bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression
Condition: Bipolar Disorder; Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of quetiapine in the
      treatment of a major depressive episode in patients with bipolar disorder.
    


Intervention name(s): SEROQUEL (quetiapine fumarate) Tablets
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Primary purpose: Treatment
Keywords: Bipolar Depression
Acetaminophen and Social Processes
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Recent research has identified heightened sensitivity to social rejection as a core feature
      of BPD. Rejection sensitivity can trigger the aggressive, impulsive, and self-injurious
      behaviors characteristic of the disorder.

      Therefore targeting therapy towards the reduction of rejection sensitivity may improve the
      low rates of effectiveness of current pharmacological and behavioral therapies. Therefore,
      this proposal tests a theoretically-based pharmacological approach that specifically targets
      the heightened sensitivity to rejection experienced by BPD patients.

      In prior research with normal controls, it was shown that chronic treatment with the physical
      pain-killer acetaminophen (e.g. Tylenol) reduced both neural responses to social rejection
      (using fMRI) as well as self-reported feelings of rejection in a daily diary study.

      It is the aim of this research project to determine if the over-the-counter analgesic,
      acetaminophen (active ingredient in Tylenol), can reduce symptoms and behaviors in BPD
      patients. The goal of this proposal is to use an open-label design to determine if
      acetaminophen improves symptoms in BPD patients.
    


Intervention name(s): Acetaminophen
Intervention type(s): Drug
Other intervention name(s): Tylenol
Intervention MeSH terms: Acetaminophen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: borderline personality disorder; rejection; social pain
Effects of Oxytocin on Reinforcement Learning and Interoception
Condition: Healthy
Study type: Interventional

Summary: 
      The main aim of the study is to investigate whether intranasal oxytocin has effects on
      reinforcement learning under dynamic environment and interoceptive processing based on
      behavioral and electroencephalogram (EEG) responses.
    

Detailed description: 
      A double-blinded, placebo-controled, between-subject design is employed in this study. In a
      randomized order, a total of 80 healthy males are instructed to self-administrated intranasal
      spray of oxytocin or placebo. (1) Participants first complete a probabilistic reward learning
      task 45 minutes after treatment with behavioral (response time and accuracy) and EEG data
      (ERP components such as FRN, ERN and P300) being collected during this task. (2) A
      resting-state recording and a heartbeat counting task are conducted following the learning
      task with ECG and EEG data being collected. Personality traits of subjects are assessed using
      validated Chinese version questionnaires including the Beck Depression Inventory (BDI-II),
      State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), the Cognitive
      Flexibility Inventory(CFI), Sensitivity to Punishment and Sensitivity to Reward Questionnaire
      (SPSRQ), Behavioral Inhibition System and Behavioral Activation System Scale (BIS/BAS).
      Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) when they just
      arrive, before and after the tasks.
    

Intervention name(s): Intranasal oxytocin; intranasal placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will be assigned to intranasal administration of oxytocin (24 IU).; Each subject will be assigned to intranasal placebo.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oxytocin; learning; interoception
Evaluation of Probiotics in the Treatment of Portal Hypertension
Condition: Liver Cirrhosis; Portal Hypertension; Encephalopathy
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Brain Diseases; Hypertension; Fibrosis
Study type: Interventional

Summary: 
      This study is to evaluate the role of probiotics in the treatment of portal hypertension. In
      particular the role of probiotics on gut microbiota in liver cirrhosis patients will be
      studied and compared with cytokines and other substances implicated in the pathogenesis of
      portal hypertension. The hypothesis whether probiotics may change the prognosis of patients
      with portal hypertension will be studied. The hypothesis whether probiotics may halt the
      pathologic cascade of events leading to various complications (e.g. hepato-renal syndrome,
      spontaneous bacterial peritonitis, bleeding varices) will be reviewed.
    

Detailed description: 
      Studied probiotics: VSL3
    

Intervention name(s): VSL3
Intervention type(s): Dietary Supplement
Intervention description(s): 2 times daily 450 billion live bacteria (in each saschet)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: VSL3; Probiotics; Gut microbiota; Cytokines; Portal hypertension; Chemokines; Liver cirrhosis
Study of Phosphatidylcholine in a Patient With Methionine Adenosyltransferase Deficiency
Condition: Methionine Adenosyltransferase Deficiency; Metabolism, Inborn Errors
MeSH terms: Metabolism, Inborn Errors; Amino Acid Metabolism, Inborn Errors
Study type: Interventional

Summary: 
      OBJECTIVES: I. Determine whether plasma choline and breast milk choline levels are low at
      fasting in a patient with methionine adenosyltransferase deficiency, and if the choline
      levels are low, determine whether choline levels respond to dietary supplementation with
      phosphatidylcholine.

      II. Determine whether this patient has a fatty liver by magnetic resonance spectroscopy.
    

Detailed description: 
      PROTOCOL OUTLINE:

      Blood is drawn for liver function tests and measurement of plasma choline levels and breast
      milk samples are taken for measurement of breast milk choline levels at fasting and at 1 hour
      after breakfast on day 1. The patient then undergoes magnetic resonance spectroscopy of the
      liver to assess liver density and choline compound mass. The patient then receives oral
      phosphatidylcholine supplement, and plasma and breast milk samples are taken at 3 and 6 hours
      after the dose. Oral phosphatidylcholine supplements continue for 30 days. The above studies
      are repeated on day 31.
    

Intervention name(s): phosphatidylcholine
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: genetic diseases and dysmorphic syndromes; inborn errors of metabolism; methionine adenosyltransferase deficiency; rare disease
Cognitive and Biological Responses in Stress
Condition: Stress, Psychological; Anxiety
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The goal of this pilot part of the study (Step 1) is to identify the optimal population of
      high and low anxiety and stress individuals who will differentially respond to a laboratory
      stress task as measured by changes in subjective stress response (affect), cognition,
      attention, and biological measures (autonomic and metabolite responses).

      Based on experience with different study populations, the investigator's believe that a
      healthy, homogenous population (Caucasian, women, premenopausal) with higher levels of state
      anxiety and perceived stress, and with greater responsiveness to laboratory stress tasks
      (which can also be used in the probiotic intervention study in Step 2) will provide the
      highest likelihood of identifying the underlying central mechanisms of stress responsiveness
      in Step 1 and then for the probiotic intervention in Step 2.

      For this pilot study, the investigator's will look at baseline measures to determine
      differences in responses to four subjective (affect/cognition/attention) stress tasks
      (primary endpoints) and biological (secondary endpoints) measures in a high stress group and
      a low stress group.

      If for Step 1 of the study, the investigator's are able to verify the stratification of the
      participants into high and low stress groups based on questionnaire data and show differences
      between participants with high and low perceived stress in psychological characteristics, lab
      stress tasks and potentially in biological responses, this will help to determine the optimal
      cut off values, and the optimal stress tasks to be conducted in the planned probiotic
      intervention study of Step 2.
    


Intervention name(s): Cognitive Stress Testing
Intervention type(s): Other
Intervention description(s): Cognitive and stress study with no product intervention and noninvasive. The high stress/anxiety group will be compared to the low stress/anxiety group in terms of changes from baseline to after the cognitive and stress tests (i.e., 4 laboratory tasks) and metabolite measures.
Other intervention name(s): ANS testing; metabolites; cognitive tasks; stress tasks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups (high stress/anxiety compared to low stress/anxiety) will be compared on their performance on within laboratory stress and cognitive tasks (4 different tests).
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: stress; women; high stress; low stress; perceived stress
A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings
Condition: Menorrhagia
MeSH terms: Menorrhagia; Hemorrhage
Study type: Observational

Summary: 
      This field based, questionnaire study will document observational data on womens perception
      of menstrual bleeding in a cross-section of women in Sweden. Each subject will complete the
      questionnaire at one occasion.
    


Intervention name(s): No drug
Intervention type(s): Behavioral
Intervention description(s): No drug intervention. The intervention is a questionnaire with quality of life and perception of menstrual bleedings. All subjects will complete both questionnaires.
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects included in the SIFO (Swedish institute of market research) volontary subject
        pool.
      
Keywords: Menorrhagia; Heavy menstrual bleeding; Uterine Hemorrhage; Menstruation Disturbancies
A Study of MK-7145 Compared to Placebo and Hydrochlorothiazide for Lowering Blood Pressure in Male Participants With Hypertension (MK-7145-009)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to evaluate the antihypertensive efficacy and tolerability of
      MK-7145 in participants with mild-to-moderate hypertension.

      The primary hypotheses for the study were as follows:

        1. Multiple dose administration of 6-mg MK-7145 results in a reduction in systolic blood
           pressure (SBP) in male participants with mild to moderate hypertension that is superior
           to placebo, as measured by time weighted average change from baseline over 24 hours
           postdose (TWA0-24hrs) on dosing Day 28

        2. Multiple dose administration of 6-mg MK-7145 results in a reduction in SBP in male
           participants with mild to moderate hypertension that is similar to hydrochlorothiazide
           (HCTZ), as measured by TWA0-24hrs on dosing Day 28

        3. The effect of MK-7145 and HCTZ on natriuresis (UNaV) as well as SBP and diastolic blood
           pressure (DBP), both as measured by TWA0-24hrs, will be estimated

        4. Multiple dose administration of MK-7145 for 4 weeks will be generally safe and
           well-tolerated.
    


Intervention name(s): MK-7145; Hydrochlorothiazide (HCTZ); Placebo to MK-7145; Placebo to HCTZ
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage
Condition: Cartilage Lesion; Degenerative Lesion of Articular Cartilage of Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and feasibility of implanting an
      engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes
      within a collagen type I/III membrane into the cartilage defect on the femoral condyle and/or
      trochlea of the knee after a traumatic injury.
    

Detailed description: 
      Articular cartilage injuries are a prime target for regenerative techniques, since
      spontaneous healing is poor and untreated defects predispose to osteoarthritis. Common
      current strategies such as arthroscopic debridement, microfracture, autologous osteochondral
      grafting, use of allografts and autologous chondrocytes implantation (ACI) still have
      drawbacks such as long and complex rehabilitation times, technically challenging operation
      techniques, defect-size limitations, donor-site morbidity, limited graft material and high
      costs. Furthermore many techniques show unsatisfactory long term results due to inferior
      quality of repair tissue as compared to native cartilage or have yet to prove the cost versus
      benefit. These drawbacks could be overcome by using a tissue engineered nasal cartilage
      graft, thereby reducing donor site morbidity without introducing additional risk of
      complication or technically challenging techniques.

      This study is a phase I, prospective, uncontrolled, investigator initiated clinical trial
      involving 25 patients, with the objective of demonstrating safety and feasibility in the use
      of engineered nasal cartilage grafts for repair of articular cartilage. The specific surgical
      target of the trial is the repair of one or two full-thickness cartilage defects from 2 cm2
      to 8 cm2 (per lesion, not exceeding a total of 8 cm2 for all lesions) due to traumatic injury
      on the femoral condyle and/or trochlea of the knee.
    

Intervention name(s): Tissue engineered cartilage graft
Intervention type(s): Biological
Intervention description(s): Autologous nasal chondrocytes expanded in vitro and cultured in a collagen type I//III scaffold
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chondral lesions in the knee after traumatic injury
Optimizing Closed-Loop Control of Type 1 Diabetes Mellitus in Adolescents
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in
      adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's
      ability to significantly improve blood glucose levels when an insulin bolus is omitted for a
      30 gram carbohydrate snack and when insulin bolus is insufficient for the amount of
      carbohydrates consumed for a meal. The primary objective of this study is to use a
      closed-loop Control-to-Range (CTR) system to significantly reduce the post-prandial blood
      glucose excursion in adolescents with type 1 diabetes who omit and/or under-bolus insulin for
      either snacks or meals. Up to 20 subjects aged ≥13 and ≤18 years old will be tested.
    

Detailed description: 
      The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in
      adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's
      ability to significantly improve blood glucose levels when an insulin bolus is omitted for a
      30 gram carbohydrate snack and when insulin bolus is insufficient for the amount of
      carbohydrates consumed for a meal. The CTR system is comprised of two algorithmic layers: (i)
      A Safety Supervision Module (SSM) which contains a predictive insulin request dampener (or
      brakes); (ii) a Range Correction Module (RCM), consisting in (a) a Hyperglycemia Mitigation
      System, and (b) Insulin on Board controller. Both modules will receive continuous glucose
      monitoring (CGM) and historical insulin delivery data. The SSM will monitor the safety of the
      subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia. The
      RCM will be responsible for optimizing blood glucose (BG) control and mitigating postprandial
      hyperglycemic excursions through a mix of increased basal rate and, potentially, isolated
      insulin boluses. To run CTR, we will use our wearable artificial pancreas platform, known as
      DiAs (Diabetes Assistant) which consists of a smart phone running CTR and connected to
      standard insulin delivery and CGM devices.
    

Intervention name(s): Diabetes Assistant (DiAs)
Intervention type(s): Device
Intervention description(s): Diabetes Assistance (DiAs) is a software residing in a Smartphone that contains the algorithms to regulate and control insulin deliveries (insulin bolus for: Basal rate, meal insulin and correction bolus) with inputs glucose values from a CGM and outputs insulin infusion by an insulin pump
Other intervention name(s): Closed-Loop system
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus (T1DM); Closed Loop Control (CLC); Diabetes Assistant (DiAs); Continuous Glucose Monitor (CGM)
"Using Epigallocatechin Gallate (EGCG) and Cognitive Training to Modulate Cognitive Performance in Patients With Fragile X Syndrome" (TESFX)
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Fragile X syndrome (FXS) presents alterations in synaptic plasticity that produce
      intellectual disability. can produce improvement. Estrogens (targeting Estrogen Receptors
      beta (ER-β) can act as neuroprotective agents, promoting synaptic plasticity and neurite
      outgrowth, and health benefits derived from flavonoids, as the flavonol epigallocatechin
      gallate (EGCG), phytoestrogens of natural origin are partially explained by their interaction
      with membrane ER. Selective ER-β flavonoids are thus good candidates for their therapeutic
      evaluation in intellectual disabilities. EGCG also targets central intracellular transduction
      signals altered in FXS and improves memory recognition in a FXS animal model(adenosine
      triphosphate (ATP)-inhibitor of phosphatidylinositol 3-kinase (PI3K)and mammalian target of
      rapamycin (mTOR) and extracellular signal-regulated kinase (ERK1/2). This study targets the
      synaptic plasticity alterations that underlie the learning and memory impairment but also the
      computational disability in FXS. The hypothesis is that EGCG can act by favoring the
      physiological processes involved in cognition.
    


Intervention name(s): EGCG; Placebo; Cognitive training
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Life Extension, Mega Green Tea Extract Decaffeinated is a dietary supplement containing EGCG extract (45% EGCG). This extract contains 98% total polyphenols and 45% epigallocatechin-3-gallate (EGCG). EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance.; Same capsules containing rice flour. No active treatment is given.; Feskits program 3 times per week (1 hour/session) Patients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention, attention/perception, working memory, auditory and visual memory, executive function and language.
Other intervention name(s): Epigallocatechin-3-gallate (EGCG); Matched placebo
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study lasts 7 months :
from day 0 to month 1, patients will receive placebo, in order to avoid the placebo effect of the treatment.
from month 1 to month 4 : patients will be divided in two cohorts, one group receiving ECGC (experimental group), and the other placebo (control group).
from mont 4 to month 7 : no treatment in given, only effects of cessation of treatment are observed.
Patients from both arms will receive Cognitive training.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine
Condition: Rapidly Escalating Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Pilot study to compare the efficacy and safety of two strengths of injections of subcutaneous
      DFN-11 in subjects with rapidly escalating migraine headaches.
    

Detailed description: 
      Pilot study to compare the proportion of subjects experiencing pain freedom at 60 minutes
      post-treatment between headache treated with Strength A of DFN-11 and Strength B of DFN-11
    

Intervention name(s): DFN-11
Intervention type(s): Drug
Intervention description(s): Sumatriptan 3 mg versus 6 mg
Other intervention name(s): Sumatriptan succinate injection
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: DFN-11 injection and placebo injection administered in one treatment period and two DFN-11 injections administered in another treatment period
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the clinical performance of three silicone hydrogel
      contact lenses over a 2 week period.
    


Intervention name(s): galyfilcon A, BC 8.30; lotrafilcon B, BC 8.60; comfilcon A, BC 8.60
Intervention type(s): Device; Device; Device
Intervention description(s): galyfilcon A, BC 8.30 soft contact lens; lotrafilcon B, BC 8.60 soft contact lens; comfilcon A, BC 8.60 soft contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment