cyrilzakka/clinical-trials huggingface dataset:
Ciclosporin to Protect Renal Function In Cardiac Surgery

The purpose of this study is to evaluate the potential of ciclosporin in reducing risk and degree of acute kidney injury after cardiac surgery.

Acute kidney injury (AKI) is a common complication after cardiac surgery and is associated with decreased long-term survival. The mechanism for inducing acute kidney injury is unknown but ischaemia-reperfusion injury is indicated to be a part of the cause.

Animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of ciclosporin in ischaemia-reperfusion injury in the kidney. The major mechanism is thought to be inhibition of the reperfusion triggered opening of the mitochondrial permeability transition pore (mPTP), responsible for reperfusion-induced necrosis. During cardiac surgery, the period of extracorporeal circulation (ECC) changes the perfusion through the kidney. Return to normal perfusion with a beating heart has similarities with reperfusion following ischemia.

Administration of ciclosporin in conjunction with percutaneous coronary intervention (PCI), heart surgery and traumatic brain injury (TBI) in humans has shown to be safe with no direct side-effects.

The investigators therefore hypothesize that a preconditioning effect of ciclosporin before coronary artery bypass grafting (CABG) can reduce the level of renal dysfunction after this type of cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Non-emergent CABG
* Written informed consent to participate
* Preoperative CyC eGFR or MDRD eGFR is 90-15.

Exclusion Criteria:

* Uncontrolled hypertension
* Hypersensitivity to ciclosporin or any of the excipients of the lipid emulsion, including egg-, soya- or peanut protein
* Pregnancy or fertile woman
* Ciclosporin treatment within 4 weeks
* Ongoing malignancy, ongoing immunosuppressive treatment, severe hepatic dysfunction, dialysis or severe infection
* Ongoing medication with dabigatran, aliskiren, bosentan, stiripentol, glibenclamid, St John's worth, or
* Off-pump surgery
Immediate Breast Reconstruction With Free Greater Omentum

Luminal subtype breast cancer, accounting for 70 to 80% of all breast cancers, has been reported to be associated with good prognosis. However, for the patients with large mass or worse mass position, free greater omentum transplantation may provide a new option for breast reconstruction.

Breast-conserving surgery, laparoscopic greater omentum harvest and vascular anastomosis was carried out orderly. The omentum was harvested laparoscopically, following breast-conserving surgery . Following the remove of resected omentum, the harvested greater omentum was poured by ice protection fluid from right gastric omentum artery. Besides, right arteriovenous vein of stomach omentum was dissected carefully under microscope. When operation started, front latissimus dorsi was separated from subaxillary incision, as well as the right thoracic dorsal artery and accompanying vein. Separated greater omentum was put on the subcutaneous deficient site of right breast incision and vascular pedicle was pulled through tunnel, reaching to the axillary incision. Under the help of microscope, vascular anastomosis between right stomach omentum arteriovenous and right thoracic dorsal arteriovenous was proceeded. Consequently, greater omentum was filled to shape the reconstructed breast. Finally, drainage tube and drainage strip were left at subcutaneous and subaxillary incision, respectively.

Eligibility Criteria:
Inclusion Criteria:

- Patient aged 18 -60 years Patient diagnosed with luminal breast cancer No neoadjuvant chemotherapy previously No distant metastasis Suitable for breast conserving surgery Willing and able to give written informed consent to participate in the study including all follow-up examinations

Exclusion Criteria:

- Participate in another clinicaltrial Bilateral lesions Pregnancy or lactation Greater omentum unable to extract or insufficient omentum Other surgical contraindication
Individual Patient Expanded Access to CA102N

This study is an individual patient expanded access protocol that the subject enrolled had completed the combination treatment of CA102N plus Lonsurf for at least 12 cycles.

In the individual patient expanded access, the subject who was enrolled in Phase 1 trial (Study Number: HS-CA102N-101) Part 2 (dose expansion) and had completed at least 12 treatment cycles with CA102N combined with trifluridine /tipiracil (LONSURF) will be provided access to treatment with CA102N (0.72 mg/kg Nimesulide Equivalent of CA102N).

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Chiropractic T Cell Study

Some studies suggest that specific chiropractic care (techniques known as "spinal manipulation therapy") can have benefits to the immune system but studies are scarce, sample sizes small, and methodology and analyses often not of the highest scientific standards. The investigators will example how 36 sessions of chiropractic care over 9-12 weeks can impact immune cell function using a randomized clinical trial design.


Eligibility Criteria:
Inclusion Criteria:

* Must be between the ages of 18-70.
* Must exhibit vertebral subluxation as measured by a misalignment between one or more vertebrae in relation to normal spinal alignment.
* Have not been sick for the past 3 weeks (immune function).
* Non-smoker.
* Must be able to fast for 10-12 hours.

Exclusion Criteria:

* To have had a chiropractic intervention within the past 6 months.
* To have a condition that may limit the ability to apply a high velocity, low amplitude (HVLA) thrust to the spine such as but not limited to ligament damage, reduced bone density, or other factors that weaken the body's ability to withstand reasonable care (bone cancer, fractures, osteoporosis, etc.)
* To have excessive scoliotic curvature of the spine (\> 30º) as measured by identifying the first vertebrae, and the most laterally displaced vertebrae that exhibits tilt below it.
DirectVision for Urinary Catheterization

The Center for Disease Control and Prevention (CDC) reports that one in four patients hospitalized in the United States is catheterized to void the bladder or monitor urinary output. In the male population, Dr. Singh, an urologist estimates that about 20% of catheterizations are difficult. Driving a catheter blindly, guessing whether to push the catheter forward or manipulate it to get around a point of resistance leads to the risk of injury which increases the more the catheter is manipulated. Additional adverse events include: urosepsis, UTI and bladder perforation. The standard of care treatment for patients with difficult urinary catheterization (DUC) is to proceed with a cystoscopic catheter placement or suprapubic tube placement.

PercuVision has the only Foley catheter with a micro-endoscope for visualization and navigation of the urethra for nurses and other qualified health care professionals. Moreover, it allows urologists to place a guidewire under direct vision rather than calling for a flexible cystoscope which is considered a minor procedure.

In this study, the investigators plan on assessing the effectiveness and ease of use of the PercuVision DirectVision® System device.

Routine placement of transurethral catheters can be challenging in some situations, such as urethral strictures, severe phimosis and false passages. Intravaginal retraction of the urethral meatus can complicate Foley placement in postmenopausal females. In men, blind urethral procedures with mechanical or metal sounds without visual guidance or guidewire assistance are now discouraged due to the increased risk of urethral trauma and false passages.

DirectVision is a new visually-guided catheterization device (VGCD) that uses a camera visual guide / microendoscope within a triple lumen flexible urinary catheter with an angled tip, essentially combining the functionality of a urinary catheter with a cystoscope. DirectVision uses fiber-optic bundle of 6,000 integrated fibers to provide illumination and transmit real-time video.

Procedures done via flexible cystoscopy or DirectVision are covered by insurance (including Medicaid/Medicare).

In this prospective study, the investigators plan on assessing the effectiveness and ease of use of DirectVision - A direct visualization system for urinary catheterization.

Eligibility Criteria:
Inclusion Criteria:

* Any patient over 18 years with a standard indication for difficult urinary catheterization

Exclusion Criteria:

* Any patient younger than 18 years of age, pregnant patients
Nutrition, Arsenic and Cognitive Function in Children

The main goals of this study are to evaluate whether supplementation with folate and vitamin B12 to 8 to 10 year old children, in conjunction with reduction in arsenic exposure, can increase arsenic methylation and lower blood arsenic and blood monomethyl arsenic (as previously observed in adults). The investigators will also explore whether folate and B12 can mitigate arsenic-related decrements in cognitive abilities.

While reducing arsenic (As) exposure in Bangladesh and the U.S. must continue to be a top priority, this has proven difficult. After decades of efforts to reduce exposure, 42 million people in Bangladesh remain exposed to As above 10 µg/L, the WHO guideline for As in drinking water. Risk for arsenic-related health outcomes lingers for decades after exposure has been reduced. Innovative strategies to lower arsenic exposure and and reduce its potential adverse health effects of As are needed.

Eligibility Criteria:
Inclusion Criteria:

* Age-eligible children of parents enrolled in the Health Effects of Arsenic Longitudinal Study cohort

Exclusion Criteria:

* siblings
* twins
* children who are not attending school
* children with known physical disability or known chronic illness
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions

To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Safety and Efficacy of Three Variants of Canaloplasty With Phacoemulsification to Treat Glaucoma and Cataract

It is a comparative study of Safety and Efficacy of Three Variants of Canaloplasty: ab-externo, ab-interno and minicanaloplasty. Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.


Eligibility Criteria:
Inclusion Criteria:

* co-existing glaucoma and cataract
* glaucoma types: primary open angle glaucoma,
* eye with characteristic glaucoma changes (biomicroscopic,visual field)
* IOP over 21 mmHg after washout
* patients not tolerating antiglaucoma medications,
* patients with poor compliance
* progression in visual field

Exclusion Criteria:

* previous surgical glaucoma procedure
* previous cataract surgery
* BCVA under 0,004
* closed angle glaucoma secondary glaucoma (pseudoexfoliative, pigmentary)
* poorly controlled diabetes mellitus
* advanced AMD
* active inflammatory disease
* pregnancy
* mental disease or emotional instability general steroid therapy
Clinical Evaluation of PROMIS in CKD

The purpose of this study is to evaluate the clinical validity of a set of PROMIS pediatric person-reported outcome measures in patients with chronic kidney disease. The evaluation includes longitudinal assessments of how measures change in association with clinical changes.

The National Institutes of Health (NIH)-sponsored Patient-Reported Outcomes Measurement Information System (PROMIS) network has developed over 20 pediatric instruments, both child-report and parent-proxy editions. Cross-sectional evaluations of the validity of the instruments have established that they are ready for integration into clinical research and practice. The next step in their ongoing evaluation is to assess their prospective clinical validity in a variety of health conditions. This study addresses the clinical evaluation of the measures in children with chronic kidney disease (CKD).

Through baseline surveys and six follow-up surveys over a two-year period, Investigators are collecting self-report (child) and parent-proxy report of 11 pediatric PROMIS measures. Each of these PROMIS measures is described in the Main Outcome Measures section. Investigators are also collecting assessments of disease activity from clinical data. The selection of self-report and parent proxy patient-reported outcome (PRO) measures were determined through qualitative content validation. The analytic goal of this project is to evaluate baseline (cross-sectional) and longitudinal associations between PROMIS pediatric outcome measures and changes in the clinical status of patients with CKD. Our primary hypothesis is that as kidney function declines, self-reported health will worsen.

Eligibility Criteria:
Inclusion Criteria:

* Child is 8-21 years old at time of enrollment
* Child is a Chronic Kidney Disease in Children (CKiD) patient OR a child who receives pediatric nephrology care at a CKiD site that participates in PEDSnet, a national pediatric learning health system
* Child seen by a pediatric nephrologist in the past 24 months
* Child has two eGFR readings (computed from serum creatinine) between 6-89 ml/min at least 3 months apart (eGFR of this level indicates CKD)
* Child speaks English
* Parent is the parent or legal guardian for the child
* Parent speaks English

Exclusion Criteria:

* Child is currently receiving dialysis
* Child received a kidney transplant
* Child has a parent-reported cognitive limitation that would preclude them from completing a questionnaire
* Child does not speak English
* Parent does not speak English
* Parent is not the parent of legal guardian for the child
Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

Validate the use of fetal urine peptidome-analysis and explore amniotic fluid markers for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.

The ANTENATAL project requires the use of fetal urine as well as post-natal urine, post-natal serum and, possibly, amniotic liquid. We will take an additional tube during the takings collected for routine management of the disease.

The analysis of samples will be carried out in Toulouse at the Institute of Metabolic and Cardiovascular Diseases or with fee-for-service suppliers.

Eligibility Criteria:
Inclusion Criteria:

* male singleton fetus with megabladder associated with urinary tract anomalies with or without dysplastic or hyperechogenic parenchyma detected in a first ultrasound;
* megabladder confirmed in a second ultrasound;
* collection of fetal urine taken during the routine management of the disease for the dosage of ß2-microglobulin;
* written informed consent.

Exclusion Criteria:

* refusal to participate in the study;
* person protected by law.
Immunotherapy of Melanoma Patients

The purpose of this study is to test whether vaccination with antigenic peptides induces an immune response in the vaccine site sentinel lymph node of patients with microscopically detectable lymph node melanoma metastases.

The study is designed for patients with skin melanoma and lymph node micrometastasis previously diagnosed by a sentinel node procedure. As a result of their diagnosis, the patients are scheduled for lymph node dissection. Before this is done, patients are vaccinated with antigenic peptides. The peptides are mixed with the adjuvant SB AS-2 or Montanide and injected in a lower limb not affected by the disease. The skin site of vaccine injection is marked with a permanent pen where, two weeks later, patent blue and 99technetium is injected. These markers allow one to locate the vaccine site sentinel node (VSSN) which will be removed during the lymph node dissection at the diseased limb.

The aim of the study is to test whether the vaccine has induced an immune response in the lymph node that drains the vaccine site.

Eligibility Criteria:
Inclusion Criteria:

* Patients with microscopically detectable lymph node metastases
* Positive detection of the Melan-A gene +/- MAGE-10 in positive sentinel node or primary tumor tissue by polymerase chain reaction (PCR) analysis of mRNA and/or by immunohistochemistry using monoclonal antibodies
* Human leukocyte antigen-A2 (HLA-A2) positive

Exclusion Criteria:

* Previous splenectomy or radiotherapy to the spleen
* Treatment with systemic antihistamines, corticosteroids, or non-steroidal anti-inflammatory drugs (except occasional or low dose non-steroidal anti-inflammatory drugs such as 100 mg aspirin/day) within 4 weeks of entry into the study
* Heart disease (New York Heart Association \[NYHA\] Class III or IV)
* Serious illness, e.g. active infections requiring antibiotics, bleeding disorders or other diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study
Culturally Based Brief Expressive Writing Intervention for the Improvement of Health in Chinese Immigrant Stage 0-III Breast Cancer Survivors, Writing to Heal Study

This clinical trial studies the effect of a culturally based brief expressive writing intervention in improving the health of Chinese immigrant stage 0-III breast cancer survivors. Culturally based brief expressive writing interventions may help researchers learn more about the experiences of Chinese immigrant breast cancer survivors and how writing about their experiences may affect their health.

PRIMARY OBJECTIVES:

I. To determine the health benefits of expressive writing compared with the control condition.

II. To characterize how acculturation moderates the effects of expressive writing interventions.

III. To identify mechanisms explaining the benefits of the interventions using mixed methods.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I (CONTROL): Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions.

ARM II (SELF-REGULATION): Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions.

ARM III (SELF-CULTIVATION): Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions.

After completion of study, patients are followed up at 6 weeks and at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Being diagnosed with stage 0-III breast cancer.
2. Completed primary treatment, including surgery, chemotherapy, radiation therapy, immune therapy, and/or targeted therapy within the preceding 5 years.
3. Foreign-born Chinese women (aged 18 and older) who lived in the U.S. for at least six months in the past.

Exclusion Criteria:

1. Exclusion criteria include inability to provide informed consent
Parental Perceptions on Prescription Opioid Use

This study involves an anonymous survey given to parents regarding their perceptions on prescription opioid use for pain control in children undergoing orthopedic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Parents of patients between 1-18 years of age scheduled for orthopedic surgery at Nationwide Children's Hospital.

Exclusion Criteria:

* Parents with children less than 1 or greater than 18 years of age or scheduled for surgery other than orthopedic.
* Non-English speaking parents.
The Effects of Dual Task Training in Individuals With Parkinson's Disease

The primary aim of the proposed project is to characterize dual tasking (DT) deficits to improve motor, cognitive, and quality of life outcomes in individuals with Parkinson's disease (PD). Phase 1 of the intervention will involve an in-depth gait analysis on 15 individuals with PD. This gait analysis will utilize the Computer Assisted Rehabilitation Environment (CAREN) system, a virtual reality system with a fully integrated 3-D motion capture system. The purpose of Phase 1 is to generalize characteristics of gait and postural control during specific DT conditions. Phase 2 (N=20) involves the clinical translation of these findings. This phase will involve creating a clinical intervention based on the objective information gathered the CAREN system. The intervention will take place 3x/week for a total of 8 weeks. Interventional groups will include: 1) DT clinical group (N=10) and 2) Single task group (N=10). Outcome measures will be used at the beginning and end of the intervention to assess the feasibility and efficacy of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic PD
* Able to provide informed consent
* Ability to ambulate ≥ 300ft with or without an assistive device
* Hoehn and Yahr stage 2-4

Exclusion Criteria:

* Undergone any surgical procedure for the treatment of PD, such as deep brain stimulation
* Those who are considered to be high risk exercisers per American College of Sports Medicine exercise screening questionnaire
* Musculoskeletal injury or neurological injury other than PD that would restrict physical activity
* Inability to follow 2 step commands
* Significant cognitive impairment as designated by ≥ 3 errors on the Short Portable Mental Status Questionnaire
Baby Item Learning and Development Study

The goal of this study is to experimentally test whether baby items can promote healthy infant development.


Eligibility Criteria:
Inclusion Criteria:

* Mothers and their infants must be healthy with no known birth complications
* Infants must be born full term (at least 37 weeks gestation)
* Mother must speak English
* Mothers must be at least 28 weeks along in their pregnancy. Mothers with newborns who are less than 2 weeks will be included.

Exclusion Criteria:

* Participants who does not meet all the inclusion criteria.
Project PARIS: Parents and Residents in Session

The study seeks to implement and test a novel approach to teach pediatric residents about patient and family-centered care (PFCC). The approach calls for a supervised meeting between a family member of a previously hospitalized child and a resident in the context of a pediatric residency rotation.

A specific patient and family centered care module will be implemented in the context of an existing training rotation. This module includes a meeting between resident physicians (trainees) and parents of previously hospitalized children (members of the Family Faculty in our institution), monitored by a senior faculty member. Patient and family centered care will be discussed using predefined, manual-driven guidance. This meeting is followed by a discussion with the faculty member to identify core components of family-centered care as exemplified in the parent interview.

Eligibility Criteria:
Inclusion Criteria:

* Residents in good standing in a pediatric residency at Mount Sinai Medical
* Center who agree to participate in the study

Exclusion Criteria:

* Residents who did not agree to participate
* Residents who have less than 3 months to complete their residency