Kornimate/medical-research-clean huggingface dataset:
effects of external electrical stimulating applied on the thigh in men with urinary incontinence after prostatectomy

Conditions: Urinary Incontinence

Summary: the aim of this study is to investigate the effects of external electrical stimulation applied on the thigh on urinary symptoms, quality of life, sexual function, perception of subjective improvement and satisfaction in men with urinary incontinence after prostatectomy

the most common complication after prostatectomy surgeries is urinary incontinence. there are conservative and surgical treatment options in post-prostatectomy urinary incontinence. one of the conservative treatment options is electrical stimulation application. electrical stimulation with the intraanal probe in men is painful and uncomfortable. and also there are few studies, demonstrating the effects of electrical stimulation on urinary incontinence after prostatectomy in the literature.

Eligibility criteria:
inclusion criteria: * being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery * being over 40 years old * not having residual cancerous tissue * volunteering to participate in the study exclusion criteria: * having serious cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients, etc.) * having sensory loss * having an ongoing urinary infection * having only urgency urinary incontinence * using a pacemaker * receiving active cancer treatment (radiotherapy, chemotherapy) * those who have a problem that interferes with cooperation and understanding
spike-specific cellular immune response after covid-19 vaccination

Conditions: COVID19; Vaccination; Immune Response

Summary: aim of this study is to evaluate whether covid-19 vaccination induces a persistent cellular immune response. to this aim, blood samples are taken from vaccinated individuals and not immunized subjects as a control group. cells isolated from blood samples are tested in vitro to assess the percentage of spike-specific t and b lymphocytes 1 and 7 months after a second dose of comirnaty vaccine.

after providing written informed consent, 28 vaccinated and 25 non vaccinated subjects were included in the study. all subjects were enrolled among healthcare workers in the research centre of irccs san raffaele roma in rome. all the subjects declared that they never tested positive for covid19. blood and serum samples were drowned twice from vaccinated subjects: 1 and 7 months after a second dose of vaccine to evaluate t and b response to vaccine; blood was drowned once in not vaccinated subjects. cells were collected form peripheral blood samples, while anti-s1 igg titre was assessed in serum. flow-cytometry was used to assess the percentage of circulating spike-specific t and b lymphocytes.

Eligibility criteria:
inclusion criteria: * vaccinated and non vaccinated subjects * subjects that never tested positive for covid19 exclusion criteria: * subjects that tested positive for covid-19
collection of blood samples from smart study participants for future genetic studies

Conditions: HIV Infections

Summary: the purpose of this study is to collect blood samples from smart study participants to use in future genetic studies.

despite progress in the treatment of hiv and a greater understanding of the pathophysiology of hiv infection, there are still unexplained differences in both the progression of untreated hiv infection and response to antiretroviral therapy. these differences are likely related to the unique genetic makeup of individuals with hiv infection. particular genes may offer protection against hiv infection, while other genes may make disease progression more likely. knowing more about the genetic makeup of hiv infected individuals may lead to the development of a targeted treatment strategy based on an individual's specific risk of disease progression and sensitivity to medication toxicity. the purpose of this substudy is to collect blood samples from smart study participants. the samples will be used in future community programs for clinical research on aids (cpcra) studies investigating the link between human genetic factors and clinical outcome data. this study will enroll individuals currently participating in the smart study. participants will provide one blood sample. individual test results from future blood analyses will not be provided to a patient unless they may have profound health implications for that patient.

Eligibility criteria:
inclusion criteria: * coenrollment in the smart study * parent or guardian willing to provide informed consent, if applicable

Keywords: treatment experienced
effect of academic detailing to reduce opioid prescribing in dentistry

Conditions: Opioid Prescribing; Pain Management

Summary: the purpose of this project is to improve quality of care for dental patients in the state of michigan. this will be achieved through educating dentists about best practices for opioid prescribing and includes three continuing education (ce) credits and one (or two) academic detailing (ad) visits. the cohort of 90 dentists who are enrolled to the ce will be randomized into two groups upon enrollment. one of these groups, half of the cohort, will receive the academic detailing. a report will be written highlighting key findings from this project and best practices for treating patients after dental care.the quality of care for dental patients will be improved by sharing this information with both participating and non-participating dental providers statewide through reports, manuscripts, and presentations. these data will inform best practice with the potential for future academic detailing and educational interventions for dentists and oral surgeons.


Eligibility criteria:
inclusion criteria: * dentists in the state of michigan with an active drug enforcement agency (dea) license. exclusion criteria: * all oral surgeons in michigan. michigan dentists who have a significant (\>5%) population living outside of michigan (self-reported), as the prescription drug monitoring program (pdmp) data we will obtain from michigan automated prescription service (maps) will only cover those prescriptions filled in the state of michigan.

Keywords: dentist
safety of transition from selexipag to remodulin® then oral treprostinil in symptomatic adult pah

Conditions: Pulmonary Arterial Hypertension

Summary: this is a multicenter, single-arm trial to evaluate the safety of the transition from selexipag to remodulin® then oral treprostinil in symptomatic subjects with pulmonary arterial hypertension (pah). the study will include about 30 subjects at approximately 10 clinical trial centers. the treatment phase of the study will last approximately 16 weeks.


Eligibility criteria:
inclusion criteria: 1. subject has a diagnosis of symptomatic idiopathic or heritable pah, pah associated with connective tissue disease, pah associated with hiv infection, pah associated with repaired congenital systemic-to-pulmonary shunt (at least 1 year since repair with respect to the date of providing informed consent), or pah associated with appetite suppressant or toxin use. 2. the subject must be classified as who fc ii or iii at baseline. 3. the subject is receiving selexipag for the treatment of who group 1 pah for a minimum of 90 days from baseline. 4. subject is in need of escalation of therapy, as determined by the investigator. 5. subject must be receiving a food and drug administration (fda)-approved pde5-i or sgc stimulator and/or an era and has been at the current stable dose for at least 28 days prior to baseline. exclusion criteria: 1. the subject is receiving selexipag for any other disease or condition other than the treatment of who group 1 pah. 2. the subject has a baseline 6mwd of less than 150 meters. 3. the subject's baseline 6mwd has decreased more than 40% from the pre-selexipag baseline. 4. the subject has a history of ischemic heart disease (defined as either symptomatic or requiring anti-anginal therapy or experienced a documented myocardial infarction within the previous 6 months of baseline), or a history of left sided myocardial dysfunction as evidenced by a pawp greater than 15 mmhg or a left ventricular ejection fraction less than 40%. 5. the subject has previously been treated with any parenteral prostacyclin or oral treprostinil for a period of 90 days or more. 6. the subject has a history of 1 or more of the following signs of relevant lung disease within 180 days before baseline: 1. total lung capacity less than 60% of predicted normal. 2. forced expiratory volume in 1 second is less than 55% of predicted normal.

Keywords: oral treprostinil remodulin selexipag 6 minute walk test
the relationship between disability, fear avoidance beliefs, physical performance and quality of life in chronic low back pain

Conditions: Low Back Pain; Chronic Low-back Pain (cLBP)

Summary: the aim of this study was to determine the multidimensional profile of individuals with chronic low back pain (clbp) and to determine the relationship between disability and fear avoidance beliefs, physical performance and quality of life in this population. individuals with chronic low back pain between the ages of 18-50 will be included in the study. disability level of the participants will be assessed with oswestry disability index (odi), fear avoidance attitudes with avoidance beliefs questionnaire-physical activity (fabq-pa), and quality of life with short form-12 (sf-12). trunk endurance, functional mobility and static-dynamic balance will be assessed for physical performance. trunk endurance will be assessed with mcgill endurance tests, functional mobility with timed up and go test (tug), dynamic balance with y-balance test, and static balance with single leg stance test.


Eligibility criteria:
inclusion criteria: * back pain for at least 3 months * pain intensity ≥ 3 on the visual analog scale exclusion criteria: * history of spinal surgery/trauma * other back pain (associated with rheumatic diseases, multiple sclerosis, malignancy, etc.) instability conditions such as spondylolysis and spondylolisthesis * pregnancy * obesity (bmi ≥ 30 kg/m²) * presence of orthopedic problems or chronic diseases that may interfere with testing

Keywords: low back pain
mechanical cough augmentation in children with nmd

Conditions: Neuromuscular Diseases; Children, Only; Airway Clearance Impairment; Cough

Summary: the study investigates the prevalence and use of mechanical insufflation - exsufflation (mi-e) in children with neuromuscular disorders (nmd) in norway. the nmd related prevalence of mie use in norway will be described and possible regional differences regarding use will be assessed.

neuromuscular diseases (nmd) in children are severe, possibly life-threatening orphan conditions. respiratory tract infections and lung complications are the main causes of increased morbidity and mortality. the use of mechanical cough augmentation with insufflation-exsufflation (mie) is a strategy to treat and prevent. possible major benefits are described, but optimal settings for best efficacy and comfort in children are not established. the main objective is to determine the prevalence and use of mie among children with nmd in norway. all children with nmd \< 18 years which has received a machine for mi-e will be invited to participate in the study. the participants will be asked to complete two questionnaires. in addition will information from the data card in the mi-e machines give information about use. the information will be linked to the national register for long term mechanical ventilation.

Eligibility criteria:
inclusion criteria: , * received a mi-e device * neuromuscular disease * \< 18 years exclusion criteria: - none

Keywords: airway management cough neuromuscular diseases pediatrics mechanical insufflation-exsufflation
trancutaneous abdominal stimulation on bowel function.

Conditions: Spinal Cord Injuries; Constipation

Summary: this is a prospective, single-center, feasibility study to determine the sensations elicited by non-invasive abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit.

this is a prospective, single-center, treatment feasibility study to determine the efficacy of electrical stimulation for bowel functions. the study will determine sensations elicited by non-invasive, transcutaneous abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. the electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit. visits are anticipated to be no more than 5 hours.

Eligibility criteria:
inclusion criteria: * for spinal cord injury subject group: * traumatic or non-traumatic spinal cord injury; * constipation; * motor-complete or motor-incomplete spinal cord injury; * quadriplegia or paraplegia; * post-injury time ≥ 1 year; * neurogenic bowel dysfunction score ≥ 7. * for able-bodied subject group: * diagnosis of intestinal constipation according to the rome iv criteria; * chronic constipation as defined by \ 3 months. * for both subject groups: can read, understand and willingly sign an institutional review board approved informed consent document that describes the study's risks and benefits. exclusion criteria: 1. presence of any organic cause for intestinal constipation; 2. have chronic fecal incontinence; 3. have skin infection/lesion in the area of electrode application or systemic skin disease; 4. have an implanted electronic device (such as heart pacemaker, insulin or baclofen pump, etc); 5. have symptomatic cardiac disease; 6. have uncontrolled diabetes; 7. presence of abdominal hernia; 8. have a stoma, rectal tear, or untreated hemorrhoids; 9. have a significant psychiatric disorder; 10. for female subjects, being pregnant, actively planning a pregnancy or breast-feeding a child; 11. be participating in another clinical study that would confound data analysis; 12. have a cognitive impairment or exhibits any characteristic that would limit the study candidate's ability to complete study assessments.

Keywords: spinal cord injury stimulation constipation
portable oxygen concentrator improvements to physical activity, oxygen usage, and quality of life in chronic obstructive pulmonary disease patients using long-term oxygen therapy (poc-step)

Conditions: COPD

Summary: to evaluate changes in activity based on the use of portable oxygen concentrators combined with standard of care (soc) long- term oxygen therapy versus soc long-term oxygen therapy alone at 12 weeks in patients with copd who require continuous (24/7) long-term oxygen therapy. the study will also assess oxygen usage, quality of life, hospitalizations and death.


Eligibility criteria:
inclusion criteria: 1. patient is 40 years or older. 2. patient has a documented diagnosis of copd. 3. patient qualifies for continuous (24/7) long-term oxygen therapy. 4. patient is prescribed oxygen at ≤ 5 l/min. 5. patient is poc-naïve, i.e., has not used a poc prior to enrolling in this study. 6. patient is able to tolerate pulsed oxygen therapy, i.e., oxygen delivered via a poc. 7. patient is able to fully understand study information and provide signed informed consent and hipaa authorization. exclusion criteria: 1. patient's condition is contraindicated for the use of a poc. 2. patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated. 3. patient is unable to complete the 6-minute walk test. 4. patient has a diagnosis (within less than two weeks prior to study entry) of pneumonia or respiratory infection, and/or acute bronchitis requiring antibiotics, or new/increased dose of systemic corticosteroids. 5. patient has had thoracic surgery or another procedure in the six months prior to enrollment that is likely to cause instability of pulmonary status. 6. patient has an open skin ulcer or rash where the activity monitor will be worn on the body. 7. patient has a life expectancy \< 1 year. 8. patient has non-copd lung disease that may affect oxygenation or survival. 9. patient has a planned intervention(s) requiring hospitalization within the three months of study participation. 10. patient is pregnant or planning to become pregnant. 11. patient is participating in a clinical study of a medical product and has not completed the required follow-up period. 12. patient, in the opinion of the investigator, should be excluded from the study.

Keywords: copd poc oxygen qol
enhanced linkage maps from family-based genetics studies

Conditions: Cardiovascular Diseases

Summary: to develop genetic maps for the genome-wide screening markers used by multiple investigators and to investigate map differences between sexes and different ethnic groups.

background: meiotic linkage maps are the foundation of both linkage and linkage disequilibrium studies for mapping disease genes. despite the importance of precise maps, existing genome-wide linkage maps were built using only a small collection of pedigrees, and so have wide confidence intervals surrounding estimates of map distance. incorrect marker order and map distances can have a profound effect on linkage analyses. using a sex-averaged map instead of a sex-specific map biases the lod scores upward, markedly increasing the false positive rate. since it is very costly to follow-up many false-positive results, there is a clear need for more precise and accurate sex-specific genetic maps. accurate estimates of meiotic map distance cannot be obtained by any means other than by linkage analysis using genotype data. the study is in response to a request for applications entitled "nhlbi innovative research grant program" released in july, 2001. the purpose of the initiative is to support new approaches to heart, lung, and blood diseases and sleep disorders that use existing data sets or existing biological specimen collections whether obtained through national heart, lung, and blood institute support or not. design narrative: the genetic epidemiology study will build improved highly-precise sex-specific linkage maps utilizing thousands of individuals who have previously been genotyped. after filtering out obvious relationship and genotype errors, the study will incorporate methods that properly model for genotyping errors. in addition to creating precise maps for the scientific community, the study will also use these genotype data to study how recombination may vary between ethnic groups. the genotypes generated by the nhlbi mammalian genotyping service are precisely the type of data required to produce more accurate maps. these data collections contain over 3,400 pedigrees with more than a 100-fold increase in information compared to that contained in the 8 ceph families that have been used to construct current genome-wide linkage maps. the new maps will be made publicly available and the genotype data from the study will be accessible by the map-0-mat linkage mapping server. in the future, the study will be broadened to incorporate genotype data from additional genotyping centers such as the center for inherited disease research (cidr).

Eligibility criteria:
no eligibility criteria
metabolism and excretion of liraglutide in healthy male volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is characterise the metabolic profile of liraglutide in plasma, urine, and faeces after a single injection of \[3h\]-liraglutide.


Eligibility criteria:
inclusion criteria: * good general health as judged by the investigator, based on medical history, physical examination including 12-lead ecg (electrocardiogram), vital signs, and blood and urinary laboratory assessments * bmi (boday mass index) of 20.0-27.0 kg/m\^2, both inclusive exclusion criteria: * history of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator * impaired renal function * active hepatitis b or active hepatitis c * positive human immunodeficiency virus (hiv) antibodies * any clinically significant abnormal ecg, as judged by the investigator * any clinically significant abnormal laboratory test results, as judged by the investigator * acute infection or inflammation or other illness that may influence the metabolism and excretion pattern of the trial product, as judged by the investigator * known or suspected allergy to trial product(s) or related products * history of alcoholism or drug abuse or positive results in alcohol and drug screens * smoking of more than 5 cigarettes per day * habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the investigator * excessive consumption of a diet deviating from a normal diet, as judged by the investigator
dose-escalation study to assess the safety, tolerability, and pharmacokinetics from single dose of intramuscular (im) and subcutaneous (sc) donepezil (gb-5001) injections versus donepezil oral tablet (aricept®) in healthy male volunteers

Conditions: Alzheimer Disease

Summary: this study is to evaluate the safety and tolerability of single dose of gb-5001 (donepezil) im and sc depot in healthy male adults. and, it is to evaluate pharmacokinetic characteristics of gb-5001 (donepezil) im and sc single dose injection vs. active comparator.


Eligibility criteria:
inclusion criteria: * healthy adult males,19 to 55 years of age, inclusive at the time of screening visit * subject with a body weight of 55 kg or more and a body mass index (bmi) equal to or greater than 18.5 kg/m² but less than 30 kg/m² * subject without congenital or chronic conditions, and with no pathological symptoms or findings on internal medical examination * subject who has been deemed suitable based on screening test results assessed by the principal investigator * subject who can understand this clinical trial, provide informed written consent prior to the clinical trial procedures exclusion criteria: * subjects with the following medical history or symptoms, as determined by the principal investigator to pose a risk to the trial. * renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immune, musculoskeletal, neurological, psychiatric, dermatological, and hematological conditions. * rhabdomyolysis * seizure, epilepsy, fainting * peptic ulcer or gastrointestinal hemorrhage * gastrointestinal pathology, uncontrollable gastrointestinal symptoms or a history of disturbing absorption, distribution, metabolism or excretion * severe physical/organ abnormalities * human immunodeficiency virus, hepatitis b virus, hepatitis c virus * subjects with a history of, or currently receiving, the following medications, as determined by the principal investigator regarded as a risk to the trial. * medications, including antidepressants, that can induce rhabdomyolysis * medications with a risk of ulcer development. * potent inhibitors of cytochrome p450 (cyp) enzymes * anticholinergic drugs, cholinomimetics, and other cholinesterase inhibitors * subjects who have difficulty with venipuncture or injection procedures via catheter or intravenous access * subjects who have been consistently engaging in excessive smoking or consuming caffeine or alcohol within the last 3 months prior to screening, or subjects who cannot abstain from smoking, caffeine, and alcohol consumption for at least 2 days before the scheduled administration of the investigational product or during the inpatient period