cyrilzakka/clinical-trials huggingface dataset:
Eye and Carotenoid Augmentation Research and Evaluation (EyeCARE)

The primary study outcomes are to investigate the effects of 4-month daily carotenoid complex supplementation on carotenoid status in the macula and skin and visual fatigue among adults 20-45 years of age. Secondary outcomes will examine the supplementation effects on cognitive function.

Lutein and zeaxanthin are carotenoids or plant-based pigments that accumulate in various human tissues including the eye, skin, adipose/fat, and the brain where they play important roles as antioxidants and light filters. Previous correlational work has shown that lutein and zeaxanthin intake is associated with multiple markers of health including visual and cognitive outcomes. However, experimental or intervention research examining the effects of lutein and zeaxanthin supplementation on the accumulation of these carotenoids in the eye and skin and implications for visual and cognitive function is still emerging. Additionally, virtually all the previous research has relied on single nutrient supplementation (e.g., only lutein or zeaxanthin) resulting in limited knowledge of the benefits of providing these carotenoids with other possibly healthful nutrients (e.g., astaxanthin, vitamin E). Accordingly, this project will test the effects of lutein and zeaxanthin supplementation provided in a complex with other antioxidants and nutrients on outcomes of nutritional status in the eye and skin as well as visual and cognitive health. The study aims will be addressed using a double-blind randomized controlled trial design. Adults 20-45 years of age will be asked to participate in a daily 4-month double-blind randomized controlled clinical trial. Treatment group (N=20) participants will be asked to consume 2 daily softgels with a daily total containing 20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel). Participants will be asked to consume the supplements with a meal of their choosing. Control group participants will be asked to consume similar-looking placebo softgels over the same period.

Eligibility Criteria:
Inclusion Criteria:

1. not pregnant
2. not breastfeeding
3. absence of hypertension
4. absence of diabetes
5. absence of cerebrovascular disease
6. absence of cardiovascular disease
7. absence of liver disease
8. absence of kidney disease
9. absence of gastrointestinal disease
10. absence of age-related macular degeneration
11. no allergy to carotenoids
12. 20/20 or corrected vision
13. MPOD less than or equal to 0.60
14. Age between 20-45 years

Exclusion Criteria:

1. pregnant
2. breastfeeding
3. presence of hypertension
4. presence of diabetes
5. presence of cerebrovascular disease
6. presence of cardiovascular disease
7. presence of liver disease
8. presence of kidney disease
9. presence of gastrointestinal disease
10. presence of age-related macular degeneration
11. allergy to carotenoids
12. not 20/20 or uncorrected vision
13. MPOD greater than 0.60
14. Younger than 20 years or older than 45 years
Evaluation the Feasibility of the FOSTI Device

Feasibility of accurate differentiation between malignant and benign tissue using the FOSTI device on surgically removed tissue

Characterization of the optical fiber sensor's interaction with the tissue.

Creating a database of tissue lesions and their 'optical signature' (lesion classifier).

Optimization of the FOSTI device by minimizing the false-positive and false-negative results.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of all ages.
* Subject is able, agree and sign the Informed Consent Form.

Exclusion Criteria:

* Subject has any conditions, which precludes compliance with study
Effectiveness of an Online Intervention Targeting Cancer-related Fatigue

This trial studies how well Untire application intervention works in reducing cancer-related fatigue in cancer patients and survivors.The Untire application focuses on themes that have been identified as causing or contributing to cancer-related fatigue. It may provide information and tips to improve lifestyle, give exercises for body and mind to increase energy levels, offer weekly reports to measure progress, and offer access to an online support community.

PRIMARY OBJECTIVES:

I. To assess the effectiveness of an online multidisciplinary psychological training program delivered via a smartphone-based application (the Untire app) in reducing patient-reported fatigue in cancer patients and survivors.

SECONDARY OBJECTIVES:

I. To determine the dose-response association between use of the Untire app and reduction in patient-reported fatigue severity.

II. To explore whether changes in positive and negative affect, depressive symptoms interact with the effects of the Untire app on fatigue severity.

III. To explore the predictive value of genetic markers (single-nucleotide polymorphisms) and personality characteristics for effectiveness of the Untire app in reducing patient-reported fatigue.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients use Untire application intervention after baseline up to 6 months.

ARM II: Patients use Untire application intervention after 3 months up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present at the Cancer-Related Fatigue Clinic or the Psychiatric Oncology Clinic for an initial consult
* Patients who speak and read English
* Patients who are willing and able to review, understand, and provide written consent
* Patients who agree to comply with all study procedures
* Patients who are in possession of a smartphone or tablet that supports the Untire app software
* Patients rating their current fatigue severity as moderate to severe (= or \> 4 on a 0-10 scale), assessed as part of the clinics' screening procedure

Exclusion Criteria:

* Case report of diagnosis of a formal thought disorder (e.g., schizophrenia)
Pectin Supplemented Enteral Feedings in Critically Ill Patients

The current study will enroll critically ill patients who are going to require enteral nutrition support and randomize them to standard formula enteral nutrition or pectin-supplemented enteral nutrition in 7 days. The occurrence of enteral nutrition-related complications will be recorded and compared between groups.

The study is trying to assess whether the use of pectin will improve the enteral nutrition-related complications in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years old, with informed consent to participate;
* Critically ill patients who require enteral nutrition support

Exclusion Criteria:

* Patients with lung infection at admission
* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Lack of enteral access
* Any condition that would contraindicate use of the enteral nutrition
* Require enteral nutrition support for less than 1week or more than 4 weeks from enrollment
Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care

The investigators aim to examine whether a motivational multicomponent lifestyle intervention as a supportive treatment for depression has a beneficial effect on recovery from depression in a primary health care setting.

Depression causes a significant global burden of disease. Among depressed individuals, poor lifestyles, such as physical inactivity, unhealthy diet, and smoking, are common and play a role in the development and maintenance of depression. Robust research evidence recommends applying one-component lifestyle interventions that focus on factors such as a healthy diet or exercise, as a supportive treatment for depression. Currently, however, there is increasing interest in identifying the most effective multicomponent lifestyle intervention that targets more than one unhealthy lifestyle simultaneously in order to reduce depressive symptoms.

The study aims to examine whether a motivational multicomponent lifestyle intervention as a supportive treatment for depression has a beneficial effect on recovery from depression in a primary health care setting. The specific study questions are as follows:

1. What is the effect of the intervention on depressive symptoms at 3- and 12-month follow-ups?
2. What is the effect of the intervention on mental well-being at 3- and 12-month follow-ups?
3. What kind of physical health do depressed patients in primary health care have? What kinds of effects does the intervention have on common physical health risk factors at 12- and 24- month follow-ups?
4. What is the effect of the intervention on health-related quality of life?
5. What is the cost-effectiveness of the intervention?

Eligibility Criteria:
Inclusion Criteria:

* adults ≥ 18 years
* depression (ICD-10, F32-F33)
* Beck Depression Inventory (BDI-1A) ≥ 10 points
* the initiation of treatment in a primary health care center

Exclusion Criteria:

* bipolar disorder
* psychosis
* substance abuse
* pregnancy or lactation
* a long-term rehabilitative psychotherapy.
The Impact of Surgical Technique on Circulating Tumor DNA in Stage I-III Non-Small Cell Lung Cancer

This clinical trial compares the effect of pulmonary vein-first surgical technique to pulmonary artery-first surgical technique in decreasing circulating tumor cell deoxyribonucleic acid (ctDNA) in patients with stage I-III non-small cell lung cancer. Pulmonary vein first and pulmonary artery first surgical techniques are standard surgical techniques for the division of the blood vessels during lung resection surgery. Pulmonary vein-first surgical technique may reduce the risk of shedding tumor cells during surgery and influence long term overall survival.

PRIMARY OBJECTIVE:

I. To determine the association between sequence of surgical resection and postoperative ctDNA levels at specified time points.

SECONDARY OBJECTIVE:

I. To determine the associated between sequence of surgical resection and postoperative ctDNA level and clinical oncologic outcomes.

II. To assess disease-free survival and the role of circulating tumor DNA in disease recurrence in patients with resectable non-small cell lung cancer.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo pulmonary vein first approach surgical procedure on day of surgery.

GROUP II: Patients undergo pulmonary artery first approach surgical procedure on day of surgery.

After completion of surgery, patients are followed up at day 1, day 7, days 7-28, 4 months, every 6 months for 2 years, then every 6 months for up to 5 years

Eligibility Criteria:
Inclusion Criteria:

* Any patients 18 years of age or older with confirmed or suspected early-stage (stage I-III) NSCLC
* Eligible and scheduled for surgical anatomic lung resection (e.g. lobectomy or segmentectomy) as routine clinical care for their disease

Exclusion Criteria:

* Previous cancer diagnosis within 5 years (except ductal carcinoma in situ \[DCIS\] of the breast, superficial bladder cancer, non-melanoma skin primary, other malignancy that does not require treatment).
* Preoperative chemotherapy, immunotherapy, or radiation therapy
* Receipt of perioperative blood transfusion
Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department

Patients often come to the emergency department with bacterial skin infections (known as "cellulitis"). Some patients with very severe infections are admitted to hospital for antibiotic treatment and some are sent home on oral antibiotics. Many patients have moderate infections and are treated as outpatients with daily intravenous antibiotics for 2-5 days. In this patient group it is unclear if treatment with oral antibiotics is as effective as intravenous antibiotics. The purpose of this study is to determine if treatment of moderate cellulitis with an intravenous antibiotic (cefazolin) for 3-5 days is as effective as treatment with an oral antibiotic (moxifloxacin). We hypothesize that the oral agent will be as effective as intravenous treatment for moderate cellulitis.

Extended description of the protocol, including information not already contained in other fields.

Objective: To compare 400 mg of oral moxifloxacin (Oral Group) once daily to 2 grams of IV cefazolin and 1 gram of oral probenecid once daily (IV group) for the treatment of moderate cellulitis.

Patients: Any patient presenting to the emergency department at St Paul's Hospital in Vancouver with a diagnosis of cellulitis requiring IV antibiotics, without contraindications to any of the study treatments, and not requiring hospital admission.

Assessments: Daily assessments are performed double-blind at 0, 1, 2, 3, 4, 5, 6, 7 and 14 days.

Primary outcome: Clinical cure at 7 days (resolution of symptoms, no change in antibiotic, no adverse events requiring discontinuation of study drug, no admission to hospital).

Secondary outcomes: Area of erythema, days of treatment, side-effects of medication, cost of treatment, patient satisfaction, relapse at 14 days.

Sample size: Based on equivalence of treatments a total of 390 patients are required (195/group).

Eligibility Criteria:
Inclusion Criteria:

* Cellulitis requiring outpatient intravenous antibiotic therapy;
* ability to understand,/sign informed consent;
* no contraindications to study medications,
* not pregnant/breastfeeding

Exclusion Criteria:

-
Diet Management on Hepatic Encephalopathy of Patients With Variceal Bleeding After Intrahepatic Portosystemic Shunt Creation

Hepatic encephalopathy is a severe complication of transjugular intrahepatic portosystemic shunt (TIPS) treatment in patients with cirrhosis and variceal bleeding. This study is specially designed to explore whether diet management strategy could decrease incidence of encephalopathy after TIPS treatment.

Hepatic encephalopathy (HE) is a severe complication of TIPS treatment in patients with cirrhosis and variceal bleeding. The overall incidence of post-TIPS encephalopathy ranges between 10% and 50%, and even the percentage of the new or worsened HE was evaluated up to 13-36%. No approach or medication was evidenced for prophylaxis of post-TIPS encephalopathy, including lactulose and rifaximin. Diet management has been used as an important part of the prophylaxis and treatment strategy for patients with metabolic diseases like diabetes and nephritis, which has drawn increasing interest of clinicians. Nevertheless, there is still no standard consensus or even recommendation for patients after TIPS procedure for now, which worsened malnutrition and affected survival. Thus, this study is specially designed to explore whether diet management strategy, drawn up from the nutritional management consensus of hepatic encephalopathy (ISHEN consensus), could decrease incidence of encephalopathy after TIPS treatment of the patient with cirrhosis and variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

* patients with decompensated liver cirrhosis regardless of the etiology
* acute variceal bleeding or with history of variceal bleeding evidenced by endoscopy
* an age between 18 and 75 years old

Exclusion Criteria:

* a total bilirubin level more than 3mg/dL (51.3mmol/L)
* a creatinine level greater than 3 mg/dL(265umol/L)
* severe dysfunction of heart and respiratory system
* pregnancy
* uncontrolled neoplasm
* active systemic infection
* history of any kind of encephalopathy, mental disease, alcohol dependence, or any other status that influence brain function
* diabetes or any other metabolic diseases
Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients

Patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate sodium prescriptions. The effects on blood pressure, interdialytic weight gain, thirst, and intradialytic symptoms will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* patients on 3 times weekly hemodialysis of at least 3 months
* elevated average ambulatory blood pressures
* current dialysate sodium prescription 140mEq/L
* average pre-dialysis serum sodium \<140mEq/L

Exclusion Criteria:

* frequent intradialytic hypotension
* estimated life expectancy \<1 year
* non-adherence to dialysis prescription
* pregnancy
* inability or unwillingness to complete study measures
Interacting Together Everyday: Recovery After Childhood Traumatic Brain Injury (TBI) "I-InTERACT

The purpose of this study is to test an on-line intervention for families of young children who have experienced moderate or severe traumatic brain injury (TBI). Previous interventions were not designed to address the needs of young children with TBI, and feedback revealed a desire for more examples and materials appropriate for families of younger children. This project builds upon the investigators previous research by modifying the online intervention content to address the needs of young children with TBI. The goal of this project is to develop an intervention that will encourage positive parenting behaviors, improve child behaviors, and reduce parent distress and burden following TBI. The investigators hypothesize that the intervention group will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the active comparison group.

Five million young children suffer from traumatic brain injury (TBI) each year resulting in new child behavior problems, parental distress, and family dysfunction. Recent studies provide evidence that online skill building interventions can reduce caregiver distress and improve child adjustment following TBI. The investigators hypothesize that the I-InTERACT group will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the IRC group. The investigators overarching goal is to reduce the risk of long-term behavioral problems and disability in young children following TBI by equipping parents with increased coping and parenting skills in a cost effective fashion. Findings will be disseminated via presentations and peer-reviewed publications, a website and newsletter, workshops with advocacy groups, and technical assistance to interested parties

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe TBI that occurred within the last 24 months
* Overnight hospital stay
* English-speaking
* Parent must be willing to provide informed consent

Exclusion Criteria:

* Child does not live with parents or guardian
* Child or parent has history of hospitalization for psychiatric problem
* Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability
A Comparator Study Evaluating Microbiological Resistance and Effects of Alternating Inhaled Antibiotic Therapies

This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing clinical and microbiological parameters.


Eligibility Criteria:
Inclusion Criteria:

* \> or = to 6 years of age
* Documentation of Cf diagnosis
* History of PA present in sputum, on a least one occasion, during the 12 months prior to Visit 1.
* Currently on inhaled antibiotic regiment
* Must be able to provide written informed consent or assent prior to any study related procedures
* Ability to expectorate sputum
* Ability ro perform reproducible pulmonary function test

Exclusion Criteria:

* Administration of any IV or oral antipseudomonal antibiotic within 28 days prior to Visit 1
* Any serious or active medical or psychiatric illness, which in the opinion of the investigator, woud interfere with participant treatment, assessment, or compliance with the protocol
* Current enrollment in an interventional clinical trial
Primary Surgical Prevention of Breast Cancer-related Lymphedema

Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.

Patients in the LYMPHA group undergo Axillary reverse mapping before the start of surgery, and after axillary lymph node resection, LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 19 years old
2. Patients who are expected to undergo surgery under the diagnosis of breast cancer, and are determined to undergo axillary lymph node dissection before surgery.

Exclusion Criteria:

1. Patients with vascular and lymph-related diseases
2. Patients with a history of surgical treatment or trauma to both arms and axillary
3. Patients with a history of receiving radiation treatment in both arms, chest, and axilla
4. Patients with confirmed systemic metastasis with stage 4 breast cancer
5. Pregnant and lactating patients
Enhancing Operability in a Hypobaric Hypoxic Environment With a Small Oxygen Storage System

This is a study to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxia.

The purpose of this study is to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxic events. To do so, the invesitgators propose the following aims:

1. Determine the ability of a portable oxygen storage device to reverse hypobaric hypoxemia in volunteers at altitude.
2. Determine the duration of time that a single portable oxygen container can maintain normoxia in normal volunteers at altitude.
3. Determine the optimum dose and timing of oxygen use to reverse hypobaric hypoxemia.

Eligibility Criteria:
Inclusion Criteria:

* Altitude chamber qualified
* Previous agreement to be approached regarding altitude chamber research

Exclusion Criteria:

-
Determination of the Optimal Volume of Liposomal Bupivacaine in Adductor Canal Block for Knee Joint Surgery

Building on Bayesian design methodologies from volume optimization studies of ropivacaine in shoulder surgery, this study pioneers the application of a seamless dose-finding strategy in knee ACB. Utilizing advanced statistical models (BOIN/BOP2 design), we aim to systematically evaluate the volume-effect relationship of liposomal bupivacaine, providing precise dosing recommendations to advance personalized and optimized analgesic protocols for knee surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective general anesthesia for unilateral knee joint surgery.
* Patients who provide informed consent.
* Aged between 18 and 65 years old, regardless of gender.
* American Society of Anesthesiologists (ASA) physical status classification of Ⅰ to Ⅲ
* Body mass index (BMI) ≤ 35 kg/m².

Exclusion Criteria:

* Femoral neuropathy.
* Coagulation dysfunction.
* Allergy to local anesthetics.
* Infection at the puncture site.
* History of chronic pain or opioid use.
* Pregnancy.
* Diabetes mellitus and peripheral neuropathy.