cyrilzakka/clinical-trials huggingface dataset:
Pooled Analysis of NHANES I/II--Race, Gender, and CHD

To conduct a pooled analysis of NHANES I/II data on race, gender, and coronary heart disease.

BACKGROUND:

Over the last 25 years, a sustained and marked decline in death rates from coronary heart disease (CHD) has occurred for all major segments of the U.S. population. Recently, however, the decline has proceeded less rapidly in blacks than in whites, and in women than men. These trends have focused further attention on possible heterogeneity in the risk factor patterns among the demographic sub-groups. Previous studies of CHD risk factors in blacks and whites using the First National Health and Examination Survey Epidemiologic Follow-up Study (NHEFS-I, 11-year follow-up), including this group's own work, demonstrate its potential strengths, while at the same time foundering on the problem of low statistical power. With the extension of the follow-up of NHANES-I cohort (1971-1974) to 1987 (14 years) and the completion of 14-year follow-up for NHANES II cohort (1976-1980), a strong rationale exists to undertake a "pooling project." The resulting data set would provide optimal characterization of CHD risk at the national level.

DESIGN NARRATIVE:

The study sought to determine whether data from NHANES I and NHANES II could be pooled. To accomplish this, the distribution of baseline measures was assessed and a determination was made whether the same logistic prediction equations fitted both studies. Also, gender-race differences were examined in individual exposure-outcome relationships, patterns of co-morbidity, and population attributable risks.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB

This project aims to test the effectiveness of ITACITINIB in sporadic Hemophagocytosis Lymphohistiocytosis (HLHs)

This project aims to test the effectiveness of ITACITINIB in sporadic Hemophagocytosis Lymphohistiocytosis (HLHs). The existence of an IFN-γ signature, in HLHs, is a strong rational for testing the use of a JAK1 inhibitor in the treatment of HLHs. We hypothesize that ITACITINIB, an inhibitor of JAK-1, may be a therapeutic of interest in the treatment of non-severe HLHs in replacement of corticosteroids by inhibiting the production and effects of IFN-γ but also those of other pro-inflammatory cytokines. The use JAK-1 inhibitor instead of corticosteroids in patients with HLHs without any sign of severity is justified by its probable lesser toxicity and higher efficiency.

In this proof of concept study, because of the vital risk associated with severe HLH and the efficacy of Etoposide in this setting, we will first include only patients with moderate HLHs

Eligibility Criteria:
Inclusion Criteria:

* Patients age \> 18 years,
* Patient is willing to provide written informed consent prior to enrolment and agrees to follow the protocol
* Patient known to have systemic juvenile idiopathic arthritis are classified as having HLH
* Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the duration of the study
* Be either affiliated to, or a beneficiary of, a social security category

Exclusion Criteria:

* Organ failure: confusion, organic kidney failure KDIGO 2 criteria, liver failure (Factor V \< 50%), heart failure, respiratory failure.
* Fibrinogen \< 0.50 g/l, platelets \<20G/L
* Indication to intensive care unit transfer on an organ failure requiring assistance (dialysis, Ventilation (assisted or VNI), shock regardless of the origin.
* Breastfeeding women
* Patient participating in another investigational therapeutic study
* Women with a positive pregnancy test or not willing to take contraceptive measures
* Known allergies, hypersensitivity, or intolerance to any of the ITACITINIB or excipients, or similar compounds
* Current or history of recurrent infections, including HBV, HCV
* Participants with active HBV or HCV infection that requires treatment or who are at risk for HBV reactivation (ie Positive HBs Ag serology)
* Candidates positive for HCV antibody and positive PCR RNA HCV
* HIV infection with positive viral charge
* Protected adults (including individual under guardianship by court order)
* Vulnerable adults, under a safeguard of justice measure
* Adults deprived of their liberty by judicial or administrative decision
* Persons under psychiatric care without their consent
* Persons admitted to social institution for purposes other this research
* Adults under legal protection (guardianship or curatorship)
* Persons unable to express their consent
The Influence of Health Beliefs and Uncertainty on Diabetes Type II Patient Compliance

To determine the predicting factors and indicators of compliance with insulin treatment in Diabetes Type II patients.


Eligibility Criteria:
Inclusion Criteria:

* With complete cognitive abilities
* Independent functioning
* Take insulin

Exclusion Criteria:

* Critically ill patients
* Psychiatric patients
One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome

The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

The trial was terminated prematurely on December 14, 2010, due to inability to recruit the planned number of subjects and shifting organizational priorities. The decision to terminate the trial was not based on any safety or efficacy concerns.

Eligibility Criteria:
Inclusion Criteria:

* Subject must present at least 2 of the following risk factors of MS at screening: Elevated waist circumference: \>102 cm in men and \>88 cm in women; Elevated triglycerides (TGs): ≥1.7 mmol/L (≥150 mg/dL); Reduced HDL-Cholesterol: \<1.03 mmol/L (\<40 mg/dL) in men and \<1.3 mmol/L (\<50 mg/dL) in women; Elevated fasting glucose: ≥ 5.6 mmol/L.
* According to the clinical judgment of the investigator, the risk factors for MS have developed in close temporal relationship to starting an antipsychotic medication.
* Substitution to a less metabolically disruptive antipsychotic medication is considered

Exclusion Criteria:

* Subjects with contraindication(s) to the use of Ziprasidone according to Canadian prescribing information.
* Subjects with a history of treatment resistance.
* Subjects with any medical condition (e.g. pre-existing diabetes, pre-existing dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that may confound the evaluation of the study drug.
* Body mass index ≥ 40 at baseline.
Central Serous Chorioretinopathy and Micropulse Laser Treatment

To evaluate choroidal and choriocapillaris changes in patients with central serous chorioretinopathy, undergone sub threshold micropulse laser treatment, following any improvement with conservative therapy with Acetazolamide and/or Eplerenone


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of central serous chorioretinopathy (CSC) with no response to conservative therapy, consisted in Acetazolamide and Eplerenone after six months.
* Foveal serous retinal detachment for at least 6 months.
* Minimum age of 18 years old at the screening time
* Reading and comprehension skills of informed consent

Exclusion Criteria:

* Previous retinal treatment for CSC, except for Acetazolamide and Eplerenone
* No diffuse retinal epitheliopathy
* Other concomitant ocular diseases, such as age related macular degeneration, diabetic retinopathy, choroidal neovascularization
* Not controlled glaucoma with eyedrops, or advanced glaucoma
* Myopia or hypermetropia greater than 6 diopters
* Opacities of dioptric media
* Low quality of optical coherence tomography (OCT) and OCT-Angiography scans
* Low quality images of Fluorescein angiography and indocyanine green angiography
* No written consensus signed.
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma

The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* For Dose Escalation:

  * Subjects with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma
* For Cohort Expansion:

  * Subjects must have a previously treated advanced solid tumor or B cell non-Hodgkin's lymphoma to be eligible
  * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  * For certain subjects, willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
  * Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men

Exclusion Criteria:

* Known central nervous system metastases or central nervous system as the only source of disease
* Other concomitant malignancies (with some exceptions per protocol)
* Active, known or suspected autoimmune disease
* Uncontrolled or significant cardiovascular disease
* History of hepatitis (B or C)
* History of active or latent tuberculosis
Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and paclitaxel in treating patients who have metastatic or unresectable cancer.

OBJECTIVES:

* Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with metastatic or unresectable cancer.
* Determine the qualitative and quantitative toxicities of this regimen in these patients.
* Determine the therapeutic response to this regimen in these patients.
* Determine the relationship between the pharmacokinetics of this regimen and toxicity and response in these patients.
* Determine the effects of oxaliplatin on peripheral blood cells and correlate this to pharmacokinetics, toxicity, and response in these patients.

OUTLINE: This is a dose escalation study.

Patients receive oxaliplatin IV over 2 hours followed by paclitaxel IV over 1 hour weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven metastatic or unresectable malignancy for which standard curative or palliative measures do not exist or are no longer effective
* No known brain metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2
* Karnofsky 50-100%

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3000/mm\^3
* Absolute neutrophil count at least 1500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin normal
* SGOT/SGPT no greater than 2.5 times upper limit of normal

Renal:

* Creatinine normal OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia

Other:

* No neuropathy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No allergy to platinum compounds or antiemetics
* No uncontrolled concurrent illness
* No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No more than 2 prior chemotherapy regimens
* No prior oxaliplatin or paclitaxel
* At least 4 weeks since prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to more than 25% of bone marrow

Surgery:

* Not specified

Other:

* No other concurrent investigational agents
* No concurrent antiretroviral therapy for HIV (HAART)
Waterproof Casting Versus Standard Casting for Short Leg Walking Casts

The purpose of the study is to determine whether the use of waterproof padding in short leg walking casts will lead to an increase in cast-related complications, as compared to the standard non-waterproof casting in children.

This study aims to prospectively examine a group of pediatric patients that receive either a waterproof or non-waterproof short leg cast. From this, we will be able to determine if there are any significant differences between the two groups. If waterproof short leg casts do not cause increased skin breakdown or lead to increases in cast complications and unintended clinic visits, then we can more confidently apply them to pediatric patients, particularly in the summer months when children are more likely to swim.

On application of a waterproof, short leg walking cast, a questionnaire will be distributed to the patient/family to track how many times the cast gets wet. During the application of the cast, materials will be tracked for cost analysis. The subject will return between 3 and 7 weeks for cast removal. On cast removal, the following questionnaires will be completed: cast condition, skin condition, overall patient/family satisfaction, and PROMIS Pediatric Lower Extremity Function - Mobility. Questionnaires will take approximately 5 - 10 minutes to complete. The parent survey regarding how many times the cast got wet will be returned (if applicable). Waterproof and non-waterproof groups will be compared in the basis of cast condition, PROMIS lower extremity survey outcomes, skin condition, overall patient/family satisfaction, number of unintended cast changes or return clinic visits, as well as cost difference.

Outside of the randomization itself, all standard of care procedures or normal practice activities will occur. Each participant will undergo cast application as recommended per standard of care. Study participation does not involve more than minimal risk since everything outside of the randomization is standard of care.

Waterproof and non-waterproof groups will be compared in the basis of cast condition, PROMIS lower extremity survey outcomes, skin condition, overall patient/family satisfaction, number of unintended cast changes or return clinic visits, as well as cost difference. A Chi-Square test will be used to analyze the data.

Eligibility Criteria:
Inclusion Criteria:

• Being placed in a short leg walking cast for one of the diagnoses listed below:

* ankle fracture
* foot fracture
* ankle sprain
* foot sprain
* toe-walking
* tendonitis
* apophysitis

Exclusion Criteria:

* Patients with wounds to the foot or ankle prior to cast placement
* Patients with cognitive dysfunction
The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.

The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. This study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. All patients received antithymocyte globulin induction. All rejection episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one year after kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota

Exclusion Criteria:

* Patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant
* Pediatric patients (\<18 years of age)
* Multi-organ transplants (e.g., kidney-pancreas, kidney-liver)
* ABO-incompatible or positive crossmatch recipients (ABO incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.)
* Patients with severe hyperlipidemia (serum cholesterol \>350 mg/dl or serum triglycerides \>500 mg/dl
* Patients with severe leukopenia (White Blood Cell count \[WBC\]\<3000 10\^3/ml)
* Patients unwilling to return to the transplant center for late follow-up visits
* Body mass index (BMI) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon
Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam

Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. In addition, it has no injection pain and infusion syndrome compared with propofol. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. Therefore, rhe purpose of the study is to compare poetoperative quality of recovery (QoR)-15 scores according to the use of anesthetics for total intravenous anesthesia in the cervical spine surgery with intraoperative neurophysiological monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who aged 20-70 years with ASA-PS 1-3,
* diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy
* intraoperative neurophysiological monitoring.

Exclusion Criteria:

* Tolerance or hypersensitivity to benzodiazepine or propofol
* Dependence or addiction to psychotropic drugs or alcohol
* Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions
Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients

There is evidence on the role of the phosphotransfer system in the energy metabolism of the heart, with altered energetics playing an important role in the mechanisms of heart failure. Phosphocreatine plays an important part in the energy heart system. The investigators have just performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and matched studies that compared phosphocreatine with placebo or standard treatment in patients with coronary artery disease or chronic heart failure or in those undergoing cardiac surgery. Patients receiving phosphocreatine had lower all-cause mortality as well as improved cardiac outcomes when compared to the control group, however, the quality of the included studies was low. Thus, the investigators plan to conduct an exploratory high quality RCT to investigate whether providing phosphocreatine compared to placebo improves the myocardial protection in high-risk patients scheduled for cardiac surgery and to determine the best research endpoint for future trials.


Eligibility Criteria:
Inclusion Criteria:

* Double/triple valve lesion that required cardiac surgery with CPB
* Aged 18 years or older
* Signed informed consent

Exclusion Criteria:

* Emergency surgery
* Concomitant coronary artery bypass grafting surgery (CABG) or procedure on any part of the aorta
* Chronic kidney disease of G3-G4-G5 categories according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria (at least one of the following present for \> 3 months: glomerular filtration rate ≤ 60 ml/min/1.73 m2, history of kidney transplantation) or solitary kidney (by any reason)
* Known allergy to PCr
* Pregnancy
* Current enrollment into another RCT (in the last 30 days)
* Previous enrollment and randomisation into the PRISE trial
* Administration of PCr in the previous 30 day
* Concomitant radiofrequency/cryo- ablation procedure
* Structural abnormalities or genetic trait point to kidney disease including glomerulonephritis and gout.
Internet Self-Management for People With Intermittent Urinary Catheters

1. Design and develop web-based self-management intervention to improve catheter-related outcomes and quality of life in people with spinal cord injury (SCI).
2. Conduct a pilot study to assess the feasibility (i.e., acceptability and usability of the website application) and preliminary effectiveness of this new self-management intervention.
3. Develop and test the reliability of new/modified measures (intermittent catheter self-efficacy and self-management).

Stages involve: (1) Develop an Internet-based intervention to improve self-management and outcomes related to clean intermittent catheterization (CIC) among people with SCI (2) Pretest the Internet application with five persons with SCI using CIC; and (3) Conduct a web-based six-month intervention pilot study in a group of 30 with SCI using CIC.

Outcomes are: catheter-related adverse health outcomes (e.g., UTI, urine leakage), CIC self- management, CIC self-efficacy, health related expenditures and quality of life.

Information from this study will be used to modify the Internet application for a future Phase 2 trial in a larger study.

Eligibility Criteria:
Inclusion Criteria:Individuals will be included if they are English speaking adults over 18 years with an SCI and are interested in participating. Inclusion criteria are:

1. use of CIC for regular bladder drainage,
2. expect to use CIC indefinitely or for at least nine months, and
3. access to and ability to use a computer and telephone. Computer and telephone use may be voice activated for those with little hand use. Study participants do not need to perform CIC entirely themselves, as people with limited hand dexterity may have caregivers who do the procedure. They do need to be able to use the computer and telephone however.

Additional inclusion criteria for the five persons in the "intervention and pretesting group" (described below in III, 1) include:

1. having used CIC for regular bladder drainage for at least one year and
2. expect to use CIC indefinitely or for at least one more year. People will need to have used CIC for at least a year so that they are well experienced in CIC because the two Peer Leaders will be selected from this group.

Exclusion Criteria:

* People will be excluded if they cannot communicate in English,
* Are terminally ill, or are expected to discontinue CIC within the next nine months. - Non-English speaking people will not be included because translated instruments (e.g., Spanish) are not available for all measures and doing this as a part of this small study might compromise the integrity of this first test of preliminary effectiveness.