bioihbjkbjnl/mcl2 huggingface dataset:
Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery
Condition: Opioid Use; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Enhanced recovery pathways (ERPs) emphasize evidence-based, multimodal anesthetic and
      analgesic choices to minimize opioid consumption while providing adequate pain control after
      surgery. Although ERPs for spine surgery are now being described, few pathways include
      regional analgesia. The Erector Spinae Plane Block (ESPB) may represent a novel opportunity
      to incorporate regional analgesia into ERPs for spine surgery. To date, there is minimal data
      to support the utility of ESPB in spine surgery, and this block has not yet been evaluated in
      complex spine surgery.

      This study seeks to see whether ESPB will reduce opioid consumption and pain scores, and
      improve patient recovery during the first 24 hours after complex spine surgery when included
      in a comprehensive ERP.
    


Intervention name(s): Bupivacaine; Dexamethasone; Saline
Intervention type(s): Drug; Drug; Other
Intervention description(s): Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.; Dexamethasone is a corticosteroid that reduces inflammation.; Saline is a mixture of NaCl and water that can be used as a placebo.
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure
Condition: Congenital Pulmonary Stenosis
MeSH terms: Pulmonary Valve Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      The aim of this study is to compare the effect of different anesthetic drugs used for
      induction of anesthesia ketamine versus sevoflurane on the RV pressure in pediatrics
      undergoing balloon dilatation for congenital pulmonary stenosis.
    

Detailed description: 
      Critical pulmonary stenosis (PS) is a life-threatening congenital heart disease which
      manifest during the neonatal period with cyanosis. Surgical valvotomy was the procedure of
      choice for critical PS; however, balloon pulmonary valvoplasty (BPV) has now become the
      standard management.

      Ketamine is often used for procedural sedation or as adjunct agent for general anesthesia in
      pediatrics with congenital heart disease. Ketamine is a chemical derivative of phencyclidine
      acting as a selective antagonist of the N-methyl-d-aspartate (NMDA) receptor, an ionotropic
      glutamate receptor that participates in analgesia, amnesia, and sedation pathways.

      Ketamine has minimal impact on hemodynamics in children with congenital heart disease when
      used at usual clinical doses. Systemic vascular resistance and pulmonary vascular resistance
      are not significantly altered.

      Sevoflurane is a sweet-smelling, highly fluorinated methyl isopropyl ether used as an
      inhalational anesthetic for induction and maintenance of general anesthesia. It proved to be
      safe as induction agent in noncardiac surgery and cardiac surgery. Sevoflurane has low
      solubility in blood, produces less arrhythmias and decrease in contractility less than
      halothane without changing pulmonary to systemic blood flow ratio in pediatrics with
      congenital heart disease.
    

Intervention name(s): induction of anesthesia
Intervention type(s): Diagnostic Test
Intervention description(s): This group includes (20) patients will receive induction by sevoflurane 3% using open circuit (modified Ayre's T-piece) till loss of consciousness and will be maintained on oxygen mask on the same concentration of sevoflurane and connected to capnogram
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Safety Study of ABT-263 in Combination With Paclitaxel in Subjects With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety study of ABT-263 in Combination with Paclitaxel in Subjects with Solid Tumors.
    

Detailed description: 
      A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination with Paclitaxel in the
      Treatment of Subjects with Solid Tumors.
    

Intervention name(s): ABT-263; paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg of ABT-263 is taken orally once daily on Days 1-3 out of each 21 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.; 175 mg/m2 over 3 hours of paclitaxel will be given by intravenous infusion on Day 1 of each 21 day cycle.
Note - The dose and schedule is subject to change based on the toxicities observed.
Other intervention name(s): Navitoclax; Taxol
Intervention MeSH terms: Paclitaxel; Navitoclax
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paclitaxel; Solid Tumors
Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation
Condition: Eosinophilic Esophagitis; Esophageal Stenosis; Esophageal Dilation; Esophageal Dilatation
MeSH terms: Esophagitis; Eosinophilic Esophagitis; Esophageal Stenosis; Inflammation; Dilatation, Pathologic
Study type: Observational

Summary: 
      A database analysis and review of histological slides (retrospective) and a patient
      questionnaire analysis (prospective) will be conducted in Bern (Switzerland) to evaluate the
      efficacy and safety of esophageal dilation and its effect on the underlying eosinophilic
      inflammation in patients with Eosinophilic Esophagitis. This trial is investigator driven.
    

Detailed description: 
      Eosinophilic esophagitis (EE) is a chronic, increasingly recognized disease of the esophagus,
      clinico-pathologically characterized by a proton-pump-inhibitor resistant, dense esophageal
      eosinophilia in combination with esophagus-related symptoms. Patients suffer mainly from
      dysphagia, a feared long-term complication is the evolution of esophageal stenoses leading to
      food-bolus impaction that have to be removed endoscopically. Anti-inflammatory therapy with
      systemic or topical corticosteroids have shown to be efficacious in children as well as in
      adults. However, relapses occur in general soon after the cessation of this medication. In
      addition, several studies have demonstrated that in adults with active EE dilation is an
      alternative safe and efficacious therapeutic option. Surprisingly, the symptom-free period
      seems to be much longer after this procedure than after medical treatment. Today, the
      selection of these two procedures depends more on local practices than on evidence based
      data, because robust data are lacking. Furthermore, there are concerns regarding the risk of
      the dilation-procedure (possible esophageal perforations and major bleeding). Furthermore, it
      has not yet been assessed if dilation changes the underlying eosinophilic inflammation. If
      not, investigations should be performed to evaluate if long-term anti-eosinophilic therapy is
      able to change the natural course of the disease and reduce the stricturing complications.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Eosinophilic Esophagitis referred to gastroenterologists in whole Switzerland
        working in private practice and in secondary and tertiary referral centers (Departments of
        Gastroenterology in hospitals)
      
Biospecimen description: 
      formalin-fixed esophageal biopsies (blinded review of histology slides)
    
Keywords: Eosinophilic Esophagitis; Dysphagia; Esophageal bougienage; Esophageal Dilation
Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections
Condition: Sacroiliac Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      In this study, the investigators are attempting to determine whether intra- or
      extra-articular injections are more effective; the relative prevalence rate of
      intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular
      injections using fluoroscopy as the reference standard. 124 consecutive patients with
      mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3
      positive provocative maneuvers will be randomized to receive SI joint injections by 2
      different approaches.

      Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive
      landmark-guided injections into the tender area around the joint. In order to determine
      whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be
      done after the injection to ascertain the location of contrast spread. The primary outcome
      measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be
      followed at 3-months, while those who fail to obtain benefit will exit the study to receive
      alternative care.
    


Intervention name(s): X-ray SI joint steroid injection; Landmark-guided SI steroid injection
Intervention type(s): Procedure; Procedure
Intervention description(s): Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance; Injection of steroid into the joint area based on palpation. The injection may be inside the joint (intra-articular) or outside the joint in the ligaments (extra-articular)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sacroiliac joint; low back pain; steroid injection
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Condition: Respiratory Syncytial Virus Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of the study are:

        -  To assess the safety profile of each dose of the study product after each and any
           administration in all infants and toddlers regardless of baseline serostatus.

        -  To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody
           responses to the study product in each vaccine group after vaccination in RSV-naïve
           participants.

      The secondary objectives of the study are:

        -  To quantify the amount of vaccine virus shed by each participant by baseline serostatus.

        -  To determine the proportion of vaccinated infants and toddlers in each vaccine group
           infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3
           and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline
           serostatus.

        -  To characterize the RSV A serum neutralizing antibody responses to the study product in
           each vaccine group after vaccination in RSV-experienced participants.

        -  To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study
           product in each vaccine group after vaccination by baseline serostatus.

        -  To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to
           the study product in each vaccine group after the RSV surveillance season or at least 5
           months after the last vaccine administration by baseline serostatus.
    

Detailed description: 
      Study duration per participant is maximum 12 months
    

Intervention name(s): RSV vaccine formulation 1; RSV vaccine formulation 2; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Pharmaceutical form: Suspension of virus Route of administration: Intranasal; Pharmaceutical form: Suspension of virus Route of administration: Intranasal; Pharmaceutical form: Suspension Route of administration: Intranasal
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Multi-Center Trial of Nepicastat for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving
      the number of subjects that achieve abstinence from cocaine and reducing cocaine use in
      subjects with cocaine dependence.
    


Intervention name(s): Nepicastat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Low Dose Primaquine for Clearance of Gametocytes
Condition: Malaria; Asymptomatic Malaria; Plasmodium Falciparum
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Primaquine (PQ) is currently the only available drug that can clear mature transmission
      stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist
      after artemisinin-combination therapy. However, there are safety concerns about the use of PQ
      at the currently recommended dose of 0.75mg/kg in individuals who are glucose-6-phosphate
      dehydrogenase (G6PD) deficient. PQ causes transient but significant haemolysis in G6PD
      deficient individuals; this side-effect is dose dependent. There are indications that a lower
      dosing of PQ may effectively reduce gametocyte carriage but the lowest efficacious dose for
      gametocyte clearance is currently unknown. Recently, the World Health Organization changed
      their recommendation to a low dose of primaquine, 0.25mg/kg. However, there is no direct
      evidence on the extent to which (low dose) PQ prevents malaria transmission to mosquitoes and
      what the lowest efficacious dose is.

      In the current study we aim to identify the lowest efficacious dose of PQ in individuals with
      normal G6PD function. Children with asymptomatic malaria and normal G6PD enzyme function will
      be randomized to treatment with artemether-lumefantrine alone or in combination with low
      doses of PQ. All enrolled individuals will receive a full three-day course of AL, and will be
      randomized to receive a dose of primaquine or placebo with their fifth dose of AL. Efficacy
      will be determined based on gametocyte carriage during follow-up, measured by molecular
      methods. For a subset of participants with patent gametocytes, primaquine effect on
      infectivity to mosquitoes will be assessed by membrane feeding assays
    


Intervention name(s): Artemether-lumefantrine combination; Artemether-Lumefantrine with a single dose of 0.25mg/kg primaquine; Artemether-Lumefantrine with a single dose of 0.4mg/kg primaquine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lumefantrine; Artemether; Primaquine; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Aripiprazole Added on for DMDD in Youths With ADHD
Condition: Disruptive Mood Dysregulation Disorder
Study type: Interventional

Summary: 
      Objectives:

        1. To investigate the effectiveness of adjuvant with aripiprazole to methylphenidate for
           disruptive mood dysregulation disorder (DMDD) in youths with
           attention-deficit/hyperactivity disorder (ADHD)

        2. To investigate the neural basis of chronic irritability in youths with functional
           magnetic resonance imaging (fMRI)

        3. To compare the clinical characteristics of youths with comorbid ADHD and DMDD to youths
           with ADHD only
    

Detailed description: 
      Background:

      Disruptive mood dysregulation disorder (DMDD) in children and adolescents with
      attention-deficit/hyperactivity disorder (ADHD) is a common clinical challenge and leads to
      severe impact and burden on both the patients and their family. Although methylphenidate
      (MPH) showed good efficacy in the treatment of ADHD, there is still lack of well-established
      pharmacological treatment for DMDD. Furthermore, little research focuses on the effect of
      pharmacological treatment on neural correlates of chronic irritability. Previous literature
      suggested the potential role of atypical antipsychotics in the treatment of DMDD. Therefore,
      this study aimed to investigate the effectiveness of adjuvant of aripiprazole (APZ) to MPH in
      patients with comorbid ADHD and DMDD. In addition, the investigators explored the clinical
      manifestation and neural basis of DMDD using inventories, neuropsychological tests and
      neuroimaging studies.

      Methods:

      The investigators enrolled patients with ADHD+DMDD (n = 31) and ADHD only (n = 27). Those
      subjects were evaluated with inventories of emotional and behavioral problems,
      neuropsychological tests, as well as fMRI with challenging tests which aimed to induce
      frustration at baseline assessment. Then, subjects of ADHD+DMDD group received 6 weeks'
      combination treatment of MPH+ APZ with flexible dosage according to clinical judgment. All
      the initial evaluations were administered again after treatment. The comparison of clinical
      characteristics and neuroimaging findings between ADHD+DMDD group and ADHD only group will be
      conducted. In addition, the effectiveness of treatment will be analyzed. The effects of
      pharmacological treatment on neural correlates of chronic irritability will also be
      investigated.
    

Intervention name(s): MPH + APZ
Intervention type(s): Drug
Intervention description(s): MPH was administered with either Ritalin (from 10mg/day to 40mg/day) or Concerta (from 18mg/day to 36mg/day) according to clinical judgement for six weeks. APZ was administered with dose from 2.5mg/day to 5mg/day according to clinical judgement for six weeks.
Other intervention name(s): MPH (Ritalin, Concerta), APZ (Abilify)
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Valsartan 320mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,
      single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg
      under fed conditions.
    

Detailed description: 
      After an overnight fast of at least 10 hours, the subjects were served a USFDA recommended
      high fat high calorie non-vegetarian breakfast, which they consumed within 30 minutes.

      A single oral dose (320 mg) of either the test or the reference product was administered to
      the subjects at 30 ± 2 minutes minutes after serving the USFDA recommended high fat high
      calorie non-vegetarian breakfast. The IMP was administered in sitting posture with 240 mL of
      drinking water at ambient temperature. The IMP administration was as per the randomization
      schedule and under open-label condition.

      A total of twenty-six (26) blood samples including pre-dose sample (duplicate), each of 02
      mL, were collected from each subject except for the discontinued / withdrawn subjects to
      analyze the pharmacokinetic profile of the test as well as the reference drug.

      The pharmacokinetic parameters were calculated from the drug concentration vs. time profile
      by non-compartmental model using WinNonlin Professional Software Version 5.3 (Pharsight
      Corporation, USA) for Valsartan. Statistical comparison of the pharmacokinetic parameters of
      the two formulations was carried out using PROC MIXED of SAS® Version 9.3 (SAS Institute
      Inc., USA) to assess the bioequivalence of both the formulations.
    

Intervention name(s): Valsartan
Intervention type(s): Drug
Intervention description(s): 320mg tablets
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Testing the Neuroscience of Guided Learning in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Major depression is a prevalent and impairing illness. To better understand the basic science
      and treatment of depression, the investigators study the behavioral and brain processes
      associated with learning in depression and how potential disruptions in learning may be
      repaired. Understanding different methods that change learning may lead to novel treatments
      that contribute to recovery in people with depression.
    

Detailed description: 
      Major depressive disorder ranks among the most significant causes of mortality and disability
      in the world. Recent data from the investigators and others highlight that impairments in
      reward and loss learning are central to depression, have distinct neural substrates, and
      improve with successful treatment. Together, these findings suggest an urgent need to
      delineate the relationships among neural and behavioral learning impairments and depression.
      Equally important, these insights suggest new targets for treatment such that manipulating
      the neural and behavioral substrates of learning may facilitate symptom change in depression.

      To address these issues, the investigators use functional neuroimaging and a computational
      psychiatry framework to i) systematically characterize the neural and behavioral substrates
      that attend reward- and loss- learning in depression and ii) assess the degree to which
      learning in depression responds to two behavioral methods that target learning in different
      ways. The investigators test the broad hypotheses that i) that depression may be
      characterized by distinct neural and behavioral disruptions of learning, and ii) these
      disruptions and associated symptoms may be ameliorated through different methods of guiding
      learning. Recent advances in computational psychiatry provide a mechanism-based framework
      within which to understand the nature and trajectory of potential learning impairments in
      depression and suggest new ways that disrupted learning and associated symptoms may be
      improved in depression
    

Intervention name(s): Standard Learning; Guided Learning: Instructed statistics; Guided Learning: Changing statistics
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.; Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.; Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other