bioihbjkbjnl/mcl2 huggingface dataset:
Emotion Study/Substudy: Flexible Brain Study
Condition: Aging; Emotions; Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The proposed research applies the highly innovative technology of real-time functional
      Magnetic Resonance Imaging (rtfMRI) to examine plasticity of brain-regulatory mechanisms
      related to cognitive and affective processing and to determine benefits for cognition and
      affect in young and older adults and in Parkinson Disease (PD) patients.
    

Detailed description: 
      There is increasing evidence that age-related alterations in brain function associated with
      affective processing and attention contribute to these motivational and emotional changes
      with age.

      Based on these theoretical considerations as well as the previous study's data, the proposed
      research will apply well-tested emotion processing and attention paradigms to address the
      pivotal question of whether brain activity can be modulated in healthy aging and PD (in the
      substudy) via contingent rt-fMRI neurofeedback and whether this neuroregulatory modulation
      increases emotion processing and cognitive performance.
    

Intervention name(s): Anterior cingulate cortex activation; Primary auditory cortex activation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Functional Magnetic Resonance Imaging Participants in the experimental group will be trained using functional magnetic resonance imaging to regulation brain activity in anterior cingulate cortex.
The anterior cingulate cortex is a brain region that is known to be involved in emotion processing. Activation of this region is expected to improve emotion processing.; Functional Magnetic Resonance Imaging Participants in each group will be trained using functional magnetic resonance imaging to regulation brain activity in primary auditory cortex. The primary auditory cortex is a brain region that is NOT specifically involved in emotion processing. Activation of this region is NOT expected to improve emotion processing; and thus activation of this brain region serves as "control/placebo" condition in the current design (placebo comparator).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Emotional Aging; Neurofeedback
Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder
Condition: HIV Associated Neurocognitive Disorder
MeSH terms: Neurocognitive Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to see if paroxetine and fluconazole are safe and effective as a
      treatment for problems with memory, concentration, thinking, and judgment in people who are
      infected with HIV. Paroxetine is an antidepressant approved by the FDA to treat major
      depression. Fluconazole is an antifungal medication approved by the FDA to treat fungal
      infections.
    

Detailed description: 
      The study will be a 24 week double-blind, placebo-controlled 2x2 factorial design pilot Phase
      I/II study in 60 HIV+ individuals with HAND. Participants will be randomly assigned to one of
      four groups: 1) fluconazole 100 mg every 12 hours orally per day, 2) paroxetine 20mg every
      evening orally per day, 3) fluconazole 100mg every 12 hours orally per day and paroxetine
      20mg every evening orally per day and 4) placebo.

      Primary Aim: To obtain preliminary data to evaluate the efficacy of fluconazole and/or
      paroxetine to decrease CSF lipid and protein markers of oxidative stress [CSF ceramide and
      (C18:0 levels) and 3-nitrosylated proteins].

      Secondary Aims:

      i) To evaluate the safety and tolerability of fluconazole and/or paroxetine in HIV+
      individuals with HAND ii) To evaluate the effect of fluconazole and/or paroxetine on
      neurocognitive performance in HIV+ individuals with HAND iii) To evaluate the effect of
      fluconazole and/or paroxetine on functional performance in HIV+ individuals with HAND iv) To
      evaluate the CNS penetration of fluconazole and paroxetine after 24 weeks of treatment v) To
      obtain preliminary data to evaluate the efficacy of fluconazole and/or paroxetine to improve
      abnormal imaging markers as measured by magnetic resonance spectroscopy (MRS) and arterial
      spin labeling
    

Intervention name(s): Fluconazole; Paroxetine; Paroxetine and Fluconazole; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One 100 MG capsule taken twice daily, 12 hour dosing; Two 10 MG capsules paroxetine once daily in the evening; One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening; One capsule in the morning, three capsules in the evening
Intervention MeSH terms: Fluconazole; Paroxetine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HIV; Neurocognitive impairment; Memory; Dementia; CSF marker; Functional assessment; MRS; Magnetic resonance spectroscopy; Arterial spin labeling; SSRI
Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia
Condition: Adult Acute Lymphoblastic Leukemia; Childhood Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional

Summary: 
      This clinical trial is studying the side effects of Erwinia asparaginase and what happens to
      the drug in the body in treating young patients with acute lymphoblastic leukemia who are
      allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work
      in different ways to stop the growth of cancer cells, either by killing the cells or by
      stopping them from dividing.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine if the 48-hour trough serum asparaginase activity is ? 0.1 IU/mL in young
      patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after allergy to
      PEG-asparaginase.

      II. To determine the frequency of asparaginase-related toxicity in these patients.

      III. To characterize the pharmacokinetics of Erwinia asparaginase in these patients.

      SECONDARY OBJECTIVES:

      I. To compare serum asparaginase activity and serum asparagine concentration between patients
      treated with Erwinia asparaginase on this trial and historical controls treated with
      PEG-asparaginase on CCG-1961 and CCG-1962.

      II. To determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the
      starting date of Erwinia asparaginase therapy.

      III. To determine the presence of anti-Erwinia asparaginase antibodies in patients treated
      with a course(s) of Erwinia asparaginase following clinical allergy to PEG-asparaginase (PEG,
      pegaspargase).

      IV. To determine if serum asparagine is adequately depleted on days 12 or 13 in a subset of
      these patients.

      OUTLINE: This is a multicenter study.

      Patients receive 6 doses of Erwinia asparaginase intramuscularly (IM) on a
      Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase
      remaining on the original treatment protocol. All other chemotherapy continues according to
      the original treatment protocol.

      Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody
      studies.

      After completion of study treatment, patients are followed periodically.
    

Intervention name(s): Asparaginase; Laboratory Biomarker Analysis; Pharmacological Study
Intervention type(s): Drug; Other; Other
Intervention description(s): Given IM; Correlative studies; Correlative studies
Other intervention name(s): ASP-1; Asparaginase II; Asparaginase-E.Coli; Colaspase; Elspar; Kidrolase; L-Asnase; L-ASP; L-Asparaginase; L-Asparagine amidohydrolase; Laspar; Lcf-ASP; Leucogen; Leunase; MK-965; Paronal; Re-82-TAD-15; Serasa; Spectrila
Intervention MeSH terms: Asparaginase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observational Study Describing the Immune Profile Induced By Pertussis Vaccines
Condition: Whooping Cough; Pertussis
MeSH terms: Whooping Cough
Study type: Observational

Summary: 
      This is an observational study designed to describe the immune profile of toddlers and
      preschoolers with acellular priming after receiving a booster dose of pertussis vaccine.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy subjects aged 15 to 59 months
      
Biospecimen description: 
      blood draw
    
Keywords: Whooping cough; Pertussis
Influence of Glidescope Assisted Endotracheal Intubation on Intraocular Presure
Condition: Effect of Intubation on Intraocular Pressure
Study type: Interventional
Phase: Phase 4

Summary: 
      Tracheal intubation with traditional Macintosh laryngoscope is associated with increase in
      intraocular pressure along with tachycardia and hypertension. These effects are not desirable
      in ophthalmic patients especially in patients with glaucoma. GlideScope video laryngoscope
      system is a new approach for laryngoscopy and tracheal intubation. It does not require a
      direct line of sight to the glottis when intubating with the Glidescope and as a result
      intubation is much less stimulating to the patient. Therefore GlideScope video laryngoscope
      assisted intubation could be a preferable technique for intraocular surgery offering
      advantages in terms of intraocular pressure and cardiovascular stability.
    


Intervention name(s): Intubation
Intervention type(s): Device
Intervention description(s): Endotracheal intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Airtraq, Intraocular pressure
Change in Skin Surface Temperature at the Neck When Using Acupuncture at Houxi Point in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Acupuncture is a method of inserting very thin needles into special points on the body which
      are called acupoints, to treat diseases. This treatment has been widely applied in health
      care for over 2500 years. Currently, by synthesizing the results of many clinical studies,
      the World Health Organization (WHO) has recognized the importance of acupuncture as an
      effective treatment for various diseases. However, the specific effect of acupoints is still
      controversial. Until now, several studies have shown that acupoints are associated with
      certain areas of the human body that are far from the acupoints and can alter the temperature
      of those area. In our study, we will survey on the change in skin surface temperature at the
      neck when using acupuncture at Houxi point in healthy volunteers.
    

Detailed description: 
      Participants and Methods: A randomize controlled trial will be conducted by comparing the
      change in the skin surface temperature before and after using acupunture at the control
      acupoint (Yuji - LU10) and the research acupoint (Houxi - SI3) on either the left or right
      hand in healthy volunteers. A total of 60 participants will be randomly assigned to 2 group
      (A and B) and the allocation was 1:1. Both groups will undergo two trial phases 07 days
      apart, corresponding to one acupoint on the same hand in each step. Group A (acupoints on the
      left hand): participants will be received acupuncture at the control acupoint (Yuji - LU10)
      in the first trial phase, and the second phase will be conducted after 07 days at the
      research acupoint (Houxi - SI3). Group B: proceeding similarly to group A, but the points are
      on the right hand. The primary outcome will be the change in skin surface temperature at the
      neck when using acupuncture at Houxi point on each hand. This trial will be performed as a
      2-arm parallel design, randomize, controlled and single blinded.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): Acupuncture is a method of inserting very thin needles into special points on the body which are called acupoints. To conduct this intervention, we will use disposable acupuncture needles the size of 0.30 x 13 mm to acupuncture the control acupoint (Yuji - LU10) in the first session and the research acupoint (Houxi - SI3) in the second session.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2-arm parallel design, randomized, controlled and single blinded trial
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Acupuncture; Skin surface temperature
Infant Microbiome in Diaper Rash
Condition: Diaper Rash
MeSH terms: Diaper Rash
Study type: Observational

Summary: 
      The objective of this study is to evaluate the microbiome composition of infant's (9-12
      month) skin experiencing diaper rash in order to determine if the onset and severity of
      erythema associated with diaper rash is influenced by the type of bacteria colonizing the
      skin.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample of male and female infants with mild to moderate diaper rash
      
Biospecimen description: 
      swabs and tape strips of the diaper rash area will be analyzed
An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
Condition: Eosinophilic Gastritis; Eosinophilic Duodenitis
MeSH terms: Gastroenteritis; Gastritis; Eosinophilic Esophagitis; Enteritis; Duodenitis; Eosinophilia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of
      lirentelimab given monthly.
    


Intervention name(s): lirentelimab
Intervention type(s): Drug
Intervention description(s): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8
Other intervention name(s): AK002
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland
Condition: Neoplasms; Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Study type: Observational

Summary: 
      Patient receiving sunitinib according the clinician's independent decision as first-line
      treatment of advanced renal cell carcinoma (RCC) will be asked for informed consent.
      Treatment with sunitinib will start and end solely on the treating clinicians and the
      patients independent discretion. Consenting patients will prospectively answer standardized
      quality of life questionnaires (15D, EQ-5D) during the treatment. Data on health care
      resource utilisation will be collected prospectively (outpatient visits, hospital stays,
      concomitant drugs, investigations, sick-leaves, travels). In addition, after treatment
      failure anti-cancer drugs, hospital stays and date of death will be recorded.

      The health economic data during sunitinib treatment and the length of the sunitinib treatment
      will be compared with the corresponding previously published data collected retrospectively
      from patients with the same condition treated with IFN-alfa. Stepwise regression analysis
      will be used to explore whether patient and tumor characteristics explain potential variation
      in treatment duration and costs that is not explained by the treatment.

      Health-related quality of life (HRQoL) data will be presented as descriptive data and
      compared to age-standardized general population.

      At least four major Finnish oncology centers have consented to participate in this study. The
      inclusion time will be approximately 24 months, and the study time approximately 48 months.
      Eighty patients will be included.
    


Intervention name(s): sunitinib
Intervention type(s): Drug
Intervention description(s): sunitinib 50 mg, per os, daily for 4 weeks then 2 weeks pause, duration months
Intervention MeSH terms: Sunitinib
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        advanced renal cell cancer patients
      
Keywords: renal cell cancer; sunitinib; costs; quality of life
Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain
Condition: Neuralgia; Myalgia
MeSH terms: Myalgia; Neuralgia; Fatigue
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Male and female participants were selected based on chronic neuromuscular pain. Patients were
      instructed to take two doses of the placebo or cuprous nicotinic acid chelate Cunermusmir
      twice a day for 28 days. Hypothesis: Cunermuspir would improve quality of life as determined
      by several questionnaires.
    

Detailed description: 
      A total of 72 subjects were consented and screened, with 56 subjects (28 males and 28 female)
      being eligible to participate in the study. Fifty-six subjects with muscle/nerve pain were
      randomized at a ratio of 1:1 to one of two treatment groups. To evaluate primary and
      secondary objectives, study assessments were conducted at Baseline, and Day 28 ± 2. The
      Individualized Neuromuscular Quality of Life Questionnaire (INQoL), Symptom Impact
      Questionnaire (SQIR), Mini-Mental State Examination (MMSE) were completed by participants to
      assess physical function, pain, fatigue/energy and cognitive function.
    

Intervention name(s): Cunermuspir; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:
Organic evaporated cane juice powder, hypromellose, titanium dioxide; same non-medical ingredients and encapsulation as Intervention 1
Other intervention name(s): cuprous nicotinic acid
Intervention MeSH terms: Nicotinic Acids; Niacin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double--blind, placebo controlled, parallel study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Copper; nicotinic acid; energy; strength; fatigue; nerve pain; muscle pain; neuralgia; myalgia
Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)
Condition: Anesthesia, General; Neuromuscular Blockade
Study type: Interventional
Phase: Phase 3

Summary: 
      The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex
      compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects
      for registration purposes in China.
    


Intervention name(s): Sugammadex; neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex was administered.; After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 50 µg/kg neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
Other intervention name(s): Org 25969, Bridion®; Neostigmine with atropine
Intervention MeSH terms: Atropine; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Anti-inflammatories in the Reduction of Bite Reactions
Condition: Mosquito Bite
MeSH terms: Bites and Stings
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate two separate antiinflammatory products for the
      relief of symptoms through suppression of the immunological and inflammatory response
      following a mosquito bite. The investigators have selected ibuprofen gel as a NSAI
      formulation and 0.05% Clobetasone butyrate as a steroid cream with their appropriate physical
      matched placebo products.
    


Intervention name(s): NSAI treatment; Steroid treatment
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen 5% gel; Steroid intervention with 0.05% w/w clobetasone butyrate.
Other intervention name(s): Fenbid gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mosquito; allergy; bite; ant-inflammatory; Aedes aegypti mosquito bite
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
Condition: Bariatric Surgery Candidate; Glucose Intolerance; Insulin Resistance
MeSH terms: Insulin Resistance; Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric
      surgery.
    

Detailed description: 
      A prospective, double-blind, randomized controlled trial was performed. Consenting obese
      adult patients with impaired glucose tolerance, undergoing bariatric surgery, were
      randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1
      ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery.
      Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose
      and insulin levels were taken every 2 hours during the first 12 hours from the onset of the
      drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score,
      the occurrence of emesis, and postoperative sedation levels were recorded as secondary
      outcomes.
    

Intervention name(s): Dexmedetomidine; 0.9% Sodium-chloride; Fentanyl; Morphine Sulfate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.; The same infusion rate used in the dexmedetomidine group.; Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).; Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Other intervention name(s): Precedex; Normal saline; Sublimaze; Morphine
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Impaired Glucose Tolerance; Obese patients; Dexmedetomidine