bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection
Condition: Haemodynamic Stability
MeSH terms: Goiter
Study type: Interventional
Phase: Phase 4

Summary: 
      Anesthesia for toxic goiter removal is a challenging because of of hemodynamic instability
      especially during induction, intubation, manipulations of the gland, after removal of the
      gland and during emergence. So, hemodynamic stability is required all through the operation
      and even in the first 12 hours of the postoperative period to protect against complications
      e.g., hypertension, tachycardia, myocardial ischemia, bleeding and thyrotoxic crisis.Mg
      sulphate used in blunting pressor response during laryngoscopy and intubation. Also it was
      used in controlled hypotension technique. Also it was reported in decreasing postoperative
      nausea, vomiting, shivering and postoperative complications compared to controlled group.
    

Detailed description: 
      Patients and Methods:

      After obtaining the approval of the Ethical Committee number (R68) of Al Fayoum University
      Hospitals and written informed consent from the patients, sixty (60) patients ASA ǀ &ǁ
      patients of both sex aging 20-70 years (with primary or secondary thyrotoxic goiter and will
      be presented for thyroidectomy) will be allocated into one of two groups: Group (M) n=30 will
      receive Mg So4 pre-induction as an intravenous bolus 20mg/kg over 10 minutes and maintenance
      dose intraoperative 5/mg/kg/h intravenous and discontinued just before the end of the
      surgery. Group (S) n=30 will receive saline in equal volume. The surgeon , anesthesiologist
      and the person who will collect the data will be blinded for the prepared solution. The
      solution will be prepared by an expert anesthesia nurse.
    

Intervention name(s): MgSO4
Intervention type(s): Drug
Intervention description(s): Group (M) n=30 will receive Mg So4 pre-induction as an intravenous bolus 20mg/kg over 10 minutes and maintenance dose intraoperative 5/mg/kg/h intravenous and discontinued just before the end of the surgery. Group (S) n=30 will receive saline in equal volume. The surgeon , anesthesiologist and the person who will collect the data will be blinded for the prepared solution. The solution will be prepared by an expert anesthesia nurse.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: sixty (60) patients ASA ǀ &ǁ patients of both sex aging 16-78 years (with primary or secondary thyrotoxic goiter and will be presented for thyroidectomy) will be allocated into one of two groups: Group (M) n=30 will receive Mg So4 pre-induction as an intravenous bolus 20mg/kg over 10 minutes and maintenance dose intraoperative 5/mg/kg/h intravenous and discontinued just before the end of the surgery. Group (S) n=30 will receive saline in equal volume.
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Thyrotoxic goiter; heamodynamics; magnesium sulphate
A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Condition: Parental/Caregiver Anxiety; Child's Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam
      and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time
      of separation, and ease of mask acceptance at induction in children. Subjects will be
      randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to
      surgery. No placebo will be administered in this study. Subjects will be male and female
      children between 2 and 9 years of age. In total, subject participation will last
      approximately the duration of their preoperative, perioperative, and immediate postoperative
      period. A member of the research team will recruit subjects preoperatively in the operating
      room holding area prior to surgery. Consent will take place at the time of recruitment in the
      preoperative holding area following a detailed explanation of the study and medications
      involved in the study. Participants will be of ASA (American Society of Anesthesiologists)
      class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to
      remain inpatient for at least 23 hours postoperatively.
    


Intervention name(s): zolpidem; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Zolpidem will be given one time at 0.25 mg/kg pre-operatively
Other intervention name(s): ambien; versed
Intervention MeSH terms: Midazolam; Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pre-medication; Pre-operative anxiety
Effect of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The study tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health
      including bone mineral density, bone turnover markers, and osteocyte biomarker in patients
      with type 2 diabetes (T2DM).
    

Detailed description: 
      Women with T2DM exhibit normal or higher bone mineral density (BMD) for their age, but with
      approximately twice the overall risk of bone fragility compared with nondiabetic subjects.
      Known the apparent association between T2DM and the risk of bone fragility, examining the
      effects of commonly used oral antidiabetic agents; such as MET and thiazolidinediones (TZDs;
      for example rosiglitazone [ROS] or PIO), on BMD and/or bone turnover is of great clinical
      relevance for both diabetic patients and their treating physicians. Recent clinical trials,
      showed that women treated with ROS had higher risk of bone fragility and self-reported
      adverse events. Similarly, women on long-term treatment with PIO for T2DM experienced higher
      incidence of distal extremity fractures. TZDs are agonists of the nuclear transcription
      factor peroxisome proliferator- activated receptor-γ (PPAR-γ) which increase insulin
      sensitivity and improve glycemic control in T2DM. PPAR (γ) acts also as a molecular factor
      that favours adipogenesis over osteoblastogenesis of mesenchymal stem cells. The latter was
      suggested as a potential mechanism for the effects of TZDs on bone among others. In humans,
      TZDs decrease BMD and increase bone fragility risk. This study tests whether pioglitazone as
      compared to MET (both are commonly used in the treatment of T2DM in Saudi Arabia and other
      countries) affects bone health including bone mineral density, bone turnover markers, and
      osteocyte biomarker in patients with T2DM.
    

Intervention name(s): Pioglitazone; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg/daily for 12 months; 850 mg/daily for 12 months
Other intervention name(s): Actos; Glucophage
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pioglitazone; metformin; hyperglycemic agents; physiological effects of drugs; bone health
A Study Of Zy-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Double Blind, Parallel, Placebo-Control, Study Of ZY-19489 Administered Via
      Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult
      Human Subjects aged between 18-55 years old (Both Inclusive).
    

Detailed description: 
      Study will conduct in two parts. In Part 1; single cohort of 8 subjects. Subjects will be
      enrolled within a 28 day screening period to ensure subjects meet all the inclusion criteria
      and none of the exclusion criteria. Subjects will be randomized in a ratio of 6:2 to receive
      single dose of ZY-19489 or placebo orally after an overnight fast of at least 10 hours.

      In Part 2: study each cohort containing eight subjects will be given either a ZY19489 capsule
      or placebo for three consecutive days. Total three cohorts are planned in this study. Dose
      escalation will be performed for subsequent cohorts.
    

Intervention name(s): ZY19489 Capsule; Placebo Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Two part study with single and multiple dose; Two part study with single and multiple dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Malaria
Efficacy and Safety of Sertraline in the Treatment of Maintenance Hemodialysis Patients With Depression
Condition: Efficacy, Team; Adverse Reaction to Drug
MeSH terms: Drug-Related Side Effects and Adverse Reactions; Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      Depression is a common mental disorder in patients undergoing maintenance hemodialysis (MHD),
      which increases the risk of cardiovascular events, hospitalization rates, and mortality, but
      has not received enough attention from patients and medical staff. Sertraline is a selective
      serotonin reuptake inhibitor with fewer adverse reactions and higher safety compared to other
      antidepressants. This study aims to investigate the efficacy and safety of sertraline in
      patients undergoing MHD with depression.

      This study used a randomized controlled design and evaluated the depression status of the
      patients using the Hamilton Depression Scale (HAMD). MHD patients with comorbid depression
      were recruited and divided into the treatment group and the control group. The treatment
      group received sertraline for antidepressant therapy, while the control group did not receive
      any antidepressant medication. To investigate the efficacy and safety of sertraline before
      and after intervention.
    

Detailed description: 
      The HAMD, the Medication Adherence Report Scale-5 (MARS-5), the Mini Nutritional Assessment
      short-form (MNA-SF) and the Kidney Disease Quality of Life-36 (KDQOL-36) scales were used to
      evaluate changes in depression status, quality of life, medication adherence and nutritional
      status before and after the intervention. Clinical and laboratory indicators were collected
      before and after the intervention. Adverse reactions during the intervention were also
      recorded.

      The initial dose ranged from 25 to 50 mg, taken orally once daily, and the dosage was
      adjusted based on the patient's response to the medication. In the control group, no
      antidepressant treatment was given.
    

Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention description(s): The initial dose ranged from 25 to 50 mg, taken orally once daily, and the dosage was adjusted based on the patient's response to the medication.
Other intervention name(s): Conventional treatment
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis; Depression; Sertraline; Efficacy; Safety
Obesity and Nonalcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Obesity
Study type: Interventional

Summary: 
      The primary goal of this study is to provide a better understanding of: 1) the pathogenesis
      and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2)
      the effect of marked weight loss on the histologic and metabolic abnormalities associated
      with NAFLD. The following hypotheses will be tested:

        1. obesity causes hepatic fat accumulation because of excessive fatty acid release from fat
           tissue and increased free fatty acid availability,

        2. increased hepatic (liver) fat content causes insulin-resistant glucose (sugar)
           production by the liver and altered liver protein synthesis,

        3. increased hepatic fat content causes increased lipid (fat) peroxidation, hepatic
           inflammation, necrosis and fibrosis, and

        4. marked weight loss improves NAFLD once patients are weight stable.
    

Detailed description: 
      Obesity is a major risk factor for non-alcoholic fatty liver disease (NAFLD), which
      represents a spectrum of liver diseases. NAFLD is a major health problem in the US because of
      its high prevalence and causal relationship with serious liver abnormalities. However, the
      mechanism(s)responsible for developing NAFLD in obese persons and the effects on liver
      function are not known. This gap in knowledge has made it difficult to identify effective
      therapy. The results from these studies will lay the groundwork for the development of novel
      therapeutic interventions for NAFLD in obese patients.
    

Intervention name(s): Niacin; fenofibrate; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects randomized to Niacin therapy will be treated with Niacin at night for 16 wks to reduce plasma free fatty acid concentrations. The dose of medication will be gradually increased: 500 mg/day during week 1, 1000 mg/day during week 2, 1500 mg/day during week 3, and 2000mg/day during weeks 4-16.; Subjects randomized to fenofibrate will be treated with 200 mgs per day for eight weeks.; Subjects randomized to placebo will be treated with one placebo pill per day for eight weeks.
Other intervention name(s): niaspan; Tricor
Intervention MeSH terms: Niacin; Fenofibrate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: non-alcoholic fatty liver disease; obesity; fatty liver disease
Brain-Gut Interactions in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      The primary aims for this research are to 1) characterize brain changes in patients with CD
      compared to age and gender-matched controls and 2) relate these brain changes to measures of
      disease activity and pain severity.
    

Detailed description: 
      Brain-gut interactions have been studied in chronic pain conditions of the gastrointestinal
      (GI) tract such as irritable bowel syndrome (IBS) and chronic pancreatitis. These studies
      suggest that alterations in the brain-gut axis may relate to disease severity and pain
      perception. Inflammatory bowel disease (IBD) is a chronic inflammatory disorder characterized
      by periods of disease activity and periods of disease quiescence. Crohn's disease (CD) is one
      of the two major subtypes of IBD. Patients with CD typically experience abdominal pain when
      the disease is active; however, many also report experiencing pain in the absence of
      objective evidence of inflammation. Alterations in brain-gut interactions may explain the
      perception of pain in these patients. Currently, there is a paucity of data regarding brain
      changes in patients with IBD and CD, specifically. We are proposing a pilot study to
      characterize brain-gut interactions of disease activity and pain modulation mechanisms in
      patients with IBD using advanced neuroimaging tools.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 18 years of age or older diagnosed with CD, as determined by endoscopy or
        radiographic imaging, will be targeted for enrollment. Patients with CD in symptomatic
        remission as defined by a Harvey-Bradshaw score of 3, will be eligible.
A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the use of 2 different Prothrombin Complex
      Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of
      rivaroxaban in healthy adult volunteers.
    

Detailed description: 
      This is a single-center, open-label (volunteers and staff will know the identity of all
      treatments), randomized (volunteers assigned to treatment by chance) study in healthy adult
      volunteers to assess the effects of 2 different Prothrombin Complex Concentrates (PCCs)
      (drugs that act to control bleeding) on the pharmacodynamics (ie, the study of the
      biochemical and physiological effects of a drug on the body) of rivaroxaban (a drug that acts
      to prevent the formation of blood clots). Eligible volunteers will receive treatment with
      rivaroxaban administered orally (by mouth) on Days 1-4. On Day 5, rivaroxaban will be
      administered orally before the randomized intravenous (IV) (into the vein) administration of
      1 of 3 treatments: Profilnine SD (a 3-factor PCC), Beriplex P/N (a 4-factor PCC), or saline.
      Blood samples will be collected from healthy volunteers during the study to assess the
      activity of rivaroxaban. Safety will be monitored throughout the study. The total length of
      participation in the study for each volunteer will be approximately 28 days (includes a
      21-day Screening Period and a 7-day Treatment Period).
    

Intervention name(s): Rivaroxaban 20 mg twice daily; Rivaroxaban 20 mg once daily; Profilnine SD; Beriplex P/N; Saline
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): One rivaroxaban 20 mg tablet administered twice a day (b.i.d.) for 4 days (Days 1-4). Interpretation by CTRL: Concentration type = Exact; Number = 20; unit=mg; route: oral use for 4 days.; One rivaroxaban 20 mg tablet administered once daily on Day 5. Interpretation by CTRL: Concentration type = Exact; Number = 20; unit=mg; route: oral use for 1 day.; Single bolus dose of Profilnine SD 50 IU/kg administered by intravenous (IV) injection on Day 5. Interpretation by CTRL: Concentration type = Exact; Number = 50; unit=IU/kg; route: intraveous use.; Single bolus dose of Beriplex P/N 50 IU/kg administered by intravenous (IV) injection on Day 5 Interpretation by CTRL: Concentration type = Exact ; Number = 50; unit=IU/kg; route : intravenous use; Single 100 cc bolus of saline administered by intravenous (IV) injection on Day 5. Interpretation by CTRL: Concentration type = Exact ; Number = 100; unit=cc; route : intravenous use use.
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy; Rivaroxaban; JNJ-39039039; BAY59-7939; Prothrombin Complex Concentrate (PCC)
Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to expand our understanding of the intergenerational
      transmission of cognitive risk for childhood anxiety disorders by examining whether changes
      in maternal interpretations of situations result in changes in child interpretations and
      child anxiety.
    


Intervention name(s): Positive Interpretation Bias Training; Neutral Interpretation Bias Training
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
[18F]SF12051 for Imaging the 18-kDa Translocator Protein (TSPO) in Brain and Whole Body of Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Inflammation in the brain plays a role in many diseases. Being able to measure inflammation
      in a person s brain might help to diagnose and treat these diseases. One protein (TSPO)
      appears in higher numbers when inflammation affects the brain. To see TSPO when a person s
      body is scanned, researchers need a substance called a radiotracer that will attach to this
      protein and no other molecules.

      Objective:

      This study will test whether a new radiotracer ([18F]SF12051) can make TSPO appear on PET
      scans of a person s brain and body.

      Eligibility:

      Healthy people aged 18 and older.

      Design:

      This study requires 2 to 4 visits to the clinic.

      All participants will be screened. They will have a physical exam. They will have blood tests
      and a test of their heart function.

      Some participants will have a positron emission tomography (PET) scan of the whole body. The
      radiotracer will be injected through a tube (catheter) placed in a vein in the arm. The PET
      scanner is a machine shaped like a doughnut. Participants will lie on a bed that slides in
      and out of the scanner. The scan will take about 2 hours.

      Some participants will have a PET scan of just their head. After they are injected with the
      radiotracer, they will lie on a bed with their head in the scanner. Blood will be drawn from
      a catheter in the wrist during the scan.

      Some participants will have a magnetic resonance imaging (MRI) scan of the brain. They will
      lie on a narrow bed that slides into a tube.

      ...
    

Detailed description: 
      Study Description:

      This study is intended to provide information on the novel [18F]SF12051 radioligand and its
      ability to localize and measure TSPO in the brain and body of healthy individuals.

      Objectives:

      Primary Objective: To study the brain uptake of [18F]SF12051 and perform kinetic modeling of
      the [18F]SF12051 in the three different TSPO genotypes.

      Secondary Objectives: To study the brain retest characteristics, biodistribution and
      dosimetry of [18F]SF12051 in healthy subjects.

      Endpoints:

      Primary Endpoint: The distribution volume of the radioligand and stability over time
      calculated with compartmental modeling, attention paid to differences in mean distribution
      volumes between TSPO genotypes for determining genotype sensitivity.

      Secondary Endpoints: Retest variability and reliability and organtime- activity curves to
      determine biodistribution and dosimetry.
    

Intervention name(s): 18F-SF12051
Intervention type(s): Drug
Intervention description(s): Injected IV followed by PET scanning
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PET Imaging; Neuroinflammation; Tspo