Kornimate/medical-research-clean huggingface dataset:
localized analysis of normalized distance from scalp to cortex and personalized evaluation (landscape)

Conditions: Aging; Dementia Alzheimers; Parkinson Disease; Dementia Frontotemporal; Depression in Old Age

Summary: scalp to cortex distance (scd), as a key technological parameter of brain stimulation, has been highlighted in the guidelines of non-invasive brain stimulation. however, in the context of age-related brain changes, the region-specific scd and its impact on stimulation-induced electric field in different types of neurodegenerative diseases remain unclear.

objective: this study aimed to investigate the region-specific scd and its relationship with morphometric features and cognitive function in age- and disease-specific populations. methods: the scd and cortical thickness (ct) of left primary motor cortex (m1) and dorsolateral prefrontal cortex (dlpfc) were measured in cognitively normal adults and dementia patients. ct-adjusted scd was used to control the influence of ct on scd. head model was developed to simulate the impact of scd on the electric field induced by transcranial electrical stimulation.

Eligibility criteria:
inclusion criteria: * right-handed as assessed by the edinburgh inventory * able to attend tms interventions * consent * independent in daily life activities exclusion criteria: * uncorrected visual or auditive deficits not allowing the realization of the test * evolutive disease (such as cancer) * neurological or psychiatric antecedent * counter-indication to mri

Keywords: aging scalp-to-cortex distance transcranial brain stimulation parkinson disease simulation predictor
pilot study of prt-201 following angioplasty in patients with peripheral artery disease (pad)

Conditions: Peripheral Artery Disease

Summary: the purpose of this study is to determine if it is safe and feasible to apply prt-201 to the adventitia of arteries following successful angioplasty (pta).


Eligibility criteria:
inclusion criteria: 1. age of at least 18 years 2. clinical diagnosis of pad, secondary to atherosclerosis affecting a lower limb 3. rutherford classification 2-4 (moderate claudication to ischemic rest pain) 4. abi \<0.90 at rest or with exercise, or a toe-brachial index \<0.70, or radiographic evidence of pad that correlates with clinical symptoms 5. de novo lesion, not previously treated by angioplasty or atherectomy 6. greater than 70% stenosis of the sfa or pa, target lesion length of 10 cm or less, and at least one patent runoff vessel. short segment occlusions (\<10 cm) are acceptable 7. if female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 1 week following study drug administration. acceptable methods of birth control include abstinence, barrier methods with spermicide, implants, injectables, oral contraceptives, intra-uterine device, or a vasectomized partner 8. ability to understand and comply with the requirements of the entire study and communicate with the study team 9. ability to provide written informed consent using a document that has been approved by the required institutional review board exclusion criteria: 1. previous treatment with prt-201 2. patients in whom arterial insufficiency in the lower extremity is the result of an immunologic or inflammatory non-atherosclerotic disorder (e.g. buerger's disease, vasculitis) 3. current severe critical limb ischemia defined as ulceration or gangrene 4. planned atherectomy of the arteries of the index leg 5. prior or planned stenting of the target lesion 6. prior bypass surgery to the target sfa or pa 7. severe concentric medial calcification of the target lesion thought to interfere with drug delivery to the adventitia that is defined subjectively by the investigator based on fluoroscopic appearance. 8. history of metastatic cancer 9. presence of aortic or peripheral artery aneurysm 10. platelet count \ 3.0 times the upper limit of normal 11. pregnancy, lactation or plans to become pregnant during the course of the study 12. presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study 13. treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent 14. known allergy to contrast media

Keywords: peripheral artery disease pad claudication angioplasty percutaneous transluminal angioplasty pta superficial femoral artery sfa popliteal artery pa prt-201 restenosis vonapanitase
safety and toxicity study of intravesical instillation of tara-002 in adults with high-grade non-muscle invasive bladder cancer (phase 1b)

Conditions: Non-muscle Invasive Bladder Cancer

Summary: this study is open-label dose expansion study to investigate the safety and toxicity of intravesical treatment of high-grade nmibc (hgta or cis, including cis with concomitant ta) after transurethral resection of bladder tumor (turbt) and/or biopsy using tara-002 in adults unable to obtain intravesical bacillus calmette-guérin (bcg), adults who have received at least one dose of intravesical bcg or adults who have received at least one dose of intravesical chemotherapy. after completion of the dose escalation phase (phase 1a) and after the rp2d has been established, the dose expansion phase (phase 1b) will start enrollment of subjects with cis nmibc with active disease to further evaluate the safety and preliminary efficacy of tara-002, at the established rp2d. cis nmibc with active disease is defined as disease present at the last cystoscopic evaluation prior to signing the icf. subjects enrolled in the dose expansion phase will not include subjects previously enrolled and treated in the dose escalation phase. all subjects will receive 6 weeks of treatment at the established rp2d.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 years of age or older at the time of signing the informed consent * subjects who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry * subjects with a histologically confirmed, high-grade ta or cis (including cis with concomitant ta) urothelial cell carcinoma of the bladder according to central review * subjects who are treatment naïve, unable to obtain intravesical bcg for the treatment of nmibc, have received at least one dose of intravesical bcg, or at least one dose of intravesical chemotherapy exclusion criteria: * penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo penicillin allergy testing prior to inclusion in the study) * predominant (defined as \> 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review * concomitant prostatic or upper tract urothelial involvement per investigator's assessment * nodal involvement or metastatic disease that existed at any time (past or present disease) * bladder cancer stage ≥ t1 within the last 36 months according to central histology review * bladder cancer stage cis with concomitant t1 for more information on eligibility criteria, please contact the sponsor.

Keywords: non-muscle invasive bladder cancer bladder cancer high grade ta carcinoma in situ high-grade nmibc
safety of an inactivated sars-cov-2 vaccine for prevention of covid-19 in adults

Conditions: COVID-19

Summary: this study is a multi-center and open design, phase ⅳ clinical trial of an inactivated sars-cov-2 vaccine (coronavac) manufactured by sinovac research and development co., ltd.the purpose of this study is to evaluate the safety of the sars-cov-2 inactivated vaccine in population aged 18 years years and older and in people with pre-existing disease to provide reference for improving the immunization strategy of covid-19 vaccine.

this study is a multi-center and open design, phase ⅳ clinical trial in population aged 18 years years and older. the experimental vaccine will be manufactured by sinovac research and development co.,ltd.the study is planned to be carried out in 11 provinces from may 2021 to december 2022, including liaoning, heilongjiang, anhui, fujian, jiangxi, hubei, guangxi, chongqing, guizhou, yunnan and gansu. each province will serve as a research center, and each research center will select the corresponding research site.a total of 121000 subjects will be enrolled with11000 for each research center, including at least 2000 people with pre-existing disease and at least 4000 people in the elderly group (60 years old and above) (including patients with pre-existing disease).and subjects will receive two doses of vaccine on day 0 and day 28.

Eligibility criteria:
inclusion criteria: * have not received any covid-19 vaccine in the past or at least one dose of coronavac manufactured by sinovac research and development co.,ltd; * population aged 18 years and above; * the subjects can understand and voluntarily sign the informed consent form and participate in the follow-up; exclusion criteria: * history of severe allergy to the vaccine such as acute allergic reaction,angioedema and dyspnea ; * severe neurological disease such as transverse myeliti,guillain-barre syndrome and demyelinating disorders; * acute diseas,acute onset of chronic disease and severe chronic diseases.
the effect of motivational interviewing on nursing students

Conditions: Motivation

Summary: studies support the idea that people diagnosed with social anxiety disorder score significantly lower on self-acceptance than healthy controls, and that self-compassion is inversely related to anxiety. motivational interviewing has been shown to improve treatment outcomes as well as predict higher self-compassion and reduced resistance among participants.it also has the ability to increase the effectiveness of motivational interviewing as an intervention with perpetrators of intimate partner violence, promoting readiness for change and progression through stages of change. in this context, this study aims to examine the effect of motivational interviewing on social anxiety level, dating violence and self-compassion in nursing students with social anxiety.

nursing as a social profession needs more social interaction. nurses should be able to develop therapeutic interaction with patients. this can only be possible when they are confident in themselves and worry about others and get rid of anxiety disorders. social anxiety symptoms have been associated with increased risk of depression, other anxiety disorders and substance misuse, as well as difficulties in making healthy social connections and adjusting to the academic environment. motivational interviewing (mi) has been found to provide symptom reduction in individuals with generalized anxiety disorder and to improve treatment outcome in individuals with sad. a meta-analysis by kirby et al. (2017) concluded that existing self-compassion-based interventions are moderately successful in enhancing compassion and reducing suffering (e.g. depression, anxiety, distress). while moderate effects are very important and encouraging, they indicate that interventions can be improved. it is suggested that including pd as a prelude to compassion-based interventions may provide similar benefits for program participation, initiation, adherence, and behavior change.it has also been shown that pd may increase sensitivity to dating violence interventions. in this context, this study aims to examine the effect of motivational interviewing on social anxiety level, dating violence and self-compassion in nursing students with social anxiety.

Eligibility criteria:
inclusion criteria: * have moderate and severe social anxiety (55 and above lscq) * volunteering to participate in the research * being in the pre-intention and intention stage according to the stage of change assessment form exclusion criteria: * have to no or low level of social anxiety (below of 55 on the lscq) * have to any psychiatric diagnosis * have received psychotherapy for social anxiety before * attend to a psychotherapy or counseling program

Keywords: social anxiety nursing students dating violence motivational interview self-compassion
exploring breathing patterns

Conditions: COPD

Summary: study title exploring patterns of speech and breathing to indicate the presence of obstructive respiratory disease. study design prospective case control study study participants participants will be patients attending the respiratory physiology clinic at the cardiopulmonary unit, prince charles hospital for an assessment of their lung function. in addition a cohort of control participants without obstructive respiratory disease will be recruited with the assistance of the british lung foundation charity. planned size of sample (if applicable) we have received funding for 52 ½ day sessions and we plan to recruit on average 2 participants per session. as such we aim to recruit a minimum of 100 participants. in addition we are working with the british lung foundation to recruit a smaller cohort of control participants and aim to recruit a minimum of 25 control participants. planned study period jan 2019 - aug 2019 research aim(s) this primary objective of this novel study it to create an anonymised database of speech patterns of patients with chronic respiratory disease and healthy aged matched controls for comparison with lung function and medical history. the primary aims are to: * collect breathing patterns from individuals under a range of talking modalities * understand how easy it is to gather short speech recordings * explore the preferences of patients to be recorded talking


Eligibility criteria:
6.1.2 inclusion criteria patient participants 1. adult patient \>18 years old referred for spirometry in the respiratory physiology clinic at prince charles hospital; 2. clinically defined obstructive or restrictive respiratory disease (indicated by spirometry) 3. clinically stable (indicated by being able to undergo spirometry) 4. no significant unstable disease co-morbidities (indicated by being able to undergo spirometry) 5. capable of providing informed consent. 6. willing to take part in all study measurements. 7. the speaking exercise will be conducted in english on this study. 8. participants are not taking part in any other research. 6.1.3 inclusion criteria control participants 1. no obstructive or restrictive respiratory disease (indicated by spirometry) 2. clinically stable (indicated by being able to undergo spirometry) 3. no significant unstable disease co-morbidity's (indicated by being able to undergo spirometry) 4. capable of providing informed consent. 5. willing to take part in all study measurements. 6. the speaking exercise will be conducted in english on this study. 7. participants are not taking part in any other research. 6.1.4 exclusion criteria for both patient and control participants 1. any form of challenge testing in the respiratory physiology department involving salbutamol. 2. severe sensory and/or cognitive impairment 3. inability to complete study measurements
a placebo-controlled study of mk0634 in patients with overactive bladder (0634-007)

Conditions: Urinary Incontinence

Summary: overactive bladder is very prevalent in postmenopausal women. the current study is designed to investigate whether a new drug may offer safe and effective treatment.

clinical development of mk-0634 was discontinued. study mk-0634-027 was a safety follow-up study to determine if there were any ocular effects of mk-0634 in participants from the united kingdom who were exposed to mk-0634 during the 007 study.

Eligibility criteria:
inclusion criteria: * postmenopausal females (ages 40-74) with predominantly urge urinary incontinence overactive bladder episodes. * patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards. exclusion criteria: * patients must not suffer from diabetes insipidus * hyperglycemia * hypercalcemia * orthostatic hypotension * active/recurrent urinary tract infections (\>6 episodes per year) * patients must be willing to discontinue their current oab medication therapy.
outcomes of irrisept irrigation as an adjunctive treatment in the management of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: irrisept™ irrigation containing chlorhexidine gluconate (chg) 0.05% in sterile water, is an irrigation method that may help reduce bacterial load considerably more than traditional saline irrigation.

the purpose of this clinical evaluation is to collect patient outcome data on irrisept™ irrigation. this is a jet irrigation of 0.05% chlorhexidine gluconate (chg) in sterile water delivered under pressure by manual compression of the bottle by the user. this treatment allows for management of bioburden in a wound through broad spectrum antimicrobial activity by the chg as well as removal of debris from the wound bed. in this trial, participants with partial and full thickness diabetic foot ulcers (dfus) - 'full skin thickness and extending through the subcutaneous or fat layers or to deeper structures such as tendon and fascia will receive standard of care treatment with indicated off-loading device (soc) for their condition in addition to wound bed irrigation with irrisept™ or saline irrigation.

Eligibility criteria:
inclusion criteria: 1. at least 18 years old. 2. presence of a partial and full thickness dfu extending at least through the dermis and into the subcutaneous tissue down to the exposed tendon and fascia. 3. wounds present anatomically on the foot as defined by beginning below the malleoli of the ankle, excluding wounds on the heel. 4. the index ulcer will be the largest ulcer if two or more eligible dfus are present and will be the only one evaluated in the study. if other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer. 5. index ulcer (i.e., current episode of ulceration) has been present for greater than 4 weeks prior to first screening visit (sv1) and less than 1 year, as of the date the subject consents for study. 6. adequate circulation to the affected foot as documented by the following: palpable pedal pulses, pulses audibly biphasic or triphasic with handheld doppler, or recent (\<6 month) vascular testing (both invasive \& non-invasive). 7. females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests. 8. subject understands and is willing to participate in the clinical study and can comply with weekly visits. 9. subject understands they can exit the study at any time. exclusion criteria: 1. clinical signs of infection at the start of the study 2. exposed bone(s) 3. immunocompromised as determined by treating physician 4. presence of greater than one full-thickness dfu less than 2 cm apart
cohort study of chronic heart failure

Conditions: Heart Failure

Summary: the goal of this observational study is to learn about the influencing factors of chronic heart failure prognosis in heart failure patients. the main question it aims to answer is that what are the influencing factors of clinical outcomes in chronic heart failure. participants will be collected multiple omics data such as phenotype group, environmental exposure group, intestinal microbiome, genome, metabolome, and noninvasive biomarkers.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years; 2. fulfill at least one of the following criteria：①history of chronic heart failure;②new-onset heart failure with lvef \ 400 pg/ml/nt-probnp(\ 450 pg/ml; 50\~75 years, \>900 pg/ml; \>75 years, \>1800 pg/ml) 3. etiology: dilated cardiomyopathy, hypertensive heart disease, ischaemic cardiomyopathy, non-severe valvular heart disease； 4. primary post-discharge therapy: oral medication; 5. sign the informed consent form. exclusion criteria: 1. patients with renal failure (ccr\<30ml/min) or patients on dialysis therapy; 2. various correctable secondary causes of cardiac insufficiency including hyperthyroid heart disease, anaemic heart disease, uncorrected congenital heart disease; severe valvular heart disease (including severe stenosis or closure of organic aortic and mitral valves); 3. patients with indications for pacemaker implantation but have not received a pacemaker implant; 4. patients with chronic obstructive pulmonary disease accompanied by type ii respiratory failure. 5. patients who cannot understand and sign an informed consent form. 6. patients with mental illness, pregnant women, and other special populations.
sphenopalatine ganglion block for management of post- dural puncture headache in obstetric patients

Conditions: Post-Dural Puncture Headache

Summary: the purpose of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post dural puncture headache in obstetric patients

background and objectives: post dural puncture headache(pdph) is a common complication of lumbar puncture, it is likely due to the loss of cerebrospinal fluid into the epidural space through the dural tear. the prevalence of pdph is higher in pregnant women.sphenopalatine ganglion block (spgb) is a non-invasive intervention with minimal adverse effects, it is indicated in acute and chronic facial/head pain like cluster headache, trigeminal neuralgia, post herpetic neuralgia and pain due to head and neck cancer.spgb can be performed by different approaches:transnasal,transoral ,sub zygomatic and lateral infratemporal.transnasal is the easiest, least invasive approach which can be done at bedside. the objective of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post-dural puncture headache in obstetric patients.the following will be recorded: pain score will be assessed using the numeric rating pain scale(nrs),heart rate and mean arterial pressure, onset and duration of analgesia, total dose of ketorolac, duration of hospital stay and patient satisfaction

Eligibility criteria:
inclusion criteria: * female patients asa i or ii post caesarean section * body weight between 60-100 kg * active pdph within days after spinal anesthesia not relieved with standard treatment such as, intravenous fluids, bed rest and caffeine. exclusion criteria: * patient refusal to participate in the study * body mass index \>35kg/m2 * patients with :coagulopathy ,nasal septal deviation,polyp * history of nasal bleeding * allergy to local anesthetic

Keywords: sphenopalatine ganglion block post-dural puncture headache
a longitudinal study of amyotrophic lateral sclerosis (als) biomarkers

Conditions: Amyotrophic Lateral Sclerosis; Nervous System Diseases; Sclerosis; Motor Neuron Disease; Spinal Cord Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Diseases; ALS

Summary: the purpose of this study is to collect biofluid samples for the banking and usage in als research. through comparison of these samples, the researchers hope to learn more about the underlying cause of als, as well as find unique biological markers, which could be used to develop new therapies.

the purpose of the research study is to collect blood samples and cerebrospinal fluid (csf) from people with amyotrophic lateral sclerosis (als). these samples will be collected approximately every 4 months.

Eligibility criteria:
inclusion criteria: * age 18 or older * diagnosis of suspected, possible, probable or definite als according to el escorial criteria * vital capacity (vc) at least 50 percent predicted * able to undergo multiple lumbar punctures exclusion criteria: * abnormal csf pressure or intracranial/intraspinal tumors * use of anticoagulant medication that cannot be safely withheld * bleeding disorders * this is a partial listing.

Keywords: biomarkers biological markers surrogate markers clinical markers plasma cerebrospinal fluid dna serum rna