cyrilzakka/clinical-trials huggingface dataset:
Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* All genders
* All non-coronary artery bypass cardiac surgery patients
* Preoperative normal sinus rhythm

Exclusion Criteria:

* Pre-existing atrial fibrillation or atrial arrhythmias
* Pre-existing heart block
* Cardiogenic shock
* Sick sinus syndrome
* Marked sinus bradycardia
* Preoperative amiodarone use
* Contraindication to amiodarone use

  * PR interval \> 240 ms
  * QTc \> 550 ms
  * 2nd or 3rd degree heart block
  * Liver impairment (INR \> 1.7, AST/ALT \> 2x normal)
  * Uncontrolled hyperthyroidism or hypothyroidism
  * Interstitial lung disease
  * Pregnancy and/or breastfeeding
  * Known hypersensitivity to any components of amiodarone, including iodine
* Emergent operation
* Planned MAZE or Pulmonary Vein Isolation procedure
Evaluation Report of the Urea / Urine Creatinine as a Marker of Nutritional Status Predictive of ICU Care Associated Infections

Malnutrition is defined by an energy supply deficit, protein, macro-molecules or micro-nutrients, resulting from an imbalance between nutrient intakes and metabolic needs of the body. It concerns 40 to 60% of patients upon entry into resuscitation and influences their prognosis. Studies over the past decade have shown that nutritional deficiency increases the morbidity and mortality in intensive care.

Several clinical and biological parameters were evaluated as markers of malnutrition, including the ratio of urea / urine creatinine.

The report would identify patients in a state of malnutrition, to optimize their nutritional care.

This setting is easy to obtain in all patients by simple urine collection unlike other clinical and biological criteria of resuscitation malnutrition assessment.

This ratio of urea / urien creatinine would optimize energy intake of critically ill patients, for which nutritional management methods are widely debated.

At present, many clinical studies have shown a link between malnutrition and infectious complications in intensive care particularly because of immune disorders.

Many studies testing different nutritional strategies used as the main criterion infectious complications.

So this is a robust standard, well documented in the literature as a reflection of malnutrition in intensive care, and we also want to use in our study.

In a pilot study in the surgical ICU of the Hotel-Dieu report the urea / creatinine urine as a biomarker of poor outcome of nutritional status in the ICU seems extremely discriminating in predicting the existence of nosocomial infection.

Furthermore the kinetics of the relationship between the intake and the 5th day of resuscitation, also appears to be relevant in predicting the occurrence of nosocomial infection.

Surgical ICU of the Hotel-Dieu proposes to conduct a multicenter study to confirm the relationship between the ratio of urea / creatinine urine, malnutrition marker, and nosocomial infections (NI) in intensive care.

Primary objective:

To evaluate the predictability of the ratio of urea / creatinine urinary J5 on the occurrence of nosocomial infection in intensive care.

Eligibility Criteria:
Inclusion Criteria:

* 18 or more
* Admission in ICU
* Estimated length of stay superior to 5 days

Exclusion Criteria:

* pathologies modifying the ratio of urea / urine creatinine: end stage renal disease ( creatinine clearance less than 15 mL / min), Gastrointestinal bleeding, Right ventricular failure
Tracheobronchitis in Respiratory Involvement on the Lung SPECT/CT Images of Coronavirus Disease (COVID-19) Patients

Tracheobronchitis signs may be observed on ventilation lung scintigraphy during coronavirus disease (COVID-19) infection. This case report study aimed to analyze the rates and associated factors of such tracheobronchitis in COVID-19 patients referred to ventilation/perfusion lung scintigraphy with shortness of breath, suspected of pulmonary embolism.

It was a retrospective study

Eligibility Criteria:
Inclusion Criteria:

* patient with Tracheobronchitis signs
* patient with lung scintigraphy exam

Exclusion Criteria:

* none
Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C


Eligibility Criteria:
Inclusion Criteria:

* Men or naturally postmenopausal or surgically menopausal women
* 18 to 80 years of age
* Baseline HDL-C \<35 mg/dL (0.9 mmol/L)

Exclusion Criteria:

* Creatine phosphokinase (CPK) \>3 × the upper limit of normal (ULN)
* Body Mass Index (BMI) \>35 kg/m2
* Uncontrolled Hypertension \>95 mm Hg
* Uncontrolled diabetes mellitus (HbA1c \>10%)
* Renal dysfunction (blood urea nitrogen \[BUN\] or creatinine \>2 × ULN);
* Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2 × ULN)
* Uncontrolled hypothyroidism (TSH \>1.5 × ULN)
* Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous 3 months
Dose Optimization of Caffeine for HIE

This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.

In a previous phase I trial (NCT03913221), the investigators characterized the pharmacokinetics (PK) of caffeine in the setting of HIE and therapeutic hypothermia using a population PK model. This is an open-label study of caffeine citrate in neonates with HIE to validate the population PK model and determine optimal dosing for HIE.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent from parent or guardian
* ≥ 36 weeks gestational age at birth
* Receiving therapeutic hypothermia for a diagnosis of HIE
* Intravenous (IV) access
* Postnatal age \< 24 hours

Exclusion Criteria:

* Receiving \> 1 anti-epileptic drug for seizures
* Sustained (\>4 hours) heart rate \> 180 beats per minute
* Known major congenital anomaly
A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants

The purpose of the study is to assess the bioequivalence of olezarsen between 2 subcutaneous (SC) formulations \[(autoinjector (AI) and vial\] at 2 dose levels in healthy adult participants.

This is a Phase 1, single-dose, randomized, open-label, two-period, crossover study in approximately 100 healthy participants. The study will consist of an up to 28-day Screening Period, two treatment periods of 15 days each - with the second treatment period starting 28-42 days after the first begins - and a Post-Treatment Follow-Up Period lasting 91 days after the second treatment period begins. Eligible participants will be randomized to two dose groups (50 mg or 80 mg olezarsen). Participants will be dosed once at the beginning of each treatment period, one time using a single-use AI and one time using a single-use vial. Within each dose group, approximately half of the participants will be dosed with the AI first, with the other participants being dosed with the vial first.

Eligibility Criteria:
Inclusion Criteria:

1. Must have given written informed consent (signed and dated) and any authorizations required by local law, be able to comply with all study requirements prior to receiving any study drug, and be able to communicate effectively with clinic staff
2. Must be a healthy, adult male or female, 18 to 64 years of age (inclusive), and non-smoking (for at least 6 months prior to first study drug administration)
3. Females must be of non-childbearing potential

Exclusion Criteria:

1. Have a known history or presence of any clinically significant hepatic (e.g., hepatic impairment), renal/genitourinary (e.g., renal impairment), gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological, or hematological disease or condition unless determined as not clinically significant by the PI/sub-investigator
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica and moderate to severe pruritus.

The study will consist of a 37-day Screening period, a 7-day Run-In period, a 8-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 14 days after the last dose of study drug.

All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a dose of 2.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1.

Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension period upon completion of the Week 8 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).

Eligibility Criteria:
Key Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

* Subject has clinically confirmed diagnosis of active Notalgia Paresthetica;
* Subject has a history of chronic pruritus due to Notalgia Paresthetica;
* Subject has moderate to severe pruritus;
* Female subject is not pregnant or nursing during any period of the study.

Key Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

* Subject has pruritus attributed to a cause other than Notalgia Paresthetica;
* Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
A Study of LY3561774 in Participants With Mixed Dyslipidemia

This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.


Eligibility Criteria:
Inclusion Criteria:

* Have fasting triglycerides (TGs) within the range of 150 (1.69 millimole/liter (mmoL) to 499 milligram/deciliter (mg/dL) 2.26 to 5.64 millimole/liter (mmol/L) at screening.
* Have fasting LDL-C ≥70 mg/dL (1.81 mmol/L) at screening.
* Have non-HDL-C ≥ 130 mg/dL (3.36 mmol/L) at screening.
* Must be on a stable moderate or high-intensity dose of a statin for at least 2 months before screening and remain on the same medication and dose for the duration of the study.
* Have a body mass index within the range of 18.5 to 40.0 kilogram/square meter (kg/m²), inclusive

Exclusion Criteria:

* Have in the 6 months prior to screening, uncontrolled Type 1 or Type 2 diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization, or have an hemoglobin A1c (HbA1c) ≥8% at screening.
* Have a history of nephrotic syndrome.
* Have a history of acute or chronic pancreatitis.
* Have had within the past 3 months prior to screening

  * Myocardial infarction
  * Unstable angina
  * Coronary artery bypass graft
  * Percutaneous coronary intervention - diagnostic angiograms are permitted
  * Peripheral artery disease
  * Transient ischemic attack, or
  * Cerebrovascular accident
* Have New York Heart Association Class III or IV heart failure or last known left ventricular ejection fraction \<30%.
* Have undergone LDL apheresis within 12 months prior to screening.
* Have clinically relevant anemia, as defined by the investigator.
* Have, within 1 year prior to screening or plan on having during the study, surgical treatment for obesity.
* Have within 3 years prior to screening a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse.
* Have uncontrolled hypertension.
* Have used or are taking products for the purpose of lowering lipid levels (except for statins, PCSK9 inhibitors, bempedoic acid, and ezetimibe). This includes lipid-regulating medication, over-the-counter products, or herbal therapies.
Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease

Celiac disease (CD) is a common auto-immune disorder induced by gluten ingestion in genetically susceptible individuals (HLA-DQ2/DQ8). Gluten induces small-bowel villous atrophy and a specific immune response characterized by the production of CD-autoantibodies against transglutaminase 2 (anti-TG2) and endomysium (EMA). In symptomatic patients with positive-serum antibodies and villous atrophy, the diagnosis of CD is clearcut.

However, 10-30% of patients evaluated for suspected CD show only mild histopathologic changes and fluctuating serologic markers, a condition identified as potential CD. In such cases the diagnosis may remain uncertain.

CD-autoantibodies are produced by intestinal B-cells in the early phases of the disease, before their appearance in the serum and when the duodenal mucosa is still normal. Intestinal CD-antibodies (I-CD-abs) are a marker of CD, have a high sensitivity and specificity for CD and identify those patients with potential CD who are at risk of progression to villous atrophy. I-CD-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies (EMAbiopsy).

The diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity. However, their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories. There is an unmet need: the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected CD patients, who may benefit from a therapy based on gluten-free diet, and to reduce both unnecessary medical investigations and diagnostic delays.

In order to simplify and shorten times for the detection of these intestinal antibodies, the study aims to substitute the EMAbiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen. The obtained samples will be tested with rapid (about 15 minutes) immune-chromatographic anti-TG2 assay (Rapid Intestinal anti-TG2 Assay).


Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing an elective esophagogastroduodenoscopy (EGD) for suspected Celiac Disease (CD), eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease.

Exclusion Criteria:

* Bleeding disorders
* Patients fulfilling the new European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) guidelines for diagnosing CD (version 2020) for a serology-based CD diagnosis
* Subjects in whom intestinal biopsies are not indicated as part of the diagnostic process
Swiss Kidney Stone Cohort (SKSC)

The SKSC is a continuous database with the objective of a standardized diagnosis and monitoring of patients with kidney stones as well as the establishment of a Biobank.

The objective of this study is multi-site, standardized observation and characterization of kidney stone patients.

Furthermore, an adequate structure should be established for the execution of studies with kidney stone patients, in order to then, if necessary, develop recommendations for useful monitoring or prophylactic measures, as well as new treatment options for kidney stone patients.

A control group of 250 stone-free volunteers matching patients cohort participants for sex and age started recruitment in October 2017 and will serve the purpose of comparison in future studies.

Eligibility Criteria:
For SKSC Patients Group:

Inclusion Criteria:

Only patients that meet all of the following inclusion criteria can be included in this study:

* Signed Declaration of informed consent
* Male or female
* Recurrent kidney stone episodes (more than 1) or an individual kidney stone episode with one or several of the following risk factors:
* The first manifestation at the a minimum age of 25
* Positive family history
* Non-calcium oxalate stones
* Gastrointestinal disorders (e.g. gastric bypass surgery, inflammatory bowel disease, malabsorption etc.)
* Osteoporosis
* Nephrocalcinosis
* Single kidneyness
* Currently pregnant
* Gout
* Metabolic syndrome ( Diabetes Mellitus type I and II )
* Residual calculi (at least 3 months after the therapy)
* Bilateral or multiple stones
* Chronic urinary tract infection
* Chronic renal failure (eGFR lower than 60 ml/min.)
* Kidney transplant

Exclusion Criteria:

Patients with at least one of the following exclusion criteria may not take part in this study.

* Not signed Informed Consent form
* Age below 18 years old

For SKSC Control Group

Inclusion criteria:

* Signed Declaration of informed consent
* Male or female
* Kidney-stone free (screening verification by low-dose CT-scan)

Exclusion criteria:

* Not signed Informed Consent form
* Age below 18 years old
* Pregnancy
* History of kidney stones
* Low-dose CT-scan positive for kidney stones during screening phase
Internet Assisted Career-Oriented Soft-skills Training for Transition Age Youth with Mental Health Conditions

The purpose of this study is to evaluate the effectiveness of an internet- assisted Career-Oriented Work-Related Soft-skills Training (iCareer) intervention, infused with cognitive behavioral therapy, targeting individuals ages 16-24 with mental health conditions, to improve employment outcomes. The overall objective is to help transition-age youth (TAY) with psychiatric disabilities achieve optimal employment outcomes as part of successful transition to adulthood. Findings will have implications for enhancing and developing pre-employment services for TAY with psychiatric disabilities.

The investigators propose to perform an open trial research study directed toward producing new knowledge about the Direct Skills Teaching intervention for employment related interpersonal "soft" skills. Soft skills are generally defined as social, emotional, interpersonal, adaptive, and problem-solving skills (Grugulis et al., 2009). The investigators will examine the feasibility of integrated Direct Skills Training modules in social, emotional, interpersonal, adaptive, and problem-solving skills (Soft Skills at Work (SSW)) on improving employment participation and success among transition age youth and young adults (TAY) with disabilities ages 18-24.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 16 and 24 years
2. Must speak English fluently
3. Receiving Individualized Education Program (IEP)/504 Plan or disability services within the past 24 months with primary disability types of psychiatric disability
4. No hospitalizations or suicide attempts within the past 2 months
5. Willing to provide informed consent (if younger than 18, parental consent) to participate in the study
6. Interested in improving work-related social skills

Exclusion Criteria:

1. Current presence of neurological disease or brain injury
2. Psychiatric instability such as gross psychosis or acute suicidality
3. Current alcohol or substance dependence
4. Hospitalization or suicide attempts in the past 2 months
Genetic and Morphological Analysis of Thyrotoxic Periodic Paralysis

The study aims to analyze the genetic variance between thyrotoxic periodic paralysis (TPP) patients and pure hyperthyroidism individuals. Meanwhile, the investigators also intended to evaluate the morphological difference in effected skeletal muscles and investigate their relation with genetic variance.

Chinese males of their third and forth decades are extremely predisposed to periodic paralysis when they are hyperthyroid. Due to their imbalanced predilection to the disease, genetic variance is considered to be critical to the pathogenesis. In addition, since proximal limb skeletal muscles are the major sites of target, and they are also believed to play a role in the disease generation. Thus, we intend to analyze the genetic and morphological variances between TPP patients and pure hyperthyroidism patients and simultaneously the relation between genetic variance and morphological difference. In this way, we hope to provide evidence for a better understanding of the disease.

Eligibility Criteria:
Inclusion Criteria:

A recent history(within three months) of acute limb muscle weakness, hypokalemia and decreased TSH with elevated free FT4, FT3.

Exclusion Criteria:

Hyperthyroid myopathy with long term muscle weakness, family periodic paralysis, renal tubular acidosis, hyperaldosteronism, hemiplegia, paraplegia, or any history of other metabolic or traumatic muscular disease,
Can Japanese Traditional Foods Lower Blood Pressure in Healthy Volunteers

The purpose of this study is to determine whether traditional japanese diet blood pressure in healthy volunteers.

Japanese traditional diet contains considerably more nitrate/nitrite than the European foods. 80% of dietary nitrate originates from vegetables. Green leafy vegetables, especially spinach, salad and seaweed are rich in nitrates. Other vegetables contain nitrate at lower concentrations, but because they are consumed in greater quantity, they may contribute more nitrate and thus nitrite from the diet. Nitrate/nitrite is attributed multiple health benefits. Japanese people have an exceptional longevity and the lowest rate of heart diseases. On the other hand, gastric cancer rate is high too. Nitrate/nitrite is strongly correlated with these phenomena. Is this high nitrate consumption protective or damaging? Understanding dietary nitrite and nitrate consumption and its metabolism therefore becomes very important.

Aim: To compare conversion of nitrate to nitrite in Japanese people, measured in blood and in saliva during consumption of traditional Japanese foods vs European diet.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* high/low blood pressure