bioihbjkbjnl/mcl2 huggingface dataset:
AD109 Dose Finding in Mild to Moderate OSA
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: AD109 dose1- A; AD109 dose2- B; Placebo- C
Intervention description: Oral administration at bedtime; Oral administration at bedtime; Oral administration at bedtime
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to
      examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild
      obstructive sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  AHI between 5 and 20 events/h

          -  PGI-S equal to or higher than 1, or one or more of the following symptoms:

               -  Snoring or nightime gasping/choking

               -  Daytime sleepiness, fatigue or decreased concentration

               -  Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning
                  headache

               -  Irritability, decreased mood or libido

        Exclusion Criteria:

          -  History of narcolepsy.

          -  Clinically significant craniofacial malformation.

          -  Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery
             disease or heart failure or hypertension requiring more than 2 medications for
             control).

          -  CPAP should not be used for at least 2 weeks prior to the study

          -  History of using oral or nasal devices for the treatment of OSA may enroll as long as
             the devices are not used during participation in the study.
Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer
Condition: Locally Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: SABR Boost Therapy
Intervention description: Initial Pelvic (+/- Para-aortic) fractionated external beam Radiation with 45 Gy to combined PTV with a boost to 55Gy for PET positive/CT enlarged nodes;
Image Guided Hypofractionated Radiation Treatment boost to Cervix High risk CTV/PTV 28GY/4 fx.
Patients will receive 4 fractions of 7 Gy each via stereotactic body radiation as boost therapy to a volume that encompasses the cervical tumor. A minimum of 40 hours should separate each treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether SABR boost therapy is effective in women
      with locally advanced cervical cancer without increased risk of acute gastrointestinal (GI)
      or genitourinary (GU) toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

        1 Locally Advanced stage Cervical Cancer 2. Zubrod performance status 0-2 3. Negative urine
        or serum pregnancy test for women of child-bearing potential 4. Agree to use adequate
        contraception (hormonal or barrier method of birth control; abstinence) prior to study
        entry and for the duration of study treatment 5. Not a candidate for intracavitary
        brachytherapy

        Exclusion Criteria:

          1. Pregnancy

          2. Concurrent untreated cancer excluding non-Melanoma skin cancer

          3. Previous pelvic radiation

          4. Active Inflammatory Bowel disease, Collagen vascular disease - systemic lupus
             erythematosus (SLE), scleroderma

          5. Age <18

          6. Unable to consent for study

          7. Severely immunocompromised patients ( such as Transplant , on immunosuppressive drugs)
Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)
Condition: Hodgkin Disease
MeSH terms: Hodgkin Disease
Intervention: Nivolumab; Doxorubicin; Vinblastine; Dacarbazine
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Doxorubicin; Nivolumab; Dacarbazine; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 294.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously
      treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Must have received prior high-dose conditioning chemotherapy followed by autologous
             stem cell transplant (ASCT) as a part of salvage therapy for cHL (cohort A, B & C -
             enrollment closed)

          -  Participants may be Brentuximab vedotin- naïve, or may have had prior Brentuximab
             vedotin treatment (cohort A, B & C - enrollment closed)

          -  Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D)

        Exclusion Criteria:

          -  Known central nervous system lymphoma

          -  Participants with nodular lymphocyte-predominant Hodgkin Lymphoma

          -  Prior allogeneic stem cell transplantation (SCT)

          -  Chest radiation ≤ 24 weeks prior to first dose

          -  Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen
High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: BeEAM
Intervention description: BeEAM
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Multiple myeloma; hematopoietic stem cell transplant

Summary:

      High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the
      up-front treatment of patients with multiple myeloma has been associated with improved
      disease-free and overall survival in multiple large randomized controlled trials. Following
      3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose
      Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70
      years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care
      preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing
      Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results
      to single-agent Melphalan with higher toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 - 70 years

          -  Karnofsky status ≥ 70%

          -  Diagnosis of Multiple Myeloma

          -  Within 9 months of the start of induction chemotherapy and no evidence of relapse or
             progression.

          -  Availability of Cryopreserved peripheral blood stem cells with a CD34 dose of at least
             2x106/kg.

        Exclusion Criteria:

          -  Poor cardiac function: left ventricular ejection fraction <40%

          -  Poor pulmonary function: FEV1, FVC, or DLCO <40% predicted

          -  Poor liver function: bilirubin >2.5 mg/dl (not due to hemolysis, Gilbert's or primary
             malignancy), AST/ALT > 3X ULN

          -  Poor renal function: Creatinine >2.0 mg/dl or creatinine clearance < 40 mL/min
             (calculated creatinine clearance is permitted)

          -  Ongoing or active systemic infection, active hepatitis B or C virus infection, or
             known human immunodeficiency virus (HIV) positive.

          -  Women of childbearing potential who currently are pregnant or who are not practicing
             adequate contraception

          -  Patients who have any debilitating medical or psychiatric illness which would preclude
             their giving informed consent or their receiving optimal treatment and follow-up.
Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Condition: Submental Fat; Healthy
Intervention: Placebo; ATX-101 (1 mg/cm^2); ATX-101 (2 mg/cm^2); ATX-101 (4 mg/cm^2)
Intervention description: Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This was a long-term follow-up study of participants who completed Kythera-sponsored trials
      of ATX-101 (06-03, 07-07, 09-15)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any subject who successfully completed a Kythera-sponsored clinical trial of ATX-101
             (06-03, 07-07, 09-15)

          -  Signed informed consent

          -  Willingness to comply with schedule and procedures of the study

        Exclusion Criteria:

          -  Subjects who have had or are undergoing treatment that may affect the evaluation of
             the submental area will be excluded
A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
Condition: Chronic Kidney Disease; Type 2 Diabetes Mellitus
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: AZD1722; Placebo
Intervention description: Placebo for AZD1722
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: albuminuria

Summary:

      The purpose of this study is to determine if the study drug is safe, tolerable and active in
      reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 to 80 years, inclusive.

          -  Body mass index between 18 and 45 kg/m2, inclusive.

          -  Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3
             months prior to randomization

          -  Stage 3 CKD

          -  MSSBP ≥130 mmHg

          -  Urinary albumin: mean UACR ≥ 200 mg/g

        Exclusion Criteria:

          -  Urinary albumin: UACR > 3500 mg/g

          -  History of a renal transplant

          -  MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in
             periods

          -  History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome
Donepezil HCl & Cognitive Deficits in Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder; Cognition Disorders; Cognitive Dysfunction
Intervention: Donepezil HCl; Placebo
Intervention description: Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.; Placebo used in placed of Donepezil HCL
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This 11-week study will examine the safety and effectiveness of the medication donepezil
      (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents
      with Autism Spectrum Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Autism Spectrum Disorder (ASD)

          -  Asperger's Disorder

          -  IQ of 75 or above

          -  Baseline assessment tests within the acceptable range

        Exclusion Criteria:

          -  Bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder

          -  Seizure disorder requiring the use of anticonvulsant medications

          -  Congenital rubella, cytomegalovirus, or tuberous sclerosis

          -  Certain medications prescribed for management of behavior (please contact the
             investigator for a complete list)

          -  Medications/preparations that are known to interact with donepezil HCl

          -  Significant medical illness, endocrinopathies, cardiovascular disease, or severe
             chronic malnutrition

          -  Pregnancy or sexually active females not using a reliable method of contraception
An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Ipilimumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 232.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore the possible links between participant
      characteristics and their cancer, with how effective the combination of nivolumab with
      ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no
             prior systemic anticancer therapy given as primary therapy for advanced or metastatic
             disease

          -  Measurable disease by CT or MRI

          -  Must have full activity or, if limited, must be able to walk and carry out light
             activities such as light house work or office work

        Exclusion Criteria:

          -  Participants with untreated central nervous system metastases

          -  Participants with active, known or suspected autoimmune disease

          -  Prior treatment with any drug that targets T cell co-stimulations pathways (such as
             checkpoint inhibitors)

        Other protocol defined inclusion/exclusion criteria apply
Study of BIIB092 in Participants With Progressive Supranuclear Palsy
Condition: Supranuclear Palsy, Progressive
MeSH terms: Supranuclear Palsy, Progressive
Intervention: BIIB092; Placebo
Intervention description: BIIB092 intravenous infusion on specified days; Placebo intravenous infusion on specified days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 490.0
Sex: All
Minimum age: 41 Years
Maximum age: 86 Years
Healthy volunteers: No

Summary:

      The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to
      placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and
      to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the
      frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory
      abnormalities.

      The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to
      placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored
      revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to
      evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global
      Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to
      placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of
      Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on
      quality of life, relative to placebo, as measured by change from baseline on the Progressive
      Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants with probable or possible PSP

          -  Able to ambulate independently or with assistance

          -  Able to tolerate MRI

          -  Have reliable caregiver to accompany participant to all study visits

          -  Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at screening

          -  Participant must reside outside a skilled nursing facility or dementia care facility
             at the time of screening and admission to such a facility must not be planned

        Key Exclusion Criteria:

          -  Presence of other significant neurological or psychiatric disorders

          -  Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neuron disease

          -  History of early, prominent rapid eye movement (REM) sleep behavior disorder

          -  History of or screening brain MRI scan indicative of significant abnormality

          -  Known history of serum or plasma progranulin level less than one standard deviation
             below the normal patient mean for the laboratory performing the assay

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: bevacizumab; Erlotinib
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      This study will evaluate the combination of bevacizumab and erlotinib in elderly patients
      with advanced non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or
             recurrent after primary surgery or radiotherapy.

          -  ECOG PS 0-1

          -  70 years of age or older

          -  Must have measurable disease

          -  ANC > 1500, platelets > 100,000

          -  Total bilirubin </= 1.5, SGOT * SGPT < 5 x ULN

          -  Able and willing to swallow and absorb oral medication

          -  Able and willing to sign consent

          -  Request archival diagnostic tissue for EGFR expression but not required

        Exclusion Criteria:

          -  Proteinuria as demonstrated by UPC ratio >/= 1.0

          -  Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or
             anti-angiogenesis agent (includes thalidomide)

          -  Prior treatment for advanced stage disease, with the exception of surgery or radiation
             (no systemic)

          -  History of gross hemoptysis within 1 month of enrollment unless treated with surgery
             or radiation

          -  Evidence of bleeding diathesis or coagulopathy or other serious/acute internal
             bleeding within 6 months of enrollment.

          -  Current, ongoing treatment with full dose warfarin or equivalent

          -  Current(within 10 days)use of aspirin (> 325mg/day) or other NSAID with antiplatelet
             activity

          -  History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6
             months. Clinically significant PVD

          -  Known CNS disease except for treated brain mets.

          -  Squamous cell histology

          -  Blood pressure > 150/100 that cannot be ameliorated with standard anti-hypertensives

          -  History of hypertensive crisis or hypertensive encephalopathy

          -  NYHA grade II or > CHF

          -  History of MI within 6 months of enrollment

          -  Major surgery, open biopsy, significant trauma within 28 days of enrollment

          -  Pregnancy, lactation

          -  Abdominal or other fistula, abcess, perforation