cyrilzakka/clinical-trials huggingface dataset:
PK-PD Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients

The purpose of this study is to determine how fast children, who have had a recent kidney transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their prescribed dose. The results may lead to better dosing based on individual needs.

This is an open-label, inpatient-outpatient population pharmacokinetic-pharmacodynamic (PK-PD) study of mycophenolic acid (MPA) in pediatric subjects (age 2-17 years) who have had a recent kidney transplant, as well as during the stable renal transplant period when on a stable oral regimen of MPA. The primary objective of this study is to develop population pharmacokinetic-pharmacodynamic (PK-PD) models for mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) in order to improve individualized pediatric dosing. Subjects will have been receiving CellCept as part of their clinical standard of care. It is anticipated that the clinical portion of the study for each patient will be approximately six months post renal transplant with four study days: a screening visit pre-transplant, two 10-hour inpatient days at 2-3 and 6-9 days post-transplant, and one (up to 10 hour) outpatient visit at 3-6 months post-transplant. Pharmacokinetic and pharmacodynamic measurements will be conducted at various time points (up to 9 hours post dose) on study days 2, 3, and 4. Safety data to be collected will include physical examinations, measurement of vital signs, and laboratory assessments, as well as data on adverse events and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects and non-pregnant female subjects aged 2 to 17 years who are about to receive a kidney transplant and will be on post transplant MMF containing immunosuppressive therapy. Subjects may be enrolled up to their 18th year.
* Minimum weight of 11 kg.
* A signed and dated IRB approved parental / guardian informed consent form and an IRB-approved child assent form if applicable.
* A high probability for compliance with and completion of the study.
* For post-transplant study period: Subjects with stable kidney allografts who are at least 3 months post-transplant and who have received the same regimen of MMF (with cyclosporine or tacrolimus) for at least 30 days before the study visit (3-6 months post-transplant).
* May have clinically important abnormalities on clinical and /or laboratory evaluations only as these abnormalities relate to an underlying condition as determined by the principal investigator.
* Other variations from established normal ranges may be acceptable if they are not clinically significant in the opinion of the investigators.

Exclusion Criteria:

* Any medical condition (active or chronic) or prior surgery that may interfere with the pharmacokinetic behavior of MMF (absorption, distribution and elimination) as determined by the PI.
* Active systemic infection.
* History of substance abuse.
* Signs or symptoms of active hepatitis (a history of hepatitis B or C virus infection is permitted).
* Known history of or suspected infection with human immunodeficiency virus (HIV).
Comparison of Acute Tart Cherry Supplement Formulation and Dose on Inflammation and Oxidative Capacity

A comparison of acute tart cherry formations (juice vs. powdered) and doses (single vs. twice daily) on inflammation and oxidative capacity.

Participants will be randomly allocated to a group: one tart cherry capsule daily, two tart cherry capsules daily, one 8oz. bottle of tart cherry juice daily, two 8oz. bottles of tart cherry juice taken 8 hours apart, one placebo pill, and one 8oz. bottle of placebo. Participants will arrive to the lab at 8 am after an overnight fast of 10 hours. They will provide a blood sample and then ingest their study treatment. Participants will stay in the lab for a further 2 hours for additional blood draws then return to the lab in 6 hours for another blood draw. At this time if they are in a twice daily group they will receive their second treatment for the day. All participants will come back to the lab 24 hours later where they will give a blood sample and receive their next treatment. If they are in the twice daily group they will be provided with their next dose and given instructions to consume it in 8 hours. Participants will arrive 24 hours later for a final blood draw with no supplementation.

Blood samples will be measured pre-ingestion, 1 hour, 2 hours, 8 hours, 24 hours and 48 hours post-ingestion. Samples will be analyzed for plasma oxygen radical absorbance capacity (ORAC), uric acid (UA), and C-reactive protein (CRP).

Eligibility Criteria:
Inclusion Criteria:

* free of cardiovascular, metabolic and inflammatory conditions
* non-smokers
* no known allergy to cherries or cherry juice
* not be taking food supplements (turmeric/curcumin, cherry products, greens, etc.).

Exclusion Criteria:

* quit smoking less than one year ago.
* currently being treated for arthritis or an inflammatory condition.
* currently being treated for uncontrolled cardiovascular disease, high blood pressure, diabetes, fibromyalgia, or irritable bowel syndrome.
* pregnant.
* regularly consume cherries or are allergic to cherries or dairy.
* currently use anti-inflammatory medications,
* have used corticosteroids in the last two months.
EO Footprint as a Landmark During DAA THA

One of the goals of Total Hip Arthroplasty (THA) is to reconstruct leg length as adequately as possible. In order to achieve this one needs landmarks that are visible both on the templating X ray as well as during surgery. The classical posterior and lateral approaches often rely on the distance from the greater trochanter (GT) to the shoulder of the femoral stem or the distance from the lesser trochanter (LT) to the side of the neck osteotomy. If the surgeon finds out on the digital template that the distance from the GT to the shoulder of the implant should be X mm to achieve equal leg length, than the surgeon can try to reconstruct this during surgery. During the Direct Anterior Approach (DAA) these landmarks usually are not visible or require additional dissection injuring important soft tissue structures along the way. One anatomical structure that appears to be always visible during the DAA is the External Obturator tendon (EO). It was recently confirmed that the level of insertion of the EO onto the proximal femur can also always be determined on pre-operative X rays. It therefore represents one of the few landmarks that is visible both on the templating X ray as well as during DAA THA. Indeed, many hip surgeons, including ourselves, believe that if the shoulder of the femoral stem is near the insertion of the EO leg length cannot be far off. However, there is no clinical data to support this. The investigators would therefore like to the correlate the distance observed intra-operatively to the actual established distance on the post-operative X ray.


Eligibility Criteria:
Inclusion Criteria:

* All patient who underwent THA via DAA by a single surgeon who routinely documents the distance from the shoulder of the stem to the upper border of the EO tendon

Exclusion Criteria:

* Distance not noted
* No radiographs available
Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects

This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single IV infusion of \[14C\]-VVZ-149 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start of infusion to measure total radioactivity and plasma drug concentrations.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy, adult, male, 19-55 years of age, inclusive
* Continuous non-smoker
* BMI ≥ 18.0 and ≤ 32.0 kg/m2
* Medically healthy with no clinically significant medical history or findings
* Must agree to adhere to the contraception requirements

Key Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* History or presence of alcohol or drug abuse within the past 2 years
* History, presence or evidence of cardiovascular, renal or hepatic impairment
* Less or abnormal bowel movements
* Unable to refrain from or anticipates the use of any prohibited drugs
* Recent donation of blood/plasma or significant blood loss
* Radiation exposure within 12 months
* Participation in another clinical study within 30 days
Weight Stigma by Association in Parent-Child Dyads

Parents of children with obesity report feeling blamed for their children's weight and reluctant to seek pediatric care after stigmatizing experiences. This "weight stigma by association" may have direct consequences for parents, children, and the parent-child relationship. The present study builds on qualitative evidence to experimentally test weight stigma and weight stigma by association in a parent-child relationship using a large, community-based sample. In an experiment conducted via an online survey, participants were randomly assigned to view a picture of a parent-child dyad, for which parent and child's gender (male vs. female) and weight status (with obesity vs. without obesity) were manipulated. Participants read identical general parenting descriptions that adhered to American Academy of Pediatrics parenting recommendations, then rated the parent's effectiveness, helpfulness, and caring.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age

Exclusion Criteria:

* Standard exclusion criteria were duplicate IP addresses, response times \< 60s or \> 3600s (the allotted time to complete the survey), or failure to complete the parenting questionnaire.
Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

This study is designed to examine the effect of benzydamine hydrochloride to postoperative sore throat in pediatric patients. We will spray benzydmaine hydrochloride or normal saline at oral cavity and the tip of endotracheal tube, than compare the prevalence of postoperative sore throat using smartphone application in pediatric patients.

1. postoperative sore throat incidence (over 2) 1; no, 2;mild, 3;moderate, 4;severe
2. scoring of pain with smartphone application (kids pain scale)
3. incidence of use of rescue pain killer

Eligibility Criteria:
Inclusion Criteria:

* general anesthesia
* intubation require

Exclusion Criteria:

* recent upper airway infection
* could not express the pain
Efficacy and Safety Study of rhuMAb VEGF to Treat Metastatic Renal Cell Carcinoma

The purpose of this study is to determine whether rhuMAb VEGF (Bevacizumab) is safe and effective for the treatment of renal cell cancer when other treatments have failed.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Histologically confirmed, metastatic renal cell cancer (RCC) of clear cell histology
* Clinical or radiographic evidence of disease progression (as assessed by the investigator and reviewed by the Sponsor) during or after completion of one, and only one, cytokine-based regimen for metastatic disease
* At least 21 days since any prior therapy for RCC
* Prior nephrectomy
* Use of an acceptable means of contraception (potentially fertile men and women)
* ECOG performance status of 0 or 1
* Life expectancy \>= 3 months
* Age 18 years or older

Exclusion Criteria:

* RCC of papillary or collecting-duct type
* More than one nonsurgical therapy for metastatic RCC (note that medroxyprogesterone acetate not used for physiologic replacement or birth control is considered a therapy for RCC for the purposes of this study)
* Prior treatment with thalidomide
* Radiotherapy within 14 days of Day 0
* Current, recent (within 21 days of Day 0), or planned participation in an experimental drug study
* Pregnant or breast-feeding subjects
* Any of the following screening clinical laboratory values: 24-hour urine collection with \>= 1 g of protein; Serum creatinine \> 2.0 mg/dL; Absolute neutrophil count (ANC) \<500/mL; Platelet count \<75,000/mL; INR \>= 1.5; Total bilirubin \> 2.0 mg/dL; AST or ALT \> 5 x the upper limit of normal (ULN) for subjects with documented liver metastases or \> 2.5 x the ULN for subjects without evidence of liver metastases; Hemoglobin \< 9 gm/dL (may be transfused or receive epoetin alfa \[e.g., Epogen\] to maintain or exceed this level)
* Other invasive malignancies within 5 years of randomization (other than squamous or basal cell carcinoma of the skin)
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
* Inability to comply with study and/or follow-up procedures
B2RAD Translational Medicine Study

Recent advances in understanding the molecular and cellular pathology of many diseases have resulted in direct benefit to today's patients. The translational research studies that have led to these advances relied on an integrated model of clinical and non-clinical laboratory investigations based on the analysis of human biospecimens that lead directly to drug discovery, drug validation, novel detection assays, and prognostic marker discovery. Translational research provides a unique mechanism to address questions specific to particular tumor or other disease types, biological modifiers and/or mechanisms of action that are essential for the advancement of healthcare. Specimens are to be collected from subjects who are having or have had a surgical or medical procedure (such as fluid or tissue removed, a biopsy or a blood or bone marrow draw). Any subject in which the primary diagnosis of disease was made within the DHR Health System and Any subject choosing to give consent for participation will be included


Eligibility Criteria:
Inclusion Criteria:

1. Any subject choosing to give consent for participation will be included.
2. Any subject in which the primary diagnosis of cancer was made at the DHR Health System.

Exclusion Criteria:

1. Any subject deemed unable to provide legally effective consent.
2. Any pediatric subject where the subject does not freely give his or her assent or where his or her parent/guardian does not give consent.
Characterization of Dynamic Stability in Normal Pressure Hydrocephalus and Parkinson's Disease

This study aims to characterize dynamic stability disorders in two conditions mainly affecting the elderly and with similar walking deficits: hydrocephalus at normal pressure and Parkinson's disease, to provide the most relevant monitoring criteria in usual care.

Walking disorders in normal pressure hydrocephalus are manifested by slowing and ataxic gait, similar to disorders in Parkinson's disease. No studies in the literature have focused on advanced measures of dynamic stability in hydrocephalus at normal pressure, compared to Parkinson's disease, on large samples. The Laboratory of Analysis and Restoration of Movement, located in a Neurorehabilitation Department, provides quantitative data on gait and in particular dynamic stability as part of additional assessments to help patients follow up. Since 2010, people with normal pressure hydrocephalus or Parkinson's disease regularly benefit from these assessments. Retrospective analysis of all these data would help to better characterize motor disorders in hydrocephalus at normal pressure, by discriminating them from those associated with Parkinson's disease. It would lead to the definition of relevant indices to be used for patient follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patient who performed a walking test in the Laboratory Analysis and Restoration of Movement
* Diagnosis of normal pressure hydrocephalus or Parkinson's disease

Exclusion Criteria:

* Levodopa drugs administrated during a delay of 12 hours before walking test
* Presence of an other neurologic disease or of any disease associated with motor disorders in lower limb.
Health Research Participation: Experiences and Decisions of Military Members

The purpose of the study is to describe service members' experiences as participants in health research, including their reasons for deciding for or against research participation.

Recent studies of war injuries have included as research participants US military service members returning from wars in Iraq and Afghanistan. Despite the increased demand for military relevant research, little is known about the recent experiences of service members as research participants or about their research participation decisions.

The study aims are to: 1). Describe the experiences of military service members who have participated in health research; 2). Explore the reasons military service members decide for or against participation in health research; and 3). Identify effective strategies for promoting military service members' participation in research.

Demographic data will be collected from up to 50 service members who have participated in health research or who have previously declined research participation.

Up to 40 service members will participate in individual, in-depth, semi-structured interviews in person or via telephone.

Eligibility Criteria:
Inclusion Criteria:

* current US military member of any branch of service at time of screening
* experience as a research participant and/or previously declined participation in at least one health research study within the past three years
* age 18-80 years
* willing to participate in this study
* willing to be interviewed
* consents to participate

Exclusion Criteria:

* people who do not meet inclusion criteria
* unable to verbally communicate in English
Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope

The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent endotracheal intubation of critically-ill patients has not been well-described in the literature. This study will answer whether using a VL will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing urgent endotracheal intubation by a pulmonary critical care medicine physician

Exclusion Criteria:

* Difficult airway
* Oxygen saturation \< 92% despite adequate mask ventilation
Dual Mobility Cup Versus Unipolar Cup

The general purpose of this study is to examine whether the dual mobility cup (Novae® Serf) reduces the number of hip dislocations after total hip replacement, both early dislocation (≤1 year) and late dislocation (\>1 year) after primary THR compared with a conventional cup design (Trabecular MetalTM Modular Acetabular System).

Surgery with THR for arthritis and other hip disorders has long been one of the most successful orthopedic surgical treatments. The majority of the patients gain pain relief and experience improved hip function. In 2017, a total of 10,691 THRs were implanted in Denmark (annual report 2018).

Hip dislocation is a known complication after THR. It is a painful condition which may have far-reaching consequences for the patient, who may experience both physical and mental discomfort. Ultimately, multiple hip dislocations may result in reoperation.

In the literature, the incidence of hip dislocation is reported at 2-6 %, and a more recent review reports a risk of 0.5-10 %.

In Denmark, recurrent hip dislocation is the cause of 21 % of the reoperations per year according to The Danish Hip Arthroplasty Register. According to the British National Joint Registry (NJR) and the Australian register (AOANJRR), hip dislocation is the cause of 15.5 % and 21 %, respectively, of the reoperations.

The best method to avoid reoperation due to instability is to choose the correct implant for the individual patient and thereby spare the patient of having to endure a painful complication and yet another procedure. There are multiple risk factors for instability after THR, and increased use of dual mobility cups (DMC) is already documented.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hip arthritis who are amenable to surgery with THR and age ≥ 65 years referred to the Department of Orthopedic Surgery at either Section Farsø, Frederikshavn Hospital or Aalborg University Hospital. Patients who are willing to participate in the trial and who give their written, informed consent after receiving oral and written information.

Exclusion Criteria:

* Patients who do not wish to participate.
* Sequelae of Calvé-Legg-Perthes' disease, caput necrosis, epiphysiolysis.
* Proximal femoral or acetabular fracture.
* Hip dysplasia with subluxation Crowe types III and IV.
* Earlier hip bone surgery (excluding arthroscopic surgery).
* Elective bilateral surgery.
* If the patient's bone morphology is unsuitable for a cemented Exeter® femoral stem.
* Patients with no e-mail.
Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors

Current guidelines recommend endocrine treatment with aromatase inhibitors (AIs) in post-menopausal women with hormone receptor-positive breast cancer. Musculoskeletal symptoms are commonly reported with AI treatment,however, we do not have consistent methods to measure these symptoms prospectively. This gap in our knowledge inhibits the ability to test and develop treatments for AI-associated musculoskeletal symptoms. This pilot study will evaluate functional tests and standardized instruments for their ability to prospectively assess musculoskeletal symptoms in women being treated with AIs for breast cancer.

Specific Aims: 1) identify a core set of instruments for measuring musculoskeletal symptoms, 2) model the time course and predictors of change in musculoskeletal symptoms, 3) explore the effect of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment.

Methods: We will prospectively assess musculoskeletal symptoms due to treatment with aromatase inhibitors. Post-menopausal women beginning AI treatment for hormone responsive breast cancer will be invited to join this study.

Eligibility Criteria:
Inclusion Criteria:

* Women with stage I - IIIa invasive breast cancer,
* Hormone-receptor positive cancer (either ER+ or PR+ or both),
* Prescribed and have agreed to take exemestane, anastrazole or letrozole,
* Have completed initial treatment of surgery, RT, and/or chemotherapy,
* Are post-menopausal,
* No previous history of aromatase inhibitor therapy for invasive breast cancer,
* Have signed the consent form.

Exclusion Criteria:

* History of rheumatoid arthritis,
* Unable to read or understand English,
* History of psychiatric disability affecting informed consent or compliance with study procedures.