cyrilzakka/clinical-trials huggingface dataset:
INST 0603C Patients With Unresectable/Metastatic Pancreatic Cancer Treated in the UNM Cancer

Chart Review of patients with pancreatic cancer treated with combination of irinotecan, oxaliplatin and cetuximab.

Chart Review to describe the clinical outcomes in patients pancreatic cancer treated with combination of irinotecan, oxaliplatin and cetuximab.

Eligibility Criteria:
Inclusion Criteria:

Patients with unresectable/metastatic pancreatic cancer treated in the UNM Cancer Research and Treatment Center.

Exclusion Criteria:

Not specified.
Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis

The purpose of this study is to expand the knowledge on the efficacy and safety of emapalumab (previously known as NI-0501) as a treatment for primary haemophagocytic lymphohistiocytosis (HLH) patients, including on long-term outcomes and quality of life assessments. Emapalumab can be administered as the first-line therapy to patients not previously treated with the current standard of care, or can be given to patients who have either failed or were unable to tolerate the available standard of care.

Emapalumab is to be administered until the start of conditioning for hematopoietic stem cell transplantation (HSCT), with an anticipated duration ranging from a minimum of 4 weeks to approximately 12 weeks and not exceeding 6 months.

After treatment completion, patients will continue in the study for long-term follow-up until 1 year after either HSCT or last emapalumab infusion (if HSCT is not performed).


Eligibility Criteria:
Main Inclusion Criteria:

* Primary HLH patients with active disease.
* Treatment naïve patients or patients having already received HLH conventional therapy, but having not responded, not achieved a satisfactory response or worsened, or reactivated, or are unable to tolerate current standard of care.
* Informed consent signed by the patient or by the patient's legally authorized representative.
* Received guidance on contraception.

Main Exclusion Criteria:

* Diagnosis of secondary HLH consequent to a proven rheumatic, metabolic or neoplastic disease.
* Active mycobacteria, Histoplasma capsulatum, Shigella, Salmonella, Campylobacter or Leishmania infections.
* Evidence of latent tuberculosis.
* Presence of malignancy.
* Concomitant disease or malformation severely affecting cardiovascular, pulmonary, central nervous system (CNS), liver, or renal function, that in the opinion of the Investigator may significantly affect the likelihood to respond to treatment and/or the assessment of emapalumab safety and/or efficacy.
* History of hypersensitivity or allergy to any component of the study regimen.
* Receipt of a BCG vaccine within 12 weeks prior to Screening.
* Receipt of a live or attenuated-live (other than BCG) vaccine within 6 weeks prior to Screening.
* Pregnant or lactating female patients.
Facet Wedge Post Market Study

A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior instrumentation. The objective of this study is to assess outcomes following implantation of the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments.

The primary objective of this study is to determine the rate of re-operations at the index level(s).

The secondary objectives of this study are to confirm the safety and performance of the device and to collect patient reported outcome data.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed with at least one of the following:

   * Degenerative Disc Disease (DDD);
   * Degenerative facet joint disease (isolated facet based symptomatic back pain);
   * Pseudoarthrosis post anterior instrumentation;
2. Subjects who are a fusion candidate for single or multiple levels fusion between L1-S1;
3. Subjects, who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

Exclusion Criteria:

Preoperative exclusion criteria:

1. Segmental instability of the index level in case of planned stand-alone FACET WEDGE usage;
2. Unilateral application , except in combination with pediclescrew fixation on the contralateral side;
3. Compromised facets due to decompression techniques;
4. Spondylolisthesis;
5. Fracture or other instabilities of the posterior elements;
6. Tumor;
7. Acute or chronic systemic or localized spinal infections;
8. Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study;
9. Subjects aged below 18 years;
10. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation;

    Intraoperative exclusion criteria:
11. Intraoperative decision to use implants other than the device under investigation.
Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

The purpose of this study is to learn more about asthma in people who are not well-controlled with current asthma medication (refractory asthma). The investigators will compare data from refractory asthmatic patients here at National Jewish Health to mild asthmatics subjects and to people without asthma. Study experiments involve looking at samples from all 3 groups and comparing them at a molecular level. These laboratory experiments may help identify subtypes of refractory asthmatics that require different treatments.


Eligibility Criteria:
Inclusion Criteria:

* Able to receive Informed Consent
* At least 18 years of age
* ICS \< 880 mcg (FP equivalents)
* PC20\<=16 mg/mL
* No more than 1 oral steroid bursts in previous 12 months
* Less that 3 urgent care visit in previous 12 months
* No deterioration with \<=25% decrease in steroids
* No near fatal asthma event

Exclusion Criteria:

* Pregnancy
* Current smoker, smoking within the past year or pack/year history \>10 years
* Respiratory infection within past 6 weeks
* Antibiotics within the past 6 weeks
* Active lung disease other than asthma
* Cancer within past 5 years (excluding basal cell skin cancer)
* Active or chronic infection
* Hematological or autoimmune disease
* Unable to safely undergo bronchoscopy as determined by doctor or study doctor
Beginning of Effective and Safe Treatment in Immunoglobulin A-1 Nephropathy-1

Immunoglobulin A nephropathy (IgAN) is the most common glomerulonephritis worldwide. IgAN is progressive, particularly when patients have a significant proteinuria (proteinuria \>1g/g creatinine), impaired kidney function, or elevated blood pressure. In 10 years, nearly 20-40% of these IgAN patients progress to end-stage renal disease (ESRD). Early IgAN is tentatively defined when proteinuria is insignificant and kidney function and blood pressure are normal. Patients with early IgAN rarely progress to ESRD. However, 30-40% of patients with early IgAN ultimately developed a significant proteinuria and hypertension in 10 years. Therefore, earlier intervention may be needed if it can prevent the development of a significant proteinuria and hypertension. Since angiotensin ll receptor blocker (ARB) is drug of choice in reducing proteinuria and controlling blood pressure, the investigators hypothesized that early introduction of ARB may be beneficial in preventing the significant proteinuria development in early IgAN patients. To prove the hypothesis, the investigators plan the current interventional study.


Eligibility Criteria:
Inclusion Criteria:

1. Biopsy-proven IgAN: dominant or co-dominant deposits of mesangial IgA in immunofluorescence stain
2. Age \>= 19 years
3. Random urine protein-to-creatinine ratio 0.3 g/g creatinine to 1.0 g/g creatinine at visit 1
4. Estimated glomerular filtration rate \>= 60 mL/min/1.73m2 at visit 1
5. People who voluntarily agreed to participate
6. People who are compliant

Exclusion Criteria:

1. Prevalent Hypertension: systolic blood pressure \>=140 mmHg and \>=90 mmHg, previous physician diagnosis of hypertension, or taking anti-hypertensive drugs
2. Prevalent Diabetes: fasting glucose \>= 126 mg/dL, HbA1c \>= 6.5%, taking insulin or anti-diabetic drugs, or previous physician diagnosis of diabetes
3. Previous immunosuppressive drugs use to treat IgAN
4. Secondary IgAN
5. Renin-angiotensin-aldosterone inhibitors (RASI) dependent patients (congestive heart failure, ischemic heart disease, and others)
6. hypersensitivity to RASI
7. Other chronic diseases: malignancy within 5 years, significant liver and gastrointestinal disease and other autoimmune disease
8. Pregnancy
9. symptomatic orthostatic hypotension
10. People who already participated in other interventional studies or taking interventional drugs within 3 month of screening visit
11. Inappropriate people ascertained by investigator
Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction

The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus Accumbens(NAc) as a novel treatment in severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for methamphetamine.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV-TR diagnosis of Drug addiction disorder;
* Age 18-65 years old;
* Proficiency in Mandarin language;
* Failure to detox more than three times;
* Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion Criteria:

* Multidrug abuse and formation of addiction;
* Serious and unstable organic diseases (e.g. unstable coronal heart disease);
* Any history of seizure disorder or hemorrhagic stroke;
* Past stereotactic neurosurgical intervention;
* Neurological disease (Abnormal PET-CT, MRI, EEG)
* Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator;
* Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases);
* HIV positive;
* Pregnancy and/or lactation;
Multihole Fully Covered Metallic Stents in the Management of Malignant Biliary Obstruction

multiholes fully covered metallic stents in the management of malignant biliary obstruction

Malignant biliary obstruction is still a diagnostic and therapeutic challenge requiring a multidisciplinary approach. Most cases are inoperable at the time of diagnosis. Relieving the obstruction and normalizing the serum bilirubin level is usually the first step by biliary catheterization and stent placement.

Biliary stent placement has largely replaced surgical bypass for the palliation of malignant biliary obstruction. Rigid plastic stents, despite it is cheap and easily removed, but with limited duration of stent patency. Self-expandable metal stents (SEMS) have larger luminal diameters and provide longer patency time than rigid plastic stents. SEMS are composed of a variety of metals and can be uncovered, partially covered, or fully covered.

Uncovered stents are prone to obstruction by tumor growths; however, covered stents may block bile duct branches and are at risk of migration. A multihole self-expandable metallic stent was developed to prevent the obstruction of bile duct branches. In addition, the holes may prevent migration due to small ingrowths which reduce the tension of the membrane

Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of malignant obstructive jaundice.
* Patient not eligible for surgery.
* Age above 18 years, any gender.

Exclusion criteria:

* Benign obstructive jaundice.
* Patient eligible for surgery.
* Failure to stent insertion.
* Patient not fit for ERCP and/or anaesthesia.
* Surgical and anatomical abnormalities interfere with endoscopy.
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer

This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced castration-resistant prostate carcinoma with progressive disease
* At least 4 weeks must have elapsed from major surgery
* Patient must be available for follow-up
* Adequate liver and kidney function
* Adequate blood values

Exclusion Criteria:

* Uncontrolled or significant heart disease
* History of seizures
* History of head injury, loss of consciousness, or stroke
* Patients undergoing alcohol withdrawal
* Any concurrent cancer
* A serious uncontrolled medical disorder or active infection
* Inability to swallow tablets
Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)

Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.

Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.

The aim is to demonstrate that the application of the Prevena™ IMS significantly reduces the incidence of postoperative wound infections. The wound infections will be classified according to Szilagyi.

The treatment phase begins following vascular surgery with wound management using either the Prevena™ IMS or a standard wound dressing, depending on the group to which the patient was randomly assigned. It involves a minimum stay of 7 and maximum 10 days in hospital.

Eligibility Criteria:
Inclusion Criteria:

* vascular surgery via right or left inguinal approach
* nicotine abuse (active or according to medical condition)
* risk factors:

  1. cardiac risk factors (arterial hypertension, coronary heart disease, status after myocardial infarction)
  2. metabolic disorders (diabetes mellitus type I type II, lipopathy or hyperhomocysteinemia) or chronic or acute renal insufficiency
* previous vascular surgery with inguinal approach
* signed informed consent form
* persons who are legally competent and mentally able to comprehend and follow the instructions of study personnel

Exclusion Criteria:

* local skin infections (fungal infections, acne)
* pregnant and breast-feeding women
* simultaneous participation in another clinical trial
* persons who have been committed to an institution by court or administrative order
* persons in a dependency or employment relationship with the sponsor or investigator
Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

Posterior tibial tendon dysfunction (PTTD) is the most common cause of painful and debilitating acquired flatfoot deformity in adults. The dysfunction is often progressive and may result in attenuation of the PTT and eventually collapse of the plantar arch or even rupture of the tendon. Current therapeutic management of PTTD is multipronged and includes management with foot orthoses, stretching, and strengthening exercises. Evidence drawn from research related to the management of painful chronic Achilles tendinosis suggests that eccentric strengthening of the posterior tibialis may lead to superior results compared to concentric. The purpose of this research is to determine the effectiveness of treatment interventions used in the management of PTTD.

All study participants receive a pair of custom made orthoses and perform daily calf-stretches. In addition to the orthoses two groups will perform tibialis posterior specific exercises; one as concentric and the second as eccentric activation. Intervention will last 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Pain (\> 3 months duration)
* Pain localized to the medial ankle and foot
* Swelling at the medial ankle
* Able to perform a single controlled heel lowering

Exclusion Criteria:

* Bilateral posterior tibial tendon dysfunction
* Fixed foot deformities
* Previous foot surgery
* Presence of any other concurrent foot pathology besides posterior tibial tendon dysfunction
* Ability to walk only with assistive device
* Neurological disorders
* Cognitive dysfunction
* Uncontrolled cardiovascular disease
* Evidence of cord compression
* Uncontrolled hypertension
* Infection
* Severe respiratory disease
* Pregnancy
* Current or recent history of low back pain
* Known rheumatic joint disease
* Peripheral vascular disease with sensory loss of the foot.
Predicting Platelet Count from Viscoelastic Testing

Viscoelastic testing is a highly recommended cornerstone of modern coagulation medicine, reducing transfusion needs. A disadvantage of viscoelastic tests is the impossibility of making a definitive statement about the platelet count.

Therefore, the aim of this retrospective observational study is, on the one hand, to predict the platelet count based on standard ROTEM parameters with the help of several machine learning methods and, on the other hand, to detect a low platelet count ( \<100000 ml-1 and \< 50000 ml-1).


Eligibility Criteria:
Inclusion Criteria:

* ROTEM measurement and platelet count measurement within 3 hours.

Exclusion Criteria:

* under 18 Years
* more than 3 hours between ROTEM and platelet count measurement
Supporting Decisions About Health Insurance to Improve Care for the Uninsured

The overall purpose of the study is to better understand how the investigators previously developed decision support (DS) tool can help people make decisions about health insurance plans available through the federal exchanges created by the Affordable Care Act (ACA). The investigators will evaluate the DS tool compared to the federal government website. The investigators will also evaluate the feasibility of disseminating this tool. There are two primary aims to be completed in this project: (1) examine the reach and effectiveness of the health insurance DS tool; and (2) collect stakeholders' feedback to improve the likelihood of implementation of the DS tool.

First, for Aim 1 part 1, the investigators will recruit 40 key stakeholders (uninsured participants, health providers, community advisors, and health policy experts) to refine the DS tool through a series of individual semi-structured interviews. Next, the investigators will use their feedback to program the DS strategies into an online DS tool. After its initial production, the tool will be pilot tested with 30 individuals to assess readability, message clarity, format, and function of the tool as well as to test the randomized trial study procedures. Then, for Aim 1 part 2, the investigators will test the DS tool in a randomized trial with 362 participants eligible for the Affordable Care Act (ACA) exchanges. Half will use the DS tool and the other half will use the federal government site to learn about the exchanges. The investigators will use computerized random assignment to assign participants to study condition, after which they will all complete the same short survey. For Aim 2, the investigators will collect 40 stakeholders' feedback on likelihood of adoption and implementation of the DS tool to plan for dissemination and implementation. Stakeholders will be asked both open-ended and closed-ended questions in order to gather feedback about delivering the DS tool. These stakeholders will be different from those who were interviewed in Aim 1 as to ensure broader applicability of the DS tool.

Eligibility Criteria:
Inclusion Criteria:

* Must be without health insurance currently; or
* Must be enrolled in one of the ACA exchange plans in the past 1 year; and
* Must speak English

Exclusion Criteria:

* Currently has health insurance that was not provided by being enrolled in one of the ACA exchange plans in the past year
* Currently has health insurance that is provided through public insurance or private employer-based insurance
* Does not speak English
Haemo-autologous Antegrade Repriming (HAR) as Minimum Impact Perfusion Strategy for Cardiopulmonary Bypass

Haemo-autologous Antegrade Repriming (HAR) is a procedure based in the combination of evidence proven measures designed to reduce the haemodilution caused by establishing the cardiopulmonary bypass (CPB) during cardiac surgery.

This clinical trial aims to determinate, in one hand, the benefits related to HAR in terms of transfusion, ICU stay, ventilation time, early mortality and complications. In the other hand analyzes the gaseous microemboli (GME) load, comparing the oxygenators venting technology´s efficiency in treatment and control group, and its relation with patient´s neurocognitive status.

HAR is a repriming technique based in Retrograde Autologous Priming (RAP), that has been implemented by recently recommended measures in terms of reducing blood transfusions.

The expected clinical benefits are related to hemodilution´s reduction up to only 300ml. The extracorporeal circuit has been reduced to 3/8 inch diameter in both lines, reducing the surface up to 1000ml of dynamic priming.

Vacuum assisted venous drainage (VAVD) allows to empty the venous line after priming and deairing, facilitating the venous flow for CPB initiation.

The antegrade repriming eliminates the maximum amount of crystalloid contained in the circuit, displacing it to a collector bag, by using autologous blood sequestered from the arterial line to the hardshell reservoir.

HAR reduces the CPB hemodilution related to priming from 1500 to 300 ml preventing the usual sudden haemoglobin level reduction occured during every extracorporeal techinque´s establishment.

Our mission is to analyze if HAR can be validated as a safe and effective tool to improve clinical outcomes in cardiac surgery procedures under extracorporeal circulation

Eligibility Criteria:
Inclusion Criteria:

- All patients purposed to undergo elective cardiopulmonary bypass for cardiac valve surgery or other pathologies requiring to open heart chambers.

Exclusion Criteria:

* Urgency and emergency
* Heart transplantations
* Severe cognitive affection
* Active sepsis
* Previous anemia
* Early re-intervention
* Pre-Op extracorporeal membrane oxygenation (ECMO) support
* Hemodynamic unstability during HAR
* Any clinical condition that may force protocol deviation
Impact of Fluid and Passive Leg Raising on Cardiac Output in Patients Undergoing Cardiac Surgery

Left Ventricular Assist Device (LVAD) implantation is a common surgical procedure in patients with end-stage heart failure. Optimal fluid management is essential for adequate postoperative treatment. It is important to identify which patients will benefit from fluid administration. Passive leg raising (PLR) is a validated dynamic method to predict fluid responsiveness in patients with heart failure by inducing a transient increase in cardiac preload. Objective: To investigate the role of PLR on the management of patients following LVAD implantation in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Patients after VAD implantation

Exclusion Criteria:

* Age under 18