bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate
Condition: Healthy
MeSH terms: Flushing
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate whether premedication with 325 mg
      microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the
      incidence and severity of flushing and GI events following oral administration of BG00012
      dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this
      study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240
      mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration
      dosing schedule in healthy volunteers.
    


Intervention name(s): BG00012 (dimethyl fumarate); BG00012 placebo; ASA; ASA placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each capsule contains 120 mg dimethyl fumarate (DMF). Fast titration involves taking one 120 mg capsule in the morning and one in the evening (240 mg daily) for one week, and then escalating to a dose of 480 mg daily (two capsules morning and evening) for the remainder of the study.Slow titration expands the dose escalation time to 4 weeks.; Placebo matching BG00012; 325 mg microcoated aspirin (ASA); Placebo matching aspirin
Other intervention name(s): BG-12; oral fumarate; DMF; acetylsalicylic acid; aspirin
Intervention MeSH terms: Aspirin; Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: BG00012; gastrointestinal events; flushing events; dose titration; pre-medication; aspirin
Virginia Commonwealth University Stress Reduction Study
Condition: Stress
Study type: Interventional

Summary: 
      This research study seeks to understand how stress reduction training influences neural
      responses (brain activation) and behavior related to stress, including emotions and reactions
      to social conflict.
    

Detailed description: 
      The full research project will be conducted over approximately 2-3 weeks, and will consist of
      two data collection sessions, one before and one after a 14-day stress reduction training
      course conducted via a smartphone that participants provide. This course entails
      instructor-facilitated stress reduction exercises previously shown to reduce stress and
      improve well-being. Participants will be randomly assigned to a mindfulness course or a
      cognitive reappraisal course. Both of these courses -mindfulness training (MT) and cognitive
      reappraisal training (RT) - involve expert-facilitated mental wellness techniques. MT
      emphasizes mindfulness-based techniques to reduce stress and promote wellbeing, whereas CT
      emphasizes reframing and reappraisal techniques to reduce stress and promote well-being.
    

Intervention name(s): mindfulness training; cognitive reappraisal training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.; Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Mindfulness
Interactions Between Drug Effects and Environments II
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine how associations between drugs and the places where
      they are experienced influence drug seeking, mood and acute drug responses.
    

Detailed description: 
      Learned associations between drug effects and the people, places, and paraphernalia (cues)
      linked with drug experiences are a major barrier to the treatment of drug addiction. These
      links are remarkably persistent and can cause relapse to drug taking even after long periods
      of abstinence. They are also key features in some of the foremost theories of addiction, yet
      there is little clinical evidence of how these associations are formed and how they come to
      profoundly control behavior. The long-term goal of this research is to understand how drug
      cues become powerfully linked with drug experiences and their influence on mood and behavior.
      In the proposed project, the investigators will use a de novo conditioning paradigm to
      examine the influence of drug contexts on drug seeking, mood and acute drug responses. The
      hypothesis is that drug-paired contexts gain motivational salience, induce approach, and
      alter acute subjective responses to the drug.This knowledge will lead to novel treatment
      strategies to counteract the effects of drug cues on mood and behavior, and also to prevent
      relapse.
    

Intervention name(s): Paired; Stimulant or sedative; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Drug conditioning is assessed by pairing drug administration with a given context.; CS+ for paired, CS0 for unpaired; CS- for paired, CS0 for unpaired
Other intervention name(s): Conditioned place preference
Intervention MeSH terms: Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: drug cues
Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      Buprenorphine is a medication used to treat opioid addiction, but individuals who use this
      drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the
      likelihood of buprenorphine addiction. This study will evaluate the potential for abuse of
      buprenorphine and a buprenorphine and naloxone combination in non-dependent opioid users.
    

Detailed description: 
      Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs
      often fail. Individuals with severe opioid withdrawal may experience shaking, muscle and bone
      pain, nausea, depression, anxiety, and drug craving. Buprenorphine, a medication that is used
      to treat opioid addiction, works by lessening the withdrawal symptoms. However, past research
      has shown that individuals who use buprenorphine are at risk for abusing the drug. Naloxone,
      another medication, is currently used to treat substance addiction. It is also used in
      combination with buprenorphine to reduce the risk of buprenorphine abuse in individuals who
      are physically dependent upon opioids. The purpose of this study is to compare the abuse
      potential of buprenorphine versus a buprenorphine and naloxone combination in non-dependent
      opioid users.

      This 7-week study will enroll non-dependent opioid users. Participants will take part in two
      medication challenge sessions per week. At each challenge session, participants will be
      randomly assigned to receive varying doses of either buprenorphine; a buprenorphine and
      naloxone combination; hydromorphone, which is a medication used to treat moderate to severe
      pain; or placebo. Buprenorphine and naloxone will be administered as tablets that are
      dissolved under the tongue. Hydromorphone will be injected. During the challenge sessions,
      participants will complete performance tasks to measure psychomotor and cognitive
      functioning. Questionnaires and self-reports will be completed to assess medication effects.
      Heart rate and blood pressure will be monitored throughout all sessions, and a specialized
      camera will be used to assess pupillary response of the eyes.
    

Intervention name(s): Buprenorphine; Buprenorphine and Naloxone; Hydromorphone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Buprenorphine; Hydromorphone; Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Opiate Addiction; Opiate Dependence
Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors
Condition: Neuroblastoma; Rhabdomyosarcoma; Ewing's Sarcoma; Ewing's Tumor; Sarcoma, Ewing's; Sarcomas, Epitheliod; Sarcoma, Soft Tissue; Sarcoma, Spindle Cell; Melanoma; Malignant Melanoma; Clinical Oncology; Oncology, Medical; Pediatrics, Osteosarcoma; Osteogenic Sarcoma; Osteosarcoma Tumor; Sarcoma, Osteogenic; Tumors; Cancer; Neoplasia; Neoplasm; Histiocytoma; Fibrosarcoma; Dermatofibrosarcoma
MeSH terms: Neoplasms; Melanoma; Sarcoma; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Fibrosarcoma; Histiocytoma; Dermatofibrosarcoma; Neuroectodermal Tumors, Primitive, Peripheral
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid
      tumors, and to see if it works to treat these solid tumors in children and young adults (in
      Phase 1 ≤ 18 years old and in Phase 2 ≤ 24 years old). After the final dose has been chosen,
      patients will be enrolled according to the specific solid tumor type, (neuroblastoma,
      rhabdomyosarcoma, or Ewing's sarcoma), to see how nab-paclitaxel works in treating these
      tumors.
    

Detailed description: 
      ABI-007-PST-001 is a Phase 1/2, multicenter, open-label, dose-finding study to assess the
      safety , tolerability, and preliminary efficacy of weekly nab-paclitaxel in pediatric
      patients with recurrent or refractory solid tumors (excluding brain tumors). The Phase 1
      portion of the study, with a dose escalation design, ended and the recommended Phase 2 dose
      (RP2D) was determined as 240 mg/m^2 intravenously (IV) in patients weighing > 10 kg and 11.5
      mg/kg in patients weighing ≤ 10 kg, on Days 1, 8 and 15 of a 28-day cycle. The Phase 2
      portion of the study will enroll additional patients at the RP2D into 1 of 3 solid tumor
      groups [neuroblastomas, rhabdomyosarcomas, Ewing's sarcomas]. Both phases of the study are
      open-label and conducted at multiple centers.

      The Phase 2 is using a Simon 2-stage design to monitor patient enrollment for each group
      separately. The rhabdomyosarcoma group, neuroblastoma or Ewing's sarcoma groups did not reach
      the expected number of 2 responders out of 14 efficacy eligible patients. Consequently, the
      groups were stopped.
    

Intervention name(s): nab-paclitaxel; nab-paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): nab-paclitaxel 120-270 mg/m2 IV on Days 1, 8 and 15 of a 28-day cycle; IV infusion
Other intervention name(s): Abraxane; Abraxane
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuroblastoma; Rhabdomyosarcoma; Soft Tissue; Pediatric Oncology; Abraxane; albumin-bound paclitaxel; nab-paclitaxel; ABI-007; taxane; solid tumors
Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Available evidences show a role of oral montelukast in acute asthma. Safety of oral
      montelukast is well established in children, as evidenced by use of oral montelukast in long
      term management of asthma.

      Therefore, the investigators planned this study to see the effect of oral montelukast as add
      on therapy to standard treatment in acute moderate to severe asthma in children between 5-15
      years of age.

      HYPOTHESIS:

      Addition of single dose of oral montelukast to standard therapy in acute moderate to severe
      asthma in children aged 5-15 years will reduce the modified pulmonary index score to less
      than 9 in 90% children compared to 70% in children receiving a placebo.
    

Detailed description: 
      Leukotrienes plays an important role as mediator for inflammatory changes in acute as well as
      chronic asthma. There are three randomized controlled trials involving 274 adult patients
      with acute asthma who were treated with montelukast (intravenous in 2 and intravenous and
      oral in one study) to see the beneficial response in spirometry. All the studies showed
      significant improvement in FEV1 in first 2 hours. These studies show that oral montelukast
      causes improved pulmonary function and has a rapid onset of action. However, these studies
      are carried out in adults. Safety of oral montelukast is well established in children, as
      evidenced by use of oral montelukast in long term management of asthma.

      Therefore, we planned this study to see the effect of oral montelukast as add on therapy to
      standard treatment in acute moderate to severe asthma in children between 5-15 years of age.
    

Intervention name(s): montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Standard case management will be carried out as per guidelines given by British Thoracic Society. All patients will receive montelukast or similar looking placebo tablets. The doses of montelukast will be as follows:
5-12 years: 5 mg chewable tablet of montelukast; > 12 years: 10 mg chewable tablet of montelukast. Study drug will be administered at time of administration of steroid.; The patients will receive placebo tablets.
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Montelukast; Acute Asthma
Intracranial Hypertension and Optic Nerve Sheath Diameter
Condition: Cerebral Stroke; Cerebral Venous Thrombosis
MeSH terms: Intracranial Hypertension; Stroke; Hypertension; Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      Intracranial hypertension (ICH) is a mortality risk factor in severe traumatic brain injury
      (TBI), in purulent meningitis, in hepatic encephalopathy and in Reye's syndrome. It is also a
      risk factor for severe neurologic sequelae in survivors. Intracranial pressure (ICP)
      monitoring is likely to guide therapeutics, and certain research on adults or on children,
      suggest that IH therapeutic approach, for instance for bacterial meningitis, would improve
      the prognosis. Two monitoring techniques are currently recommended. They are reference
      methods for ICP measure :

        -  monitoring with intraventricular catheter,

        -  intra-parenchymal monitoring using optical fiber catheter. Non invasive methods have
           been suggested, including ultrasound measurement of optic nerve sheath diameter (ONSD)
           which is the most interesting one. The ONSD measured ultrasonically is correlated with
           ICP level in adults with severe TBI. A diameter over 5,9 mm predicts ICH within the
           first 24 hours. In children, ONSD average values have been worked out, and an ONSD
           increase is found in children suffering from hydrocephalus with IH and in children with
           TBI. ICH precocious detection is fundamental in children sensitive to ICH because their
           cerebral development is not finished yet. Difficulties met for ICP monitoring
           implementation in infants and its invasive nature are often disliked by clinicians. A
           non-invasive exam is then essential to allow a better care of children with ICH in
           intensive care unit.
    


Intervention name(s): ONSD ultrasound
Intervention type(s): Other
Intervention description(s): Description of the ONSD ultrasound: ONSD is measured 3 mm behind the globe and perpendicularly to the optic nerve axis (2 dimensions mode).
For each optic nerve, 2 measures are performed: 1 sagittal and 1 transverse. The patient is positioned in 30° dorsal elevation. Gel is applied on the eyelid and a 7,5 MHz probe is used.
At the same time and on the same side, a transcranial Doppler is performed using a 2 MHz probe placed on the temple. Are measured: systolic velocity, mean velocity, diastolic velocity, resistance index and pulsatility index.
As ONSD measures cannot be done blinded (regarding ICP monitoring), a centralised evaluation (by 2 experts) of the recorded sonograms is planned.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: paediatrics; optic nerve sheath diameter; ultrasound
An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic
      Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill changes in
      Korean participants with Attention-Deficit Hyperactivity Disorder (ADHD).
    

Detailed description: 
      This is 12 week, open label (all people involved know the identity of the intervention),
      prospective (study following participants forward in time), single arm, multicenter study
      (when more than one hospital or medical school team work on a medical research study) of OROS
      methylphenidate HCl. The study will consist of 6 visits at Screening, Baseline, Week 1, 3, 6
      and 12. The participants already on other ADHD medications in addition to methylphenidate
      will be required to undergo a washout period (period when receiving no treatment) of at least
      1 week. The participants will be on once daily study medication starting at 18 milligram per
      day (mg/day) in participants with less than 30 kilogram (kg) of body weight or at 27 mg/day
      in participants with more than 30 kg. The dose will be increased by 9 mg or 18 mg every week
      for up to Week 6 based on the treatment efficacy and tolerability, followed by a maximum
      maintenance dose of 72 mg orally once daily up to Week 12, during which the dose can be
      decreased by 9 mg depending on tolerability. Efficacy will primarily be assessed using
      Clinical Global Impression of Severity of Illness (CGI-S) scale, Clinical Global Impression
      of Improvement of Illness (CGI-I) scale, Korean version of ADHD-IV Rating Scale (K-ARS) and
      Learning Skill Test (LST) score. Participants' safety will be monitored.
    

Intervention name(s): OROS Methylphenidate HCl
Intervention type(s): Drug
Intervention description(s): Osmotic Release Oral System (OROS) Methylphenidate HCl tablet will be given orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) of body weight and 27 mg for those more than or equal to 30 kg; the dose can be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg will be given orally once daily up to Week 12.
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate hydrochloride; Methylphenidate; CONCERTA
Physiological Response and Visual Attention to Visual Food Images in Healthy Subjects and in Functional Dyspepsia Patients
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      In functional dyspepsia (FD), abnormal cognitive and emotional changes such increased
      sensitization, anxiety, and depression scores have been reported in addition to the
      peripheral changes in gastrointestinal tract functions. In this study, investigators will
      evaluate the activity of autonomic nervous system, emotional response, and visual attention
      to food and non-food images in 30 male and female FD patients and 30 age/gender-matched
      healthy volunteers. These data will provide a new finding of the influence of impaired
      cognitive processing of food on symptom generation in functional gastrointestinal disorder
      patients.
    


Intervention name(s): visual images
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: skin conductance response; facial muscle activity; heart rate variability; eyetracking
Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment
Condition: Compare Two Nutrition Screening Tools
Study type: Observational

Summary: 
      Researchers are studying ways to predict if cancer patients are at risk for poor nutrition
      during their chemotherapy treatment. They hope to identify children with nutrition problems
      early in treatment. This may help prevent weight loss and other nutrition problems later in
      treatment.
    

Detailed description: 
      The PEDSGA is a newly developed nutrition tool that includes a training manual that be used
      to teach health care professionals to identify at-risk patients by doing a nutrition physical
      exam. The PEDSGA also includes questions that the patient/caregiver answers regarding
      appetite, recent treatment, and activity level. This method of screening is new and may be
      able to identify at-risk patients better than the standard method. This study will use both
      methods and evaluate the two, in hope of determining which method works best to identify
      at-risk patients.
    

Intervention name(s): Nutritional Screening Tools
Intervention type(s): Other
Intervention description(s): To compare the nutrition risk identification abilities of two nutrition screening tools: PEDSGA tool and the standard assessment tool.
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Participant is between 2 and 16 years of age and receiving treatment for a hematologic or
        solid malignancy at St. Jude Children's Research Hospital.
      
Keywords: All Malignancies