bioihbjkbjnl/mcl2 huggingface dataset:
The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Placebo; Montelukast; Fluticasone propionate
Intervention MeSH terms: Fluticasone; Xhance; Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: perennial allergic rhinitis

Summary:

      Some people with nasal allergy symptoms continue to have symptoms even after treatment with a
      nasal steroid spray. The purpose of this study is to see if these patients are helped by
      adding another medication (montelukast) to their treatment compared to placebo (a substance
      that looks like the active medication but does not contain the drug).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical history of perennial allergic rhinitis and a positive skin prick test to
             dust mite, cockroach, mold, or cat or dog antigens.

          -  Willingness of the subject to participate in and complete the study, and the ability
             to understand the purpose of the trial.

        Exclusion Criteria:

          -  Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.

          -  Women of childbearing potential who are pregnant, trying to become pregnant or nursing
             a child.

          -  Subjects treated with systemic steroids during the previous 30 days.

          -  Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom
             or Opticrom during the previous 15 days.

          -  Subjects treated with oral antihistamines/decongestants during the previous seven
             days.

          -  Subjects treated with topical (intranasal or intraocular) antihistamines/decongestants
             during the previous 3 days.

          -  Subjects treated with immunotherapy who are escalating their dose.

          -  Subjects on chronic anti-asthma medications.

          -  Subjects with polyps in the nose or a significantly displaced septum.

          -  Subjects who have incurred an upper respiratory tract infection within 14 days of the
             start of the study.
Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren; Telmisartan; Placebo to Aliskiren; Placebo to Telmisartan
Intervention description: Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks.; Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks.; Placebo to Aliskiren tablets taken orally daily. 1 Tablet for the first 2 weeks and 2 tablets during the no treatment (withdrawal) week.; Placebo to Telmisartan capsule taken orally daily. 1 capsule for the first 2 weeks and 2 capsules during the no treatment (withdrawal) week.
Intervention MeSH terms: Telmisartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 822.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; ABPM; systolic blood pressure; diastolic blood pressure; cardiovascular disease; aliskiren; telmisartan

Summary:

      This study was specifically designed to provide additional information on the mechanism of
      action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The
      purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that
      of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood
      Pressure Monitoring setting after a one week treatment withdrawal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg

          -  24-hr mean ambulatory systolic blood pressure ≥ 135 mmHg

        Exclusion Criteria:

          -  Severe hypertension defined as mean sitting systolic blood pressure ≥ 180 mmHg and/or
             mean sitting diastolic blood pressure ≥ 110 mmHg

          -  Patients with Type 1 diabetes mellitus

          -  Secondary hypertension of any etiology

          -  Other protocol-defined inclusion/exclusion criteria may apply
Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers
Condition: Obesity; Overweight
MeSH terms: Overweight
Intervention: Calcium Carbonate; Energy restriction
Intervention description: tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks; A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Intervention MeSH terms: Calcium Carbonate; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Calcium Carbonate; Vitamin D; Body weight; Body fat; Metabolic parameters; Energy restriction; Very-low calcium consumers; Obesity; Overweight

Summary:

      The purpose of the study is to determine whether calcium plus vitamin D supplementation is
      conducive to weight and fat loss during energy restriction in very-low calcium consumers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 18 to 25 years of age, generally healthy

          -  Habitual calcium intake below 600mg/d

          -  Overweight or obese (BMI between 24 and 35kg/m2, refer to the Chinese standard)

          -  Stable body weight (body weight change less than 1kg two months before screening)

          -  Less than 3 times of 20min of physical exercise per week

          -  Signed written informed consent

        Exclusion Criteria:

          -  Coronary heart disease, hypertension, diabetes; hepatic insufficiency or renal
             insufficiency, hyper- or hypothyroidism, mal-absorption, cholesterol concentrations
             requiring pharmaceutical treatment

          -  Pregnant or lactating woman

          -  Use of calcium supplements, oral antidiabetic agents, antihyperlipidemics or any other
             medications affecting metabolism 30 days before randomization

          -  Participating in another weight loss programs (i.e. taking oral pharmacotherapeutic
             agents and/or herbal preparations intended for the management of obesity; excessive
             physical activity; be on a diet)

          -  On special diets (i.e. vegetarian)

          -  Presently taking or have recently taken a prescription drug such as fluoroquinolone
             antibiotics, tetracycline, or levothyroxine (thyroid medication)

          -  Participating in another clinical trial 6 months before randomization

          -  Unlikely to be compliant (i.e. alcohol, drug abuse)

          -  Refusal or inability to give informed consent to participate in the study
ARIA (Atacand Renoprotection In NephropAthy Pt.)
Condition: Non-diabetic Nephropathy With Hypertension
MeSH terms: Kidney Diseases; Hypertension
Intervention: Candesartan Cilexetil; Candesartan Cilexetil; Candesartan Cilexetil 32mg
Intervention description: 8 mg oral once daily dose; 16 mg oral once daily dose; 32 mg oral once daily dose
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Candesartan Cilexetil; Non-diabetic Nephropathy; hypertension; urine protein creatinine ratio

Summary:

      To determine the effective dose of candesartan cilexetil for reduction of urinary protein
      excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline
      urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in
      urinary protein/creatinine ratio from baseline to the end of 28-week treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  hypertension; a)135mmHg < Systolic Blood Pressure <180mmHg and/or 85 mmHg < Diastolic
             Blood Pressure <100 mmHg. or b) The subject has been treated with antihypertensive
             medication

          -  proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g)

        Exclusion Criteria:

          -  Current serum-creatinine > 265 mmol/L (>3 mg/dL).

          -  Current serum-potassium > 5.5 mmol/L

          -  Known hypersensitivity to angiotensin (AT)1-receptor blocker
Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?
Condition: Mild Intermittent Asthma
MeSH terms: Hypersensitivity
Intervention: Fluticasone propionate (Flovent Diskus) 250 mcg; budesonide 400 mcg; Placebo
Intervention description: Flovent Diskus 250 mcg; budesonide 400 mcg; Placebo
Intervention MeSH terms: Fluticasone; Xhance; Budesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: late allergic response; fluticasone propionate

Summary:

      The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded,
      randomized, crossover study in which single doses of placebo, will be compared to Fluticasone
      propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen
      challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from
      post-allergen peak)
    

Eligibility criteria:

        Inclusion Criteria:

          -  mild asthma

          -  nonsmokers

          -  allergen-induced early and late asthmatic response

        Exclusion Criteria:

          -  no medication other than infrequent ( < twice weekly) inhaled beta2-agonists

          -  not be exposed to sensitizing allergens

          -  asthma exacerbation or respiratory tract infection in the past4 weeks
The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
Condition: Pneumococcal Pneumonia; Influenza
MeSH terms: Influenza, Human; Pneumonia, Pneumococcal
Intervention: Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®; Sequential administration of Pneumovax NP® and Fluvic HA syringe®
Intervention description: Injections of pneumococcal vaccine and influenza vaccine simultaneously.; Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: quadrivalent influenza vaccine; 23-valent pneumococcal vaccine; immunogenicity

Summary:

      The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and
      pneumococcal vaccine was unknown. The purpose of present study is to compare the
      immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine
      with that of separate administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults aged ≧65 years who had never received pneumococcal vaccine and quadrivalent
             influenza vaccine of 2015/2016 season

        Exclusion Criteria:

          -  a sensitivity to pneumococcal and influenza vaccine

          -  received other inactivated vaccine within 14 days

          -  received other live vaccine within 28 days

          -  the presence of conditions known to impair pneumococcal vaccine response

          -  having malignant disease

          -  taking oral corticosteroids or immunosuppressive agent

          -  history of splenectomy

          -  history of an acute febrile illness or signs of severe acute illness at the time of
             vaccination

          -  other inappropriate condition to receive vaccination

          -  suffering an acute illness requiring antibiotics or steroids within the past month

          -  not expected to survive 12 months were also excluded
Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders
Intervention: Sublingual orally disintegrating olanzapine (SODO); Oral olanzapine
Intervention description: 5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.; 5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.
Intervention MeSH terms: Olanzapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is testing if under the tongue olanzapine for schizophrenia, related psychosis,
      schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that
      is swallowed, in patients who are already gaining weight on olanzapine.
    

Eligibility criteria:

        Inclusion Criteria (Patients must):

          -  Be at least 18 years old

          -  Have gained weight while taking olanzapine

          -  Be able to visit the doctor's office seven times over 4 months (17 weeks)

        Exclusion Criteria (Patients must NOT):

          -  Have started a weight loss program within the last 8 weeks

          -  Have an illness that might affect patient's weight during the study

          -  Have an allergy to phenylalanine, mannitol or saccharine

          -  Be taking any medication (except for olanzapine) that might affect patient's weight
Covid-19 Associated Coagulopathy
Condition: COVID 19 Associated Coagulopathy
MeSH terms: COVID-19; Hemostatic Disorders; Blood Coagulation Disorders
Intervention: Intermediate dose thromboprophylaxis; Standard of Care thromboprophylaxis
Intervention description: 2) Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI<30kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).; Patients randomized to the standard of care arm will receive standard prophylactic dose enoxaparin (40 mg subcutaneously daily if BMI <30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30 kg/m2).
Intervention MeSH terms: Enoxaparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multi-center, randomized, open-label study comparing standard prophylactic dose enoxaparin (40 mg SC daily or 30 or 40 mg SC twice daily if BMI ≥30kg/m2; standard of care arm) versus intermediate-dose enoxaparin (1 mg/kg SC daily or 0.5 mg/kg SC twice daily if BMI≥30kg/m2; intervention arm) in hospitalized patients with laboratory-confirmed SARS-CoV-2 infection.
Masking: None (Open Label)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This prospective, randomized, open-label, multi-center interventional study is designed to
      compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the
      University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria
      score ≥3. Patients will be randomized to standard prophylactic dose LMWH (standard of care
      arm) or intermediate-dose LMWH (intervention arm).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Laboratory confirmed SARS-CoV-2 infection

          -  Age ≥18 years

          -  Requires hospital admission for further clinical management

          -  Modified ISTH Overt DIC score ≥ 3

        Exclusion Criteria:

          -  Indication for full therapeutic-dose anticoagulation

          -  Acute venous thromboembolism (deep vein thrombosis or pulmonary embolism) within prior
             3 months

          -  Acute cardiovascular event within prior 3 months

          -  Acute stroke (ischemic or hemorrhagic) within prior 3 months

          -  Active major bleeding

          -  Severe thrombocytopenia (<25,000/mm3)

          -  Increased risk of bleeding, as assessed by the investigator

          -  Acute or chronic renal insufficiency with Creatinine Clearance < 30 ml/min calculated
             by the modified Cockcroft and Gault formula

          -  Weight < 40 kg

          -  Known allergies to ingredients contained in enoxaparin, allergy to heparin products or
             history of heparin induced thrombocytopenia
Neurotoxin and Physical Therapy
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botox injection; Physical Therapy; Transcranial magnetic stimulation (TMS)
Intervention description: Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms; Participants will undergo physical therapy sessions with a physical therapist trained in movement disorders. Participants will be instructed to continue these exercises five times per week, and will be called weekly by the investigator to check progress.; For these tests, participants will sit in a chair that looks like one found at the dentist's office. A nerve stimulator will be placed on the wrist of the right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of the head.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cervical Dystonia; Botox

Summary:

      This study aims to compare Botox injections without Physical Therapy sessions to Botox
      injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is
      expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms
      and quality of life more than Botox alone. It is also expected that Botox combined with
      Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new
      connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox
      injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-80 with a diagnosis of Cervical Dystonia, which will be confirmed by a
             movement disorders specialist

          -  Positive response to at least two prior treatments with Botox as indicated by an
             improvement in Clinical Global Improvement Scale.

          -  Received last dose of Botox a minimum of 12 weeks prior to baseline visit.

        Exclusion Criteria:

          -  Any conditions that would contraindicate transcranial magnetic stimulation (for
             example, pregnancy or epilepsy)

          -  Any secondary, fixed, post-traumatic, or psychogenic dystonia
Conversion to Embeda With Rescue Trial
Condition: Chronic Disease; Pain
MeSH terms: Chronic Disease
Intervention: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Intervention description: Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.
Intervention MeSH terms: Naltrexone; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 684.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: chronic pain; Embeda; opioid; moderate pain; severe pain; conversion; converting; switching; morphine; aberrant behavior; Pain (DT) + Chronic Disease (DT)

Summary:

      The purpose of the research study is to find out if opioid dependent chronic pain patients
      who are judged by their physician to be eligible to change their current opioid medicine and
      to participate in this study can be successfully adjusted to a stable dose of EMBEDA
      (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's
      risk for prescription opioid abuse, misuse and diversion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be able to read, speak and understand English

          -  Have chronic moderate to severe pain for at least 3 months

          -  Require around the clock opioid medication for the relief of pain

          -  Have been taking a daily opioid for at least 30 days prior to starting the study

          -  Be able to be safely switched to a different pain medication

          -  Be practicing acceptable birth control methods for female patients of childbearing
             potential

          -  Be willing to participate in the study and able to comply with study procedures

        Exclusion Criteria:

          -  Be currently diagnosed with or participating in and/or seeking treatment for opioid
             and/or alcohol abuse

          -  Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids

          -  Be currently taking tramadol and/or extended release morphine products

          -  Have respiratory depression

          -  Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease

          -  Have migraines as your main source of pain

          -  Have any form of bowel obstruction

          -  Be pregnant or breast feeding

          -  Have had 2 or more surgeries for low back pain

          -  Be planning a major surgery during the study

          -  Be staying in a hospital or nursing home

          -  Be planning to have steroid injections for your chronic pain during the study

          -  Have a life expectancy of less than 2 months