cyrilzakka/clinical-trials huggingface dataset:
Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics

Retrospective study to assess incidence and predictors of opioid abuse overdose and death associated with opioid overdose among patients prescribed opioid products in long-term use.

The purpose of this study is to quantify risk, and predictors of risks for opioid overdose and for death associated with opioid overdose in persons who are or have been long-term recipients of prescriptions for Schedule II opioids. The study uses coded terms in large heath databases maintained by healthcare providers and health insurers, supplemented by overdose deaths identified from the National Death Index. The terms for overdose are combined following validated rules as developed in companion studies. The study is being conducted in parallel with a prospective questionnaire-based cohort study of the same risks.

Eligibility Criteria:
Inclusion Criteria:

* In the primary analysis, persons known to have had at least six months of no opioid dispensing who subsequently receive at least 70 days of Schedule II opioid dispensed within a 90-day period and who have not previously experienced an opioid overdose.
* In a secondary analysis, persons who have been long-term users of IR/SA opioids and who switch to a different Schedule II IR/SA opioid product or to an ER/LA opioid
* In another secondary analysis, persons with at least six months of presence in the health insurance data who have not received opioids in the preceding 30 days, and have not previously experienced an opioid overdose

Exclusion Criteria:

• Experience of opioid overdose in the six months preceding inclusion
The Effect and Safety of the Seasonal Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Not on Dialysis

In recent years, several studies revealed that the current influenza vaccine strategy might be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and mortality in the end-stage renal disease population than previously thought. Thus, this also raised the question about the effectiveness of administration of influenza vaccination in chronic kidney disease patients not on dialysis. In this study, the investigators aim to evaluate the effectiveness of seasonal trivalent influenza vaccine, formulation 2013-2014, in patients with different stage of chronic kidney disease (CKD) not on dialysis.

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by the method of hemagglutination inhibition (HI) and ELISA-based microneutralization (microNT-ELISA) assays. All participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 4). The investigators will collect serum of participants at the 5th weeks, 9th weeks, and 21th week post vaccination and evaluate the difference of immune response in these 3 groups.

Eligibility Criteria:
Inclusion Criteria:

1. .Males and non-pregnant females and aged ≥ 18 years with chronic kidney disease not on dialysis;
2. .Willing and able to adhere to visit schedules and all study requirements;
3. .Subjects read and signed the study-specific informed consent.
4. .Subjects who has either received the first dose of 2013-2014 seasonal influenza vaccination before or not.

Exclusion Criteria:

1. .Subject or his/her family is employed by the participated hospital;
2. .History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
3. .Personal or family history of Guillain-Barré Syndrome;
4. .An acute febrile illness within 1 week prior to vaccination;
5. .Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
6. .Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
7. .Female subjects who are pregnant during the study.
8. .Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
9. .Immunodeficiency, or under immunosuppressive treatment.
10. .Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
11. .Receipt of any blood products, including immunoglobulin in the prior 3 months;
12. .Any severe illness needed to be hospitalization within three months.
13. .Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial

The study hypothesis is to investigate whether a moderate weight loss (i.e. a weight reduction of at least 5%) could improve the response rate to a suboptimal dose of cyclosporine in patients with severe psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age,active but clinically stable plaque psoriasis involving at least 10 percent of the body surface area and a psoriasis area and severity index (PASI) score ≥10 and a body mass index ≥30.

Exclusion Criteria:

* Other type of psoriasis (guttate, erythrodermic and pustular psoriasis)
* Uncontrolled hypertension
* Severe congestive heart failure
* Renal and liver impairment
* Active or chronic infections, including HIV, HBV and HCV infections, latent tuberculosis
* Previous or active malignancies
* Pregnancy and lactations
* Previous treatment with cyclosporine
* Phototherapy or any systemic or topical therapy for psoriasis within the previous 4 weeks before enrolment.
Assessment of the Professional Difficulties of Adult With Attention Deficit / Hyperactivity Disorder Patients

Attention Deficit/Hyperactivity Disorder (ADHD), which is common and well known in children, persists into adulthood in more than 60% of cases, with significant impact on quality of life. Professional domain is particularly impaired.

The investigators hypothesize that ADHD symptoms causes professional difficulties, on the emotional, cognitive, physical and relational levels.

The main objective of this study is to better characterize these professional difficulties at to follow-up these difficulties after one year. Difficulties will be assessed by questionnaires and semi-directive interview.

The secondary objective is to determine what factors modulate these difficulties and what compensation strategies are implemented to address the patients.


Eligibility Criteria:
Inclusion criteria:

* Patients aged 18 to 62 years
* Diagnosis of attention deficit disorder with or without hyperactivity by a psychiatrist
* No treatment for ADHD in childhood or adolescence
* Patient who has been in a professional situation during the last 3 months

Exclusion criteria:

* Patient on sick leave or unemployed for more than 3 months
* Depressive episode in acute phase
* Subject with a mobility project that prevents follow-up for 1 year (planned move)
* Impossibility of providing the subject with informed information (subject in an emergency situation, difficulties in understanding the subject, mental retardation, illiteracy or insufficient command of the French language...)
* Subject under the protection of justice
* Subject under guardianship or curatorship
Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis

The purpose of this study is to determine the effects of CyberKnife stereotactic body radiotherapy in combination with irinotecan chemotherapy in patients with colon or rectal cancer that has spread to the liver.

Conventional radiation therapy has a limited role in the treatment of patients with liver metastases because the radiation doses are limited by liver toxicity. The CyberKnife system is a type of radiation machine that precisely focuses large doses of x-rays on the tumor, so that injury from radiation to the nearby normal tissue will be minimal. It is approved by the U.S. Food and Drug Administration to treat tumors, lesions and conditions anywhere in the body when radiation therapy is required. While the device is no longer classified as "investigational", the best treatment dose and times are still being evaluated.

Chemotherapy delivered with radiation therapy can increase the effectiveness of treatment, and may allow for a lower dose of radiation therapy to be utilized, thereby limiting negative side effects.

In this study, patients will receive Cyberknife radiosurgery directed to liver metastasis for 3-5 treatments, given every other day. Irinotecan 40mg/m2 will be administered intravenously daily for 3-5 days (5 treatments within 10 elapsed days), and prior to radiation therapy. Patients will have follow-up visits at months 1,2,4,6,9,12,15,18, 24, 30, 36, and every 6 months thereafter for 3 years.


Eligibility Criteria:
* Age\>18 years
* Histologically confirmed primary colorectal cancer
* Stage IV colorectal cancer with \</= 3 metastases, up to 5cm in size.
* CT scan or MRI of the abdomen with contrast, 60days prior to enrollment
* If patient is allergic to contrast, imaging without contrast is acceptable
* Positron-Emission Tomography 60 days prior to enrollment
* No additional sites of metastasis at the time of protocol enrollment. History of other sites of metastasis that are currently controlled are acceptable.
* No malignant ascites
* At least 4 weeks from any chemotherapy
* No prior liver radiation therapy
* ECOG performance status 0-1
* Life expectancy\>3months
* Laboratory evaluations completed 60 days prior to treatment including CMP, CBC with differential, liver function test, and prothrombin time.
Correlation of the Objective and Subjective Measures of the Nasal Obstruction Before and After Surgery of the Nasal Septum

Nasal obstruction is a very subjective sensation but it's also a frequent reason of consultation. Two specific questionnaire NOSE and RhinoQOL were validated; but rhinomanometry value is still a question to debate. As well as the difference between acoustic rhinometry and rhinomanometry.

Usually nasal obstruction due to a septal deviation is treated by septoplasty. If the anatomic result can be proved true, the patient's felt would be unsuccessful.

The aim of this study is to assess the impact of septoplasty on the nasal obstruction, objectively by rhinometry and subjectively by questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* age \>18
* with medical insurance
* programmed for septoplasty
* nasal obstruction with septal deviation
* accept participation

Exclusion Criteria:

* nasal sine polyposis
* endonasal mass
* chronic sinusite
* previous nasal surgery
A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how safe, tolerable and effective the study drug is when given alone.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug versus Standard of Care (SOC)
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
* Comparing the impact from the study drug versus SOC on quality-of-life and ability to complete routine daily activities


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed
2. Have primary refractory or relapse 12 months or less (≤) from initiation of frontline therapy Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment
3. Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\])
4. Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
6. Adequate hematologic and organ function.

Key Exclusion Criteria:

1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol
2. History of or current relevant CNS pathology, as described in the protocol
3. A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated
4. Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol
5. Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
6. Allergy/hypersensitivity to study drug, or excipients.

NOTE: Other protocol defined inclusion / exclusion criteria apply
CANadian Clinical Evaluation of SpiderFlash Arrhythmia DETECTion in SpiderFlash™ Device

This clinical investigation is a prospective, non-randomized, multi-center pivotal trial.

This trial aims to validate the automatic detection features provided by the external long-duration SpiderFlash-t™ Event recorder coupled with its analyser EventScope™, and to assess the performances of the Mode Switch function provided by Sorin Group Implantable Cardioverter-Defibrillators (ICDs).

This trial is being performed first in order to demonstrate the ventricular tachycardia (VT)/ ventricular fibrillation (VF) sensitivity of the automatic VT/VF detection function of the EventScope™ software.

Patients will be implanted with an ICD from Sorin Group, with PARAD+ arrhythmia detection enabled and Mode Switch (MS) algorithms activated in all patients.

Arrhythmic events will be documented over a period of 6 to 8 weeks for each patient.


Eligibility Criteria:
Inclusion Criteria:

Patients already implanted with an OVATIO DR or CRT-D device may be included in the study if they presented with at least one clinical VT/VF event at the follow-up visit preceding the enrolment.

ICD or CRT-D device upgrading or replacement are allowed but under the condition that existing bipolar RV sensing/pacing lead and/or defibrillation lead and/or LV pacing lead (where applicable) are not of poor or questionable integrity.

Patients with implanted pacemakers may be included in the study only if the pacemaker is to be explanted or otherwise disabled prior to implanting the ICD or CRT-D system, to avoid any potential pacemaker-ICD interactions.

Patients must comply with all the following criteria in order to be included in the CAN-DETECT study:

1. Patient is eligible for implantation of a dual-chamber ICD or a CRT-D device according to current available guidelines for primary or secondary ICD indication .
2. A stable, optimal (as determined by the enrolling physician) drug regimen
3. Scheduled for implant of an OVATIO DR Model 6550 or OVATIO CRT 6750 or an equivalent device from Sorin Group.
4. Signed and dated informed consent.

Exclusion Criteria:

Any patient complying with any of the following criteria cannot be included in the CAN-DETECT study:

1. Any contraindication for standard cardiac pacing
2. Any contraindication for ICD therapy
3. Permanent high-degree AV Block for patients planned for dual-chamber ICD implant only.
4. Permanent AF for patients planned for dual-chamber ICD implant only.
5. Abdominal implantation site
6. Acute myocarditis
7. Mechanical tricuspid valve
8. Heart transplant recipient
9. Already participating in another clinical study
10. Life expectancy less than 6 months
11. Inability to understand the purpose of the study or refusal to cooperate
12. Inability or refusal to provide informed consent
13. Unavailability for scheduled follow-up at the implanting center
14. Under guardianship
15. Age of less than 18 years.
Wet-suction Versus Slow-pull for EUS-FNB of Solid Lesions

A randomized cross-over study investigating the impact of two different suction techniques on histological yield and sample quality of specimens collected by endoscopic ultrasound biopsy from solid lesions using histology needles.


Eligibility Criteria:
Inclusion Criteria:

* Solid pancreatic lesions 3 1cm
* Peri-GI tract lymph nodes 3 1cm
* Peri-GI tract masses
* Lesions of the GI wall
* Signed informed consent

Exclusion Criteria:

* Pancreatic cystic lesions (more than 50% of the volume)
* Diameter of lesion ≤ 1 cm
* Lesion not seen at EUS
* Pregnancy
* Coagulopathy (platelet count \<50.000/mm3 and/or international normalized ratio \>1.5);
* Severe cardiorespiratory dysfunction precluding endoscopy;
* Failure to provide informed consent
The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases

Investigator-initiated, prospective, non-randomized, open label, non-interventional multicenter registry to evaluate current treatment of three major cardiovascular disease entities in clinical practice using a standardized variable-set of relevant covariates and outcome measures.

Heart failure (HF), coronary artery disease (CAD) and atrial fibrillation (AF) are among the most relevant cardiovascular diseases contributing to overall morbidity and mortality each itself and in particular in case of their coexistence. Several new therapies have been introduced in randomized controlled trials but confirmation data of treatment effects in real-world cohorts using a standardized methodology is scarce. The International Consortium for Health Outcomes Measurement (ICHOM) defined standard variable sets for all three diseases in order to objectively monitor the course of disease.

To evaluate current health care utilization and interactions between diseases and treatments in patients with HF, CAD and AF as well as patient-oriented values study initiator will build a prospective, observational, multicenter cardiovascular registry using standardized patient variables and endpoints based on the ICHOM recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Inpatient Treatment
* Present diagnosis of at least one of the three cardiovascular disease entities of interest according to the current guidelines of the European Society of Cardiology (ESC): HF, CAD, AF

Exclusion Criteria:

* Inability to provide informed consent
* Initial presentation (index hospitalization) in cardiogenic shock or other kinds of shock
* Patient after heart transplantation or patient with present ventricular assist device (VAD)
Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

The total incidence of abdominal pain after colonoscopy is almost 50%. Butorphanol is a mixed opioid receptor agonist-antagonist, which has strong sedative and analgesic effects. This clinical study aims to explore the effectiveness and safety of butorphanol combined with propofol for colonoscopy to reduce postoperative visceral pain, and provide a basis for improving the quality of surgery and comfortable medical treatment for patients.


Eligibility Criteria:
Inclusion Criteria:

* ASA status I-11
* patients performing colonoscopy
* sign the informed consent

Exclusion Criteria:

* BMI\>30, pregnant
* diabetes
* depression
* patients dependent on opioids
* hypertension poorly controlled
* serious complications of important organs
* obvious abdominal pain before colonoscopy
Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention (REPTAR)

The post-marketing study is designed to evaluate the activity level and exercise tolerance of patients with deferred percutaneous intervention due to FFR (fractional flow reserve) greater or equal to 0.81 and treatment with Ranolazine versus placebo.

Ranolazine was approved as Ranexa in the United States on January 31, 2006 for the treatment of chronic angina. This post-marketing study is a single-center, double-blind, prospective, randomized, parallel-group evaluation of patients randomized 1:1 between Ranolazine and placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be willing and able to comply with schedules visits, treatment plan, and other study procedures.
2. There must be evidence of personally signed and dated informed consent documents.
3. Subjects must have a documented history of anginal chest pain equal to or greater than one (1) episode per week prior to cardiac catheterization.
4. Subjects must have greater than or equal to one (1) episode of angina chest pain between screening visit and randomization visit.
5. Subject must have documented cardiac catheterization with deferred percutaneous intervention and fractional flow reserve (FFR) greater than or equal to 0.81 within thirty (30) days, or an (FFR) less than 0.81if not a candidate for revascularization based upon operator discretion.

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Exclusion Criteria:

1. Subjects with a congenital or acquired QT interval prolongation (greater than or equal to 440ms in men/greater than or equal to 460ms in women).
2. Subjects prescibed strong CYP3A inhibitors (including ketaconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir and saquinavir.) and/or strong CYP3A inducers (rifampin, rifabutin, rifapentin, Phenobarbital, phenytoin, carbamezepine and St. John's wort).
3. Subjects prescribed to Simvastatin (Zocor) that cannot have dose reduced to appropriate levels (20mg QD) per physician or have medication discontinued during the clinical trial.
4. Subjects prescribed Metformin that cannot have dose reduced to appropriate levels (less than or equal to 850mg BID) per physician or have medication discontinued during the clinical trial.
5. Subjects prescribed Digoxin that cannot have dose reduced to appropriate levels (0.125mg QD) per physician or have medication discontinued during the clinical trial.
6. Subjects with life expectancy less than the duration of the trial.
7. Subjects with a history of liver cirrhosis.
8. Subject with chronic renal disease with creatinine clearance of less than 30mL/min.
9. Subjects participating in any other clinical trial for the duration of the trial.
10. Females who are of childbearing potential, who are unwilling or unable to use highly effective method of contraception -