bioihbjkbjnl/mcl2 huggingface dataset:
QUILT-3.033: Haplo NK With SQ ALT-803 for Adults With Relapsed or Refractory AML
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted,
      ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after
      lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute
      myelogenous leukemia (AML).
    


Intervention name(s): ALT-803
Intervention type(s): Biological
Intervention description(s): Preparative Regimen:
Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4
ALT-803 Stimulated Donor NK Cells:
The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be stimulated by overnight incubation with 36.1 ng/mL ALT-803 under GMP conditions and infused on day 0.
ALT-803 to Facilitate NK Cell Survival and Expansion:
ALT-803 at 10 mcg/kg subcutaneously (SC) with the 1st dose administered on day 0 (no sooner than 4 hours post NK cells), day +5 and day +10 for 3 doses total
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on Statins
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To obtain safety and tolerability information in healthy subjects is administered as a single
      dose
    

Detailed description: 
      -  Study Classification: Pharmacokinetics and Pharmacodynamics

        -  Intervention Model: Single Ascending Dose (SAD) study

        -  Allocation: Randomized Non-Stratified
    

Intervention name(s): BMS-962476; Placebo matching with BMS-962476
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Effectiveness of Taking Choline Supplements During Pregnancy for Improving Infant Brain Development
Condition: Pregnancy; Child Development
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and effectiveness of taking choline supplements during
      pregnancy, and whether choline supplementation has an effect on infant development.
    

Detailed description: 
      Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and
      other meats. It is important for the composition and repair of normal cellular membranes,
      normal brain function, and normal cardiovascular function. Research has suggested that the
      presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure
      healthy fetal brain development. Additionally, adequate prenatal choline levels may have
      long-lasting positive effects on cognitive function, including memory. However, sufficient
      research has not been done on the effects of choline on pregnant women and their unborn
      babies. This study will evaluate the safety and effectiveness of taking choline supplements
      during pregnancy, and whether taking choline during pregnancy will have an effect on infant
      development.

      Participants in this double-blind study will be randomly assigned to receive either placebo
      or 900 mg of choline daily throughout pregnancy, until delivery. Babies will then begin
      receiving either placebo or choline daily from the time of birth until they are 3 months old.
      Participants will attend a baseline study visit that will include eligibility assessment,
      urine collection, measurement of vital signs, dispensing of study medication, and an
      ultrasound. Subsequent study visits will occur every 4 weeks throughout pregnancy and 6
      months postpartum. Vital signs will be taken, urine samples will be collected, and study
      medication will be given at each visit. Two blood samples will be taken between Weeks 32 and
      36 of gestation. Heel sticks will be performed on babies when they are 4 and 12 weeks old.
      Follow-up visits will be held every 6 months until the baby is 18 months old.
    

Intervention name(s): Choline; Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 900 mg every day until birth of infant; Corn oil every day in place of choline
Other intervention name(s): Polyenylphosphatidylcholine
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Clinical Analysis of Pain After Hysterectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical
      examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The
      aims of the study are:

        1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons
           for the pain.

        2. to reveal the type of pain, neuropathic, nociceptive or idiopathic.

        3. to reveal the impact of pain on quality of life.
    

Detailed description: 
      Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical
      examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. All
      patients were treated in Pirkanmaa District Hospital and the anesthesia was either
      propofol-infusion or sevoflurane gas with remifentanil-infusion.

      6months after the surgery, questionnaires about pelvic pain were sent to the patients.
      Patients still having pain at that time, were invited for detailed sensory and gynecological
      examinations.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergone hysterectomy for 1-3 years previously and suffering from persistent pain 6
        months after surgery. The patients are invited to participate in this study, if they have
        participated in previous studies "Sevoflurane, Propofol, Postoperative pain" by Yli-Hankala
        and Pokkinen and study:" Vaginal hysterectomy, laparoscopic hysterectomy, postoperative
        pain" by Yli-Hankala and Pokkinen.
      
Keywords: Chronic pain; Hysterectomy; Quality of life
Vitreous Levels of Cysteine-rich 61 in Patients With Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      To determine the vitreous levels of fractalkine, cysteine-rich 61 (Cyr61), and VEGF in
      patients with PDR. Verifying that it is greater to that found in non-diabetic patients with
      different non-angiogenetic diseases.
    

Detailed description: 
      Introduction:

      Angiogenesis, the growth and proliferation of new blood vessels, is an important aspect of
      the vascular proliferation found in tumor growth, wound repair, inflammatory states, and
      ischemic sequel in the ocular angiogenetic diseases. Intraocular neovascularization, the
      major eventually complication of diabetic mellitus, may result in vitreous hemorrhage,
      tractional retinal detachment, neovascularization glaucoma and eventually blindness. The
      involved factors include basic fibroblast growth factor (bFGF), insulin-like growth factor-I
      (IGF-I), vascular endothelial cell growth factor (VEGF), and Connective tissue growth factor
      (CTGF)/Cysteine-rich protein (Cyr61)/Nephroblastoma overexpressed gene (CCN) family. VEGF is
      a primary angiogenic factor that mediates ischemic-induced retinal neovascularization. VEGF
      level are elevated in the vitreous fluid in patients with proliferative diabetic retinopathy
      (PDR). The unselective anti-VEGF antibody bevacizumab has been used for the treatment of
      diabetic retinopathy.

      Problem:

      In spite of its potent anti-VEGF property, it does not completely inhibit ischemia-induced
      retinal neovascularization. Several other factors which were detected to have increased
      vitreous levels in the PDR patients might participate in the angiogenic process of diabetic
      retinopathy. One of the member of the CCN family, connective tissue growth factor (CTGF), was
      found to be involved in the angiogenesis and fibrosis mechanism of PDR. It is unclear if the
      other factors in the CCN family might also control the development of retinal angiogenesis
      and fibrosis.We measured vitreous cysteine-rich 61 (Cyr61) levels in PDR patients,
      non-diabetic patients,and PDR patients pretreated with bevacizumab. We further correlated the
      cysteine-rich 61 levels with different stages of PDR. Concomitant VEGF level was also
      measured to better understand the interaction of different factors.
    

Intervention name(s): intravitreal injection of 1.25 mg of bevacizumab
Intervention type(s): Drug
Intervention description(s): Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy
Other intervention name(s): Bevacizumab(Avastin, Genentech, Inc., South San Francisco)
Intervention MeSH terms: Bevacizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Post-Marketing Safety Study in Japan in Participants With High Risk of Severe Exacerbation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine
Condition: SARS-CoV-2
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The goal of this study is to assess the adverse events in the acute phase observed after
      vaccination with the mRNA-1273 vaccine in persons with underlying diseases who are considered
      to have a high risk of severe exacerbation specified in COVID-19.
    

Detailed description: 
      Data collected from the JDMC Claims Database between August 2020 to November 2021.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population was selected from participants who were registered to receive the
        mRNA-1273 vaccine in the Pep Up vaccination history Database and those who met the
        definition of underlying disease based on the claim data for 6 months from August 2020 to
        November 2021.
      
Keywords: mRNA-1273; mRNA-1273 vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Virus Diseases; Messenger RNA; COVID-19; COVID-19 Vaccine; Moderna
A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if medication designed to improve memory will help
      patients with Multiple Sclerosis (MS) who are experiencing memory problems using fMRI to
      track brain activity.
    

Detailed description: 
      Donepezil HCI (Aricept®) is an FDA-approved drug now used to enhance memory in patients with
      Alzheimer's disease. The aim of this project is to examine the effects of Donepezil HCI
      (Aricept®) on memory induced brain activation patterns in the context of a double-blind,
      crossover trial of patients with multiple sclerosis (MS). We will perform task activation
      experiments involving two cognitive domains. The proposed work on MS patients should yield
      new information regarding functional anatomic relationships during cognitive activity, and
      how these relationships change as a function of drug treatment.
    

Intervention name(s): Donepezil HCI (drug)
Intervention type(s): Drug
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Memory impairment
Effect of Resistance Training on Microvascular, Hemodynamic and Physical Parameters in Obese Adolescents
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect os resistance training on
      microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart
      rate, body composition and physical fitness in obese adolescents.
    


Intervention name(s): Resistance training
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Endothelial function; Microvascular reactivity; Obesity; Adolescents
Nurse Counseling for Physical Activity in Primary Care Patients
Condition: Chronic Disease; Exercise
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      Many elderly primary care patients are at high risk for health complications and functional
      impairment due to low levels of physical activity. Previous trials of counseling of elderly
      patients in primary care clinics have not demonstrated lasting physical activity change and
      have not evaluated fitness changes associated with any increased activity.
    

Detailed description: 
      Background:

      Many elderly primary care patients are at high risk for health complications and functional
      impairment due to low levels of physical activity. Previous trials of counseling of elderly
      patients in primary care clinics have not demonstrated lasting physical activity change and
      have not evaluated fitness changes associated with any increased activity.

      Objectives:

      The primary objective was to determine if nurse telephone counseling could assist 60 to 80
      year old VA primary care patients to establish and maintain a regular walking program.

      Methods:

      In this randomized clinical trial, 60-80 year old patients were referred to a walking program
      by primary care providers. All participants received individualized counseling by the nurse
      and, over the next year, one of three follow-up interventions: 1) 20 calls initiated by the
      nurse; 2) ten calls initiated by the nurse and ten initiated by an automated telephone
      message delivery system; or 3) no follow-up calls. All kept walking diaries and mailed these
      in to a data collector blinded to intervention group. Follow-up research visits were
      scheduled at six and 12 months. Self-reported walking, the primary outcome measure, was
      assessed from the walking diaries and validated by reports of significant others and
      accelerometer data. Improvement in fitness was assessed at 12 months with a standardized six
      minute walking test. Tinetti mobility scores, body mass index, and body girths were also
      assessed. Several quality of life measures were also administered.

      Status:

      Complete.
    

Intervention name(s): Telephone Care
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Telephone
Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety/tolerability and
      pharmacokinetics/pharmacodynamics of CKD-519
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, phase I clinical trial to investigate the
      safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519 after oral
      administration in healthy adult volunteers Part I- single dosing / Part II- multiple dosing
    

Intervention name(s): CKD-519; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1~D14; Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1~D14
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dyslipidemia
Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to
      placebo in reducing the signs and symptoms of fibromyalgia syndrome.
    

Detailed description: 
      This was a proof-of-concept study and not powered for statistical comparisons.

      The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper
      Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they
      were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance
      Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly
      intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week
      Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment
      Phase was defined as the combined Titration and Maintenance Phases.
    

Intervention name(s): Lacosamide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg; Matching placebo tablet administered twice daily
Other intervention name(s): Vimpat; Harkoseride
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia Syndrome; Lacosamide; Vimpat; Harkoseride
AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the
      study drug. Further, the study will determine how much of the study drug gets into the
      bloodstream and how long it takes the body to get rid of it when given as a single dose to
      healthy male subjects.
    


Intervention name(s): Radiolabeled SPD602 (FBS0701, SSP-004184)
Intervention type(s): Drug
Intervention description(s): A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Other intervention name(s): SPD602
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the drug levels of deucravacitinib after oral
      administration in healthy participants.
    


Intervention name(s): Deucravacitinib; Famotidine
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Other intervention name(s): BMS-986165; Pepcid
Intervention MeSH terms: Deucravacitinib; Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Participants; Deucravacitinib; BMS-986165
Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study was to test whether adalimumab can induce mucosal healing in subjects
      with moderate to severe ileocolonic Crohn's Disease.
    


Intervention name(s): adalimumab; placebo; adalimumab
Intervention type(s): Biological; Biological; Biological
Intervention description(s): At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab 40 mg eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.; At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.; At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab or placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8. In the Open-Label arm, interventions were either adalimumab 40 mg SC eow or adalimumab 40 mg SC weekly. There was no placebo intervention post Week 52.
Other intervention name(s): ABT-D2E7; Humira; ABT-D2E7; Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment