cyrilzakka/clinical-trials huggingface dataset:
VISION and VQI Paclitaxel Safety Analysis

Objectives

1. The VQI-VISION Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel-coated balloons and stents in the treatment of PAD through analysis of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry module with linkage to claims. By linking VQI patients to Medicare claims retrospectively from 2012 to 2016, we will be able to identify additional paclitaxel devices enabling longitudinal follow-up of mortality out to 5 years for paclitaxel-eluting stents and 3 years for paclitaxel-coated balloons.
2. To analyze factors associated with mortality, specifically comparing paclitaxel patients surviving vs. paclitaxel patients with mortality. The goal is to identify independent factors predictive of mortality in US pivotal trials and model registry data exposures with sufficient factors to track competing risk paradox and show emulation or not of mortality outcomes with both PTX and PTA exposures.
3. To confirm the effectiveness of paclitaxel devices by comparing reintervention for paclitaxel and non-paclitaxel devices. In-hospital mortality from open and percutaneous target vessel revascularization (TVR) will be reported to determine the impact of subsequent revascularizations on survival. Major amputation will be comparted for patients with chronic limb-threatening ischemia.

The proposed safety analyses will evaluate two types of paclitaxel-coated interventional devices used to treat PAD and compare patient outcomes with propensity score-matched patients of similar risk who receive non-paclitaxel devices.

The primary outcome will be freedom from all-cause death using propensity-matched survival analysis.

Three principle analyses are planned:

1. Paclitaxel DCB (including the Bard Lutonix, Medtronic In.Pact Admiral, and Philips Spectranetics Stellarex DCB's) as compared with propensity-matched patients treated with plain balloons.
2. Paclitaxel delivering DES (Cook Zilver PTX) as compared with propensity-matched cases using bare-metal stents (BMS).
3. Patients treated with either Paclitaxel DCB or Paclitaxel DES compared with propensity-matched controls (with DCB patients matched to patients treated with plain balloons, and DES patients matched to patients treated with BMS).

Note that this analysis is planned at the device class level and is not intended to compare early or late mortality between specific devices or brands.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years old
* Date of index procedure is within 10/1/2012 to 12/31/2016
* Symptomatic disease ranging from intermittent claudication to chronic limb-threatening ischemia (including ischemic rest pain and/or tissue loss)
* Elective or urgent procedures

Exclusion Criteria:

* Aneurysmal disease of the superficial femoral or popliteal artery
* Treatment for acute limb ischemia
* Treatment of common femoral artery or profunda femoral artery occlusive disease
* Emergency procedures
* PVI and concomitant femoral endarterectomy, suprainguinal or infrainguinal bypass
Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry

The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees
* Sagittal Vertical Axis (SVA) \> 5cm
* Pelvic Tilt \> 25 degrees
* Thoracic kyphosis \> 60 degrees
* Age 18 or greater at the time of enrollment.

Exclusion Criteria:

* Diagnosis of scoliosis other than degenerative or idiopathic (i.e. paralytic/neuromuscular, congenital)
* Age \<18 yrs at time of surgery or initial consultation
21st Century Skills of Nursing Students

It was aimed to investigate the effect of Twenty first century (21st) century skills on the clinical decision making of nursing students. Within the scope of the cross sectional study, answers to the following research questions will be sought:

* What are the 21st century skill levels of nursing students?
* Are nursing students' 21st century skills affected by their sociodemographic characteristics?
* What are the clinical decision-making levels of nursing students?
* Are the clinical decision-making levels of nursing students affected by their sociodemographic characteristics?
* Do nursing students' 21st century skills affect their decision-making levels?

In this cross-sectional study, it is planned to investigate the effects of 21st century skills on clinical decision making of nursing students. Junior and senior students of a nursing undergraduate program in Turkey will be recruited. The universe of the research consists of junior (167 people) and senior (210 people) nursing students of a nursing undergraduate program in a university in Turkey in the 2022-2023 academic year. Sample selection will not be made and those who volunteer to participate will be included. According to the university's nursing program curriculum, first and second year students were excluded from the study because they did not have clinical practice experience. Data will be collected using an Information Form containing sociodemographic data, Multidimensional 21st Century Skills Scale and Nursing Decision Making Instrument. Data collection forms will be collected on the online platform in line with the link created through Google forms. The link address will be shared via students' smartphones. After explaining to the students that the purpose of the study before the application, the participation is on a voluntary basis and the confidentiality of the information obtained will be ensured, they will be asked to fill in the online questionnaire by entering the address in the link. Data collection time is planned to take approximately 10-15 minutes. The dependent variable of the study was clinical decision making; independent variables are 21st century skills and sociodemographic characteristics. In this direction, data analysis will be based on the comparison of dependent and independent variables. If the data is continuous, it will be displayed as percentile, mean, standard deviation; comparison will be made by correlation analysis. Discrete data will be compared with dependent variable according to data level by t test or analysis of variance. The effect of 21st century skills and sociodemographic characteristics of nursing students on clinical decision making will be tested with multivariate regression analysis enter method. For categorical variables, a dummy model will be created and converted into continuous data. Statistical significance value will be accepted as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Nursing undergraduate program junior and senior students
* Volunteering to participate

Exclusion Criteria:

* Nursing undergraduate program 1st and 2nd year students
Effect of Fish Oil on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is the most common malignant disease among children. Treatment results have improved over time due to intensive risk-adapted therapy and the 5-year survival rate is now above 90%. However, the burden of therapy has increased proportionally. Many children develop serious acute and chronic side effects, which impact on the patients expected lifespan and impair their quality of life as a result of therapy. Treatment with PEG-asparaginase and dexamethasone increases the levels of triglycerides and total cholesterol. Consequently, the incidence of hyperlipidemia is high during initial ALL therapy. Studies have suggested that hyperlipidemia is a risk factor for development of osteonecrosis, thrombosis and possibly acute pancreatitis.

Long-chained marine omega-3 fatty acids, found in fish oil, decrease levels of triglycerides and total cholesterol in hyperlipidemic patients. Due to the high survival rate, it is of great interest to develop methods to reduce treatment related toxicities.

The investigators hypothesise that daily intake of fish oil will prevent development of hyperlipidemia during ALL treatment phases with dexamethasone and PEG-asparaginase compared to placebo and that fish oil intake may reduce the incidence of severe adverse events related to ALL treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children (1-17.9 years) and young adults (18-45 years) diagnosed with ALL, stratified to very-low risk (VRL), intermediate risk low (IR-low) and intermediate risk high (IR-high) in the ALLTogether protocol.

Exclusion Criteria:

* Patients diagnosed with ALL, stratified to high risk (HR) after induction treatment or stem cell transplantation in the ALLTogether protocol
Study of Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides

The purpise of this study was to determine the effect of low-dose (4 Gy) total skin electron beam therapy as a second-line treatment of stage IB-II mycosis fungoides.

Current treatment modalities are usually not curative and having treatment options suitable for the long-term control therefore essential. Electron beam therapy is generally applied to the skin in total doses of 30-36 Gy over a 8-10 week period.Due to the potential risk of toxicity including bone marrow supression, no more than 2-3 courses in a life time are generally recommended. In the current study we explored the possibility of using lower radiation doses for total skin electron beam therapy for long-term disease control.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed mycosis fungoides stage I-II with failure to obtain full remission after standard PUVA treatment or relapse within 4 months of PUVA treatment

Exclusion Criteria:

* under 18 years, pregnancy, other somatic diseases with a life expentancy under 1/2 years, psycological disorder preventing the patient to understand the information and cooperate in the treatment
Effect of Thermal Stimulation on Cortical Excitability and Motor Function in Chronic Stroke Patients

Functional magnetic resonance imaging (fMRI) has confirmed that thermal stimulation (TS) may facilitate cortical excitability in healthy adults. However, it is unknown whether TS can increase cortical excitability in stroke patients. Compared to the fMRI, the transcranial magnetic stimulation (TMS) possesses more concise conditions in temporal resolution, and it can present the cerebrum activation situation more instantaneously. This study aimed to use TMS examining the effect on corticomotor excitability, reorganization and functional motor recovery after TS on affected upper limbs of chronic stroke patients.

The study was an assessor-blinded randomized controlled clinical trial. The participants (more than 3 months posts-stroke)were randomly assigned to experiment (EXP) and control (COT) groups. All participants received regular conventional rehabilitation programs. The EXP and COT received additional upper extremity TS protocol for 30 minutes a day for 20 days. The TS temperature of EXP for noxious stimulation was set at 46-47°C for heat and 7-8°C for cold stimulation; the temperature of COT for innoxious stimulation was set at 40°C for warm and 20°C for cold stimulation. The motor and sensory performance were evaluated at baseline and post-20th- TS by Brunnstrom's recovery stage, Modified Ashworth Scale (MAS), Barthel Index (BI), Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment (UE-FM) and Thermal Quantitative Sensory Testing (tQST). At pre-1st-TS, post-1st-TS, post-10th-TS and post-20th-TS, focal TMS was used to obtain measurement of motor threshold (MT), motor evoked potentials (MEPs), size of cortical motor output map and location of the amplitude-weighted centre of gravity of the motor output map (CoG) from abductor pollicis brevis (APB) in bilateral upper extremities.

Eligibility Criteria:
Inclusion Criteria:

1. first-ever stroke survivors with unilateral hemispheric lesions from a ischemic stroke.
2. stroke onset more than 3 months
3. no severe cognitive impairments and able to follow instructions
4. the ability to sit on a chair for more than 30 minutes independently
5. no family history of epilepsy

Exclusion Criteria:

1. musculoskeletal or cardiac disorders that could potentially interfere with experimental tests;
2. diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy;
3. speech disorder or global aphasia;
4. participating in any experimental rehabilitation or drug studies;
5. skin injuries, burns, or fresh scars at the sites of stimulation;
6. contraindication of heat or ice application
Effects of Sleep Disruption on Drug Response

The central scientific premise of the proposed study is that sleep disruption (SD) will influence individuals' subjective response to blinded medication administration. The investigators further believe these responses will vary among patients who have chronic low back pain (CLBP) vs. healthy controls, and that sex will moderate effects.

The proposed study evaluates whether CLBP patients' subjective responses to study medication administration are altered by SD. The investigators focus on two outcome domains: abuse liability (i.e., drug liking and valuation) and response to pain testing.

The investigators propose a mixed between-within randomized crossover human-laboratory experiment that investigates placebo-controlled effects of study medication on 1) abuse liability metrics (Drug Liking and Monetary Valuation) and 2) response to laboratory-evoked standardized pain measures, after one night of uninterrupted sleep (US) and again after one night of SD. The investigators will recruit both CLBP patients(\*) and healthy controls (N = 60).

(\*) We originally aimed to accrue 60 subjects with CLBP. However, we have been granted approval by the National Institute on Drug Abuse (NIDA) to reduce expectations for the target N for the CLBP cohort. We are no longer expected to recruit N=60 CLBP participants; this is a COVID-19 modification, and we are not required to re-do a power analysis.


Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria:

* 18-60 years old
* Less than 2 servings/day of caffeinated beverages and willing to discontinue 3 days prior to admission.

CLBP-Specific Inclusion Criteria:

* Have a physician-confirmed diagnosis of CLBP
* Report chronic low back pain.

Exclusion Criteria:

General Exclusion Criteria:

* BMI \>40
* Significant medical or psychiatric morbidity within 6 months or lifetime history of bipolar disorder, psychotic disorder, seizure disorder
* Lifetime history of opioid use disorder
* Clinically significant abnormal complete blood count or comprehensive metabolic profile
* Any contraindicated medical condition (status asthmaticus; chronic obstructive pulmonary disease; reduced respiratory function; hypotension; hypertension; impairment of hepatic, pulmonary or renal functions; myxedema or hyperthyroidism; adrenocortical insufficiency; gastrointestinal obstruction; gall bladder disease; acute alcoholism; history of convulsive disorders; history of head injury)
* Current use of stimulants, opioids, benzodiazepines or other Central Nervous System (CNS) depressant
* Positive toxicology screen for opioids, stimulants, or recreational drugs
* Pregnancy or lactation
* Significant preadmission psychological distress.

Healthy Control and CLBP-Specific Exclusion Criteria:

* Report current medical/psychiatry history
* Report acute painful injury (within 3 months)
* Have a diagnosed chronic pain disorder.
Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports

Inhospital the blood transfusion process consists of many phases: ordering the blood product, analysis of the blood sample, delivery, transport and storage of the blood product and administration. In each of these phases (near) accidents may occur. A severe transfusion incident refers to the transfusion of a wrong blood product, whereas a near miss is detected before transfusion.

In 2010 the University Hospitals Leuven introduced a new electronic patient incident report system for transfusion events.

In this study the investigators will analyze the reported blood transfusion events to detect the most common causes of blood transfusion events and the weakest link in the blood transfusion chain.

A retrospective survey will be conducted of all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012. Both severe accidents and near misses will be included.

Data will be drawn from the incident report system. Data concerning the number of transfused blood products will be required from the Medical Administration Service.

Events will be classified according to the severity and the cause of the event. The different settings where the events took place will be compared using a chi-square test (p\<0,05).

Eligibility Criteria:
Inclusion Criteria:

* all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012
* Both severe accidents and near misses were included

Exclusion Criteria:

* Transfusion reactions
Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption

Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. There is no definitive evidence on the optimal management of SCAD, but the general approach is conservative.

Unlike established evidence-based rehabilitation programs for ACS and heart failure, no cardiac rehabilitation protocol exists for SCAD.

The aim of the study is to report and detail the cardiac rehabilitation program which was proposed to patients previously included in The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection. (DISCO trial - NCT02799186).

The cardiac rehabilitation program was proposed to the patients presenting with SCAD in each interventional cardiology department, according physician's in charge of the patient decision.

The patient who has undergone a cardiac rehabilitation program following the ACS is included in a retrospective way. The patients are informed about this study by the investigator. After a reflection period, the patient is included.

Details regarding the entrance psychosocial evaluation, the entrance exercise treadmill test, the medications changes during rehabilitation, the training program modalities, the exit exercise treadmill test, and the left ventricular ejection fraction evolution (evaluated by echocardiography) were recorded. The safety for each cardiac rehabilitation program was also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patient previously recruited in The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection. (DISCO trial - NCT02799186) :

  * Patient over 18 years old
  * Patient with a possible diagnosis of spontaneous coronary dissection defined by:
  * ACS presentation
  * Angiographic signs compatible with a SCAD
  * More or less confirmed by intracoronary imaging (OCT/IVUS) or remote angiographic control (upper to 1 month).
  * Patient with signed informed consent to participate in the DISCO study
  * Subject agreeing to the use of his or her personal data in the form of anonymous coding, including in scientific publications.
* patient who has undergone cardiac rehabilitation following the management of acute coronary syndrome.

Exclusion Criteria:

o Exclusion criteria for the DISCO study :

* Minor patient
* Patients of legal age under protective supervision (guardianship, trusteeship)
* Non affiliation to the French social security system
* Coronary dissection of iatrogenic or traumatic origin.
TBE-vaccine to Patients With Rheumatoid Arthritis Who Are Using Immunosuppressive Drugs

The investigators intend to check whether the efficacy of a TBE-vaccine is substantially deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress the immune system. The investigators aim to detect a difference of at least 10 % compared to healthy individuals (historical controls) in protection when analysed with serology. If the investigators detect a difference, the investigators will continue to explore whether protection can be achieved by additional doses


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis treated with methotrexate and/or TNF-alfa blocking drugs
* Interest to be vaccinated
* Written consent
* Age 18 years or more

Exclusion Criteria:

* Previous TBE-infection
* Previous Vaccination with TBE
* Pregnancy
* Breast feeding
* Treatment with rituximab the last 9 months
* Inability to follow study protocol
Anesthetic Effect on Immune Cell in Patients With Cancer

Anesthetics agents has an effect on immune response during the cancer surgery.This influence can regulatory to immune activity or cancer cell survival.

The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.

1. immediate before anesthesia induction
2. postoperative 1 hours
3. postoperative 24 hours

Immune cells isolation from patients peripheral blood mononuclear cells. Next, immune cell were co-culture with human cancer cell line (MCF-7) for 24 hours. investigation for immune cell or cancer cell survival by flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* patient who was planned to undergo breast cancer surgery.

Exclusion Criteria:

* age \< 20 years old
* history of hypersensitivity reaction in propofol or sevoflurane
* history of previous cancer
* patient with ongoing inflammation