bioihbjkbjnl/mcl2 huggingface dataset:
[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
Condition: Diabetic Foot Infection
MeSH terms: Infections; Communicable Diseases; Osteomyelitis; Focal Infection; Diabetic Foot
Intervention: [124I]FIAU
Intervention description: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic
      imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients >/= 18 years on the day of signing consent.

          2. A diagnosis of diabetes mellitus, type I or II, as evidenced either by HbA1c>6.5% or
             receipt of antidiabetic medication at time of enrollment.

          3. Ability to provide informed consent

          4. An inframalleolar ulcer of perfusion, extent/size, depth/tissue loss, infection and
             sensation (PEDIS) grade 2 or 3. At the discretion of the Investigator, patients with
             PEDIS grade 4 infections may be included if they are sufficiently stable.

          5. For females of childbearing potential, a negative urine pregnancy test on the day of
             dosing.

          6. For females of childbearing potential, a willingness to use 2 methods of contraception
             for 30 days after receiving [124I]FIAU.

          7. Ability to return for all study assessments.

          8. Clinically euthyroid, or on stable thyroid replacement therapy.

        Exclusion Criteria:

          1. Patients who ar unable to comply with study requirements.

          2. Indication, in the opinion of the principal Investigator for urgent surgery that would
             preclude the time needed for PET-CT scanning, or clinical instability that precludes
             PET-CT scanning.

          3. History of an inherited mitochondrial disorder (eg. Leber's hereditary neuropathy,
             neuropathy, ataxia, retinitis pigmentosa and ptosis [NARP], myoneurogenic
             gastrointestinal encephalopathy [MNGIE], myocolonic epilepsy with ragged red fibers
             [MERFF] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like
             syndrome [MELAS])

          4. Alanine aminotransferase (ALT)>5x Upper Limit of Normal (ULN) OR aspartate
             aminotransferase (AST) >5x ULN.

          5. Body mass that exceeds the rating of the CT table.

          6. Hypersensitivity to iodine.

          7. Pregnant or breast-feeding.

          8. Any condition that would put the patient at unreasonable risk in the opinion of the
             Investigator.
Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis
Condition: Bronchiectasis; Lung Disease; Respiratory Diseases
MeSH terms: Lung Diseases; Bronchiectasis; Respiratory Tract Diseases; Respiration Disorders
Intervention: AZD5069; Placebo
Intervention description: Oral dose bid; Oral dose bid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Bronchiectasis; Neutrophil; Respiratory disease; Sputum

Summary:

      The purpose of this study is to investigate the effect of AZD5069 in patients with
      bronchiectasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, or female of non-child bearing potential; ie, women who are permanently or
             surgically sterilised or post-menopausal.

          -  Aged 18 to 80 years inclusive at screening (Visit 1)

          -  Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed
             with a historical high resolution computerised tomography (HRCT) or bronchogram

          -  Be sputum producers with a history of chronic expectoration on most days of most weeks
             of the year. Patients should have a history of spontaneously producing sputum on a
             daily basis and should be able to provide at least 2 of the 3 required baseline sputum
             samples with an average of 3 mL or more.

          -  Be on a stable treatment regimen, as judged by the investigator.

        Exclusion Criteria:

          -  Any clinically significant disease or disorder

          -  Patients with other latent or chronic infections or at risk of infection within 90
             days before Visit 2

          -  An acute exacerbation or acute respiratory infection (upper or lower) requiring oral
             steroids or antibiotics within 30 days prior to Visit 2

          -  An FEV1 of <30% of predicted normal at Visit 1

          -  Patients who have received live or live-attenuated vaccine in the 2 weeks prior to
             dosing (Visit 2)

          -  Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or
             COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis

          -  Bronchiectasis associated with a generalised immunodeficiency disorder, where
             manifestations other than bronchiectasis predominate
A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: rituximab [MabThera/Rituxan]
Intervention description: 375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with
      relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive
      once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a
      second time in case of relapse (defined as progression after complete or partial response).
      The anticipated time on study treatment is <3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >= 18 years of age;

          -  centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;

          -  relapse after chemotherapy (with or without interferon maintenance therapy).

        Exclusion Criteria:

          -  primary refractory lymphomas;

          -  more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;

          -  clinically significant cardiac disease.
Odiparcil For The Prevention Of Venous Thromboembolism
Condition: Deep Vein Thrombosis; Fibrillation, Atrial; Venous Thromboembolism; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Atrial Fibrillation
Intervention: Odiparcil; Warfarin; Coumadin
Intervention MeSH terms: Warfarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Enrollment: 961.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: deep vein thrombosis; total knee replacement; PE; Venous thromboembolism; DVT; pulmonary embolism; VTE

Summary:

      Odiparcil is being studied to determine if it can prevent blood clots from forming after a
      total knee replacement and also to prove that odiparcil is safe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women must be unable to have children.

          -  Will have a total knee replacement.

        Exclusion Criteria:

          -  Allergic to any X-ray dye.

          -  Allergies or reactions to warfarin or coumadin.

          -  Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT).

          -  On anticoagulation therapy.

          -  Renal impairment.

          -  Participated in any clinical trial in the past 30 days.
Candin Safety & Efficacy Study for the Treatment of Warts
Condition: Warts; Human Papilloma Virus
MeSH terms: Warts; Papilloma
Intervention: Candida albicans Skin Test Antigen
Intervention description: 0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Treatment; common wart lesions; (verruca vulgaris)

Summary:

      The primary objective of this study is to determine the safety of Candin® (Candida albicans
      Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common
      warts (Verruca vulgaris).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have at least 3 and not more than 10 common warts not located on the palms or
             digits

          -  Positive DTH response to Candin® required

        Exclusion Criteria:

          -  No previous medical treatment for warts other than OTC

          -  No immunocompromising medical conditions or medicines allowed

          -  No preexisting inflammatory conditions at treatment site allowed
Hypogonadotropic Hypogonadism in Obese Young Males
Condition: Hypogonadism, Hypogonadotropic
MeSH terms: Hypogonadism
Intervention: Clomiphene; Placebo
Intervention description: clomiphene capsule 25mg twice a week; placebo capsule 25mg twice a week
Intervention MeSH terms: Clomiphene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: Male
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obesity can lead to low testosterone concentrations in young men. This study will study the
      effects of low testosterone in those men and the result of treating them with clomiphene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males

          -  Age 18-30 years inclusive will be recruited.

        A total of 90 males will be recruited:-

          -  30 obese males (defined as BMI ≥30 kg/m2) with HH,

          -  30 obese males with normal FT concentrations and

          -  30 lean males (defined as BMI <25 kg/m2) with normal FT concentrations.

        Exclusion Criteria:

          -  Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health
             supplements which contain androgens currently or in the past 6 months

          -  Hematocrit > 50%

          -  Congestive heart failure

          -  currently suffering from depression

          -  type 1 diabetes

          -  Hepatic disease (transaminase > 3 times normal) or cirrhosis

          -  Renal impairment (eGFR<30 ml/min/1.73m2)

          -  HIV or Hepatitis C positive status

          -  Participation in any other concurrent clinical trial

          -  currently suffering from foot ulcer, significant periodontal disease or any other
             chronic infectious condition
Qsymia as an Adjunct to Surgical Therapy in the Superobese
Condition: Obesity; Metabolic Surgery; Weight Loss; Bariatric Surgery Procedures
MeSH terms: Weight Loss
Intervention: Phentermine/topiramate; low calorie diet
Intervention description: Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery.; The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese
      individuals planning to undergo weight loss surgery. Individuals taking the medication before
      and after surgery will be compared to historical controls who had surgery without taking the
      medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI ≥ 50 kg/m2

          -  Determined to be a good candidate for surgery based on medical and psychological exam.

          -  Willing to participate in a 3-6 month medically supervised weight loss plan prior to
             surgery.

          -  Planning to remain in the reasonable vicinity of the Wake Forest Baptist Health -
             Weight Management Center for the duration of the study.

        Exclusion Criteria:

          -  History of prior weight loss surgery (removal/conversion from band to sleeve will not
             be excluded)

          -  Pregnant (women of childbearing potential will complete a pregnancy test (blood draw)
             to make sure they are not pregnant at the time that they initiate the medication).
             Ongoing monitoring of pregnancy status is the responsibility of the patient and they
             are instructed as such in the consent form.

          -  Ongoing use of weight loss medication

          -  Contraindications to use of Qsymia, including pregnancy, history of glaucoma, unstable
             cardiac disease (unstable angina, recent heart attack or stroke (in the past 6
             months), uncontrolled arrhythmia), hyperthyroidism, taking monoamine oxidase
             inhibitors (MAOIs) or allergy to either topiramate or sympathomimetic amines like
             phentermine.
Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
Condition: Hyperkalemia; Resistant Hypertension
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension; Hyperkalemia
Intervention: Patiromer; Placebo; Spironolactone
Intervention description: 2 packets/day starting dose, administered orally; 2 packets/day starting dose, administered orally; 25 mg tablet/day starting dose, administered orally
Intervention MeSH terms: Spironolactone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of Hyperkalemia; Hyperkalemia; Potassium; Chronic Kidney Disease; Hypertension; Resistant Hypertension; Spironolactone

Summary:

      The purpose of this study is to determine if patiromer treatment in chronic kidney disease
      (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will
      result in more persistent use of spironolactone through prevention of hyperkalemia and lead
      to improved blood pressure control compared with treatment with spironolactone alone
      (placebo).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Taking at least three medications for blood pressure (one a diuretic)

          -  Uncontrolled high blood pressure

          -  Abnormal kidney function (with-eGFR, a measure of kidney function, of 25 - ≤ 45
             mL/min/1.73m2

          -  Normal Blood serum Potassium in a specific range (4.3 - 5.1 mEq/L)

        Exclusion Criteria:

          -  History of untreated known causes of high blood pressure, excluding kidney disease
             (not CKD)

          -  Inability to measure BP

          -  Not taking high blood pressure medications as prescribed medications

          -  Recent change in renal function (in the past 3 months) which has required
             hospitalization or dialysis

          -  Renal transplant

          -  History of cancer within past 12 months

          -  Recent cardiovascular event with last 3 months

          -  Clinically significant abnormalities of heart rhythm (ventricular arrhythmia or atrial
             fibrillation with uncontrolled heart rate)

          -  Inability to take study medication

          -  Alcoholism
A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer
Condition: Prostate Neoplasms; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone; Prednisone
Intervention description: Participants will receive abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized low-fat meal and high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14.; Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic castration-resistant prostate cancer; CRPC; Abiraterone Acetate; Prednisone; Food Safety

Summary:

      The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone
      acetate and oral prednisone following short-term administration after standardized low-fat or
      high-fat meals to patients with metastatic (spreading) castration-resistant prostate cancer
      (mCRPC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adenocarcinoma of the prostate

          -  Metastatic disease documented by bone, computed tomography (CT) or magnetic resonance
             imaging (MRI) scan

          -  Surgical or medical castration with testosterone less than 50 ng/dL (< 2.0 nM)

          -  Prostate-specific antigen (PSA) or radiographic progression documented by assessments
             specified in study protocol

          -  Platelets >100,000/µl

          -  Hemoglobin >=9.0 g/dL

          -  Liver function tests (LFTs): Serum bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN;
             Eastern Cooperative Oncology Group (ECOG) status score of <=2

        Exclusion Criteria:

          -  Small cell carcinoma of the prostate

          -  Known brain metastasis, chronic liver disease with elevated LFTs

          -  Prior cytotoxic chemotherapy for metastatic prostate cancer

          -  Treatment of prostate cancer within 30 days of Day 1 Cycle 1 with surgery, radiation,
             chemotherapy or immunotherapy

          -  Use of investigational drug within 30 days of Day 1 Cycle 1 or current enrollment in
             an investigational drug or device study

          -  Recent history of ischemic heart disease, Electrocardiogram (ECG) abnormalities or
             atrial fibrillation

          -  Active infection or other medical condition that would make prednisone
             (corticosteroid) use contraindicated

          -  Chronic medical condition requiring a higher dose of corticosteroid than prednisone 5
             mg twice daily
A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: CSF-1; CSF-1 Component #1; CSF-1 Component #2
Intervention description: This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.; This treatment arm consists of 2 different concentrations of CSF-1 Component #1.
Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.; This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 166.0
Sex: All
Minimum age: 45 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating
      the safety and efficacy of CSF-1 in the treatment of presbyopia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must:

               1. Have presbyopia

        Exclusion Criteria:

          -  Subjects must not:

               1. Have any contraindications to the study medications or diagnoses that would
                  confound the study data