bioihbjkbjnl/mcl2 huggingface dataset:
Interaction Between Reboxetine and 3,4-Methylenedioxymethamphetamine: Pharmacodynamics (PD) and Pharmacokinetics (PK)
Condition: Mood Disorder; Substance-related Disorders; Amphetamine-related Disorders
MeSH terms: Substance-Related Disorders; Amphetamine-Related Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      MDMA releases dopamine, serotonin, and norepinephrine in the brain. Serotonin uptake
      inhibitors have been shown to interact with 3,4-Methylenedioxymethamphetamine (MDMA) and to
      decrease its psychoactive and cardiovascular stimulant effects. This finding indicates that
      MDMA acts in part by releasing serotonin through the serotonin uptake site. However, in vitro
      studies show that MDMA binds more potently to the norepinephrine uptake site that to the the
      serotonin or dopamine uptake transporter. In addition, norepinephrine uptake site blockers
      such antidepressant drugs attenuate some of the behavioral effects of MDMA in animals. These
      preclinical data indicate that norepinephrine may also contribute to the response to MDMA in
      humans. To test this hypothesis this study evaluates the interacting effects of the selective
      norepinephrine transporter inhibitor reboxetine on the subjective and cardiovascular
      stimulant effects of MDMA in healthy volunteers.
    

Detailed description: 
      The study will use a randomized double-blind cross-over design with four experimental
      sessions. Reboxetine (8 mg) or placebo will be administered the night before the experimental
      session and 1 h before the administration of MDMA (125 mg) or placebo to 16 healthy
      volunteers. Subjective and cardiovascular responses and plasma samples for pharmacokinetics
      will be repeatedly assessed throughout the experiments.

      We hypothesize that the highly selective norepinephrine uptake inhibitor reboxetine will
      attenuate subjective and especially heart rate and blood pressure responses to MDMA. Such a
      result would indicate that norepinephrine is critically involved in the pharmacology of MDMA
      and may provide helpful in the use and development of treatments for Ecstasy intoxications.
    

Intervention name(s): MDMA; Reboxetine, 8 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg, single dose; two doses 12h and 2h before MDMA; capsules identical to MDMA or Reboxetine
Intervention MeSH terms: Reboxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: MDMA; norepinephrine; Ecstasy; stimulant
Disulfiram for Cocaine-Alcohol Abuse - 3
Condition: Alcohol-Related Disorders; Cocaine-Related Disorders
MeSH terms: Alcoholism; Cocaine-Related Disorders; Alcohol-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate disulfiram for cocaine-alcohol abuse.
    


Intervention name(s): Disulfiram
Intervention type(s): Drug
Intervention MeSH terms: Disulfiram
Primary purpose: Treatment
Keywords: Cocaine-Related Disorders
A Study of Famitinib Malate in HER2-negative Metastatic Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this clinical research study is to discover if the study drug Famitinib
      Malate can shrink or slow the growth of pretreated HER2-negative metastatic breast cancer.
    

Detailed description: 
      Famitinib Malate is a tyrosine kinase inhibitor mainly targeting vascular endothelial growth
      factor receptor 2(VEGFR2), and its anti-angiogenesis effect has been viewed in preclinical
      tests. The investigators' phase I study has shown that the drug's toxicity is manageable and
      the recommended phase II dose is 25 mg. The hypothesis of this clinical research study is to
      discover if the study drug Famitinib Malate can shrink or slow the growth of pretreated
      HER2-negative breast cancer. The safety of Famitinib Malate will also be studied. Patients
      physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained
      while on-study will help the research team decide if Famitinib Malate is safe and effective
      in pretreated HER2-negative metastatic breast cancer patients.
    

Intervention name(s): Famitinib Malate
Intervention type(s): Drug
Intervention description(s): The starting dose of Famitinib Malate will be 25 mg/d. Two dose reductions will be allowed to 20 and then 15 mg/d.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Famitinib Malate; Metastatic Breast Cancer; HER-2 negative
Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure
Condition: Sleep Apnea Syndrome; Coronary Artery Disease
MeSH terms: Apnea; Sleep Apnea Syndromes; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Syndrome
Study type: Interventional

Summary: 
      Published data indicate that obstructive sleep apnea syndrome (OSAS) worse the prognosis of
      coronary artery disease (CAD) and that oxidative stress can link this 2 diseases.

      Investigators hypothesise that oxidative stress decrease after 3 months of continuous
      positive airway pressure (CPAP) in this specific population.

      The results may have major implication in the comprehension of physiopathologic processes
      linking OSAS and CAD and in the treatment of OSAS in this specific population.
    

Detailed description: 
      Obstructive sleep apnea syndrome (OSAS) is a common disorder characterized by recurrent upper
      airway collapse during sleep and has been associated with worsened prognosis in patients with
      coronary artery disease (CAD). Moderate OSAS can be defined by an apnea hypopnea index (AHI)
      between 15 and 30 events/hour.

      Pathophysiologic processes are complex and it seems that oxidative stress play and important
      role. Studies showed that continuous positive airway pressure (CPAP) influence oxidative
      stress but the results are conflicting.

      Moreover there are uncertainties whether diagnosing and treating OSAS can inﬂuence the
      pathophysiological and clinical outcomes in patients with CAD.

      Therefore, we aim to test the effects of 3 months of CPAP on systemic redox balance evaluated
      by plasma GSH/GSSG ratio.

      Patients with moderate OSAS will be randomized for the intervention.

      Patients with AHI <15/h or >30/h will be included in an ancillary study (blood and urinary
      test, MIBG scintigraphy) to characterize the biological profile of coronary patients based on
      their AHI.

      For a alpha threshold of 5% and a study power of 80%, the study should include 16 patients in
      each group. Taking in account a possible 20% of dropout the study will need to include 20
      patients by randomized arm to demonstrate an effect.
    

Intervention name(s): Continuous positive airway pressure; Sham-continuous positive airway pressure
Intervention type(s): Device; Device
Intervention description(s): Continuous positive airway pressure treatment during three months with adherence recording; Sham-continuous positive airway pressure during three months with adherence recording
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Apnea syndrome; Coronary artery disease; Oxidative stress; Continuous positive airway pressure; Endothelial dysfunction
Incidence and Predictive Factor of Irritable Bowel Syndrome After Acute Diverticulitis in Korea
Condition: Diverticulitis and Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Diverticulitis; Syndrome
Study type: Observational

Summary: 
      The pathogenesis of irritable bowel syndrome (IBS) is considered immune reaction of
      gastrointestinal tract. Therefore there is growing evidence that IBS could occur after
      gastroenteritis. However, little is known about the incidence of IBS after acute
      diverticulitis. We thought that post diverticulitis status could induce IBS because
      diverticulitis was also bowel inflammatory disorder. This survey was designed to identify
      incidence of post-diverticulitis IBS and risk factor in Korea.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had admitted Severance hospital, Seoul, South Korea.
Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study are to evaluate the synergistic effect of a combination
      product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing
      symptoms of depression in patients with Major Depressive Disorder.

      The safety and tolerability of the combination product will also be evaluated as measured by
      adverse events and vital signs.
    

Detailed description: 
      Approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will
      be randomized in the study.
    

Intervention name(s): BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD; BCI-024 (Buspirone); Matching placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BCI-024: over-encapsulated Buspirone tablet 15 mg QD and Drug BCI-049: over-encapsulated Melatonin tablet 3 mg QD taken in combination for 6 weeks; Drug BCI-024 (Buspirone) taken once a day at bedtime for 6 weeks.; Placebo comparator once a day at bedtime for 6 weeks.
Other intervention name(s): Buspar is the brand name of buspirone.; Buspar is the brand name of buspirone.
Intervention MeSH terms: Melatonin; Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression
Self Help Intervention to Decrease Stress
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The present study is designed to test the feasibility and efficacy of a stand alone self help
      program for decreasing stress and anxiety and enhancing quality of life. The intervention
      will be offered in the form of a self help book and three handouts with no in-person
      instructor time.
    

Detailed description: 
      Stress is a ubiquitous problem and a mediator of symptoms for a variety of medical
      conditions. Most medical diagnoses, procedures, and physician visits are associated with
      considerable stress. Excessive stress is associated with adverse medical outcomes, unhealthy
      coping mechanisms, symptoms of anxiety and depression, and overall a poor quality of life. No
      specific pharmacologic treatment is available for treating stress. Further, it is often
      difficult or sometimes impossible to change the reality of circumstances causing stress in an
      individual. Thus increasing individual coping mechanisms and ability of a person to handle
      stress, rather than changing the stressors itself might be a more feasible approach towards
      reducing stress.

      Several interventions are available to decrease stress. Majority of these programs entail
      extensive in-person training which impacts on widespread dissemination of the program. We are
      interested in applying an innovative approach toward stress management by testing the
      efficacy of a stand alone self help program offered in the form of a book with no in-person
      instructor time. Participants will receive a copy of the book, "Train Your Brain Engage Your
      Heart Transform Your Life" along with three handouts summarizing the contents of the book.
      This book describes the program of Attention and Interpretation therapy that is designed to
      help decrease stress and anxiety and has been developed at Mayo Clinic Rochester.
    

Intervention name(s): Attention and Interpretation Therapy
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a copy of the book, "Train Your Brain Engage Your Heart Transform Your Life" along with three handouts summarizing the contents of the book.
Other intervention name(s): AIT; Stress Management Program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress; Anxiety; Resilience; Mindfulness; Quality of Life; Stress Management
Effects of Intensity of Early Communication Intervention
Condition: Communication Disorders; Developmental Disabilities
MeSH terms: Communication Disorders; Developmental Disabilities
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine if a more intensive application of communication
      intervention, i.e. 5 hours per week, will result in more frequent intentional communication
      acts, greater lexical density, and a better verbal comprehension level than children who
      receive the same communication intervention only one time per week.
    

Detailed description: 
      Our research team has pioneered the development of a prelinguistic communication intervention
      referred to as Parent Responsivity Education-Milieu Communication Teaching (PRE-MCT). This
      intervention is designed to establish and enhance the development of intentional
      communication prior to the onset of spoken language in children with language delays and
      disorders. In the early stages of intervention, clinicians target children's use of gestures,
      vocalizations, and eye contact to produce more frequent and more complex nonverbal
      communication acts. As the children develop, goals shift to the direct teaching of words and
      sentence structures.

      Our preliminary research using randomized experimental designs has tested the effects of the
      intervention when delivered in a very small 'dose', averaging just over one hour per week for
      six months. This standard dose has led to significant but modest effects in the children's
      use of intentional communication and early language, such that it could be adopted by
      speech-language pathologists as part of standard care. Unfortunately, the early benefits have
      not always been maintained 6 and 12 months after the therapy phase ends and have not always
      benefitted all children.

      This research is a test of the hypothesis that a more intensive application of the
      intervention will have dramatically more positive outcomes than the standard dosage.
    

Intervention name(s): Milieu Communication Teaching
Intervention type(s): Behavioral
Intervention description(s): Communication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week
Other intervention name(s): Parent Responsivity Education-Milieu Communication Teaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)
Condition: PCDH19-Related Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone
      therapy compared to placebo for the treatment of seizures in female children and young adults
      with genetically confirmed PCDH19 gene mutation.
    

Detailed description: 
      The Violet Study is a global, double-blind, placebo-controlled, Phase 2 clinical trial that
      plans to enroll approximately 25 female patients between the ages of 1 and 17 with a
      confirmed disease-related PCDH19 gene variant. Patients will undergo a baseline period before
      being randomized to receive, in addition to their existing anti-seizure treatment, either
      ganaxolone or placebo for 17 weeks. Following the treatment period, all patients that meet
      certain eligibility requirements will have the opportunity to receive ganaxolone in the open
      label phase of the study. The study's primary efficacy endpoint is percent reduction in
      seizures. Secondary outcome measures will include non-seizure-related endpoints to capture
      certain behavioral and sleep disturbances that have been seen in previous clinical studies
      with ganaxolone.
    

Intervention name(s): Ganaxolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): active drug; inactive
Other intervention name(s): Placebo (for ganaxolone)
Intervention MeSH terms: Pregnanolone; Ganaxolone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The double-blind phase will randomize subjects to adjunctive ganaxolone or placebo at a 1:1 ratio to standard of care.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: refractory seizures; epilepsy in children; seizure disorder
Impact of Dexamethasone Added to Intra-articular Morphine and Bupivacaine for Post-operative Analgesia After Knee Arthroscopy
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized double-blinded clinical trial was carried out on 40 patients undergoing knee
      arthroscopy. Patients were divided randomly into two equal groups. All drugs used were
      injected intra-articularly at the end of arthroscopy. In the control group, patients were
      administered 10mg morphine added to bupivacaine 25mg. In the study group, patients were
      administered 10mg morphine and 8mg dexamethasone added to bupivacaine 25mg. Visual analog
      score for pain at rest and movement, time to first analgesic request, total analgesic
      consumption, duration of analgesia and adverse effects were recorded.
    


Intervention name(s): group M; group MD
Intervention type(s): Drug; Drug
Intervention description(s): 10mg morphine in 5ml normal saline + 10ml of 0.25% bupivacaine ( total volume 15 ml) were injected intra-articularly; 10mg morphine + 8mg dexamethasone completed to 5 ml with normal saline + 10 ml of 0.25% bupivacaine (total volume of 15ml) were injected intra-articularly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexamethasone; Bupivacaine; Morphine
Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects
Condition: Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, investigator blind, subject blind, sponsor-open, placebo
      controlled, multiple dose escalating, sequential, parallel cohort study of PF-04287881.
      Subjects will undergo screening procedures within 28 days prior to dosing. At least 1 day
      after the Screening visit, eligible subjects who meet the entry criteria will be admitted to
      the Clinical Research Unit (CRU) and confined in the unit until discharge on Day 15.

      Approximately 60 healthy volunteers (20 volunteers of Japanese origin for Cohorts 5 and 6),
      18 to 55 years of age, males and females (women of non childbearing potential only) will be
      enrolled and randomized in a 4:1 ratio to treatment with either PF-04287881 or placebo within
      each cohort. Each cohort will have a 10 day dosing period and each will consist of 10
      subjects (8 active and 2 placebo). In each cohort, each subject will receive a single daily
      oral dose of either placebo or PF-04287881 under fasted state for 10 days.
    

Detailed description: 
      Following a Serious Adverse Event (potential Hy's Law case), a risk-benefit assessment review
      of all preliminary safety data, and a review by Pfizer's internal hepatic injury advisory
      panel, it was concluded that PF-04287881 had an unacceptable therapeutic window. The FDA was
      notified of our intention to discontinue development as of 09April2010.
    

Intervention name(s): PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 500 mg once daily for 10 days; To match 500 mg dose once daily for 10 days; 750 mg once daily for 10 days; To match 750 mg dose once daily for 10 days; 1100 mg once daily for 10 days; To match 1100 mg dose once daily for 10 days; Optional cohort with dose not greater than 1100 mg; Optional cohort to match dose not greater than 1100 mg; 750 mg dose once daily for 10 days; To match 750 mg dose once daily for 10 days; 1100 mg dose once daily for 10 days; To match 1100 mg dose once daily for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: safety; tolerability; pharmacokinetics; multiple-dose; macrolide