bioihbjkbjnl/mcl2 huggingface dataset:
Single-dose, Study of RBP-6000 in Opioid Dependent Individuals
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile
      of an injection of RBP-6000.
    

Detailed description: 
      This is an open-label, single-center, first-in-human study, designed to evaluate the safety,
      tolerability and pharmacokinetic (PK) profile of a single subcutaneous (SC) injection of
      RBP-6000 in opioid dependent subjects. Enrollment will begin with 6 subjects, and additional
      subjects will not be enrolled until safety through Day 4 has been reviewed and analyzed.
      Subjects will remain in a residential unit through Day 30 post-injection and will continue
      with visits to the clinical unit until Day 85 or plasma buprenorphine levels are below 100
      pg/mL, whichever comes later. The expected maximum duration of participation for each subject
      (including screening) is 120 days.

      Safety will be assessed by adverse events, electrocardiograms, clinical laboratory
      assessments, local injection site tolerability and vital signs. PK will be assessed by
      measuring concentrations of buprenorphine and norbuprenorphine in plasma. The need for rescue
      medication will be assessed using clinical judgment along with information provided by the
      COWS scores.
    

Intervention name(s): RBP-6000
Intervention type(s): Drug
Intervention description(s): A single injection of RBP-6000 containing a low dose of buprenorphine in the Atrigel delivery system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Can Glucose Monitoring Improve (CGMi Study)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this 2-year randomized controlled trial (RCT) is to implement and evaluate a
      family-focused behavioral teamwork intervention aimed at overcoming barriers to sustained
      continuous glucose monitoring (CGM) use in youth with type 1 diabetes (T1D). We hypothesize
      that CGM implemented with a family-focused, behavioral teamwork intervention will result in
      sustained CGM use and greater improvement in A1c compared to routine implementation of CGM.
    

Detailed description: 
      Consistent CGM use in youth with T1D has been difficult to sustain historically. Youth with
      T1D and their families have routinely felt burden related to the introduction of this
      technology into their care management. Additionally, there can be difficulties with
      calibration, skin irritation, frequent skips, excessive or nuisance alarms and inaccurate
      readings which often lead to diminished use or discontinuation entirely. The purpose of this
      protocol is to implement and evaluate a family-focused behavioral teamwork intervention aimed
      at overcoming barriers to sustained CGM use in youth with T1D. In this 2-year RCT, we will
      assess the long-term acceptability and durability of CGM use and its associated glycemic and
      psychological outcomes in youth with T1D and their families. We will randomize 120 families
      to one of two groups: (1) CGM implemented according to usual care (CGM-Usual Care, CGM-UC) or
      (2) CGM implemented with a family teamwork intervention (CGM-Teamwork, CGM-TW). This
      intervention will allow participants and families to overcome barriers to sustained CGM use
      and achieve glycemic benefits that have been afforded to adults using CGM as demonstrated in
      other research. In year 1, all CGM supplies will be provided and covered by study resources.
      In year 2, study participants will be asked to cover the costs associated with sensor use and
      any costs associated with replacement of CGM components in a manner consistent with routine
      clinical care as the investigators believe that it is important to assess durability of CGM
      use in clinical practice.
    

Intervention name(s): CGM Family Teamwork Intervention
Intervention type(s): Behavioral
Intervention description(s): The family-focused behavioral intervention targets barriers associated with sustained CGM use in youth with type 1 diabetes. During months 1-18, families in the intervention group will participate in the intervention at each study visit for about an additional 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
Condition: Dengue
MeSH terms: Dengue; Yellow Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to assess the immunogenicity and safety of the concomitant
      and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine
      (TDV) in healthy participants aged 18 to 60 years living in country non-endemic for both
      dengue and YF.
    

Detailed description: 
      The vaccine tested in this study is TDV also known as TAK-003 (DENVax). TDV with concomitant
      and sequential administration of yellow fever (YF-17D) vaccine will be tested to assess
      immunogenicity and safety in healthy adult participants in non-endemic area(s) for both
      dengue and YF.

      The study will enroll 900 healthy participants. Participants will be randomized to 3 groups
      in 1:1:1 ratio and will be administered concomitantly and sequentially. The 3 groups are:

        -  Group 1: YF-17D vaccine + placebo concomitantly administered on Day 1, first dose of TDV
           administered on Day 90 and second dose of TDV administered on Day 180.

        -  Group 2: first dose of TDV + placebo concomitantly administered on Day 1, second dose of
           TDV administered on Day 90 and YF-17D vaccine administered on Day 180.

        -  Group 3: first dose of TDV + YF-17D vaccine concomitantly administered on Day 1, second
           dose of TDV administered on Day 90 and placebo administered on Day 180.

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is 360 days. Participants will make multiple visits to the clinic
      with a 6-month follow up including a final visit at Day 360 for a follow-up assessment.
    

Intervention name(s): YF-17D; TDV; Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): YF-17D SC injection.; TDV SC injection.; Normal Saline (0.9% NaCl) SC injection.
Other intervention name(s): TAK-003; DENVax
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Drug Therapy
Quantification of Upper Extremity Use and Effects of Feedback in the Home Setting
Condition: Feedback Intervention (Participants Post-stroke); Healthy Control
Study type: Interventional

Summary: 
      A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two
      hand use) in healthy controls and people post-stroke from which the investigators will
      develop use-based feedback to improve recovery in the home setting. The objectives of this
      pilot study are to:

      i.) determine the feasibility of using accelerometers to quantify amount of UE use in the
      home setting in healthy individuals and individuals chronic post-stroke,

      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger
      (non-paretic) UEs,

      iii.) quantify and compare amount of UE use in healthy controls to that of people chronic
      post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and

      iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on
      unilateral and bilateral UE use.

      v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between
      healthy controls and subjects post-chronic stroke pre and post feedback (for the people after
      stroke).
    


Intervention name(s): Accelerometer Based Feedback
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV
Condition: HIV Infections
MeSH terms: Infections; HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the early virological response (EVR = undetectable
      [ribonucleic acid-hepatitis C virus] RNA-HCV or a reduction of > 2 log10) of patients with
      chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon
      alpha-2a (40 KD) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of
      treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day
      versus treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200
      mg/day for 12 weeks.
    

Detailed description: 
      This study seeks to ascertain whether treatment with higher doses of PEGASYS (270 µg/week)
      and ribavirin (1600 mg/day) for the first four weeks achieves the plasma concentrations of
      the product in the blood needed to reduce the half-life of the virions and accelerate the
      elimination thereof. This would bring the viral kinetic curves in coinfected patients closer
      to the model described for mono-infected HCV patients, probably achieving improved rates of
      response in week 12 (early virological response) and posterior in week 72 (sustained
      virological response).

      Therefore, the patients were randomised to treatment with two different doses, 270 µg and 180
      µg of PEGASYS, and 1600 mg and 1000-1200 mg of ribavirin.
    

Intervention name(s): Peginterferon alfa-2a, Ribavirin, epoetin-β; Peginterferon alfa-2a + Ribavirin for 12 weeks
Intervention type(s): Drug; Drug
Intervention description(s): Peginterferon alfa-2a(270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (180 µg/week) + Ribavirin(1000-1200 mg/day) for 8 weeks; Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; Co-infection; Induction dose; HIV; HIV Infections
Beta-alanine Supplementation and High-intensity Interval Training
Condition: Healthy
Study type: Interventional

Summary: 
      The present study will seek to quantify whether a period of HIIT alongside β-alanine
      supplementation will improve the adaptation to training, and therefore performance, more than
      a period of HIIT alone.
    

Detailed description: 
      Whilst high-intensity interval training (HIIT) is a powerful stimulus to increase endurance
      exercise performance, there are potential nutritional interventions that can be put in place
      to further increase performance gains.

      Energy for the contraction of muscles is created in the mitochondria. HIIT can improve the
      function of mitochondria, therefore improving performance.

      Β-alanine is a commonly used supplement that can improve exercise performance by increasing
      the amount of carnosine in muscle. Carnosine has many functions that may help improve
      exercise capacity.

      The present study will seek to quantify whether a period of HIIT alongside β-alanine
      supplementation will improve the adaptation to training, and therefore performance, more than
      a period of HIIT alone.
    

Intervention name(s): Beta-alanine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): N/A: see arm description; N/A: see arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia
Condition: Chronic Sinusitis With Nasal Polyps and Eosinophilia
MeSH terms: Sinusitis; Nasal Polyps; Eosinophilia; Polyps; Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2, open-label, multi-center study to evaluate the clinical effects of oral
      administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal
      polyps and eosinophilia.
    

Detailed description: 
      This open-labelled study will evaluate the safety and preliminary efficacy of dexpramipexole
      for reducing the number of eosinophils in the peripheral blood and in improving nasal polyp
      score when administered to 20 subjects with chronic sinusitis with nasal polyps and
      eosinophilia.

      Subjects will received dexpramipexole for up to 6 months and will have safety tests performed
      monthly and will have efficacy evaluations performed at month 1, month 3, and month 6 after
      beginning study drug.
    

Intervention name(s): dexpramipexole
Intervention type(s): Drug
Intervention description(s): Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
Other intervention name(s): KNS-760704; BIIB050; RPPX
Intervention MeSH terms: Pramipexole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sinusitis; Rhinosinusitis; CRS; CRSwNP; CSNP-E; Nasal polyps; Nasal polyposis; Eosinophilia; Asthma
Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to determine if altered renal function affects the plasma
      pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal
      impairment are required. The objective of this study is to compare the pharmacokinetics of
      gepotidacin administered as a 750 milligram (mg) intravenous (IV) dose in normal healthy
      subjects compared with subjects with mild, moderate, and severe renal impairment, and with
      subjects with end stage renal disease (ESRD). This is a Phase I, nonrandomized, open-label,
      parallel-group, multi-center, multi-part study. In Part 1, up to 16 subjects with normal
      renal function will be matched to approximately 8 subjects with moderate renal impairment,
      and approximately 8 subjects with severe renal impairment and/or subjects with ESRD not on
      hemodialysis for a total of approximately 32 subjects. In Part 2 (optional), approximately 4
      to 8 subjects with normal renal function (if enrolled), approximately 4 to 8 subjects with
      mild renal impairment, and approximately 4 to 8 subjects with ESRD on hemodialysis will be
      enrolled for a total of approximately 12 to 24 subjects. The duration from Screening to the
      Follow-up Visit will be approximately 44 days for Part 1 and approximately 50 days for Part
      2.
    


Intervention name(s): Gepotidacin
Intervention type(s): Drug
Intervention description(s): Gepotidacin after reconstitution is a clear, dark brown to dark brownish-yellow solution, free from visible particulate matter. Subjects will receive gepotidacin 750 mg single IV dose over 2 hours.
Intervention MeSH terms: Gepotidacin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Normal Renal Function; end stage renal disease (ESRD); Pharmacokinetics; Gepotidacin; Renal Impairment
Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of
      vortioxetine, once daily (QD), compared with placebo in adults with major depressive
      disorder.
    

Detailed description: 
      The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested
      to treat depression in adults who have major depressive disorder (MDD). This study looked at
      MDD relief in people who took varying dosages of vortioxetine.

      The study enrolled 469 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the three treatment groups-which remained undisclosed to the
      patient and study doctor during the study (unless there was an urgent medical need):

        -  Vortioxetine 10 mg

        -  Vortioxetine 15 mg

        -  Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug
           but had no active ingredient.

      All participants were asked to take one capsule at the same time each day throughout the
      study.

      This multi-center trial was conducted in the United States. The overall time to participate
      in this study was up to 14 weeks. Participants made 7 visits to the clinic, and were
      contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): Vortioxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Encapsulated vortioxetine immediate release tablets; Vortioxetine placebo-matching capsules
Other intervention name(s): Lu AA21004; Brintellix®
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Drug Therapy
Civamide Patch Safety, Tolerability and PK Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and
      0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess
      the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug
      from civamide patch in a subset of study subjects.
    

Detailed description: 
      This is a double-blind, randomized study of the tolerability of two different strengths of a
      Civamide Patch compared to placebo patch. The study consists of a Screening Period (Days -21
      to Day 1), a one week Treatment Period (Days 1-8) and a follow-up telephone call to subjects
      on Day 10.

      Pharmacokinetics will be assessed relative to dosing on Day 1, Day 2, and Day 8 in a subset
      of subjects. Subjects will also rate stinging and burning sensation at the application site
      during the Treatment Period.

      Twenty-four (24) hours after the last patch application, subjects will return to the study
      site on Day 8. The treatment area will be evaluated by the Study Physician. Subjects will
      complete a Subject's Global Rating of Stinging and Burning Sensation and a Subject's Global
      Rating of Tolerability.
    

Intervention name(s): Zucapsaicin; Zucapsaicin; Placebo patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Civamide patch 0.0075% q.d. 24 hours for 7 days; Civamide patch 0.0150% q.d. 24 hours for 7 days; Placebo patch q.d. 24 hours for 7 days
Other intervention name(s): Civamide; Civamide; placebo
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Adverse Events; Erythema Rating; Pharmacokinetics; Civamide; Phase 1; Pain; Patch
Effect of Antidepressants on Back Pain
Condition: Back Pain; Sciatica
MeSH terms: Sciatica; Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether different types of antidepressant medicines
      relieve back pain that has lasted at least six months on a daily basis. Study participants
      will be assigned to treatment with either a antidepressant acting on the serotonin system in
      the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control
      medication not expected to relieve pain (benztropine). Each participant will be seen at least
      nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.
    


Intervention name(s): Desipramine; Fluoxetine; Benztropine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL); Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL); Daily dose 0.125 to 0.5mg
Other intervention name(s): Anafranil; Prozac; Cogentin
Intervention MeSH terms: Benztropine; Fluoxetine; Desipramine; Clomipramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesia; Back pain; sciatica
Bronchoscopic Approach to the Peripheral Lung Nodule - Endobronchial Ultrasound, Electromagnetic Navigation and Cryobiopsy
Condition: Lung Nodules
Study type: Interventional

Summary: 
      In patients with peripheral lung nodules, what is the additional diagnostic yield of biopsies
      obtained with flexible cryoprobes compared to standard techniques? For patients with
      peripheral nodules, we hypothesize use of the cryoprobe will allow larger samples of tissue
      to be obtained and therefore, will increase the diagnostic yield over conventional techniques
    


Intervention name(s): cryobiopsy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: bronchoscopy; lung nodule; diagnosis; cryobiopsy
A Clinical Trial to Evaluate the Effectiveness of Hairfinity on Improving Hair Health and Rate of Growth
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary outcome of the study is the effect of Hairfinity vs. Placebo on the rate of
      distal hair growth, assessed using Trichoscan HD, in healthy female adults from baseline to
      day 90 (end of study).
    


Intervention name(s): Hairfinity #1; Hairfinity #2; Hairfinity #3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Main Hairfinity formulation; Variation to main formulation; Variation to main formulation; No active ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other