Kornimate/medical-research-clean huggingface dataset:
laser speckle imaging in ischaemic tissue loss

Conditions: Vascular Diseases

Summary: peripheral arterial disease is a condition in which the arteries become narrowed due to a build up of cholesterol, as a result, blood cannot flow efficiently through the arteries and this can compromise the parts of the body supplied by these arteries. in its most severe form, peripheral arterial disease can lead to decomposition of tissues in the feet, leading to ulcers or gangrene. patients with peripheral arterial disease undergo procedures to improve blood flow. however, there are often multiple arteries to treat and each intervention carries risk. it therefore can be difficult to judge how much treatment is sufficient to promote healing. laser speckle imaging is a technique used to demonstrate blood flow in the skin. it is hoped that changes in skin blood flow, as measured by lsi, immediately after a procedure to improve blood flow, may help in the decision making as to whether further intervention is necessary. an lsi scan will be performed before a procedure for tissue loss and immediately after it is performed. the patient's clinical records will then be checked to see whether the wound has improved and whether the difference in lsi scans correlated with this.


Eligibility criteria:
inclusion criteria: patients with diabetes patients with a foot ulcer or open wound patients aged over 18 patients able to given consent patients undergoing femoropopliteal bypass or superficial femoral / popliteal artery angioplasty exclusion criteria: nability to consent planned major limb amputation for the affected limb
smoking cessation intervention: effectiveness in primary care

Conditions: Tobacco Dependence

Summary: the information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.

randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection, motivation, and adherence. to have a positive public health impact, a treatment must be accessible and acceptable to a broad range of smokers and effective under normal use conditions. the proposed project will assess primary care patients willingness to use cessation treatment and will determine the relative effectiveness of five cessation pharmacotherapies. this research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study. in the proposed research, 1320 primary care patients presenting for a regular outpatient visit will be recruited by medical assistants to participate in a free smoking cessation program and will be randomly assigned to one of five active pharmacotherapies: patch, lozenge, bupropion, patch+lozenge, and bupropion+lozenge (n = 264/condition). interested participants who pass medical screening will pick up their medications at clinic pharmacies and will receive proactive telephone counseling from the wisconsin tobacco quit line. assessment will be limited to preserve the generalizability of the findings, but select individual differences will be assessed pre-quit to validate algorithms (from project 1: efficacy) designed to optimize pharmacotherapy selection for smokers based on gender, level of dependence, and other factors. smoking behavior will be assessed at six months and one year post-quit so that abstinence rates across pharmacotherapy conditions can be compared. the cost of incorporating tobacco dependence treatment into primary care will also be estimated.

Eligibility criteria:
inclusion criteria: * smoke at least 10 cigarettes per day for the previous 6 months - expired co \> 9 ppm - motivated to quit smoking - able to read and write english - willing to complete required study assessments, aurora participating clinic patient exclusion criteria: * uncontrolled hypertension (systolic \>180mm hg or diastolic \>110mm hg) - history of bipolar disorder or psychosis - myocardial infarction or other serious cardiac problem in the previous 4 weeks - history of diagnosed anorexia and/or bulimia - diagnosis of alcohol dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - history of seizure and/or serious head injury involving loss of consciousness - use of contraindicated medications (mao inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - currently pregnant or breast-feeding - unwilling to use effective contraception during the treatment phase - more than one participant from the same household - allergic reactions to 3 or more classes of drugs
evaluation of seelens af, an aspheric intra-ocular lens

Conditions: Cataract

Summary: senile cataract is managed by cataract extraction and intra-ocular lens (iol) implantation. the purpose of this study is to evaluate the safety and efficacy of the seelens af, an acrylic hydrophilic aspheric iol. this lens was designed to reduce vision aberrations and secondary cataract formation rate. preoperative evaluation: best corrected visual acuity, refraction, comprehensive slit lamp examination and biometry. surgical procedure: cataract surgery using a clear corneal incision (1.8mm to2.4mm), phacoemulsification and implantation of the seelens af to the capsular bag. iol implantation parameters will be evaluated by the surgeon. postoperative follow up: best corrected visual acuity, uncorrected visual acuity, refraction and comprehensive slit lamp examinations up to 3 months after surgery.


Eligibility criteria:
inclusion criteria: * senile cataract * age \>18 years * cataract extraction using phacoemulsification * corneal incision less than 1.5 mm exclusion criteria: * allergy/sensitivity to eye drops used during and after cataract surgery * amblyopia/ strabismus * ocular disease, other than cataract, diminishing visual acuity, such as corneal opacity, advanced glaucoma, diabetic retinopathy, exudative or moderate to severe non-exudative age-related macular degeneration, uveitis. * previous ocular surgery or ocular trauma in the investigated eye * ocular anomaly, such as microphthalmos * keratometry values less than 40 diopters or more than 47 diopters. * ocular axial length less than 21.0 mm or longer than 25.0 mm * intra-operative complications prior to intraocular lens implantation, such as tear of the posterior capsule. * posterior capsular scar * visual acuity in the fellow eye less than 20/200

Keywords: cataract cataract surgery intraocular lens aspheric lens
long-term treatment study of mra for rheumatoid arthritis (ra) from study mra012jp

Conditions: Rheumatoid Arthritis

Summary: this is an open-label, extension, phase iii study to evaluate the long-term safety and efficacy of mra in patients with ra who participated in study mra012jp.


Eligibility criteria:
inclusion criteria * patients must suffer from ra, and must have participated in the preceding study. * patients must have been confirmed to be appropriate on week 52 of the preceding study by x radiography. exclusion criteria * patients evaluated as belonging to steinbrocker's class iv within 4 weeks before administration of the study drug * patients who have not been registered by 3 months after week 52 of the preceding study
the role of lactate in viral and bacterial infection

Conditions: Viral Infection; Bacterial Infections; Lactate Blood Increase

Summary: acute upper respiratory tract infection(auri) is common in children, and viral infection is the main cause. however, several children with viral infection are easy to suffer from secondary bacterial infection, and the mechanism is unclear.

lactate is an important molecule in the spread and metastasis of tumor by suppressing the innate immune response. as is known, the immune system is not mature in children and it is reverse related to the age of children. an reasonable hypothesis is that the lactate is a independent risk factor in the children with viral infection progress to bacterial infection. here, our aim is to test the hypothesis.

Eligibility criteria:
inclusion criteria: * child's age is from 0 to 18 years * a child is at least diagnosed with viral infection exclusion criteria: one of the following conditions appeared: * congenital heart disease or other abnormalities * respiratory failure * hereditary and/or metabolic disease
customized acoustic stimulation for the treatment of tinnitus

Conditions: Tinnitus

Summary: the purpose of this study is to determine the efficacy of a customized sound therapy in reducing tinnitus loudness and increasing the residual inhibition.


Eligibility criteria:
inclusion criteria: * 18 years or older * male or female * tinnitus present for 6 months or more * adequate command of english exclusion criteria: * active illicit drug use, alcohol dependence * treatable cause of tinnitus * history of psychosis * subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.
duct-to-mucosa versus invagination for pancreaticojejunostomy

Conditions: Pancreatic Neoplasms; Biliary Tract Neoplasms

Summary: the purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. this single-centre, open, randomized controlled trail is conducted following isgpf criteria for pancreatic fistula (pf). the duration of the study is supposed to start from jan 5th 2012 and last to dec 2014, until 100 or more cases are accessible. patients diagnosed with pancreatic cancer, peri-ampullar carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy will be included. main outcomes are pancreatic fistula rate, mortality, morbidity, reoperation and hospital stay. the investigators assumption that duct-to-mucosa is better than invagination.


Eligibility criteria:
inclusion criteria: * patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy * 18 to 80 y/o * operation-tolerated * informed consent exclusion criteria: * history of gastrointestinal operation * pancreaticoduodenectomy is given up during operation * pancreatic duct is difficult to locate * patients require to exit from the study anytime
home telemonitoring of resting spontaneous breathing in severe asthma: a pilot study

Conditions: Asthma

Summary: asthma exacerbations account for a significant morbidity and disproportionate health care costs. however, there is no currently available biomarker or lung function parameter that can accurately predict the risk of future exacerbations. the current work aims at evaluating the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (amars). we hypothesize that monitoring amars is potentially able to detect an increased risk of asthma exacerbations.

asthma exacerbations represent an acute or sub-acute worsening in symptoms and lung function from the patient's usual status. early detection of exacerbations is a major public health issue. in clinic, management of asthma involves asthma control questionnaires and pulmonary function tests (forced expiratory volume (fev1), fractional exhaled nitric oxide or feno). at home, the peak expiratory flow rate (pefr) measured by the peak flow meter is an aid to monitor asthma but its ability to predict asthma exacerbations remains controversial. anharmonic morphological analysis of the respiratory signals (amars) is a new morpho-mathematic biomarker that produces objective and accurate measures of the shape of the ventilatory flow. the current study aims at monitoring the resting spontaneous breathing at home in asthmatics. changes in amars may be a predictor of early symptoms of asthma exacerbations. we will recruit 120 asthmatic patients. patients will be given a portable device for telemonitoring. resting spontaneous breathing will be measured during 2-3 min in the morning and in the evening, twice a week at least for 12 months. three visits will be scheduled in clinical investigation center before (v1), after 6-month (v2) and 12-month (v3) telemonitoring period.

Eligibility criteria:
inclusion criteria: * male or female aged more than 18 yrs * written informed consent * diagnosis of asthma according to global initiative for asthma (gina) criteria * history of at least one moderate to severe exacerbation in the previous 12 months exclusion criteria: * smoker or former smoker (\> 10 packs-year) * concomitant asthma exacerbation (at v1) * prisoners * protected adults * no affiliation to the french social security system

Keywords: asthma exacerbations telemonitoring biomarkers
learning through play plus for psychosis

Conditions: Psychosis

Summary: evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. this may cause insecure attachment in infants of mothers with psychosis. children of parents with schizophrenia have poor developmental and clinical outcomes. however, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. learning through play (ltp) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. the proposed study will integrate ltp with existing culturally appropriate cognitive behaviour theray (cbt) for psychosis (cacbt-p) and test its feasibility and acceptability for parents with schizophrenia.

objectives * to determine whether the proposed intervention is acceptable to the parents with schizophrenia. * to assess the feasibility of proposed intervention for target population (no of sessions attended, content, duration and location, uptake and retention). * to determine most suitable outcome measures for future randomized controlled trial. * to identify any barriers in recruitment of participants. recruiting up to 75% of total sample will be a success criteria. methods design: mixed method feasibility randomised controlled trial study sites the participants will be recruited from outpatient departments of psychiatry and community settings in 7 cities of pakistan i.e. karachi, hyderabad, lahore, rawalpindi, multan, peshawar and quetta. sample size: a total of 90 individuals (45 in each arm) meeting the eligibility criteria will be recruited to participate in the study from different psychiatric units. randomization participants will be randomized into one of the two treatment conditions (ltp plus or tau) through computer generated algorithm.

Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual-v (dsm-v) diagnosed first episode psychosis, schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder. * parents (mother or father), age 18 year and above * parents (mother or father) having a child from birth to 36 months * parents (mother or father) living within the catchment area of recruitment site. * competent and willing to give informed consent * parents (mother or father) are stable on medication for at least 3 months prior to the intervention. exclusion criteria: * violation of any inclusion criteria * failure to perform screening or baseline examinations. * patients who will meet the criteria for a dsm-v diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for dsm-v alcohol or substance dependence (other than for nicotine) within the last 6 months * temporary resident unlikely to be available for follow up.
prophylactic corticosteroid to prevent covid-19 cytokine storm

Conditions: Covid-19

Summary: this is a phase ii pilot exploratory study designed to investigate if prophylactic treatment with short term steroids administered to high risk covid-19 patient might prevent cytokine storm and progression to respiratory failure. high risk is defined based on serologic markers of inflammation that include abnormalities of interleukin 6 (il-6), ferritin , d-dimer, lactate dehydrogenase (ldh), as well as lymphopenia and impaired o2 saturation prior to or on the 7th day of first symptom of covid-19.

to decrease the rate of progression to hypoxemic respiratory failure in high risk patients with covid-19, treated with prophylactic steroids during the first phase of the disease.

Eligibility criteria:
inclusion criteria: * all patients diagnosed with covid-19 will be registered on the study regardless pf their severity, but only those who meet high risk criteria will be treated with steroids. those who don't meet the criteria will only be registered with no need to collect further data except baseline labs and ct chest. they should sign the consent form and the data manager can collect the rest of the information. * patients older than 18 years diagnosed with covid-19 by polymerase chain reaction (pcr) or by rapid serological test will be eligible. cases who are immunoglobulin g (igg) positive but immunoglobulin m (igm) negative, will not be considered eligible unless they are positive for molecular pcr test. eligible patients will be registered on study on or before 7 days from first onset of symptoms. exclusion criteria: * any patient with life expectancy \< 1 month * any patient who is oxygen dependent * any patient with long standing history of severe chronic obstructive pulmonary disease (copd) * any patient who is chronically oxygen dependent because of previous existing lung disease * anyone with severely uncontrolled diabetes despite adequate management * anyone with active serious bacterial infection such as septicemia or pneumonia * anyone receiving tocilizumab (anti il-6 therapy) or plasma therapy * any patient already receiving steroids from another pre-existing illness

Keywords: severe acute respiratory syndrome (sars)-cov-2 virus
articulatory adaptation following oral cancer treatment

Conditions: Oral Cavity Squamous Cell Carcinoma; Speech Disorders

Summary: the goal of this longitudinal study is to learn more about the articulatory consequences of surgical oral cancer treatment. the main aims are to study the coordination and development of speech articulation of patients who will undergo surgical treatment for oral cancer longitudinally and whether individual differences in the reliance on auditory or tactile information can predict the success of speech compensatory strategies. participants will perform multiple speech tasks while motion tracking sensors track the articulatory gestures.


Eligibility criteria:
inclusion criteria: 1. diagnosed with t1 or t2 tumor in the oral cavity 2. at least 18 years old and able to provide informed consent 3. native speaker of dutch 4. has nog been treated for oral cancer before exclusion criteria: 1a. recurrence of disease (for patients) 1b. treated for oral cancer (for healthy controls) 2. speech problems (e.g., stuttering) 3. problems with sight or hearing that impede reading or understanding instructions. when glasses or a hearing aid resolve these problems, then participants are not excluded. 4. neurological or psychological disorders (e.g., stroke) 5. non-removable metal in, on or around the head (piercings, braces, pacemaker, electrodes) 6. self-reported signs of depression

Keywords: articulation
pilot study evaluating the impact of stress reduction on atherosclerotic : heart and mind study

Conditions: Atherosclerosis; Stress; Inflammation

Summary: the plot study aims to evaluate the effect of 8 weeks of stress reducing intervention on atherosclerotic plaque inflammation in adults, as quantified by positron emission tomography (pet) with fluorine-2-deoxy-d-glucose (fdg) in individuals with increased psychosocial stress.

this randomized controlled imaging study will be performed to evaluate the impact of mindfulness-based stress reduction via a mind body program on arterial inflammation in individuals with self-identified high levels of stress. individuals will undergo baseline fluorodeoxyglucose-positron emission tomography / magnetic resonance imaging and will then be randomized to the stress-reduction intervention group or no intervention groups by blocks of 2:1, with stratification by age and sex. the stress reduction sessions focus on developing an understanding of stress physiology and the physiology of the relaxation response, on developing a regular practice of eliciting the relaxation response, and on learning cognitive behavioral and positive psychology/resilience skills. during the screening period, patient acceptability for the study will be assessed based on medical history, concomitant medications, physical examination, and clinical laboratory test results. acceptability for study participation will be confirmed for subjects who identify as having increased levels of stress and/or a perceived stress scale score \>5. once the patient has passed screening, they will undergo baseline imaging followed by randomization and group assignment. approximately 12 weeks after randomization, all individuals will return for follow-up imaging and evaluation. thus, 2 fluorodeoxyglucose-positron emission tomography / magnetic resonance imaging scans will be performed throughout the study for baseline and follow up to assess the intervention's impact on the brain and arterial inflammation, along with changes in related positron emission tomography / magnetic resonance imaging imaging parameters. perceived stress scale will be delivered prior to fluorodeoxyglucose-positron emission tomography / magnetic resonance imaging, during both imaging visits to measure perceived psychological stress. during both imaging sessions, subjects will be exposed to overt faces to measure signals during brain imaging.

Eligibility criteria:
inclusion criteria: * • aged between 30-65 years * identifies as having increased levels of stress and/or has a perceived stress scale (pss) score \>5 at baseline, and is interested in participating exclusion criteria: * perceived stress scale (pss) score \<6
a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparison trial to investigate the effect of nalmefene on alcohol consumption reduction in patients with alcohol dependence (phase 3 trial)

Conditions: Alcohol Dependence

Summary: the efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparative trial. the superiority of nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol consumption.


Eligibility criteria:
inclusion criteria: * japanese males and females aged 20 or above who have signed the informed consent form * the patient has alcohol dependence, diagnosed according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) and confirmed by mini-international neuropsychiatric interview (m. i. n. i.) * the patient has a drinking risk level of high or above (\> 60 g for men and \> 40 g for women) both at the screening visit and at the randomization visit . exclusion criteria: * the patient with a current diagnosis or history of substance use disorders (except for alcohol, nicotine, and caffeine), according to dsm-iv-tr and confirmed by m. i. n. i. * the patient has reported current use of, or has tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines, barbiturates) at the screening test