cyrilzakka/clinical-trials huggingface dataset:
Collection of Samples for the Evaluation of Wound Biofilm in Acute and Chronic Wounds

The Specific Aim of examining wounds microscopically is to attempt to demonstrate the presence of biofilm in chronic wounds and to understand these populations on a cellular level.

Characterizing the surface of the acute wound is important because the characterization can act as a control and can give a standard by which to judge the microscopic pathology observed in chronic wounds.

Eligibility Criteria:
Inclusion Criteria:

* The subject must be 18 years of age or older.
* The subject must have a full thickness acute or chronic wound. The sampling is restricted to subjects with the presence of a full thickness wound in order to reduce any risk for infection to the subject. Biopsying a wound that is already full thickness should not increase the subject's risk.
* The subject must have no history of coagulopathy
* If the subject's acute wound will be biopsied, the wound must be less than 48 hours old.
* The subject must be a candidate for sharp debridement

Exclusion Criteria:

* The subject may not have myelosuppression indicated by a CBC which may include a WBC less than 1500 cells per cubic millimeter, platelet count less than 125,000 per cubic millimeter, or hemoglobin less than 9 g/dL.
* The subject may not be on anticoagulation therapy because anticoagulation therapy increases the risk of bleeding.
* The subject may not have a TCpO2 less than 20 torr. Subjects with low tissue oxygenations may have some risk from biopsy due to their poor ability to heal and, therefore, are excluded.
* The subject may not be pregnant
* The subject's wound must not be in the region of the face, neck, or genitalia
IDMet (RaDiCo Cohort) (RaDiCo-IDMet)

The goal of this observational study is to describe the natural history of imprinting disorders (IDs) according to their metabolic profile in all patients (adults and children) affected with an ID regardless of the severity of the disease, with a molecular characterization, with a signed informed consent for all subjects, followed in one partner's center.

The main questions it aims to answer are:

* Can we identify common metabolic profiles for all imprinted diseases?
* Which imprinting disorders have an impact on the metabolic profiles of IDs?
* Which are the metabolic risks associated to IDs?
* Can we use the metabolic profiles for the clinical classification and prognosis of IDs?
* Are there common therapeutic approaches for all IDs?


Eligibility Criteria:
Inclusion Criteria:

* Patients (adults and children) affected with an ID regardless of the severity of the disease
* A confirmed diagnosis of ID (based on molecular diagnosis)
* A signed informed consent for adults or signed informed consent of parents/guardians of minors/ protected adult.

Non-Inclusion Criteria:

There are no non-inclusion criteria.
Retinal Nerve Fiber Layer Thickness Measurement on Parapapillary Atrophy With the Cirrus High-Definition (HD) Optical Coherence Tomography (OCT)

Retinal nerve fiber layer (RNFL) thickness measurement on the parapapillary atrophy is incorrect. Because a new spectral domain OCT, the Cirrus HD OCT, uses a movable circle to analyze the RNFL thickness, we may suggest a new analysis strategy for the parapapillary atrophy.

Recently, the retinal nerve fiber layer (RNFL) thickness measurement using the optical coherence tomography (OCT) becomes very useful to detect such a glaucomatous damage. However, there are some difficult cases including parapapillary atrophy to perform this measurement. Because the RNFL thickness is so sensitive to the position of measurement and the measurement of RNFL thickness on parapapillary atrophy is incorrect, it is difficult to determine exact RNFL thickness in patients with a large parapapillary atrophy. In the present study, we want to find the proper method to analyze the RNFL thickness on parapapillary atrophy. The previous OCT used a fixed circle to measure the RNFL thickness, but the new spectral domain OCT, the Cirrus HD OCT, uses a movable one. Therefore, we may suggest a new analysis strategy for the parapapillary atrophy.

Eligibility Criteria:
Inclusion Criteria:

* Qualified OCT images (signal strength \> or = 8)

Exclusion Criteria:

* Previous intraocular surgery history
* Media opacity
* DM
CardioTOxicity Induced by andRogeNICS and Their Antagonists (TORNICS)

Anti-androgenic therapies relying on peripheral and/or central blockade for the treatment of prostate cancer seems to have an impact on the cardio-vascular system. This study investigates reports of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification: sex hormones (G03), hypothalamic hormones (H01C) and sex hormones used in treatment of neoplastic diseases (L02) in the French pharmacovigilance database and European Clinical Trials (EudraCT) database.

Hormone replacement therapies and contraceptive pills are responsible of a wide range of cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart disease. The difference of incidence and type of cardio-vascular events between men and women are strongly related to sex hormones. Androgenic agonists and antagonists are used in various indication including prostate cancer or hormone replacement therapies. This study investigates the main characteristics of patients affected by cardiovascular side effects (of which ventricular arrhythmia's, QT prolongation and Torsade de Pointe) imputed to drugs classified as G03, H01C and L02 according to ATC. A causality assessment according to both Begaud's method and the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) is systematically applied.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the French pharmacovigilance database and EudraCT database from 01/01/1985 to 14/04/2017
* Adverse event reported were including the MedDRA terms: SOC Cardiac Affections and the HLT Death and Sudden Death
* Patients treated with hormonal therapies included in the ATC classification references: G03, H01C and L02

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment.

The initial study was 34 weeks long; however, the protocol was amended to extend the open-label period of the study from 8 weeks to 12 weeks (38 weeks total).

Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for Adult Attention-Deficit/Hyperactivity Disorder (ADHD) as assessed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID).
* Have a Clinical Global Impression for ADHD Severity Score (CGI-ADHD-S) of 4 or greater Visit 2 and 3.
* Adult Men and Women age 18 years or older at time informed consent is obtained.
* Must be in a reciprocal relationship with a person of the opposite sex living in same defined household (cohabitating) with their spouse/significant other for a period of at least 3 months. This spouse/significant other cannot change during the study.
* Must have one or more children 6-17 years of age living the home as the primary residence.

Exclusion Criteria:

* Anyone meeting Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for any history of bipolar disorder or any history of a psychotic disorder.
* Anyone meeting diagnostic (DSM-IV) criteria for current major depression or current anxiety disorder.
* Taking psychotropic medications on a regular basis.
* Having any medical condition that would be exacerbated or not appropriate for inclusion in this trial.
* Previously taken an adequate trial of atomoxetine.
Depression and Anxiety Among Chronic Pain Patients in the Netherlands

The goal of this observational study is to determine the prevalence of depression among patients with chronic pain in the Netherlands. The main questions it aims to answer are:

* How often does depression and/or anxiety occur among patients with chronic pain.
* The relationship between pain, depression and sociodemographic factors.
* The effect of pain and depression on the quality of life.

Participants have completed questionnaires during their treatment at the chronic pain outpatient clinic. Therefore the patients do not have to complete any new questionnaires. Informed consent for participation in the study was asked during visit at the outpatient clinic or via a letter of objection.

Chronic pain is defined as pain which exists for a period longer than 3 months. The prevalence of chronic pain in the Netherlands is estimated to be 19 percent. Chronic pain is a complex disorder which is often challenging to treat. The dynamic interaction between de different aspects of chronic pain, like the somatic, physical and social aspects, make the treatment challenging. Patients with chronic pain have a three times increased risk of developing psychiatric symptoms (usually mood and anxiety disorders) and vice versa, patients with depression have a three times increased risk of developing chronic pain. Also independently chronic pain and depression are both invalidating disorders, regardless of age and gender. It has been found that there is an increased risk of suicide among patients with chronic pain. The complex interaction between chronic pain and depression and their cumulative effect on the quality of life in the Netherlands has not yet been completely identified. This is because the interaction between chronic pain and depression is not yet fully understood. The treatment can be improved when the interaction between pain and depression is better understood.

The research acts as a preliminary investigation for the treatment of patients with chronic pain with intrvenous esketamine, a recently approved treatment for treatment resistant depression.

Eligibility Criteria:
Inclusion Criteria:

* Pain which exists longer than 3 months
* Under treatment at chronic outpatient clinic
* Completed Hospital Anxiety and Depression Scale (HADS) and Short Form Health Survey (SF12) questionnaires

Exclusion Criteria:

* Objection to participation
AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

The AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial compares the efficacy of circulatory assist by manual chest compression versus an automated chest compression device (AutoPulse™) during the resuscitative attempt following out-of-hospital cardiac arrest.

Extensive early experience yielded no reliably validated instances of out-of-hospital arrest associated with tachyarrhythmia being resuscitated without successful defibrillatory shock. This together with the increasing availability of automated external defibrillators (AEDs), at increasingly attractive prices, led, in the past decade, to a strong emphasis on early defibrillation. This emphasis may have inadvertently resulted in a decreased emphasis on cardiopulmonary resuscitative techniques, particularly in light of publications decrying the uniformly poor quality of CPR performed by laymen, medical professionals, and even EMS personnel. However, recent research strongly suggests that assisted reperfusion prior to defibrillation may actually significantly improve survival rates. These reports, based on clinical studies, have received substantial confirmation from carefully controlled laboratory studies, particularly in pigs.

If assisted reperfusion prior to defibrillation (and subsequent to failed shock) is important, it is reasonable to suppose that the benefit is related to quality of chest compressions. Observations of resuscitative efforts in the field indicate that maintaining compressions is one of the more difficult tasks, for a variety of reasons. Observations in the laboratory with trained paramedics show that the depth of compression and the compression rate diminish rapidly with time from the onset of CPR, without the participant being aware that his/her effort is actually diminished.

The desire to provide consistent and quality compressions has led to the development of a mechanical compression assist device called the AutoPulse. It is a self-contained, portable chest compression device that is rapidly field deployable.

Eligibility Criteria:
Inclusion Criteria:

* All persons with out-of-hospital cardiac arrest who are attended by a vehicle involved in the randomization process and who are treated by the emergency medical service (EMS).

Exclusion Criteria:

* Persons under the age of 18
* Victims with traumatic arrest
* Less than the legal age of consent
* Resuscitation attempt discontinued because of do not resuscitate (DNR) orders or on request of authorized decision-maker
* Wards of the state, including prisoners
* Chest or abdominal surgery within 6 weeks
* Site specific exclusions
Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography

The main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT parameters by SonR technology is able to increase the rate of CRT-D responders, based on significant LV reverse remodeling, as compared to Standard of Care settings.

This study will also evaluate the effectiveness of CRT-D SonR system as compared to Standard of care (SoC) programming methods in providing appropriate LV filling, as expected from the Ritter method.

This study will evaluate the effectiveness of CRT-D SonR system as compared to SoC programming methods to:

* Increase the rate of patients responding to CRT
* Provide appropriate hemodynamic cardiac effect, as expected from the Ritter method.

The identification of CRT responders, as defined by echocardiography, generally refers to a significant reduction of the LV End-Systolic Diameter (LVESD) and/or LVESV during Follow-Up (FUp).

Patients will be considered as responders to CRT if their LVESV decreased by \> 15% after 6 months of CRT therapy as compared to baseline. The percentage of CRT responders will be compared between the two study arms.

SoC is defined as the standard CRT system programming/optimization method currently used by physicians in study centers and any method may be used in the study if considered as routine practice in the study center.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines ;
* In Sinus Rhythm;
* Have reviewed, signed and dated an informed consent

Exclusion Criteria:

* Previous implant with a pacemaker, an Implantable Cardioverter-Defibrillator or a CRT device (except upgrade from single chamber ICD with a fully functional defibrillation lead not under recall or surveillance);
* Persistent atrial arrhythmias (or cardioversion for Atrial Fibrillation) within the past month;
* Ventricular tachyarrhythmia secondary to reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
* Incessant ventricular tachyarrhythmia;
* Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past 4 weeks;
* Correctable valvular disease that is the primary cause of heart failure;
* Mechanical heart valve or indication for valve repair or replacement;
* Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months);
* Post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
* Already included in another clinical study that could confound the results of this study;
* Life expectancy less than 1 year;
* Inability to understand the purpose of the study;
* Unavailability for scheduled follow-up or refusal to cooperate;
* Sensitivity to 1 mg Dexamethasone Sodium Phosphate (DSP);
* Age of less than 18 years;
* Pregnancy;
* Drug addiction or abuse;
* Under guardianship
Longitudinal Study of the Menopause and Fat Patterning

To study the natural history of the accumulation of intra-abdominal fat as women progress through the menopause.

BACKGROUND:

Menopause alters the risk for a variety of chronic diseases, including cardiovascular disease, which is the number one cause of mortality in older women. While the associations between menopause, increased total and intra-abdominal fat (IAF), and risk for coronary disease are well established, prospective studies describing the accumulation of IAF, the association with risk factors, and potential mechanistic aspects, are still lacking. This study has the potential to provide important information on the trajectory of IAF accumulation across the menopausal transition in minority and non-minority women.

DESIGN NARRATIVE:

The prospective study will be conducted on an intact biracial cohort of 868 women (419 African Americans; 449 Caucasians) who are participating in a larger study (Women in the Southside Health \[WISH\] Project) of women undergoing the menopausal transition. This is a population-based cohort that was randomly selected from an existing census with a 72 percent participation rate, approximately equal distribution of socioeconomic status within the African American and Caucasian subgroups, and a dropout rate of only 1 percent/year. As part of the larger study, this cohort undergoes annual exams in which a variety of cardiovascular, hormonal, and lifestyle factors are tracked. These annual measurements consisting of a large number of relevant covariates, including demographics, anthropometrics, serum lipids, blood pressures, insulin, glucose, hormones, lifestyle, health and psychosocial status will be available from the parent study. For this study, two additional clinical tests will be added to the battery at the fourth or fifth annual exam for the 536 women who are expected to be eligible by virtue of not having had a hysterectomy or begun taking hormone therapy. The two tests will be a computed tomography scan for the assessment of intra-abdominal fat, and a dual energy X-ray absorptiometry (DEXA) scan for the assessment of total body fat. These tests will be repeated on an annual basis for the next three years. By the end of the study, it is projected that 462 transitions in menopausal status will have taken place. Random effects models will be used to estimate longitudinal changes in level and rate of intra-abdominal fat as one moves from one menopausal status to another.

Eligibility Criteria:
Women eligible for this ancillary study had no history of diabetes, chronic liver disease or renal disease, no self-reported history of anorexia nervosa, no alcohol or drug abuse, were not currently pregnant or planning to become pregnant, and had not undergone hysterectomy and/or bilateral oophorectomy. Equipment limitations precluded participation of women with breast implants, hip replacements, or weighing ≥299 pounds.
An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis

Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. This study aims to describe the long term usage and effectiveness with risankizumab (RZB) relative to other advanced therapeutic options for the management of PsA in daily clinical practice.

Risankizumab is an approved drug for the treatment of psoriatic arthritis. The study will not be conducted in the United States, however it will be conducted in approximately 15 countries and include at least 900 and up to 1200 participants with a 2 to1 ratio of participant allocation between participants receiving risankizumab and participants receiving other advanced therapeutic agents.

The therapy is prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. All study visits will occur during routine clinical practice and participants will be followed for 24 months.

There is expected to be no additional burden for participants in this study.


Eligibility Criteria:
Inclusion Criteria:

* Participant with a clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening visit and fulfillment of ClASsification for Psoriatic ARthritis (CASPAR) at Baseline visit to confirm that the participant has active disease.
* Participant must have demonstrated an inadequate response to at least 1 Disease-modifying antirheumatic drug (DMARD) (with max 50% Biologic DMARD-Inadequate Response); alternatively, participant must have demonstrated an intolerance to or contraindication for csDMARDs as determined by the investigator.

Exclusion Criteria:

- Participants demonstrated an inadequate response to three or more bDMARDs/targeted synthetic DMARDs (tsDMARDs).
Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy

The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores after operation compared with placebo patch in patients undergoing laparoscopic cholecystectomy.

* The 5% lidocaine patch have been approved for the treatment of postherpetic neuralgia.
* The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores, pain controlled drug(opioids, NSAID) in post operative period.

Eligibility Criteria:
Inclusion Criteria:

* patients of ASA Ⅰ-Ⅱ
* aged 18\~65
* scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia.

Exclusion Criteria:

* patients with chronic pain
* patients with taking regular analgesics
* patients with allergy to ketorolac or lidocaine
Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Informed consent understood and signed
* Will comply with post-treatment follow-up requirements up to 5 years
* Candidate for Powerlink Infrarenal Bifurcated Graft

Exclusion Criteria:

* Life expectancy \< 2 years
* Participating in another clinical research study
* Pregnant or lactating women
* Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study
* Creatinine level \> 1.7mg/dl
* Renal transplant patient
* Patient with \> 75% renal artery stenosis and not eligible for PTA/stent intervention prior to suprarenal device fixation