bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of DAV132 in Healthy Volunteers
Condition: Healthy
Intervention: DAV132; Moxifloxacin; Negative Control
Intervention description: DAV132 is associated to moxifloxacin or it is evaluated alone; Moxifloxacin is used alone or associated to DAV132; Moxifloxacin is used alone
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether DAV132 is safe and effective for capturing
      fecal residues of moxifloxacin in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers

          -  Normal digestive transit, with usually one daily stool.

          -  Females participating in the study :

        must be either of non-child bearing potential (surgically sterilized at least 3 months
        prior to inclusion, or postmenopausal or having a negative pregnancy test and be not
        breastfeeding at screening, and using abstinence or a double contraception method during
        the treatment period and for additional period of 2 weeks after the end of investigational
        treatment.

          -  Having given and signed the written study informed consent prior to undertaking any
             study-related procedure.

          -  Covered by the French Health Insurance system.

        Exclusion Criteria:

          -  Any history or presence of clinically relevant cardiovascular, pulmonary,
             gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and
             joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or
             infectious disease, or signs of acute illness.

          -  Contra-indications to fluoroquinolones, or risk factors for adverse events associated
             to fluoroquinolones.

          -  Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase
             deficiency should be excluded.

          -  Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase
             deficiency or glucose-galactose malabsorption should be excluded.

          -  Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or
             haemorrhage, recent digestive tract surgery.

          -  Fecal colonisation by Clostridium difficile.

          -  Recent history of hospitalisation (within 3 months prior to inclusion).

          -  Any antibiotic administration within 3 months before inclusion.

          -  Any vaccination within the last 28 days.
Effects of RLIC on Motor Learning in Middle-aged and Older Adults
Condition: Adults; Older Adults
Intervention: RLIC; Sham conditioning; Balance training
Intervention description: See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.; See descriptions under arm/group descriptions. Sham conditioning is delivered for 7 visits, occurring on consecutive weekdays.; All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blinded, randomized, controlled trial
Masking: Single (Participant)
Masking description: Participants are masked to their group assignment.
Enrollment: 82.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: remote ischemic conditioning, motor learning

Summary:

      The purpose of this research is to determine if the beneficial effects of remote limb
      ischemic conditioning on learning seen in young adults are found in middle-aged and older
      adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 40-80 years old

          2. Had sufficient cognitive skills to provide informed consent and actively participate.

        Exclusion Criteria (determined by self-report):

          1. History of a neurological condition, balance impairment, or vestibular disorder.

          2. History of attentional disorders (ADD/ADHD) that could affect learning.

          3. History of sleep apnea which could confound the effects of RLIC.

          4. Presence of lower extremity condition, injury, or surgery that would compromise
             performance on the balance task.

          5. Learning disability, sensory, or communication problem that would prevent completion
             of the study.

          6. History of epilepsy, peripheral vascular disease, or blood diathesis which could
             contraindicate RLIC.

          7. Current intensive weight lifting or interval training exercise which could confound
             the effects of RLIC.

          8. Current substance abuse or dependence.
A Study Comparing Two Topicals in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: FMX101 vehicle; Hydro-alcohol solution
Intervention description: FMX101 vehicle - hydrophobic oil based vehicle (Test Article A); Hydro-alcohol solution based vehicle (Test Article B)
Intervention MeSH terms: Minocycline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and
      Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has facial acne vulgaris with:

             16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right
             and left side of the face should be similar IGA score of moderate (3) on both the
             right and left side of the face

        Exclusion Criteria:

          -  Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any
             dermatological condition of the face or facial hair (eg, beard, sideburns, mustache)
             that could interfere with the clinical evaluations.

          -  More than two facial nodules/cysts

          -  Sunburn on the face
A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation
Condition: Healthy Volunteers
Intervention: TAK-831
Intervention description: TAK-831 film-coated tablet.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of
      TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK
      of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Weighs greater than or equal to (>=) 45 kilogram (kg) and has a body mass index (BMI)
        between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.

        Exclusion Criteria:

          1. Has received TAK-831 in a previous clinical study.

          2. Has poor peripheral venous access.

          3. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 45 days prior to
             first dose of study drug.

          4. Has any dietary restrictions or preferences that may interfere with the conduct of the
             study.
SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
Condition: Mild-Moderate Alzheimer's Disease; Healthy Elderly
MeSH terms: Alzheimer Disease
Intervention: MEDI1814 for IV injection; MEDI1814 for Subcutaneous Injection; IV Placebo; Placebo for Subcutaneous Injection
Intervention description: Monoclonal antibody for IV Injection; Monoclonal antibody for subcutaneous injection; Placebo for IV injection; Subcutaneous Placebo Injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety, drug levels and effects on the body of 1
      or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy
      elderly people.
    

Eligibility criteria:

        Inclusion Criteria Male and female (non child bearing potential) subjects Mild-moderate
        Alzheimer's Disease

        Exclusion Criteria History or evidence of significant autoimmune disease Presence of
        psychiatric disorder which would affect completion of the study Current serious or unstable
        clinically important illness
A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.
Condition: Severe Sepsis
MeSH terms: Sepsis; Toxemia
Intervention: Nivolumab
Intervention description: Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in
      participants with severe sepsis or septic shock.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women ages ≥ 18 years old

          -  Documented or suspected infection

          -  Severe sepsis or septic shock for at least 24 hours

          -  Sepsis-induced immunosuppression

          -  In Intensive Care Unit (ICU) with no plans to discharge in next 24 hours

        Exclusion Criteria:

          -  Previous episode of severe sepsis or septic shock with ICU admission during the
             current hospitalization

          -  Autoimmune disease

          -  Organ or bone marrow transplant

          -  Cancer treatment in the past 6 weeks

          -  Human immunodeficiency virus (HIV) infection and not on therapy prior to this episode
             of sepsis; hepatitis C virus(HCV) infection and still has virus (not cured); Chronic
             hepatitis B virus (HBV) infection and not on treatment

        Other protocol defined inclusion/exclusion criteria could apply
ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan
Condition: Malignant Solid Tumor
MeSH terms: Neoplasms
Intervention: ONO-4538
Intervention description: 1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts
Intervention MeSH terms: Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: ONO-4538; MDX-1106; solid tumors

Summary:

      Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and
      multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and
      exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of solid tumor with at least one measurable
             lesion of ≥ 10mm.

          -  Tumor must be advanced or recurrent which is refractory to standard therapies or for
             which no alternative, appropriate therapy exists.

          -  ECOG Performance Status of 0-1

          -  Life expectancy ≥ 3 months

          -  Other inclusion criteria as specified in the study protocol

        Exclusion Criteria:

          -  History of severe hypersensitivity reactions to other antibodies.

          -  Residual adverse reactions or effect of prior therapy, which deemed to affect the
             safety evaluation of the study drug by the investigator or subinvestigator.

          -  Two or more synchronous tumors, except for adequately treated basal cell cancer or
             cancer in situ, or superficial bladder cancer, or any other cancers from which the
             patient has been disease-free for at least 5 years.

          -  Patients with any active autoimmune disease or a documented history of chronic or
             recurrent autoimmune disease, or current medical condition that requires systemic
             immunosuppressive doses of steroids or other immunosuppressive medications.

          -  Other exclusion criteria as specified in the study protocol
A Study Of PF-06647263 In Patients With Advanced Solid Tumors
Condition: Neoplasms; Triple-Negative Breast Cancer
MeSH terms: Triple Negative Breast Neoplasms
Intervention: PF-06647263; PF-06647263
Intervention description: Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.; Part 2- Patients with triple negative breast cancer will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ADC; PF-06647263; solid tumors; tumors; neoplasm metastasis; TNBC; Triple negative breast cancer

Summary:

      To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients
      with advanced solid tumors in order to determine the maximum tolerated dose and select the
      recommended Phase 2 dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy
             or for whom no standard therapy is available

          -  Performance Status of 0 or 1

          -  Adequate bone marrow, kidney, and liver function

          -  Part 2 includes advanced triple negative breast cancer patients.

        Exclusion Criteria:

          -  Brain metastases requiring steroids

          -  Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
             study treatment start

          -  Active and clinically significant bacterial, fungal or viral infection
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
Condition: HIV-1 Infection
Intervention: Lenacapavir; Placebo; B/F/TAF; TAF
Intervention description: Administered subcutaneously in the abdomen; Administered subcutaneously in the abdomen; 50/200/25 mg tablets administered orally once daily; Tablets administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are:

      Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with
      respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day
      10 compared to placebo in HIV-1 infected adults who are antiretroviral treatment naive or are
      experienced but capsid inhibitor (CAI) naive.

      Part B: To evaluate the short-term antiviral activity of tenofovir alafenamide (TAF) with
      respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day
      10 in HIV-1 infected adult subjects who are antiretroviral treatment naïve or are experienced
      but without resistance to TAF.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Plasma HIV-1 RNA ≥ 5,000 copies/mL but ≤ 400,000 copies/mL and CD4+ cell count > 200
             cells/mm^3

          -  Treatment naive or experienced but CAI (for Part A only) and integrase strand transfer
             inhibitor (INSTI) naïve, and have not received any antiretroviral therapy (ART) within
             12 weeks of screening

          -  Screening genotype report must show sensitivity to B/F/TAF to allow its initiation on
             Day 10

          -  Screening genotype report must show sensitivity to at least one agent in either
             non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)
             class to allow its use as part of standard of care oral antiretroviral treatment in
             the future

          -  Have adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min)

          -  No clinically significant abnormalities in electrocardiography (ECG) at Screening

          -  Willing to initiate B/F/TAF on Day 10 after completion of all assessments

        Key Exclusion Criteria:

          -  Pregnant or lactating females

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone
Condition: Actinic Porokeratosis
MeSH terms: Porokeratosis
Intervention: Lovastatin 2%, 2% Cholesterol Cream; Lovastatin 2% Cream
Intervention description: Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.; Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will analyze the effects of topical lovastatin/cholesterol vs topical lovastatin
      alone in patients with disseminated superficial actinic porokeratosis. Patients will be
      divided into two groups, topical lovastatin/cholesterol and topical lovastatin alone.
      Patients will apply topical treatment twice daily to lesions over the course of 12 weeks.
      Follow up will occur in the virtual setting and photographs will be used to document
      progress.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients 18 years and older with the diagnosis of disseminated superficial actinic
             porokeratosis.

        Exclusion Criteria:

          -  Patients with allergies or contraindications to lovastatin or cholesterol

          -  Female patients currently pregnant or lactating.

          -  Female patients with plans to become pregnant.

          -  Patients actively taking approved forms of long-term contraception (oral
             contraceptives, implantable intrauterine devices, or other hormone eluting implants)
             will be allowed to participate as long as they have no plan to become pregnant during
             the course of the study. A urine pregnancy test will be administered to these patients
             to confirm that they can be included in the study.

          -  Inability or unwillingness of subject or legal guardian/representative to give
             informed consent
Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies
Condition: B-cell Malignancies
MeSH terms: Neoplasms
Intervention: Zanubrutinib; Fluconazole; Diltiazem; Voriconazole; Clarithromycin
Intervention description: Capsules administered at a dose and frequency as specified in the treatment arm; Capsules administered at a dose and frequency as specified in the treatment arm; Capsules administered at a dose and frequency as specified in the treatment arm; Capsules administered at a dose and frequency as specified in the treatment arm; Capsules administered at a dose and frequency as specified in the treatment arm
Intervention MeSH terms: Clarithromycin; Fluconazole; Voriconazole; Zanubrutinib; Diltiazem
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to assess the steady-state zanubrutinib
      pharmacokinetics (PK) when co-administered with moderate and strong cytochrome P450 family 3
      subfamily A (CYP3A) inhibitors.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Histologically or cytologically confirmed CLL/SLL, MCL, WM, or MZL.

          2. Relapsed or refractory disease after at least 1 prior line of systemic therapy.
             Participants with MZL are required to have failed an anti-CD20 monoclonal
             antibody-containing chemotherapy regimen.

          3. Baseline Eastern Cooperative Oncology Group performance status of 0 to 1.

          4. Meet protocol guidelines for adequate bone marrow, kidney, liver, and cardiac
             function.

        Key Exclusion Criteria:

          1. Requirement of chronic treatment with strong and moderate CYP3A inhibitors or inducers
             or with drugs that are not allowed to be used in combination with diltiazem,
             clarithromycin, fluconazole, or voriconazole.

          2. History of stroke or intracranial hemorrhage (within 6 months of treatment start).

          3. Known hypersensitivity or contraindication to zanubrutinib, diltiazem, clarithromycin,
             fluconazole, or voriconazole.

          4. Prior exposure to zanubrutinib or other Bruton tyrosine kinase inhibitor

          5. Unable to swallow capsules or disease significantly affecting gastrointestinal
             function such as malabsorption syndrome, resection of the stomach or small bowel,
             bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or
             complete bowel obstruction.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.