bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Impact of Aripiprazole (Abilify®) Once Monthly Versus Standard of Care Oral Antipsychotic Medications on Changes in Brain Structure and Metabolism
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, randomized, open-label, parallel group study designed to assess the
      clinical and biological effects of 12 months of treatment with long acting intramuscular (IM)
      aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on
      magnetic resonance imaging (MRI) scans in subjects with schizophrenia compared with SOC oral
      antipsychotic medications and compared with a healthy control group.

      It is hypothesized that improved treatment compliance will lead to fewer white matter changes
      in the brain. Fewer white matter changes will be demonstrated via neuroimaging as increased
      FA and BPF values in the prefrontal region, and an increase in metabolites in a voxel
      centered on the anterior cingulate cortex (ACC) as seen with MRS. Therefore, the aim of this
      study is to examine the structural and metabolic effects of aripiprazole (Abilify®) once
      monthly in patients with schizophrenia using MRI techniques and to examine these effects in
      association with cognitive and clinical measures.
    


Intervention name(s): Standard of Care Oral antipsychotics; IM aripiprazole once monthly; No Treatment
Intervention type(s): Drug; Drug; Other
Intervention description(s): A total of 15 to 20 subjects with schizophrenia will receive SOC oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI(Geodon®)) or once monthly aripiprazole (Abilify®), PO daily, in accordance with their respective product labeling.; A total of 30 to 40 subjects with schizophrenia will receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM or an approved dose based on the investigator's judgment and in accordance with product labeling.; A total of 15 healthy controls will participate in the study and will not receive medication
Intervention MeSH terms: Aripiprazole; Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MRI; Imaging; Antipsychotic
The Effect of Health Provider's Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome
Condition: Metabolic Syndrome; Physical Activity
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The Effect of Health Provider's Feedback on Physical Activity Surveillance using Wearable
      Device-Smartphone Application for Resolution of Metabolic Syndrome; a 12-Week Randomized
      Control Study
    

Detailed description: 
      Patients diagnosed with metabolic syndrome were recruited and prescribed to live for 12 weeks
      using a wrist-wearable device (B.BAND, B Life Inc, Korea). The block randomization method was
      used to distribute the participants between an intervention group (n=35) and control group
      (n=32). In the intervention group, an experienced study coordinator provided feedback on
      physical activity to individuals through telephone counseling every other week.
    

Intervention name(s): Receving feedback; No regular feedback
Intervention type(s): Other; Other
Intervention description(s): Receving regular feedback from a health provider; No regular feedback from a health provider
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: In the intervention group, the researcher provided feedback on the participants' exercise amount through telephone contact every two weeks during the 12-week study period. It includes recommendations for continuing exercise therapy based on the recommendations for physical activity. Through phone consultations, they answered questions about exercise or discussed problems, were encouraged to continue exercising, answered questions or discussed problems related to wearable devices and apps, and encouraged for continuous data transmission.
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder
Condition: Tourette Syndrome; Motor Tic Disorder
MeSH terms: Tourette Syndrome; Tics; Tic Disorders; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Two-part study consisting of a double-blind, randomized, placebo-controlled, study at two
      target dose levels (Part 1) and an open-label, non-randomized study (Part 2) to determine the
      efficacy of ABX-1431 in treating adult patients with Tourette syndrome or Chronic Motor Tic
      Disorder as measured by the change from baseline in Total Tic Score of the Yale Global Tic
      Severity Scale (YGTSS-TTS) compared with placebo.
    

Detailed description: 
      ABX-1431 is a potent and selective, orally available, irreversible inhibitor of
      monoacylglycerol lipase, a metabolic enzyme that regulates the activity of the endogenous
      cannabinoid (endocannabinoid) system. It is being developed as a potential first-in-class
      compound for the treatment of Tourette Syndrome.

      This study will assess the safety, tolerability, and effect on tics ABX-1431 in adults with
      Tourette Syndrome or chronic motor tic disorder in an 8-week study. It is a two-part study.
      Part 1 is a double-blind, randomized, placebo-controlled study of ABX-1431 at two target dose
      levels. Part 2 is an optional, open-label, non-randomized study of ABX-1431.

      Patients will participate in the main study (Part 1) for approximately 10 to 14 weeks (up to
      30-day screening period; 56-day treatment period; 14-day follow-up period). For patients who
      choose to participate in Part 2, there is a period of up to 4 weeks between the last study
      visit in Part 1 and first study visit in Part 2. Patients who choose to enter Part 2 will be
      treated with open-label ABX-1431 for an additional 6 weeks (28-day treatment period; 14-day
      follow-up period).
    

Intervention name(s): ABX-1431; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part 1: 8 weeks with daily administration; Patients who choose to enter Part 2: additional 4 weeks with daily administration; Part 1: 8 weeks with daily administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tourette Syndrome; Chronic Motor Tic Disorder
Effects of Smartphone Use on Posture, Pain, Function and QoL
Condition: Postural; Defect; Neck Pain, Posterior; Shoulder Pain; Quality of Life
MeSH terms: Shoulder Pain; Neck Pain
Study type: Observational

Summary: 
      The aim of the study is to determine the effects of the use of smartphone on the neck and
      shoulder posture, pain, and functions, and the quality of life in young adults. The sample of
      the study consists of university students. According to the scores they got from the
      Smartphone Addiction Scale-Short Version, all participants will be divided into two groups.
      The neck and shoulder posture, pain, and functions, and the quality of life will be compared
      between the two groups.
    

Detailed description: 
      The study will include 106 university students who are 18-25 years old. According to the
      scores they got from the Smartphone Addiction Scale-Short Version, all students will be
      divided into two groups as Excessive Smartphone Use Group and Non-excessive Smartphone Use
      Group, both consisting of 53 participants. Participants whose scores are higher than 30 will
      be included to the Excessive Smartphone Use Group, and whose scores are 30 or less will be
      included to the Non-excessive Smartphone Use Group. In the assessment of pain level, the
      Visual Analogue Scale will be used. Functional levels of the neck and shoulders will be
      evaluated with the Copenhagen Neck Functional Disability Scale and the Shoulder Disability
      Questionnaire. World Health Organization Quality of Life Instrument-Short Form will be
      utilized to assess the quality of life. Postural analyzes of the participants will be
      fulfilled with the New York Posture Rating Chart. All scores will be evaluated by comparing
      between the two groups.
    

Intervention name(s): Assessment
Intervention type(s): Other
Intervention description(s): The structured questionnaire, Visual Analogue Scale, Copenhagen Neck Functional Disability Scale, Shoulder Disability Questionnaire, World Health Organization Quality of Life Instrument-Short Form, and Smartphone Addiction Scale-Short Version will be applied to all participants respectively. Lastly, posture analysis will be performed to all participants by using the New York Posture Rating Chart.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The sample of the study will consist of university students.
      
Keywords: Smartphone addiction; Forward head posture; Rounded shoulder; Neck pain; Shoulder pain; Quality of life
How Many Days Would You Want to Practice a Skill to Achieve it?
Condition: Motor Learning
Study type: Interventional

Summary: 
      Practice is required to improve your shot in basketball or to play a musical instrument. The
      learning of these motor skills can be further enhanced by non-invasively stimulating regions
      of the brain that control movements with electrical currents. These electric currents can
      strengthen or weaken connections of the brain, which consequently affects a person's ability
      to improve their performance on a skill. Non-invasive brain stimulation (NIBS) is widely
      applied in many disciplines of neuroscience research, and has potential therapeutic
      application. There are two specific types of NIBS that will be used in this research study:
      1) Transcranial Direct Current Stimulation (tDCS), which applies very weak electrical
      currents via two rubber electrodes on the scalp, and 2) Transcranial Magnetic Stimulation
      (TMS), which applies magnetic pulses via a coil against the head, to stimulate regions of the
      brain. Both types of non-invasive brain stimulation (i.e., tDCS, and TMS) are well-tolerated,
      painless, and safe. The application of tDCS to brain regions that control movements,
      concurrently with practice of a skill, results in better skill performance, than practice
      alone with no tDCS. Therefore, in this study, we will be testing different types of brain
      stimulation and different amounts of practice.
    


Intervention name(s): Sham TDCS; Anodal TDCS; Transcranial Magnetic Stimulation (TMS)
Intervention type(s): Device; Device; Device
Intervention description(s): Placebo stimulation is applied to the left motor cortex while participants perform a motor task in the right hand. During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.; Excitatory stimulation is applied to the left motor cortex while participants perform a motor task in the right hand. During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.; Participants will receive Transcranial Magnetic Stimulation (TMS) to allow research investigators to determine the location of the left motor cortex.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: motor; transcranial direct current stimulation; transcranial magnetic stimulation
Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.
Condition: Blood Coagulation Disorders; Hemorrhage
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger
      levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the
      treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study
      hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF <
      13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after
      start of surgery as compared to a trigger level of ROTEM FibTEM MCF < 8 mm.
    


Intervention name(s): Human fibrinogen concentrate
Intervention type(s): Drug
Intervention description(s): Administration of human fibrinogen concentrate (30 mg / kg bw) over 15 min Repetition if hourly intraoperative ROTEM measurements revealed hypofibrinogenemia according to treatment group definition
Other intervention name(s): Haemocomplettan P, CSL Behring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fibrinogen; Blood coagulation disorders; Postoperative bleeding; Transfusions
Cerebral Oximetry and Anesthetic Technique
Condition: Disorder of Hip Joint
Study type: Interventional

Summary: 
      The purpose of the study is to compare the effects of spinal and general anesthesia on
      transcranial regional cerebral oxygen saturation in geriatric patients undergoing total hip
      arthroplasty.
    

Detailed description: 
      Geriatric patients who received anesthesia undergoing total hip arthroplasty were randomized
      by means of a computer-generated randomization order into two groups; general anesthesia
      group (Group 1) and spinal anesthesia group (Group 2). Before and after induction of the
      general or spinal anesthesia, patients were monitorized with near infrared spectroscopy for
      regional cerebral oxygen saturation. Findings were compared statistically.
    

Intervention name(s): general anesthesia; spinal anesthesia
Intervention type(s): Other; Other
Intervention description(s): effect of general anesthesia on transcranial regional cerebral oxygen saturation; effect of spinal anesthesia on transcranial regional cerebral oxygen saturation
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: total hip arthroplasty; cerebral oxygen saturation; general anesthesia; spinal anesthesia
Endotracheal Extubation With Suctioning Versus Positive Pressure in Children After General Anaesthesia.
Condition: Endotracheal Extubation
Study type: Interventional

Summary: 
      Comparing extubation of endotracheal tube in children after general anaesthesia by applying
      suctioning to the endotracheal tube versus applying positive pressure to the endotracheal
      tube.
    

Detailed description: 
      Extubation after general anaesthesia involves removal of the endotracheal tube. This is done
      by either applying suctioning or applying positive pressure to the endotracheal tube. My
      study aims at identifying which technique is superior to the other.
    

Intervention name(s): Endotracheal extubation with suctioning; Endotracheal extubation with positive pressure
Intervention type(s): Procedure; Procedure
Intervention description(s): General anestheisa is maintained with an endotracheal tube. At the end of anesthesia, the endotracheal tube is removed by applying suctioning.; General anesthesia is maintained with an endotracheal tube. At the end of anesthesia, the endotracheal tube is removed by applying positive pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Efficacy of Different Versions of the Best Possible Self Intervention
Condition: General Population
Study type: Interventional

Summary: 
      The aim of this study is to analyze the efficacy of several variations of an already
      validated Positive Psychology Intervention (PPI) called Best Possible Self, using Information
      and Communication Technologies (ICT) in general population. Participants are randomly
      assigned to one of 4 conditions: BPS PAST condition, BPS PRESENT condition, BPS FUTURE
      condition, and CONTROL condition (daily activities).
    

Detailed description: 
      Intervention lasts 7 days. Participants come to the laboratory the first day, they fill up
      assessment questionnaires and practice the assigned exercise. Then, they practice the
      assigned exercise for 6 more days at home.

      The main hypothesis is that all three experimental conditions will enhance wellbeing
      comparing to the control condition.
    

Intervention name(s): BPS PAST; BPS PRESENT; BPS FUTURE; CONTROL
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Best Possible Self; Positive Intervention; Optimism
A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)
Condition: HIV-1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral
      therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human
      immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a
      safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1
      ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5
      log (base10) copies/mL.
    


Intervention name(s): 1 mg islatravir; 2 mg islatravir; 10 mg islatravir; 30 mg islatravir; 0.5 mg islatravir; 0.25 mg islatravir
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of 1 mg islatravir administered following ≥8 hour fast; Single oral dose of 2 mg islatravir administered following ≥8 hour fast; Single oral dose of 10 mg islatravir administered following ≥8 hour fast; Single oral dose of 30 mg islatravir administered following ≥8 hour fast; Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast; Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast
Other intervention name(s): MK-8591; MK-8591; MK-8591; MK-8591; MK-8591; MK-8591
Intervention MeSH terms: Islatravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC)
      evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering
      therapy.
    

Detailed description: 
      Eligible participants with screening central laboratory low-density lipoprotein cholesterol
      (LDL-C) values ≥ 75 mg/dL (1.9 mmol/L) were instructed to follow National Cholesterol
      Education Program (NCEP) Adult Treatment Panel III (ATP) Therapeutic Lifestyle Changes (TLC)
      diet and were assigned to 1 of the following 4 background lipid-lowering therapies for a
      4-week stabilization period based upon their screening LDL-C and its distance from the
      individual's required goal as stipulated by their NCEP ATP III risk category:

        1. no drug therapy required - diet alone

        2. low dose drug therapy required - diet plus atorvastatin 10 mg orally (PO) once daily
           (QD)

        3. high dose drug therapy required - diet plus atorvastatin 80 mg PO QD

        4. maximal drug therapy required - diet plus atorvastatin 80 mg PO QD plus ezetimibe 10 mg
           PO QD.

      If the participant met entry criteria at the end of the lipid stabilization period they were
      randomized 2:1 to receive evolocumab 420 mg or placebo subcutaneously once a month for 52
      weeks in addition to their background therapy.
    

Intervention name(s): Evolocumab; Placebo; Atorvastatin; Ezetimibe; Diet Only
Intervention type(s): Biological; Biological; Drug; Drug; Other
Intervention description(s): Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month; Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.; Background lipid lowering therapy: ezetimibe 10 mg orally once a day; Diet only, no lipid lowering background drug given
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Atorvastatin; Ezetimibe; Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cholesterol; High Cholesterol; Elevated Cholesterol; Raised Cholesterol
Bevacizumab Therapy for Brain Arteriovenous Malformation
Condition: Brain Arteriovenous Malformation
MeSH terms: Hemangioma; Arteriovenous Malformations; Congenital Abnormalities
Study type: Interventional
Phase: Phase 1

Summary: 
      Bevacizumab Therapy for brain arteriovenous malformation that is not amenable to surgical
      intervention.
    

Detailed description: 
      Brain AVMs are relatively rare, though their potential for ICH along with the existence of
      effective treatments makes their diagnosis and management essential to the community. The
      2-4% annual incidence of such secondary ICH creates controversy regarding treatment for
      asymptomatic patients. Brain AVMs thus require multidisciplinary evaluation for optimal
      management especially for surgical grades III - V lesions that often require some combination
      of embolization, microsurgery, and/or radiosurgical treatment. Currently there is no
      designated medical therapy for bAVM, though there is growing animal and human evidence
      supporting a role for bevacizumab to reduce the size of AVMs in the brain and liver,
      respectively. This proposal is a pilot study to assess the efficacy and safety of bevacizumab
      in humans with bAVMs.
    

Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): Bevacizumab dosing of 5mg/kg q 2 weeks for 12 weeks (2.5 mg/week).
Other intervention name(s): avastin
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment