Kornimate/medical-research-clean huggingface dataset:
proclaim: study examining effects of clopidogrel compared to placebo on inflammation in subjects with metabolic syndrome

Conditions: Metabolic Syndrome x

Summary: the purpose of this study is to examine the effects of clopidogrel compared to placebo on markers of inflammation in subjects with metabolic syndrome who are receiving background therapy including low dose aspirin.


Eligibility criteria:
inclusion criteria: 1. men and women at least 18 years old 2. women must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception and must agree to use an effective method of contraception throughout the study. 3. subject must meet 3 of the 5 national cholesterol education program/adult treatment panel iii (ncep/atp iii) criteria for the classification of metabolic syndrome: triglycerides \>/= 150 mg/dl; blood pressure (bp): systolic blood pressure (sbp) \>/= 130 mmhg/diastolic blood pressure (dbp) \> 85 mmhg; fasting glucose \>/= 110 mg/dl; waist circumference: men - \> 101.6 cm (40 in)/women - \> 88.9 cm (35 in); high-density lipoprotein (hdl) cholesterol: men - \< 40 mg/dl/women - \< 50 mg/dl. 4. subject has high-sensitivity c-reactive protein (hs-crp) levels of \>/= 2.0 but \<10.0 mg/l at the screening visit (week -2). 5. current medication regimen must be stable for six (6) weeks, i.e. no initiation of new prescription medication nor change in dosage of any previously initiated medication within three months of entering this study. 6. subject is normally active and judged to be in good health, based on medical history, routine safety laboratory tests (screening visit, week -2), and a brief physical examination (week -2). exclusion criteria: 1. intolerance or contraindication to the use of clopidogrel or aspirin. 2. thrombocytopenia as defined by platelet count \< 100,000/mm3. 3. current use or use within the past 3 months of oral anticoagulants, or dipyridamole or thienopyridine (ticlopidine or open-label clopidogrel) or oral glucocorticoids. 4. daily aspirin in excess of 81 mg, or chronic use of non-steroidal anti-inflammatory agents. 5. use of oral hormone replacement therapy or oral contraceptives including transdermal patch. 6. history of pathologic bleeding (i.e., peptic ulcer or intracranial hemorrhage). 7. history of chronic inflammatory disease or any recent medical event(s) resulting in tissue injury, infection, or inflammation. 8. myocardial infarction, coronary artery bypass graft, or angioplasty within the 6 months prior to screening. 9. uncontrolled hypertension (systolic blood pressure \>/= 180 mmhg or diastolic blood pressure \>/= 100 mmhg) at screening. 10. history or presence of cancer in the past 2 years, except for successfully resected basal cell carcinoma of the skin. 11. recent history (within the past 12 months) for alcohol or substance abuse. 12. currently taking another investigational study medication or has taken investigational study medication within 30 days prior to screening visit. 13. any condition the investigator believes would interfere with evaluation of the subject, or which could put the subject at undue risk.

Keywords: metabolic syndrome
trial of artificial intelligence for chest radiography

Conditions: Pneumonia; Lung Cancer

Summary: randomized clinical trial of the impact of chest radiograph ai-assisted triage and report generation upon clinical outcomes and an economic analysis of impact of ai decision support on radiology service delivery.

randomized, prospective selection of patients. control group involves radiologists reporting chest radiographs as per reference standard clinical workflow intervention group involves radiologists assisted with ai reporting an ai-triaged worklist of chest radiographs using an ai report generation tool clinical outcomes on patients are studied at pre-determined study endpoints, including time to discharge from the hospital and re-admission rates. economic analysis on cost-avoidance from man-hours saved from report generation and triage.

Eligibility criteria:
inclusion criteria: * all patients attending radiography to have chest radiographs during the study period exclusion criteria: * age below 14 * deceased before discharge * chest radiograph performed in non-standard projections

Keywords: radiology artificial intelligence triage radiography
multicentre study to determine the feasibility of using an integrated consent model to compare three standard of care regimens for the treatment of triple-negative breast cancer in the neoadjuvant/adjuvant setting (react-tnbc)

Conditions: Breast Cancer

Summary: triple-negative breast cancer (tnbc) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (er) and the progesterone receptor (pr) and do not over express her2. tnbc is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. clinically, patients with tnbc have a poorer prognosis compared to patients diagnosed with other breast cancer subtypes. because of the aggressive phenotype and due to observations that systemic chemotherapy offers significantly higher benefit in er negative disease, current treatment guidelines from provincial and other organizations recommend that patients receive adjuvant systemic chemotherapy for any tnbc greater than 0.5 cm in greatest diameter or node positive independent of primary tumor size. currently, there is no world-wide standard recommended chemotherapy regimen for the management of tnbc in the neoadjuvant/adjuvant setting, with treatments varying from region and institution. as physicians do not know what the "best" treatment for patients is, genuine uncertainty ("clinical equipoise") exists. physicians will choose between different "standards" in their personal practice, using idiosyncratic decision making processes, without the physician or the patient knowing the optimal option. this is not good for patients, physicians and society as a whole. determining the optimal treatment remains an important medical issue for patients, physicians and society. this study will survey opinions on a novel method to allow comparisons of established standard of care prophylactic treatment using the "integrated consent model" as part of a pragmatic clinical trial and attempt to compare head to head standard chemotherapy regimens in patients with tnbc.


Eligibility criteria:
inclusion criteria: * histologically confirmed primary tnbc breast cancer * planned for chemotherapy * ≥18 years of age * able to provide verbal consent * willing to complete a survey exclusion criteria: * metastatic disease * contraindication to one or more of the chemotherapy agents being evaluated in the study

Keywords: her2 negative
clinical and economic outcomes of high sensitivity troponin for no st elevation myocardial infarction in patients with chest pain in emergency departments in italy-an observational study

Conditions: NSTEMI - Non-ST Segment Elevation MI

Summary: myocardial infarction is one of the leading causes of death and disability worldwide. in addition to standard diagnostic methods, it has been shown that high-sensitivity cardiac troponin assays allow greater sensitivity in the diagnosis of myocardial infarction and assume a central role for both exclusion ("rule out") and confirmation ("rule in") of acute myocardial infarction , while allowing to reduce the time interval between er admission and presumptive diagnosis. considering the relevance of this topic, we propose to conduct an observational study in real world clinical practice settings at emergency departments, aiming to evaluate clinical and economic aspects deriving from the use of the different quantitative assays of high-sensitivity cardiac troponin currently available in patients with suspected acute myocardial infarction and non-st-elevation ecg (nstemi) on the admission, including time of diagnosis and number of laboratory and imaging tests performed.

observational, prospective, real-world clinical practice, multicentric study, conducted at 12 emergency departments in italy. patients with suspected non-st-elevation myocardial infarction (nstemi) who have undergone at least one high-sensitivity cardiac troponin test will be included. patients will be enrolled in the study after verification of selection criteria. enrollment is consecutive; each center will suspend enrollment when it has reached the expected number of patients. an electronic data collection form (ecrf) will be used to automatically generate an enrollment number to identify each patient. given the observational nature of the study, high-sensitivity cardiac troponin assays will be used according to current clinical practice. patients will be examined in the ed, and on a 30-day follow-up.

Eligibility criteria:
inclusion criteria: * patients with chest pain * performing at least one cardiac troponin determination test * written informed consent exclusion criteria: * refusal to provide informed consent * elevation of the st segment to the ecg * pregnancy or breastfeeding * any other clinical condition not judged by the investigator compatible with participation in the present study.

Keywords: troponin
brief video-based mindful movement intervention prior to pelvic exams

Conditions: Anxiety State; Pain; Depression

Summary: this study endeavors to implement a brief video-based mindfulness intervention within a clinic setting for women undergoing pelvic examinations, in hopes of reducing state anxiety and pain intensity during pelvic exams and improving overall exam satisfaction and likelihood to return for follow-up exams. this will be a pilot study will take place the university of texas southwestern (utsw) lowe foundation center for women's preventative health care. there will be a treatment and a control arm, estimated 50 women per group.

participants will be randomly assigned to either a treatment group or a control group. treatment group will receive a 5-minute mindful movement video-based intervention before their previously scheduled pelvic exam. control group will not receive the mindful movement video-based intervention and will instead be given a handout about the benefits of mindfulness to read prior to the pelvic exam. control group will be given access to the mindfulness intervention via an online link upon completion of participation in the study to ensure they are provided the opportunity to benefit from mindfulness practice. participants will be recruited from a group of female patients at the lowe foundation center who have already been scheduled for an upcoming pelvic exam. therefore the pelvic exam procedure itself is standard of care, the experimental piece is the mindfulness intervention before the pelvic exam - either the video, or the written educational materials depending on whether participants are randomly assigned to the treatment or control group.

Eligibility criteria:
inclusion criteria: 1. female 2. age of 18+ years 3. scheduled physical evaluation including pelvic exam at ut southwestern's lowe foundation center for women's preventative health care. exclusion criteria: 1. participants who are unable to read, speak, write or understand verbally spoken english 2. participants who are blind or otherwise visually impaired will be excluded due to nature of video intervention. 3. participants who are pregnant will be excluded from the study. 4. individuals presenting to the clinic for an acute pain reason will be excluded from the study.
an investigation of tumor necrosis factor (tnf)-alpha in asthma using biopsy explants and primary bronchial epithelial cell cultures

Conditions: Asthma

Summary: we have developed in vitro systems including primary epithelial cell cultures and explant cultures of bronchial tissues to study the interaction between the bronchial mucosa and allergens. this approach involves culturing bronchial biopsies under optimal conditions and stimulate them with allergens thus enabling us to perform a dynamic study without the need of performing several bronchoscopies and will allow the testing of unapproved substances, which could, otherwise, not be delivered, in vivo. we wish to apply these ex vivo bronchial culture systems to assess cytokine release in moderately severe asthmatics and evaluate the effects of blocking tnf-alpha signalling using anti tnf-alpha monoclonal antibodies.

volunteers with moderately severe asthma will be recruited and carefully characterized in terms of lung function, asthma symptom scores, medication usage and allergen sensitivity (by blood and skin tests). if suitable, they will then be asked to withdraw their corticosteroids for a week with careful monitoring of the symptoms and peak flows before undergoing fibreoptic bronchoscopy as was carried out in the previous explant study. bronchial brushings and biopsies will be carried out as per standard technique used in university medicine. primary epithelial cell cultures will be established from bronchial brushings and will be used for optimising the dose of anti tnf-alpha required for inhibition of tnf-alpha induced responses. the biopsies will be placed in either culture medium alone, allergen extract or allergen extract plus anti tnf-alpha antibody and cultured for 24 hours. the biopsies will then be either snap frozen in liquid nitrogen for analysis of cytokines or processed for immunohistochemical analysis. the supernatants from each study will be recovered and analysed for cytokine (il-5, il-8, il-13, mip 1 alpha and rantes) release by elisa.

Eligibility criteria:
inclusion criteria: * moderately severe asthmatics * male or female * uses inhaled beclomethasone 400-1000 mcg or equivalent * documented positive skin test to common allergens and * fev1 of \>60% predicted exclusion criteria: * smokers * subjects with an acute asthmatic episode in the last 6 weeks * other significant clinical illnesses * pregnant women * those sensitive to lignocaine

Keywords: asthma tnf alpha epithelial cell culture
an audit of the impact of tailored information delivered via a digital learning platform

Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Summary: the study intends to audit the impact of optimal insulin injection technique on clinical parameters and self-care behaviour of insulin treated diabetes patients in a prospective manner with a follow-up of 6 months. the optimal injection technique is delivered through education via a multimodal tailored approach augmented with a digital 'tailorable' patient learning platform . the study is conducted in multiple sites across belgium. diabetes patients with or without lipohypertrophy will be entered into the audit. the end points will include the impact on use of insulin, long term blood glucose control (hba1c), hypoglycaemia, glucose variability, needle reuse, patient injection habits and clinician education, training and information inputs.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus, or type 2 diabetes mellitus * injecting insulin for at least 1 year * self-managing injection therapy, including daily glucose monitoring * access to a device with internet * confident in navigating the internet exclusion criteria: * pregnant or likely to become pregnant during study period * impaired cognitive ability which would prevent informed consent * syringe only user * insulin pump user * glucagon-like peptide (glp)-1 receptor agonists therapy only
a study to evaluate the safety of raptiva in adults with plaque psoriasis previously enrolled in study acd2600g

Conditions: Psoriasis

Summary: this is an open label, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with plaque psoriasis who previously participated in study acd2600g.


Eligibility criteria:
inclusion criteria: * signed informed consent * previous participation in study acd2600g * for women of childbearing potential, continued use of an acceptable method of contraception for the duration of the study exclusion criteria: * any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to efalizumab

Keywords: moderate to severe plaque psoriasis
stem cell injection for peripheral vascular disease

Conditions: Peripheral Vascular Disease

Summary: severe peripheral vascular disease of the legs causes narrowing of the blood vessels in the legs, which keeps the blood from flowing adequately through these vessels. this study is designed to examine whether treating patients with their own previously collected blood stem cells will improve blood flow in the most severely affected leg. blood stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream.


Eligibility criteria:
inclusion criteria: * atherosclerotic ischemic peripheral vascular disease with rest pain defined as pain that occurs at night or at rest that involves the foot and is a sign of end stage vascular disease and / or ischemic lower extremity ulcers due to infra-inguinal disease and/or peak walking time of 1 to 6 minutes on two exercise tests separated by 2 weeks on graded treadmill. * either a or b 1. ankle brachial index (abi) \< 1.0. 2. doppler waveforms at posterior tibial artery and dorsalis pedis artery are monophasic with toe pressure \< 30 mmhg. * a non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi- segment disease, or extensive infra-popliteal disease not amenable to a vascular graft. * age \> 18 years old. exclusion criteria: * popliteal vascular entrapment syndrome * lower extremity infection or infected ulcer * hypercoagulable state * hiv positive * hbsag positive * uncontrolled arrhythmia, that is, persistence of an arrhythmia despite medical therapy * unstable angina * thrombocytopenia \< 100,000/ul * anemia that cannot be transfused to a hemoglobin greater than 10 g/dl * leukemia or myelodysplasia * allergy to e coli or its products * patients with metal in their bodies cannot undergo mris (mra). therefore, patients with, cochlear implants, or aneurysm clips are not eligible. coronary artery stents are not a contraindication. patients with pacemakers are still candidates provided they have normal creatinine (\< 1.1 mg/dl) and can receive contrast dye (no allergy) for angiogram instead of mra. * patients who are pregnant * poorly controlled diabetes (hba1c \> 6.5) * current malignancy, except squamous cell or basal cell skin cancers thought to be easily controlled. * ast, alt, or bilirubin more than twice the upper limit of normal. * wbc \< 2.5 / ul. * any patient who is actively bleeding, including blood on urine dipstick or fecal occult blood. * no patient may be re-treated until at least 5 patients have completed 6 months of follow-up with no notable safety findings and evidence of therapeutic efficacy (improved abi or healing ulcer) occurred at stem cell doses higher than the patient received in this dose escalation study or response occurred in the treated leg and the untreated leg meets eligibility criteria. re-treated patients must meet eligibility criteria. * patients who smoke unless stop smoking at least two weeks before enrollment and agree not to smoke thereafter.
short-term effect of chewing gum in patients with mild-moderate dysphagia after anterior cervical fusion

Conditions: Dysphagia

Summary: the aim of the study is to estimate the effect of chewing gum after anterior cervical fusion surgery on decreasing the severity of dysphagia in patients with mild-moderate dysphagia.

postoperative dysphagia is the most common complication of anterior cervical fusion surgery. previous studies showed that chewing gum helped to improve swallow frequency and latency. however, its short-term effect on alleviating dysphagia symptom after anterior cervical surgery is still unknown. a randomized, parallel controlled, superiority trial is performed in patients with postoperative mild-moderate dysphagia. dysphagia severity will be assessed using dysphagia short questionnaire (dsq) score in the chewing gum group and control group during 7 days after surgery, and the changes in dsq score between two groups will be compared, to estimate the effect of chewing gum on alleviating dysphagia symptom.

Eligibility criteria:
inclusion criteria: * age from 18 years to 80 years. * underwent anterior cervical fusion surgery for degenerative cervical disease. * diagnosed with mild or moderate postoperative dysphagia 1 day after surgery using bazaz scale. exclusion criteria: * patients underwent revision procedures or procedures treating conditions other than degenerative cervical disease. * patients with preoperative dysphagia. * patients unable to chew, or unable to follow the directions for chewing gum. * patients unable to attend follow-up visits or finish the dysphagia questionnaires.

Keywords: dysphagia anterior cervical fusion chewing gum
effectiveness of extended telephone monitoring

Conditions: Alcohol Dependence

Summary: the purpose of this study is to determine the effectiveness of extended telephone monitoring for alcohol-dependent patients receiving intensive outpatient treatment. it is hypothesized that telephone monitoring will produce better alcohol use outcomes relative to treatment as usual. it is also hypothesized that adaptive telephone monitoring plus brief counseling will produce better alcohol use outcomes over time relative to telephone monitoring plus feedback only.


Eligibility criteria:
inclusion criteria: * enrolled in intensive outpatient substance abuse treatment for at least 2 and no more than 4 weeks at study entry * qualify for a current dsm-iv diagnosis of alcohol dependence (during the month prior to entrance into the iop or detoxification program prior to iop); * willingness to participate in research and be randomized; * 4th grade reading level (as determined by the slosson oral reading test; slosson, 1963); * able to provide the names of several informants who will know his/her whereabouts during the follow-up period exclusion criteria: * acute medical or psychiatric problems that preclude outpatient treatment (e.g., in a psychotic episode and not stabilized on medication); * iv heroin use during the past year; * anticipated involvement in other forms of intensive treatment (e.g., inpatient) during the 6-month period after enrollment.
point prevalence of side strain in fast bowlers and effectiveness of core strength training.

Conditions: Sport Injury; Sports Physical Therapy

Summary: to find out the prevalence of side strain in fast bowlers and determine the effectiveness of core strength training in treating side strain

a fast bowler needs to have strong core muscles in order to prevent side strain, which can hider the performance. variation in deliveries , bowling speed and bowling action can be compromised due to side strain injuries specifically in fast bowlers. a strong and stable core helps to maintain balance and provide strength while performing repetitive movements such as bowling. core strengthening program should include exercises that are sports specific, conditioning exercises that focus on anterior and posterior musculature of the trunk and hip. the aim of this study is to find out the prevalence of side strain in fast bowlers and to incorporate strengthening exercises for core muscles to evaluate its effectiveness for side strain.

Eligibility criteria:
inclusion criteria: * male fast bowlers * age 14 to 40 years exclusion criteria: * athletes who have undergone any surgery * anyone with history of chest pain due to cardiopulmonary disorders