bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      The primary objective of this clinical study is to investigate the suitability of an infant
      formula containing five different human milk oligosaccharides to support normal physical
      growth (evaluated per weight gain), in comparison with infant formula without human milk
      oligosaccharides, when the formula is fed as the sole source of nutrition.
    

Detailed description: 
      The main goal of the study is to investigate the suitability of an infant formula containing
      five different human milk oligosaccharides to support normal physical growth of term infants
      (evaluated per weight gain, body length and head circumference), in comparison with infant
      formula without human milk oligosaccharides, when the formula is fed exclusivly in the first
      four month of life. Additionally, a comparison of the two formula fed groups against a
      reference group with breastfed infants as well as the WHO growth standard reference tables
      will be performed. An assessment of safety and tolerability will be performed as well.

      As a secondary out come of the study, we will examine the effect of the formula on the infant
      microbiome, as well as the HMO status of the mother's milk towards the microbial composition
      of the infant microbiome.
    

Intervention name(s): human milk oligosaccharides
Intervention type(s): Dietary Supplement
Intervention description(s): mixture of five different human milk oligosaccharides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: human milk oligosaccharides; infant formula
Telephone Support Program for Lung Cancer Patients and Their Family Caregivers
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The goal of this project is to examine the physical and psychological health benefits of a
      novel, telephone-delivered symptom management intervention for advanced lung cancer patients
      and their family caregivers.
    


Intervention name(s): Telephone counseling; Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: lung cancer; family caregiving; behavioral intervention; counseling; symptom management
Effect of Perioperative Clopidogrel Responsiveness on Ischemic Outcome in Patients With Acute Coronary Syndrome Undergoing Off-pump Coronary Artery Bypass Surgery
Condition: Acute Coronary Syndrome (ACS)
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational

Summary: 
      The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength,
      maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in
      platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A
      study reported that the TEG® can be used as routine monitoring of the variability in ADP
      receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay,
      we could find out the perioperative clopidogrel responsiveness of the patients with ACS
      undergoing OPCAB.

      The purpose of this study is to determine whether the rate of the major adverse cardiac
      events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in
      the patients with high degree of clopidogrel resistance, who are scheduled to undergo the
      OPCAB due to ACS.
    


Intervention name(s): MACE after OPCAB; without MACE after OPCAB
Intervention type(s): Device; Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with acute coronary syndrome (ACS) undergoing off-pump coronary artery bypass
        surgery
      
Keywords: off-pump coronary artery bypass surgery, clopidogrel responsiveness, ischemic outcome
Caspofungin Acetate in Treating Children With Fever and Neutropenia
Condition: Fever, Sweats, and Hot Flashes; Infection; Kidney Cancer; Leukemia; Lymphoma; Neuroblastoma; Neutropenia; Sarcoma
MeSH terms: Lymphoma; Leukemia; Neuroblastoma; Kidney Neoplasms; Neutropenia; Fever; Hot Flashes
Study type: Interventional

Summary: 
      RATIONALE: Giving caspofungin acetate may be effective in preventing or controlling fever and
      neutropenia caused by chemotherapy or bone marrow transplantation.

      PURPOSE: Clinical trial to study the effectiveness of caspofungin acetate in treating
      children who have fever and neutropenia caused by a weakened immune system.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the pharmacokinetics and serum levels of caspofungin acetate in
           immunocompromised children with new-onset fever and neutropenia.

        -  Determine the safety and tolerability of this drug in this patient population.

      OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
      age (2 to 11 vs 12 to 17).

      Patients receive caspofungin acetate IV over 1 hour once daily for 4 to 28 days in the
      absence of the need to start standard empirical antifungal therapy, a breakthrough fungal
      infection, any deterioration of patient condition, or unacceptable toxicity.

      Cohorts of 16 patients (8 per stratum) receive caspofungin acetate at 1 of 2 dose levels.
      Caspofungin acetate is escalated to dose level 2 if no more than 1 of 8 patients experiences
      dose-limiting toxicity at dose level 1.

      Patients are followed at 14 days.

      PROJECTED ACCRUAL: A total of 32-64 patients (16 per dose level (cohort), 8 per stratum) will
      be accrued for this study.
    

Intervention name(s): caspofungin acetate
Intervention type(s): Drug
Intervention MeSH terms: Caspofungin
Primary purpose: Supportive Care
Keywords: recurrent childhood acute lymphoblastic leukemia; recurrent childhood rhabdomyosarcoma; disseminated neuroblastoma; recurrent neuroblastoma; recurrent Wilms tumor and other childhood kidney tumors; recurrent childhood lymphoblastic lymphoma; recurrent childhood acute myeloid leukemia; fever, sweats, and hot flashes; childhood acute promyelocytic leukemia (M3); recurrent/refractory childhood Hodgkin lymphoma; neutropenia; infection; recurrent childhood small noncleaved cell lymphoma; recurrent childhood large cell lymphoma; previously treated childhood rhabdomyosarcoma
Bioequivalence Study of Minocycline 100mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study was to determine the bioequivalence of Minocycline formulations
      after administration of single doses to normal healthy subjects under fasted conditions.
      These data were to be evaluated statistically to determine if the products meet
      bioequivalence criteria.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomised, two-treatment, two-period,
      two-sequence, single-dose, crossover , bioequivalence study on minocycline comparing
      minocycline 100mg tablets of Ranbaxy pharmaceuticals inc with Minocin 100mg capsules of in
      healthy, adult, human, subjects under fasting conditions.

      A total of 28 non-smoking subjects (16 men and 12 women) were included in this study, of
      which 28 finished the study according to the protocol,
    

Intervention name(s): Minocycline 100mg Tablets
Intervention type(s): Drug
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence Minocycline Tablets
Assessment of the Analgesic Effects of PF-05089771 and Pregabalin in Healthy Volunteers Using Evoked Pain Endpoints
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the activity of PF-05089771 and pregabalin, alone and in combination
      on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in
      healthy male subjects
    


Intervention name(s): PF-05089771 300mg; PF-05089771 300 mg + pregabalin 300 mg; Placebo; pregabalin 300 mg; ibuprofen 600 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-05089771 300 mg; PF-05089771 300 mg + pregabalin 300 mg; Placeco; pregabalin 300 mg; ibuprofen 600 mg
Intervention MeSH terms: Ibuprofen; Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Assess the Safety, Tolerability, PK, ECG Effects, Food Effect, and Drug-drug Interaction (DDI) of Hormonal Contraceptives of PTI-428 in Healthy Female Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will consist of three parts: the first two parts will enroll healthy female
      volunteers into a single ascending dose (SAD) and multiple ascending dose (MAD) treatment
      groups.

      The SAD treatment group is comprised of at least 3 cohorts where subjects will be randomized
      to a single dose of either PTI-428 or placebo and will be followed for 7 days post dose. A
      total of 24 subjects are anticipated to participate in this part of the study.

      Following the conclusion of the respective SAD level dose groups and after sufficient review
      of study data and approval by the SRC, a second set of healthy adult female subjects will
      participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3
      cohorts where subjects will be randomized to either PTI-428 or placebo and will be followed
      for a total of 14 days. The SRC will convene after the completion of each cohort to evaluate
      safety, PK and other relevant data. The SRC will determine whether to proceed to the next
      planned dose level, to reduce the dose, or to stop the study. The next cohort may commence
      only after written SRC approval. A total of 24 subjects are anticipated to participate in
      this part of the study.

      Following completion of the SAD and MAD, 40 female healthy volunteers will participate in two
      treatment periods of the DDI study component: Treatment period A will consist of once daily
      oral contraceptive (OC) for 28-days (21-day hormonal active + 7 days off).

      Treatment period B will randomize subjects to PTI-428 or placebo in combination with once
      daily OC for 28 days (21-day hormonal active and PTI-428 or placebo + 7 days off). Following
      completion of the subjects' second treatment period, they will be followed for 7-days after
      their last dose.
    


Intervention name(s): PTI-428; Placebo; ethinyl estradiol and levonorgestrel
Intervention type(s): Drug; Other; Drug
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco
      withdrawal symptoms and increases long term cessation rates when combined with transdermal
      nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized,
      parallel group trial in which smokers aged 18-70 will be subject to the combination of oral
      and patch treatments.
    


Intervention name(s): nortriptyline; transdermal nicotine
Intervention type(s): Drug; Drug
Intervention description(s): Dose titrated to 75 mg daily as tolerated combined with transdermal nicotine 21 mg; Transdermal nicotine 21 mg, titrated down plus placebo
Intervention MeSH terms: Nortriptyline; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation
Nicotine Patch Bioequivalence Study
Condition: Healthy Smokers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability of nicotine following
      single application of a new transdermal formulation to that of a reference formulation.

      4 single 24hour applications separated by 48hour intervals.
    


Intervention name(s): V0116 transdermal patch (Test treatment ); Nicotine transdermal patch (Reference Treatment )
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Smoking cessation; Nicotine; Tobacco Use Disorder; Central Nervous System Agents
Development of a New Electronic Measure of Pediatric Pain: A Pilot Study
Condition: Pediatric Pain
Study type: Observational

Summary: 
      The purpose of this study is to test the accuracy of a computer-based program to self-report
      the location and intensity of a child's pain in comparison to a traditional self-report paper
      and pencil measure and physician physical exam. Using a computer to assess pediatric pain may
      offer many advantages and improvements in how pediatric pain is diagnosed and treated.
    

Detailed description: 
      Approximately 1 in 4 children aged 5-18 report experiencing pain. As many as 2 in 3 of these
      children will develop a significant physical, emotional, social or academic impairment.
      Recent research has identified pediatric pain as an area where biological, psychological and
      social treatments can interact to provide substantial changes in pain symptoms. However,
      there is a lamentable dearth of empirical studies evaluating the efficacy of treatments for
      chronic pain in children. These findings necessitate more intensive efforts to improve
      methods on initial assessment and treatment, but an important first step is to improve the
      sensitivity of outcome evaluation.

      Existing measures of pediatric pain have been concerned with symptom intensity and the
      general locus of pain. Children are traditionally asked to mark with a number or a color the
      region in which they experience pain. This is helpful for understanding generality that a
      large area such as the head, joints, or stomach hurts. However, it does not allow the child
      the option to specify a narrow area of discomfort within a broader region (e.g., upper right
      quadrant of the stomach). Consequently, current pain instruments may lead to an inaccurate or
      imprecise understanding of a child's pain, which can adversely impact clinical care of the
      quality of clinical trials.

      The current study will compare a widely used paper-based "pain mapping" tool to a new
      electronic tool designed by study investigators to capture the same information as the paper
      measure, while adding more precision regarding pain regions and greater range in terms of
      pain intensity. We expect that children's responses on these two measures (pencil/paper and
      electronic) will be generally similar, but we expect that the electronic measure will map
      more closely onto the Attending Physician's notes regarding discrete pain location,
      intensity, and/or diagnosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Presentation to either Abdominal Pain Clinic or Integrative Pain Management Clinic. A total
        of ten patients from each clinic, five (5) aged 8-12 and five (5) aged 13-17.
      
Keywords: Electronic Diary; Body Map; Electronic Measure of Pediatric Pain
Analgesia After Total Hip Arthroplasty: Peri-Articular Injection Versus Epidural Patient Controlled Analgesia (PCA)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The best way to provide analgesia after total hip arthroplasty is hotly debated. There are
      two protocols in use at Hospital for Special Surgery(HSS). Both protocols have their
      proponents, but there are limited data for making an informed choice of protocols. For total
      hip arthroplasty at HSS, epidural analgesia is used most frequently as it reduces pain with
      physical therapy. However, epidural analgesia can be associated with nausea, pruritis,
      dizziness, and orthostatic hypotension. These side-effects can slow physical therapy and may
      prolong the time until the patient is ready for discharge. Some surgeons at HSS have decided
      to use a different analgesic protocol, based on a peri-articular injection. This protocol
      avoids epidural analgesia and systemic opioids. However, patients are given oral opioids as
      part of a multimodal pain therapy. The investigators propose to compare peri-articular
      injection to epidural patient controlled analgesia (Epidural PCA). The investigators will
      enroll 90 total patients (45 per study arm). The enrollment period will be approximately one
      year and the duration of the follow-up with study patients will be three months following
      their procedure.
    


Intervention name(s): Peri-Articular Injection; Epidural Patient Controlled Analgesia (Epidural PCA)
Intervention type(s): Procedure; Procedure
Intervention description(s): Use of a different analgesic protocol, based on a peri-articular injection; Epidural analgesia pathway.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Hip Arthroplasty; Total Hip Replacement
Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure
Condition: Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      OBJECTIVES: I. Determine the maximum tolerated dose and safety of alpha-melanocyte
      stimulating hormone (alpha-MSH) in patients with acute renal failure.

      II. Determine the safety and pharmacokinetics of alpha-MSH in patients at high risk of acute
      renal failure after renal transplantation.

      III. Determine the safety and pharmacokinetics of alpha-MSH in patients with established
      ischemic acute renal failure.

      IV. Determine the effect of alpha-MSH on interleukin-10 pharmacokinetics.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a dose escalation, double blind, placebo controlled, multicenter
      study.

      Group 1: Patients are infused with alpha-melanocyte stimulating hormone (alpha-MSH) or
      placebo over 5 minutes. A cohort of 5 patients is infused at each dose level of alpha-MSH
      until the minimum effective dose (MED) and the maximum tolerated dose (MTD) are determined.

      Group 2: Patients receive a single dose of the MED of alpha-MSH IV over 5 minutes at the time
      anastomoses are complete. Other patients receive alpha-MSH at the MTD. Cohorts of 5 patients
      each are treated at the MED and the MTD.

      Group 3: Patients receive alpha-MSH as in group 2. Additional dose levels are also tested.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): alpha-melanocyte stimulating hormone
Intervention type(s): Drug
Intervention MeSH terms: Hormones; alpha-MSH; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Masking: Double
Primary purpose: Treatment
Keywords: acute renal failure; rare disease; renal and genitourinary disorders
Noninvasive Ventilation and Thoracic-abdominal Kinematics in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Introduction: Noninvasive ventilation (NIV) has been used to minimize such impairment and
      increasing ventilator reserve in individuals with heart failure. Aim: To analyze
      thoracoabdominal kinematics (TK) in individuals with HF associated to cardiomegaly after
      using NIV. Methods: A randomized crossover clinical trial with allocation consisted of two
      experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30
      minutes of bi-level ventilation was performed. Any type of ventilator support was offered
      during control phase. Optoeletronic plethismography was performed to asses TK.
    


Intervention name(s): Noninvasive ventilation
Intervention type(s): Other
Intervention description(s): In the experimental phase with NIV ventilatory support with bilevel positive pressure was used for 30 minutes with the subject comfortably seated. The NIV (Vivo 40 Bi-Level, General Electric Company) was fitted to the face of volunteer through a face mask, was initially adopted an inspiratory pressure (IPAP) of 15 cm H2O and an expiratory pressure (PEEP) of 5 cmH2O, resulting in a variation in pressure of 10 cm H2O, where the IPAP would be increased, subject to the comfort of the patient until the patient reached a tidal volume of 6-8 ml / kg, not exceeding the maximum of 20 cmH2O for IPAP.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Deep vs Moderate Neuromuscular Blockade in Day Case Laparoscopic Cholecystectomy.
Condition: Muscle Relaxation
Study type: Interventional
Phase: Phase 4

Summary: 
      Laparoscopic cholecystectomy (LC) is commonly performed on ambulatory basis as a result of
      its ability to improve postoperative quality of recovery (QOR) and significantly reduce
      hospital stay .
    

Detailed description: 
      Laparoscopic cholecystectomy (LC) is commonly performed on ambulatory basis as a result of
      its ability to improve postoperative quality of recovery (QOR) and significantly reduce
      hospital stay.

      The surgeon requires a good surgical conditions to perform the operation, whereas the
      anesthesiologist is concerned with postoperative QOR. Pneumoperitoneium -associated expansion
      of the abdominal cavity during LC is related to postoperative pain.

      and other physiological changes, affecting the postoperative QOR negatively . Poor
      postoperative QOR leads to prolonged hospital stay .
    

Intervention name(s): Rocuronium Bromide
Intervention type(s): Drug
Intervention description(s): DEEP block to PTC 1-3
Other intervention name(s): Neuromuscular blocker
Intervention MeSH terms: Bromides; Rocuronium; Neuromuscular Blocking Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care