bioihbjkbjnl/mcl2 huggingface dataset:
Convalescent Plasma to Stem Coronavirus (CSSC-001)
Condition: Coronavirus; Convalescence
MeSH terms: Coronavirus Infections; Convalescence
Intervention: Anti- SARS-CoV-2 Plasma; SARS-CoV-2 non-immune Plasma
Intervention description: SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320; Normal human plasma collected prior to December 2019
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 ratio
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19

Summary:

      Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control
      (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day
      28.
    

Eligibility criteria:

        Inclusion Criteria

          1. Subjects must be 18 years of age or older

          2. Close contact exposure (as defined by CDC guidelines) to person with COVID-19 within
             96 hours of randomization (and 120 hours of receipt of plasma)

        Exclusion Criteria

          1. Receipt of any blood product in past 120 days.

          2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the
             opinion of the principal investigator, would affect subject safety and/or compliance.

          3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of
             breath) at time of screening.

          4. Laboratory evidence of COVID-19 infection at time of screening.

          5. History or known laboratory evidence of previous COVID-19 infection.

          6. History of prior reactions to transfusion blood products.

          7. Inability to complete therapy with the study product within 24 hours after
             randomization.
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Condition: Anemia; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: AKB-6548; Placebo
Intervention description: oral dose administered once daily for 42 days; oral Placebo administered once daily for 42 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; erythropoietin; safety; efficacy; tolerability; pharmacokinetics

Summary:

      The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic
      response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in
      pre-dialysis participants with anemia with repeat dosing for 42 days.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 to 79 years of age, inclusive

          -  Chronic Kidney Disease (eGFR <60 mL/min), not yet on dialysis

          -  Hemoglobin (Hgb) ≤ 10.5 g/dL

          -  Transferring saturation ≥ 20%

          -  Ferritin ≥ 50 ng/mL

        Key Exclusion Criteria:

          -  Body mass index >42

          -  Red blood cell transfusion within 12 weeks

          -  Androgen therapy within the previous 21 days prior to study dosing

          -  Therapy with any approved or experimental erythropoiesis stimulating agent (ESA)
             within the 11 weeks prior to the Screening visit

          -  Participants meeting the criteria of ESA resistance within the previous 4 months

          -  Individual doses of intravenous iron of greater than 250 mg within the past 21 days

          -  Aspartate aminotransferase or alanine aminotransferase >1.8x upper limit of normal
             (ULN)

          -  Alkaline phosphatase >2x ULN

          -  Total bilirubin >1.5x ULN

          -  Uncontrolled hypertension

          -  New York Heart Association Class III or IV congestive heart failure

          -  Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to
             dosing
Combined Spinal-Epidural Temperature and Duration of Action
Condition: Pain
Intervention: combined spinal epidural
Intervention description: Combined Spinal Epidural
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Combined spinal epidural duration; labor pain

Summary:

      The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have
      a shorter period of pain relief than that maintained at room temperature. The temperature of
      the dose of medication will be measure with an infrared thermometer immediately prior (within
      5 minutes) to administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >/= 18 years of age not allergic to medications used to treat labor pain </= 6cm
             cervical dilation visual pain score >/=3

        Exclusion Criteria:

          -  <18 years of age > 6 cm cervical dilation non-English speaking subjects
Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer
Condition: HER2 Positive Breast Carcinoma; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Copper Cu 64-DOTA-Trastuzumab; Laboratory Biomarker Analysis; Pertuzumab; Positron Emission Tomography; Therapeutic Conventional Surgery; Trastuzumab
Intervention description: Given IV; Correlative studies; Given IV; Undergo PET; Undergo surgery; Given IV
Intervention MeSH terms: Copper; Antineoplastic Agents, Immunological; Trastuzumab; Pertuzumab; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission
      tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab
      before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive
      breast cancer that has spread from where it started to nearby tissue or lymph nodes.
      Diagnostic procedures, such as copper Cu 64 DOTA-trastuzumab PET, may help predict a
      patient's response to trastuzumab and pertuzumab before surgery in patients with locally
      advanced HER2 positive breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be women who have histological confirmation of HER2 positive breast
             cancer

          -  The primary tumor must be >= 2.0cm in size and/or have biopsy proven axillary nodes
             that are >= 2.0cm in size by mammography, ultrasound, or magnetic resonance imaging
             (MRI)

          -  The current cancer must over express HER2 as determined by immunohistochemistry (IHC)
             and/or fluorescence in situ hybridization (FISH)

          -  Patients may not have received prior HER2 directed therapies

          -  Participants must have normal cardiac ejection fraction (per label, as defined as
             institutional normal)

          -  Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and
             chemotherapy

          -  Ability to provide informed consent

          -  Negative Serum Pregnancy test

        Exclusion Criteria:

          -  Participants who are not considered candidates for pertuzumab + trastuzumab +
             chemotherapy

          -  Concurrent malignancy other than non-melanoma skin cancer

          -  Patients must not have known metastatic disease

          -  Patients must not have received prior treatment for the current breast cancer
SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: SGI-110
Intervention description: SGI-110 will be administered by subcutaneously (SC) on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity
Intervention MeSH terms: Guadecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced
      hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a
      Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at
      16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease
      control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC
      after failure of prior sorafenib.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older

          2. Histological or cytological confirmed hepatocellular carcinoma with advanced stage
             disease

          3. Received prior sorafenib treatment, and showed evidence of disease progression, which
             is defined as Investigator verified radiologic progression, or intolerance of prior
             systemic therapy, which is defined as having had clinically significant adverse events
             that persisted despite one or more dose reductions or interruptions

          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          5. Acceptable organ function

          6. Signed an approved informed consent

        Exclusion Criteria:

          1. Known hypersensitivity to SGI-110

          2. Adequate washout of prior radiation, chemotherapy or other locoregional therapy

          3. Abnormal left ventricular ejection fraction

          4. Uncontrolled ischemic heart disease or a history of congestive cardiac failure

          5. Known brain metastases

          6. Clinically evident ascites

          7. Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points

          8. Prior malignancy, except for adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, non-metastatic prostate cancer with normal
             prostate-specific antigen (PSA) or other cancer from which the subject has been
             disease free for at least three years

          9. Known history of human immunodeficiency virus (HIV)
Endothelial Facilitation in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Simvastatin; L-Arginine; Tetrahydrobiopterin
Intervention description: Simvastatin, 40 mg per day orally; L-Arginine, 2 Gm four times per day orally;; Tetrahydrobiopterin 20 mg/kg/day orally
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Early Alzheimer; Mild Cognitive Impairment; Drug treatment; Cerebral blood flow; Endothelial facilitation; Cognitive improvement

Summary:

      Purpose of the study: Patients with mild Alzheimer's Disease will be given three different
      drugs over a 4-month period to try to increase the blood flow to their brains, and improve
      blood vessel and brain function. Each drug can help to open the blood vessels in the brain,
      and together they may be more effective than each drug alone. The hypothesis is that small
      blood vessels secrete substances that maintain the integrity of the brain, and may prevent
      loss of nerve cells leading to Alzheimer's Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have mild Alzheimer's Disease or Mild Cognitive Impairment (MCI);

          -  age between 55-85;

          -  Mini Mental Status Exam (MMSE) between 15-26;

          -  a caregiver who can provide information, and bring patient to the sessions;

          -  no known allergies to any of the medications to be used;

          -  normal renal function; willingness of patient and spouse/responsible caregiver to
             participate.

        Exclusion Criteria:

          -  Significant Psychiatric disorder;

          -  stroke; current use of any of the test medications (e.g., statin, L-Arginine, Kuvan);

          -  phenylketonuria (PKU) ;

          -  elevated serum phenylalanine level (>10 mg/dL);

          -  allergy to any of the medications; current active malignancy;

          -  renal insufficiency (elevated creatinine above 1.3mg/dl);

          -  abnormal liver function (Alanine Aminotransferase (ALT) or Aspartate Transaminase
             (AST) 2x normal);

          -  other serious disease including coronary insufficiency or congestive heart failure,
             carotid stenosis greater than 50%, active peptic ulcer, urinary tract or other active
             infection, cancer (except skin cancer, or 5 years inactive breast or prostate cancer
             )etc.;

          -  pregnancy; or

          -  inability to come to UMass for follow-up. Subjects may continue to take
             anticholinesterase drugs for Alzheimer's Disease (Aricept, Exelon, Razadyne) and/or
             Namenda, if they have been on the drug(s) for at least 3 months. Subjects on levodopa
             and male subjects taking drugs for erectile dysfunction (Viagra, Cialis, Levitra) are
             cautioned regarding hypotension.
Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Eculizumab
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Hemolytic Paroxysmal Nocturnal Hemoglobinuria; Eculizumab; PNH; Japan

Summary:

      A study to assess the safety and efficacy of eculizumab in Japanese patients with hemolytic
      PNH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese individuals at least 12 years of age

          -  Diagnosis of PNH > 6 months

          -  At least one transfusion in the past 2 years for anemia or anemia-related symptoms

          -  LDH level ≥ 1.5 x upper limit of normal within 12 weeks

          -  Presence of a glycosylphosphatidylinositol (GPI)-deficient red blood cell (RBC) clone
             (type III cells) by flow cytometry of ≥10%

          -  Negative serum pregnancy test for women of child-bearing potential

        Exclusion Criteria:

          -  Platelet count < 30,000/µL

          -  Absolute neutrophil count ≤ 500/µL

          -  Known or suspected hereditary complement deficiency

          -  History of hematopoietic stem cell transplant

          -  History of meningococcal disease
Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain
Condition: Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain
Intervention: Corticosteroid; Placebo Injection
Intervention description: 40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine; A placebo injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to receive either an injection of methylprednisolone acetate plus lidocaine or to receive an injection of saline with lidocaine using a randomized block design with a 1:1 allocation.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: Female
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Sciatica; Pelvic girdle pain

Summary:

      The purpose of this study is to see if pelvic girdle pain can be more effectively treated
      with the use of injectable anti-inflammatory medication plus physical therapy compared with
      physical therapy and a saline injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who are not doing other therapies for pain (physical therapy, chiropractic
             management, pool)

          -  Women between age 21 and 50 who plan to deliver at Loyola or Gottlieb

          -  Pain Numeric Rating Scale (NRS) on average of greater than or equal to 5/10 at Visit 1

          -  Pain must be between the upper level of the iliac crests and the gluteal folds in
             conjunction with or separately from pain in the pubic symphysis and influenced by
             position and locomotion

          -  2/4 positive physical examination tests on the symptomatic side including the P4 test,
             the LDL test, pubic symphysis palpation and the acute straight leg rise (ASLR)

        Exclusion Criteria:

          -  Women presenting with PGP in the first or third trimester (<13 weeks gestation or >28
             weeks gestation)

          -  Women with pubic symphysis (anterior) pain alone

          -  Women who do not plan to deliver a baby at Loyola or Gottlieb

          -  Pain above the upper level of the iliac crest

          -  History of lumbar or pelvic fracture, neoplasm, inflammatory disease, active
             urogenital infection or active gastrointestinal illness, current physical therapy or
             other therapies for PGP, or previous surgery of the lumbar spine, pelvic girdle, hip
             joint or femur

          -  History or signs of radiculopathy or other systemic neurologic disease

          -  Women with diabetes or gestational diabetes
CSTC1 for Diabetic Foot Ulcers Phase II Study
Condition: Diabetic Foot Ulcer; Diabetes Mellitus; Wounds
MeSH terms: Diabetic Foot; Foot Ulcer; Diabetes Mellitus; Ulcer
Intervention: CSTC1; CSTC1 Matched vehicle
Intervention description: vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Diabetic Foot Ulcer; Diabetes Mellitus; Debridement; Standard of Care; wounds

Summary:

      The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with
      diabetic foot ulcers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  With either gender aged at least 20 years old;

          -  With a diabetic ulcer (which is defined as the target ulcer) on the foot and not
             healing for at least 2 weeks;

          -  The target ulcer is classified as grade 1 or 2 ulcer according to modified Wagner
             system;

          -  The target ulcer should show "infection control" at investigator's discretion;

          -  Subject should be free of any necrosis or infection in soft and bone tissue;

          -  Subject has signed the written informed consent form

        Exclusion Criteria:

          -  With active osteomyelitis;

          -  With target ulcer size decreased by at least 50% after at least 2 weeks of
             standard-of-care-only period or any other recorded regular therapy before
             Randomization visit;

          -  With poor nutritional status (albumin < 3g/dl), poor diabetic control (HbA1c > 12%),
             anemia (hemoglobin<10 g/dL), a leukocyte counts < 1,000/mm3, abnormal liver function
             (AST, ALT>3 x upper limit of normal range);

          -  Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic
             agents;

          -  Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;

          -  Receiving revascularization surgery performed <8 weeks before entry in the study;

          -  With known or suspected hypersensitivity to any ingredients of study product and
             vehicle;

          -  With coronary heart disease with myocardial infarction, coronary artery bypass graft
             (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior
             to study;

          -  Pregnant or lactating or premenopausal with childbearing potential but not taking
             reliable contraceptive method(s) during the study period;

          -  Enrollment in any investigational drug trial within 4 weeks before entering this
             study;

          -  With any uncontrolled illness judged by the investigator that entering the trial may
             be detrimental to the subject.
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