cyrilzakka/clinical-trials huggingface dataset:
Financial and Clinical Impact of Repeal of the Pennsylvania Motorcycle Helmet Law

The purpose of this study is to find out how many helmeted versus non-helmeted motorcycle accident victims (MCA) sustain head and/or face injuries. Also, we will find out how much it costs to get medical care for head and face injuries in helmeted versus non-helmeted motorcycle victims. Finally, we will compare how long it takes helmeted versus non-helmeted motorcycle victims with face and head injuries to return to work.

This is a prospective, quasi-experimental research study that will compare clinical outcomes of helmeted versus non-helmeted motorcycle victims admitted to trauma centers, as well as victims treated and released from emergency departments.

The primary objective of this study is:

* To determine if the financial charges and ratio of cost to charges (RCC), including acute hospitalization, rehabilitation or skilled care, outpatient care, and time to return to work (implying lost wages) is different between helmeted versus non-helmeted motorcyclists with head or face injuries

Secondary objectives include:

* To determine if inpatient mean total acute care and downstream charges and RCC are higher for non-helmeted versus helmeted motorcycle victims admitted to three Pennsylvania trauma centers with head and face injuries
* To determine the mean time of return to full duty work (at previous level of employment) is shorter for helmeted or non-helmeted motorcycle victims admitted to three Pennsylvania trauma centers with head and face injuries
* To determine if non-helmeted or helmeted motorcycle victims admitted to three Pennsylvania trauma centers have increased incidence and severity of head and face injuries
* To determine the incidence and severity of non-helmeted motorcycle accident victims is higher than helmeted counterparts treated and released from emergency departments for face and head injuries
* To determine if non-helmeted motorcycle victims die at scene or in emergency departments (from head and face injuries) more often than helmeted motorcycle victims
* To determine if more helmeted or non-helmeted motorcycle accident victims require no immediate medical care for head and face injuries

Eligibility Criteria:
Inclusion Criteria:

* All English speaking drivers/passengers of motorcycle accidents, 18 years or older, with head or face injuries served by participating study trauma centers, emergency departments or coroners.
* All English speaking drivers/passengers of motorcycle accidents, 18 years of age or older, served by Pennsylvania police but did not require acute medical services.

Exclusion Criteria:

* Non-English speaking
* Served by trauma center, emergency department or coroner, but without haed or face injury
* Less than 18 years of age
* Moped accidents
* Motorized bicycle accidents
* Parked motorcycle accidents
* Off road motorcycle accidents, not on a public street or highway
* Dirtbike or motorcross accidents, involving vehicles not licensed for highway use
99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404

This trial is a single-blind, cross-over design. Up to three patients with confirmed metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation B). Whole-body planar scintigraphic images will be acquired at various time points on the day of study drug administration. A pelvic SPECT/CT image will be acquired on the day of study drug administration. Blood will be collected for pharmacokinetic measurements following study drug administration. Each participant will receive an initial study drug administration (preparation A) and a second study drug administration (preparation B) approximately 7 to 21 days later. A final follow-up visit will occur approximately 2 - 3 weeks after the second study drug administration.


Eligibility Criteria:
Inclusion Criteria:

* Male aged 21 years or older.
* Ability to provide signed informed consent and willingness to comply with protocol requirements.
* Participants must agree to use an acceptable form of birth control throughout the study period. Participants must agree to use condoms for a period of seven days after each study drug administration, if engaged in sexual activity.

Additional Inclusion Criteria for Metastatic Prostate Adenocarcinoma Patients:

* Histologic diagnosis of prostate cancer by validated medical history (pathology report, if available).
* Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT scan, or MRI
* Karnofsky performance is ≥ 60

Additional Inclusion Criteria for Healthy Volunteers:

* PSA laboratory assessment within normal range (PSA \< 4 ng/ml)
* Normal findings on a digital rectal examination
* Hemoglobin and hematocrit within normal range

Exclusion Criteria:

* Received a radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
* Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
* Participant is determined by the Investigator to be clinically unsuitable for the study
* Serum creatinine ≥ 2.0 mg/dl
* Total bilirubin ≥ 2.0 mg/dl
* Liver transaminases ≥ 1.5 x ULN
* Platelet count \< 100,000/mm3
* Absolute neutrophil count (ANC) \< 2,000/mm3
* Hematocrit \< 30% or hemoglobin \< 10 g/dl

Additional Exclusion Criteria for Metastatic Prostate Adenocarcinoma Patients:

* Have received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants; or 12 months for 125I implants
* Have had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, in which the diagnosis and location have not been defined as clinically controlled or treated to complete response
Stroke and PMSI (Medicalisation Information Systems Programm)

Evaluation of the sensitivity and specificity of PMSI to identify the burden of stroke in France,from 2500 cases


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stroke in the hospital activity board

Exclusion Criteria:

* none
Feasibility and Reliability of Ultrasound in Acute Burns.

This trial investigates the feasibility and reliability of different ultrasound protocols to determine quadriceps muscle architecture in acutely admitted burn patients. The results of this trial will provide more clarity as to whether ultrasound can be used as a bedside tool to monitor muscle wasting.

BACKGROUND Despite the ubiquity of muscle wasting following burns, practical and accurate tools to measure the degree of muscle wasting are lacking in burn care. Ultrasound has been used for this purpose in the critically-ill population and has shown to be valid and reliable. Whether this can be extrapolated to the burn population, however, remains unclear. Open wounds, fluid status, and uncertainty regarding which protocol to use are amongst factors that complicate the use of ultrasound during the acute phase of burns.

AIM This study examines the reliability and feasibility of ultrasound measures in the acute burn setting comparing different techniques and locations of application.

METHODS Burned adults were assessed at admission in two Belgian burn centers by two trained assessors using B-mode ultrasound with a linear transducer. Ultrasound-derived variables included quadriceps muscle layer thickness (QMLT) and rectus femoris cross-sectional area (RF-CSA) on both thighs. Both maximum and minimum compression techniques were used for QMLT, while RF-CSA was determined by minimum compression only. QMLT was measured at a proximal and distal location on the thigh, and RF-CSA was measured at the most proximal location possible where the entire muscle belly still remained visible.

Eligibility Criteria:
Burn subjects:

Inclusion Criteria:

* ≥10 - ≤80 %TBSA
* Burn depth: 2nd deep / 3rd degree

Exclusion Criteria:

* Electrical burn (except flash burns)
* Associated injury: fracture lower limb
* Diabetes Mellitus type 1
* Central / peripheral neurological/neuromuscular disorders (interfering with exercise)
* Cognitive / psychological disorders (interfering with cooperation)
* Cardiopulmonary disease (interfering with exercise safety)
* Pregnancy
* Palliative care

Healthy subjects:

* none
Inflammation Biomarkers in the Diagnosis of Postoperative Infectious Complications in Colorectal Cancer Surgery

This is a longitudinal, single-center, prospective study to determine the efficiency of WBC Count, CRP, PCT, Neutrophil CD64 and Monocyte Human Leukocyte Antigen- DR in the diagnosis of postoperative infectious complications in colorectal cancer surgery

Blood samples for inflammation markers are carried out from patients with сolorectal cancer surgery in a single center on the day of the surgery in the operating room before intravenous fluid application started. Each patient receives systemic antibiotic prophylaxis for gramnegative and anaerobic bacteria on induction of anesthesia and prior to skin incision. A standardized protocol for general and epidural anesthesia is used. Values of WBC count, CRP, PCT, CD64n and HLA-DR monocyte are recorded before surgery and after surgery on POD (postoperative day) 1, 3 and 6 or 7. SIRS criteria on POD 1, 3, 6 or 7 and postoperative infections up to 30 days after surgery are recorded. SSIs (incisional, organ / space), pneumonia, central venous catheter related bloodstream infections (CRBSIs), urinary tract infections (UTIs) and enterocolitis records are taken. Microbial cultures are using as the gold standard. Criteria for SIRS reconsidered in the year 2001 by SCCM / ESICM / ACCP / ATS / SIS International Sepsis Definitions Conference and criteria for Dosage Control and Prevention (CDC) are taken into consideration. After discharge, each patient is being monitored by outpatient clinic examinations. The study will recruit approximately 100 patients during three consecutive years.

Eligibility Criteria:
Inclusion Criteria:

* Have a elective colorectal resection for colorectal cancer
* Have signed approved informed consent form for the study

Exclusion Criteria:

* Significant simultaneous surgical procedure (e.g., liver resection of metastasis)
* Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery
* Neo-adjuvant chemotherapy and/or radiotherapy
* Autoimmune conditions
* Inflammatory bowel diseases
The Effect-site Concentration of Remifentanil for Preventing Cough During Emergence From Balanced Anesthesia for Nasal Surgery

After nasal surgery, emergence cough or straining will produce venous engorgement and increase bleeding from the surgical site, so the necessity for smooth extubation without severe cough during emergence provides a challenge for the anesthetists. Recently, remifentanil is commonly used short-acting opioid, and several studies have demonstrated the antitussive effect of remifentanil via effect-site target-controlled infusion during emergence. However, there may be gender difference in response to opioid, and the previous studies about antitussive effect of remifentanil are targeted at female patients and there is no investigation of effect site concentration of remifentanil for male patients undergoing nasal surgery. The purpose of this study is to evaluate the effect-site concentration of remifentanil via target-controlled infusion for preventing cough in man after sevofluorane balanced anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* all male aged 18-60 years
* ASA(American Society of Anesthesiologists)physical status I or II
* who underwent ESS(endoscopic sinus surgery)or septoplasty under sevoflurane-remifentanil balanced anesthesia

Exclusion Criteria:

* predicted difficult airway,
* BMI(Body Mass Index) of more than 30 kg/m2,
* chronic respiratory disease,
* recent respiratory track infection,
* chronic coughing,
* significant cardiovascular,
* hepatic or renal disease,
* current smokers
* medical history of medication of opioid or ACEI(angiotensin covering enzyme inhibitor)
Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject must have cytologically or histologically confirmed non-squamous NSCLC
* Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.
* Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).
* Subject has an ECOG Performance Score of 0-1.
* Willing to take adequate measures to prevent pregnancy.

Exclusion Criteria:

* The subject has NSCLC with a predominant squamous cell histology
* Subject has hypersensitivity to paclitaxel.
* Subject has received any anti-cancer therapy for treatment of NSCLC.
* Subject has received radiation therapy within 21 days of Study Day 1.
* Subject has had major surgery within 21 days.
* Subject has untreated brain or meningeal metastases.
* Subject is receiving therapeutic anticoagulation therapy.
* Subject has a central thoracic tumor lesion as defined by location within the hilar structures.
* Subject has proteinuria CTC Grade \> 1 at baseline.
* Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.
* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) \> 90 mm Hg or systolic BP \> 140 mm Hg.
* The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1.
* The subject has a documented left ventricular (LV) ejection fraction \< 50%.
* The subject has known autoimmune disease with renal involvement (i.e., lupus).
* The subject is receiving combination anti-retroviral therapy for HIV.
* The subject has clinically significant uncontrolled condition(s).
* The subject has a history of another active cancer within the past 5 years.
* The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
* The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
* The subject is pregnant or breast feeding.
Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation

The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles with and without the FES system. Initially, the context-aware motion assessment and neuroprosthetic control in a clinic will transition to in-home settings as the study progresses, broadening its application for safe and effective use at home.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Capacity to consent
* Post-stroke community-dwelling adults
* Ability to follow 3-step commands

Exclusion Criteria:

* Undomiciled
* Active substance use disorder
* Active psychosis
* Domestic violence or neglect
* Inability to communicate with investigators
* Other comorbidities that prevent full participation in the research
Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect

To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide change and to analyze the cost-effectiveness of its dual diagnosis.

To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Age\>=20 years old.
* Patient who can understand informed consent of the clinical study and signed the consent.
* Patient who is adaptable to CAG and/or coronary revascularization
* Patient who has evaluated stenotic lesion (stenosis\>50% in visual judgment) by CAG at main epicardial vessel and its branch or who suspected to have it.

Exclusion Criteria:

* Patient with known contraindications to Adenosine Triphosphate(ATP) and/or papaverine hydrochloride
* Target vessel diameter\<=2.0mm
* Lesion with Chronic Total Occlusion(CTO) (registration allowed if other branch has stenosis more than 50% in visual judgment)
* Patient with temporary/permanent artificial pacemaker implantation, left bundle branch block, second-degree and third-degree atrioventricular block.
* Acute Myocardial Infarction(AMI) patient
* Patient who is disqualified for FFR and coronary revascularization by the investigator.
* Lesion is disqualified for Percutaneous Coronary Intervention(PCI) by the investigator.
* Patient who has critical valvular disease of heart. (moderate or severe Aortic valve stenosis(AS)/Aortic Regurgitation(AR)/Mitral Stenosis(MS)/Mitral Regurgitation(MR)）
* Patient with a prior Coronary Artery Bypass Graft(CABG) on target vessel.
* Patient with severe renal dysfunction. (serum creatinine\>=2.0mg/dl)
* Patient on hemodialysis.
* Body weight\>=200kg
* Patient who needs ventricular assist device to ensure hemodynamic stability (heart rate\<50/min, SBP\<90mmHg)
* Patient who expects to live less than 2 years at the registration
* Patient with contraindications to an antithrombotic therapy or an anticoagulant therapy.
* Patient who is poor compliance with drug treatment.
* Patient who is allergic to contrast agent.
* Left Ventricular Ejection Fraction(LVEF)\>=30%
* Patient who has the history of PCI with Drug-Eluting Stent(DES) in recent 3 months before registration.
* Patient who has the history of PCI with Bare Metal Stent(BMS) or Plain Old Balloon Atherectomy(POBA) in recent 1 year before registration.
* Patient who has possibility of pregnancy, under breast-feeding and positive pregnancy test in 14days prior to the PCI.
* Patients with inadequacy to join this clinical study.
* Patient who has been enrolled any other clinical study.
Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies

To define the maximum tolerated dose of oral daily ENMD 2076 in patients with relapsed or refractory hematological malignancies


Eligibility Criteria:
Inclusion Criteria:

* Patients must have relapsed/refractory hematological malignancy for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) \[i.e., IPSS ≥ 1.5\] or chronic myelomonocytic leukemia (CMML) are also candidates for this protocol. Relapsed/refractory leukemias include acute non lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible. Patients with relapsed or refractory lymphoma or myeloma may also participate.
* Age ≥18 years.
* Adequate performance status
* Interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents and adequate recovery from prior toxicities. If the patient had a transplant, at least 6 months must have passed before initiation of treatment on this protocol and stable graft versus host disease (no change in severity) for 4 weeks preceding study entry (if applicable).
* Persistent clinically significant chronic toxicities from prior therapy must have resolved to baseline or NCI CTCAE Grade \< 1
* Adequate laboratory results within 10 days of ENMD-2076 administration (unless the abnormality is considered attributable to leukemia)

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy.
* Impaired cardiac function including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, uncontrolled hypertension, or uncontrolled congestive heart failure. Blood pressure must be \< 150/90 at the time of enrollment.
* Receiving any other treatment for their disease
* QTc prolongation defined as ≥ 470 ms.
Impact of Different Dialysis on Sleep Apnea in Patients With Renal Failure

The purpose of this study is to determine whether hemodiafiltration, a new form of hemodialysis can improve sleep apnea in patients with end stage kidney disease.

Sleep apnea or breathing problems during sleep are frequent, occurring in 6% of the general population. However, more than half of all patients on dialysis suffer from breathing problems related to sleep. Sleep apnea is associated with high blood pressure, excessive sleepiness, fatigue, poor memory and concentration as well as depression in those with normal kidneys.

Hemodiafiltration is a new kind of dialysis that is more efficient at clearing toxins that accumulate in kidney failure. It has been used successfully in Europe for over 15 years. However, the effects of hemodiafiltration on sleep apnea in dialysis patients have never been assessed.

We are conducting a clinical trial to examine the effects of hemodiafiltration on sleep apnea in dialysis patients. Fifteen patients with sleep apnea, already on dialysis will be treated with hemodiafiltration 3 times a week, instead of their regular hemodialysis treatment for a period of 3 months. We will repeat sleep studies in these patients before and after the hemodiafiltration period and assess their quality of life.

We hope to decrease the severity of sleep apnea with hemodiafiltration. This could result in better sleep, improved energy level, mood, memory, concentration and blood pressure control in those afflicted by sleep apnea and on dialysis. Our findings would also give us better insight into the cause of sleep apnea in patients with end stage kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients currently stable on a thrice weekly hemodialysis regimen for a minimum of 3 months
* Patients with vascular access and no contraindications to anticoagulation
* Presence of sleep-related breathing disorder defined as a mean apnea-hypopnea per hour of recording greater than 10 based on cardiorespiratory monitoring

Exclusion Criteria:

* Patients already on hemodiafiltration therapy
* Patients already on treatment for sleep disordered breathing.
* Patients with significant neuromuscular disease
* Patients with an expected lifespan \< 1 year
* Patients unable to complete sleep related quality of life questionnaires and consent forms due to language barriers or dementia
* Patients with known substance abuse
* Patients with a respiratory disturbance index greater than 30 with active cardiovascular disease defined by unstable angina, myocardial infarction within 3 months or an Epworth sleepiness score greater than 15 while actively working in a stress situation (for example bus driver, taxi driver). These patients will be evaluated by a sleep specialist.
* Living further than 30 km from dialysis centre