bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: SPARC Placebo; SPARC1310 I; SPARC1310 II; SPARC1310 III
Intervention description: Placebo; SPARC1310 I; SPARC1310 II; SPARC1310 III
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study will assess the efficacy and safety of SPARC1310 when compared to placebo and
      active control
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants aged 18 to 65 years with history of seasonal allergic
             rhinitis

          -  Participants able to understand and willing to sign the informed consent form

        Exclusion Criteria:

          -  Anotomical deviations of the nasal septum that significantly impair ventilation or
             airflow

          -  Pregnant or nursing women

          -  Positive serology for infectious disease (Hepatitis B or C, HIV) at screening

          -  Parallel participation in another current investigational study, participation in a
             study within less than 30 days prior to study entry, or previous participation in this
             same study.
Randomized Clinical Trial of Skin Closure With Staples Versus Suture
Condition: Wound Infection; Wound Complication
MeSH terms: Wound Infection; Wounds and Injuries
Intervention: 4-0 monofilament suture; Stainless steel staples
Intervention description: Skin closure using 4-0 monofilament suture; Skin closure using stainless steel staples.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 173.0
Sex: Female
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Wound infection; Wound separation; Skin staples; Subcuticular suture

Summary:

      Women with gynecologic cancers are often obese and have other risk factors for post-operative
      wound separation. Data from obstetrics and orthopedic surgery literature have shown a
      decreased risk of wound separation and complications when the skin is closed with suture as
      compared to staples. Skin closure with either staples or suture is considered standard of
      care. Traditionally, most wounds have been closed with staples given their ease of use and
      quick application. In this randomized study the investigators plan to evaluate and compare
      the complication rate associated with both standard closures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All women, >=18 and <= 85 years of age, undergoing surgery, via a midline laparotomy.

          -  Body mass index >=30

          -  Benign or oncologic indications for surgery.

          -  Women of childbearing age will be required to have a negative human chorionic
             gonadotropin (HCG) test within seven days of surgery.

          -  Surgery will be supervised by one of the gynecologic oncology attendings at Washington
             University School of Medicine.

          -  Ability to understand and willingness to sign an IRB approved written informed consent
             document.

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Pfannenstiel or transverse abdominal incision

          -  Concomitant panniculectomy or plastic surgery

          -  Women <18 years of age

          -  History of prior abdominal or pelvic radiation

          -  Inability to sign an informed consent form prior to registration on study

          -  Inability to understand spoken or written English

          -  Prisoner

          -  Mental incapacity

          -  A history of allergic reactions attributed to either Monocryl suture or stainless
             steel staples.
Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Melatonin; Placebo (Methylcellulose) capsule
Intervention description: Melatonin will be administered orally as a 10 mg dose three times a day for 14 days. Size 4 clear vegetable cellulose capsules containing 10 mg melatonin, microcrystalline cellulose, and rice concentrate prepared by Life Extension® will be over-encapsulated in opaque gelatin capsules. Over-encapsulation of melatonin treatments will be done by the research pharmacist and will be mailed to study subjects directly by courier. Melatonin capsules will be stored at room temperature.; Placebo capsules will be prepared with opaque gelatin capsules, filled using methylcellulose and over-encapsulated to appear identical to interventional drug. Placebo capsules will be given orally in the same regimen as intervention (three times daily for 14 days). Capsules will be prepared by the research pharmacist and will be mailed to study subjects directly by courier. Placebo capsules will be stored at room temperature.
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: placebo-controlled randomized double-blind pilot trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melatonin; COVID-19; SARS-CoV-2

Summary:

      This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate
      the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with
      COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant female adult ≥18 years of age at time of enrollment.

          -  Women of childbearing potential must agree to use at least one primary form of
             contraception for the duration of the study.

          -  Subject provides written informed consent prior to initiation of any study procedures.

          -  Understands and agrees to comply with planned study procedures.

          -  Agrees to the collection and storage of saliva samples per protocol.

        Exclusion Criteria:

          -  Severe chronic liver disease

          -  Severe chronic kidney disease or requiring dialysis

          -  Pregnancy or breast feeding.

          -  Allergy to the study medication

          -  Currently taking melatonin

          -  Currently taking high dose (>500 mg/day) Vitamin C
The Relationship Between Neuropsychological Testing and MRI, PET and COBRE - Project 1: AIM 2 (GE-180)
Condition: Alzheimer Disease; Parkinson Disease; Inflammation
MeSH terms: Parkinson Disease; Alzheimer Disease; Inflammation
Intervention: GE180 PET Scan
Intervention description: GE180 PET Scan
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants will receive one Flutriciclamide (18F-GE180) PET scan.
Masking: None (Open Label)
Masking description: No masking
Enrollment: 24.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: neuroinflammation

Summary:

      The complex pathological cascades leading to both Alzheimer's disease (AD) and Parkinson's
      disease (PD) involve, at various points, inflammation. Since inflammation is a treatable
      symptom, understanding how and when it impacts the brain, and where specifically in the
      brain, would offer important guidance in the development of new treatments, sorely needed in
      both diseases.

      Microglia play an important anti-inflammatory role, and produce a substance, mitochondrial
      translocator protein (TSPO), whose presence can be used as a marker of regional inflammation.
      GE180 is a newly developed PET ligand which binds to TSPO and hence can be used in imaging
      studies to analyze regional inflammation in living patients. In prior studies it has shown
      regional specificity in multiple sclerosis and brain injury. In the current study, the
      investigators will be using GE180 to analyze regional and global inflammation in the brains
      of patients with AD and PD at a single time point.

      The results of the current study will provide enriched understanding of inflammation in these
      conditions, and potentially provide preliminary data to inform design of future
      interventional trials.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be enrolled in CNTN

          2. Aged 55 to 90

          3. Available study partners

          4. Willing and able to participate in longitudinal follow-up study

          5. For MCI patients, fit criteria based in Movement Disorders Task Force or NIA

        Exclusion Criteria:

          1. Significant neurological disorders other than AD or PD;

          2. Unstable medical conditions

          3. History of major psychiatric diseases

          4. MRI evidence of infarction or other focal lesion or multiple lacunes

          5. Clinically significant abnormalities in B12 or TSH

          6. Identified as having a common polymorphism (rs6971) in the TSPO gene which has been
             shown to reduce binding affinity of tracers similar to GE180. This testing will be
             done as part of their CNTN participation.
A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Bevacizumab; Oxaliplatin; Folinic Acid; 5-fluorouracil; Preoperative Radiotherapy; Surgery
Intervention description: Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.; Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m^2) as a 2-hour IV infusion.; Folinic acid will be administered at a dose of 200 mg/m^2 as a 2-hour infusion.; 5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.; Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.; Radical rectal excision based on the TME technique.
Intervention MeSH terms: Leucovorin; Folic Acid; Bevacizumab; Fluorouracil; Oxaliplatin; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of two different neoadjuvant treatment
      approaches including bevacizumab in newly diagnosed participants with high risk locally
      advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A
      or Arm B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically confirmed locally advanced rectal cancer;

          -  measurable disease;

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

        Exclusion Criteria:

          -  prior treatment with bevacizumab;

          -  prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;

          -  previous history of malignancy (other than basal and squamous cell cancer of the skin,
             or in situ cancer of the cervix);

          -  history or evidence of central nervous system (CNS) disease;

          -  clinically significant cardiovascular disease;

          -  chronic treatment with high dose aspirin (more than [>] 325 milligrams per day
             [mg/day]) or non-steroidal anti-inflammatory drugs.
Study of Pharmacology of 17-OHPC in Pregnancy
Condition: Pregnancy
Intervention: 17-OHPC; Blood Draws
Intervention description: Intra-muscular injection of 250 mg 17-OHPC administered weekly between the second and third trimesters of pregnancy, until time of delivery.; 10 cc of blood will be drawn prior to the fifth weekly administration of 17-OHPC during second trimester of pregnancy, and then once daily for seven consecutive days post-dose. 10 cc of blood also will be drawn prior to weekly administration of 17-OHPC from sixth weekly dose in the second trimester until the last scheduled dose in the third trimester. Prior to this last scheduled dose, 10 cc of blood will be drawn, as well as once daily for seven consecutive days post-dose.
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second
      and third trimesters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Singleton gestation prior to 20 0/7 weeks gestation

          -  Planning to receive or receiving 17-OHPC (250 mg IM weekly)

          -  Previous history of preterm birth

          -  Able to give consent

        Exclusion Criteria:

          -  Fetal demise, anomaly, or growth restriction

          -  Hepatic or renal dysfunction

          -  Placental previa or abruptio placenta

          -  Polyhydramnios/oligohydramnios

          -  Short cervix or planned cerclage

          -  Chronic use of steroids, antiepileptics, antihypertensives, SSRS, street drugs

          -  Participation in another interventional study that influences gestational age at
             delivery

          -  Heparin treatment of known platelet count <100,000/mm3 (because of contraindication to
             intra-muscular injections)
PD of VAY736 in Patients With Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: VAY736; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Treatment was unblinded at an individual patient level at Week 24 to determine their progress in the study (follow-up, open-label VAY736 or End of Study Visit).
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: primary Sjögren's syndrome, pharmacodynamics

Summary:

      This study was designed to evaluate the safety, tolerability, pharmacokinetics and
      therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS
      patients
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Fulfilled revised European US consensus criteria for pSS

          -  ESSDAI value ≥ 6

          -  Elevated serum titers at screening of ANA (≥ 1:160)

          -  Seropositive at screening for anti-SSA and/or anti-SSB antibodies

          -  Stimulated whole salivary flow rate at screening of > 0 mL/min

        EXCLUSION CRITERIA:

        - Prior or previous use of (specific dosages and intervals prior to study start may apply):
        B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig
        (abatacept), anti-TNF-α mAb, cyclophosphamide, azathioprine and medications known to cause
        dry mouth.

        Hydroxychloroquine or methotrexate in a consistent dose for ≥ 3 months prior to
        randomization is allowed

          -  Active or recent history of clinically significant infection

          -  Vaccination within 2 month prior to study

          -  History of primary or secondary immunodeficiency
Niclosamide for Mild to Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Niclosamide; Placebo; Telehealth monitoring
Intervention description: Participants in the treatment arm will receive Niclosamide 2 grams orally once daily for 7 days in addition to current standard of care treatment. Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14. Fecal samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14, 21. A baseline fecal and oropharyngeal sample will be obtained on Day 1 prior to starting dosing of Niclosamide/ placebo.; The collection of oropharyngeal samples will be observed by a Study Team member via the telehealth platform.; In addition to Niclosamide or placebo treatments, all enrolled patients will be provided a home thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. The collection of oropharyngeal samples will be directly observed by a Study Team member via the telehealth platform.
Intervention MeSH terms: Niclosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded randomized controlled trial.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: As all members of the Study Team will be blinded, Tufts Investigational Drug Services (IDS) will be unblinded and will dispense both the Niclosamide and placebo. The study intervention (Niclosamide) and placebo will be packaged and as indistinguishable as possible.
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; Coronavirus; Treatment; Pill; Telehealth; Viral shedding

Summary:

      This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for
      mild to moderate coronavirus disease 2019 (COVID-19).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive SARS-CoV-2 test by PCR

          -  No requirement of oxygen supplementation

          -  Ability to take oral medication

        Exclusion Criteria:

          -  Known allergic reactions to any components of Niclosamide medication

          -  Participation in another trial or use of any experimental treatment for COVID-19,
             including chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir

          -  Hospitalization or requirement of hospitalization at the time of enrollment
BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: BIIB023; mycophenolate mofetil; oral corticosteroids
Intervention description: titrated to a target daily dose of 2 g (1 g twice daily); oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 19 Years
Maximum age: 76 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the long-term safety and tolerability of
      BIIB023 in participants with lupus nephritis (LN).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects who completed Week 52 of Study 211LE201 (NCT01499355) and did not discontinue
             BIIB023 or placebo study treatment.

          -  Subjects of childbearing potential must practice effective contraception during the
             study and be willing and able to continue contraception for 6 months after their last
             dose of study treatment.

        Key Exclusion Criteria:

          -  Any significant change in medical history in subjects from Study 211LE201, including
             laboratory tests or current clinically significant condition that, in the opinion of
             the Investigator, would have excluded the subjects' participation. The Investigator
             must re-review the subject's medical fitness for participation and consider any
             diseases that would preclude treatment under this protocol.

          -  Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to
             Week 52 of Study 211LE201.

          -  Female subjects considering becoming pregnant while in the study, currently pregnant,
             or breast feeding.

          -  Unwillingness or inability to comply with the requirements of the protocol including
             the presence of any condition (physical, mental, or social) that is likely to affect
             the subject's ability to comply with the protocol.

          -  Other unspecified reasons that, in the opinion of the Investigator or Biogen, makes
             the subject unsuitable for enrollment.

        NOTE: Other Protocol-defined Inclusion/Exclusion Criteria May Apply.
Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: bapineuzumab
Intervention description: 5 mg/week subcutaneous bapineuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: open-label; safety; antibody

Summary:

      This study will evaluate the safety and tolerability of bapineuzumab when administered by
      subcutaneous injection. The study is open only to subjects who participated in the preceding
      double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab
      for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will
      receive active treatment (bapineuzumab) and no subjects will receive placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer disease

          -  Completed preceding double-blind study (3133L1-2203 US)

          -  MMSE score > 9.

        Exclusion Criteria:

          -  Significant brain MRI abnormalities

          -  Clinically important psychiatric symptoms

          -  History of stroke