bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
Condition: Pancreatic Cancer; Stage IV Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and
      PK of vantictumab when combined with nab-paclitaxel and gemcitabine.
    

Detailed description: 
      Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined,
      up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the
      safety, tolerability and PK of vantictumab combined with nab-paclitaxel and gemcitabine. Up
      to approximately 34 patients may be enrolled into the study.
    

Intervention name(s): Vantictumab; Nab-Paclitaxel; Gemcitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered intravenous (IV) infusion.; Nab-Paclitaxel will be administered by intravenous (IV) infusion.; Gemcitabine will be administered by intravenous (IV) infusion.
Other intervention name(s): OMP-18R5
Intervention MeSH terms: Paclitaxel; Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic Cancer; Stage IV Pancreatic Cancer
MMR and Varicella Vaccine in Premature Infants
Condition: Chickenpox; Rubella; Rubeola; Mumps
MeSH terms: Chickenpox; Rubella; Premature Birth
Study type: Observational

Summary: 
      This research is designed to address the question, "Does the relative deficit in vaccine
      immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We
      propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in
      relatively healthy, 12-to-15 month-old children born at <29 weeks gestation, when compared to
      full-term infants, as measured by the relevant viral serologies.
    

Detailed description: 
      Title: MMR and Varicella Vaccine Responses in Extremely Premature Infants

      Phase: IV

      Population: 16 generally healthy premature infants born at < 29 weeks' gestation, < 16 months
      old from the Rochester area 16 generally healthy full-term infants born at >/= 37 weeks'
      gestation, < 16 months old from the Rochester area

      Number of Sites: University of Rochester

      Study Duration: 1.5 - 8.5 months

      Description of Agent or Intervention:

      Subjects will make 2 study visits. The first, at 15 months of age, will coincide with a
      routine well child visit. Subjects will have 2 mL of blood drawn at the time of their
      routine, 15-month MMR, varicella, and pneumococcal conjugate immunizations. At a second study
      visit 4-6 weeks later, another 2 mL of blood will be drawn.

      Objectives:

      Primary: We propose to measure the immunogenicity of routinely administered varicella and
      mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at <29
      weeks gestation (premature), when compared to that in full-term infants.

      Measles titers will be measured by neutralization assay. Mumps and rubella titers will be
      measured by enzyme-linked florescent immunoassay. Varicella titers will be measured by enzyme
      linked immunosorbent assay.

      Safety will be assessed by parental recall of vaccine-related adverse events and by active,
      prospective collection of blood-draw-associated adverse events.

      Schematic of Study Design:

      Subjects will be approached at 9-12 months of age for inclusion, and will consent at this
      time or at Visit 1

      Visit 1 (15 mos):

      Preterm N = 16, Full term N = 16, 2 ml blood draw

      Routine MMR, varicella vaccines administered by primary pediatrician per standard of care (at
      Visit 1)

      Visit 2 (16 mos):

      Preterm N = 16, Full term N = 16, 2 ml blood draw

      Varicella, mumps, measles and rubella vaccine titers measured by ELISA
    

Time perspective: Prospective
Keywords: immunization; vaccine; low birth weight infant; premature infant
The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects
Condition: Obesity
Study type: Interventional

Summary: 
      The study evaluated the safety and efficacy of the ReShape Intragastric Balloon as an adjunct
      to diet and exercise in obese patients compared with diet and exercise alone. The study
      device is designed to occupy space within the stomach and induce satiety. After approval from
      the institutional review board, patients provided written consent and were randomized to the
      treatment group (with endoscopic placement of study device) or the control group (no
      placement of study device) on an unblinded basis. Both groups received similar diet and
      exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events,
      and quality of life data were evaluated throughout the 48 week study duration.
    


Intervention name(s): ReShape Intragastric Balloon; Control Arm
Intervention type(s): Device; Other
Intervention description(s): Placement of ReShape Medical Intragastric Balloon for twenty four weeks; Behavioral Modification (Diet and exercise counseling) alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective is to compare the efficacy and safety of masitinib in combination with riluzole
      in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).
    

Detailed description: 
      Masitinib is novel tyrosine kinase inhibitor that targets microglia and mast cells through
      inhibiting a limited number of kinases. Masitinib blocks microglia proliferation and
      activation, and mast cell-mediated degranulation, the release of cytotoxic substances that
      might further damage the motor nerves.

      There are two distinct populations of ALS patients: population of "Normal progressors" and
      population of "Faster progressors". Targeted population for primary analysis is population of
      "Normal progressors".

      "Normal progressors" are ALS patients whose progression of ALSFRS-R score before
      randomization is less than 1.1 point per month.
    

Intervention name(s): Masitinib (4.5); Riluzole; Placebo; Masitinib (3.0)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4.5 mg/kg/day; 3 mg/kg/day
Other intervention name(s): AB1010; Rilutek; Placebo Oral Tablet; AB1010
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis (ALS) - masitinib
Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss
Condition: Tinnitus; Hearing Loss
MeSH terms: Hearing Loss; Deafness; Tinnitus
Study type: Interventional

Summary: 
      This study aimed at trying transcranial magnetic stimulation and transcranial direct current
      stimulation as potential treatments to decrease tinnitus in patients with significant hearing
      loss.
    

Detailed description: 
      Tinnitus is a very common condition and affects approximately 15% of the population,
      disrupting sleep, emotional balance and social life of the patients. Acoustic deprivation
      causes hearing loss and is responsible for a cascade of processes that result in the
      reorganization of the cortex through a synchronization of neuronal activity related to a
      cortical re-mapping. Consistent with the hypothesis that tinnitus is caused by abnormal
      activation of the auditory cortex, repetitive transcranial magnetic stimulation (rTMS) can
      temporarily reduce cortical hyperactivity through direct neuromodulation of the temporal
      cortex. Furthermore, studies have shown that transcranial direct current stimulation (tDCS)
      can also suppress tinnitus. Objective: To determine the effectiveness of rTMS and TDCS in the
      treatment of patients with chronic tinnitus and auditory loss. Methods: We performed an
      analytical experimental double-blind study using rTMS and tDCS in patients with chronic
      tinnitus and hearing loss.
    

Intervention name(s): Transcranial Magnetic Stimulation; Transcranial Direct Current Stimulation
Intervention type(s): Procedure; Procedure
Intervention description(s): TMS over the left temporoparietal cortex; TDCS over the left temporoparietal cortex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tinnitus; hearing loss; Transcranial magnetic stimulation; Transcranial direct current stimulation
The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia
Condition: Cirrhosis
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Interventional

Summary: 
      All Cirrhosis liver patients (Child A/B/C) presenting to Institute of Liver and Biliary
      Sciences will be screened for sleep disturbance and excessive daytime sleepiness with Epworth
      sleep score/ Pittsburgh sleep quality index. 52 patients of clinical/ radiological/ biopsy
      proven cirrhosis (Child A/B) will be enrolled after ruling out possibility of psychiatric
      illnesses like depression and anxiety with the help of PHQ-9 / GAD-7 questionnares. Patients
      who are suffering with sleep disturbance as evaluated with Pittsburgh sleep quality index
      will undergo polysomnography and will be randomised to two groups after fulfilling all
      inclusion criterias. Patients in group (Group 1) will receive zolpidem 5mg at bed time daily
      and patients in control group will receive placebo at bed time daily. The treatment will be
      continued for 4 weeks. After 4 weeks enrolled patients will be reassessed with PSQI and
      polysomnography. All patients will be advised regarding sleep hygiene.
    


Intervention name(s): Zolpidem; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
HIV Testing and Brief Alcohol Intervention for Young Drinkers in the Emergency Department
Condition: Alcohol Consumption; Sexual Risk Behaviors
MeSH terms: Emergencies; Alcohol Drinking
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether a brief counseling intervention coupled
      with rapid HIV testing was feasible and effective at decreasing alcohol consumption and
      sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency Department.
    


Intervention name(s): Counseling intervention with rapid HIV testing
Intervention type(s): Behavioral
Intervention description(s): Counseling intervention (modeled after Brief Negotiation Interview and Project RESPECT-2) coupled with rapid HIV testing. Telephone booster at 2 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: alcohol consumption; sexual risk behaviors; young, unhealthy drinkers
Anidulafungin PK in Infants and Toddlers
Condition: Invasive Fungal Infections
MeSH terms: Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in
      infants and toddlers less than 24 months of age with suspected serious infection. There will
      be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive
      anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24
      hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling
      scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those
      observed in older children and adults.
    


Intervention name(s): Anidulafungin
Intervention type(s): Drug
Intervention description(s): Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.
Other intervention name(s): Eraxis
Intervention MeSH terms: Anidulafungin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurobiology of Alcohol and Nicotine Co-Addiction
Condition: Alcohol Use Disorder; Nicotine Use Disorder
MeSH terms: Alcoholism; Tobacco Use Disorder
Study type: Observational

Summary: 
      This proposal addresses the critical absence of information about the neurobiology of
      recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users.
    

Detailed description: 
      This proposal addresses the critical absence of information about the neurobiology of
      recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users. AUD and nicotine use
      disorder (NUD) are the most commonly abused (non-prescription) substances in the U.S.
      Co-addiction is particularly high in military veterans. Although nationwide estimates peg the
      rate of AUD/NUD co-addiction at 80%, the Substance Abuse Treatment Program (SATP) at the
      Veterans Affairs Portland Health Care System (VAPORHCS) finds that 90% of veterans treated
      for AUD also meet criteria for NUD. The investigators hypothesize that a support vector
      machine learning algorithm will be able to use the measures to classify subjects as AUD, NUD
      both or neither and that the algorithm will predict outcome (sobriety or relapse) at three
      months.
    

Intervention name(s): magnetic resonance imaging (MRI)
Intervention type(s): Behavioral
Intervention description(s): All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be recruited from the Portland VA, Oregon Health & Science University,
        community substance abuse treatment programs and by advertisement.
      
Biospecimen description: 
      Cheek swab Plasma
Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers
Condition: Healthy Volunteers
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period,
      Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of
      Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of
      Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of
      Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to
      determine a dose of budesonide that when formulated with glycopyrronium and formoterol
      fumarate in BGF MDI provides comparable systemic exposure [pharmacokinetics (PK)] to
      budesonide following administration of Symbicort MDI.
    


Intervention name(s): Inhaled BGF (PT010) Dose 1; Inhaled BGF (PT010) Dose 2; Inhaled BGF (PT010) Dose 3; Inhaled GFF (PT003); Inhaled Symbicort Dose 1; Inhaled Symbicort Dose 2
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Smoking Cessation for Smokers With Sleep Problems
Condition: Nicotine Dependence; Cigarette Smoking; Insomnia
MeSH terms: Dyssomnias; Parasomnias; Tobacco Use Disorder
Study type: Interventional

Summary: 
      This is a pilot research study examining two types of behavioral counseling along with the
      nicotine patch for smoking cessation. The study is designed to find out whether one of these
      counseling interventions is more effective for smoking cessation among individuals with sleep
      problems. The study has three parts: 1) an intake session; 2) a 10-week treatment phase, and
      3) a 1-month follow-up.
    

Detailed description: 
      This is a developmental study to: 1) create and test an integrated cognitive-behavioral
      smoking cessation and insomnia intervention with 30 smokers who report current insomnia.
      Participants are randomized to 1 of 2 counseling conditions. The cognitive-behavioral
      intervention provides standard care smoking counseling along with counseling to address
      insomnia. The smoking counseling intervention provides standard care smoking counseling
      adapted from the American Lung Association Freedom from Smoking program. Efficacy data from
      this trial will be used to determine effect size estimates for biologically confirmed
      self-reported point prevalence smoking abstinence at the end of treatment and 1 month after
      completing treatment. Changes in sleep efficiency and self-control to resist smoking urges
      will also be examined. If the effect size estimates are sufficiently large and medically
      important to pursue a definitive trial, these data will be used to propose a full scale large
      study.
    

Intervention name(s): Cognitive-Behavioral Counseling; Smoking Cessation Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia.; The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program.
Other intervention name(s): CBT-I + SC; SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking; Nicotine; Nicotine polacrilex; Nicotine replacement
Multicenter Myocardial Viability Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      The purpose of this study is to test the hypothesis of whether contrast enhanced Magnetic
      Resonance Imaging can be used to predict improvement of the wall motion in regions of the
      heart with abnormal movement following bypass surgery or percutaneous angioplasty in various
      institutions across three continents.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients were recruited from 9 institutions on 3 different continent. All patients
        recruited for the study had a history of angiographically documented chronic coronary
        artery disease and resting wall motion abnormalities, and were scheduled for cardiac
        revascularization (coronary artery bypass surgery or percutaneous intervention).
      
Keywords: Myocardial Viability; Delayed Enhancement Magnetic Resonance Imaging; Functional Recovery
Safety and Tolerability Study of the Taris Placebo System
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the
      development program and to provide key safety and tolerability data for the Taris platform.
    


Intervention name(s): TARIS Placebo; Sham Procedure
Intervention type(s): Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: TARIS Placebo; Bladder; Interstitial Cystitis; Normal Healthy Volunteers
Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19
Condition: Covid19; Vitamin D; Children, Only
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      Open controlled clinical trial. Hospitalized pediatric patients with COVID-19 will be
      included. Upon admission to hospital serum determination of vitamin D, interleukins, ferritin
      and Dimer D will be performed. Subsequently, randomization will be performed to identify
      which group the patient belongs. Adverse effects will be evaluated on a daily basis. Serum
      levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken at the beginning
      of hospitalization and on the 7th day after admission. It will be recorded if the patient
      presents deterioration of the respiratory function that requires endotracheal intubation and
      / or admission to intensive care and / or if he dies, and at what time of hospitalization
      does this outcome occur. The study will culminate when the patient is discharged from
      hospitalization.
    

Detailed description: 
      Hospitalized pediatric patients with COVID-19 will be included. The diagnosis of COVID-19
      performed through RT-PCR. Upon admission to hospital, a serum determination of Vitamin D,
      interleukins, ferritin and dimer-D will be performed. Subsequently, randomization will be
      performed to identify which group the patient belongs to. In case of being in the vitamin D
      group, in children under 12 months they will be given 1000U and in children over 12 months
      they will be given 2000U every 24 hours orally. Adverse effects will be evaluated on a daily
      basis. Subsequently, serum levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will
      be taken on day 7 of admission. It will be recorded if the patient presents deterioration of
      the respiratory function that requires endotracheal intubation and / or admission to
      intensive care and / or if he dies, and at what time of hospitalization does this outcome
      occur. The study will culminate when the patient is discharged from hospitalization. On the
      day of hospital discharge, a blood sample will be taken to determine vitamin D.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): 1000U or 2000U every 24 hours orally
Other intervention name(s): vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open controlled clinical trial
Masking: None (Open Label)
Primary purpose: Treatment