bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Four Doses of the Study Drug, HF1020 in Healthy Volunteers
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to:

        -  study the safety of the drug (HF1020) in healthy male adults

        -  study how well the study drug (HF1020) is tolerated in healthy male adults

        -  find the maximum dose that is tolerated in healthy male adults
    

Detailed description: 
      This is a single-centre, randomised, double-blind, placebo-controlled, ascending dose study.

      Male subjects will be randomised to give a total of 32 evaluable subjects.

      Subjects will be sequentially enrolled into 4 cohorts of ascending dose.

      Subjects in Cohort 1 will be randomised to receive 0.5 milligrams (mg) HF1020 or placebo
      (ratio 3:1). When at least 8 subjects within the cohort have completed Day 2 procedures (i.e.
      Day 1 + 24 hours) and all ongoing subjects have completed the final Day 15 visit, a Safety
      Review Committee (SRC) will meet, review all safety data prior to dose escalation to the next
      cohort.

      Subjects in Cohort 2 will be randomised to receive 2.5 mg HF1020 or placebo.

      Subjects in Cohort 3 will be randomised to receive 10mg HF1020 or placebo.

      Subjects in Cohort 4 will be randomised to receive 25mg HF1020 or placebo.
    

Intervention name(s): HF1020; HF1020 placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single doses at 0.5 mg capsules, 2.5 mg capsules, 10 mg capsules, and 25 mg capsules in each of cohorts 1, 2, 3 and 4 respectively.; Single dose: HF1020 placebo capsule
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in healthy participants designed to assess the effect of multiple doses of
      itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of
      BMS-986278.
    


Intervention name(s): BMS-986278; Itraconazole; Gemfibrozil; Carbamazepine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Itraconazole; Carbamazepine; Gemfibrozil
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BMS-986278; Itraconazole; Gemfibrozil; Carbamazepine; Idiopathic pulmonary fibrosis; Drug interaction
Estrogen Exposure and Atherosclerosis in Postmenopausal Women
Condition: Atherosclerosis; Menopause; Estrogens; Carotid Intima-media Thickness; Coronary Stenoses; Women
MeSH terms: Atherosclerosis; Coronary Stenosis
Study type: Observational

Summary: 
      One hundred Spanish postmenopausal women accepted to be investigated for cardiovascular risk
      actors including clinical features, serum biochemical parameters, single nucleotide
      polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness
      (91 women) and coronary computed tomography (32 women). Multivariable analysis confirmed that
      both age and glucose level directly affected IMT. Estrogenic exposure, as measured by the
      allele associated with lower expression of the ER beta gene, was protective at the sinus and
      the wall. Findings at the coronary arteries, either moderate or high calcium index (CAC)
      and/or significant lumen stenosis were sporadic and did not allow for establishing
      association with any of the variables assessed.
    

Detailed description: 
      One hundred postmenopausal women living in the urban area of Valencia were invited to
      participate in a cross-sectional study in which a list of clinical and analytical risk
      factors for cardiovascular disease were assessed. Clinical factors included weight, waist
      circumference, body mass index and blood pressure. Analytical parameters included lipidogram,
      serum glucose and insulin, thyroid hormones (TSH and total T4), vitamin D, ultra-sensitive
      C-reactive protein, estradiol, and osteoprotegerin. Imaging studies were performed to
      identify the atherosclerotic burden at the carotid artery (intima-media thickness, measured
      by a high frequency ultrasound probe), and the coronaries (both coronary artery calcium(CAC)
      score and the degree of lumen stenosis). Genetic susceptibility was measured by studying
      single nucleotide polymorphisms of the estrogen receptor. The independent effect of each
      variable was analyzed with multivariate analysis.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Postmenopausal women attending a clinical outpatient service in a third-level hospital for
        health control.
      
Keywords: atherosclerosis, endogenous estrogens, age
Transplantation of Vaginal Mikrobiome
Condition: Vaginal Dysbiosis; Vaginal Microbiome; Transplantation
MeSH terms: Dysbiosis
Study type: Interventional

Summary: 
      Vaginal dysbiosis is a common condition among women. Vaginal dysbiosis covers imbalances in
      the vaginal flora, caused by the composition of microbes, bacteria, viruses and fungi.
      Dysbiosis occurs in about 16% of all women in Denmark. A large proportion of women who have
      vaginal dysbiosis do not experience any symptoms.

      However, vaginal dysbiosis can present challenges in several contexts, including a higher
      tendency for bacterial infections in the female genitals, lower chances of pregnancy in women
      undergoing fertility treatment, just as it can predispose to premature birth.

      This project is aimed at women aged 18-40, who wants to participate in a study to investigate
      whether, by transplanting vaginal secretion from one woman with a normal vaginal bacterial
      flora to another woman with an imbalance in the vaginal bacterial flora (called vaginal
      dysbiosis), can establish a normal vaginal bacterial flora in the recipient of the
      transplant.

      The study will also explore weather genetic, immunological, hormonal, metabolic, health
      behaviors and clinical factors have significance on whether a normal vaginal flora is
      achieved after transplantation.
    

Detailed description: 
      06.12.2021 - Amendment to protocol. A subgroup of 24 women included in the main study as
      recipients, were asked to participate in delivery of menstrual blood (2-3 times) and
      peripheral blood (2-3 times). This to analyse immunological cells via flowcytometry in women
      with vaginal dysbiosis and if there is a change after engraftment of the VMT product.

      17.05.2022 - Amendment to protocol. Those/if any women who did not convert their vaginal
      microbiome is asked to participate in a substudy with 2 arms. Local pretreatment with
      antiseptic and saline water before VMT and local pretreatment with saline water before VMT.

      26.09.2022 - Amendment to protocol. Study arm with only pretreatment of antiseptic was added
      to the amendment from the 17.05.2022.
    

Intervention name(s): Vaginal Microbiome Transplant; Vaginal Microbiome Transplant Placebo; No intervention
Intervention type(s): Biological; Biological; Other
Intervention description(s): Vaginal Microbiome Transplant is given at least once and up to three times. The transplant is admitted with a syringe; Vaginal Microbiome Transplant Placebo is given at least once and up to three times. The transplant Placebo is admitted with a syringe; Donors have no intervention. This group deliver the transplant to arm 'Vaginal Microbiome Transplant'.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Crossover Study to Evaluate the Pharmacokinetics of Ezogabine/Retigabine in Taiwanese Subjects
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics of single oral doses of
      ezogabine/retigabine and the primary metabolite (NAMR) in healthy male and female Taiwanese
      volunteers. Subjects will receive four separate doses of ezogabine/retigabine tablets: 50 mg,
      100 mg, 200 mg and 400 mg administered once orally. Blood samples will be obtained at
      pre-defined timepoints over the duration of the study to determine the concentration of
      ezogabine/retigabine and NAMR. Safety assessments will include measurements of vital signs,
      collection of adverse events, clinical laboratory tests and the Columbia Suicide Severity
      Rating Scale.
    

Detailed description: 
      Ezogabine/retigabine (GW582892), N-[2-amino-4(4-fluorobenzylamino)-phenyl] carbamic acid
      ethyl ester, is a novel anti-epileptic compound which has been developed as an adjunctive
      treatment for partial onset seizures in patients with refractory epilepsy.

      This is an open-label, randomized, single-center, 4-way crossover study to investigate the
      pharmacokinetics of single oral doses of ezogabine/retigabine and the n-acetyl metabolite of
      ezogabine/retigabine (NAMR) in healthy male and female Taiwanese volunteers. The study
      consists of a screening phase, 4 treatment periods and a follow-up visit. Subjects will
      receive each of the following four treatments administered in a randomized four-way crossover
      design: 50 mg, 100 mg, 200 mg and 400 mg ezogabine/retigabine tablets administered once
      orally. Serial blood samples will be obtained at pre-defined timepoints for pharmacokinetic
      analysis of ezogabine/retigabine and NAMR. Safety assessments will include measurements of
      vital signs, collection of adverse events, clinical laboratory tests and the Columbia Suicide
      Severity Rating Scale.
    

Intervention name(s): 50mg Ezogabine/retigabine; 100mg Ezogabine/retigabine; 200mg Ezogabine/retigabine; 400mg Ezogabine/retigabine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single 50mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state; A single 100mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state; A single 200mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state; A single 400mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state
Other intervention name(s): GW582892; GW582892; GW582892; GW582892
Intervention MeSH terms: Ezogabine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ezogabine; Pharmacokinetics; Retigabine
ImmuneRACE - Immune Response Action to COVID-19 Events
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      ImmuneRACE is a study, which is designed to better understand the immune response to
      COVID-19. This is critically important because the immune system may be able to tell us
      important information about how our own bodies detect and respond to the disease that current
      tests cannot. De-identified data collected from this study may accelerate the development of
      better diagnostics for COVID-19 and improve outcomes for many.
    

Detailed description: 
      PURPOSE Aim 1. Compare disease-specific TCR signatures in patients vs. controls Aim 2.
      Identify antigens that elicit a T-cell response Aim 3. Risk Stratification based on immune
      signature Aim 4. Early detection

      Secondary Aim:

      Aim 5. Identify and/or confirm antigenic binding (BCR PairSEQ/neutralizing antibodies)

      STUDY POPULATION Approximately 1000 individuals, between the ages of 18 - 89 Cohort 1.
      EXPOSED to someone with a confirmed diagnosis of COVID-19 Cohort 2. ACTIVE COVID-19

      Individuals with a confirmed diagnosis of COVID-19:

      Clinical diagnosis made by a medical professional, or Positive laboratory test Cohort 3.
      RECOVERED from COVID-19

      Individuals with a previously confirmed diagnosed and cleared from active infection by
      either:

      Testing negative on two consecutive swab tests, or Cleared by a healthcare professional, or
      Resolution of symptoms

      METHODS Decentralized study (visits occur at participant's houses) Utilizing remote
      phlebotomy to collect (1) whole blood, (2) serum, (3) nose or throat swab Collection of
      relevant metadata by electronic questionnaire

      Option for longitudinal collection of up to 4 additional blood draws and questionnaires
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1000 individuals, between the ages of 18 - 89, who reside within the United States. Blood
        samples and nose or throat swabs will be collected at affiliated sites or with mobile
        phlebotomy. These samples will be shipped frozen or transported refrigerated or at room
        temperature to Adaptive Biotechnologies for processing, including, but not limited to DNA
        extraction and analysis. Minors, pregnant women, prisoners, mentally disabled persons, and
        wards-of-the-state will be excluded to prevent any risk to vulnerable populations. The
        selection of participants will be equitable per 45 CFR 111(a).
Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying
Condition: Healthy
Study type: Interventional

Summary: 
      This is a clinical research study to establish normal values for the infusion of a synthetic
      form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is
      released from the small bowel to stimulate the pancreas and gallbladder to help digest and
      absorb food. Some people have gallbladder problems and need to be tested with the synthetic
      cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out
      how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying.
      The findings in normal subjects will be used to establish normal values that can then be
      compared with patients with suspected gallbladder disease.
    

Detailed description: 
      This study enrolled 60 healthy volunteers from four institutions (Johns Hopkins University,
      Pennsylvania State University, Memorial Health University Medical Center, and Temple
      University. Subjects had to be healthy men or women 18-65 years old with no gastrointestinal
      disease as confirmed by initial screening using a modified Mayo Clinic Research
      Gastrointestinal Disease Screening Questionnaire, and normal results for CBC, metabolic
      profile, serum amylase and gallbladder ultrasonography. Women could not be enrolled if
      pregnant.

      Subjects had 3 infusion studies at least 2 days apart within 3 weeks.
    

Intervention name(s): Experimental Sequence ABC; Experimental Sequence ACB; Experimental Sequence BAC; Experimental Sequence BCA; Experimental Sequence CAB; Experimental Sequence CBA
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes; Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes; Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion; Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion; Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion; Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion
Other intervention name(s): Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: CCK infusion; Gallbladder ejection fraction; Normal volunteers
COPD AND ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION
Condition: COPD
Study type: Interventional

Summary: 
      Background: Beneficial effects from noninvasive ventilation (NIV) in acute COPD are
      well-established, but couple to nebulization is still challenging. Aim: To compare
      radioaerosol pulmonary deposition and radioaerosol mass balance in the different compartments
      (pulmonary and extrapulmonary) using vibrating mesh nebulizer (VMN) and jet nebulizer (JN)
      coupled to NIV.Methods: It was a crossover study involving 9 stable moderate to severe COPD
      randomly allocated for both phases of the study: Phase 1(NIV+MN,n=9) and phase 2(NIV+JN,n=9).
      Bronchodilators were delivered during NIV using a facemask (pressures of 12 cmH2O and 5 cmH2O
      - inspiratory and expiratory, respectively). Radioactivity counts were performed using a
      gamma camera and regions of interest(ROIs) were delimited. We determine aerosol mass balance
      from the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory
      filters, and mask as a percentage.
    


Intervention name(s): Noninvasive ventilation; Jet Nebulizer; Vibrating Mesh Nebulizer (VMN)
Intervention type(s): Other; Device; Device
Intervention description(s): Bilevel positive pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure after a period of adaptation before beginning the procedure to avoid ventilator-patient asynchrony; Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. JN (Mist yMax, Air Life, Yorba Linda, USA) was positioned in the circuit using a "T" piece, particle size generation in a 5 µm range (according to the manufacturer information) and flow oxygen tritated at 8 L/min; Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. VMN (Aeroneb Solo, Galway, Ireland) was positioned in the mask using an elbow (Elbow Kit, Respironics®, Murrysville, Pennsylvania, USA), particle size generation in a 1 µm and connected to electrical energy.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nebulizers,; noninvasive ventilation; COPD; scintigraphy,; aerosol
A Study of MEDI7352 in Painful Osteoarthritis of the Knee
Condition: Chronic Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, drug levels and effects on the body of
      MEDI7352, in subjects with painful osteoarthritis of the knee.
    

Detailed description: 
      An interleaved SAD/MAD Study to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of MEDI7352 in subjects with painful osteoarthritis of the knee.
    

Intervention name(s): MEDI7352 for IV infusion; Placebo for IV infusion; MEDI7352 for Subcutaneous Injection; Placebo for Subcutaneous Injection
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): MEDI7352 for IV infusion; IV Placebo infusion; MEDI7352 for subcutaneous injection; Subcutaneous Placebo Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy
Condition: Milk Hypersensitivity; Food Sensitivity; Protein Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Milk Hypersensitivity
Study type: Interventional

Summary: 
      The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly
      developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.
    


Intervention name(s): extensively hydrolyzed rice protein formula
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Cow's Milk protein Allergy
Periosteal Stimulation for Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      185 veterans with chronic knee pain and advanced knee osteoarthritis will be recruited to
      participate in this study designed to test the effectiveness of a special type of electrical
      acupuncture called periosteal stimulation (PST). Participants will be divided into three
      groups. They will receive PST or a control condition once a week for 10 weeks. Two-thirds of
      the participants will receive booster sessions periodically over the course of the next 6
      months. Everyone will be called monthly during the 6 month period and then will be asked to
      return for an evaluation on site at the end of this period.
    

Detailed description: 
      We have performed a promising initial trial of periosteal stimulation (PST, that is,
      electrical stimulation of 4 acupuncture needles around the knee that touch periosteum) as an
      analgesic for older veterans with advanced knee osteoarthritis (OA) and daily pain. The
      primary aim of the proposed trial is to optimize and sustain the efficacy of PST for reducing
      pain in veterans with advanced knee OA and unrelieved pain by combining it with booster PST.
      Our secondary aims are to 1) improve physical performance in these individuals, and 2)
      ascertain the physical and psychological predictors of response to PST. In a randomized
      controlled clinical trial, 180 veterans (age 50 and older) with persistent knee pain who have
      x-ray evidence of advanced OA will be assigned to one of three intervention groups: 1)
      control PST once a week for 10 weeks (i.e., needle placement with brief stimulation of
      non-periosteal needles), 2) PST once a week for 10 weeks followed by tapering PST boosters
      over 6 months, or 3) PST once a week for 10 weeks followed by tapering control-PST boosters
      over 6 months. Prior to initiating the intervention, immediately after the last session, and
      6 months later, the following parameters will be assessed: 1) pain severity (WOMAC), 3)
      physical performance (gait velocity, stair climb, repetitive chair rise, timed up and go),
      and 4) psychological function (mood, coping, self-efficacy). Monthly telephone calls will
      assess pain, interim illness and physical activity.
    

Intervention name(s): Periosteal stimulation; Control-Periosteal Stimulation
Intervention type(s): Other; Other
Intervention description(s): Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.; Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: acupuncture