cyrilzakka/clinical-trials huggingface dataset:
Effects of Fat Emulsions on PNALD and Oxidative Stress in Premature Infants

Abnormal liver function or cholestasis is the result of multiple factors, include low birth weight, smaller than gestational age, preterm birth, infection, lipid emulsion (LE) in parenteral nutrition (PN), insufficient enteral nutrition (EN) etc. Most are inevitable, but the LEs in PN can be selected. So the investigators compare two LEs, and want to see if the SMOF LE can improve hepatic index in preterm infants.

For preterm infants, especially for very or extremely low birth weight infants, it's impossible to achieve total enteral feeding in short time. So, PN has played an important role to sustain normal life. But, it also has an adverse effect on liver namely parenteral nutrition-associated liver disease (PNALD). LE(s) in PN has been showed to result in PNALD. So changing the type of LEs has been an ideal solution.

Two types of lipid emulsions are currently used for pediatric patients: one LE(the second generation) is composed of 50% long-chain triacylglycerols (LCTs) and 50% medium-chain triacylglycerols (MCTs), prepared from soybean oil and coconut oil respectively. A new LE (SMOF) contains 30% LCTs, 30% MCTs, 25% olive oil, and 15% fish oil. SMOF is rich in omega-3 polyunsaturated fatty acids which derived from fish oil. It may reduce inflammation in premature infants, prevent or treat cholestasis, and reduce oxidative stress.

Because of the different compositions, they have different effect on liver, inflammation, oxidative stress, etc. Therefore, the investigators designed a prospective, randomized and double-blind study to compare the different LEs (MCTs/LCTs and SMOF), so as to select a more suitable fat emulsion for premature infants in order to improve clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Premature infants (gestational age \< 32 weeks) with birth weight \< 1500g were admitted to NICU of Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China within 24 hours after birth
* No contraindications to parenteral nutrition
* Expected PN support for 14 days or more
* Parents or guardians agree

Exclusion Criteria:

* Parenteral nutrition support was provided prior to enrollment
* EN calorie for 10% or more
* Congenital intestinal structural/functional abnormalities
* Liver function damage caused by viral hepatitis, genetic metabolism and abnormal biliary tract
* Congenital or acquired immunodeficiency
* Complex congenital heart disease
Iodine Status After Intake of Sushi and Seaweed Salad

Seaweed is becoming increasingly popular in the Western part of the world, especially sushi wrapped in nori and seaweed salad, also called wakame. There are limited data on the iodine content of different seaweed products in the Norwegian Food composition table. Furthermore, there is limited available research regarding in vivo bioavailability of iodine from seaweeds. The objective of this study is to assess whether iodine from a sushi meal (with nori, Porphyra spp), and a wakame salad (Undaria pinnatifida) has similar bioavailability as a potassium iodide reference supplement of similar iodine content.


Eligibility Criteria:
Inclusion Criteria:

* healthy women aged 18 to 40 years

Exclusion Criteria:

* pregnant or lactating
* known thyroid disease or thyroid autoimmunity,
* planning to conceive,
* known kidney problems or kidney disease.
* women with coeliac disease could not participate due to possible gluten exposure from the wakame salad
Automatic Thermomechanical Massage Bed for Acute Pain Relief for Chronic Nonspecific Low Back Pain

This prospective, double-blinded, sham-control, parallel-arm, randomized pilot trial will recruit n=40 participants, ages 18-65 (inclusive), with chronic low back pain (LBP) in the lower region, to be randomly assigned using 1:1 randomization method to receive a 40-minute single session of either active or sham Automated Thermo-mechanical Therapy (ATT). All research procedures, including informed consent, ATT session, and pre- and post-ATT assessments, will be completed in one single session.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65
* Has had chronic non-specific lower back pain persisting for 12 weeks or more
* Conversational level of English

Exclusion Criteria:

* Contraindications to mechanical manipulation of the back
* History of back surgery within the past three years
* Recent back injury
* Presence of back implants or active implanted devices
* Low back pain resulting from other specific conditions (e.g., infection, neoplasm)
* Sensitivity to heat
* Circulatory insufficiency
* Heart disease
* Pregnant or breastfeeding
* Individuals with a history of substance use disorder
* Body weight over 298 lbs (135 kg)
CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers

This is a Phase 1/1b open-label, dose escalation and dose expansion study of CPI-006, a humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.


Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
2. Documented incurable cancer with one of the following histologies: nonsmall cell lung cancer, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability(MSI), bladder cancer, cervical cancer, uterine cancer, sarcoma, endometrial cancer, and metastatic castration resistant prostate cancer.
3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
4. For Escalation: At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease. For Expansion: Subject must have progressed on, be refractory to, or intolerant to 1-3 prior systemic therapies.
5. Willingness to provide tumor biopsies.

Exclusion Criteria

1. History of severe hypersensitivity reaction to monoclonal antibodies.
2. Subjects who have received prior therapy with regimens containing cytotoxicT-lymphocyte antigen-4 (CTLA-4), programmed cell death ligand 1 (PDL1), or PD1 antagonists are NOT permitted to enroll unless all adverse events (AEs) while receiving prior immunotherapy have resolved to Grade 1 or baseline prior to screening.
3. History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.
4. The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
5. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.

The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, aged 18 - 30 years
* Signed informed consent after being advised of the risks and benefits of the study in a language able to understand, and prior to performance of any study specific procedure.
* Free of obvious health problems with acceptable medical history by screening evaluation and physical examination.
* Subject of not of child-bearing potential or all of the following: A urine/serum ß-HCG pregnancy test gives a negative result, use of adequate contraceptive precautions for 30 days before first vaccination.

Exclusion Criteria:

* Known or suspected history of smallpox vaccination or typical vaccinia scar.
* Positive test result in MVA specific ELISA or PRNT at screening.
* Positive result in HIV or HCV antibody test at screening.
* HbsAG positive at screening.
* Pregnancy or breast-feeding.
* Uncontrolled serious infection i.e. not responding to antimicrobial therapy
* History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the subject.
* History of autoimmune disease
* History of malignancy.
* History of chronic alcohol abuse and/or intravenous drug abuse.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* History of anaphylaxis or severe allergic reaction.
* Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment.
* Any vaccinations within a period starting 30 days prior to administration of the vaccine and ending at study conclusion.
* Chronic administration of immuno-suppressants or other immune-modifying drugs.
* Administration or planned administration of immunoglobulins and/or any blood products during the study period.
* Use of any investigational or non-registered drug or vaccine.
Preschoolers Learning and Active in PLAY (PLAY Extension)

The PLAY 2 Study is the continuation of an R21 pilot PLAY study. In the R21, we tested the acceptability, feasibility and initial efficacy of three early childhood education setting- based, multi-level interventions to promote preschoolers' physical activity using wearable technology and additional behavior change techniques to engage educators and parents. We have selected one of these 3 as the main intervention for the R33 portion of the grant. The intervention will contain components of teacher wellness, parent engagement, and activity level monitoring.

Physical activity in early childhood is important for numerous aspects of children's health and development. Preschoolers are thought to be very active but previous studies have shown that they are sedentary for the majority of time and not getting adequate opportunities to engage in active play. Experts have recommended strategies to promote physical activity in early learning settings and to involve parents in efforts to promote active living from a young age. Through early learning settings, we may be able to change behaviors in large groups of children and particularly benefit more vulnerable children who have fewer opportunities for outdoor play and physical activity at home or in their neighborhoods. However, meaningful engagement from families is also important and research suggests that there is gap in communication and perhaps alignment between educators and parents on the topic of preschoolers' physical activity. This research uses wearable technology to monitor physical activity in children, motivate parents and educators to help create active play opportunities, and create a platform for communication and shared accountability about this important health behavior. We will focus particularly on children from lower income backgrounds who suffer from disparities in both health and educational outcomes. Our primary outcome of interest is accelerometer measured physical activity. We will also explore how changes in preschooler's physical activity relate to behavioral indicators, which are topics of great significance to early childhood educators, policy makers and parents.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 3-5 who attend participating preschools and their parents s are eligible.
* Teachers and staff who work at participating preschools are eligible.

Participating preschools:

1. child care centers that offer full day child care
2. at least 1 classroom for children ages 3-5

Exclusion Criteria:

- family based child care homes
Preoperative Gabapentin for Post-tonsillectomy Pain in Children

The typical post-operative course for children following surgical removal of their tonsils and adenoids can be challenging, especially for pain control. First line medications for pain include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be short-lived. Gabapentin has been shown in adult studies to tone down the body's response to pain and decreases opioid use post-operatively. The purpose of this study is to see if a single preoperative dose will reduce post-operative pain scores and the amount of analgesic used.

This is a randomized, double blind, placebo-controlled trial to study the effect of a preoperative oral dose of gabapentin on postoperative analgesic requirements and subjective pain levels in children undergoing tonsillectomy with adenoidectomy. Investigators will also look for a limited set of genotypic variations to explain any difference between individuals or groups in their response to the medication. Additionally, investigators will document potential adverse effects including excessive sedation, respiratory issues, surgical bleeding and emergence agitation/delirium.

Investigators hypothesize that gabapentin will reduce opioid analgesic requirements and pain scores up to 36 hours post adenotonsillectomy without increased adverse effects such as emergence delirium, respiratory complications or bleeding. The clinical effect may depend on the individual's pharmacogenetic profile to look for a specific set of genetic polymorphisms that relate to the metabolism and effect of the study drug, gabapentin, and opioid analgesic pain medications.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for outpatient tonsillectomy and adenoidectomy
* \< 60 Kg, between 5th and 95th percentile for weight
* ability to self-report pain
* complete pain diary with assistance from parent or guardian

Exclusion Criteria:

* require pre-anesthesia medication for anxiety
* require interpreter for verbal or written communication
* Obstructive sleep apnea significant enough to not qualify for outpatient surgery per surgeon
* ongoing oxygen dependence, pulmonary hypertension
* elevated risk of regurgitation
* history of seizures
* currently taking psychoactive medications or having a psychiatric condition requiring medications
* chronic pain disorders requiring medications
* renal disease
* developmental or cognitive disabilities
* history of adverse reactions to components of liquid gabapentin or placebo
Evaluation of a New Cardiac Biomarker Assay

The objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, Troponin I, in an intended use population. Blood specimens will be tested using the new investigational test that detects the level of Troponin I. Results will be compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.

The purpose of the cardiac biomarker Troponin I is to aid in the diagnosis of myocardial infarction.The assay is also intended to assist in the prognosis relative risk to all cause mortality (ACM) and major adverse cardiac events (MACE) consisting of myocardial infarction, revascularization, and cardiac death in patients who present with symptoms suggestive of acute coronary syndrome (ACS) without a diagnosis of myocardial infarction.

All specimens were collected under a separate specimen collection protocol (Protocol No, 7B5-02-09A01-01: Clinical Specimen Procurement for Biomarker Evaluation of Suspected ACS). The specimens that will be tested include approximately 8300 specimens collected from 1101 subjects presenting to Emergency Departments with signs and symptoms of Acute Coronary Syndrome and will be provided to the clinical sites performing investigational Troponin I testing.

Eligibility Criteria:
Inclusion Criteria:

* presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.
* an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS).
* greater than 18 years of age.
* not known to be pregnant.
* agreement to the follow-up required by the study.

Exclusion Criteria:

* prior participation in this study.
* require dialysis for end stage renal disease.
* history of a previous heart transplant.
* coexisting disorder associated with limited life expectancy.
* currently participating in another investigational device or drug study.
Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

The main objective of the study is to develop or validate a clinical prediction rule for major bleeding in patients on oral anticoagulant therapy who have been safely anticoagulated without bleeding or venous thromboembolism (VTE) recurrence for at least 3 months since diagnosis and are being considered for long-term oral anticoagulant therapy.

Oral anticoagulant therapy for patients who are at risk of developing blood clotting problems is used by between 400,000-600,000 Canadians annually. The use of this drug represents the most common cause of patient adverse medical outcomes due to medical errors. Furthermore, many patients have adverse outcomes using these drugs because physicians are not able to predict which patients are likely to have bleeding outcomes. Much effort has gone into developing ways to predict which patients are at risk of clotting but almost no work has gone into ways of predicting which patients would be at high risk of bleeding. This information is required to balance off the risk-benefits and to enable physicians and patients to understand the risks and benefits of taking these medications. Our study will develop a tool that can be used to predict bleeding risk in patients taking oral anticoagulant therapy. It will enable more informed decision making by both physicians and patients and will result in better control of the use of these drugs. In addition, patients who are at risk for being difficult to accurately dose on oral anticoagulants will be identified through our study.

Eligibility Criteria:
Inclusion Criteria:

* \>=18 years old
* provoked or unprovoked venous thromboembolism
* objectively confirmed venous thromboembolism
* treated with an oral anticoagulant(vitamin K antagonist or new oral anticoagulant) for at least 3 months with plans to continue long-term
* if taking a vitamin K antagonist; INR target is between 2.0-3.0
* if taking a vitamin K antagonist; must have taken it for the last 3 consecutive weeks (minimum)

Exclusion Criteria:

* major bleeding while taking oral anticoagulants
* active bleeding at study enrollment
* active cancer - current or at the time of VTE diagnosis
* unable to provide written informed consent
* refusal to provide written informed consent
Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Subject has signed informed consent
* Subject is age 40-80
* Subject is able to have an MRI
* Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of:

  a) Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy.
* Localized tenderness in anterior knee area
* Kellgren-Lawrence grade 1, 2, or 3 as assessed by weight-bearing knee radiographs
* Synovitis present as assessed by WORMS
* VAS \>50 mm
* WOMAC score \>30

Exclusion Criteria:

* Rheumatoid arthritis
* Local infection of the target knee(s)
* Kellgren-Lawrence grade \>3
* Osteonecrosis evident by MRI
* Prior knee arthroplasty
* Allergy to iodinated contrast agents that cannot be managed by prophylaxis
* Hypersensitivity to gelatin products
* Any known condition that limits catheter-based intervention or is a contraindication to embolization
* Active malignancy other than non-melanomatous skin cancer
* Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
* Any other condition related to the subject's health and wellbeing deemed exclusionary in the opinion of the investigator
Improving Quality of Life for Veterans With Stroke and Psychological Distress

The study will create a treatment to improves mobility, physical activity, engagement in activities with family and friends and overall satisfaction with life for Veterans who have depression and anxiety after having a stroke. The treatment will then be tested to ensure it makes the desired improvements in the Veterans.

The study has three aims. The first aim is to develop a client-centered, behavioral stroke self-management program (I'm Whole) for Veterans with stroke and psychological distress (e.g., symptoms of anxiety and/or depression). This will be done using expert input from a multidisciplinary team of a clinical psychologist, nurse practitioner, exercise physiologist and social role functioning expert will be used to create the I'm Whole patient workbook and clinician manual.

The second aim is to pilot the I'm Whole treatment by delivering the intervention to 5 Veterans suffering from stroke and comorbid depression and/or anxiety symptoms. The feasibility (barriers and facilitators to completing I'm Whole and acceptability of the intervention) will be assessed through qualitative interviews posttreatment. Veterans' feedback about ways to improve I'm Whole will be analyzed and used to improve treatment.

The third aim is to test the feasibility and preliminary efficacy of I'm Whole on quality of life (primary outcome) physical functioning, physical activity, social role functioning, psychological distress, and satisfaction with I'm Whole (secondary outcomes). To test the feasibility and efficacy, a small randomized controlled trial (RCT) with 30 Veterans (15 I'm Whole and 15 education+usual care) with stroke and psychological distress will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* a documented history of stroke and/or transient ischemic attack within the last 30 days
* a modified Rankin score of \> 3)
* regular access to a computer or tablet with internet and a camera
* ability to give appropriate informed consent
* score \> 5 on a measure of depression (Patient Health Questionnaire \[PHQ-8\]) and/or \>17 on a measure of anxiety (Generalized Anxiety Disorder-7 \[GAD-7\]) assessments
* ability to ambulate with or without assistance of a cane or walker

Exclusion Criteria:

* cognitive impairment, as evidenced by a score of \>3 on a brief cognitive screener
* documented diagnosis of psychotic disorder or schizophrenia
* documented severe depression, anxiety (based on PHQ-8 or GAD-7 score of \> 20), or hospitalization for psychiatric illness within the past 30 days