cyrilzakka/clinical-trials huggingface dataset:
Hyperuricemia on Hypertension and Metabolic Syndrome

The purpose of this study is to evaluate the influence of hyperuricemia treatment compared with placebo on participants with high risk of hypertension and metabolic syndrome.

Elevated consumption of high fructose corn syrup has lead to an increase of 30% of fructose intake since the last 20 years. Important data supporting this fact can be reflected on incidence and prevalence of Metabolic syndrome and hyperuricemia.

A peculiar effect of fructose intake demonstrated in animal models is the development of elevated uric acid levels; also some studies have found a clear association between hyperuricemia as an important risk factor for hypertension, diabetes mellitus, chronic kidney disease and metabolic syndrome.

Taking into account the existing evidence, our clinical research team presents this protocol as a way to evaluate the effect of uric acid treatment and its relation with Fructose consumption, metabolic syndrome parameters, hyperuricemia and risk of hypertension.

Confirming evidence with clinical basis may be the initial strategy to create primary prevention programs to control this health problems affecting Mexican Population.

Eligibility Criteria:
Inclusion Criteria:

* adults with blood pressure from 120/80 mmHg and less than 140/90 mmHg
* no pharmacological treatment for blood pressure control

Exclusion Criteria:

* hypertension (more than 140/90mmHg)
* Diabetes Mellitus type 1 or 2
* Chronic kidney disease (MDRD less than 60)
* Hepatic Disease
* Malignancy
* Pregnancy
* patient receiving any medication
Neurological Fate, Prematurity and Genetic Susceptibility Factors

This study could help identify aggravating or protective genetic polymorphisms associated with cerebral palsy. Populations of premature babies at different risk of cerebral palsy could thus be individualized with an impact on their monitoring and on the pathophysiological understanding of the processes leading to neurological lesions.


Eligibility Criteria:
Inclusion Criteria:

* children born prematurely at term \<34 weeks between 2008 and 2015
* assessed at the age of 2 within the Growing Together Network in Pays de Loire
* parental consent for the collection of data from their child and for intraoral sampling for the search for genetic factors.

Exclusion Criteria:

* children who died after the age of 2
* children who refused and / or whose parents refused to participate in the study
A Study of the Association Between Tobacco Smoking and Bipolar Affective Disorder

The purpose of this study is to examine whether tobacco smoking is associated with bipolar affective disorder (severity of depressive and manic symptoms, presence of psychotic symptoms, history of a suicide attempts and other clinical features.)

An association exists between smoking and schizophrenia, independent of other factors and related to psychotic symptomatology. Only a few small descriptive studies have examined the prevalence and correlates of tobacco use among bipolar patients with conflicting results. Patients who smoke score higher on rating scales for psychotic symptoms than their non-smoking peers. While the association of smoking with psychotic symptomatology in schizophrenia is established, such association according to bipolar affective disorder has been reported in a few studies and remains unclear. Also a few studies reported about association of smoking with depressive and manic symptoms, and with suicidal behavior in bipolar patients. Thus further investigation of these issues is warranted.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 male or female
* DSM -IV criteria for bipolar I affective disorder
* Ability and willingness to sign informed consent for participation in the study

Exclusion Criteria:

* Unwillingness or inability to participate in the study
Variations in Anesthesia Care for Hip Fracture Surgery

The investigators will use health administrative data to examine the variation of anesthesia type for hip fracture surgery, as well as sources of variation and predictors of variation.

To evaluate the sources of variance in utilization of neuraxial anesthesia the investigators will use multilevel multivariable modeling strategies. This will allow identification of sources of variation (hospital, vs physician, vs patient characteristics), as well as identification of independent predictors of neuraxial use at each of these three levels.

The investigators will also evaluate the independent association of hospital level variation in neuraxial use on our outcomes of interest using multilevel multivariable regression.

Eligibility Criteria:
Inclusion Criteria:

* Had hip fracture surgery
* Admitted to hospital on a non-elective basis

Exclusion Criteria:

* Do not hold a valid provincial health insurance account
Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery

The aim of this study is to determine the analgesic effect of perioperative nefopam on acute pain in patient undergoing orthognathic surgery.


Eligibility Criteria:
Inclusion Criteria:

* aged 20-60 years
* undergoing elective orthognathic surgery

Exclusion Criteria:

* pregnancy
* psychiatric disease
* hepatobiliary or renal disease
* monoamine oxidase inhibitor-taking patients
Can Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?

Rheumatoid patients have higher fall risk than normal population. Several fall risk factors were studied. No previous study investigated the role of musculoskeletal ultrasound as a predictor of fall risk in rheumatoid arthritis.

Adults with rheumatoid arthritis are exposed to higher risk of fracture. Risk factors included joint tenderness, fatigue, muscle weakness, impaired balance and disease activity.

Musculoskeletal ultrasound is a bed side radiographic tool that gained much attention in the last decade.It can detect stuctural chnges in the musculoskeletal system even before beeing detected by the x ray.

Nowadays, musculoskeletal ultrasound is a very useful tool in examining rheumatoid patients.

No previous study was done to investigate the role of musculoskeletal ultrasound as a predicting factor of fall risk in rheumatoid patients.

Predicting the fall risk in such disease could help setting preventing measures to prevent falls with its sequels.

Eligibility Criteria:
Inclusion Criteria:

* Adults with Rheumatoid arthritis.

Exclusion Criteria:

* patients aged \< 18 years
* Patients with lower limb disability preventing the participant from performing the mobility tests,
* Patients who were using antidepressants and sedatives.
* Patients with severe comorbidities, severe vision impairment, or hearing loss or neurological diseases that interferes with the mobility as stroke or neuropathy, were also excluded.
Cholecystoduodenal Fistula With and Without Gallstone Ileus

Observative and descriptive study of 10 patients, which were diagnosed with a Cholecystoduodenal fistula, All electronic medical records were retrospectively reviewed.

A cholecystoenteric fistula is an uncommon complication of gallstone disease, although most studies in the English literature concern biliary-enteric fistulas. The aim of this study was to present a case series of patients with a cholecystoduodenal fistula (CDF), with or without gallstone ileus, along with the surgical outcomes.

From 2015 to 2018, 3245 consecutive patients underwent cholecystectomy for gallbladder disease at our institution, of whom 10 were diagnosed with a CDF. All electronic medical records were retrospectively reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cholecystoduodenal fistula

Exclusion Criteria:

* Patients with cholecystocolonic fistula or cholecystogastric fistula
The Effect on Caregivers of a Family Support Program

The purpose of this study is to investigate the effect of a family support program based on the nurse-led case management model on individuals providing care for patients who are confined to bed at home.

It is of paramount importance to enable the patients receiving home care and their relatives to adapt social life, to fulfil their social integration, to relieve the burden of family members of the individual in need of care, especially the individual providing care, by supporting them in the environment where they live. In this study, it is aimed to investigate the effect of the family support program based on the nurse-led case management model for family members who care for bedridden patients.The family support program based on a five-stage nurse-led case management model is administered for the caregivers in the intervention group, the caregivers in the control group is monitored by home health services through routine follow-ups. The research will conducted as a randomized controlled study with an experimental design.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* To have been taking care of the caregiver for at least 6 months,
* Being literate
* Not to have sensory loss such as vision and hearing,
* Being open to communication and cooperation,
* Internet access and being able to use it,
* Having a phone where he can be reached,
* Not receiving any remuneration for the provision of care,
* Having a family bond with the person being cared for.

Exclusion Criteria:

* Caregivers who do not meet the inclusion criteria,
* Caregivers who did not give consent at any stage of the study and left.
The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty

The aim of this prospective randomized-control study was to evaluate the impact of a single high-dose intravenous vitamin C added to ultrasound-guided blocks at induction on postoperative pain, sngception and early functional rehabilitation of the knee joint in patients under-going total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Physical status according to American Society of Anesthesiologists (ASA) I-III
2. Patients scheduled for total knee arthroplasty
3. Age ranging from 50 to 80 years old

Exclusion Criteria:

1. Previous operation on the same knee
2. Allergy or intolerance to one of the study medications
3. Coagulopathy
4. Having lower limbs neuropathy
5. End-organ failure (CKD stage V or VI, NYHA III or IV)
6. BMI \> 35
7. Chronic opioid use or drug abuser
8. Difficulty in communication (Impaired mental status)
9. Hyperuricemia or Glucose-6-phosphate dehydrogenase deficiency patient
Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study

This is a prospective observational cohort study that will collect data from the point of referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years). The data collected will allow estimation of the success of any intervention (in terms of reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks associated with the three procedures. Clinical outcomes in the three treatment groups will be described.

Aims

We aim to answer the following questions:

1. Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is the risk of aneurysm growth, dissection, rupture, permanent neurological injury or death? What is the effect on quality of life (QoL)?
2. If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what is the risk of growth, dissection, rupture, permanent neurological injury or death?
3. How does QoL change from pre- to post intervention?
4. Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?
5. What is the most cost-effective strategy in:

   1. Patients eligible for either ESG or OSR?
   2. Patients eligible for either ESG or best medical therapy (BMT)?
   3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?
6. What further research is required? What would be the most important research to pursue?


Eligibility Criteria:
Inclusion Criteria:

* Thoracic Aortic Aneurysm \> 4cm
* Age ≥18 years
* Able to give informed consent

Exclusion Criteria:

* Intervention required below the level of the coeliac axis
* Acute dissection or malperfusion syndromes (such as myocardial infarction,acute stroke or limb ischaemia)
The Effect of Exercise on Anxiety and Cognition in Students at University

RATIONALE: Exercise may improve the mood and cognition in young people.

PURPOSE: It has been well-known that physical exercise can generally benefit the mental health. However, most evidences that physical exercise improves psychiatric symptoms come from retrospective or cross-sectional studies. Moreover, the studies on the effect of physical exercise in the young adults' mental health were limited. This randomized-controlled trial aims to determinate the effects of a chronic and aerobic exercise on the mood and cognition of young people.

OBJECTIVES: The anxiety and depression symptoms in young people are worth paying attention to, in China and worldwide. Meanwhile, cognitive function is very important for young people's learning and work. This project aims to evaluate the effectiveness of the moderate aerobic exercise to alleviate anxiety and depression in young people.

DESIGN \& METHODS: Undergraduate and graduate students aged 18-35 years will be randomly and evenly assigned to exercise and control groups. Subjects assigned to exercise group will receive an running exercise intervention more than 30 minutes and 3 times per week for 8 weeks. The control group will be advised not to engage in physical activities. Outcome measures include the score of the Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), the response time of Schulte Grid test, and the response time of Stroop Colour-Word Test at baseline and post-intervention in two groups. In addition, these assessments will be followed up at week 20 (3 months after the end of intervention).

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate and graduate students aged 18 to 35 years.

Exclusion Criteria:

* Heart disease, hypertension, cardiovascular and respiratory system diseases such as asthma and are unable to tolerate the frequency and strength of exercise requirements.
* Any neurological or psychiatric disorders.
* Physical disabilities.
* Severe dysmenorrhea when they couldn't exercise more than 5 days before or after menstruation.
* Color blindness.
Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in SIADH

The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2018"

Exclusion Criteria:

-
Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19

Two randomized controlled trials will be conducted to examine the effect of a food supplement on proinflammatory cytokines and biomarkers in an adult population recently diagnosed with COVID-19 who are asymptomatic or experiencing only mild symptoms. The supplement, palmitoylethanolamide (PEA), is marketed under the trademarked product with increased bioavailability and format versatility: Levagen+™ (Gencor Pacific Limited, Irvine, CA). The supplement curcumin is marketed under the trademarked product with increased bioavailability: HydroCurc (Gencor Pacific Limited, Irvine, CA)

Inflammation is at the core of many chronic conditions and exacerbates infectious conditions, and inflammatory responses appear to be key determinants of the severity of COVID-19 infection. Hence, controlling inflammation is considered a key strategy for slowing the progression of disease and tissue pathology. This research offers a natural, dietary approach to managing inflammation by reducing the mediators of inflammation. The beneficial effects of palmitoylethanolamide (PEA) and for curcumin for reducing inflammation is documented in the research literature. The proposed research will expand this literature in a novel manner. The investigators propose to demonstrate the efficacy of these dietary supplements in individuals from a campus population with robust immune protection - those who recently tested positive for COVID-19 but were asymptomatic or mildly symptomatic. Since a college population is under many stressors which raise inflammatory profiles during the academic year, and since a college population is exposed to infectious agents on campus, maintaining strong protective immune system following a COVID-19 infection is important.

Eligibility Criteria:
Inclusion Criteria:

* Male and females 18-65 years old
* Generally healthy
* Able to provide informed consent
* Recent positive COVID-19 test (per RT-PCR Test)\*

Exclusion Criteria:

* Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy, HIV, lung conditions or chronic asthma)
* Serious mood disorders, neurological disorders such as MS, or cognitive damage
* Active smokers and/or nicotine or drug abuse
* Active, regular marijuana or other cannabinoid use, other street/recreational drug use
* Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
* Allergic to any of the ingredients in active or placebo formula including peanuts, eggs or turmeric
* Pregnant or lactating woman
* People medically prescribed to take drugs that would affect the immune and/or the inflammatory response
* People who have had treatment (last 5 years) for cancer, or chronic use of steroids
* BMI \>40
COVID-19 Related Lung Ventilation and Perfusion Injury

Little is currently known about the immediate and long-term effect of COVID-19 on lung ventilation (delivery of air to the lungs) and lung perfusion (delivery of blood to the lungs). Some people who survive COVID-19 may have lung ventilation and/or perfusion injury that persists following COVID-19 recovery. This lung injury may be related to inflammation in the lung, breathlessness, exercise limitation and reduced quality of life. Therefore, towards the goal of understanding the effects of COVID-19 on lung health, the purpose of this study is to characterize and understand the clinical relevance of COVID-19 related lung ventilation and perfusion injury and associated inflammatory status, ≤4 weeks and 6-months following COVID-19 recovery in an asthmatic and healthy population. To do this, an asthmatic and healthy population who have, and have not, been previously diagnosed with COVID-19 will be studied.


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Males and females ≥ 18 years of age
* Individuals able and willing to provide written informed consent
* Individuals able and willing to comply with the study protocol

For participants with asthma:

* Individuals with physician confirmed asthma (12% bronchodilator reversibility or PC20 methacholine less than 8mg/ml)
* Individuals treated with inhaled corticosteroids, oral corticosteroids and/or anti-T2 biologics

For participants who recently recovered from covid-19:

* Individuals previously diagnosed with covid-19 confirmed by FLOQswab test
* Individuals who recently (≤4-weeks) recovered from covid-19

Exclusion Criteria:

For all participants:

* Males and females \< 18 years of age
* Individuals who are unable to read and/or understand English
* Individuals who are pregnant or breastfeeding
* Individuals who currently smoke or are an ex-smoker with ≥10 pack-year smoking history
* Individuals who in the opinion of the investigator, are mentally or legally incapacitated, preventing informed consent from being obtained
* Individuals who are unable to complete one or more study manoeuvres

For participants with no history of lung disease:

* Individuals with a history of respiratory infection or disease

For participants who have not been diagnosed with covid-19:

* Individuals who have previously had covid-19 confirmed by FLOQswab test
Chronic Cardiovascular and Gut-bacteria Effects of Phenolic Rich Oats in Adults With Above Average Blood Pressure

In this proposed human trial, the investigators aim to establish whether 4 weeks of daily consumption of beta-glucan matched meals providing either a high dose or a moderate dose of oat avenanthramides and phenolic acids leads to dose-dependent chronic improvements in markers of CVD risk and gut health relative to an energy matched control intervention in healthy adults with above average blood pressure.

* To investigate the chronic effects of daily intake of oat products on flow mediated dilatation of the brachial artery (FMD; primary endpoint), microvascular endothelial function (measured by laser Doppler iontophoresis), pulse wave analysis, gut microbiota diversity, 24h blood pressure, activity of the renin angiotensin system, markers related to cellular production of nitric oxide and reactive oxygen species, inflammatory cytokines, and further potentially emerging biochemical markers of CVD risk.
* To establish if phenolic acids and avenanthramides from oat products exert cardiovascular and microbial effects in a dose dependent manner.
* To measure urinary and fecal excretion of avenanthramide and phenolic acid metabolites.

To explore correlations between bacterial population changes and CVD risk markers.

Eligibility Criteria:
Inclusion Criteria:

* Above average blood pressure (i.e. systolic 120-159 mmHg and diastolic 75-99 mmHg)

Exclusion Criteria:

* Abnormal biochemical, haematological results as assessed at health screening
* Hypertension (i.e. SBP/DBP ≥160/100 mm Hg)
* BMI \>35
* Current smoker or ex-smoker ceasing \<3 months ago
* Past or existing medical history of vascular disease, diabetes, hepatic, renal, haematological, neurological, thyroidal disease or cancer
* Prescribed or taking lipid lowering, antihypertensive, vasoactive (e.g. Viagra), anti-inflammatory, antibiotic or antidepressant medication
* Allergies to whole grains
* Parallel participation in another research project
* Having flu vaccination or antibiotics within 3 months of trial start
* Chronic constipation, diarrhea or other chronic gastrointestinal complaint
* On a weight reduction regime or taking food, probiotics or prebiotics supplements or laxative within 3 months of trial start
* Performing high level of physical activity (i.e. ≥150min aerobic exercise/week)
* Consumption of ≥21 units of alcohol/week
* Females who are breast-feeding, may be pregnant, lactating or, if of reproductive age and not using a reliable form of contraception (including abstinence)