Kornimate/medical-research-clean huggingface dataset:
study of gw685698x in patients with seasonal allergic rhinitis

Conditions: Rhinitis, Allergic, Seasonal

Summary: this study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. the focus of this study, seasonal allergic rhinitis (sar), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.


Eligibility criteria:
inclusion criteria: * informed consent * outpatient * diagnosis of seasonal allergic rhinitis with symptoms * able to comply with study procedures exclusion criteria: * significant concomitant medical condition * use of corticosteroids/allergy medications * laboratory abnormality * positive pregnancy test * allergy to any component of investigational product

Keywords: gw685698x allergic rhinitis seasonal allergic rhinitis
assessing efficacy of carboplatin and atezolizumab in metastatic lobular breast cancer

Conditions: Breast Cancer

Summary: this is a single arm multicenter non-randomized phase ii trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ilc


Eligibility criteria:
inclusion criteria: * signed and written informed consent * age 18 year or older * metastatic or incurable locally advanced lobular breast cancer with confirmation of the lobular histology and e-cadherin loss on a biopsy of a metastatic lesion. * metastatic lesion accessible for histological biopsies * evidence of progression of disease * a maximum of two lines of palliative chemotherapy * who performance status of 0 or 1 * evaluable disease or measurable according to recist 1.1 exclusion criteria: * leptomeningeal disease localization * history of having received other anticancer therapies within 2 weeks of start of the study drug * history of immunodeficiency, autoimmune disease, conditions requiring immunosuppression * prior treatment with immune checkpoint blockade * live vaccine within 2 weeks prior to start of study * active other cancer * active hepatitis b

Keywords: lobular metastatic or incurable locally advanced cancer disease progression on endocrine therapy in advanced setting
fractional flow reserve-guided stenting versus medical therapy in atherosclerosis renal artery stenosis

Conditions: Renal Artery Stenosis Atherosclerotic; Secondary Hypertension Renal Arterial

Summary: although randomized trials have demonstrated there is no benefit of renal-artery stenting in addition to medical therapy for patients with atherosclerosis renal artery stenosis, many patients indeed gained benefit in daily practices after stenting, such as reduction in blood pressure and recovery in renal functions. one important gap is that there is no universal standard to determine whether to stent in these patients. fraction flow reserve (ffr) has been studied for many year in chronic coronary heart disease and ffr-guided revascularization strategy is known to be better than both angiography-guided revascularization and medication alone. based on the primary finding of fair-pilot study (nct05732077), ffr-guided renal artery stenting is practical. the overall purpose of the fair trial is to compare the clinical outcomes and safety of ffr-guided stenting plus optimal medical treatment (omt) versus omt alone in patients with renal-vascular hypertensive patients. with the 'all comers' design, participants met the inclusive/exclusive criteria will be enrolled, and hyperemic ffr induced by dopamine will be measured in all participants. if ffr is ≥0.80, patients will be treated with omt alone and follow up. if ffr is \<0.80, participants will be randomized to stenting in the renal artery plus omt or omt alone on a 1:1 ratio. the blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring, all participants will be followed up for 1 year.


Eligibility criteria:
inclusion criteria: * with recorded hypertension, and the blood pressure is not controlled (daytime mean sbp ≥135 mmhg and/or dbp ≥85 mmhg based on abpm) on 2 or more classes of anti-hypertensive drugs; * evidence of renal artery stenosis and undergoing renal artery angiography; * able to follow the study protocol and provide informed consent; * renal artery angiography shows at least 1 main artery with stenosis of 50%-90%, and the diameter is ≥ 4.0mm. exclusion criteria: * sbp ≥200mmhg and/or dbp ≥120mmhg at the day or randomization; * fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis; * pregnancy or unknown pregnancy status in female of childbearing potential; * participation in any drug or device trial during the study period; * any stroke/tia, or with ≥70% stenosis of carotid artery; * any major surgery, myocardial infarction or interventional therapy 30 days prior to study entry; * lvef \<30%; * comorbidity condition causing life expectancy ≤1 year; * allergy to contrast or any of the following: aspirin, clopidogrel; * previous kidney transplant; * previous renal artery bypass surgery or stent intervention; * kidney size less than 8 cm measured by ultrasound; * local lab serum cr \>3.0 mg/dl (265.2μmol/l) on the day of randomization; * reference vessel size \ 8 mm.
the effect of peer-guided pilates exercise on premenstrual syndrome symptoms and healthy lifestyle behaviors: a randomized controlled study

Conditions: Premenstrual Syndrome

Summary: this project is to examine the effect of pilates exercise, which is applied by university students under the guidance of peers, on premenstrual syndrome symptoms and healthy lifestyle behaviors. methods: the research to be carried out within the scope of the project is randomized controlled and has an experimental research design. the population of the research consists of 385 female students studying at the department of midwifery at istanbul university-cerrahpaşa faculty of health sciences. in the study, it is aimed to reach all students without making a sample calculation in order to identify the students with pms symptoms among all students. students who score 110 and above on the premenstrual syndrome scale (pmss) will be considered to have pms symptoms. the sample size of the students showing pms symptoms was determined by using the g\*power (3.1.9.2) program and considering the 0.05 margin of error and data loss, according to 95% power and medium effect size; 27 people should be included in the experimental group and 27 people in the control group. in determining the groups, the participants will be assigned to the experimental and control groups using the "randomizer.org" program. students included in the research will be given information about the study and will be presented with an "informed consent form" and a "volunteer consent form". while the experimental group will be given pilates exercises, under the guidance of a peer, for half an hour twice a week for six months, the control group will maintain their routine habits. at the beginning of the study, data will be collected with the "personal information form", "premenstrual syndrome scale (pmsö)" and "healthy lifestyle behaviors scale-ii (sybds-ii)". in the third and sixth months of the study, the hypotheses will be tested by applying pmss and hlbs-ii. the data obtained in the research will be entered into the database in the ibm spss 25.0 (statistical package for the social sciences) program and all necessary statistical analyzes will be performed in the same program.


Eligibility criteria:
inclusion criteria: * being an undergraduate student studying in the midwifery department of istanbul university-cerrahpaşa faculty of health sciences, * having a score of 110 and above in pmss, * having an internet connection, * the zoom program is installed and ready to use on its electronic device (phone or computer), * having the environment to do pilates. exclusion criteria: * being under the age of 18, * changes in menstruation characteristics after the diagnosis of pms, * having a chronic or physical illness that prevents pilates exercise.

Keywords: healthy living peer guidance pilates exercise premenstrual syndrome
efficacy of a dietary supplementation with lactobacillus reuteri for digestive health in an elderly population

Conditions: Constipation; Diarrhea; Indigestion; Reflux; Abdominal Pain

Summary: the purpose of this study is to investigate the effect of a daily supplement consisting of the probiotic bacteria, lactobacillus reuteri, on the digestive health among persons 65 years and older.

the overall purpose of the study is to investigate the effect of daily supplementation, during a three months period, of l. reuteri on digestive health in an elderly swedish population, residing in the municipality of örebro. in addition an extensive screening of the study population in regard of overall health status, functionality and well-being as well as the composition of the gut microbiome will be assessed prior study start through the collection of baseline data

Eligibility criteria:
inclusion criteria: * age ≥ 65 years * informed consent signed by study participant or legal guardian exclusion criteria: * known gastrointestinal disease, with strictures, malignance's and ischemia. * inflammatory bowel diseases (ibd) * participation in other clinical trials in the past three months.
efficacy and safety of calcipotriol plus betamethasone dipropionate gel in scalp psoriasis

Conditions: Psoriasis of Scalp

Summary: the purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis. the primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.


Eligibility criteria:
inclusion criteria: * scalp psoriasis amenable to topical treatment with a maximum of 100 g of medication per week * clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs * extent of scalp psoriasis involving more than 10% of the total scalp area * investigator's assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs * disease severity on the scalp graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity exclusion criteria: * puva or grenz ray therapy within 4 weeks prior to randomisation * uvb therapy within 2 weeks prior to randomisation * systemic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation * systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin d analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation * any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation * topical treatment of the face, trunk and/or limbs with very potent who group iv corticosteroids within 2 weeks prior to randomisation * current diagnosis of erythrodermic, exfoliative or pustular psoriasis
bowel function after laparoscopic colon surgery: effect of iv lidocaine

Conditions: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis

Summary: patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.

the aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early postoperative physical activity recovery of patients scheduled for laparoscopic colorectal resection. the study focuses on patients with colorectal disease, which receive the laparoscopic (assisted) surgical approach. it is hypothesized that in those patients receiving perioperative and post-operative intravenous lidocaine, bowel function recovery will be faster, probably as a result of a significant opioid sparing, less pain and attenuated inflammatory response.

Eligibility criteria:
inclusion criteria: * scheduled to undergo laparoscopic colorectal resection exclusion criteria: * patients who have trouble to understand, read or communicate either in french or in english * dementia * patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity * patients suffering from severe cardiac or respiratory disease (status asa iv * patients suffering from metastatic carcinoma * patients who have a history of chemoradiation within the six months preceding surgery * allergy to lidocaine * morbid obesity * patients with chronic opioid use.

Keywords: 60 patients scheduled to have a colorectal surgery recruit at montreal general hospital
placebo-controlled multi-centre double-blind trial for adults with extended-release methylphenidate for adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: investigation of efficacy and tolerability of extended-release mpd in adults with adhd, compared with a placebo, and to acquire knowledge through long-term observation of adults


Eligibility criteria:
inclusion criteria: * patient treated as outpatient or inpatient * patient has a good command of german * score of 85 or greater in the iq test (mwt-b) * diagnosis of adhd according to adhd-cl (dsm iv) and wri-wraadds \> 28 points * adhd symptoms have existed since childhood (wurs-k \>= 30) * body mass index \>= 20 * willing to eat breakfast * patient is willing and able to come to the observation appointments * written consent of the patient to participate in the study exclusion criteria: * treatment with psychostimulants in the past 2 weeks * inconsistencies in the caars- s:l \>= 8 (inconsistency index) * shift work or night work * alcohol, medication or drug dependency in the past 6 months or manifest drug abuse * diagnosis of a psychosis (skid-i) * epileptic attacks in the past * eeg results which suggest epilepsy * clinically relevant liver disease * clinically relevant hyperthyroidism (relevantly elevated tsh, t4) * acute depressive episode according to icd-10 f32.2 and icd-10 32.3 (skid-i) * illnesses with schizophrenic symptoms (skid-i) * acute manic episode, bipolar disorder (skid-i) * diagnosis of a tic disorder * acute anorexia * acute prominent panic disorder and generalised anxiety (skid-i) * clinically relevant kidney disorders * known high blood pressure * known occlusive arterial disease * known angina pectoris * known coronary heart disease and state after myocardial infarction * known tachycardial arrhythmias * post-stroke status * known elevated intra-occular pressure * known enlarged prostates * participation in a clinical study within the past 30 days * participation in this study at an earlier point in time * simultaneous participation in another clinical trial * women of child-bearing age without adequate contraception * patients with terminal illness (e.g. cancer) * pregnancy (positive pregnancy test) or lactation period

Keywords: adhd attention deficit hyperactivity disorder adult methylphenidate hydrochloride medikinet retard long-term observation controlled clinical trial safety randomized, double-blind, placebo-controlled trial treatment central nervous system stimulants therapeutic uses
intracranial arterial stenosis and resin of cannabis use

Conditions: Cannabis Users

Summary: there is an association between intracranial arterial stenosis and ischemic stroke in young adults. the aim of this study is to evaluate the prevalence of intracranial arterial stenosis in asymptomatic regular resin of cannabis users in comparison with control subjects.


Eligibility criteria:
inclusion criteria: * regular resin of cannabis users exclusion criteria: * taking vasoactive medications * taking other illicit drugs
optimizing protein patterns for skeletal muscle preservation and sleep in the medical management of parkinson disease

Conditions: Parkinson Disease

Summary: the purpose of this pilot study is to generate preliminary data on the impact of the dietary protein pattern on markers of skeletal muscle health and drug efficacy in parkinson disease.

parkinson's disease (pd) is a complex neurological disease that affects \~6.1 million people worldwide - mostly older adults \>60 years. the most effective treatment for pd is dopaminergic therapy, particularly levodopa (ldopa). people with pd have variable responses to ldopa, including degrees of motor fluctuations (mf) throughout the day. the half-life of ldopa is \~1.5 h and therefore, dosage and timing are essential to mitigate mf. ldopa is a large neutral amino acid (lnaa), and the bioavailability of ldopa is compromised when simultaneously ingested with lnaa (e.g., leucine). both ldopa and lnaas from food are absorbed through the same intestinal transporter, but lnaas from food are preferentially absorbed by the enterocyte, limiting the bioavailability of ldopa. thus, the scientific community often recommends the protein-redistribution diet (prd). with prd, patients limit protein (\ 30 g of protein, in a single meal, will not sufficiently increase muscle protein synthesis. additionally, the impact of the prd on skeletal muscle quality and function has not been determined, and it is unclear, based on prior studies, whether the prd enhanced drug absorption. therefore, the objective of this study is to address these gaps in knowledge. this study will quantify the effects of dietary protein pattern on skeletal muscle in pd; determine the effects of dietary protein pattern on sleep quality in pd. this study is an acute, 5-week, crossover intervention with pd participants randomly assigned to first adhere to either the pcd or prd. participants will receive diet prescriptions and meal plans for their respective diet, and outcome measures will be assessed at days 0, 14, 21, and 35.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic pd for 5 or more years * 45 years or older * on a stable levodopa regimen for 3 or more months * self-reported to experience motor fluctuations exclusion criteria: * following a specific diet that would preclude participation * renal disease * deep brain stimulation * known narcolepsy * untreated sleep apnea * any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures

Keywords: parkinson disease diet protein skeletal muscle sleep
effects of inspiratory muscle training on breathing pattern in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Muscle Weakness Conditions

Summary: the improvement in inspiratory muscle function might result in beneficial changes in breathing pattern during whole body exercise. the hypothesis is the effect of inspiratory muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing pattern during an incremental cycle exercise.


Eligibility criteria:
inclusion criteria: * clinically stable copd patients * maximal inspiratory pressure \<100% of the predicted normal value exclusion criteria: * major comorbidities preventing successful participation in an 8 week exercise training intervention
bleeding events and oral anticoagulant treatment in non-valvular atrial fibrillation

Conditions: Non-valvular Atrial Fibrillation

Summary: in a population of patients with non-valvular atrial fibrillation (nvaf), and treated with oral anticoagulants (oac) in routine clinical practice in england, this study will describe patients treated with each oac, and to estimate and compare event rates of treatment discontinuation, bleeding, and healthcare resource utilisation (hcru) across oac treatments.


Eligibility criteria:
inclusion criteria: 1. have a prescription for apixaban, rivaroxaban, dabigatran, or vka during the study period 2. are ≥ 18 years of age at index date 3. have ≥ 12 months of computerised medical data prior to index date (date of oac initiation) 4. have a record of af on or ever prior to index date exclusion criteria: 1. have a record for a valvular condition that is considered causal for af on or ever prior to index date 2. have a history of the oacs which are prescribed during the study period (ie, history of index oac, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran, or vka) 3. have more than 1 oac exposure which starts on the same date
interactions of brain regions in visuomotor adaptation

Conditions: High Intensity Focused Ultrasound; Deep Brain Stimulation

Summary: the purpose of this study is to better understand the roles the cerebellum, basal ganglia, and thalamus play in motor learning. patients undergoing high intensity focused ultrasound (hifu) treatment will be receiving an ablation procedure to their thalamus as a part of their medical procedure. participation in this study will include completing a behavioral task before and after the procedure to see how motor learning task performance differs with and without the thalamus. similarly, patients undergoing deep brain stimulation (dbs) treatment will have an electrode implanted in their thalamus as a part of their medical procedures. participation in this study will include completing the motor learning task performance "on" and "off" thalamic electrical stimulation.


Eligibility criteria:
inclusion criteria: * be a patient receiving either high intensity focused ultrasound treatment or deep brain stimulation treatment for tremor * able to provide informed consent and complete study procedures * must speak english * age 18-85 exclusion criteria: * not receiving one of the specified inclusion criteria * unable to provide consent or complete study procedures * women who self-report pregnancy * patients who are currently incarcerated

Keywords: ultrasound thalamus cerebellum basal ganglia deep brain stimulation high intensity focused ultrasound