Kornimate/medical-research-clean huggingface dataset:
study of nerve reconstruction using avance in subjects who undergo robotic assisted prostatectomy for treatment of prostate cancer

Conditions: Peripheral Nerve Injury; Prostate Cancer; Radical Prostatectomy; Nerve Reconstruction; Cavernous Nerve Injury

Summary: the purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. the study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age, but ≤70 years of age; * iief ef domain\*1 score ≥ 22; * be able to effectively communicate with study personnel; * be considered by the physician to be available for subsequent visits; * be willing to comply with all aspects of the treatment and evaluation schedule over a 24 month duration; * sign and date an irb-approved written informed consent prior to initiation of any study procedures, including screening procedures; and * require radical prostatectomy. exclusion criteria: * prior surgery in the last 6 months which could affect sexual function; * history of peyronie's disease; * significant neurological disorder (i.e. multiple sclerosis, peripheral neuropathy); * treatment for major psychiatric disorders; * history of penile implant or prosthesis; * history of diabetic neuropathy; * life expectancy of less than two years; * concurrently involved in another investigational study; * uncontrolled hypertension with systolic bp \>200mmhg or diastolic bp \>115mmhg is present at screening; * currently receiving or planned treatment with chemotherapy or radiation therapy; * diagnosis of bony metastasis; * known allergy or severe intolerance to pde-5 inhibitors; or * cardiac pacing equipment or other electro-mechanical devices which preclude the use of cavermap™ neurostimulator.

Keywords: nerve repair erectile function prostate cancer robot assisted laparoscopic prostatectomy continence
efficacy in controlling glycaemia with victoza® (liraglutide) as add-on to metformin vs. oads as add-on to metformin after up to 104 weeks of treatment in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of the trial is to investigate efficacy in controlling glycaemia with victoza® (liraglutide) as add-on to metformin background treatment vs. oads as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: - male or female at least 18 years of age at the time of signing informed consent - subjects diagnosed (clinically) with type 2 diabetes equal to or above 90 days prior to the screening visit - stable daily dose of metformin as monotherapy equal to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit - hba1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit exclusion criteria: - female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) - treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. an exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness - receipt of any investigational medicinal product within 30 days before the screening visit - any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
rtms pilot for anxiety

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to evaluate the safety and tolerability of 1 hz parietal stimulation in anxiety. our approach will be to administer 1 week of open-label accelerated 1 hz parietal rtms (5 days, 8 sessions/day, 600 pulses/session) and measure the effect of this neuromodulation on aps, and short term memory in a cohort of anxiety gad patients.

aims 1 and 2 of this project will be tested using a within-subjects design where anxiety patients will receive a 5-day course of accelerated 1 hz rtms (8x session x 600 pulses/session) to the right ips. in aim 1, we will test the effects of this stimulation on arousal during the npu threat task (npu section). in aim 2 below, we will test the effects of this stimulation on arousal-related attention control deficits using the vstm task (vstm section). subjects will undergo 7 study visits spaced over a roughly 3-week period depending upon availability. first, subjects will have a pre-stimulation test visit. on this visit they will undergo the following procedures: 1) motor threshold testing, 2) noise habituation, 3) shock workup 4) npu task, 5) vstm task. then they will have 5 rtms visits. on these visits, subjects will receive 8 trains of 1 hz rtms (600 pulses per train, each separated by \~50 min). finally, they will have a post-stimulation test visit, which will included the noise habituation, shock workup, npu task, and vstm task.

Eligibility criteria:
inclusion criteria * meet the dsm-v criteria for an anxiety disorder (i.e. generalized anxiety disorder, social anxiety disorder, panic disorder, etc.) * subjects must be 18-50 years old * able to give their consent * right-handed exclusion criteria * non-english speaking * any significant medical or neurological problems * current or past (non-anxiety) axis i psychiatric disorder(s), active or history of active suicidal ideation * alcohol/drug problems in the past year or lifetime alcohol or drug dependence * any medical condition that increases risk for tms * history of seizure * history of epilepsy * increased risk of seizure for any reason * pregnancy, or positive pregnancy test * hearing loss
dispensing evaluation of printed etafilcon a with polyvinylpyrrolidone (pvp)

Conditions: Myopia

Summary: the purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon a with polyvinylpyrrolidone (pvp).


Eligibility criteria:
inclusion criteria: 1. the subject must be at least 18 years of age and less than 40 years of age. 2. the subject must be a light eye caucasian female habitual soft contact lens wearer. 3. the subject must be concept acceptors for cosmetic and/or limbal ring lenses. a concept screening questionnaire will be used and top 3 box (in 5-point scale) is eligible. 4. the subject must have no known ocular or systemic allergies that might interfere with contact lens wear. 5. the subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear. 6. the subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00d. 7. any cylinder power must be ≤ -0.75d. 8. the subject must have visual acuity best correctable to 20/25+3 or better for each eye. 9. the subject must have normal eyes (no ocular medications or ocular infection of any type). 10. the subject must read and sign the statement of informed consent. 11. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. exclusion criteria: 1. ocular or systemic allergies or disease which might interfere with contact lens wear. 2. systemic disease or use of medication which might interfere with contact lens wear. 3. clinically significant (grade 3 or worse) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. 4. clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 5. any ocular infection. 6. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. any color deficiencies - to the best of the subject's knowledge. 8. pregnancy or lactation. 9. diabetes. 10. infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. hiv). 11. habitual contact lens type is toric, multifocal, or is worn as extended wear.
understanding the role of monoaminergic neurotransmitters in cognitive functions using fast-cyclic voltammetry in patients with neurological and psychiatric diseases eligible for neurosurgical treatment (cogamine)

Conditions: Neurological Diseases or Conditions; Psychiatric Diseases; Candidates for Deep Brain Stimulation; Candidates for Invasive S-EEG; Candidates for Awake Surgery

Summary: this study aims at dynamically mapping local variations in the concentrations of monoaminergic neurotransmitters (for e.g. dopamine, serotonin and noradrenaline) in the human brain using fast-scan cyclic voltammetric recordings (fscv). this study will be carried out on patients with neurological (for e.g. brain cancer, parkinson disease (pd) or treatment-resistant epilepsy ...) or psychiatric (for e.g. treatment resistant obsessive compulsive disorder, depression, tourette syndrome ...) diseases who are eligible to neurosurgical treatment. typical neurosurgical treatments non-exhaustively include: (1) deep brain stimulation (dbs) electrode implanted as part of the routine management of their pathology (pd, etc.) or as part of clinical trials (treatment resistant depression, resistant obsessive-compulsive disorder, etc.), as well as on patients whose pathology requires invasive exploration by stereotactic-electroencephalography (s-eeg) for therapeutic purposes, either as part of their routine management or as part of a clinical trial. the aim of this mapping is to assess fluctuations in local concentrations of key monoaminergic neurotransmitters involved in cognitive functions at an individual level, with a high temporal (sub-second) and spatial resolution, as well as a sensitivity, that was previously unattainable with other neuroimaging techniques. the data collected in this study will improve our understanding of the role of monoaminergic neurotransmitters in normal human cognition, as well as their dysfunctions in psychiatric and neurological disorders. these data may guide research into new therapeutic targets for the treatment of these pathologies. this study requires a large cohort of patients to build up the most comprehensive database possible, for which access to the information collected is essential.


Eligibility criteria:
inclusion criteria: * patient of 18 years old or older; * patient undergoing s-eeg invasive exploration or a neurosurgical procedure (such as dbs or resection neurosurgery in an awake patient) as part of the management of a neurological or psychiatric disease (routine management or participation in a clinical study); * patient informed and having signed the consent form; * patient able to perform the cognitive tasks proposed. exclusion criteria: * patient not affiliated to a social security or other social protection scheme; * patient with contraindication to s-eeg or neurosurgery.

Keywords: deep brain stimulation monoaminergic neurotransmitters awake surgery intracerebral fscv
post-authorisation safety cohort observation of retacrittm (epoetin zeta) administered subcutaneously for the treatment of renal anaemia

Conditions: Renal Anemia; Pregnancy; Lactation

Summary: the purpose of this study is to estimate the incidence of pure red cell aplasia (prca), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. the other key objective of this study is to obtain information on adverse drug reactions (adr) associated with retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.

this is a non-interventional, multi-centre, longitudinal observation with a defined population using a prospective cohort design to estimate the incidence of pure red cell aplasia (prca), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia.

Eligibility criteria:
inclusion criteria: * patients currently under treatment with retacrit™ (epoetin zeta) administered subcutaneously for renal anaemia. * informed consent given in writing after being provided with detailed information about the characteristics of this observation by the physician. * patients expected to be available for 3 years of observation exclusion criteria: * any contraindications as per the current summary of product characteristics (spc) of retacrit™
clinical study to evaluate the safety and efficacy bmmnc in cerebellar ataxia

Conditions: Cerebellar Ataxia

Summary: cerebellar ataxia is a complex motor disturbance, which, can occur as a result of many diseases and presents with symptoms of an inability to coordinate balance, gait, extremity and eye movements. lesions to the cerebellum can cause dyssynergia, dysmetria, dysdiadochokinesia, dysarthria and ataxia of stance and gait. deficits are observed with movements on the same side of the body as the lesion (ipsilaterally).


Eligibility criteria:
inclusion criteria: * age limit: 18 -65 * diagnosed as cerebellar ataxia * willingness to undergo bone marrow transplantation bmmnc. * to give an informed consent as well as sign the required informed consent form (icf) for the study. * willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol. exclusion criteria: * patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis a) gastrointestinal , cardiac, immunodeficiency (including hiv) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc. * women who are pregnant or lactating * chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders. * suffering from severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores. * positive test results for hiv and aids complex ,hcv , hbsag and syphilis

Keywords: stem cell cerebellar ataxia bmmnc
results of emotional support activities during hospital admission with a diagnosis of covid19

Conditions: Covid19

Summary: the aim of the study is to find out what care patients affected by anxiety, fear or loneliness have perceived and the perceived impact of this care. this knowledge will allow us to design measures aimed at improving nursing care of these aspects in the future.

this is a cross-sectional descriptive study to be carried out at the consorci corporació sanitària parc taulí (ccspt). the results of this study will provide information on the care received by patients admitted to covid 19 affected by anxiety, fear or loneliness, the perceived impact of this care and will enable measures to be implemented to improve nursing care in the future. 450 patients, randomly selected from the hospital de sabadell database, will be included. in the sample, we will ensure that the proportion of women and men is in line with the distribution of the population to enable the incorporation of the gender perspective in the analyses. the quantitative variables will be described by means of their mean and standard deviation. qualitative variables will be described in absolute and relative frequencies. in order to evaluate the suitability of the intervention to the needs of the patient, a table of concordance will be constructed between the actions proposed by the panel of experts and the actions carried out as referred by the patient. the kappa concordance index will be calculated and the degree of concordance will be classified according to the landis and koch scale. as regards the effectiveness of the intervention, the patients who were treated correctly and those who were not will be identified, and the percentage of positive impacts according to csq-8 between the two groups will be compared by means of the chi-square test.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 who were admitted with a diagnosis of covid-19 to any ccspt unit between march 13, 2020 and april 30, 2020 and were discharged with a recovery result exclusion criteria: * communication problems or inability to read and speak spanish

Keywords: nursing care anxiety loneliness fear covid-19
imaging modality effects on the multi-dimensional infrared analysis (mira) technology

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the effect of everyday practice modalities (mammography, us) on the mira technology.

the objective of the current clinical study is to collect sufficient mira imaging data of subjects arriving for a routine screening mammography, before and after they undergo the mammography. this is in order to reach a conclusion whether the the firm breast compression involved in the mammography procedure affects the performance of the mira technology. at the current stage of the development of the device, the goal of this clinical trial is in no way to arrive at a statistical analysis.

Eligibility criteria:
inclusion criteria: * gender: female * age: 50 years and older * subjects summoned for a routine screening mammography, ultrasound, diagnostic mammography or breast biopsy. * subject who have signed an informed consent form. exclusion criteria: * subjects who have had a mammography, ultrasound, and/or mri examination performed on the day of the study, prior to their first imaging session with the realimager. * subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study. * subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study. * subjects who have undergone a mastectomy. * subjects who have undergone a lumpectomy. * subjects who have a large scar (causing breast deformation). * subjects who have previously undergone or are currently undergoing breast radiation therapy. * subjects who have previously undergone or are currently undergoing chemotherapy. * subjects with prior breast reduction surgery or breast augmentation surgery. * subjects who are pregnant. * subjects who are breast-feeding.
neuro anatomical correlation of oropharyngeal swallowing revisited in cerebrovascular stroke patients

Conditions: Stroke, Acute

Summary: stroke, main cause of disability in adults, is thought to be the primary cause of swallowing difficulty (dysphagia). dysphagia is one of the common physical condition among patients with stroke, affecting the large number of stroke patients in the world. it is reported that the occurrence rate of post-stroke dysphagia (psd) is varies widely, ranging from 19% to 81%, the reason may be associated with the type of stroke, the assessment tools, the timing of the assessment, and so on .dysphagia is associated with pneumonia, malnutrition, dehydration, increased mortality, and poor long-term outcome. it has been shown that early detection of dysphagia allows for immediate intervention and thereby reduces morbidity, duration of hospitalization, and overall health care costs. oropharyngeal dysphagia (od) can have a high impact on the general health of affected patients and can produce two main types of complications in patients with post stroke: (1) those caused by impaired efficacy of swallow, present in 25%-75% of patients, which leads to malnutrition and dehydration and (2) impaired safety of swallow which leads to tracheobronchial aspiration that may cause pneumonia in 50% of cases. both od and aspiration are highly prevalent conditions in patients with stroke . dysphagia is more common in hemorrhagic stroke compared with ischemic stroke, so far, most studies have focused on the latter, presumably due to its higher incidence .the recognition of a brain lesion pattern associated with oropharyngeal dysphagia could help to distinguish those patients in need of more in-depth evaluation and the subsequent adoption of preventive measures. however, it is difficult to predict which patients are susceptible to developing swallowing alterations depending on neuroimaging findings. however, the findings have been inconsistent, mainly due to simplification in the classification of brain injuries into a small number of groups, or to the different methods employed in assessing swallowing function


Eligibility criteria:
inclusion criteria: - adult patients\> (18 years). conscious patients stroke patients confirmed by brain imaging stroke in the acute and sub-acute phase exclusion criteria: * previous stroke non stroke dysphagia history of other neurologic disorders other than cerebrovascular disease.
oxxynea® gs: study for glycaemia management

Conditions: Prediabetic State; Overweight

Summary: the aim of this study is to develop a proof of concept establishing a causal relationship between glycemia improvement through combination of polyphenols-rich botanical extracts or polyphenols-rich botanical extracts associated with white kidney bean extract and chromimum picolinate + zinc bisglycinate with chronic supplementation. chronic glycemia improvement will be assessed by following the evolution of hba1c, postprandial glucose and insulin kinetics, and questionnaires. the study design is double blinded randomized with 3 arms and 29 volunteers per arm.


Eligibility criteria:
inclusion criteria: * fasting plasma glucose 75 - 125 mg/dl * hba1c: 5.-6.5 % * both sexes * overweight bmi range (25-30 kg/m2) * age: 20-50 years old exclusion criteria: * metabolic/chronical disease * menopausal women * being pregnant, breastfeeding or wanting to have a baby * former obese with a history of yoyo effect * have been involved in a weight loss program in the past 12 months or subjected to weight reduction surgery * having started or quit smoking, having a high alcohol consumption * have in the past been in a long-term antibiotherapy (1 month or more) and/or a regular antibiotherapy in the past 12 months * allergy to olive, blackcurrant, pomegranate, grapefruit, white kidney bean, or corn.
postoperative pain in lumbar disc surgery

Conditions: Erector Spinae Plane Block; Wound Infiltration; Lumbar Disc Herniation; Postoperative Pain

Summary: this study included 46 patients who underwent lumbar disc herniation surgery under general anesthesia. after the operation, us-guided espb was performed on group e, and wi was performed on group w. postoperative pain was assessed, and the time to first analgesic requirement, total analgesic amount in 24 hours, and side effects were recorded. ibm spss statistics 22 was used for statistical analyses.


Eligibility criteria:
inclusion criteria: * anesthesiologists (asa) physical status i-ii exclusion criteria: * patients with recurrent lumbar disc herniation, * obesity (body mass index \>35 kg/m2), * infection in the surgical site, * known local anesthetic drug allergy, * chronic pain, and coagulation disorders were excluded.
an observational study of first-line bevacizumab (avastin) with fluoropyrimidine-based chemotherapy in participants with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this multicenter observational study will evaluate the efficacy and safety of first-line bevacizumab (avastin) in combination with fluoropyrimidine-based chemotherapy in participants with metastatic colorectal cancer (mcrc). participants for whom the treating physician has decided to initiate first-line fluoropyrimidine based chemotherapy in combination with bevacizumab will be observed for approximately 4 years.


Eligibility criteria:
inclusion criteria: * participants with histologically confirmed metastatic colorectal cancer who will receive bevacizumab in combination with first-line fluoropyrimidine-based chemotherapy exclusion criteria: * participants not qualified for bevacizumab treatment according to the local label