cyrilzakka/clinical-trials huggingface dataset:
Anti-inflammatory Agents and Cholesterol Metabolism

We hypothesize that administration of anti-inflammatory medications such as celecoxib, naprosyn and diclofenac will cause changes in the blood plasma and white blood cells of patients such that they will be less able to efficiently process cholesterol.

Drugs that inhibit cyclooxygenase (COX) are frequently administered to relieve pain and inflammation, but have been associated with cardiovascular (CV) toxicity and an elevated risk of acute myocardial infarction. We have demonstrated that drugs that inhibit the COX-2 isoform act to interfere with cellular cholesterol movement by suppressing expression of proteins that facilitate efflux of cholesterol as well as by enhancing expression of scavenger receptors that mediate cholesterol uptake. We further showed that in cultured THP-1 human macrophages, COX-2 inhibition with drugs (celecoxib, NS398) or by COX-2 RNA silencing leads to foam cell transformation, a critical component of atherogenesis. Thus, COX-2 inhibitors act in a pro-atherogenic fashion on a series of genes which we have named the "Cholesterol Metabolic Signature." Alterations in this signature may contribute to heightened risk of development of atherosclerotic CV disease associated with prolonged use of this drug class. COX enzyme activity supports cholesterol homeostasis through catalysis of prostaglandin (PG) production, and we have shown in vitro that specific subsets of these PGs (PGD2 or PGE2) are sufficient to maintain balance. The aims of this project is: In an observational study of persons with pharmacologic COX-2 selective inhibition (celecoxib) or COX-1/2 inhibition (naproxen, diclofenac), document treatment effects on the Cholesterol Metabolic Signature in isolated subject mononuclear cells and in naïve THP-1 monocytes/macrophages exposed to subject plasma. This will allow detection of variations in degree of pro-atherogenic response of the Cholesterol Metabolic Signature to COX inhibition within human patients that may be associated with a higher likelihood of developing CV sequelae. Understanding the nature of the association between COX inhibition and cholesterol metabolism, and the extent to which they may promote atherosclerotic CV disease, is of critical importance in developing analgesic and anti-inflammatory medications with a more favorable risk profile. The knowledge gained may also improve clinical decision-making by identifying subsets of patients most vulnerable to adverse CV effects of COX inhibition.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70, osteoarthritis, male or female

Exclusion Criteria:

* other known autoimmune or inflammatory rheumatic conditions, renal disease, current or recent (\>1 month) corticosteroid or statin treatment, contraindications to medication (i.e. those taking oral anticoagulants, e.g. warfarin), those pregnant or trying to become pregnant or breastfeeding. Participants will not have consumed any medications containing aspirin or other NSAIDs for at least 2 weeks before the trial.
Service Dogs for Veterans With PTSD

The purpose of this study is to evaluate use of service dogs for individuals who have been diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the impact service dogs have on the mental health and quality of life of Veterans; (2) to provide recommendations to the VA to serve as guidance in providing service dogs to Veterans; and (3) To determine cost associated with total health care utilization and mental health care utilization among Veterans with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Referral from provider.
* PTSD diagnosis
* In active treatment for PTSD for at least three months at time of enrollment, with plans to remain in active treatment
* Acceptance by the dog vendor for the service dog
* Ability to adequately care for a dog - physically/financially
* Able to travel to vendor for pairing with dog

Exclusion Criteria:

* Been hospitalized for mental health reasons in the prior 6 months
* Not living at the same residence for 6 months.
* Diagnoses: Psychoses, Delusions, dementia, active alcohol/substance dependence. Moderate to severe TBI. Any other diagnosis deemed by PI to limit ability to participate or give informed consent
* At time of enrollment - Active suicidal ideation, homicide, cognitive disabilities that would preclude safety of animal and ability needed for participation in the study.
* Children under age 10 living in the home
The Effects of Multi-Psycho-Oncology Care Courses

When the patient's mood has not yet reached a moderate to high severity level, psychological support is usually provided by the clinical nurses. However, the result of past research showed that the needs of patients and their caregivers were not satisfied with the psychological level. Scholars pointed out that it may be related to factors such as excessive clinical workload or insufficient psychological support and care capacity. In addition, under the influence of COVID-19 in the past two years, medical staff are facing more physical and mental pressure. Oncology nurses have a heavy workload and are affected by the COVID 19 epidemic, which reflects that nurses need psychological support. Therefore, this study intends to reduce stress through remote physical and mental support activities, and use the Internet to intervene in guided relaxation and meditation. Considering the scheduling of clinical nurses, a remote and unstructured course content that does not require continuity will be selected, and then advanced to provide the empathetic care skills of oncology nurses.


Eligibility Criteria:
Intervention group

* Inclusion Criteria:
* Over 20 years old (inclusive)
* Oncology nurses currently working in clinical practice
* Exclusion Criteria:
* Those who are unwilling or unable to participate in this course training for a full one- year period.
* Those who have registered for the advanced oncology nursing course organized by the Society in the current year.

Control group

* Inclusion Criteria:
* Over 20 years old (inclusive)
* Oncology nurses currently working in clinical practice
* Those who have registered for the advanced oncology nursing course organized by the Society in the current year
* Exclusion Criteria:
* Those who have participated in multiple oncology psychological care courses, those who are unwilling or unable to participate in the training of distance psychological support courses for a full one-year period.
* Those who participate in the advanced course of oncology nursing are unwilling or unable to participate in the data evaluation of the complete bi-annual time point.
* Those who have participated in this research project.
Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis

The purpose of this study is to test and evaluate the Preparing Heart and Mind™ (PHM™) patient engagement pathway as a nurse-guided intervention to lower psychological distress and enhance caregiving competencies among mothers/birthing persons and their caregiving partners after a major fetal anomaly diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* A study participant can include a pregnant person past 20 weeks of pregnancy (this includes a vulnerable population)
* Willing and able to comply with study procedures.
* Participants must be ≥ 18 years old.
* Participants must be able to read, write and speak English.
* Participants must have access, and ability to use a smartphone, tablet, or computer in a private location.
* The pregnant woman/person and her caregiving partner are planning for infant delivery and care.
* The fetal diagnosis of the major anomaly affects the heart (i.e., CCHD). See definition of CCHD included earlier in the protocol. Other anomalies could be present and potentially impair other organs.
* The infant's anomaly will likely require surgical and/or medical intervention within the first year of life.
* The fetus/infant is expected to live with surgical and/or medical intervention (this includes a vulnerable population).
* There may be genetic and/or chromosomal conditions in addition to the heart/structural anomalies

Exclusion Criteria:

* Pregnancy termination
* The fetal anomaly diagnosis is highly likely to result in fetal or infant demise shortly after birth.
* Adults lacking the capacity to consent
* Adults who do not have access to a smart phone, tablet, or device.
* Caregiving partner cannot enroll if mother is not enrolled
Emergency Contraception (ECP): Reducing Unintended Pregnancies

Emergency contraception is a method of birth control that can be used up to three days after sexual intercourse. Emergency contraceptive pills (ECPs) can be given to a woman before she needs them (advance provision) or when she needs them (emergency provision). This study will compare these two methods of providing ECPs.

ECPs can give women a "second chance" to prevent an unintended pregnancy that might arise because of lack or improper/defective use of contraceptives. By using ECP, a woman can reduce her risk of pregnancy by at least 75%; however, there is little information on what distribution patterns and other factors are most likely to encourage ECP use. This study will compare the use and cost of two ECP distribution patterns: advance provision and emergency provision. It will also identify environmental, situational, and behavioral factors associated with ECP acceptance and use.

Participants in this study will be recruited from four family planning clinics in the Philadelphia area and five family planning clinics in the Pittsburgh area. Participants from the Philadelphia clinics will be given ECPs as part of a regular clinic visit (advance provision); participants from the Pittsburgh clinics will be given ECPs on an emergency basis (emergent provision). Each participant will complete a short intake form and will be issued a pager. Participants will be paged every month over an 18-month period as a reminder to respond to a short automated telephone survey on ECP, contraceptives, and pregnancy status. Approximately half of the participants will be randomly selected to participate in in-depth interviews at study entry and Months 9 and 18. Clinic visit data will augment the surveys to verify use of the clinic and contraceptive method and to develop cost data.

Eligibility Criteria:
Inclusion Criteria

* Patient at a participating clinic

Exclusion Criteria

* Pregnant
* Medical or surgical procedure preventing pregnancy (e.g., tubal ligation, hysterectomy)
* Norplant or IUDs
* Desires to become pregnant
Evaluation of a New Radiotracer (64Cu-DOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography

The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-AE105 for PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and less aggressive tumors. This is a first in human study to test the radiotracer in cancer patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (1,3 and 24 hours post injection).

The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-AE105 for PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and less aggressive tumors. This is a first in human study to test the radiotracer in cancer patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (1,3 and 24 hours post injection). The primary end points are Biodistribution and dosimetry of 64Cu-DOTA-AE105. In addition, the quantitative uptake of 64Cu-DOTA-AE105 in tumors and expression of uPAR in tumor tissue obtained by surgery or biopsies (either 14 days before (only biopsies) or after the PET scans) will be compared to validate the image-derived data on UPAR expression

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of cancer of prostate, breast or urinary bladder
* capable of understanding and giving full informed consent

Exclusion Criteria:

* pregnancy
* lactation
* contraindication for the use of intravenous CT contrast-agencies
* claustrophobia
* other current/or former diagnosed cancers, except non melanoma skin cancer or carcinoma in situ cervicis uteri
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear

The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral user of CII/HiRes90K™ implant(s) (minimum of one year in each implanted ear), Harmony™ BTE processor(s) with HiRes Fidelity 120™ (with or without ClearVoice™) as preferred sound processing strategy
* 18 years of age or older at time of implant
* Postlingual onset of severe-to-profound hearing loss (≥ 6 years of age)
* At least moderate open-set speech recognition abilities (defined as CNC word score ≥ 50% in medical records or assessed at the Baseline Visit with implant alone for unilateral users, with both implants together for bilateral users)
* English language proficiency
* Willingness to use a Harmony™ BTE processor and refrain from ClearVoice™ use for the duration of the study
* Willingness and ability to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

• Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing
Feasibility Study for Electroacupuncture for Chemotherapy- Induced Peripheral Neuropathy (CIPN)

The purpose of the study is to determine the validity of a point-of-care nerve conduction device (NeuroMetrix) and Rydel-Seiffer tuning fork in assessing the level of peripheral neuropathy in patients with chemotherapy-induced peripheral neuropathy (CIPN). Chemotherapy-induced peripheral neuropathy (CIPN) is a common, persistent toxicity among patients who receive chemotherapy. It is characterized by a variety of sensory and motor symptoms such as numbness, tingling, reduced sense of touch, reduced proprioception (awareness of your limb and body position in space), pain, weakness, balance disturbances, and deficits in motor skills.


Eligibility Criteria:
Inclusion Criteria:

* Must have undergone chemotherapy with taxane and/or platinum agent
* Presence of numbness, paresthesias, loss of deep tendon reflexes, or other symptoms in the lower extremities those were absent prior to treatment with neurotoxic chemotherapy.
* Three or more months status post platinum containing chemotherapy completion
* Grade ≥1 Level of CIPN that is determined by the NCI Common Toxicity Criteria for Adverse Events.

Exclusion Criteria:

* Peripheral neuropathy from causes other than chemotherapy, such as documented
* a. Nerve compression (carpal tunnel syndrome, sciatica, etc)
* b. Previously known leptomeningeal carcinomatosis
* c. Evidence of disease in the brain or spine by prior imaging
* Comorbidities with documented pre-existing neuropathy prior to the chemotherapy such as
* a. Diabetes (HbA1c 6.5% or greater)
* b. HIV
* c. Multiple myeloma
* d. Alcoholism
* Pain medication dosing, including opioids, anti-convulsants, and anti- depressantshas been increased due to worsening symptoms less than in the two weeks prior to study registration
* Current use of acupuncture (manual or electro acupuncture)
* Pregnancy
* Cardiac issues (AHA class 3 or greater)
* Pacemaker or an imbedded neural stimulator
* Full therapeutic anticoagulation or a INR \> 1.4
* Currently undergoing chemotherapy with a platinum agent or have received a platinum chemotherapy agent in the past 3 months.
A Clinical Practice Snapshot on Pediatric Kidney Transplantation

The aim is to create an overview of the similarities and differences in daily practice among the different centers performing pediatric kidney transplantation in Europe.

For this purpose, a Clinical Practice Snapshot will be used to provide insight in the current approaches.

In order to create an overview of the current care for pediatric kidney transplant (PKT) recipients a clinical practice snapshot was developed.

All participating centers were asked to answer 6 clinical questions on their last 30 transplanted patients.

Patient characteristics, donor charactertistics, use of stents, immunosuppressive medication and renal function are compared between centers.

Eligibility Criteria:
Inclusion Criteria:

* Kidney received \<18 years
* at least one month of follow-up
* transplantation and follow-up in dedicated PKT center

Exclusion Criteria:

* combined transplantation
5 Fractions of Pelvic SABR With Intra Prostatic SABR

Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes + 6-18 months of ADT

SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma (centrally reviewed)
* High- tier intermediate risk defined as:

PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 )

• High-risk prostate cancer, defined as at least one of: T3, OR Gleason 8-10, OR PSA \> 20 ng/mL

* Willing to give informed consent to participate in this clinical trial
* Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire

Exclusion Criteria:

* Prior pelvic radiotherapy
* Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
* Contraindication to prostate MRI
* Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* Diagnosis of bleeding diathesis
* Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT.
* Previous TURP
* Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20
* Significant medical co-morbidity rendering patient unsuitable for general anesthetic
* No evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
* Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
Ametop Compared to Ametop With Pain Ease Spray

The investigators propose to examine if Pain Ease spray, used as an adjunct to the topical anesthetic Ametop Gel, can improve the percentage of pain-free IV starts.

Purpose:

The aim of this study is to assess the effectiveness of Pain Ease® spray, used as an adjunct to Ametop Gel™.

Hypothesis:

The investigators hypothesize that using Pain Ease® spray as an adjunct to the standard use of Ametop Gel™ will increase the number of pain free venipunctures from 30% to 50% or more.

Objectives:

Primary Objective

1. To determine if using Pain Ease® spray as an adjunct to Ametop Gel™ will increase the number of pain free venipunctures Secondary Objectives
2. To document the side effects of Pain Ease® spray and Ametop Gel™
3. To document the number of attempts for a successful IV insertion

Research Design:

The investigators propose a patient-blinded randomized control trial of Ametop Gel™ with and without Pain Ease® spray as an adjunct.

Statistical Analysis:

An interim analysis will be performed at the study's halfway point after recruitment of 120 participants. A score on the Faces Pain Scale - Revised (FPS-R) of either 0 or 2 will be considered a pain-free IV start, while a score of 4-10 will be considered a painful IV cannula insertion. Fischer's Exact test will be used to determine statistical significance; a critical alpha of 0.05 will be considered for significance.

Eligibility Criteria:
Inclusion Criteria:

* ASA I \& II
* Elective day case procedure requiring an IV

Exclusion Criteria:

* Planned IV insertion after inhalation induction
* Developmental delay or inability to interpret the Revised Faces Pain Scale (FPS-R)10
* Ametop Gel™ application \< 30 minutes before estimated IV start at time of screening
* Allergies to any of the components in Ametop Gel™, Pain Ease® spray, or adhesives
* Patients receiving sedative pre-medication
* Severe Needle phobia
Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Nail Psoriasis

The primary aim of the study is to assess the effect of methotrexate on the development of distal interphalangeal joint extensor tendon enthesopathy.

Nail psoriasis is one of the risk factors for psoriatic arthritis (PsA), especially with distal interphalangeal joints affected. Nail changes in psoriasis have been observed in 10-55% of patients, and the nail psoriasis-related inflammation can spread to adjacent structures, including DIP joints and digital extensor tendons. Enthesopathies are among the characteristic features of psoriatic arthritis. In everyday practice, assessment of psoriatic changes in nails is based mainly on clinical indices, such as nail psoriasis severity index (NAPSI) and modified NAPSI (mNAPSI), while imaging examinations, such as ultrasonography are performed much less frequently.

The findings of this study may assess the reasonableness of systemic treatment of nail psoriasis in patients without arthritis as enthesopathy prevention as well as the usability of US nail examinations in Ps and PsA patients in assessment of morphological changes and a response to treatment.

A US examination of nails and distal interphalangeal joint extensor tendons are conducted in all of the patients twice at an interval of six months. The examination is conducted by a rheumatologist experienced in ultrasound examinations of the skeletal and muscular system. An assessment of the nails, extensor tendons and DIP joints is made by placing the head on the dorsal side. In order to avoid pressure on surface tissues, an appropriate amount of gel without gel pads was used. The intensified blood flow, made visible by the PD technique, is confirmed by pulsed wave Doppler spectrum. The nail thickness is measured as the maximum distance between the dorsal and ventral nail plates. The nail bed thickness is measured as the distance between the ventral plate and the bone margin of the distal phalanx. The nail matrix thickness is measured at the proximal end of the nail bed.

The study was approved by the Bioethics Committee of the Warmia and Mazury Chamber of Physicians The study are conducted according to the Good Clinical Practice guidelines. Each participant signs an informed consent and be coded with unique ID.

Results of analyses will be saved by indexing with ID code only, personal data with individual IDs will be saved in additional file. All hard copy will be archived in secure room with coded electronic key.

Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriatic changes in nails treated at the Rheumatological Clinic in Olsztyn and the Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology of the University of Warmia and Mazury in Olsztyn, in whom a US examination revealed DIP joint extensor tendon enthesopathy

Exclusion Criteria:

* Patients diagnosed with osteoarthritis of hands, those who work hard physically and those with changes in nails other than caused by psoriasis