bioihbjkbjnl/mcl2 huggingface dataset:
CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)
Condition: Non-muscle Invasive Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
Intervention: CVA21; Mitomycin C
Intervention description: CAVATAK is a purified preparation of CVA21; Chemotherapy
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coxsackievirus A21; bladder cancer; CVA21; CAVATAK

Summary:

      The study consisted of 2 sequential parts. Part A assessed the safety and tolerability of
      CAVATAK administered via intravesical instillation in patients with non-muscle invasive
      bladder cancer scheduled to undergo TUR. Part B assessed the safety and tolerability of
      CAVATAK administered in sequential combination with low dose Mitomycin C in the same patient
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of NMIBC based on cystoscopic appearance

          -  ECOG 0-2

          -  No intravesical therapy within 6 weeks of study entry

          -  No prior radiation to the pelvis

          -  ANC >1500/mm³; Hb >9.0 g/dL; Platelet >100000/mm³

          -  Serum creatinine ≤ 1.5 mg/dL

          -  Bilirubin within normal limits; AST ≤ 2.5x upper limit of normal (ULN); ALT ≤ 2.5 x
             ULN; alkaline phosphatase ≤ 2.5x ULN unless bone metastasis is present in the absence
             of liver metastasis

          -  INR < 1.2; aPPT = 0.8-1.2; PT = 0.9-1.8

          -  Candidate for TUR and planning to undergo TUR

          -  Negative pregnancy test within 7 days of treatment start

          -  Patients of child-bearing potential must agree to use an effective method of birth
             control

        Exclusion Criteria:

          -  Prior local or systemic treatments for NMIBC

          -  Concurrent treatment with any chemotherapeutic agent

          -  Patients not deemed acceptable for general anaesthesia

          -  Women who are pregnant or lactating

          -  History of vesicoureteric reflux or an indwelling urinary stent

          -  Administration of an investigational agent within 3 months of study entry

          -  Active cardiac disease

          -  Known infection with HIV, hepatitis B or C

          -  Active uncontrolled infection
A Target Occupancy Study With Ritlecitinib.
Condition: Healthy
Intervention: Ritlecitinib 50 mg; Ritlecitinib 200 mg
Intervention description: 50 mg single dose; 200 mg single dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase 1, open label, two-arm study to assess target occupancy and functional
      inhibition of JAK3 and TEC kinases by Ritlecitinib in healthy adult participants
    

Eligibility criteria:

        Inclusion Criteria:

        Participants are eligible to be included in the study only if all the following criteria
        apply:

          -  Participants who are willing and able to comply with all scheduled visits, treatment
             plan, laboratory tests, lifestyle considerations, and other study procedures.

          -  Male and female participants who are overtly healthy as determined by medical
             evaluation including medical history, physical examination including BP and pulse rate
             measurement, 12-lead ECG, or clinical and laboratory tests.

          -  BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

        Exclusion Criteria:

        Participants are excluded from the study if any of the following criteria apply:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at the time of dosing).

          -  Infection with HIV, hepatitis B or hepatitis C viruses

          -  Have evidence of untreated or inadequately treated active or latent Mycobacterium TB
             infection

          -  Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other
             infections.

          -  Have received only one of the 2 required doses of COVID-19 vaccine.

          -  Participants have a known present or a history of malignancy other than a successfully
             treated or excised non metastatic basal cell or squamous cell cancer of the skin or
             cervical carcinoma in situ.