bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]; fusidic acid [Verutex]; erythromycin [Eritex]; Fisiogel
Intervention description: 150mg po daily; topical, daily for 30 days.; topical, daily for 30 days.; topical, daily for 30 days
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Fusidic Acid; Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 3 arm study will compare the efficacy and safety of three different dermatological
      creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients
      with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have
      recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily
      treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity
      of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the
      target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV);

          -  eligible to start treatment with Tarceva, or receiving Tarceva for <=5 days.

        Exclusion Criteria:

          -  presence of skin rash or other signs of skin toxicity;

          -  treatment with any systemic or intranasal antibiotic within 7 days before
             randomization;

          -  treatment with other topical formulation within 14 days before randomization;

          -  other anticancer therapy in addition to Tarceva.
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Atogepant 60 mg; Placebo
Intervention description: Atogepant tablets.; Atogepant matching placebo tablets.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Episodic migraine

Summary:

      This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared
      with placebo in participants with episodic migraine and who have previously failed 2 to 4
      classes of oral prophylactic treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis
             according to the ICHD-3, 2018.

          -  Age of the participant at the time of migraine onset < 50 years -History of 4 to 14
             migraine days per month on average in the 3 months prior to Visit 1 in the
             investigator's judgment

          -  Female participants willing to minimize the risk of inducing pregnancy for the
             duration of the clinical study and follow-up period. Male participants willing to
             minimize the risk of inducing pregnancy for the duration of the clinical study and
             follow-up period.

          -  4 to 14 migraine days in the 28-day baseline period per eDiary

          -  Failed oral migraine prophylaxis medications from 2 to 4 medication classes

        Exclusion Criteria:

          -  Any clinically significant hematologic, endocrine, pulmonary, hepatic,
             gastrointestinal, or neurologic disease

          -  Participant has any other concurrent pain condition that, in the opinion of the
             investigator, may significantly impact the current headache disorder

          -  In the opinion of the investigator, confounding psychiatric conditions, dementia,
             epilepsy, or significant neurological disorders other than migraine

          -  Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in
             the investigator's judgment

          -  Has ≥ 15 headache days in the 28-day baseline period per eDiary

          -  Clinically significant cardiovascular or cerebrovascular disease

          -  Has a history of migraine accompanied by diplopia or decreased level of consciousness
             or retinal migraine as defined by ICHD-3, 2018

          -  Has a current diagnosis of chronic migraine, new persistent daily headache, medication
             overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful
             cranial neuropathy as defined by ICHD-3, 2018
Buprenorphine for Treatment Resistant Depression
Condition: Depression; Depressive Disorder; Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major
Intervention: Buprenorphine; Placebo
Intervention description: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day); matched placebo
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Buprenorphine; Receptors, opioid; Receptors, opioid, kappa

Summary:

      The purpose of this study is to compare the safety and efficacy of buprenorphine with placebo
      for adults with treatment resistant depression (TRD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21 and older

          -  Major depressive disorder

          -  Non-responder to at least 2 FDA-approved antidepressants prescribed at a therapeutic
             dose, each for at least 6 weeks, or is a depression non-responder from an ongoing
             study of late-life depression at our research clinic.

          -  For women of child-bearing age, must have negative pregnancy test and agree not to get
             pregnant while participating.

        Exclusion Criteria:

          -  Concomitant use of strong or moderate CYP3A4 inhibitor.

          -  Refusal to stop all opioids.

          -  Refusal to discontinue all alcohol.

          -  Refusal to discontinue benzodiazepines other than the equivalent of lorazepam 2 mg/day
             prescribed at a stable dose for at least the past 2 weeks.

          -  Hepatic impairment (AST/ALT > 1.5 times upper normal).

          -  Lung disease requiring supplemental oxygen (CPAP for sleep apnea is acceptable).

          -  Estimated creatinine clearance <30 mL/min.

          -  Inability to provide informed consent.

          -  Depressive symptoms not severe enough (i.e., MADRS < 10) at the baseline assessment.

          -  Dementia, as defined by MMSE < 24 and clinical evidence of dementia

          -  Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective
             disorder, schizophreniform disorder, delusional disorder, or current psychotic
             symptoms.

          -  Abuse of or dependence on alcohol or other substances within the past 3 months.

          -  Meets criteria for history of abuse or dependence upon opioids.

          -  High risk for suicide.

          -  Contraindication to buprenorphine.

          -  Inability to communicate in English.

          -  Non-correctable clinically significant sensory impairment.

          -  Unstable medical illness.

          -  Subjects taking psychotropic medications that cannot be safely tapered and
             discontinued prior to study initiation.
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Intervention: Diclofenac sodium topical gel 1%; Placebo
Intervention description: Diclofenac sodium topical gel 1%, 4 times daily; Placebo, 4 times daily
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankle sprain, soft tissue injury

Summary:

      The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1%
      compared with placebo applied four times a day in subjects with acute ankle sprains under
      'in-use' conditions, in particular with regard to pain relief.
    

Eligibility criteria:

        Inclusion criteria:

          1. Male or female aged 18 years and over.

          2. Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.

          3. Injury within past 12 hours.

        Exclusion criteria:

          1. Pain medication was taken within the 6 hours that precede randomization.

          2. During the past 3 months: Grade I-III sprain of the same ankle.

          3. During the past 6 months: Grade II-III sprain, any other significant injury (such as
             fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or
             foot.

          4. Pain or instability in the same ankle attributable to previous ankle sprain or any
             other trauma.

          5. Ankle sprain attributable to a known disease affecting the ligaments, such as ligament
             hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's
             syndrome, Ehlers-Danlos syndrome).

        Other protocol-defined inclusion/exclusion criteria may apply
Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis
Condition: Bile Acid Synthesis Defect
Intervention: Cholic Acid
Intervention description: 10-15 mg/kg body weight/day supplied in 50 or 250 mg Cholic Acid Capsules
Intervention MeSH terms: Cholic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Healthy volunteers: No
Keywords: Cholic Acid; Inborn Error; Bile Acid Metabolism; Inborn Error of Bile Acid Synthesis

Summary:

      The primary purpose of the study is to evaluate the therapeutic efficacy and safety of cholic
      acid in subjects with identified inborn errors of bile acid synthesis.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects who received cholic acid through CCHMC protocols 91-10-10 or CAC-002-01 and meet
        the following criteria are eligible for study participation.

          1. The subject and/or parent/legal guardian must have provided informed consent prior to
             study start.

          2. The subject must have a diagnosis of an inborn error of bile acid synthesis.

          3. The subject must be willing and able to comply with all study assessments and
             procedures.

          4. Subjects with other organ dysfunction will not be excluded
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Condition: Cholestasis, Extrahepatic
MeSH terms: Cholestasis; Cholestasis, Extrahepatic
Intervention: WallFlex™ Biliary Fully Covered Metal Stent placement
Intervention description: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Malignant; Cholestasis, Extrahepatic; Biliary obstruction

Summary:

      The overall objective of this study is to assess the functionality of the WallFlex™ Biliary
      Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Clinical symptoms of biliary obstruction

          -  Inoperable extrahepatic biliary obstruction by any malignant process

          -  Willing and able to comply with the study procedures and provide written informed
             consent to participate in the study.

        Exclusion Criteria:

          -  Participation in an Investigational Study within 90 days prior to date of patient
             consent

          -  Strictures that cannot be dilated enough to pass the delivery system

          -  Perforation of any duct within the biliary tree

          -  Presence of a metal biliary stent

          -  Presence of any esophageal or duodenal stent

          -  Patients for whom endoscopic procedures are contraindicated

          -  Patients with known sensitivity to any components of the stent or delivery system

          -  Patients with active hepatitis or intrahepatic metastases that extensively involves
             both lobes of the liver

          -  Patients with an anticipated life expectancy of < 3 months
A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Docetaxel; Placebo to bevacizumab; Bevacizumab
Intervention description: Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.; Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.; Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Intervention MeSH terms: Bevacizumab; Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 736.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with
      docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast
      cancer who are candidates for taxane-based chemotherapy but who have not received prior
      chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the
      target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion criteria:

          -  Female patients ≥ 18 years of age.

          -  Human epidermal growth factor receptor 2 (HER2)-negative cancer of the breast with
             locally recurrent or metastatic disease, suitable for chemotherapy.

          -  No adjuvant chemotherapy within 6 months before randomization, and no taxane-based
             chemotherapy within 12 months before randomization.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

        Exclusion criteria:

          -  Previous chemotherapy for metastatic or locally recurrent breast cancer.

          -  Radiotherapy for treatment of metastatic disease.

          -  Other primary tumors within last 5 years, except for controlled limited basal cell or
             squamous cancer of the skin, or cancer in situ of the cervix.

          -  Spinal cord compression or brain metastases.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to randomization.

          -  Inadequate bone marrow, liver, or renal function.

          -  Uncontrolled hypertension.
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
Condition: Cutaneous T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous
Intervention: SGX301 (synthetic hypericin); Placebo
Intervention description: 0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.; USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.
Intervention MeSH terms: Hypericin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CTCL; Mycosis fungoides; Hypericin; SGX301; MF

Summary:

      To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with
      patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage
             IB, or Stage IIA.

          -  Subjects must have a minimum of three (3) evaluable, discrete lesions.

          -  Subjects must be willing to refrain from sunbathing for the duration of the study.

        Exclusion Criteria:

          -  History of sun hypersensitivity and photosensitive dermatoses including porphyria,
             systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous
             light eruptions or radiation therapy within 30 days of enrolling.

          -  Pregnancy or mothers who are breast feeding.

          -  Males and females not willing to use effective contraception.

          -  Unhealed sunburn.

          -  Subjects receiving topical steroids or other topical treatments for CTCL within 2
             weeks.

          -  Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy
             (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic
             therapies for CTCL within 3 weeks of enrollment.

          -  Subjects with significant history of systemic immunosuppression due to drugs or
             infection with HIV or HTLV 1.

          -  Subjects taking other investigational drugs or drugs of abuse within 30 days of entry
             into this study.
Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma
Condition: Nasal Polyps
MeSH terms: Nasal Polyps; Polyps
Intervention: Fevipiprant 150 mg; Fevipiprant 450 mg; Placebo
Intervention description: Fevipiprant (QAW039) 150 mg once daily administered orally as tablet; Fevipiprant (QAW039) 450 mg once daily administered orally as tablet; Placebo once daily administered orally as tablet
Intervention MeSH terms: Indoleacetic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double blind, double dummy study design.
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nasal Polyposis; Asthma; Nasal polyp score (NPS); Nasal congestion score (NCS); Bronchial Diseases; Lung Diseases; Nose Diseases; Respiratory Hypersensitivity; Fevipiprant; QAW039

Summary:

      A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg,
      compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing
      endoscopic nasal polyp score in adult (≥ 18 years) patients with nasal polyposis and
      concomitant asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score
             >= 4 with minimum score of 2 in each nostril.

          -  Concomitant diagnosis of asthma for a period of at least 6 months prior to screening.

          -  Patients on stable asthma treatment of at least inhaled corticosteroids (any dose)
             alone for at least 6 months prior to screening or ICS for 6 months prior to screening
             with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to
             screening.

        Exclusion Criteria:

          -  Asthma exacerbation, within 6 weeks prior to screening, that required systemic
             corticosteroids, hospitalization or emergency room visit.

          -  Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of
             OCS for a period of 1 month or more, within 1 year of screening

          -  Use of biologics for asthma or any other indications, that has the potential to
             interfere/affect either asthma or nasal polyposis disease progression, within 6 months
             of screening.

          -  Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30
             days of screening or during the run-in period.

          -  Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of
             screening.

          -  History of nasal surgery modifying the structure of the nose such that assessment of
             the nasal polyp score is not possible.

          -  Patients with baseline ACQ-5≥1.5