bioihbjkbjnl/mcl2 huggingface dataset:
Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To evaluate the plasma and urine PK of givinostat following multiple oral doses of
      givinostat.

      Secondary objective:

      To assess the safety and tolerability multiple oral doses of givinostat.
    

Detailed description: 
      This study was planned as a phase I, open-label, 3-part, fixed-sequence, nonrandomized study
      in healthy male and female subjects. The study (Part 3) aimed at assessing Givinostat and its
      metabolites (ITF2374, ITF2375, ITF2440 and ITF2563) plasma and urine concentrations and
      thereof derived pharmacokinetic parameters following single oral dose administration of
      givinostat (day 1) and following multiple oral dose administration of givinostat (day 5 to
      day 13). More precisely, Gmean and corresponding 95% CI of givinostat plasma and urine
      concentration and givinostat metabolites plasma concentration versus time profiles following
      single (Day 1) and multiple-dose (Day 5 to Day 13) administration of givinostat are reported
      using Linear Scale and Semi- Logarithmic Scale.

      Descriptive statistics of givinostat plasma pharmacokinetic parameters and givinostat
      metabolites PK parameters following single-dose administration of givinostat (day 1) and
      following multiple-dose administration of givinostat (Day 13) were calculated.

      Descriptive statistics of givinostat and its metabolites urinary excretion profile following
      single-dose administration of givinostat (day 1) and following multipledose administration of
      givinostat (Day 13) were calculated.

      Descriptive statistics of givinostat and its metabolites cumulative amount of urinary
      excretion profile following single-dose administration of givinostat (day 1) and following
      multiple-dose administration of givinostat (Day 13) were also calculated using linear scales.
    

Intervention name(s): Givinostat
Intervention type(s): Drug
Intervention description(s): Drug: ITF2357 Givinostat 10mg/mL Dose: 10mg/mL; Dosage form: oral suspension
Other intervention name(s): ITF2357
Intervention MeSH terms: Givinostat hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PK; Pharmacokinetics; Givinostat; Givinostat metabolites
A Single-Dose Study of an Investigational Capsule Formulation of 2 mg/0.5 mg Buprenorphine/Naloxone
Condition: Healthy
Study type: Observational

Summary: 
      A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg
      Buprenorphine/Naloxone.

      NIDA Contract No. HHSN271200577414C
    


Intervention name(s): Buprenorphine / Naloxone
Intervention type(s): Drug
Intervention description(s): oral formulation of buprenorphine / naloxone
Other intervention name(s): NanoBUP
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy normals between the ages of 18 and 55 (inclusive)
      
Keywords: healthy normals, phase 1; phase 1a study for healthy normals
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg
Condition: Contraceptives, Postcoital
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover,
      randomized, prospective design was chosen with a washout of 14 days between the two study
      periods. Treatment groups are balanced with the same number of male healthy volunteers who
      were randomly assigned to the study drug administration sequences.
    


Intervention name(s): Levonorgestrel Emergency Pill (BAY86-5028); Postinor 2
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 1.5 mg coated tablet; Single dose of 1.5 mg tablet
Intervention MeSH terms: Levonorgestrel; Norgestrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the performance characteristics of a novel [18F] amyloid detection
      ligand (18F]-AV-45) with respect to its ability to distinguish patients with
      clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects
      and to independently compare its diagnostic performance characteristics with the ability of
      [11C]PIB to correctly categorize the same subjects.

      SPECIFIC HYPOTHESES

        1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have
           increased brain retention of [18F]-AV-45 compared to cognitively normal elderly
           individuals.

        2. There will be no clinically meaningful difference in the amyloid retention performance
           characteristics of [18F]-AV-45 and [l1C]PIB.
    

Detailed description: 
      15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively
      normal elderly control subjects will receive both [18F]-AV-45 and [11C]PIB to compare the
      diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal
      subjects. In addition to clinical diagnostic category, ligand retention will be evaluated
      with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and
      tau.
    

Intervention name(s): florbetapir F 18; [11C]-PIB
Intervention type(s): Drug; Drug
Intervention description(s): 370 MBq (10 mCi), intravenous (IV) injection, single dose; 555 MBq (15 mCi), IV injection, single dose [11C]-PIB
Other intervention name(s): 18F-AV-45; Amyvid; florbetapir; C-11 PIB
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Amyloid imaging; Positron Emission Tomography; 18F-AV-45; florbetapir F 18; Diagnostic imaging
Young Consumers' Attitudes and Behaviour Towards Sustainable and Healthy Eating
Condition: Sustainable Healthy Eating Behaviour
Study type: Interventional

Summary: 
      The purpose is to investigate young consumers' attitudes and behaviour towards sustainable
      and healthy eating by applying a multidisciplinary approach, taking into account economical,
      marketing, public health and environmental related issues. In order to achieve this goal,
      consumers' reactions on interactive tailored informational messages about sustainable from
      social, environmental and economical point of view, as well as healthy eating behaviour in a
      group of Polish young adults will be investigated. Main research questions that will be
      addressed: What is consumer's current behaviour and perception of sustainable healthy eating?
      What are factors determining consumers' reactions to messages about sustainable healthy
      eating? What are consumers' reactions on interactive tailored communication about sustainable
      and healthy eating behaviour? About 200 Polish consumers will take part in this randomized
      controlled trial. A stratified design will be used to recruit 18-30 years old adults using
      smart phones. The sample will be represented for gender and region. Participants will be
      randomly assigned to either a study or a control group. They will complete a baseline and
      follow-up survey. An application for smart phones will be developed by a professional IT
      company in order to deliver personalised messages to the participants. Intervention will take
      one month. Messages developed following the theory-linked definitions of behaviour change
      techniques will be sent to the participants every 2-3 days. The six principles of sustainable
      and healthy behaviour introduced in the campaign "Livewell 2020" will be used as a base to
      communicate to consumers.
    


Intervention name(s): Consumer reactions to tailored messages sent via app
Intervention type(s): Behavioral
Intervention description(s): The intervention will take 1 month. Participants from the Intervention group will receive tailored messages every 2-3 days with a push notification. Additionally, interaction with the participants via the use of app is foreseen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sustainable healthy eating; consumer behaviour; consumer attitudes
The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Dexamethasone is commonly used in clinical practice.However, intravenous dexamethasone sodium
      phosphate may cause perineal discomfort.With the popularization of comfortable medical
      technology, patients have higher and higher requirements for comfortable medical
      treatment.Perineal pruritus caused by intravenous dexamethasone sodium phosphate may cause
      adverse physiological and psychological effects on patients and increase the incidence of
      unpleasant experiences during anesthesia.Therefore, it is very important to find a practical
      and effective method of inhibition.Midazolam is a water-soluble benzodiazepine commonly used
      in clinical practice, which has been proved to effectively inhibit the itching caused , while
      its effect on the itching caused by dexamethasone has not been reported.By observing the
      effect of pre-injection midazolam on the perineal itching caused by dexamethasone sodium
      phosphate, this experiment intends to preliminarily explore its possible mechanism .
    

Detailed description: 
      Nighty patients scheduled for selective surgery,aged 18-65years,ASA physical status I~II,BMI
      18~30kg·m-2 were selected in this study.The patients were equally randomized into two groups:
      midazolam (M) group and normal saline (N) group, 45 cases in each group. Before anesthesia
      induction, M group received intravenous injection of 0.03mg·kg-1 (1mg·ml-1) midazolam, while
      N group received corresponding intravenous normal saline of the same volume. After 1 min,
      both groups received intravenous injection of dexamethasone sodium phosphate injection of
      10mg (injection was completed in 2s). The anesthesiologist assessed perineal irritation in
      both groups and recorded the number of cases,visual analogue scores (VAS) ,duration of
      itching or pain,Ramsay scores and observed the occurrence of adverse reactions such as
      dizziness and respiratory depression in the two groups.
    

Intervention name(s): Midazolam; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): M group received intravenous injection of 0.03mg·kg-1 (1mg·ml-1) midazolam, After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg (injection was completed in 2s); N group received corresponding intravenous normal saline of1ml·kg-1 .
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: midazolam; Dexamethasone; pruritus
Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game Among Chinese Older Adults
Condition: Advance Care Planning; Game; Older Adults
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This proposed study aims to examine the effects of a culturally-sensitive theory-driven
      advance care planning (ACP) game in increasing the self-efficacy and readiness of ACP
      behaviours among Chinese community-dwelling older adults. This is a mixed methods study with
      the quantitative paradigm being the main research approached used. The quantitative arm will
      be a randomized controlled trial (RCT). The qualitative arm will adopt focus group interviews
      for data collection. Recruited subjects from the community centres will be randomly allocated
      to the intervention and control group. The older adults in the experimental group will
      receive an ACP board game delivered by trained facilitators, whereas the older adults in the
      control group will receive another board game about healthy lifestyle. The outcome measures
      of the older adults will include the ACP Engagement scale, the Life-Support Preferences
      Questionnaire (LSPQ), a self-developed ACP knowledge questionnaire and those data will be
      collected at baseline (T0), immediately post-intervention(T1), at 1 month (T2), and 3 month
      (T3). The qualitative arm of this study will contribute to the understanding of issues and
      effects of ACP game as an intervention. Its finding will complement the results obtained from
      the RCT.
    


Intervention name(s): ACP game; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the intervention group will be divided into groups of 4 participants to play a 1-hour culturally-sensitive theory-driven ACP board game with 15-minute debriefing delivered by facilitators. The ACP board game is developed by the principle investigator in a previous project.; Participants in the control group will receive a 1-hour board game about health lifestyle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Comparison of SCH 486757 to Codeine and Placebo in Subjects With Persistent Postviral Cough (Study P03069AM2)(COMPLETED)
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, multicenter, parallel-group, double-blind, double-dummy, placebo- and
      active-controlled study will evaluate the efficacy and safety of SCH 486757 in subjects with
      persistent cough resulting from a recent viral upper respiratory infection (URI). The primary
      objective is to assess the efficacy of SCH 486757 administered at a dose of 100 mg twice
      daily for 5 days in the reduction of cough severity score compared with placebo. The key
      secondary objective is to evaluate the reduction in the number of coughs with SCH 486757
      compared with placebo. Because codeine is a widely used as a cough medication, it is included
      as a treatment arm in the study.
    


Intervention name(s): SCH 486757
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study Called Champion-HMB to Learn More About Females With Heavy Menstrual Bleeding and Available Treatments to Enable Earlier Diagnosis and to Predict Courses of Treatment
Condition: Heavy Menstrual Bleeding
MeSH terms: Menorrhagia; Hemorrhage
Study type: Observational

Summary: 
      This is an observational study in which patient data from the past of females with heavy
      menstrual bleeding (HMB) is studied.

      • HMB describes menstrual periods with abnormally heavy or prolonged bleeding. Women
      concerned may not be able to maintain their usual activities during their period. Thus, HMB
      can reduce the quality of life and may lead to other medical problems. It is described that
      up to 30 of 100 women ask doctors for help concerning HMB during their fertile years. HMB is
      often not recognized and treated timely. In addition, there is little information about
      characteristics of women with HMB and real-world data on available treatments are missing.

      Despite the availability of non-invasive therapeutic options, for some women with severe HMB,
      surgical treatments (also called invasive) may be needed that can lead to infertility.

        -  In this study researchers want to learn more about:

        -  the percentage of women diagnosed with HMB

        -  characteristics of these women like age at diagnosis or medical problems

        -  treatment pathways of women with HMB in usual care

      Regarding treatment pathways, the researchers are especially interested in:

        -  the percentage of women who use different therapeutic options over time

        -  the percentage of women receiving invasive treatment for HMB after they received
           treatment as recommended by guidelines versus those not treated as recommended

        -  To do this, researchers will collect information from five observational healthcare
           databases. Data will be from the year 2000 up to 2020.

        -  Besides this data collection, no further tests or examinations are planned in this
           study.

        -  In future, this information shall help to identify women with HMB and to learn what
           information may predict if invasive treatment will be needed later on.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes 11 to 55-year-old women diagnosed with HMB in France,
        Germany, UK and US from 2000 to 2020.
Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a functional exercise program
      associated with Low Level Laser Therapy (LLLT) on pain, functional capacity and quality of
      life of individuals with fibromyalgia. Half of participants will receive functional exercise
      and LLLT, while the other half will receive functional exercise and placebo LLLT.
    


Intervention name(s): Functional Exercise; Low Level Laser Therapy; Placebo Low Level Laser Therapy
Intervention type(s): Other; Radiation; Radiation
Intervention description(s): Low Level Laser Therapy with the device off
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low Lever Laser Therapy; Exercise Therapy; Chronic Pain
Comparison of the Efficacy of Pharmacology and Non-pharmacological Treatment in Women With Primary Dysmenorrhea.
Condition: Pelvic Floor; Exercise; Telerehabilitation; Acupressure; Dysmenorrhea Primary; Drug Effect
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Primary dysmenorrhea is a common problem in women. Women use many treatment methods to deal
      with primary dysmenorrhea. Therefore, this study aims to find the most effective treatment by
      determining the effectiveness of conservative and non-conservative treatment in women with
      primary dysmenorrhea. Another aim of the study is to generalize the use of conservative
      treatment methods in the treatment of primary dysmenorrhea.On the other hand, it aims to
      spread the telerehabilitation method, which allows the global Covid 19 outbreak to be
      maintained remotely online, in the world and in our country.
    

Detailed description: 
      This study aims to determine the effects of different treatment approaches in women diagnosed
      with primary dysmenorrhea. Patients who are examined by a physician and diagnosed with
      primary dysmenorrhea using ultrasonography will be included in the study. The cases will be
      divided into 5 groups by randomization. In the first group, patients who are prescribed
      diosmin by the attending physician will be taken. The second group; Patients who are
      prescribed naproxen sodium by the attending physician will be taken. The third group; Pelvic
      floor exercises will be performed 2 days a week and 12 weeks a week using the motor
      imagination technique created by the women health physiotherapist. In the fourth group,
      acupressure technique applied by applying pressure to non-invasive acupuncture points will be
      applied daily for 12 weeks. The fifth group will be the control group. Online access will be
      synchronized with the phone or computer, and training sessions will not be recorded to
      protect the patient's personal information. Cases will be evaluated online at the beginning
      of the study and at the end of the 12-week program.
    

Intervention name(s): Conservative and Non-conservative treatments
Intervention type(s): Other
Intervention description(s): This program includes Focused Pelvic Floor with Motor Imagery Technique Group ,Nonsteroidal Anti-Inflammatory Drug Group, Diosmin Group, Acupressure Group (LI-4 (Bilateral), CV-6, CV-4, SP-6 (Bilateral). It is aimed to determine the most effective treatment among these groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pelvic Floor; Dysmenorrhea Primary; Drug therapy; Telerehabilitation; Acupressure
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the pharmacokinetics (PK) and excretion
      of E7090 and its metabolites in healthy male participants. Also, to assess the safety and
      tolerability of a single dose of E7090 in healthy male participants.
    


Intervention name(s): [14C]E7090
Intervention type(s): Drug
Intervention description(s): [14C]E7090, oral capsule.
Other intervention name(s): E7090
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Participants; Phase 1; Pharmacokinetics
Gluten Ingestion Biomarkers in Patients w Gluten Sensitivity and Healthy Controls Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study
Condition: Non Celiac Gluten Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence
      of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved
      by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The
      pathologic mechanism of the disorder is unknown, and there are no known biomarkers or
      associated histopathologic findings. In this prospective, randomized controlled trail, we are
      investigating the utility of patient reported symptom questionnaires, as well as stool gluten
      and urine quantification tools in patients with NCGS and healthy controls.
    


Intervention name(s): High dose Gluten; Low dose Gluten; Lactose free placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic