bioihbjkbjnl/mcl2 huggingface dataset:
PLATelet Function Operating Room Monitoring
Condition: Platelet Dysfunction Due to Drugs; Bleeding
Study type: Observational

Summary: 
      Prospective cohort study on adult cardiac surgery patients. Platelet function evaluated
      before and after cardiopulmonary bypass. Bleeding and transfusion recorded. Primary endpoint
      is finding the association between postoperative platelet function and bleeding.
    

Detailed description: 
      Preoperative platelet function is a known determinant of postoperative bleeding in cardiac
      surgery patients (1,2). Conversely, there is a lack of information with respect to
      postoperative platelet function and postoperative bleeding, and specific cut-off values have
      not been identified yet.

      This study will verify the hypothesis that postoperative platelet function is associated with
      bleeding, and will test the ability of platelet function tests (PFTs) in predicting severe
      postoperative bleeding. Additional analyses linking platelet function to other preoperative
      and intraoperative conditions are planned.

      Patients: Enrollment between February 2017 and January 2018. 800 consecutive adult cardiac
      surgery patients are considered based on our usual surgical activity. Exclusion criteria:
      unwillingness to participate, known congenital coagulopathy. Moderate/severe bleeding occurs
      in about 12% of our patient population. Considering a 15% dropout rate, there are about 80
      predicted events. Power analysis: to build a predictive model, at least 60 events of
      moderate/severe bleeding are required. The study will be stopped at reaching (whatever comes
      first) 800 enrolled pts; 60 events; or 31st January 2018.

      Methods: all the patients will receive a preoperative (in the operating room) PFT (ADPtest
      and TRAPtest) using the aggregometry Multiplate (Roche). The same test will be repeated after
      protamine administration at the end of CPB.

      Definitions of bleeding: 12-hours chest drain blood loss; moderate/severe bleeding
      adjudicated based on the universal definition of perioperative bleeding (3).

      Statistics: ROC analysis with identification of adequate cut-off values and definition of the
      PPV and NPV
    

Intervention name(s): Platelet function test
Intervention type(s): Device
Intervention description(s): Measurement of P2Y12 and PAR-dependent platelet function activity before and after cardiac surgery by ADPtest and TRAPtest
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult cardiac surgery patients
Drug Discrimination in Methadone-Maintained Humans Study 1
Condition: Drug Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves giving psychoactive drugs intramuscularly (injected into the muscle of
      the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the
      difference between one drug and another, as well as measuring the effects of the drugs on
      mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each
      subject will receive 2-4 of the listed interventions.
    


Intervention name(s): Cycloserine; Diltiazem; Gabapentin; Isradipine; Naloxone; Nifedipine; Placebo; Saline; Verapamil
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Device; Drug
Intervention description(s): Cycloserine: 500, 675, 750 mg oral capsule may possibly be given; Diltiazem: 30, 60, 120 mg oral capsule may possibly be; Gabapentin: 100, 200, 400 mg oral capsule may possibly be given; Isradipine: 5, 10 mg oral capsule may possibly be given; Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given; Nifedipine: 5, 10, 20 mg oral capsule may possibly be given; Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given; Saline: I.M. injection may possibly be given; Verapamil: 30, 60, 120 mg oral capsule may possibly be given
Other intervention name(s): Calan; Veralan; Cardizem; Neurontin; DynaCirc; Narca; Adalat; Procardia; Veralan
Intervention MeSH terms: Cycloserine; Verapamil; Diltiazem; Isradipine; Nifedipine; Gabapentin; Naloxone
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: opioid dependence; methadone; opioid
Combination Chemotherapy in Treating Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known which combination chemotherapy regimen is more effective for breast cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination
      chemotherapy regimens in treating women with breast cancer who have undergone surgery to
      remove the tumor.
    

Detailed description: 
      OBJECTIVES: I. Determine whether doxorubicin/docetaxel (DD) will improve disease-free
      survival and overall survival when compared to doxorubicin/cyclophosphamide (DC) in women
      with lymph node positive (1-3 positive nodes) or high risk lymph node negative breast cancer.
      II. Compare the toxicity of DD to DC in this patient population.

      OUTLINE: This is a randomized study. Patients are stratified by node status (positive vs
      negative), menopause status (pre- vs post), estrogen receptor (ER) status/progesterone
      receptor (PR) status (ER/PR unknown vs ER+/PR+ vs ER+/PR- vs ER-/PR+ vs ER-/PR-). Patients in
      arm I receive doxorubicin IV plus docetaxel IV over 1 hour every 3 weeks for 4 treatment
      courses. Patients in arm II receive doxorubicin IV plus cyclophosphamide IV every 3 weeks for
      4 treatment courses. All patients who are estrogen receptor or progesterone receptor positive
      receive oral tamoxifen daily for 5 years following chemotherapy. Some patients may also
      receive radiotherapy following chemotherapy. Patients are followed every 3 months if patient
      is less than 2 years from study entry; every 6 months if patient is 2-5 years from study
      entry; and every 12 months if patient is greater than 5 years from study entry.

      PROJECTED ACCRUAL: Approximately 2778 patients will be accrued for this study within 2.5
      years.
    

Intervention name(s): cyclophosphamide; docetaxel; doxorubicin hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer
Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema
Condition: Diabetic Retinopathy; Macular Edema
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of ocular topic antiinflammatory
      therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness
      secondary to selective photocoagulation in diabetics with clinically significant macular
      edema.
    

Detailed description: 
      Selective photocoagulation is the standard treatment for clinically significant macular
      edema. This treatment decreased the incidence of moderate visual loss in the long term.
      Nonetheless, in the first six weeks after treatment it is induced, probably because an
      exacerbation of macular edema secondary to treatment. An inflammatory response has been
      reported after selective photocoagulation. Therefore, antiinflammatory therapy like ketorolac
      or nepafenac could be useful to manage center point thickness secondary to selective
      photocoagulation in diabetics with macular edema.
    

Intervention name(s): Ketorolac; Nepafenac; Polietilenglicol 400, propilenglicol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week; topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week; ocular presentation Polietilenglicol 400 (4 mg), propilenglicol (3 mg), HP guar (1.9 mg)/1 ml
dosage: one drop (0.2 mg polietinglicol 400, 0.15 mg propilenglicol, 0.095 mg HP guar) 3 times a day during one week
Other intervention name(s): Godek; Nevanac; Systane
Intervention MeSH terms: Ketorolac; Nepafenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: diabetic retinopathy; clinically significant macular edema; selective photocoagulation; topic ketorolac; topic nepafenac; efficacy; treatment
Exercise Tolerance in Patients With CABG and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery
Condition: Coronary Artery Bypass Surgery
Study type: Observational

Summary: 
      In this study, up to 20 healthy individuals, 20 endo-ACAB patients, and 20 CABG patients
      undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only).
      Exercise tolerance is compared between groups.
    

Detailed description: 
      In this prospective observational study, up to 20 healthy individuals (no history or presence
      of any chronic disease, sedentary), 20 endo-ACAB patients, and 20 CABG patients (matched for
      age, gender and BMI) undergo a maximal cardiopulmonary exercise test after hospital discharge
      (for patients only).During this exercise test, following parameters are assessed at peak
      effort and at the second ventilatory threshold (determined by VE/VCO2 slope method): oxygen
      uptake (VO2), oxygen saturation (SaO2), carbon dioxide output (VCO2), resoiratory gas
      exchange ratio (RER), expiratory volume (VE), ventilatory equivalent for VCO2 (VE/VCO2),
      ventilatory equivalent for VO2 (VE/VO2), end-tidal O2 pressure (PETO2), end-tidal CO2
      pressure (PETCO2), heart rate (HR), oxygen pulse (VO2/HR), cycling power output (W), tidal
      volume (Vt), respiratory rate (RR), systolic blood pressure (SBP), diastolic blood pressure
      (DBP), rate pressure product (RPP). Peak exercise effort is validated by RERpeak.
    

Intervention name(s): Cardiopulmonary exercise test
Intervention type(s): Other
Intervention description(s): Maximal exercise test with ergospirometry.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing CABG surgery or endo-ACAB surgery.
      
Keywords: exercise tolerance
Impact of Child Positioning on Pain During a Lumbar Puncture
Condition: Hematological Malignancies
MeSH terms: Hematologic Neoplasms
Study type: Interventional

Summary: 
      This protocol is a pilot study on standard care. The main goal is to assess the impact of
      positioning on lumbar puncture process especially on pain sensitivity in children.

      It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period
      is one year, and number of inclusions forecasted is about 30. Each patient will have one LP
      in a seated position and one in a lying position.
    

Detailed description: 
      In Pediatric Oncology Hematology, invasive procedures such lumbar punctures or myelograms are
      essential to diseases diagnosis and treatment.

      In hematological malignancies, lumbar punctures are particularly frequent as the therapy
      processes. Despite a good analgesia, this repeated procedure can generate pain, anxiety,
      apprehension leading to an increasing difficulty in the procedure realization.

      Two positions are possible to carry out lumbar puncture: seated or lying position.

      The main goal of this study is to assess the impact of the child positioning during the
      lumbar puncture process in term of pain, anxiety and stress.

      This study is a prospective, monocentric, randomized, open-label, cross-over study. Inclusion
      period is 1 year, 30 patients will be included from 2 to 18 years old.

      Each patient will have 2 LP one in seated and one in lying position in a specific order
      determined by randomization.

      All data regarding pain and anxiety will be collected the day of LP. Patients will be re
      contacted 48 hours and 15 days after LP procedure in order to evaluate complications such
      post-lumbar puncture syndrome or hematoma. The main analysis will be done on
      intent-to-treat-analysis basis and will compare pain intensity between the two groups.
    

Intervention name(s): LP in a seated position then LP in a lying position; LP in a lying position then LP in a seated position
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Research Study Looking at New Protein-based Tablets in Healthy Male Participants
Condition: Healthy Volunteers; High Blood Cholesterol Levels; Type 2 Diabetes
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, four new tablet versions of two compounds will be investigated.

      The aim of this study is to investigate the amount of the active ingredient and helping agent
      in the blood after doses of four different tablet versions. The tablet versions, participants
      will receive, i.e. the treatment arm participants will be assigned to, is decided by chance.

      Participants will receive one treatment for 10 days in the first period. For the second
      period, directly following, participants will receive a different treatment for five more
      days.

      The study can last for up to approximately 10 weeks for each participant. This includes a
      screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a
      follow-up visit (5 weeks after the last dosing)
    


Intervention name(s): Semaglutide D; Semaglutide G; Semaglutide H; Semaglutide I; NNC0385-0434 B; NNC0385-0434 C; NNC0385-0434 D; NNC0385-0434 E
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Study of Oral QPX2015 in Healthy Adult Subjects
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      QPX2015 (beta-lactam antibiotic) is being studied at higher than approved doses to combine
      with a new beta-lactamase inhibitor to treat bacterial infections, including those due to
      multi-drug resistant bacteria.
    

Detailed description: 
      The worldwide spread of resistance to antibiotics among gram-negative bacteria, particularly
      members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of both
      hospital acquired and community acquired infections. In particular, the increase in
      Enterobacteriaceae expressing extended spectrum beta-lactamases (ESBLs) and carbapenemases
      that are resistant to all oral beta-lactams and fluoroquinolones in the community have
      resulted in many patients requiring admission just for IV antibiotics to treat their
      infections.

      Qpex Biopharma is developing a fixed combination antibiotic of QPX2015 (beta-lactam
      antibiotic) plus a new beta-lactamase inhibitor.
    

Intervention name(s): QPX2015; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): antibiotic; Placebo comparator
Other intervention name(s): oral dose; oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, placebo controlled ascending single- and multiple-dose
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: beta-lactam antibiotic
Study to Characterize Absorption, Distribution, Metabolism and Excretion of 14C PF-06651600 and to Evaluate the Absolute Oral Bioavailability and Fraction Absorbed of PF-06651600.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the absorption, distribution, metabolism and excretion (ADME) of
      14C PF-06651600 and characterize plasma, fecal and urinary radioactivity and identify any
      metabolites, if possible, of 14C PF-06651600 in humans.
    


Intervention name(s): 14C-PF-06651600; 14C-PF-06651600 IV; PF-06651600
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral solution of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi radioactivity; IV solution 60 micrograms of 14C labeled PF-06651600 containing approximately 300 nCi radioactivity; Oral solution 200mg
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Male; healthy
Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss
Condition: Cytomegalovirus Infection
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections; Hearing Loss; Deafness
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an international, multi-center, double-blind, placebo-controlled evaluation
      valganciclovir treatment for up to 54 children (up to 4 years of age) with
      virologically-confirmed congenital CMV infection and hearing loss. Subject participation will
      be over a six-month period and study subjects will be stratified according to age. The
      primary objective is to assess whether a six-week course of oral valganciclovir can stabilize
      the hearing of children with congenital CMV infection who present with hearing loss.
    

Detailed description: 
      Congenital cytomegalovirus (CMV) infection is the most frequent known viral cause of mental
      retardation, and is the leading non-genetic cause of sensorineural hearing loss in many
      countries including the United States. This is a Phase II international, multi-center,
      double-blind, placebo-controlled evaluation of 6 weeks of oral valganciclovir treatment or 6
      weeks of placebo for fifty-four male and female infants/toddlers 1 month through 3 years of
      age (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing
      loss. Patient who are between 1 month and 4 years of age and who have SNHL (Sensorineural
      Hearing Loss) and are eligible for enrollment. The expected study duration is 3.5 years from
      enrollment of first study subject. The primary objective is to assess whether a six week
      course of oral valganciclovir can stabilize the hearing of children with congenital CMV
      infection who present with hearing loss. The secondary objective is to define the following
      responses as a function of systemic exposure to ganciclovir (active metabolite of
      valganciclovir): CMV viral load in blood; CMV viral load in urine; and CMV viral load in
      saliva. Also, to define the safety and tolerability of valganciclovir in enrolled subjects.
      The tertiary objective is to define the pharmacokinetics of ganciclovir (metabolite)
      following administration of valganciclovir (prodrug) in enrolled subjects.
    

Intervention name(s): Placebo; Valganciclovir
Intervention type(s): Other; Drug
Intervention description(s): Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks; Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.
Intervention MeSH terms: Valganciclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: CMV; Cytomegalovirus; Hearing Loss; Infants; Valganciclovir
"Pecos" B-adrenergic and PPAR-G Stimulation Upregulates Lipid Metabolism in Human Subcutaneous Fat
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares four treatments to see which one causes the most weight loss, fat loss,
      loss of abdominal fat and improvement in blood tests like cholesterol. The four treatments
      are: Placebo, Ephedrine plus caffeine, Pioglitazone, Combined pioglitazone and ephedrine plus
      caffeine
    

Detailed description: 
      The sympathetic nervous system, via the intracellular messenger cAMP and MAPK activation, and
      thiazolidinediones via PPARγ control lipid metabolism have been implicated in body weight
      regulation. The present study was undertaken to determine whether the simultaneous activation
      of these two signaling systems might synergize to exert beneficial effects on the expression
      of key genes involved in lipid metabolism and mitochondrial biogenesis in subcutaneous fat in
      healthy, non-diabetic subjects. Fifty seven non-diabetic women and men were randomized into
      four groups: 1) placebo/placebo (PP); 2) ephedrine plus caffeine/placebo (ECP); 3)
      placebo/pioglitazone (PPio); 4) ephedrine plus caffeine/pioglitazone (ECPio). Adipose tissue
      samples were obtained after 12 weeks of treatment to determine gene expression by real time
      RT-PCR.
    

Intervention name(s): Ephedrine; Pioglitazone; Caffeine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pioglitazone; Ephedrine; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: UCP-1; ephedrine; caffeine; pioglitazone