bioihbjkbjnl/mcl2 huggingface dataset:
Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: CS-1008 (humanized anti-DR5 antibody); gemcitabine
Intervention description: CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.; Gemcitabine - 1000mg/meter sq
Intervention MeSH terms: Gemcitabine; Antibodies
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
Healthy volunteers: No
Keywords: Pancreatic cancer; chemotherapy naive; unresectable or metastatic pancreatic cancer; CS1008; Gemcitabine; Gemzar

Summary:

      Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to
      subjects with previously untreated and unresectable (unable to be surgically removed) or
      metastatic (spread to other areas beyond the pancreas) pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed resectable or metastatic pancreatic cancer;
             not previously treated with chemotherapy; measurable disease; 18 years of age or older

        Exclusion Criteria:

          -  Anticipation of need for major surgery or radiation therapy during the study

          -  Heart Disease exclusions: myocardial infarction or unstable angina within the past 6
             months; severe or unstable angina pectoris within the past 6 months; coronary or
             peripheral artery bypass graft within the past 6 mo., etc.

          -  Clinically significant active infection or history of HIV

          -  Partial or complete bowel obstruction

          -  Poorly controlled psychiatric illness
A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)
Condition: Progressive Supranuclear Palsy
MeSH terms: Supranuclear Palsy, Progressive
Intervention: Placebo; ABBV-8E12
Intervention description: Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.; Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data.
Intervention MeSH terms: Tilavonemab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 378.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: PSP; Steele-Richardson-Olszewski syndrome; Tauopathy

Summary:

      The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics
      of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female participant with age 40 years or greater at the time of signed consent

          -  Meets the criteria for possible or probable progressive supranuclear palsy (PSP;
             Steele-Richardson-Olszewski Syndrome)

          -  Presence of PSP symptoms for less than 5 years

          -  Participant is able to walk 5 steps with minimal assistance (stabilization of one arm
             or use of cane/walker)

          -  Participant has an identified, reliable, study partner (e.g., caregiver, family
             member, social worker, or friend)

        Key Exclusion Criteria:

          -  Participants who weigh less than 44 kg (97 lbs) at screening

          -  Mini-Mental State Examination (MMSE) score less than 15 at screening

          -  Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)

          -  Participant resides at a skilled nursing or dementia care facility, or admission to
             such a facility is planned during the study period

          -  Evidence of any clinically significant neurological disorder other than PSP

          -  The participant has a history of or currently has schizophrenia, schizoaffective
             disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental
             Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10)
             criteria

          -  Participant has had a significant illness or infection requiring medical intervention
             in the past 30 days
Vaccination Plus Ontak in Patients With Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: 4-peptide melanoma vaccine; Ontak
Intervention description: Experimental cancer vaccine given as a shot under the skin once every two weeks; A single dose of Ontak given as an intravenous infusion over 30 minutes, 4 days before the first vaccine is given.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic melanoma

Summary:

      The purpose of this study is to determine if an experimental melanoma vaccine can produce an
      immune response in patients with metastatic melanoma, and if combining this vaccine with the
      drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor
      shrinkage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Melanoma with evidence of metastatic disease

          -  Life expectancy of at least 12 weeks.

          -  Karnofsky performance status index of greater than or equal to 80%.

          -  Adequate hematopoietic, renal, and hepatic function, defined as:

          -  Patient must express HLA-A2

          -  Tumor biopsy: patient must agree to undergo biopsy of accessible tumor before and
             after therapy, when feasible, to study tumor cell properties and characteristics of
             immune cells.

          -  EKG without evidence of arrhythmia or changes that indicate acute ischemia.

          -  Pulse oximetry showing oxygen saturation of at least 90% on room air.

        Exclusion Criteria:

          -  Significant cardiovascular disease, or cardiac arrhythmia requiring medical
             intervention.

          -  Pregnant or nursing women.

          -  Biological therapy in the 4 weeks prior to the start of dosing.

          -  Patients with intrinsic immunosuppression, including seropositivity for HIV antibody.

          -  Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis
             C.

          -  Concurrent systemic corticosteroids (except physiologic replacement doses)or other
             immunosuppressive drugs (eg. cyclosporin A).

          -  Psychiatric illness that may make compliance to the clinical protocol unmanageable or
             may compromise the ability of the patient to give informed consent.

          -  Active or history of autoimmune disease

          -  Active gastrointestinal bleeding or uncontrolled peptic ulcer disease.

          -  Presence of untreated brain metastases.
A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy
Condition: Small Fiber Neuropathy
MeSH terms: Small Fiber Neuropathy
Intervention: VX-150; Placebo
Intervention description: Participants received VX-150 1250 milligrams (mg) once daily (qd) orally for 6 weeks.; Participants received placebo matched to VX-150 for 6 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter
      study evaluating the efficacy of VX-150 for the treatment of pain caused by small fiber
      neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg

          -  Diagnosis of small fiber neuropathy, as per European Federation Neurological Societies
             (EFNS)/American Academy of Neurology (AAN) guidelines, with pain for at least 3 months
             prior to screening

          -  Reduction below the 5th percentile of sex and age-adjusted normal values in epidermal
             nerve fiber density on punch skin biopsy at the distal site of the leg performed at
             screening

          -  Normal nerve conduction studies (NCS), including presence of sural response.

          -  Average NRS score between ≥4 and ≤9 reported in the daily diary on Days -7 through -1

        Exclusion Criteria:

          -  History in the past 10 years of malignancy except for squamous cell skin cancer, basal
             cell skin cancer, and Stage 0 cervical carcinoma in situ

          -  History of connective tissue disorders, sarcoidosis, Sjögren's syndrome, amyloidosis,
             Fabry's disease, celiac disease, lyme disease, autoimmune disorders

          -  A known or clinically suspected infection with human immunodeficiency virus or
             hepatitis B or C viruses

          -  Current clinically significant liver or kidney dysfunction

          -  Current uncontrolled thyroid dysfunction

          -  A diagnosis of diabetes, HbA1C ≥8% at screening

          -  History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)

          -  Concomitant severe pain conditions which may impair self-assessment of pain due to
             small fiber neuropathy

        Other protocol defined Inclusion/Exclusion criteria may apply.
A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251
Condition: Chronic Obstructive Pulmonary Disease, COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QBW251; Placebo
Intervention description: QBW251 capsule(s) taken orally twice per day; Matching placebo capsule(s) taken orally twice per day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: COPD,; chronic bronchitis,; inflammation,; airway,; LCI,; pulmonary function test,; lung function,; controlled clinical trial,; randomized,; airflow,; smoker

Summary:

      To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo
      administered orally, on airway function, lung volume, and quality of life in patients with
      chronic obstructive pulmonary disease (COPD)
    

Eligibility criteria:

        Inclusion Criteria: Must have a diagnosis of GOLD II-III chronic obstructive pulmonary
        disease (COPD); Must have clinical diagnosis of chronic bronchitis; Must be either a
        current smoker (smoked ≤ 1 pack per day on average for the last 3 months with at least a 10
        pack year smoking history) OR an ex-smoker with at least a 10 pack year smoking history;
        Exclusion Criteria: Must not be receiving chronic, daily, systemic steroids; Must not have
        severe emphysema (determined by HRCT); Must not have had a COPD exacerbation or respiratory
        tract infection requiring antibiotics or oral steroids or hospitalization within 6 weeks of
        screening; Must not be pregnant or nursing or a woman of child bearing potential; Other
        protocol-defined inclusion/exclusion criteria may apply
[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer
Condition: Adult Liver Carcinoma; Liver Cirrhosis
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis
Intervention: 18F-Fluoromisonidazole; Arterial Embolization; Computed Tomography; Positron Emission Tomography
Intervention description: Undergo [18F] FMISO PET/CT; Undergo transcatheter arterial embolization; Undergo [18F] FMISO PET/CT; Undergo [18F] FMISO PET/CT
Intervention MeSH terms: Misonidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This clinical trial studies how well 18F-fluoromisonidazole ([18F]FMISO) positron emission
      tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in
      imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks
      blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor.
      [18F]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that
      have a low level of oxygen, and the radiation given off by [18F]FMISO is picked up by a PET
      scan and this may help researchers learn whether changes occur in the tumors after treatment,
      which can help decide how well the treatment worked earlier than is currently possible
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Histopathologic or imaging and clinical features of tumor(s) diagnostic for
             hepatocellular carcinoma with at least one tumor >= 1.5 cm; imaging features
             diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and
             Data System (LIRADS) 4 or greater

          -  Total bilirubin < 3.0

          -  Child Pugh A or B

          -  Tumor amenable to transcatheter arterial embolization

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Uncontrolled large ascites

          -  Main or segmental portal vein thrombosis

          -  Locoregional treatment of hepatocellular carcinoma within the prior 3 months or
             chemotherapy within the previous 3 months

          -  Inability or contraindication to undergo transcatheter arterial embolization

          -  Inability to lay flat for at least 2 consecutive hours

          -  Severe acute illness

          -  Uncontrolled chronic illness such as hypertension, diabetes, or heart failure

          -  Contraindication to CT or MRI contrast

          -  Pregnancy
Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Sotagliflozin; Placebo
Intervention description: Sotagliflozin 400 mg, once daily before the first meal of the day; Placebo, once daily before the first meal of the day
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on
      Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes
      mellitus (T1DM) who have poor glycemic control on their current insulin regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had given written informed consent.

          -  Young adult participants >=18 to <=30 years old at Screening, with a confirmed
             diagnosis of T1DM made at least 1 year prior to informed consent.

          -  Participants were being treated with insulin or insulin analogue delivered via
             continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).

          -  At Screening, must had A1C >= 9.0%.

          -  Must be willing and able to perform self-monitored blood glucose (SMBG) and complete
             the study diary.

          -  Females of childbearing potential must use an adequate method of contraception and had
             a negative pregnancy test.

        Exclusion Criteria:

          -  Any prior use of LX4211/sotagliflozin.

          -  Use of antidiabetic agent other than insulin or insulin analogue at the time of
             screening.

          -  Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of
             the placebo Run-in Period.

          -  Chronic systemic corticosteroid use.

          -  Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the
             Investigator.

          -  History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6
             months prior to the Screening Visit.

          -  History of severe hypoglycemic event within 1 month prior to the Screening Visit.
Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Netarsudil Ophthalmic Solution 0.01%; Netarsudil Ophthalmic Solution 0.02%; Netarsudil Ophthalmic Solution 0.04%; Netarsudil Ophthalmic Solution Placebo
Intervention description: Topical sterile ophthalmic solution; Topical sterile ophthalmic solution; Topical sterile ophthalmic solution; Topical sterile ophthalmic solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 215.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Glaucoma; Ocular Hypertension; Open-Angle Glaucoma

Summary:

      Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04%
      relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be 20 years of age or older

          2. Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG
             in one eye and OHT in the fellow eye is acceptable)

          3. BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent

          4. Able and willing to give signed informed consent and following study instructions

        Exclusion Criteria:

          1. Clinically significant ocular diseases

          2. Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle
             closure glaucoma or narrow angles

          3. Previous glaucoma intraocular surgery

          4. Refractive surgery in either eye

          5. Ocular trauma

          6. Ocular infection or inflammation

          7. Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic
             solution

          8. Cannot demonstrate proper delivery of the eye drop

          9. Clinically significant abnormalities in screen lab tests

         10. Clinically significant systemic disease

         11. Participation in any investigational study within 30 days of screening

         12. Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or
             not using a medically acceptable form of birth control
A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
Condition: Excessive Sleepiness; Parkinson Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Intervention: JZP-110; Placebo
Intervention description: 75 mg, 150 mg, 300 mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending
      dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and
      PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult
      subjects with idiopathic PD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.

          2. Hoehn and Yahr stage 1, 2, or 3.

          3. Screening and Baseline ESS scores >11.

        Exclusion Criteria:

          1. Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear
             palsy, multiple system atrophy [MSA], or dementia with Lewy bodies [DLB]).

          2. Usual nightly time in bed of <6 hours, including the night before the Baseline visit.

          3. Untreated or inadequately treated moderate to severe OSA.

          4. Has evidence at screening of severe cognitive impairment or has cognitive impairment
             that in the opinion of the investigator would prevent completion of study procedures
             or the ability to provide informed consent.