bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide
Intervention description: Oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bone turnover; hormone-naïve; prostate specific antigen; Prostate Cancer

Summary:

      To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with
      prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed prostate cancer (all stages) for whom androgen deprivation
             therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)

          -  Asymptomatic from prostate cancer

          -  Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening

          -  PSA ≥ 2 ng/mL at screening

        Exclusion Criteria:

        Has previously or is currently receiving:

          -  Hormonal therapy with intent to treat prostate cancer

          -  Systemic glucocorticoids

          -  Chemotherapy with the intent to treat prostate cancer

          -  Opiate analgesics for pain from prostate cancer

          -  Radiation therapy for treatment of the primary tumor or metastases

          -  Has history of known or suspected brain or skull metastases or leptomeningeal disease

          -  Has history of seizure including febrile seizure or any condition that may predispose
             to seizure or history of loss of consciousness or transient ischemic attack

          -  Clinically significant cardiovascular disease
Xeloda (Capecitabine) and External Beam Radiation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Radiation Therapy; Capecitabine
Intervention description: 50-57 Gy per faction once or twice a day, 5 days a week, for about 5 -7 weeks, about 15-30 minutes each time.; During 5-7 weeks of radiation therapy, 825 mg/m2 (pills) by mouth, 2 times a day, about 12 hours apart, 30 minutes after eating food and about 2 hours before radiation therapy.
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Inflammatory Breast Cancer; Non-Inflammatory Breast Cancer; Capecitabine; Xeloda; Concomitant Radiation; Radiation Therapy; Radiotherapy; Women

Summary:

      The goal of this clinical research study is to find out if Xeloda® (capecitabine) and
      radiation therapy can help to control breast cancer that did not respond well to
      chemotherapy.

      The safety of this study treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological confirmation of invasive breast cancer

          2. No contraindications to receiving a course of radiation treatment (pregnancy, prior
             radiation to the volume with disease, or systemic disease in which radiation therapy
             is an absolute contraindication)

          3. Patients who have chemo-refractory gross disease in the breast causing symptoms (pain,
             drainage, duress) OR gross disease in the breast (greater than or equal to T3) and/or
             lymph node(s) progressive, persistent, or minimally responsive to chemotherapy deemed
             inoperable or questionable inoperable OR Recurrent gross disease in a previously
             unirradiated breast or on the chest wall or in the regional lymphatics (core biopsy
             will not be offered to patients without gross disease in the breast).

          4. Are able to swallow and retain oral medication (intact pill)

          5. Age over 18

          6. Female gender

        Exclusion Criteria:

          1. Have an active or uncontrolled infection

          2. Have dementia, altered mental status, or any psychiatric condition that would prohibit
             the understanding or rendering of informed consent

          3. Have used an investigational drug within 21 days preceding the first dose of study
             medication

          4. Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)

          5. Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or
             physical exam

          6. Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.
A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo; NVA237
Intervention description: Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.; NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Bronchodilator

Summary:

      This study was intended to assess how well inhaled NVA237 opens up the airways of patients
      with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged greater than 40 years with COPD Current or ex-smokers

        Exclusion Criteria:

          -  Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other
             protocol-defined inclusion/exclusion criteria may apply
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Risankizumab; Placebo for risankizumab
Intervention description: Risankizumab is administered as a SC injection in pre-filled syringe (PFS); Placebo for risankizumab is administered as a SC injection in PFS
Intervention MeSH terms: 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: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hidradenitis Suppurativa; Risankizumab; Placebo

Summary:

      The primary objective of this study is to assess the safety and efficacy of risankizumab 180
      mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe
      hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before
      the Baseline visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant with moderate to severe HS for at least 1 year prior to baseline visit.

          -  HS lesions present in at least two distinct anatomical areas.

          -  Draining fistula count of ≤ 20 at Baseline visit.

          -  Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.

          -  Participants are required to use a daily antiseptic wash on their HS lesions.

          -  Participant must have a history of inadequate response or intolerance to an adequate
             trial of oral antibiotics for treatment of HS.

        Exclusion Criteria:

          -  Participant has a history of active skin disease other than HS that could interfere
             with the assessment of HS.

          -  Participant has active tuberculosis (TB) or concurrent treatment for latent TB or
             evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human
             immunodeficiency virus (HIV) infection.

          -  Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3
             months or 5 half-lives, whichever is longer, prior to baseline.

          -  Participant has received prescription topical therapies (including topical
             antibiotics) within 14 days prior to the Baseline visit.

          -  Participant has received systemic non-biologic therapies that can also be used to
             treat HS within 4 weeks prior to the Baseline visit.

          -  Participant has received any systemic (including oral) antibiotic treatment within 4
             weeks prior to the Baseline visit.
Safety and Tolerability Study of Drug to Treat Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone 20 mg; Lurasidone 40 mg; Lurasidone 80mg
Intervention description: Lurasidone 20mg oral tablet taken once daily for 6-months; Lurasidone 40mg oral tablets taken once daily; Lurasidone 80mg oral tablet taken once daily
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Latuda; Lurasidone

Summary:

      The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with
      schizophrenia.
    

Eligibility criteria:

        Inclusion criteria:

          -  Successful completion of participation in protocol #D1050049

        Exclusion criteria:

          -  Substance abuse

          -  Prolactin level of ≥200ng/mL at baseline

          -  Pregnancy
Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Erlotinib hydrochloride; Sirolimus
Intervention description: Patients will receive single-agent Tarceva, 150 mg/day; Patients will receive a loading dose of 6 mg of Rapamune seven days after beginning treatment with Tarceva™ followed by a dose of 2mg/day.
Intervention MeSH terms: Sirolimus; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carcinoma, Renal Cell; Receptor, Epidermal Growth Factor; mTOR protein; Sirolimus; Erlotinib

Summary:

      The purpose of this study is to test the safety and efficacy of the combination of erlotinib
      hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with
      metastatic kidney cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent to participate in this study.

          -  Histological diagnosis of renal cell carcinoma.

          -  Age greater or equal 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) Performance status of 2 or better.

          -  Life expectancy of at least 3 months.

          -  Failure or intolerance to previous treatment with Sutent® and/or Nexavar®.

          -  Most recent systemic treatment at least 1 month from the beginning of treatment.

          -  Most recent local treatment (surgery or irradiation) > 2 weeks from the beginning of
             treatment.

          -  At least one site of measurable disease by CT scan or MRI (RECIST criteria).

          -  Baseline hemoglobin >9 g/dl, platelets > 100,000/mm3, absolute neutrophil count (ANC
             >1500/mm3.

        Exclusion Criteria:

          -  Previous treatment with Tarceva™, Iressa™, Rapamune™, temsirolimus or everolimus.

          -  Untreated metastasis to the central nervous system.

          -  Previous solid organ, bone marrow or stem-cell transplant.

          -  Known AIDS or HIV infection.

          -  Symptomatic or poorly controlled chronic heart failure.

          -  Chronic renal failure requiring dialysis on a regular basis.

          -  Chronic liver failure.

          -  Serum aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), alkaline
             phosphatase or bilirubin >1.5 x the upper limit of normal for the local laboratory.

          -  Pregnant or breast-feeding women.

          -  Other invasive malignant diseases within 5 years (other than squamous or basal cell
             carcinoma of the skin).

          -  Inability to provide informed consent

          -  Any other serious and/or unstable medical, psychiatric, or other condition considered
             by the P.I. to preclude safe or reasonably compliant participation in the protocol.
Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: GW685698X
Intervention description: Inhaled Corticosteroid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 190.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare once and twice daily GW685698 in asthma
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of Asthma

          -  Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes
             following 2 to 4 puffs of albuterol

          -  FEV1 between 40-85% predicted

          -  Currently on short acting beta2 agonist therapy

        Key Exclusion Criteria:

          -  History of life threatening asthma

          -  Respiratory Infection or oropharyngeal candidiasis

          -  Asthma exacerbation

          -  Uncontrolled disease or clinical abnormality

          -  Allergies

          -  Taking another Investigational medications or other prohibited medications
Mesenchymal Stemcells for Radiation Induced Xerostomia
Condition: Xerostomia
MeSH terms: Xerostomia
Intervention: Mesenchymal stem cell; Isotonic NaCl
Intervention description: Stemcells injected into submandibularis
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
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The current study aims to assess the safety and feasibility of the injection of autologous
      adipost tissue derived MSCs on radiation-induced salivary gland hypofunction and xerostomia
      in head and neck cancer participants. The project can potentially help to develop a
      clinically relevant treatment option for the growing number of patients suffering from
      xerostomia after radiotherapy. The development of new therapies is especially important,
      since only sub-optimal symptomatic treatments are currently available and the symptom of
      xerostomia greatly reduces the quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

        Previous radiotherapy for HPV-positive oropharyngeal head and neck cancer with bilateral
        irradiation of the neck.

          -  2 years follow-up without recurrence

          -  Clinically reduced salivation and hyposalivation, evaluated by a screening

          -  Unstimulated salivary flow rate between less than 0.2ml/min and above 0.05ml/min

          -  Only participants with previous T1-T2 and N0, N1 or N2a.

          -  Informed consent

          -  Grade 1-3 xerostomia as evaluated by the UKU side effect rating scale

        Exclusion Criteria:

          -  Any cancer in the previous 2 years

          -  Xerogenic medications

          -  Any other diseases of the salivary glands, e.g. Sjögrens syndrome, sialolithiasis,
             etc.

          -  Pregnancy or planned pregnancy within the next 2 years

          -  Breastfeeding

          -  Any other disease/condition judged by the investigator to be grounds for exclusion

          -  Treatment with anticoagulant that cannot be stopped during the intervention period.
Pre to Postoperative Smoking Cessation
Condition: Cigarette Smoking; Obesity
Intervention: Varenicline; Contingency Management; Behavioral Counseling
Intervention description: Varenicline will be administered as clinically indicated and will begin approximately 4-6 weeks prior to surgery. All participants will receive a 1-week dose induction period before transitioning to a full maintenance dose.; Contingency Management payments will begin on the target quit date (week 2) and will be in place for 5 weeks or until surgery (whichever is sooner). Participants will receive monetary incentives for biochemical evidence of smoking abstinence.; All participants will complete a 3-session behavioral counseling intervention with a trained member of our study staff during 3 of the pre-surgical study visits. This brief counseling intervention provides participants with information about the experience of quitting smoking, including a benefits/disadvantage analysis, functional analysis of craving/risk periods, and skills-building exercises to prevent lapse and relapse.
Intervention MeSH terms: Varenicline
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
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The study will evaluate the feasibility of integrating an intensive pre- post-surgical
      smoking cessation intervention into a hospital setting, and assess measures of postsurgical
      recovery as a function of smoking cessation status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoker who has surgery scheduled 5-10 weeks in advance

        Exclusion Criteria:

          -  being contraindicated for varenicline use

          -  evidence of psychiatric instability

          -  being unwilling/unable to adhere to the study schedule

          -  be unwilling to provide study access to medical records

          -  being otherwise judged by the study team to be inappropriate for study participation
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: RO7234292 (RG6042)
Intervention description: Intrathecal injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No

Summary:

      This study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of
      RO7234292 administered intrathecally to adult patients with Huntington's Disease.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have completed dosing in ISIS 443139-CS1

        Key Exclusion Criteria:

          -  Any new condition or worsening of existing condition that could make the patient
             unsuitable for participation or interfere with the patient participating in and/or
             completing the study
Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Capmatinib; Spartalizumab; Docetaxel
Intervention description: Capmatinib 400 mg (tablets) orally taken twice daily; Spartalizumab 400 mg via intravenous infusion once every 28 days; Docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days
Intervention MeSH terms: Docetaxel; Spartalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Run-in part was single group. Randomized part (parallel design) was not opened.
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small-cell lung carcinoma; Non-small-cell lung cancer; NSCLC; epidermal growth factor receptor wild type; EGFRwt; Anaplastic lymphoma kinase negative; ALK-; INC280; capmatinib and spartalizumab; combination therapy; docetaxel

Summary:

      The purpose of this trial was to evaluate the safety and efficacy of capmatinib in
      combination with spartalizumab in adult participants with epidermal growth factor receptor
      (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic
      lymphoma kinase (ALK) rearrangement negative in locally advanced (stage IIIB, not eligible
      for definitive chemo-radiation) or metastatic (stage IV) Non-small cell lung cancer (NSCLC)
      after failure of platinum doublet and checkpoint inhibitor treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed locally advanced/metastatic (stage IIIB/IV), EGFR wild-type,
             ALK rearrangement negative, non-small cell lung cancer

          -  Subject had demonstrated progression following one prior platinum doublet and one
             prior PD-(L)1 checkpoint inhibitor (either alone or in combination, the most recent
             treatment regimen must have contained a PD-(L)1 checkpoint inhibitor)

          -  Subjects must be candidates for single agent docetaxel

          -  Subjects must have at least one lesion evaluable by RECIST 1.1

        Exclusion Criteria:

          -  Prior treatment with a MET inhibitor or HGF (Hepatocyte growth factor) targeting
             therapy

          -  Any untreated central nervous system (CNS) lesion

          -  Use of any live vaccines against infectious diseases within 12 weeks of initiation of
             study treatment.

        Other protocol-defined inclusion/exclusion criteria might apply.