bioihbjkbjnl/mcl2 huggingface dataset:
Deciphering the Role of Oxytocin in Motivation: an fMRI Study
Condition: Focus of Study: Neural Correlates of Oxytocin Administration
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study will investigate the effects of intranasal oxytocin administration on
      neural activity associated with social and non-social motivation.
    

Detailed description: 
      Oxytocin is a well-known social and reproductive hormone demonstrated to have a variety of
      prosocial effects in humans including enhancing trust and generosity, improving positive
      communication, increasing eye gaze, and reducing anxiety. Oxytocin is hypothesized to
      facilitate social behaviors via its modulation of motivational networks. With this study, we
      will characterize oxytocin's effects on the neural processing of salient stimuli. We will
      utilize a noninvasive brain imaging technique, functional magnetic resonance imaging (fMRI),
      to assess brain activity while participants perform tests designed to engage neural circuits
      associated with the processing of social and non-social stimuli.
    

Intervention name(s): Placebo; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.; Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.
Other intervention name(s): Syntocinon®
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Oxytocin; Functional Magnetic Resonance Imaging; Social; Motivation
Nilotinib Pre and Post Allogeneic Stem Cell Transplantation
Condition: Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia; Stem Cell Transplantation
MeSH terms: Leukemia; Leukemia, Myeloid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 2

Summary: 
      Current therapeutic results in advanced chronic myeloid leukemia (CML) and Ph+ acute
      lymphoblastic leukemia (ALL) are rather disappointing. Most of these patients will eventually
      undergo allogeneic stem cell transplantation. Nilotinib is a novel TKI tyrosine kinase
      inhibitor with 30 fold more potency than Imatinib. Based on previous preliminary experience
      the author we rationalize that Nilotinib therapy pre- allogeneic transplantation for patients
      with advanced CML and Ph+ALL will reduce tumor mass pre- transplant achieving a state of
      minimal residual disease (MRD) and therefore may improve transplantation outcome without
      increasing toxicity. In addition it will allow time for improving patient medical condition
      and for finding an unrelated donor which will enable allogeneic transplantation , and to
      induce anti tumor effect post PBSC w\o DLI ( donor lymphocyte infusion)
    


Intervention name(s): Nilotinib
Intervention type(s): Drug
Intervention description(s): Nilotinib 400 mg po/BID until transplant. Nilotinib 200-400 mg po/BID post transplant in escalated doses.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic myeloid leukemia; Ph+ acute lymphoblastic leukemia; stem cell transplantation; nilotinib
Effects of Ezetimibe on the Absorption of Oxidized Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test the effects of Zetia™ (ezetimibe) 10 milligrams (mg) on
      the absorption of oxysterol into the blood following a meal containing oxysterol.
    

Detailed description: 
      There are a number of cholesterol-lowering drugs available that can lower blood cholesterol
      to a healthier level. Zetia™ (ezetimibe) 10 mg is available by prescription for the treatment
      of high cholesterol. While Zetia has been shown to inhibit the absorption of dietary
      cholesterol into the bloodstream, its effects on oxysterol absorption from the diet have not
      been completely evaluated.
    

Intervention name(s): ezetimibe; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Blinded study medication (ezetimibe 10 mg in tablet form) will be taken orally once daily in the morning on rising. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period.; Blinded study medication (matched placebo) will be taken orally once daily in the morning on rising. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period.
Other intervention name(s): Zetia; Sugar Pill
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Hypercholesterolemia; Oxysterol; Ezetimibe; Zetia
Exploring Oxytocin Response to Meditative Movement
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This pilot study is designed to test effects of a single session of meditative movement (Tai
      Chi Easy) on older adults' blood pressure, perceptions of connection, mood, and oxytocin
      levels.
    

Detailed description: 
      Endogenous oxytocin (the "cuddle hormone") is associated with lowering blood pressure (BP),
      suggesting that finding ways to increase oxytocin even in the absence of social connection,
      may be beneficial. Meditative movement emphasizing breath, meditative state and flow-inducing
      movements holds potential for reducing BP, improving mood and releasing oxytocin. In a
      single-group pilot study we exposed 21 OAs with mild-moderate hypertension to a 50-minute
      "Tai Chi Easy (TCE)" (simplified Tai Chi/Qigong) session, collecting BP, saliva samples for
      oxytocin, and psychosocial measures (connection, mood) pre/post intervention.
    

Intervention name(s): Tai Chi Easy
Intervention type(s): Behavioral
Intervention description(s): A meditative movement practice that includes simple qigong movement/breath practices and single, repeated tai chi movements taught to generate a meditative state and flow
Other intervention name(s): Qigong/Tai Chi; taiji
Intervention model: Single Group Assignment
Intervention model description: Meditative movement practice: Tai Chi Easy
Masking: None (Open Label)
Primary purpose: Prevention
Catastrophizing and Virtual Reality's Impact on Pain in Patients With Fibromyalgia
Condition: Fibromyalgia; Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study evaluates the potential association between Virtual Reality, pain catastrophizing
      thoughts and pain measures in fibromyalgia.
    


Intervention name(s): Cold Pressor Test; Cold Pressor Test + Virtual Reality
Intervention type(s): Other; Other
Intervention description(s): The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.; The participant submerges one limb into a tank of cold (1-2 ° C), circulating water while interacting with a virtual reality environment
Intervention MeSH terms: Vasoconstrictor Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Half the participants will start with intervention 1 after which they will crossover to intervention 2. The other half will start start with intervention 2 before crossing over to intervention 1.
Masking: Single (Participant)
Primary purpose: Basic Science
Limiting Trunk Flexion as a Self-treatment for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of the proposed study is to test the effect of an intervention technique that
      reduces trunk flexion upon rising, on the outcome measures of self-reported back pain and
      functional impairment in individuals with chronic or recurrent non-specific low back pain
      (LBP). The intervention is a self-administered and requires no medical intervention or drugs.
      The technique referred to as the restrained sitting treatment (RST), involves training in
      minimizing forward bending of the trunk immediately upon rising. The technique builds upon a
      previous randomized controlled study conducted and published by members of the research team.
      The underlying premise of RST exploits the natural diurnal pattern as the intervertebral
      discs (people are tallest when they first wake up). The discs are fully hydrated upon rising,
      disc internal hydrostatic pressures and external forces acting on surrounding soft tissues
      are greatest at this time, and these pressures and forces can increase significantly with
      trunk flexion. The RST technique utilizes a back support used in sitting during the first
      hour upon rising to minimize trunk flexion during this critical period as the intervertebral
      discs begins the diurnal cycle of fluid loss. The study will test the null hypothesis that
      there are no significant difference in outcome (LBP, work or social function/disability)
      between groups performing RST, the experimental group performing RST upon rising, the control
      group performing prior to going to bed.
    


Intervention name(s): Restrained Sitting Treatment
Intervention type(s): Other
Intervention description(s): Training in avoidance of trunk flexion, with the use of a tall backrest with lumbar support to which the participant straps themselves. Participants are taught to strap into the backrest while while seated in a chair, and with hips and knees bent at right angles, for one hour at the appointed time of day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: self treatment technique; chronic; non specific; LBP; control trunk flexion; diurnal
Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and tolerability of the combination of
      epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in
      patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two
      addition second endpoints was added to the trial, one was to compare the consistence of two
      types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for
      predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This
      modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the
      approval number was IRB50-15-1101A.
    

Detailed description: 
      ECF regimen is considered as a reference regimen for gastric cancer in Europe. Now, no
      regimen has been proved to be more effective while less toxicity than ECF regimen.
      Oxaliplatin has demonstrated synergy with 5-FU in vitro, in vivo, and in the clinical setting
      in advanced colorectal cancer. It presents a better toxicity profile than cisplatin. Recently
      some studies used combination regimens of oxaliplatin, folinic acid, and continuous infusion
      5-FU for about 44 hours (e.g FOLFOX4 ) to treat A/MGC, and yielded good response rates and
      median overall survival times while resulting in lower rates of grade 3-4 adverse events.
      Therefore, it is logical to modify ECF regimen with oxaliplatin replacing cisplatin and a
      short-term FU infusion replacing 21-day FU infusion. Our objective is to evaluate whether the
      EOF5 regimen is less toxicity while is comparable effective as ECF regimen.
    

Intervention name(s): EOF5
Intervention type(s): Drug
Intervention description(s): epirubicin 50 mg/m2 day 1, oxaliplatin 130 mg/m2 day 1, and 5-FU 375-425 mg/m2/d day 1 through 5 continuous infusion, repeated every 3 weeks
Other intervention name(s): treatment group
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Time to Progression; Overall survival; Response rate; Quality of Live; Toxicities
Dose Finding Study in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the optimum dose of BEA 2180 BR
      inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in
      patients with COPD.
    


Intervention name(s): BEA 2180 BR; tiotropium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Is Perfusion Index an Indicator of Block Success in Ultrasound-guided Infraclavicular Brachial Plexus Block
Condition: Carpal Tunnel Syndrome; Perfusion Index
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries,
      provides additional advantages such as reduction in opioid consumption by providing analgesic
      effect in the postoperative period as welll. The success of peripheral nerve blocks is
      usually assessed by subjective feedback from the patient, and patient cooperation is needed.
      The aim of this study is to assess whether the perfusion index level, which can be measured
      noninvasively, can be a predictor of the infraclavicular block success.
    

Detailed description: 
      Thirty patients who were operated on for carpal tunnel syndrome under infraclavicular
      brachial plexus block were included in our study. After the procedure, at 10-minute
      intervals, the sensory block was assessed by a pinprick test, and the motor block was
      assessed by the ability to flex the hand and the forearm. In addition, PI and skin
      temperature were measured 0-10-20-30 minutes after the block and at postoperative 2, 4, and 6
      hours. 30 minutes after the measurements, the surgical procedure was allowed to begin in
      patients with successful block.
    

Intervention name(s): Infraclavicular nerve block; Without nerve block
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.; The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Infraclavicular block; Perfusion index; Ultrasonography; Block assessment
A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women
Condition: Breast Cancer; Cervical Cancer; Colorectal Cancer
MeSH terms: Breast Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Studying the barriers that prevent minority and low-income women from undergoing
      cancer screening, and offering encouragement to them over the telephone, may help improve
      cancer screening rates.

      PURPOSE: This randomized phase II trial is studying how well a telephone-based Prevention
      Care Manager increases screening rates for breast cancer, cervical cancer, and colorectal
      cancer in minority and low-income women.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether telephone support for patients, provided through a Prevention Care
           Manager (PCM), can increase breast, cervical, and colorectal cancer screening rates
           among minority and low-income women.

        -  Measure the amount of PCM time required to improve early cancer detection provided to
           age-eligible ethnically diverse women seen in community health centers in the New York
           City area.

        -  Learn barriers faced by this population in obtaining indicated services (mammograms, Pap
           tests, fecal occult blood testing, and sigmoidoscopy).

        -  Assess at baseline and follow-up the office environment and work processes in each
           participating center (in PCM randomized controlled study only).

        -  Develop and implement the PCM intervention to help patients overcome barriers.

        -  Evaluate the impact and costs of the PCM in a randomized controlled efficacy trial.

      OUTLINE: This is a randomized, controlled, single-blind, multicenter study. Patients are
      randomized according to participating center.

        -  Part 1: Some patients undergo a series of structured interviews about the obstacles to
           early cancer detection. Participating sites are assessed for study eligibility.

        -  Part 2: Pilot testing, training, and competency testing of the Prevention Care Managers
           (PCM) are conducted.

        -  Part 3: Patients are randomized to 1 of 2 intervention arms.

             -  Arm I: Patients are offered health education and follow-up services by telephone
                with a PCM.

             -  Arm II: Patients receive usual care.

      PROJECTED ACCRUAL: A total of 2,729 (1,413 for PCM randomized controlled study and 1,316 for
      pilot study) patients will be accrued for this study.
    

Intervention name(s): educational intervention; study of socioeconomic and demographic variables
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: breast cancer; cervical cancer; colon cancer; rectal cancer
Study of Medication Patch to Treat Children Ages 6-12 With ADHD
Condition: ADHD; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effectiveness of a medication skin patch
      called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a
      placebo patch. We want to find out how well it treats ADHD during the early morning hours
      before a child leaves for school or summertime routines.
    


Intervention name(s): Methylphenidate Transdermal System; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses); Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)
Other intervention name(s): Daytrana
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Hyperactivity Disorder; Daytrana; MTS Patch; Methylphenidate Transdermal System
Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program for Cervical Cancer
Condition: HPV Infection
MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections
Study type: Observational

Summary: 
      Cervical cancer is due to a persistent infection with a group of viruses known as high-risk
      Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a
      procedure called 'HPV testing', which can be used as a relevant screening test. A pilot
      screening program called START-HPV has been set up in the Ardennes, a French administrative
      area localized in the North of France, with HPV testing as a primary screening test.This
      observational study aimed to evaluate hrHPV genotypes repartition in the population who
      participate in the START-HPV screening program. This study will allow a better knowledge of
      hrHPV infection epidemiology in a screened population.
    


Intervention name(s): Human papillomavirus genotyping
Intervention type(s): Biological
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who participate in START-HPV pilot screening program and tested positive for
        high-risk HPV
      
Biospecimen description: 
      DNA extraction from cervical smears (DNAPap Cervical Sampler device, Qiagen) or from
      self-collected vaginal lavages (Delphi-screener device, DelphiBioscience) and HPV genotyping
      with the Multiplex HPV Genotyping kit© (Multimetrix, Progen) based on a Luminex technology.
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day
      delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission
      in patients with ulcerative colitis (UC)
    


Intervention name(s): LT-02; Placebo; Mesalamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily; LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily; LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the safety and tolerability of single, escalating oral doses
      and repeat oral doses (7 days, once daily) of GSK835726 in healthy male subjects
    

Detailed description: 
      A double-blind, placebo controlled, randomized cross-over single dose escalation study and a
      double-blind, placebo controlled, randomised parallel group 7-days once daily repeat dose
      study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of oral
      H1/H3 dual antagonist compound in healthy male subjects
    

Intervention name(s): GSK835726; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK835726 will be available in single dose and repeat dose formulations.; Placebo will be given to subjects.
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Allergic rhinitis; first time in human