bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of the Metabolism and Pharmacokinetics of 10 mg [14C] BI 1356 Administered Orally Compared to 5 mg [14C] BI 1356 Administered Intravenously in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the basic pharmacokinetics of BI 1356 BS, its metabolite CD 1750 XX and
      radioactivity including excretion mass balance, excretion pathways and metabolism following
      the intravenous and oral administration of [14C] BI 1356 BS
    


Intervention name(s): [14C] BI 1356 as oral (p.o.) solution; [14C] BI 1356 solution for i.v. infusion
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin; Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial
      twice daily treatment and subsequent twice weekly prophylactic application can effectively
      treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.
    


Intervention name(s): tacrolimus ointment; Placebo ointment
Intervention type(s): Drug; Drug
Intervention description(s): Topical application; Topical application
Other intervention name(s): Protopic®; FK506 ointment
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dermatitis, atopic; Tacrolimus; Child; treatment outcomes
Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults
Condition: Electrical Stimulation; Phrenic Nerve
Study type: Observational

Summary: 
      The goal of this observational study is to characterize the standardized stimulation
      parameter for noninvasive, transcutaneous, repetitive phrenic nerve electrical stimulation.

      The main questions it aims to answer are:

        -  Is the phrenic nerve repetitive electrical stimulation test feasible for use as
           non-invasive transcutaneous electrical stimulation?

        -  What is the most optimal stimulation parameters for repetitive phrenic nerve electrical
           stimulation in healthy adult populations in terms of effective and safe activation of
           diaphragm?
    


Intervention name(s): Transcutaneous, repetitive phrenic nerve electrical stimulation
Intervention type(s): Procedure
Intervention description(s): Phrenic nerve electrical stimulation with different stimulation intensity and frequency
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy adult population who have read the recruitment announcement, voluntarily expressed
        their intention to participate, and have met the eligibility criteria.
The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      To develop a pragmatic migraine model the investigators will induce headache in healthy
      volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor
      (cilostazol). If the headache responds to sumatriptan, the model can be used to test new drug
      candidates.
    

Detailed description: 
      There remains a great need for more effective anti-migraine drugs with fewer side effects.
      Human experimental models are valuable in early phase development of new anti-migraine drugs
      but useful models have not yet been developed. The investigators' group has shown that
      Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers
      and in patients with migraine without aura (MO). To validate this model, the headache must
      respond to specific migraine treatment with sumatriptan.

      Hypothesis: Cilostazol induces a migraine-like headache in both healthy subjects and in
      MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.

      Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
    

Intervention name(s): Cilostazol; Sumatriptan; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan; Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan; Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Other intervention name(s): Pletal; Imigran
Intervention MeSH terms: Cilostazol; Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
Condition: Growth Disorder; Idiopathic Short Stature
MeSH terms: Dwarfism; Growth Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety
      of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Intervention description(s): A weekly dosage of 0.469 mg of somatropin per kg of body weight per week will be injected subcutaneously (under the skin) in the evening in 7 days per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
People-Powered Medicine (PPM): Rheumatoid Arthritis Non-responders to Biologic Therapies (RANT)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The investigators are interested in enrolling patients with rheumatoid arthritis (RA) who had
      a difficult time getting their disease under control even after trying multiple RA therapies.
      The investigators believe that there may be common patterns in the genes of this group of RA
      patients compared to those with more "textbook RA." Understanding genetic factors can help
      doctors to know in advance who may not respond to conventional therapies and start with
      treatments that work. Learning about underlying genes that influence treatment may help the
      investigators to identify new targets for therapy, to ultimately improve the lives of
      patients with RA and inflammatory arthritis.
    

Detailed description: 
      The investigators are looking for patients with rheumatoid arthritis (RA) with an inadequate
      response to tumor necrosis factor inhibitor (TNFi) and another biologic disease modifying
      anti-rheumatic drug (bDMARD) or small molecule approved for treating RA. The investigators
      are conducting this research to learn more about RA and the genetic patterns associated with
      patients whose RA cannot be well controlled with most RA treatments. Investigators anticipate
      that these patients will differ from "classic" RA patients in their biomarker and genetic
      composition and that they represent a mixed group of individuals who may be similar in ways
      that are not currently being measured.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with rheumatoid arthritis (RA) that have failed TNFi therapy and another
        bDMARD or small molecule approved for RA.

        TNFi= adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), infliximab
        (Remicade), golimumab (Simponi)

        bDMARDs or small molecules for RA in addition to TNFi above: abatacept (Orencia),
        baricitinib (Olumiant), sarilumab (Kevzara), tocilizumab (Actemra), rituximab (Rituxan),
        tofacitinib (Xeljanz), upadacitinib (Rinvoq)
      
Biospecimen description: 
      One-time blood draw to measure proteomics and conduct whole genome sequencing.
    
Keywords: Treatment non-response; Tumor necrosis factor inhibitor (TNFi); Rheumatoid Arthritis; Disease modifying anti-rheumatic therapy; Biologic therapy
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out if a new investigational hepatitis B virus vaccine,
      HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years
      old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at
      least as good as that of Engerix-B®.
    

Detailed description: 
      This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared
      with three injections of a commercially available hepatitis B virus (HBV) vaccine,
      Engerix-B®, in subjects 11 to 55 years old. About 2,400 subjects will be included in the
      study. Once subjects are consented, screened, and randomized to treatment, all subjects will
      receive a total of three injections over a 24-week period, with a follow-up visit at 28
      weeks. Subjects randomized to Engerix-B® will receive 3 injections of active vaccine, while
      subjects randomized to HEPLISAV™ will receive 2 injections of active vaccine plus 1 injection
      of placebo. Safety and tolerability will be evaluated by occurrence of adverse events,
      periodic laboratory tests, vital signs, and local/systemic reactogenicity.

      Comparison: Subjects will receive treatment with either HEPLISAV™ or the comparator vaccine,
      Engerix-B®.
    

Intervention name(s): HEPLISAV and/or Placebo; Engerix-B
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24; Intramuscular (IM) injections on Week 0, Week 4, and Week 24
Other intervention name(s): HEPLISAV; Hepatitis B vaccine (recombinant), adjuvanted; Hepatitis B vaccine (recombinant)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HBV vaccine; Hepatitis B vaccine; Hepatitis B; Hepatitis; HBV; Immunostimulatory sequence (ISS)
Phase III Cat-PAD Study
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the treatment effect of two treatment regimens of
      Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue
      medication usage and Quality of Life.
    


Intervention name(s): Cat-PAD; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 dose every 4 weeks; 1 dose every 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cat allergy; Rhinoconjunctivitis
Tissue Sodium in Pre-hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Cardiovascular disease is the first common cause of death worldwide. Hypertension is the
      number one driving risk factor. Hypertension has long been associated with dietary salt
      intake. We believe that the accumulation of salt in the interstitium and inside cells
      represents a neglected risk factor, which initiates a pro-inflammatory state, chronically
      increases blood pressure, and leads to systemic energy imbalance. We will explore the concept
      that Na+ storage in the skin and in muscle is associated with increased blood pressure, a
      pro-inflammatory state, and reduced insulin sensitivity. We will do so by addressing the
      following specific aims:

        -  Specific Aim 1: To test the hypothesis that African Americans are characterized by
           increased tissue Na+ storage, which is paralleled by higher blood pressure, reduced
           forearm blood flow, and enhanced pulse wave velocity

        -  Specific Aim 2: To test the hypothesis that treatment with spironolactone reduces tissue
           Na+ content

        -  Specific Aim 3: To test the hypothesis that Na+ storage leads to immune cell activation

        -  Specific Aim 4: To test the hypothesis that the accumulation of salt in skin and muscle
           is associated with decreased insulin sensitivity and propensity to diabetes mellitus
    


Intervention name(s): Spironolactone; Chlorthalidone; Diet; Placebo
Intervention type(s): Drug; Drug; Dietary Supplement; Drug
Intervention MeSH terms: Chlorthalidone; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Na+ MRI; salt stores
Cerebral Microemboli in Venoarterial ECMO Patients
Condition: Complication of Extracorporeal Membrane Oxygenation; Cerebral Microembolism; Cerebral Perfusion
Study type: Observational

Summary: 
      Extracorporeal membrane oxygenation (ECMO) is progressively used in critically ill patients
      with cardiac or respiratory failure as a bridging option for potential organ recovery.
      However, ECMO survivors often suffer from poor neurocognitive outcome due to neurological
      complications such as microembolic (ME) strokes.

      In venoarterial (va) ECMO circuits the pulmonary circulation, which usually serves as
      microembolic filter, may be bypassed and generated ME are prone to reach the brain in
      substantial amounts and potentially impair cerebral integrity. Although patient exposure to
      cerebral ME has been thoroughly investigated in cardiopulmonary bypass procedures, there is
      only limited research on cerebral ME in patients undergoing ECMO therapy.

      The primary study goal of this study is to determine the load and nature of cerebral ME in
      critically ill patients under va-ECMO support. We also aim to compare the results to
      measurements in healthy subjects und intensive care unit (ICU) patients without
      extracorporeal support to get a better impression on the relevance of ME generation during
      ECMO support.
    

Detailed description: 
      The addition of ICU patients was made according to reviewer suggestions after an initial
      submission to a medical journal.
    

Intervention name(s): Transcranial Doppler Ultrasound
Intervention type(s): Device
Intervention description(s): Transcranial Doppler Ultrasound is used to monitor cerebral microembolism
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of three patient groups with all receiving transcranial
        Doppler exam: 1. patients undergoing ECMO therapy in the ICU; 2. healthy volunteers, and 3.
        critically ill controls (patients on the ICU without ECMO)
A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D745 and D150
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical trial to investigate the pharmacokinetic drug interaction and safety of CKD-501,
      D745 and D150
    

Detailed description: 
      A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the
      Pharmacokinetic Drug Interactions and Safety after Oral Administration of D745, D150 and
      CKD-501 in Healthy Adults
    

Intervention name(s): CKD-501; D745, D150; CKD-501, D745, D150
Intervention type(s): Drug; Drug; Drug
Intervention description(s): QD, PO; QD, PO; QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of
      nintedanib
    


Intervention name(s): Nintedanib; Rifampicin; Nintedanib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose administration; single dose once daily for 7 days; single dose administration
Intervention MeSH terms: Rifampin; Nintedanib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft
      (FDBA) materials in the preservation of alveolar bone following extraction of non-molar
      teeth. The primary objective is to histologically evaluate and compare the healing of
      extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for
      ridge preservation.
    


Intervention name(s): cortical FDBA; Cancellous FDBA
Intervention type(s): Device; Device
Intervention description(s): cortical mineralized freeze-dried bone allograft; CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tooth extraction; bone grafting
Hop Botanical Dietary Supplements - Metabolism and Safety in Women
Condition: Food-Drug Interactions
Study type: Interventional

Summary: 
      Human safety studies were carried out to test whether hop botanical dietary supplements used
      by peri- and post-menopausal women are safe to use with Food and Drug Administration
      (FDA)-approved drugs. To test this, a hop dietary supplement (previously tested in women at
      the University of Illinois at Chicago without any harmful effects) was given with four
      selected FDA-approved drugs to determine if the hop supplement can increase or decrease how
      these medications are absorbed, metabolized and excreted by the human body. Preclinical
      studies had predicted that the hop supplement might affect the metabolism or break down of
      these probe drugs.
    

Detailed description: 
      At the start of a study, subjects were administered low doses of a mixture of four
      FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial
      blood samples were drawn and analyzed for the concentration of each drug over time.
      Afterwards, participants consumed the hop dietary supplement twice daily for 14 days to allow
      for potential inhibition or induction of drug metabolizing enzymes and transporters.
      Thereafter, the same drugs were taken again to obtain a second measure of drug concentrations
      in blood over time. Changes in the concentration-time curve values for each probe drug
      obtained before and after ingestion of the supplement would indicate that metabolism of the
      probe drugs is impacted by the hop dietary supplement.
    

Intervention name(s): Humulus lupulus
Intervention type(s): Dietary Supplement
Intervention description(s): Extract of spent hops standardized to xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin
Other intervention name(s): hops
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Humulus lupulus
Prospective Study Using Hybrid PET/MRI to Evaluate Men With Suspected Recurrence Following Treatment for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Study type: Interventional

Summary: 
      Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical
      management of men with suspected recurrent prostate cancer post prostatectomy or
      radiotherapy.

      We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible and
      will lead to changes in management decisions among men being re-staged for suspected prostate
      cancer recurrence post-surgery or radiation who are potentially eligible for local salvage
      therapy.
    

Detailed description: 
      The study will be a non-randomized, prospective study of men with suspected local recurrence
      of prostate cancer post-prostatectomy or radiation with negative bone and CT scans. Hybrid
      PET/MRI using 18F-FCH will be obtained and a consensus staging report generated for the
      attending clinician. Clinical management questionnaires completed by the study investigator
      will be obtained pre and post imaging in order to gauge the impact of the hybrid imaging on
      clinical decision making.
    

Intervention name(s): 18F-FCH PET/MRI imaging
Intervention type(s): Other
Intervention description(s): Patients will first undergo screening to ensure eligibility. If eligible, they will undergo one scan in a Hybrid PET/MRI scanner using 18F-FCH as the radiolabeled tracer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Prostate Cancer; PET; MRI; Hybrid; Recurrence; Fluorocholine
Evaluating the Pharmacokinetics of 400 mg Oral Dose of Raltegravir in HIV-Infected Pre-Menopausal Women
Condition: HIV Infections
Study type: Observational

Summary: 
      The purpose of this study is to characterize the pharmacokinetics of raltegravir in
      cervicovaginal fluids as compared to blood plasma of HIV-infected pre-menopausal women.
    

Detailed description: 
      Participants: Six HIV-positive pre-menopausal women already undergoing therapy with
      raltegravir.

      Procedures (methods): This study will be conducted at a single site: the University of North
      Carolina at Chapel Hill. An outpatient screening visit will assess subject suitability and
      willingness to participate. During one pharmacokinetic visit women will be asked to
      self-collect cervicovaginal samples using a cervicovaginal fluid aspirator at the following
      time points: pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours after raltegravir 400mg dose
      administration. One 3mL EDTA tube will be collected at the same time points to analyze blood
      plasma. A follow-up safety visit will be completed within 30 days of the inpatient stay.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Six HIV-infected adult pre-menopausal women (> or equal to 18 and less than or equal to 49
        years of age) currently undergoing treatment with raltegravir with an intact uterus and
        cervix will be considered for enrollment. Pregnant women and women testing positive for
        STDs (bacterial vaginosis, syphilis, gonorrhea, chlamydia, or trichomonas) will be
        excluded. The six HIV-infected women enrolled in this study will come from the UNC-Chapel
        Hill Infectious Diseases Clinic and associated clinics in local Health Departments.
      
Keywords: Pre-menopausal; Pharmacokinetics; Raltegravir; Women; HIV-infected