bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Atrophy
Study type: Observational

Summary: 
      Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate
      have not been examined in patients with relapsing forms of multiple sclerosis (MS). As
      patients on long term therapy typically have little or no overt signs of white matter
      inflammatory activity (T2, gad lesions), brain atrophy measures can provide insight into
      whether there is continued progression of MS in these patients. What remains unknown is
      whether patients on a particular therapy have a slower rate of brain atrophy. This would
      provide convincing evidence that central nervous system tissue injury is further suppressed.
      Such information would be of substantial clinical benefit when deciding between various
      therapies.

      The investigators will estimate the impact of long term use of fingolimod therapy (defined as
      a minimum of two years on therapy) on whole brain atrophy in treated patients with relapsing
      forms of MS as compared to age and gender matched patients on Glatiramer Acetate.

      The investigators secondary goal is to determine the correlation between brain atrophy and
      cognitive performance in treated patients with relapsing forms of MS.

      The investigators will also examine the correlation between the NeuroQualityofLife (NeuroQOL)
      PROs, patient self-reports of disability, clinical assessment of physical disability, work
      productivity, clinical assessments of cognitive functioning with whole brain volume loss for
      patients on long term fingolimod vs. long term glatiramer acetate therapy matched on age and
      gender.

      The investigators anticipate the findings of this study will generate relevant hypotheses
      about these relationships.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MS patients who have been taking either fingolimod or glatiramer acetate for at least 2
        years
Levocetirizine 5 mg: Reduction of Symptoms, Airway Resistance and Sleep Impairment in Persistent Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate, whether levocetirizine 5 mg relieves nasal and
      ocular symptoms of persistent allergic rhinitis and reduces increased airway resistance and
      sleep impairment due to this condition.
    

Detailed description: 
      Levocetirizine 5 mg is well established as the treatment of seasonal and perennial
      rhinoconjunctivitis. This study has been designed, to investigate its efficacy in patients
      suffering from persistent allergic rhinitis as defined by the ARIA (Allergic Rhinitis and its
      Impact on Asthma) working group of the WHO.

      The study is divided in an 8 ± 2 day screening and a 56 ± 3 day treatment phase. During both
      periods patients keep a diary reporting on the severity of their nasal and ocular complaints,
      the use of rescue medication (cromoglycate eye drops and nasal spray), other concomitant
      medication and adverse events. They apply a 0 to 3 point score (0 = no, 1= mild, 2 =
      moderate, 3 = severe symptoms) to rate nasal obstruction, rhinorrhea, nasal itching, sneezing
      and ocular symptoms in regard to their experience during the preceding 24 hours. During the
      treatment period they additionally report the time of intake of study medication and their
      assessments of their nasal peak inspiratory flow (NPIF). NPIF is measured every evening
      before symptom scoring and additionally before each intake of rescue nasal spray. A device
      similar to the peak flow meters employed for monitoring bronchial asthma is used. Before the
      treatment period in its middle and at its end patients undergo a polysomnography. Furthermore
      2 weeks after the start of treatment and at its end patients and investigators employ a
      5-step scale (1 = very good, 2 = good, 3 = moderate, 4 = poor, 5= not at all effective) to
      assess the efficacy of the study medication.

      Efficacy is to be established by comparison of a levocetirizine and a placebo treated group.
    

Intervention name(s): Levocetirizine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intake of 1 tablet of Levocetirizine 5mg OD for 8 weeks; 1 tablet OD in the morning for 8 weeks
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: allergic rhinitis; histamine antagonist; sleep disorder
Erector Spinae Plan Block for Postoperative Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after
      laparoscopic cholecystectomy arises significantly from port site incisions in the anterior
      abdominal wall. Innervation of the anterior abdominal wall is segmentally supplied by pain
      afferents in the plane of fascia between transversus abdominis and the internal oblique
      muscles. Opioids analgesia is used to control postoperative pain, but it carries the risk of
      increased nausea and vomiting, ileus and sedation that may delay hospital discharge.

      Several techniques have been tried as.neuroaxial narcotics, intraperitoneal lavage of local
      anesthetic and transversus abdominis plan (TAP) block and successfully reduced opioid use and
      improve postoperative analgesia.

      The ultrasound-guided erector spinae plan(ESP) block is a recently described technique which
      produces reliable unilateral analgesia at thoraco-lumbar dermatomes. ESP block carries the
      advantages of being simple, safe, easily recognizable by ultrasound, and a catheter can be
      threaded to extend the duration of analgesia.

      Few case series reported the efficacy of (US)-guided ESP blocks in reducing postoperative
      pain and opioids consumption.

      Because of that, the investigators aimed to test the hypothesis that US-guided ESP blocks can
      decrease opioid consumption during the first 24 h after of laparoscopic cholecystectomy in
      comparison with the conventional systemic analgesia.
    


Intervention name(s): Erector Spinae Plan Block; Oblique subcostal TAP
Intervention type(s): Procedure; Procedure
Intervention description(s): The trocar site incision was done 15 minutes after the block in the three groups. The skin was disinfected with chlorhexidine solution, and the high-frequency transducer was isolated with a sterile disposable plastic cover and gel. The patient was placed in lateral position. A high-frequency linear ultrasound probe was placed longitudinally lateral to the T8 spinous process by 3 cm. After identification of the 3 muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced in a cephalo-caudal orientation. The needle tip was positioned fascial plane between rhomboid major and erector spinae muscles. Hydrodissection by 1-2 ml of normal saline to visualize the plan, then deposition of local anesthetic was done. A total of 20 mL of 0.25% bupivacaine was injected here. The same procedure was repeated on the other side.; ultrasound-guided bilateral oblique subcostal TAP block with bupivacaine 0.25% (20ml on each side)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Erecror Spinae Plan Block; postoperative pain; Laparoscopic cholecystectomy
Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether 5 - methyltetrahydrofolate and vitamin B12
      supplementation can ameliorate cell plasma membrane features in pediatric patients with
      cystic fibrosis
    

Detailed description: 
      Cystic fibrosis (CF) is one of the most common fatal autosomal recessive disorders in the
      Caucasian population caused by mutations of gene for the cystic fibrosis transmembrane
      conductance regulator (CFTR). New experimental therapeutic strategies for CF propose a diet
      supplementation to affect the plasma membrane fluidity and to modulate the cellular amplified
      inflammatory response in CF target organs. Red blood cells (RBCs) were used to investigate
      plasma membrane, because RBCs share lipid, protein composition and organization with other
      cell types.
    

Intervention name(s): 5-methyltetrahydrofolate and vitamin B12
Intervention type(s): Dietary Supplement
Intervention description(s): children with cystic fibrosis were supplementated for 6 months with 5-MTHF, 7,5 mg/day ; vitamin B12, 0,5 mg/day
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: cystic fibrosis; folate; vitamin B12
Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
Condition: Metabolic Syndrome X; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases
MeSH terms: Metabolic Syndrome; Insulin Resistance; Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism
Study type: Interventional

Summary: 
      The order in which the different components of a meal are eaten may have impact on the
      postprandial metabolic responses to carbohydrates, fat and proteins. This study will compare
      blood lipids and glycemia regulation following lunches of identical composition but varying
      the order of intake of the different meal components.
    

Detailed description: 
      The order in which the different components of a meal are eaten may have impact on the
      postprandial metabolic responses to carbohydrates, fat and proteins. Some of these responses
      are associated with the risk for developing cardiometabolic complications.

      The study will be carried out in a cohort of healthy subjects with a wide BMI range and
      normal fasting glycemia. Postprandial metabolic responses to a reference meal starting with
      bread and butter (BB) will be compared with those registered after 3 other meals of identical
      composition, in which the starter will be permutated. Each meal is tested on an independent
      experimental session, with a 1 week washout interval.

      The intervention will be carried out at the Food for Health Science Centre - Lund University.
      Additionally, the plan contemplates an initial information visit including screening of
      fasting blood glucose. In total, each volunteer completing the study will pay five visits to
      the clinical unit.

      Based on the results from the above-described phase, a second step of the study will compare
      various quality attributes of the most effective starter on the impact on cardiometabolic
      risk markers, as a way to optimize putative protective actions and to gain further
      mechanistic insight.
    

Intervention name(s): Standard meal, bread/butter as starter; Standard meal with soup as starter; Standard meal with cheese as starter; Standard meal with salad as starter
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Reference lunch. Bread and butter are eaten during the first 15 min. Soup, cheese and salad are eaten within the following 15 min.; Lunch meal in which soup is eaten during the first 15 min. Bread, butter, cheese and salad are eaten within the following 15 min.; Lunch meal in which cheese is eaten during the first 15 min. Bread, butter, soup and salad are eaten within the following 15 min.; Lunch meal in which salad is eaten during the first 15 min. Bread, butter, soup and cheese are eaten within the following 15 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 2 diabetes risk; Cardiovascular disease risk
Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the use of pramipexole dihydrochloride and quetiapine
      (Seroquel) XR as combination therapy for bipolar depression. The proposed benefit of the
      combination therapy investigated in this study is improved treatment of bipolar depression.
    

Detailed description: 
      Quetiapine is a first-line option in Canadian guidelines for the treatment of bipolar
      depression; however, there is room for improvement as the remission rate is approximately 50%
      and the response rate is approximately 60%. Pramipexole, which is currently used to treat
      Parkinson's disease and restless legs syndrome, is reported to have antidepressant effects in
      patients with unipolar or bipolar depression. There are no other clinical studies to evaluate
      the efficacy of pramipexole combined with an atypical antipsychotic, such as quetiapine XR,
      in the treatment of bipolar depression.

      This study is a multicentre, randomized, double-blind and placebo-controlled exploratory
      study in which patients will receive one of three treatment arms for a treatment period of 16
      weeks: quetiapine XR plus placebo, quetiapine XR plus 0.25mg pramipexole, or quetiapine XR
      plus 0.50mg pramipexole.
    

Intervention name(s): quetiapine (Seroquel) XR; quetiapine (Seroquel) XR; placebo; pramipexole dihydrochloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablets and caplets, take with liquid before bedtime; tablets, take with liquid before bedtime; placebo; tablets and caplets, take with liquid before bedtime
Other intervention name(s): Seroquel XR; Seroquel XR; mirapex
Intervention MeSH terms: Pramipexole; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: bipolar; bipolar depression; bipolar disorder; depression; quetiapine; pramipexole; Seroquel XR; Mirapex
Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions
Condition: Pharmacokinetics; Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      In this open label, single-sequence study, subjects received one dose of XS004 Dasatinib
      Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation at the start of study
      on Day 1 and Day 6. Omeprazole 40 mg was administered on Day 2, 3, 4, 5 and 6. The study was
      conducted in two groups.
    


Intervention name(s): Dasatinib ASD; Omeprazole 40 MG
Intervention type(s): Drug; Drug
Intervention description(s): XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation; Omeprazole Delayed Release Capsules, USP 40 mg
Intervention MeSH terms: Dasatinib; Omeprazole
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
OZ439 PhIIa Study in Plasmodium Falciparum: Extended Observation
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to investigate the concentration dependent effects of OZ439 on the clearance
      of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum
      inhibitory concentration (MIC) of OZ439. Characterisation of PK-PD
      (Pharmacokinetic-Pharmacodynamic) relationships is essential for rational evidence based
      dosing. The adaptive investigation of a range of doses will provide the best chance of
      accurate PK-PD characterisation, allowing the observation of Plasmodium falciparum growth
      dynamics and the subsequent identification of MIC and MPC (minimum parasiticidal
      concentration). Additionally the tolerability and pharmacokinetics of OZ439 will be
      confirmed. The PK/PD relationship between OZ439 exposure and subsequent effects on
      parasitaemia will be investigated.
    


Intervention name(s): OZ439
Intervention type(s): Drug
Intervention description(s): OZ439 is a novel synthetic trioxolane antimalarial agent
Intervention MeSH terms: Artefenomel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: P. falciparum; malaria
Mechanisms of Intradialytic Hypertension
Condition: Renal Failure Chronic Requiring Hemodialysis; Haemodialysis-induced Symptom; Hypertension
MeSH terms: Kidney Failure, Chronic; Hypertension
Study type: Interventional

Summary: 
      Patients with end-stage renal disease (ESRD) are at significantly higher risk for death due
      to cardiovascular disease. Those with paradoxical increases in blood pressure (BP) during
      hemodialysis (HD), defined as intradialytic hypertension (IDH), are at even greater risk of
      cardiovascular mortality. This study seeks to determine the mechanisms that underlie IDH, and
      whether mindfulness meditation might improve BP during dialysis in these patients. The
      investigators will first determine if increased adrenaline levels during volume removal
      contributes to IDH. The investigators will then determine lack of suppression of adrenaline
      levels in the setting of a high BP also contributes to IDH. This will be done by manipulating
      blood pressure by using small amounts of vasoactive drugs, and determining if an appropriate
      response in adrenaline levels occurs. Lastly, the investigators will determine if an
      intradialytic mindfulness meditation program improves BP and adrenaline levels in ESRD
      patients with IDH.
    


Intervention name(s): Mindfulness Meditation; Health Education
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Use of Bispectral Index Monitoring to Detect Deep Sedation in Mechanically Ventilated Patients: Validity Study
Condition: Disorder; Mental, Sedative; Depressed Level of Consciousness; Mechanical Ventilation Complication; Psychosis Associated With Intensive Care
MeSH terms: Consciousness Disorders; Mental Disorders
Study type: Observational

Summary: 
      In the previous study, the investigators obtained the cutoff value of Bispectral Index to
      detect early deep sedation in patients with mechanical ventilation. Bispectral Index
      monitoring can be used as an adjunct tool in screening and confirming deep sedation during
      the early period of mechanical ventilation. In present study, validation test will be carried
      out to clarify the sensitivity and specificity of obtained cutoff value in screening deep
      sedation in patients with mechanical ventilation.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients admitted to 3 ICUs in University Affiliated Hospital will be screened daily
        and enrolled consecutively.
High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With HIV
Condition: HIV Infection; Coronary Heart Disease
MeSH terms: Heart Diseases; Acute Coronary Syndrome; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin
      therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg daily)
      in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease
      (CHD).
    

Detailed description: 
      HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin
      therapy versus high-dose statin therapy in HIV-infected persons taking antiretroviral therapy
      (ART) who have coronary heart disease (CHD).

      All subjects will have an initial 2-week run-in period with pravastatin 40mg daily (Week 0 to
      2). Subjects not demonstrating significant toxicity at week 2 will then be randomized to
      rosuvastatin 20mg (high intensity dose group) versus continuing pravastatin 40mg daily
      (moderate intensity group) for 12 weeks (Weeks 2 to 14). At week 6, those in the rosuvastatin
      arm who do not demonstrate significant toxicity and whose LDL-c is >60mg/dl and decreased by
      less than 25% compared with week 2 will then have doses increased to rosuvastatin 40mg.
    

Intervention name(s): Pravastatin; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 40mg daily (Weeks 2 - 14); 20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK <+1.5 x ULN, and LDL-c is >60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily
Other intervention name(s): CRESTOR
Intervention MeSH terms: Rosuvastatin Calcium; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment