bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients
      with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ
      following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these
      patients.

      Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing
      substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits
      antimicrobial activity that may extend to Cryptosporidial infection.
    

Detailed description: 
      Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing
      substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits
      antimicrobial activity that may extend to Cryptosporidial infection.

      Patients are enrolled in groups of 7. Group A receives the lowest dose of NTZ. Groups B - D
      receive sequentially higher doses. Patients in Groups B - D do not begin therapy until all
      patients have been enrolled at the preceding dose. For determination of single-dose
      pharmacokinetics, patients receive a single dose of NTZ on Day 1 and blood samples are
      obtained over the next 24 hours. Immediately following the 24-hour blood sample collection,
      patients begin the treatment phase during which they take NTZ for an additional 13 days.
      Blood samples are obtained again on Day 14 to determine full plasma concentration-time
      profiles over the dosing interval. At the end of treatment, responders discontinue treatment
      and nonresponders continue NTZ treatment for an additional 14 days on the same dose. Patients
      who still fail to respond are provided with an additional month of NTZ. Patients have
      scheduled visits for clinical and parasitologic efficacy assessments and safety laboratory
      tests.
    

Intervention name(s): Nitazoxanide
Intervention type(s): Drug
Intervention MeSH terms: Nitazoxanide
Primary purpose: Treatment
Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET
Condition: Opiate Dependence; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders
Study type: Interventional

Summary: 
      This study aims to measure synaptic density in the brains (including in ventral striatum [VS]
      and medial prefrontal cortex [mPFC]) of abstinent subjects with Cocaine Use Disorder (CUD) or
      Opiate Use Disorder (OUD) as compared to healthy control (HC) subjects using 11C-UCB-J PET.
      Subjects will undergo a single 11C-UCB-J (also known as 11C-APP311) PET scan.

      This would be the very first to image synaptic density in human cocaine and opiate users,
      thereby testing whether altered synaptic density in the rodent brain is recapitulated in CUD
      and OUD humans. If confirmed, the current study would provide compelling
      clinical-translational support for an important pathophysiological mechanism of addiction -
      aberrant structural synaptic plasticity. As such, the current study has considerable
      potential for advancing the neurobiological understanding of human cocaine and opiate
      addiction.
    


Intervention name(s): 11UCB-J PET Scan
Intervention type(s): Diagnostic Test
Intervention description(s): 11UCB-J PET Scan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effects of Dexmedetomidine on Inflammatory Mediators After One Lung Ventilation During Video-assisted Thoracoscopic Surgery
Condition: One Lung Ventilation in Thoracic Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      During lung surgery, mechanical one-lung ventilation is usually mandatory to provide
      appropriate surgical condition. However, not only mechanical ventilation is associated with
      inflammatory response, but also one lung ventilation will result in detrimental effects such
      as ischemia and reperfusion injury, and systemic inflammatory responses.

      Dexmedetomidine is an alpha-2 selective agonist. It was reported that dexmedetomidine
      decreased reperfusion injury, reduce the release of proinflammatory mediator and protected
      lungs from reperfusion injury in esophageal cancer patients who undergoing one lung
      ventilation from reducing oxidative stress metabolites. However, other details of protective
      effects is still unknown.

      High mobility group box 1 (HMGB1) is an important proinflammatory factor. It was found to be
      related to ventilator induced lung injury in several condition. Animal studies also showed
      that dexmedetomidine reduces the expression of messenger ribonucleic acid in
      lipopolysaccharide-activated macrophage so that decrease the amount of HMGB1 release.
      However, clinical trials about these are still lacking.

      In this study, we will investigate the protective effects of dexmedetomidine to patients
      undergoing video-assisted thoracoscopic surgery, especially on the specific inflammatory
      markers- plasma HMGB1 and other inflammatory cytokines (eg. interleukin-1. interleukin-6).
      This will let us to know the role of HMGB1 during one-lung ventilation injury and the effect
      of dexmedetomidine in regulating the release of HMGB1. This study will become a basis of
      further medical therapy in treating inflammation.
    


Intervention name(s): Dexmedetomidine; Placebo control
Intervention type(s): Drug; Drug
Intervention description(s): In dexmedetomidine group, dexmedetomidine infusion starts at the time after induction of general anesthesia and before one lung ventilation. The infusion has continued until end of the operation.; In normal saline group, normal saline infusion starts at the time after induction of general anesthesia and before one lung ventilation. The infusion has continued until end of the operation.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: inflammatory cytokine; protective effect; Dexmedetomidine; Precedex; one lung ventilation; ischemia-reperfusion
Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
Condition: Anhedonia; Major Depressive Disorder
MeSH terms: Anhedonia; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of
      anhedonia in participants with major depressive disorder (MDD).
    


Intervention name(s): Placebo; NBI-1065846
Intervention type(s): Drug; Drug
Intervention description(s): Tablets for oral administration; Tablets for oral administration
Other intervention name(s): TAK-041
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anhedonia; Major Depressive Disorder; MDD; NBI-1065846; TERPSIS; Neurocrine; Antidepressant; Depression; TAK-041
Prevalence of Fatigue in Hemodialysis Patients
Condition: Hemodialysis Patients
MeSH terms: Fatigue
Study type: Observational

Summary: 
      The prevalence of end stage renal disease in Taiwan was listed first all over the world.
      Fatigue, which makes patients unable to be competitive to play their functional roles, is one
      of the most bothersome symptoms of patients receiving long-term hemodialysis. Tracing back to
      the development of its relating studies, there is no accurate reason that why does people
      undergoing hemodialysis feel fatigued. Conclusive predictors of fatigue are still not shown
      up yet. Paper review indicated that the level of L-Carnitine concentration, which affect
      metabolism of fatty acid, had correlation with fatigue and muscle strength in this
      population. The serum concentration of L-Carnitine is influenced a lot by hemodialysis. When
      there is deficiency of energy supply, it resulted to decline of muscle strength, which
      increased frequency and intensity of fatigue. Hence, the purposes of this study are (1) to
      understand the basic condition of fatigue level, muscle and metabolism of fat and
      carbohydrate among hemodialysis patients, (2) to analyze correlation among muscle strength,
      metabolism of fat/carbohydrate, and fatigue, and (3) to understand correlations among
      demographic characteristics, blood test data (hemoglobin, albumin, Kt/V, urea reduction
      ratio(URR), blood urea nitrogen(BUN), creatinine, calcium, phosphorus, and C-reactive
      protein), mental and social conditions (depression, anxiety, and social support), muscle
      strength and fatigue, seeking further exploring predictors of muscle strength and fatigue.

      The study use cross-sectional descriptive correlative design with consecutive sampling.
      Recruit patients from a hemodialysis unit in a medical center in north Taiwan after informed-
      consent. The estimated sample size is 100. To understand relationship among muscle strength,
      by-products of fatty acid and carbohydrate and fatigue, we collect data by measuring their
      muscle strength (handgrip and 30 seconds sit-to-stand), and analyzing blood test data and the
      structured questionnaires which included mental/social data (depression, anxiety, social
      support and fatigue level). Descriptive statistics, ANOVA, Pearson's correlation, Spearsman's
      rank correlation and stepwise regression were used to analyze the collected data. Hope this
      research can get advance in comprehension of cause of fatigue and improve the fatigue symptom
      of hemodialysis patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ESRD patients receiving regular hemodialysis thrice or twice per week
      
Biospecimen description: 
      human blood: 5c.c.
    
Keywords: Hemodialysis; Fatigue; Muscle strength; Metabolomics
The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and
      safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese
      subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible
      subjects will continue their metformin background treatment during the trial.
    


Intervention name(s): liraglutide; sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.; Administered orally once daily as add-on to the subject's stable pre-trial metformin dose.
Intervention MeSH terms: Sitagliptin Phosphate; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to establish the maximum maintenance dose of SPM 962
      in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by
      conducting safety evaluation of each patient following once-daily transdermal doses of SPM
      962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard
      8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation
      period) Exploratory evaluation of each patient's maintenance dose will also be conducted with
      attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will
      also be examined.
    


Intervention name(s): SPM 962
Intervention type(s): Drug
Intervention description(s): SPM 962 transdermal patch once a daily up to 36.0 mg/day
Other intervention name(s): rotigotine
Intervention MeSH terms: Rotigotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SPM 962; rotigotine; Parkinson's disease
Radiation and Combination Immunotherapy for Melanoma
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 study designed to evaluate the combination of checkpoint blockade and
      aldesleukin (IL-2) therapy after a course of standard of care palliative radiation in the
      management of unresectable metastatic melanoma. To be eligible, a patient must have a minimum
      of 3 (preferably >5) radiographically distinct, measurable (>1.5 cm) lesions based on RECIST
      1.1. Metastatic cutaneous melanoma must be refractory to standard immunotherapy drugs,
      molecular targeted agents and/or chemotherapy. Patients with ocular melanoma subtypes may
      enroll in this study without prior therapy, as there is no standard front-line therapy for
      this subset of patients.
    


Intervention name(s): Aldesleukin: All Patients; Nivolumab: Cohort 1 (Cutaneous); Nivolumab: Cohort 2 (Ocular); Ipilimumab: Cohort 2 (Ocular)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cycle 1:
(600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient.
Days 1-5 and Days 15-19 (all patients); Cycle 1: 6 Week Duration Nivolumab 240 mg IV
Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29
Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15
Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study; Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29
OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:
Nivolumab 1 mg/kg IV on Day 29
Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29
Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29.
Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study; Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29
OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:
Ipilimumab 3 mg/kg IV on Day 29
Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29
Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29
Other intervention name(s): IL-2
Intervention MeSH terms: Aldesleukin; Nivolumab; Ipilimumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MM
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be the first time PF-06842874 is administered to humans. The purpose of Part
      A of the study is to investigate the safety, tolerability, and pharmacokinetics of
      PF-06842874 following administration of single oral doses as an immediate-release or
      modified-release formulation to healthy adult participants. Part B of this study will
      evaluate the relative bioavailability of a modified-release formulation of PF-06842874 for
      its potential use in future clinical studies. The effect of food on PF-06842874
      pharmacokinetics may also be evaluated in this study.
    


Intervention name(s): PF-06842874; Placebo; Relative Bioavailability
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose administration of PF-06842874; Single dose administration of placebo; Relative bioavailability assessment of modified-release formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-06842874; first in human; cyclin-dependent kinase 4; cyclin-dependent kinase 6; CDK4/6; healthy participants; immediate release; modified release; relative bioavailability
Multiparametric MRI Study of Endogenous Analgesia and Prediction the Efficacy of Migraine Pharmacological Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      To delineate brain mechanisms that subserve EA in the healthy state and to identify
      alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance.
      Individuals with migraine will be examined between episodes in order to assess basal
      alterations in the efficiency of spatial and temporal filtering of noxious information. This
      population provides the unique opportunity to examine such processes without confounds
      arising from ongoing pain.
    

Detailed description: 
      Pain is a uniquely individual experience that is powerfully shaped by the action of
      descending control mechanisms. These systems may play crucial roles in the moment-to-moment
      tuning of the sensitivity, spatial, and temporal response characteristics of nociceptive
      processing mechanisms during both acute and pathological pain states. However, these systems
      remain poorly understood in human subjects. The proposed research will use psychophysics and
      multiparametric MRI to (i) delineate the brain mechanisms that subserve and regulate
      endogenous analgesia (EA) in the healthy state and (ii) to identify alterations in mechanisms
      supporting EA in chronic pain and their therapeutic relevance. In both healthy subjects and
      chronic pain patients, EA will be probed using the DNIC (diffuse noxious inhibitory controls)
      and offset analgesia paradigms. Functional MRI will examine activation of brainstem
      mechanisms important in EA, while both functional and structural connectivity analyses will
      assess the regulation of these brainstem mechanisms by cerebral cortical regions involved in
      attention and affect. One pathological painful condition, migraine, will be examined since it
      allows changes in EA associated with chronic pain to be investigated between episodes of
      pain. Finally, EA and EA associated structural and functional parameters will be used to
      predict the efficacy of one compound, amitriptyline, to treat migraine in individual
      patients. Taken together, the proposed research will provide substantial insights into basic
      mechanisms supporting and regulating EA and can provide a foundation for mechanism-based
      individualized choice of therapy that may benefit all chronic pain patients.
    

Intervention name(s): Doluxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg/d; suger pill 30mg/d
Other intervention name(s): duloxetine; sugar
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: migraine; pain; CPM; offset analgesia; fMRI
Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project
Condition: Autism; Pervasive Developmental Disorder
MeSH terms: Autistic Disorder; Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The purpose of the JEMImE project is to create a serious game to help children with Autism
      and Pervasive Developmental Disorder (PDD) develop facial and vocal emotions in context.

      The objective of this study is to record facial and vocal emotional productions in children
      with autism and PDD in order to create an algorithm for the recognition of facial emotional
      expressions implemented in the serious game JEMImE.
    


Intervention name(s): Recordings of facial and vocal emotional productions
Intervention type(s): Other
Intervention description(s): Children are asked to perform three tasks:
an emotional production on imitation (the child with autism or TED will imitate the emotion expressed by an animated avatar)
an emotional production by mime of the emotion on command (oral and written) without visualizing the model of imitation
Emotional production in context: the child with autism or EFD will describe images forming the story of Frog and as it is read, will produce the appropriate facial and vocal emotions in the context.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: autism; Pervasive Developmental Disorder
Outcomes of Antipsychotic Medication Used in the Emergency Department
Condition: Agitation,Psychomotor
MeSH terms: Psychomotor Agitation; Emergencies
Study type: Observational

Summary: 
      To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol)
      in order to evaluate outcomes.
    

Detailed description: 
      A retrospective chart review will be performed for all patients presenting to the ED with
      agitation and subsequently given antipsychotic therapy for treatment. Identification of
      patients will be through chart review of patients presenting with agitation. Data to be
      recorded include patient age, gender, medical history, time of presentation, time of
      treatment, co morbidities, use of restraint, time to disposition and patient outcome.
      Inclusion criteria include all patients over age 18 presenting to the ED with agitation and
      treated with antipsychotics. No patients will be knowingly excluded from analysis. We will
      compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to
      other commonly prescribed antipsychotics through its rate of discharge home and overall time
      in the emergency department.
    

Intervention name(s): Adasuve; Alternative medications
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled medication to treat acute agitation in the emergency department; Medication given to treat acute agitation in the emergency department
Other intervention name(s): Loxapine; Haloperidol, Serenace, Peridol, Haldon, Geodon, Ziprasidone
Intervention MeSH terms: Haloperidol; Ziprasidone; Loxapine
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        subjects treated in the emergency department for agitation
      
Keywords: Bipolar 1 disorder; schizophrenia