cyrilzakka/clinical-trials huggingface dataset:
The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery

The purpose of this study is to determine whether giving omega-3 fatty acids prior to and after cardiac bypass surgeries decreases the incidence of postoperative delirium in patients aged 65 and over.

Patients aged 65 years and over requiring elective cardiac bypass surgeries will receive either 0, 2, or 4 grams of omega-3 ethyl esters before their surgery and for 3 days postoperatively to determine whether there is an affect on the incidence of postoperative delirium. All patients will receive hospital standard of care therapy for their surgery and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* American Society of Anesthesiologists (ASA) Class Physical Status I-IV

Exclusion Criteria:

* Inability to obtain written informed consent.
* Inability to take study drug due to intubation or other reason.
* Delirium present at screening.
* Known hypersensitivity (e.g. anaphylactic reaction) to omega-3 ethyl esters or any of its components
* Allergy to fish or shellfish
* Currently taking warfarin (Coumadin), apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa/Lixiana), rivaroxaban (Xarelto), or other anticoagulant drugs.
* Currently taking omega-3, omega-6, vitamin E, or fish oil supplements.
* Significant renal disease with a serum creatinine ≥ 2 mg/dL.
* Significant liver disease with alanine aminotransferase (ALT) levels 1.5 times the normal range of 6-45 units/liter and aspartate transferase (AST) levels 1.5 times the normal range of 10-42 units/liter.
* History or diagnosis of diabetes.
* History or diagnosis of neurodegenerative disease such as Parkinson's, Alzheimer's, or dementia.
* History or diagnosis of bleeding disorder.
* History or diagnosis of metabolic syndrome or disorder.
* History or diagnosis of thyroid problems such as hyperthyroidism or hypothyroidism.
CLamp vs Off Clamp Kidney During Partial Nephrectomy

Prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

* normal coagulation trim
* pre operative Glomerular Filtration Rate (GFR) \> 60 ml/min
* healty contralateral kidney
* low (4-6) or intermediate (7-10) RENAL score
* availability of Da Vinci Robotic System

Exclusion Criteria:

* altered coagulation trim
* pre operative Glomerular Filtration Rate (GFR) \< 60 ml/min
* anatomic or functional solitary kidney
* RENAL score \>10
Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer


Eligibility Criteria:
Inclusion Criteria:

Able to understand and willing to sign an Institutional Review Board（IRB） approved written informed consent document.

At least 18 years of age. Histologically or cytologically confirmed HER2-negative (0 or 1+ by immuno-histochemical (IHC) or non-amplified by FISH) breast cancer that is stage IV.

There is no standard therapy. At least one measurable disease by RECIST 1.1 is required. Karnofsky performance status (KPS)\>70, life expectancy \> 12 weeks

Exclusion Criteria:

Lack of adequate organ function as defined below within 2 weeks of registration:

Absolute neutrophil count (ANC)\<1.5×109/L，platelet counts (PLT)\<75×109/L or hemoglobin (Hb)\<100g/L Total bilirubin (TBiL)\>2×upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\>2.5×ULN（or\>5 x ULN for patients with liver metastases）; Alkaline phosphatase (ALP)\>2.5×ULN; serum creatinine concentration (Scr)\>140umol/L Pregnant and/or breastfeeding. History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias.

Having a history of uncontrolled paroxysmal diseases, including central nervous system diseases or mental disorders which may have an impact on the understanding and signature of informed consent Uncontrolled acute infection Currently receiving any other investigational agents or systemic cancer therapy.

Allergy to any investigational drug ; Any other condition that investigator considers inappropriate to participate in this trail
Spiritual Health Scale in Chinese Pediatric Cancer Patients

Pediatric cancer patients experience spiritual concerns such as meaningless, hopeless of life, fear of death and losses at all stages of illness. The availability of a valid and reliable instrument that accurately assesses the level of spiritual health among pediatric cancer patients is crucial before any appropriate interventions to solve their spiritual concerns can be appropriately planned and evaluated.

The study aimed to adapt the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp-12) scale and validate it in Chinese pediatric cancer patients.

A two-phase sequential method design will be used. Phase I will use a descriptive qualitative approach to understand pediatric cancer patients' opinions related with spiritual issues and experience. At least 12 participants are expected to be interviewed. The results of the qualitative study will be used to compare with the items of the original scale, and emerging themes will be used to generate new items. Phase Ⅱ will translates and adapt the scale based on the result of Phase I. Further, the adapted version of the scale will be validated among 200 pediatric cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* age 8-17 years old,
* diagnosed with any type of cancer who were treated at these sites at any point after their diagnosis,
* knowing about condition and prognosis of their disease,
* their parents agree to sign the informed consent form,
* able to communicate with Chinese and read Chinese.

Exclusion Criteria:

* younger than age 8-17 years old
* cancer survivors
A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled Hypertension

The purpose of this study is to evaluate the effect of ION904 on plasma angiotensinogen (AGT) in participants with uncontrolled hypertension.

This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study. It will include up to approximately 48 participants with mild to moderate hypertension who have uncontrolled blood pressure (˃ 130 - ≤ 170 millimeters of mercury \[mmHg\] systolic) and have been on one or more anti-hypertensive medications for at least one month. Following an up to 4-week screening period, eligible participants will receive multiple doses of ION904 during a 13-week treatment period, followed by a 13-week post-treatment follow-up period.

Eligibility Criteria:
General Inclusion Criteria:

1. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), she uses a highly effective contraceptive method. Aged 18 - 75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent
2. Body mass index (BMI) ≤ 45.0 kilograms per square meter (kg/m\^2) at screening
3. History of uncontrolled hypertension (HTN) on one or more antihypertensive medications without changes in antihypertensive regimen within 4 weeks of screening and will be required to maintain this regimen throughout the Treatment Period

General Exclusion Criteria:

1. History of secondary HTN including, but not limited to any of the following: renovascular HTN (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug induced HTN
2. Unstable/underlying known cardiovascular disease defined as:

   * Any history of congestive heart failure (New York Heart Association \[NYHA\] Class III-IV)
   * Any history of previous myocardial infarction, coronary revascularization, unstable or stable angina pectoris ˂ 6 months prior to screening
   * Any hemodynamically unstable atrial or ventricular arrhythmias
   * Significant uncorrected valvular heart disease
   * Any history of stroke or transient ischemic attack \< 6 months prior to screening
3. A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening
Natural Fruit Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Level

This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.

The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 18.5 and ≤ 25.0 kg/m2.
* Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery \[with exception of cholecystectomy and appendectomy\] and inflammatory diseases).
* Fasting blood glucose value of subjects is ≥ 3.4 and \<6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening.

Exclusion Criteria:

* Use of antibiotics within 3 months before day 1; use of any other medication within 14 days before day 1 except for both paracetamol and hormonal contraception.
Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community

The proposed Conexion resource combines best publicly available evidence-based information and local community resources in one place. The information is curated and contextualized to meet local needs of consumers and providers. Content is tailored culturally and geographically to fit the community. This approach is consistent with evidence showing that individuals' interactions with health information and technology are "community embedded".

Nationwide, Hispanics have many barriers to accessing health information, and are subject to significant health disparities, including disproportionate burden of diabetes and untreated mental illness. The research team's preliminary research has identified diabetes and depression as the highest priority needs in the study community of Washington Heights-Inwood (WAHI), which is an urban, low-income neighborhood in New York City with 71% Hispanic residents, predominantly immigrants from the Dominican Republic. Many high-quality health information resources already exist on the internet but they are not reaching many segments of the population, including parts of the WAHI community. The novel concept the investigators propose here is an information resource localized to a community.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Washington Heights/Inwood resident (zip codes 10032, 10033, 10034, 10040)
* interest in information on diabetes or depression
* speak English or Spanish

Exclusion Criteria:

-
A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy

Primary Objectives

* To compare the amount of post-operative wound drainage between the group of patients in which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™ placebo is utilized (Arm B).
* To compare the length of time to drain removal between Arm A and Arm B. Secondary objectives
* To compare the incident or rates of seroma, hematoma, and post-operative edema between the two groups.
* To compare the reported pain experienced in each group at selected time points using a standard numerical rating scale (NRS).
* To compare the length of hospital stay between the two groups of patients.


Eligibility Criteria:
Inclusion Criteria

* Patients must have an initial diagnosis of thyroid neoplasmcarcinoma or goiter that requires total or hemithyroidectomy.
* Patients must have an ECOG performance status of 0-2
* Laboratory values must be within the following ranges:

  * Platelet count \> 100 k/mm3
  * Hemoglobin \> 10.0 g/dL
  * WBCs \> 3.0 k/mm3
  * Total bilirubin \< 2.6
  * Serum Creatinine \< 2.0
  * PTT and PT/INR within institutional normal limits
* Patients must sign informed consent for study participation

Exclusion Criteria

* Evidence of distant metastasis of thyroid carcinoma
* Recurrent thyroid cancer
* Prior thyroid surgery or surgery to the neck.
* Patients with diagnosed coagulation disorders
* Prior irradiation to the neck area
* Prior chemotherapy for the current diagnosis
* Patients on therapeutic warfarin
* Patients with psychological or cognitive issues that, in the opinion of the investigator, will make them unable to adequately report pain levels
* Patients in an immune deficient state
Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure

The purpose of this study is to determine whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation.

The clinical efficacy of noninvasive positive pressure ventilation (NPPV) has been demonstrated. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. Studies assessing NPPV in weaning are not enough and generally are performed with face masks as device for NPPV. This study assesses the efficacy of helmet as device for NPPV during weaning from mechanical ventilation in an ICU and compares this procedure with invasive mechanical complication (IMV) by analyzing respiratory parameters, clinical course and complications.

Eligibility Criteria:
Inclusion Criteria:

* endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure,
* patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours),
* spontaneous breathing trial failure
* written informed consent obtained (patient or family)

Exclusion Criteria:

* respiratory and hemodynamic instability
* initial difficult intubation
* bronchial hypersecretion at the weaning time
* non cooperant patient
* recent history of upper gastro-intestinal surgery
* recent history of myocardial infarction
Risk of CV Events With EFV vs. EFV-free Regimens

The purpose of this study is to determine whether there is an increased risk of cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in patients with HIV.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Aged 18 years or older on the index date
* Have at least one pharmacy claim for efavirenz or a drug in the comparison cohort during the period spanning January 1, 2007 through December 31,2013.
* Clinical Modification (ICD-9) diagnosis code for HIV infection including 042 (HIV disease), V08 (asymptomatic HIV infection status), 795.71 (nonspecific serologic evidence of HIV), and 079.53 (HIV, type 2) any time prior to the index claim.
* Have at least 6 months (180 days) of continuous enrollment prior to the index claim

Exclusion Criteria:

* Patients who have been dispensed any antiretroviral medications anytime before the index date including the 180-day baseline period
* Patients with evidence of a cardiovascular outcome of interest during the 180-day baseline period
Stroke and CPAP Outcome Study 3

A problem with breathing during sleep, called obstructive sleep apnea (OSA), likely increases the risk of stroke and is common in people who have had a stroke, present in about 2/3 of stroke survivors. There is also evidence that OSA predicts worse outcome after stroke. The question being addressed in the Stroke and CPAP Outcome Study 3 (SCOUTS3) is how to improve use of continuous positive airway pressure (CPAP) therapy to treat OSA when started during intensive stroke rehabilitation.

In an initial single-arm study, participants with stroke will be tested for OSA and treated with auto-titrating CPAP during inpatient stroke rehabilitation and continued for a 3-month treatment period. Multiple behavioral interventions will be used to improve CPAP use, including intensive CPAP technical support, motivational enhancement therapy, and phone and mobile health automated support. The multicomponent behavioral intervention will be optimized to improve CPAP adherence with the engagement and input of stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days
* Person providing consent (patient or legally authorized representative) able to be consented in English or Spanish

Exclusion Criteria:

* Unable to obtain informed consent from participant or surrogate
* Incarcerated
* Known pregnancy
* Current mechanical ventilation, tracheostomy or supplemental oxygen use \> 4L/min
* Current use of positive airway pressure or use within 14 days prior to stroke
* History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use
* Stroke related to tumors, vascular malformations or subarachnoid hemorrhage
* Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA)
* Anticipated inpatient rehabilitation length of stay \< 3 nights
Efficacy of Botulinum Toxin Type A in Patients With Bladder Pain Syndrome/Intersticial Cystitis and Hunners' Lesions

The etiology of bladder pain syndrome is unknown. Therefore the management is directed to pain relief, as bladder pain is believed to drive both voiding frequency and nocturia. Botulinum toxin A has been shown to decrease noxious input. Several studies showed efficacy of botox for treatment of painful bladder.

The aim of this study is to evaluate the efficacy of Botulinum toxin in patients who are suffering bladder pain syndrome with Hunner lesions during cystoscopy.


Eligibility Criteria:
Inclusion Criteria:

* longer than 6 months of bladder pain syndrome/interstitial cystitis with Hunner Lesion(s) during cystoscopy

Exclusion Criteria:

* Pregnancy
* neurologic diseases
* urinary tract infections
* bladder outlet obstruction
* previous pelvic radiotherapy
Continuous Femoral Block With Levobupivacaine 0.125% or Ropivacaine 0.2% in Elderly Patients With Femoral Fractures

This study evaluates the continuous femoral block between levobupivacaine 0.125% and ropivacaine 0.2% in patients with proximal femoral fracture.These patients will be divided into 2 groups of 35 patients, one L group (levobupivacaine 0.125%) and one R group (ropivacaine 0.2%) distributed randomly, receiving continuous infusion through patient controlled analgesia (PCA) pump with the following parameters: infusion 5 ml / h, bolus 5 ml, lockout 30 min.

Pain is associated with neurohormonal stress, myocardial ischemia and delayed mobilization, thus being able to increase the hospitalization time and associated with increased postoperative mortality. Regional anesthesia through simple or continuous femoral nerve block are options for analgesia in patients with femoral fracture, as well as analgesia by venous opioids. A potential benefit of regional anesthesia is precisely to avoid the use of opioids and other general anesthetics, which in turn are also closely related to postoperative delirium. Continuous femoral block, since the preoperative period, is associated with the reduction of acute pain and opioid consumption, in patients with femoral neck fractures. There are few studies available in the literature comparing analgesic equipotency between levobupivacaine and ropivacaine in peripheral nerve blocks. In none of them, the peripheral analgesia in the femoral nerve, for proximal femoral fracture was compared.

Eligibility Criteria:
Inclusion Criteria:

* 70 years old or more
* patients with femur fracture
* physical status risk American Society of Anesthesiologists (ASA) P1 - P3

Exclusion Criteria:

* physical status ASA P4
* patients with BMI \> 35
* systemic infection
* Injury or infection at the site of installation of the femoral perineural catheter
* Catheter displacement of the perineural site
* Montreal Cognitive Assessment (MoCA) \< 26
* Patients operated before 24 hours of hospital admission
Evaluation of the Feasibility a New Silicone Hydrogel Contact Lens

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of an investigational contact lens.


Eligibility Criteria:
Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Be myopic and require lens correction in each eye.
* Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Exclusion Criteria:

* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* An active ocular disease, any corneal infiltrative response or are using any ocular medications.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Allergic to any component in the study care products.
Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp

Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales) disorder patterned on the sebum-rich areas of the scalp, face, and trunk.

The current treatment does not cure the disease permanently. Therefore it must be repeated when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease, but are associated with a high frequency of relapse when treatment is stopped. They are reserved for acute flare-ups only as they may precipitate recurrences and dependence. In addition, chronic use of corticosteroids is associated with side-effects.

The scientific rationale for the use of K40 for treatment of SD was based on clinical evidence that K40 improves erythema and desquamation with mild adverse reactions in a few cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and desquamation scores at Week 4.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (including fertile women)
* 18-65 years of age
* Seborrhoeic dermatitis of the scalp for at least 2 months
* Presenting erythema and desquamation of mild, moderate, pronounced or severe intensity
* Signed written informed consent

Exclusion Criteria:

* Patient on an antifungal, selenium sulphite or corticosteroid therapy within the last 2 weeks prior to start of study treatment
* Any other cutaneous disease of the face requiring a specific topical treatment (corticosteroids, antifungals, antibiotics, retinoids, benzoyl peroxide or a-hydroxyacids) during the previous 15 days
* Oral treatment with cyclines, lithium, antifungals or inhaled corticosteroids during the previous month
* Use of systemic corticosteroids and retinoids during the previous 2 months
* SD associated with Parkinson's disease, human immunodeficiency virus infection
* Current or any history of ear, nose and throat carcinoma,
* Current or any history of severe concomitant disease according to Investigator'sjudgement
* Allergy to any of the tested treatment components