bioihbjkbjnl/mcl2 huggingface dataset:
Copper Balance in Healthy Participants Administered ALXN1840
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the change from baseline in mean daily copper balance in healthy
      participants with repeat-dose administrations of ALXN1840 over 2 weeks.
    

Detailed description: 
      This study will also characterize the steady state absorption, distribution, metabolism, and
      excretion (mass balance) of total molybdenum, which is a surrogate measure of ALXN1840
      disposition.

      Safety will be monitored throughout the study.
    

Intervention name(s): ALXN1840
Intervention type(s): Drug
Intervention description(s): Administered orally as tablets.
Other intervention name(s): formerly WTX101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Copper Balance; Molybdenum Balance; Healthy; ALXN1840
Use of NovoSeven® in Active Variceal Bleeding
Condition: Acquired Bleeding Disorder; Cirrhosis
MeSH terms: Liver Cirrhosis; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Asia and Europe. The trial is planned to investigate the
      effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active
      variceal bleeding.
    


Intervention name(s): activated recombinant human factor VII
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Active variceal bleeding in patients with advanced cirrhosis
Evaluating the Foot Touch Framework Model
Condition: Barefoot Running
Study type: Observational

Summary: 
      A Foot Touch framework model has been developed to express the ground reaction force
      waveforms observed for walking and running. The purpose of this research is to collect ground
      reaction force data during walking and running that can be used to evaluate and verify the
      Foot Touch framework.
    


Intervention name(s): Four speeds; Foot Strike Pattern
Intervention type(s): Other; Other
Intervention description(s): Four speeds ranging from a set walking speed up to 9 mph; Foot strike sequences (rearfoot strike, midfoot strike, forefoot strike)
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy, able-bodied participants will be recruited from the general public.
Benzo[a]Pyrene Ultralow Dose-Response Study
Condition: Environmental Exposure
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Evaluation of the pharmacokinetics for [14C]-benzo[a]pyrene ([14C]-BaP) and metabolites in
      plasma and urine over 48 hours following 4 oral doses of 25, 50, 10 and 250 ng (2.7-27 nCi).
    

Detailed description: 
      The pharmacokinetics for [14C]-BaP and metabolites will be assessed by UHLPC-Accelerator Mass
      Spectrometry (AMS, Lawrence Livermore National Laboratory) in plasma and urine collected over
      48 hours following oral doses of 25, 50, 100 or 250 ng (2.7-27 nCi). Metabolite profiles and
      kinetics of elimination over this dose range are predicted to be consistent with a BaP
      physiologically based pharmacokinetic (PBPK) model developed by Pacific Northwest National
      Laboratory (PNNL). A non-smoker, not exposed occupationally, receives 270-700 ng of BaP
      daily; about 95% dietary. The WHO has set an estimated safe daily lifetime (70 year/70 Kg
      individual, cancer endpoint) exposure to BaP of 42-350 ng. This protocol represents de
      minimus risk.
    

Intervention name(s): [14C]-benzo[a]pyrene
Intervention type(s): Drug
Intervention description(s): Oral micro-dose range (25, 50, 100 and 250 ng)
Other intervention name(s): Carcinogenic PAH environmental pollutant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Benzo[a]pyrene; Accelerator Mass Spectrometry; Polycyclic Aromatic Hydrocarbons
Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to analyze the effects of the consumption of yogurt with
      concentrated and lyophilized probiotic cultures on the parameters associated with glucose
      homeostasis, inflammation and oxidative stress in patients with Type 2 Diabetes Mellitus
      (T2DM).
    

Detailed description: 
      After being informed about the study and the potential risks, all patients who gave their
      written informed consent underwent a screening period of 1 week to determine their
      eligibility to participate in the study. At week 0, patients who met the eligibility
      requirements were randomized in a double-blind manner (participant and investigator) to the
      American Diabetes Association (ADA) diet + yogurt with premium probiotics (300 g/d) or ADA
      diet + conventional yogurt (300 g/d) or ADA diet without fermented dairy.
    

Intervention name(s): Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205; Lactobacillus bulgaricus and Streptococcus thermophillus; No culture
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Cultures containing 3.7 × 10 ^ 9 CFU/mg; Cultures containing 3.7 × 10 ^ 6 CFU/mg; No probiotic cultures
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: probiotics; glucose homeostasis
Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
Condition: Nausea
MeSH terms: Nausea
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to compare the incidence of side effects caused by Oxycodone and
      Hydromorphone.
    

Detailed description: 
      Nausea and vomiting in the post-operative period is considered strongly undesirable by
      patients and has adverse effects on recovery from outpatient procedures, contributing
      significantly to delays in discharge from recovery. A know major contributor to the
      occurrence of post-operative nausea and vomiting is the use of opiate medications which are
      the cornerstone of post-operative pain management. The investigators hypothesize that the
      occurrence of this side-effect is different between patients prescribed oxycodone and those
      receiving hydromorphone for acute pain management after total hip replacement surgery. This
      investigation is a randomized, double-blind, head-to-head comparison to equipotent
      administration of oxycodone vs. hydromorphone to determine whether such a difference exists.
    

Intervention name(s): Oxycodone; Hydromorphone
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive oxycodone 10mg (5mg if > 65) every 2 hours based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.; Patients will receive an initial dose of hydromorphone 2mg (1mg if > 65) every 2 hours as needed based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.
Other intervention name(s): Supeudol; Palladone, Dilaudid
Intervention MeSH terms: Oxycodone; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nausea
Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers
Condition: Normal Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study type: Interventional Description of intervention(s) / exposure

      For single ascending dose, five dose target ranges of BT-11 (depending on body weight the
      doses in each cohort will be 5.9 - 7.7 mg/kg; 18.9 - 25.0 mg/kg; 44.3 - 50.0 mg/kg; 68.5 - 75
      mg/kg and 94.2 - 100.0 mg/kg) will be evaluated, based on subject's weight on Day 1.

      For multiple ascending dose (once daily for 7 days), three dose target ranges of BT-11
      (depending on body weight the doses in each cohort will be 5.9 - 7.7 mg/kg; 44.3 - 50.0
      mg/kg; and 94.2 - 100.0 mg/kg) will be evaluated, based on subject's weight on Day 1.

      White tablets containing 500 mg BT-11 or matching placebo tablets will be dispensed.

      Single ascending dose duration of administration will be once. For multiple ascending dose it
      will be up to 7 days.

      The mode administration will be oral tablet. Compliance and adherence to the intervention
      will be performed based on the tablet return, tablet not consumed by the subject.

      The safety monitoring committee will evaluate safety at conclusion of single ascending cohort
      2 prior to the commencement of dosing for the multiple ascending dose.
    


Intervention name(s): Placebo; BT-11
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fasting Bioavailability Study of Mylan's Revefenacin Inhalation Solution
Condition: Healthy Volunteers Bioavailability Study
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-Dose Fasting Bioavailability Study of Revefenacin Inhalation Solution, 175 mcg/3 mL in
      24 Healthy Chinese Adult Male and Female Volunteers. This study will evaluate the safety and
      tolerability of Revefenacin Inhalation Solution in the Chinese population. For the
      determination of the pharmacokinetic disposition of the formulations, The bioavailability of
      Revefenacin Inhalation Solution, 175 mcg/3 mL will be assessed through various
      pharmacokinetic parameters derived from the plasma concentration-time curves of revefenacin
      and its active metabolite, THRX-195518.
    

Detailed description: 
      A single-dose, open-labeled, one-period, one-treatment study to investigate the
      bioavailability of Revefenacin Inhalation Solution, 175 mcg/3 mL following administration of
      a single, nebulized, inhaled 175 mcg (1 x 175 mcg/3mL) dose in a total of 24 healthy,
      Chinese, adult male and female volunteers under fasting conditions. In addition, this study
      will evaluate the safety and tolerability of Revefenacin Inhalation Solution in the Chinese
      population. Ten milliliter (1 × 10 mL) blood samples will be collected at pre-dose and the
      following times after the initiation of dosing: 5, 10, 15, 30, and 45 minutes along with 1,
      1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.

      The bioavailability of Revefenacin Inhalation Solution, 175 mcg/3 mL will be assessed through
      various pharmacokinetic parameters (such as AUC0-t, AUC0-∞, Cmax, and Tmax) derived from the
      plasma concentration-time curves of revefenacin and its active metabolite, THRX-195518.
    

Intervention name(s): Revefenacin Inhalation Solution
Intervention type(s): Drug
Intervention description(s): Revefenacin Inhalation Solution, 175 mcg/3 mL following a single nebulized inhaled 175 mcg (1 x 175 mcg/3 mL) dose administered under fasting conditions.
Other intervention name(s): Yupelri
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
Condition: Knee Osteoarthritis; Total Knee Arthroplasty; Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      The objective of this study is to determine and compare the in vivo kinematics and
      vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized
      (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.
    

Detailed description: 
      The objective of this study is to determine and compare the in vivo kinematics and
      vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized
      (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs. The Journey II BCS Knee
      System was designed to resect and replicate both the PCL and ACL, the Journey II CR System
      retains the posterior cruciate ligament, while the Journey II XR System retains the cruciate
      and collateral ligaments so they remain intact.
    

Intervention name(s): Journey II Bi-Cruciate Stabilized TKA; Journey II Cruciate Retaining TKA; Journey II Bi-Cruciate Retaining TKA
Intervention type(s): Device; Device; Device
Intervention description(s): Total Knee Arthroplasty System; Total Knee Arthroplasty System; Total Knee Arthroplasty System
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and
        Bi-Cruciate Retaining (XR) TKAs
      
Keywords: Total Knee Arthroplasty
Immediate Postpartum Insertion of Contraceptive Intrauterine Devices
Condition: Contraception
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In this randomized trial, investigators intend to determine the expulsion and discontinuation
      rate of immediate postpartum intrauterine devices in the patient population of the University
      of Oklahoma Women's Healthcare Specialists Clinic (OUWHSC).
    

Detailed description: 
      Between 40-57% of women report having unprotected intercourse prior to the 6 week postpartum
      visit. Immediate postpartum long-acting reversible contraception (LARC) is extremely
      important in preventing short-interval and unintended pregnancies. The postpartum period is
      an excellent time for intrauterine device (IUD) or implant insertion as women are often
      highly motivated to prevent unwanted pregnancies at this time. Per the American College of
      Obstetrics and Gynecology (ACOG), expulsion rates for immediate postpartum IUD insertion are
      higher than for interval or post-abortion insertion. Despite the higher expulsion rate of
      immediate postpartum IUD placement over interval placement, cost-benefit analysis data
      strongly suggest the superiority of immediate placement in reduction of unintended pregnancy,
      especially for women at greatest risk of not attending the postpartum follow-up visit. This
      study will randomly allocate participants one to one to the Kyleena or the Mirena IUD group,
      and participants will be blinded to allocation of groups. Participants will follow up at
      routine postpartum visit within 4 weeks of delivery, and a second follow up will be performed
      at 10 weeks. Ultimately, this study will attempt to provide more detailed information on the
      difference of rates of expulsion and discontinuation of the different-sized Mirena and
      Kyleena intrauterine devices.
    

Intervention name(s): Kyleena Intrauterine System; Mirena Intrauterine System
Intervention type(s): Drug; Drug
Intervention description(s): Participant will be randomly allocated to this intervention; Participant will be randomly allocated to this intervention
Other intervention name(s): levonorgestrel intrauterine system; levonorgestrel intrauterine system
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly allocated one to one to the Kyleena or Mirena group and assessment will occur in parallel
Masking: Single (Participant)
Primary purpose: Other
A Study to Evaluate Abuse Potential of Istradefylline
Condition: Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the abuse potential of single-doses of istradefylline compared to
      placebo and phentermine in recreational stimulant users. Subjects will participate in an
      outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a
      6-period Treatment Phase, and an outpatient safety Follow-Up visit. Study will be
      approximately 25 weeks total.

      Within 28 days of the Screening visit, eligible subjects will be admitted to the CRU (Day -1)
      for the Qualification Phase. During the Qualification Phase, subjects will receive single
      oral doses of phentermine 60 mg and matching placebo in a randomized, double blind, crossover
      manner, with each drug administration separated by approximately 48 hours (Day 1 and Day 3),
      to ensure that they can discriminate and show positive subjective effects of the active
      controls. Following evaluation of eligibility, subjects may be discharged (those who fail
      Qualification criteria) or remain in the CRU (those who pass criteria and are eligible) and
      then proceed directly to the Treatment Phase. The washout interval between last drug
      administration in the Qualification Phase and first drug administration in the Treatment
      Phase will be at least 96 hours (4 days).

      Following confirmation of eligibility from the Qualification Phase, subjects will be
      randomized to one of 6 treatment sequences according to a 6x6 Williams square. Subjects will
      receive single oral doses of each of the 6 treatments in a randomized, double-blind,
      crossover manner, Istradefylline 40 mg, Istradefylline 80 mg, Istradefylline 160 mg,
      Phentermine 45 mg, Phentermine 90 mg, Placebo.

      Each drug administration will be separated by at least 21 days. Serial pharmacodynamic
      evaluations will be conducted up to 24 hours after each study drug administration to confirm
      exposure to istradefylline.
    


Intervention name(s): Istradefylline; Phentermine 45 mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Istradefylline 40, 80, 160 mg; Phentermine 45 or 90 mg; Placebo
Other intervention name(s): 6002
Intervention MeSH terms: Phentermine; Istradefylline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Recreational stimulant users; Recreational Drug Users
SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a comparator study to assess the relative efficacy of the combination product
      fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations
      of chronic obstructive pulmonary disease (COPD) over a two year study interval.
    

Detailed description: 
      A Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104 Week Study to
      Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE)
      50/500mcg with Tiotropium Bromide 18 mcg on the Rate of Exacerbations in Subjects with Severe
      Chronic Obstructive Pulmonary Disease (COPD)
    

Intervention name(s): Tiotropium bromide 18mcg; Fluticasone propionate/ salmeterol combination 50/500mcg
Intervention type(s): Drug; Drug
Other intervention name(s): Tiotropium bromide 18mcg
Intervention MeSH terms: Fluticasone; Xhance; Bromides; Tiotropium Bromide; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: fluticasone propionate/salmeterol combination; tiotropium; SERETIDE; COPD exacerbation
Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      A study to explore whether two different treatment approaches, myofascial trigger point
      release and core stabilization exercises, both with and without additional paced breathing
      training, can help patients with chronic low back pain (CLBP) and whether one of the two
      treatments is superior.
    

Detailed description: 
      This is a randomized controlled trial to evaluate the effect of myofascial trigger point
      release therapy compared to core stabilization exercises, both with and without additional
      paced breathing training, on patients with chronic low back pain (CLBP). The main focus is on
      changes in pain severity, anxiety and depression, heart rate variability, and use of
      analgesic medication. Outcomes are measured at baseline (pre-intervention), after ten
      treatments (post-intervention), at three- and at six-month follow-up.
    

Intervention name(s): Core stabilization exercises; Core stabilization exercises and paced breathing training; Myofascial trigger point release; Myofascial trigger point release and paced breathing training
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Twelve specific exercises following a standard protocol aiming at an intersegmental stabilization of the spine and strengthening and stabilization of specific muscle groups. The exercises are performed under instruction and supervision by a physiotherapist twice per week for 45 minutes; Twelve specific exercises following a standard protocol aiming at an intersegmental stabilization of the spine and strengthening and stabilization of specific muscle groups. The exercises are performed under instruction and supervision by a physiotherapist twice per week for 45 minutes. In addition, the participants practice paced breathing training (before and during the CSE sessions as well as 15 minutes twice per day at home) which has a modulating effect on the autonomic nervous system; A standard protocol of 12 myofascial and trigger point release grips followed by so-called roll-down maneuvers and manual rhythmical oscillation, applied to specific muscles and muscle groups. The treatment is applied twice per week for 45 minutes; A standard protocol of 12 myofascial and trigger point release grips followed by so-called roll-down maneuvers and manual rhythmical oscillation, applied to specific muscles and muscle groups. The treatment is applied twice per week for 45 minutes. In addition, the participants practice paced breathing training (before and during the MTPR sessions as well as 15 minutes twice per day at home) which has a modulating effect on the autonomic nervous system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Low-back Pain; Myofascial Trigger Point Release; Core Stabilization Exercises; Paced Breathing Training; Pain Severity; Anxiety; Heart Rate Variability