Kornimate/medical-research-clean huggingface dataset:
effect of almonds on immune strength and response to flu vaccination in overweight men

Conditions: Immune Response; Inflammation

Summary: this research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight middle-aged men

the proposed study is a parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial on 54 overweight middle-aged men. this study will be carried out in two phases: phase 1 will examine the effects of almonds on clinically relevant markers of immune function, and phase 2 will assess the antibody response to influenza vaccination following almond consumption. participants will attend a baseline clinic and will be randomized to one of two groups. the almond group will receive 15% of daily energy intake in the form of almonds as a snack and the control group will receive an isocaloric carbohydrate-based commercial snack (pretzels). the intervention will be for 12 weeks, at which time both group participants will receive the influenza vaccination, and continue the same dietary intervention for another 16 weeks.

Eligibility criteria:
inclusion criteria: * overweight men (basal metabolic index 25-32) * age limit between 40-65 years * be able to commute to loma linda university exclusion criteria: * intolerance or allergy to almonds * bad dentures, inability to chew almonds * regular intake of almonds and or other nuts * use of immune boosting supplements * exposure to antibiotics and corticosteroids immediately prior to study * have received influenza vaccination in past 10 months * uncontrolled chronic disease and psychiatric illness

Keywords: almonds immunity inflammation
compare the safety and effectiveness of two different kinds of stent system in intracranial aneurysms

Conditions: Intracranial Aneurysm

Summary: the primary objective of this trial is to evaluate the safety and efficacy of sinomed ias in patients with intracranial aneurysms.

this study is a prospective, multicenter, 1:1 randomized clinical trial to evaluate the safety and efficacy of stent system in the treatment of intracranial aneurysms. a total of 204 patients are planned to be included. the primary endpoint is the incidence of success aneurysm occlusion at 6-month post procedure. all patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Eligibility criteria:
inclusion criteria: 1. age 18 years to 80 years. 2. wide-necked (wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2), saccular, intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 5mm. 3. modified rankin scale (mrs) ≤ 2. 4. subject understands the nature of the procedure, provides voluntary written informed consent prior to the treatment, and is willing to comply with specified follow-up evaluation. 5. the investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm. exclusion criteria: 1. target aneurysm is an aneurysm requiring staged procedure. 2. target aneurysm that has been previously treated with vascular embolization or surgery. 3. target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations. 4. hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery. 5. acutely ruptured aneurysm within 14 days of enrollment. 6. hunt and hess (h\&h) scale ≥3. 7. subject who had moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms. 8. severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device. 9. platelet count \ 3.0. 10. known hypersensitivity/allergies or contraindication to contrast media, stent components, antiplatelets, anticoagulants. 11. life expectancy \< 1 year, and unable to complete the required follow-ups; 12. female who was pregnant or breastfeeding, women/men planning to havve children in the next year. 13. currently enrolled in another investigational device or drug study.

Keywords: wide-necked cerebral aneurysms brain aneurysm cerebral aneurysm stent
whole body cryotherapy and morphological and rheological indicators

Conditions: Quality of Life

Summary: the aim of the planned study was to evaluate the effect of repeated cryostimulation treatments on immunological, morphological, and biochemical indicators of the peripheral blood of healthy, young men

a group of 18 healthy men aged 19-26 participated in the study. the group included a group of ten students with high physical activity and a group of eight students with moderate physical activity. whole-body cryotherapy was performed in a cryochamber located in the malopolska cryotherapy centre in krakow (poland) in the spring of 2013 and in the winter and spring of 2014. the temperature inside the vestibule during the procedure was about -60 ºc and in the actual chamber about -120 ºc. the concentration of oxygen in the air of the cryochamber was kept constant at 21-22% and continuously controlled by two independent oxygen probes. the participants of the study were subjected to 24 whole-body cryotherapy treatments (one treatment three times a week for two months). before the procedure, they were informed about how to move and breathe in the cryochamber. each entrance to the cryochamber was preceded by a 30-second adaptation period in the vestibule at a temperature of -60 ºc. then the subjects entered the cryochamber for three minutes. during the treatment, the men wore short trousers, woollen socks and gloves, hats or headbands to protect against freezing and clogs. moreover, the mouths and noses of the participants were covered with surgical masks, secured with a strip of gauze. during the procedure, the subjects were in permanent eye contact with the doctor and the staff.

Eligibility criteria:
inclusion criteria: * informed consent for research; * equal age and above 18 years of age; * no contraindications to cryostimulation procedures; * physically active exclusion criteria: * lack of informed consent for research * children and adolescents under 18 years of age, * patients with inflammatory diseases, infectious, autoimmune and cancer

Keywords: whole-body cryotherapy healthy men blood components
exhaled breath condensate assessment in stable non-cystic fibrotic bronchiectasis

Conditions: Bronchiectasis

Summary: the measurement of markers in the expired breath condensate has proven to be a useful method for assessing and monitoring airway inflammation. the aim of this study is to determine the amounts of ph in the expired breath condensate of patients with bronchiectasis, and the relationship between ph and the severity of bronchiectasis.

the aim of this study is to determine the amounts of ph in the expired breath condensate of patients with bronchiectasis, and the relationship between ph and the severity of bronchiectasis. further clarify the link between ebc ph and the risk of future acute exacerbations, mortality and lung function decline through a one-year follow-up. hoping to explore new validated biomarkers of the disease severity and progression in bronchiectasis. during the observation, ebc ph and other valid indicators will be measured when patients were enrolled.

Eligibility criteria:
inclusion criteria:each subject must meet all of the following criteria to be included in this study: 1. willing to join in and sign the informed consent form. 2. age\>18 years, the diagnosis of bronchiectasis need reference to the definition of "non-cystic fibrosis bronchiectasis guideline" published by british thoracic society in 2010 or 2012 china bronchiectasis expert consensus, clinical symptoms of cough and expectoration, with or without intermittent hemoptysis, and chest ct showed bronchiectasis there. 3. all patients were clinically stable and had no evidence of infection or acute infective exacerbation (lower or upper respiratory tract) for at least 4 weeks before the study. 4. patients with good compliance: the subject must be willing to follow the test plan requirements in the research center to complete all the assessment of the visit. control subjects: 1. all normal subjects had a negative history of allergy (negative skin prick tests to common allergens); 2. normal lung function, and normal bronchial reactivity. 3. no history of any lung disease (except for the history of pneumonia in the past time and small pulmonary nodules). exclusion criteria:subjects who meet any of the following criteria should be excluded from this study: 1. patients with a history of other respiratory diseases (cystic fibrosis, allergic bronchopulmonary aspergillosis, asthma, 1-antitrypsin deficiency, pulmonary tuberculosis, copd, lung cancer, interstitial lung disease)and atopic diseases were excluded； 2. serious comorbidities (chronic renal failure, hepatic disease, etc.) ; 3. patients were on inhaled or oral mucolytics, or were receiving oxygen therapy or long-term oral antibiotics； 4. poor compliance or cannot cooperate judged by doctors; 5. participated in other clinical trials for nearly three months;
next generation personalized tx(therapy) with plasma dna trial-2 in refractory solid tumors (the next-2 trial)

Conditions: Metastatic Gastrointestinal Cancer; Genitourinary Cancer

Summary: analysis of cell free dna(cfdna), unlike tissue biopsy, presents a new tool for the monitoring and treatment of cancer. the investigators have developed a differentiated sequencing assay, digital sequencing technology (dst) that enables detection of rare genomic abnormalities with ultra high-specificity and sensitivity. the investigators assay is able to eliminate the error and distortion created by sample-prep and sequencing processes in standard ngs(next-generation sequencing ) workflows and produce near-perfect representations of all rare variants. the investigators have shown that in sequencing a comprehensive cancer panel of 80kbp in 0.1% cancer cell line titration samples, standard illumina sbs(sequencing by synthesis ) generates many high-quality false positive variant calls in the range of 0.05-5%, while the investigators assay resulted in highly sensitive and completely error-free variant calls across the entire panel. this work indicates the remarkable potential of using the investigators assay in deep analysis of cfdna, thereby allowing researchers and clinicians to comprehensively and non-invasively monitor the genetic dimension of cancer throughout the body.

same as above

Eligibility criteria:
inclusion criteria: * patients older than 20 years * patients with histologically confirmed metastatic gastrointestinal cancer, rare cancer, lung cancer * patients with histologically confirmed metastatic cancer, who do not have sufficient biopsy material to undergo mutational testing of their tumor, or do not have feasible biopsy sites; melanoma/lung cancer and any solid tumor cancer types will be eligible for the study. * written informed consent form exclusion criteria: * concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety. * double primary cancer (except for any cancer in remission for \> 5 years, cervix cancer in situ, basal cell cancer in situ, any in situ cancers that are resected)
leo 90100 compared to vehicle in subjects with psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: the purpose of this trial is to compare the efficacy of treatment with leo 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs * psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the body surface area (bsa) * an investigator's global assessment of disease severity (iga) of at least mild at day 0 (visit 1) * a modified pasi (m-pasi) score of at least 2 at day 0 (visit 1) * a target lesion of a minimum of 5 cm at its longest axis and preferably not located on the extensor surface on an elbow or knee, scoring at least 1 for each of redness, thickness and scaliness, and at least 4 in total by the investigator's assessment of severity of the target lesion exclusion criteria: * systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation: * etanercept - within 4 weeks prior to randomisation * adalimumab, infliximab - within 8 weeks prior to randomisation * ustekinumab - within 16 weeks prior to randomisation * other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer) * systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation. * subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation. * puva therapy within 4 weeks prior to randomisation. * uvb therapy within 2 weeks prior to randomisation. * topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation. * topical treatment on the face, scalp and skin folds with corticosteroids, vitamin d analogues or prescription shampoos within 2 weeks prior to randomisation. * planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ace inhibitors) during the trial. * current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. * previously randomised in this trial or any previously conducted trial of leo 90100.
predicting, understanding and speeding recovery after tka

Conditions: Pain; Total Knee Replacement; Total Hip Replacement

Summary: the objective of this research study is to better understand patterns of recovery after total knee arthroplasty (tka) amd total hip replacement (tha). the study will evaluate how pain, activity and cognitive (i.e., thinking style) responses determine patterns of recovery, and the study will evaluate the efficacy of gabapentin versus placebo for improving recovery after surgery.

the investigators propose a two-site, longitudinal, double-blind, randomized clinical intervention study to examine three specific aims: aim 1: characterize the dynamic pain experience, activity, and cognitive response after tka and determine patterns of recovery in these domains aim 2: test whether gabapentin alters time course of recovery after tka or tha in a manner dependent on its interaction with pre-drug pupil diameter and preferred style in the catastrophizing-optimism dimension aim 3: test whether gabapentin increases pupil diameter in patients undergoing tka or tha who are on high dose opioids preoperatively and to examine whether opioid use moderates the associations in aim 1 primary hypothesis: novel variance beyond established associations in recovery from pain following tka or tha surgery is accounted for by the interaction between pupil diameter and cognitive-affective (c-a) state, and this interaction predicts efficacy of gabapentin to speed recovery. key secondary hypotheses: disability, impulsivity, and attentional deficits recover after tka or tha surgery follow a log of time pattern, and are predicted by c-a state and its interaction with pupil diameter. gabapentin increases resting pupil diameter in patients scheduled for tka who are receiving high doses of opioids.

Eligibility criteria:
inclusion criteria: * adults scheduled for elective total knee or hip replacement * american society of anesthesiologists physical status 1-3 * participants must be able to read and write english exclusion criteria: * inability to complete questionnaires * pregnancy * litigation or workers compensation related to joint surgery * for 250 subjects in primary analysis - taking \ 100 mg morphine equivalents/day * history of raynaud's disease of the feet * suffering from a psychotic disorder or a recent psychiatric hospitalization * history of eye surgery or topical eye medications that would render pupillometry unreliable or would directly affect pupil diameter. * any disorder that would affect pupil responsivity or prevent accuracy of pupillometry such as movement disorders
metformin for hiv inflammation

Conditions: HIV; Coronary Artery Disease

Summary: this proposal seeks to assess the impact of 24 weeks of metformin on non-calcified plaques and calcified plaques assessed by coronary ct angiography, and on whether these changes can be explained by metformin-induced phenotypic and secretory changes of monocytes.


Eligibility criteria:
inclusion criteria: * hiv+ * on suppressive art stable for \> 1 year * age \> 45 years * ability and willingness to provide written informed consent exclusion criteria: * uncontrolled chronic medical condition or cancer * acute illness within 2 weeks of entry * diagnosis of diabetes or impaired fasting glucose * chronic diarrhea * known hypersensitivity or contraindication to metformin use * hepatitis c co-infection * serum b12 level below the reference normal range as listed by the commercial laboratory (diagnostic laboratory services) * pregnancy, or intent to become pregnant * any immunomodulator, hiv vaccine, any other vaccine, or investigational therapy within 30 days of study entry. * current or past history of coronary artery disease or congestive heart failure * resting heart rate \> 100 beats/min * presence of conduction abnormalities or pathologic arrhythmia on ekg * the following lab values: hemoglobin \ 5x uln * calculated creatinine clearance (cockcroft and gault) \< 60 ml/min * patients over 450 lbs * history of iodine allergy or x-ray contrast allergy * history of allergy to metoprolol * active or recent past history (within past 2 years) of illicit substance or alcohol use or abuse which, in the judgment of the investigator, will interfere with the patient's ability to comply with the protocol requirements * patients in whom there are other reasons that the cac/cta procedure is contra-indicated or who are at higher risk of adverse events * patients, who, in the opinion of the investigator, are unable to comply with the dosing schedule and protocol evaluation or for whom the study may not be advisable
valproic acid (depakote er) in patients with advanced thyroid cancer

Conditions: Head and Neck Cancer

Summary: rationale: drugs such as valproic acid may make thyroid cancers more radioiodine sensitive, which will allow for detection of tumor and make further ablation treatment effective.

purpose: this phase ii trial is studying how well valproic acid works in treating patients with thyroid cancers that do not respond well to other treatments.

Eligibility criteria:
inclusion criteria: disease characteristics * diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin that is radioiodine-unresponsive * cumulative dose of radioiodine \< 800 mci * no radioiodine uptake on whole body scan within 18 months of enrollment * inoperable extensive locoregional tumor mass and/or metastatic spread * failed conventional therapy that included total thyroidectomy and radioactive iodine i 131 ablation * elevated thyroglobulin level (\>2ng/ml on thyroid hormone, \>10ng/ml off thyroid hormone)or tg-antibody positive patient characteristics -18 years or older entry lab results: * hemoglobin \> 8.0 gm/dl * absolute neutrophil count \> 750 cells/mm3 * platelet count \> 75000/mm3 * bun \< 1.5 times upper limit of normal (uln) * creatinine \< 1.5 times uln * total protein \> 6.4 * total bilirubin should be \< 1.5 times uln. * ast (sgot), alt (sgpt), alkp and amylase \< 1.5 times uln * amylase \< 1.5 times uln * albumin \> 2.5 * ammonia \< 1.5 times uln exclusion criteria: * not pregnant * no nursing within the past 3 months * no allergy to valproic acid * no coexisting malignancy other than basal cell carcinoma * no hepatic disease or significant dysfunction * karnofsky score \> 80 * no pancreatitis * no kidney dysfunction * fertile patients must use effective contraception
finding atrial fibrillation in stroke - evaluation of enhanced and prolonged holter monitoring

Conditions: Stroke

Summary: the purpose of this study is to assess whether repeated enhanced and prolonged ecg monitoring after ischemic stroke results in a higher detection of atrial fibrillation (/flutter) compared to usual care (at least 24 hour of cardiac monitoring).


Eligibility criteria:
inclusion criteria: * recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting \> 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging. * stroke symptoms started ≤ 7 days ago. * age ≥ 60 years. * modified rankin scale ≤ 2 (prior to index event). exclusion criteria: * known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ecg. * indication for oral anticoagulation at randomisation. * absolute contra-indication against oral anticoagulation at randomisation. * intracerebral bleeding in medical history. * patient scheduled for holter-ecg or cardiac event-recording monitoring ≥ 48 hours. * significant carotid artery or vertebral artery stenosis \> 50% (nascet classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms. * implanted pacemaker device or cardioverter/defibrillator. * life expectancy \< 1 year for reasons other than stroke (e.g. metastatic cancer). * concomitant participation in other controlled randomised trial.

Keywords: ischemic stroke ecg monitoring atrial fibrillation (/flutter)
drug interaction study between rifabutin and lersivirine (uk-453,061)

Conditions: Healthy Volunteers

Summary: approximately 1/3 of persons living with hiv infection are co-infected with tuberculosis (tb). rifabutin, used in the treatment of tb, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. lersivirine is a modest inducer of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * history of regular alcohol consumption exceeding 7 drinks/week for women and 14 drinks/week for men (1 drink = 150 ml of wine or 360 ml of beer or 45 ml of hard liquor). * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. * hypersensitivity/allergic reactions to any component of the study drugs.

Keywords: pharmacokinetics hiv tuberculosis lersivirine uk-453 061 rifabutin hiv infections