bioihbjkbjnl/mcl2 huggingface dataset:
Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil
      Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH)
      after Fontan operation with univentricular physiology.
    

Detailed description: 
      PH is a significant contributor to the postoperative morbidity and mortality of congenital
      heart disease, especially after Fontan operation with univentricular physiology. Mild
      increase of pulmonary vascular resistance may lead to failure of Fontan circulation.
      Remodulin® has been approved for the treatment of adults with PH, but little is known about
      the effects in children with PH after Fontan operation. The study aim is to determine the
      safety and efficiency of Remodulin® to reduce the pulmonary arterial pressure and prevent PH
      in children after Fontan operation. Meanwhile pharmacokinetics of the drug were checked with
      or without the peritoneal dialysis.
    

Intervention name(s): Remodulin; distilled water
Intervention type(s): Drug; Drug
Intervention description(s): After Fontan operation, the mean pulmonary arterial pressure (mPAP)evaluated by CVP or transpulmonary pressure gradient(TPG) evaluated by Echo will be measured firstly, if the data met the criteria, and the patients were enrolled in the experimental group, the patients would be administrated intravenously of Remodulin® with the beginning of 5ng/kg/min, with the rate of 10ng/kg/min every 30 minutes up to 80ng/kg/min.; After Fontan operation, the mPAP (evaluated by CVP) or TPG (evaluated by Echo) will be measured firstly, if the data met the criteria, and the patients were enrolled in placebo group, then the patients would be administrated intravenously of distilled water with the beginning of 0.15ml/hr, with the rate of 0.3ml/hr every 30 minutes up to 2.45ml/hr.
Other intervention name(s): Treprostinil Injection; placebo
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Remodulin®; pulmonary vascular resistance; univentricular physiology
Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation
Condition: Endophthalmitis Following Cataract Surgery
MeSH terms: Endophthalmitis; Cataract
Study type: Interventional

Summary: 
      The purpose of the present study is to elucidate the qualitative and quantitative variation
      of ocular flora after treatment with eyedrops containing 0.6% povidone-iodine in the eye of
      patients undergoing routine cataract surgery.
    

Detailed description: 
      Two conjunctival swabs will be executed at 3 days before and at the day of routine cataract
      surgery in each eye of patients undergoing routine cataract surgery. After the collection of
      the first conjunctival swab a three-days treatment with eyedrops containing 0.6%
      povidone-iodine in the eye undergoing routine cataract surgery will be performed. Bacterial
      isolates will be identified by using standard microbiological protocols and total bacterial
      load will be determined at the two different time points. In vitro susceptibility testing to
      determine methicillin resistance in isolated Staphylococcus species will be performed.
      Controlateral eye of each patient will be used as control. Descriptive statistics will be
      calculated.
    

Intervention name(s): IODIM
Intervention type(s): Device
Intervention description(s): Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides
Intervention model: Single Group Assignment
Intervention model description: Each patient has self-control of the IODIM treatment in the eye undergoing to cataract surgery with the contralateral eye. Microbiological studies will be performed by means of conjunctival swabs evaluation.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cataract; Endophthalmitis; Microbiological evaluation
The Effect of PXR Activation on Blood Pressure Regulation
Condition: Blood Pressure Regulation
Study type: Interventional
Phase: Phase 4

Summary: 
      We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of
      blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR
      activator) and placebo will be given for a week to volunteers and blood pressure is measured
      24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will
      be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood
      pressure.
    


Intervention name(s): Rifampicin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Rimapen
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: rifampicin; pregnane X receptor; blood pressure
Automated Breast Ultrasound Screening
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to
      participate in a automated volume breast ultrasound scanner. The study evaluates
      prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when
      BIRADS category 3 lesions are given a 1 year follow-up recommendation.
    

Detailed description: 
      Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to
      participate in a automated volume breast ultrasound scanner. If the women agrees to
      participate and sign informed consent she undergoes an automated whole breast scan. The scan
      is interpreted independent of the mammogram. Scans are assigned a BIRADS category score of 1,
      2, 3,or 0. BIRADS category 3 lesions are reported as no evidence of malignancy and a 1 year
      follow-up is recommended. BIRADS category 0 lesions are requested to have a hand held
      ultrasound including elastography. Follow up is then determined by BIRADS score and
      elastography results of hand held ultrasound.

      The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer
      detection rate when BIRADS category 3 lesions are given a 1 year follow-up recommendation.
    

Intervention name(s): Breast ultrasound
Intervention type(s): Procedure
Intervention description(s): automated whole breast ultrasound
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women age >18 scheduled for routine screening mammogram. Women with Density 3 or 4 and
        BIRADS category 1 or mammogram are asked to participate in study
      
Keywords: Breast Cancer; Automated whole breast ultrasound; BI-RADS category 3 lesions
Donation Network to Optimize Organ Recovery Study
Condition: Brain Death; Organ Donation
MeSH terms: Brain Death
Study type: Interventional

Summary: 
      This study consists in an cluster-randomized clinical trial involving near 60 Brazilian
      intensive care units (ICUs) with a high notification rate of potential donors of organs and
      tissues. ICUs will be randomized in a 1:1 ratio to manage potential organ donors through the
      use of a evidence-based checklist or to manage potential organ donors according usual care.
      The primary outcome is the rate of losses of potential donors due to cardiac arrest.
      Secondary outcome measures include number of effective organ donors and number of organs
      recovery per effective donor. The first subject was enrolled on June 20, 2018.
    


Intervention name(s): Checklist use; Usual care
Intervention type(s): Other; Other
Intervention description(s): Management of the potential donor guided by the use of an evidence-based checklist. This checklist is based on main recommendations of the Brazilian guideline for the management of potential multiple organ donors.; Management of the potential donor according usual care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the present study ICUs will be randomized to manage potential organ donors through the use of a evidence-based checklist or to manage potential organ donors according usual care.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Intensive Care Units; Brain Death; Organ Donation; Family interview
Study of Surufatinib Single Agent or Surufatinib Combined With Toripalimab in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, single arm, open-label, multicenter study to evaluate the efficacy and
      safety of Surufatinib single agent or Surufatinib combined with Toripalimab in patients with
      advanced solid tumors.
    

Detailed description: 
      The study population is about 260 patients with advanced solid tumors, who fails or can not
      tolerate standard therapies, or for whom no effective standard therapy is available, or who
      refuses standard therapies. This study includes two arms. One is that Surufatinib single
      agent 300mg once a day (QD) will be orally administrated in patients with advanced
      neuroendocrine carcinoma (NEC). In another arm Surufatinib 250 mg QD will be orally
      administrated and Toripalimab 240mg will be intravenously administered every 3 weeks up to
      documented disease progression, development of unacceptable toxicity, participant request, or
      withdrawal of consent. For Toripalimab, the upper time limit for treatment is 2 years. The
      primary objective is safety of safety run-in (about 6 patients) and objective response rate
      (ORR) of Surufatinib single agent in patients with advanced NEC or Surufatinib combined with
      Toripalimab in patients with advanced solid tumors.
    

Intervention name(s): Surufatinib; Toripalimab
Intervention type(s): Drug; Drug
Intervention description(s): Surufatinib is a tablet in the form of 50mg, oral, once a day.; Toripalimab is an injection in the form of 240mg, intravenous, once three weeks.
Other intervention name(s): HMPL-012; JS001
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multi-center, Double-blinding, Parallel and Positive-controlled Phase III Clinical Trial for Efficacy and Safety Evaluation of Ilaprazole Sodium for Injection on Prevention of Stress Ulcer Bleeding
Condition: Stress Ulcer Bleeding
MeSH terms: Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of the study drug (Ilaprazole Sodium
      for Injection) for potential effect on preventing stress ulcer bleeding in vulnerable
      population by comparing the radio of upper gastrointestinal bleeding when they are
      administered Ilaprazole Sodium for Injection and Esomeprazole Sodium for Injection
      respectively.
    


Intervention name(s): Esomeprazole 40mg; Ilaprazole Sodium; Placebo 1; Placebo 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 40 mg i.v. twice daily (q12h); 10 mg i.v. once daily, 20 mg i.v. in the first day.; Physiologic saline for injection, 100 ml/bag, q24h, following Ilaprazole Sodium with a time interval of 12 h.; Physiologic saline for injection, 100 ml/bag, q12h, dosing on the first day.
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Craniosacral Therapy as Additive Procedure.
Condition: Central Nervous System Diseases
MeSH terms: Nervous System Diseases; Central Nervous System Diseases
Study type: Observational

Summary: 
      This observational, retrospective study has shown, that the addition of craniosacral therapy
      to the Vojta method has improved the effects of the therapy in 6 months follow-up period. The
      chance for improvement was 9.42 times higher in Vojta + craniosacral group compared to the
      group conducted only with Vojta method.

      The study results suggest that the craniosacral procedure should be considered as an additive
      regimen to the Vojta method in the therapy of children with central coordination disorders
      (CCD) . More data is still needed to improve the rehabilitation process in this group of
      patients.
    

Detailed description: 
      The aim of the retrospective, observational study was the comparison between the
      effectiveness of Vojta therapy used alone and its combination with craniosacral therapy after
      6 months of the therapy.

      Data for analysis was from one Rehabilitation Center and covered the observation period:
      January 1, 2014 - November 30, 2019. The data was analyzed for the purpose of the study
      between January 1, 2022 - July 1, 2022.

      To assess the effectiveness of the mentioned rehabilitation models for the children with
      central coordination disorders (CCD), the neurological status of the patient, expressed as
      the number of abnormal reactions (Vojta tests), at the beginning (W0) and after 6 months (W6)
      of the therapy was recorded blindly, based on the individual's records (collected previously
      for the purpose of the other study). Children who had completed six months of therapy and had
      efficacy results documented in their medical records were divided into group A (children
      treated with Vojta therapy alone) and group B (children treated with Vojta therapy combined
      with craniosacral therapy). Information about: the age at which the children started therapy,
      the APGAR score at the first minute of their life, the week in which they were born, mode of
      delivery, sex, birth weight, mother's age at delivery and duration of breastfeeding, was also
      collected to compare the groups.

      Finally data from 32 children in group A and 19 children in group B was analyzed.
    

Intervention name(s): craniosacral therapy
Intervention type(s): Other
Intervention description(s): subtle form of applied touch, type of osteopathy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children with confirmed CCD (central coordination disorders), between 1-6 months of age
      
Keywords: children; rehabilitation; central nervous system; Vojta therapy; cranio-sacral therapy; reflex locomotion
Bioequivalence Fasting Study in Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg
      manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10
      mg.
    

Detailed description: 
      To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg
      manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10
      mg following a multiple-dose administration in adult human patients who are receiving a
      stable twice daily dose of asenapine maleate EQ 10 mg base.

      To monitor the safety and tolerability of a multiple doses of asenapine sublingual tablets 10
      mg in adult human patients who are receiving a stable twice daily dose of asenapine maleate
      EQ 10 mg base.
    

Intervention name(s): Asenapine Sublingual Tablets 10 mg; Asenapine Sublingual Tablets 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): White to off-white, round, uncoated,unscored, flat-faced radius edge tablet. Debossed with A on one side and 17 on the other side; Round, white to off-white sublingual tablets, with "10" on one side within a circle
Intervention MeSH terms: Asenapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of a Non-invasive Brain Compliance Measurement Device
Condition: Diabetes; Diabetic Ketoacidosis
MeSH terms: Ketosis; Diabetic Ketoacidosis
Study type: Observational

Summary: 
      This is a research study to understand how diabetic ketoacidosis may affect the brain and
      learning and to see if these changes are transient or permanent. The investigators hope to
      learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing
      a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™
      (NNS), learning, talking, behavior, or development. The investigators will compare those
      results from those with diabetes mellitus to those age and gendered matched healthy controls.
      Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less
      than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17
      years old.
    

Detailed description: 
      At enrollment, 1 week, 1 month, 3 month, 12 month Computerized neurocognitive testing Wear
      NNS

      MRI of the brain at 3 month and 12 months

      Formal neurocognitive testing at 3 months and 12 months
    

Intervention name(s): this is not an intervention study; this is not an intervention study; MRI
Intervention type(s): Other; Other; Device
Intervention description(s): Subjects will wear the headband/helmet-like device for approximately 10 minutes on four different occasions: t=0, t=1week, t=1month, t=3months. Of note, part of the device also involves electrodes that are worn to obtain an electrocardiogram or EKG.; Subjects will be asked to participate in both computerized and non-computerized tests to assess subjects' cognitive (learning, language and memory) abilities, developmental level, and behavior. Tests will take place at t=0, t=1week, t=1month, t=3months.; MRI study of the brain will be performed at t=3months.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children between 10-16 with DKA
Synbiotics in Infants With Cyanotic Congenital Heart Disease
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Infants with congenital heart disease have more frequent infections and exposures to
      antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce
      the rate of sepsis and necrotizing enterocolitis in infants with CHD
    

Detailed description: 
      Infants with congenital heart disease have more frequent infections and exposures to
      antibiotics than healthy infants. Probiotics may prevent pathogen colonization in infants
      with CHD. Therefore, the investigators hypothesized that synbiotics may reduce the rate of
      sepsis and necrotizing enterocolitis in infants with CHD
    

Intervention name(s): Bifidobacterium lactis plus inulin; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given; same amount of maltodextrin per day will be given as placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: congenital heart disease, probiotic, prebiotic
Memantine Augmentation of Antidepressants
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is evaluating the efficacy and safety of the drug memantine (trade name NAMENDA)
      as an augmentation agent for the treatment of depression in people who are not fully
      responding to antidepressant medications.
    

Detailed description: 
      - Objective

      The objective of this study is to evaluate the efficacy and safety of 20 mg of memantine
      administered once daily as an augmentation agent for subjects who have been taking
      antidepressants for at least 1 month but who have experienced an incomplete or absent
      therapeutic response.

      - Background

      Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor
      antagonist that is approved for the treatment of moderate-to-severe dementia of the
      Alzheimer's type. It has been commercially available in 23 countries worldwide since 1982.

      There are reports in the published literature that suggest NMDA receptors may be involved in
      the etiology of depressive disorders. The NMDA antagonist ketamine has been shown to have
      antidepressant effects in a placebo-controlled clinical trial (Berman et al., 2000).
      Uncompetitive NMDA receptor antagonists, including memantine, have been shown to exhibit
      antidepressant-like activity in animal models of depression (Moryl et al., 1993, Papp and
      Moryl 1994). Animal studies also support the possibility that uncompetitive NMDA receptor
      antagonists may work synergistically in combination with antidepressants in animal models of
      depression (Rogoz et al., 2001). Some authors have hypothesized a role for NMDA receptors in
      the therapeutic effects of numerous antidepressants (Skolnick et al., 1996).

      - Study Design and Duration

      This is a randomized, single site, double-blind, placebo-controlled, parallel-group study in
      outpatients. The study consists of an 8-week double-blind treatment period. Approximately 25
      patients will be randomized to each treatment group (memantine or placebo) for a total of
      approximately 50 patients.
    

Intervention name(s): memantine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): memantine 5mg - 20mg PO daily; 5mg - 20mg PO daily over 8 weeks
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: memantine; Namenda; augmentation; add-on; depression; MDD (major depressive disorder); unipolar depression; NMDA; ketamine; uncompetitive NMDA receptor antagonist