bioihbjkbjnl/mcl2 huggingface dataset:
Magnetoencephalography in Absence Seizures
Condition: Seizures
MeSH terms: Seizures; Epilepsy, Absence
Study type: Observational

Summary: 
      Background:

        -  An absence seizure is a type of seizure that usually begins in childhood and goes away
           by early adulthood. Scientists do not yet know where absence seizures begin in the
           brain. Some evidence suggests that these seizures begin in the thalamus, a structure
           deep in the brain, but other studies suggest that they begin in the frontal cortex, at
           the front part of the brain.

        -  Magnetoencephalography is a type of brain scanning procedure that is useful in
           determining information about what happens to the brain during epileptic seizures.
           Understanding where absence seizures come from may help doctors find new treatments for
           them.

      Objectives:

        -  To gain a better understanding of which parts of the brain are affected in absence
           seizures.

      Eligibility:

        -  Patients 7 to 35 years of age who have been diagnosed with absence seizures.

      Design:

        -  Procedures are for research purposes only, not to diagnose or treat a particular medical
           condition.

        -  Two outpatient visits to the National Institutes of Health Clinical Center: evaluation
           and scanning.

        -  Researchers will evaluate potential participants with a medical history, physical
           examination, and electroencephalography (EEG). These tests will be performed under
           another protocol, 01-N-0139.

        -  Patients will undergo magnetoencephalography (MEG) and magnetic resonance imaging (MRI)
           of the brain. The study procedures will be performed one time; however, an MEG or MRI
           scan may need to be repeated for technical reasons. Researchers will not do more than
           two MEG or MRI scans.

        -  The MEG will record very small magnetic field changes produced by the activity of the
           brain. An EEG will be recorded at the same time as the MEG.

        -  The MRI will use a magnetic field to take pictures of the inside of the brain.

        -  The MEG will take 3 hours to complete (2 hours for preparation, 1 hour in the scanner).
           The MRI will take approximately 1 hour.
    

Detailed description: 
      Objective:

      This protocol will test the hypothesis that the 3-Hz spike-wave discharges seen in absence
      epilepsy originate in the thalamus. We will use an emerging modality, magnetoencephalograpy
      (MEG), to test this hypothesis.

      Study Population:

      33 patients with absence seizures.

      Design:

      This is a non-invasive imaging study that involves a 275-channel whole head MEG recording and
      a structural MRI for co-registration of MEG data.

      Outcome Measure:

      The primary outcome measure is the source localization of spike-wave discharges on
      magnetoencephalography.
    

Time perspective: Prospective
Keywords: Epilepsy; MEG; Seizures
Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021)
Condition: Diabetic Neuropathy, Painful
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the
      treatment of painful diabetic neuropathy (PDN) in adults.
    


Intervention name(s): MK-6096; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.; Matching compressed tablets, taken once daily at bedtime for 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Olanzapine vs. Comparator and Placebo in the Treatment of Patients With Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The goals of this study are:

      A. To determine whether olanzapine can help patients with bipolar disorder who currently have
      mild to moderate mania.

      B. To assess the safety of olanzapine and any side effects that might be associated with it,
      as well as the quality of life and functioning of patients treated with olanzapine.

      C. To assess how olanzapine compares to divalproex.
    


Intervention name(s): olanzapine; divalproex sodium; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Valproic Acid; Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia
Condition: Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
MeSH terms: Anemia; Thalassemia; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      In this feasibility trial, the investigators will compare participants treated with
      montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8
      weeks.
    

Detailed description: 
      The primary hypothesis for this trial is that montelukast adds efficacy to hydroxyurea
      therapy for improving vaso-occlusion when compared to hydroxyurea alone. The following
      specific aims will be tested in adolescents and adults with sickle cell disease (SCD):

      Aim 1. To determine whether montelukast versus placebo added to hydroxyurea will improve
      markers of vaso-occlusion-associated tissue injury in adolescents and adults with sickle cell
      disease.

      Aim 2. To evaluate physiologic effects of montelukast versus placebo added to hydroxyurea in
      adolescents and adults with sickle cell disease.

      Subaim 2A. To determine if montelukast versus placebo added to hydroxyurea will improve lung
      function in adolescents and adults with sickle cell disease.

      Subaim 2B. To determine if montelukast versus placebo added to hydroxyurea will improve
      forearm microvascular blood flow in adolescents and adults with sickle cell disease,
      respectively.

      Funding Source - FDA OOPD
    

Intervention name(s): Montelukast added to Hydroxyurea; Placebo added to Hydroxyurea
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydroxyurea; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study
      to investigate the diagnostic performance and evaluation efficacy of 99mTc-ABH2 in breast
      cancer patients. A single dose of 370±54 Mega-Becquerel (MBq)99mTc-ABH2 will be injected
      intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.
    

Detailed description: 
      99mTc-ABH2 is an affibody probe targeting HER2. The investigators will determine the use of
      99mTc-ABH2 SPECT/CT in the detection of HER2-positive breast cancer, and to compare its
      diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging,
      specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help
      for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may
      improve the treatment strategy of breast cancer. The investigator will determine the use of
      99mTc-ABH2 SPECT/CT in stratifying breast cancer.
    

Intervention name(s): 99mTc-ABH2
Intervention type(s): Biological
Intervention description(s): 99mTc-ABH2 were injected into the patients before the SPECT/CT scans
Other intervention name(s): 99mTc labelled HER2 affibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: SPECT/CT; HER2 imaging
Drug-drug Interaction Study With TS-142 in Healthy Adult Subjects (Concomitant Administration of Itraconazole)
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-center, single-sequence study to evaluate the concomitant
      effects of the potent CYP3A inhibitor itraconazole on the single-dose pharmakokinetics,
      safety and tolerability of oral TS-142 in healthy subjects.
    


Intervention name(s): TS-142; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): TS-142 will be given as 1 mg per capsule administered orally with water.; Itraconazole will given as 50 mg per capsule administered orally with water.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacodynamic Study of a Personalized Strategy for P2Y12 Inhibition Versus Ticagrelor in Reducing Ischemic and Bleeding Risk
Condition: Acute Coronary Syndrome; Percutaneous Coronary Intervention
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In patients with heart attacks, the treatment of choice is to restore blood flow with
      percutaneous coronary intervention (PCI) (use of stents (metal meshes) to open blockages).
      After PCI, the standard drug treatment includes aspirin and clopidogrel. These medications
      block full function of the platelet cells, which are responsible for clotting. Despite their
      use, patients after PCI are at risk for heart attacks, sudden clotting of stents or death. A
      major contributor may be resistance to clopidogrel. New more potent drugs, which can overcome
      the resistance, are now available; however, they come with an increase chance of severe
      bleeding and costs. An ideal solution would be to identify at-risk patients and selectively
      treat them with more potent drugs, while lower-risk patients continue with clopidogrel. This
      type of strategy (personalized strategy) would decrease heart attacks and death (compared to
      clopidogrel), while also preventing bleeding complications (compared to treating all patients
      with the new drugs).

      Of resistant patients, many carry genes (inherited units) that prevent proper absorption of
      clopidogrel. Our group has developed and tested a new bedside genetic test, which identifies
      carriers of at-risk genes. However, this technique alone does not identify all at-risk
      patients. Consequently, we have now devised a novel tool, which combines genetics with
      patient characteristics to identify high-risk patients.

      The present study combines this new tool into a strategy for personalized treatment. Patients
      with heart attacks who undergo PCI will be randomly assigned to 1 of 3 strategies: a) new
      personalized strategy, b) clopidogrel strategy (previous standard drug) or c) ticagrelor
      strategy (stronger approved drug). The function of the platelet cells will be measured at 1
      month to determine potential benefits. Evaluation of this new personalized strategy is
      important for improving patient outcomes after PCI. The hypothesis is that patients receiving
      a personalized strategy will have decrease risk for future heart attacks and bleeding.
    


Intervention name(s): Ticagrelor, Prasugrel, Clopidogrel
Intervention type(s): Drug
Intervention MeSH terms: Clopidogrel; Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Preventing Smoking Relapse After Total Joint Replacement Surgery
Condition: Smoking; Smoking Cessation
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      Hospitalization for elective knee or hip replacement surgery presents an outstanding
      opportunity to motivate people to quit smoking, because it provides an opportunity to
      encourage patients to remain smoke-free as they proactively quit to optimize their surgery
      outcomes. This study will conduct a comparative effectiveness trial of patients who quit
      smoking pre-operatively, comparing the current standard of care with a novel comprehensive
      relapse prevention intervention guided by Marlatt's Relapse Prevention Model.
    

Detailed description: 
      The specific aims of this study are to evaluate the effectiveness and cost-effectiveness of
      the relapse prevention intervention and will: 1) compare the effectiveness of standard
      post-operative cessation treatment with a comprehensive relapse prevention intervention on
      smoking cessation outcomes; 2) conduct a comparative economic analysis to assess the value of
      the relapse prevention intervention for patients and the healthcare system; and 3) explore
      the impact of the interventions on surgical complications and readmissions.
    

Intervention name(s): Comprehensive Relapse Prevention Intervention; Standard Treatment Counseling; Nicotine Replacement Therapy (NRT)
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): This intervention consists of 4 components:
Visit Prior to Discharge: counselor from research team will visit patient at hospital bedside to provide counseling
Follow up calls after discharge: 6 proactive counseling calls and initiate unlimited reactive calls to their counselor, at days 1,3,7,14,30,an 60 days after hospital visit
Text messaging support: patients will be registered in NCI's Smokefree TXT while in the hospital and will receive multiple daily messages, designed for someone who has already quit
Caregiver support: 10 minute training session to the caregiver on how to help patient prevent relapse by increasing self efficacy, maintaining motivation and dealing with high risk situations; Participants will receive two 10 minute counseling calls from the staff of the preoperative counseling program during the first month after the hospital discharge; Patients in both arms will be encouraged to receive NRT
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Exercise on Blood Coagulation in Persons With Chronic Spinal Cord Injury
Condition: Cardiovascular Disease; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Cardiovascular Diseases; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine if exercise affects the clotting of blood
      (hemostasis). The effect of exercise on hemostasis will be determined in persons with spinal
      cord injury, a population reported to have an increased prevalence of cardiovascular disease
      (CVD). It is expected that this study will increase our understanding of CVD in persons with
      SCI, and it will eventually help reduce the occurrence of premature heart disease.
    

Detailed description: 
      Regular moderate intensity physical exercise decreases platelet aggregability as a
      consequence of increasing levels of tissue plasminogen activator (tPA) and reducing levels of
      plasminogen activator inhibitor-1 (PAI-1). In addition, the exercise-associated improvement
      in the lipid profile and reduction in fat mass may decrease platelet aggregability and blood
      coagulation, as well as increase fibrinolysis. Thus, it can be hypothesized that physical
      exercise training has a powerful beneficial impact on blood coagulation and fibrinolysis.
      Although, regular exercise has been shown to reduce the incidence of CVD and death or causes
      a regression of symptoms in able-bodied individuals, this salutary effect of prolonged
      (months) exercise in persons with SCI has not been documented. The present study will
      evaluate the effects on hemostasis of exercise training in persons with chronic SCI. The
      effect of exercise on hemostasis will be determined in persons with SCI, a population
      appreciated to have an increased prevalence of cardiovascular disease (CVD). It is
      anticipated that this study will ultimately increase our understanding of CVD in this group,
      and it will eventually help reduce the occurrence of premature macrovascular disease.
    

Intervention name(s): ERGYS BikeFunctional Electrical Stimulation Ergometry
Intervention type(s): Device
Intervention description(s): A
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular Disease; Exercise; Functional electrical stimulation; hemostasis; Spinal cord injury
Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Condition: Hypertension, Pulmonary; Heart Failure With Normal Ejection Fraction
MeSH terms: Hypertension, Pulmonary; Hypertension; Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to

      • Assess the pharmacodynamic profile of riociguat in subjects with symptomatic pulmonary
      hypertension and heart failure with preserved ejection fraction

      The secondary objectives of this study are to

        -  Assess safety and tolerability of riociguat in this study population

        -  Assess changes in dimensions of left and right ventricles and cardiac function
           parameters using cardiac magnetic resonance imaging
    


Intervention name(s): Riociguat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Adempas up-titrated to max. 1.5mg TID; Placebo sham-titrated TID
Other intervention name(s): Adempas
Intervention MeSH terms: Riociguat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PH-HFpEF
A Study to Evaluate the Effect of Food on the Oral Bioavailability of Relacorilant in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effects of a high-fat meal and of a
      low-fat meal on the bioavailability of relacorilant in healthy subjects.
    

Detailed description: 
      Enrolled healthy male and female subjects will be randomized to receive 1 of 6 treatment
      sequences, each consisting of 3 treatments in 3 periods, in a crossover design. The 3
      treatments will be a single oral dose of relacorilant 400 mg 1) under fasted conditions, 2)
      after a high-fat meal, and 3) after a low-fat meal. Each period will last 5 days, and a 7-day
      washout will follow Periods 1 and 2. Blood samples will be collected predose and at serial
      timepoints up to 4 days (Day 5) after dosing in each period for evaluation of the
      bioavailability of relacorilant. Secondary objectives of the study will be evaluation of the
      bioavailability of relacorilant metabolites, and evaluation of safety and tolerability of
      relacorilant when administered to healthy subjects under fasted and fed conditions.
    

Intervention name(s): Relacorilant under fasted conditions; Relacorilant after a high-fat meal; Relacorilant after a low-fat meal
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 under fasted conditions; Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a high-fat meal; Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a low-fat meal
Other intervention name(s): CORT125134; CORT125134; CORT125134
Intervention MeSH terms: Cortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Fibrosis
Study type: Interventional

Summary: 
      Liver transplantation has been universally recognized to improve survival of patients
      suffering from end-stage (Pugh C) alcoholic cirrhosis. However, for Pugh B patients, the
      benefit of liver transplantation remains to be demonstrated. The aim of the present study was
      to compare the outcome of Pugh B patients with alcoholic cirrhosis randomly assigned for
      immediate liver transplantation (group 1) or standard treatments (group 2).
    

Detailed description: 
      120 patients (60 per group) were included. The therapeutic strategy defined by randomization
      was achieved in 68% of group 1 patients and 75% of group 2 patients (NS). All-causes death
      and cirrhosis-related death were not different in group 1 and group 2 patients: the five-year
      survival rate was 58% in group 1 and 69% in group 2 patients (NS). Through multivariate
      analysis, the independent predictors of long-term survival were absence of ongoing alcohol
      consumption (p<0.001), recovery from Pugh C (p=0.046), and baseline Pugh score<8 (p=0.029).
      Liver transplantation was associated with a higher rate of de novo malignancies (30.4% vs.
      7.8%, OR=5.1, p=0.001).
    

Intervention name(s): liver transplantation; standard care for liver disease
Intervention type(s): Procedure; Other
Intervention description(s): liver transplantation; standard care for liver disease included therapy for ascitis (spironolactone, furosemide), portal hypertension (oesophageal varices ; propranolol), encephalopathy (lactulose), and bacterial infections whatever their localization (prophylaxis of spontaneous peritonitis with norfloxacin). All medical or instrumental procedures were allowed. Patients undergoing iterative paracentesis, variceal band ligation or sclerotherapy, peritoneojugular shunt (LeVeen), transjugular intrahepatic portosystemic shunt (TIPS) or surgical portocaval anastomosis were considered as receiving "standard medical therapy".
Intervention MeSH terms: Liver Extracts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cirrhosis transplantation