cyrilzakka/clinical-trials huggingface dataset:
Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI

For patients with anterior ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), whether early application of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors to rapidly reduce low-density lipoprotein cholesterol (LDL-C) before PCI could effectively inhibit left ventricular remodeling has been rarely reported. The aim of this study was to investigate the effect of early application of PCSK9 inhibitors Evolocumab to rapidly reduce LDL-C levels before primary PCI treatment on left ventricular remodeling in STEMI patients.

Eligible patients were randomly randomized 1:1:1 to one of the following three groups immediately after enrollment: (1) Intensive statin group: rosuvastatin 20 mg per day, in addition to usual therapy; (2) Combined intensive statin and PCSK9 inhibitor group: rosuvastatin 20 mg per day and subcutaneous injection of evolocumab 140 mg twice a month, for at least 3 months, and preferably 6 months; (3) PCSK9 inhibitor alone group: subcutaneous injection of evolocumab 140 mg, twice a month for at least 3 months and preferably 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Persistent chest pain or chest discomfort
* Onset within 12 hours
* ST-segment elevation ≥0.1 millivolt in two adjacent precordial leads, or a new-onset left bundle branch block with dynamic changes
* Primary PCI is planned

Exclusion Criteria:

* Contraindications to Statins or PCSK9 inhibitors
* Prior intravenous thrombolytic therapy
* Prior use of Statins, PCSK9 inhibitors or Ezetimibe
* Cardiogenic shock
* Acute heart failure or pulmonary edema
* Prior chronic heart failure
* Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate \<30ml/min/1.73m2, or on dialysis)
* Prolonged (\> 20 minutes) cardiopulmonary resuscitation
* Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)
* Malignant arrhythmias that are difficult to control with drugs
* Severe chronic obstructive pulmonary disease or respiratory failure
* Severe infection
* Neurological disorders
* Bleeding history of cerebrovascular, gastrointestinal, respiratory, urinary or other organs within the last month
* Active bleeding or bleeding diatheses
* Use of anticoagulants
* Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year
* Pregnant or lactating women
Effect of Memantine Oral Pump on Language in Patients With Probable Alzheimer's Disease

This study will evaluate the pharmacological efficacy on language capability and compliance with combination of new Ebixa oral pump and donepezil compared to donepezil only in patients with probable Alzheimer's disease. Primary objective is to evaluate the efficacy of memantine on language capability in moderate to severe Alzheimer's disease patients who are taking stable donepezil treatment.Secondary objectives are to evaluate the efficacy of maintain on cognitive function and disease progression with K-MMSE, NPI, ROSA, and SIB-short form in probable AD.


Eligibility Criteria:
Inclusion Criteria:

* probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria
* MMSE score equal to or less than 20
* Brain CT or MRI scan performed within the past 12 months
* living or having regular visit at least three times a week from caregiver
* able to visit outpatient clinic and to perform cognitive function test
* already taking stable dose of donepezil for 3 months prior to screening
* subject and caregiver who signed informed consent

Exclusion Criteria:

* involved in another clinical trial within 4 weeks prior to screening
* severe or unstable disease: acute or severe asthma, unstable or severe cardiovascular disease, acute peptic ulcer,chronic renal failure
* bradycardia (pulse rate less than 50bpm), sick sinus syndrome
* any laboratory finding including cognitive impairments(vitamine B12 or folic acid, syphilis, thyroid disease)
* severe auditory or visual disturbance
* other degenerative disease or psychosis
* taken any drug used for the treatment of Alzheimer's disease or dementia
Clinical Decision Support Tools for Antibiotic Prescribing

The goal of this study is to assess the utility of a data visualization tool for providers' understanding patients' past microbiological culture sensitivities. Providers that are ordering antibiotics for patients with previous culture data in the medical record will be asked to answer questions regarding past sensitivity results. They will be randomized to either using the visualization tool before answering the questions or using the standard medical record tools. They will then be surveyed about their decision-making, knowledge, and the usefulness of the tool.


Eligibility Criteria:
Inclusion Criteria:

* provider is caring for a patient with a previous positive urine or blood cultures
* provider is caring for a patient currently in a clinical location being investigated
* provider is caring for a patient with orders placed for an intravenous, intramuscular, oral antibiotics

Exclusion Criteria:

* the patient has already received the antibiotic by the time of the intervention
* the antibiotic has been cancelled by the time of intervention
* the research assistant is unable to reach the ordering provider before the visit is completed
* participation by the clinician in the study would impede clinical care
* age \< 18
Treatment for Patients With Osteoarthritis (OA) of the Knee

The purpose of this study is to evaluate the clinical response in subjects with symptomatic OA of the knee following a single 50 mg anakinra, 150 mg anakinra or placebo intra-articular (IA) injection.


Eligibility Criteria:
Inclusion Criteria: - Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria - Pain defined by a level of greater than 30 mm on a 100 mm Visual Analogue Scale (VAS) - No evidence of active effusion or inflammatory flare, confirmed by investigator - Must exhibit radiographic evidence of tibio-femoral compartment knee OA within 12 months of screening - Stable doses of any non-prescribed supplements (e.g. glucosamine or chondroitin sulphate, shark cartilage, diacerhein, soya extract) for at least 2 months prior to screening - Unchanged use of physical therapy, biomechanical devices or orthotic support within at least 2 months of screening - Subjects on nonsteroidal anti-inflammatory drug (NSAID) therapy must discontinue NSAIDs 3 days prior to baseline (Day 1) - Before any study-specific procedure is performed, the appropriate written informed consent for participation in the study must be obtained Exclusion Criteria: - Malignancy within the previous 5 years, except for basal cell or in situ cancer - Significant hematologic disease - Active infection or history of recurrent or chronic infections - Known diagnosis of HIV, hepatitis B, or hepatitis C infection - Uncontrolled diabetes or cardiovascular disease and hypertension - Inflammatory arthropathy including secondary OA - Isolated OA of the patellofemoral joint (bi or tri-compartmental involvement are not exclusions) - End-stage ("bone-on-bone") OA (Kellgren Lawrence score of 4) - OA of the hip ipsilateral to the index knee - Total white cell count less than 2.0 x 109/L and/or platelet count less than 100 x 109/L observed within 1 month preceding screening - Prior IA injection of anakinra or experimental interleukin-1 (IL-1) inhibitor therapy - Concurrent treatment with subcutaneous (SC) anakinra - Concurrent or recent (less than or equal to 1 month) use of experimental therapy - Prior IA corticosteroid injection within 1 month of study - Prior viscosupplement therapy within 3 months of study - Contraindication(s) to IA injections - Subjects who are pregnant or breast-feeding, or plan to become pregnant during the study - Subject is not using adequate contraception - Known allergy to E coli-derived products - Unable to understand informed consent - Concerns regarding subject's compliance with the protocol procedures - Subject will not be available for follow-up assessment - Active substance abuse
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).

Primary Objective:

* To evaluate the clinical efficacy of Naturetti (jelly sugar free)
* To test medication on subjects who suffer chronic functional constipation in 30 days use.

Secondary Objectives:

* To demonstrate the clinical tolerability when daily used (repeated doses) of the components of the study drug. The components will be evaluated by the adverse events occurrence classified by possibly related, probably related and definitely related
* To demonstrate the clinical tolerability of the study medication by the continuous use during the second phase study
* To identify any adverse events related to the study drug
* To identify any drug interaction.


Eligibility Criteria:
Inclusion criteria:

* Having chronic functional constipation by ROME IIII criteria
* Having the majority of the stool as type 1 or 2 by Bristol Stool Scale
* Female subjects should be using an effective contraceptive method more than 3 months if they are sexually active and on reproductive stage
* ICF signature
* Be able to understand and agree to undertake the study procedures
* Having no contraindication related to the study drug
* To perform all study visits.

Exclusion criteria:

* Having previous history or current neurological disorder and/or metabolic one
* Having constipation caused by previous surgery
* Having intestinal obstruction including colon/rectum cancer
* Having endocrine disorder as diabetes mellitus
* Having Irritable bowel syndrome or inflammatory bowel disease
* Having multiple sclerosis
* Having Parkinsons disease
* Having Hirschsprungs disease and dyssynergy defecation
* Continuous treatment with the following: analgesics, anticholinergic (antihistamines, antispasmodics, antidepressants, antipsychotics) iron supplements or aluminum, opiates, antihypertensive, calcium channel blockers and ganglionic blocker
* Treatment with any other laxative medication other than the rescue medication during the study
* Patients who could not confirm the chronic functional constipation during the phase I study
* Pregnancy or breast feeding woman
* Abnormal laboratory results, or clinical result that shows significant by the Investigator
* Corporeal mass index \> 30
* Patients who have participate in other clinical study within 30 days
* Unable to fulfill the questionnaire (diary)
* Any condition that makes impossible to the patient in participates by Investigator opinion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study of the Prevalence of TGFBI Corneal Dystrophies

To determine the prevalence of 5 specific corneal dystrophies in a subgroup of patients seeking refractive surgery, and to use that information to inform them and their refractive surgeons of the presence of the corneal dystrophies so that they may make safer choices when considering refractive surgery.

It is well established in the peer-reviewed literature that elective keratorefractive surgery is contraindicated in individuals with granular corneal dystrophy type 2 (GCD2).1,2,3,4 Although all reported cases of exacerbation of dystrophic stromal deposits have been in individuals with GCD2, it may be assumed that a similar accelerated deposition would occur in individuals with any of the TGFBI dystrophies, and thus elective keratorefractive surgery should be avoided in any individual with a TGFBI dystrophy. The commercially available Avellino Refractive Surgery Safety Test (Avellino Universal Test) offers an accurate, rapid and affordable way to screen for five corneal dystrophies associated with mutations in the TGFBI gene prior to keratorefractive surgery. These dystrophies are granular dystrophy type 1 (GCD1), GCD2, lattice corneal dystrophy type 1 (LCD1), Reis-Buckler corneal dystrophy, and Thiel- Behnke corneal dystrophy.

This is a multicenter, cross-sectional, observational study of the prevalence of TGFBI corneal dystrophies in a North American population. Patients presenting to the clinical site for an ocular examination with a refractive complaint (non-medical complaint) or for refractive surgery consultation will be asked to participate in this study. Prior to the collection of any study data, Informed Consent will be obtained.

A a serial number / bar code controlled case report form (CRF) single nucleotide variants implicated in the pathogenesis of the TGFBI corneal dystrophies. The CRF will be used to collect demographic information from the patient. Slit lamp examination of the corneas will be performed, and the presence or absence of corneal opacities, whether characteristic or not of a TGFBI dystrophy, will be documented on the CRF form.

Once all data has been collected, descriptive statistics will be computed to identify the prevalence of each of the TGFBI corneal dystrophies as defined by the genotype. Demographic data will be compared between unaffected individuals and those identified to have a coding region mutation associated with one of the five aforementioned TGFBI corneal dystrophies.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Able and willing to provide written informed consent and sign a HIPAA form.

Exclusion Criteria:

• None
Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder

The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the AutoLap system compared with the standard operation.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years
2. Able to provide a written informed consent

Exclusion Criteria:

1. Pregnancy
2. Obesity (BMI \>35 Kg/m2)
3. Contra-indications for performing laparoscopy
Infections and Latent Autoimmune Diabetes in Adults

Infections are proposed risk factors for type 1 diabetes in children. The investigators will examine whether a diagnosis of infectious disease also confers an increased risk of latent autoimmune diabetes in adults.

The investigators will use data from a population-based Swedish case-control study (ESTRID) with incident cases of LADA (n=597) and matched controls (n=2386). History of infectious disease are ascertained through national and regional patient registers. The investigators will estimate adjusted odds ratios (OR) with 95% CI for ≥1 respiratory (any/upper/lower), gastrointestinal, herpetic, other or any infectious disease episode, or separately, for 1 and ≥2 infectious disease episodes, within 0-1, 1-3, 3-5 and 5-10 years before LADA diagnosis/matching. Stratified analyses will be performed based on HLA risk genotypes and GADA levels.

Eligibility Criteria:
Inclusion Criteria:

* 35 years or older, residing in Scania or Uppsala county.

Exclusion Criteria:

* Less than 35 years
[18F]-F13640 as a New Brain Radiopharmaceutical

This clinical assay is designed to validate that \[18F\]F13640 as a radiotracer of 5-HT1A functional receptors. A first group of healthy subjects underwent a PET scan with arterial blood sampling to determine the kinetic model of the tracer. A second group of healthy subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the reproducibility of measures.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects
* Weight between 50 kg and 90 kg
* Affiliated to a social security or similar scheme
* Not subject to any legal protection measures

Exclusion Criteria:

Subjects with neurologic or psychiatric disease including all substance addictions

* Daily smokers
* Active infectious disease
* MRI contraindications
* PET contraindications determined with FDG injection
* Subjects deprived of their liberty by judicial or administrative decision
* Subjects unable to sign written consent for participation in the study.
* Severe and progressive medical pathology
* Volunteer who has exceeded the annual amount of compensation authorized for participation in research protocols
Oral Oxycodone After Major Cardiac Surgery

Postoperative pain and analgesic treatment still remains a challenge in daily perioperative medicine. Skin incisions, intraoperative tissue retraction and -dissection, intravasal cannulations and drainages, sternotomy and pericardiotomy are the most important reasons for postoperative pain. Poorly controlled pain can contribute directly or indirectly to postoperative complications, such as myocardial ischemia, pulmonary dysfunction like hypoventilation, pneumonia and atelectasis, a delayed return of gastrointestinal function and decreased mobility. In addition, prolonged acute pain also results in chronic pain.

Opioids are internationally recognized as the golden standard in the treatment of acute postoperative pain. On one side, the high potency of opioids in pain relief is clearly undisputed, but on the other hand, the administration of opioids is associated with nausea, vomiting, sedation and with the development of bowel dysfunction, which encompasses symptoms including bloating, abdominal spasm, cramps and constipation. Opioid-induced constipation is a frequently reported adverse effect and sometimes requires discontinuation of therapy, which results in analgesic under-treatment, severely impairing quality of life. However, there are many different regimes for the treatment of postoperative pain using opioids. Patient-controlled analgesia (PCA) using morphine is widely used, but requires trained staff and expensive equipment. Once patients are able to tolerate oral medications, the oral route is preferred postoperatively because it is more convenient, noninvasive and less expensive.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 90 years
* ASA physical status 1-3
* Elective major cardiac surgery requiring sternotomy
* Oral and written consent
* Postoperative extubation within four hours after arrival at the ICU
* Cognitive ability in the use of the PCA pump and the VAS

Exclusion Criteria:

* Chronic use of opioids in the last three months
* Chronic use of tranquilizer or pain medications
* Hypersensitivity against opioids
* Use of monoamine oxidase inhibitors in the last two weeks before surgery
* Alcohol or drug abuse
* Renal dysfunction (GFR \< 30 or necessity of dialysis)
* Liver Dysfunction defined as Child-Pugh-Score 7-15
* Ejection fraction (EF\< 40%)
* Malabsorption syndrome
* Neurologic or cognitive dysfunction
* Pregnancy
* Participation in another clinical trial
* Severe respiratory depression with hypoxia and/or hypercapnia
* Severe chronic obstructive pulmonary disease
* Severe bronchial asthma
* Non-opioid induced paralytic ileus
* Risk of seizures
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study

Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study

Fiberoptic bronchoscopy (FOB) is the essential procedures for diagnosis and treatment of respiratory diseases。 Fever following FOB has been frequently reported. Fever is usually caused by patient discomfort and delay recovery from illness, or even worse. The reported frequency of this complication ranges from 1 to 20%. According to previous reports, postbronchoscopy fever is associated with advanced age, the presence of abnormal bronchoscopic findings,documented endobronchial obstruction, bronchoscopic intervention for malignancy, BAL, bronchial brushing, endotoxin contamination during bronchoscopy, instillation of topical anesthetic through the bronchoscope, abnormal differential cell counts in the BAL fluid (BALF), bacterial growth in the BALF culture,and the severity of bleeding. At present, guidelines recommend sedation and analgesia combined with airway surface anesthesia for Fiberoptic bronchoscopy. laryngeal spray and cricothyroid anesthesia often used in clinical.Cricothyroid local anesthesia has a good effect, but it is an invasive operation, this is risk factors for fever after bronchoscopy.Therefore, to compare fever in the two kinds of airway anesthesia on Bronchoscopy . So as to provide the local anesthesia method with little influence on the patient.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III

Exclusion Criteria:

* use of immunosuppressive agents or corticosteroids
* body temperature 37.3°C during the 24 h prior to FOB,intubation or mechanical ventilation
* therapeutic bronchoscopy (foreign body removal, bronchial toilet, or stenting), discharge within 24 h of FOB
* surgical or diagnostic procedures within 24 h of FOB.
Ultrasound Screening of Congenital Anomalies of Kidney and Urinary Tract in Neonates

This cross sectional study will be conducted to investigate the incidence of the congenital anomalies of kidney and urinary tracts in neonates born or admitted at Tanta University Hospital.

This cross sectional study will be conducted for one year from October 2023 to October 2024 at Pediatric and Radiology Departments Tanta University Hospital (TUH).

This study will be conducted on neonates who will be born or admitted at Tanta University Hospital.

All patients included in the study will be subjected to: history taking, clinical examination and Ultrasound screening: by (SonoScape A6, Yizhe Building, Yuquan, Road Shenzhen, 518051, China). General-purpose diagnostic abdominal ultrasound equipment was used, with a 7.5-MHz linear-type probe. Screenings will be performed by radiologist with appropriate practice. The ultrasound examination will take 10 min for each patient. The recordings will consist of two bilateral renal images will be obtained and one transverse and longitudinal images. The urinary bladder will be observed with the patient in a supine position, and images will be recorded when abnormalities will be identified. The following will be investigated by ultrasound: number, size (including differences between sides), and location of the kidneys; pelvic dilatation; echogenicity, and other findings indicating cysts or tumours. Shape and wall thickening of the urinary bladder, as well as ureter dilatation, will be also examined.

Eligibility Criteria:
Inclusion Criteria:

* Neonates in the first month of life.

Exclusion Criteria:

* no exclusions