bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: ritonavir; saquinavir [Invirase]
Intervention description: 2.5-3.0mg/kg po bid (starting dose) for 48 weeks; 50mg/kg po bid (starting dose) for 48 weeks
Intervention MeSH terms: Ritonavir; Saquinavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 4 Months
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the pharmacokinetics, safety and activity of saquinavir
      (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination
      with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6
      years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg
      or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug
      exposures are found to be dissimilar to those previously seen in older children and adults,
      or are associated with toxicities, subsequent dose adjustments will be made. The anticipated
      time on study treatment is 3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  infants and children, 4 months to <6 years;

          -  confirmed HIV-1 infection;

          -  patients for whom saquinavir/ritonavir together with >=2 background ARVs is considered
             appropriate.

        Exclusion Criteria:

          -  body weight >4kg/8.8 pounds;

          -  use of any concomitant medications that may interfere with the pharmacokinetics of
             saquinavir or ritonavir;

          -  malabsorption, severe chronic diarrhea or vomiting within 28 days of the study.
Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is to examine a moderate hypofractionation regimen of proton beam therapy for high
      risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are
      treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the
      regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180
      centigray/fraction) simultaneously. The overall treatment time is 5 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male; Age ≥ 18 years.

          -  Histological confirmation of adenocarcinoma of the prostate within 6 months of study
             enrollment.

          -  Clinical stage T1-2 N0 M0, Gleason Score 7, Prostate Specific Antigen (PSA) 20-100
             ng/mL, or Clinical stage Any T N0 M0, Gleason Score 8-10, PSA ≤ 100 ng/mL, or Clinical
             stage T3-4 N0 M0, any Gleason Score, PSA ≤ 100 ng/mL, or Clinical stage T1-2 N0 M0,
             Gleason Score 4+3, PSA 10-20 ng/mL

          -  Zubrod performance score (PS) ≤ 1

          -  Total bilirubin, aspartate aminotransferase, alkaline phosphatase, and serum
             creatinine: < 2 x upper normal limit

          -  Signed informed consent.

        Exclusion Criteria:

          -  Any known nodal (N1) or distant metastasis (M1)

          -  Previous androgen deprivation therapy lasting more than 6 months

          -  History of inflammatory bowel disease

          -  Presence of a hip prosthesis

          -  Prior pelvic radiotherapy or prostatectomy

          -  Prior or concurrent antineoplastic agents (chemotherapy)

          -  Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years
             of diagnosis of prostate cancer.

          -  Inability to start the protocol treatment within 1 month after study enrollment.

          -  Medical or psychiatric conditions that preclude informed decision-making or compliance
             with the protocol treatment or follow-up
Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Zilucoplan (RA101495)
Intervention description: Subjects will continue to receive the final maintenance dose they were receiving in the qualifying study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to enable continued access to zilucoplan (RA101495) for patients
      with paroxysmal nocturnal hemoglobinuria (PNH) after they complete a zilucoplan clinical
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of a qualifying Ra Pharmaceuticals sponsored zilucoplan (RA101495) PNH
             study

          -  Evidence of ongoing clinical benefit in the opinion of the Investigator

        Exclusion criteria:

          -  History of meningococcal disease

          -  Current systemic infection or suspicion of active bacterial infection
An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia
Condition: Pneumonia; Bacterial Pneumonia; Ventilator-Associated Pneumonia; Infections, Nosocomial
MeSH terms: Infections; Pneumonia; Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Cross Infection
Intervention: doripenem
Intervention description: 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
Intervention MeSH terms: Doripenem
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pneumonia; Lung Infection; Bacterial Infection; Hospital-Acquired Infection; Ventilator Infection; Antibiotic Therapy

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of doripenem
      monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients suffering from Nosocomial Pneumonia or Ventilator-Associated Pneumonia

          -  All patients must be hospitalized throughout the treatment period

          -  Patients must have microbiological samples (respiratory secretions) suitable for
             culture and microscopy

        Exclusion Criteria:

          -  Known or suspected severe kidney impairment

          -  Known or suspected liver dysfunction

          -  Treatment with any investigational drug or device within 30 days before enrollment

          -  Patients with one or more of the following: cystic fibrosis, lung abscess, active
             tuberculosis

          -  Women who are pregnant or lactating
Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: AIN457; Placebo
Intervention description: 10 mg/kg; Matching placebo to AIN457
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's disease, moderate, severe, active, AIN457

Summary:

      This study will assess the safety and efficacy of AIN457 in patients with moderate to severe
      active Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female; 18-75 years old

          -  Diagnosis of Crohn's disease for at least 3 months prior to screening

          -  Confirmation of Crohn's disease by endoscopic or imaging examination

          -  Moderately active Crohn's disease at baseline, defined as:

          -  CDAI ≥220 and ≤450

          -  Active disease despite prior treatment with corticosteroids for at least 2 weeks, or
             immunosuppressants for at least 3 months. Treatment with azathioprine, 6-MP or MTX is
             allowed but must have been on a stable dose for at least 10 weeks, corticosteroids are
             allowed but must have been on a stable doses of prednisolone not exceeding 40 mg for
             two weeks prior to baseline. Immunosuppressants other than those listed above, such as
             cyclosporine, tacrolimus and mycophenolate, are not allowed and must be stopped
             (wash-out periods defined in the protocol);

        Exclusion Criteria:

          -  Body Mass Index >34

          -  Positive PPD tuberculin skin test or QuantiFeron test

          -  Any subject with evidence of active pulmonary disease or evidence of latent
             tuberculosis or fungal infection at screening or within past 3 months

          -  Symptoms associated with active bowel structuring disease and pre-stenotic dilation on
             radiographs

          -  Fistulizing disease if complicated by sepsis and/or untreated abscess

          -  Multiple bowel surgeries and clinically important short bowel syndrome defined as an
             inability to maintain caloric intake

          -  Use of certain medications as specified in the protocol

          -  Clinical improvement due to other Crohn's therapy

        Other protocol-defined inclusion/exclusion criteria may apply
Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: PPX with cisplatin and radiation
Intervention description: weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks
Intervention MeSH terms: Paclitaxel; Cisplatin; Paclitaxel poliglumex
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Esophageal Cancer

Summary:

      Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal
      Cancer: A Phase II Trial. (CTI#X64001
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are required to have pathologically confirmed adenocarcinoma or squamous cell
             carcinoma of the esophagus or gastroesophageal junction

          -  Patients may have celiac adenopathy

          -  There must be no evidence of distant organ metastases

          -  No prior chemotherapy or radiation for esophageal cancer

          -  Patients must be > 18 years of age, and non pregnant

          -  Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2.0 and
             bilirubin < 1.5 x ULN-ECOG performance status 0-1.

          -  Female patients, must either be not of child bearing potential or have a negative
             pregnancy test within 14 days of starting study treatment. Patients are considered not
             of child bearing potential if they are surgically sterile (they have undergone a
             hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
             postmenopausal. Pregnant or lactating females are not eligible

          -  No contraindications to esophagectomy

          -  Signed informed consent

        Exclusion Criteria:

          -  Active or uncontrolled infection

          -  Patients must not have other coexistent medical condition that would preclude protocol
             therapy.

          -  Any concurrent chemotherapy not indicated in the study protocol or any other
             investigational agent(s).
Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
Condition: Acute Pain; Breast Carcinoma; Peripheral Neuropathy
MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases; Acute Pain
Intervention: Minocycline Hydrochloride; Placebo; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given PO; Given PO; Ancillary studies; Ancillary studies
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized pilot trial studies how well minocycline hydrochloride works in reducing
      chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer
      undergoing treatment with paclitaxel. Drugs used in chemotherapy, such as paclitaxel, may
      cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and
      toes. Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the
      quality of life in breast cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to complete questionnaires by themselves or with assistance

          -  Planned paclitaxel at a dose of 80 mg/m2 IV given, in the adjuvant breast cancer
             (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks
             without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody
             and/or small molecule treatment is allowed, except for PARP inhibitors)

          -  Life expectancy > 6 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for
             women of childbearing potential only (determined per clinician discretion)

        Exclusion Criteria:

          -  Any of the following:

               -  Pregnant women

               -  Nursing women

               -  Men or women of childbearing potential who are unwilling to employ adequate
                  contraception

          -  Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause

          -  History of allergic or other adverse reactions to minocycline

          -  Prior exposure to neurotoxic chemotherapy

          -  Diagnosis of fibromyalgia

          -  Current or planned use of methoxyflurane, oral contraceptives, isotretinoin,
             penicillin, or ergot alkaloids

          -  History of allergic or other adverse reactions to tetracycline
Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Liposomal Doxorubicin; Docetaxel
Intervention description: Liposomal Doxorubicin; Docetaxel
Intervention MeSH terms: Docetaxel; Doxorubicin; Liposomal doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer

Summary:

      The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will
      be evaluated as first line treatment in metastatic breast cancer patients, with subsequent
      crossover to the opposite arm at disease progression or patient intolerance. We will explore
      this as well as any possible cross resistance between these two agents.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Metastatic breast cancer confirmed by biopsy

          -  Prior adjuvant/neoadjuvant treatment allowed

          -  Measurable disease

          -  Able to perform activities of daily living with minimal assistance

          -  Age 18 years or older

          -  Adequate bone marrow, liver and kidney function

          -  Normal heart function

          -  Written informed consent

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Pre-existing moderate peripheral neuropathy

          -  History of significant heart disease

          -  Meningeal metastases.

          -  Prior chemotherapy for metastatic breast cancer

          -  No measurable disease (including bone only, pleural effusions, etc.)

          -  Receiving Herceptin therapy.

          -  Women who are pregnant or lactating.

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.
A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer
Condition: Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer; Invasive Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Vorinostat and Tamoxifen
Intervention description: vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days
Intervention MeSH terms: Tamoxifen; Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Preoperative; Neoadjuvant

Summary:

      This research study is designed to look at the effects of the combination of vorinostat
      (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The
      investigators will do this by comparing tissues from the original breast biopsy to tissues
      obtained after taking vorinostat and tamoxifen for 2 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage I-III invasive breast cancer

          -  Awaiting surgery or neoadjuvant treatment

          -  ECOG performance status 0, 1 or 2

          -  Adequate organ function

          -  Prior use of hormone contraception or replacement therapy must have been discontinued
             at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo
             an additional biopsy for the study)

        Exclusion Criteria:

          -  Prior or current treatment of any kind for the current breast cancer

          -  Current use of any other investigational drugs

          -  Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or
             psychiatric illness
Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Raltegravir
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV infection; Raltegravir; Switch; Hyperlipidemia; Women

Summary:

      This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to
      evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen
      after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.

      This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV
      infected women from a PI based regimen to raltegravir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV-1 infection in female patients, age ≥18 years

          -  Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral
             agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI)
             for at least the previous 6 months

          -  Plasma HIV viral load <50 copies/ml on current boosted PI containing regimen for ≥ 6
             months prior to study entry

          -  Fasting LDL cholesterol >130 mg/dl

          -  Fasting triglycerides <450 mg/dl

        Exclusion Criteria:

          -  History of virological failure during previous antiretroviral therapy
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Tilavonemab
Intervention description: solution for IV infusion
Intervention MeSH terms: Tilavonemab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 364.0
Sex: All
Minimum age: 57 Years
Maximum age: 88 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in
      participants with early AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects with early AD who complete Study M15-566 (NCT02880956), meet all
             inclusion criteria, and do not meet any exclusion criteria are eligible for enrollment

          -  Subject was compliant during participation in Study M15-566 (NCT02880956)

          -  Subject has an identified, reliable study partner who has frequent contact with the
             subject and who will provide information as to the subject's cognitive and functional
             abilities

        Exclusion Criteria:

          -  The subject has any significant change in his/her medical condition since
             participation in Study M15-566 (NCT02880956) that could interfere with the subject's
             participation in Study M15-570, could place the subject at increased risk, or could
             confound interpretation of study results

          -  More than 8 weeks have elapsed since the subject received his/her last dose of study
             drug in Study M15-566 (NCT02880956)

          -  The subject is concurrently enrolled in another interventional clinical study
             involving a therapeutic agent with the exception of Study M15-566 (NCT02880956)