bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Potential Pharmacokinetic Interactions Between Phenytoin or Carbamazepine and Telaprevir
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the potential pharmacokinetic (what the body does
      to the drug) interactions between multiple doses of phenytoin 200 mg every 12 hours or
      carbamazepine 200 mg every 12 hours and telaprevir 750 mg every 8 hours at steady-state
      (constant concentration of medication in the blood) in healthy participants.
    

Detailed description: 
      This is a Phase I, open-label (all people know the identity of the intervention), randomized
      (the study medication is assigned by chance), 2-panel, sequential treatment study. In this
      study 24 healthy participants will be randomly assigned equally to 2 panels. In Panel 1 the
      participants will receive telaprevir in Part 1 (telaprevir 750 mg every 8 hours from Day 1 to
      Day 9 followed by a single 750 mg dose in the morning on Day 10) and phenytoin/telaprevir in
      Part 2 (phenytoin 200 mg every 12 hours from Day 1 to Day 16 followed by a single 200-mg dose
      in the morning on Day 17; and telaprevir 750 mg every 8 hours from Day 8 to Day 16 followed
      by a single 750 mg dose in the morning on Day 17). In Panel 2 the participants will receive
      telaprevir (telaprevir 750 mg every 8 hours from Day 1 to Day 9 followed by a single 750 mg
      dose in the morning on Day 10) and carbamazepine/ telaprevir (carbamazepine 200 mg every 12
      hours from Day 1 to Day 16 followed by a single 200-mg dose in the morning on Day 17; and
      telaprevir 750 mg every 8 hours from Day 8 to Day 16 followed by a single 200-mg dose in the
      morning on Day 17). In both panels, Part 1 and Part 2 are separated by a washout period of at
      least 2 weeks and maximum 4 weeks. Safety and tolerability will be assessed by evaluating
      adverse events, electrocardiogram, clinical laboratory examinations, vital signs and physical
      examination throughout the study period.
    

Intervention name(s): Telaprevir; Phenytoin; Carbamazepine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=375, form=tablet, route=oral. Two tablets of telaprevir will be administered as per the dosing regimens for each part of both the panels.; Type=exact number, unit=mg, number=100, form=capsule, route=oral. Two capsules of phenytoin will be administered as per the dosing regimen in Part 2 of Panel 1.; Type=exact number, unit=mg, number=200, form=tablet, route=oral. One tablet of carbamazepine will be administered as per dosing regimen in Part 2 of Panel 2.
Intervention MeSH terms: Carbamazepine; Phenytoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Hepatitis C virus; Telaprevir; Phenytoin; Carbamazepine; HCV; Interaction
Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Asthma
Condition: Asthma; Healthy
MeSH terms: Asthma
Study type: Observational

Summary: 
      "Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in
      Children With Moderate Asthma" is an observational prospective study in outpatient clinic of
      Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular
      Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), Italy.

      The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the
      level of airway inflammation for different respiratory diseases, especially in children. To
      date, there are no data on the within-day and the between-day repeatability of the breath
      pattern in healthy children and in children with moderate asthma.

      The breath pattern will be analyzed by collecting, for each child, three samples of the
      breath through the E-nose. Within-day repeatability will be assessed using two consecutive
      measurements (the second one after 30 minutes). Between-day repeatability will be assessed
      using a third measurement repeated after 7 days.

      The study is expected to provide information about the accuracy of E-nose measurements for a
      child population.
    


Intervention name(s): Assessment of E-nose measurements
Intervention type(s): Other
Intervention description(s): Breath sampling through E-nose pneumopipe
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A study population of 15 asthmatic children (moderate asthma) attending the outpatient
        clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and
        Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).

        A control group of healthy children (n=30), recruited from the primary schools involved in
        the municipal project "educational pathways" (Palermo, Italy) to which the PAP group
        partecipates.
      
Keywords: Breath pattern; Children; Repeatability
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      The study was conducted to determine if ProQuad may be used in place of the second dose of
      M-M-R II routinely given to children 4 to 6 years old who were previously immunized with
      M-M-R II and Varivax.
    


Intervention name(s): ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live); Comparator: M-M-R II; Comparator: Varivax; Comparator: Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): A Single 0.5 mL subcutaneous injection at Day 1; A Single 0.5 mL subcutaneous injection at Day 1; A Single 0.5 mL subcutaneous injection at Day 1; A Single 0.5 mL subcutaneous placebo injection at Day 1
Other intervention name(s): ProQuad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Quality of Life After Routine Nasogastric Decompression After Distal Gastrectomy for Gastric Cancer Patients
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate whether distal gastrectomy without post-operative
      nasogastric decompression tube is better in terms of quality of life.
    

Detailed description: 
      Nasogastric decompression tube is an intra-operative routine in most of the time to
      facilitate exposure of operative field during elective distal gastrectomy, however, whether
      it should be retained post-operatively is controversial. Nasogastric decompression tube helps
      to drain the gastric remnant in case there is edema around the gastrojejunostomy, ileus and
      delayed gastric emptying, which can theoretically relieve nausea and abdominal distension.
      However, nasogastric intubation could cause patients discomfort; also it has been shown that
      it would cause gastroesophageal reflux which may be associated with pulmonary complication.
    

Intervention name(s): nasogastric tube; without nasogastric tube
Intervention type(s): Device; Device
Intervention description(s): insertion of nasogastric tube for 2 days after operation; without nasogastric tube after operation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distal gastrectomy; quality of life
Effect of Pea Flour in Bread on Blood Glucose
Condition: Post-prandial Glycaemic Response
Study type: Interventional

Summary: 
      This study's overall goal is to investigate methods to improve the acceptability of pulse
      containing foods that provide a health benefit to consumers. The health benefits we are
      testing are post-prandial blood glucose attenuation and appetite related sensations in
      healthy human volunteers.
    

Detailed description: 
      A randomized, controlled, cross-over study designed to examine the post-prandial glycaemic
      response, metabolism of bioactives and appetite related sensations to 20% incorporation of
      yellow pea flour (untreated, heat treated with 0% moisture and heat treated with 10%
      moisture) into bread will be conducted at the I.H. Asper Clinical Research Institute in
      Winnipeg, Manitoba. Eligible participants who have provided consent will be asked to attend 4
      clinic visits in a fasted state. Participants will be given bread containing 20% yellow pea
      flour at 3 visits and bread with 100% wheat flour at 1 visit. At each visit participants will
      provide 7 venous blood samples via indwelling catheter, 7 capillary blood samples via finger
      poke, 2 urine samples, 5 questionnaires about their appetite and a questionnaire about the
      acceptability of the products. Each visit will last approximately 3h and be separated by 3-14
      days.
    

Intervention name(s): Untreated; Heat treated with 0% moisture; Heat treated with 10% moisture; Wheat
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Bread made with 20% yellow pea flour that was untreated.; Bread made with 20% yellow pea flour that was heat treated with 0% moisture.; Bread made with 20% yellow pea flour that was heat treated with 10% moisture.; Bread made with 100% wheat
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, controlled, cross-over study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: blood sugar; insulin; peas; bread; metabolites
Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women
Condition: Healthy Adult Women
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of a commercially available fermented
      dairy product containing probiotics (4 weeks, twice a day) on the improvement of
      gastrointestinal well being and digestive symptoms in adult women reporting minor digestive
      troubles among the general population.
    


Intervention name(s): 1-Fermented Probiotic Dairy Product (test); 2-Milk-based non-fermented dairy product(control)
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: probiotics; gastrointestinal well being; digestive symptoms; healthy population
A Prospective, Single-center, One-arm Clinical Study of Apatinib Combined With Chemotherapy for Pretreated Patients With Advanced Small Cell Lung Cancer
Condition: Small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      At present, with the increasing intensities of the tobacco industry and air pollution in
      China, the incidence and mortality of lung cancer have become the most important issue that
      threatens human health.Over the past two decades, the treatment of SCLC still stays in the
      mode of treatment based on radiotherapy and chemotherapy.

      This is a prospective, single-center, one-arm clinical study designed to evaluate the
      efficacy and safety of apatinib plus chemotherapy for second-line and above treatment of
      advanced SCLC.

      30 patients will receive apatinib 500mg qd orally, if the patient has a grade 3/4 adverse
      reaction during apatinib treatment, it can be reduced to apatinib 250mg qd orally.The dose
      was later reduced from 500 mg to 250 mg per day based on a recommendation of the principal
      investigator to reduce the adverse events. Chemotherapeutic agents are limited to irinotecan
      or docetaxel alone.The primary outcome endpoint was progression-free survival
    


Intervention name(s): Apatinib; chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg qd/250mg; Chemotherapeutic agents are limited to irinotecan or docetaxel alone.
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HPV Vaccine Acceptability Among Young Men Who Have Sex With Men
Condition: HPV Vaccine Attitudes; HPV Vaccine Intention
Study type: Observational

Summary: 
      The FDA has recently approved Gardasil for the prevention of anal cancer in people aged 9-26.
      Men who have sex with men (MSM) have disproportionately high rates of anal cancer and could
      benefit greatly from vaccination. Vaccine uptake among young MSM (YMSM) is poor, and little
      is known about factors associated with vaccine acceptance in this population. With the risk
      of anal cancer among MSM higher than the risk of cervical cancer among women before routine
      cytological screening was introduced, acceptance of a prophylactic vaccine in this subgroup
      is the most cost-effective and attainable strategy to greatly reduce the prevalence of anal
      cancer. While the investigators can assume the human papillomavirus (HPV) vaccine has many
      acceptable concepts among these men, there are multiple barriers which may potentially
      interfere with their likelihood of initiating the vaccine series. Vaccine catch-up rates
      among women of a similar age has been poor, and there is no reason to expect this to be
      higher among men. One potential strategy to increase vaccine uptake in this catch-up group is
      to implement a patient-driven program to promote vaccination among men.

      This project will contribute to the investigators understanding of how the investigators can
      utilize social networks to identify barriers to HPV vaccination among YMSM, and how to
      potentially influence a patient-driven vaccination effort to increase uptake among men in the
      catch-up age group. This research will inform future interventions to targeted populations
      that may be incorporated into online social networking websites to encourage HPV vaccination.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will be an internet-based, cross-sectional study targeting all US profiles of
        two separate online social/sexual networking communities of YMSM. A recruitment email will
        be sent internally to all active US profiles for men 18-26 years old.
      
Keywords: HPV vaccine; acceptability; males; men who have sex with men
Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Idiopathic pulmonary fibrosis (IPF) is a disease of unknown cause that results in scarring of
      the lungs.

      Cough is reported by 85% of patients with IPF and can be a distressing symptom with
      significant physical, social and psychological consequences particularly anxiety and
      depression.

      The cause of cough in IPF is poorly understood and there are currently no proven effective
      therapies. Morphine has long been advocated for the suppression of chronic cough in other
      conditions. While morphine is frequently used as a palliative agent for breathlessness in
      IPF, its effects on cough have never been tested. The aim of this study is therefore to
      explore and compare the effect of low dose morphine, one of the few therapies shown to be
      effective in some patients with otherwise refractory chronic cough, in patients with IPF, to
      an inactive substance known as a placebo.

      To make a fair comparison, patients will be randomly allocated to receiving either morphine
      or placebo in a blinded fashion. This means neither the doctor nor the patient will know
      which drug they are receiving, and the drugs will appear the same. However, the trial is
      designed so that you will receive both morphine and placebo, but at different times (this is
      called a cross-over study). More specifically, you will be given either morphine or placebo
      for 14 days at a time.

      In this study, it is hypothesised that compared with placebo, low dose (5mg) controlled
      release Morphine sulfate (MST) will reduce the number of coughs recorded during a 24hr period
      in patients with IPF.
    


Intervention name(s): Morphine Sulfate; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.; capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effects of rTMS in Rehabilitation Following Spinal Cord Injury
Condition: Spinal Cord Injury; Rehabilitation; Transcranial Magnetic Stimulation; Neurorehabilitation
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The project will investigate whether repetitive transcranial magnetic stimulation (rTMS) can
      be used to potentiate/prime spinal cord injured patients' nervous systems for more intense
      rehabilitation exercise of longer duration - thus leading to greater recovery of motion
      function. The technique, in which a magnetic coil is positioned above the scalp and forms a
      magnetic field that activates the desired center of the brain (eg motor cortex), is used in
      clinical practice for the treatment of a number of disorders. However, although a combination
      of rTMS and gait training in SCI patients previously has proven beneficial, it is unknown
      whether additional functional gains can be achieved by combining rTMS and supervised,
      high-intensity resistance training.

      In this project, 30 newly-admitted patients will be recruited and randomized to receive
      either active rTMS and strength training (n = 15) or sham (imitated) rTMS + strength
      training, in parallel with standard care. The investigators hypothesize that the active rTMS
      group will have superior gains in locomotor function and muscle mass, compared to the sham
      group.
    


Intervention name(s): repetitive transcranial magnetic stimulation; Sham stimulation
Intervention type(s): Device; Other
Intervention description(s): Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training; Imitated magnetic stimulation: An active coil will be activated under the subject's head, firing down into the mattress, while an inactive coil will be held over the scalp
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Placebo Controlled Clinical Intervention Study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Study in Healthy Men to Test if Different Formulations of BI 764198 With or Without Food Influence the Amount of BI 764198 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      BI 764198 is intended to be used in patients hospitalized for COVID-19 at risk of respiratory
      complications. The present trial will investigate the relative bioavailability of BI 764198
      administered as capsules versus tablets in a first part, and the relative bioavailability and
      food effect of four oral formulations: the newly developed tablet formulation under fed and
      fasted conditions as well as suspension from capsules and suspension from tablets in a second
      part.
    


Intervention name(s): BI 764198 - Formula A; BI 764198 - Formula B; BI 764198 - Formula C; BI 764198 - Formula D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BI 764198; BI 764198; BI 764198; BI 764198
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Dimethylxanthenone acetic acid may stop the growth of cancer cells by stopping
      blood flow to the tumor.

      PURPOSE: Phase I trial to study the effectiveness of dimethylxanthenone acetic acid in
      treating patients with solid tumors that have not responded to previous therapy.
    

Detailed description: 
      OBJECTIVES: I. Determine the toxicity of dimethylxanthenone acetic acid (DMXAA) in patients
      with solid tumors. II. Establish a maximum tolerated dose for this drug in these patients.
      III. Determine the pharmacokinetics of DMXAA in these patients. IV. Determine the effect of
      this regimen on coagulation parameters, TNF and other cytokine production, nitric oxide, and
      serotonin production in these patients. V. Assess the efficacy of this drug in this patient
      population. VI. Determine the effect of this drug on tumor vasculature by evaluating any
      changes apparent on MRI scans in these patients.

      OUTLINE: This is a dose escalation, multicenter study. Patients receive dimethylxanthenone
      acetic acid (DMXAA) IV over 20 minutes once weekly for 6 weeks, followed by 2 weeks of rest.
      An additional course of therapy may be administered in the absence of unacceptable toxicity
      or disease progression. Cohorts of 3 patients receive escalated doses of DMXAA until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
      which 2 of 3 patients experience dose limiting toxicity.

      PROJECTED ACCRUAL: A minimum of 3 patients will be accrued to each dose level used to
      determine the maximum tolerated dose.
    

Intervention name(s): vadimezan
Intervention type(s): Drug
Intervention MeSH terms: Vadimezan
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty
Condition: Fast Track; Tranexamic Acid Adverse Reaction; Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Patients undergoing total knee arthroplasty will follow two different rehabilitation
      protocols. In one of them, they will start walking the day of surgery and discharged on a 48
      hours basis. On the other one, start walking 3 days after surgery and discharged on a 96
      hours basis. Outcomes will be satisfaction, pain, range of movement, incidence of DVT and
      overall complications.
    

Detailed description: 
      Randomization will be performed concealed the day before surgery. Tranexamic acid will be
      used in both groups. Rapid recovery group will not be using a drain, whereas the standard
      protocol group will have one.
    

Intervention name(s): Walk within 24 hours
Intervention type(s): Behavioral
Intervention description(s): Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.
Other intervention name(s): Drain; Discharge the day after walking
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: fast track; total knee arthroplasty; tranexamic acid; drain