bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection
Condition: General Anesthesia With Propofol
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to compare the effectivity between ondansetron 8 mg and lidocain 40 mg in
      preventing pain due to propofol injection
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study.
      Non-invasive blood pressure (NIBP) monitor, ECG and pulse-oximeter was set on the subjects in
      the operation room. After a tourniquet made from NIBP cuff were inflated, subjects were given
      either Ondansetron 8 mg or Lidocain 20 mg intravenously, then the tourniquet was set off.
      Hemodynamic data was recorded. Propofol 1 mg/kg of body weight (BW) injection was given.
      Verbal rating scale was used to measure pain at 0 s, 5 s and 30 s. Data was analyzed using
      Statistical Package for the Social Sciences (SPSS), for numeric data using uni-variate
      analysis and bi-variate analysis. Significant value is p<0.05.
    

Intervention name(s): Ondansetron 8 mg; Lidocain 40 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lidocaine; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: lidocain; ondansetron; pain; propofol
Virtual Reality for Neglect Diagnostics
Condition: Spatial Neglect; Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      Compared to the classical "paper and pencil"-tests, testing patients in our virtual reality
      setup might have a higher sensitivity and specificity.
    


Intervention name(s): virtual reality setup; paper and pencil tests; c-mri
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): testing for neglect in a virtual reality setup; testing for neglect with the classical paper-and-pencil tests; structural and functional (resting state) imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with acute (< 2 wks after stroke), subacute (2 wks- 3 months after stroke)or
        chronic (3- 24 months after stroke)stroke with neglect or hemianopsia.

        Healthy, age-matched controls.
      
Keywords: stroke; neglect; hemianopsia; virtual reality
A Study to Compare COREG CR to COREG CR Fixed-dose Combination in Patients With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Carvedilol controlled release is a marketed drug to treat high blood pressure. This study is
      to compare carvedilol controlled release to carvedilol controlled release plus lisinopril
      (fixed-dose combination) after repeat dosing in patients with high blood pressure. This is to
      make sure that when carvedilol controlled release is given with lisinopril it acts the same
      in the body as when given alone. The study will also assess the safety and tolerability of
      the fixed-dose combination.
    


Intervention name(s): SK&F-105517 (COREG CR FDC)
Intervention type(s): Drug
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension,; carvedilol,; repeat-dosing
A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma
Condition: Exfoliation Syndrome; Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Exfoliation Syndrome; Hypertension; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Glaucoma is the world's the second leading cause of irreversible blindness. The World Health
      Organization (WHO) estimated the incidence of blindness due to glaucoma to be 4.4 million
      people worldwide in 2002. Intraocular pressure (IOP) is the sole proven modifiable risk
      factor for the development and progression of glaucomatous optic neuropathy. Medical therapy
      is aimed at lowering IOP in order to prevent or slow progression.

      Exfoliation syndrome (XFS) is the most common identifiable cause of open-angle glaucoma,
      affecting an estimated 60 to 70 million people worldwide. Approximately two-thirds of
      patients have disease in only one eye on clinical examination; however, XFS is detectable in
      the other eye with conjunctival biopsy. XFS is also a systemic disease, with effects on the
      cardiovascular and cerebrovascular systems.

      Patients with XFS are twice as likely to convert from ocular hypertension to glaucoma.
      Glaucoma in XFS is more severe than primary open angle glaucoma. There is greater diurnal IOP
      fluctuation, greater visual field loss and optic nerve head damage at the time of diagnosis,
      poorer response to medications, more rapid visual field progression and more frequent need
      for surgery.

      Because you meet eligibility criteria for our study, we ask for your consent to participate
      in the study described below. In brief, you will be taking an investigational drug (AR-12286,
      rho-kinase Inhibitor) at either 0.5% or 0.7% once a day for 6 months. This drug is currently
      being tested in patients with primary open-angle glaucoma, but not yet in glaucoma in
      exfoliation syndrome. Because of the mechanism of glaucoma in XFS and the mechanism of action
      of rho-kinase inhibitors, there is reason to think it would be more effective in eyes with
      XFS and glaucoma than in primary open-angle glaucoma (ordinary glaucoma). There will be a
      baseline and study day 1 visit, week 1 visit, month 1 and 3 visit, week 13 visit, month 6
      visit and a week 25 visit; for a total of 7 office visits.
    


Intervention name(s): AR-12286
Intervention type(s): Drug
Other intervention name(s): Rho-Kinase Inhibitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Characterization of Intestinal Microbiota Stability in Preterm Born Neonates
Condition: Necrotising Enterocolitis; Late-Onset Neonatal Sepsis
MeSH terms: Neonatal Sepsis; Enterocolitis; Enterocolitis, Necrotizing
Study type: Observational [Patient Registry]

Summary: 
      Study around very-low birthweight preterm infants at high risk of developing necrotizing
      enterocolitis (NEC) or late-onset sepsis (LOS). Collection of stool and other biological
      samples to assess the strain-level stability of gastrointestinal microbiota in these preterm
      infants who may or may not develop NEC/LOS.
    

Detailed description: 
      This study aims to collect biological samples (stool, stomach fluid, and blood) from preterm
      infants at risk of developing NEC or LOS; as well as environmental samples from infants'
      hospital surroundings (swabs, air), nutritional intake (formula, breastmilk) and samples from
      their family members (faeces, vaginal swab).

      The main focus of the study is to assess strain-level stability of gastrointestinal
      microbiota in these infants and potentially assess the source of disease-causing microbiota
      species/strains.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is represented by infants born at gestational age below 32 weeks (very
        preterm born infants) or with a birthweight below 1500g (very low birthweight infants). It
        is estimated that approximately 100 infants will be enrolled during the study period. As
        the aim is to study stability of the premature microbiota within individual patients, the
        study design precludes the need of control groups.
Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels Volunteers With Elevated LDL Cholesterol Levels
Condition: Cardiovascular Health
Study type: Interventional

Summary: 
      To evaluate the efficacy of daily consumption of a combination of concentrated extracts of
      garlic (Allium sativum L.) and onion (Allium cepa L.) on LDL cholesterol levels in healthy
      volunteers. Parameters related to metabolic syndrome, cardiovascular health and the immune
      system will also be analyzed.
    

Detailed description: 
      It is a controlled, randomized, double-blind, parallel-group nutritional intervention study.

      64 healthy volunteers lwith elevated LDL cholesterol levels but who do not require
      pharmacological treatment will be randomly distributed into 2 equal groups: control group and
      intervention group.

      For 8 weeks the volunteers will take the product immediately after lunch. During that time
      they will maintain their lifestyle and nutritional habits.

      Blood samples will be taken at 0, 2, 4 and 8 weeks. Anthropometric parameters and
      health-related data were also measured.

      Parameters related to lipid metabolism, metabolic syndrome and the immune system will be
      analized.
    

Intervention name(s): Garlic and onion concentrate; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).; Microcrystalline cellulose
Other intervention name(s): AlioCare; Excipient
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Controlled, randomized, double-blind, parallel group nutritional intervention study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Garlic; Onion; LDL cholesterol; Cardiovascular health
A Study of RO5186582 Treatment on Cytochrome P450 (CYP) 3A4 Activity in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-randomized, open-label, five treatment, fixed sequence cross-over study to
      investigate the effect of RO5186582 treatment on CYP3A activity using midazolam as a probe
      CYP3A substrate, and also to assess the pharmacodynamic measures of brain electrical activity
      and sedation to explore the pharmacodynamic interaction between the gama-amino butyric acid
      (GABA)A negative allosteric modulator RO5186582 and the prototypical GABAA positive
      allosteric modulator midazolam. The anticipated study duration is up to nine weeks.
    


Intervention name(s): Midazolam, IV; Midazolam, oral; RO5186582
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 milligrams per milliliter (mg/mL) midazolam solution for IV administration. For a 1 mg dose, the midazolam solution (0.5 mL of 2 mg/mL) will be injected at 2 milligrams per minute (mg/min).; 0.1 mg/mL midazolam for oral administration. For a 5 mg dose, participants will receive 50 mL of 0.1 mg/mL midazolam.; RO5186582 120 mg film-coated release tablet.
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Optimizing Function Outcomes After Bariatric Surgery With Core Stabilization Training: A Randomized Controlled Study
Condition: Bariatric Surgery; Surgery
Study type: Interventional

Summary: 
      Bariatric surgery has been reported to be the most effective treatment option for losing and
      maintaining body weight and improving comorbidities and mortality associated with morbid
      obesity. Nevertheless, even though physical activity is recommended to optimize bariatric
      surgery results. Very little is known, about whether engaging in an exercise program after
      surgery can provide additional improvement in health outcomes. While to date there are
      relatively few researches studied the effect of exercise in patients who have undergone
      bariatric surgery.
    

Detailed description: 
      This study will investigate the effect of core stabilization exercise on patients who
      underwent bariatric suergery.
    

Intervention name(s): Core stabilization training
Intervention type(s): Other
Intervention description(s): Exercise training will be given to the participants in the study group in the form of core training exercises for 8 weeks.
Other intervention name(s): Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bariatric surgery; Core training; Stabilization exercises
Effects of a Vestibular Rehabilitation Maneuver
Condition: Vertigo
MeSH terms: Vertigo
Study type: Interventional

Summary: 
      Rotational maneuver is a vestibular rehabilitation method, performed in a supervised manner.
      Using a rotating chair, subjects are rotated towards the opposite direction of dominant side
      in order to inhibit this side and simultaneously, stimulate the subordinate side. We propose
      that the rehabilitative effect is the result of a decrease in the vestibular imbalance,
      mainly due to a decrease in the response of the dominant vestibular side. Previously, we have
      shown the short-term effects of this maneuver on patients with recent onset vestibular
      imbalance. In the present study, we investigated the long-term effects of the rotational
      maneuver in patients with a history of peripheral vestibular vertigo for at least one year,
      originally confirmed by clinical tests. Our results show a significant improvement which
      lasted for >4 weeks after the end of rehabilitation (i.e., the last time tested). Moreover,
      there seems to be a relationship between the decrease in DP values and a decrease in
      subjective symptoms. We propose that this maneuver can be used as an effective method for
      both short- and long-term rehabilitation.
    


Intervention name(s): rehabilitation maneuver
Intervention type(s): Other
Intervention description(s): rotation in the direction of the weak vestibular response, every 3-7 days over a period of a month. Each rotation lasts about 2 minutes and a total of 3-7 rotations are used per session.
Other intervention name(s): rotatory maneuver
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: vestibular; vertigo; rehabilitation; rotation; balance
Effects of FXR Activation on Hepatic Lipid and Glucose Metabolism
Condition: Metabolic Syndrome; Familial Hypertriglyceridemia; Familial Combined Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipoproteinemia Type IV; Metabolic Syndrome; Hyperlipidemias; Hypertriglyceridemia; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether chenodeoxycholic acid decreases de novo
      hepatic lipogenesis, hepatic fat content, hepatic triglyceride production and plasma
      triglyceride concentrations and improves hepatic glucose metabolism in patients with the
      metabolic syndrome, Familial Hypertriglyceridemia and Familial Combined Hyperlipidemia.
    

Detailed description: 
      Insulin resistance has been found to be the key pathophysiological factor of the metabolic
      syndrome and may precede the onset of impaired glucose tolerance, diabetes and dyslipidemia.
      Recently, nonalcoholic fatty liver disease (NAFLD), has been identified as another feature of
      this syndrome. Importantly, a close relation between liver fat content and hepatic insulin
      sensitivity has been described. We hypothesize that activation of FXR with chenodeoxycholic
      acid decreases hepatic de novo lipogenesis and subsequently hepatic fat content and
      triglyceride production. The decrease in liver fat content will be associated with improved
      hepatic insulin sensitivity and a decrease in hepatic glucose production.

      Patients diagnosed with metabolic syndrome, familial hypertriglyceridemia or familial
      combined hyperlipidemia will be recruited from the the outpatients department of the Division
      of Endocrinology, Diabetology and Clinical Nutrition, University Hospital Basel. Eligible
      patients will be admitted to the CRC for metabolic studies, including baseline blood samples
      for the measurement of hormones, cytokines and adipokines, euglycemic-hyperinsulinemic clamp
      studies for the assessment of glucose turnover and insulin sensitivity and in vivo NMR
      studies to determine intrahepatic and intramyocellular lipid content. Patients will
      alternatively receive chenodeoxycholic acid and placebo. The study population will be
      compared to a group of age, gender and weight matched normolipidemic controls.
    

Intervention name(s): chenodeoxycholic acid; placebo capsules
Intervention type(s): Drug; Drug
Intervention description(s): chenodeoxycholic acid 500 mg capsules tid po; placebo capsules containing mannitol tid po
Intervention MeSH terms: Chenodeoxycholic Acid
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial Evaluating the Combination of Vandetanib and Dasatinib During and After Radiation Therapy (RT) in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
Condition: Diffuse Intrinsic Pontine Glioma
MeSH terms: Glioma; Diffuse Intrinsic Pontine Glioma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I clinical trial evaluating the combination of vandetanib and dasatinib
      during and after radiation therapy (RT) in children with newly diagnosed diffuse intrinsic
      pontine glioma (DIPG).
    

Detailed description: 
      This trial will estimate the maximum safe dose of vandetanib and dasatinib which can be
      administered during the 6 weeks of local RT in children with newly diagnosed DIPG.
    

Intervention name(s): vandetanib and dasatinib
Intervention type(s): Drug
Intervention description(s): Two oral investigational agents (vandetanib [VEGFR2, RET, and EGFR inhibitor] and dasatinib [bcr-abl, PDGFRA and B, src, lck, yes, and c-kit inhibitor] will be administered during and after local RT, which is the only standard therapy for children with DIPG.
Intervention MeSH terms: Dasatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Multiple sclerosis (MS) is a chronic inflammatory disease associated with central nervous
      system (CNS) demyelination and subsequent axonal degeneration. Multiple sclerosis exhibits an
      unpredictable and variable clinical course.

      Multiple sclerosis plaques contain numerous types of cells and infiltrating macrophages have
      been identified to contribute significantly to demyelination in both clinical MS and animal
      models of MS. Granulocyte-macrophage colony-stimulating factor (GM CSF) stimulates
      proliferation and activation of macrophages, monocytes, neutrophils, eosinophils, dendritic
      cells and microglia with subsequent induction of proinflammatory biomolecules.

      Therefore blocking GM CSF activity might be a therapeutic approach for the treatment of MS.
    

Detailed description: 
      Recent clinical studies demonstrated a possible dysregulation of the balance of pro and anti
      inflammatory lymphocytes, which may contribute to the pathogenesis of MS.

      It was shown in animal models of EAE that during the disease effect or phase GM CSF sustained
      neuroinflammation via myeloid cells that infiltrate the CNS proving an essential role of GM
      CSF in encephalitogenicity.
    

Intervention name(s): MOR103; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Anti-GM-CSF monoclonal antibody; Placebo to anti-GM-CSF monoclonal antibody
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means
Condition: Appetitive Aggression
MeSH terms: Aggression
Study type: Interventional

Summary: 
      Heightened levels of aggression are fuelling violent incidents at all levels, especially in
      post-war regions. Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)
      aims to address trauma symptoms along with reactive and instrumental/appetitive aggression to
      encounter the downward cycle of perpetration and enforce a sustainable (re-)integration into
      civil life. In the present study, the investigators provide an adapted version of FORNET to
      former combatants in the North Kivu, Eastern DR Congo. Structured baseline, 3 and 6 month
      follow up interviews will be administered to assess the main outcome measures recent violent
      acts and appetitive aggression.
    

Detailed description: 
      Participants will be recruited through local NGOs and eligible clients randomized to the
      treatment or waitlist control group, respectively. The treatment will be provided by
      supervised local counsellors after a 4-week training. At baseline, 3-month and 6-month follow
      up, sociodemographic data, trauma exposure, perpetrated violent acts, PTSD, recent
      aggression, functionality and drug dependency will be assessed. The interviews will be
      conducted by blind Congolese psychological interviewers after an intensive 3-weeks training
      and continuous supervision.
    

Intervention name(s): FORNET (adapted version)
Intervention type(s): Behavioral
Other intervention name(s): Narrative Exposure Therapy for Forensic Offender Rehabilitation (adapted version)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aggression; Violence; Post-conflict reconstruction; Demobilization; Traumatized offenders