bioihbjkbjnl/mcl2 huggingface dataset:
The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
Condition: Delayed Sleep Phase Syndrome
MeSH terms: Sleep Disorders, Circadian Rhythm
Intervention: Melatonin 0.5 MG; Dim Light Melatonin Onset (salivary)
Intervention description: Melatonin tablet; Test to determine the time of melatonin onset in saliva under dim light conditions
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will test whether measuring the circadian clock during treatment of delayed
      sleep-wake phase disorder results in greater improvements in sleep compared to estimating the
      circadian clock.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet diagnostic criteria for delayed sleep wake phase disorder

          -  Female participants of childbearing potential must agree to use a reliable method of
             contraception from the screening visit until 4 weeks after the study has completed.

        Exclusion Criteria:

          -  Hypersensitivity to melatonin or any other component of the product

          -  Sleep disorder other than delayed sleep wake phase disorder

          -  Medical and psychiatric conditions that may influence sleep or be affected by
             melatonin

          -  Current use of medications which may have interactions with melatonin

          -  Pregnancy or breastfeeding

          -  Routine night shift work

          -  Past month travel or planned travel during the study across more than one time zone

          -  Use of melatonin in the past month

          -  Current use of medications that may interfere with the measurement of melatonin
Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: TAS-118 plus Oxaliplatin; S-1 plus Cisplatin
Intervention MeSH terms: Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 711.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Gastric Cancer; Gastrointestinal Diseases; Gastrointestinal Neoplasms; First Line Treatment; Antineoplastic Agents

Summary:

      The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared
      with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients who are diagnosed as gastric cancer.

          -  No prior treatment for gastric cancer.

          -  Negative or unknown for HER2 testing.

          -  ECOG performance status of 0 or 1.

        Key Exclusion Criteria:

          -  Unmanageable diarrhea.

          -  Current peripheral sensory neuropathy or paresthesia.

          -  Pregnant or lactating female.
Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
Condition: Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis
MeSH terms: Macular Edema; Uveitis; Panuveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Uveitis, Anterior
Intervention: 4mg CLS-TA Suprachoriodal Injection; Sham Procedure
Intervention description: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints; Sham procedure administered at 2 timepoints
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uveitis; UME; Posterior Uveitis; Anterior Uveitis; Intermediate Uveitis; Panuveitis; Non-infectious Uveitis; Triamcinolone; Choroid; Choroidal Injection; Suprachoroidal; Microneedle; Microinjection; Triamcinolone acetonide

Summary:

      The study is designed to evaluate the safety and efficacy of suprachoroidally administered
      triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with
      non-infectious uveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)

          -  Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥
             300 microns)

          -  Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters
             read (20/40 Snellen equivalent), in the study eye

        Exclusion Criteria:

          -  Any active ocular disease or infection in the study eye other than uveitis

          -  Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; subjects are
             not excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications.

          -  Any uncontrolled systemic disease that, in the opinion of the Investigator, would
             preclude participation in the study

          -  Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or
             periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX
             implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years
             prior to baseline.
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Virus Diseases; Hepatitis; Fibrosis
Intervention: SOF/VEL; RBV
Intervention description: 400/100 mg FDC tablet administered orally once daily; Capsules administered orally in a divided daily dose
Intervention MeSH terms: Ribavirin; Sofosbuvir-velpatasvir drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Communicable Diseases; Hepatitis; Hepatitis C; Virus Diseases; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Velpatasvir; RNA Virus Infections; Ribavirin; Sofosbuvir; Antiviral Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Decompensated Cirrhosis

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without
      ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and
      decompensated cirrhosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV-infected males and non-pregnant/non-lactating females

          -  Treatment naive or treatment experienced individuals

          -  Child-Pugh-Turcotte Score 7-12 at screening

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Vilaprisan (BAY1002670); Placebo
Intervention description: Orally, coated tablet 2 mg, once daily; Orally, coated tablet, once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heavy menstrual bleeding

Summary:

      The primary objective of this study was to show superiority of vilaprisan in the treatment of
      heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo

      The secondary objectives of this study were to additionally evaluate the efficacy and safety
      of vilaprisan in subjects with uterine fibroids
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women, 18 years or older in good general health

          -  Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1
             fibroid with largest diameter more than 30 mm and less than 120 mm

          -  Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening
             period each with blood loss volume of >80.00 mL documented by the alkaline hematin
             (AH) method

          -  An endometrial biopsy performed during the screening period without significant
             histological disorder such as endometrial hyperplasia (including simple hyperplasia)
             or other significant endometrial pathology

          -  Use of an acceptable non-hormonal method of contraception (ie, either male condom,
             cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1
             until the end of the study

        Exclusion Criteria:

          -  Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation
             before start of treatment)

          -  Hypersensitivity to any ingredient of the study drug

          -  Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion
             (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron
             supplementation)

          -  Any diseases, conditions, or medications that can compromise the function of the body
             systems and could result in altered absorption, excessive accumulation, impaired
             metabolism, or altered excretion of the study drug

          -  Any diseases or conditions that might interfere with the conduct of the study or the
             interpretation of the results

          -  Abuse of alcohol, drugs or medicines (e.g. laxatives)

          -  Use of other treatments that might interfere with the conduct of the study or the
             interpretation of results

          -  Undiagnosed abnormal genital bleeding
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Recurrence
Intervention: Fluconazole Tablet; IBREXAFUNGERP; Placebo oral tablet
Intervention description: 150 mg every 72 hours for 3 doses; 300 mg BID (one day) every 4 weeks for a total of 6 dosing days; BID (one day) every 4 weeks for a total of 6 dosing days
Intervention MeSH terms: Fluconazole; Ibrexafungerp
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label (acute phase treatment) followed by Randomized, Double Blinded phase
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 440.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Recurrent yeast infection; Recurrent yeast vaginitis; Chronic yeast vaginitis; Ibrexafungerp; SCY-078; RVVC

Summary:

      This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
      evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to
      placebo in female subjects 12 years and older with recurrent VVC (RVVC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast
             and normal vaginal pH.

          -  History of 3 or more episodes of VVC in the past 12 months.

          -  Culture confirmation and resolution of the signs and symptoms of the initial VVC
             episode (with treatment).

          -  Able to take oral tablets and capsules.

        Key exclusion Criteria:

          -  Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or
             evaluation of response to therapy.

          -  Recent use of systemic and/or topical vaginal antifungal products.

          -  Pregnant.

          -  History of major system organ disease.
Isoflurane-induced Neuroinflammation in Children With Hydrocephalus
Condition: Toxicity; Hydrocephalus
MeSH terms: Hydrocephalus; Neuroinflammatory Diseases
Intervention: Isoflurane; Dexmedetomidine
Intervention MeSH terms: Dexmedetomidine; Isoflurane
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 1 Day
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      The investigators will quantify inflammatory biomarkers in cerebrospinal fluid (CSF) and
      serum of children with hydrocephalus who are undergoing ventriculoperitoneal shunt placement
      under isoflurane anesthesia.
    

Eligibility criteria:

        Inclusion Criteria (HC study patients):

          -  Pediatric patients, aged 6 months-less than 11 years, diagnosed with hydrocephalus
             undergoing a primary surgical (non-bedside) shunting procedure with general
             anesthesia.

          -  Participants must have a parent/guardian who is able to provide written informed
             consent in accordance with human investigation committee guidelines.

          -  The shunting procedure must be an initial VPS placement (not a VPS revision).

        Inclusion Criteria (MRI with general anesthesia: peripheral blood patients; anesthesia but
        no surgery):

          -  Otherwise healthy pediatric patients, aged 6 months-less than 11 years, undergoing MRI
             with general anesthesia for evaluation of non-neurologic, non-inflammatory disease.

          -  Participants must have a parent/guardian who is able to provide written informed
             consent in accordance with IRB guidelines.

        Exclusion Criteria (HC study patients):

          -  Any active infection or infection within the last 14 days.

          -  Treatment in the last 48 hours with non-steroidal anti-inflammatory (NSAID) or
             corticosteroid medications.

          -  Anticoagulant administration in the last 48 hours.

          -  Treatment with any drug known to induce or suppress inflammation.

          -  Clinically unstable patients.

          -  Patients that have an American Society of Anesthesiologists physical status ≥4
             (severe, life-threatening disease).

          -  Infants born more than 4 weeks premature.

        Exclusion Criteria (MRI with general anesthesia: peripheral blood patients; anesthesia but
        no surgery):

          -  Known central nervous system disease.

          -  Treatment in the last 48 hours with non-steroidal anti-inflammatory (NSAID) or
             corticosteroid medications.

          -  Treatment with any drug known to induce or suppress inflammation.

          -  Patients that have an American Society of Anesthesiologists (ASA) physical status ≥4
             (severe, life-threatening disease).

          -  Infants born more than 4 weeks premature.
A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19
Condition: COVID-19; Coronavirus; Coronavirus Infection
MeSH terms: COVID-19; Coronavirus Infections
Intervention: INOpulse; Placebo
Intervention description: Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.; Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID; Sars-CoV-2; iNO; INOpulse; Severe Acute Respiratory Syndrome (SARS) Pneumonia; Severe Acute Respiratory Syndrome Coronavirus 2; SARS-CoV 2; COViNOX; pulsed inhaled nitric oxide; inhaled nitric oxide; portable pulsed inhaled nitric oxide; nitric oxide

Summary:

      A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of
      pulsed inhaled iNO compared to placebo in subjects with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  At least 18 years old

          -  Subjects must be hospitalized and have the following:

               -  proven or high suspicion of SARS-CoV-2 infection and,

               -  requiring oxygen supplementation defined as:

               -  SpO2 ≤ 92% regardless of supplemental oxygen (ie on room air or on oxygen), or

               -  SpO2 ≥ 92% on supplemental O2 and in the opinion of the Investigator it is not
                  safe to decrease or remove the supplemental oxygen

               -  require supplemental oxygen of no more than 10 L/minute, and

               -  radiologic suspected or proven COVID-19 pneumonitis (chest x-ray or CT scan)

          -  Female subjects must have a negative pregnancy test

          -  Willing and able to comply with the treatment schedule and study procedures

        Exclusion Criteria:

          -  Participating in another clinical trial of an investigational treatment for COVID-19

          -  Methemoglobin > 3%

          -  Evidence of severe multi organ failure

          -  Use of assisted ventilation prior to initiation of iNO

          -  Pregnancy or positive pregnancy test pre-dose

          -  Open tracheostomy

          -  Chronic use of a nitric oxide donor agent such as nitroglycerin or drugs known to
             increase methemoglobin such as lidocaine, prilocaine, benzocaine, nitroprusside,
             isosorbide, or dapsone at screening

          -  History or clinical evidence of systolic heart failure, left ventricular dysfunction
             (LVEF <40%)

          -  Subjects reporting massive hemoptysis associated with the current illness or with
             radiologically proven pulmonary embolus
Established Status Epilepticus Treatment Trial
Condition: Benzodiazepine Refractory Status Epilepticus
MeSH terms: Status Epilepticus
Intervention: Fosphenytoin; Levetiracetam; Valproic acid
Intervention MeSH terms: Fosphenytoin; Levetiracetam; Valproic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: ESETT had 478 enrollments. They were 16 re-enrollers. This was an EFIC trial so all consents happened after treatment and all enrollments went through the same process of consent even if they were re-enrolled. Some information presented here only includes the first 400 patients since there was a prespecified stopping rule and the trial stopped early for futility.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 478.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: status epilepticus, refractory, benzodiazepine, fosphenytoin, levetiracetam, valproic acid

Summary:

      The primary objective is to determine the most effective and/or the least effective treatment
      of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There
      are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and
      valproic acid (VPA).

      The second objective is comparison of three drugs with respect to secondary outcomes.

      The final objective is to ensure that the trial is informative for treatment of established
      SE in children by describing the effectiveness, safety, and rate of adverse reactions of
      these drugs in children.
    

Eligibility criteria:

        Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to
        treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose
        of a benzo was administered in the 5-30 minutes prior to study drug administration. The
        doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2
        years or older

        Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a
        second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in
        the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties
        other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the
        MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder;
        Known liver disease; Known severe renal impairment; Known allergy or other known
        contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia < 50 mg/dL; Hyperglycemia > 400
        mg/dL; Cardiac arrest and post-anoxic seizures
Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.
Condition: Polycythemia Vera
MeSH terms: Polycythemia Vera; Polycythemia
Intervention: Ruxolitinib
Intervention description: supplied as 5 mg, 10 mg and 20 mg tablets to be taken orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Polycythemia Vera; Hematologic Diseases; Myeloproliferative Disorders; INC424; Ruxolitinib; hydroxyurea resistant; adult

Summary:

      The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP)
      was to provide early access to ruxolitinib and evaluate safety information in patients with
      polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and who had no other
      standard treatment option, nor did they qualify for another clinical study for PV
    

Eligibility criteria:

        Inclusion Criteria:

        •Confirmed diagnosis of PV according to the 2008 World Health Organization criteria,
        palpable spleen, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1
        or 2; did not have access to a comparable or satisfactory alternative treatment

        Exclusion Criteria:

        •Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral
        infection requiring treatment, Active malignancy within the past 5 years, except treated
        cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell
        carcinoma of the skin, with no evidence for recurrence in the past 3 years., Women who were
        pregnant or nursing.