cyrilzakka/clinical-trials huggingface dataset:
Pre-Op Sildosine and Ureteral Dilation During F-URS

We proposed that silodosin administration preoperatively may facilitate ureteral access sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of ureteric injury in some difficult cases.

Urolithiasis is a common urological disorder in the world and has a significant effect on the global health system. The goal of treatment is to achieve the highest stone-free rate (SFR) with the least invasive. Per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (F-URS) are the two main minimally invasive procedures for the treatment of upper urinary tract stones.

The challenging step in flexible ureterorenoscopy (F-URS) is ureteroscopic access sheath (UAS) placement, which facilitates fast and safe access to the ureter and collecting system; improves visibility; reduces the risk of infection by reducing intrarenal pressure. However, in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (UAS) placement.

Eligibility Criteria:
Inclusion Criteria:

* Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm).
* 2. Non stented.
* Age (Above 18 years old).

Exclusion Criteria:

* Acute or chronic renal insufficiency.
* Uncorrected coagulopathy.
* Previous open (lumber or ureteric) surgery.
* Active urinary tract infection unless treated.
Study of Brain Activity Underlying Predictive Mechanisms During the Perception of Visual Scenes

This study aims to clarify the mechanisms by which the predictions we have about our visual environment influence the processing of expected or unexpected visual stimuli at the cerebral level.

Current models of visual perception agree that perception is a proactive process. According to these models, perception of the visual environment would allow to continuously generate expectations or "predictions" about the likely characteristics of a visual scene, which would facilitate their processing and visual recognition. At the neurobiological level, these models postulate that visual perception is the result of a permanent exchange between prediction signals (i.e., predicted characteristics of the visual stimulus) and prediction error signals (i.e., unprovevised characteristics of the stimulus to update predictions) between consecutive levels of the hierarchy of cortical visual areas. However, the neurophysiological correlates of these mechanisms remain debated. The results of some work suggest that the prediction signals generated by high-level cortical areas would make it possible to pre-process the predicted characteristics of a stimulus within lower-level areas, by inhibiting the activity of neurons dedicated to their processing. Conversely, other work postulates that the prediction signals generated by high-level areas would increase the sensitivity of neurons encoding expected characteristics while inhibiting the response of neurons encoding unexpected features in lower-level areas. Accordingly, brain activity in these regions would rather reflect the processing of expected features of visual stimuli. It has also been proposed that these two mechanisms coexist but that they intervene alternately during the temporal course of brain processing and depending on the quality of the visual signal. However, this hypothesis has never been systematically tested. The objective of the project is to improve fundamental knowledge about the mechanisms of visual perception by studying at the cerebral level how predictions about the visual environment influence its visual perception. Specifically, investigators will use electroencephalography (EEG) recordings from healthy volunteer participants to measure how brain activity related to visual processing of images of objects and scenes is modulated by their expected or unexpected character, taking into account the temporal course of brain processing and considering the quality of visual signals.

Eligibility Criteria:
Inclusion Criteria:

* Participants between 18 and 35 years old
* Normal or corrected-to-normal visual acuity
* Ability to consent or oppose to the research
* No opposition to the research

Exclusion Criteria:

* Important visual impairments
* Neuropsychiatric pathology
* Use of drug or medication with neurocognitive effects
* Minors, or persons under psychiatric care, or protected persons
Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel

The aim of this study is to investigate if the genetic variant CYP2C19\*17 affects the pharmacokinetics of proguanil and clopidogrel.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Written consent
* Age 18-65
* CYP2C19\*1 and or CYP2C19\*17 genotype.

Exclusion Criteria:

* Daily medication
* Alcohol abuse
* Pregnancy
* Breastfeeding
Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds

Several studies have highlighted the value of analyzing a patient's psychological profile with the Bortner scale questionnaire (defined as type A or B personality). This analysis helps to better understand and anticipate patients' behaviour, stress and compliance with their disease and its progression. The Type A personality profile combines hyperactivity, competitiveness and exaggerated ambition, while the B profile is characterized by lower sensitivity to stress and reduced competitiveness.

It has been shown that the type B psychological profile in patients with type 2 diabetes is an independent risk factor for inflammation and that, in type 1 diabetes, the type A psychological profile is associated with a decrease in the expression of the pro-inflammatory cFos gene.

Thus, the psychological profile appears to have an impact not only on the patient's behaviour but also on his or her biology.

It has never been determined whether the type A or B psychological profile assessed by Bortner's self-administered questionnaire can influence the development of foot wounds in patients with type 2 diabetes who often have a medically unfavourable prognosis and socio-economic difficulties. We would therefore like to study the psychological profile of these individuals in order to make comparisons with the data obtained in a previous study that included patients with type 2 diabetes who did not have a foot wound.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 2 diabetes
* patient \> 18 years old
* with a diabetic foot wound
* person who has expressed non-opposiyion to participation in the study

Exclusion Criteria:

* a person who is not affiliated to national health insurance
* person subject to legal protection (curatorship, guardianship)
* person under limited judicial protection
* pregnant, parturient or breastfeeding woman
* adult unable to consent
* minor
Effect of Two Colonoscopy AI Systems for Colon Polyp Detection

Computer-aided detection (CADe) systems have been actively researched for polyp detection in colonoscopy. The investigators aim to identify the effect of two CADe systems according to the system performance on false positive rate

Artificial intelligence technology based on deep learning is being applied in various medical fields, and research is being actively conducted to develop computer-aided detection (CADe) systems for colonoscopies to overcome the limitation of the variance of human skills. These well-trained CADe systems demonstrated high performance for neoplastic polyp detection and reported a 44% increase in adenoma detection rate (ADR) for endoscopists. However, the level of performance in the CADe system is not clear for expert endoscopists to be useful for ADR increase.

Furthermore, false positives(FPs) of the CADe system may negatively influence ADR during a screening colonoscopy. Accordingly, the investigators sought to identify the effect of the colonoscopy CADe system according to FP performance in endoscopists with various levels. The investigators hypothesized that the CADe system with low FPs would be useful to prevent the decrease in ADR in case of a high endoscopy workload according to the performance of CADe systems.

Eligibility Criteria:
Inclusion Criteria:

patient for screening or surveillance colonoscopy patients agreed with participating in the study

Exclusion Criteria:

patients who do not agree with participating in the study patients with a history of colon resection patients with a history of inflammatory bowel resection patients with poor bowel preparation
Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis

The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.


Eligibility Criteria:
Inclusion Criteria:

Both males and females.

* Diabetic and non-diabetic patients.
* Age \>18 years old.
* Overweight and obese patient: Body mass index (BMI) ≥ 25 kg/ m2 but \<40 kg/ m2.
* Patients with heartburn, peptic ulcer, gastrointestinal reflux disease, erosive esophagitis, Zollinger-Ellison syndrome and helicobacter pylori infection.
* Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (\>2 but \<5 times upper limit of normal), hepatic steatosis index (HIS) \>36, HAIR score of 2 or 3.

Exclusion Criteria:

* Patients with a history of hypersensitivity to esomeprazole.
* Patients with BMI ≥ 40 kg/ m2.
* Patients taking warfarin, clopidogrel, digoxin, diazepam and phenytoin to avoid drug-drug interactions as these drugs are CYP2C19 substrates.
* Patients infected with human immune deficiency virus taking antiretroviral medicines or dosage forms containing rilpivirine.
* Patients with a history of viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, biliary obstruction, primary biliary cirrhosis, hemochromatosis, Wilson's disease and alpha-1 antitrypsin deficiency.
* Patients on medications associated with steatosis such as NSAIDs, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate.
* Patients with cancer or with a history of cancer.
* Patients with cardiovascular diseases.
* Pregnant and lactating females
Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects

This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in healthy Chinese male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Subjects aged 18 - 45 years
* Subjects weighing ≥ 50.0 kg and ≤ 100.0 kg
* Subjects with a body mass index (BMI) ≥ 19.0 and ≤ 26.0 kg/m2

Exclusion Criteria:

* Subjects with evidence or history of clinically significant disease
* Subjects with a history of previous cancer
* Subjects with a history of hypertension, or abnormal blood pressure at screening/baseline measurements (systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg confirmed by a repeat measurement on the same day)
* Subjects with a history of blood donation 3 months before study drug infusion
* Subjects with a history of exposure to antibodies 12 months before study drug infusion
* Subjects with previous exposure to anti-VEGF therapy
A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis

This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, \> 50 years of age
* Diagnosed osteoporosis
* Bone mineral density \< minus 2.5 SD or osteoporotic fracture
* At least 3 years after menopause

Exclusion Criteria:

* Impaired renal function
* Contra-indication to Calcium or Vitamin D therapy
* Previous or current treatment with biphosphonates
Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to assess the pharmacokinetics (PK), efficacy, and safety of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Chronic AD that has been documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit
* EASI score \>=16 at both screening and baseline visits
* IGA score \>=3 at both screening and baseline visits
* AD involvement \>=10% of BSA at both screening and baseline visits
* Peak (maximum) PP NRS score of at least 4.0 at both screening and baseline visits
* Agree to apply a moisturizer throughout the study from the screening visit daily, and liberally as needed; agree to apply an authorized topical corticosteroids (TCS) from the screening visit and throughout the study as determined appropriate by the investigator
* Participant and caregiver willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Body weight less than 10 kilogram (kg)
* Child in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation
* Participants with a current medical history of chronic bronchitis
* Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit
* Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C (HCV) antibody with positive confirmatory test for HCV (example; polymerase chain reaction \[PCR\]), or human immunodeficiency virus (HIV) antibody at the screening visit
* History of lymphoproliferative disease, hypersensitivity (including anaphylaxis) to an immunoglobulin product and intolerance to low or mid potency topical corticosteroids
* Known or suspected immunosuppression
* Participants unwilling to refrain from using prohibited medications during the clinical trial.
* Other protocol defined exclusion criteria could apply
Sparkle Respiratory Effort Validation

This study has been developed in order to demonstrate the validity of the Sparkle respiratory effort signal.

The rationale for undertaking this study is to demonstrate that the agreement between the Sparkle respiratory effort signal amplitude and esophageal manometry is non-inferior to the agreement between the thoracic belt respiratory effort signal amplitude and esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the Sparkle device, respiratory belts, and esophageal manometry. Data collection will be completed during wakefulness, while participants undergo a series of breathing maneuvers.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years;
* Fluent in English;
* Able to provide informed consent.

Exclusion Criteria:

* Contraindication to esophageal pressure monitoring, including a sensitive gag reflex (determined by a positive response to the screening question "do you sometimes or often gag while brushing your teeth?"), dysphagia, nasal obstruction, and/or esophageal disorder likely to impact placement of the balloon;
* History of allergic reactions to medical adhesives;
* Known allergy to lidocaine;
* Known seizure disorder;
* Severe medical condition (controlled or uncontrolled) impacting breathing including neuromuscular disease, chronic obstructive pulmonary disease, respiratory failure or insufficiency, or requirement for oxygen therapy;
* Chronic cardiopulmonary or renal disease, including a history of irregular heart rhythms;
* At risk for excessive bleeding including use of anticoagulants;
* An employee, or spouse of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips);
* An employee, or spouse of an employee, of Pulmonary and Critical Care Associates of Baltimore.
Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

The purpose of this study is to determine the safety and efficacy of intravenous magnesium in shortening the duration of a pain crisis and to determine the health-related quality of life and short term outcomes of children treated with intravenous magnesium during an acute pain crisis.

It is well known that children with sickle cell disease are at risk for acute pain crises. The usual treatment for these pain crises, intravenous fluids and pain medicines such as morphine, has changed little over the past three decades. In a pilot study, the addition of intravenous magnesium to standard therapy decreased length of stay; however, this study was not randomized, not blinded, not placebo-controlled, and not adequately powered to assess safety.

We will conduct a multi-center, randomized, double-blind, placebo controlled trial of about 208 children, ages 4-21 years. Patients will be randomized to receive intravenous magnesium sulfate or placebo every 8 hours for a total of 6 doses, or until discharge. Patients will return for a routine clinic visit up to 3 months after discharge for a baseline assessment. Patients will also complete health-related quality of life measures at 4 timepoints throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* age 4-21 years, inclusive
* Sickle cell anemia (Hb SS) or Sickle beta zero thalassemia disease (Hb Sβ°)
* failed intravenous opioid pain management in the emergency department prior to the decision to admit the patient
* admitted to the inpatient unit for sickle cell pain crisis

Exclusion Criteria:

* patient received more than 12 hours of intravenous pain medication prior to enrollment
* previous enrollment in this study (only one admission per child is eligible)
* history of allergy/intolerance to both intravenous morphine and hydromorphone
* known other cause for pain (avascular necrosis, gall bladder disease, priapism, etc.)
* patient with greater than 10 admissions for pain crisis in the past year
* patient maintained on daily opioids or chronic transfusions for chronic sickle cell pain
* transfusion within the previous two months
* known kidney or liver failure (elevation of liver function tests does not warrant exclusion)
* known pulmonary hypertension
* pregnancy
* diagnosis of bacterial infection, fever ≥39.5°C, acute chest syndrome, hemodynamic instability or sepsis
* current oral magnesium supplementation or current enrollment in another therapeutic study protocol
* previously diagnosed clinical stroke
* current or planned use of neuromuscular blocker, nifedipine, ritodrine, or terbutaline
* allergy to magnesium sulfate
* discharge from an inpatient unit within 72 hours of arrival in the emergency department for the current pain crisis
Re-thinking the Role of Peers And Training Patients [RePeAT]

This study, Re-thinking the role of Peers And Training Patients \[RePeAT\], is designed to test the feasibility of training peer-coaches to prepare limited health literacy (LHL) patients to engage in shared-decision making (SDM) for cardiovascular disease (CVD) risk-reduction.

The investigators will use a 2-arm pilot RCT design to assess the feasibility, and acceptability of the intervention. Up to 60 primary care patients will be randomly assigned to participate in the peer-coaching or control group. Patients will be randomized at a 1:1 ratio, stratified by the clinician. Half of the subjects (n=30) will be assigned to the peer-coaching intervention, and the other half will be assigned to the control group.

Eligibility Criteria:
Inclusion Criteria:

* A patient of Highland Family Medicine practice
* At least 40 years old and no more than 75 years old
* Be at ≥10% risk for CVD as calculated using the ASCVD Risk Estimator Plus
* No plans to leave the practice in the next 12 months
* English speaking
* Limited Health Literacy (self-report)

Exclusion Criteria:

* Have experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA) or have had a CVD procedure such as installation of a stent or angioplasty
* Gave peripheral vascular disease, intermittent claudication or peripheral arterial disease
* Lack of capacity to consent
Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX

This registration is for clinical use of the FENIX, a Humanitarian Use Device (HUD) for fecal incontinence. This device is indicated for the treatment of fecal incontinence in patients who are not candidates for or have previously failed conservative treatment and less invasive therapy options (e.g. bulking agents, radiofrequency ablation, sacral nerve stimulation).

The FENIX is surgically placed. This surgery could be an outpatient procedure or at most an overnight stay in the hospital. The design of the device allows it to be effective immediately. The device is similar to the LINX device used for esophageal reflux. It is a circular set of magnets which surrounds the ano-rectal support. The size of the device is determined at the time of surgery so that the ano-rectum is closed. When the patient strains at stool, this pressure separates the magnets and allows passage of stool. The magnets are held together by an independent malleable titanium wire. Once straining at stool stops, the magnets are able to re-connect or close the rectum. We will monitor patients for postoperative complications related to surgery.

Eligibility Criteria:
Inclusion Criteria:

* non-pregnant female patients
* 18 years of age or older with fecal incontinence
* failed conservative therapy ( pelvic floor physical therapy, medications) and failed trial of interstim.

Exclusion Criteria:

* patients less than 18 years of age,
* pregnant
* previous radiation to pelvis,
* chronic diarrhea or inflammatory bowel disease.
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection

Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.

20 patients with cervicocephalic arterial dissection will be randomized to open-label aspirin or warfarin, rate of stroke and adverse events will be endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and imaging diagnosis of cervicocephalic arterial dissection within 3 months.

Exclusion Criteria:

* Any contraindication to aspirin or warfarin.