bioihbjkbjnl/mcl2 huggingface dataset:
Metformin for Treatment Antipsychotic-induced Metabolic Syndrome in Bipolar Disorder Patients
Condition: Bipolar Disorder
MeSH terms: Metabolic Syndrome; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test the efficacy of metformin for treatment
      antipsychotic-induced metabolic syndrome in bipolar disorder patients.
    

Detailed description: 
      Patients aged 18 to 45 years with bipolar disorder diagnosed in accordance with criteria set
      out in the Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
      were eligible for our study, and the Structured Clinical Interview of DSM-IV Axis I Disorders
      (SCID-1), Clinical Version, was used during the screening phase. To be qualified for this
      study, patients had to meet, 1) have experienced metabolic syndrome as defined below within
      the first year of treatment with one of four antipsychotics-clozapine, olanzapine,
      risperidone, or sulpiride; 2) had been either discharged from inpatient units or first visit
      in the outpatient clinic in the 12 months before enrollment, and their glucose and lipid
      levels, weight, blood pressure and antipsychotic treatment were documented; 3) had taken
      single antipsychotic medication, with no more than a 25% change in dosage, over the past 3
      months. All participants had to be under the care of a parent or another adult caregiver who
      monitored and recorded the intake of medication daily during the trial to assure the
      adherence to medication. Patients were excluded from the study if there was evidence of liver
      or renal dysfunction, cardiovascular disease, or diabetes mellitus; or if they were pregnant
      or lactating; or had any psychiatric diagnosis other than schizophrenia.

      The primary outcome was the level of LDL-C or the percentage of patients who had LDL-C
      greater or equal 3.37mmol/L (130mg/dl). The secondary outcomes were fasting triglyceride,
      total cholesterol, HDL-C, insulin and glucose levels, insulin resistance index, body weight
      and body mass index, as well as incidence of adverse events. Body mass index was calculated
      as weight in kilograms divided by height in meters squared. Insulin resistance index was
      calculated based on the homeostasis model assessment as: fasting insulin (mIU/L)×fasting
      glucose (mmol/L)/22.5. the assessment was conducted by members of a trained independent
      research team connected to the centre. Inclusion or exclusion was decided by the team. After
      a complete description of the study to the subjects, written informed consent was obtained in
      accordance with National Health and Medical Research Council guidelines.
    

Intervention name(s): Metformin; Starch
Intervention type(s): Drug; Other
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metformin; antipsychotic-induced metabolic syndrome; bipolar disorder
Study the Effect of Electroacupuncture on Prevention and Treatment of Hypotension After Intraspinal Anesthesia
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to assess the prevention and treatment effect of transcutaneous
      acupoint electrical stimulation on hypotension after intraspinal anesthesia.
    

Detailed description: 
      After being informed about the study and potential risks, all patients giving written
      informed consent will undergo the doctors' and researchers' examination to determine
      eligibility for study entry. At beginning of the study, patients who meet the eligibility
      requirements will be randomized in a open manner（participant and electroacupuncture
      executor）in a 1:1 ratio to TEAS group (10 minutes before intraspinal anesthesia, bilateral
      Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical
      stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of
      the participant, and the stimulation last until 30 minutes after subarachnoid administration)
      or Control group (Electrodes are connected at bilateral Neiguan points and Zusanli points 10
      minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation
      is given, the duration is the same as that of the TEAS group).
    

Intervention name(s): transcutaneous acupoint electrical stimulation
Intervention type(s): Other
Intervention description(s): The corresponding transcutaneous acupoint electrical stimulation is given to different groups before spinal anesthesia, which last from 10 minutes before anesthesia to 30 minutes after subarachnoid administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: TEAS group: 10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration.
Control group: Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group.
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Regional Lung Deposition of Inhaled Saline Using the tPAD Device
Condition: Lung Diseases
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      Purpose: Characterize the depositional attributes of a specialized trans-nasal aerosol
      delivery device in healthy people using clinical measurements of mucociliary clearance.

      Procedures (methods): 14% hypertonic saline (HS) aerosol containing the radio tracer
      Tc99m-sulfur colloid will be delivered via the tPAD and compared to the well characterized
      PARI LC Star nebulizer (7% HS) using planar gamma scintigraphy (i.e. particle clearance). The
      fraction of sulfur colloid particles that clear over the ensuing 24 hours with each device
      will indicate the fraction deposited in conducting airways.
    

Detailed description: 
      Purpose: This is an early device characterization study to define the fraction of delivered
      aerosol generated by a novel nebulizer (tPAD) that deposits in conducting airways.

      Design: Open label, cross-over design, using a standard oral nebulizer (PARI LC Star) as a
      comparator. The order of visits will be randomized.

      Methods: Gamma scintigraphy will be performed following use of each device on separate study
      visits.

      Primary Outcome: Fraction of inhaled particles that clears over 24 hours.
    

Intervention name(s): tPAD Device; PARI LC Star Nebulizer
Intervention type(s): Device; Device
Intervention description(s): A novel, transnasal aerosol generator; Standard oral nebulizer
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Healthy subjects will use each nebulizer device in random order at separate study visits.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Healthy Volunteers
Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
Condition: Social Anxiety Disorder; Social Phobia; Alcohol Use Disorder; Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism; Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether an SSRI, paroxetine, improves social anxiety
      symptoms and alcohol use in individuals who drink to cope with social anxiety disorder.
    

Detailed description: 
      Social anxiety disorder (also known as social phobia) is an Axis I anxiety disorder
      characterized by intense fear and avoidance of social or performance situations in which one
      might be scrutinized. Its onset is typically in the early teen years. It is the third most
      common mental disorder in the United States, exceeded in prevalence only by depression and
      alcoholism. Approximately 20% of the individuals with social anxiety disorder have alcohol
      problems. Anecdotal and empirical evidence suggests that alcohol is used by some socially
      anxious individuals to self-medicate anxiety symptoms, a practice that could lead to alcohol
      abuse and/or dependence. The proposed project further explores the self-medication hypothesis
      through the use of a double-blind, randomized, placebo-controlled clinical trial. Paroxetine
      (a selective serotonin reuptake inhibitor) is the drug to be used in the study. Individuals
      who drink alcohol to cope with social anxiety symptoms and who meet DSM-IV criteria for the
      dual-diagnoses of social anxiety disorder and alcohol use disorders will be enrolled in the
      trial. All individuals will be seeking treatment for social anxiety disorder. The treatment
      phase will last 16 weeks. Dosing will start at 20 mg/day (paroxetine or placebo) and will
      increase gradually to a maximum dose of 60 mg/day. Each week during treatment and at the end
      of the trial, assessments will be made with standard instruments to determine the effect of
      paroxetine (versus placebo) on social anxiety severity, alcohol use, and more specifically,
      the intentional use of alcohol to cope with social anxiety symptoms. Additionally, 6 month
      and 12 month follow-up interviews will be conducted. The overarching hypothesis is that
      because paroxetine will improve social anxiety severity, alcohol use and/or alcohol use for
      coping will also be reduced in the paroxetine-treated group.
    

Intervention name(s): Paroxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day; treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
Other intervention name(s): paxil; sugar pill
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pharmacotherapy; Self medication
Effects of Spironolactone Combination Therapy on Proteinuria, Kidney Function, and Blood Pressure
Condition: Type 2 Diabetes Mellitus; Diabetic Nephropathy; Essential Hypertension
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Essential Hypertension; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The detrimental effects of aldostrone are not adequately arrested by the use of angiotensin
      converting enzyme (ACE), angiotensin II receptor blocker (ARB) or a combination of both.
      Recent evidence has provided robust evidence that aldostrone escape plays an important role
      in this regard. It is believed that aldostrone escape occurs quite commonly with reports
      indicating prevalence rates as high as 22% with ARBs and 40% with ACE inhibitors. In a trial
      of patients with diabetes and hypertension it was shown that treatment of aldostrone escape
      with spironolactone 25 mg daily for three months significantly reduces proteinuria. A number
      of other trials have similarly observed that addition of spironolactone to an ACE inhibitor
      based regimen provides additional benefits on proteinuria reduction, blood pressure control,
      and prevention of glomerular filtration rate (GFR) decline. Most of the available trials in
      this regard are of short duration (e.g. three months), and have added spironolactone to an
      ACE or ACE+ARB based regimen (the so-called triple blockade). Currently, evidence evaluating
      efficacy of a combined ARB+spironolactone regimen compared with conventional double RAS
      blockade (i.e. ACE+ARB) is lacking. Hence, this randomized open label trial was initiated to
      determine the effects of addition of spironolactone 25 mg daily to losartan over a period of
      18 months.
    


Intervention name(s): spironolacone 25 mg tablets added to losartan
Intervention type(s): Drug
Intervention description(s): spironolactone 25 mg once daily added to losartan
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Suprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.
Condition: Diabetic Macular Edema of Left Eye
MeSH terms: Macular Edema; Edema
Study type: Interventional

Summary: 
      Background Retinal vascular disorders, such as diabetic retinopathy, hypertensive
      retinopathy, retinal hemorrhage, and retinal vein occlusion are significant causes of vision
      impairment and blindness worldwide. Diabetic retinopathy (DR) is the most common retinal
      vascular disorder and is the leading cause of vision loss among patients aged 25 to 74 years.

      Aim to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus
      Posterior Subtenon Triamcinolone acetonide alone versus suprachoroidal triamcinolone in the
      management of diabetic macular edema.
    


Intervention name(s): Triamcinolone Acetonide; Formulated Triamcinolone
Intervention type(s): Drug; Drug
Intervention description(s): Triamcinolone Acetonide is a corticosteroid that has antiangiogenic and anti-inflammatory effects that can inhibit the expression of VEGF and other proinflammatory cytokines, improving best-corrected visual acuity and decreasing central retinal thickness (CRT) in patients with macular edema; Formulated Triamcinolone: is triamcinolone and sodium hyaluronate and chondroitin sulfate
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D Supplementation for Extremely Preterm Infants
Condition: Vitamin D Deficiency; Preterm Infants; Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Premature Birth; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study hypothesis states that giving early enteral Vitamin D supplementation to preterm
      infants will decrease respiratory morbidity in extremely preterm infants.
    

Detailed description: 
      After informed consent obtained, infants will be randomized using computer-generated
      stratified randomization codes by the pharmacy. Clinicians, researcher, and primary
      caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or
      to a placebo concurrent control.

      Early vitamin D supplementation/placebo will be initiated within the first 7 days after
      birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D:
      either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started
      within 72 hours of enteral feeds being initiated and will continue until postnatal day 28.
      After this period of supplementation, routine supplementation will be conducted in all
      groups.

      Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D
      [25(OH)D]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured
      on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium
      excretion if high serum calcium concentrations are found.

      Supplementation will be discontinued and infant will exit the study if surgical necrotizing
      enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations >60ng/mL
      (>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If
      infant made briefly NPO (<24h) for feeding intolerance, suspected sepsis,
      hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D
      will not be discontinued.

      All infants will be followed to discharge for primary, secondary outcomes as well as adverse
      events.
    

Intervention name(s): Cholecalciferol; Cholecalciferol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours. Other 3 doses will be placebo (sterile water). Duration of 28 postnatal days; 800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours. Duration of 28 postnatal days; Sterile water 0.5ml given orally every 6 hours. Duration of 28 postnatal days
Other intervention name(s): Vitamin D; Vitamin D
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; Newborn; Preterm; Supplementation; Respiratory
Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the
      decline in kidney function in participants with moderate to advanced diabetic kidney disease
      (DKD).
    

Detailed description: 
      Following the screening period, eligible participants will enroll into a Run-in period of at
      least 5 weeks and receive placebo to match SEL for at least 1 week and then SEL for at least
      4 weeks. After completing Run-in period, eligible participants will be randomized and receive
      either SEL or placebo to match SEL for at least 48 weeks.
    

Intervention name(s): SEL; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet administered orally once daily; Tablet administered orally once daily
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Participants received Run-in and Randomized treatments sequentially and in the Randomized Phase, the treatments were assigned in parallel.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acceleration of Recovery From General Anesthesia - Efficacy of Isocapnic Hyperpnoea in Obese Patients Undergoing Isoflurane Anesthesia
Condition: Recovery Time From Isoflurane Anesthesia in Obese Patients
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Faster recovery from anesthesia is important for obese patients because they are at high risk
      of respiratory complications following tracheal extubation. Isoflurane has several properties
      that make it a preferable agent for anesthesia in obese patients. Its main limitation is a
      longer recovery time due to slower elimination in comparison to other agents. Elimination of
      isoflurane from the lungs can be accelerated by increasing in patient's minute ventilation,
      which decreases the level of CO2 in blood (hypocapnia).Isocapnic Hyperpnoea (IH) is a method
      allowing increased ventilation and therefore enhancement of the elimination of inhalation
      agents while maintaining a normal blood CO2 level. The investigators will compare recovery
      time from isoflurane anesthesia in obese patients during standard anesthesia management
      protocol (control) to a group treated with IH.
    


Intervention name(s): Isocapnic Hyperpnoea
Intervention type(s): Other
Intervention description(s): IH is a method of increasing alveolar ventilation (Va) while preventing the unwanted hypocapnia by addition of CO2 to the inhaled mixture.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Isocapnic hyperpnoea; obesity; isoflurane; Recovery of obese patient from isoflurane anesthesia
Local Anesthetic Concentration and Nerve Block Duration
Condition: Peripheral Nerve Block
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Local anesthetic (LA) concentration and nerve block duration is sparsely
      described in a heterogenic study mass.

      Aim: To investigate the effect of LA concentration on peripheral nerve block duration in
      healthy volunteers.

      Methods: Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of
      LA (ropivacaine) using a constant dose.

      Primary endpoint: Sensory nerve block defined by insensitivity towards cold.
    

Detailed description: 
      Background:

      Important factors for a safe and successful nerve block include volume, dose and
      concentration of local anesthetic (LA). Knowing the duration of peripheral nerve blocks is
      important to prevent pain breakthrough. With the advancements in ultrasound (US)-guided nerve
      block techniques it has been possible to substantially reduce the amount of LA required to
      perform a successful nerve block. This has reduced the risk of systemic toxicity. However,
      lowering LA volume may reduce nerve block duration, but the extent of this is sparsely
      described in a heterogenic study mass.

      Diluted and large volumes of LA seem to correlate with nerve block duration. Furthermore,
      increasing LA concentration seems to increase the level of motor block, but not the block
      duration. A long-lasting nerve block without dense motor block is preferable for optimized
      pain control and better opportunities to rehabilitate/ambulate.

      Aim:

      To investigate the effect of LA concentration on common peroneal nerve block duration in
      healthy volunteers.

      Methods:

      Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA
      (ropivacaine) using a constant dose (10mg).

      Primary outcome: Duration of sensory nerve block defined by insensitivity towards cold.

      Secondary outcome: Duration of motor nerve block defined by either paresis or paralysis.

      Explorative outcomes: Degrees of sensory and motor nerve block; Onset times of sensory and
      motor nerve block; Length of neural exposure to LA.
    

Intervention name(s): Ropivacaine
Intervention type(s): Drug
Intervention description(s): Perineural injection using a peripheral nerve block catheter and a constant infusion rate (10mL/h)
Other intervention name(s): Isotonic saline (natriumchloride)
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science