bioihbjkbjnl/mcl2 huggingface dataset:
Magnetic Stimulation of the Brain in Schizophrenia or Depression
Condition: Schizophrenia; Depression; Anhedonia; Avolition
MeSH terms: Anhedonia; Depression; Depressive Disorder; Schizophrenia
Study type: Interventional

Summary: 
      The primary objective is to evaluate if repetitive transcranial magnetic stimulation (rTMS)
      with theta burst frequency over dorsomedial prefrontal cortex (DMPFC) is an effective
      treatment for negative symptoms (anhedonia and avolition) in schizophrenia or depression.
      Other objectives are to increase the understanding of the underlying neurobiology of negative
      symptoms and the mechanisms for the treatment effect of rTMS.
    

Detailed description: 
      This is a double blind parallel randomized sham controlled trial. The intervention is
      intermittent theta-burst stimulation (iTBS), which is rTMS with theta burst frequency with
      2400 pulses/day in two sessions at 90% of resting motor threshold intensity over the DMPFC,
      given in ten days on week days (10 treatment days must be completed within a maximum of 21
      days). Stratified (depression and schizophrenia diagnosis) block randomization will be used
      for treatment allocation to active or sham side of the stimulation coil.

      Patients will be referred from their regular psychiatric care facilities. At the screening
      visit the patient will be assessed if fulfilling all inclusion and none of the exclusion
      criteria. At the baseline visit thorough psychiatric, cognitive and neurophysiological
      examination will be performed. The latter include investigation of cortical excitability with
      paired-pulse TMS, mismatch negativity (MMN, a measure of aberrant stimulus detection),
      startle-response, habituation, electrodermal activity (EDA), near-infrared spectroscopy
      (NIRS), 24 hour actigraphy and heart rate registration.

      During 10 week days the participants will receive a daily rTMS (or sham) treatment. On the
      day after last rTMS treatment the examinations performed at the baseline visit will be
      repeated. Four weeks after baseline there is a shorter visit to follow-up symptoms and
      functioning. At the end of this visit the blinding is unmasked and patients who have received
      sham rTMS will be offered active treatment in an open-phase. After the four weeks follow-up
      there are two additional and identical visits at 10 and 26 weeks after start of treatment.
    

Intervention name(s): dmPFC iTBS; dmPFC Sham iTBS
Intervention type(s): Device; Device
Intervention description(s): 2400 pulses/day over 10 week days over bilateral dmPFC using MagPro X100 and the cool D-B80 A/P coil; Sham iTBS
Other intervention name(s): rTMS with intermittent theta-burst frequency
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS; negative symptoms; intermittent theta burst; iTBS; repetitive transcranial magnetic stimulation; dorsomedial prefrontal cortex; dmPFC; NIRS
Observational Study of Cortical Spreading Depression in Human Brain Trauma
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Depression
Study type: Observational

Summary: 
      Since the primary damage from traumatic brain injury (TBI) is irreversible, the focus of
      medical management of TBI is preventing secondary injury that can be life-threatening and
      worsen patient outcome. Insight into the pathologic mechanisms of secondary injury, which are
      largely unknown, is required for developing better treatments.

      In preliminary studies, the investigators have found that a pathologic brain activity, known
      as spreading depression, recurs in a large number of TBI patients in the first week after
      injury. Spreading depressions are short-circuits of brain function that arise spontaneously
      from an injury and spread repeatedly as waves into neighboring brain tissue. Animal research
      has shown that spreading depressions can cause secondary injury to the brain.

      The primary objective of this observational study is to determine whether the occurrence or
      severity of spreading depression is related to worse neurologic recovery from TBI. Results
      from the study will determine whether monitoring of spreading depression should be used as a
      guide or target for improved medical management of the TBI patient.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to study hospitals who require neurosurgery for acute traumatic brain
        injury.
      
Keywords: spreading cortical depression; electroencephalography; traumatic brain injury; intensive care; vascular hypotension; intracranial hypertension
Sympathetic Renal Denervation Versus Increment of Pharmacological Treatment in Resistant Arterial Hypertension.
Condition: Resistant Arterial Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Background: In hypertension, a highly prevalent disease, up to 10-15% of hypertensive
      patients have uncontrolled blood pressure despite a regimen of ≥ 3 drugs, which is known as
      resistant hypertension (RH). Cardiovascular prognosis in patients with RH is worse than in
      controlled hypertensives. Efferent renal sympathetic nerves play an important role in volume
      homeostasis and blood pressure. A novel minimally invasive technique based on the use of
      selective radiofrequency renal sympathetic denervation has shown promising preliminary
      results for the treatment of these patients. On the other hand, some patients with RH could
      improve their blood pressure control by adding spironolactone, an antagonist of aldosterone
      receptors.

      Objective: To evaluate the efficacy of radiofrequency renal sympathetic denervation in
      patients with RH, as compared with the addition of spironolactone to the therapeutic regimen
      at baseline.

      Method: interventional, prospective, randomized, open study, of a cohort of 50 patients with
      RH, with office systolic blood pressure ≥ 150 mmHg and also with 24h systolic blood pressure
      ≥ 140 mmHg, despite treatment with ≥ 3 drugs in adequate doses, one of them a diuretic, and
      whitout treatment with either spironolactone or eplerenone. Patients will be randomized (1:1)
      to renal sympathetic denervation treatment or spironolactone (50mg), performing determination
      of office blood pressure and 24h-ABPM at pre-randomization, 1, 3 and 6 months, as well as
      laboratory tests, echocardiography, measurement of carotid intima-media thickness and central
      blood pressure measurement at pre-randomization and after 6 months.
    


Intervention name(s): Sympathetic Renal Denervation; Treatment with aldactone
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post-Pandemic Perception of Public Space in Singapore
Condition: Stress; Anxiety
Study type: Interventional

Summary: 
      In this study it is aimed to investigate the difference between the brain response to
      different urban environments in Singapore before and after the COVID-19 pandemic. The
      datasets acquired from 34 healthy individuals as part of ongoing study "Effects of Landscape
      on the Brain" (IRB Ref #: S-18-352) will be used. These datasets consist of
      neurophysiological data recordings and behavioral self-reported measures and were collected
      before 20 of January 2020. The same experimental protocol would be followed, given that the
      data collection in the lab-setting would start after 7 th May 2020/whenever research
      activities are allowed to resume, and the outdoor sessions after the "circuit-breaker" period
      in Singapore is over.
    

Detailed description: 
      The aim is to explore the difference between pre and post COVID-19-related isolation on their
      perception of green and public spaces, as well as mood, neuroelectrical (EEG) and
      haemodynamic (fNIRS) response.

      The hypothesi is that crowded, busy public spaces, such as experimental site near Chinatown
      MRT, may induce more patterns of brain activity related to stress, anxiety and aversive
      attitudes after COVID-19 as compared to before. Similarily, it is expected that green urban
      spaces, such as experimental site at Hortpark, perceived after COVID-19 can elicit more
      salutogenic effect of relaxation, positive emotions and attention restoration than before the
      pandemic.

      This study will allow better understanding of the mental health consequences of unprecedented
      period of isolation at home and social distancing. The relationship between city residents
      and their living environment may change due to COVID-19 and it's very important to uncover
      the mental health implications of social distancing to prepare for potential future outbreaks
      through developing tools and solutions addressing specific issues. Finally, for the urban
      planning and design the study may highlight important trends in changing human perception of
      space and redefine the concept of a "healthy city".
    

Intervention name(s): Public space exposure
Intervention type(s): Other
Intervention description(s): landscapes with nature and/or classified as contemplative (through a CLM psychometric measure) are expected to elicit different brainwave oscillations as compared to noncontemplative ones.
Intervention model: Sequential Assignment
Intervention model description: within-subjects before/ after study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: landscape; exposure; EEG; fNIRS; stress; urban; self-isolation; covid-19; pandemic; public space; brain
The Effect of D-cycloserine on Emotional Processing
Condition: Cycloserine; Healthy Volunteer
Study type: Interventional

Summary: 
      To investigate the effects of N-methyl-D-aspartate (NMDA) partial agonist DCS on emotional
      processing, memory and stress tasks
    

Detailed description: 
      The aim of the present study is to assess the effect of DCS on emotional processing relevant
      to antidepressant drug activity. For this, 40 healthy volunteers will be recruited to the
      study and randomized to receive a single session of 250mg DCS or placebo. 3 hours and 24
      hours after active drug/placebo administration, the effects of emotional processing via the
      use of cognitive tasks will be assessed. Also, given the important role of DCS in memory and
      stress, we also include tasks to explore changes in autobiographical memory and in
      psychological and physiological measures of stress and arousal.
    

Intervention name(s): d-cycloserine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose; Single dose
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Emotion processing; Autobiographical memory; Stress
Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers
Condition: Healthy; Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of
      single ascending doses and multiple ascending doses of APX-115 in healthy males. This study
      also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and
      potential interaction between caffeine and APX-115 in healthy males.
    


Intervention name(s): SAD: APX-115; SAD: Placebo; MAD: APX-115; MAD: Placebo; Food effect: fasted and fed; Metabolic probe with or without APX-115
Intervention type(s): Drug; Drug; Drug; Drug; Other; Other
Intervention description(s): Drug: APX-115 SAD APX-115 SAD for 1day; Drug: Placebo Placebo for 1day; Drug: APX-115 MAD APX-115 MAD repeatedly administered.; Matching study drug will be repeatedly administered.; A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.; A metabolic probe will be administered with and without APX-115.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel design for SAD and MAD studies Crossover design for Food and Drug interaction studies
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MR Scanning of Very Young Children With Severe Developmental Disorders
Condition: Autism; Mental Retardation; Language Disorder
MeSH terms: Language Disorders; Intellectual Disability; Developmental Disabilities
Study type: Observational

Summary: 
      The specific is to study the MR morphologic and spectroscopic brain correlates and predictors
      of development in children with severe developmental disorders (autistic spectrum disorders
      and/or mental retardation and/or language disorders). Given the frequently observed
      association of autism with known medical conditions, particularly in cases with comorbid
      mental retardation and in cases with atypical autism (Rutter et al., 1994; Gillberg, 1995),
      children with suspected autism or related developmental disorders will be asked to
      participate in an extensive state of the art laboratory work-up which includes T1 and T2
      weighted MRI of the brain. MRI data will be analyzed both qualitatively, looking for focal
      abnormalities and degree of myelination, and quantitatively, measuring volumes of total
      brain, cerebellum, ventricles and grey and white matter. For research purposes, the work-up
      will be supplied with proton Magnetic Resonance Spectroscopy (MRS) of the brain. This data
      set provides the opportunity to chart brain-behavior relationships in young children with
      suspected autism and related PDD cross-sectionally.
    


Observational model: Natural History
Time perspective: Other
Keywords: Autism; MRI; Developmental Disorders
Identification of Non-responders to Levothyroxine Therapy
Condition: Hypothyroidism; Biomarkers; Endocrine System Diseases
MeSH terms: Hypothyroidism; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess differential effects of T4 and T3 on cell and tissue
      level
    

Detailed description: 
      15-20% of the patients with hypothyroidism remain symptomatic, despite adequate thyroxine
      substitution. Endocrinologists are split in their opinion on combination therapy with T4 and
      T3 on patients with poorly regulated hypothyroidism. There are no objective means, by which
      to identify individuals who would benefit from combination therapy. The purpose of this study
      is to assess differential effects of T4 and T3 on body temperature, metabolism, muscle
      strength and brain function. The main aim is to try to identify biomarkers reflecting
      different effects of T4 and T3 on cell and tissue level.
    

Intervention name(s): Levothyroxin; Liothyronine
Intervention type(s): Drug; Drug
Intervention description(s): 3 months; 3 months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thyroxine; Triiodothyronine
ACE Inhibition and Novel Cardiovascular Risk Factors
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the effects of an angiotensin converting enzyme inhibitor (ACE inhibitor),
      fosinopril, on multiple blood markers in 286 adults at high risk for cardiovascular disease.
    

Detailed description: 
      BACKGROUND:

      Angiotensin converting enzyme inhibitors (ACE inhibitors) may prevent cardiovascular events
      in high risk persons and improve skeletal muscle function in heart failure patients by means
      of mechanisms that are independent of blood pressure changes. However, there is limited
      knowledge of all the mechanisms underlying the therapeutic benefits of ACE inhibition. ACE
      inhibitors may favorably modify markers of fibrinolysis, inflammation, endothelial function,
      and extracellular tissue remodeling, all of which are associated with atherosclerosis and
      cardiovascular disease. But, clinical trial evidence on these effects is limited. In
      addition, polymorphisms of the ACE, angiotensinogen, PAI-1 and IL-6 genes may modify the
      therapeutic response to ACE inhibitors.

      DESIGN NARRATIVE:

      This was a double-blind cross-over, randomized, placebo controlled trial in 286 persons with
      high cardiovascular risk to compare the effects of 6 months of treatment with fosinopril and
      6 months with placebo on the following primary outcomes: plasma plasminogen activator
      inhibitor-1 (PAI-1) antigen, C- reactive protein (CRP), interleukin-6 (IL-6) and soluble
      vascular cell adhesion molecule-1 (sVCAM-1). The secondary objectives were (a) to assess the
      effects of fosinopril on IL-6/IL-6 Soluble Receptor ratio, PAI-1 activity, tissue plasminogen
      activator (TPA) antigen, fibrinogen, endothelin-1, TNF-alpha, soluble intercellular cell
      adhesion molecule-1 (sICAM-1), E-selectin, matrix metalloproteinase-1 (MMP-1) and tissue
      inhibitor of metalloproteinase-1 (TIMP-1); and (b) to explore the effects of ACE,
      angiotensinogen, PAI-1, and IL-6 gene polymorphisms on these biomarkers, and test the
      interaction of the gene polymorphisms with the effects of fosinopril. The study had
      sufficient power to detect small changes in several biomarkers compared to placebo. The
      assessment of these biological mechanisms had clinical relevance for identifying the patients
      who may benefit the most from ACE inhibition. While the focus of the study was on novel
      cardiovascular risk factors, the results may also have future implications for developing new
      indications for ACE inhibitors, such as, for example, the prevention of age-related muscle
      wasting and physical disabilities in older persons, for which inflammation may be a causal
      factor.
    

Intervention name(s): Fosinopril
Intervention type(s): Drug
Intervention MeSH terms: Fosinopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Pharmacokinetics Study of Liposomal Paclitaxel in Humans
Condition: Cancer
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether there is any difference of the
      pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in
      Chinese cancer patients with solid tumors.
    

Detailed description: 
      The pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) has never been
      studied in Chinese cancer patients. This clinical trial is designed to find out the
      pharmacokinetics of liposomal paclitaxel at the dose of 175mg/m2 and whether it has a
      different pharmacokinetic profile to paclitaxel.
    

Intervention name(s): Liposomal paclitaxel; Paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.; Patients will be given paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Liposomal paclitaxel
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)
Condition: Acute Myocardial Infarction; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Autologous stem cells may improve myocardial regeneration after intracoronary administration
      in patients with acute myocardial infarction. The primary hypothesis of this prospective,
      placebo-controlled, double-blind trial is that the increase of ejection fraction determined
      by magnetic resonance imaging between baseline and 6 months follow-up is superior in active
      treated patients compared to patients receiving placebo. The study includes an integrated
      pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by
      cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size
      will be calculated. The primary endpoint is the improvement in left ventricular ejection
      fraction with an assumed 2.5% higher improvement in the cell treated population compared to
      the placebo treated group.
    

Detailed description: 
      There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients
      will be stratified according to age, localization of myocardial infarction and left
      ventricular function.
    

Intervention name(s): autologous stem cells; placebo suspension
Intervention type(s): Other; Other
Intervention description(s): intracoronary administration at the same day of cell aspiration using the stop flow technique; intracoronary administration at the same day as cell aspiration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Thorough Corrected QT Interval Trial
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of K-877 on ECG parameters with a focus
      on cardiac repolarization compared with placebo in healthy adult subjects.
    


Intervention name(s): K-877 Low Dose; Moxifloxacin; Placebo; K-877 High Dose
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): K-877 Low Dose; K-877 High Dose
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment