cyrilzakka/clinical-trials huggingface dataset:
TYGRIS - ROW: TYSABRI Global Observational Program in Safety - Rest of World

The primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAEs) in participants with multiple sclerosis (MS) treated with TYSABRI (natalizumab).

The TYSABRI Global Observational Program in Safety for Rest of World (TYGRIS - ROW)is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with TYSABRI in a clinical practice setting in countries other than the United States and Canada.

The Prescribing Physician will collect participant information at routine clinic visits (using standard data collection tools) at approximately 6-month intervals for 5 years from the first TYSABRI infusion.

Eligibility Criteria:
Key Inclusion Criteria:

* All Multiple Sclerosis (MS) participants in Rest of World (ROW) who are prescribed and receiving TYSABRI in normal clinical practice at centers that are taking part in the study are eligible to participate in TYGRIS - ROW. Participants must have received at least 1 and not more than 3 infusions of TYSABRI.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Satisfaction Assessment After Axillary Block

Satisfaction assessment at 24 and 48 hours post operatively, after Axillary Brachial Plexus Block for Distal Arm Surgery.

Inclusion after distal Arm Surgery performed under Axillary Brachial Plexus Block.

Satisfaction assessment at 24 and 48 hours post operatively by self-administered survey questionnaire based on different scales: Evan-LR, Net Promotor Score, Satisfaction score.

Eligibility Criteria:
Inclusion Criteria:

* patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block

Exclusion Criteria:

* Refusal, inability to consent
* inability to fill self-administered survey questionnaire
* pregnancy and breastfeeding
* surgery \> 2 hours
* second surgical site requiring anaesthesia or analgesia
* chronic use of analgesia (including opioids) or illegal drugs
Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have supratentorial glioblastoma multiforme.

OBJECTIVES:

* Determine the overall and progression-free survival in patients with supratentorial glioblastoma multiforme treated with accelerated radiotherapy and conformal stereotactic radiotherapy boost followed by carmustine.
* Determine the short and long-term toxicity of this regimen in these patients.
* Determine the feasibility of this regimen in these patients.

OUTLINE: Patients receive daily accelerated radiotherapy 5 days a week on weeks 1-2. On weeks 3-6, patients receive accelerated radiotherapy 4 days a week (3 days a week on week 6) and conformal stereotactic radiotherapy boost once weekly. Patients then receive carmustine IV over 1-2 hours on days 1-3 every 8 weeks for 6 courses beginning within 1 month after the completion of radiotherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 15 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed supratentorial glioblastoma multiforme by surgical biopsy or resection within 5 weeks of study
* Postoperative residual contrast enhancing tumor and resection tumor cavity together no greater than 60 mm in maximum diameter
* No well-differentiated or anaplastic astrocytomas or multifocal glioma
* No tumors originating in the brainstem
* No residual tumor within 10 mm of optic chiasm
* No recurrent glioblastoma multiforme

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Hemoglobin greater than 9 g/dL
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 2.0 mg/dL
* Serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal

Renal:

* Creatinine less than 1.8 mg/dL
* Blood urea nitrogen (BUN) less than 30 mg/dL

Pulmonary:

* Chest x-ray normal OR
* Diffusion capacity of lung for carbon monoxide (DLCO) greater than 60% predicted

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Neurologic functional status 0-3
* No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Concurrent steroids allowed

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* Concurrent anticonvulsants allowed
PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home

PAPRIKA establishes a technologically enabled and personalized prehabilitation and follow-up after surgical intervention program for patients undergoing elective major surgery Program creates close collaboration between the medical environment and the patients empowering them to co-create their own care.

It is at the first stage aimed to high-risk patients undergoing major surgery. Better condition before the surgery is proved to reduce the perioperative complications and to improve patients' health-related quality of life while cutting the associated costs. The concept integrates short-term (average 4 weeks) preoperative interventions including endurance training, promotion of physical activity and nutritional and psychological support. Interventions are planned both at community and at hospital reducing unnecessary interactions between patients and tertiary care.

PAPRIKA tackles three major drivers: i) human perspective ii) organizational challenges and iii) technical aspects. The project is based on previous experience on prehabilitation and the already refined service using design thinking methodologies. It will be also based on the proven reduction of associated costs for the healthcare system.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 70 years old and/or American Society of Anesthesiologist (ASA) index 3-4 and/or highly aggressive surgery or solid organ transplantation.

Exclusion Criteria:

* Non-elective surgery; metastatic disease.
Analysis of Heart Rate Variability During Emergency Flight Simulator Missions in Fighter Pilots

The autonomous response of fighter and attack pilots who attend sessions in a flight simulator will be evaluated by measuring and analyzing heart rate variability (HRV).

The autonomous response of fighter and attack pilots during emergency situations in a flight simulator will be assessed by measuring and analysing heart rate variability (HRV). Eighteen pilots with instructor or student status assigned at the time of the evaluation to the ALA 23 district of the Talavera la Real Air Base of the Ministry of Defence of the Spanish Government (Badajoz) were studied during emergency situations in flight simulator. Subjects were assigned by non-probabilistic randomisation to an instructor group (IG; 7 subjects), and to a student group (AG; 11 subjects).

The recording of the parameters indicated corresponds to the emergency situations described above. Data collection was made in three different moments:

1. Take-off: it starts after reading the checklist until the engine fault is resolved.
2. Flight: during manoeuvres characterised by the recovery of abnormal positions.
3. Landing: where the pilot performs the landing manoeuvre, with the loss of spatial situation.

Eligibility Criteria:
Inclusion Criteria:

* Pilots who had the status of instructor or student assigned at the time of assessment to the ALA 23 district of the Talavera la Real Air Base of the Ministry of Defense of the Government of Spain (Badajoz).

Exclusion Criteria:

* Any uncontrolled neurological or cardiac disorder.
* Being involved in ongoing medical-legal conflicts.
X-rays Trauma Request's by the Triage And Intake Nurse Intake and Referral Nurse:

The number of consultations in emergency departments is increasing day by day, and the time to treat patients is getting longer. Different French studies have shown a significant reduction in the time spent in the emergency department after the implementation of the national protocol for the delegation of early radiography prescriptions. The investigators hypothesised that an early request for a standard X-ray by the intake and referral nurse in the case of isolated trauma to the extremities of a limb (from the knee to the toes and from the shoulder to the fingers) enables a reduction in medical management time and, consequently, in the time spent in the emergency department for the patient.

This study is divided into two steps to three month.

* The first step of the study corresponds to the current standard of care (SoC) in the emergency department of Orléans. In this first step, the intake and Referral Nurse (IRN) will carry out the usual triage and refer the participant to the appropriate emergency department before being appointed by the physician. The radiography will be requested after the medical consultation.
* In the second step, the intake and referral nurse will carry out the usual triage and then request one, or more, radiography(ies) depending on the standard protocol. This ensures that the physician has access to the imaging before the consultation with the patient. If necessary, the X-ray technician is authorized to refuse the exams or complete the request, the choice of the incidence is up to him/her according to the intake and referral nurse.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 15 years and 3 months admitted in adult emergency department of regional hospital center of ORLEANS with a simple and isolated trauma having occurred less than 48 hours prior to admission of a limb extremity (from the knee to the toes or from the shoulder to the fingers), and with no previous imagery assessment within 48 hours prior to admission in the emergency department.

Exclusion Criteria:

* Multiple trauma
* Patient with at least one Vittel criteria (except age)
* Patient refusing the protocol
* Hemodynamic instability and/or disorder of consciousness
* Sensory and/or vascular disorders downstream of the traumatized area
* Protected population (under guardianship or curators)
* Patient under court protection
* Pregnant or breastfeeding woman or one who declares herself to be pregnant or breastfeeding
* Patient with an expired blood alcohol level \> 0.4 mg/L and/or positive blood alcohol level
* Patient with diagnosed dementia
* Patient hospitalized after being taken in charge
Mindfulness Training Effect on Self-monitoring Adherence and Group CBT Outcomes for Binge Eating Disorders

Bulimia Nervosa (BN), Binge Eating Disorder (BED) and Night Eating Syndrome (NES) are Binge Eating Disorders (BE-Dis) in which binge eating episodes are a main symptom. Cognitive Behavioral Therapy (CBT) is the leading evidence-based treatment for patients suffering from these disorders. CBT-E is an "enhanced" trans-diagnostic version of the treatment which appears to be more effective in a variety of Eating Disorders (EDs). The main goals of this treatment are reducing dietary restrictions and EDs symptoms as well as food intake regulation. Self-monitoring (SM) is an important and central tool in this type of treatment considered crucial for its success. Therefore, during treatment, patients are required to monitor their eating, the circumstances, and their thoughts and feelings proximate to the time of eating. Nevertheless, despite the importance of this tool, research has shown that there are many difficulties challenging the clients' adherence to SM, which might reduce this treatment's effectiveness and outcome. Additionally, in recent years there has been cumulative data supporting the use of mindfulness in the treatment of EDs. Mindfulness, as a western psychological approach, is defined as the "unique non-judgmental focus of one's attention at the present moment". Although SM requires the ability to observe, describe and identify occurrences, no studies have yet examined the direct effect of mindfulness skills on SM adherence, and therefore the improvement of treatment outcomes.

The main objective of the present study is to examine the effect of a mindfulness based intervention on SM adherence during a CBT intervention for BE-Dis, and on the treatment outcomes as seen in the ED psychopathology and compliance to the nutritional instructions and food intake composition. Other aims include examining the differences between the experimental group and the control group, regarding their level of mindfulness and SM adherence. In addition, mediating and moderating processes between mindfulness and SM adherence will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18-60 who meet the criteria for BN, BED or NES according to the DSM-V.
* The participants will be recruited via convenience sampling among patients applying for treatment in the ED unit in "Hanotrim" outpatient clinic ("Shalvata" mental health center) and through internet advertising.
* Participation in the research program will be allowed only after evaluation and a diagnostic procedure to examine if the criteria for CBT are met in terms of diagnosis and motivational status. This procedure will be conducted through psychological and nutritional intake.

Exclusion Criteria (contraindications to starting CBT-E immediately):

* Current suicidal ideation
* Current substance/alcohol dependence or abuse
* Current psychosis
* Pregnancy (which began prior inclusion)
* Inability to attend treatment on a regular basis
Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment

This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
* No previous targeted treatment such as gefitinib, erlotinib.
* With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) according to RECIST Criteria
* WHO performance status(PS)\<= 2
* N\>=1.5×109/L, Plt\>=1.0×109/L,Hb\>=10g/dL;AST\&ALT should \<3ULN(without liver metastasis) or \<5ULN(with liver metastasis).TBIL\<=1.5ULN.
* Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

* Allergic to icotinib
* Patients with metastatic brain tumors with symptoms.
* Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty

The objective of this study is to establish a near-real-time prospective monitoring program in Medicare, Optum and MarketScan Research data to evaluate the benefit of new cardiovascular disease (CVD) drugs for older adults with frailty. Prospective monitoring program seeks to find early effectiveness and safety signals of new drugs by updating the analysis at regular intervals as new Medicare data become available. This study specifically aims to emulate a prospective surveillance of the effectiveness and safety of non-vitamin K oral anticoagulants (NOAC) vs. a comparator, warfarin, in older adults with atrial fibrillation and different frailty status. This program will be enhanced by incorporating a novel claims-based frailty index, which has been shown useful in assessing how the benefits and harms of drug therapy vary by frailty.

Data sources of use for this study are: Medicare Database, Optum Database, and MarketScan Research Database. All data from years 2013-2020 (available data may vary depending on the database) will be analyzed in the study.

This study follows a sequential cohort monitoring design. The monitoring analysis will include 1) retrospective analysis of available data (2013-2018) at the time of first analysis (April 2021) and 2) prospective analysis of new data (2019-2020) as they become available to the researchers. Within each database and by frailty status (frail vs non-frail), the investigators will emulate annual updating of data by creating a propensity score (PS)-matched cohort of new users every 1-year interval. Each sequential cohort will be followed for development of the outcomes of interest. At the end of each interval, time-to-event data from all sequential cohorts will be pooled for outcome analysis. The surveillance will be performed by frailty status (frail vs non-frail) at the time of drug initiation.

Eligibility Criteria:
Inclusion Criteria:

* Initiation of a NOAC or warfarin (day 0 is the initiation day)
* Continuous enrollment in medical and drug insurance in \[-183, 0\] days
* Diagnosis of AF in \[-183, 0\] days
* CHA2DS2-VASc score ≥2 (moderate or high risk for stroke)
* No prior use of NOAC or warfarin in \[-183, -1\] days
* No recent hospitalization for stroke or major bleeding in \[-60, 0\] days
* No recent nursing facility stay in \[-60, 0\] days

Exclusion Criteria:

* Contraindication to either drug in \[-183, 0\] days
* Valvular heart disease or mechanical heart valve in \[-183, 0\] days
* Intracranial or retroperitoneal hemorrhage in \[-183, 0\] days
* Chronic kidney disease stage V, end-stage renal disease, or dialysis in \[-183, 0\] days
* Other indications for anticoagulation therapy in \[-183, 0\] days
The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation

This study will investigate whether two clinical tests can be used to diagnose and predict the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery treatment.

The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.

150 patients will be included for the prospective cohort study. Patients will be recruited from the Region of Southern Denmark and Capital Region. Participants will undergo MRI scanning of the lumbar spine, fillout a questionnaire and undergo assessment with the two clinical tests. An 8-week follow-up will be made with patients completing a questionnaire. The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiologically diagnosed lumbar disc herniation.
* Low back pain with pain below the knee or anterior thigh pain in one or both legs.
* Dermatomal leg pain.
* Average pain intensity of 3 or more on a Numerical Rating Scale (0-10 NRS).

Exclusion Criteria:

* History of previous lumbar spine surgery.
* Surgery in general in the past 4 months.
* Current use of anticoagulants.
* Diagnoses which could confound with the diagnosis e.g. lumbar spinal stenosis, local muscle trauma, cancer metastases, fibromyalgia, neuropathy.
Empirical Antibiotic and Outcome in Community-onset Bacteremia

Empirical antibiotic and outcome in Community-onset Bacteremia Caused by third generation cephalosporin resistant Enterobacteriaceae

Prospective cohort study is conducted for monitoring outcomes and risk factors among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae.

Primary endpoint is mortality rate among those who received initially inappropriate antimicrobial which switch to appropriate antimicrobial later when culture and antimicrobial susceptibility test reported among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Community-onset Bacteremia Caused by third generation cephalosporin resistant Enterobacteriaceae. Age \> 18 years

Exclusion Criteria:

* Pregnancy
* Polymicrobial infection
Echographic Measurement of Skin Thickness

To optimize a medical device for intradermal injection, knowledge concerning the thickness of epidermis and dermis at the proximal forearm is required. Since scientific knowledge is lacking, the investigators will examine the skin thickness (epidermis and dermis) of adults using imaging technology (High Frequency Ultrasound). The investigators hypothesize that they are able to correlate the thickness of the (epi)dermis to a specific combination of parameters age, gender, and BMI.

Based on these results, the investigators can define which needle type and length is needed to correctly perform injections into the dermal layer.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Age: 18-65 years
* Dutch-speaking
* Caucasian

Exclusion Criteria:

* Pregnancy or lactating
* Using ointment, crème, or gels based on corticoids
* Suffering from skin diseases (psoriasis, burning wounds)
Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia

The purpose of this study is to investigate the effects of low-intensity and prolonged vibrotactile sensory stimulation on brain activity and functional connectivity in fibromyalgia patients.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Care Res 2010;62:600-10).
2. Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion)
3. Diagnoses established by an expert on fibromyalgia.
4. Stable treatment of chronic use.
5. Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.

Exclusion Criteria:

1. Generalized inflammatory articular or rheumatic disease.
2. Severe, non-stable medical, endocrinological or neurological disorder.
3. Psychotic disorder or drug abuse.