Kornimate/medical-research-clean huggingface dataset:
omega (n)-3 pufa enriched beef & health outcomes.

Conditions: CVD; Cholesterol; Metabolic Disorder; Inflammation

Summary: red meat is an integral component of the habitual diet among the uk and irish population, with adults consuming an average of 71grams/day. although typically high in saturated fatty acids (sfa), red meat is also an important dietary source of protein and essential nutrients including iron, zinc, b vitamins and long chain n-3 polyunsaturated fatty acids (pufa) which provide numerous benefits to human health, particularly related to cardiovascular disease (cvd) risk. n-3 and n-6 pufa are a family of fatty acids with important roles in cardiovascular health, and it is often recommended in dietary guidelines to replace sfa with unsaturated fats, such as pufa. owing to the social and economic burden of cvd, increasing the proportions of these unsaturated fatty acids, in combination with a reduction in sfa within meat, could have a large impact on cvd risk at the population level, whilst retaining the beneficial nutrients and n-3 pufa which meat provides. in this research, a total of 90 eligible and consenting participants will be randomly allocated to consume three portions per week of n-3 enriched beef (from either dietary supplemented or grass-fed cattle) or control beef (from standard supply). this beef will be offered within a lunchtime meal and served from the human intervention studies unit at ulster university, coleraine for a period of 5 weeks. a fasting blood sample will be taken before and after intervention to determine the effect the n-3 enriched beef on cholesterol concentrations, lipid profile, pufa status and inflammation. blood pressure, stiffness of the arteries and body shape, size and composition will also be assessed, and some health and lifestyle habits will be captured using questionnaires.


Eligibility criteria:
inclusion criteria: * free-living, apparently healthy adults * aged 20+ years at recruitment * low oily fish consumers (\<2 servings/mo), or those willing to reduce their fish consumption 1 month prior to commencing the study * non-smokers * not regularly consuming plant stanols or other n-3 enriched foodstuffs exclusion criteria: * non-free-living adults * adults \<20 years at recruitment * oily fish consumers (2 servings/mo or more) * current smokers * pregnant/lactating females (or planning to become pregnant) * food allergy or intolerance that would prevent consumption of the study meals * diagnosed with a chronic medical condition (such as diabetes; cvd; autoimmune/ inflammatory disorders; cancer) * prescribed cholesterol or blood pressure lowering medications * currently taking any fish oil-containing supplement daily consumption of plant stanols or other n-3 enriched foodstuffs

Keywords: enriched beef omega poly unsaturated fatty acids (pufa) cholesterol grass fed
a study of sustained-release desvenlafaxine hydrochloride for the treatment of major depressive disorder

Conditions: Major Depressive Disorder

Summary: a multicenter, 10-week study to evaluate the efficacy and safety of sustained-release desvenlafaxine hydrochloride versus sustained-release venlafaxine hydrochloride in adult with major depressive disorder.


Eligibility criteria:
inclusion criteria: * adult with primary diagnosis of major depressive disorder * aged from 18 years to 65 years * a primary diagnosis of major depressive disorder based on the criteria in the diagnostic and statistical manual of mental disorders, 4th edition (dsm- iv-tr), single or recurrent episode, without psychotic features * hamilton psychiatric rating scale for depression (ham-d 17) total score of ≧ 20 * clinical global impressions scale-severity (cgi-s) score of ≧4 exclusion criteria: * known hypersensitivity to desvenlafaxine or venlafaxine * significant risk of suicide based on clinical judgment * women who were pregnant,breast-feeding,or planning to become pregnant during study * had a history of seizure disorder * history or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs * any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results * cancer
the effect of buprenorphine continuation for patients with opioid use disorder

Conditions: Opioid-use Disorder

Summary: there is limited guidance on the optimal management of buprenorphine perioperatively and both buprenorphine discontinuation and continuation are acceptable standards of care. buprenorphine continuation at low analgesic dosing is also accepted, however is not provided as a potential treatment strategy by the substance abuse and mental health services administration (samhsa). there is the risk of inadequate pain control necessitating opioid escalation when buprenorphine is continued. preliminary clinical observations support buprenorphine continuation at low analgesic doses (8mg) as it adequately facilitates postoperative pain management without interrupting opioid use disorder (oud) treatment, however to date, no prospective trial has investigated this treatment strategy in comparison to full dose buprenorphine continuation. since optimal perioperative dosing strategies remain unknown, the purpose of this study is to investigate if buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery.

the purpose of this study is to investigate whether buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery. adults scheduled for elective surgery who are taking ≥12mg buprenorphine for oud treatment will be eligible for this study. enrolled participants will be randomized to receive either a reduced analgesic dose of buprenorphine (8mg) or to continue buprenorphine on the day of surgery without dose reduction. the primary outcome of interest is postoperative pain scores. the secondary outcomes of interest are opioid consumption, opioid dispensing up to 30 days following the surgical procedure and oud related symptoms, including opioid withdrawal, cravings and relapse. the investigators hypothesis is that there will be a clinically significant increase in pain scores when buprenorphine is continued in full compared to when it is continued at a lower analgesic dose. clinical significance will be defined as a difference in composite pain scores of greater than 20% between groups. the investigators also hypothesize that opioid consumption and opioid dispensing will be greater with full dose buprenorphine continuation compared to low-dose continuation.

Eligibility criteria:
inclusion criteria: * age 18 and older * american society of anesthesia health class i-iii * currently taking buprenorphine formulation equivalent to 12mg or greater for at least 30 days for treatment of opioid use disorder * scheduled for surgery at maine medical center for a procedure with a greater than 4/10 pain intensity is expected on post-op day one. exclusion criteria: * unable to consent to the study * currently pregnant * current major medical illness that could limit the ability to utilize medications within our protocol driven multimodal analgesic plan (e.g. cancer, severe end-stage organ disease, or dementia)
a phaseⅰstudy of hs-10381 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: hs-10381 is a small molecular, oral potent, shp2 inhibitor. the first-in-human trial is conducted to assess the maximum tolerated dose (mtd) and dose limiting toxicity (dlt), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of hs-10381 in patients with advanced solid tumors.

this is a phase 1 open-label, multicenter study to evaluate the safety, tolerability, pk and preliminary efficacy of hs-10381 in patients with advanced solid tumors by using a "3+3" dose escalation.

Eligibility criteria:
inclusion criteria: 1. men or women aged more than or equal to (≥) 18 years 2. advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable 3. patients have at least one target lesion according to recest 1.1. the requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required) 4. ecog performance status was 0-1 and did not deteriorate in the previous 2 weeks 5. estimated life expectancy greater than (\>) 12 weeks 6. females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential 7. sign informed consent form exclusion criteria: 1. treatment with any of the following: 1. previous or current treatment with drugs targeting shp2 2. any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug 3. radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose. 4. major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug. 5. known and untreated, or active central nervous system metastases. 2. existing abnormal ctcae≥grade 2 resulted from previous treatment 3. history of other malignancy 4. inadequate bone marrow reserve or organ function 5. evidence of hepatitis b virus (hbv) or hepatitis c virus (hcv), unless the hepatitis is considered to be cured, known history of hiv 6. history of hypersensitivity to any active or inactive ingredient of hs-10381. 7. judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements. 8. any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.

Keywords: hs-10381 shp2 advanced solid tumor
post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines

Conditions: Influenza, Human

Summary: the purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse drug reaction (adr) system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per european medicines agency (ema) guidance and pharmacovigilance risk assessment committee of ema (prac) requirements, and to identify additional data which may need to be collected in order to appropriately address the requirement.


Eligibility criteria:
inclusion criteria: • volunteers receiving an influenza vaccine and receiving an adr card at the beginning of the 2016/17 season. exclusion criteria: • in the database analysis, registered patients who have explicitly opted out of data sharing will be excluded from the analysis.

Keywords: seasonal influenza vaccines passive enhanced safety surveillance england pilot study
long term effect of buspirone on esophageal function and esophageal symptoms in patients with systematic sclerosis (ssc)

Conditions: Systemic Sclerosis

Summary: esophagus is commonly affected in systemic sclerosis (ssc) and esophageal function is compromised in about 75% of patients. previous studies have shown that buspirone, an orally available 5-ht1a (serotonin 1a receptor agonist), enhances esophageal motility in healthy volunteers. recently, the investigators observed that a single dose of buspirone (10mg) improves lower esophageal sphincter (les) function in patients with ssc and esophageal involvement . objectives: to evaluate the effect of continuous administration of buspirone on esophageal dysfunction and related symptoms in ssc using high resolution manometry (hrm).

systemic sclerosis (ssc) is a chronic autoimmune disease affecting the skin and other organs especially the gastrointestinal tract. esophageal involvement occurs in up to 90% of ssc patients. symptoms of esophageal disease are due to gastroesophageal reflux disease (gerd) and esophageal motor dysfunction. thus, heartburn, regurgitation and dysphagia have been reported by 80% of ssc patients. the gold standard method for the assessment and detection of esophageal dysmotility in ssc patients is manometry. high-resolution manometry (hrm) is the most accurate tool to assess esophageal motility using multiple closely spaced (\<2cm) pressure sensors, assessment of esophageal motility is more sensitive ,and allows a better assessment of les and of the whole esophagus. buspirone, an orally available 5-ht1a receptor agonist, exerts a beneficial acute effect on esophageal motor dysfunction and les pressure and may enhances an important role in improvement of esophageal symptoms in ssc patients. thus, the investigators will conduct a study to evaluate the putative beneficial long-term effect of buspirone i) on esophageal motor dysfunction and ii) on esophageal symptoms in symptomatic ssc patients.

Eligibility criteria:
inclusion criteria: * ssc patients with esophageal symptoms exclusion criteria: * none
prevalence of pre-clinical sjögren disease and other immune disturbances in subjects with autoimmune thyroiditis disease

Conditions: Sjögren; Autoimmune Thyroid Disease

Summary: the main study hypothesis is that sjögren disease (sd), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. there are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic sd in pediatric age to biobank-based studies showing that biological signs of sd may precede the disease clinical onset by years or decades. the best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with autoimmune thyroiditis (at) have a high risk of developing sd (7%); 2) in cases with comorbidity of sd and at the diagnosis of at had usually been made before; 3) subjects with at routinely undergo periodic blood examination and neck ultrasonography (us), which may include salivary gland ultrasound (sgus) providing contributive data to detect an asymptomatic pre-sd. the knowledge of the real association between at and pre-sd may impact on several aspects of medicine.


Eligibility criteria:
inclusion criteria: * subjects between 0-17 years with autoimmune thyroiditis * subjects between 0-17 years with previous diagnosis of sd or pre-sd exclusion criteria: * no informed consent from the patient's guardians * active or recent infection within one week

Keywords: autoimmune thyroiditis sjögren disease immune dysregulation disorders
safety, tolerability, and pharmacokinetics of ux053 in patients with glycogen storage disease type iii (gsd iii)

Conditions: Glycogen Storage Disease Type III

Summary: the primary objective of the study is to evaluate the safety of ux053 in adults with glycogen storage disease type iii (gsd iii).

this study is a phase 1/2 first-in-human (fih), study to evaluate the safety, tolerability, and pharmacokinetic (pk) of a single ascending dose (sad) and repeat doses (rd) of ux053 in patients with gsd iii. the sad cohorts will be open-label (ol). there will be two types of rd cohorts, an open-label (ol-rd) and a randomized, double-blind (db), and placebo-controlled (db-rd).

Eligibility criteria:
key inclusion criteria: * confirmed diagnosis of gsd iii by gene sequencing or enzymatic testing * alanine aminotransferase at or below 5 times normal during the three months prior to dosing * willing and able to comply with standard dietary management of gsd iii inclusion criteria for participants rescreening into ol-rd cohorts after treatment with ux053 in sad cohort: * if a significant rise in alt occurs after the prior dose, alt should show a decreasing trend toward the subject's baseline value * total bilirubin, platelets and international normalized ratio (inr) is within normal limits key exclusion criteria: * history of liver transplant or currently awaiting liver transplant * history of cirrhosis * active hepatitis b or c * severe kidney impairment * history of liver cancer or large liver tumors * history of any cancer within the past 3 years * known history of hiv infection * known severe allergy to polyethylene glycol (peg), polysorbate, or mrna vaccine * heart failure that causes marked limitation in physical activity * poorly controlled diabetes * poorly controlled hypothyroidism * treatment with immunosuppressive medications such as those used to treat chronic autoimmune conditions and solid organ transplants * pregnant or nursing, or planning to become pregnant during the study exclusion criteria for participants rescreening into ol-rd cohorts after treatment with ux053 in sad cohort: * new or worsening symptoms of liver disease (including new or worsening hepatomegaly) along with any increase in transaminase levels * receipt of any blood product administration (eg, packed red blood cells, platelet, ffp) for management of consumptive coagulopathy * an alt level that is ≥ 8x uln and \> 2x the participants baseline value in the absence of an alternative explanation note: additional inclusion/exclusion criteria may apply, per protocol
lifestyle, exercise, and nutrition study early after diagnosis

Conditions: Breast Neoplasms

Summary: the proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy.

currently the department of health and human services, the american cancer society and others provide diet and exercise guidelines for cancer survivors. many women with breast cancer do not follow these guidelines, and also elect to delay concerted efforts toward following them until active treatment is complete. however, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse changes in body composition and breast cancer biomarkers and may even improve the efficacy of treatment resulting in improved breast cancer prognosis. further, by increasing our understanding of the mechanisms mediating the association between lifestyle behaviors and breast cancer survival, this study will improve our knowledge of how changes in diet and physical activity influence breast cancer outcomes. lastly, guidelines for breast cancer survivors also overlap with those for diabetes and cardiovascular disease (cvd) prevention, the latter being a common cause of breast cancer mortality. the proposed study will examine, in 172 women newly diagnosed with stage i-iii breast cancer who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive neoadjuvant or adjuvant chemotherapy, the effect of a 1-year dietary and physical activity guidelines intervention vs. usual care on the following breast cancer outcomes measured before beginning chemotherapy (time 0), post chemotherapy (time 1), at one-year post-diagnosis (time 2), at two years post-diagnosis (time 3), and at five-years post-diagnosis (time 4): adherence to treatment, and changes in biomarkers, body composition, diet, physical activity and quality of life.

Eligibility criteria:
inclusion criteria: * diagnosed with stage i-iii breast cancer * scheduled to receive neoadjuvant or adjuvant chemotherapy * physically able to walk * able to complete forms, understand instructions and read intervention book in english * agrees to be randomly assigned to either intervention or usual care group exclusion criteria: * women who have completed their 2nd chemotherapy * women already practicing dietary or physical activity guidelines * are pregnant or intending to become pregnant in the next year * recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \< 40% * presence of dementia or major psychiatric disease * non-english speaking
manuka honey in second- and grafted third-degree burns

Conditions: Second-degree Burn; Third-Degree Burn

Summary: treatment strategies of ii. degree burn wounds and split-skin grafted iii. degree burn wounds aim at reducing infection and improving reepithelialization. the aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.

in plastic and reconstructive surgery, treatment strategies of second-degree burn wounds and split-skin grafted third-degree burn wounds aim at reducing infection and improving reepithelialization. although previous studies indicate that burn patients benefit from wound dressings containing manuka honey, only a few studies can be found. therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.

Eligibility criteria:
inclusion criteria: * consent-capable male and female patients (or guardian) * ≥18 years of age * ability to asses pain exclusion criteria: * immunosuppressive therapy * clinical wound infection * allergy against honey * relationship to someone who is involved in the study design or assessment * participation in other clinical trials