bioihbjkbjnl/mcl2 huggingface dataset:
Perioperative Inflammation and Cyclooxygenase 2 (COX-2)
Condition: Neurosurgery; Pain
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      Surgery initiates a complex cascade of events involving the release of chemical compounds
      from nerve endings and damaged tissue which leads to an inflammatory and pain response. The
      purpose of this investigation is to measure various chemical mediators in the blood and
      cerebrospinal fluid, and to test the hypothesis that they will be decreased in patients
      treated with a COX-2 inhibitor.
    

Detailed description: 
      Surgery initiates a complex cascade of events involving the release of nociceptive compounds
      from nerve endings and damaged tissue which leads to an inflammatory and hyperalgesic
      response. COX-2 inhibitors are often used for treating pain. This is a double-blind
      randomized study in surgical patients receiving a spinal drain for surgical purposes. The
      hypothesis is that valdecoxib will reach therapeutic concentrations in CSF, and will decrease
      plasma and CSF concentrations of inflammatory mediators. Subjects will receive valdecoxib 40
      mg or placebo approximately 1 hr prior to surgery. Serial blood and CSF samples will be
      obtained. Valdecoxib and cytokine concentrations will be measured.
    

Intervention name(s): valdecoxib
Intervention type(s): Drug
Intervention MeSH terms: Valdecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: neurosurgery; COX-2; inflammation; pain
Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?
Condition: CMV; Prenatal Diagnosis; Ultrasound; MRI
MeSH terms: Cytomegalovirus Infections
Study type: Observational

Summary: 
      Cytomegalovirus (CMV) is the largest member of the virus family Herpesviridae that infects
      almost all humans at some point in their lives (Ross, 2004). Congenital CMV infection is most
      likely to occur when the mother experiences a primary infection during pregnancy, and it is
      much less common in cases of reactivation of the disease or infection by a different CMV
      strain (Boppana 1999, Endres 2001). The prevalence of congenital CMV infection varies between
      0.15-2.2% (Ross 2004, Ross 2006, Malm 2007). While most infants born with congenital CMV
      infection are asymptomatic, 10 to 15% show clinical findings at birth (Ross 2004).

      It is generally agreed that congenital CMV infection, whether it is symptomatic or not, is a
      major risk factor for perceptual deficits. However, its influence on children's future
      neuropsychological functioning is less well established. Symptomatic congenital CMV infection
      is a major risk factor for poor developmental outcome (Williamson 1982, Kylat 2006, Dollard
      2007), but the available data regarding neuropsychological outcome for asymptomatic children
      is extremely diverse (Conboy 1986, Ivarson 1997, Kashdan 1998, Temple 2000, Zhang 2007).

      We evaluated the neuropsychological outcome of children with congenital cytomegalovirus (CMV)
      infection and normal consecutive fetal neurosonographic examinations and determined whether
      Magnetic Resonance Imaging (MRI) provided additional information in these cases.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children of woman with CMV proved intrauterine infections
      
Keywords: CMV; Prenatal Diagnosis; Ultrasound; MRI
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
Condition: Narcolepsy; Excessive Daytime Sleepiness; Cataplexy Narcolepsy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Cataplexy; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult
      patients with narcolepsy. The study will enroll approximately 60 patients and eligible
      patients will be treated to receive either NLS-2 or placebo for 4-weeks.
    


Intervention name(s): mazindol extended release; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosed orally, once daily for up to 3 weeks; Dosed orally, once daily for up to 4 weeks.
Other intervention name(s): NLS-2
Intervention MeSH terms: Mazindol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense
Condition: Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial is to evaluate the clinical effectiveness of the administration
      of a depigmented and polymerized allergen extract of Phleum pratense in the
      rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass
      pollen.
    

Detailed description: 
      Immunotherapy is a specific treatment for allergic diseases. Unlike conventional
      pharmacological treatment, immunotherapy is the only treatment that could modify the natural
      course of allergic disease. This is a prospective double-blind placebo controlled study with
      three arms of treatment: placebo and two active (one of the active arms will receive a dose
      that is 10x the dose of the other arm).
    

Intervention name(s): Immunotherapy with modified extract of P. pratense pollen; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Sublingual (2 drops daily); Placebo 2 drops daily
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergoid; Depigmented; Polymerized; Allergen-extract; Rhinoconjunctivitis; Asthma
Neuroaxial Labour Analgesia
Condition: Labor Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      The primary outcome of this clinical trial is to compare the pain scores during labour and
      delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural

      The secondary objective of this study is to compare the and fetomaternal outcomes
    


Intervention name(s): Dural Puncture Epidural Technique; Combined Spinal Epidural without intrathecal opioids; epidural
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): three labor analgesia techniques; three labor analgesia techniques; three labor analgesia techniques
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial assignment placed in sealed envelopes.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Plasma Volume
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and
      renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin
      and being treated for high blood pressure.
    

Detailed description: 
      This is a double-blind (neither the patient or study staff will know the identity of the
      treatment assigned) in patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate
      glycemic (blood sugar) control on metformin monotherapy (metformin taken alone for control of
      T2DM) and who are currently being treated for hypertension (high blood pressure) with agents
      called angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers
      (ARBs). In the study, patients will be randomized (assigned by chance) to receive treatment
      with canagliflozin or a placebo (a treatment identical in appearance to canagliflozin but
      does not contain active drug) for 12 weeks. During the 12-week treatment period, patients
      will also take metformin at a dose of at least 1500 mg/day in addition to their prescribed
      ACEI or ARB for hypertension. Patients will participate in the study for up to approximately
      22 weeks.
    

Intervention name(s): Canagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Type = exact number, unit = mg, number = 300, form = capsule, route = oral use. One encapsulated tablet once daily for up to approximately 85 days (approximately 12 weeks); Form = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks)
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Plasma Volume; Canagliflozin; Metformin; Hemoglobin A1c; Hypertension; Angiotensin-Converting Enzyme Inhibitors (ACEIs); Angiotensin Receptor Blockers (ARBs); Pharmacodynamics; Pharmacokinetics
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in China. The aim of this trial is to assess the safety and
      tolerability of HS-20004 in healthy Chinese subjects.
    


Intervention name(s): HS-20004; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prevention Strategies for Adolescents at Risk of Diabetes
Condition: Type 2 Diabetes; Chronic Disease
MeSH terms: Diabetes Mellitus; Chronic Disease
Study type: Observational

Summary: 
      The primary aim of PRE-STARt Phase 1 is to pragmatically evaluate and refine a risk
      assessment tool to identify those children with chronic disease risk factors (including Type
      2 Diabetes).
    

Detailed description: 
      Data will be collected in 5 European Commission countries (500 adolescents in total). A range
      of biological and lifestyle measures will be collected in order to investigate the
      adolescent's lifestyle and will include body weight and other anthropometric measurements,
      blood pressure, blood capillary sample, self-reported physical activity, sedentary behaviour
      and dietary habits. Their parent/guardian will complete a number of questions to gather
      information about variables that have been associated with chronic disease (including type 2
      diabetes) and include peri-natal history (birth weight, gestational diabetes), socioeconomic
      status, family health and medical history.

      A draft risk tool to identify those children with a 'higher risk' of developing type 2
      diabetes in the future has been developed systematic review results and a Delphi procedure.
      This draft tool will be evaluated and refined. This draft risk tool will be evaluated by
      independent clinical reviewers against the data collected from the 500 adolescent data sets.
      The results for each adolescent will be independently reviewed by clinicians who will assign
      either a "lower" or "higher" risk to each case. The results will be compared to the results
      from the draft 'PRE-START tool', used to further refine this identification tool using
      appropriate statistical methods.

      The outputs of this study will be a fit for purpose 'PRE-STARt tool' that can be used for
      recruitment to interventional studies whose primary objective is to reduce the risk of
      developing chronic disease (including type 2 diabetes) in the future.
    

Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Boys and girls who are between 12 and 14 years of age who do not have an existing diagnosis
        of type 1 or type 2 diabetes.
      
Keywords: risk factors; screening; adolescents
Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Nonalcoholic fatty liver disease (NAFLD), defined by fatty infiltration of the liver in the
      absence of excess alcohol consumption, affects an estimated 30% of adults in the United
      States. A proportion of people with NAFLD will develop progressive, inflammatory nonalcoholic
      steatohepatitis (NASH), which can progress to liver cirrhosis and liver failure. NAFLD is
      expected to be the most common indication for liver transplantation by the year 2020. We
      hypothesize that among adults with NAFLD, aspirin will reduce intrahepatic lipid content, as
      quantified by 1H magnetic resonance spectroscopy (1H-MRS).
    


Intervention name(s): Aspirin 81 mg; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.; Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aspirin; Liver Disease; Anti-inflammatory
Pain Research: Innovative Strategies With Marijuana
Condition: Chronic Pain; Chronic Low Back Pain; Cannabis Use
MeSH terms: Low Back Pain; Chronic Pain; Marijuana Abuse
Study type: Observational

Summary: 
      This study tests the effects of cannabinoid levels in blood on pain relief, inflammation, and
      cognitive dysfunction in chronic pain patients who choose to use edible cannabis. Over a
      two-week period, participants use an edible product of their choice. Blood levels of
      9-delta-tetrahydrocannabinol (THC) and cannabidiol (CBD) will be measured before, during, and
      after the two-week exposure period to determine whether there are associations with pain,
      inflammation, sleep, physical activity, anxiety/depression, and cognitive dysfunction. After
      the two-week self-administration period, participants will be followed for six months to
      collect self-report data on cannabis use, pain levels, sleep quality, and mental health
      symptoms.
    

Detailed description: 
      The National Center for Health Statistics reports that approximately 76 million Americans
      suffer from chronic pain, affecting the lives of more Americans than cancer, diabetes, and
      heart disease combined. Perhaps because of its ubiquity and the challenge to its treatment,
      relief from chronic pain is by far the most commonly cited condition by patients for use of
      marijuana, with 87%-94% of medical marijuana users reporting using for relief of a pain
      condition.

      Although the mechanisms are still unclear, marijuana and its constituent cannabinoids,
      including 9-delta-tetrahydrocannabinol (THC), are thought to be involved in reducing pain and
      associated inflammation. However, THC is also associated with harm in the form of cognitive
      dysfunction. Synergistic interactions of multiple cannabinoids are believed to produce
      different effects on both pain relief and cognitive function as compared to THC alone. For
      example, cannabidiol (CBD) is another primary cannabinoid that may work synergistically with
      THC in a multi-target analgesic approach.

      This study examines the effects of cannabinoids in edible form on pain relief, inflammation,
      and cognitive dysfunction in chronic pain patients who choose to use marijuana in the context
      of a short-term (2 weeks), patient-oriented, observational design and a mobile pharmacology
      and phlebotomy lab.
    

Intervention name(s): Cannabis Edible
Intervention type(s): Drug
Intervention description(s): Self-Directed Use (ad-libitum)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Biospecimen description: 
      Blood samples collected for cytokine and cannabinoid quantitation.
    
Keywords: Cannabis; Pain; Cytokines; Inflammation; Cognition
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy of single anastomoses sleeve jejunal
      bypass as a treatment for morbid obesity
    

Detailed description: 
      in this study the investigators aim to test a new technique ( single anastomoses sleeve
      jejunal as a treatment for morbid obesity Which is a modification of Single anastomoses
      sleeve ileal bypass with short biliary limb ( about one third of the small intestine from the
      Duodeno-jejunal junction
    

Intervention name(s): Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
Intervention type(s): Procedure
Intervention description(s): Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors
Condition: Testicular Neoplasms; Germ Cell Tumors
MeSH terms: Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the use of a sequential high dose
      chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin, etoposide,
      and bleomycin [PEB]) in patients with metastatic poor prognosis germ cell tumors.
    


Intervention name(s): Cyclophosphamide; Etoposide; Cisplatin; Bleomycin; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): High dose carboplatin
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Etoposide; Bleomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Pharmacodynamic Equivalence of Enoxaparin Rovi to Clexane®, in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the pharmacodynamic (PD) equivalence of enoxaparin Rovi (100 mg/mL) 100-mg SC
      injection to Clexane® (100 mg/mL) 100-mg SC injection in healthy volunteers.

      As secondary objective, to evaluate the safety and tolerability of enoxaparin Rovi (100
      mg/mL) in healthy volunteers.
    

Detailed description: 
      This is a single-dose, randomized, double-blind, 2-period, 2 sequence crossover study.
      Subjects will be screened up to 30 days before the study begins and admitted to the clinic on
      Day -1 of Period 1 for baseline assessments. Before dosing on Day 1 of Period 1, subjects
      will be randomly assigned to a treatment sequence. Subjects will receive a single dose of
      study drug on Day 1 of each treatment period.

      On Day 1 of Period 1, subjects will receive a single dose by subcutaneous route of the
      assigned study drug: enoxaparin (100 mg/mL) 100-mg SC injection manufactured by Rovi Spain,
      or Clexane (100 mg/mL) 100-mg SC injection manufactured by Sanofi EU; after an overnight
      fasting period of at least 10 hours. Subjects will continue fasting for at least 4 hours
      after study drug administration.

      The washout period between administrations of study drug in each period will be at least 7
      days.

      On Day 1 of Period 2, subjects will cross over to receive the dose of the other drug, after
      an overnight fasting period of at least 10 hours. The total duration of the study will be
      approximately 6 weeks.
    

Intervention name(s): Enoxaparin; Clexane
Intervention type(s): Drug; Drug
Other intervention name(s): Enoxaparin (Rovi, Spain); enoxaparin sodium; Clexane (Sanofi, EU); enoxaparin sodium
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: single-dose, randomized, double-blind, 2-period, 2-sequence crossover study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: antithrombotic; heparin; anticoagulant; low molecular weight heparin; pharmacodynamic equivalence
Comparison of the Effectiveness of CAM Therapies in Pediatric Patients Undergoing Sedation
Condition: Neurological Disorders
MeSH terms: Nervous System Diseases
Study type: Interventional

Summary: 
      The investigators conducted a prospective open unblinded clinical four-arm evaluation of
      Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who
      were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation.
      Children were assigned to active music therapy, passive music therapy, distraction therapy,
      and no intervention; measures included doses and numbers of sedation medications, time of
      sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines,
      before and immediately after the intervention was completed. The Time Frame for the outcome
      measures are at the start of the intervention and immediately following the procedure
      (generally about 150 minutes). No further follow up was conducted.
    


Intervention name(s): Active Music Therapy; Passive Music Therapy; Distraction Therapy
Intervention type(s): Other; Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CAM; Sedation; MRI; Music Therapy
Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to demonstrate that treatment with a free combination
      of tiotropium and salmeterol provides superior improvement in static lung volumes and
      exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients
      with COPD.

      The secondary objective includes assessment of safety.
    


Intervention name(s): Tiotropium plus Salmeterol; Fluticasone/Salmeterol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluticasone; Tiotropium Bromide; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Intervention model: Crossover Assignment
Primary purpose: Treatment