bioihbjkbjnl/mcl2 huggingface dataset:
Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains
Condition: Translational Electrophysiology
Study type: Observational

Summary: 
      The overarching goal of this multi-disciplinary research program is to develop and optimize
      new cross-species translational assessments of reward and cognition that will not only be
      assessed in parallel in humans and rats, but also produce neurophysiological and behavioral
      metrics that can be objectively compared across species. The research will build on prior
      studies by further developing and optimizing (in Phase 1), then validating via
      pharmacological challenge (in Phase 2), the following assays in both humans and rats:

        1. advanced neurophysiological and computational modeling techniques to record and analyze
           EEG activity within and across species; and

        2. behavioral assessments of reward learning, cognitive control, and cognitive flexibility
           will be analyzed within and across species.

      The second phase of the study will test the translational validity of these assays, by
      assessing the impact of a targeted drug on task performance and EEG activity in both species.
    

Detailed description: 
      The overarching goal of this multi-disciplinary research program is to develop and optimize
      new translational assessments of reward and cognition that will produce neurophysiological
      and behavioral metrics that enable objective comparison of drug effects.

      Phase 1 (2016-2018) will seek to develop and optimize computer-based tasks to measure of
      reward learning and cognition, to be administered during an EEG examination. Each participant
      will be asked to come for a single visit to complete a brief psychological assessment
      (interview and surveys), then perform two of the computer-based tasks while EEG data are
      collected. The three tasks are the Flanker Task, the Reversal Learning Task, and the
      Probabilistic Reward Task (PRT).

      In Phase 2 (2018-2021), a new set of participants will be enrolled for four visits. At the
      first visit they will have a brief psychological assessment (interview and surveys). They
      will then be assigned to one of the tasks developed during Phase I, and they will also be
      assigned to one of the study drugs: modafinil (a cognitive enhancer) or methylphenidate (a
      dopamine enhancer). At the second, third, and fourth visit, the subject will be given their
      drug in one of the three doses: a low dose, a higher dose, and a placebo. They will then
      perform the assigned task during an EEG exam.
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention description(s): cross-over, single-dose intervention
Other intervention name(s): Modafinil
Intervention MeSH terms: Methylphenidate; Modafinil
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults
      
Biospecimen description: 
      blood samples, saliva samples
    
Keywords: Translational; Electrophysiology
Immunological Response to Intravesical BCG Therapy of Superficial Bladder Cancer by Prior Administration of RUTI®
Condition: High-Risk Non-Muscle-Invasive Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal
      immunological response and provide safety information after the use of RUTI® administration
      to individuals with NMIBC.

      The study will enroll individuals treated with Transurethral resection of bladder tumor
      (TURBT), diagnosed to have high-risk Non-muscle invasive bladder cancer (NMIBC) and suitable
      candidates for BCG therapy and who meet all eligibility criteria.

      Forty individuals will be recruited and randomized 1:1 to receive two subcutaneous shots of
      25 μg RUTI® or placebo. After vaccination, individuals will receive the standard induction
      course, of intravesical Bacillus Calmette-Guerin (BCG)therapy (weekly BCG for six weeks).

      4 to 8 weeks after the last intravesical BCG administration (BCG6) a visit will be performed
      (Visit 1, end of the interventional phase). Once all participants have performed VISIT 1
      immunological assays will be performed and data will be analyzed.

      At the end of the Interventional Phase the blind will be opened, except for the study
      physicians who will remain blind during all the follow-up. All the individuals will be
      followed up for three years since TURBT.
    


Intervention name(s): RUTI®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of RUTI®; Administration of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: NMIBC; Immunotherapy; RUTI; Non-muscle invasive bladder cancer
The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of repetitive TMS in reduction of
      depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical
      trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to
      receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety
      symptoms and quality of life will be assessed before the treatment (pre test) during the
      treatment (10th session), and after the treatment (post test). QEEG apply before and after
      rTMS in all subjects.
    


Intervention name(s): Transcranial Magnetic stimulation
Intervention type(s): Device
Other intervention name(s): Magstim rapid 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea
Condition: Acute Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      This study was aimed to look at the effect of lactose free formula milk in comparison with
      home-made plain yogurt in children with acute watery diarrhea.
    

Detailed description: 
      A randomized controlled trial using non probability consecutive sampling was carried out on
      60 children (30 in each group) in Department of Paediatrics Unit I, Services Hospital Lahore.
      An informed written consent was taken from parents of the children. Ethical issues considered
      and maintained throughout the study. Then all children were randomly divided in two groups by
      using lottery method. In group 1; children were given yogurt while in group 2, children were
      given lactose free formula milk. In both groups, feed was given 5-8 times per day. Patients
      were followed-up till resolution of symptoms and discharge from hospital.
    

Intervention name(s): YOGURT; LACTOSE FREE FORMULA MILK
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Group 1 was given yogurt; Group 2 was given lactose free formula milk
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were divided in 2 groups.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LACTOSE FREE FORMULA MILK; YOGURT
Examining the Efficacy of tDCS in the Attenuation of Epileptic Paroxysmal Discharges and Clinical Seizures
Condition: Ohtahara Syndrome
MeSH terms: Seizures
Study type: Interventional

Summary: 
      The current study examined the feasibility of High-Definition tDCS (HD-tDCS) in reducing
      epileptiform activity in a 30-month-old child suffering from early onset epileptic
      encephalopathy. HD-tDCS was administered over 10 intervention days spanning two weeks
      including pre- and post-intervention video-electroencephalography (EEG) monitoring.
    


Intervention name(s): High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor
Intervention type(s): Device
Intervention description(s): Non-invasive focal neuromodulation
Other intervention name(s): tDCS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin)
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive
      containing drospirenone and ethinylestradiol) with or without levomefolate calcium
      (Metafolin, a registered vitamin supplement) in the body and to examine and compare the
      uptake of levomefolate calcium with or without Yasmin in the body, in healthy volunteers not
      using hormonal contraception.
    


Intervention name(s): EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131); EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca); L-5-MTHF Ca 0.451 mg (Metafolin)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral administration of 1 coated tablet SH T470FA (Yasmin, film-coated tablets with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP); single oral administration of 1 coated tablet SH T04532A (film-coated tablet with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin; single oral administration of 1 coated tablet SH T04532C, containing 0.451 mg Metafolin
Intervention MeSH terms: Tetrahydrofolates; Drospirenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase Ib/IIa Clinical Study of ApTOLL for the Treatment of Acute Ischemic Stroke
Condition: Stroke; Acute Stroke; Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a prospective, multicenter, double-blind, randomized, placebo-controlled, Phase
      Ib/IIa clinical study to assess the administration of ApTOLL together with endovascular
      therapy in acute ischemic stroke patients who are candidates to receive reperfusion
      therapies.
    

Detailed description: 
      This is a prospective, multicenter, double-blind, randomized, placebo-controlled, Phase
      Ib/IIa clinical study to assess the administration of ApTOLL together with endovascular
      therapy in acute ischemic stroke (AIS) patients with confirmed Large Vessel Occlusion (LVO)
      who are candidates to receive reperfusion therapies including endovascular treatment with or
      without i.v. rt-PA (recombinant tissue Plasminogen Activator).

      The study will be a Phase Ib/IIa trial where 2 doses selected, based on safety criteria, on
      Phase Ib will be administered in the following Phase IIa.The objective of the study is to
      evaluate if administration of ApTOLL at different doses is safe and well tolerated compared
      to placebo when administered with endovascular therapy (EVT), with or without i.v. rt-PA, in
      the AIS target population.
    

Intervention name(s): ApTOLL; Placebo
Intervention type(s): Drug; Other
Intervention description(s): ApTOLL is a Toll-like receptor 4 (TLR4) antagonist, a receptor that is involved in innate immune responses but also responds to tissue damage, and therefore it is directly involved in a large number of diseases where the inflammatory response is involved. ApTOLL has demonstrated specific binding to human TLR4 as well as a TLR4 antagonistic effect, reducing inflammation and improving outcome after different disease models.; White freeze-dried powder which is indistinguishable to ApTOLL for taste, color, texture and size.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Aerobic Exercise on Cognitive Function and Brain-derived Neurotrophic Factor in Young Adults
Condition: Physical Conditioning, Human; Cognition
Study type: Interventional

Summary: 
      The present study will investigate the effects of aerobic exercise on cognition and growth
      factors including brain-derived neurotrophic factor (BDNF) in young adults aged 15-21 years.
      The included subjects will be randomized to three different groups including one control
      group and two exercise groups. Subjects randomized to the exercise groups will complete 30
      minutes of aerobic exercise 3 times a week for 9 weeks incorporating low (group I) or high
      (group II) intensity aerobic exercise. The exercise will be conducted as running or indoor
      cycling (supervised). At baseline and 9-weeks follow-up all subjects will complete two
      cognitive tests (measures of concentration and sustained attention), a maximal cycling test
      (direct measures of VO2max), an intelligence quotient test, anthropometric measures, fasting
      blood samples and blood samples immediately following the cycling test. The blood samples
      will be analyzed for growth factors including BDNF and metabolic factors.
    


Intervention name(s): High intensity aerobic exercise; Low intensity aerobic exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Aerobic exercise; Cognitive function; Executive function; Brain-derived neurotrophic factor
SENSIMED Triggerfish in Closed Eyes
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates the effect of eye opening/closure on the quality of IOP (intraocular
      pressure) related patterns recorded with SENSIMED Triggerfish. Each subject receives 2
      24-hour recording sessions, one with the recorded eye open and the other with the eye
      closed,using an ophthalmic patch.
    


Intervention name(s): SENSIMED Triggerfish
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may
      kill more tumor cells.

      PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone
      or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV
      non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To select a regimen (erlotinib hydrochloride with or without carboplatin and paclitaxel)
           for further testing against standard treatment, based on median progression-free
           survival for ≥ 3 months, in patients with stage IIIB or IV non-small cell lung cancer
           with a Zubrod performance status of 2.

      Secondary

        -  To assess the feasibility of selecting patients for a trial based on central EGFR
           testing of serum in a cooperative group setting.

        -  To evaluate the objective tumor response rates (confirmed and unconfirmed, complete and
           partial response), in a subset of patients with measurable disease.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses
           repeat every 21 days in the absence of disease progression or unacceptable toxicity.

        -  Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes
           on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats
           every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses,
           patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib
           hydrochloride repeat every 21 days in the absence of disease progression or unacceptable
           toxicity.

      After completion of study treatment, patients are followed every 3 months for 1 year and then
      every 6 months for 2 years.
    

Intervention name(s): carboplatin; erlotinib hydrochloride; paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): given IV; given orally; given IV
Intervention MeSH terms: Paclitaxel; Carboplatin; Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; large cell lung cancer; squamous cell lung cancer
Study of Stomatognathic System of the Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The aim is to identify differences in the stomatognathic system, mastication and deglutition
      functions between obese and normal weight subjects.
    

Detailed description: 
      The aim of this study was to identify differences in the stomatognathic system between obese
      and normal weight subjects. The habitual chewing of a French bread and deglutition of solids
      and liquid was evaluated five times in obese subjects and controls. The tonus of the lips,
      tongue, cheeks, masseter and temporal muscles were evaluated by clinical observation and
      palpation and defined as either normal or reduced. Twenty obese patients (body mass index
      (BMI) > 30kg/m2) and twenty volunteers of normal weight (BMI 18.5-24.9 Kg/m2) were evaluated.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        twenty obese patients (6 Male /14 Female, mean age 32.2 ± 9.9, mean BMI 43,3 ± 9.6 Kg/m2)
        and twenty lean volunteer (4 Male / 16 Female mean age 30.7 ±6.7, mean BMI 22.3 ± 1.9
        Kg/m2)
      
Keywords: chewing; deglutition; orofacial motricity; obesity
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
Condition: Leishmaniasis, Mucocutaneous
MeSH terms: Leishmaniasis; Leishmaniasis, Mucocutaneous
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given
      as three injections every 28 days at each of three dose levels of Leish-111f protein, in
      combination with standard pentavalent antimony therapy in adult patients with mucosal
      leishmaniasis.
    

Detailed description: 
      Mucosal leishmaniasis is a disfiguring and possibly fatal infection. All available medical
      therapies require weeks of treatment and cause significant toxicity. In Peru, the standard
      therapy is daily intravenous (IV) pentavalent antimony (20 mg/kg/day) for 28 days. It appears
      that Leishmania infections can be eliminated by T helper 1 immune responses. These findings
      argue that a vaccine that augments mucosal leishmaniasis patients' T helper 1 responses will
      eliminate the infection and disease. This study is a phase 1, randomized, double-blind,
      placebo controlled, sequential dose-escalating trial to evaluate the safety and
      immunogenicity of three injections of 5, 10, or 20 μg of Leish-111f protein + 25 μg of MPL-SE
      adjuvant given at 4 week intervals as an adjunct to standard chemotherapy with pentavalent
      antimony (20 mg/kg/day for 28 days) in patients with mucosal leishmaniasis.
    

Intervention name(s): Leish-111f + MPL-SE vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Leishmaniasis; Subunit vaccine; therapeutic; T-cell; pentavalent antimony
Changes in Respiratory Effort in Preterm Infants
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature
      respiratory center and having respiratory distress. CPAP requires intensive care monitoring
      and special qualified staff. Continuous positive pressure makes a constant noise around the
      child and can lead to an uncomfortable environment.The fixture of the binasal prongs can
      cause nasal trauma after to tight attachment.Minimizing the time on CPAP is considered
      important for the child.

      Recently High-Flow Nasal Cannula (HFNC) has become widely used in modern newborn intensive
      care units.HFNC is considered to be easy to apply and a more comfortable respiratory support
      for the preterm infant with mild and moderate respiratory distress. HFNC gives warm humified
      air with high flow through a nasal cannulae. HFNC is used as part of withdrawal from
      intensive respiratory support, to prevent respiratory distress and as a respiratory support
      after extubation.

      There is still uncertainty about safety and effectiveness of HFNC. The aim of this study is
      to investigate the preterm infants respiratory effort by measuring electrical activity in
      diaphragm (Edi max and Edi min), respiratory parameters and a clinical observation using a
      scoring system inspired by Silverman- Andersen retraction score. It is expected that measured
      electrical activity in the diaphragm, measured respiratory parameters combined with bedside
      observations provide applicable knowledge about preterm infants respiratory effort in
      transition from CPAP to HFNC.
    

Detailed description: 
      Data material will be stored on a separate computer in a sheltered home Directory. All data
      will be anonymous. Edi signals are transported from Servo-I ventilator with neural access
      through a communication port to a personal computer.Respiratory parameters will be stored in
      Picis (High Performance Hospital Information System). For the Statistical analyzes a T-test
      will be carried out, and data from the pilot study will decide the power to see whether we
      reject or retain the 0 hypothesis: " There are no changes in the preterm infants respiratory
      effort in transition from CPAP to HFNC".
    

Intervention name(s): High Flow Nasal Cannulae (HFNC); Continuous Positive Airway Pressure (CPAP)
Intervention type(s): Procedure; Procedure
Intervention description(s): HFNC 6 l/pr.min; CPAP 6 l/pr.min
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Respiration; Noninvasive Ventilation; Work of breathing; Infant, premature; Electromyography; Diaphragm