bioihbjkbjnl/mcl2 huggingface dataset:
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
Condition: Brain Stem Neoplasms, Primary; Neoplasms, Brain Stem
MeSH terms: Neoplasms; Glioma; Brain Neoplasms; Brain Stem Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin.
      Thalidomide has been available for many years and has been used to treat many different
      illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by
      blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have
      blood vessels providing oxygen and nutrients, it will not be able to grow. This research will
      look at how combining the effects of thalidomide (preventing tumor growth) with the tumor
      killing effect of carboplatin effects the long-term outlook for patients with these tumors.

      This study will try to find out how well Thalomid™ and carboplatin combined with radiation
      therapy works in treating children newly diagnosed with brain stem glioma. This study will
      look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem
      glioma. This study will also look at any side effects of these treatments.
    


Intervention name(s): Carboplatin; Thalomid; External Beam Radiation Therapy
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Thalidomide; Carboplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain stem glioma
Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults
Condition: Glucose Tolerance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      Previous preclinical investigations have found that Medicago sativa promotes the decrease of
      glucose concentrations. To evaluate the acute effect of Medicago sativa administration on
      glucose tolerance, insulin secretion, and insulin sensitivity in healthy individuals.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, two-period, cross-over clinical trail will be
      carrie out in 15 healthy, sedentary individuals of both genders, who meet the following
      inclusion criteria: 25 to 40 years of age, normal fasting plasma glucose (≤ 5.5 mm/L), blood
      pressure (<130/90 mmHg), body mass index of 25 to 29.9 kg/m2, no taking any medication known
      to affect glucose tolerance, nondrinkers and nonsmokers. No pregnant, and lactation estate
      for female participants. They will be select from the same neighborhood and socioeconomic
      status.

      After a fasting blood sample patients will be assigned at random-order through a
      closed-envelope selection, to receive one of two possible sequences during which they
      received either single oral doses of Medicago sativa or homologated placebo in 1,500 mg and
      were crossover with a difference of at least 7 days washout interval. Thirty minutes after
      each intervention patients underwent a 75-g oral glucose tolerant test (OGTT). Area under the
      curve of glucose and insulin, phases of insulin secretion, and insulin sensitivity will be
      calculate for each treatment period.
    

Intervention name(s): Medicago Sativa; Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.; Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.
Other intervention name(s): Alfalfa; Lucerne
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Medicago sativa; Insulin secretion; Insulin Sensitivity
Nasal Decongestion and Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea Syndrome; Rhinitis
MeSH terms: Rhinitis; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Whether impaired nasal breathing contributes to sleep related breathing disturbances has not
      been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a
      drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep
      and nocturnal breathing and daytime performance.
    


Intervention name(s): xylometazoline
Intervention type(s): Drug
Intervention description(s): xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril
Other intervention name(s): Otrivin
Intervention MeSH terms: Xylometazoline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep apnea, rhinitis
Bergamot and Cardio-Metabolic Risk Factors
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      Bergamot-derived products have shown significant effects on plasma lipids. We aim in the
      present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.
    

Detailed description: 
      The research hypothesis is to assess whether bergamot reduces plasma lipids (total
      cholesterol, triglycerides, low-density lipoprotein (LDL)-cholesterol and high-density
      lipoprotein (HDL)-cholesterol), atherogenic lipoproteins, carotid intima-media thickness
      (IMT) and liver steatosis in patients with dyslipidemia.

      The primary objective is to assess whether bergamot reduces plasma lipids and atherogenic
      lipoproteins in patients with dyslipidemia.

      Primary endpoint: Reduction in plasma lipids and atherogenic lipoproteins. The secondary
      objective is to assess whether bergamot reduces carotid intima-media thickness (IMT) and
      liver steatosis in patients with dyslipidemia.

      Secondary endpoint: Reduction in IMT and and liver steatosis.

      Clinical diagnostic tools will include the measurement of:

        1. cIMT, that will be assessed by B-mode real-time ultrasound using a single sonographer
           (Medison SonoAce Pico, with a probe of 7.5-10.0 MHz) in a standardized manner with fixed
           angles of insonation;

        2. liver steatosis, that will be assessed by by abdominal ultrasound.

      Biochemical analyses will include the analysis of:

        1. Routine testing of plasma lipids;

        2. Atherogenic lipoproteins, e.g. the analysis of 11 distinct lipoproteins including
           very-low-density lipoprotein (VLDL), 3 intermediate density lipoprotein (IDL) subclasses
           and 7 low density lipoprotein (LDL) subclasses.
    

Intervention name(s): Bergamot-derived product
Intervention type(s): Dietary Supplement
Intervention description(s): Group 1: 500mg/day Group 2: 1000mg/day
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult subjects with dyslipidemia
      
Biospecimen description: 
      Serum and plasma samples
The Role of Oxytocin in the Perception of Faces
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The main objective of this project is to study whether intranasal oxytocin (OT) affects how
      young adults perceive and attend to infant and adult faces. Based on existing research the
      investigators predict that oxytocin will facilitate the allocation of attentional resources
      on infant faces (compared to adult faces). The investigators also predict that oxytocin will
      enhance the activity of reward neural-networks associated with the perception of infant
      faces. The behavioral effects of OT (visual attention and face recognition) will be measured
      with eye-tracking while participants look at photographs of adult and infant faces.
      Neurological effects (the activity of emotion and reward networks) will be measured with
      functional Magnetic Resonance Imaging (fMRI) while participants look at infant faces on a
      computer screen.
    


Intervention name(s): Syntocinon (synthetic oxytocin); Placebo
Intervention type(s): Drug; Other
Intervention description(s): Dosage and details described in arm.; Dosage and details described in arm.
Other intervention name(s): OT
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics of FTY720 and its metabolites in
      patients with severe renal insufficiency and in matched, healthy volunteers. This study will
      allow a better understanding of the effects of renal insufficiency on the disposition of
      FTY720.
    


Intervention name(s): fingolimod (FTY720)
Intervention type(s): Drug
Intervention MeSH terms: Fingolimod Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: FTY720, Pharmacokinetics, Renal insufficiency
Physica KR Fluoroscopy Study
Condition: Total Knee Replacement
Study type: Interventional

Summary: 
      The aim of this study is to assess the in vivo kinematics and range of motion of a
      single-surgeon clinical series of TKA performed with a fixed-bearing cruciate retaining total
      knee arthroplasty that has a roll-back mechanism and compare it with the kinematic of the
      normal healthy knee.

      Patients would be evaluated by fluoroscopic examination during weight bearing activities
      (lounging, kneeling and stairs climbing).
    


Intervention name(s): Fluoroscopic examination
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment
Condition: Secondary Headache Disorders; Medication-overuse Headache
MeSH terms: Headache Disorders; Headache Disorders, Secondary; Headache
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the influence of personality profiles in patients with
      MOH and to evaluate the effect of a custom-made educational programme as an add-on to
      standard treatment as compared to standard treatment alone in MOH patients using a randomized
      controlled trial (RCT) design.
    

Detailed description: 
      Worldwide, two percent of the population suffers from medication-overuse headache (MOH), a
      paradox condition where the headache is caused by overuse of headache medication. Common
      treatment is withdrawal, but there is no consensus on what constitutes the best treatment.

      The study consists of a RCT with MOH patients randomized to standard treatment versus
      standard treatment + a 12-week, 6-session educational programme as add-on. The programme is
      based on theory of motivational interviewing, and patients can choose between individualized
      education or education in groups.

      Primary endpoint: Headache frequency measured by self-reported headache diary on number of
      days with headache pre-vious month. Secondary endpoints: NEO-FFI-3 personality test, coping
      strategies, pain intensity, bothersomeness, patient satis-faction and reported medication
      intake.
    

Intervention name(s): Educational programme
Intervention type(s): Behavioral
Intervention description(s): The 6-session educational programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups. The standard treatment consists of withdrawal and consultations by neurologist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Medication-overuse Headache; Educational Programme; Personality Profiles
Splinting Versus Casting for Type I Supracondylar Fractures
Condition: Bone Fractures
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      Elbow fractures are very common in young children. Type I supracondylar fractures are stable
      fractures to the elbow that are treated conservatively across the world and typically heal
      very well without complications. There are several treatment options, including an above
      elbow cast or long arm splint. This study aims to determine if one treatment is no worse than
      the other in order to standardize the treatment of these fractures at our institution. The
      investigators hope to save families from extra hospital visits and reduce the amount of
      x-rays required for treatment of these fractures.
    


Intervention name(s): Above Elbow Cast; Long Arm Splint
Intervention type(s): Procedure; Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible participants will be recruited from the Emergency Department at BC Children's
        Hospital
      
Keywords: Fracture; Supracondylar; Pediatric; Orthopedic
The Efficacy of Peripheral Nerve Blocks With Intrathecal Morphine in Improving Analgesia After Unilateral Total Knee Arthroplasty
Condition: Anesthesia; Total Knee Arthroplasty
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether intrathecal morphine (ITM) alone or its
      combination with peripheral nerve blocks (PNB) provides better analgesia for patients
      undergoing total knee arthroplasty (TKA).
    

Detailed description: 
      Total knee arthroplasty (TKA) surgery is associated with severe pain. The success of knee
      rehabilitation following surgery depends largely on adequate pain control that permits early
      physical therapy. Postoperative modern analgesic recommendations specific to TKA propose
      either spinal block with intrathecal morphine (ITM) or a combination of general anesthesia
      with single shot femoral nerve block (SFNB). Femoral nerve block (FNB) too has proven
      analgesic advantages in TKA surgery. However, we do not know if the combination of the two
      analgesic techniques, ITM and peripheral nerve blocks (PNB), provides superior analgesia to
      ITM alone.

      Thus, this study aims to determine whether ITM alone or its combination with PNB provides
      better analgesia for patients undergoing total knee arthroplasty (TKA).

      Eligible patients undergoing unilateral TKA under spinal anesthesia consenting to a
      multimodal analgesic regimen inclusive of ITM, FNB, and SNB will be recruited. All patients
      will receive spinal with intrathecal morphine. Patients will be randomly assigned using a
      computer generated table of random numbers to receive either spinal with intrathecal morphine
      (morphine group), a combination of intrathecal morphine and femoral nerve block
      (morphine-femoral group), or a combination of intrathecal morphine and femoral nerve block as
      well as sciatic nerve block (morphine-femoral-sciatic group).
    

Intervention name(s): Combined spinal epidural anesthesia technique with intrathecal morphine; A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block; A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid
      Arthritis patients who showed unsuccessful response against methotrexate.
    


Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Prograf; FK506
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; Prograf; Calcinurin inhibitor; Rheumatoid arthritis (RA)
Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
Condition: Pulmonary Hypertension; COPD
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®)
      in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary
      Disease (COPD)
    

Detailed description: 
      This is a pilot study of 10 patients that have COPD-PH. Primary outcome measure is to see if
      this drug is safe for this patient population and the secondary measure is to see if the drug
      improves patient functional capacity.
    

Intervention name(s): Inhaled Treprostinil Therapy
Intervention type(s): Drug
Intervention description(s): Treprostinil: Inhaled prostanoid therapy
Other intervention name(s): Tyvaso ®
Intervention MeSH terms: Treprostinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD PH; COPD associated Pulmonary Hypertension; COPD and Pulmonary Hypertension; Disease
Combined Hormonal Contraceptive Use in High Risk Women: A Longitudinal Study
Condition: Pregnancy
Study type: Observational

Summary: 
      This study is an examination of "high risk" young women, 15-24 years of age, who initiate
      first time use of vaginal ring, oral contraceptives, contraceptive path, or Depo-provera.
    

Detailed description: 
      Approximately 1600 young women will be enrolled in a 12 month, observation study of their
      contraceptive use. They will complete surveys at baseline, 3, 6 and 12 months. They will also
      undergo pregnancy testing at baseline, 6 and 12 month visits. The study is examining such
      things are the relationship between partnerships, parental and peer influences, and
      contraceptive choice; Factors associated with long term continuation of contraceptive
      methods; Attributes of new hormonal contraceptive associated with user satisfaction and
      long-term continuation; And the extent to which high-risk women who use these methods are
      also condom users and determine the characteristics of these users.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Planned Parenthood patients who present to start a hormonal birth control for the first
        time.
      
Biospecimen description: 
      urine for pregnancy testing
    
Keywords: pregnancy; hormonal contraception
The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23
Condition: Healthy Controls
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to: Improve the effectiveness of vaccinations by
      identifying the effect of cholesterol medication, statins, on immune responses.
    

Detailed description: 
      Due to the anti-inflammatory action of statins, it was proposed that statin treatment would
      decrease the efficacy of vaccination. This response has yet to be explored following a
      primary vaccination such as pneumococcal pneumonia. In this study, healthy volunteers will be
      divided into 2 arms receiving treatment for 28 days: 40 mg atorvastatin or placebo.

      Antibody titer for 23 serotypes, complete blood count (CBC), high-sensitivity c-reactive
      protein (hsCRP), erythrocyte sedimentation rate (ESR), lipids, cytokines (TNF-alpha,
      IFN-gamma, interleukins, etc.) and key membrane receptors (toll-like receptors, etc.) will be
      measured for baseline before statin or placebo treatment. On day 7 of treatment,
      pre-vaccination measures of the above parameters will be taken and an immune response will be
      induced in all groups using Pneumovax 23 at Day 7. On days 8, 14, 21, and 28 post-vaccination
      measures will be compared to baseline and between groups.
    

Intervention name(s): Atorvastatin; Pneumovax 23; Placebo (lactose pill)
Intervention type(s): Drug; Drug; Other
Intervention description(s): 10-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days.; Pneumovax 23 injected once, intramuscularly at Day 7.; 10-person arm receiving treatment for 28 days: Placebo (lactose pill), taken orally, once daily for 28 days.
Other intervention name(s): Lipitor; 23-valent pneumococcal polysaccharide vaccine
Intervention MeSH terms: Atorvastatin; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Health Controls
Treatment of Mirizzi Syndrome
Condition: Mirizzi Syndrome; Cholelithiasis; Acute Cholecystitis
MeSH terms: Cholecystitis; Cholecystitis, Acute; Cholelithiasis; Cholecystolithiasis; Gallstones; Mirizzi Syndrome; Syndrome
Study type: Observational

Summary: 
      Mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. Extrinsic
      compression of the common hepatic duct is usually caused by an impacted stone in Hartmann's
      pouch or cystic duct resulting in the development of cholecystobiliary fistula. This syndrome
      is classified based on the presence and severity of cholecystobiliary fistula. Mirizzi
      syndrome is challenging to diagnose preoperatively and may require complex biliary surgical
      procedures for resolution. Endoscopic treatment is a safe alternative with a high success
      rate. Single-operator cholangioscopy combined with lithotripsy has been shown to have a
      90-100% success rate in the treatment of biliary stones. Herein, A single center experience
      treating Mirizzi syndrome with single-operator cholangioscopy guided electrohydraulic
      lithotripsy is presented. Difficult management of Mirizzi syndrome has led to research of new
      treatment options to minimize the risk of high rate complications. Single-operator
      cholangioscopy in combination with laser lithotripsy is an adequate and safe alternative for
      the treatment of this condition.
    


Intervention name(s): Single-operator cholangioscopy guided electrohydraulic lithotripsy
Intervention type(s): Procedure
Intervention description(s): Single-operator cholangioscopy guided electrohydraulic lithotripsy has the advantage of providing direct visualization of the bile ducts, enabling a single physician to diagnose and perform the therapeutic intervention in a single procedure.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A 34-year-old female, A 54-year-old male, A 40-year-old female. with diagnosed Mirizzi
        Syndrome by an image study, with a concomitant common bile duct dilatation.