bioihbjkbjnl/mcl2 huggingface dataset:
Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The study investigates if CPX-351 will be a) more effective than the standard intensive
      salvage AML treatment and b) more tolerable than the standard intensive salvage treatment
      regimens.

      The study compares the investigational product CPX-351 vs the standard intensive salvage
      treatment for first relapse AML patients.
    

Detailed description: 
      This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled
      Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On
      entry, patients are randomized to receive either CPX-351 or intensive first salvage
      treatment.

      Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR
      between the two arms.
    

Intervention name(s): CPX-351; Intensive Salvage Therapy
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute; Myeloid; Leukemia; Adult; First; Relapse; AML; Acute Myelogenous leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Acute myelocytic leukemia
Improving Dental Health Among Toddlers in the Dominican Republic
Condition: Dental Caries in Children; Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Caries prevalence in the Dominican Republic (DR) seems high, although recent information is
      lacking. In DR there is a growth and development program for all children from the age of 0
      to 5.Even though there is a mandatory educational health program for children and parents in
      this program, where periodically pediatricians examine them, this program does not include
      oral health education/prevention. Thus, it is proposed A) to devise materials to be used by
      pediatricians to share relevant information about caries control to parents of toddlers, and
      B) to evaluate the impact of such material on caries prevention for groups of toddlers over a
      1.5-year period. Educational material will be developed for parents, and the pediatricians
      will deliver this material to 10-months-old children randomly selected at Plaza de la Salud
      Hospital. The PI will train the pediatricians in caries prevention and how to deliver the
      information to the parents in a clear manner. A total of 306 will be allocated into two
      groups. The experimental group (128 children) will receive the devised educational materials
      at 10 months, follow-up information will be provided at growth and development visits when
      the child is 18-, and 24 months old. The second group will be considered as the control group
      and will not receive any educational materials (178 children). All the enrolled children will
      receive fluoride containing toothpaste and tooth brushes. After 18 months when the children
      will be about 3 years old they will be examined to assess dental caries status. A sample
      mortality rate of 40% is expected during the two-year follow-up. Differences in caries status
      between the two groups will be examined using Welch's independent t-tests for unequal
      variances.
    


Intervention name(s): Oral Health education including printed educational material
Intervention type(s): Behavioral
Intervention description(s): Printed and online educational materials were developed and provided to pediatricians so they can share relevant information about caries control to parents of toddlers. A previous interview was performed to pediatricians as focus groups to know how they are doing their evaluations and what do they take into account during the children visits in order to identify where to focus for the training what it is necessary to change. After that pediatricians were trained to give oral health recommendations. So, to the intervention group, the pediatricians will give these recommendations to the parents and also they will give them a printed educational material previously developed for the project.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and
      its intensity is directly related to the neurological outcome. The thresholds for
      irreversible tissue damage following TBI indicate a particular vulnerability of injured
      brain. Improving brain oxygenation after severe TBI is the focus of modern TBI management in
      the intensive care unit (ICU).

      The calculation of cerebral perfusion pressure (CPP), with CPP = mean arterial pressure (MAP)
      - intracranial pressure (ICP), has become the most used estimator of cerebral blow flow. To
      prevent ischemia due to elevated ICP, current international guidelines recommend maintaining
      CPP at 60-70 mmHg and ICP below 20 mmHg. However, episodes of brain hypoxia/ischemia, as
      assessed with brain tissue oxygen pressure (PbtO2) measurements, might occur despite
      optimization of CPP and ICP, and have been independently associated with poorer patient
      outcome. PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an
      independent predictor of unfavorable outcome and death. The aggressive treatment of low PbtO2
      was associated with improved outcome compared to standard ICP/CPP-directed therapy in cohort
      studies of severely head-injured patients. On the basis of these findings, it is hypothesized
      that an early optimization of brain oxygenation, together with keeping ICP and CPP within
      recommended values, could reduce the volume of vulnerable lesions following severe TBI and
      possibly improve neurological outcome.
    


Intervention name(s): PbtO2 probes; No PbtO2 probes
Intervention type(s): Device; Other
Intervention description(s): PbtO2/ICP/CPP-directed therapy according to international recommendations; ICP/CPP-directed therapy according to international recommendations
Intervention MeSH terms: 3,4,4a,10b-tetrahydro-4-propyl-2H,5H-(1)benzopyrano(4,3-b)-1,4-oxazin-9-ol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, and Pharmacokinetics of Oral EC5026 in Healthy Subjects
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study with EC5026, a new drug candidate intended to treat
      neuropathic pain. The purpose of the study is to provide initial safety, tolerability, and
      pharmacokinetics data of single ascending oral doses of EC5026 in healthy subjects.
    

Detailed description: 
      This is a single-center, double-blind, placebo-controlled, Phase 1a single ascending dose
      study evaluating the safety, tolerability and pharmacokinetics of sequential doses of oral
      EC5026 in healthy male and female subjects. EC5026 is an inhibitor of the soluble Epoxide
      Hydrolase (sEH) enzyme developed as a first-in-class analgesic for the treatment of pain.
      This study will help refine the dosing strategy for subsequent multiple-dose studies in
      healthy subjects and for future clinical trials in patients with neuropathic pain.

      sEH is an enzyme that is downstream in the cytochrome P450 (CYP) pathway of the arachidonic
      acid (AA) cascade. The sEH enzyme is responsible of metabolizing a class of epoxy-fatty acids
      known as epoxyeicosatrienoic acids (EETs), which are potent, naturally occurring analgesics.
      EETs are produced at high concentrations in areas of tissue damage and inflammation, but are
      rapidly metabolized by the sEH enzyme into inactive compounds. Effective inhibition of sEH
      activity prolongs the ability of EETs to exert their analgesic activity.
    

Intervention name(s): EC5026 oral capsule; Placebo oral capsule
Intervention type(s): Drug; Other
Intervention description(s): 5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort).
Oral doses of EC5026 tested in each cohort: 0.5 mg (Cohort 1), 2 mg (Cohort 2), 8 mg (Cohort 3), 16 mg (Cohort 4), and 24 mg (Cohort 5).
A blinded sentinel group of 2 subjects (1 active and 1 placebo) will be dosed at least 2 days before the remaining 6 subjects (5 active and 1 placebo) will receive blinded doses of active study drug or placebo.; 5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Prediction of Relapse in Schizophrenia/Schizoaffective Disorder With Smartphones and On-body Sensors
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Recurrence; Schizophrenia; Psychotic Disorders
Study type: Observational

Summary: 
      This study is dedicated to achieving a better understanding of how to identify patterns that
      indicate someone might be at high risk for relapse in schizophrenia or schizoaffective
      disorder. The investigators are utilizing smartphone technology along with on body sensors to
      achieve this goal. The study will observe participants behavior in their natural environment
      for a period of 16 weeks or until a signal of relapse is obtained. Participants will also
      complete scales in a clinical research environment biweekly.
    

Detailed description: 
      This study will follow a group of participants who have recently been discharged from the
      emergency room or the hospital using several new "high-tech" methods, including the use of a
      smartphone, health and wellness wristbands/watches and an optional arm patch sensor. These
      devices (some of which are commercially available to the public for purchase), will capture
      ongoing physiological information including sweat gland activity, movement, skin temperature,
      heart rate, breathing rate, and sleep. The smart phone, and an installed application, will
      administer bidaily and weekly symptom assessment, track the general location of the
      participant, and collect statistics about text messaging and cell phone use.

      In addition to the on-body devices participants will come into the clinical research office
      to complete clinical scales every other week. These scales will be used to determine symptom
      exacerbation or relapse. This signature will then be utilized as a marker to examine the data
      collected from the devices.

      The investigators hope to go beyond clinical evaluation and identify a signature of relapse
      that is reliably detected from on body devices in a natural setting. This would cut down on
      the time it takes to successfully treat psychotic illnesses and would reduce the amount of
      pain and and suffering experienced by patients during relapse.
    

Intervention name(s): schizophrenia/schizoaffective disorder.
Intervention type(s): Device
Intervention description(s): Participants with schizophrenia/schizoaffective disorder will be observed remotely and at weekly/biweekly laboratory visits over a period of 16 weeks or until relapse occurs.
Observational model: Ecologic or Community
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        schizophrenia/schizoaffective disorder
      
Keywords: biomarker of relapse; schizophrenia; schizoaffective disorder; on-body sensors; smartphone; observational
JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type
      2 diabetes mellitus in a routine clinical practice setting
    


Intervention name(s): JARDIANCE 10mg; JARDIANCE 25mg
Intervention type(s): Drug; Drug
Intervention description(s): T2DM with JARDIANCE 10mg; MT2DM with JARDIANCE 25mgax
Intervention MeSH terms: Empagliflozin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        type 2 diabetes mellitus in Korea
Tissue Engineered Constructs for Alveolar Cleft Repair
Condition: Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      Description of the research question

      In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on
      collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone
      grafting?

      Objective of the study:

      • Research hypothesis

      The tissue engineered constructs will provide sufficient bone of a good quality and quantity
      if compared to autogenous bone graft in children undergoing unilateral alveolar cleft
      reconstruction.

        -  The objectives

      The primary objective:

      Assessment of bone volume (quantity) which will be provided by tissue engineered constructs
      compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.

      The secondary objective:

      Assessment of bone density (quality) which will be provided by tissue engineered constructs
      compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.
    


Intervention name(s): tissue engineered group; autogenous bone graft group
Intervention type(s): Other; Procedure
Intervention description(s): cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)
Other intervention name(s): BM-MSCs on collagen matrix (Osteovit)
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: tissue engineering.; stem cells.; autogenous grafts.
Effects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes
Condition: Macular Holes; High Myopia; Macular Detachment
MeSH terms: Myopia; Retinal Perforations; Dissociative Disorders
Study type: Interventional

Summary: 
      Full-thickness macular Hole associated with macular detachment is a one of the maculopathies
      of high myopia. There is controversy in the primary treatment for this situation. This study
      will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic
      eyes with this situation.
    

Detailed description: 
      A randomized, open label, single center study comparing the efficacy of macular muckle + gas
      injection versus internal limiting membrane peeling + gas tamponade on full-thickness macular
      hole associated with macular detachment in eyes with high myopia.
    

Intervention name(s): Buckle; Vitrectomy; Limbal paracentesis; Gas injection; Peeling internal limiting membrane; Gas tamponade
Intervention type(s): Procedure; Procedure; Other; Other; Other; Other
Intervention description(s): Surgical procedures of macular buckling; Surgical procedures of small gauge vitrectomy; Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis; Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.; Peeling internal limiting membrane with forceps; Filling the vitreous cavity with gas (C3F8, 14%)
Other intervention name(s): Implantation of a device of macular buckling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: macular buckling; full-thickness macular hole; macular detachment; internal limiting membrane peeling; high myopia
Drug-drug Interaction (DDI) Study of Spironolactone (Perpetrator) and Digoxin (Substrate Drug)
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period,
      crossover oral drug-drug interaction study of spironolactone (perpetrator) and Digoxin
      (substrate drug) in healthy adult human subjects under fasting condition.
    

Detailed description: 
      Drug interaction studies between spironolactone and digoxin, particularly studies in which
      digoxin was administered intravenously (Waldorf, S 1978; Fenster, P.E. 1984), indicate that
      spironolactone may decrease the renal clearance of digoxin by 18-25%, and increase the (area
      under curve) AUC of digoxin by 35-44%. Although the radioimmunoassay used in the study may be
      confounded, these results suggest that inhibition of P-gp in the renal proximal tubules may
      be possible. To account for possible renal P-gp inhibition, subjects in the test group will
      be pretreated with spironolactone for about 5 days to allow accumulation of some of the
      metabolites which have a long half-life (e.g., canrenone ~33 hours) and continue to be
      treated with spironolactone while digoxin is renally eliminated from the body. Based on this
      assessment, the FDA suggested study design is Treatment A: Single dose of digoxin alone.
      Treatment B: Digoxin + Spironolactone; Day 1- 9: Spironolactone single dose; Day 6: Digoxin
      single oral dose.

      Also, digoxin has a long half-life of 1.5-2 days, and the Pharmacokinetic (PK) sampling
      scheme of up to 72 hours may not be enough to characterize the elimination kinetics of
      digoxin. Hence, the plasma concentrations of digoxin up to 96 hours (4 days) postdose is
      considered This will allow you to detect possible differences in the clearance of digoxin
      mediated by an interaction with P-gp in the renal proximal tubules.

      The study also involves collecting urine samples and measuring renal clearance (CLR) and
      unchanged drug excreted in urine (fe) for digoxin.
    

Intervention name(s): Digoxin 250 MCG Oral Tablet; Spironolactone 25 mg/ 5 mL S/F Suspension
Intervention type(s): Drug; Drug
Intervention description(s): The intervention is for study of drug drug interaction of digoxin when administered with spironolactone oral suspension; The intervention is for study of drug drug interaction of digoxin when administered with spironolactone oral suspension
Other intervention name(s): Spironolactone Oral Suspension 20 mL of 25 mg/mL; DDI Spironolactone oral suspension interaction with digoxin
Intervention MeSH terms: Digoxin; Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An open label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, crossover, drug-drug interaction study in healthy adult human subjects under fasting condition for spironolactone oral suspension (Carospir®)
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Use of Low Level Laser Therapy to Reduce Acne
Condition: Acne
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether low level laser light therapy is effective
      in the treatment of acne blemishes.
    

Detailed description: 
      Acne is a chronic inflammatory disorder plaguing the sebaceous follicle, and debate still
      remains over what truly initiates lesion formation. Experts agree that an increase in
      androgen production plays a significant role in the onset of acne. Androgens promote the
      increase in size of sebaceous glands and stimulate sebum production. The simple act of
      sebaceous gland stimulation via androgens could ultimately promote the upregulation of
      pro-inflammatory cytokines like tumor necrosis factor-α (TNF-α) and interleukin (IL-1α)
      without propionibacteria even being present. The synthesis of IL-α and other pro-inflammatory
      cytokines including prostaglandins occurs via the inducible enzyme known as cyclooxygenase-2
      (COX-2). Studies analyzing the pathogenesis of mucositis have identified COX-2 as an
      important contributor to the upregulation of pro-inflammatory cytokines and thus a major
      contributor to the progression of the disorder itself.

      Recent evidence indicates that low-level laser therapy (LLLT) is able to significantly
      diminish the expression of COX-2, resulting in the reduction of inflammation. The ability to
      modulate the COX-2 pathways via LLLT is believed to inhibit the production of
      pro-inflammatory cytokines (i.e. TNF-α and IL- α) present in acne-prone skin.
    

Intervention name(s): Erchonia MLS + Erchonia THL
Intervention type(s): Device
Intervention description(s): The Erchonia® MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.
The Erchonia THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.
Administration of the MLS and the THL occur simultaneously over the 6-week administration phase.
The intent is to evaluate the effectiveness of Erchonia MLS & Erchonia THL when administered together, and not to compare Erchonia MLS vs. Erchonia THL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind multi-center, phase III study comparing the efficacy and
      safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in
      subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell
      carcinoma.

      After the interim analysis conducted by the iDMC, an open-label assignment of experimental
      arm therapy will continue in regions outside of China, in order to further evaluate the
      efficacy and safety of sintilimab in combination with chemotherapy in subjects representing
      the western population with advanced esophageal squamous cell carcinoma
    


Intervention name(s): Sintilimab; Cisplatin; Paclitaxel; Fluorouracil; Placebo
Intervention type(s): Biological; Drug; Drug; Drug; Drug
Intervention description(s): For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1; 75mg/m^2 IV Q3W day 1; 87.5 mg/m^2 IV Q3W day 1, day 8 for first cycle and 175mg/m^2 IV Q3W day 1 after first cycle; 800 mg/m^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W; For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Intervention MeSH terms: Paclitaxel; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ESCC; Esophageal Cancer; Esophageal Neoplasms; Esophageal Neoplasms Malignant; Esophageal Squamous Cell Carcinoma; Neoplasms, Squamous Cell; Esophageal Diseases; Carcinoma, Squamous Cell; Gastrointestinal Diseases; Paclitaxel; Cisplatin; Fluorouracil; Antineoplastic Agents; Anti-PD-1; Sintilimab