cyrilzakka/clinical-trials huggingface dataset:
Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients

The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.

The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.

This is a prospective cohort study where all research persons have SLN biopsy using both SPIO and the dual technique. Then the investigators will compare SLN detection rates between Magtrace 0.1 ml and the dual routine technique with radioactive tracer (Technetium99m, Tc99) +/- blue dye.

Eligibility Criteria:
Inclusion Criteria:

* Planned for sentinel lymph node biopsy at (or after) breast surgery
* Signed and dated written informed consent before the start of specific protocol procedures

Exclusion Criteria:

* Pregnant or breast-feeding
* Iron overload disease
* Known hypersensitivity to iron, dextran compounds or blue dye.
* Inability to understand given information and give informed consent or undergo study procedures
Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores

The goal of this study is to evaluate the efficacy of a hypercaloric, hyperproteic enteral formula enriched with immunonutrients in preventing and treating pressure injuries in hospitalized malnourished patients.

Participants will take enteral formula (a complete hyperproteic and hypercaloric oral nutritional supplement with a fibre mixture enriched in omega 3, L-arginine and nucleotides, providing vitamin C and Zinc) or a hyperproteic and hypercaloric oral nutritional supplement with fibre mixture every day for 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized chronic patients with complex needs in the Internal Medicine Department of a regional hospital.
* Malnourished or at risk of malnutrition.
* Moderate-high risk of developing pressure-related injuries or the presence of pressure-related injuries.

Exclusion Criteria:

* Limitations in oral intake (due to pathologies, state of health, among others).
* Contraindications for using the oral route and digestive intolerance or allergy to any of the components of the products.
Psychedelics and Wellness Study (PAWS)

The Psychedelics and Wellness Study (PAWS), is an anonymous online survey investigating the interrelationship between psychedelics and wellness. The study population is adults ages 18 and older that have taken a psychedelic at least once. The maximum sample size is 5,000 survey respondents. It is expected that this anonymous online survey will support the hypothesis that there is a robust interrelationship between past psychedelic use and its impact on wellness.

Following a four-decade moratorium, the therapeutic use of psychedelics has once more captured the collective attention of the medical community and the public at large. Now, at the forefront of a renaissance in psychedelic research, this study is investigating the interrelationship of psychedelics and mental wellness - a state of well-being in which the individual realizes his or her own abilities, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to his or her community. This work will be unique in that it will collect both objective and subjective data to assess the interrelationship between psychedelic and wellness. It will lend support to the growing body of research in the use of psychedelics for both mental health conditions and the pursuit of overall mental wellness.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18 and older that have taken a psychedelic at least once.

Exclusion Criteria:

* Individuals less than 18 years old and have previously never taken a psychedelic substance.
An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform

The study intends to audit the impact of optimal insulin injection technique on clinical parameters and self-care behaviour of insulin treated diabetes patients in a prospective manner with a follow-up of 6 months. The optimal injection technique is delivered through education via a multimodal tailored approach augmented with a digital 'tailorable' patient learning platform .

The study is conducted in multiple sites across Belgium. Diabetes patients with or without lipohypertrophy will be entered into the audit. The end points will include the impact on use of insulin, long term blood glucose control (HbA1c), hypoglycaemia, glucose variability, needle reuse, patient injection habits and clinician education, training and information inputs.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus, or Type 2 Diabetes Mellitus
* Injecting insulin for at least 1 year
* Self-managing injection therapy, including daily glucose monitoring
* Access to a device with internet
* Confident in navigating the internet

Exclusion Criteria:

* Pregnant or likely to become pregnant during study period
* Impaired cognitive ability which would prevent informed consent
* Syringe only user
* Insulin pump user
* Glucagon-Like Peptide (GLP)-1 receptor agonists therapy only
Antiseptic-coated Intermittent Urinary Catheter

Study design is a prospective, randomised, double-blind, and interventional. Primary aim of the study is to investigate efficacy of antiseptic-coated intermittent hydrophilic urinary catheters in prevention and reduction of catheter-associated urinary tract infections in children with neurogenic bladder. Secondary aim is to assess feasibility of antiseptic-coated intermittent hydrophilic urinary catheters in neurogenic bladder management. Octenidine chloride will be used as antiseptic.


Eligibility Criteria:
Inclusion Criteria:

* neurogenic bladder
* use of intermittent catheterisation for neurogenic bladder management
* informed oral and written consent from the child and both parents/legal guardian

Exclusion Criteria:

* Congenital anomalies of urinary tract or genitals
* Immunodeficiency
* Urinary tract fistula
Randomized Trial of ARCON in Larynx Cancer

TITLE:

A multicentre, randomised, phase III clinical trial comparing accelerated radiotherapy with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in clinical stage T2-4 laryngeal carcinoma.

PRIMARY OBJECTIVE:

Does the addition of carbogen and nicotinamide to a schedule of accelerated radiotherapy in patients with clinical stage T2-4 laryngeal carcinoma improve local primary tumour control? Definitive analysis will be performed on local control rates at two years after completion of radiotherapy.

SECONDARY OBJECTIVES:

Does the addition of carbogen and nicotinamide

* increase the larynx preservation rate?
* increase the regional control rate?
* increase the toxicity of accelerated radiotherapy?
* improve the overall quality of life?
* improve the disease-free survival?
* improve the overall survival?

STUDY DESIGN:

An open-label, randomised clinical trial assigning patients in a 1:1 ratio to one of the following treatment arms:

* accelerated radiotherapy
* accelerated radiotherapy plus carbogen and nicotinamide

PATIENT CHARACTERISTICS AND NUMBER:

344 patients with clinical T2-4 laryngeal carcinoma

MEASUREMENTS:

* time to local failure
* time to regional failure
* survival with functional larynx
* overall and disease-free survival
* frequency and severity of complications related to radiotherapy and carbogen and nicotinamide
* quality of life assessment


Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmed squamous cell carcinoma of the larynx.
* TNM-classification (UICC 1997, appendix I):
* T3-4 glottic or supraglottic carcinoma
* T2 glottic carcinoma with impaired cord mobility or subglottic extension
* T2 supraglottic carcinoma with invasion of mucosa of base of tongue or vallecula or invasion of the medial wall of the piriform sinus.
* any N-stage, M0.
* WHO performance status 0 or 1 (appendix II).
* Age \> 18 years.
* Written informed consent.
* Quality of life questionnaire completed.

Exclusion Criteria:

* Prior or concurrent treatment for this tumour.
* Severe stridor and adequate debulking of airway not possible.
* Impaired renal function: serum creatinine above upper normal limit.
* Use of nefrotoxic medication (including ACE-inhibitors) that cannot be discontinued for the duration of the radiation treatment.
* Impaired hepatic function: ASAT and ALAT more than 1.5 times the upper normal limit.
* Use of anti-convulsants that cannot be discontinued for the duration of the radiation treatment.
* History of malignancy during the previous 5 years except basal cell carcinoma of skin, carcinoma in situ of the cervix, or superficial bladder neoplasm (pTa).
Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis

This randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to assess the safety of GB-0998.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have sclerosis located proximal to the elbow joint with diffused systemic scleroderma.
* Patients who have not less than 20 points of TSS.
* Patients with no appropriate therapeutic treatment.

Exclusion Criteria:

* Patients with severe hepatic disorder, severe renal disorder or severe heart disorder.
* Patients with malignant tumors.
* Patients who have the anamnesis of shock or hypersensitivity to this drug.
* Patients who have the anamnesis of cerebral infarction or symptom of these diseases.
* Patients who have been diagnosed as IgA deficiency in their past history.
* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant.
* Patients who had any dose increase or new dosing of steroid within 12 weeks before consent.
* Patients who were administered other investigational drug within 12 weeks before consent.
Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive Arterial Disease

The purpose of this study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.

Rationale for ambulatory hospitalization is based on increased demand of hospital care, hospital budgets constraints and patients who ask for a prompt recovery. Consequently, physicians should find ways to optimize the resources' allocation, without compromising quality, safety and efficiency of patient care. Several studies and routine practice have shown that ambulatory hospitalization was safe but we are still lacking evidence to demonstrate the cost-utility of this kind of management.

Eligibility Criteria:
Inclusion Criteria:

* Patients limping
* Patients with PAD requiring endovascular management
* Patients with stabilized level 1 to 3 ASA (classification of the American Society of Anesthesiology)
* Ability to walking
* Endovascular indicated and compatible with an introducer 5F to 7F
* Agreeing to participate in the study and having signed an informed consent.
* Agreeing to lend itself to a post-operative monitoring a duration of 30 days
* Social Insured

Exclusion Criteria:

* No possibility of an outpatient management
* Previous participation in the AMBUVASC study
* Refusal of patient to participate in the study
* Patient with hemostasis disorders
* Acute Ischemia
* Using a more 7F introducer
* Radial or brachial puncture
* Antegrade femoral puncture
* Contraindication to endovascular treatment
* Less than one month life expectancy
* Participation in another clinical trial
Arginine as an Adjuvant Treatment Against Tuberculosis

The purpose of this study was to investigate if adjuvant treatment with arginine (the substrate for nitric oxide production) rich food supplements could improve clinical outcome in patients with smear positive tuberculosis by affecting nitric oxide production.

Tuberculosis (TB) is disease of increased global public health importance. Because of emerging multi drug resistance and the long treatment duration there is a need to optimize the current chemotherapy. Host immunity is important in determining the susceptibility and outcome of disease as could be exemplified by co infection with HIV which dramatically increases the risk to develop TB.

Previous results from our group and others show that nitric oxide produced by activated macrophages from arginine might be important to control the disease. However, the relative importance of nitric oxide in human TB has been debated. In a previous study in Gondar, Ethiopia, we observed an effect of adjuvant treatment with arginine capsules on sputum smear conversion and reduction of cough. In this study we wanted to test the hypothesis based on previous observations that an arginine rich food supplementation might enhance clinical improvement in patients with smear positive tuberculosis and if this effect could be due to increased nitric oxide production.

Eligibility Criteria:
Inclusion Criteria:

* Informed and written consent to take part in the study
* Previously untreated and newly diagnosed smear positive Tb patients according to the WHO definitions

Exclusion Criteria:

* Hospitalization
* Pregnancy
* Known allergy against peanuts
* Chronic or acute disease other than tuberculosis/HIV
Study of Medial-Lateral Center of Pressure Displacement in Unilateral Transfemoral Amputees

The purpose of this study is to examine the path and velocity of the center of mass (CoM) and center of pressure (CoP) during double support of persons walking with a unilateral above-the-knee prosthesis and determine the effects of prosthetic foot stiffness and effective length on CoM and CoP.Persons with a lower limb amputation walk with compensatory movements that affect the smooth trajectory of the center of mass (CoM) during weight transfer. The lack of control in the foot/ankle complex reduces fine motor movements, influencing the progression of the CoM and transfer of ground reaction forces represented by the center of pressure (CoP). Without control of the ankle joint, prosthetic users "fall" off of their trailing prosthetic limb during weight transfer, resulting in much more abrupt CoM and CoP transfers from trailing to leading limb. These abrupt movements during transfer not only increase stress on the sound limb, but also decrease the subject's energy efficiency during ambulation. The current study will further examine the CoP path and velocity in relation to the CoM path and velocity during double support of men with a transfemoral prosthesis, as well as explore how prosthetic foot ankle stiffness and effective length affects the CoP path and velocity.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a transfermoral amputation and use an above-the-knee prosthesis with an articulating knee joint on a daily basis.
* Participants must be male.
* Age greater than or equal to 18 years, but less than 65 years.
* Participants must have no known pathology or comorbidites that would affect their ambulatory ability
* Ability to tolerate walking for a minimum of 100 yards over the course of a two and a half hour time period.
* Ability to walk one block without needing to rest.

Exclusion Criteria:

* Use of ambulatory aids such as canes or crutches.
* Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
* Bilateral amputations.
Effectiveness of Non-surgical Interventions for the Trigger Finger: a Randomized Clinical Trial

The aim of this study is to assess the effectiveness of therapeutic modalities (paraffin, ultrasound and orthotics) versus corticosteroid injection for trigger finger.

There are several forms of nonsurgical treatment for trigger finger, the most used are:

* Oral nonsteroidal and steroidal antiinflammatory's drugs use to resolve the inflammatory process
* Corticosteroids local injection: that proposes to control the inflammation, these injections have shown good effectiveness for trigger finger treatment.
* Orthotic: with the aim of to immobilize the affected joint until the resolution of the inflammatory process.
* Electrotherapeutic modalities:
* Paraffin that increases cellular metabolism and promotes peripheral vasodilatation, favoring the transduction tissue fluid, lymph flow, hyperemia and consequent absorption of exsudato.
* LASER -Lower Level Laser Therapy (LLLT): the absorption of light through the skin's photoreceptors stimulates mitochondrial chain reactions, promoting adenosine triphosphate (ATP) synthesis, acting on gene expression, which raises the level of growth factors and Tissue repair

Although the non-surgical treatment is often used there is no evidence in the literature of which is the most effective conservative treatment for trigger finger. Thus, it is necessary use appropriate methodology to define the benefits and harms of each treatment modality and assess the effectiveness of these nonsurgical treatments, and may define which one has a higher resolution and lower rates of trigger finger recurrences in short, medium and long term.

Eligibility Criteria:
Inclusion Criteria:

* 2-3 grade of trigger finger (Quinnell´s classification)
* Signing the Terms of Consent.

Exclusion Criteria:

* Presence of finger trigger in children
* Presence of traumatic finger trigger
* Secondary causes (patients with tumor of the tendon sheath,

synovitis tuberculosis, etc ...)
Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

Overall Objective: To determine the efficacy of rbLf supplementation in a healthy adult population, specifically with regard to iron regulation (primary), gut health (secondary), and immune function (secondary). Purpose: The purpose of this study is to determine the effects of rbLf on iron regulation, exercise performance, gut health, and immune function as compared to cow's milk derived bLf.

Participants: To account for an approximate \~10% dropout rate (and rounding up to ensure equal number of enrolled participants per group), n=25 per group for males (N=50) and n=30 per group for females (N=60) will be enrolled for a total sample size of N=110.

Procedures: Participation in this study will include 6 in-person visits over 14 weeks. Anemia will be checked and excluded at the first visit using a single finger prick, followed by a 10-20 min exercise test on a treadmill to evaluate exercise capacity. On visit 2 participants will perform three 3-15 minute exercise tests on a treadmill with rest in between each test in order to determine exercise performance. A finger prick will be performed before and after each run to determine lactate levels. After visits 2 participants will be randomized to their respective supplement group recombinant Bovine Lactoferrin supplement (rbLf) (Male and Fame), a bovine-milk derived Lactoferrin supplement (Female), or a placebo (Male) once daily for 4 weeks. Blood samples will be obtained prior to and after each supplement phase to determine change in iron levels and red blood cell capacity. After a 2-week washout participants will return to complete the same testing outcomes and will receive the subsequent supplement. At visit 6 a final blood sample will be collected.


Eligibility Criteria:
Inclusion Criteria:

* 18-42 years
* Body mass index less than 35 kg/m\^2
* Finger prick hemoglobin levels fitting within "normal range"

  * Males: 14-18g/dL
  * Females: 12-16g/dL
* Active: meeting American College of Sports Medicine exercise guidelines or exercising more than 2 days per week of

  ● For females specifically:
* Pre-menopausal: experiencing a regular period with no signs of perimenopause or menopause.

Exclusion Criteria:

* Clinically diagnosed iron-deficiency anemia, pagophagia, hemochromatosis, or other blood or iron related medical conditions.
* Allergy or intolerance to milk, egg, soy, peanut, wheat, coconut, or almond dairy
* Smokers or vapers of nicotine or nicotine products
* Immunocompromised or diagnosed with Type I or II diabetes
* Irritable Bowel Disease, Crohn's disease, Celiacs
* Bowel movements less than three times per week, or clinically constipated
* Oral contraceptive users that have combined iron supplementation, or non-monophasic oral contraceptive users.
* Pregnant or nursing
* Chronic eczema or clinically diagnosed asthma.
* Current antibiotic use or antibiotic use within the past 6 weeks
* If flu, corona virus, or cold occurs, subject will remain in the study with their original scheduled visits, but immune values will be excluded.
* Vegan (due to supplement ingredients).
Uric Acid Lowering Trial in Youth Onset T2D

Adolescents and young adults with youth-onset type 2 diabetes (T2D) are disproportionally impacted by hyperuricemia compared to non-diabetic peers and youth with type 1 diabetes (T1D). In fact, 50% of males with youth-onset T2D have serum uric acid (SUA) greater than 6.8 mg/dl. The investigators also recently demonstrated that higher SUA conferred greater odds of developing hypertension and diabetic kidney disease (DKD) in youth with T2D over 7 years follow-up. Elevated SUA is thought to lead to cardiovascular disease (CVD) and DKD by inflammation, mitochondrial dysfunction and deleterious effects on nephron mass. While there are studies demonstrating beneficial effects of uric acid (UA) lowering on vascular health in the general population, there are no studies in youth-onset T2D. Youth-onset T2D carries a greater risk of DKD and CVD compared to adult-onset T2D and T1D.

Accordingly, a clinical trial evaluating UA lowering therapies is needed in youth-onset T2D. Krystexxa (pegloticase), a uricase, effectively lowers SUA and therefore holds promise as a novel therapy to impede the development of CVD and DKD in youth-onset T2D. This proposal describes a pilot and feasibility trial evaluating the effect of UA lowering by pegloticase on markers of CVD and DKD in ten (n=10) youth aged 18-25 with youth-onset T2D (diagnosed \<21 years of age) over 7 days. The overarching hypothesis is that pegloticase improves marker of cardiorenal health by lowering UA.


Eligibility Criteria:
Inclusion Criteria:

* Men
* Ages 18-25
* Youth-onset T2D (diagnosis \<21 years)
* serum uric acid ≥ 5 mg/dl

Exclusion Criteria:

* Glucose-6-phosphate (G6P) deficiency
* Allergies to seafood or iodine
* MRI contraindications (severe claustrophobia, non-MRI compatible implantable devices, weight ≥ 450 lbs)
* HbA1C ≥ 12%
* Recent (1 month prior) diagnosis of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemia
* Congestive heart failure
* History of multiple and/or severe allergies or anaphylactic reactions
* Uric acid lowering medications (ie: allopurinol, febuxostat)
* Pegvisomant, pegvaliase, peginterferon alfa 2b, peginterferon alfa 2a, pegfilgrastim, pegaspargase, pegaptanib, pegademase and certolizumab pegol
* Participation in another investigational study within 2 weeks prior to study