bioihbjkbjnl/mcl2 huggingface dataset:
Skin Tape Transcriptome Methods in Children
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      This pilot study will evaluate new methods for the collection, storage, shipment, and RNA
      extraction of skin tape specimens from children with atopic dermatitis (AD) that will
      facilitate the multi-center SunBeam Birth Cohort study. Additionally, this pilot study will
      test new methods for the generation of whole transcriptome sequencing data from skin tape RNA
      and whether these data reflect the transcriptional state of the skin in health and disease.
    


Intervention name(s): Skin tape strips
Intervention type(s): Other
Intervention description(s): Skin tape strips will be collected from lesional and non-lesional skin. Adhesive skin sampling discs will be firmly pressed against the skin in a hairless location (not the face) followed by lifting it free of the skin. These discs will then be used to evaluate proteins and lipids in the upper layers of skin.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The investigators will recruit 20 children; 10 patients with moderate to severe AD and 10
        healthy control subjects aged 4-12 (pre-puberty) years of age
Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery
Condition: Cardiac Surgery; Acute Normovolemic Hemodilution
Study type: Interventional

Summary: 
      The application of acute Normovolemic Hemodilution in cardiac surgery can effectively reduce
      perioperative blood transfusion, reduce postoperative complications and mortality, and is a
      low-cost, operable and effective blood protection measure.For the application of Acute
      Normovolemic Hemodilution in heart surgery, we still face an urgent problem: to what extent
      can Acute Normovolemic Hemodilution achieve better "blood saving effect", that is, whether a
      large number of Acute Normovolemic Hemodilution can reduce perioperative blood transfusion to
      a greater extent
    


Intervention name(s): Large volume Acute Normovolemic Hemodilution
Intervention type(s): Procedure
Intervention description(s): Following induction of anesthesia, the volume of blood to be removed during Acute Normovolemic Hemodilution was calculated using an established formula:V=Weight（Kg）×12-15（mL/Kg）;Blood to be removed was capped at： Vmax=EVB×(Hi-Hf)/Hav（EBV= estimated blood volume （male:70mL/Kg，female:65mL/Kg）；Hi= initial hemoglobin ；Hf=target Hb（ 10g/dL ）；Hav= the average of the initial and minimal allowable hemoglobin）.Ensure the volume of removed blood does not exceed the upper limit and Hb ≥10g/dL after blood removed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block
Condition: Lung Cancer
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was a prospective, randomized, controlled, and double-blind trial. Major
      assessments were made during the operation and 48 h postoperatively.
    

Detailed description: 
      The prime outcomes were the time in minutes from leave the postoperative care unit to the
      first patient-controlled intravenous analgesia press.The secondary outcomes were to compare
      the following: (1)blood concentrations of ropivacaine was measured at 0.5 h, 1 h, 2 h, 3 h,
      and 24 h after paravertebral nerve block; and (2) the patient's intraoperative opioid use,
      phenylephrine use, fluid intake, urine output, dry mouth score, and 24 h and 48 h visual
      analogue scale.
    

Intervention name(s): Dexmedetomidine Group; dexamethasone group; control group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): combination of ropivacaine and dexmedetomidine 100 ug every time; combination of ropivacaine and dexamethasone 10mg every time; block with only ropivacaine
Intervention MeSH terms: Dexamethasone; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine or dexamethasone
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf
      and MR4 in new kidney transplant recipients
    


Intervention name(s): Prograf; MR4
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Tacrolimus; FK506; Modified Release Tacrolimus; FK506MR; FK506E
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Organ Transplantation; Tacrolimus; Prograf; FK506MR
Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery
Condition: Arthroscopic Knee Surgery
Study type: Interventional

Summary: 
      Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in
      ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic
      (a medication that, when injected around nerves, blocks nerve conduction, resulting in
      numbness and weakness) used in the spine, but too low a dose can result in an incomplete
      block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of
      fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this
      study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with
      fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.
    


Intervention name(s): Mepivacaine (24 mg) plus fentanyl; Mepivacaine (27 mg) plus fentanyl; Mepivacaine (30 mg) plus fentanyl; Mepivacaine
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Mepivacaine (24 mg) and fentanyl (10 µg); Mepivacaine (27 mg) and fentanyl (10 µg); Mepivacaine (30 mg) and fentanyl (10 µg); Mepivacaine 37.5 mg
Intervention MeSH terms: Fentanyl; Mepivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Different Ventilation Mode During One-lung Ventilation
Condition: Thoracic Surgery; One Lung Ventilation; Ventilator-Induced Lung Injury
MeSH terms: Lung Injury; Ventilator-Induced Lung Injury
Study type: Interventional

Summary: 
      It is controversial as to which ventilation mode is better in one-lung ventilation(OLV),
      volume controlled ventilation(VCV) or pressure controlled ventilation(PCV). This study was
      designed to figure out if there was any difference between these two modes on oxygenation and
      postoperative complications under the condition of protective ventilation(PV).
    

Detailed description: 
      This is a single center, single blinded prospective study on two different ventilation mode
      during one lung ventilation for patients under video assistant thoracoscopy(VATS) lobectomy.
      After institutional approval and written informed consent were obtained, 60 patients with
      primary lung cancer under VATS lobectomy in Zhongshan Hospital Fudan University were enrolled
      and randomized into two groups:VCV group(group V) or PCV group(group P).

      Inclusion criteria were age between 18-75 years , ASA I-II, lateral decubitus position with
      at least 1h OLV and preoperative FEV1>50% predicted. Preoperative exclusion criteria were
      previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for
      epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal
      suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment
      maneuver of dependant lungs.
    

Intervention name(s): VCV mode; PCV mode
Intervention type(s): Other; Other
Intervention description(s): set fixed 6ml/kg tide volume; adjust pressure to achieve tide volume of 6ml/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)
Condition: Heat Stroke
MeSH terms: Stroke; Heat Stroke; Sunstroke
Study type: Interventional
Phase: Phase 2

Summary: 
      Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study
      of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered
      intravenously (IV), to current standard of care (SOC). SOC for the treatment of EHS is
      defined as effective body cooling, which should be implemented as quickly as available after
      diagnosis of exertional heat stroke.
    

Detailed description: 
      The study will take place at emergency medical facilities.

      Due to the life-threatening nature of exertional heat stroke (EHS), rapid assessment for
      inclusion into the study and subsequent immediate treatment must occur. Following initial
      triage and primary assessment of a subject, the subject's baseline status should be
      documented, and once a diagnosis of EHS is obtained, SOC treatment will be initiated
      immediately, the subject will be randomized to one of two treatment arms (SOC only or SOC
      plus Ryanodex).

      Patients will be remain hospitalized for up to 72 hours after administration of the first
      dose of study drug and implemented SOC and will receive all necessary supportive measures
      until resolution of symptoms.

      Study duration: 72 hours
    

Intervention name(s): Dantrolene sodium for injectable suspension
Intervention type(s): Drug
Intervention description(s): Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg.
Other intervention name(s): Ryanodex; EGL-4104
Intervention MeSH terms: Dantrolene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transfer Accuracy of Indirectly Bonded Orthodontic Braces With Different Transfer Trays
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The aim of this study is to comparatively investigate the performances of two different and
      widely used transfer trays during indirect bonding of the orthodontic braces.
    

Detailed description: 
      The aim of the study is to compare the accuracy of orthodontic bracket and tube transfer
      between double layer silicone and double layer vacuum formed trays. The sample included 368
      attachments bonded in 16 patients. Each patient received one silicone and one vacuum formed
      tray which were randomly allocated to provide 8 trays of each type for the upper and lower
      arches. 3D scan data and local best-fit alignments were used to calculate the translational
      and rotational movements of the orthodontic attachments. Chi-square and Mann-Whitney U tests
      were used to compare transfer accuracy and success between the groups.
    

Intervention name(s): Indirect bonding
Intervention type(s): Device
Intervention description(s): Indirect bonding is the technique where orthodontic appliances are first placed on a model of the patient and then transferred to the patient using some kinf of trays
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Indirect bonding; Accuracy
Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn about how food and a PPI (omeprazole) affect
      LOXO-305 in healthy participants. Participation could last about nine weeks.
    


Intervention name(s): LOXO-305; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Oral LOXO-305; Oral omeprazole
Intervention MeSH terms: Omeprazole; Pirtobrutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to compare conventional chemotherapy: daunorubicin and
      the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg
      in divided doses.
    

Detailed description: 
      Patients with a morphologically proven diagnosis AML and both the two following criteria:

        -  Age > 50 years and £ 70 years.

        -  Not previously treated for their disease.

      Randomization will be centralized by phone :

      Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and
      Mylotarg.
    

Intervention name(s): conventional chemotherapy (AraC + Daunorubicin),; Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),
Intervention type(s): Drug; Drug
Intervention description(s): Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.
Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.; Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.
Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.
Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1.
Intervention MeSH terms: Cytarabine; Daunorubicin; Gemtuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myeloid Leukemia; patient aged 50 to 70 years
IVIVR Assessing PK Parameters Used to Establish Bioequivalence
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether defined and limited changes in in vitro
      dissolution impact the in vivo pharmacokinetics (PK) and relative bioavailability of
      allopurinol and the active metabolite oxypurinol.
    

Detailed description: 
      In this study, a single oral dose of Zyloprim® (300 mg tablet) and 3 separate single oral
      doses of 300 mg allopurinol test formulations (Regimens B, C and D) will be administered
      sequentially to each subject on separate occasions. Following the administration of Regimens
      B and C, there will be a period of interim analysis during which the PK data will be reviewed
      to determine the formulation within the process design space that provides the desired in
      vitro dissolution variant for dosing in the subsequent study period.
    

Intervention name(s): Zyloprim® 300 mg; Allopurinol 300 mg; undergranulated, high hardness condition; Allopurinol 300 mg; alternative condition 2; Allopurinol 300 mg; alternative condition 3
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): There will be a period for interim analysis after administration of Regimen B to determine the formulation within the process design space that provides the desired in vitro dissolution variant for dosing in the subsequent study period; There will be a period for interim analysis after administration of Regimen C to determine the formulation within the process design space that provides the desired in vitro dissolution variant for dosing in the subsequent study period
Intervention MeSH terms: Allopurinol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)
Condition: EGFR-TKI Resistant Mutation
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small
      cell lung cancer with EGFR gene mutation. The median progression free survival time is around
      11 months with the first generation EGFR-TKI. Patients with acquired resistance with first
      generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug
      administration maybe prolong patients PFS and evently prolong OS.
    

Detailed description: 
      1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose
      which is account about 60% patients acquired resistance to the drug. Resistance patients may
      be benefit to a bolus drug use to block T790M gene.
    

Intervention name(s): history data
Intervention type(s): Other
Intervention description(s): history data of PFS after 1st line or second line theray
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        histological confirmed local advanced or metastatic lung adenocarcinoma with EGFR mutation
        diagnosed by 2nd generation sequence system.
      
Keywords: Progression-Free Survival
A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine
Condition: Cocaine Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone
      (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®;
      now marketed as oxazepam (generic) only).

      This Phase 1b cocaine interaction study is being conducted in order to assess the safety and
      PK of EMB-001 and cocaine in combination.
    

Detailed description: 
      This is a single center, randomized, double-blinded, multiple-dose, PLB controlled, 2-period,
      4-sequence, crossover study design.

      After establishing eligibility approximately 16 subjects with cocaine use disorder will be
      randomized to one of four sequences.

      Treatment periods will be separated by a 7-day in-patient washout period. EMB-001/PLB will be
      orally administered for 7 consecutive days, BID for 6 days (starting on Day 1 and Day 15)
      followed on the last day (Day 7 and Day 21) by one EMB-001/PLB oral dose in the morning.
      Infusion of 40 mg IV cocaine and IV saline-to-match cocaine infusion will be administered in
      a randomized order, 2 hours apart, starting 3 hours after the last morning EMB-001/PLB oral
      administration.

      The subjects will be discharged from the research clinic 2 days after the last dose of
      cocaine, and will have a follow-up visit 7 days after last dose.
    

Intervention name(s): EMB-001; Placebo; Cocaine IV; Saline IV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): EMB-001 is a combination of metyrapone (720mg per dose in this study) and oxazepam (24mg per dose in this study); EMB-001 matched placebo; Cocaine administered at doses of 20 and 40mg; Cocaine matched placebo
Other intervention name(s): metyrapone and oxazepam; oral placebo; IV cocaine; IV saline
Intervention MeSH terms: Cocaine; Oxazepam; Metyrapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy
Condition: Colonoscopy; Colon Polyps
MeSH terms: Colonic Polyps
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to demonstrate that AQUAVAN® is effective in providing adequate
      sedation in patients undergoing colonoscopy as well as to assess the safety profile of
      AQUAVAN versus that of midazolam. Prior to the procedure, patients received fentanyl citrate
      for pain management followed five minutes later by AQUAVAN® Injection for sedation.
      Throughout the procedure, study personnel assessed the patient's vital signs and depth of
      sedation. After the procedure, the patient, physician, and an evaluator were asked to
      complete satisfaction surveys.
    

Detailed description: 
      This is a randomized, open-label study designed to assess the safety and efficacy of AQUAVAN®
      Injection versus midazolam HCl following pretreatment with an analgesic, fentanyl citrate
      injection, in producing sedation in patients undergoing colonoscopy. Randomization will be
      stratified by site. Following completion of pre-procedure sedation assessments, patients will
      be randomly assigned to 1 of the 2 i.v. treatment groups at a 3:1 (AQUAVAN® Injection:
      midazolam HCl) allocation ratio. All study patients, irrespective of treatment group
      assignment, will receive fentanyl citrate injection as an analgesic pretreatment.
      Supplemental doses of fentanyl citrate injection may be administered if the patient reports
      pain or if inadequate analgesia is present as demonstrated by increased heart rate and/or
      blood pressure in the presence of adequate sedation. At no time should fentanyl citrate
      injection be administered to increase sedation levels. AQUAVAN® Injection and midazolam HCl
      will be administered to induce a state of adequate sedation, defined as a Modified Observer's
      Assessment of Alertness / Sedation (OAA/S) score of 4 or less. Supplemental doses will be
      administered to increase depth or duration of sedation. Supplemental doses will not be
      administered if the Modified OAA/S score is 2 or less or if there is no purposeful response
      to stimulation. The depth of sedation will be measured by the Modified OAA/S scale, a
      validated measure. Patient and Investigator assessments will be used to confirm the depth of
      sedation provided met the goals of sedation, reduction of anxiet, and reduced awareness.
    

Intervention name(s): fospropofol disodium
Intervention type(s): Drug
Intervention MeSH terms: Fospropofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colonoscopy; Sedation