bioihbjkbjnl/mcl2 huggingface dataset:
Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-EYP001a After a Single Oral Dose
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to investigate the absorption, metabolism, and excretion of EYP001a as
      well as the safety/tolerability of EYP001a following the administration of a single oral dose
      to healthy male volunteers. The EYP001a dose is administered in a [14C]-labeled form to
      enable detection and quantitation of dose-related material independent of possible
      biotransformation.
    

Detailed description: 
      This is a single site, open-label, mass balance phase 1 study.

      Six healthy male subjects will receive a single oral dose A of [14C]-EYP001a containing 100
      μCi radioactivity.

        -  Eligibility is assessed during a screening period of up to 4 weeks.

        -  Subjects will check into the clinic one day prior to dosing (Day -1) for baseline
           assessments and to (re-)confirm eligibility.

        -  The study drug will be administered on Day 1, after an overnight fast of at least 10
           hours.

        -  Blood, urine and fecal samples will be collected up to and including Day 4. If the study
           discharge criteria are not met on Day 4, blood, urine and fecal samples will be
           collected in 24- hour intervals until the study discharge criteria are met.

        -  An End of Study Visit will be planned at Day 14 (+/- 1 Day).
    

Intervention name(s): [14C]-EYP001a
Intervention type(s): Drug
Intervention description(s): Oral drinking suspension
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Spinal Cord Stimulation For Heart Failure
Condition: Systolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objectives of this feasibility study are to determine the safety of spinal cord
      stimulation (SCS) as a therapy in patients with systolic heart failure and to gather
      observational information for potential efficacy markers
    

Detailed description: 
      Morbidity and mortality in heart failure patients remain relatively high, even with recent
      advances in therapies. Previous studies show that the autonomic nervous system plays an
      important role in the pathophysiology of heart failure (HF)and sudden cardiac death.

      SCS is a neurostimulation therapy, which involves the stimulation of selected nerve fibers
      and intends to create end-organ responses characterized by changes in blood flow, decrease of
      catecholamines and reduction in inflammation. These changes that occur due to SCS are shown
      to be effective in reducing the symptoms of chronic angina and pain secondary to peripheral
      vascular disease where both situations are characterized by decreased blood flow and
      inflammation.

      The SCS system consists of an implantable pulse generator(IPG) and lead(s). Each lead has
      electrodes on the distal end. Electrical impulses travel from the IPG through the leads to
      the electrodes positioned at the selected nerve fibers to provide the therapeutic
      stimulation. By virtue of its potential in augmenting blood flow, decreasing catecholamines
      and reducing inflammation, SCS may further benefit patients with heart failure (HF).
    

Intervention name(s): Spinal cord stimulation system
Intervention type(s): Device
Intervention description(s): An implantable pulse generator (IPG) will deliver low-intensity electrical pulses which travel from the IPG through the leads to the electrodes positioned at the selected nerve fibers to provide the therapeutic stimulation.
Other intervention name(s): Eon Mini Neurostimulation System,; Octrode® percutaneous lead (Model 3186),; Eon Mini IPG (Model 3788),; Eon Patient ProgrammerTM (Model 3851),; Multi-program trial stimulator (Model 3510),; Rapid programmer (Model 3832),; Eon Mini Charging System (Model 3721).; Similar St. Jude Medical commercially available neurostimulation system with the same capabilities may also be used.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord stimulation; systolic heart failure
Delayed Cord Clamping at Term Cesarean
Condition: Maternal Blood Loss; Cesarean Delivery; Delayed Cord Clamping; Neonatal Health
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The purpose of this research study is to find out how delaying cutting the umbilical cord
      until one minute after delivery of the baby during a cesarean impacts the amount of blood the
      mother loses during surgery. The study will also examine the benefits to the newborn from
      delayed cord clamping during cesarean.
    

Detailed description: 
      After delivery of a baby, the umbilical cord is cut to separate the baby from the placenta
      and the mother. The best time to cut the umbilical cord of full term babies is unknown.
      Traditionally, the umbilical cord is cut immediately at birth. There is however, continued
      blood flow from the placenta to the baby after delivery and so there may be a benefit to the
      baby from waiting to cut the cord until one minute after delivery. Studies show that delaying
      cutting the cord until at least one minute after delivery increases a full term baby's blood
      count in first two days of life and increases the baby's iron levels. The impact of delaying
      cutting the umbilical cord on a mother's health is not fully known. Delaying cutting the cord
      has minimal impact on the mother's health when the baby is delivered vaginally, but it is not
      known how delaying cutting the cord impacts the mother's health (and specifically the amount
      of blood a mother loses at delivery) when the baby is delivered by cesarean.
    

Intervention name(s): Umbilical cord clamping
Intervention type(s): Procedure
Intervention description(s): The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Maternal blood loss; Cesarean delivery; Delayed cord clamping; Neonatal health
HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms
Condition: Childhood Trauma; Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study evaluates the association between early trauma, depression and metabolic symptoms.
    

Detailed description: 
      Early traumatic stress is associated with alterations of the hypothalamic-pituitary-adrenal
      axis (HPA-axis) indicated by an increased response to stress, a diminished negative feedback
      and alterations in expression of glucocorticoid receptors. Patients with a history of
      childhood trauma are more likely to develop metabolic disorders such as diabetes mellitus
      type 2 or metabolic syndrome.

      The investigators will examine participants with and without early life stress and with and
      without major depression. The investigators assume that traumatized study participants (1)
      show an increased endocrine stress reaction to psychosocial stress, (2) display an altered
      sensitivity of GR, and (3) therefore suffer from an adverse cardiovascular risk profile in
      comparison to not-traumatized participants.

      The investigators study will increase current knowledge on possible sequel of early traumatic
      stress. The results will lead to a more comprehensive understanding of stress-related eating
      behaviour and its implications.
    

Intervention name(s): stress
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type
Condition: EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT; CHROMOSOME 2q31.2 DELETION SYNDROME
MeSH terms: Ehlers-Danlos Syndrome; Ehlers-Danlos Syndrome, Type IV; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Ehlers-Danlos syndrome vascular type (EDS-IV) is caused by a genetic defect of collagen type
      III. Patient die (median 40 yrs) of vascular complications. There is no treatment. We showed
      that arteries are thin and overloaded in this patients. We test the protective effect of
      celiprolol on cardiovascular events in a 5 years, randomized, PROBE design
    

Detailed description: 
      100 patients with verified EDS-IV syndrome are included. Patients are randomized to either
      celiprolol (50 to 400 mg BID)or no treatment. Patients who are not randomized enter a
      longitudinal survey of events. The hypothesis is a 50% reduction in the occurrence of
      cardiovascular events under treatment, assessed by a blinded, independent events committee.
    

Intervention name(s): celiprolol; Control
Intervention type(s): Drug; Drug
Intervention description(s): celiprolol; Untreated controls excluding betablockers
Other intervention name(s): celiprolol? Dose ranging 100 to 400 mg, dose adaptation; every 6 months by increment of 100 mg, based on tolerance
Intervention MeSH terms: Celiprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arteries; ultrasonography; Ehlers Danlos syndrome; Cardiovascular disease; beta adrenergic antagonists
A Pharmacokinetics and Safety of Methylphenidate HCl in Healthy Japanese Adult Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics and safety of 3 single doses of
      Methylphenidate HCl in healthy Japanese adult male volunteers.
    

Detailed description: 
      This is an open-label (name of assigned treatment is known), single-center study of the
      pharmacokinetics (blood levels) and safety of 3 single doses of methylphenidate HCl
      administered orally (by mouth) to healthy Japanese adult male volunteers. Methylphenidate HCl
      is a drug that is currently approved for the treatment of adults with
      attention-deficit/hyperactivity disorder (ADHD) in regions outside Japan, including the
      United States where this study will be conducted. Volunteers will participate in the study
      for a maximum of 42 days. Blood samples will be collected from volunteers during the study to
      determine the concentration of the methylphenidate HCl in the blood after dosing. Safety will
      be monitored throughout the study by evaluating adverse events reported, changes in clinical
      laboratory test results, vital signs measurements, physical examination results, and other
      protocol-specified safety assessments. All volunteers will receive a single oral dose of
      methylphenidate HCl with 240 mL (1 cup) of noncarbonated water after at least a 10-hour fast
      (without eating food) during 3 treatment periods as follows: Period 1, one 36-mg tablet;
      Period 2, three 18-mg tablets; and Period 3, two 36-mg tablets. Treatment periods will be
      separated by 3 to 7 days. Volunteers will continue fasting until at least 4 hours after
      dosing.
    

Intervention name(s): Methylphenidate HCl
Intervention type(s): Drug
Intervention description(s): Period 1: One tablet, oral, 36 mg, once daily, single-dose on Day 1
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: CONCERTA; Methylphenidate HCl; Pharmacokinetic; Safety; Adult; Men; Male
Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2; Newly Diagnosed
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to investigate and evaluate the effects of different
      interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell
      function in newly diagnosed drug-naïve type 2 diabetic patients.
    

Detailed description: 
      One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function.
      Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct
      effects on β-cell, which indicates that it may not only contribute to the glucose control but
      also delay disease progression. There are trials demonstrated efficacy, safety and
      tolerability of exenatide. However, no study has compared the effects of exenatide with other
      hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type
      2 diabetic patients. This current study is thus designed to evaluate the effects of
      exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly
      diagnosed drug-naïve type 2 diabetic patients.
    

Intervention name(s): exenatide injection; Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R; Pioglitazone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients in exenatide group will be treated with exenatide (Byetta®, Eli Lilly and Company) 5 µg BID for the first 4 weeks and then 10 µg BID thereafter.; Patients in insulin group will be treated with premixed insulin analog (Humalog Mix 25, Eli Lilly and Company). The initial insulin doses are 0.4 IU/kg per day(50% before breakfast and 50% before dinner). Insulin doses are titrated following a forced schedule according to blood glucose before breakfast and dinner.; Patients in thiazolidinedione group will be treated with Pioglitazone 30mg daily as single dose. The dose will be increased to 45mg daily after 4 weeks.
Other intervention name(s): Byetta®(Eli Lilly and Company); Humalog Mix 25®（Eli Lilly and Company)
Intervention MeSH terms: Insulin; Pioglitazone; Exenatide; Insulin Lispro; Insulin, Globin Zinc; Protamines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus, type 2; newly diagnosed; exenatide; premixed insulin analog; thiazolidinedione; β-cell function; glycemic control
Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome
Condition: Metabolic Syndrome; Insulin Sensitivity
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to look at how insulin (a hormone that helps the cells get
      energy from sugar) in our body affects blood vessels (elasticity in the bigger blood vessels
      and blood flow in the smaller blood vessels in the arm) and how Metformin (a drug that makes
      you more sensitive to insulin) affects insulin's action on the blood vessels.
    

Detailed description: 
      In our protocol, we will study vascular function using pulse wave velocity (PWV) augmentation
      index (AI), flow mediated dilation (FMD) and contrast enhanced ultrasound (CEU) as well as
      insulin sensitivity (euglycemic clamp) in 50 adults with metabolic syndrome, age 18-60 years.
      They will each be studied 4 times,before and after two 12-wk interventions (randomly
      assigned) as follows: 1) Placebos and 2) Metformin . This is a cross-over design.
    

Intervention name(s): Placebos; metformin
Intervention type(s): Drug; Drug
Intervention description(s): A 12 week single blind placebos; A 12 week single blind metformin
Other intervention name(s): inactive substance; glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to examine the effect of pramlintide on body weight and its safety and
      tolerability in obese subjects.
    


Intervention name(s): pramlintide acetate
Intervention type(s): Drug
Other intervention name(s): Pramlintide acetate injection (Pramlintide (0.6 mg/mL)) is a clear, colorless, sterile solution for SC injection
Intervention MeSH terms: Pramlintide; Islet Amyloid Polypeptide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: obesity; weight loss; Amylin; pramlintide; Symlin
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
Condition: Bioequivalence; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is a comparative bioavailability study performed to assess bioequivalence
      between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC
      "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal
      product Arcoxia® 120 mg etoricoxib film-coated tablets, Marketing Authorisation Holder: UAB
      "Merck Sharp&Dohme", Lithuania) in healthy volunteers.
    


Intervention name(s): Exib 120 mg etoricoxib film-coated tablets; Arcoxia® 120 mg etoricoxib film-coated tablets
Intervention type(s): Drug; Drug
Intervention description(s): Oral, COX-2 highly selective, non-steroidal anti-inflammatory generic drug; Oral, COX-2 highly selective, non-steroidal anti-inflammatory innovative drug
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two-period, two-sequence, two-way crossover single dose study
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; etoricoxib; healthy subjects; pharmacokinetics
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Aim 1 - Determine the pharmacokinetics of PMO (menthol) of three different doses in children
      with functional abdominal pain (FAP) (n=30).

      Aim 2 - Determine pharmacodynamic effect of three different doses of PMO on gut microbiome
      composition and contractile activity/gut transit rate.
    

Detailed description: 
      Children with functional abdominal pain (FAP) ages 7-12 years (n=30) will be recruited.

      The study participants will be admitted to the Children's Nutrition Research Center. A
      medical history and a general physical examination performed by the investigator or the
      research nurse. The height, weight, and vital signs (pulse rate, respiratory rate, and seated
      blood pressure) will be obtained. After application of a topical anesthetic to the site
      chosen for study-related blood sampling, a cannula will be inserted e to obtain repeated
      blood samples.

      At approximately 0900, subjects will receive one of three doses of PMO as a single oral dose.
      Immediately prior to administration of the PMO, a blood sample will be obtained to measure
      total menthol concentration and leukocytes for isolation of DNA for CYP2A6 and UGT2B7
      genotyping.

      After PMO administration, repeated blood samples will be obtained over 24 hours.

      At 2 hours after PMO administration, participants will be given a standardized meal and will
      eat ad libitum thereafter.

      After completion of the final (24 hours) blood samples, vital signs will be reassessed and
      the venous cannula removed. Parents will receive a follow-up call from the research
      coordinator to access/evaluate if any adverse effects from dose or blood sampling received at
      the overnight study visit.

      Prior to and after administration of peppermint oil (PMO) for 1 week at the dose defined
      above, children will undergo measurement of gut microbiome composition and GI motility and
      transit time. At the time of the stool collection, the child will also keep a 3 day diet
      history.
    

Intervention name(s): Peppermint oil
Intervention type(s): Drug
Intervention description(s): Three doses of peppermint oil will be investigated: 180, 360, 540 mg; i.e. three arms.
Other intervention name(s): Enteric coated peppermint oil capsules
Intervention MeSH terms: Peppermint oil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants randomized to one of three prospective arms as reflected by three treatment doses for the duration of the study.
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in
      healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days
    


Intervention name(s): 3 mg PF-06412562; 10 mg PF-06412562; 25 mg PF-06412562; PF-06412562 TBD mg; PF-06412562 TBD mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days; oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days; oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days; oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts; oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: multiple doses; pharmacokinetics; safety; tolerability; healthy volunteers; steady state; cognitive impairment associated with schizophrenia