cyrilzakka/clinical-trials huggingface dataset:
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_FRA)

To determine the safety and feasibility of investigational product to reduce aortic dissection false lumen perfusion.


Eligibility Criteria:
Inclusion Criteria:

≥18 years of age. A candidate for false lumen (FL) embolization with a type B dissection, and no prior primary entry tear/TL treatment, OR A candidate for FL embolization with a type B or type A dissection, in whom the primary entry tear/TL was treated in a previous procedure, and is now presenting with a FL requiring treatment.

Exclusion Criteria:

An inability to provide informed consent. Enrolled in another clinical study other than a registry. Hyperacute or acute aortic dissection (\<15 days from symptom onset). Untreated or uncovered primary entry/reentry tear proximal to left subclavian artery (before FL treatment with the investigational product).

Vascular disease, aortic rupture, and/or anatomy and/or dissection membrane condition that precludes the safe access and positioning of an introducer sheath and delivery (and expansion) of the investigational product into the FL.

Prior treatment of the FL. Planned use of investigational devices to treat the primary entry tear and/or TL.

Absence of/inability to create a reentry tear/fenestration adequately positioned and large enough to allow introducer sheath access into the FL.

Planned use of FL embolic devices other than the investigational product. Prior abdominal aortic aneurysm (AAA) treatment. Planned concomitant major surgery (e.g., gastrointestinal surgery). Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos syndrome). Coagulopathy or uncontrolled bleeding disorder. Serum creatinine level \>2.5 mg/dL (within 90 days prior to the procedure). Cerebrovascular accident within 90 days prior to the procedure. Myocardial infarction and/or major heart surgery within 90 days prior to the procedure.

Atrial fibrillation that is not well rate controlled. Unable or unwilling to comply with study follow-up requirements. Life expectancy of \<2 years postprocedure. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.

A condition that inhibits radiographic visualization during the study procedure and planned follow-up imaging.

History of allergy to contrast medium that cannot be managed medically. Uncontrolled comorbid medical condition, including mental health issues, that, in the opinion of the investigator, would adversely affect participation in the study.

Participant is planning to become pregnant or is currently pregnant or lactating. For participants of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study.
Diffusion of Local Anesthetic After Median Nerve Block

Median nerve block is widely practised, avoiding general anaesthesia in a number of cases and producing excellent post-operative analgesia in orthopedic surgery. Even realised by experienced anaesthetists,a failure rate of 5-15% is noticed. The principal aim of the study is to observe the local anesthetic solution diffusion after a conventional median nerve block technique using neurostimulation. The secondary objective is to compare diffusion and of block efficacy..


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective hand surgery requiring a median block nerve.

Exclusion Criteria:

* age lower than 18 years
* pregnancy
* contraindication to nerve block
* inability to read, write or speak French
* mental illness.
Concentrations of Maraviroc in the Semen of HIV-Infected Men

The objective of this study is to determine if concentrations of maraviroc in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.

The secondary objective is to determine the extent of maraviroc penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of maraviroc in semen, and to determine the variability in the penetration of maraviroc into the seminal compartment over the maraviroc dosing period.

The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months. Patients will be enrolled from one clinic in downtown Toronto and a hospital affiliated HIV specialty clinic in Ottawa, Ontario. Eligible patients will have evidence of full virologic suppression (HIV viral load \< 50 copies/mL) at least one month prior to enrollment in the study. No changes will be made to the patients antiretroviral therapy during the course of the study.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected male
* 18 years old or older
* on maraviroc twice daily as part of their antiretroviral regimen for at least 3 months prior to screening
* viral load \< 50 copies/mL at least one month prior to enrolling
* able to read, understand and sign a written informed consent prior to initiation of the study
* medically stable at the time of the study, with no evidence of acute illness

Exclusion Criteria:

* having difficulty adhering to current antiretroviral therapy
* patient is expected to have difficulties adhering with study protocol
* patients with malignancy, or acute renal or liver disease
* patient with active AIDS-defining illness
* patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent
* patient with any of the following abnormalities at the time of screening:
* hemoglobin \< 85 g/L
* absolute neutrophil count \< 1000 cells/uL
* platelet count \< 50,000 cells/uL
* AST, ALT or total bilirubin \> 3 times the upper limit of normal
* serum creatinine \> 1.5 times upper limit of normal
* patient receiving concomitant therapy with rifampin or St. John's wort
Clinical Study to Assess Safety, PK and PD Parameters of CDR132L

This is a Phase I, randomized, double-blind, placebo-controlled study to assess safety, pharmacokinetics and pharmacodynamic parameters of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).

Objectives:

Primary

• To assess the safety of one single and one repeated dose of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).

Secondary • To characterize the pharmacokinetic (PK) profile of CDR132L in patients with stable heart failure of ischemic origin.

Exploratory

• To determine the effect of CDR132L on pharmacodynamic (PD) parameters.

Eligibility Criteria:
Inclusion Criteria:

* Stable heart failure of ischemic origin

Exclusion Criteria:

* Heart failure of non-ischemic origin (hypertensive heart disease, myocarditis, alcoholic cardiomyopathy and cardiac dysfunction due to rapid atrial fibrillation),
The Use of Exhaled Nitric Oxide in Conjunction With the Asthma Control Test to Determine Asthma Control in Pediatric Patients

The purpose of this study is to determine if exhaled nitric oxide (eNO) levels will be increased in pediatric patients with uncontrolled asthma as determined by the Asthma Control Test (ACT). During the study the investigators will also examine if the combination of eNO and ACT will better predict asthma control that either tool alone when compared to a medical provider's assessment of the patient's asthma control.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of asthma by pediatric pulmonologist
* Age 6-18 years

Exclusion Criteria:

* Age \<6 years or \>18 years
* history of bronchopulmonary dysplasia
* history of cystic fibrosis
* history of primary ciliary dyskinesia
* current acute asthma exacerbation
* current acute viral upper respiratory infection
* recent ingestion of nitrate-rich foods
Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation

Stroke survivors struggle to meet clinical recommendations for physical exercise duration and intensity. During the past two decades, music interventions have increasingly shown effectiveness in several motor tasks in stroke rehabilitation. Additionally, music has been found effective in increasing exercise performance in athletes and other clinical populations. Based on a meta-theoretical review paper by Clark, Baker \& Taylor (2016), it was hypothesized that the therapeutic effects of music in physical exercise is modulated by the preference and task-specificity of the music. We will test this hypothesis using a three-armed randomized cross-over design comprised of the following auditory conditions: 1) a group-tailored playlist 2) radio as active control and 3) a non-music control condition during cycle ergometry cardiorespiratory exercise sessions. Participants are inpatient stroke survivors undergoing rehabilitation between 2-12 weeks post infarct.


Eligibility Criteria:
Inclusion Criteria:

* between 2-12 weeks post ischemic or hemorrhagic stroke
* assessed eligible to participate in cardiorespiratory exercise by the patient's primary physiotherapist and interdisciplinary team -≥18 years old

Exclusion Criteria:

* uncontrolled medical contraindications for physical activity
* severe hearing deficit or cochlear implants
* severe deficit of both auditory and visual communication not allowing for guiding the patient in the exercise task
Translation of an Intervention for Violence Among Adolescents in Emergency Departments

The translation study aims to refine and package intervention and training materials essential to translating an efficacious Emergency Department (ED) based Brief Intervention (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist remotely. The study will take place in two phases. During the Effectiveness phase, we will determine the effectiveness of the interventions \[on-site therapist delivered BI + text messages (n=133); remote therapy delivered BI + text messages (n=133)\], as compared to a usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored text messages will be delivered daily for the first month post-discharge, and three times per week in the second month post-discharge to the BI groups. During the Implementation phase, components of the RE-AIM model will be assessed over a 4-month period.

Participants who screen positive for the study during the effectiveness phase, will be randomized to either the therapy or control at a rate of 2:1. Whether the participant receives the on-site therapist or the remote therapist will depend on day of week or shift. Over the course of the study, the proportion of shifts covered by on-site verses remote therapists will be balanced for seasonality and time of day (evening vs. day time).

Eligibility Criteria:
Inclusion Criteria:

* youth (ages 14-18) presenting to the Hurley Medical Center (HMC) ED who are medically stable. Patients classified by medical staff as having unstable vital signs or "Level 1" trauma (e.g., unconscious, in need of immediate lifesaving procedures such as surgery), will be approached during their inpatient stay after stabilization (4% based on prior work);
* access to a parent or guardian for consent among adolescents ages 14-17 (over 90% based on our prior work).
* Positive past 3 month violence screen criteria: Youth will be eligible for the study if they endorse on self-report computer survey past three month violence perpetration

Exclusion Criteria:

* youth who do not understand English
* youth deemed unable to provide informed assent/consent by ED or research staff
* prisoners at time of ED presentation.
* youth who present to the ED as victims of sexual abuse or child abuse
Clinical and Functional Outcomes of Tourniquet Use in Primary Total Knee Arthroplasty

Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery

randomized controlled trials , comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: post-operative pain measure with analogue visual scale function with Oxford Score , Lysholm score and International Knee Documentation Committee Score intraoperative blood loss measurement of quadriceps tonus in pre- and post-operative according to the international rating measurement of quadriceps area circumference duration of surgery, and length of hospital stay

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis Kellgren and Lawrence score III or IV
* Written consent
* Total knee arthroplasty

Exclusion Criteria:

* Neurological dysfunction
* Coagulation disorder
* Glucocorticoids, aspirin, heparin, coumadine, warfarin
* History of pulmonary embolism
Clinical and Medico-economic Evaluation of the Cohort "People at Risk of Falling"

The goal of this study is to evaluate the effectiveness of the IsereADOM service package compared to conventional follow-up on the risk of recurrence of falls at 6 months in frail elderly subjects.

There is a medico-economic goal too, is to conduct a cost-utility analysis of the IsereADOM service bundle compared to conventional 6-month follow-up from the community perspective in the cheat population at risk of re-offending.


Eligibility Criteria:
Inclusion Criteria :

* Patient falling at least 2 times in the year preceding the inclusion, one of them has been reported or consulted by a health care service ;
* Patient fragile and loss of autonomy: level of dependence with GIR 3, 4 and 5 ;
* Patient domiciled in the department of Isère ;
* Patient who can be followed regularly for 6 months ;
* Patient benefiting from an assistance plan : APA, PAP, CARSAT ;
* Patient affiliated with social security or beneficiary of such a scheme ;
* Patient able to read, write and understand French ;
* Patient having signed informed consent to participate.

Exclusion Criteria :

* Patient without professional or family carer of proximity ;
* Patient with moderate to severe cognitive impairment defined by MMS \<23 ;
* Patient residing in a nursing home or institution for dependent person ;
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all persons protected: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject of a legal protection measure).
Clinical Presentations, Microbiology, Antibiotic Resistance Patterns and Management Outcomes of Culture-proven Infection Among Adolescent and Adult in A Tertiary Hospital in Saudi Arabia

The characteristics of patients as well as microbiologic profile of culture-proven infection will be studies in conjunction with clinical outcome within 28-days


Eligibility Criteria:
Inclusion Criteria:

* Any individual aged ≥13 year old requested for him/her bacterial/fungal culture.
* Able to provide a written informed consent.

Exclusion Criteria:

* Age \<13 years old.
* Unable/unwilling to provide a written informed consent.
Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy

To investigate the effect of pelvic floor muscle training taught in a general exercise class during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.

Pregnancy and childbirth are known risk factors for development of female urinary incontinence (UI). Studies have found that Pelvic Floor Mucle Trainig (PFMT) is effective in preventing and reducing UI during pregnancy and after childbirth. However, in a recent study, no effect was found when PFMT were taught in a general fitness class without former palpation of the pelvic floor muscles (Bo y Haakstad, 2011).

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous with singleton baby
* Not suffering from urinary incontinence
* Giving birth at Hospital Universitario de Fuenlabrada
* Able to comunicate in Spanish
* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines

Exclusion Criteria:

* Multiparity
* At risk of Premature birth
* Following another exercise program
Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers

Emerging adulthood is a period of heightened vulnerability for problematic alcohol use. Considerable research has been devoted to reducing alcohol risks in college student populations, though far less effort has focused on their noncollege-attending peers. Research targeting nonstudent emerging adults is critical as this group is at risk for experiencing alcohol-related harms. Consequently, the main objective of the present study was to examine the preliminary efficacy of a brief personalized feedback intervention (PFI) tailored for nonstudent at-risk drinkers.


Eligibility Criteria:
Inclusion Criteria:

* Study eligibility included being 18 to 25 years old, having no prior or current college attendance (e.g., technical/vocational programs, associate's degree programs, or four year college programs), and not being currently enrolled in high school. High school completion was not a required eligibility criteria. They also had to report engaging in a minimum of two heavy drinking episodes (i.e., 4/5+ standard drinks for women/men on one occasion) in the past month

Exclusion Criteria:

* Exclusion criteria included consumption above 40 drinks weekly and/or a history of substance use treatment
Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

This study is for people with advanced cancer of the digestive tract and cancer that cannot be completely removed by surgery. Radiation therapy is commonly used in the treatment of these types of cancer in combination with a chemotherapy drug, called 5-fluorouracil (5-FU). In this study, doctors will administer the standard dose of radiation therapy in combination with an investigational chemotherapy drug, called irinotecan. Irinotecan can decrease the size of tumors and also appears to increase the effectiveness of radiation. The purpose of this study is to determine the highest dose of irinotecan that can be given safely in combination with radiation therapy, and to determine the side effects when these two treatments are given together. Irinotecan is approved by the Food and Drug Administration (FDA) for the treatment of colon cancer, but is not approved for cancers of the digestive tract. However, the FDA is allowing its use in this research study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed neoplasm of the upper gastrointestinal tract (pancreas, stomach, duodenum, common bile duct, ampulla of Vater) or metastatic tumor to the upper abdomen.
* Eligible patients include patients with locally advanced unresectable tumors, positive surgical margins, local recurrence and resected stage II-III pancreatic, gastric, duodenum, bile duct or ampulla of Vater carcinoma.
* Performance status SWOG 0-2
* Fully recovered from prior surgery or chemotherapy (greater than or equal to 4 weeks). Patients previously treated with 5-FU or gemcitabine may start therapy 2 weeks after the last dose of 5-FU or gemcitabine.
* Absolute granulocyte count (AGC) \> 1500; platelets \> 100,000; serum creatinine \< 2.0 mg/dl; total bilirubin \< 2.0 mg/dl; AST or ALT and alkaline phosphatase \< 3 times the upper limit of normal.
* Prior chemotherapy is allowed.

Exclusion Criteria:

* Prior radiation therapy to the upper abdomen
* Tumors of the gastroesophageal junction.
* Other medical, psychological or social circumstances that, in the opinion of the investigator, would prevent participation in the clinical trial
* Pregnancy.
Ethanol Consumption in the Heat

Climate change has significantly increased the earth's average surface temperature and heat waves have been predicted to increase in frequency, intensity and duration. Extreme heat events have increased the susceptibility to heat-related illnesses, such as heat exhaustion, heat stroke or death. Heat health action plans have been designed to advertise cooling behaviours to mitigate physiological strain. Heat health action plans suggest avoiding alcohol consumption during extreme heat as it may increase dehydration and impair behavioural or physiological temperature regulation and thermal perception. Regardless of these messages, alcohol sales continue to remain high during the summer months year after year, and 1/5 of adults identify alcohol as a hydration strategy during extreme heat events. A recent scoping review investigating the effects of alcohol and heat has demonstrated that acute alcohol consumption does not negatively influence thermoregulation, hydration, or hormone markers of fluid balance in the heat compared to a control fluid (https://doi.org/10.1186/s12940-024-01113-y). Further, alcohol consumption may elicit sex- and age-specific alterations in physiological and perceptual responses, neither of which have been explored.

Therefore, this study aims to comprehensively evaluate how alcohol consumption systematically alters physiological responses and perceptions during conditions similar to those experienced indoors during extreme heat events in younger and older adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female above the age of 19
* Able to provide informed consent

Exclusion Criteria:

* History of cardiovascular disease, cancer, type 1 or 2 diabetes, chronic obstructive pulmonary disorder, cystic fibrosis, or alcohol addiction or dependence
* Been hospitalized due to COVID-19
* Pregnant/Breastfeeding
* Scoring an eight or above on the Alcohol Use Disorders Identification Test (AUDIT)