bioihbjkbjnl/mcl2 huggingface dataset:
DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: DFD06 Cream; Clobetasol Propionate Cream 0.05%
Intervention MeSH terms: Clobetasol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA
      (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream
      when applied twice daily for 15 days.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque
        psoriasis.

        Subjects with psoriasis involving 20 to 50% Body Surface Area (BSA), not including the
        face, scalp, groin, axillae and other intertriginous areas.

        Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit Subjects
        whose results from the screening Adrenocorticotropic hormone (ACTH) stimulation test are
        considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no
        other signs of abnormal HPA function or adrenal response

        Exclusion Criteria:

        Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
        exfoliative or pustular psoriasis.

        History of organ transplant requiring immunosuppression, HIV, or other immunocompromised
        state.

        Have received treatment for any type of cancer within 5 years of the Baseline Visit except
        skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the
        Baseline Visit.

        Use within 60 days prior to the baseline Visit of: 1) immunosuppressive drugs (e.g.,
        tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate,
        cyclosporine, hydroxyurea) Use within 30 days prior to the Baseline Visit of: 1) topical
        antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) psoralen and
        ultraviolet A (PUVA) therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate
        mofetil, sulfasalazine, 6-thioguanine), or 4) ultraviolet B (UVB) therapy.

        Use within 30 days prior to the Screening Visit of any product containing corticosteroids.
        Inhaled, intraocular, intranasal, etc. steroids are not allowed.

        Subjects who have an abnormal sleep schedule or work at night. Subjects with a known
        history of acute adrenal crisis, Addison's disease or decreased adrenal output, low
        pituitary function or pituitary tumors.

        Subjects who have a history of an adverse reaction to cosyntropin injection or similar test
        reagents.

        -
Antithrombin III in Infectious Disease Caused by COVID-19
Condition: Antithrombin III Deficiency; Covid19
MeSH terms: COVID-19; Communicable Diseases; Infections; Antithrombin III Deficiency
Intervention: Antithrombin III
Intervention description: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
Intervention MeSH terms: Antithrombins; Antithrombin III
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to see if participants who have SARS-CoV-2 and low
      levels of AT3 in the blood will benefit by being given AT3.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          1. >18y of age,

          2. Subject or proxy who can provide informed consent

          3. Positive SARS-COV-2 by Polymerase Chain Reaction (PCR) or as determined by clinical
             team

        EXCLUSION CRITERIA:

          1. Adults or Proxy unable to consent

          2. Individuals who are not yet adults (infants, children, teenagers)

          3. Pregnant women

          4. Prisoners

          5. Patients expected to die within 24 hours or with a "do not resuscitate" order,

          6. Multi-organ failure,

          7. History of hypersensitivity or allergy to any component of the study drug,

          8. Ongoing massive surgical or unexplained bleeding,

          9. History of bleeding or clotting disorder,

         10. Severe traumatic brain injury (Glasgow Coma Scale <6),

         11. Spinal or multiple-trauma,

         12. Cancer (incurable/terminal phase) and/or patients receiving palliative care,

         13. Enrollment in another concurrent clinical interventional study if considered
             interfering with this study objectives

         14. Per study team discretion, any condition(s) that may prevent safe treatment, preclude
             adequate evaluation or adding further risk to their underlying illness.
A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: lithium carbonate
Intervention description: The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
Intervention MeSH terms: Lithium Carbonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig's Disease; Lithium; Lithium Carbonate

Summary:

      This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is
      to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the
      progression of the disease. Since there is no placebo in this study, all patients will be
      taking lithium carbonate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of laboratory-supported probable, probable, or definite ALS

          -  Vital capacity of at least 75% of predicted

          -  Onset of weakness within 3 years prior to enrollment

          -  If patients are on riluzole, they must be on a stable dose for at least 30 days prior
             to baseline visit

          -  Women of childbearing potential must be surgically sterile or using an effective
             method of birth control and have a negative pregnancy test

          -  Willing and able to give informed consent

        Exclusion Criteria:

          -  Diagnosis of other neurodegenerative disease

          -  Need tracheotomy ventilation or non-invasive ventilation 23 or more hours/day

          -  Clinically significant history of any unstable medical condition in past 30 days

          -  History of renal

          -  History of liver disease

          -  Current pregnancy or lactation

          -  Use of lithium within thirty days of enrollment

          -  Significantly limited mental capacity

          -  History of recent drug or alcohol abuse

          -  Use of any investigational drug within 30 days prior to enrollment
Study of VVN001 Ophthalmic Solution in Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: VVN001 Ophthalmic Solution 1%; VVN001 Ophthalmic Solution 5%; Vehicle
Intervention description: VVN001 Ophthalmic Solution 1%; VVN001 Ophthalmic Solution 5%; VVN001 Ophthalmic Solution Vehicle
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-masked parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-masked
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2a, multi-center, double-masked, randomized, vehicle-controlled,
      parallel-group study designed to evaluate the safety and tolerability and to explore the
      efficacy activity of VVN001 ophthalmic solution versus vehicle in subjects with dry eye
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent prior to any study-related procedures .

          -  Are 18 years of age or older.

          -  Are willing and able to follow instructions and willing to be present for the required
             study visits for the duration of the study.

          -  Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in
             the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic
             Retinopathy Study (ETDRS) at the screening visit and randomization visit.

          -  Have a history of dry eye disease in both eyes

          -  Are currently using artificial tears and have been using within 30 days of the
             screening visit.

          -  Have an Eye dryness score ≥40 at Visit 1 and ≥35 at Visit 2, one score for both eyes
             (0-100 point VAS)

          -  Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the
             following criteria in the study eye and the same eye at Visit 1 and Visit 2:

          -  Inferior CFS (iCFS) score of ≥2 (NEI; 0-4 scale; using 0.5 unit increments)

          -  Have a Schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min.

        Exclusion Criteria:

          -  Have a known hypersensitivity or contraindication to the IP or components of IP.

          -  Have a Schirmer score (without anesthesia) of <1 or >7 mm/5 min in the study eye.

          -  Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening
             visit or are being treated with eye drops for glaucoma in the study eye. Or the
             subject has had laser or surgery for glaucoma in the study eye within 90 days of the
             study.
A Study of Avastin (Bevacizumab) and Transarterial Chemoembolisation (TACE) Treatment in Patients With Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Intervention: Bevacizumab; Transarterial chemoembolisation (TACE)
Intervention description: Bevacizumab was supplied as a sterile liquid in single-use vials.; TACE was conducted by the transfemoral artery approach with selective cannulation of the artery supplying the tumor. Cisplatin mixed with Lipiodol in a 1 mg:1 mL ratio was infused intra-arterially up to a maximum dose of 30 mg, depending on tumor size, followed by embolization of the artery using Gelfoam particle until the blood flow slowed. Bilobar lesions were treated by separate catheterization of right and left hepatic arteries followed by injection of the cisplatin-Lipiodol mixture and embolization.
Patients with stable disease or a partial response after 4 TACE sessions could be given further TACEs upon the investigator's discretion until there was evidence of progressive disease or contraindication due to severe complication or technical failure to perform the TACE.
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab)
      treatment combined with transarterial chemoembolisation (TACE) in patients with localized
      unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4
      sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously
      was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE
      sessions until disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age.

          -  Liver cancer, not suitable for resection.

          -  At least 1 measurable lesion, and overall tumor lesions occupying < 50% of liver
             volume

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

        Exclusion Criteria:

          -  Patients receiving concurrent radiotherapy or immunotherapy.

          -  Patients who have received previous chemotherapy, biological agents, or radiotherapy.

          -  Prior transarterial chemoembolisation (TACE) or transarterial embolisation (TAE).

          -  Prior liver transplantation or liver resection.

          -  Current or recent (within 10 days of study start) use of full-dose anticoagulants for
             therapeutic purposes.

          -  Patients with high risk esophageal/gastric varices.
Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic CHD - A Prospective Control Trial
Condition: Cyanotic Congenital Heart Disease; Anemia; Cyanosis; Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital; Cyanosis
Intervention: Epoetin Alfa and Iron; Iron
Intervention description: Patients in the treatment group will receive weekly EPO injections and iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization) They will be followed for 14 weeks.; Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks.
Intervention MeSH terms: Iron; Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 4.0
Sex: All
Maximum age: 8 Weeks
Healthy volunteers: No
Keywords: Erythropoetin; Cyanotic Heart Disease; Transfusion; Congenital Heart Disease

Summary:

      Cyanotic congenital cardiac patients require higher hemoglobin concentrations (red blood cell
      levels) for optimal oxygen delivery to the body. Prophylactic erythropoietin (EPO) and iron
      can prevent and/or decrease the amount of blood transfusions needed in this population. We
      seek to investigate if EPO and iron make a clinically significant difference in the number of
      transfusions given to these patients and the morbidity associated with it.
    

Eligibility criteria:

        Inclusion Criteria

          -  Newborns less than 4 weeks old at diagnosis

          -  Gestational age >34 weeks

          -  Birth weight 2.2-4kg

          -  Cyanotic heart disease who have had a surgical shunt or a catheterization intervention
             that is equivalent to a shunt (patent ductus arteriosus stent, right ventricular
             outflow tract stent).

          -  Baseline hematocrit to be below <40%.

          -  Completes at least 1 injection in the study by 8 weeks of age.

        Exclusion Criteria

          -  Infants diagnosed at greater than 4 weeks of age

          -  Gestation <34 weeks

          -  Birth weight <2.2 kg or >4kg

          -  Hematocrit >40%

          -  Newborns with acyanotic heart disease

          -  Infants with significant co-morbidities:

               -  Renal failure (Creatinine > 2 standard deviations above age adjusted norm)

               -  Hepatic failure (elevated AST/ALT levels > 2 standard deviations above age
                  adjusted norm

               -  Hemolytic disease

               -  Hemoglobinopathies (Sickle-cell disease, Thalassemias)
Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris
Condition: Pemphigus Vulgaris
MeSH terms: Pemphigus
Intervention: VAY736; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Pemphigus vulgaris; pemphigus; blistering disease

Summary:

      The study evaluated the efficacy, safety and pharmacokinetics of VAY736 in the treatment of
      patients with pemphigus vulagaris (PV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients 20 to 70 years of age

          -  Confirmed diagnosis of pemphigus vulgaris

          -  Presence of mild to moderate pemphigus vulgaris

          -  Patients must weight between 40 kg and 150 kg inclusive

          -  on a stable dose of oral corticosteriod therapy (with or without azathioprine or
             mycophenolate)

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential unless they are using a highly effective method of
             birth control during dosing and for 4 months following study treatment

          -  Recent previous treatment with photo therapy, biological therapy, steroids,
             immunosuppresive agents (unless washout period applied)

          -  Active or recent history of clinically significant infection

          -  use of rituximab within 1 year Other protocol-defined inclusion/exclusion criteria may
             apply.
Taxol Carboplatin and Erythropoetin
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Paclitaxel
Intervention description: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Time to progression (physical examination and radiologic imaging
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with primary ovarian cancer

          -  ECOG- 0-2

          -  Age >= 18

          -  no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer

          -  adequate bone marrow, liver and kidney reserve: leukocytes ≥ 2.0 x 109/l, platelets ≥
             100 x 109/l, bilirubin <= 2,0 mg%, creatinine <= 1,5 mg% or creatinine clearance ≥ 60
             ml/ min, hemoglobin ≥ 9 g/ dl SGOT, SGPT an AP within 3 fold of the reference
             laboratory's normal range

          -  written informed consent

        Exclusion Criteria:

          -  before-existing heart illness, Cardiac infarct within last 6 months

          -  Radiotherapy within 4 weeks for study entry

          -  Patients in pregnancy or breast feeding (in premenopausal women anticonception has to
             be assured: intrauterine devices, surgical methods of sterilization, or, in hormone
             insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen
             containing contraceptives)
Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-04937319 - 3mg; PF-04937319 - 20mg; PF-04937319 - 50mg; PF-04937319 - 100mg; Sitagliptin - 100mg
Intervention description: double-dummy placebo tablets administered once-daily for 84-days; PF-04937319 3mg administered as tablets once-daily for 84-days; PF-04937319 20mg administered as tablets once-daily for 84-days; PF-04937319 50mg administered as tablets once-daily for 84-days; PF-04937319 100mg administered as tablets once-daily for 84-days; Sitagliptin 100mg administered as tablets once-daily for 84-days
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Phase 2; type 2 diabetes mellitus; PF-04937319

Summary:

      B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2
      diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

        Exclusion Criteria:

          -  patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory
             test results at screening
A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
Condition: Ovarian Cancer; Basal Cell Carcinoma; Metastatic Colorectal Cancer
MeSH terms: Carcinoma, Basal Cell
Intervention: Vismodegib; FOLFOX; FOLFIRI; Bevacizumab
Intervention description: Vismodegib was supplied in capsules.; FOLFOX (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and oxaliplatin [OX]) was supplied as solutions for intravenous administration.; FOLFIRI (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and irinotecan [IRI]) was supplied as solutions for intravenous administration.; Bevacizumab was supplied as a solution for intravenous administration.
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hedgehog pathway inhibitor

Summary:

      This was a multicenter, open-label extension study. Patients who received vismodegib
      (GDC-0449) in a Genentech-sponsored study and who had completed the parent study or who
      continued to receive vismodegib at the time the parent study closed were eligible for
      continued treatment in this protocol.
    

Eligibility criteria:

        This study only enrolled participants who took part in previous studies of vismodegib
        conducted by Genentech.

        Inclusion Criteria:

          -  Completed vismodegib treatment within 2-4 weeks in a Genentech-sponsored parent study
             or continued to receive vismodegib at the time the Genentech-sponsored parent study
             closed.

          -  Expectation by the investigator that the participant may continue to benefit from
             additional vismodegib treatment.

        Exclusion Criteria:

          -  Intervening anti-tumor therapy not specified in the parent study (ie,
             non-protocol-specified chemotherapy, other targeted therapy, radiation therapy, or
             photodynamic therapy).