cyrilzakka/clinical-trials huggingface dataset:
Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia

The goal of this study is to find out if giving intravenous B-vitamins before general anesthesia with nitrous oxide prevents the increase in homocysteine, a metabolite that has been linked to cardiovascular complications.

Patients will be randomized into the following arms:

* Arm A: patients will receive N2O (60% N2O/40% O2) in an open-label fashion during surgery and vitamin supplementation (vitamin B12, 1 mg, and folate, 5 mg) before surgery.
* Arm B: patients will receive N2O 60% N2O/40% O2) in an open-label fashion during surgery and placebo before and after surgery.
* Arm C: patients will not receive N2O, vitamin supplementation, or placebo during/before surgery. Patients in this arm will not be randomized.

Patients will have blood drawn (total of 1-2 teaspoons over 3 days). We will take these samples before their surgery, when their surgery is completed, and in the morning of post-operative day 1. We will be checking their troponin I and troponin T, homocysteine, Vitamin B12, and folate levels. We will also perform a 12-lead EKG. Before and after surgery for patients in Arm A or B, will receive either vitamin B12 (1 mg) and folic acid (5 mg) (or placebo) added to their IV infusion. We also plan to use a non-invasive test known as a nerve conduction study to measure the function of their nerve system. Briefly, 2 small electrodes are attached to their skin over a nerve and, like an EKG, faint electrical pulses are generated and recorded. A typical nerve conduction measurement lasts about 10 minutes.

After the patients surgery we will do genetic testing of MTHFR genotype.

All study samples have been collected.

Of note: there were no secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective surgery with expected duration \> 2 hours
* Healthy patients undergoing moderate surgery where the use of N2O is unproblematic

Exclusion Criteria:

* Contraindication against N2O (pneumothorax, mechanical bowel obstruction, middle ear occlusion, laparoscopic surgery, raised intracranial pressure)
* Patients requiring supplemental oxygen
* Urgent or emergent surgery
* Patients with vitamin B12 or folate deficiency or megaloblastic anemia
* Patients with seizure disorder (epilepsy)
* Allergy or hypersensitivity against IV cobalamin or folate
* Patients with Leber's disease (hereditary optic nerve atrophy)
* Patients taking supplemental vitamin B12 or folate
Study Of Celecoxib In Healthy Subjects

A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers

Exclusion Criteria:

* Endoscopic evidence of ulceration, erosion or active bleeding etc. in the esophagus, stomach, pylorus and/or duodenum prior to treatment endoscopy
* A history of gastrointestinal ulcer
* Any use of celecoxib, nonsteroidal anti-inflammatory drugs (including aspirin), anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks prior to the first dose of study medication
Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths

Port wine stain are a congenital, progressive vascular malformation of human skin. The pulsed dye laser is approved by the Food and Drug Administration for the treatment of choice. However, the degree of port wine stain blanching seen following pulsed dye laser treatment remains variable and unpredictable. If the ultimate standard required is complete lesion blanching, the average success rate is below 10%, even after undergoing numerous pulsed dye laser treatments. Moreover, less than 50% of patients achieve 50% fading of their Port wine stain in response to pulsed dye laser therapy.

The researchers' specific aim is to determine whether the use of the pulsed dye laser operating at a wavelength of 577 nm will improve therapeutic outcome as compared to a pulsed dye laser operating at 595 nm.

The researcher can treat port wine stain treated using a pulsed dye laser operating at a wavelength of 577 nm and the other half at a wavelength of 595 nm. The researcher can determine that the 577 nm pulsed dye laser improved port wine stain blanching responses more than the areas treated with 595 nm.

The degree of port wine stain blanching which will determine by visible reflectance spectroscopy skin imaging device measurements. Post-treatment blanching responses can compare with pre-treatment measurements of port wine stain fractional blood volume.

Eligibility Criteria:
Inclusion Criteria:

* Port Wine Stain suitable for comparison testing
* Age \> 6 months of age; minor will be accompanied in the room by parents or guardians during laser treatment
* Apparent good health as documented by medical history
* Ability to understand and carry out subject instructions

Exclusion Criteria:

* History of photodermatoses or skin cancer
* Any therapy within the previous two months to the proposed Port Wine Stain treatment sites
* Inability to understand and carry out instructions
Calcinosis Reduction by Pyrophosphate in SSC

Calcinosis, i.e. crystal-like nodules are troublesome complication of systemic sclerosis, an autoimmune disease. Pyrophosphate inhibits its formation is laborytory. We would like to test if orally administered pyrophosphate prevents calcinosis formation.

Calcinosis, the formation of hydroxyapatite subcutaneous nodules, often complicates systemic sclerosis. There is no standard treatment for it. Based upon our preclinical experienc, we would like to test it orally administered pyrophosphate inhibits calciosis.

Eligibility Criteria:
Inclusion Criteria:

* to meet ACR/ EULAR classification criteria

Exclusion Criteria:

* severe upper minfestation of SSC
* hypo- or hyperthyreoidism
* QT prolongation on ECG
Effect of G-CSF on MDSC and Cancer Stem-cells Interactions in Non-small Cell Lung Cancers (CIRCUIT)

Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to immunologic (myeloid immunosuppressive cells) and non-immunologic (cancer stem- cells (CSC)) mechanisms. CSC are able to circulate within blood, protected from destruction by immunosuppressive cells such as MDSC. Some factors such as G-CSF, administered to lower febrile neutropenia, should modulate properties of MDSC and CSC, but data are contradictory, and literature remain poor regarding its effects on the interactions between MDSC and CSC in blood clusters. Indeed, this project aims at better characterizing the effect of G-CSF on these interactions and on their functions in NSCLC patients receiving G-CSF.

MDSC, CSC and the clusters in blood from NSCLC patients will be assessed to evaluate the impact of G-CSF on their phenotype and functions. Samples from 2 groups of NSCLC patients receiving chemotherapy and immunotherapy will be used: 15 receiving concomitant G-CSF, and 15 not receiving concomitant G-CSF

Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female) aged ≥ 18 years
* Histological or cytological proven lung adenocarcinoma, metastatic or locally advanced not accessible to local therapy
* Receiving chemotherapy and immunotherapy as first-line treatment
* Signed written informed consent (no later than the day of inclusion, and before the blood sample collection)
* Patient affiliated or beneficiary to a health security system;

Exclusion Criteria:

* Patient with a small cell lung carcinoma
* Non-metastatic disease
* Actionable mutation or genomic alteration in EGFR, ALK or ROS1
* Corticosteroids \> 10 mg/j
* Autoimmune disease
* Active and uncontrolled HIV infection
* Concomitant cancer
* Pregnancy or lactating women
* Psychiatric or medical conditions that prohibit the understanding and rendering of informed consent
* Patient under a legal protection measure
* Patient with a deprived liberty condition
* Patient incapable of giving signed informed consent
* Patient within the exclusion period for another clinical trial, or participating to another interventional trial within 30 days before the beginning of this project
Cognitive Health Awareness Program in Surgical Patients

Addressing brain health and cognitive impairment (CI) in the aging population is important, especially in those undergoing surgery. While certain adverse outcomes are beyond control due to various factors, some may be preventable, such as delirium. It is crucial for patients and their families to be fully aware of the heightened risks associated with CI. By discussing the implications for individuals and their families, patients can make informed decisions about their health. Additionally, patients can be better prepared for their post-operative care and informed about post-operative complications. Education is a practical and viable solution to promote awareness and empower individuals to manage their cognitive health, especially in the context of surgery. Also, it can act as an early intervention. Thus, there is a need to proactively educate older adults about brain health.

The objective of the Web-Based Brain Health Education Study is to determine the impact of preoperative education on the knowledge of cognitive health of older surgical patients. Specifically, our study will examine the changes in knowledge scores after patients participate in a web-based education program on promoting brain health during their surgical journey. We hypothesize that a web-based education program will increase patient knowledge and empower them proactively about their brain health during the surgical journey.

The primary objective of this study is to determine the impact of a web-based educational program in promoting brain health in older surgical patients by changes in their knowledge score after education. For the secondary objectives, we aim to 1) determine participant satisfaction with the educational program, and 2) gain insights regarding perceived benefits and drawbacks of the brain health program.

This multicenter study will target older patients from pre-admission clinics at Toronto Western (TWH) and Mount Sinai Hospitals (MSH). Written informed consent to participate in the study will be obtained from all patients in person during the visit.

In a pre-operative assessment 1-30 days prior to their scheduled surgery, patients will be asked to participate in our web-based educational program. The program will be delivered on a research laptop/iPad at the clinic. The entire program, including pre- and post-education questionnaires and satisfaction survey should take about 20 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

* patients ≥60 years old
* undergoing elective non-cardiac surgery
* competent to provide informed consent in English and
* possess some computer skills

Exclusion Criteria:

* previous major neurocognitive disorder
* uncontrolled psychiatric disorders
* hearing and/or vision impairment
Prescribing Appropriateness of Thrombo-prophylaxis in Intensive Care Unit of Tertiary Hospital

Hospitalized patients are at high risk of venous thromboembolism (VTE), and the appropriate use of thromboprophylaxis can significantly reduce the incidence of VTE in high-risk patients. We investigated the pattern of VTE prophylaxis administration among elderly medical patients and assessed its appropriateness based on the American College of Chest Physicians (ACCP) recommendations. Methods A cross-sectional single-center study will be conducted between July 2024 and December 2024, including hospitalized (\> 48 h), (≥ 60 years), medical and surgical patients, and excluding patients receiving anticoagulant for other reason, having contraindication to thromboprophylaxis, or had VTE diagnosed within 48 h. The Padua and caprine prediction scores will be used to determine the patients' risk for VTE, and thromboprophylaxis use will be assessed against the ACCP recommendations.


Eligibility Criteria:
Inclusion Criteria:

Patient records

* admitted to the ICU with
* medical or surgical causes
* recieved anticoagulants for DVT prophylaxis

Exclusion Criteria:

* Patients already on anticoagulant therapy,
* had history of previous DVT,
* had End-stage liver disease,
* admitted with hemorrhage/bleeding
* not prescribed DVT prophylaxis
Polymeric Microspheres vs Sculptra® in the Treatment of Moderate to Severe Nasolabial Folds

This is a single-dose, randomized, double-blind, active-controlled, split-face, multiple centers, non-inferiority study. Approximately 50 nasolabial fold subjects will be enrolled. Each enrolled subject will be randomized equally into one of the following groups:

1. Group 1: right face will be injected with PBF PLLA microsphere, and left face with Sculptra®
2. Group 2: right face will be injected with Sculptra® and left face with PBF PLLA microsphere Subjects will be administrated on Visit 1 by applying PBF PLLA microsphere on one side of face and Sculptra® on the other.


Eligibility Criteria:
Inclusion Criteria:

1. Participant whose age is ≥ 18 and ≤ 65 years old.
2. Participant who is able to read, understand, sign, and date a written informed consent form (ICF) before study participation at screening.
3. Participant is able to understand and comply with protocol requirements and instructions and likely to complete the study as planned.
4. Participant who has moderate to severe nasolabial folds on two sides of face, WAS Score ≥ 3. WAS Score is determined by investigator.
5. Participant whose difference in WAS score of nasolabial folds on two sides of face ≤ 1. WAS Score is determined by investigator.
6. Participant's skin condition is considered by Investigator suitable for the treatment of Poly-L-lactic Acid (PLLA).

Exclusion Criteria:

-

1. Participant who has previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area prior to the Baseline visit.

1. Treatment with collagen or hyaluronic acid (HA) in the last 12 months.
2. Had facelift treatment (high intensity focused ultrasound, radio frequency, or thread) within 12 months.
3. Had face laser treatment within 6 months.
4. Had been treated with Calcium Hydroxyapatite (CaHA), PLLA or permanent (non-biodegradable).

2. Participant who has severe allergies with a history of severe reactions (anaphylaxis) or multiple severe allergies or has known/previous allergy or hypersensitivity to any of the PLLA, other constituents of PBF PLLA microsphere or Sculptra®, or drugs containing lidocaine such as Lidiprine Cream and its constituents. 3. Participant who has obvious defects, trauma, or scars near the treatment area.

4. Participant who has been diagnosed head cancer in the last 3 years. 5. Participant who has trauma, open wound, active skin disease or inflammation at the injection site.

6. Participant who has serious systematic disease that judged by Investigator which is not suitable for the treatment.

7. Participant who has connective tissue disease, bleeding disorders, active hepatitis, immune deficiency disease, disease such as cancer, stroke and/or myocardial infarction and on any immunosuppressive therapy.

8. Participant who previously had or have risks factors for hypertrophic scarring or keloid formation near the treatment area.

9. Participant who has used immune system suppression drugs, steroids, anti-inflammatory drugs, anticoagulant drugs, or aspirin within 7 days before treatment.

10. Female participant who is pregnant or lactating.
Glutamine Supplementation in Cystic Fibrosis

Patients with cystic fibrosis develop frequent and potentially life-threatening lung infections. Recent studies suggest that the nutrient "glutamine" may help the body fight off infection. Glutamine is an amino acid; a type of nutrient the body requires to build muscle. It is one of the building blocks of protein. During an illness, blood levels of glutamine tend to be lower than normal. Also, many patients with cystic fibrosis have difficulty getting normal levels of nutrients from food. The aim of this study is to see if patients with cystic fibrosis have low levels of glutamine when they experience an infection, and whether a dietary glutamine supplement taken daily for three months can raise these levels. We also want to see if this supplement can improve other blood markers of immunity (the body's ability to defend itself from infection). We hope to enroll 40 people with cystic fibrosis who experience a lung infection, over a one year period, into this study.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years of age) with cystic fibrosis who give informed consent
* Patients must have a clinically diagnosed pulmonary exacerbation at time of enrollment, characterized by clinical requirement for oral or intravenous antibiotics associated with pulmonary symptoms such as increased cough or decreased forced expiratory volumes (FEV1)
* Participants must agree to provide phlebotomy samples and complete all study protocol at presentation and at return visits

Exclusion Criteria:

* Any patients taking specific glutamine supplements within 30 days of enrollment
* Pregnant or lactating women
* Patients involved in any other research protocol involving intake of a study drug, in the last 60 days.
* Patients who are chronically immunosuppressed due to drugs or immunosuppressive illness other than CF (e.g. HIV/AIDS, chronic autoimmune disease)
* Patients receiving hemodialysis or with creatinine \>2.5mg/dL
* Patients with liver failure from any cause
* Patients with a history of cancer within the past 12 months or currently receiving anti-neoplastic therapy.
* Patients with a history of seizures
Exercise in Hypoxia and Nitrate Supplementation in Athletes: is the Whole Greater Than the Sum of Its Parts?

Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions.

Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions. It is hypothesized that the combined effect of these interventions will promote an additional performance and health improvement in this population at sea-level and altitude conditions, compared with the single effect.

Eligibility Criteria:
Inclusion Criteria:

* trained male subjects, regularly involved in competitive running, cycling and/ or triathlon events (4-5 times per week) in the past five years

Exclusion Criteria:

* smoking or other chronic issues
* using medication or dietary supplements in the last 3 months, or during the duration of the study
* being exposed to altitude (≥2000 m) in the last 3 months
Effects of Improved Calf Muscle Function on Gait, Balance and Joint Loading in Older Adults

This study investigates the role of calf muscle function in gait performance, balance and knee joint loading.

Previous studies have linked age-related loss of calf muscle function with impairments in gait performance and balance, and increased loading of the areas of the knee joint that are susceptible to the development of osteoarthritis. In this study, an exercise intervention targeting structural and neural aspects of impaired calf muscle function with ageing is utilized. The intervention lasts 8 weeks and includes either biofeedback training using electromyography to alter muscle activation patterns or a combination of biofeedback training and strength training for the calf muscle to modify calf function during walking. The study will test whether the intervention improves walking speed, reduces the metabolic cost of walking, improves standing balance and reduces knee joint loading.


Eligibility Criteria:
Inclusion Criteria:

* age between 65 and 75

Exclusion Criteria:

* dependent living status
* not able to walk without an assistive device or for 30 min without stopping
* diagnosed neurological disease or joint disorder and pain during walking
* surgery on lower extremities
* current musculoskeletal injury
* previous cardiovascular event or symptoms during exercise (acute ECG change, coronary disease, symptomatic arrhythmia, symptomatic coronary stenosis, heart failure, myocarditis, pericarditis, pulmonary embolism, pulmonary infarct, artery bulge or rupture risk)
* body mass index \<18 or \>35 kg/m2
* contraindications for magnetic resonance imaging
* Mini Mental State Examination score of 23 points and lower
A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers

This study aims to investigate the effect of IN-A001 50mg on the pharmacokinetics of Tacrolimus 5mg in healthy volunteers

This is a open-label, 1-sequence, 2-period, multiple oral dose, phase 1 study. Healthy subjects will be assigned to a group and sequentially administerd Tacrolimus and IN-A001.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index(BMI) ≥ 19.0 and ≤ 28.0 kg/m\^2 at the time of screening.
2. Those who agreed to use combination of effective or medically approved contraceptive method from the date of first administration of investigational product(IP) to the end of the clinical trial (when testing for final safety evaluation).
3. In the case of female participant, who has negative result at the hCG urine pregnancy test and is not pregnant or currently breastfeeding.

Exclusion Criteria:

1. Has clinically significant infections
2. Has a history of malignancy
3. Has a history of gastrointestinal disease that may affect the absorption of investigational product.
4. Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder etc.
5. History of hypersensitivity and severe allergic reaction to any of the components of IP.
6. Has participated in any other clinical study, etc. and received IPs within 180 days prior to the screening visit.
7. Excessive smoking (\> 10 cigarettes/day) within 14 days prior to the screening visit.
8. Excessive drinking ((\> 21 units/week) within 14 days prior to the screening visit.
9. Has shown the following results from the laboratory test during the screening period.

   * AST, ALT level \> 1.5 × ULN at screening;
   * eGFR(estimated glomerular filtration rate) estimated on the basis of CKD-EPI is less than 60 mL/min/1.73 m2;
10. Has shown the following results during the 12-lead electrocardiogram during the screening period.

    * QTc \> 450 ms
    * Clinically significant abnormal rhythm and findings when the investigator medically determines
11. Determined ineligible for study participation by the investigator for other reasons.