bioihbjkbjnl/mcl2 huggingface dataset:
ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: ACP-196; ACP-196 in combination with pembrolizumab
Intervention MeSH terms: Pembrolizumab; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic
      Pancreatic Cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age

          -  ECOG performance status of 0 or 1

          -  Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma
             that is unresectable or metastatic

          -  Prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic
             pancreatic cancer or unwilling/unable to receive systemic chemotherapy

        Exclusion Criteria:

          -  Prior malignancy (other than pancreatic cancer), except for adequately treated basal
             cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which
             the subject has been disease free for ≥ 2 years or which will not limit survival to <
             2 years.

          -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, symptomatic inflammatory bowel disease,
             partial or complete bowel obstruction

          -  Breastfeeding or pregnant
Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Condition: Chronic Migraine or Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Placebo; AMG 301
Intervention description: Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days.; AMG 301 was packaged in 5 mL clear glass vials containing 1 mL of 70 mg/mL of AMG 301. All injections were administered within 30 minutes on treatment days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Prevention; Prophylaxis

Summary:

      To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period
      in monthly migraine days in subjects with migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.

          -  History of migraine (with or without aura) for ≥ 12 months before screening according
             to the International Headache Society (IHS) Classification ICHD-III (Headache
             Classification Committee of the International Headache Society, 2013)

          -  Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before
             screening.

          -  Failed at least 1 medication for prophylactic treatment of migraine due to
             tolerability or lack of efficacy

        Exclusion Criteria:

          -  Older than 50 years of age at migraine onset.

          -  History of cluster headache, hemiplegic migraine headache.

          -  Unable to differentiate migraine from other headaches.

          -  Migraine with continuous pain, in which the subject does not experience any pain-free
             periods (of any duration) during the 1 month before the screening period.

          -  History or evidence of any other clinically significant disorder, condition or disease
             that, in the opinion of the investigator or Amgen physician, if consulted, would pose
             a risk to subject safety or interfere with the study evaluation, procedures or
             completion.
A Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Intervention: Tc99m tilmanocept
Intervention description: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of
      lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single
      dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided written informed consent with HIPAA authorization

          -  Has cervical cancer and is a candidate for surgical intervention, with lymph node
             dissection being a part of the surgical plan.

          -  Is at least 18 years of age at the time of consent

          -  Has an ECOG performance status of Grade 0 to 2

          -  Has the following International Federation of Gynecology and Obstetrics (FIGO)
             IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still
             be considered eligible as consistent with FIGO guidelines.

          -  If of childbearing potential, the subject has a negative pregnancy test within 48
             hours before administration of Lymphoseek, has been surgically sterilized, or has been
             postmenopausal for at least 1 year

        Exclusion Criteria:

          -  The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy
             within the 30 days prior to Lymphoseek administration

          -  Has had previous surgery or radiation to node basins that would be involved in the ILM
             procedure

          -  Has a known allergy to dextran

          -  Is breast-feeding or pregnant

          -  Before the administration of Lymphoseek, has received any radiopharmaceutical within 7
             radioactive half-lives of that radiopharmaceutical

          -  Is scheduled for surgery and/or another invasive procedure other than the primary
             surgical intervention within the 3 days after Lymphoseek administration

          -  Has received an investigational product within the 30 days prior to Lymphoseek
             administration
Study of Eteplirsen in Young Participants With Duchenne Muscular Dystrophy (DMD) Amenable to Exon 51 Skipping
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Eteplirsen
Intervention description: Infusion for intravenous use.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 6 Months
Maximum age: 48 Months
Healthy volunteers: No
Keywords: DMD; Duchenne; Eteplirsen; dystrophy; dystrophin; exon 51

Summary:

      This is a multicenter, open-label, dose-escalation study to evaluate the safety,
      tolerability, and PK of once-weekly IV infusions of eteplirsen in approximately 12 male
      participants, ages 6 months to 48 months (inclusive), who have genotypically confirmed DMD
      with a deletion mutation amenable to exon 51 skipping.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male between 6 months to 48 months of age (inclusive)

          -  Diagnosis of DMD with a deletion mutation amenable to exon 51 skipping

          -  Parent(s) or legal guardian(s) who is willing to provide written informed consent

        Exclusion Criteria:

          -  Received treatment that might have an effect on muscle strength or function within 12
             weeks prior to dosing

          -  Received previous or current treatment with any experimental treatment

          -  Clinically significant illness other than DMD

          -  Clinically significant laboratory abnormality

          -  Any other condition that could interfere with the participation in the study.
Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
Condition: Parkinson's Disease; Cognitive Impairment
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Intervention: Atomoxetine; Placebo
Intervention description: The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Parkinson's disease

Summary:

      The purpose of this study is to determine the safety and effectiveness of a drug called
      atomoxetine for the treatment of cognitive impairment for Parkinson 's disease. Atomoxetine
      (ATM) is an approved drug currently on the market for the treatment of attention deficit. It
      works to increase the amount of norepinephrine (a chemical in the brain that helps keep us
      awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration
      (FDA) to be used in the treatment of PD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of idiopathic PD according to the United Kingdom Parkinson's
             Disease Society Brain Bank (UKPDSBB) criteria

          -  Male or female subjects aged between 35 and 75 years, inclusive at the time of consent

          -  Hoehn & Yahr Stage I-IV

          -  Diagnosis of PD mild cognitive impairment (MCI), Montreal Cognitive Assessment (MoCa)
             score 21-25

          -  Stable concomitant medications for 60 days

        Exclusion Criteria:

          -  Secondary parkinsonism or atypical parkinsonism, Prior Deep Brain Stimulation (DBS) or
             other brain surgery

          -  PD Dementia; MoCA score <21

          -  Presence of Psychosis, pregnancy, suicidal ideation on the Columbia Suicide Severity
             Rating Scale (C-SSRS) type 4 or 5 in past 3 months.

          -  Current treatment with anticholinergics, monoamine oxidase (MAO) inhibitors or
             neuroleptics (including quetiapine)

          -  Serious cardiac abnormalities, Narrow angle glaucoma, Pheochromocytoma, Bipolar
             Disorder

          -  Liver Function Tests (LFTs) >1.5 X upper limit of normal value
PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection
Condition: Adult Hepatocellular Carcinoma; Localized Resectable Adult Liver Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Intervention: Computed Tomography; 18F-fluoromethylcholine; Positron Emission Tomography
Intervention description: Undergo FCH PET/CT; Undergo FCH PET/CT; Undergo FCH PET/CT
Intervention MeSH terms: Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This clinical trial studies positron emission tomography (PET)/computed tomography (CT) in
      diagnosing patients with liver cancer undergoing surgical resection. Diagnostic procedures,
      such as fluorine-18 fluoromethylcholine PET/CT, may help find and diagnose liver cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Liver tumor diagnosed histologically as HCC or suspected of being HCC in association
             with serum alpha-fetoprotein level > 200 or tumor mass with characteristics of
             malignancy on diagnostic imaging

          -  Under the care of a surgical attending

          -  Deemed a surgical candidate and has agreed to surgery to remove a portion of the liver
             containing tumor

          -  Child-Pugh A/B

        Exclusion Criteria:

          -  Weight > 350 lbs

          -  Pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks
             or less before the date of the FCH PET/CT scan in all women capable of becoming
             pregnant

          -  Serious underlying medical condition that would impair patient's ability to tolerate
             the imaging procedure

          -  Concurrent treatment with chemotherapy, molecule-selective, biological, or
             radiotherapeutic agent
Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities
Condition: Cerebral Palsy; Child, Preschool
MeSH terms: Cerebral Palsy
Intervention: Power wheelchair; No power wheelchairs
Intervention description: Children used power wheelchairs for one year. They continued to receive their usual early intervention services.; Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 14 Months
Maximum age: 30 Months
Healthy volunteers: No
Keywords: cerebral palsy; wheelchair; disabled children

Summary:

      Self-produced locomotion often is limited in children with cerebral palsy and other
      conditions that cause severe motor impairments. As a result, these children may be at risk
      for secondary impairments in spatial cognition, communication, social development, and other
      domains influenced by independent mobility. To compensate, power mobility has increasingly
      been advocated for young children with severe motor impairments. The study hypotheses were:

        1. Children with severe disabilities that prevent independent locomotion who learn to use
           power mobility devices when they are 14- to 30-months-of-age will have greater
           communication, social, and cognitive development over a 12-month period, and will
           demonstrate more competent coping skills than children with the same characteristics who
           do not use power mobility.

        2. Parents of children who use power mobility will view it as a positive influence on their
           children's lives, and will perceive their children's development to be more mature than
           the parents of children who do not use power mobility will perceive their children's
           development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 14 to 30 months

          -  Motor impairment that prevents functional independent mobility

          -  Vision and hearing adequate to use a power mobility device safely.

          -  Cognitive abilities assessed to be at least equivalent to a 12-month level or
             alertness and interest in the environment that suggests a trial of power mobility is
             warranted.
A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: pregabalin; pregabalin/PF-00489791; Placebo
Intervention description: 75mg bid titrating to 150mg bid on day 4; Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4; Placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain,
      however, not all patients will respond to this drug. This study will compare the efficacy of
      pregabalin when administered with an experimental drug PF-00489791, in patients with
      post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin
      alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of non-childbearing potential

          -  Pain present for more than 3 months after healing of herpes zoster skin rash

          -  VAS score of >=40mm at screening and baseline visits

        Exclusion Criteria:

          -  Patients with pain conditions which might impair the assessment of postherpetic
             neuralgia

          -  Skin conditions in the affected dermatome that could alter sensation other than
             postherpetic neuralgia

          -  History or diagnosis of DSM IV major depressive disorder
SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: PEGASYS [peginterferon alfa-2a]
Intervention description: There were 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS
      in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and
      biochemical response after treatment with interferon alfa. After 48 weeks therapy with
      interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized
      into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4
      therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly
      for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational
      arm will receive no specific antiviral treatment. The anticipated time on study treatment is
      1-2 years, and the target sample size is 100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  liver disease consistent with CHB;

          -  evidence of chronic HBeAg-negative CHB prior to initial course of interferon alfa;

          -  patients who have responded to previous 48 weeks treatment with interferon alfa.

        Exclusion Criteria:

          -  coinfection with HCV, HDV or HIV;

          -  decompensated liver disease, hepatocellular cancer, or evidence of a medical condition
             associated with chronic liver disease other than viral hepatitis;

          -  any other systemic antiviral, antineoplastic or immunomodulatory treatment <=6 months
             prior to first dose of randomized treatment.
Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: zilucoplan (RA101495); Placebo
Intervention description: Daily subcutaneous (SC) injection; Daily subcutaneous (SC) injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with
      generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive
      daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IVa] at
             Screening

          -  Positive serology for acetylcholine receptor (AChR) autoantibodies

          -  QMG score ≥ 12 at Screening and Randomization

          -  No change in corticosteroid dose for at least 30 days prior to Randomization or
             anticipated to occur during the 12-week Treatment Period

          -  No change in immunosuppressive therapy, including dose, for at least 30 days prior to
             Randomization or anticipated to occur during the 12-week Treatment Period

        Exclusion Criteria:

          -  Thymectomy within 6 months prior to Randomization or scheduled to occur during the 12
             week Treatment Period

          -  History of meningococcal disease

          -  Current or recent systemic infection within 2 weeks prior to Randomization or
             infection requiring intravenous (IV) antibiotics within 4 weeks prior to Randomization