bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
Condition: Severe Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: GRF6019; Placebo
Intervention description: GRF6019 for IV infusion; Placebo for IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 60 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Brain Diseases; Nervous System Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dementia; Tauopathy

Summary:

      This study will evaluate the safety, tolerability, and potential cognitive benefit of the
      experimental treatment GRF6019 in subjects with severe Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable AD according to the National Institute on Aging-Alzheimer's
             Association (NIA-AA) Criteria

          -  MMSE Score 0-10 inclusive

          -  Modified Hachinski Ischemia Scale (MHIS) score of 4 or less

          -  Provided a signed and dated informed consent form (either the subject and/or subject's
             legal representative)

        Exclusion Criteria:

          -  Evidence of clinically relevant neurological disorder(s) other than probable AD

          -  History of blood coagulation disorders or hypercoagulability; any concurrent use of an
             anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa
             inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.

          -  Unstable coronary heart disease, e.g. myocardial infarction or severe or unstable
             angina in the 6 months prior to dosing.

          -  Moderate to severe congestive heart failure (New York Association Class III or IV).

          -  Poorly controlled high blood pressure (systolic blood pressure of 160 mmHg or higher
             and/or diastolic blood pressure of 100 mmHg or higher) despite treatment during the 3
             months prior to dosing, or treatment refractory high blood pressure, defined as
             treatment requiring 3 or more antihypertensives from different classes.

          -  Prior hypersensitivity reaction to any human blood product or intravenous infusion;
             any known clinically significant drug allergy.

          -  Treatment with any human blood product, including transfusions and intravenous
             immunoglobulin, during the 6 months prior to screening.

          -  History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke,
             anaphylaxis, or thromboembolic complications of intravenous immunoglobulins.

          -  Hemoglobin <10 g/dL in women; and <11 g/dL in men.
Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
Condition: Tumors With Aberrations in ALK or ROS1
MeSH terms: Neoplasms
Intervention: Ceritinib
Intervention description: Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally,once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days. There were no breaks between dosing cycles.
Intervention MeSH terms: Ceritinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hematological malignancy; solid tumor malignancy; mutation; translocation; rearrangement; amplification; ALK; ROS1; NSCLC; B-cell lymphoma

Summary:

      The purpose of this signal seeking study was to determine whether treatment with ceritinib
      demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic
      malignancies to warrant further study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient had a confirmed diagnosis of a select solid tumor (except ALK+ NSCLC) or
             hematological malignancy and was in need of treatment because of radiologic
             progression or relapse.

          -  Patient must have been pre-identified as having a tumor with an ALK or ROS1 positive
             mutation, translocation, rearrangement or amplification. The qualifying alteration
             must have been assessed and reported by a CLIA-certified laboratory. ALK positivity as
             assessed by IHC or FISH were allowed.

          -  Patient must have received at least one prior treatment for recurrent, metastatic
             and/or locally advanced disease and for whom no standard therapy options were
             anticipated to result in a durable remission.

          -  Patient had progressive and measurable disease as per RECIST 1.1 or other appropriate
             hematological guidelines.

          -  Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

        Exclusion Criteria:

          -  Patient had received prior treatment with ceritinib.

          -  Patients with symptomatic CNS metastases who were neurologically unstable or required
             increasing doses of steroids within the 2 weeks prior to study entry to manage CNS
             symptoms.

          -  Patient had received chemotherapy or anticancer therapy ≤ 4 weeks (6 weeks for
             nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug.
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
Condition: Neutropenia
MeSH terms: Neutropenia
Intervention: SPI-2012; Pegfilgrastim; Docetaxel; Cyclophosphamide
Intervention description: SPI-2012 SC injection.; Pegfilgrastim SC injection, per manufacturer's Prescribing Information.; Docetaxel given based on standard dose for chemotherapy.; Cyclophosphamide given based on standard dose for chemotherapy.
Intervention MeSH terms: Cyclophosphamide; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration
      of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are
      candidates for adjuvant or neoadjuvant chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant
             chemotherapy

          -  Candidate for docetaxel and cyclophosphamide chemotherapy

          -  Female or male at least 18 years of age

          -  Eastern Cooperative Oncology Group (ECOG) ≤ 2

          -  Absolute neutrophil count (ANC) ≥ 1.5×109/L

          -  Platelet count ≥ 100 x 10^9/L

          -  Creatinine ≤ 1.5 x upper limit of normal (ULN)

          -  Total bilirubin ≤1.5 mg/dL(≤ 25.65 μmol/L).

          -  Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT)
             and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (ALT/SGPT) ≤
             2.5 x ULN

          -  Hemoglobin > 9 g/dL

          -  Alkaline phosphatase ≤ 1.5 x ULN

        Exclusion Criteria:

          -  Known sensitivity to E. coli-derived products or known sensitivity to any of the
             products to be administered

          -  Known Human Immunodeficiency Virus (HIV) infection

          -  Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral
             load or immunological evidence of chronic active disease

          -  Active infection or any serious underlying medical condition that would impair ability
             to receive protocol treatment

          -  Prior bone marrow or stem cell transplant

          -  Prolonged exposure to glucocorticosteroids and immunosuppressive agents
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
Condition: Endometrial Cancer; Papillary Serous; Clear Cell Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Vaginal Cuff Brachytherapy
Intervention description: Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Endometrial cancer; Gynecologic Cancer; Vaginal Cuff Brachytherapy; Vaginal radiation

Summary:

      The purpose of this study is to determine the progression-free survival of patients with
      surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with
      high-intermediate risk factors treated by vaginal cuff brachytherapy followed by
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have undergone specified complete surgical staging.

          -  Patients must be surgically staged endometrial cancer patients at high-risk for
             recurrence.

          -  Patients must have adequate bone marrow, renal and hepatic function.

        Exclusion Criteria:

          -  Patients with recurrent disease.

          -  Patients with GOG performance status of 3 or 4.
Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Spesolimab (low dose); Placebo; Spesolimab (high dose)
Intervention description: 12 weeks treatment; 12 weeks treatment; 12 weeks treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in
      patients with PPP following multiple intravenous administrations compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, 18 to 65 years of age at screening.

          -  Palmoplantar Pustulosis

          -  Further inclusion criteria apply

        Exclusion Criteria:

          -  Presence or known history of anti- Tumor necrosis factor (TNF)-induced Palmoplantar
             Pustulosis (PPP)-like disease.

          -  Active or latent tuberculosis

          -  Further exclusion criteria apply
Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Stanford V Chemotherapy; Radiation Therapy
Intervention description: The Stanford V regimen is an abbreviated, multi-agent, dose-intensive regimen that utilizes many of the most active chemotherapy agents for Hodgkin lymphoma: Vinblastine, Doxorubicin, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone; Patients who achieve less than a complete response after 8 weeks of chemotherapy will receive 25.5 Gy to individual nodal sites (tailored fields) starting 2-3 weeks following completion of all chemotherapy and recovery of ANC to at least 1000.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Hodgkin Lymphoma

Summary:

      This phase II trial is studying how well combination chemotherapy with or without radiation
      therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in
      chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride,
      vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the
      growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving
      more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy
      uses high-energy x-rays to kill cancer cells for those patients that still had residual
      cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may
      kill more cancer cells and allow doctors to save the part of the body where the cancer
      started.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, previously untreated Hodgkin lymphoma.

          -  Age: Participants must be 21 years of age or younger

          -  Stage must be classified as one of the following:

        Ann Arbor stage IA or IIA with:

          -  Non-bulky mediastinal disease (< 33% mediastinal to thoracic ratio on CXR)

          -  < 3 nodal regions involved on the same side of the diaphragm

          -  No "E" lesion

          -  Female patients who are post-menarchal must have a negative pregnancy test. Patients
             of reproductive potential must agree to use an effective contraceptive method.

          -  Signed informed consent

          -  If re-evaluation of a patient's disease shows intermediate risk features, the patient
             will be removed from the HOD08.

        Exclusion Criteria:

          -  Intermediate or High risk disease, defined as Stage IB, any III or IV or IA/IIA with
             "E" lesion(s), 3 or more nodal sites involved, or bulky mediastinal adenopathy
A Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor in Paediatric Patients With Sickle Cell Disease
Condition: Investigation of Platelet Aggregation in Paediatric Patients With Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Ticagrelor Dose 1a + Dose 2a; Ticagrelor Dose 1b + Dose 2b
Intervention description: Ticagrelor Dose 1a and ticagrelor Dose 2a single doses + 1 week ticagrelor repeated dosing followed by 4 weeks repeated dosing ticagrelor or placebo.; Ticagrelor Dose 1b and ticagrelor Dose 2b single doses + 1 week ticagrelor repeted dosing followed by 4 weeks repeated dosing ticagrelor or placebo.
Intervention MeSH terms: Ticagrelor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: sickle cell anemia; paediatric

Summary:

      The purpose of this Phase II dose-ranging study is to investigate pharmacokinetic (PK) and
      pharmacodynamic (PD) properties of various doses of ticagrelor followed by 4 weeks of
      twice-daily treatment in paediatric patients with sickle cell disease
    

Eligibility criteria:

        Inclusion criteria

          -  Children aged ≥2 to <18 years of age

          -  Diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0)

        Exclusion criteria

          -  At risk for haemorrhagic or bradycardic events

          -  Significant hepatic impairment

          -  Renal failure requiring dialysis

          -  Concomitant oral or intravenous therapy with strong CYP3A4 (cytochrome) inhibitors,
             CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers.

          -  Surgical procedure planned to occur during the study.

          -  Patients who are currently pregnant or breastfeeding or planning to become pregnant
             during the study.

          -  Patients who have known hypersensitivity or contraindication to ticagrelor.
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: QGE031; Omalizumab; Placebo
Intervention MeSH terms: Omalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: QGE031; ligelizumab; omalizumab; chronic; spontaneous; urticaria; adults; CSU

Summary:

      This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and
      safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic
      Spontaneous Urticaria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic spontaneous urticaria for at least 6 months

          -  Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of
             randomization

        Exclusion Criteria:

          -  Clearly defined underlying etiology for chronic urticaria other than chronic
             spontaneous urticaria

          -  Evidence of parasitic infection

          -  Any other skin disease with chronic itching

          -  Previous treatment with omalizumab or QGE031

          -  Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or
             epinephrine

          -  History of anaphylaxis

          -  History or current diagnosis of ECG abnormalities indicating significant risk of
             safety for patients participating in the study

          -  History of hypersensitivity to any of the study drugs or its components of similar
             chemical classes

          -  Pregnant or nursing (lactating) women

        Other protocol defined inclusion/exclusion criteria may apply.
68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga-RM2 (RM2); PET/CT Scan
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 68Ga-RM2; PET/CT scan; Gastrin Releasing Peptide Receptor (GRPr); 14-146

Summary:

      The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can
      show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled
      DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study
      is being done because there are unmet medical needs to improve the current ways of detecting
      prostate cancers before surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Biopsy proven adenocarcinoma of the prostate

          -  Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN
             guidelines (2.2014) will be included

          -  Planned radical prostatectomy at MSKCC

          -  Multiparametric MRI of the pelvis (performed or planned) as routine care

        Exclusion Criteria:

          -  Patients meeting any of the following exclusion criteria will not be eligible for
             study entry:

          -  Hematologic

               -  Platelets <75K/mcL

               -  ANC <1.0 K/mcL

          -  Hepatic laboratory values

               -  Bilirubin >2.0 x ULN (institutional upper limits of normal)

               -  AST/ALT >2.5 x ULN

          -  Renal laboratory values

             o Creatinine > 2.0 x ULN

          -  Claustrophobia interfering with MRI and PET/CT imaging

          -  Prior pelvic radiation

          -  Prior androgen deprivation therapy

          -  Patients deemed not surgical candidates due to prohibitive co-morbidities
Oxytocin for Couples Conflict Resolution
Condition: Substance Misuse; Interpersonal Conflict; Neuroendocrine Reactivity
Intervention: Oxytocin; Placebo
Intervention description: Placebo for Oxytocin
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Oxytocin is a promising new medication found to have positive effects on prosocial behavior,
      reduce negative affect such as fear and anxiety, and reduce stress-induced addictive
      behaviors. This study aims to investigate the extent to which a 40 IU dose of intranasal
      oxytocin improves couples' conflict resolution skills and subjective, physiological, and
      neuroendocrine responses to conflict. Conflict resolution discussions will take place in the
      laboratory and will be videotaped.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-65 years of age

          2. both partners are willing to participate, and

          3. at least one partner has engaged in hazardous drinking (i.e. 4 or more drinks for
             women, 6 or more for men) or illicit drug use during the past 60 days

        Exclusion Criteria:

          1. pregnancy for women

          2. current psychotic or bipolar disorders

          3. active suicidal or homicidal ideation and intent

          4. subjects who would present a serious suicide risk, such as those with severe
             depression, or who are likely to require hospitalization during the course of the
             study

          5. severe, unilateral intimate partner violence in the past year

          6. BMI greater than 39.