cyrilzakka/clinical-trials huggingface dataset:
iMRI Prone Positioning Frame Design Feasibility Study

The goal of this study is to learn if the prototype adjustable prone positioning frame is a feasible design for use during neurosurgical procedures which utilize intraoperative magnetic resonance imaging (iMRI). The main questions it aims to answer are:

* Is the prototype prone positioning device design feasible for use during neurosurgical procedures which utilize intraoperative MRI?
* Does use of the prototype device place the patient at increased risk of complications compared to the standard positioning pads? Researchers will place patients in the prone position on the prototype device during neurosurgical procedures that utilize intraoperative MRI and observe for any problems with the positioning device or complications attributable to the positioning device.

Laser Interstitial Thermal Therapy (LITT) ablations are neurosurgical procedures which are performed for several indications including brain tumors and epilepsy. LITT procedures are performed utilizing intraoperative magnetic resonance imaging (MRI) scans. Some of these procedures must be performed in the prone position and can last 8 hours or longer. Investigators have observed several minor skin breakdown complications as well as a few major thromboembolic complications during these long prone procedures. Investigators hypothesize that the cause of the major thromboembolic complications are a result of compression of the femoral veins by the gel pads used to support the patient in the prone position. Many long spine surgeries are performed in the prone position and fewer episodes of skin pressure wounds are experienced and no major intraoperative thromboembolic complications. The study team hypothesizes that the difference is the way that the spine surgery pads support the hips does not compress the femoral vein, therefore significantly decreasing the risk of developing a thrombus intraoperatively.

The aim of this project is to design a modular, adjustable plastic frame to support the spine surgery Jackson table chest and hip pads. Investigators will produce a prototype of the frame and test it during LITT procedures. The prototype of the frame will be 3D printed using the 3D printer owned by the Department of Neurosurgery. The hypothesis is that supporting the patient in the prone position using similar positioning methods to those used for spine surgeries will reduce the rate of skin pressure injuries and prevent future major thromboembolic complications.

Eligibility Criteria:
Inclusion Criteria:

Adult patients undergoing prone laser interstitial thermal therapy procedures for epilepsy at the University of Kansas Medical Center (KUMC).

Exclusion Criteria:

* Patients under the age of 18
* Patients who are unable to provide informed consent for participation in the study
* Weight above the safe threshold for the device (weight capacity will be determined through computational stress analysis prior start of the study)
* Patients who do not speak English fluently enough to provide informed consent in English
* Vulnerable populations including prisoners, pregnant women, and KUMC employees/students.
Balance Acceptance and Commitment Therapy for Long COVID

This randomised controlled trial aims to investigate the efficacy of a psychological intervention for long COVID (LC) / post-COVID-19 syndrome (PCS) called Balance Acceptance and Commitment Therapy (Balance ACT).

The primary objective of this trial is to investigate whether Balance-ACT improves quality of life over treatment as usual (i.e., self-help leaflet) in people with PCS/LC.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. LC/PCS diagnosis as defined by National Health Service (NHS) / National Institute for Health and Care Excellence (NICE) (i.e., symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis). A checklist will be used to ensure participants fulfil the diagnostic criteria as per the NICE guidelines
3. Ability to travel to the research site for the study assessments
4. Consent to wear a smartwatch throughout the study
5. Having registered with a General Practitioner (GP) in the United Kingdom (UK) and consent to provide their details for the study team to contact
6. Ability to provide informed consent
7. Ability to read and write English

Exclusion Criteria:

1. Current diagnosis of an active major mental health disorder likely to interfere with participation
2. Unstable alcohol / drug dependency
3. Unstable complications associated with LC/PCS
4. Past hospitalisation for COVID-19
5. Current or recent participation in other treatment intervention studies (\<4 weeks after completion)
6. Currently receiving psychological support or psychotherapy
7. Implanted medical devices (ie., Pacemaker/defibrillator or implanted neurostimulator/infusion device; implanted metal objects; artificial hip/knee replacement, spinal surgery; cardiac surgery requiring the placement of metal clips, valves or wires)
8. Pregnancy
Investigating the Effects of Beta-Hydroxy-Beta-Methylbutyrate on Glucose Handling in Older and Younger Men.

This study intends to examine the effect of a commercially available nutritional supplement, Beta-hydroxy-beta-methylbutyrate(HMB) on whole-body responses to a sugar load.

One change associated with human aging is a reduction in "fitness", both in terms of how far or quickly a person can run/cycle/swim and also in how well their blood vessels work. Additionally a person's metabolic fitness decreases; this is how well the body copes with nutrition and is why, for example, older people have a higher risk of diseases like type 2 diabetes. Previous studies have shown that as people become less fit, they are at increased risk of suffering a complication whilst undergoing surgery. It has also been shown that measuring how fit someone is, is better at predicting the risk of a surgical complication than purely using a person's age alone. Lots of research has shown that exercise can potentially reverse some of the age-related declines in fitness, however most has used long sessions of continuous exercise over a long period of time. High-intensity interval training (HIT), whereby people cycle on an exercise bike very hard for a minute, followed by a short rest, repeated over the course of 15 minutes can rapidly improve a person's fitness. However not everyone will be able to, or indeed want to participate in exercise this strenuous; therefore this research seeks to explore whether other options, such as dietary supplements can improve aspects of fitness

This study intends to examine the effect of giving a dietary supplement on the way a person's body handles the glucose (from carbohydrates/ sugars) in a meal. Previous work has shown that taking a beta-hydroxy beta-methyl butyrate (HMB) supplement may improve may improve a patient's response to glucose, however the evidence is not clear. HMB is a commercially available nutritional supplement providing a compound that the body produces each time protein is consumed, and is most commonly used by bodybuilders to help gain muscle.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged 18-35 or 65-85
* Male

Exclusion Criteria:

* Current participation in a formal exercise regime
* A BMI \< 18 or \> 32 kg·m2
* Active cardiovascular disease:

  o uncontrolled hypertension (BP \> 160/100), angina, heart failure (class III/IV), Significant arrhythmia, right to left cardiac shunt, recent cardiac event
* Taking beta-adrenergic blocking agents,
* Cerebrovascular disease:

  o previous stroke, aneurysm (large vessel or intracranial), epilepsy
* Respiratory disease including:

  o pulmonary hypertension, significant COPD, uncontrolled asthma,
* Metabolic disease:

  o hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, type 1 or 2 diabetes
* Active inflammatory bowel or renal disease
* Malignancy
* Clotting dysfunction
* Significant musculoskeletal or neurological disorders
* Family history of early (\<55y) death from cardiovascular disease
Primary Immunodeficiencies in Costa Rican Adults

Primary immunodeficiencies represent a underdiagnosed group of rare diseases which if diagnosed well and in time can be treated in an efficient manner and prevent complications that may affect the quality of patients life in an severe manner. Neither in Costa Rica nor in Central America studies or national registries regarding the prevalence and characterization of primary immunodeficiencies in adult patients exist up to now. This study reflects for the first time the epidemiologic situation of primary immunodeficiencies in a Central American country, characterizing adult patients diagnosed with primary and idiopathic immune disorders treated in two specialized immunodeficiency clinics in Costa Rica.


Eligibility Criteria:
Inclusion Criteria:

* All patients from adult primary immunodeficiency clinics will be included.

Exclusion Criteria:

* Patients with HIV
* Proven secondary immunodeficiencies.
Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the treatment of muscle cramps in cirrhotic patients.

Muscle cramps are common in liver disease, especially in patients with cirrhosis. Despite the association of muscle cramps with liver disease, there is a paucity of information regarding treatment in these patients. Many treatment options have been reported in the literature but no standard of treatment has been established.

Oral vitamin E replacement has been used successfully in the management of nocturnal muscle cramps in cirrhotic patients. Ropinirole is primarily used for treatment of restless leg syndrome. An off label trial of low dose Ropinirole in clinical practice has shown some success in providing relief of muscle cramps in patients with cirrhosis. This study will compare Ropinirole to vitamin E treatment in a prospective cross-over study.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age in the Vanderbilt Medical Center Hepatology Practice
* diagnosis of cirrhosis
* Self report regular muscle cramping

Exclusion Criteria:

* Patients without cirrhosis
* Patients under the age of 18
* Pregnant women
TGIR Randomized Placebo-controlled Healthy Subject Study

The primary research objective of this study is to confirm the absence of side-effects and explore any analgesic properties of the botanical formulation TGIR (Traditional Gastrointestinal Remedy) in healthy participants.

This study is a randomized, placebo-controlled, crossover, clinical trial with 24 healthy volunteers. Participants will be randomized to receive each of the two treatments, TGIR (500mg/capsule, total 1.0g) followed by Placebo (2 matching capsules), or vice-versa, with a week between treatments. Participants will remain in the clinic for a 4-hr observation period each day for a total of 2 clinic visits. During the course of treatment, participants will receive physiological monitoring: heart rate and blood pressure. Any adverse events and side effects will be documented throughout the study, in addition to participant feedback and perceived effects. On each day of treatment (TGIR and placebo-control), participants will receive a standardized test of analgesia using Brief Thermal Sensitization (BTS) and measures of reaction time using a computer-based Psychomotor Vigilance Task (PVT).

Eligibility Criteria:
Inclusion Criteria:

* Self-reported to be in good health
* Between the ages of 18 and 65
* No chronic pain diagnosis
* Willing and able to follow study protocol and schedule

Exclusion Criteria:

* Participants who are pregnant, breastfeeding or planning to become pregnant during the course of the study
* History or current clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, neurological, or psychiatric disease that may pose a significant safety risk or diminish a participant's ability to undergo all study procedures and assessments
* Participants who have been diagnosed with a severe medical or psychiatric condition
* Participants who are actively taking pain medication in the past 7 days
* COVID-19 positive and/or showing symptoms of COVID-19
* Concurrent use of other supplements containing sedative types of herbs, such as valerian, skullcap, hops, california poppy, passiflora, and cannabis during the study period
An Investigational Scan (Magnetic Resonance Elastography) in Detecting Treatment Response in Patients With Advanced Liver Cancer

This trial studies how well an investigational scan (magnetic resonance elastography \[MRE\]) works with standard imaging (magnetic resonance imaging \[MRI\]) in detecting response to treatment in patients with liver cancer that has spread to other places in the body. Diagnostic procedures, such as MRE with MRI, may make it easier for researchers to see if the treatment for liver cancer is working.

PRIMARY OBJECTIVE:

I. To evaluate the ability of magnetic resonance (MR) elastography (MRE) to detect changes in hepatocellular carcinoma (HCC) between baseline and after initial 6 weeks of treatment (change in MRE liver tumor stiffness compared to percent non-viable/necrotic tumor).

SECONDARY OBJECTIVES:

I. Correlate MRE imaging measurements with patient survival (overall survival and time to tumor progression) over 18 months.

II. Correlate MRE measurements with change in tumor size and enhancement on standard of care MR imaging sequences.

OUTLINE:

Patients undergo standard of care MRI and MRE over 30-90 minutes within 5 days of liver biopsy before receiving any medical treatment for HCC, at 6 weeks after medical treatment for HCC, and then every 12 weeks for up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Liver cancer.
* Available tumor and liver parenchyma tissue (biopsy-proven HCC).
* No contraindications to MRI (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form.
* Able to undergo informed consent.
* Not pregnant.

Exclusion Criteria:

* Contraindication to MRI (including cardiac pacemaker; ferromagnetic foreign objects in the patient; metallic eye fragments; claustrophobia).
* Inability to comply with study and/or follow-up procedures.
Dietary Impacts on Oral Health in Autistic Children: A Cross-Sectional Analysis

The study aims to explore how dietary habits affect oral health in children with autism. By examining a cross-section of the autistic paediatric population, the research seeks to identify patterns or specific dietary preferences that may contribute to or mitigate oral health issues. This observational study does not intervene in participants' diets but observes existing habits and their oral health outcomes, aiming to provide insights that could guide better dietary recommendations and oral health practices for children with autism.

The study investigates oral health implications of dietary preferences in autistic children, revealing diverse oral statuses and emphasizing tailored interventions. Key findings include significant associations between hygiene practices, periodontal disease, and dietary choices. The research highlights the need for personalized dental care, influenced by factors like age, gender, family income, parental education, and ASD severity. The study contributes to understanding oral health challenges in autistic children, suggesting dietary factors play a crucial role in oral health outcomes, calling for targeted strategies to improve their dental well-being.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 2 and 12 diagnosed with autism spectrum disorder are eligible to participate in the study.
* Informed consent from parents or legal guardians is a prerequisite.

Exclusion Criteria:

* Challenges that may impact study outcomes include coexisting medical conditions.
* Severe behavioral issues that may impede participation.
* Difficulties in obtaining informed consent, posing obstacles to comprehensive research endeavors.
Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease

This study evaluates the efficacy and safety of Edoxaban with the combination of edoxaban and antiplatelet in patients with stable CAD (coronary artery stenosis ≥50% on medical treatment or revascularized stable CAD \[≥ 12 months for acute coronary syndrome and ≥ 6 months after stable CAD\]) and high-risk atrial fibrillation (CHA2DS2-VASc score ≥2).


Eligibility Criteria:
Inclusion Criteria

1. A subject was ≥ 18 years of age
2. Patients with nonvalvular atrial fibrillation with high embolic risk (CHA2DS2-VASc score ≥2)
3. Patients with Stable coronary artery disease

   * Anatomically confirmed coronary artery disease (with ≥50% stenosis of major epicardial coronary artery documented by cardiac catheterization or coronary computed tomographic angiography) on medical therapy alone.
   * Revascularized coronary artery disease (either Percutaneous Coronary Intervention or coronary bypass surgery) whom the last revascularization should be performed ≥12 months before study enrollment for the acute coronary syndrome and ≥6 months for stable angina pectoris.

Exclusion Criteria

1. Patients with thrombocytopenia
2. High risk of bleeding which prohibits the anticoagulant use. (baseline comorbidities, hyper or hypercoagulable state, increased prothrombin time or activated partial thromboplastin time)
3. Prior history of intracranial haemorrhage
4. Mechanical prosthetic valve or moderate to severe mitral stenosis
5. The risk of bleeding increased due to the following reasons;

   * i. history of gastrointestinal ulcers within 1 month
   * ii. Malignant tumor with high risk of bleeding
   * iii. Brain or spinal cord injury within 1 month
   * iv. History of intracranial or intracerebral hemorrhage within 12 months
   * v. Esophageal varices
   * vi. Spinal cord vascular abnormalities or intracerebral vascular abnormalities
   * vii. Active bleeding
   * viii. Hemoglobin level \<7.0 g/dL or platelet count ≤ 50,000 / mm3
   * ix. History of major surgery within 1 month
6. Uncontrolled severe hypertension
7. Hemodynamically Unstable or pulmonary embolism requiring thrombolysis or pulmonary embolectomy
8. History of hypersensitivity to Edoxaban, aspirin, or clopidogrel
9. Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
10. Planned Percutaneous Coronary Intervention or coronary bypass surgery was planned within 1 year after randomization
11. Liver cirrhosis or liver dysfunction (AST or ALT \> x3 of normal range or coagulation abnormality)
12. Estimated CrCl by Cockcroft-Gault equation\<15 mL/min
13. Life expectancy less than 12 months
14. The subject was unable to provide written informed consent or participate in long-term follow-up
15. Pregnant and/or lactating women
16. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain

The purpose of this study is to evaluate the influence of coping strategies and catastrophizing thoughts on disability and the prognosis of back and neck pain in patients treated within the Spanish National Health Service. Patients will be given a visual analog scale (VAS) to rate intensity of pain, the Roland Morris Questionnaire (RMQ) or the Neck Disability Index (NDI) to rate the degree of disability, and the Coping Strategies Questionnaire (CSQ) to rate coping strategies and catastrophizing. Questionnaires will be given at baseline and three months later.


Eligibility Criteria:
Inclusion Criteria:

* Subjects treated for back or neck pain in the Spanish National Health Service.
* Able to read and write Spanish.
* Have signed the informed consent form.

Exclusion Criteria:

* Diagnosis or "red flags" for systemic diseases (e.g., cancer, infection).
* Pain due to fracture or direct trauma to the neck or back.
* Criteria for referral to surgery (e.g., neurogenic claudication due to spinal stenosis, cauda equina syndrome, serious nerve root compression for more than 6 weeks due to disc herniation).
Verify if Amelogenins Had Some Benefits in Improving Lower 2nd Molar Periodontal Healing After 3rd Molar Extraction

Background: Prevention of periodontal defects after the extraction of lower third molars remains a challenge. Various methods have been proposed in the literature, but there are no studies which evaluated the effectiveness of amelogenins.

Methods: A single-blind split-mouth randomized controlled clinical trial (RCT) was performed on 5 patients to verify if amelogenins had some benefits in improving lower second molar periodontal healing after adjacent third molar extraction. A PPD ≥ 8 mm associated with a radiographic bone defect of at least 5 mm were the main inclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \< 27, for which the extraction of both lower third molars was indicated
* Bilateral total (bone or osteo-mucosal) third molar impaction
* Bilateral bone defect ≥ 5mm distal to the lower second molars, evaluated on pre- operative periapical radiographs performed with Rinn's film holders
* PPD ≥ 8mm distal to the second lower molars, in at least one of the following probing sites: buccal, disto-buccal, disto-central, disto-lingual
* Intra-operative integrity of both third molar buccal and lingual alveolar cortices

Exclusion Criteria:

* Smoking habit
* Systemic disorders with serious immunologic impairment
* Taking cortisone or other drugs that might interfere with healing process
* Allergy to penicillins
* Previous periodontal treatment
* Less than 2 mm of adherent gingiva at second molar level
* Second molars with a prosthetic crown
* Previous endodontic treatment of second molars
* Furcation involvement of the second molars