cyrilzakka/clinical-trials huggingface dataset:
Long-term Investigation of Resveratrol on Fat Metabolism in Obese Men With Nonalcoholic Fatty Liver Disease

The purpose of this study is to investigate potential metabolic effects of resveratrol in obese healthy men with non-alcoholic fatty liver disease.

The investigators hypothesize that resveratrol will:

* decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion
* decrease liver fat content
* increase insulin sensitivity

The investigators will look at changes in:

* lipid turnover (VLDL-TG kinetics, palmitate kinetics, indirect calorimetry)
* liver fat content (MR liver spectroscopy)
* insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)
* body composition (DXA and MRI)
* lipase activity and fat cell size (fat biopsy from abdominal and femoral adipose tissue)


Eligibility Criteria:
Inclusion Criteria:

* Male
* 25-65 years
* Obesity (BMI \> 28 kg/m2, waist/hip ratio \> 0,95)
* Have nonalcoholic fatty liver disease (NAFLD)(intervention group) or do not have NAFLD (control group)
* May have hypertension and/or hypercholesterolemia
* Written informed consent

Exclusion Criteria:

* Any other disease than NAFLD (e.g. diabetes, thyroid or parathyroid disease, heart, liver or kidney disease)
* Present and previous malignancy
* Alcohol dependency (more than 21 units of alcohol per week)
* History of smoking
* Participation in studies with radioactive isotopes within the last six months
* Hemoglobin under normal range regarding to sex (under 8.3 mmol/l for men)
Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses

This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
2. Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day.
3. The prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
4. Subjects must have best spectacle corrected visual acuity of at least 0.5 logMAR in each eye.
5. Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing).

Exclusion Criteria:

1. Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
2. Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.

   Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.
3. Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
4. Subjects who are participating in any other clinical trial (FDA or other)
Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder

Chronic alcohol consumption leads to perturbations in gut microbiome balance (dysbiosis) and disruption of gut barrier integrity. As a result, bacteria, toxins, and metabolites can enter the blood stream and reach distant organs, triggering inflammation and oxidative stress. Through this mechanism gut leak is closely related to the onset of metabolic diseases, such as nonalcoholic fatty liver disease (NAFLD) and diabetes.

Despite the prominent role of diet and alcohol in the pathogenesis of metabolic diseases, there is a lack of treatments to mitigate their effects in triggering systemic inflammation and oxidative stress. Novel treatments using generally recognized as safe (GRAS) compounds focused on restoring the intestinal barrier to mitigate metabolite endotoxemia are sorely needed. This project will test the potential of broccoli sprouts extract (BSE) as a GRAS treatment to minimize the combined effect of poor nutrition and alcohol on the gut. Broccoli sprouts are rich in sulforaphane, a bioactive compound derived from the glucosinolate glucoraphanin with anti-inflammatory and antioxidant proprieties. BSE supplementation has been used in preclinical and clinical studies as a health- promoting food, showing significant positive changes in the gut microbiota composition, protection against colitis, cardiometabolic improvement, and lower inflammation. We believe that BSE is a viable alternative therapeutic approach for patients who are resistant to lifestyle changes such as healthy eating and reducing alcohol use. Our purpose is to test BSE supplementation in human subjects with poor nutrition compounded by alcohol use, specifically in older adults who we believe will receive greater benefit from this approach. At the completion of the proposed study, we expect to have determined that treatments using generally recognized as safe (GRAS) compounds can be useful to restore the gut barrier integrity, and as consequence of reduced gut leak we expect to observe lower inflammation and oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 50 years of age at enrollment.
* Consume at least 8 alcoholic drinks/week. AUDIT-C score \>8.

Exclusion Criteria:

* Bowel-related diseases
* Diagnosed Diabetes
* Allergy or intolerance to broccoli.
* Any acute illness within the last 6 weeks.
* Chronic anti-inflammatory use or antibiotic treatment in the last 7 days.
* Acute illness within the preceding six weeks (defined as fever, new antibiotic use or unscheduled healthcare visit - for illness).
* Acute alcohol intoxication upon arrival on the day of study visit.

Additional exclusion criteria:

• Any health issue that, the study investigator's judgement, confers excess risk for participation.
Peri-operative Aspirin Continuation Versus Discontinuation

This study evaluates the continuation (non-discontinuation) of Aspirin during TURBT. Half of participants will continue their usual low-dose Aspirin regimen during TURBT and throughout the perioperative period, while the other half will discontinue Aspirin use ten days prior to surgery (standard recommendation) and restart therapy two weeks post-discharge.

Recently, the American College of Chest Physicians in their 2012 clinical guidelines on perioperative anti-thrombotic therapy associated TUR of bladder tumour (TURBT) with an increased risk of bleeding associated with anti-thrombotic therapy. Despite this, contemporary series of TURBT identify the rate of significant in-hospital postoperative bleeding at only 2-3.4%. Previous prospective work by our group demonstrated no increase in postoperative hemorrhagic complications with early initiation of Aspirin following TURBT. These findings are supported by a recent retrospective work on TURBT showing a similar complication profile between continued perioperative antiplatelet therapy and antiplatelet naive patients.

The risk associated with Aspirin withdrawal prior to surgery, including increased thrombogenicity, has been extensively studied. Following cessation of Aspirin, full platelet recovery is expected within 12-14 days, however, hemostasis may be regained with as little as 20% of normal platelet activity. Further, evidence supports a platelet rebound phenomenon in the setting of acute Aspirin withdrawal and a resultant clinical prothrombotic state, with thrombotic events peaking ten days following drug cessation. Finally, the acute stress response postoperatively is well known; one component being hypercoagulability which lasts at least seven days after major and uneventful abdominal surgery, predominantly caused by increased platelet activity.

Whereas TURBT generally carries a low overall risk of cardiac morbidity, the general requirement to discontinue Aspirin pre-operatively potentially increases certain patients' cerebrovascular or cardiac risk (eg. post-coronary stent placement). As shown above, the risk of significant post-operative hematuria is minimal, and as such, Aspirin withdrawal may be unnecessary. We will perform a prospective, randomized controlled trial to address the safety and tolerability of continued Aspirin use during TURBT.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 years and older with the ability for self-consent,
* referred for elective TURBT,
* receiving low-dose daily Aspirin prophylaxis.

Exclusion Criteria:

* known coagulopathy or abnormal coagulation profile (prothrombin time, partial thromboplastin time, or platelet count),
* receiving other anti-thrombotic, anti-coagulant, or non-steroidal anti-inflammatory medication (NSAIDs),
* pregnancy.
Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis

The primary aim of this study is to investigate and describe the limited efficacy of the Spring Distraction System (SDS) and Bilateral One Way Rod (NEMOST) in maintaining curve reduction without repeat lengthening procedures and complications.

Secondary aims are to describe growth of the instrumented spine, health-related quality of life, and to compare both devices.

Several innovative solutions have been developed to treat growing children with a severe scoliosis. One device (SDS) was developed internally at the department of orthopaedics UMC Utrecht in the Netherlands. The other device (NEMOST) was developed at the Necker Hospital in France.

This study is designed as a multicenter, limited-efficacy study using two prospective cohorts according a randomised clinical trial. The study will be performed in two centers (UMC Utrecht, Amsterdam UMC and Erasmus MC).

Primary endpoints are the limited-efficacy in terms of maintenance of curve correction and occurrence of SAEs related to the procedure. These data will be compared to a recently described cohort of patients that received a "standard treatment", the MGCR (Skov et al., 2017). Secondary endpoints include spinal- and implant growth, patient performance based on the EOSQ 24 questionnaire and surgical parameters.

Eligibility Criteria:
Inclusion Criteria:

* Non ambulant
* Neuromuscular or syndromal scoliosis
* Progressive scoliosis indicated for bipolar fixation extending to the pelvis
* Diagnosis of scoliosis before age 10
* Patient under 12 and open triradiate cartilage (usually closes around 12 years for girls and 14 years for boys)
* Main curve proximal end vertebra below Th 3
* Non rigid curve
* Patients who have an indication for a primary surgery

Exclusion Criteria:

* Ambulant
* Patients with closed triradiate cartilage
* Patients with a skeletal dysplasia that effects growth (Achondroplasia, SED)
* Patients with a systemic disease which severely influences bone quality e.g. osteogenesis imperfecta, metabolic diseases
* Patients with soft tissue weakness (Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)
* Patients that have a congenital anomaly of the spine of more than 5 vertebrae
* Patients with an active systemic disease such as JIA, HIV, oncologic treatment
* Patients with a previous surgical fusion of the spine
* Patients that are expected to be lost to FU due to e.g. likely to immigrate within 1 year.
* Patients that have had a previous spine surgery.
Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage

The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage


Eligibility Criteria:
Inclusion Criteria:

* Severe vitreous hemorrhage that obscures visualization of the fundus on indirect ophthalmoscopy, that has been present \>/= 1 month by history or exam
* BCVA is worse than 20/200 at time of screening

Exclusion Criteria:

* Corneal or lenticular abnormalities that preclude fundus observation
* Ongoing ocular infection, inflammation or history of herpetic corneal lesion
* Current or prior retinal detachment or retinal tears or breaks or intraocular tumor
* More than 1 severe vitreous hemorrhage within 6 months
* Previous vitrectomy for any reason
* Hemorrhage is exclusively pre-retinal, or old \& organized
* Prior Vitrase for intravitreal injection in either eye
* No light perception in either eye at any time
* Known contraindications to study medication
* Sickle cell disease
Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder

The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.

This study was set-up to examine the controversial issue whether or not it is safe to drive a car or not when treated with methylphenidate.

On-the-road driving tests during normal traffic are conducted to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.In addition, two laboratory tests are conducted to examine memory functioning and inhibitory control.

Eligibility Criteria:
Inclusion Criteria:

* adult ADHD patient over 21 years old
* valid driver's license for at least 3 years
* treated with methylphenidate
* written informed consent

Exclusion Criteria:

* use of illicit drugs
* use of drugs or having medical conditions known to affect driving ability
Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC

This is a phase I, single-center, non-randomized, 3+3 dose-escalation study of alpha lipoic acid given during chemotherapy-radiation in HNSCC patients with non-metastatic disease.

The study will be completed when the MTD and RP2D are determined. This will be either when 2 or more patients have a DLT at a particular dose level, or when 6 patients have completed treatment at the highest dose level (600 mg TID). The final 3 patients enrolled at the highest tolerated dose will also complete PK studies.

Eligibility Criteria:
Inclusion Criteria:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Be a male or female aged 18-100.
4. Histologically or cytologically confirmed stage II-IVB HNSCC of the oral cavity, hypopharynx, oropharynx, larynx, or nasopharynx.
5. Ability to take medication orally or per feeding tube and be willing to adhere to the medication regimen.
6. Patients who are deemed appropriate for definitive, adjuvant, or palliative radiation with total planned dose \> 30 Gy.
7. Patients who are deemed appropriate for concurrent systemic therapy with radiation including cisplatin (100 mg/m2 triweekly or 30-40 mg/m2 weekly), carboplatin (AUC 1-2 weekly) +/- paclitaxel (30 mg/m2 weekly) or cetuximab (400 mg/m2 loading followed by 250 mg/m2 weekly.

   a. The final 3 patients in the dose expansion group undergoing the PK/PD study must be deemed appropriate for cisplatin.
8. For females of reproductive potential: use of highly effective contraception including hormonal contraceptives, intrauterine devices (IUD), vasectomy, tubal ligation, and double barrier methods (combination of male condom, female condom, cervical cap, diaphragm, contraceptive sponge).
9. For males of reproductive potential: use of condoms.
10. ECOG performance status ≤ 2.

Exclusion Criteria:

1. Participation in another clinical study with an investigational product during the last 30 days.
2. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, a clinical study not involving pharmaceutical or radiation techniques, or during the follow-up period of an interventional study.
3. Women who are pregnant or lactating. Patients of reproductive potential must have a negative serum or urine pregnancy test within 72 hours of start of study drug.
4. Patients who are currently taking gabapentin, pregabalin, amitriptyline, nortriptyline, or duloxetine.
5. Known allergy or hyposensitivity to alpha lipoic acid.
6. Judgement by the investigator that the patient is unsuitable to participate in the study and the patient in unlikely to comply with study procedures, restrictions, and requirements.
The Colorectal Breath Analysis (COBRA) Study

This study aims to determine whether a breath test could be used for early detection of colorectal cancer and colorectal polyps.

Patients who are attending for a planned colonoscopy or who are scheduled to undergo elective resection of histologically confirmed colorectal cancer (adenocarcinoma) will be approached to provide a breath sample.

Multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between colorectal cancer, benign colorectal disease (e.g. polyps) and healthy controls.

Colorectal cancer is the 2nd most common cause of cancer death in the UK where survival rates are among the lowest in Europe. If diagnosed early survival may exceed 90%.

The proposed breath test is a non-invasive investigation that can detect the presence of volatile organic compounds (VOCs) in breath and their relative abundance in disease states including colorectal cancer. This test has potential to be used in a primary care setting to identify patients at high risk of colorectal cancer, supporting earlier referral for definitive investigation. A negative test may provide reassurance to patients and prevent unnecessary tests in this group. The test could also have an application for colorectal cancer screening.

In this study the investigators will determine the diagnostic accuracy of an exhaled breath test for the detection of colorectal adenocarcinoma and colonic polyps. To determine the accuracy of the breath test a multicentre cross-sectional study will be conducted to analyse single breath samples from patients attending hospital for planned colonoscopy or elective resection of histologically confirmed colorectal cancer. The target for the study is 1463 patients.

Breath collection will be conducted using a previously validated method. Samples of breath (500ml) collected using a CE-marked handheld ReCIVA sampling device (Owlstone Medical Ltd., Cambridge, UK) during a period of tidal breathing (approximately 5minutes) will be absorbed onto thermal desorption tubes (Markes International, Llantrisant, UK). All patients will have received bowel preparation and will be fasted for a minimum of 6 hours prior to the breath sample. Breath samples collected within thermal desorption tubes will be transferred to a central laboratory for analysis by gas chromatography mass spectrometry (GC-MS) and proton transfer reaction time of flight mass spectrometry (PTR-ToF-MS). Raw data files will be extracted and analysed in accordance with established protocols. Quality assurance measures will be formally assessed at each stage of sample handling.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years and ≤90 years of age
* Undergoing planned colonoscopy or elective resection of histologically confirmed colorectal adenocarcinoma
* Fasted \>6 hours
* Able to provide informed written consent

Exclusion Criteria:

* Any patient \<18 years or \>90 years of age.
* Lacks capacity or is unable to provide informed written consent.
Analysis of Intraoperative Bleeding Characteristics in Laparoscopic Pancreaticoduodenectomy

In this study, we analyze the common bleeding characteristics in laparoscopic pancreaticoduodenectomy by reviewing and annotating bleeding information from previous surgical videos as well as surgical operation OSATS technique scores. From there, we reflect on the correlation between surgical operating technique and intraoperative bleeding, as well as on the correlation between intraoperative bleeding and short-term postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* the surgical video is complete including the resection and reconstruction phases

Exclusion Criteria:

* the surgical video is not complete
* the cases combined with resection and reconstruction of mesentericoportal vein
Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

Intranasal dexmedetomidine has shown to be an effective sedative when used prior to anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in previous study and it produced satisfactory sedation in more than 50% of the children at the time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain satisfactory sedation prior to anaesthetic induction when higher dose is used.


Eligibility Criteria:
Inclusion Criteria:

* Age 1-12 years old
* American Society of Anesthesiologists (ASA) 1-2
* Elective surgery
* Children with autism or pervasive personality disorder

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) 3-5
* Allergy or hypersensitive reaction to dexmedetomidine
* Known cardiac arrhythmia or congenital heart disease
* Mentally disabled
A Study Protocol for Research Investigating How Geriatric Risk Assessment and Shared Decision-making Conversations Affect Treatment Decisions and Quality of Life in Patients Eligible for Open-heart Surgery.

The goal of this study is to determine whether intervention by the PRIME clinic influences cardiac treatment decisions, as well as patients quality of life and healthcare utilization.

The main questions this study aims to answer are:

* Does PRIME consultation influence treatment recommendations?
* Does a personalized treatment plan for cardiac patients influence health-related quality of life?
* Does a personalized treatment plan influence healthcare costs (in terms of quality-adjusted life years)?

Participants will:

* Visit the PRIME clinic once
* Complete quality of life questionnaires twice
* Track their healthcare usage over the course of a year and complete a corresponding questionnaire four times.

The primary outcome of this study is the difference between treatment recommendations; the first treatment recommendation (the decision before the patient visits the outpatient clinic) will be compared with the treatment recommendation after the assessment at the outpatient clinic.

Secondary and other outcomes that will be collected are baseline demographic data including age, gender, body mass index, education level, European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and co-morbidities such as stroke, reduced cognitive function, chronic obstructive pulmonary disease (COPD) GOLD III or IV, renal failure (a reduced renal function prior to surgery with a kreatinine level ≥150mmol/L), a reduced left ventricular function, reduced mobility, cardiac reoperation and type of surgical procedure (CABG, valve replacement or repair, surgery of the thoracic aorta or a combination of several procedures).

Data will be collected using several questionnaires:

* Health-related Quality of Life (the RAND-36 questionnaire)
* The Katz Index of Independence in Activities of Daily Living to assess functional status
* The Cognitive Impairment Test
* The Timed Up and Go Test
* Outcome Prioritization Tool to assess the most important goals of treatment The RAND-36 and KATZ-ADL will be completed by all patients, including those receiving standard care.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 years and older
* Eligible for cardiac surgery
* Having two or more risk factors: stroke; reduced cognitive function; Chronic Obstructive Pulmonary Disease (COPD); obesity; reduced left ventricular ejection fraction; renal failure; reduced mobility; cardiac reoperation; and the complexity of the procedure.

Exclusion Criteria:

* Unable to read or understand Dutch