bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma
Condition: Metastatic Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: MEDI4736 monotherapy; tremelimumab+MEDI4736
Intervention description: MEDI4736 via IV infusion.; tremelimumab+MEDI4736 via IV infusion.
Intervention MeSH terms: Durvalumab; Tremelimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Ductal Adenocarcinoma, PDAC

Summary:

      A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in
      Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.
    

Eligibility criteria:

        Inclusion Criteria: -

          1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior
             chemotherapy regimen

          2. Eastern Cooperative Oncology Group 0 or 1

          3. At least 1 lesion, not previously irradiated, that can be accurately measured at
             baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short
             axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan
             and that is suitable for accurate repeated measurements

        Exclusion Criteria:

          1. Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy
             for cancer treatment.

          2. History of leptomeningeal carcinomatosis

          3. Ascites requiring intervention

          4. Brain metastases or spinal cord compression.
Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)
Condition: Leukemia
MeSH terms: Leukemia
Intervention: Dasatinib; BMS-833923
Intervention description: Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response; Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelogenous; Chronic; BCR-ABL Positive

Summary:

      The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP)
      CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥ 18 years of age who have signed informed consent

          -  Philadelphia positive Chronic Myeloid Leukemia (CML) in chronic phase

          -  Previously untreated chronic phase CML, except for Anagrelide or Hydroxyurea.

          -  Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2

        Exclusion Criteria:

          -  Known Abl-kinase T315I or T315A mutation

          -  Serious or uncontrolled medical disorder (including infection or cardiovascular
             disease) or dementia or other serious psychiatric condition

          -  Prior chemotherapy.

          -  Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP)
             who are unwilling or unable to use an acceptable method to avoid pregnancy during the
             entire study period.
The Effects of Intravenous Heme Arginate on Heme Oxygenase-1 Expression (HO-1) and Oxidative Stress in the Human Heart
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Ischemia
Intervention: Heme arginate 3mg/kg; Heme arginate 1mg/kg; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: carboxyhemoglobin; neutrophil; reactive oxygen species; reperfusion injury

Summary:

      Ischemia reperfusion injury may be attenuated by HO-1 induction. Our previous data confirmed
      strong HO-1 induction in peripheral blood cells following heme arginate infusion in healthy
      humans. Furthermore, we could demonstrate the amelioration of experimental ischemia
      reperfusion injury in the calf musculature by heme arginate in healthy subjects as measured
      by functional MRI.

      Therefore, we propose that HO-1 induction in the human heart may be a suitable target to
      mitigate cardiac ischemia-reperfusion injury.

      The HO-1 induction will be assessed in a clinical trial by myocardial biopsy prior to and
      after aortic cross-clamping in subjects with or without preceding heme arginate treatment in
      two different dosages. The HO-1 expression will also be measured in the clinical trials in
      peripheral blood mononuclear cells. As additional outcome, levels of myoglobin,
      creatine-kinase and troponin T and reactive oxygen species will be measured in plasma
      according to standard laboratory procedures.
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed informed consent

          -  Men and women aged between 40 and 85 years (inclusive)

          -  Body mass index < 35 kg/m2

          -  Ability to communicate well with the investigator in the local language and to
             understand and comply with the requirements of the study

        Exclusion criteria (any of the following):

          -  Known hypersensitivity to the study drug or any excipients of the drug formulation

          -  Treatment with another investigational drug within 3 weeks prior to screening

          -  History or clinical evidence of any disease and/or existence of any surgical or
             medical condition, which might interfere with the absorption, distribution, metabolism
             or excretion of the study drug

          -  Severe renal failure (glomerula filtration rate < 30 ml/min)

          -  Moderately or severe impaired left ventricular function (ejection fraction < 40%)

          -  Moderately or severe impaired right ventricular function

          -  Systolic pulmonary pressure > 45 mmHg

          -  Acute or recent (<7 days) myocardial infarction

          -  Child bearing potential
Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention
Condition: Adherence, Medication
Intervention: Vaginal Renewal Program
Intervention description: Therapeutic vibrating wand.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Intervention model description: Prospective Simon two-stage study design
Masking: None (Open Label)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Breast cancer patients commonly take medications to reduce the risk of recurrence, including
      aromatase inhibitors (AIs). AIs can cause significant side effects that reduce patient
      adherence. Early discontinuation of AI therapy results in an increased risk of cancer
      recurrence and increased risk of breast cancer-related death. Common side effects include
      vaginal dryness and vulvovaginal atrophy leading to worsening sexual function. To increase AI
      adherence, the investigators will study a non-pharmaceutical Vaginal Renewal Program (VRP)
      aimed at stimulating nitric oxide production to consequently increase vaginal lubrication,
      and improve the symptoms of vulvovaginal atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed active primary treatment

               -  defined as surgery chemotherapy and/or radiation for the treatment of breast
                  cancer

               -  Does not include immunotherapy or other targeted therapies such as trastuzumab,
                  CDK 4/6 or mTOR inhibitors

          -  Have been receiving AIs for at least 6 months prior to enrollment

          -  Plan to continue AIs for an additional 3 months

          -  Amenorrhea for at least 12 months at enrollment

          -  Participants must be able to read and write in English

          -  Participants must have < 2% superficial vaginal cells on cytologic evaluation

        Exclusion Criteria:

          -  Pre-existing hypertonic pelvic floor dysfunction identified in the medical record

          -  Unresolved or recurrent vaginismus identified in the medical record

          -  Aversion to touching one's own body, including genitals, or using vibration therapy on
             the genitals

          -  Currently receiving estrogen therapy, including topical and/or systemic estrogens

          -  Have received estrogen therapy within 6 months of study enrollment, including topical
             and/or systemic estrogens

          -  Any surgical procedure to the vagina or vulva, excluding office biopsies, within the
             previous 12 months

          -  Receipt of pelvic or vaginal or vulvar radiation therapy within the 12 months prior to
             enrollment or if the subject is anticipated to receive radiation targeted to any of
             these 3 locations within 6 months following enrollment

          -  Any use of the VRP off study within the last 6 months
Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
Condition: Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Endocarditis
MeSH terms: Staphylococcal Infections; Bacteremia; Endocarditis
Intervention: CF-301; Placebo
Intervention description: CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion; Placebo, given as a single 2 hour iv infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Staphylococcus aureus; bacteremia; staphylococcal endocarditis

Summary:

      The purpose of this study is to evaluate the safety, tolerability, efficacy and
      pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC)
      antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream
      infections (bacteremia), including endocarditis in adults. Patients will be randomized to
      receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial
      therapy. Patients will be prescribed standard of care antibiotics selected by the
      investigators based on their professional experience, practice guidelines and local
      antibiotic susceptibility information for the treatment of S. aureus bacteremia.

      CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has
      demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone
      and in addition to conventional antibiotics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female, 18 years or older

          -  blood culture positive for S. aureus

          -  at least one sign or symptom attributable to S. aureus bacteremia

          -  known or suspected complicated S. aureus BSI and/or endocarditis by Modified Duke
             Criteria

          -  patient is not pregnant or breastfeeding and is not of reproductive potential or
             agrees to use contraception if of reproductive potential.

        Exclusion Criteria:

          -  patient previously received CF-301.

          -  treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for
             more than 72 hours within 7 days before randomization.

          -  presence of any removable infection source that will not be removed or debrided within
             72 hours after randomization.

          -  brain abscess or meningitis.

          -  community acquired pneumonia or known polymicrobial bacteremia
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: 4 mg CLS-TA; Sham; IVT aflibercept
Intervention description: 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension); suprachoroidal sham procedure; 2 mg intravitreal injection of aflibercept
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RVO; ME; Central Subfield Thickness; OCT; optical coherence tomography; cystoid macular edema; subretinal fluid; Eylea; aflibercept; anti-VEGF

Summary:

      A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to
      evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA,
      triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT)
      injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein
      occlusion (RVO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of macular edema following RVO

          -  History of ME ≤ 12 months

          -  20-70 letters inclusive BCVA using ETDRS

        Exclusion Criteria:

          -  has had an IVT injection of anti-VEGF for RVO in the study eye

          -  has had a corticosteroid injection in the past 3 months in the study eye

          -  any uncontrolled ophthalmic condition in the study eye other than RVO
Bevacizumab Against Recurrent Retinal Detachment
Condition: Retinal Detachment; Proliferative Vitreoretinopathy
MeSH terms: Retinal Detachment; Vitreoretinopathy, Proliferative; Dissociative Disorders
Intervention: Bevacizumab
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Retinal detachment; Proliferative vitreoretinopathy

Summary:

      The investigators hypothesize that bevacizumab instilled into the vitreous after primary
      retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and
      subsequent retinal re-detachment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Eyes with rhegmatogenous retinal detachment

        Exclusion Criteria:

          -  Presence of PVR

          -  Need for a procedure other than primary PPV such as a scleral buckle with or without
             PPV, laser retinopexy, or pneumatic retinopexy.

          -  Recent intravitreal injection of an anti-VEGF agent less than 3 months prior

          -  Secondary retinal detachment repair

          -  Use of silicone oil as tamponade agent

          -  Patients less than 18 years of age

          -  Pregnancy

          -  Known allergy or contraindication to intravitreal bevacizumab
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
Condition: Stable Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: MEDI5884; Placebo
Intervention description: Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.; Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 133.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Coronary heart disease; Pharmacokinetic; Pharmacodynamics

Summary:

      A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in
      Adults With Stable Coronary Heart Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of stable coronary heart disease prior to screening

          -  Currently receiving high intensity statin(s)

        Exclusion Criteria:

          -  Unstable cardiovascular conditions

          -  Any planned arterial revascularizations

          -  Fasting Laboratory values at screening: Triglycerides > 500 mg/dl, Low Density
             Lipoprotein-Cholesterol > 100 mg/dL

          -  Any disease or condition or laboratory value that would place the participant at an
             unacceptable risk.
Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV
Condition: HIV-1-infection
Intervention: Oral Lenacapavir; F/TAF; Subcutaneous Lenacapavir; TAF; BIC; B/F/TAF
Intervention description: Tablets administered without regard to food; Tablets administered without regard to food; Administered in the abdomen via subcutaneous injections; Tablets administered without regard to food; Tablets administered without regard to food; Tablets administered without regard to food
Intervention MeSH terms: Emtricitabine tenofovir alafenamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly
      GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Antiretroviral (ARV) naive with no use of any ARV within one month of screening. Use
             of pre-exposure prophylaxis (PrEP) (any duration), post-exposure prophylaxis (PEP)
             (any duration), or HIV-1 treatment (< 10 days therapy total) > 1 month prior to
             screening is permitted

          -  HIV-1 ribonucleic acid (RNA) ≥ 200 copies/mL at screening

          -  Cluster Determinant 4+ (CD4+) cell count ≥ 200 cells/microliter at screening

        Key Exclusion Criteria:

          -  Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ABBV-3067; Placebo ABBV-3067; ABBV-2222; Placebo ABBV-2222
Intervention description: Tablet taken orally.; Tablet taken orally.; Capsule taken orally.; Capsule taken orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; ABBV-3067; ABBV-2222, F508del Mutation

Summary:

      This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and
      in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are
      homozygous for the F508del mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the
             F508del CF transmembrane conductance regulator (CFTR) mutation

          -  Stable pulmonary status

          -  Lung function >= 40 and <= 90% of predicted normal for age, gender and height at
             Screening

        Exclusion Criteria:

          -  History of solid organ or hematopoietic transplant

          -  Cirrhosis with portal hypertension

          -  Use of CFTR modulator therapy within 60 days prior to Screening
EEG Studies of Sevoflurane-Induced General Anesthesia
Condition: Anesthesia
Intervention: Sevoflurane; Ketamine
Intervention description: Subjects will received sevoflurane for approximately 60 minutes.; Subjects will received sevoflurane and ketamine for approximately 60 minutes.
Intervention MeSH terms: Ketamine; Sevoflurane
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators are performing this research study to find out how and where the anesthetic
      drugs sevoflurane and ketamine act in the brain. Sevoflurane and ketamine are anesthetics (a
      drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness).
      The investigators will study the brain using a machine that records the brain's electrical
      activity, called an electroencephalogram (EEG).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the ages of 18 and 50

          -  Normal body weight and habitus, BMI ≤ 30

          -  Non-smoker

          -  American Society of Anesthesiologists (ASA) physical status classification P1

        Exclusion Criteria:

          -  Chronic health conditions