cyrilzakka/clinical-trials huggingface dataset:
Fruit and Vegetable Juice Concentrate Effects on RBP4 and Antioxidant Capacity in Lean and Overweight 6-10 Year Old Boys

Our study aims to evaluate if the consumption of a Fruit and Vegetable Juice Concentrate (FVJC) vs. placebo can exert changes in the serum levels of Retinol Binding Protein 4 (RBP4), carotenoids, tocopherol, antioxidant capacity, pro-inflammatory markers, insulin sensitivity in conjunction with weight management in a cohort of lean as compared to overweight healthy six to ten year-old boys. The boys will undergo a detailed medical and family history and a complete physical examination during the screening visit. Careful anthropometric measures and body composition by DEXA will be performed. Nutritional and exercise counseling will be given at the start of the study. The outcome measures will include differences in serum RBP4, antioxidant levels, inflammatory markers and insulin sensitivity at baseline and six months after consumption of FVJC in a randomized double blind placebo control manner.


Eligibility Criteria:
Inclusion Criteria:

* 6-10 year old healthy boys
* Lean or overweight
* Have not started puberty

Exclusion Criteria:

* Chronic illness, asthma, or GI disorder
* Vegan Diet
* Use of routine medications or vitamins 4 weeks before study
Improving Stroke Care in North-Norway Through Artificial Intelligence

Prospective observational multi-center intervention study. The study aims to evaluate whether an artificial intelligence (AI) support tool for radiological image processing (StrokeSens, Circle NVI) can accelerate decision making and increase detection rate in patients with an acute ischemic stroke caused by intracranial large vessel occlusion (LVO) or medium vessel occlusion (MeVO) in Northern Norway. Relevant outcomes will be compared between centres with and without available software during the study period.

This study aims to evaluate whether an AI support tool (StrokeSens, Circle NVI) can accelerate decision making and increase detection rate in patients with an acute ischemic stroke caused by intracranial large vessel occlusion (LVO) or medium vessel occlusion (MeVO) in Northern Norway. The software will be a decision support tool in addition to standard radiological services where image interpretation is done by a radiologist or resident in radiology. The AI-tool will be available in 5 of 10 primary hospitals in Northern Norway. The AI-software employed in this study can automatically evaluate the presence of ischemic changes in the vascular territory of the middle cerebral artery according to the Alberta Stroke Program Early CT Score (ASPECTS) and detect occlusions in the intracranial segment of the internal carotid artery and the proximal segments of the middle cerebral artery (MCA).

The main goal of this project is to evaluate if access to the AI-software:

1. Accelerates identification and handling of stroke patients harbouring an intracranial LVO.
2. Leads to a higher detection rate of anterior circulation LVO and MeVO.

The secondary goal is to evaluate:

1. If AI software leads to a higher number of thrombectomy treated LVO and MeVo patients.
2. If AI software may lead to improved patient outcomes.

Hypothesis: Implementation of AI-based image analysis software as a decision support tool for radiologists, reduces time from imaging to transfer request in patients harbouring LVO/MeVO, and increases detection rate of large and medium sized vessel intracranial occlusion compared to the present day practices in primary stroke centres within the health region.

All outcomes will be a compared between primary stroke centres with and without access to the AI-software and historical data from the same sites as collected prior to software implementation (2019-2022).

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute stroke symptoms admitted to a participating hospital within 24 hours of symptom onset

Exclusion Criteria:

* Patients not available for follow-up assessments (e.g. non-resident)
Thyroid Ultrasound Elasticity (TrUE) Imaging

In this study the researchers will scan the thyroid nodules of patients scheduled for surgical removal of these nodules. During their preadmission testing, but prior to their surgery, the researchers will perform standard ultrasound and shear wave elasticity imaging (SWEI) scans of the thyroid nodules in these patients. Both images can be generated by the same ultrasound scanner and within the same imaging session without having to switch out any equipment. The results of the SWEI scans will be compared to the definitive diagnosis from pathology obtained after pathologists have examined the removed nodules post-operatively.

Thyroid ultrasound is a first-line procedure to assess patients with thyroid nodules. Unfortunately, standard ultrasound has low sensitivity, and thus low positive predictive value, for malignancy and many patients with thyroid nodules are referred for additional imaging studies or biopsy. Shear wave elasticity imaging (SWEI) is a non-invasive ultrasound technology that allows clinicians to assess the stiffness of tissues. In many solid tumors, increased stiffness is highly specific for underlying malignancy, and preliminary studies have shown this to be true for thyroid malignancies. Both standard sonography and SWEI can be performed on the same ultrasound equipment and within the same imaging session. Therefore, integrating SWEI into standard thyroid diagnostic workflow is a logical approach towards improving the positive predictive value of these first-line sonographic studies. Other studies have demonstrated the ability of SWEI techniques to differentiate benign from malignant thyroid nodules. However, shear wave techniques still need to overcome challenges before they can be successfully integrated into the clinical paradigm. These techniques still struggle to accurately classify follicular carcinomas and few have been validated in patients with multiple thyroid lesions, a scenario which is clinically common. The researchers believe that a multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. To this end, this study will perform proof-of-concept studies of MAC-SWEI in thyroid patients undergoing standard ultrasound scans and compare the results of shear wave images to results from corresponding pathology.

Study participants will undergo a single SWEI session within their normally-scheduled preadmission testing during which both standard b-mode and shear images of the thyroid nodule(s) will be acquired. The 36 patients will be randomized to receive MAC-SWEI, standard SWEI, and ultrasound, or only standard SWEI and ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Scheduled to undergo a thyroid biopsy, thyroidectomy, or cervical node biopsy

Exclusion Criteria:

* None
Extended Therapeutic Effect of 35kDa Hyaluronan Fragment Injection in Patients With Chronic Pain Caused by Myofascial Pain Syndrome

To verify the efficacy and safety of HA35 in chronic pain management and to further supplement effective treatments for chronic pain, we designed a proof-of-concept clinical study. This study aims to evaluate the 15-day treatment of HA35 on patients with myofascial pain syndrome and to observe the effects for up to 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, aged 18-65 years old ;
* suffering from muscle strain, sprain, fall, wind and other diagnosed as myofascitis in patients with chronic back pain;
* the pain reported by the subject should reach level 3 or higher on the digital rating scale of 0-10 ( 0 means no pain, 10 represents the strongest pain imaginable );
* the mental state is good, and the pain level can be evaluated independently;
* be able to cooperate with the treatment independently and sign a written consent.

Exclusion Criteria:

* Previous severe trauma with permanent musculoskeletal dysfunction;
* symptomatic lumbar disc herniation with neurological deficits;
* specific spinal diseases, including rheumatoid arthritis, ankylosing spondylitis, and osteoporosis;
* diagnosed with mental illness;
* agree not to sign the written consent;
* pregnant, lactating or fertile women;
* currently participating ( or participating in the past 30 days ) in research-based treatment or equipment trials.
Peroperative Effect of Regional Anesthesia in Hip Surgery

A total of 120 patients scheduled for surgical operation due to hip fracture were divided into two randomized groups. The first group received pericapsular nerve group (PENG) block, while the second group received lumbar erector spinae plane (L-ESP) block prior to the surgery. Subsequently, all patients were positioned in the lateral decubitus position before spinal anesthesia and compared in terms of anesthesia effectiveness through pain scores.


Eligibility Criteria:
Inclusion Criteria:

- American Society of Anesthesiologists(ASA) 2-3 patients undergoing surgery due to hip fracture.

Exclusion Criteria:

* Patients in whom regional anesthesia is contraindicated.
* Patients who are unable to communicate.
* Patients with a known allergy to local anesthetics.
* Patients with organ failure.
Do Anesthesiologists Follow Belgian KCE Guidelines for Preoperative Evaluation?

For more than 50 years it has been shown that preoperative evaluations by anesthesiologists include too many unnecessary tests. Many of the tests ordered do not change the management of the patients. One example are preoperative coagulation tests which rarely give relevant information and can be omitted if the patients have a negative structured bleeding questionnaire. This situation has lead to the publication of many guidelines on preoperative evaluation, one of the most comprehensive being the 2022 guidelines by the European Society of Cardiology for the preoperative evaluation of cardiac patients undergoing non-cardiac surgery.

In Belgium, an independent center of experts, the Kenniscentrum - Centre d'Expertise (KCE) was created to give expert and independent opinions on healthcare related subjects. These recommendations are often used by Belgian authorities to guide public health law and determine which medical procedures or tests are covered by the social security.

The KCE has published an extensive guide on preoperative evaluation of patients undergoing non-cardiac surgery (KCE Reports 280Bs. D/2016/10.273/102.) These guidelines are freely available, either in print version, on the dedicated Website or as an App, and have been extensively spread in the anesthesiology community. Laboratory tests not recommended in these guidelines are not covered by the social security if no solid reason is given in the medical chart.

In this retrospective study, adherence to the KCE guidelines on preoperative evaluations will be evaluated in a tertiary University hospital. All patients, scheduled for elective surgery, will be included for a period of 3 month. For every patient the recommended tests will be determined and compared to the actual tests prescribed by the anesthesiologist during the preadmission visit.


Eligibility Criteria:
Inclusion Criteria:

* All patients examined at the anesthesiology preadmission clinic during Oct 1st 2022 and december 31st 2022 and scheduled for elective surgery at Erasme University hospital under general or locoregional anesthesia

Exclusion Criteria:

* Non elective surgery
* Age \< 18 years
* surgery under local anesthesia
Osteoprotegerin Before and After Periodontal Surgery

The study hypothesis:

Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?

assessment of osteoprotegerin in patients with chronic periodontitis before and after periodontal surgery in gingival crevicular fluid, saliva and gingival tissues.

Eligibility Criteria:
Inclusion Criteria:

* severe chronic periodontitis, having pocket depth of ≥ 5 mm and clinical attachment level ≥ 5 mm

Exclusion Criteria:

* pregnant women
* subjects had \<22 permanent teeth
* having any given systemic disease
* taking any type of medication and/or antibiotic therapy during the 3 months before the study
* received periodontal treatment within the past 12 months
* current or former smokers.
Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.


Eligibility Criteria:
Inclusion Criteria:

* Patient had at least a 6-month history of migraine, with or without aura
* Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
* Patient was judged to be in good health, apart from migraine

Exclusion Criteria:

* Patient was pregnant or a nursing mother
* Patient had abused drugs or alcohol within 12 months prior to entering the study
* Patient had a history of cardiovascular disease
* Patient had clinically significant Electrocardiography (ECG) abnormality
* Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
* Patient received treatment with an investigational device or compound within 30 days of the study start
* Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
* Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
* Patient had hypersensitivity to sumatriptan
* Patient had participated in any previous study involving rizatriptan
Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
* Specific inclusion criteria for subject with type 1 diabetes:
* Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
* Specific inclusion criteria for subject with type 2 diabetes:
* Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
* Treated with insulin for the past 3 months prior to screening
* Body Mass Index (BMI) between 22.0 and 35.0 kg/ m\^2 (both inclusive)

Exclusion Criteria:

* Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
* Subject with a history of or presence of cancer
* Any condition that the Investigator and/or Sponsor feels would interfere with study
* Specific exclusion criteria for subject with type 2 diabetes:
* Therapy with oral antidiabetic drugs within the past 3 months prior to screening
Impact of Consumption of Orange-fleshed Sweet Potatoes on the Vitamin A Status of Bangladeshi Women of Reproductive Age

The primary purpose of this study is to determine whether daily consumption of orange-fleshed sweet potatoes increases the vitamin A status of Bangladeshi women of reproductive age. Secondary purposes of the study are to determine whether consumption of orange-fleshed sweet potatoes has an effect on the intestinal absorption of dietary iron or dietary zinc in Bangladeshi women of reproductive age.

Biofortification of plant source foods is a promising strategy for increasing dietary vitamin A intake and vitamin A status in populations at risk of deficiency. The primary purposes of this study are:

1. to assess the efficacy of daily consumption of boiled or fried orange-fleshed sweet potatoes (OFSP) for increasing the vitamin A status of non-pregnant, non-lactating Bangladeshi women, and
2. to estimate the relative vitamin A equivalency of beta-carotene from the two different preparations of OFSP (boiled or fried).

Secondary purposes are to assess the effect of daily consumption of OFSP on intestinal absorption of iron and zinc. Specifically, 120 non-pregnant, non-lactating women at risk of vitamin A deficiency will be randomly assigned to one of the following 4 treatment groups to receive, 600 micrograms RAE/d, 6 d/wk, for 60 days as either:

1. boiled OFSP
2. fried OFSP
3. retinyl palmitate, or 0 micrograms RAE/d as white-fleshed sweet potato (WFSP)

The paired stable isotope dilution technique will be used to estimate total body vitamin A pool size before and after 60-days of supplementation. The efficacy of consumption of OFSP will be assessed by comparing the mean change in vitamin A pool size in the OFSP groups to the mean change in vitamin A pool size in the negative control group (WFSP group). Relative vitamin A equivalency factors will be estimated by comparing the mean change in vitamin A pool size in the OFSP groups with the mean change in vitamin A pool size in the retinyl palmitate group. Intestinal iron absorption and iron status will be assessed before and after the 60-day supplementation period in a subset of women (n=50); and intestinal zinc absorption and zinc status will be assessed after the 60-day supplementation period (n=50). Intestinal absorption of iron and zinc will be compared by treatment group to determine whether consumption of OFSP has any effect on iron or zinc absorption in these women.

Eligibility Criteria:
Inclusion Criteria:

* Serum retinol concentration \< 1.12 umol/L
* Serum C-reactive protein concentration \< 10 mg/L

Exclusion Criteria:

* Pregnant
* Lactating
* Diarrhea within past week
* Severe anemia (\< 9g Hb/dL)
* Symptoms of nightblindness
* Clinical symptoms of xerophthalmia
* Chronic disease
Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE

Antiphospholipid syndrome (APS) has a close association with ischemic stroke; however, the optimal treatment strategy for APS-related stroke has yet to be established. The clinical guidelines suggest using warfarin for APS-related stroke, but these suggestions are largely based on retrospective studies from the 1990s and expert opinion, rather than high-quality clinical trials. Moreover, the evidence on the role of antiplatelet drugs other than aspirin (e.g., clopidogrel) in APS-related stroke is particularly limited. Considering the relatively young age of patients with APS and the high clinical burden of using warfarin, it is necessary to verify whether warfarin is essential. Thus, the investigators aim to compare clopidogrel-based antiplatelet therapy and warfarin as a secondary preventive medication for patients with APS-related stroke. APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS who have a history of ischemic stroke will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematous, or indications for continued antiplatelet or anticoagulant therapy will be excluded. Eligible patients will be 1:1 randomized to receive clopidogrel-based antiplatelet therapy or warfarin. Patients assigned to the clopidogrel-based antiplatelet therapy group will be permitted to use additional antiplatelet drugs other than clopidogrel at the investigator's discretion. The primary outcome is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during a follow-up period of at least 4 years. This study would provide valuable information for determining the optimal secondary prevention strategy for APS-related stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 years or older
* History of ischemic stroke (cerebral infarction, transient ischemic attack, or retinal arterial ischemic event)
* Patients who meet the laboratory diagnostic criteria for antiphospholipid syndrome (APS)
* Patients or guardians who agree to the study protocol and sign with informed consent

Exclusion Criteria:

* Patients with high-risk antiphospholipid antibody profile (triple positivity; persistent high-titers exceeding 80 U/mL of anti-cardiolipin or anti-β2 glycoprotein I antibodies)
* Systemic lupus erythematous
* Patients unable to discontinue previously taken anticoagulants or antiplatelet agents (e.g., atrial fibrillation, valvular heart disease, or a history of percutaneous coronary intervention)
* Women who are pregnant, breastfeeding, or intending to become pregnant during the study period
* Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion