bioihbjkbjnl/mcl2 huggingface dataset:
Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia
Condition: Overweight and Obesity; Dyslipidemias
MeSH terms: Obesity; Overweight; Dyslipidemias
Study type: Interventional

Summary: 
      The aim of this trial is to evaluate the possible benefits on saciety and dyslipidemia in
      subjects with overweight/obesity (BMI ≥25 y <40 kg / m2) and dyslipemia after consumption of
      a modifed honey with soluble fiber and polyphenols.

      Some studies have shown the contribution of high-fiber foods in the reduction of the
      cardiovascular risk. Besides, polyphenols have reported with their potent antioxidant effect
      and their implication lowering the vardiovascular risk.
    

Detailed description: 
      The trial was designed as a randomized, parallel, double-blind and controlled study with 2
      experimental arms. This study was performed to evaluate the effect on saciety and
      dyslipidemia of subjects with overweight/obesity after a long consumption (3 months) of a
      modified honey with soluble fiber and polyphenols. Additionally, a short-term randomized,
      cross-over, doble-blind and controlled trial was also performed to evaluate immediate saciety
      effect on the same subjects.

      For the middle-term study, investigators included 67 participants (8 men and 59 women)
      between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers were randomized into 2
      study groups, and participants received the 2 different study products during the 3 months.
      On the other hand, the associated short-term trial included 10 participants (5 men and 5
      women) between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers were randomized into
      2 study groups, and participants took the 2 different study products in two non-consecutive
      days.
    

Intervention name(s): Control honey; Modified honey with soluble fiber and polyphenols
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day); Honey modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Saciety; Honey; Fiber; Polyphenols; Visual Analogue Scale; Cross-over; Parallel
Study to Evaluate the Effect of Multiple-dose of Fluvoxamine on the Plasma Concentration of Quetiapine (FK949E) in Healthy Male Volunteers
Condition: Healthy; Pharmacokinetics of Quetiapine
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to assess the effect of multiple-dose fluvoxamine on the
      pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects. The safety of FK949E
      in the population was also evaluated.
    


Intervention name(s): FK949E; fluvoxamine
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): extended release formulation of quetiapine; Luvox®
Intervention MeSH terms: Quetiapine Fumarate; Fluvoxamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: FK949E; fluvoxamine; Antipsychotic; Quetiapine
An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to continue to provide aripiprazole intramuscular
      (IM) depot treatment (400 milligrams [mg] or 300 mg) to participants with schizophrenia
      completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the
      secondary objective was to collect additional long-term safety data on aripiprazole IM depot
      treatment.
    

Detailed description: 
      This was an open-label study that enrolled participants with schizophrenia who had completed
      the 52-week, open-label safety and tolerability Study 31-08-248 and continued to provide
      aripiprazole IM depot treatment.

      Participants received this treatment until aripiprazole IM Depot was commercially available
      in any dosage (including generic formulations) in the country where the study was being
      conducted or the commercial availability of aripiprazole IM Depot was terminated by the
      sponsor, or until the study completion date of 06 Dec 2018 was reached.

      Eligible participants entered this study at the end of treatment visit (Week 52) of Study
      31-08-248. Participants continued to receive aripiprazole IM depot every month (study months
      were every 4 weeks, which were defined as 28 [-2/+10] days) as a continuation of their
      previous monthly dose in Study 31-08-248.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Aripiprazole IM depot - 300 mg or 400 mg
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia
A Safety Study of LY3372689 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine the safety profile of the study drug after it is
      given by mouth to healthy participants. Blood tests will be performed to check how much
      LY3372689 gets into the bloodstream and how long the body takes to get rid of it. Each
      enrolled participant will receive multiple doses of LY3372689 or placebo and will remain in
      the study for up to eight weeks.
    


Intervention name(s): LY3372689; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Vascular Interaction With Age in Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The body produces a natural compound, nitric oxide (NO), which is known to improve the
      elasticity of blood vessels effect cardiac function and play a role in the remodeling process
      after a heart attack. The primary source of NO is one of the amino acids that the body uses
      to form new proteins, L-Arginine; although many individuals with heart disease also take
      medicines to increase the concentrations of NO such as nitroglycerine. The VINTAGE-MI trial
      is intended to investigate wether supplementation of the bodies supply of NO with oral
      administration of L-Arginine will improve the functional recovery of older patients who have
      recently suffered their first heart attack.
    

Detailed description: 
      BACKGROUND:

      As we age, both our blood vessels and heart muscle naturally become stiff and loose their
      ability to flex as the heart beats and blood pressure changes. This is believed to worsen
      both blood vessel and cardiac function in older individuals. The stiffened tissue is likely
      to be less able to adapt to the stresses and remodeling that occur after a heart attack
      (myocardial infarction) because the loss of functional heart tissue predisposes the heart to
      poor function and the hearts blood vessels undergo various changes in order to increase the
      supply of blood to the damaged areas.

      DESIGN NARRATIVE:

      VINTAGE-MI is a randomized, double blind study enrolling patients who have recently suffered
      their first heart attack. There are two recruitment clinics within the Johns Hopkins
      University Network, the Johns Hopkins Hospital and the Hopkins Bayview Medical Center.
      Following preliminary testing to establish eligibility and baseline function of both the
      heart and blood vessels, study participants will be randomly assigned to receive either
      L-Arginine or a placebo pill which is identical except that it does not contain L-Arginine.
      These pills will be taken orally 3 times a day for 6 months. Participants will return to the
      clinic 1, 3, and 6 months after they begin taking their medication to have the same
      functional testing repeated.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): L-Arginine
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Biomarker Feedback to Motivate Tobacco Cessation in Pregnant ALaska Native Women: Phase 2
Condition: Cancer; Tobacco Use; Pregnancy
Study type: Observational

Summary: 
      Use of tobacco is very high among Alaska Native pregnant women. The investigators are
      conducting a three phase study. The first study is nearly completed and involved measuring
      biomarkers of tobacco exposure in mothers and infants. The second phase of the research is a
      qualitative study to translate the biomarker findings to an intervention.
    

Detailed description: 
      Developing effective tobacco cessation interventions during pregnancy for American Indian and
      Alaska Native people is a national priority and will contribute to the U.S. public health
      objective of reducing tobacco-related cancer health disparities. The proposed project builds
      on our successful partnership with the Alaska Native community and previous work with Alaska
      Native pregnant women. We propose to develop and test a novel biomarker feedback intervention
      relating cotinine levels in the urine of pregnant women with the woman and infant's likely
      exposure to the tobacco specific nitrosamine and carcinogen
      4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK). This 5-year project will be conducted
      in three phases. In Phase 1 we utilized a non-randomized, clinical observational trial to
      examine biomarkers of nicotine and carcinogen exposure (urine cotinine and total NNAL [a
      metabolite of NNK], respectively) among maternal-infant pairs with assessments conducted
      during pregnancy and at delivery. In Phase 2, we will obtain qualitative feedback on the
      findings from Phase 1 through individual interviews conducted with women who use tobacco and
      a confidant (partner/friend/relative) they have identified to develop the biomarker feedback
      intervention messages. Phase 3 will consist of a formative evaluation of the biomarker
      feedback intervention with pregnant women using a two-group randomized design to assess the
      intervention's feasibility and acceptability, and the biochemically confirmed abstinence rate
      at the end of pregnancy. All phases of the project will be guided by a Community Advisory
      Committee. Each phase is an important step to advance our understanding of the potential for
      biomarker feedback as a strategy to help Alaska Native pregnant women quit tobacco use. The
      potential reach of the intervention is significant from a public health perspective as over
      600 tobacco users deliver each year at the Alaska Native Medical Center in Anchorage where
      the proposed project will take place. Developing effective interventions for tobacco
      cessation during pregnancy is important to reduce adverse health consequences for the mother
      and neonate and future risk of tobacco-caused cancers.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Alaska Native women and their confidants
      
Keywords: cancer; tobacco use; pregnancy
Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers
Condition: Hypertrophic Scar
MeSH terms: Cicatrix, Hypertrophic
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in
      Healthy Male Volunteers
    

Detailed description: 
      A Randomized, Single Blind, Single Dose, Placebo-controlled, Dose-escalation Phase I Study to
      Investigate the Pharmacokinetics, Safety, and Tolerability of Intradermal Dosage Form of
      BMT101 in Healthy Male Volunteers
    

Intervention name(s): BMT101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BMT101 is administered to 6 subjects in each of 4 groups.; Placebo is administered to 2 subjects in each of 4 groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Scar; Scar prevention; siRNA
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis
Study type: Interventional

Summary: 
      To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to
      clinical efficacy, defined as implantation success based on the VARC-2 criteria.
    

Detailed description: 
      Study Title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide
      Transcatheter Aortic Valve Replacement (TAVR-CMR).

      Coordinating Prinicpal Investigator: Prof. Bernhard Metzler, University Clinic of Internal
      Medicine III, Cardiology and Angiology, Innsbruck Medical University.

      Planned Study Period: 2017-2023.

      Objective: To investigate, for the first time, the non-inferiority of TAVR-CMR to
      contrast-enhanced computed tomography (TAVR-CT) regarding efficacy and safety end-points.

      Design: Prospective, randomized, open-label, multi-centre trial.

      Patients (planned): 270 patients.

      Diagnosis / Inclusion Criteria: Symptomatic severe aortic stenosis scheduled for TAVR based
      on a local heart-team decision.

      Methods: Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR
      protocol or to receive a standard TAVR-CT protocol within two weeks after inclusion.

      Main Outcome Measure: Follow-up will be performed at hospital discharge after TAVR and after
      6 months. The primary efficacy outcome is device implantation success at discharge. The
      secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint
      at baseline and at 6 months, as well as a comparison of imaging procedure related variables
      (see section 5.11.2). Endpoint definitions are based on the updated 2012 VARC-2 consensus
      document.
    

Intervention name(s): TAVR-CMR; TAVR-CT
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.; CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
SpO2 Hypoxia Accuracy Validation Study
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry
      accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor
      cable, and an oximetry system during non-motion conditions.
    

Detailed description: 
      The primary objective of this study is to evaluate the %SpO2 accuracy of a combined pulse
      oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system
      during non-motion conditions.
    

Intervention name(s): Pulse Oximeter
Intervention type(s): Other
Intervention description(s): Pulse Oximeter
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        A minimum of 12 subjects will be enrolled. The subject population will include both male
        and female subjects with a variety of skin tones.
A Study to Evaluate the Effect of GW870086X on Allergen Challenge in Mild Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will measure the early and late asthamtic response using an allergen challenge.
      This study will evaluate the safety and patients tolerance to repeat inhaled doses of
      GW870086X using a number of clinical and biological markers.
    


Intervention name(s): GW870086X; FP; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Investigational product; Positive control; Placebo control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; late phase response; allergen; challenge; GW870086X
The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation
Condition: Medication Compliance
Study type: Interventional

Summary: 
      The purpose of this study is to examine the feasibility and acceptability of a mobile app to
      improve self-management skills and medication adherence in kidney transplantation, to assess
      the clinical benefit of mobile app in combination with tailored coaching using text messaging
      to enhance patient activation, self-management and medication adherence and to determine
      whether immunological biomarkers such as cell-free DNA and donor specific antibodies are
      associated with self-management and medication adherence.
    


Intervention name(s): Smartphone App; Tailored education
Intervention type(s): Other; Behavioral
Intervention description(s): An app for monitoring medications, blood pressure, exercise, healthy eating; in-person coaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: kidney transplant; teens; mobile app
Human Breast Tissue Bioavailability of Topically Applied Limonene
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall objective of this project is to determine the safety and breast tissue
      bioavailability of limonene following massage application of limonene containing massage oil
      to the breast.
    


Intervention name(s): limonene containing massage oil
Intervention type(s): Other
Intervention description(s): daily massage application to the breast for 4 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer prevention
Endocannabinoid Control of Microglia Activation as a New Therapeutic Target in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The main objective of this study is to compare microglia activation as measured with proton
      Magnetic Resonance Spectroscopy (1H-MRS) between recent-onset schizophrenia patients who are
      randomised to CBD and those randomised to placebo.
    

Detailed description: 
      Schizophrenia is a chronic and severe mental disorder with an urgent need for new and more
      effective treatments. A promising novel pharmacological target in this respect is the
      endocannabinoid system. In particular the cannabinoid compound cannabidiol (CBD) displays a
      highly favourable profile for development as a new antipsychotic agent. Increasing evidence
      indicates a significant role for neuroinflammation in the pathophysiology of schizophrenia,
      especially for activation of resident macrophages of the brain: microglia. Interestingly,
      converging preclinical evidence suggests that microglia activation is under control of the
      endocannabinoid system. However, how manipulation of the endocannabinoid system affects
      microglia activation in humans has not been established, but it is presumably related to
      clinical improvement of schizophrenia patients.

      In this project, we propose to study endocannabinoid control of microglia activation as a new
      therapeutic target in the treatment of schizophrenia. Using a placebo-controlled, randomised,
      double-blind design, we will investigate this in a group of 36 recent-onset schizophrenia
      patients after four weeks of daily CBD treatment, in addition to their regular antipsychotic
      medication. First, we will examine if CBD treatment attenuates microglia activation and
      levels of peripheral inflammatory markers. In vivo microglia activation is assessed before
      and after treatment using 1H-MRS, with the level of myo-inositol being regarded as a marker
      of glia function. Second, we will determine if reduced microglia activation and levels of
      inflammatory markers relate to improvement of symptomatology and cognitive function. Third,
      we will assess how microglia activation and levels of inflammatory markers before treatment
      predict the clinical response to CBD.
    

Intervention name(s): Placebo; Cannabidiol
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; Cannabidiol
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Schizophrenia; Cannabidiol; Magnetic Resonance Spectroscopy (1H-MRS); Microglia
Study of Dehydroepiandrosterone Treatment for Poor Responders in In Vitro Fertilization Patients
Condition: Infertility; Poor Responder to IVF Treatment
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to show solid evidences of the efficacy of DHEA in improving the
      success rates of in-vitro fertilization (IVF) patients facing poor ovarian reserve.
    

Detailed description: 
      Poor responders to IVF treatment occurs in 5-24% of in-vitro fertilisation (IVF) cycles,
      resulting in the cancellation of the cycle translating in very low pregnancy rate. Current
      interventions based upon the use of different stimulation regimen do not address the
      fundamental underlying physiological basis of follicular recruitment and development.

      The over-riding objective of this proposal is to devise novel therapeutic approaches to the
      treatment of poor responders of IVF treatment through dietary supplementation with
      Dehydroepiandrosterone (DHEA). The investigators hypothesise that DHEA supplementation leads
      to improvements in ovarian steroidogenesis in poor responders, leading to improved IVF
      outcome. Specifically, the investigators aim to

        1. Conduct a prospective randomised controlled trial (RCT) on the effects of DHEA
           supplementation in women who are poor responders to IVF treatment.

        2. Investigate the effects of DHEA supplementation on ovarian steroidogenesis and
           biochemical and ultrasonographic markers of ovarian reserves.
    

Intervention name(s): Dehydroepiandrosterone
Intervention type(s): Dietary Supplement
Intervention description(s): DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment