bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
Condition: Cytokine Storm (Covid-19)
MeSH terms: COVID-19; Cytokine Release Syndrome
Intervention: Ruxolitinib; Placebo
Intervention description: Ruxolitinib 5 mg tablets; Matching-image placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 432.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: COVID-19 pneumonia; cytokine release syndrome; SARS-COV-2; ruxolitinib

Summary:

      This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess
      the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with
      placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.
    

Eligibility criteria:

        Inclusion Criteria:

        Patient or guardian/health proxy must provide informed consent (and assent if applicable)
        before any study assessment is performed.

        Male and female patients aged ≥ 12 years (or ≥ the lower age limit allowed by Health
        Authority and/or Ethics Committee/Institutional Review Board approvals).

        Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction
        (PCR) test or another rapid test from the respiratory tract prior to randomization.

        Patients currently hospitalized or will be hospitalized prior to randomization.

        Patients, who meet at least one of the below criteria:

          -  Pulmonary infiltrates (chest X ray or chest CT scan);

          -  Respiratory frequency ≥ 30/min;

          -  Requiring supplemental oxygen;

          -  Oxygen saturation ≤ 94% on room air;

          -  Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg
             (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions
             (over 1000m).

        Exclusion Criteria:

        History of hypersensitivity to any drugs or metabolites of similar chemical classes as
        ruxolitinib.

        Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8
        μmol/L), or have estimated creatinine clearance < 30 ml/min measured or calculated by
        Cockroft Gault equation or calculated by the updated bedside Schwartz equation.

        Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).

        Currently intubated or intubated between screening and randomization. In intensive care
        unit (ICU) at time of randomization. Intubated or in ICU for COVID-19 disease prior to
        screening. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs
        (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).

        Unable to ingest tablets at randomization. Pregnant or nursing (lactating) women
Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Fostamatinib Disodium
Intervention description: Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to assess the long term safety of fostamatinib in
      subjects with persistent/chronic ITP
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued
             early due to lack of response.

          -  Able and willing to give written informed consent

        Exclusion Criteria:

          -  Discontinued participation in Study C935788-047 or Study C935788-048 for any reason
             other than lack of response

          -  Poorly controlled hypertension during Study C935788-047 or Study C935788-048

          -  Significant infection, an acute infection such as influenza, or known inflammatory
             process
Eslicarbazepine Acetate Monotherapy Long Term Study
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Eslicarbazepine acetate
Intervention description: 800 to 2400 mg once daily (QD)
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: open label
Enrollment: 274.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Seizures; Epilepsy; Anticonvulsant; Monotherapy; Epilepsy with simple or complete partial onset seizures

Summary:

      This is a long term, open-label, safety extension study in subjects with partial onset
      seizures.
    

Eligibility criteria:

        Subject Inclusion/Exclusion Criteria:

          -  Subject who completed, exited, or discontinued for reasons other than safety from the
             18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue
             participation in this study are eligible. Subject must have completed at least the
             first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or
             093-046 to be eligible.

          -  Subject must give written informed consent prior to participation in the study. For
             subjects <18 years of age, the informed consent must be signed by the subject's parent
             or legal guardian, and, when appropriate and/or required by state or local law, minor
             subjects must give written informed assent prior to participation in the study. All
             subjects must sign privacy authorization form, if applicable. All females of child
             bearing potential (≤65 years of age) must also sign the "Women of Childbearing
             Potential" Addendum.

          -  Subjects must, in the opinion of the Investigator (with consultation with Medical
             Monitor as appropriate), continue to potentially benefit from continued study
             participation and have no new medical conditions that would preclude study
             participation.

          -  If female subject, must continue the accepted method of birth control defined in
             Protocols 093-045 or 093-046 for the duration of this study as well

          -  Criterion for Continuation into the Post 1 year Part of Study:

        For subjects to continue into the post 1 year part of the study, subjects must, in the
        opinion of the Investigator (with consultation with Medical Monitor, as appropriate),
        continue to potentially benefit from continued study participation and have no new medical
        conditions that would preclude study participation.
Extension Study for Patients Entered Into Study Infacort 003
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Intervention: Infacort®
Intervention description: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 1 Month
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      A Phase 3, open-label, single-group, non-randomised, observational study of the safety and
      biochemical disease control of Infacort® in neonates, infants and children with adrenal
      insufficiency and congenital adrenal hyperplasia who had completed study Infacort 003. All
      subjects who had satisfactorily completed study Infacort 003 were offered the opportunity to
      take part in Infacort 004.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects successfully completing study Infacort 003, whose inclusion criteria were:

          1. Male and female children less than 6 years of age.

          2. A diagnosis of adrenal insufficiency (AI) as confirmed by an inappropriately low
             cortisol usually with other supporting tests.

          3. Receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without
             fludrocortisone).

          4. Adequately hydrated and nourished. In addition, the parents/carers must be able to
             understand and give written Informed Consent for this extension study.

        Exclusion Criteria:

          1. Clinically evident acute AI (adrenal crisis) (Note: the subject can be re-evaluated
             for eligibility once the episode is over)

          2. Inability of the child to take oral therapy

          3. Subjects with clinical signs of acute infection or fever on inclusion (Note: the
             subject can be re-evaluated for eligibility once the episode is over)

          4. Any surgical or medical condition that in the opinion of the Investigator may place
             the subject at higher risk from his/her participation in the study

          5. Parents/carers of subjects unwilling to consent to saving and propagation of
             pseudonymised medical data for study reasons

          6. Subjects who are in a dependent relationship with the Investigator or the Sponsor
An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
Condition: Hemophilia A; Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: rVIII-SingleChain
Intervention description: Recombinant single-chain coagulation factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: Male
Healthy volunteers: No

Summary:

      This multicenter, open-label, phase 3 extension study will investigate the safety and
      efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in
      at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and
      previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to
      rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no
      previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in
      this study. A substudy (open to both PTPs and PUPs) will investigate the use of
      rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to
      rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance
      induction (ITI) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        PTPs:

          -  Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII
             activity levels < 1%) and who participated in a previous CSL-sponsored clinical study
             with rVIII-SingleChain.

          -  Males 0 to <65 years age who have been diagnosed with severe congenital hemophilia A
             (FVIII activity levels < 1%), who have at least 50 EDs to any FVIII product, and who
             are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.

        PUPs:

          -  Males 0 to <18 years of who have been diagnosed with severe congenital hemophilia A
             (FVIII activity levels < 1%)

          -  No prior exposure to any Factor VIII product (with the exception of short-term use of
             blood products).

        ITI substudy:

          -  PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of
             rVIII-SingleChain or Chinese hamster ovary (CHO) proteins.

          -  Currently receiving a therapy not permitted during the study.

          -  Serum creatinine > 2 x upper limit of normal, alanine aminotransferase or aspartate
             aminotransferase > 5 x upper limit of normal at Screening (if specified)

          -  Any first-order family (eg, siblings) history of FVIII inhibitors

          -  For PTPs not rolling over directly from a CSL-sponsored clinical study with
             rVIII-SingleChain: any history of or current FVIII inhibitors
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Oliceridine; Placebo; Morphine
Intervention MeSH terms: Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine
      administered as needed (PRN) compared with placebo in patients with moderate to severe acute
      postoperative pain after bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and
             internal fixation) with no additional collateral procedures.

          -  Experiences a pain intensity rating of moderate to severe acute pain.

          -  Able to provide written informed consent before any study procedure.

        Exclusion Criteria:

          -  ASA Physical Status Classification System classification of P3 or worse.

          -  Has surgical or post-surgical complications.

          -  Has clinically significant medical conditions or history of such conditions that may
             interfere with the interpretation of efficacy, safety, or tolerability data obtained
             in the trial, or may interfere with the absorption, distribution, metabolism, or
             excretion of drugs.

          -  Has previously participated in another TRV130 clinical study.
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
Condition: Radiotherapy Induced Mucositis; Head and Neck Cancer
MeSH terms: Mucositis; Stomatitis
Intervention: manuka honey; placebo gel
Intervention description: Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.; Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The study was blinded to all except necessary pharmacy staff until after the study was closed.
Enrollment: 106.0
Sex: All
Healthy volunteers: No
Keywords: Mucositis; Radiation; Honey

Summary:

      The primary hypothesis of this study is that regular topical oral application of Manuka Honey
      will reduce the severity and duration of oral mucositis in patients who are undergoing
      mucotoxic radiation therapy for cancer treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients commencing radiation therapy of 50 Gy or higher with the dosage field
             affecting the oral mucosa unilaterally or bilaterally (minimum 3 observable sites
             affected).

          -  Patients willing and able to attend weekly assessments throughout their treatment,
             plus one week after completion of treatment.

        Exclusion Criteria:

          -  Patients unable to understand the consent process (translators will be used if
             necessary so being English-speaking is not required).

          -  Patients unable to attend the follow-up visits

          -  Patients participating in other clinical trials which might affect the severity of
             mucositis

          -  Patients allergic to honey, multiple pollens, or to celery
A Trial of Corticosteroids for Low Back Pain
Condition: Radicular Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Intramuscular methylprednisolone acetate; Placebo
Intervention description: Intramuscular methylprednisolone acetate 160mg; Normal saline intramuscular injection
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: low back pain; emergency department; corticosteroids

Summary:

      Low back pain is a common symptom that functionally disables many people. When the low back
      pain is accompanied by pain that shoots down the leg, it is felt to be caused by a herniated
      disc. We are conducting this study to determine if a powerful anti-inflammatory agent will
      decrease the pain and functional impairment that is associated with this illness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21-50 years old, non-traumatic low back pain for one week or less,

        Exclusion Criteria:

          -  fever, pregnancy, lactation, allergy or intolerance to study medication, suspected
             active oncologic, urologic, or gynecologic disease
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: SYM-1219
Intervention description: Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water
Intervention MeSH terms: Secnidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 325.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of
      SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent
      girls with bacterial vaginosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are adult females or postmenarchal adolescent girls ≥ 12 years of age.

          -  Are in good general health as confirmed by a medical history and physical examination,
             with no known medical or mental health conditions that, in the Investigator's opinion,
             may interfere with study participation.

          -  Have a negative urine pregnancy test result prior to study treatment initiation. In
             addition, female patients of childbearing potential must be using an acceptable form
             of birth control as determined by the Investigator

          -  Agree to abstain from alcohol for 3 days following study treatment.

          -  Have a clinical diagnosis of bacterial vaginosis

          -  Agree not to use vaginal douches or similar products for the duration of the study.

        Exclusion Criteria:

          -  Are pregnant, lactating, or planning to become pregnant during the study.

          -  Are menstruating or have vaginal bleeding at the Baseline visit (Day 1).

          -  Are menopausal as determined by the Investigator

          -  Are suspected clinically (or confirmed diagnostically) of having alternative causes of
             vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis,
             Neisseria gonorrhoeae or Herpes simplex

          -  Have active genital lesions, including active Herpes simplex lesions, or other vaginal
             or vulvar conditions which could confound the interpretation of the clinical response,
             as determined by the Investigator

          -  Have consumed any alcohol within 12 hours prior to treatment with study medication.

          -  Have a history of an abnormal Pap smear which required cervical biopsy or cervical
             cauterization within 3 months of the Baseline visit (Day 1).

          -  Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
A Long Term Safety Extension Study (CHS-0214-05)
Condition: Rheumatoid Arthritis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: CHS-0214
Intervention description: Open label
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 359.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An Open-label, Safety Extension Study (OLSES) evaluating the longer-term safety and
      durability of response of subjects who completed 48 weeks of evaluations in the confirmatory
      safety and efficacy studies, CHS 0214-02 or CHS-0214-04, evaluating CHS-0214 in patients with
      rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed 48 weeks of evaluations in CHS-0214-02 and, at Week 48, had at least an
             ACR20, or completed 48 weeks of evaluations in CHS-0214-04 and, at Week 48, had at
             least a PASI-50

        Exclusion Criteria:

          -  None