bioihbjkbjnl/mcl2 huggingface dataset:
CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks (VLA-008 CALM Ext)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: CVA21
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; CALM

Summary:

      This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA
      007 trial. There may be patients who have benefitted from the study drug and who might
      benefit from further treatment. In order to accommodate those patients further treatment to
      complete 48 weeks of CVA21 intratumoral injections will be made available.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Patients must have reached Week 24 of the core protocol in immune-related complete
             response (irCR), immune-related partial response (irPR), immune-related stable disease
             (irSD), or immune-related progressive disease (irPD) (unconfirmed) with evidence of
             tumor inflammatory reaction.

          -  2. If patient is in irPD (unconfirmed) status, they must not have had a decrease in
             their Karnofsky Performances Scale (KPS) score > 10 points and to be judged to not
             have "rapid clinical deterioration" by the investigator since the subject's last tumor
             measurement leading to irPD assessment.

          -  3. Patients must start treatment in the extension protocol within 8 weeks of their
             last injection administered in the core protocol.

          -  4. Patient is able and willing to provide written informed consent to participate in
             the study.

          -  5. Fertile males and females must agree to the use of an adequate form of
             contraception, e.g., condoms for males.

        Exclusion Criteria:

          -  1. Tumors to be injected lying in mucosal regions or close to an airway, major blood
             vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion
             or compression in the case of tumor swelling or erosion into a major vessel in the
             case of necrosis.

          -  2. If lesions are too small to be visualized or palpable for accurate injection.

          -  3. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of
             tumor inflammatory response, or with rapid clinical deterioration, or with a decrease
             of 10 points or more on their KPS score since their last assessment before irPD
             (unconfirmed) assessment.
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Diclofenac Capsules low dose; Diclofenac Capsules high dose
Intervention MeSH terms: Diclofenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The purposes of this study are to evaluate the safety and tolerability and to model the
      single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children
      ages 6 to <17 years experiencing mild to moderate acute postoperative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight ≥18 kilograms.

          -  Mild to moderate acute pain requiring treatment with analgesic medication.

          -  Willing to have blood samples taken for PK sampling using an indwelling catheter.

          -  Must be able to swallow capsules and can tolerate oral medication.

          -  For females: is not of reproductive potential (defined as premenarchal) or is
             practicing an acceptable method of birth control

        Exclusion Criteria:

          -  Severe acute pain

          -  Chronic analgesic or glucocorticoid use for any condition within 6 months before
             dosing with study drug.

          -  Emergency surgery

          -  History of allergic reaction, hypersensitivity, or clinically significant intolerance
             to diclofenac, aspirin, codeine, acetaminophen, or any NSAID

          -  History of peptic ulcer disease or a GI event (eg, perforation, obstruction, or bleed)
             within 6 months before screening

          -  Current use of any medication that may cause a clinically significant drug interaction
             when co-administered with diclofenac

          -  Current use of any medication that might affect the pharmacokinetics of diclofenac

          -  History of bleeding disorders .

          -  Developmental delay or behavioral problems that would make it difficult to assess
             pain.

          -  Impaired liver function

          -  Clinically significant renal or cardiovascular disease

          -  Any medical condition that compromises ability to swallow, absorb, metabolize, or
             excrete the study drug

          -  Previously received any investigational product or device within 30 days before
             Screening or scheduled to receive an investigational device or another investigational
             drug (other than that in this study) during the course of this study.

          -  Previous participation in this clinical study or currently taking diclofenac.
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Tilavonemab
Intervention description: solution for IV infusion
Intervention MeSH terms: Tilavonemab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 364.0
Sex: All
Minimum age: 57 Years
Maximum age: 88 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in
      participants with early AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects with early AD who complete Study M15-566 (NCT02880956), meet all
             inclusion criteria, and do not meet any exclusion criteria are eligible for enrollment

          -  Subject was compliant during participation in Study M15-566 (NCT02880956)

          -  Subject has an identified, reliable study partner who has frequent contact with the
             subject and who will provide information as to the subject's cognitive and functional
             abilities

        Exclusion Criteria:

          -  The subject has any significant change in his/her medical condition since
             participation in Study M15-566 (NCT02880956) that could interfere with the subject's
             participation in Study M15-570, could place the subject at increased risk, or could
             confound interpretation of study results

          -  More than 8 weeks have elapsed since the subject received his/her last dose of study
             drug in Study M15-566 (NCT02880956)

          -  The subject is concurrently enrolled in another interventional clinical study
             involving a therapeutic agent with the exception of Study M15-566 (NCT02880956)
Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Condition: Female Reproductive Cancer
Intervention: serum-derived bovine immunoglobulin protein isolate; placebo; laboratory biomarker analysis; quality-of-life assessment; questionnaire administration
Intervention description: Given PO; Given PO; Correlative studies; Ancillary studies; Ancillary studies
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein
      isolate works in improving quality of life and post-operative recovery in patients with
      cancer of the female reproductive tract after undergoing surgery. Serum bovine immunoglobulin
      may help provide nutrition to patients who are not able to eat or digest ordinary food. This
      may improve the quality of life of patients with gynecological cancer and help them recover
      more quickly from surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of gynecological cancer of any type or strong suspicion for cancer

          -  Patients must have begun postoperative oral intake of food prior to registration

          -  Open laparotomy or laparoscopic surgery undertaken with cancer therapeutic intent (not
             a subsequent surgery to manage a postoperative complication) that had occurred =< 7
             days prior to registration and that entailed more than a simple hysterectomy

          -  Creatinine =< 1.5 x the upper limit of normal (ULN)

          -  Absolute neutrophil count >= 1500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Provide informed written consent

          -  Negative (serum) pregnancy test done =< 7 days prior to randomization, for women of
             childbearing potential only

          -  Willing to provide mandatory baseline blood samples for correlative research purposes

        Exclusion Criteria:

          -  Symptomatic and/or untreated brain metastases

          -  Ongoing parenteral nutrition (receiving intravenous nutrition support at the time of
             enrollment); note: patients may be receiving maintenance intravenous (IV) fluids

          -  Current enrollment in any other trial that entails the concurrent administration of
             any other agent designed to enhance postoperative recovery

          -  Allergy to beef
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Condition: Nutrient Deficiency; Pregnancy Related
Intervention: Carotenoid Group; Control Group
Intervention description: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil; Placebo ingredients: Safflower oil
Intervention MeSH terms: Carotenoids
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a
      period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation
      with 10 milligrams of lutein and 2 milligrams of zeaxanthin will have significant effects on
      ocular and systemic biomarkers of maternal and infant carotenoid status relative to a
      matched, standard-of-care prenatal supplement without added lutein and zeaxanthin; and (3)
      newborn infants with the highest systemic and ocular carotenoid status will have more mature
      foveal structure.

      Mothers will be enrolled in the study during their first trimester, and will take the study
      carotenoid or control supplements for 6 to 8 months. The final study outcome measurements of
      mothers and infants will be completed within two weeks of the baby's birth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women, 18 or older of all races and ethnicities who have an uncomplicated
             obstetric history and plan to deliver either vaginally or by Caesarian section at the
             University of Utah for their current pregnancy.

        Exclusion Criteria:

          -  Women who have regularly taken carotenoid supplements containing more than 0.5 mg of
             lutein and/or zeaxanthin daily during the six months prior to screening

          -  Women who have significant eye disease associated with macular pigment abnormalities
             such as Stargardt disease, albinism, or macular telangiectasia type II (MacTel).

          -  Women with conditions associated with high-risk pregnancy such as adolescent
             pregnancy, multifetal pregnancy, current or past history of diabetes, pre-eclampsia,
             previous premature delivery, drug abuse or other significant medical illness
A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: IGF-1; Placebo/saline
Intervention description: IGF-1 is an FDA-approved (IND exemption #113450), commercially available compound that crosses the blood-brain barrier and has beneficial effects on synaptic development by promoting neuronal cell survival, synaptic maturation, and synaptic plasticity.; Placebo
Intervention MeSH terms: Mecasermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Autism Spectrum Disorder; IGF-1

Summary:

      The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of
      autism. We will use a double-blind, placebo-controlled crossover trial design in five
      children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments
      in socialization, language, and repetitive behaviors. We expect to provide evidence for the
      safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic
      Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on
      secondary outcomes of social impairment, language delay, and repetitive behavior, as well as
      on functional outcomes of global severity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet DSM-5 criteria for Autism Spectrum Disorder confirmed by the Autism Diagnostic
             Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule- Generic
             (ADOS-G)

          -  Children between the ages of 5-12 years of age

          -  Language delay (lack of fluent phrase speech) reflected by use of ADOS Module 1 or 2

          -  Must be on stable medication regimens for at least three months prior to enrollment,
             assuming the concomitant medication is safe for use with IGF-1

        Exclusion Criteria:

          -  Closed epiphyses

          -  Active or suspected neoplasia

          -  Intracranial hypertension

          -  Hepatic insufficiency

          -  Renal insufficiency

          -  Cardiomegaly/valvulopathy

          -  History of allergy to IGF-1

          -  Patients with comorbid conditions deemed too medically compromised to tolerate the
             risk of experimental treatment with IGF-1
Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis; Kidney Failure, Chronic
Intervention: LDV/SOF
Intervention description: 90/400 mg fixed- dose combination (FDC) tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the safety, efficacy and tolerability of
      treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are
      on dialysis for ESRD.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/
             nonlactating females aged 18 years or older who are on dialysis for ESRD, including
             adults with HIV coinfection if they are suppressed on a stable, protocol-approved
             antiretroviral (ARV) regimens for ≥8 weeks prior to screening.

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving
Condition: Cocaine Addiction
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Intervention: lidocaine following cue-induced craving; lidocaine following neutral stimulus; saline
Intervention description: as described in Arm Description; as described in Arm Description; as described in Arm Description
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 25 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: cocaine; addiction; lidocaine; memory; drug abuse

Summary:

      We propose that the systemic administration of lidocaine following the induction of
      cue-induced craving, relative to saline plus cue-induced craving or lidocaine without
      cue-induced craving, will block the reconsolidation of cue memories. This will lead to a
      reduction in cue-induced craving upon repeated testing as well as subsequent cocaine use and
      basal craving.
    

Eligibility criteria:

        Inclusion Criteria:

          -  25-60 years old

          -  men or women

          -  any race or ethnicity

          -  cocaine addition is primary present and lifetime drug of abuse

          -  live locally

        Exclusion Criteria:

          -  Patients with active DSM (Diagnostic Statistical Manual)-IV other Substance Dependence
             (except nicotine) within the previous three months, Affective Disorder, Schizophrenic
             Disorders.

          -  significant cognitive impairment (WTAR<70) (Wechsler Test of Adult Reading <70)..

          -  use of tricyclic anti-depressants, benzodiazepines, cimetidine, mood stabilizers,
             opioids, lithium, sympathomimetics, anticonvulsants, sedative/hypnotics, β-blockers,
             or dopamine agonists will be excluded from the study.

          -  Medical conditions that might limit cooperation (e.g. dementia) or put the patient at
             medical risk (i.e. significant hematologic, hepatic, renal, or cardiovascular
             pathology - particularly arrhythmias) will be excluded.

          -  Patients with congenital or idiopathic methemoglobinemia or patients taking
             medications associated with increased risk of methemoglobinemia (including
             sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine,
             dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin,
             nitroprusside, pamaquine, paraaminosalicylic acid, phenacetin, phenobarbital,
             phenytoin, primaquine, quinine) will be excluded.

          -  Patients with past or present neurologic disorders (i.e. severe head trauma, transient
             ischemic attacks, stroke, tumor, etc.) will be excluded. - Active suicidal ideation,
             pregnant or nursing women, and prisoners will be excluded from the study.
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
Condition: Urinary Bladder Neoplasm; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Urinary Bladder Neoplasms
Intervention: Bempegaldesleukin; Nivolumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder; Bladder Cancer; CD122; Cisplatin Ineligible; Immuno-oncology; Immunotherapy; Locally Advanced Urothelial Cancer; Metastatic Urothelial Cancer; mUC; Natural Killer Cells; Nivolumab; NKTR-214; Opdivo®; PD-L1; Urothelial Cancer; Urothelial; Metastatic Urothelial Carcinoma; Urothelial Carcinoma; Bempegaldesleukin; BEMPEG; CPI Combination; IL-2

Summary:

      The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin
      (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in
      cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Provide written, informed consent to participate in the study and follow the study
             procedures

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

          -  Measurable disease per RECIST 1.1 criteria

          -  Histologically or cytologically documented inoperable, locally advanced or metastatic
             urothelial cell carcinoma (also termed TCC)

          -  Fresh biopsy or archival tissue

          -  No prior systemic chemotherapy or investigational agent for inoperable locally
             advanced or mUC

          -  Ineligible for cisplatin

        Key Exclusion Criteria:

          -  Patients who have an active, known or suspected autoimmune disease

          -  Patients must not have received prior IL-2 therapy

          -  Prior treatment with an anti PD-1, anti PD-L1, or anti cytotoxic T lymphocyte
             associated protein 4 (anti CTLA-4) antibody, agents that target IL-2 pathway, or any
             other antibody or drug specifically targeting T-cell co-stimulation or immune
             checkpoint pathways

          -  Patients with hypertension must be on a stable antihypertensive regimen for the 14
             days prior to Cycle 1 Day 1

        Additional protocol-defined inclusion/exclusion criteria applied