bioihbjkbjnl/mcl2 huggingface dataset:
Early Treatment of Cytokine Storm Syndrome in Covid-19
Condition: Cytokine Storm; COVID-19
MeSH terms: COVID-19; Cytokine Release Syndrome
Intervention: Anakinra; Normal saline
Intervention description: The active treatment group will receive anakinra 100 mg subcutaneously every 6-12 hours for a period of 10 days; The control group will receive normal saline placebo subcutaneously every 6-12 hours for period of 10 days
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two parallel treatment arms
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Investigator, care provider, and participant blinded
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This proposal addresses the problem of preventing the very high mortality and morbidity
      associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory
      failure in Covid-19 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years old or older

          2. Molecular (pcRNA) diagnosis of SARS-CoV-2 infection

          3. Chest imaging studies consistent with Covid-19 pneumonia

          4. Hyperferritinemia (>700 ng/ml)

          5. History of fever >38 degrees C

          6. Any three of the following:

               1. Elevated d-dimer (> 500 ng/ml)

               2. thrombocytopenia (< 130,000/mm3)

               3. leucopenia (WBC <3500/mm3) or lymphopenia (<1000/mm3)

               4. elevated AST or ALT (> 2X ULN)

               5. elevated LDH (> 2X ULN)

               6. CRP > 100 mg/L

        Exclusion Criteria:

          1. Participation in other investigational treatment protocols for Covid-19 infection

          2. Culture confirmed active bacterial infection requiring antibiotic therapy

          3. On mechanical ventilation

          4. Previous known hypersensitivity reaction to anakinra

          5. Previous known hypersensitivity reaction to E Coli derived proteins

          6. Pregnant or breast-feeding females
Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections
Intervention: GSK1024805A; Prevenar; Infanrix hexa; Havrix; Varilrix
Intervention description: No vaccination in this trial; No vaccination in this trial; No vaccination in this trial; No vaccination in this trial; No vaccination in this trial
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 524.0
Sex: All
Minimum age: 28 Months
Maximum age: 32 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Streptococcus pneumoniae; Haemophilus influenzae; Pneumococcal conjugate vaccine; Antibody persistence

Summary:

      This protocol posting deals with objectives & outcome measures of the extension phase up to
      48-50 months post booster vaccination, to assess long-term antibody persistence in children
      at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal
      conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a
      separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in
      order to comply with the FDA AA (Sep 2007).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between, and including, 28-30 months of age at the time of first blood
             sampling.

          -  Subjects who previously participated in the 105553 and 107046 studies and who received
             a full four dose regimen of pneumococcal conjugate vaccine during the primary and
             booster studies.

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  Written informed consent, covering visits 1, 2 and 3, obtained from the parent or
             guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

        Exclusion Criteria:

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within 6
             months prior to the blood sampling

          -  Administration of any additional pneumococcal vaccine since end of 107046 study.

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the blood sampling.

          -  Administration of immunoglobulins and/or any blood products less than 6 months prior
             to blood sampling.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition since the
             end of the 107046 study, based on medical history and physical examination.
Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
Condition: Inflammatory Bowel Disease; Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer
Intervention: Balsalazide Disodium
Intervention MeSH terms: Balsalazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 443.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IBD; UC; Ulcerative Colitis; Inflammatory Bowel Disease

Summary:

      The objective of the study is to evaluate the long-term safety and tolerability of treatment
      with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or
      who have mildly to moderately active UC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a documented history of UC and is either in remission or currently
             presents with mildly to moderately active UC symptoms as determined by the
             investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency,
             and rectal bleeding). Additionally, the diagnosis of UC must be confirmed by past
             flexible sigmoidoscopy/colonoscopy which may include colonic mucosal pathological
             findings on biopsy consistent with UC.

          -  Subject is capable and willing to comply with all study procedures.

        Exclusion Criteria:

          -  Subject has a history of allergy or intolerance to aspirin, mesalamine or other
             salicylates.

          -  Subject has participated in an investigational drug or device study, other than a
             previous balsalazide disodium tablet trial (i.e., BZUC3002 or BZUC3003), within 30
             days of entering the current study.

          -  Subject discontinued from a previous balsalazide disodium tablet study due to study
             drug-related AE(s), including UC flare or associated symptoms that were perceived by
             the subject/investigator as being caused by study drug.

          -  Subject has had any prior bowel surgery, except appendectomy and cholecystectomy.

          -  Subject has unstable cardiovascular, coagulopathy, or pulmonary disease.

          -  Regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) except cardioprotective
             ASA (i.e., less than or equal to 162 mg ASA per day).

          -  Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C).
             Subjects with a history of hepatitis B and C will be eligible provided the screening
             LFTs are within normal limits.
An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: TMC435; Peginterferon-alpha (PegIFNα-2a); Ribavirin (RBV); Placebo
Intervention description: TMC435 100 mg or 150 mg capsules taken orally (by mouth) with food once-daily for 12 weeks (Week 12).; PegIFNα-2a (180 micrograms [μg] once weekly) administered as weekly subcutaneous (s.c.) (under the skin) injections of 0.5 mL for 24 or 48 weeks.; Ribavirin 1000 or 1200 mg/day (taken as 100 mg or 200 mg tablets) depending on body weight (If body weight is < 75 kg the total daily dose of RBV will be 1000 mg, administered as 400 mg intake with food in the morning and 600 mg intake with food in the evening. If body weight is > or = 75 kg the total daily dose will be 1200 mg, administered as 2 x 600 mg per intake with food, morning and evening) for 24 or 48 weeks.; Matching placebo capsules taken orally with food once-daily for 48 weeks.
Intervention MeSH terms: Ribavirin; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 457.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; TMC435; Ribavirin; peginterferon-alpha (PegIFNα-2a)

Summary:

      The purpose of this study is to provide confirmatory efficacy and safety data of TMC435 as
      part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) in
      patients with genotype 1 Hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A liver biopsy within 3 years prior to the screening visit (or between screening and
             day of randomization) with histology consistent with chronic Hepatitis C virus (HCV)
             infection

          -  Presence of contraindications for a liver biopsy in patients who are otherwise deemed
             eligible for participation does not exclude the patient from participation

          -  Genotype 1 HCV infection (confirmed at screening)

          -  Plasma HCV RNA of > 10,000 IU/mL at screening

        Exclusion Criteria:

          -  Prior treatment with any approved or investigational drug for the treatment of
             hepatitis C

          -  Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone furoate nasal spray (MFNS); Matching placebo nasal spray
Intervention description: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days; Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 324.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study seeks to prospectively demonstrate that Nasonex is better than placebo in
      relieving nasal congestion in patients with seasonal allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A subject must be 12 years of age or older, of either sex, and of any race.

          -  A subject must have at least a 2-year history of SAR which exacerbates during the
             study season.

          -  A subject must have a positive skin prick test response to an appropriate seasonal
             allergen at Visit 1.

          -  A subject must be clinically symptomatic at the Screening and Baseline Visits.

        Exclusion Criteria:

          -  A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.

          -  A subject who has had an upper respiratory tract or sinus infection that required
             antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or
             who has had a viral upper respiratory infection within 7 days prior to the Screening
             Visit.

          -  A subject who has used any drug in an investigational protocol in the 30 days prior to
             the Screening Visit.

          -  A subject who is participating in any other clinical study.

          -  A subject who is part of the staff personnel directly involved with this study.

          -  A subject who is a family member (parent, spouse, or sibling) of the investigational
             study staff.

          -  A female subject who is breast-feeding, pregnant, or intends to become pregnant.

          -  A subject previously randomized into this study.

          -  A subject who has a family member (parent, spouse, or sibling) currently enrolled in
             this study.
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: zolpidem tartrate sublingual tablet; Placebo
Intervention description: 3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.; Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Intervention MeSH terms: Zolpidem
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Insomnia

Summary:

      The purpose of the study is to evaluate sleep onset following administration of zolpidem
      tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with history of sleeplessness

        Exclusion Criteria:

          -  Allergic to investigational drug

          -  Any conditions and medications that may interfere with study drug evaluation
Rotavirus Efficacy and Safety Trial (REST)(V260-006)
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Intervention: Rotateq™; Comparator: Placebo
Intervention description: 3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.; 3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 69274.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was designed to evaluate the safety of the investigational rotavirus vaccine and
      the efficacy to prevent rotavirus gastroenteritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infants

        Exclusion Criteria:

          -  None Specified
Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase
Condition: Macular Edema; Macular Degeneration; Diabetes
MeSH terms: Macular Degeneration; Macular Edema; Edema
Intervention: Ranibizumab 0.5mg
Intervention description: Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ranibizumab; Diabetic Macular Edema

Summary:

      The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in
      diabetic patients presenting with reduced visual acuity due to diabetic macular edema and
      evaluating spacing out of follow-up after initial intensive treatment phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type I or type II diabetes with HbA1c≤10%

          -  Visual impairment due to a diabetic macular edema

          -  Stable antidiabetic treatment (since more than 3 months) or hygiene-dietary

        Exclusion Criteria:

          -  Inflammation or infection in one eye

          -  Women of childbearing potential without an efficient contraception, pregnant or
             breastfeeding

        Other protocol-defined inclusion/exclusion criteria may apply
GA YAZ ACNE in China Phase III
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: EE20/Drospirenone (YAZ, BAY86-5300); Placebo
Intervention description: 20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd; Inert tablet
Intervention MeSH terms: Drospirenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 179.0
Sex: Female
Minimum age: 14 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Moderate Acne Vulgaris; Oral contraceptive; Female

Summary:

      The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg /
      ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne
      vulgaris over 6 treatment cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women of age 14-45 years

          -  >1 year post-menarche with moderate acne vulgaris who have no known contraindications
             to combined oral contraceptives

          -  Otherwise healthy, except for the presence of moderate acne

          -  Smokers up to a maximum age of 30 (inclusive) at inclusion

        Exclusion Criteria:

          -  Pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or
             lactation before start of treatment)

          -  Obesity (Body Mass Index > 30 kg/m2)

          -  Hypersensitivity to any ingredient of the study drug

          -  Any disease or condition that may worsen under hormonal treatment
Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: 1% Lidocaine; 0.25% Bupivacaine; Bupivacaine plus Lidocaine
Intervention description: 10 mL of 1% lidocaine; 10 mL of 0.25% bupivacaine; 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Intervention MeSH terms: Lidocaine; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 75.0
Sex: Female
Minimum age: 19 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Local anesthetic; Labor epidural

Summary:

      This study will compare and determine the most ideal local anesthetic (LA) solution to
      activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus
      lidocaine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant patients over the age of 19 who are scheduled for an induction of labor and
             request an epidural are eligible for the study

        Exclusion Criteria:

          -  age <19

          -  allergy to the drug or drug class

          -  preexisting neuropathy

          -  history of back pain prior to pregnancy or history of back surgery

          -  history of chronic opioid use

          -  history of hypertension or hypertensive disorders of pregnancy

          -  congenital or acquired cardiac disease

          -  contraindication to epidural placement (patient refusal, severe coagulopathy,
             infection at site of epidural needle insertion, severe hypovolemia)
A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: M207 Microneedle System
Intervention description: M207 Microneedle System 3.8 mg
Intervention MeSH terms: Oxazolidinones; Zolmitriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single dose, open-label treatment
Masking: None (Open Label)
Masking description: Open-label
Enrollment: 342.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: migraine; migraine headache; acute migraine; acute migraine headache

Summary:

      This is an open-label, twelve-month safety study. There is a screening period followed by a
      run-in period to record migraine activity. Qualified subjects will receive study medication
      for up to twelve months for the treatment of multiple migraine attacks. Using the electronic
      diary (eDiary) to confirm they are experiencing a qualified migraine, subjects will
      self-administer the patches and respond to questions in the eDiary post treatment
      administration.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Women or men 18 to 75 years of age

          2. Greater than 1 year history of episodic, migraine (with or without aura) with onset
             prior to 50 years of age.

          3. Migraine history during the prior 6 months must include:

               1. at least 2 migraines per month

               2. no more than 8 migraines per month

               3. no more than 15 headache days per month

          4. Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy
             and use an acceptable double-barrier method of birth control during the trial.

          5. Willing and able to treat a minimum of 2 migraines per month with study medication and
             consistently complete eDiary for up to 12 months.

        Main Exclusion Criteria:

          1. Contraindication to triptans

          2. Use of selective serotonin reuptake inhibitors (drugs like Prozac®) or serotonin or
             norepinephrine reuptake inhibitors (drugs like Effexor®) or anti-coagulants (drugs
             like Coumadin®)

          3. Known allergy or sensitivity to zolmitriptan or its derivatives or formulations

          4. Known allergy or sensitivity to adhesives and/or titanium

          5. Women who are pregnant, breast-feeding or plan a pregnancy during this study

          6. Three or more of the following cardiovascular risk factors:

               -  Current tobacco use

               -  Hypertension or receiving anti-hypertensive medication for hypertension

               -  Hyperlipidemia or on prescribed anti-cholesterol treatment

               -  Family history of premature coronary artery disease

               -  Diabetes mellitus

          7. History or current abuse or dependence on alcohol or drugs