Kornimate/medical-research-clean huggingface dataset:
the efficacy of therapeutic exercises delivered by smartphone application

Conditions: Urinary Incontinence

Summary: therapeutic exercise has been shown to be effective in urinary incontinence management. however, there is a lack of physiotherapy services provided such necessary treatment. moreover, mobile applications are becoming popular, and there are limited applications designed to help women with urinary incontinence. consequently, no study investigated the effect of a smartphone application with specific exercises program for urinary incontinence management. therefore, the aim of this study is to determine the effect of a urinary incontinence exercises delivered by smartphone application on ui outcomes.

urinary incontinence (ui) is a common health disorder among women in jordan and worldwide. ui affects women's quality of life, mental health symptoms, and social participation. however, limited numbers of women with ui seek help for their problems for many reasons, including lack of rehabilitation services, feelings of shame, and unwillingness to discuss their problems. therapeutic exercise has been shown to be effective in ui management. however, there is a lack of physiotherapy services provided such necessary treatment. moreover, mobile applications are becoming popular, and there are limited applications designed to help women with ui. consequently, no study investigated the effect of a smartphone application with specific exercises program for ui management. therefore, the aim of the study is to develop an evidence-based therapeutic exercise application for ui and investigate its efficacy on ui clinical outcomes. we hypothesize that patients in the intervention group will have a significantly lower score of international consultation on incontinence questionnaire-urinary incontinence short form (iciq-ui sf) , a lower score of perceived stress scale, lower depression anxiety and stress scale (dass-21) score, a higher score of multidimensional scale of perceived social support (mspss), a higher short form health survey (sf-12) score, and a higher score of incontinence modular questionnaire-lower urinary tract symptoms quality of life (iciq-lutsqol) in comparison to the control group. a randomized controlled trial design. sixty women with urinary incontinence will be included in this study. participants will be randomized to the intervention group who will receive the mobile application (will include general information about ui and exercises) and the intervention group who will receive the sham application (include information about ui only). outcome measures will include arabic iciq-ui sf to assess the frequency of urinary incontinence, the arabic version of mspss to assess the social support, the arabic version of (dass-21) to assess the mental health symptoms, sf-12 to assess the quality of life, and iciq-lutsqol to assess the quality of life of women with ui.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ui, aged between 18-40, ability to read and own and use smartphone applications exclusion criteria: * women with no medical diagnosis.
continuous bladder irrigation following transurethral resection of bladder tumors

Conditions: Non-muscle Invasive Bladder Cancer (NMIBC); Bladder Tumor (TURBT)

Summary: the purpose of this pilot study is to determine if washing out the bladder with large volumes of saline after surgical removal of bladder tumors helps to decrease the number of loose cells floating within the bladder after surgery. anticipated decrease in tumor recurrence and/or progression rates will be measured.

bladder tumor recurrence after resection of non-muscle invasive bladder cancer (nmibc) occurs in 50-70% of patients despite the use of adjuvant anticancer therapy after surgery. this is a single-arm, non-randomized pilot study looking to determine whether post-transurethral resection of bladder tumor (turbt) cells counts differ significantly between continuous washout of the bladder (cbi) with normal saline compared to pre-cbi wash out. anticipated decrease in tumor recurrence and/or progression rates will also be measured, and each participant will act as their own internal control.

Eligibility criteria:
inclusion criteria: * patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging study * primary bladder tumor occurrence exclusion criteria: * patients with unresectable bladder tumors, as determined at the time of diagnosis or turbt , or imaging concerning of t2 or higher disease * patients with bladder perforation at the time of turbt, which is a contraindication to cbi * patients from vulnerable populations, including but not limited to impaired subjects, pregnant women, prisoners, family members of the study team * any previous history of bladder tumor resection or intravesical chemotherapy/immunotherapy * history of previous pelvic radiation * bladder tumor volume \> 5 cm, involvement of prostatic urethra, or any evidence of hydronephrosis on imaging
spirit v: post-marketing evaluation of the xience v® everolimus eluting coronary stent system in europe

Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Summary: the purpose of this clinical evaluation is a continuation in the assessment of the performance of the xience v® everolimus eluting coronary stent system (xience v® eecss) in the treatment of patients with de novo coronary artery lesions.

the spirit v clinical evaluation consists of two concurrent studies,the diabetic sub-study and the registry. the spirit v registry is a prospective, single arm, multi-center registry evaluating performance of the xience v® eecss in real-world use, per its instruction for use (ifu). 2,700 patients will be enrolled in the spirit v registry. the long term safety and efficacy of the xience v eecss have been demonstrated in the spirit first trial up to 5 years, the spirit ii trial up to 4 years, and in the spirit iii randomized control trial (rct) up to 3 years. in addition, these pre-approval studies have shown low rates of target vessel failure and major adverse cardiac events (mace) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. this benefit in mace is sustained for up to 5 years and is also independent of the first year results. the post approval spirit v study demonstrated that the use of the xience eecss in complex lesions in a real-world population resulted in 1 year mace, stent thrombosis and target lesion revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria. therefore, based on existing data from these trials, abbott vascular has decided to discontinue further follow up in the spirit v registry study after 2 years.

Eligibility criteria:
inclusion criteria: * at least 18 years * able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the xience v® eecss and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate medical ethics committee of the respective clinical site * evidence of myocardial ischemia * acceptable candidate for coronary artery bypass graft (cabg) surgery * undergo all cip-required follow-up examinations * artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned xience v® eescc * target lesions must be de novo lesions * target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate * target lesion ≤ 28 mm in length by visual estimate exclusion criteria: patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.

Keywords: drug eluting stents stents angioplasty coronary artery disease total coronary occlusion coronary artery restenosis stent thrombosis vascular disease myocardial ischemia coronary artery stenosis
chloroquinoxaline sulfonamide in treating patients with small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of chloroquinoxaline sulfonamide in treating patients who have small cell lung cancer that has not responded to platinum-based chemotherapy.

objectives: i. determine the efficacy of chloroquinoxaline sulfonamide in patients with platinum-refractory small cell lung cancer. ii. determine the toxic effects of this drug in these patients. outline: patients receive chloroquinoxaline sulfonamide iv over 1 hour once a week for 4 weeks. treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. patients are followed until death. projected accrual: a total of 12-38 patients will be accrued for this study within 12-18 months.

Eligibility criteria:
disease characteristics: histologically confirmed platinum-refractory small cell lung cancer no response or progression during or within 6 months of completing platinum based therapy measurable disease no symptomatic brain or leptomeningeal metastases patient characteristics: age: 18 and over performance status: swog 0-2 life expectancy: at least 12 weeks hematopoietic: granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 no hemolytic anemia hepatic: bilirubin normal ast no greater than 2.5 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl or creatinine clearance at least 60 ml/min cardiovascular: no history of cardiac arrhythmias other: no other active malignancy requiring concurrent treatment no allergy to sulfonamides not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics no more than 2 prior chemotherapy regimens at least 3 weeks since prior chemotherapy and recovered endocrine therapy: no concurrent corticosteroids to control symptoms of brain and/or leptomeningeal metastases radiotherapy: at least 4 weeks since prior radiotherapy no concurrent radiotherapy to measurable lesions surgery: not specified other: no concurrent hypoglycemic agents (including insulin)

Keywords: extensive stage small cell lung cancer recurrent small cell lung cancer
a low interventional study to monitor activity using wearable sensors in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy (DMD)

Summary: the purpose of this low interventional study is to collect data on everyday movement in boys with duchenne muscular dystrophy (dmd) using wearable activity sensors. the activity sensors could provide useful information beyond what is currently collected by functional (movement, strength) assessments in clinic. this information can help with the understanding of the impact of dmd, and perhaps with how possible treatments can affect this impact.


Eligibility criteria:
inclusion criteria: * diagnosis of duchenne muscular dystrophy confirmed by medical history and genetic testing * body weight between 15 and 50 kg * receipt of glucocorticoids for 6 months and a stable daily dose for at least 3 months prior to study entry * ability to rise from floor within seven (7) seconds and ability to walk exclusion criteria: * current exposure to systemic immunosuppressant agents other than glucocorticoids. * prior exposure to any gene therapy agent, including exon-skipping and missense agents. * exposure to other investigational drugs within 30 days or 5 half-lives, whichever is longer. * any injury which may impact functional testing per investigator's judgement. previous injuries must be fully healed prior to consenting. prior lower limb fractures must be fully healed and at least 3 months from injury date at screening. * any planned surgeries which may impact physical activity and performance. * presence or history of musculoskeletal or neurological disease in addition to dmd. * any known allergies or skin reactions to stainless steel, versaflex, and silicon that may cause possible discomfort by wearable sensors. * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, cancer, autoimmune or allergic disease that may interfere with the study conduct as per investigator's judgment, excluding untreated, asymptomatic, seasonal allergies at time of screening. * investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are pfizer employees, including their family members, directly involved in the conduct of the study.
elbow hemiarthroplasty versus orif for distal humeral fractures

Conditions: Distal Humerus Fracture; Comminuted Fracture; Intra-Articular Fractures

Summary: this is a randomized control trial comparing the outcome of orif (open reduction and internal fixation) with eha (elbow hemiarthroplasty) for distal humeral fractures in patients aged 50 years or above.

intraarticular distal humeral fractures ao/ota type c2 and c3 pose a surgical challenge despite the evolution of surgical implants and techniques. open reduction and internal fixation (orif) is often preferred as the first choice of treatment, but the results are varying, and sometimes disappointing. total elbow arthroplasty (tea) has been widely used for fractures that are not amenable to orif in elderly patients, but the mechanical complications remain a challenge, especially in active patients. elbow hemiarthroplasty (eha) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semiconstrained tea. there are no studies comparing the results of eha to that of tea or orif, but case series have reported promising results. in this study, forty-four patients with ao/ota type c2 or c3 fractures of distal humerus will be randomized to either orif or eha. the patients will be examined after the operation and at 3 months and 1, 2, 5 and 10 years after the surgery. the main objective of this study is to investigate the best treatment option for distal humeral fractures in patients aged 50 years or above. this can be of value to future patients sustaining these complicated fractures.

Eligibility criteria:
inclusion criteria: 1. distal humeral fracture ao/ota type c2 or c3 confirmed by plain radiographs with 2 perpendicular views and ct scan. 2. asa score 1-3 and physically fit for surgery. 3. age of 50 years or above. exclusion criteria: 1. patients unable to follow the rehabilitation protocol or answer the danish questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon. 2. significant elbow osteoarthritis as evaluated by the recruiting surgeon based on plain radiographs and ct scan. 3. fractures that are older than 6 weeks. 4. other associated elbow fractures. 5. pathological fractures or relevant elbow pathology.
biology and experience of eating in women with obesity

Conditions: Obesity

Summary: the purpose of this study is to understand how the opioid system is involved in eating behavior.

obesity is associated with greater risk for cardiovascular disease (cvd), stroke, diabetes, and mortality, and is a heterogeneous condition with various causes and thus a diversity of intervention targets. compulsive overeating afflicts 30% of people seeking obesity treatment and increases risk for cvd factors. this trial involves two participant visits to test whether opioid blockade (day 1 or 2, depending on randomization), compared to placebo (day 1 or 2, depending on randomization), will elicit common symptoms of opioid withdrawal, including nausea. participants will receive each condition on separate days.

Eligibility criteria:
inclusion criteria: * obese, as defined by bmi greater than or equal to 30 * self-reported binge eating as defined in the diagnostic and statistical manual of mental disorders (dsm-5), in the last 4 weeks * if sexually active with men, must agree to use birth control until the final study visit is complete (e.g., barrier methods, oral contraceptive) * subject must be able to complete written informed consent procedures and be able to comply with the requirements of the study. exclusion criteria: * pregnant or breastfeeding * severe hypotension (\< 90/60 mmhg) * recent or current use of vasoconstrictor or vasodilator medication * current or history of diabetes * allergies to any ingredients in naloxone hydrochloride * history of or current alcoholism or drug dependence * bulimia nervosa as defined in dsm 5 * current or past use of opiate-containing medications in the last 30 days * plan to use opiate-containing medications during study participation period * medical conditions that are contraindicated with intranasal procedures: nasal septal abnormalities, nasal trauma, epistaxis, excessive nasal mucus, and intranasal damage caused by the use of substances (e.g., cocaine) * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data

Keywords: obesity binge eating
safety & efficacy of pilocarpine eye solutions for temporary improvement of near vision in presbyopic adults

Conditions: Presbyopia

Summary: volunteer participants are evaluated for eligibility during a screening visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. at each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. afterwards, efficacy and safety assessments are performed over a 3-hour period.


Eligibility criteria:
primary inclusion criteria: * poor near vision impacting daily living that requires near correction * best-corrected distance visual acuity (bcdva) of 0.0 logmar or better * manifest refraction spherical equivalent ≥ -2.00 diopters (d) and ≤ +2.00 d * monocular dcnva between 0.4 and 0.7 logmar, inclusive primary exclusion criteria: * diagnosis of glaucoma or ocular hypertension * narrow iridocorneal angles * history of intraocular surgery, refractive surgery, laser treatment, or iris surgery * clinically significant abnormality of cornea, lens, retina, ciliary body, or iris * presence/history of a severe/serious ocular condition or any other unstable medical condition * presence or history of manifest strabismus, amblyopia, or nystagmus * current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears * clinically significant external ocular inflammation within 30 days of screening visit * current use or history of rigid gas permeable (rgp) contact lens use within 30 days of screening visit * known pilocarpine allergy or contraindication to use of pilocarpine * presence or history of congenital heart anomaly, valve disease, or other cardiac disease * disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the optejet
dual-task training combined with tdcs on cognitive-motor performance and brain activity in stroke patients

Conditions: Stroke; Cortical Excitability

Summary: the purpose of this study is to evaluate tdcs combined with cognitive-motor training on dual-task interference during dual-task walking, dual-task foot pedaling and the corresponding alterations of brain activity.

in china, the prevalence of stroke increased by 106.0% (93.7-118.8) between 1990 and 2019, highlighting the persistent and substantial burden of this condition. post-stroke recovery, particularly the ability to achieve community ambulation, plays a critical role in improving health-related quality of life. effective community ambulation in daily life requires the ability to dual-task-namely, to perform concurrent tasks requiring attentional resources while maintaining walking function and balance. emerging evidence suggests that stroke survivors face greater challenges in walking function and dual-task balance compared to their age-matched, able-bodied counterparts. for instance, when tasked with recalling a shopping list while walking, stroke patients exhibit a more pronounced decline in both walking speed and cognitive performance relative to control groups. given the necessity for stroke survivors to reintegrate into the community, it is imperative to thoroughly investigate this phenomenon of cognitive-motor interference.

Eligibility criteria:
inclusion criteria: * a diagnosis of stroke, stroke onset of more than 6 months, * aged 50 or more, * capable of following verbal and visual instructions, * having a montreal cognitive assessment score ≥ 22, * able to walk for 10 meters with/without a mobility aid, * community-dwelling, unilateral stroke exclusion criteria: * neurological disorders, gait-precluding pain or comorbidity, * receiving any formal rehabilitation training, * contraindications to exercise (e.g., unstable angina), * contraindications to fnirs, mri, and tdcs (e.g., brain skin injury, pacemaker, metal implants in the brain), * history of seizure or epilepsy, * color blindness. * unable to walk with/without a mobility aid while responsing stimulus by the remote control

Keywords: dual-task training cognitive-motor interference tdcs