cyrilzakka/clinical-trials huggingface dataset:
Generation of an Induced Pluripotent Stem (iPS) Cell Bank Immune Matched to a Majority of the US Population

The purpose of this study is to develop a collection of iPS cells called a bank ("Bank") that are immune-matched to a large percentage of the US population by containing the most common HLA haplotypes in the US population.

This study is being done to produce a bank of iPS cells that researchers from around the world can use for many different purposes. Some examples of such uses include basic research, discovery of new medicines, developing new products and services useful for studying human disease, and developing new cell-based products useful for treating people that have diseases. The idea of using cells made from human iPS cells to treat human diseases is of great interest in medicine. In this bank, a single donor's cells could be used to treat many people.

The iPS cells that are made as part of this study will be included in a bank owned by CDI. The iPS cells and the cells made from them will be available for laboratory research or for clinical use in patients. It is possible that the iPS cells made from the blood donated and cells made from the iPS cells could be beneficial to many different patients and be used for many different research projects to understand human biology and disease.

Eligibility Criteria:
Inclusion Criteria:

1. Be associated with an NMDP/Be The Match-operated donor center or non-operated donor center that has an IRB Authorization Agreement with the NMDP IRB and allows NMDP staff to directly contact their donors
2. Possess an HLA haplotype of interest to the Study
3. Be at least 18 years of age and not past 61st birthday
4. Meet the following criteria and requirements:

4.1 Meet the donor requirements under 21 CFR 1271 and related August 2007 guidance 4.2 Body weight of at least 110 pounds 4.3 Complete and pass the abbreviated Health History Screening questionnaire 4.4 Complete and pass the full Health History questionnaire after donor enrollment 4.5 Non-reactive for any FDA-listed relevant communicable disease agent 4.6 Non-reactive for cytomegalovirus (CMV) 4.7 Express blood group O

Exclusion Criteria:

1. Be unwilling or unable to give informed consent
2. Be pregnant
3. Have a prior history of: (i) a bone marrow transplant, or (ii) cancer of any type
Predictors of Postoperative Complications in Surgery With Pneumoperitoneum in the Trendelenburg Position

Evaluate early postoperative complications after surgery in Trendelenburg position with increased intraabdominal pressure (surgery with pneumoperitoneum). Evaluate the relationship between hemodynamic and metabolic changes on perioperative outcome.


Eligibility Criteria:
Inclusion Criteria:

* ASA Class I-IV.
* Planned for laparoscopic surgery in the Trendelenburg position that is expected to last more than 2 hours.
* Planned arterial catheter insertion.

Exclusion Criteria:

* Pregnancy.
* Planned open abdominal surgery.
* Renal Replacement Therapy.
Copeptin in Adolescent Participants With Type 1 Diabetes and Early Renal Hemodynamic Function

Over 1.25 million Americans have type 1 diabetes (T1D), increasing risk for early death from cardiorenal disease. The strongest risk factor for cardiovascular disease (CVD) and mortality in T1D is diabetic kidney disease (DKD). Current treatments, such as control of hyperglycemia and hypertension, are beneficial, but only partially protect against DKD.

Hyperfiltration is common in youth with T1D, and predicts progressive DKD. Hyperfiltration is also associated with early changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure. Intrarenal hemodynamic function is strongly influenced by the renin-angiotensin-aldosterone system (RAAS), which is also considered a key player in the pathogenesis of DKD. Preliminary data demonstrate differences in intrarenal hemodynamic function and RAAS activation in early and advanced DKD in T1D. However, the pathophysiology contributing to the differences observed in RAAS activation and intrarenal hemodynamic function in T1D are poorly defined Animal research demonstrates that arginine vasopressin (AVP) acts directly to modify intrarenal hemodynamic function, but also indirectly by activating RAAS. Preliminary data suggest that elevated copeptin, a marker of AVP, which predicts DKD in T1D adults, independently of other risk factors. However, no human studies to date have examined how copeptin relates to intrarenal hemodynamic function in early DKD in T1D. A better understanding of this relationship is critical to inform development of new therapies targeting the AVP system in T1D. Accordingly, in this study, the investigators propose to define the relationship between copeptin and intrarenal hemodynamics in early stages of DKD, by studying copeptin levels, renal plasma flow, and glomerular filtration in youth (n=50) aged 12-21 y with T1D duration \< 10 y.


Eligibility Criteria:
Inclusion Criteria:

* Antibody+ T1D with \<10 yr duration
* Age 12-21 years
* BMI ≥ 5%ile
* Weight\<350 lbs and \> 57 lbs.
* No anemia
* HbA1c \<12%

Exclusion Criteria:

* Severe illness, recent diabetic ketoacidosis (DKA)
* Estimated Glomerular Filtration Rate (eGFR) \<60ml/min/1.73m2 or creatinine \> 1.5mg/dl or history of ACR≥300mg/g
* Anemia or allergy to shellfish or iodine
* Pregnancy or nursing
* MRI scanning contraindications (claustrophobia, implantable devices, \>350 lbs)
* Angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), diuretics, sodium-glucose co-transport (SGLT) 2 or 1 blockers, daily NSAIDs or aspirin, sulfonamides, procaine, thiazolsulfone or probenecid, atypical antipsychotics and steroids
Spinal Cord Injury Collaborative Care Study

The objective of this study is to test the effectiveness of a collaborative care approach to improving outpatient treatment for inactivity, chronic pain and depression as a way of improving overall Quality of Life for patients with SCI.

Individuals with SCI were treated by a care manager who worked in collaboration with the participant's physician to decrease pain, decrease depression symptoms, and/or to increase physical activity. This was done by collaborating on current treatments to make sure that they are being as effective as possible and by providing non-pharmacological treatments.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* diagnosis of traumatic spinal cord injury by medical record review
* receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic
* positive screening for pain related to SCI diagnosis and/or
* positive screening for low mood and/or
* negative screening for physical activity levels
* able to speak and understand English

Exclusion Criteria:

* psychiatric condition that would interfere with participation
* major surgery in the next 8 months
A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease

The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Subject is \>= 20 years of age.
* Subject is diagnosed with CKD Stage 5, and must be on maintenance (chronic) hemodialysis (HD) three times a week for at least 2 months prior to the Screening Visit and expected to remain on HD for the duration of the study.
* If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:

  * Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
  * Contraceptives (oral or parenteral) for three months prior to study drug administration
  * In a monogamous relationship with a vasectomized partner
* If female, subject is not breastfeeding and has a negative serum pregnancy test prior to the treatment phase.
* Subject has an intact PTH value \> 200 pg/mL at Screening only (or Re-screening, if applicable).
* Subject has a serum calcium level \< 10.2 mg/dL at Screening only (or Re-screening, if applicable).
* Subject has a serum phosphorus level \< 6.5 mg/dL at Screening only (or Re-screening, if applicable).
* Subject has a CaxP product \<= 65 at Screening only (or Re-screening, if applicable).
* Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the conduct of any study-specific procedure.

Exclusion Criteria:

* Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
* Subject has chronic gastrointestinal disease, which in the Investigator's opinion, may result in clinically significant GI malabsorption.
* Liver function defects defined as \> 2 times the upper limit of normal for liver enzyme (SGOT/AST, SGPT/ALT) levels.
* Subject has a hemoglobin level \< 9.0 g/dL.
* Subject is taking maintenance calcitonin, Sensipar® (cinacalcet), glucocorticoids in an equivalent dose \> 5 mg prednisone daily, or other drugs that may affect calcium or bone metabolism within 2 weeks prior to screening, other than females on stable (same dose and product for 3 months) estrogen and/or progestin therapy.
* For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive pharmacological doses of vitamin D.
* Subject has received any investigational drug within 4 weeks prior to the Treatment Phase.
Lidocaine and Perioperative Cytokine Levels in Blood and Cerebrospinal Fluid in Cerebral Aneurysm Patients

Cerebral aneurysm surgery has significant mortality and morbidity rate. Inflammation plays a key role in the pathogenesis of intracranial aneurysms, their rupture, subarachnoid haemorrhage and neurologic complications. Brain injury activates immune cells and triggers cytokine release. Cytokine level in blood and cerebrospinal fluid is an indicator of inflammatory response. Cytokines contribute to secondary brain injury and can worsen the outcome of the treatment. Preventing secondary brain injury by modulating inflammatory response represents a therapeutic target. Lidocaine is local anesthetic that can be used in neurosurgery for regional anesthesia of the scalp and for topical anesthesia of the throat prior to direct laryngoscopy and endotracheal intubation. Except analgetic, lidocaine has systemic anti-inflammatory and neuroprotective effect. It acts through several mechanisms on various types of immune cells producing immunosuppressing effect. Lidocaine can act on activated microglia within central nervous system causing attenuation of immune response.

Primary aim of this prospective randomized trial is to determine influence of lidocaine administration on inflammatory cytokine levels in serum and cerebrospinal fluid during and following cerebral aneurysm surgery. Secondary aim is to determine possible correlation between levels of cytokines and incidence of neurologic and infectious postoperative complications. For that purpose, postoperative neurological clinical status will be recorded. Signs of vasospasm and pathological postoperative brain CT scan findings will be recorded. Incidence of meningitis, pneumonia and sepsis in postoperative period will also be analyzed.

Hypothesis of this trial is that lidocaine administration during cerebral aneurysm surgery would significantly change levels of pro-inflammatory cytokines in cerebrospinal fluid and serum. Lower concentrations of pro-inflammatory cytokines can possibly contribute to better outcome and significantly lower incidence of postoperative complications. Enzyme-immunochemical analysis will be used to measure levels of interleukin-1β, interleukin-6 and tumor necrosis factor-α in cerebrospinal fluid and serum. Investigation group will have, during cerebrovascular surgery under general anesthesia, regional anesthesia of the scalp and topical anesthesia of the throat prior to laryngoscopy, all done with lidocaine. Control group will have general anesthesia without lidocaine administration.


Eligibility Criteria:
Inclusion Criteria:

* ASA ( American Society of Anesthesiologists) grading status I-III,
* scheduled for cerebral aneurysm surgery under general anesthesia,
* signed informed consent for participating in the research.

Exclusion Criteria:

* poorly controlled chronic or acute cardiovascular, respiratory or autoimmune disease,
* acute infectious disease,
* renal or hepatic insufficiency,
* preoperative Glasgow Coma Scale score lower than 15,
* allergic reaction to any of the medications in protocol,
* pregnancy
* refusal to participate in the research.
A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity

The goal of this randomized clinical trial is to learn if topical treatment with ATR04-484 can treat skin rash in patients undergoing EGFR inhibitor (EGFRi) therapy. The primary goal of the study is to determine safety and tolerability of ATR04-484, and the secondary goal of the study is to assess efficacy signals of ATR04-484. Researchers will compare treatment of ATR04-484 to its vehicle. Participants will:

* Apply ATR04-484 or vehicle daily for 28 days
* Visit the clinic periodically for evaluation and sample collection

This is a multicenter, randomized, blinded, vehicle-controlled Phase 1/2 trial of topically applied ATR04-484 in adult patients with moderate to severe EGFRi-related non-infected dermal toxicity affecting the face. The neck, chest, back, and other areas may also be affected.

The safety, bioavailability, pharmacodynamics (PD), and preliminary effect of ATR04-484 (at a single concentration) will be compared to that of its vehicle, in 2 patient cohorts. In each cohort, eligible patients will be randomized (3:1 ratio) to ATR04-484 or its vehicle. The initial cohort (n = 8) will receive a single 4 g application of the study drug to the face, chest, and back, followed by a 7-day observation period. Upon completion of this observation period, the patients in this cohort may continue in the study with daily applications of study drug for an additional 28 days. Following a safety observation period, a subsequent cohort (n = 24) may be enrolled and will receive a 4 g application of the study drug once daily for 28 days. Each cohort will be followed for 28 days after the last application of study drug.

Clinical assessments of treatment effect will be evaluated at each area that has received a full application of study drug (coverage of all lesional surfaces). The primary endpoint is safety and tolerability. Secondary endpoints including clinical efficacy, including: (1) the severity of the dermal toxicity using a 5-point regional assessment scale, based on modified CTCAE descriptors for skin toxicity (including a score of 0 for clear or unaffected skin through 4 for severely affected skin); (2) numeric rating scales for pruritus and pain; and (3) a quality-of-life assessment (Functional Assessment of Cancer Therapy-EGFRI 18 \[FACT-EGFRI 18\]). Bioavailability of ATR04-484 will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Has Grade 2 or 3 non-infected moderate to severe EGFRi-related dermal toxicity affecting the face (the neck, chest, back and other areas may also be affected)

Exclusion Criteria:

* Significant skin disease other than EGFRi-related dermal toxicity
* Treatment with topical mid- to high-potency topical corticosteroids, or topical antibiotics or antibacterial washes on the face, neck, chest, or back within 14 days prior to baseline; treatment with systemic antibiotics or systemic corticosteroids within 14 days prior to baseline
* Residing with an immunocompromised person residing with them in the same dwelling from the baseline visit through 2 weeks after the treatment period
Parents As The Agent Of Change For Childhood Obesity (PAAC)

The objective of this study is to test and evaluate the effectiveness of a parent-only treatment for childhood obesity. This study provides state-of-the-art treatment for childhood obesity. Parents and children will participate in treatment groups for 6 months. These treatment groups include recommendations to decrease overall caloric intake (by increasing fruits and vegetables), increasing physical activity, decreasing sedentary behavior and changing the home food environment. We are currently implementing this treatment in the Healthy Choices Program which is part of the Childhood Obesity Clinic at the University of Minnesota. Len Epstein at the University of Buffalo has been publishing on this treatment protocol for 30 years.

The objective of this study is to pilot test and evaluate the efficacy of a parent-only treatment for childhood obesity. The central working hypothesis is that the parent-only treatment will result in greater weight loss for the overweight child as compared to the parent + child treatment. The specific aims of this application focus on comparing a behavioral parent-only intervention to a parent + child intervention for childhood obesity.

The primary aim of the proposed study is to compare the efficacy of the parent-only treatment to the parent + child treatment for childhood obesity.

The secondary aim is to compare treatment groups on change in the child and parent diet and exercise behavior, change in the home food environment, and parent weight post-treatment and at 6-months post-treatment.

This study is a randomized, clinical pilot trial evaluating two 6-month treatments for childhood obesity; parent + child and parent-only groups, with 6-months of post-treatment follow-up. The two treatments will differ in terms of the designated recipient of treatment, which will be delivered either to parents-only or to parents and children separately. Study outcomes will be assessed at baseline, immediately post-treatment, and 6-months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* An overweight child (\>95th%) in the family who is between the ages of 8-12.
* A parent willing to participate and attend all treatment meetings.
* Family willing to commit to 6 months of treatment attendance, and follow-up for 6 months post-treatment.
* Family willing to submit the $60 deposit.

Exclusion Criteria:

* Child psychiatric disorder diagnoses (based on parent report).
* Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed.
* Family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home.
* Child with physical difficulties that limit the ability to exercise.
* Child with an active eating disorder.

All exclusionary and inclusionary criteria are similar to those in previous studies of Epstein and colleagues and Golan and colleagues.
Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System

The Office of Evaluation Sciences is collaborating with Emory University and the Atlanta VA Health Care System to increase adult immunizations uptake among veterans. The intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the VA electronic health record system. The team will evaluate the intervention using a randomized controlled trial.

The Office of Evaluation Sciences is collaborating with Emory University and the Atlanta VA Health Care System to increase adult immunizations uptake among veterans. The intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the VA electronic health record system.

The intervention includes a bundled vaccination reminder for influenza, pneumococcal and TDap vaccines, an immunization dashboard that relays a patient's vaccination status and history, and talking points for providers to use in their dialogues with patients. This intervention was designed to mitigate potential bottlenecks to vaccination, based on conversations and observations with facility clinicians.

The team will evaluate the intervention using a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have appointments with active primary care providers (physicians, physician assistants and nurse practitioners) in the Atlanta VA Health Care System
Discharge Planning for Elderly Patients in the Emergency Department: Use of a Brief Phone Call After Discharge to Improve Medication Utilization and Physician Follow-up

The investigators hypothesize that the acquisition and correct utilization of medications as well as arranging and attending follow-up appointments will improve as a result of a phone call intervention 1-3 days after elderly patients are discharged from the emergency department (ED).

Older patients seen in the ED are at high risk of functional decline and return visits to the ED. Previous studies have shown that a comprehensive assessment by a geriatric specialist at the time of discharge from the ED along with extensive integration with home services and/or referral to community services can decrease functional decline and return visits to the ED as well as increase patient satisfaction, but this intervention is resource intensive requiring a geriatric discharge specialist to be available to the emergency department 24 hours a day/ 7 days a week. It is also known that in other patient populations telephone reminders to make follow up appointments can increase rate of follow up and that comprehension of discharge instructions is the primary barrier to compliance with discharge instructions. It has been shown that telephone follow-up interviews are feasible for geriatric patients discharged from the ED, and that many elderly patients discharged from the ED do not understand their discharge instructions or attend follow-up appointments. However, there are no published studies evaluating whether a follow up telephone call after discharge from the ED can improve patient compliance with the medical treatment plan including obtaining follow - up appointments and obtaining prescribed medications as well as using them appropriately. We seek to determine if we can increase compliance with medications and outpatient follow up with a phone call from a nurse provider 1-3 days after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or over
* Discharged from the UNC emergency department

Exclusion Criteria:

* In the hospital at the time of phone call follow-up
* Neither the patient nor their responsible party are able to pass a standardized test to assess cognitive function