bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment
Condition: Mild Cognitive Impairment; Mild Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: AZD5213; AZD5213; AZD5213; Placebo
Intervention description: AZD5213 doseA daily; AZD5213 doseB daily; AZD5213 doseC daily; Placebo tablet daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 164.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Mild Cognitive Impairment; Mild Alzheimer's disease; Safety; Tolerability

Summary:

      This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease
      or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is
      to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient and study partner to sign informed consent before initiation of any
             study-related procedures.

          -  Clinical diagnosis of Alzheimers (AD) or mild cognitive impairment (MCI) disease.

          -  Single caregiver for at least 6 months prior to Screening, capable of accompanying the
             patient on clinic visits as needed. The caregiver must either be living with or
             visiting the patient at least 10 hours per week, split over multiple (at least 2)
             days, for the duration of the study.

          -  Single study partner, for at least several months prior to Screening, capable of
             accompanying the patient on clinic visits as needed. The study partner must either be
             living with or visiting the patient at least 3 days per week for the duration of the
             study.

          -  A body mass index (BMI=weight/height2) of 18 kg/m2 to 32 kg/m2.

        Exclusion Criteria:

          -  Significant neurological disease or dementia other than AD or MCI.

          -  Current episode or symptoms of major depressive disorder or other major psychiatric
             disorder.

          -  History of self-reported sleep duration of less than 4 hours per night or less than 4
             hours average total sleep time per night during Baseline PSG assessment.

          -  History or present symptoms of a sleeping disorder such as sleep apnea.

          -  History of cancer in the last 5 years.

          -  Use of anti-AD drugs (including off-label drugs and herbal medications) with the
             exception of donepezil, memantine, and/or rivastigmine transdermal system, as
             monotherapy or in combination in the following conditions: treatment with donepezil (5
             mg to 10 mg daily), memantine, and/or rivastigmine transdermal system or combination
             regimens for at least 3 months and a stable dose(s) for the last 2 months prior to
             randomization is allowed.
A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome
Condition: Antiphospholipid Syndrome
MeSH terms: Antiphospholipid Syndrome; Syndrome
Intervention: Rituximab
Intervention description: Rituximab 1000mg IV on Days 0 and 15
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: antiphospholipid syndrome

Summary:

      RITuximab AntiphosPholipid Syndrome (RITAPS) Study is designed to evaluate whether a
      medication called rituximab would reduce the signs and symptoms of antiphospholipid antibody
      (aPL) -related certain clinical problems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Positive aPL profile defined as:

               -  Positive lupus anticoagulant test as defined by the International Society on
                  Thrombosis and Haemostasis, on two or more occasions, at least 12 weeks apart
                  and/or

               -  Positive anticardiolipin antibody (aCL) immunoglobulin G(Ig)G/M/A isotype,
                  present in > 40U, on two or more occasions, at least 12 weeks apart and/or

               -  Positive anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A isotype, present in > 40U, on
                  two or more occasions, at least 12 weeks apart

        AND

        - Clinical features attributable to aPL that are resistant to warfarin and/or heparin:

          -  Persistent thrombocytopenia and/or

          -  Persistent autoimmune hemolytic anemia and/or

          -  Cardiac valve disease and/or

          -  Chronic skin ulcers and/or

          -  Renal thrombotic microangiopathy and/or

          -  Cognitive dysfunction with/without white matter changes

        Exclusion Criteria (selected):

          -  > 4/11 American College of Rheumatology Classification Criteria for SLE

          -  Acute thrombosis

          -  History of stroke (only for patients with cognitive dysfunction)

          -  Positive Hepatitis B or C serology

          -  History of positive HIV

          -  Acute or chronic pancreatitis

          -  Treatment with any investigational agent within 4 weeks of screening

          -  Receipt of a live vaccine within 4 weeks prior to randomization

          -  Previous Treatment with Rituximab (MabThera® / Rituxan®)

          -  Previous treatment with Natalizumab (Tysabri®)

          -  Known active bacterial, viral fungal mycobacterial, or other infection

          -  Pregnancy

          -  Concomitant malignancies or previous malignancies, with the exception of adequately
             treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the
             cervix

          -  History of psychiatric disorder that would interfere with normal participation in this
             protocol

          -  Significant cardiac or pulmonary disease
A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan
Condition: Colorectal Cancer Metastatic
MeSH terms: Colorectal Neoplasms
Intervention: Aflibercept; Levofolinate; Irinotecan; 5-FU
Intervention description: Pharmaceutical form: Concentrated solution (100 mg/4 mL [25 mg/mL], 200 mg/8 mL [25 mg/mL]) for infusion; Route of administration: Intravenous; Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous; Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous; Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous
Intervention MeSH terms: Leucovorin; Irinotecan; Aflibercept; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To assess efficacy aflibercept + 5-fluorouracil (5-FU)/levofolinate/irinotecan (FOLFIRI) by
      objective response rate (ORR).

      Secondary Objective:

      To assess the following:

        -  safety profile;

        -  progression free survival (PFS);

        -  overall survival (OS);

        -  pharmacokinetics (PK);

        -  immunogenicity.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically or cytologically proven adenocarcinoma of the colon or rectum.

          -  Metastatic disease that was not amenable to potentially curative treatment.

          -  Participants with measurable disease.

          -  One prior chemotherapeutic regimen (containing oxaliplatin) for metastatic disease.

          -  Participants who relapsed within 6 months of completion of oxaliplatin-based adjuvant
             chemotherapy were also eligible.

        Exclusion criteria:

          -  Prior therapy with irinotecan.

          -  Less than 28 days elapsed from prior radiotherapy, prior surgery, or prior
             chemotherapy to the time of registration.

          -  Unresolved toxicity (grade >1) from prior anticancer therapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status >1.

          -  Brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis.

          -  Other prior malignancy.

          -  Pregnant or breast-feeding women.

          -  Uncontrolled hypertension.

          -  Inadequate bone marrow function, liver function, or renal function.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: CSJ117; Placebo
Intervention description: CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
CSJ117 = inhaled monoclonal antibody fragment; Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.
Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 335.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CSJ117; uncontrolled asthma

Summary:

      The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses
      (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to
      standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect
      to change from baseline in FEV1 at the end of 12 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed asthma

          -  Male and female patients aged ≥18 and ≤75 years

          -  Patients who have been treated with medium or high dose ICS plus LABA with up to 2
             additional controllers

          -  Morning pre-BD FEV1 value of ≥ 40% and ≤ 85% of the predicted normal

          -  A positive reversibility test

          -  ACQ-5 score of ≥ 1.5 at screening and end of run-in visits.

        Exclusion Criteria:

          -  Patients who have a cigarette smoking history of greater than 10 pack years or current
             smokers

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using specified methods of contraception during
             dosing of study drug and until 12 weeks after last study drug treatment

          -  Patients with a history of immunodeficiency disease or hepatitis B, untreated and not
             cured hepatitis C or HIV.
A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation
Condition: Neoplasms
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary
Intervention: Vemurafenib
Intervention description: Vemurafenib 960 mg orally twice daily.
Intervention MeSH terms: Vemurafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib
      (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC)
      positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants
      will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or
      unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants. >/= 18 years of age

          -  Histologically confirmed metastatic or unresectable papillary thyroid cancer for which
             standard curative or palliative measures do not exist or are no longer effective;
             participants whose tumors exhibit areas of "other histology" may be enrolled, provided
             the tumor histology remains predominantly papillary

          -  Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test)

          -  Radioactive Iodine resistant disease

          -  Prior therapy excluding (Cohort 1, TKI Naive) or including (Cohort 2, TKI Experienced)
             TKI

          -  Clinically relevant disease progression according to RECIST criteria within the prior
             14 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Adequate hematological, renal and liver function

        Exclusion Criteria:

          -  Histological diagnosis other than papillary PTC, including squamous cell variants of
             PTC or PTC with areas of squamous metaplasia

          -  Active or untreated central nervous system metastases

          -  History of or known carcinomatous meningitis

          -  Anticipated or ongoing administration of any anti-cancer therapies other than those
             administered in the study

          -  Active squamous cell skin cancer that has not been excised or adequately healed post
             excision

          -  Previous treatment with any agent that specifically and selectively targets the MEK or
             BRAF pathway

          -  Prior radiotherapy to the only measurable lesion

          -  Clinically relevant cardio-vascular disease or event within the prior 6 months
Study of Debio 1450 for Bacterial Skin Infections
Condition: Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Intervention: Debio 1450 IV; Debio 1450 Oral; Linezolid; Debio 1450 Oral Placebo; Linezolid Placebo; Vancomycin IV
Intervention description: Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).; Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).; Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.; Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.; Linezolid placebo will be supplied as film-coated compressed tablets.; Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.
Intervention MeSH terms: Vancomycin; Linezolid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of 2 different doses of
      intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in
      the treatment of patients with staphylococcal ABSSSI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has clinically documented infection of the skin or skin structure suspected or
             documented to be caused by a staphylococcal pathogen

          -  Meets other protocol-specified criteria for qualification and contraception

          -  Is willing and able to remain confined in the study unit for the entire duration of
             each treatment period and comply with restrictions related to food, drink and
             medications

          -  Voluntarily consents to participate and provides written informed consent prior to any
             protocol-specific procedures

        Exclusion Criteria:

          -  Has history or current use of over-the-counter medications, dietary supplements, or
             drugs (including nicotine and alcohol) outside protocol-specified parameters

          -  Has signs, symptoms or history of any condition that, per protocol or in the opinion
             of the investigator, might compromise:

               1. the safety or well-being of the participant or study staff;

               2. the safety or well-being of the participant's offspring (such as through
                  pregnancy or breast-feeding);

               3. the analysis of results
A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
Condition: Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Leucovorin; Fluorouracil - bolus; Bevacizumab; Fluorouracil - infusion; ABT-165; Irinotecan
Intervention description: Intravenous; Intravenous; Intravenous; Intravenous; Intravenous; Intravenous
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; colorectal cancer; ABT-165; FOLFIRI; Bevacizumab; bowel cancer; metastatic colorectal cancer; metastatic colorectal

Summary:

      A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to
      bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of
      the colon or rectum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of
             the colon or rectum.

               -  Primary tumor has been resected > 3 months prior to randomization.

          -  At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance
             imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid
             Tumors (RECIST), Version 1.1.

          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.

          -  Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen
             in the metastatic setting.

          -  Adequate hematologic, renal and hepatic function.

        Exclusion Criteria:

          -  Any prior therapy with irinotecan

          -  Unresolved clinically significant toxicities from prior anticancer therapy, defined as
             any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2

          -  Clinically significant conditions that increase the risk for antiangiogenic therapy.

          -  History of any of the following during first-line therapy with a
             bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel
             perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.
A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia; Disease Progression
Intervention: LY3202626; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 316.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: BACE inhibitor

Summary:

      The main purpose of this study is to evaluate the safety and the effect on brain tau of the
      study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with mild AD dementia based on the National Institute on Aging (NIA) and the
             Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified
             clinician approved by the Sponsor or designee.

          -  Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.

          -  Has a florbetapir PET scan consistent with the presence of amyloid pathology at
             screening.

        Exclusion Criteria:

          -  Significant neurological disease affecting the central nervous system (CNS), other
             than AD, that may affect cognition or ability to complete the study, including but not
             limited to, other dementias, serious infection of the brain, Parkinson's disease,
             multiple concussions, or epilepsy or recurrent seizures (except febrile childhood
             seizures).

          -  Ocular pathology that significantly limits ability to reliably evaluate vision or the
             retina.

          -  Use of strong inducers of cytochrome P450 3A (CYP3A).

          -  Sensitivity to florbetapir or ¹⁸F-AV-1451.

          -  Contraindication to MRI or PET or poor venous access for blood draws.