bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old
Condition: Influenza Vaccine
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and
      immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered
      intranasally to a healthy adult population age 50 to 85 years.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and
      immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered
      intranasally to a healthy adult population age 50 to 85 years. Eligible subjects will be
      randomized 2:1 to receive one administration of Sing2016 M2SR or placebo followed by a dose
      of age-appropriate licensed inactivated influenza vaccine (IIV) at least 28 days later. Two
      lead-in groups of adults ages 50-64 years (Cohort 1) and 65 - 85 years (Cohort 2) will be
      followed by enrollment of an expansion group, ages 65 - 85 (Cohort 3). Safety data will be
      reviewed between enrollment of successive cohorts.
    

Intervention name(s): Sing2016 M2SR H3N2 influenza vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.; This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Three Cohorts will be enrolled sequentially with safety data reviewed between enrollment of successive cohorts.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
Condition: Healthy Volunteers; Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and
      moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and
      tolerability of GP681, compared with a control group with normal hepatic function following
      oral administration of GP681 as single dose.
    

Detailed description: 
      This is a multicenter, open-label, parallel group, single-dose study to compare
      pharmacokinetics of GP681 after a single 40mg oral dose in eight healthy subjects and eight
      mild or eight moderate hepatic impairment subjects. Subjects with hepatic impairment will be
      enrolled into either mild (Child-Pugh A, score 5-6) or moderate (Child-Pugh B, score 7-9)
      hepatic impairment groups. The healthy subjects will match with impaired hepatic function
      patients on ethnic group, sex(+/- 1 subject), age (+/- 10 years) and weight (+/- 25%).

      Participants will be admitted into the Clinical Research Units(CRU) on Day-1. On the morning
      of Day 1, subjects will receive a single 40 mg oral dose of GP681 following an overnight fast
      (i.e., at least 10 hours). Participants will be confined to the CRU until discharge on Day
      12, with PK blood sample draws for measurement of GP681 and its main metabolites being taken
      throughout the confinement.

      Safety assessments will include physical examinations, ECGs, vital signs, standard clinical
      laboratory evaluations (hematology, blood chemistry, urinalysis, coagulation), AE and serious
      adverse event (SAE) monitoring.

      All participants will have a post-study safety follow-up contact conducted approximately 12
      days after administration of study treatment. The study will be considered complete once all
      the participants have finished the required assessments, dropped out, or been lost to
      follow-up before completing the required assessments.
    

Intervention name(s): GP681
Intervention type(s): Drug
Intervention description(s): GP681, tablet, oral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Emotional Stimulation on the Stress Levels of Healthy Persons
Condition: Depression; Somatization Disorder; Anger; Anxiety
MeSH terms: Somatoform Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of a short-term emotional stimulation on
      the mood of healthy persons.
    

Detailed description: 
      The trial assesses the effects of a emotion-centered stimulation on the mood of healthy
      persons. The outcomes will be evaluated with standard questionnaires.
    

Intervention name(s): Emotional stimulation
Intervention type(s): Other
Intervention description(s): Increase of the physical correlates of an emotion
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
Condition: Opioid Dependence, on Agonist Therapy
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to assess retention in treatment after induction with
      buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after
      stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives
      included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and
      safety.
    

Detailed description: 
      This prospective, randomized, multicenter, parallel-group, non-inferiority study was
      conducted at 43 centers in the United States from August 2013 to April 2014. A non-inferior
      design was used because both products contain the same active components, and it was
      considered unethical to include a placebo arm. The study comprised an induction phase of 2
      days and a stabilization phase of 20 days, with study visits scheduled on Days 1, 2, 3, 4, 8,
      15, and 22. Eligible opioid-dependent patients were randomly assigned within 14 days of
      screening to induction with either the BNX sublingual tablets or generic buprenorphine
      tablets for 2 days. On Day 3, patients initially allocated to buprenorphine were switched to
      BNX film, whereas those allocated to BNX sublingual tablets continued on the same treatment.
      On Day 15, patients receiving BNX film were switched to BNX sublingual tablets, and those on
      BNX sublingual tablets were switched to BNX film. At the final study visit on Day 22,
      patients were offered the option of continuing in an open-label follow-up study of BNX
      sublingual tablets.
    

Intervention name(s): BNX sublingual tablets; BNX sublingual film; Buprenorphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Buprenorphine/naloxone sublingual tablets; Buprenorphine/naloxone sublingual film; Buprenorphine sublingual tablets
Other intervention name(s): OX219; Zubsolv; Suboxone film; Generic buprenorphine
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid; Dependence; agonist; buprenorphine; naloxone; BUP/NAL
Provitamin A Absorption and Conversion With Avocados
Condition: Healthy
Study type: Interventional

Summary: 
      Vitamin A is necessary in the human diet. The form of vitamin A found in fruits and
      vegetables is not "active" and must be converted to the active form in the human body.
      However, information on the ability of humans to absorb and convert vitamin A to the active
      form is still lacking. In this study, the investigators will observe the absorption and
      conversion of vitamin A from orange tomato sauce and/or carrots after a meal with fat (from
      avocado fruit) and a meal without fat. The investigators will also test whether eating these
      foods might protect the blood against damage that could lead to heart disease.
    

Detailed description: 
      The primary objective of this study will be to demonstrate that adding avocados to a carotene
      rich meal will promote the absorption of provitamin A carotenoids and enhance the delivery of
      greater quantities of vitamin A. This objective will be accomplished by quantitation of the
      immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites
      after subjects consume a meal with or without avocado in combination with a serving of tomato
      sauce (containing nutritionally relevant amounts of beta-carotene) or carrots.

      The secondary objective of this study will be to determine if higher levels of carotenoids
      and other antioxidants transported in the bloodstream will have a protective role in
      promoting cardiovascular health. This objective will be accomplished by testing the oxidation
      capacity of lipoprotein fractions before and after meal supplementation.
    

Intervention name(s): Post-prandial Feeding Study
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: post-prandial absorption; provitamin A carotenoids; vitamin A; avocado; tomato; carrot
A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled Phase Ib/IIa clinical study in Chinese
      patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise
      and/or treated with irregular use of antidiabetic drugs to evaluate the safety, tolerability,
      pharmacokinetics and efficacy of GZR18 injection in adult subjects with T2DM. This study is
      divided into Part A and Part B, which are to be conducted simultaneously.
    


Intervention name(s): GZR18; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 0.5mg-13mg; administered the same volume as GZR18
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is the evaluation of the therapeutic benefit of intratympanic AM 101
      injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus
      following acute sensorineural hearing loss.
    

Detailed description: 
      Tinnitus may seriously impact the ability to sleep, relax, or to concentrate, or lead to
      tiredness, irritation, nervousness, despair, frustration, or depression, thus severely
      impacting the quality of life and health of the affected person. To date, there exists no
      pharmaceutical treatment for persisting tinnitus.

      Non-clinical studies with AM-101 have shown that the inhibition of cochlear NMDA receptors is
      successful in suppressing tinnitus without affecting normal glutamate neurotransmission
      respectively hearing function. In particular, it could be demonstrated that local
      administration of AM-101 in a single dose resulted in a complete suppression of tinnitus
      induced by acute acoustic trauma without any relapse thereafter.
    

Intervention name(s): AM-101
Intervention type(s): Drug
Intervention description(s): Triple intratympanic injection (one on each day 1, 2, and 3)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tinnitus
Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia
Condition: Lipaemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The overall aim of this study is to investigate how dairy products with different structures
      and textures affect lipid absorption kinetics in the acute postprandial period via blood
      lipid biochemistry.

      The study will be conducted as a randomized acute cross-over meal study. Apparently healthy
      men will be recruited in the study. They will on 4 test days consume the 4 dairy products and
      blood will be drawn the following 8 hours.
    

Detailed description: 
      The overall aim of this study is to investigate how dairy products with similar nutrient
      content but different structures and textures affect lipid absorption kinetics in the acute
      postprandial period via blood lipid biochemistry, as well as nuclear magnetic resonance (NMR)
      and liquid chromatography mass spectrometry (LCMS)-based metabolomics.

      The study will be conducted as a randomized acute cross-over meal study. On four different
      test days (with a minimum of 2 weeks washout period) four dairy products with similar
      nutrient composition but different structures or textures will be tested. During each meal
      test a single dairy product (+ bread and water) is served and postprandial blood samples are
      collected the following 8 hours. Subjective appetite measurements (VAS) are filled in during
      the 8-hour period and an ad libitum meal is served in the end of the day.

      25 apparently healthy men (weight stable, 18-40 years, 18.5-24.9 kg/m2) will be recruited.
    

Intervention name(s): Cheddar cheese; Blended and homogenized cheddar cheese; An analog milk; An analog cheese
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The reference product is a commercial matured cheddar cheese; A blended and homogenized cheddar cheese (a spread) which, compared to the reference, has a minimal protein network and has smaller fat droplet; An anolog milk (i.e. milk with a cheese-like nutritional composition) which, compared to the reference, does not contain a protein network; This analog cheese (a gel/yoghurt) is produced from the analog milk which, compared to the reference, has a protein network, however it is a network that differs from the reference
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: glycaemia; insulinemia; lipaemia; appetite
High-sensitivity C-reactive Protein and United Kingdom Prospective Diabetes Study (UKPDS) Risk Score in Type 2 Diabetes
Condition: Atherosclerosis; Type 2 Diabetes
MeSH terms: Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The UKPDS risk score is recommended to assess global risk for future coronary heart disease
      (CHD) events in primary prevention. Recently, high-sensitivity C-reactive protein (hsCRP) has
      emerged as a strong independent risk factor for CHD. 18F-fluorodeoxyglucose (FDG) positron
      emission tomography (PET) is a promising imaging technique for the evaluation of vascular
      inflammation that reflects vulnerable atherosclerotic plaque.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        type 2 diabetes
Oxytocin Administration and Emotion Recognition Abilities in Adults Reporting Adverse Childhood Experiences
Condition: Healthy
Study type: Interventional

Summary: 
      This study evaluates whether intranasal administration of a single dose of oxytocin improves
      the ability to recognize emotional states. In a cross-over design, half of the participants
      first received oxytocin, the other half first received placebo.
    

Detailed description: 
      Adverse childhood experience such as neglect or abuse can lead to long-term deficits in
      emotion processing abilities, and these effects might be mediated via alterations in oxytocin
      production or sensitivity. The goal of this study was to test whether emotion recognition
      abilities and empathy might be improved by intranasal oxytocin administration in adults with
      a history of childhood maltreatment.

      In a double-blind, placebo-controlled experiment with a crossover design, we assessed the
      performance of 40 healthy participants with a history of childhood adversity on the Reading
      the Mind in the Eyes Test (RMET) and an emotion recognition task under 24 IU oxytocin vs.
      placebo and compared them to a control group of 40 matched individuals without traumatic
      childhood experiences.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+
Condition: Fibromyalgia; HIV-1 Infection
MeSH terms: Infections; Communicable Diseases; Fibromyalgia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare duloxetine with conventional treatment of pain in
      HIV-1 infected patients.
    

Detailed description: 
      Among HIV-1-infected patients, diagnosis of fibromialgy has increased over the last years .
      Appropriate identification of firomialgy in these patients is challenging and sometimes can
      be more complicated than in HIV-negative population. Concomitant infectious processes and
      symptoms due to HIV infection itself need to be ruled out before establishing a formal
      diagnosis.

      The treatment of this disease frequently includes muscular relaxants , pain-killers,
      anti-inflammatories and antidepressives despite no drug is formally indicated for this
      pathology.

      Duloxetine approved indications include both treatment of major depressive disorders (MDD)
      and diabetic neuropathic pain. Recent studies in HIV negative patients show efficacy to
      control pain and depressive symptoms in patients with fibromialgy The main purpose of this
      pilot study is to assess the efficacy of duloxetine in HIV-1-infected patients with
      fibromialgy.

      The main purpose of this pilot study is to assess the efficacy of duloxetine in
      HIV-1-infected patients with fibromialgy or chronic fatigue syndrome presenting with
      widespread pain.
    

Intervention name(s): Duloxetine 60 mg, QD
Intervention type(s): Drug
Intervention description(s): Duloxetine 60 mg, 1 table/day, 1 year
Other intervention name(s): Xeristar
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; fibromialgy; chronic fatigue syndrome; duloxetine; pain; treatment experienced; Fibromialgy in patients with HIV-1 infection
Study Evaluating LXR-623 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of a single dose of LXR-623 in healthy subjects.
    


Intervention name(s): LXR-623
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Safety; Healthy; healthy subjects
Fibromyalgia and Naltrexone: The FINAL Study
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effect of low dose naltrexone (LDN) on pain in women with
      fibromyalgia (FM). The study is designed as a parallel randomized (1:1) double blind,
      placebo-controlled superiority trial. Half of the participants will receive treatment with
      LDN while the other half will receive treatment with placebo.
    

Detailed description: 
      Low dose naltrexone (LDN) is used widely as off label treatment in patients with
      fibromyalgia, despite the lack of larger randomized controlled trials (RCT) supporting an
      effect.

      LDN has antagonistic effect on both opioid receptors and on toll-like receptors in glia
      cells. Mediated via those receptors, LDN can potentially reduce neuroinflammation and induce
      homeostasis in the endorphin system in patients with fibromyalgia.

      The aim of the trial is to investigate whether treatment with LDN has a superior effect
      compared to placebo on pain among female patients with fibromyalgia, evaluated after 12 weeks
      of treatment. The study is also exploring secondary aims regarding a possible improvement of
      other fibromyalgia core symptoms and a possible improvement of global assessment, daily
      functioning and health-related quality of life. Among the exploratory secondary objectives
      are changes in muscle exhaustion, physical fitness, pain sensitivity, inhibition of pain,
      augmentation of pain, and pro-inflammatory cytokines.
    

Intervention name(s): Naltrexone Pill; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with LDN for 12 weeks, including af titration phase of 4 weeks. Initial dosage of 1.5 mg, dose is increased by 1.5 mg every 7th day to 6 mg at week 4. Dosing is increased based on safety and tolerability and delayed increments are allowed. The participants are maintained on the highest tolerable dose for the last 8 weeks of the treatment period.; Treatment with LDN-placebo for 12 weeks, including af titration phase of 4 weeks. Initial dosage of 1.5 mg, dose is increased by 1.5 mg every 7th day to 6 mg at week 4. Dosing is increased based on safety and tolerability and delayed increments are allowed. The participants are maintained on the highest tolerable dose for the last 8 weeks of the treatment period.
Other intervention name(s): LDN; LDN-placebo
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A parallel randomized (1:1) double blind, placebo-controlled superior trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment