bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3209590 in Participants With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY3209590; Insulin Degludec
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug LY3209590 is safe and effective in
      participants with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year

          -  Participants must have been using multiple daily injections without interruption for
             at least 3 months

          -  Participants must have HbA1c values of 5.6% to 9.5%, inclusive

          -  Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared
             (kg/m²)

        Exclusion Criteria:

          -  Have had more than 1 emergency room visit or hospitalization due to poor glucose
             control within 6 months prior to study screening

          -  Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6
             months prior to screening

          -  Have any of the following cardiovascular (CV) conditions: acute myocardial infarction,
             New York Heart Association Class III or IV heart failure, or cerebrovascular accident
             (stroke)

          -  Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other
             liver disease

          -  Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m²

          -  Have active or untreated cancer

          -  Are receiving chronic (>14 days) systemic glucocorticoid therapy
COVID-19: Povidone-Iodine Intranasal Prophylaxis in Front-line Healthcare Personnel and Inpatients
Condition: COVID-19; SARS-CoV 2
MeSH terms: COVID-19
Intervention: Povidone-Iodine Nasal Spray and Gargle; Povidone-Iodine Nasal Spray and Gargle; Povidone-Iodine Nasal Spray and Gargle
Intervention description: Healthcare workers will receive standard PPE and a pre- and post-study nasal swab COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle (10% diluted 1:30) to use at the beginning of their shift, in the middle, and at the end of their shift.; Patients will receive standard of care treatment and a pre- and post-study nasal spray COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle shortly after admission or preoperatively.; Community members will receive a pre- and post-study nasal swab COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle (10% diluted 1:30) to use at home.
Intervention MeSH terms: Iodine; Cadexomer iodine; Povidone-Iodine; Povidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19; SARS-CoV 2; Health Care Workers; COVID-19 Prophylaxis

Summary:

      Povidone-iodine (PVP-I) is a broad-spectrum antiseptic with activity against bacteria, fungi,
      and viruses. It has been previously used in both intranasal preparations against Methicillin
      Resistant Staphylococcus Aureus (MRSA) as well as oral preparations in in-vitro studies of
      Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV), Middle Eastern Respiratory Syndrome
      Coronavirus (MERS-CoV), influenza H1N1, and rotavirus with good efficacy. This study will
      evaluate the efficacy of PVP-I as prophylaxis in Coronavirus Disease 2019 (COVID19)-negative
      front-line health care workers, hospital patients, and community members.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthcare worker OR

          -  patient with expected hospital stay of 7+ days OR

          -  patient admitted for major surgery OR

          -  community member

          -  COVID19 negative by nasal swab test

          -  asymptomatic for COVID19

          -  able to consent

        Exclusion Criteria:

          -  positive for COVID19 by nasal swab

          -  symptomatic for COVID19

          -  unable to consent
A Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
Condition: Idiopathic Polypoidal Choroidal Vasculopathy
MeSH terms: Polypoidal Choroidal Vasculopathy; Vascular Diseases
Intervention: Zimura
Intervention description: Subjects will receive monthly intravitreous injections of Zimura in combination with Lucentis, Avastin or Eylea.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: idiopathic polypoidal choroidal vasculopathy; IPCV; Zimura™; Avastin®; Eylea®; Lucentis®

Summary:

      The objectives of this study are to evaluate the safety and tolerability of Zimura™
      intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF)
      therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  Diagnosis of IPCV

          -  Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8
             injections in the previous twelve (12) months

        Exclusion Criteria:

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry

          -  Any prior thermal laser in the macular region, regardless of indication

          -  Any ocular or periocular infection in the twelve (12) weeks prior to entry

          -  History of any of the following conditions or procedures in the study eye:
             Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g.
             trabeculectomy), glaucoma drainage device, corneal transplant

          -  Previous therapeutic radiation in the region of the study eye

          -  A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy
             and/or leakage from retinal vasculature in a subject with diabetes mellitus)
Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
Condition: Peritoneal Carcinomatosis
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma; Peritoneal Neoplasms; Hyperthermia
Intervention: Paclitaxel; Radical surgery-peritonectomy
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ovarian cancer

Summary:

      A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed
      with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical
      surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues
      (R0) or macroscopic tumor residues < 1cm (R1)) followed by hyperthermia against normothermia
      intraperitoneal intraoperative chemotherapy with paclitaxel
    

Eligibility criteria:

        Inclusion Criteria:

          1. age ranged between 18 and 75 years old;

          2. histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian
             cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));

          3. Karnofsky index > 70 or performance status ≤2;

          4. informed consent form filled out correctly.

        Exclusion Criteria:

          1. unfulfillment of inclusion criteria;

          2. extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);

          3. concomitance of another malignant neoplasm;

          4. renal, hepatic or cardiovascular dysfunction;

          5. intolerance during the treatment; - (6) refusal to participate in the study.
Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects
Condition: Seasonal Influenza; Influenza; Influenza Due to Unspecified Influenza Virus; Human Influenza
MeSH terms: Influenza, Human
Intervention: MF59C.1-adjuvanted subunit influenza vaccine; Sub unit, Inactivated, Influenza vaccine
Intervention description: 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm; 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 84.0
Sex: All
Minimum age: 6 Months
Maximum age: 36 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cell mediated immunity; cell mediated immune response; Children; adjuvanted

Summary:

      This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and
      hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit
      influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated
      children aged 6 to <36 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female previously unvaccinated healthy children aged 6 to <36 months.

        Exclusion Criteria:

          -  Any known or suspected impairment of the immune system, any serious disease.

          -  Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or
             4 weeks (for live vaccines) prior to enrollment in this study.

          -  Individuals who have had influenza vaccine or documented suspected influenza disease
             prior to day 1.
A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: AIN457; AIN457
Intervention description: (10mg/kg i.v.).; (10mg/kg i.v.).
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis,; demyelinating autoimmune diseases,; interleukin-17,; monoclonal human antibody

Summary:

      The study will assess the long-term safety and tolerability of AIN457 in patients with
      relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of
      maintenance of efficacy and health related quality of life will be explored.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Was exposed to AIN457 or placebo in study CAIN457B2201 and completed the CAIN457B2201
        study, up to at and including Visit 10 (week 24).

        Exclusion Criteria:

          1. Have been treated with:

               -  immunosuppressive medications such as azathioprine or methotrexate within 1 month
                  prior to enrollment, if lymphocyte count normal.

               -  immunoglobulins and/or monoclonal antibodies (with the exception of AIN457)
                  within 2 month prior to enrollment, or if the immunosuppressive effects are
                  likely to persist at enrollment (such as presence of B cell depletion after
                  rituximab treatment).

          2. Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab,
             cladribine, cyclophosphamide, mitoxantrone or other immunosuppressive treatments with
             long-lasting (over 6 months) or permanent effects.

          3. Have received any live or live attenuated vaccines (including live vaccines for
             varicella-zoster virus or measles) within 2 months prior to enrollment.

          4. A diagnosis of chronic disease of the immune system other than MS, or of an
             immunodeficiency syndrome.

          5. Current severe depression.

          6. Pregnant or nursing (lactating) women.

          7. Malignancy diagnosed since enrollment in the core study (except for
             successfully-treated basal or squamous cell carcinoma of skin).

          8. A new diagnosis of diabetes

          9. Positive testing for tuberculosis (QuantiFeron or chest X-ray).

         10. Subjects with clinically significant cardiac abnormalities

         11. Unable or unwilling to undergo multiple venipunctures

         12. Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants
             incompatible with MRI.

        Other protocol-defined inclusion/exclusion criteria may apply
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
Condition: Candida Vulvovaginitis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Vulvovaginitis
Intervention: Fluconazole; SCY-078
Intervention description: Oral Antifungal comparator; Investigational Antifungal
Intervention MeSH terms: Fluconazole; Ibrexafungerp
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, double-dummy, active-controlled, dose-finding
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 186.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, double-dummy, active-controlled,
      dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus
      oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute
      Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per
      treatment group) will be enrolled and randomized into the study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Subject is a female of at least 18 years of age

          2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive
             microscopic examination with 10% KOH in a vaginal sample revealing yeast forms
             (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

        Key Exclusion Criteria:

          1. Subject has any vaginal condition other than AVVC that may interfere with the
             diagnosis or evaluation of response to therapy, such as suspected or confirmed
             concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)

          2. Need for systemic and/or topical (vaginal) antifungal treatment, including
             prescription or over-the-counter products during the study and treatment for VVC 28
             days prior to randomization

          3. Subject is actively menstruating at the time of the Baseline visit.

          4. Subject has uncontrolled diabetes mellitus.

          5. Subject has a vaginal sample with pH >4.5.

          6. Subject has a history of or an active cervical/vaginal cancer.
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic
Intervention: Alendronate; Denosumab; Placebo
Intervention description: Alendronate 70 mg PO QW; denosumab 60 mg SC q 6 mos; Placebo for alendronate and placebo for denosumab
Intervention MeSH terms: Denosumab; Alendronate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 247.0
Sex: Female
Minimum age: 50 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Post Menopausal; Osteoporosis; MicroCT; Amgen; denosumab; Extreme CT; XCT; Fosamax; Alendronate

Summary:

      This study is structured to estimate the effect of denosumab, compared to placebo and
      alendronate, on several bone parameters.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good
             health.

          -  Must have low bone mineral density and meet specific eligibility criteria.

        Key Exclusion Criteria:

        -Subjects must not currently be receiving any medication that affects bone metabolism or
        have an underlying condition that affects their ability to take alendronate or receive
        denosumab.
Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492
Condition: Adrenocortical Adenoma; Endometrial Stromal Sarcomas
MeSH terms: Sarcoma; Adenoma; Sarcoma, Endometrial Stromal; Adrenocortical Adenoma
Intervention: MRI, CT or ultrasound was permitted if MRI was contraindicated; Dexamethasone Supression Test; Sonogram; Biopsy; BGG492
Intervention description: MRI/CT/ultrasound of abdomen; Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol; Sonogram of the uterus (females only); Uterine endometrial biopsy (females only); No study-drug was administered in this study
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adrenocortical Adenoma,; Endometrial Stromal sarcomas; BGG492

Summary:

      To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study
      CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent had to be obtained before any assessment was performed;

          2. Patients had to be cooperative, willing to participate in the study assessments, and
             be able to report AEs (adverse events) themselves or have a caregiver who can record
             and report the events;

          3. Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have
             been greater than 28 days

          4. At least 1 year had to have elapsed since the patient received his or her last dose of
             BGG492.

        Exclusion Criteria:

        - There were no exclusion criteria for this study. All patients meeting the inclusion
        criteria were eligible to participate in the follow-up safety assessments
Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Cetuximab; 5-Fluorouracil; Radiation
Intervention MeSH terms: Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 5-FU; cetuximab; radiation; adenocarcinoma of the rectum; neoadjuvant therapy

Summary:

      The standard treatment for rectal cancer is to receive the chemotherapeutic drug
      5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal
      cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is
      to determine if Cetuximab improves the benefits of neoadjuvant chemoradiotherapy when given
      with 5-FU and radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the rectum that begins within 15cm of the
             anal verge as determined by sigmoidoscopy and/or colonoscopy, with no evidence of
             distant metastatic disease. A complete colonoscopy to the cecum is recommended prior
             to initiating protocol therapy.

          -  Staging with transrectal ultrasound or endorectal coil Magnetic resonance imaging
             (MRI) to confirm clinical stage of T3 or T4 or lymph node positive rectal
             adenocarcinoma

          -  Tumor is K-ras wildtype by method of choice at respective institution (testing codons
             12 and 13)

          -  Performance status: Eastern Cooperative Oncology Group Performance Score (ECOG PS)
             less than or equal to 2

          -  18 years of age or older

          -  No evidence of metastatic disease by abdominal/pelvic (Computed tomography) CT and
             chest imaging

          -  Adequate bone marrow, renal,and hepatic function as outlined in protocol

          -  All patients will be evaluated by a surgeon and considered a candidate for definitive
             surgery

          -  Coumadin or heparin management for line care of other indications is permitted. The
             International Normalised Ratio (INR) will be monitored weekly in patients taking
             coumadin.

        Exclusion Criteria:

          -  Prior treatment for this malignancy

          -  Prior history of pelvic radiation therapy

          -  Prior history of 5-FU based or EGFR receptor inhibitor therapy

          -  Prior history of an allergic reaction to a monoclonal antibody

          -  Uncontrolled serious medical or psychiatric illness

          -  Significant history of uncontrolled cardiac disease

          -  Sexually active women of childbearing potential must use an effective method of birth
             control during the course of the study

          -  Unwilling to agree to pre and post-cetuximab sigmoidoscopy and biopsy