bioihbjkbjnl/mcl2 huggingface dataset:
Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma
Condition: Thymoma and Thymic Carcinoma
MeSH terms: Carcinoma; Thymoma; Thymus Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to compare the effectiveness of octreotide alone or with prednisone
      in treating patients with metastatic or recurrent thymoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the objective response rate in patients with metastatic or recurrent
      thymoma treated with octreotide. II. Determine the duration of remission in these patients.
      III. Determine the toxicity of the octreotide regimen in this population. IV. Determine the
      response rate, duration of remission, survival and toxicity of prednisone added to octreotide
      in patients with stable disease following octreotide alone.

      OUTLINE: All patients receive octreotide subcutaneously three times daily for 1 month. After
      two courses of treatment, patients are assessed for response. Patients experiencing partial
      or complete response continue octreotide for a maximum of 1 year (12 courses) in the absence
      of unacceptable toxicity or disease progression. Patients with stable disease after 2 courses
      of octreotide receive daily oral prednisone in addition to octreotide for an additional 2
      courses. These patients are then reevaluated and continue on octreotide plus prednisone for a
      maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients
      are followed every 3 months for 1 year, every 4 months for the second year, every 6 months
      for the next 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: There will be 38 patients accrued into this study over approximately 2
      years.
    

Intervention name(s): octreotide acetate; prednisone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Prednisone; Octreotide
Primary purpose: Treatment
Keywords: invasive thymoma and thymic carcinoma; recurrent thymoma and thymic carcinoma
The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in
      reducing the serum cholesterol in human with hypercholesterolemia.
    

Detailed description: 
      In a randomized, placebo-controlled double-blind mono-centric study,179 subjects with total
      cholesterol (TC) level above 5.18mmol/L and triglyceride (TG) level lower than 2.25mmol/L
      were assigned to 500ml of low lactose milk enriched with 1.58g plant sterol esters or 500ml
      plain milk without plant sterols (placebo) or without any dairy product consumption (control)
      for 60 days. Subjects were instructed to maintain stable diet pattern and physical activity.
      Plasma concentrations of TC,TG,LDL cholesterol(LDL-C) and HDL cholesterol(HDL-C) were
      measured at initial visits, after 30days and after 60 days. The primary measurement was the
      change in TC. Secondary measurements were changes in TG,LDL-C and HDL-C.
    

Intervention name(s): Milk fortified with plant sterol esters; Plain milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 250mL of Shuhua milk fortified with plant sterol esters(with plant sterol esters 262mg/100mL) has been taken twice per day. 500mL of Shuhua milk in total has been taken per day during the 60-days intervention.; 250mL of placebo milk (plain milk) has been taken twice per day. 500mL of plain milk in total has been taken per day during the 60-days intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Shuhua Milk; plant sterol esters; serum cholesterol; human
Clinical Characteristics and Discharge Assessment of Patients From Palliative Care
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      The number of people having chronic diseases and the demand for palliative care has
      increased. The factors that have an impact on length of stay and discharge of patient who
      were admitted to palliative care center will be investigated.
    

Detailed description: 
      Adult patients admitted to the Diskapi Yildirim Beyazit Teaching and Research Hospitals
      Palliative Care Unit between August 2018 and September 2020 and discharged to their home will
      be retrospectively evaluated.

      Patient's age, gender, diagnosis, conditions/comorbidities, Karnofsky Performance Scale,
      discharge status (death, intensive care unit or at home), gastrostomy status, presence of
      tracheostomy and/or mechanical ventilation, nutritional status (total parenteral nutrition or
      enteral nutrition), pressure ulcers, the lowest and highest recorded hemoglobin
      concentration, white blood cell count and serum sodium concentration and the education level
      of the patient and the caregiver will be recorded. Patients will be grouped according to
      length of stay (LOS) as Group 1: discharged in equal or less than 21 days or Group 2:
      Prolonged discharged in longer than 21 days and analysed accordingly
    

Intervention name(s): Discharged ≤ 21 days; Prolonged discharge
Intervention type(s): Other; Other
Intervention description(s): Discharged from palliative care unit in equal less than 21 days; Discharged from palliative care unit in longer than 21 days
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with a critical ilness/conditions
      
Keywords: Critical illness; Palliative care; Length of stay
Sensitization Study of ATx201 in Healthy Volunteers
Condition: Sensitivity, Contact
MeSH terms: Dermatitis, Contact
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-site study to evaluate the sensitization potential of topically
      applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.
    


Intervention name(s): ATx201; ATx201 Placebo Gel
Intervention type(s): Drug; Drug
Intervention description(s): two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms; two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Dietary protein differing by their amino acid composition could modulate undesirable
      metabolic and functional responses to a meal rich in saturated fat and sugars. This study
      aims at examining the specific effects of dairy protein with different cysteine contents on
      the postprandial undesirables effects elicited by the ingestion of a high fat meal in
      overweight subjects.
    


Intervention name(s): Postprandial metabolic and functional measures
Intervention type(s): Dietary Supplement
Intervention description(s): After ingestion of a high fat meal containing the different protein sources, the subjects undergo a series of measures of endothelial dysfunction and blood and urine sampling for the assessment of proinflammatory cytokines levels and metabolomics determinations.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      The goals of this study are:

        -  To determine whether the visual acuity improvement obtained with part-time (6 hours)
           patching is equivalent to the visual acuity improvement obtained with minimal patching
           (2 hours) for moderate amblyopia.

        -  To develop more precise estimates than currently available for the visual acuity
           improvement that occurs during treatment of amblyopia with patching.

        -  To identify factors that may be associated with successful treatment of amblyopia with
           patching.
    

Detailed description: 
      Amblyopia is the most common cause of monocular visual impairment in both children and young
      and middle-aged adults. Patching has been the mainstay of amblyopia therapy. It is generally
      held that the response to treatment is best when it is instituted at an early age,
      particularly by age two or three, and is poor when attempted after eight years of age.

      For moderate amblyopia, patching is the most commonly prescribed treatment although other
      modalities such as atropine penalization are also prescribed. There is no specific patching
      regimen that is widely accepted for treatment of moderate amblyopia and limited or no data
      available to favor the use of one specific regimen; both minimal occlusion (e.g., 2 hours per
      day) and six or more hours per day of patching are prescribed in clinical practice.

      The study is a randomized trial comparing daily patching regimes for children with moderate
      amblyopia. It will consist of about 160 children. Patients in the moderate (20/40-20/80)
      group will patch part-time (6 hours) or minimal time (2 hours) of each day for the 4-month
      study period. There are at least two follow up visits during the 4-month period. Visual
      acuity is the major study outcome. It is assessed at the 4-month exam.
    

Intervention name(s): Eye patch
Intervention type(s): Device
Intervention description(s): adhesive patch to cover the sound eye
Other intervention name(s): Coverlet; Opticlude
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy Who Previously Participated in ISIS 396443-CS1 (NCT01494701)
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to examine the safety and tolerability of nusinersen
      (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA)
      who previously participated in ISIS 396443-CS1 (NCT02865109). The secondary objective was to
      examine the plasma pharmacokinetics of a single dose of ISIS 396443 administered
      intrathecally to participants with SMA who previously participated in ISIS 396443-CS1.
    

Detailed description: 
      This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc.

      In August 2016, sponsorship of the trial was transferred to Biogen.
    

Intervention name(s): nusinersen
Intervention type(s): Drug
Intervention description(s): Administered by intrathecal (IT) injection
Other intervention name(s): Sprinraza; ISIS 396443; IONIS-SMN Rx; BIIB058
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Muscular Atrophy; SMA; SMN; SMNRx; ISIS-SMNRx; ISIS 396443
Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients
Condition: Pain
MeSH terms: Pressure Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      Mechanically ventilated patients experiencing pain are frequent in intensive care units (ICU)
      however their treatment remains unclear. This prospective pharmacodynamic study relates to
      the analgesia of procedural pains. The primary objective was to determine the 90% effective
      dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral
      Pain Scale (BPS) at 3 or 4) during lateral decubitus (LD) of mechanically ventilated
      patients.

      Material and Method. Patients who, at rest before the 48th hour of mechanical ventilation,
      reach the objectives of BPS at 3 or 4 and Ramsay sedation score between 3 and 5, were
      included.

      During a 72h evaluation phase, BPS was used to measure the efficiency of a bolus of
      sufentanil on the analgesia of the LD. The dose of this bolus was raised gradually every new
      LD until BPS was at 3 or 4.
    


Intervention name(s): Sufentanil
Intervention type(s): Drug
Intervention description(s): From 0 to 0,05 µg/kg to a maximum of 4 µg/kg of sufentanil. 7 minutes before nursing 3 nursing per day during 3 days
Intervention MeSH terms: Sufentanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mechanical ventilation; Midazolam; Ramsay; Sufentanil
The Impact of an Antimicrobial Utilization Program on Antimicrobial Use
Condition: Antimicrobial Prescribing Practices
Study type: Interventional

Summary: 
      Multidisciplinary antimicrobial utilization teams (AUT) have been proposed as an effective
      mechanism for improving antimicrobial use, but data on their efficacy remain limited. The
      researchers postulated that a multi-disciplinary AUT would improve antimicrobial use in a
      teaching hospital when compared to the standard of care (no AUT intervention).

      Design: Randomized-controlled intervention trial. Setting: A 953-bed urban teaching hospital.

      Patients: Patients admitted to internal medicine ward teams who were prescribed selected
      antimicrobial agents (piperacillin-tazobactam, levofloxacin, or vancomycin) during the
      10month study period.

      Intervention: Eight internal medicine ward teams were randomized monthly to academic
      detailing by the AUT while 8 internal medicine ward teams were randomized indication-based
      prescription of broad spectrum antimicrobials.

      Measurements: Proportion of appropriate empiric, definitive, and end antimicrobial usage
      (antimicrobial use from the initiation of therapy until definitive therapy is prescribed).
    

Detailed description: 
      This study was conducted when Bernard C Camins, MD (BCC), one of the investigators, was still
      employed at Emory University. The principal investigator is no longer at Emory University.
      This trial is being registered by one of the investigators, BCC, so we can submit the
      manuscript for publication. BCC is now at Washington University and this study was conducted
      while he was at Emory University.
    

Intervention name(s): Academic Detailing by the Antimicrobial Utilization Team (AUT)
Intervention type(s): Behavioral
Intervention description(s): Physicians caring for patients who were prescribed one of three antimicrobials were randomly assigned to academic detailing by the AUT. The AUT would review the antimicrobial prescription and provide consultation to the ordering physician if the prescription is appropriate and provide feedback on a better alternative if inappropriate.
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Antimicrobial prescribing; Antimicrobial utilization
A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fed Condition
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP
      20 mg manufactured by OHM Laboratories with Pepcid® AC Acid reducer famotidine tablets 20 mg
      (containing famotidine 20 mg) distributed by Johnson & Johnson. Merck Consumer Pharmaceutical
      Co. Fort Washington, PA 19034 USA under fed conditions.
    

Detailed description: 
      Following an overnight fast of at least 10 hours, all subjects were served a high-fat
      high-calorie breakfast. Thirty minutes after the start of the breakfast, subjects were
      administered a single oral dose of famotidine tablets, USP 20 mg or Pepcid® AC Acid reducer
      famotidine tablets 20 mg (containing famotidine 20 mg) under low-light condition during each
      period of the study, along with 240 mL of drinking water at ambient temperature and under
      supervision of trained study personnel.

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Adverse event monitoring was done
      throughout the study. Laboratory parameters of hematology and biochemistry (except blood
      glucose and cholesterol) were repeated at the end of the study for all the subjects.
    

Intervention name(s): Famotidine
Intervention type(s): Drug
Intervention description(s): Tablets
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Famotidine tablets fed study
A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label (both the physician and healthy volunteer know which medication will be
      administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of
      oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated
      by the body). This study will consist of three parts that will take place over approximately
      90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period
      each.
    

Detailed description: 
      This study will estimate the PK and relative BA of oxycodone following single oral 40-mg
      doses of 3 modified PF-00345439 Formulations E, F, and G compared with the reference
      PF-00345439 Formulation A under fed conditions in healthy volunteers in order to aid in
      selection of a final formulation.
    

Intervention name(s): Oxycodone; Oxycodone; Oxycodone; Oxycodone; Oxycodone; Oxycodone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): One capsule of 40 mg PF-00345439 Formulation A, single dose; One capsule of 40 mg PF-00345439 Formulation E, single dose; One capsule of 40 mg PF-00345439 Formulation F, single dose; One capsule of 40 mg PF-00345439 Formulation G, single dose; One capsule of 5 mg PF-00345439 Formulation TBD, single dose; One capsule of 40 mg PF-00345439 Formulation H, single dose
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; bioavailability; oxycodone.
Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and
      multiple-ascending doses of CTP-656 dosed for 7 days.
    

Detailed description: 
      This two-part study will assess in healthy male and female subjects a solid oral dose
      formulation of CTP-656 vs. Kalydeco® and the safety, tolerability and pharmacokinetic
      profiles of escalating CTP-656 solid oral doses following 7 days of dosing. In Part B, three
      doses of CTP-656 ranging from 75 mg up to 300 mg per day will be studied.
    

Intervention name(s): CTP-656; Placebo for CTP-656; Kalydeco
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Safety and Pharmacokinetics
Development of Oral Amino Acid Tracers to Study Protein Turnover in Humans
Condition: Healthy Adult Males
Study type: Interventional

Summary: 
      Previous studies have used a combination of oral L-[1-13C]leucine and intravenous labeled
      L-[5,5,5-2H3]leucine to assess the acute postprandial changes in whole-body protein turnover
      (12, 19). Intravenous and dietary-labeled amino acid tracers have also been used in tandem to
      assess rates of myofibrillar protein synthesis in response to bolus protein ingestion and
      resistance exercise (46). By validating whole-body net balance to myofibrillar protein
      synthesis, our proposed multi-tracer approach will develop minimally invasive models to study
      protein turnover in a variety of populations in which traditional infusions and/or repeated
      blood samples are not possible (i.e. pediatric, free-living populations).
    

Detailed description: 
      The primary objective of the proposed study is to validate the use of a novel oral tracer
      model to accurately and reliably measure myofibrillar protein synthesis. It is hypothesized
      that oral L-[1-13C]leucine and L-[ring-2H5]phenylalanine, ingested as a bolus to mimic an
      intravenous 'pulse dose' administration (51, 65), will reveal similar rates of myofibrillar
      protein synthesis when compared to traditional intravenous L-[5,5,5-2H3]leucine infusion.
      Moreover, it is hypothesized that both methods will reveal the expected graded changes in
      myofibrillar protein synthesis in response to feeding and resistance exercise (i.e.
      fasted<feeding<exercise & feeding).

      The secondary objective of the proposed study is to develop and validate non-invasive models
      to measure whole-body amino acid oxidation and net balance in response to feeding and
      resistance exercise. It is hypothesized that whole-body net balance, as determined by a novel
      oral tracer model (i.e. L-[1-13C]leucine) , will align with traditional intravenous tracer
      methodology (i.e. L-[5,5,5-2H3]leucine) and reveal the expected physiological changes in
      whole-body protein turnover in response to feeding and resistance exercise (i.e.
      fasted<feeding<exercise & feeding).
    

Intervention name(s): Crystalline amino acids to assess myofibrillar protein synthesis rates; Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Amino acid dose = 0.25g/kg bodyweight; Amino acid dose = 0.25g/kg bodyweight
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three groups: Fast, Fed, Ex-Fed Two trials per group
Masking: None (Open Label)
Primary purpose: Treatment