bioihbjkbjnl/mcl2 huggingface dataset:
Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar
Condition: Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Erlotinib
Intervention description: Orally every day for about 4-6 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: 41.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tarceva; erlotinib; squamous cell carcinoma of the vulvar

Summary:

      In this research study we are looking to see how vulvar cancer responds to erlotinib therapy.
      Two distinct patient populations are targeted: women with locally advanced measurable
      squamous cell carcinoma of the vulva, primary or recurrent, who are candidates for definitive
      treatment with surgery or chemoradiation (Cohort 1) and women with radiographically
      measurable distant metastatic cancer either at time of presentation or with recurrence
      (Cohort 2). Another goal of this study is to learn more about the proteins and genes present
      in vulvar cancer and how they may affect response to erlotinib. Erlotinib treats cancer by
      preventing cancer cells from growing and multiplying. It does this by blocking certain
      proteins that are on the surface of some types of cancer cells. Laboratory tests show that
      vulvar cancer cells have high levels of these proteins.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed measurable squamous cell carcinoma of the vulvar with an
             assessable lesion on the vulva or measurable metastatic disease. Tumors may be primary
             or recurrent. Patients must have plans for surgery or definitive treatment with
             chemotherapy +/-radiation unless they have measurable metastatic disease.

          -  18 years of age or older

          -  No concurrent chemotherapy or radiotherapy

          -  NO previous chemotherapy or radiotherapy within the preceding 1 month

          -  ECOG performance status of 0-1

        Exclusion Criteria:

          -  Known hypersensitivity reaction to erlotinib

          -  Other coexisting malignancies diagnosed within the last 5 years, with the exception of
             basal cell carcinoma

          -  Treatment with a non-FDA approved or investigational drug within 30 days

          -  Persistent toxicities (grade 2 or above) from previous treatment, expect alopecia or
             lymphedema

          -  Serum creatinine level greater than CTC grade 2

          -  Pregnancy or breast feeding

          -  Severe or uncontrolled systemic disease

          -  Significant clinical disorder or laboratory finding that makes it potentially unsafe
             for the subject to participate
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: teriparatide; Placebo; BA058 20 µg; BA058 40 µg; BA058 80 µg
Intervention description: teriparatide 20 µg subcutaneous daily; Placebo subcutaneous daily; BA058 20 µg subcutaneous daily; BA058 40 µg subcutaneous daily; BA058 80 µg subcutaneous daily
Intervention MeSH terms: Teriparatide; Abaloparatide; Parathyroid Hormone-Related Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 222.0
Sex: Female
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: osteoporosis; postmenopausal; bone loss

Summary:

      The purpose of this study is to determine whether BA058 is effective in building bone in
      postmenopausal women with osteoporosis.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  The patient has a bone mineral density T-score ≤ 2.5 at the lumbar spine or hip
             (femoral neck) by dual energy x-ray absorptiometry (DXA). Women with a bone mineral
             density T-score of 2.0 or lower and a prior low-trauma forearm, humerus, vertebral,
             sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years, or who have
             an additional risk factor such as age 65 or greater or a strong maternal history of
             osteoporosis defined as a fracture related to osteoporosis or osteoporosis itself as
             determined by BMD criteria, are also study candidates.

          -  The patient is in good general health as determined by medical history and physical
             examination and is without evidence of clinically significant abnormality in the
             opinion of the Investigator.

        Primary Exclusion Criteria:

          -  History of bone disorders (e.g., Paget's disease) other than postmenopausal
             osteoporosis.

          -  Prior treatment with approved or as yet unapproved bone-acting investigational agents.

          -  History of carcinoma, nephrolithiasis or urolithiasis within the past five years or
             osteosarcoma at any time.

          -  History of radiotherapy (radiation therapy).
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: HOE901-U300 (new formulation of insulin glargine); Lantus (insulin glargine)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Primary Objective:

        -  To compare the glucose control during treatment with a new formulation of insulin
           glargine and Lantus in adult participants with type 1 diabetes mellitus

      Secondary Objectives:

        -  To compare a new formulation of insulin glargine and Lantus given in the morning or in
           the evening

        -  To compare the incidence and frequency of hypoglycemic episodes

        -  To assess the safety and tolerability of the new formulation of insulin glargine
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants with Type 1 diabetes mellitus

        Exclusion criteria:

          -  HbA1c greater than (>) 9% (at screening)

          -  Participants receiving >0.5 U/kg body weight basal insulin in the last 30 days prior
             to screening visit

          -  Participants not on stable insulin dose (+/- 20% total basal insulin dose) in the last
             30 days prior to screening visit

          -  Less than 1 year on any basal plus mealtime insulin

          -  Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or
             any antidiabetic drugs other than basal insulin and mealtime analogue insulin in the
             last 3 months before screening visit

          -  Use of an insulin pump in the last 6 months before screening visit;

          -  Any contraindication to use of insulin glargine as defined in the national product
             label

          -  Not willing to inject insulin glargine as assigned by the randomization process once
             daily in the morning or evening

          -  Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring
             3rd party assistance) in the last 6 months prior to randomization

          -  Initiation of any glucose-lowering agents in the last 3 months before screening visit

          -  Weight change of greater than equal to (>=) 5 kg during the last 3 months prior to
             screening visit

          -  Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic
             retinopathy or macular edema likely to require laser, surgical treatment or injectable
             drugs during the study period

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Condition: Atrophy, Geographic
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: GSK933776; Placebo
Intervention description: GSK933776; 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: 191.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: age-related macular degeneration; geographic atrophy; dry AMD

Summary:

      The purpose of this study is to determine the safety and efficacy of GSK933776 in the
      treatment of geographic atrophy secondary to age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients ≥55 years of age inclusive

          -  Evidence of AMD confirmed by the presence of at least 1 druse ≥125 μm diameter

          -  Well-demarcated GA due to AMD of total area 1.9-17 mm2 measured in the study eye

          -  Best-corrected visual acuity score of ≥ 35 letters (approximately 20/200 Snellen VA
             equivalent or better) in the study eye

        Exclusion Criteria:

          -  Additional eye disease in the study eye that could compromise assessment of
             best-corrected visual acuity or imaging of the posterior pole

          -  History of CNV secondary to AMD in the study eye

          -  Any previous treatment for AMD in the study eye, approved or investigational, with the
             exception of dietary supplements

          -  Risk of cerebrovascular disease, cerebral hemorrhage or stroke

          -  History of systemic autoimmune disease

          -  Use of platelet anti-aggregants or anti-coagulants (aspirin up to 325 mg/day is
             allowable, or in subjects allergic or intolerable to aspirin, clopidogrel up to 75
             mg/day is allowable)

          -  Use of chronic corticosteroids

          -  Uncontrolled hypertension in spite of antihypertensive medications

          -  Renal or hepatic insufficiency or clinically significant anemia

          -  More than moderate MRI white matter changes
Effect of Inhaled Albuterol in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Albuterol; Placebo
Intervention description: inhalation of 270μg albuterol through a spacer; inhalation of placebo through a spacer
Intervention MeSH terms: Albuterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the present pilot study is to test the hypothesis that in patients with group
      1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator
      therapy, inhaled albuterol causes transient pulmonary vasodilation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A Mean Pulmonary Artery Pressure >25mmHg, Pulmonary Vascular Resistance >3 wood/units
             and pulmonary arterial wedge pressure <15mmHg, as documented by right heart
             catheterization within the last 3 years

          -  Regular use of oral pulmonary vasodilators

        Exclusion Criteria:

          -  Presence of chronic respiratory disease (as documented by prior lung imaging and
             pulmonary function tests), cardiovascular disease (as documented by prior
             echocardiography and/or left heart catheterization), thromboembolic PAH (as documented
             by pulmonary angiography)

          -  women of childbearing potential who do not use accepted birth- control measures

          -  pregnant and breast-feeding women

          -  respiratory infection within 4 weeks of testing

          -  A systemic systolic arterial BP> 150 and/or diastolic arterial BP>100 on the
             experiment day

          -  A resting O2 saturation of < 90%

          -  Current smoking

          -  BMI >35 kg/m2 and/or a diagnosis of obstructive sleep apnea

          -  Use of inhaled or intravenous pulmonary vasodilators
Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: IMA-638 is a biologic
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a
      subject with mild asthma inhaling an allergen.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  generally healthy, men and women with mild allergic asthma, aged 18 to 60 years

          -  only asthma med is short-acting bronchodilator used not more than twice weekly

          -  FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen
             induction

        Exclusion Criteria:
Pharmacological Intervention Project (Fluoxetine)
Condition: Alcoholism; Depression
MeSH terms: Alcoholism; Depression
Intervention: fluoxetine (Prozac); Placebo plus Treatment As Usual
Intervention description: fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up; placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 15 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: fluoxetine,; adolescents,; alcohol dependence,; major depression; Alcoholism

Summary:

      This is a large scale study involving fluoxetine (Prozac) versus a placebo in the treatment
      of adolescents with alcohol use disorder (AUD) and major depression (MDD). All individuals
      will receive treatment for 12 weeks with a followup phase lasting 9 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets criteria for alcohol use disorder and major depressive disorder.

        Exclusion Criteria:

          -  Meets criteria for bipolar disorder, schizoaffective disorder, or schizophrenia.

          -  Hyper- or hypothyroidism, significant cardiac, neurologic, or renal impairment, and
             those with significant liver disease.

          -  Receiving antipsychotic or antidepressant medication in the month prior to entering
             the study.

          -  Use of any illicit substance abuse or dependence other than cannabis abuse (and
             alcohol abuse).

          -  History of intravenous drug use.

          -  Pregnancy, inability or unwillingness to use contraceptive methods.

          -  Inability to read or understand study forms

          -  Less than 15 years of age or over 18 years of age will be excluded.
PNT2258 for Treatment of Patients With Richter's Transformation (Brighton)
Condition: Richter's Transformation
Intervention: PNT2258
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: 18 Years
Healthy volunteers: No
Keywords: PNT2258; Richter's Transformation; NHL; Non-Hodgkin's Lymphoma; Lymphoma; DLBCL; Diffuse Large B-cell Lymphoma; Lymphoma, Large B-cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, B-cell

Summary:

      This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a
      multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to
      characterize anti-tumor activity and collect safety data on patients with Richter's
      Transformation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed Richter's transformation (RT) from chronic lymphocytic
             leukemia/small lymphocytic lymphoma (CLL/SLL).

          2. Availability of fresh or archived tumor tissue.

          3. FDG PET-CT (disease) positive baseline scan with measurable disease.

          4. ECOG performance status of 0-1.

          5. Evidence of disease progression at study entry.

          6. Discontinuation of prior anticancer therapy for ≥ 7 days prior to C1D1 and recovered
             to ≤ CTCAE grade 2 (or baseline) from any acute or chronic toxicity associated with
             prior therapy.

          7. Must have previously received at least one prior chemotherapeutic regimen for RT.

             - Previously untreated RT patients deemed ineligible for, or that refuse, intensive
             chemotherapy are eligible.

          8. Adequate bone marrow, renal, and hepatic function.

          9. Normal Coagulation profile.

         10. Agreement to use acceptable methods of contraception during the study and for ≥ 120
             days after the last dose of PNT2258 if sexually active and able to bear or beget
             children.

         11. Ability to participate in the clinical study for a minimum of at least 2 cycles (6
             weeks).

        Exclusion Criteria:

          1. Concurrent non-hematologic malignancies requiring treatment.

          2. No more than 2 prior regimens for DLBCL.

          3. Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma,
             interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or
             prolymphocytic transformation.

          4. Ongoing risk of bleeding.

          5. CNS or leptomeningeal involvement of lymphoma

          6. Concurrent clinically significant illness, medical condition, surgical history,
             physical finding, electrocardiogram or laboratory finding that, in the opinion of the
             investigator, could adversely affect the safety of the subject or impair the
             assessment of the study results.

          7. Pregnancy or breast-feeding.

          8. Previous exposure to PNT2258.
A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study
Condition: Sarcopenia
MeSH terms: Sarcopenia
Intervention: bimagrumab; Placebo
Intervention description: bimagrumab low dose bimagrumab moderate dose bimagrumab high dose
Patients enrolled prior to the protocol amendment 1 (Population I ), who received bimagrumab in the core study, entered the extension study at Week 25 and were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Study medication was administered as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45.; Placebo
Patients enrolled prior to the protocol amendment 1 (Population I), who received placebo in core study, entered the extension study at Week 25 and received placebo as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Sarcopenia, muscle wasting, elderly, strength, physical function, lean body mass, gait speed

Summary:

      This extension study was a 24-week off-drug follow-up of the core CBYM338E2202 (NCT ) study
      and the main objective was to determine the long-term durability of bimagrumab (BYM338)
      effect after a 6-month treatment period.
    

Eligibility criteria:

        Inclusion criterion:

        - Men and postmenopausal women aged 70 years or older that have participated in, and have
        completed the full study treatment period per protocol (24 weeks/EOT visit) in the
        preceding core study (CBYM338E2202)

        Exclusion criterion:

        - Any condition which should have led to treatment discontinuation per protocol in the core
        study (CBYM338E2202)
Alzheimer's Disease: Potential Benefit of Isoflavones
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Novasoy; Placebo
Intervention description: 100mg/day soy isoflavones; 100mg/day matching 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: 72.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to evaluate the potential effects of soy isoflavone
      supplements on cognitive function for men and women with Alzheimer's Disease (AD).
      Preliminary studies evaluating the effects of soy supplements on memory in cognitively
      healthy older adults have yielded promising results that are now being evaluated in patients
      with AD. It is hypothesized that isoflavone supplements will ameliorate cognitive declines
      for older adults diagnosed with Alzheimer's disease, when compared to subjects on placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable AD

          -  Has reliable and available caregiver to assist with medication and appointments

          -  On a stable dose of cholinesterase inhibitor, or if unable to tolerate medication,
             patient has no plans to re-initiate cholinergic therapies while in the study

        Exclusion Criteria:

          -  Current or recent use (<6 months) of menopausal Hormone Replacement Therapy (HRT)

          -  Current or recent use (<4 months) or oral antibiotic therapy

          -  Typical dietary intake of soy isoflavones >5 mg/day

          -  History or significant gastro-intestinal or colon disease, or colon/intestinal
             resection

          -  Irritable bowel syndrome

          -  History of breast cancer, or abnormal mammogram within 12 months

          -  History of chronic obstructive pulmonary disease, diabetes mellitus, liver disease or
             unstable ischemic heart disease

          -  Significant neurological disease other than AD that might affect cognitive function,
             such as stroke, Parkinson's disease, multiple sclerosis, or serious traumatic brain
             injury