gas, pressure-familiar individuals should be excluded from blinded
      clinical trials of hyperbaric oxygen.
    

Intervention name(s): Hyperbaric Oxygen (1.5 atm abs); Sham Chamber Session
Intervention type(s): Drug; Drug
Intervention description(s): Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.; Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
Other intervention name(s): HBO2; HBO; HBOT; Sham control; Air pressurization
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Hyperbaric oxygen
Intubation With Different Angles of the Intubation Tube Using C-macr d Blade Videolaringoscope;
Condition: Intubation; Difficult or Failed; Sore-throat; Hoarseness
MeSH terms: Pharyngitis; Hoarseness
Study type: Interventional

Summary: 
      In this study we compared the intubation success, time needed for intubation, subglottic
      damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal
      intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.
    

Detailed description: 
      In this study we compared the intubation success, time needed for intubation, subglottic
      damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal
      intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.
      After the approval of the Ethics Committee, patients were randomized into three groups with
      closed envelope technique. In Group A endotracheal tube (ETT) is shaped into an angel of 90
      degrees, in Group B 80 degrees and in Group C 60 degrees with three different stylets.
      Laryngoscopy was performed using D-Blade in all 3 groups. Heart rate and blood pressure
      before and after intubation, time from the entrance of the laryngoscope into the mouth to the
      passage of the vocal cords, time from the appearance of the cords to intubation,
      Cormack-Lehane (C-L) classification were recorded. Subglottic damage was examined with
      fiberoptic bronchoscope. Patients were evaluated regarding postoperative sore throat and
      hoarsness at 30 minutes, 4, 12, 24 hours postoperatively.
    

Intervention name(s): Intubation using C-MAC D blade videolariyngoscope
Intervention type(s): Other
Intervention description(s): all patients were intubated using the C-MAC D-Blade videolaryngoscope but for each group the intubation tubes were angled in different degrees. First group was intubated using the stylet of 60 degrees, second group was intubated using the stylet of 80 degrees and the third group was intubated using the stylet of 90 degrees.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study we compared the intubation success, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different angled intubation stylets with C-MAC R videolaryngoscope D- blade.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Videolaryngoscope,; Intubation; C-MAC R Videolaryngoscope,; D- Blade; Subglottic damage; Postoperative sore throat,; Hoarsness
The Use of Public Messaging for the Promotion of Firearm Safety to Veterans
Condition: Injuries
Study type: Interventional

Summary: 
      This pilot study seeks to determine if exposure to the firearm safety public service
      announcement (PSA) developed by the U.S. Department of Veterans Affairs (VA) is associated
      with changes in related beliefs and safe storage practices. Participants are randomly
      assigned to message exposure or control conditions. Data from this project will inform injury
      prevention outreach efforts targeted towards Veteran populations.
    


Intervention name(s): Exposure to firearm safety PSA; Exposure to health promotion PSA
Intervention type(s): Other; Other
Intervention description(s): Exposed to firearm safety PSA; Exposed to general health promotion PSA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other