Kornimate/medical-research-clean huggingface dataset:
acute and long-term cardiovascular toxicity after modern radiotherapy for breast cancer

Conditions: Breast Neoplasms; Cardiovascular Diseases

Summary: in europe, breast cancer is by far the most common form of cancer diagnosed in women today, accounting for 29% of all cases. the 5-year survival rate is approximately 90%. surgery is usually combined with radiotherapy (rt), anthracyclines, aromatase inhibitors and/or trastuzumab (herceptin) which all have improved the life expectancy and survival in breast cancer patients. unfortunately, rt is associated with a broad spectrum of cardiovascular diseases, which includes coronary artery disease, valvular dysfunction, congestive heart failure and stroke, and is the most common non-malignancy cause of death. during the last two decades, rt regimens for breast cancer have changed and the doses of radiation to which the heart is exposed are now potentially lower due to new and improved rt techniques. however, there are no data on whether these new regimes decrease the risk of cardiovascular disease. in this study the incidence and prevalence of cardiovascular diseases will be estimated 8 and 15 years after both conventional and laser assisted breath controlled rt, and compared with cardiovascular diseases in the general female population. a further aim is to evaluate signs and prevalence of acute cardiotoxicity from rt with the use of cardiac magnetic resonance imaging, coronary fractional flow reserve, ecg and inflammatory and cardiac biomarkers and to investigate whether these signs can predict later cardiovascular disease. the importance of traditional cardiovascular risk factors (age, hypertension, hypercholesterolemia, smoking habits and physical activity, as registered before rt) will also be evaluated.

the study is an observational study. in 2007-2012 conventional rt was part of the common treatment regime for breast cancer, but has recently been replaced by laser assisted breath controlled rt. thus, two cohorts of breast cancer patients treated with different modes of rt will be followed for the development of cardiovascular disease for the subsequent 15 years.

Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer * expected life-expectancy above 10 years exclusion criteria: * not willing to participate

Keywords: radiotherapy biological markers magnetic resonance imaging echocardiography tomography, x-ray computed risk factors heart quality of life
efficacy and safety of concomitant montelukast sodium and levocetirizine dihydrochloride in perennial allergic rhinitis (par) patients

Conditions: Perennial Allergic Rhinitis

Summary: the purpose of this study is to demonstrate that the efficacy of concomitant montelukast sodium and levocetirizine dihydrochloride is superior to that of levocetirizine and montelukast monotherapies and to compare the safety and tolerability of concomitant montelukast sodium and levocetirizine dihydrochloride to those of levocetirizine and montelukast monotherapies in perennial allergic rhinitis (par) patients.

randomized, double-blind, active-controlled, multicenter, phase 3 trial

Eligibility criteria:
inclusion criteria: * patients with at least 2 years history of par prior to the study * positive results of skin prick test * patients who provided a signed written informed consent form * patients who are able and willing to complete subject diaries * patients who agree to maintain consistency in their surroundings throughout the study period * at visit, 2 patients whose symptom scores recorded in the subject diary meet all of the followings during the last one week of baseline period a.daily mean of 6 points or above for daytime nasal symptom score (maximum 12 points) b.daily mean of 1.8 points or above for daytime nasal obstruction symptom score (maximum 3 points) exclusion criteria: * patients also with non-allergic rhinitis with different causes. * patients with severe asthma who meet the followings. * presence of nasal polyps or any clinically important nasal anomaly. * history of acute • chronic sinusitis within 30 days of visit 1 * history of intranasal / eye surgeries within 3 months of visit 1 * initiation of immunotherapy or dose modification within 1 month prior to visit 1 * upper respiratory infections including cold and systemic infections within 3 weeks of visit 1. * chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug * at visit 2, patients who recorded daytime nasal symptom scores for fewer than 4 days in the subject diary during the last one week of baseline period

Keywords: par
an investigation into the effects of acute exercise on activities of daily living and cognition in older adults

Conditions: Physical Inactivity

Summary: research has demonstrated the positive effects of chronic exercise on cognitive functioning and performance of activities of daily living (adls). however, minimal research exists regarding the effects of acute exercise. to address this gap in the literature, the present study investigated the effect of an acute bout of exercise on executive functions, balance, and adls among healthy older adults. based on the current literature, we expected participants in the exercise group to perform better on executive function tasks and adls compared to participants in the control group.


Eligibility criteria:
inclusion criteria: * over the age of 60. exclusion criteria: * health complications preventing the ability to cycle on a recumbent bike and walking at moderate intensity as indicated by the health history questionnaire, taking anti-depressant medication, or having color blindness.
combined stn/snr-dbs for the treatment of refractory gait disorders in parkinson's disease

Conditions: Parkinson's Disease

Summary: 12 patients with idiopathic parkinson's disease and refractory gait disturbances under best individual subthalamic nucleus stimulation and dopaminergic medication will be included into this randomised double-blind cross-over two-armed clinical trial. the treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus \[stnmono\] and (ii) combined stimulation of distant electrode contacts located in the subthalamic nucleus and caudal border zone of stn and substantia nigra pars reticulata \[stn+snr\].

a composite 'axial score' including the major clinical and anamnestic items on gait, posture and balance function from updrsii (items 13-15) and updrs iii (items 27-31) constitutes the primary outcome measure. secondary outcome measures include specified clinical and anamnestic assessments on freezing of gait, balance, quality of life, non-motor symptoms, impulsivity, impulse control and neuropsychiatric symptoms. the aim of the present trial is to investigate the efficacy and safety of combined stimulation on subthalamic and nigral electrode contacts \[stn+snr\] in refractory hypokinetic gait disturbances compared with \[stnmono\] (active comparator). the results will clarify, whether the combined \[stn+snr\] stimulation improves otherwise refractory gait disturbances in pd.

Eligibility criteria:
inclusion criteria: * written informed consent * age: between 18 and 80 years * idiopathic parkinson's disease (according to the "british brain bank criteria" (hughes, 1992) including genetic forms and therapy with stn-dbs (activa pulse generators) at least six months from surgery * optimized subthalamic stimulation at study enrolment (refer 'treatment' section) * gait disturbance refractory on best individual stn-dbs (stnmono) and dopaminergic therapy: 'gait score' in the best clinical \[medon/stnmono\] condition ≥ 12 * clinical and image-guided (and facultatively electrophysiological) confirmation of (i) one of the two rostral contacts of the quadripolar electrode localized in the stn area, and (ii) the caudal contacts in the border zone of stn and snr. * dopaminergic medication constant for at least four weeks prior to study enrolment * disease duration ≥ 5 years exclusion criteria: * cognitive impairment (mini mental state exam \< 25) * participation in other clinical trials within the past three months and during enrolment in our study * suicidality, psychosis * other severe pathological chronic condition that might confound treatment effects or interpretation of the data * pregnancy * acute adverse events from stimulation on contacts in the caudal stn / snr border interfering with the intended stimulation protocol

Keywords: parkinson's disease gait deep brain stimulation substantia nigra pars reticulata subthalamic nucleus
cannabidiol solution for the treatment of behavioral symptoms in older adults with mild cognitive impairment or alzheimer's dementia

Conditions: Alzheimer Disease; Anxiety; Agitation,Psychomotor; Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Summary: this is an open label, eight week, clinical trial of a proprietary high cbd/low thc sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (mci) or mild to moderate alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: 1. diagnosis of probable alzheimer's dementia via criteria from mckhann et al., or mci 2. mmse score of 15-30 (inclusive) 3. clinically significant degree of anxiety, as defined by a clinical impression total column score of ≥4 on the anxiety domain of the npi-c 4. a health care proxy available to sign consent on behalf of the participant (if applicable) 5. a caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits 6. participants and their study partner must be fluent in english 7. must be 55-90 years old (inclusive) exclusion criteria: 1. serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes. 2. seizure disorder 3. lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the mini 4. current episode of major depression, as determined by the mini 5. active substance abuse or dependence within the past 6 months, as determined by the mini 6. delirium (as measured by the cam) 7. current inpatient hospitalization 8. current regular use of cannabinoid products (\>1 use per month) 9. positive urine screen for thc at the screening or baseline visit 10. allergy to coconut 11. participants taking strong inhibitors or inducers of cyp3a4 (e.g. fluconazole, fluoxetine, fluvoxamine, ticlopidine, st. john's wort, etc.), cyp2c19 (ketoconazole, erythromycin, etc.), or anti-epileptic drugs

Keywords: cannabidiol older adults dementia
measurement of intravaginal and intra-abdominal pressure and pad test during sports activities (sportvagpres)

Conditions: Stress Urinary Incontinence; Athletes

Summary: to compare the impact of selected physical activities on pelvic floor and stress urinary incontinence in sportwoman.

this is an observational comparative pilot study in which we will compare intravaginal and intra-abdominal pressure and an innovative pad test in 5 female athletes with stress urinary incontinence and 5 without incontinence.

Eligibility criteria:
inclusion criteria * nulliparous women * aged 18-35 * high-intensity physical activity * performed sport at least three days per week, 90 minutes per day, for more than two years exclusion criteria: * handicapped sportswomen * performance of various kinds of sport * no regular sport activity * performance of sports for less than two years * after childbirth * surgical treatment of gynaecological and urological illnesses * urinary tract infection * disease of respiratory tract * not sufficiently completed questionnaires * refusal to participate * body mass index greater than 30 (bmi = m/h2, where m = body weight in kilograms and h = body height in metres) * symptoms of overactive bladder

Keywords: stress urinary incontinence athletes intravaginal pressure intra-abdominal pressure
validation of a predictive algorithm to determine the effectiveness of orthokeratology for myopia control

Conditions: Myopia

Summary: this is a prospective study to validate a predictive algorithm for identifying fast progressing myopes.

orthokeratology (ortho-k) has been demonstrated to slow myopic progression and reduce axial elongation in young patients, but this treatment is limited by the need for contact lens wear, which is the common cause for keratitis in children, and therefore cautious use is recommended. there is a need to identify the patients that could benefit most from this treatment. in order to do so, we conduct a retrospective study and create a large database (n = 10,000) of de-identified data to train an algorithm for identifying fast progressing myopes. in addition, we will perform a prospective study to validate this predictive algorithm and determine the effectiveness of orthokeratology among different individual patients in china.

Eligibility criteria:
inclusion criteria: * -6.0d≤ser≤-0.5d * astigmatism≤2.0d exclusion criteria: * contraindications of wearing ortho-k. * diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases. * currently involved in other clinical studies.
the role of treatment expectation in exposure training with spider fearful participants

Conditions: Phobic Disorders

Summary: this study evaluates the role of treatment success expectation in spider fearful individuals on the actual treatment success. half of participants will have positive treatment success expectations, while the other half will have neutral treatment outcome expectations.

the investigator plan to conduct a randomized, single blind study with two parallel groups. both groups undergo the same standardized psychotherapeutic intervention, i.e. exposure training. all participants will receive the same exposure training in groups of maximum three participants of the same study group. the two study groups only differ regarding the induced treatment expectations towards the effects of the exposure training. while the experimental group will get an open administration of treatment and be informed in order to have a positive treatment expectation, the comparator group will receive a hidden administration of treatment and get neutral information, thus treatment expectations will be neutral. study members conducting the exposure training with the participants will not be aware of the allocation of the study participants. study participants will be informed about the aim of the allocated condition, but they will be blind to the aim of the study in order to induce the specific expectation. differences in treatment outcomes are compared between both groups to investigate the association with treatment expectation.

Eligibility criteria:
inclusion criteria: * good knowledge of german language * fulfilling criteria a-e and g for specific phobia according to diagnostic and statistical manual of mental disorders (dsm)-v (fulfilling criteria f is not an inclusion criteria) * marked fear or anxiety about spiders * spiders almost always provoke immediate fear or anxiety * spiders are actively avoided or endured with intense fear or anxiety * the fear or anxiety is out of proportion to the actual danger posed by spiders * the fear, anxiety, or avoidance is persistent, typically lasting for 6 months or more * the disturbance is not better explained by the symptoms of mental disorders as agoraphobia, obsessive-compulsive disorder, posttraumatic stress disorder, separation anxiety or social anxiety disorder exclusion criteria: * acute or chronic psychiatric disorder * currently in psychological or psychiatric treatment * knowledge of exposure training

Keywords: psychotherapy exposition spider fear expectation
molecular testing to direct extent of initial thyroid surgery

Conditions: Thyroid Cancer

Summary: the research study consists of the participant agreeing to 1) the use of preoperative molecular testing (thyroseq) to guide extent of initial surgery and 2) the prospective collection of medical record data related to treatment of thyroid cancer.

the aim of the proposed pilot study is to use a clinical algorithm that incorporates molecular, clinical and radiographic factors to inform surgical management. this study is the first to propose molecular-directed surgical management for this commonly diagnosed cancer.

Eligibility criteria:
inclusion criteria: * thyroid nodule is \>1.5 cm * preoperative fna biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer exclusion criteria: * prior thyroid/parathyroid surgery * clinical indications for total thyroidectomy including hypothyroidism, history of head or neck radiation when \<18 years old * recurrent laryngeal nerve dysfunction * diagnosis of concurrent primary hyperparathyroidism

Keywords: thyroid cancer thyroid nodule thyroidectomy personalized medicine
identification of physiological data by a wearable monitor in subjects suffering from major depression disorders

Conditions: Major Depressive Disorder

Summary: to evaluate, over a period of six months, the links between physiological data collected such as electrodermal activity (or galvanic skin response), motor activity measured by accelerometer, heartbeat measured by photoplestimograph and the clinical evaluation performed by the physician, in patients suffering from major depression disorder.


Eligibility criteria:
inclusion criteria: * patient able to give written informed consent, - presenting a major depressive episode defined according to dsm v criteria, - presenting a madrs score ≥ 20 - able to understand all study procedures and follow-up exclusion criteria: * - inability to wear the wearable monitor for the duration of the study (6 months) * patient with a severe medical condition at the discretion of the investigator (neurological, rheumatological, etc.) * resistant depression * chronic depression, dysthymia * depression with psychotic features not congruent with mood, schizophrenia disorder * depression with catatonic features * substance use disorder in the last 6 months * extreme sports during the conduct of the study * pre-existing skin infection at the wearable monitor site * pregnant or lactating woman * participation in another drug or medical device study * inability to give informed consent
longterm outcome after ventricular septal defect closure

Conditions: Ventricular Septal Defect

Summary: isolated ventricular septal defect (vsd) is a well know congenital heart anomaly. if discovered in infancy or early childhood surgical intervention can be of necessity depending on the size of the defect, to assure a healthy adulthood. the long-term results of surgical closure of vsd in childhood are good and after surgery the children are considered as equally healthy and physically fit as their peers. however, there is inconsistency in data regarding follow-up on this group of patients, in relation to exercise capacity as a measure of the cardiopulmonary function. to further approach this matter the post-operative cardiac factors of these patients have to be investigated. with this study the investigators intend to examine the long-term outcome on cardiac output after heart surgery in vsd-patients. it presents an opportunity to also evaluate the correlation between cardiac output determined by gas-exchange and by mri. the overall objectives of this study are to 1) examine whether vsd-operated patients have reduced cardiac output during exercise in comparison with matched controls, and furthermore 2) to evaluate a correlation between cardiac output measured by mri and cardiac output determined by gas-exchange. the project is designed as a long-term follow-up and method study. a cohort of 20 children who in the 1990's underwent surgical closure of a congenital vsd will be asked to participate in this study. an equal amount of healthy young adults, will function as control group. each participant will complete two different exercise tests, a mri of the heart during lower body exercise on a supine ergometer bicycle, and a supine ergometer bicycle exercise test. this data can be used for comparing cardiac output between the test groups, and furthermore it allows an evaluation of the correlation between the two methods. vsd is as described, the most common congenital heart anomaly. if not intervened with in childhood, it can cause severe heart complications later in life. it is unclear whether this intervention can cause long-term impact on patients exercise capacity, and for that reason it is of great importance that we strive for improving our knowledge of the long-term postsurgical outcome after vsd-closure.


Eligibility criteria:
inclusion criteria: * patients: surgical correction of vsd between 1990 and 1995 * controls: 18-25 years old, with no medical records of heart disease exclusion criteria: * missing journal * operation by ventriculotomy * other congenital anomalies * metallic implants or foreign objects * pregnancy
a comparative study of subjects past their final follow-on visit

Conditions: Cardiomyopathies; Heart Diseases; Aging Frailty

Summary: a comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. subjects will be selected from a pool of previous interdisciplinary stem cell institute trial participants.

a comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. subjects will be selected from a pool of previous interdisciplinary stem cell institute trial participants. subjects will be followed during the study depending on the initial visit for this trial. the time point at which they are followed will depend on the subject's injection date in the previous trial. depending on the subjects first treatment date (day of injection) in the previous interdisciplinary stem cell institute (isci) cardiovascular clinical trial, subjects may be eligible for one to four study visits in this trial. those who do not have a three, five, seven, nine or eleven year visit may receive informed consent at the year thirteen visit. thus, subjects can be enrolled and consented at any visit if the previous eligible visit was missed.

Eligibility criteria:
inclusion criteria: * be 18 years of age and older * provide written informed consent * have been previously enrolled or currently participating in an investigator-initiated cardiovascular trial at isci (in cases where participants are currently enrolled in another clinical trial they are still able to participate concurrently in this trial). exclusion criteria: * have known, serious radiographic contrast allergy, which cannot be managed with premedication only if able to undergo mri or ct. * have a history of drug or alcohol abuse within the past 24 months

Keywords: stem cells cardiovascular quality of life cardiomyopathy