bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer
Condition: Bladder Cancer; High Risk Superficial
MeSH terms: Urinary Bladder Neoplasms
Intervention: Bacillus Calmette-Guérin (BCG)
Intervention MeSH terms: BCG Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bacillus Calmette-Guérin (BCG); 14-174

Summary:

      This is a phase II study. This means that BCG therapy has already been found to be safe in
      humans. The investigators just want to see if using more treatments works better.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have high risk non-muscle invasive urothelial bladder carcinoma (Tis,
             TaHG, or T1) that is pathologically confirmed by the Memorial Sloan Kettering
             Department of Pathology or a documented history of TaHG or T1 non-muscle invasive
             urothelial bladder tumors.

          -  18 years and older

          -  All visible papillary lesions must be macroscopically resected within 60 days of
             treatment initiation.

          -  Absence of urothelial carcinoma involving the upper urinary tract (documented by
             radiological imaging or biopsy) preferably within 12 months from the start of
             treatment. Should the imaging or biopsy be performed outside this window it will be up
             to the physicians discretion to re-scan/biopsy.

          -  Patients who have received a single dose of mitomycin C following staging TUR.

        Exclusion Criteria:

          -  Currently being treated or scheduled to have radiation treatment for bladder cancer
             during the study.

          -  Treatment with intravesical BCG or chemotherapy for a patient's current <T2 tumor
             during the 12 months prior to the current diagnosis.

          -  Currently being treated or scheduled to have treatment with any systemic or
             intravesical chemotherapeutic agent during the study.

          -  Currently being treated with or having been treated in the last 12 months with any
             investigational drug for high risk superficial bladder cancer.

          -  Previous muscle-invasive (i.e., stage T2 or higher) transitional cell carcinoma of the
             bladder.

          -  Currently being treated for metastatic transitional cell carcinoma.

          -  Scheduled to have surgery for bladder cancer during the study.

          -  Presence of clinically significant infections or congenital or acquired
             immunodeficiency.
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: SAGE-547
Intervention description: Intravenous injection
Intervention MeSH terms: Brexanolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Postpartum depression

Summary:

      This is an open-label proof-of-concept study designed to evaluate the safety, tolerability,
      pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants
      diagnosed with severe postpartum depression (PPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult females, 18-45 years old who experienced a major depressive episode in the
             postpartum period beginning within the first 4 weeks following delivery

          -  Participant has ceased lactating, or if still lactating has already fully and
             permanently weaned their infant; if still actively breastfeeding, participant must
             agree to cease giving breast milk to their infant prior to study entry

        Exclusion Criteria:

          -  Recent history or active clinically significant manifestations of metabolic, hepatic,
             renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal,
             dermatological, urogenital, or eyes, ears, or nose and throat (EENT) disorders

          -  Active psychosis

          -  Medical history of seizures
Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF/VEL; SOF/VEL
Intervention description: SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment); SOF/VEL FDC 200/50 mg oral granules
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.

      The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm
      the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric
      participants with chronic hepatitis C virus (HCV) infection.

      The primary objective of the Treatment Phase is to evaluate the safety and tolerability of
      SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV-infected, treatment-naive and treatment-experienced adolescent and
             pediatric individuals aged 3 to < 18 as determined at Day 1.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Tarceva; Radiotherapy
Intervention description: Tarceva 150 mg/day; 66 Gy/33 F/5 F per week for 5 weeks
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Lung cancer; Non-small cell lung cancer; Tarceva; Radiotherapy; Local-regionally advanced non-small cell lung cancer

Summary:

      The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in
      inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the
      phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy
      (2 Gy x 33 F, 5 F per week).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Patients with histologically or cytologically documented diagnosis locally advanced
             NSCLC stage IIB to IIIB without pleural effusion

          -  Performance status ≤2 on the ECOG scale

          -  Serum bilirubin must be ≤1.5 upper limit of normal (ULN)

          -  ALAT ≤2 x ULN

          -  Able to comply with study and follow-up procedures

          -  Patients with reproductive potential must use effective contraception

          -  Written (signed) informed consent to participate in the study

        Exclusion Criteria:

          -  Any unstable systemic disease (including active infection, unstable angina, congestive
             heart failure, severe hepatic, renal, or metabolic disease)

          -  Any other malignancies within 5 years (except for adequately treated carcinoma in situ
             of the cervix or basal or squamous cell skin cancer)

          -  Inability to take oral medication, or requirement of intravenous alimentation

          -  Nursing mothers
Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: NBI-98854; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of
      NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will
      enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette
      Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of Tourette Syndrome (TS)

          2. Have at least moderate tic severity

          3. Have TS symptoms that impair school, occupational, and/or social function

          4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g.
             obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
             be on stable doses

          5. Be in good general health

          6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for
             amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or
             cannabinoids and a negative alcohol screen

          7. Subjects of childbearing potential who do not practice total abstinence must agree to
             use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently during the screening, treatment and follow-up periods of the study

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening

          2. Have a known history of long QT syndrome or cardiac arrhythmia

          3. Have a known history of neuroleptic malignant syndrome

          4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)

          5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors

          6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening

          7. Have a known history of substance dependence, substance (drug) or alcohol abuse

          8. Have a significant risk of suicidal or violent behavior

          9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the
             screening period or at baseline or plan to initiate CBIT during the study

         10. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study
Theophylline as a Treatment for Children With Pseudohypoparathyroidism Type 1a (Albright Hereditary Osteodystrophy)
Condition: Pseudohypoparathyroidism Type 1a; Albright Hereditary Osteodystrophy
MeSH terms: Pseudohypoparathyroidism; Pseudopseudohypoparathyroidism
Intervention: Theophylline
Intervention description: 24 hour infusion of IV theophylline
Intervention MeSH terms: Theophylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 10 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This study will test an investigational drug, theophylline, in children with
      pseudohypoparathyroidism type 1a (PHP1a). This study involves a 3 day visit to the Vanderbilt
      Clinical Research Center.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 10 to 21 years old

          2. English proficiency

          3. Clinical and genetic diagnosis of PHP1a

        Exclusion Criteria:

          1. Use of a PDE inhibitor in the past 30 days

          2. History of a seizure disorder unrelated to hypocalcemia

          3. History of a cardiac arrhythmia (not including bradycardia)

          4. History of hepatic insufficiency

          5. AST or ALT >2x upper limit of normal

          6. Total bilirubin >1.5 x upper limit of normal (unless patient has a diagnosis of
             Gilbert's syndrome and no other causes leading to hyperbilirubinemia are identified)

          7. Congestive heart failure

          8. Cigarette use in the past 30 days

          9. Alcohol use within the past 24 hours

         10. Current pregnancy

         11. Untreated hypothyroidism (defined as free T4 level < 0.6 ng/dL or TSH >10 mcU/mL)

         12. Active peptic ulcer disease

         13. Fever >101 degrees in the past 24 hours

         14. Current use of medications known to effect theophylline levels (listed below)

         15. Severe sleep apnea requiring BiPAP

        Drugs with clinically significant drug interactions with theophylline:

          -  Allopurinol

          -  Cimetidine

          -  Ciprofloxacin

          -  Clarithromycin

          -  Enoxacin

          -  Ephedrine

          -  Erythromycin

          -  Estrogen

          -  Flurazepam

          -  Fluvoxamine

          -  Lithium

          -  Lorazepam

          -  Methotrexate

          -  Midazolam

          -  Pentoxifylline

          -  Propranolol

          -  Rifampin

          -  Sulfinpyrazone

          -  Tacrine

          -  Thiabendazole

          -  Ticlopidine

          -  Troleandomycin

          -  Verapamil
A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: Placebo Cream; Ruxolitinib Phosphate Cream
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hair loss; alopecia areata; alopecia totalis; alopecia universalis; JAK inhibitors; topical hair growth

Summary:

      A phase 2 study to find out if the drug ruxolitinib Phosphate Cream is safe and has
      beneficial effects in people who have alopecia areata (partial or complete hair loss) when
      applied to the skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AA

          -  Duration and extent of current episode of AA

          -  Evidence of active hair loss

        Exclusion Criteria:

          -  Evidence of diffuse, spontaneous terminal hair regrowth

          -  Receipt of treatment known to potentially affect the course of AA within last month
Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Tisagenlecleucel
Intervention description: Tisagenlecleucel Cell Dispersion for Infusion given once during the study.
The approved dose range for tisagenlecleucel is: 0.2 to 5.0×106 CAR positive viable T cells / kg for patients' ≤ 50 kg body weight or 0.1 to 2.5×108 CAR-positive viable T cells for patients > 50 kg body weight.
Intervention MeSH terms: Tisagenlecleucel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 2 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: CTL019; Kymriah; Tisagenlecleucel; B-Cell Acute Lymphoblastic Leukemia; Leukemia; ALL; Pediatric; Young Adult; Reinfusion

Summary:

      This was a multi-center Phase II study investigating the efficacy and safety of reinfusion of
      tisagenlecleucel in pediatric and young adult patients with acute lymphoblastic leukemia
      (ALL) who were treated with tisagenlecleucel and experience B cell recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent must be obtained prior to participation in the study

          -  Must have an additional dose of unexpired, commercial tisagenlecleucel available and
             prescribed by a physician in the course of medical practice

          -  Age up to and including 25 years

          -  Patients must have CD-19+ Leukemia

          -  Patients who were previously treated with tisagenlecleucel and present with evidence
             of B-cell recovery as defined by: Peripheral blood (PB) absolute B lymphocyte count ≥
             50/µL, OR PB B lymphocyte ≥ 10% of the total lymphocytes

        Exclusion Criteria:

          -  Prior gene therapy other than tisagenlecleucel

          -  Prior adoptive T cell therapy other than tisagenlecleucel

          -  Active CNS involvement by malignancy

          -  Active or latent hepatitis B or active hepatitis C, or any uncontrolled infection at
             screening

          -  HIV positive test within 8 weeks of screening
Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung
Intervention: Pembrolizumab; Acalabrutinib
Intervention MeSH terms: Pembrolizumab; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small
      cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age

          -  ECOG performance status of 0 or 1

          -  Histologically confirmed recurrent or metastatic NSCLC (adenocarcinoma, large cell,
             squamous cell, or not otherwise specified) that has either progressed during or after
             platinum-based chemotherapy

          -  Received at least 1 platinum-based chemotherapy regimen. Note: Subjects with EGFR
             mutations or ALK translocations are required to have received prior therapy with
             appropriate TKI; prior platinum-based chemotherapy is not required for this specific
             patient population

        Exclusion Criteria:

          -  Prior malignancy (other than lung cancer), except for adequately treated basal cell or
             squamous cell skin cancer, in situ cervical cancer, or other cancer from which the
             subject has been disease free for ≥ 2 years or which will not limit survival to < 2
             years

          -  Known central nervous system metastases and/or carcinomatous meningitis

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, symptomatic inflammatory bowel disease,
             partial or complete bowel obstruction, or gastric restrictions and bariatric surgery,
             such as gastric bypass

          -  Breastfeeding or pregnant
A Study of LY3437943 in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY3437943; Dulaglutide; Placebo
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 281.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in
      participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on
      diet and exercise alone or on a stable dose of metformin. This study will last about 43
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have Type 2 Diabetes (T2D)

          -  Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and
             exercise alone or with a stable dose of metformin (either immediate release or
             extended release, 1000 milligram (mg)/day and not more than the locally approved dose)
             for at least 3 months prior to screening.

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus (T1DM)

          -  Have ketoacidosis

          -  Have retinopathy, maculopathy

          -  Have history of pancreatitis

          -  Have obesity induced by other endocrine disorders

          -  Have uncontrolled hypertension

          -  Have acute or chronic hepatitis

          -  Have chronic kidney disease

          -  Have an autoimmune abnormality for example, lupus or rheumatoid arthritis

          -  Have an active or untreated malignancy