bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants
Condition: Pharmacokinetics of Mirabegron; Food Effect; Healthy Chinese Subjects
Study type: Interventional
Phase: Phase 4

Summary: 
      This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of
      mirabegron in healthy Chinese male and female participants.

      This study also evaluated the safety and tolerability of single oral doses of mirabegron in
      healthy Chinese male and female participants.
    

Detailed description: 
      An open-label, randomized, 2-period, single oral dose crossover design at 2 dose levels in
      healthy Chinese male and female participants. Each participant took part in 2 periods
      separated by a washout of at least 10 days between investigational product (IP)
      administrations in each period.

      Participants were screened for up to 21 days prior to IP administration on day 1 of period 1.
      Eligible participants were admitted to the clinical unit on day -1 of each period and were
      confined until the last pharmacokinetic sample had been drawn within each period. PK samples
      were collected predose on day 1 of each period and at multiple time points following each
      dose.
    

Intervention name(s): mirabegron
Intervention type(s): Drug
Intervention description(s): Oral adminstration
Other intervention name(s): Betmiga
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a two-way crossover design with 2 period and 2 dose groups. Participants were randomized to 1 of 4 sequences dependent on dose and period assigned.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: mirabegron; pharmacokinetics; two-way crossover
Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI
Condition: Cerebrovascular Disorders
MeSH terms: Cerebrovascular Disorders
Study type: Observational

Summary: 
      This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the
      method with first-in-human studies.
    

Detailed description: 
      This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol
      as a contrast agent, and validate the method with first-in-human studies. Subjects who are
      already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion.
      The ferumoxytol infusion itself is not a part of the study. The project will provide brain
      angiograms and establish a human cerebrovascular atlas that will enable future quantitative
      diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that
      characterize disease, a tool which doesn't currently exist, and which could lead to many
      exciting discoveries and clinical applications in neurology.
    

Intervention name(s): Quantitative Magnetic Resonance Imaging
Intervention type(s): Diagnostic Test
Intervention description(s): Radiological diagnosis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with iron deficiency anemia already scheduled to receive ferumoxytol infusion for
        iron replacement therapy.
      
Biospecimen description: 
      Subject blood sample before each scan
    
Keywords: Magnetic Resonance Imaging; Ferumoxytol
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to learn if Abatacept or Infliximab in
      combination with Methotrexate demonstrate a greater reduction in disease activity over
      placebo.
    


Intervention name(s): Abatacept (ABA) + Methotrexate (MTX), double-blind (DB); Infliximab (INF) + MTX, DB; Placebo (PLA) + MTX, DB; PLA + MTX switched to ABA+ MTX, DB; ABA, open-label (OL)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.; Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.; Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.; Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months; Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months
Other intervention name(s): Orencia; Orencia; Orencia
Intervention MeSH terms: Infliximab; Methotrexate; Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Objective Brain Function Assessment of mTBI/Concussion
Condition: Brain Injuries, Traumatic; Concussion, Mild; Concussion, Intermediate; Concussion, Severe; Concussion, Brain
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      This study (Part 3) is designed to build a database including EEG, neurocognitive
      performance, clinical symptoms, history and other relevant data, which will be used to derive
      a multimodal EEG based algorithm for the identification of concussion and tracking of
      recovery.
    

Detailed description: 
      Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points
      following injury. Subjects will come from the sports and other populations of concussed
      individuals. They will be matched with controls i.e. not head injured subjects who will also
      undergo the same set of tests and the same time intervals as the injured subjects. An
      additional pool of uninjured (not head injured) subjects will be collected who will be
      assessed at a single time point. This data will be used to populate a database for the
      purpose of deriving a multimodal concussion index.
    

Intervention name(s): BrainScope Ahead 300iP
Intervention type(s): Device
Intervention description(s): The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 490 Injured, Matched Control and Healthy Volunteer subjects will be recruited
        from high schools, college universities, concussion clinics and emergency rooms.
      
Keywords: Concussion; Mild Traumatic Brain Injury; Sport Related Concussion; Non-Sport Related Concussion
Warming IV Fluids and Incidence of Hypotension
Condition: Assault by Hot Fluids
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 1

Summary: 
      This prospective, double-blinded, randomized, controlled study was undertaken to evaluate
      whether warming IV fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine
      and transfusion requirement and lower fluid consumption than use of room-temperature fluids
      (22 oC) in cesarean delivery patients undergoing spinal anesthesia.
    

Detailed description: 
      Inadvertent perioperative hypothermia during cesarean delivery is not rare and frequently
      neglected, despite the recommendations by clinical guidelines. Exposure to cold air and
      infusing non-warmed intravenous (iv) fluids are the other main sources of inadvertent
      hypothermia. Spinal anesthesia used during the cesarean delivery has also been demonstrated
      to impair normal autonomic thermoregulatory control and extend inadvertent perioperative
      hypothermia. Various measures such as pre-warming of patients or fluids before anesthesia,
      peroperative warming of iv fluids and active/passive cutaneous warming techniques have all
      been used to prevent or to reduce inadvertent perioperative hypothermia. This prospective,
      double-blinded, randomized, controlled study was undertaken to evaluate whether warming IV
      fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine and transfusion
      requirement and lower fluid consumption than use of room-temperature fluids (22 oC) in
      cesarean delivery patients undergoing spinal anesthesia.

      The hypothesis was that in elective caesarean delivery patients undergoing spinal anesthesia,
      warming intravenous fluids, would reduce the incidence of hypotension, ephedrine and
      transfusion requirement and volume consumption. Thus, the primary outcome measure of the
      present study was the incidence of intraoperative maternal hypotension and ephedrine
      requirement during spinal anaesthesia for caesarean section. Secondary outcome measures were
      total volume consumption, blood loss, pain scores, shivering and maternal and foetal side
      effects.
    

Intervention name(s): Active Comparator: Warming group
Intervention type(s): Other
Intervention description(s): Placebo Comparator: Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Effects of Eszopiclone on Sleep and Memory in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The investigators will test the hypothesis that the sleep medication, eszopiclone, can
      normalize brain activity during sleep and improve memory in patients with schizophrenia. The
      investigators will do this by measuring sleep and memory performance on two conditions
      separated by one week: taking 3 mg of eszopiclone and taking placebo. The investigators will
      study healthy subjects and chronic, medicated outpatients with schizophrenia.
    

Detailed description: 
      Sleep spindles, a defining oscillation of stage 2 non-rapid eye movement sleep (N2), are
      strongly linked to memory and IQ in healthy individuals. Schizophrenia is characterized by a
      spindle deficit that correlates with deficient sleep-dependent memory consolidation, symptom
      severity, IQ and executive function. In a small pilot study of schizophrenia patients,
      eszopiclone , significantly increased sleep spindles but its effect on memory was not
      significant. Here, in a larger double-blind, placebo-controlled, cross-over design study, we
      investigated whether eszopiclone can both increase spindle density and improve memory
      consolidation. Chronic, medicated schizophrenia outpatients and demographically-matched
      healthy control participants were randomly assigned to receive either placebo first or 3mg of
      eszopiclone first for two consecutive nights with high density polysomnography. Placebo and
      eszopiclone visits were one week apart. Participants were trained on the Motor Sequence Task
      (MST) at bedtime of the second night of each visit and tested the following morning to probe
      sleep-dependent motor memory consolidation.
    

Intervention name(s): eszopiclone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg of eszopiclone for two consecutive nights (Baseline Night and Experimental Night). Sleep spindle density (primary outcome) is measured for both nights. Memory consolidation (secondary outcome) is measured over Experimental Night.; placebo capsule for two consecutive nights. (Baseline Night and Experimental Night). Sleep spindle density (primary outcome) is measured for both nights. Memory consolidation (secondary outcome) is measured over Experimental Night.
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep; memory; schizophrenia; eszopiclone
A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind
Condition: Blindness
MeSH terms: Blindness
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety of the BrainPort vision device and to
      demonstrate improved object recognition and word identification and ambulation with use of
      the BrainPort vision device in subjects who are medically documented as blind, with acuity of
      20/ 5000 or worse.
    


Intervention name(s): BrainPort Vision Device
Intervention type(s): Device
Intervention description(s): 2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Assistive Technology; Non-Surgical Visual Prosthetic; Sensory Substitution
Metabolic Effects of One-weak Heavy Drinking
Condition: Metabolic Disturbance; Alcohol; Harmful Use; Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      Examination of the effect of one week's unhealthy lifestyle on glucose metabolism and liver
      parameters in a group of young, healthy males participating in Roskilde Festival 2016.
    

Detailed description: 
      Metabolic effects of intermittent unhealthy lifestyle in otherwise young healthy adults are
      poorly studied. The investigators evaluated the effect of one week's unhealthy lifestyle on
      glucose metabolism and liver parameters in a group of young, healthy males participating in
      Roskilde Festival 2016.

      Festival participants were studied before and after participation (one week) in Roskilde
      Festival 2016 and matched with controls who lead a normal life for an equivalent period of
      time. An oral glucose tolerance test (OGTT), abdominal ultrasound and strain elastography for
      liver stiffness were performed together with a bioimpedance scan and cognitive tests.
    

Intervention name(s): Festival participation
Intervention type(s): Behavioral
Intervention description(s): One week's participation in Roskilde Festival 2016 or living a normal daily life.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main goal of this study is to find a reasonably safe and tolerable treatment for adult
      patients with type 1-diabetes and that regain some of the endogenous insulin secretion,
      improve the patients' quality of life (QoL) and reduce the risk of both short- and long-term
      complications. The hypothesis tested is that oral GABA treatment with the newly developed
      compound Remygen will be safe and induce regain of some endogenous insulin secretion in adult
      patients with type 1-diabetes diagnosis for more than five years. The first part of the study
      will include 6 patients and be performed as a Safety and Dose Escalation study in three
      steps. The main study is a three-arm, open label, single center, clinical trial. Eligible
      patients will be randomized into one of three active treatment arms to receive oral GABA
      treatment for 6 months.
    


Intervention name(s): Gamma-Aminobutyric Acid (GABA); Alprazolam
Intervention type(s): Drug; Drug
Intervention description(s): Patients eligible for the main study will be randomized in a 1:1:1 ratio stratified by the C-peptide level to receive 200 mg of GABA (Remygen) for 6 months, 600 mg of GABA (Remygen) for 6 months, or Alprazolam 0.5 mg combined with GABA 600 mg (Remygen) for 3 months followed by treatment with GABA 600 mg (Remygen) only for another 3 months. The start of the arms with high dose GABA will be delayed and started first after that a data safety monitoring board has evaluated and approved the safety data of the first 4 patients included in the arm with low dose GABA. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period.; Patients eligible for the main study will be randomized in a 1:1:1 ratio stratified by the C-peptide level to receive 200 mg of GABA (Remygen) for 6 months, 600 mg of GABA (Remygen) for 6 months, or Alprazolam 0.5 mg combined with GABA 600 mg (Remygen) for 3 months followed by treatment with GABA 600 mg (Remygen) only for another 3 months. The start of the arms with high dose GABA will be delayed and started first after that a data safety monitoring board has evaluated and approved the safety data of the first 4 patients included in the arm with low dose GABA. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period.
Other intervention name(s): GABA (Remygen)
Intervention MeSH terms: Alprazolam; gamma-Aminobutyric Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Remygen; GABA
Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      In patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective
      in the treatment of psychosis. In patients with borderline personality disorder (BPD), as far
      as the investigators know, no well designed controlled studies have been performed on the
      effect of one of the newer atypical antipsychotics on psychotic symptoms.

      It is of interest to investigate the benefit of quetiapine treatment in these types of
      patients. Quetiapine possibly gives less side-effects because of the expected lack of
      elevated prolactin levels, which is of importance in this patient group, overrepresented by
      young females. In this double blind, randomized, placebo controlled, 8 week, parallel group,
      multi-center study, quetiapine (in flexible doses between 200 mg/day and 600 mg/day) will be
      compared with the placebo.
    


Intervention name(s): Quetiapine fumarate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): flexible doses from 200 mg to 600 mg; placebo
Other intervention name(s): Seroquel; 204,636
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Borderline personality disorder
Exercise and Insulin Signaling in Human Skeletal Muscle
Condition: Insulin Sensitivity; Obesity; Sedentary Lifestyle
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Obesity is associated with a decrease in skeletal muscle insulin sensitivity. Aerobic
      exercise can increase insulin sensitivity in the few hours following exercise, however the
      cellular mechanisms are not completely understood. The current project is to investigate
      mechanisms of exercise improvements to skeletal muscle insulin sensitivity.
    

Detailed description: 
      Study Overview: We are investigating the mechanisms by which exercise improves the response
      of skeletal muscle to insulin in lean and obese adults. Participants will complete 4 study
      visits consisting of: 1) screening visit, 2) maximal exercise test visit, and then a
      randomized order of 3) a resting metabolic study visit, and 4) an exercise metabolic study
      visit. Metabolic study visits for resting and exercise conditions will be identical, other
      than remaining sedentary or performing exercise. Skeletal muscle biopsy samples will be
      collected during resting, immediately post-exercise and during insulin stimulated conditions.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Participants will perform 2 metabolic study days of either resting or acute bout of cycling exercise in a randomized cross-over design.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise
Ultrasound-guided Block for Thoracic Surgery Pain
Condition: Postoperative Pain; Thoracic Cancer
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The investigators aimed to assess Ultrasounde- guided serratus anterior plane block can be
      effective in acute postoperative pain following thoracic surgery.
    

Detailed description: 
      Analgesic options for thoracotomy are various with each having their own merits and
      demerits.Thoracic epidural is said to be the gold standard for management of thoracotomy
      pain. However, it is invasive procedure and many side effects. Other options include
      paravertebral block, interpleural block, intrathecal opioids. Especially, paravertebral block
      is thought good alternative to epidural anethesia. Most of these invasive neuraxial
      techniques demand normal coagulation parameters to be present.

      The serratus anterior plane block(SAPB) was done under ultrasound guidance in the
      mid-axillary line at the level of the fourth rib and the catheter was placed superficial to
      the serratus plane. The patient expressed relief in pain within 10 minutes of being given the
      bolus of local anaesthetic.Pain following thoracotomy is chiefly due to rib retraction, and
      damage to the serratus/intercostal muscles and intercostal nerves. A SAPB addresses both
      these aspects. SAPB has been mentioned in previous studies for management of rib fractures
      and breast surgeries. The investigators try to evaluate whether the SAPB is easy to perform
      and provides effective analgesia in patients undergoing thoracotomy with minimal side
      effects.
    

Intervention name(s): serratus anterior plane block; patient controlled analgesia
Intervention type(s): Procedure; Drug
Intervention description(s): before surgery :ultrasound-guided serratus anterior plane block; two groups have same intravenous patient controlled analgesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: serratus anterior plane block; ultrasound-guided; regional anesthesia; thoracic surgery; postoperative pain