cyrilzakka/clinical-trials huggingface dataset:
The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health

This study will examine the effect of a healthy diet containing cottonseed oil compared to healthy diets containing other commonly consumed plant oils on biomarkers of heart and metabolic health after 4 weeks.

This is a 3-period randomized crossover complete feeding study examining if a dietary pattern containing cottonseed oil improves lipids/lipoproteins and other cardiometabolic disease risk factors to a greater extent than a fatty acid matched diet devoid of cottonseed oil and a diet lower in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFA), but with a matched PUFA:SFA ratio

Eligibility Criteria:
Inclusion Criteria:

* LDL-C ≥100 mg/dL and ≤190 mg/dL
* BMI of 25-40 kg/m2
* Blood pressure \<140/90 mmHg
* Fasting blood glucose \<126 mg/dL
* Fasting triglycerides \<350 mg/dL
* ≤10% change in body weight for 6 months prior to enrollment

Exclusion Criteria:

* Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
* Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs
* Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
* Diagnosed liver, kidney, or autoimmune disease
* Prior cardiovascular event (e.g., stroke, heart attack)
* Current pregnancy or intention of pregnancy within the next 6 months
* Lactation within prior 6 months
* Follows a vegetarian or vegan diet
* Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
* Antibiotic use within the prior 1 month
* Oral steroid use within the prior 1 month
* Use of tobacco or nicotine containing products with in the past 6 months
* Cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
* Participation in another clinical trial within 30 days of baseline
* Currently following a restricted or weight loss diet
* Prior bariatric surgery
* Intake of \>14 alcoholic drinks/week and/or lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hour prior to test visits
Forearm Vascular Relaxation

The purpose of this study is to learn the effect of inherited differences on forearm blood flow responses to hormones and drugs

Differences in at least 4 genes are believed to have an important effect on responses to hormones and drugs. For this study, healthy volunteers of normal body weight will be screened to find xxx individuals with the genes of interest. Very small doses of hormones and drugs will be given so that changes in forearm blood flow can be measured, while not causing effects throughout the body. A brachial artery line and venous line will be placed in the study arm so that blood samples may be withdrawn to compare amounts given into the artery and coming out of the vein after circulating through the arm. Forearm blood flow is determined by the rate of swelling of the arm after a blood pressure cuff is inflated (above venous and below arterial blood pressure). The hormones and drugs being studied include angiotensin I, angiotensin II, acetylcholine, sodium nitroprusside, enalaprilat, L-arginine, phenylephrine, endothelin-1, verapamil, and isoproterenol. This procedure will last 4-6 hours. The process will be repeated with the same participant over 2 weeks later.

Eligibility Criteria:
Inclusion Criteria:

* Normal physical status without any medical interventions or agents which would alter the defined status of normal

Exclusion Criteria:

* Age less than 21 or greater than 45
* Unable to give informed consent
* BMI (Body Mass Index) less than 18 or greater than 25
* Clinically significant abnormal laboratory values
* Abnormal physical exam
* Abnormal EKG
* Pregnancy
* Smoking or drug usage (illicit or otherwise)
* Post-menopause
* Participation in another clinical trial in the past month
* Chronic Illness
The Incidence, Effect and Persistence of Fragmented-QRS, in Patients Presenting With ST-Elevation Myocardial Infarction

This study will assess the incidence, effect and persistence of F-QRS (Fragmented-QRS) in STEMI (ST-elevation Myocardial Infarction) patients post-PCI (percutaneous coronary intervention). The aim is to add to the existing research field surrounding F-QRS. It is hypothesised that patients with F-QRS present on the surface ECG, following PCI, will have incurred a higher degree of damage. As a result, it is hypothesised that these patients will have reduced LV (left-ventricular) systolic function, increased incidence of regional wall motion abnormalities (RWMAs), and increased troponin levels on admission. This study will additionally look for correlations between F-QRS and culprit vessels. To our knowledge there is minimal research regarding this.

This is a Physiological - Retrospective data collection from STEMI patients. Data from 100 STEMI patients treated with primary PCI will be extracted.

Data will be collected from presentation / initial admission, 6-week post-MI (Myocardial Infarction) clinic and 6 month post-MI clinic from the hospital system at New Cross Hospital. Data from admission includes; 12-lead ECG, echo reports and blood test results. Additionally, the 12-lead ECGs undertaken at 6-week and 6-months will be assessed for the presence of F-QRS.

Eligibility Criteria:
Inclusion Criteria:

* Look back to data at least 12 months old in order to ensure 6-week and 6-month follow up data is available. The inclusion criteria will be patients that presented with STEMI and were treated with primary PCI.

Exclusion Criteria:

* From the cath lab reports and clinical letters exclusions apply to patients that did not present with STEMI. In addition, patients that were not treated with primary PCI, or patients that deceased prior, during or post procedure (during hospitalization).
Localization of Microvascular Dysfunction

Microvascular dysfunction is an independent predictor of poor prognosis. Such response in the culprit vessel is common even after successful revascularization. This study investigated whether the microvascular dysfunction differed between culprit and non-culprit vessels in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI).

The prospective study included 115 patients with ACS. In this study, after successful PCI, culprit and non-culprit intracoronary hemodynamic measurements were performed and repeated at 6-month follow-up. 13N-ammonia positron emission tomography (PET) was performed at 6-month follow-up visit to determine absolute myocardial blood flow (MBF). The resistance values of each vessel were calculated using the coronary pressure data and the MBF values obtained from 13N-ammonia PET data. Such physiological measures were compared between culprit and non-culprit vessels in baseline and 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Individuals were eligible for inclusion if they underwent PCI for ACS, if the target lesion was found in the proximal or middle segments of a major epicardial coronary artery, and if the lesion was successfully treated with a coronary stent.

Exclusion Criteria:

* a previous infarction other than in the vessel of interest or a history of coronary artery bypass surgery, cardiogenic shock requiring inotropic support, chronic kidney disease requiring renal replacement therapy, hypertrophic cardiomyopathy, collateral flow to the target vessel greater than angiographic grade 1, or statin or ticagrelor use within 1 year.
Preoperative Treatment of Malleolar Fractures

This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby preventing delay of surgery due to swelling.

The investigators will include patients with malleolar fractures that require surgery in two groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.

Malleolar fractures are often complicated by tissue swelling due to soft tissue injury, haemorrhage and secondary inflammation.

This can lead to severe oedema which can compromise the ability to perform surgery due to blister formation or the inability to close the skin after surgery. Studies have shown that the use of intermittent pneumatic foot-compression (IPC) can reduce waiting time from diagnosis to surgery as well as reduce length of hospital stay.

Purpose of the study is in a randomized study to investigate whether patients requiring surgery because of malleolar fractures has a lower diagnosis-to-surgery time when using IPC than patients not using IPC.

All patients age 18 or above admitted to our hospital with malleolar fractures (AO type 44-A, 44-B, 44-C) requiring surgery, will be randomized to either in-cast IPC or only cast-immobilization. Time from diagnosis of the fracture(time of the x-ray) until start of surgery(time of incision) will be the primary outcome. Patients will be seen in a postoperative ambulatory follow-up at 14 days, 6 weeks, 3 months and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Malleolar fracture requiring surgery.

Exclusion Criteria:

* Severe arteriosclerosis.
* Known or suspected acute DVT or flebit.
* Severe decompensated heart failure.
* Pulmonary embolism.
* Acute skin conditions as dermatitis, infected wounds or recent skintransplant.
* Open fracture.
* Inability and/or unable to comply with treatment regime and/or to attend postoperative ambulatory follow-up.
* Pregnancy.
Real World Evidence of Fedratinib Effectiveness in MF

This is a multicenter prospective and retrospective observational clinical study in patients with primary or post polycythemia vera or post essential thrombocythemia myelofibrosis to test the efficacy of fedratinib in the rea world. Participants will be managed according to the clinical practice of the participating Center. All Centers will be Italian Hematology Units belonging to the GIMEMA Organization in Italy.

This is a multicenter prospective and retrospective observational clinical study with the aim of assessing the efficacy of fedratinib upon AIFA approval in patients with primary myelofibrosis or post polycythemia vera or post essential thrombocythemia myelofibrosis. Patients must meet current diagnostic criteria of MF, according to the WHO (World Health Organization) classification version 5th or the ICC (International Consensus Conference) either published in 2022 or post- polycythemia vera and post-essential thrombocythemia myelofibrosis (according to the ICC classification 2022). Patients enter the study at diagnosis or already in follow-up, at any stage of disease, except if transformed to blast phase. Patients who received fedratinib after June 2022 (time of AIFA reimbursement in Italy) will be enrolled and will be included both those ruxolitinib-naïve and ruxolitinib-exposed.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* Patients diagnosed with primary myelofibrosis \[according to the WHO (World Health Organization) classification version 5th or the ICC (International Consensus Conference) either published in 2022 or post-polycythemia vera and post-essential thrombocythemia myelofibrosis (according to the ICC classification 2022)\].
* Patients who met the reimbursement criteria for fedratinib, in accordance with the AIFA (Agenzia Italiana del Farmaco) after June 2022.
* Patients eligible or not for stem cell transplant (SCT) or patients already undergoing SCT.
* Patients on non-JAKi cytoreductive treatment.
* Patients with palpable splenomegaly at baseline of fedratinib treatment.
* Informed consent signed, if applicable.

Exclusion Criteria:

* Diagnosis of MPN, unclassifiable, myelodysplastic/myeloproliferative neoplasms, myelodysplastic syndromes, essential thrombocythemia, polycythemia vera.
* Blast phase of MF.
* Patients with platelets \<50 x10\^9/L at baseline of fedratinib treatment.
* Patients ruxolitinib-exposed for other diseases.
An Investigational Study to Test Usability of the Electronic Dosing Equipment Medicpen

This is a study of the electronical dosing tool MedicPen and it's qualities with regards to user friendliness and medication compliance.

The medical device MedicPen will be investigated for it's qualities with regards to medication compliance and user friendliness. The patient group selected here is patients with Crohn's disease that are treated with Azathioprine. The patient selection was made since the metabolite can be easily measured and the compliance can be therefore be followed. The treatment will follow the standard care given to these patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years or older
* Provided written informed consent
* Diagnosed with Chron's disease or Ulcerative Colitis
* Treated with Azathiprine for at least 6 months prior to study start

Exclusion Criteria:

* Patients who are, for some reason, judged by the responsible investigator to be unable to handle the device to be tested.
Evaluating the Impact of Chronic Rhinosinusitis on the Health-Related Quality of Life Among Adults With Cystic Fibrosis

Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates mucous. CFTR defects may result in the accumulation of thick mucous in the sinus cavities. As a result, the tiny hair-like structures that sweep mucous out of the sinuses cannot function properly, which can lead to recurrent infection and swelling of the sinus walls. When symptoms are persistent for more than 12 weeks, this is known as chronic rhinosinusitis (CRS). The symptoms that are associated with CRS are nasal discharge, congestion, facial pain or pressure and reduced sense of smell. CRS in non-CF patients affects a large number of individuals in Canada and has been found to be associated with poor quality of life. In the CF population the life expectancy is increasing but chronic disease like CRS is becoming increasingly prevalent. Investigators currently do not know the impact that CRS has on the health-related quality of life in adults with CF and how many suffer from symptoms. The investigators aim to determine the impact of CRS among adults with CF, in order to gain a better understanding of chronic disease among these individuals. The investigators strongly feel this research will improve the referral processes between Respirologists and Otolaryngologists, thereby improving treatment and quality of life for patients.


Eligibility Criteria:
Inclusion Criteria:

* 19 years of age or older
* Definitive diagnosis of cystic fibrosis from positive genetic or sweat chloride test
* Currently enrolled at the St. Paul's Cystic Fibrosis Clinic

Exclusion Criteria:

* Individuals unable to understand the purpose, methods and conduct of this study.
* Patients unwilling to provide informed consent.
High vs Low-frequency of High-intensity Training in Chronic Stroke

The purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.

This study will utilize a 2 arm randomized trial to investigate potential differences in locomotor and community outcomes following 18 visits of high-intensity gait training provided over 6 weeks (high frequency) or 12 weeks (low frequency). Following confirmation of eligibility and baseline testing, individuals will be randomized to either high or low frequency of training and complete subsequent testing at 6 weeks, 12 weeks, and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral deficits following stroke \&gt; 6 months prior; however individuals \&gt; 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until \&gt; 6 months
* Age 18-85
* Weight \&lt; 350 pounds
* Able to follow 3-step commands
* Able to ambulate with self-selected gait speeds between 0.10-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed
* Lower extremity Fugl-Meyer \&lt; 34
* Medical clearance to participate

Exclusion Criteria:

* Evidence of cerebellar ataxia
* Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities such that, in the judgement of the PI, could compromise the safety of the participant, limit the ability to complete the study, or compromise the objectives of the study.
* Currently participating in other physical therapy
* \&gt;50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months
Assessment of the Feasibility of a Systematic Multidimensional Evaluation of the Outcome of Traumatic Brain Injury Patients and Their Relatives.

The main objective is to assess the feasibility of collecting and implementing a multidimensional evaluation in a sample of patients with a mild to severe traumatic brain injury (TBI) and their relatives, evaluated at 6 months (primary outcome), and at 12 then 18 months post-injury (secondary outcomes).

The study aims to assess the feasibility of collecting multidimensional outcomes of patients with traumatic brain injury, taking into account the patient-relative dyad. However, this multidimensional assessment may pose enormous problems of feasibility during the follow-up: loss of the patient's pathway, moderate acceptance by patients and relatives, difficulties of remote assessment sometimes carried out several times.... All these factors can affect the methodological quality of the evaluation of patient outcomes, with measurement and reporting biases influencing the results of biomedical trials. In order to improve the quality of clinical research in this field, it is therefore essential to fully appreciate the factors that facilitate or, on the contrary, hinder high-quality longitudinal follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU with Glasgow score during initial car ≤ 14 and CT-confirmed head injury
* Patients admitted to ER with Glasgow score during initial care ≤ 15 or concussion and CT-confirmed head injury or displaying clinicalsigns such as headaches or vomiting.

Exclusion Criteria:

* Patients under 18 years of age
* Single patient, without relative or informal caregiver
* Non-French-speaking patient
* Refusal of consent
* Patient under guardianship
PMCF Study of the Axonics SNM System Model 5101 (R20)

Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.

This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments

Exclusion Criteria:

1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)
2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
5. A female who is breastfeeding
6. A female with a positive urine pregnancy test
Hypoxia in Flight Simulation in Obese Patients

The purpose of this pilot study is to determine whether obese adults,obese (BMI\>30 kg/m2) with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic chamber test.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* patients with COPD (GOLD I-IV Group A-D) with obesity (BMI\> 30kg/m2), obese healthy adults with BMI\> 30kg /m2, patients with Obesity hypoventilation syndrome
* informed consent provided

Exclusion Criteria:

* patients less than BMI \<30 kg/m2 with or without COPD, OHS
* Age \< 18 years
* pregnancy, lactation
* any medical, psychological or other condition restricting the patient's ability to provide informed consent
* participation in another clinical trial
Oral Care and Gram-negative Pathogen in Children

Critical care nursing interventions related to oral care can reduce the microorganisms in the oropharynx available for translocation to other sites. THis is a randomized, controlled and double blinded study performed in a pediatric intensive care unit (PICU) from a Brazilian university hospital which objectives were to analyze 0.12% chlorhexidine digluconate influence on Gram-negative pathogens colonization of oropharyngeal and tracheal secretions of mechanically ventilated children.


Eligibility Criteria:
Inclusion Criteria:

* All the PICU children during 24 months of study were selected for participation.

Exclusion Criteria:

* newborns, those that fulfilled the Centers for Disease Control and Prevention criteria for pneumonia in infants and children at the time of PICU admission, PICU LOS less than 48 hours, presence of tracheostomy and those that declined to participate.
Comparing Fetoscopic Surgery Protocols

Determine surgeon and patient satisfaction with remifentanil-dexmedetomidine (REMI) and dexmedetomidine-fentanyl (DEX) sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures


Eligibility Criteria:
Inclusion Criteria:

Pregnant patients undergoing one of the following procedures

* Laser photocoagulation of abnormal anastomotic vessels in patients with a twin-twin transfusion syndrome
* Selective radiofrequency ablation or fetoscopic cord coagulation in patients with TRAP sequence or in the presence of intrauterine death of one twin
* Vesicoamniotic shunts or placement of amnioports in patients with LUTO
* Placement of amnioports in patients with oligohydramnios or anhydramnios
* Fetal thoracentesis or placement of thoracoamniotic shunts in patients with congenital pulmonary airway malformation or fetal hydrothorax
* FETO (fetoscopic endotracheal occlusion) as well as balloon removal in patients with congenital diaphragmatic hernia and laser release of amniotic bands

Exclusion Criteria:

Pregnant patients undergoing fetoscopic procedures requiring the following

* Additional procedures (e.g. cerclage)
* Laparotomy with uterine exteriorization to access the uterine cavity
* General anesthesia
* Mid-gestation neural tube defect repair
* EXIT procedures
* Preoperative opioid use
* Diagnosed substance abuse
* Moderate to severe obstructive sleep apnea
* History of allergic reactions to medications to be administered during the study