bioihbjkbjnl/mcl2 huggingface dataset:
Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy
Condition: Urologic Neoplasms
MeSH terms: Urologic Neoplasms
Intervention: Afatinib
Intervention MeSH terms: Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to assess the anti-tumour activity and safety of afatinib
      monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3
      (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family
      of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor
      Receptor) amplification positive tumours (Cohort B), progressing despite previous platinum
      based chemotherapy, and thereby to improve their prognosis.

      The antitumour activity of afatinib monotherapy in these patients will be assessed by
      progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the
      trial. A key secondary endpoint will also be defined, the objective response rate (ORR).
    

Eligibility criteria:

        Inclusion criteria:

          -  Recurrent or metastatic urothelial cancer

          -  Patients must have failed prior platinum based treatment (adjuvant or 1st line)

          -  Archival tissue sample available for biomarker testing at pre-screening and tissue
             banking.

          -  Patients should complete a pre-screening biomarker analysis and should fulfill the
             following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family
             receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should
             show EGFR (Epidermal Growth Factor Receptor) amplification.

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Prior use of EGFR, ERBB2 or ERBB3 targeted treatment

          -  Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy
             or investigational agents within 4 weeks prior to the start of study treatment or
             prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first

          -  Known brain metastases or signs hereof, uncontrolled spinal cord compression or
             leptomeningeal carcinomatosis

          -  Further exclusion criteria apply
Study to Evaluate the Safety of AT2220 (Duvoglustat) in Pompe Disease
Condition: Pompe Disease
MeSH terms: Glycogen Storage Disease Type II
Intervention: Duvoglustat
Intervention description: Powder in a bottle for dissolution in water for oral administration
Intervention MeSH terms: 1-Deoxynojirimycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Amicus Therapeutics; Duvoglustat; AT2220

Summary:

      The main purpose of this study was to determine the safety and tolerability of 3 different
      doses of duvoglustat (AT2220) in participants affected by Pompe disease. The study also
      evaluated the effects of duvoglustat on functional parameters in Pompe disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 74 years of age inclusive

          -  Diagnosis of Pompe disease based on clinical assessment, enzyme assay, and/or
             genotyping. Confirmatory genotyping will be performed on all participants who are
             screened for the study

          -  Naïve to enzyme replacement therapy (ERT) or has not received ERT in the 3 months
             prior to screening

          -  Willing not to initiate ERT or other prohibited treatment during study participation

          -  Functional grade for arms and/or legs ≥2 OR sitting forced vital capacity ≥30% and
             <80% of predicted value, reproducible between screening and baseline (±15%)

          -  Participants of reproductive potential agree to use reliable methods of contraception
             during the study

          -  Participant or legal representative is willing and able to provide written informed
             consent

        Exclusion Criteria:

          -  Any intercurrent condition that may preclude accurate interpretation of study data

          -  Obstructive pulmonary disease

          -  Invasive ventilatory support

          -  Use of noninvasive ventilatory support >8 hours/day while awake

          -  History of QTc prolongation >450 milliseconds (msec) for males and >470 msec for
             females

          -  History of allergy or sensitivity to the study drug, including any prior serious
             adverse reaction to iminosugars (such as miglustat or miglitol)

          -  Pregnancy or breast-feeding

          -  Current or recent drug or alcohol abuse

          -  Treatment with another investigational drug within 30 days of study start

          -  Use of prohibited medications ≤3 months prior to screening

          -  Otherwise unsuitable for the study in the opinion of the Investigator
Convalescent Plasma in the Treatment of COVID 19
Condition: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); COVID; Coronavirus
MeSH terms: Coronavirus Infections; Severe Acute Respiratory Syndrome
Intervention: Convalescent Plasma
Intervention description: treatment with 2 Units of convalescent plasma
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma

Summary:

      The purpose of this study is to collect blood from previously COVID-19 infected persons who
      have recovered and use it as a treatment for those who are currently sick with a severe or
      life-threatening COVID-19 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All genders

          -  Age > 18 yrs and < 90 yrs

          -  Must have laboratory confirmed COVID-19

          -  Must provide informed consent

          -  Must have severe or immediately life-threatening COVID-19,

        Severe disease is defined as:

          -  dyspnea,

          -  respiratory frequency ≥ 30/min,

          -  blood oxygen saturation ≤ 93%,

          -  partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300

          -  lung infiltrates > 50% within 24 to 48 hours

        Life-threatening disease is defined as:

          -  respiratory failure,

          -  septic shock

          -  multiple organ dysfunction or failure

        Exclusion Criteria:

          -  No gender exclusion

          -  Age < 18 yrs and > 90 yrs

          -  COVID-19 negative
Buspirone in Parkinson's Disease
Condition: Parkinson Disease; Anxiety
MeSH terms: Parkinson Disease
Intervention: Buspirone; Placebo
Intervention MeSH terms: Buspirone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet
      it frequently remains untreated and there have been no clinical trials dedicated to
      evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is
      effective for the treatment of generalized anxiety disorder in the general and elderly
      population. It is not known if it is effective for the treatment of anxiety in Parkinson's
      disease. This is a single-center, placebo-controlled, double-blind design with participants
      randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg
      twice daily) or placebo for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic PD by UK Parkinson's Disease Society Brain Bank Clinical
             Diagnostic Criteria

          -  Significant anxiety as determined by the self-rated Parkinson Anxiety Scale (score ≥
             14)

          -  Able to provide written informed consent

          -  At least 18 years of age

        Exclusion Criteria:

          -  Diagnosis of atypical or secondary parkinsonism

          -  Concomitant treatment with an MAO inhibitor within the 14 days prior to screening
             visit

          -  Significant renal or hepatic impairment

          -  Significant cognitive impairment defined as MOCA score < 23

          -  On-going depression with suicidal or homicidal ideation and concern for patient safety
             based on clinical determination by the investigator

          -  Allergy or intolerance to study drug, matching placebo, or their formulations

          -  History of prior exposure to study drug

          -  Lactating or pregnant woman

          -  Concomitant treatment with a disallowed medication (detailed in section 6.2)

          -  Active drug or alcohol use or dependence that, in the opinion of the investigator,
             would interfere with adherence to study requirements

          -  Concomitant treatment with an anxiolytic or antidepressant will be allowed however
             potential participants who had dosage changes in the 30 days prior to the screening
             visit will be excluded

          -  Use of an investigational drug within 30 days prior to screening visit

          -  Any medical or psychiatric comorbidity that, in the opinion of the investigator, would
             compromise study participation

          -  Dysphagia defined as a score of ≥ 2 on MDS-UPDRS Item 2.3 Chewing and Swallowing
A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
Condition: Indolent Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Duvelisib
Intervention description: Phosphoinositide-3-kinase (PI3K) inhibitor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PI3K Inhibitor

Summary:

      This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a
      monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma
      [FL], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab
      and to either chemotherapy or radioimmunotherapy (RIT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who had been diagnosed with iNHL that had progressed.

          -  Participants must have exhibited lack of CR or progressive disease (PR) or progression
             within 6 months after the last dose of a chemotherapy induction regimen or RIT.

          -  Participants must have had rituximab-refractory disease, defined as lack of CR or PR
             or PD within 6 months of last dose.

          -  Measurable disease with a lymph node or tumor mass ≥1.5 centimeters in at least one
             dimension by computed tomography (CT), positron emission tomography/CT or magnetic
             resonance imaging.

          -  Adequate renal and hepatic function.

        Exclusion Criteria:

          -  Candidate for potentially curative therapies in the opinion of the investigator.

          -  Previous treatment with a PI3K inhibitor or Bruton's tyrosine kinase inhibitor.

          -  Prior history of allogeneic hematopoietic stem cell transplant.

          -  Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents
             within 4 weeks before first dose of study drug.

          -  Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of
             lymphoma.

          -  Symptomatic central nervous system NHL.

          -  Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of
             study treatment.

          -  Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for
             hepatitis C virus antibodies, hepatitis B surface antigen, or hepatitis B core
             antibodies.

          -  History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia
             requiring medication or mechanical control within the last 6 months prior to first
             dose of study drug.
Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma
Condition: Small Cell Lung Cancer
MeSH terms: Small Cell Lung Carcinoma; Lung Neoplasms
Intervention: Rucaparib and Nivolumab
Intervention description: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Intervention MeSH terms: Nivolumab; Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rucaparib; nivolumab; platinum-sensitive; maintenance; SCLC; immune checkpoint; PARP

Summary:

      The purpose of this study is to evaluate survival and response rate of the combination
      rucaparib and nivolumab as maintenance therapy in platinum-sensitive small cell lung
      carcinoma.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients with histologically or cytologically confirmed stage IV, extensive stage,
             small cell lung cancer who achieved either partial or complete remission per RECIST
             1.1 post frontline chemotherapy with platinum doublet (Cisplatin or
             Carboplatin/etoposide).

          -  Enrollment is within 6 weeks of last (4th cycle) of chemotherapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Adequate Bone Marrow Function

          -  Adequate Hepatic Function

        Exclusion Criteria

          -  Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune
             checkpoints)

          -  Major surgery within 4 weeks of initiation of study medication.

          -  Current use of (some) immunosuppressants

          -  Active infection requiring systemic therapy

          -  HIV/AIDS

          -  Hepatitis B virus or hepatitis C virus infection at screening

          -  Autoimmune disease

          -  Persisting toxicity related to prior therapy

          -  Pregnancy

          -  Vaccination (except inactive) within 4 weeks of the first dose of nivolumab

          -  Hypersensitivity to the study drugs

          -  Cardiovascular disease

          -  Untreated central nervous system (CNS) metastases or leptomeningeal carcinomatosis

          -  (Some) active secondary malignancy

          -  Active pneumonitis or interstitial lung disease
Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
Condition: Moderate-to-Severe Asthma
MeSH terms: Asthma
Intervention: Anti-GM-CSF Monoclonal Antibody 400mg; Placebo
Intervention description: Anti-GM-CSF Monoclonal Antibody 400mg; Normal Saline
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; GM-CSF; Moderate-to-Severe Asthma

Summary:

      This study will evaluate the safety, tolerability and efficacy of a single dose level of
      KB003 in subjects with inadequately controlled asthma.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A diagnosis of asthma established for at least 2 years

          -  Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire

          -  Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone
             or budesonide, or other corticosteroids, for at least 12 weeks

          -  Currently receiving inhaled long-acting beta agonist (LABA) or previously documented
             LABA intolerability or lack of responsiveness

          -  At least 2 exacerbations (no more than 6) in the previous 12 months that required
             systemic corticosteroids or at least a doubling of daily oral dose

        Key Exclusion Criteria:

          -  Acute asthma worsening (requiring emergency room visit, hospitalization, urgent care,
             physician visit, or change in asthma medications) or lower respiratory tract infection
             requiring the use of antibiotics, within 4 weeks prior to Screening Visit.

          -  History of life-threatening asthma with admission to the intensive care unit requiring
             the use of mechanical ventilation within the past 12 months

          -  Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an
             investigational agent within 4 weeks prior to Screening Visit

          -  History of any cardiovascular, neurological, hepatic, or renal condition

          -  History of smoking within the past 12 months
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
Condition: Chronic Renal Insufficiency; Diabete Mellitus; Congestive Heart Failure
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Heart Failure; Diabetes Mellitus
Intervention: GE-145
Intervention description: GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 284.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: CATH Catheterization; CI-AKI Contrast-induced acute kidney injury; DM Diabetes mellitus; eGFR Estimated glomerular filtration rate; MDRD Modification of Diet in Renal Disease; NYHA New York Heart Association; PCI Percutaneous coronary intervention; SCr Serum creatinine

Summary:

      To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when
      compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either
      chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive
      heart failure (CHF) NYHA Class III or greater, who are referred for a coronary
      catheterization procedure with or without PCI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 65 years of age with cardiovascular disease who are referred for a
             coronary catheterization procedure with or without PCI.

          -  The subject has at least one of the following comorbidities:

          -  1) Chronic renal insufficiency, (eGFR <60 but 15 mL/min/1.73 m2 according to the MDRD
             equation) as measured within 2 weeks or at the screening visit;

          -  2) DM diagnosed greater than 6 months prior to study entry and which requires either
             insulin or anti-hyperglycemic drug therapy;

          -  3) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the
             screening visit.

        Exclusion Criteria:

          -  The subject has known allergies to either iodine or any ICM.

          -  The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the
             MDRD equation) or is on dialysis.

          -  The subject has acute coronary syndrome requiring emergency coronary angiography
             and/or intervention.

          -  The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at
             the time of the study procedure.
Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: single dose of 5 mcg; single dose of placebo; single dose of 40 mcg; single dose of 20 mcg; single dose of 2 mcg; single dose of 10 mcg
Intervention description: solution for inhalation; solution for inhalation; solution for inhalation; solution for inhalation; solution for inhalation; solution for inhalation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 36.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744
      CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI
      1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for
      additional PK assessments which are not defined as primary or secondary endpoints.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of chronic obstructive pulmonary disease

          2. Smoking history of more than 10-pack years

        Exclusion criteria:

          1. History of asthma, allergic rhinitis, myocardial infarction or unstable of
             life-threatening cardiac arrhythmias

          2. Marked baseline prolongation of QT/QTc interval