Kornimate/medical-research-clean huggingface dataset:
phase 2 study of tlk286 administered weekly in advanced non-small cell lung cancer

Conditions: Carcinoma, Non-small-cell Lung

Summary: the purpose of this study is to determine the effectiveness of tlk286 in the treatment of advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of non-small cell lung carcinoma * progressed while on or after treatment on platinum-based regimen * patients may not have had more than one prior cytotoxic chemotherapy regimen * stage iv or iiib * age at least 18 years * adequate liver and kidney function * adequate bone marrow function exclusion criteria: * pregnancy or lactation * unstable medical conditions * chemotherapy, hormonal therapy, radiotherapy, radiopharmaceuticals or immunotherapy within 3 weeks of tlk286 * cns metastasis unless controlled by treatment
treatment of enuresis nocturna by circular muscle exercise (paula method)

Conditions: Monosymptomatic Enuresis Nocturna

Summary: several treatment modalities for children suffering from monosymptomathic nocturnal enuresis are available including drugs, alarms, acupuncture, pelvic floor training and biofeedback. the aim of this study is to to test if paula method (circular muscle exercise) can be an another treatment modality.

paula method is based on circular muscle exercises. the theory behind the paula method is that all sphincters in the human body work simultaneosly, mutually affecting one another possibly mediated by "oscillation" of the spinal cord. according to this theory, exercising the ring muscles in a certain area of the body will result in strengthening the circular muscles in other areas. this method was found to to be efficacious for treatment of urinary stress incontinence in women.

Eligibility criteria:
inclusion criteria: 1. age- 7 to 15 years old suffering from monosymptomatic enuresis nocturna 2. informed consent exclusion criteria: 1. uti 2. neurological diseases or syndromes 3. metabolic disesaes 4. congenital disease or malformation of the urinary tract

Keywords: enuresis nocturna paula method circular muscle exercise sphincter
effect of neuromuscular training on shoulder function

Conditions: NMT

Summary: this study will be conducted to compare the effect of neuromuscular training versus traditional strength training in terms of shoulder joint function, proprioception accuracy and isometric external and internal rotator muscles strength in patients with sis, it will be conducted at the out-patient clinic of physical therapy in pharos university in alexandria, egypt

double-blinded randomized controlled trial (patient and research assistant (the examiner of all patients) will be blinded). participants: thirty-four patients of both genders will be selected through non-probability sampling diagnosed as neer's stage ii sis and their age range from 25-45 years will be randomly assigned to 1 of 2 groups. each patient will sign an informed consent before starting the study (appendix iii). eligible patients will be recruited by physical therapist via referral from the treating orthopedic surgeon who will diagnose sis based on clinical and radiological examination. group i (control): it includes 17 patients who will receive traditional strength training program. group ii (experimental): it includes 17 patients who will receive upper extremity neuromuscular training exercises

Eligibility criteria:
inclusion criteria: * patient age from 25-40 with a clinical diagnosis of neer's stage ii sis (consigliere et al., 2018). shoulder pain for at least three months (heron et al., 2017) painful arc of movement during flexion or abduction (heron et al., 2017). positive neer's or kennedy- hawkins test (heron et al., 2017). pain on resisted external rotation, abduction or empty can test (ager et al., 2019). exclusion criteria: symptoms of cervical radiculopathy. diagnosed inflammatory disorder. neurological disorder. widespread pain condition. evidence of complete rc tear (positive drop arm test). previous surgery to the affected shoulder. :

Keywords: nmt= neuromuscular training
indego® exoskeleton; assessing mobility for persons with spinal cord injury (sci).

Conditions: Spinal Cord Injury

Summary: this study will evaluate the indego® device for safety and effectiveness at allowing persons with sci who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.


Eligibility criteria:
inclusion criteria: * be 18 years or older * height 5'1" to 6'3" (acceptable height may vary by a few inches depending on femur length). * hip width as measured in sitting no greater than 16.6" (42 cm) (acceptable hip width may vary depending on soft tissue). * femur length as measured in sitting must be between 14 inches (35.5cm) and 18.5 inches (47 cm) * weight 250lbs (113.4 kg) or less * present with spinal cord injury and nli c5 and lower, with isncsci a, b, c or d who are non-ambulatory or poorly ambulatory. * there are no restrictions on time since injury. however, each subject must have signed medical clearance/approval for full weight bearing and locomotor training. * determined to have sufficient bone health for walking with full weight bearing without undue risk for fracture. meeting of this criterion is at the discretion of each subject's personal md and must be approved by each site's medical pi. * passive range of motion (prom) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid. * skin must be intact where it interfaces with robotic device * modified ashworth scale for spasticity score must be 3 or less. * blood pressure and heart rate within established guidelines for locomotor training: * at rest; systolic 150 or less diastolic 90 or less and heart rate 105 or less * exercise; systolic 180 or less diastolic 105 or less and heart rate 145 or less * tolerate being in an upright standing position (passive or active) without being lightheaded or having a headache. exclusion criteria: * weight in excess of 250 lbs * heterotopic ossification that, in the opinion of the investigator, would place the subject at undue risk for fracture. * any subject deemed at increased risk for injury by medical personnel * lower extremity joint limitation that exceeds 10 degrees at their hips, knees or ankles. * light headedness or headache in standing position (active or passive) * moderate to severe traumatic (or acquired) brain injury * inability to follow instructions * colostomy bag * women who are pregnant or attempting to become pregnant during the study intervention. * unable to obtain informed consent (either from the subject or from the subjects legally authorized representative). * any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol specified assessments * unlikely to be available for follow-up phone call. * any other issue which, in the opinion of the investigators, will make the subject unsuitable for study participation.

Keywords: sci indego walking
long-term safety and tolerability of canakinumab prefilled syringes in frequently flaring acute gouty arthritis patients

Conditions: Acute Gouty Arthritis

Summary: this is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.


Eligibility criteria:
inclusion criteria: * compliance and completion of the canakinumab pfs core study * unchanged significant clinical medical history from entry into core study exclusion criteria: * physician judgment of unsuitability for the study * pregnant or nursing women other protocol-defined inclusion/exclusion criteria may apply

Keywords: gout arthritis gout flare acute gout gouty rheumatic disease uric acid podagra
effect of intravenous magnesium during robot assisted prostatectomy

Conditions: Prostatic Neoplasms

Summary: the primary purpose of this study is to investigate the effect of intravenous magnesium on blood pressure after trendelenburg position during robot assisted prostatectomy. the secondary purpose of this study is to investigate the effect of intravenous magnesium on pain after robot assisted prostatectomy.


Eligibility criteria:
inclusion criteria: * robot assisted prostatectomy exclusion criteria: * allergy to magnesium * chronic pain * chronic opioid use * chronic nsaid use * renal dysfunction * liver dysfunction * cardiac arrythmia * seizure
analgesia of fibula free flap donor site by peri-neuronal catheter in oro-pharyngeal carcinoma surgery

Conditions: Oropharyngeal Neoplasms

Summary: this trial examines the analgesia of the fibula free flap donor site by peri-neuronal catheter in oro-pharyngeal carcinoma surgery by comparing continuous infusion of a local anesthetic with systemic multimodal analgesia.


Eligibility criteria:
inclusion criteria: * adult patients scheduled for oro-pharyngeal carcinoma surgery with reconstruction by fibula free flap exclusion criteria: * allergy to propofol or local anesthetic (ropivacaine) * severe renal or cardiac failure

Keywords: oro-pharyngeal carcinoma surgery
mortality related to amr in patients with hospital-acquired infection

Conditions: Hospital-acquired Infections

Summary: this is a prospective surveillance study to estimate excess deaths due to and risk factors associated with antibiotic-resistant infection among patients with hospital-acquired infection (hai) in a resource-limited setting. we will focus on six pathogenic bacteria that are of clinically important in the hospital.

we will first identify patients with pathogenic bacteria isolated from clinical sample collected \>48 hours after admission. these patients will then be screened for eligibility criteria. signed informed consent will be sought from the enrolled patients. the primary outcome is survival status within 28 days since the first specimen culture positive for one of the six organisms of interest. all patients with hospital-acquired infection will be assessed for in-hospital 28-day survival as part of the routine hospital surveillance system. follow-up to confirm 28-day outcome via telephone call will be performed only if patient signed informed consent and permission is granted. all isolates from positive cultures will be collected and stored securely. this study will not interfere with standard patient care or routine diagnosis procedure, hence subject will receive no direct medical harm or benefits from being in the study. researchers of this study will not be involved in the management, care and treatment of study subjects. patient care will remain under the responsibility of the attending medical staff according to standard practice of care. the study team will work closely with the hospital infectious control team to screen and enroll patients as part of the hai surveillance data system in sunpasitthiprasong hospital. this study will be an enhancement of the current hai surveillance system, which will provide data on 28-day survival status, charlson comorbidities index (cci) score and sequential organ failure assessment (sofa) score for each patient and risk factors related to acquiring hospital-acquired infection to the hospital infectious control (ic) team.

Eligibility criteria:
inclusion criteria: * male or female of any age admit at sunpasitthiprasong hospital * at least one of the six organisms, which include staphylococcus aureus, enterococcus spp., escherichia coli, klebsiella pneumoniae, pseudomonas aeruginosa, acinetobacter spp., isolated from clinical specimen \>48 hours after admission * acquired bloodstream infection (bsi), lower-respiratory tract infection(lrti), skin/soft tissue infection (ssti), surgical-site infection (ssi), urinary tract infection (uti) or infection at other body sites \>48 hours after admit at the hospital exclusion criteria: • clinical symptoms of current infection presented ≤48 hours of admission

Keywords: antibiotic-resistant infections risk factors prospective surveillance
early age-related hearing loss investigation (earhli)

Conditions: Alzheimer Disease; Hearing Loss; Cognitive Impairment

Summary: early age-related hearing loss investigation (earhli) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. participants will be followed for 1 year. this study will provide information on reducing cognitive decline in those at risk for alzheimer's disease and alzheimer's disease related dementias (ad/adrd).

earhli will be a phase ii 1:1 randomized controlled trial of a hearing intervention (including prescription hearing aids) versus a health education program. participants must be 55-75 years old and have early-stage age-related hearing loss and amnestic mild cognitive impairment. the trial will last 1 year and occur at a single site (columbia university irving medical center). outcome measurements will include cognition, social engagement, and change in brain organization/connectivity. assessments will occur at study start, 6 months, and 12 months. a total of 150 participants will be enrolled (75 per intervention group). participants will also have a hearing test and a blood test. approximately half of participants will have two mri scans. as part of participating, all participants will get prescription hearing aids, either at study start or end.

Eligibility criteria:
inclusion criteria: * age 55-75 years of age * adult-onset hearing loss of approximately mild to moderate in severity (4-frequency 0.5, 1, 2, 4 khz pure tone average 20 db to 55 db hl in better hearing ear) * aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear * amnestic mild cognitive impairment (mci) defined by mini-mental state exam (mmse2) score \>23, clinical dementia rating (cdr) global score equivalent = 0.5, and adni3 criteria of logical memory ii score of ≤6 if 0-7 years of education, ≤9 if 8-15 years, and ≤11 if ≥16 years * availability of a study partner (informant) for the administration of the cognitive screen and the adcs-activities of daily living-prevention instrument (adcs-adl-pi) * community-dwelling * fluent in english or spanish * availability of participant in area for study duration exclusion criteria: * self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (\<45 years old) * prior dementia diagnosis * reported disability in ≥ 2 activities of daily living (adls) * current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials) * unwillingness to wear hearing aids regularly (≥8 hours/day) * medical contraindications to the use of hearing aids (e.g., actively draining ear) * corrected vision impairment (worse than 20/63 on mnread acuity chart in worse eye) * untreatable conductive hearing loss with air-bone gap \> 15 db in two or more contiguous octave frequencies in both ears

Keywords: hearing loss alzheimer's alzheimer hearing aid memory loss memory audiogram cognition
cardiopulmonary complication in aneurysmal subarachnoid haemorrhage patients

Conditions: Aneurysmal Subarachnoid Heamorrhage; Nontraumatic Subarachnoid Haemorrhage

Summary: this is a prospective cohort study investigating cardiac function and cardiac biomarkers in patients with acute aneurysmal subarachnoid haemorrhage (asah). the aims of the study are to document the incidence of myocardial dysfunction,to find the predictive factors of myocardial dysfunction, describe heart rate variability and to assess the impact of all cardiac problems on morbidity and mortality.

laboratory markers daily: routine laboratory test (blood gases, haemoglobin, thrombocytes, leukocytes, inr, bilirubin, creatinine, c-reactive protein, ck, ck-mb, tnt, bnp, sodium, potassium, magnesium) are taken at 8 a.m. study laboratory tests (sensitive ischemia markers, remodelling marker mmp-9 and cga as surrogate marker for increased sympathetic activity) are taken four times during study period at the same time as cardiac echoes and holtering. gene sample is taken once on day one. primary outcome measurement is to document the incidence of myocardial dysfunction and the predictive factors during the hospital stay and at three months. secondary outcome is to assess the impact of cardiac problems on morbidity and mortality during first three months.

Eligibility criteria:
inclusion criteria: * patients with nontraumatic subarachnoid haemorrhage * age \> 18 years * aneurysmal bleeding exclusion criteria: * no consent * age \< 18 years * anticipated brain death \< 24 hours * otherwise moribund patient

Keywords: subarachnoid haemorrhage cardiopulmonary complications
effect of neo40 on pad

Conditions: Peripheral Artery Disease

Summary: reduced nitric oxide (no) availability is a hallmark of a number of cardiovascular diseases (cvd) including peripheral artery disease (pad). the investigators will test the hypothesis that sub-chronic neo40™ supplementation will improve vascular no function and improve intermittent claudication in patients with pad. using a prospective, double blind, placebo controlled experimental design in 30 patients, graded treadmill tests will be performed at baseline and after 3 months after randomization, according to the skinner-gardner protocol. initial claudication distance (icd) and absolute claudication distance (acd) will be recorded. two consecutive treadmill tests will be performed within 1 week at baseline (before administration of study drug); and 2 test will be performed at 3 months. functional status will also be assessed by the walking impairment questionnaire and the health status survey sf-36 questionnaire (sf-36). vascular function will be assessed with the use of a vendys® vascular reactivity (endothelial function) test (endothelix inc). digital pulse amplitude will be assessed using sensor probes on the index finger during reactive hyperemia. blood will be collected for measurement (by neogenis) of plasma levels of nitrite and nitrate at baseline and at the completion of the study. based on previously published trials using this no technology, the investigators predict that the group receiving the active supplement will exhibit an improvement in claudication distance and all measures of vascular function after 3 months.


Eligibility criteria:
inclusion criteria: * persons of at least 45 years of age * persons with unilateral or bilateral pad confirmed by a resting ankle-brachial index (abi) \<0.9 * persons with stable intermittent claudication for the previous 3 months * persons with the ability to walk 1 to 12 minutes on a treadmill. the pre-randomization treadmill test is limited by exercise-induced leg pain, which is relieved by cessation of the test. variability of maximum walking distances between 2 consecutive screening treadmill tests will be \<10%. exclusion criteria: * persons with ischemic rest pain, ulceration or gangrene * persons with history in the previous 3 months of acute coronary syndrome or revascularization involving the peripheral or coronary arteries * persons with major amputation * persons with malignancy within the previous 5 years (except for treated non-melanoma skin cancer) * persons with proliferative retinopathy * persons with uncontrolled hypertension * persons with active inflammatory, infectious, or autoimmune diseases. * persons taking taking phosphodiesterase inhibitors, organic nitrates and/or hydralazine

Keywords: nitric oxide neo40 supplement, exercise tolerance
safety and efficacy study of fostamatinib to treat immunoglobin a (iga) nephropathy

Conditions: IGA Nephropathy

Summary: the purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of iga nephropathy


Eligibility criteria:
inclusion criteria: * renal biopsy findings consistent with iga nephropathy * treatment with an angiotensin converting enzyme inhibitor (acei) and/or an angiotensin ii receptor blocker (arb) for at least 90 days at the maximum approved (or tolerated) dose * proteinuria \> 1 gm/day at diagnosis of iga nephropathy and proteinuria \> 0.50 gm/day at the second screening visit * blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents exclusion criteria: * recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or rituximab. * use of \> 15 mg/day prednisone (or other corticosteroid equivalent).

Keywords: iga glomerulonephritis nephritis, iga type
understanding excretion and infectivity of zika virus in semen during and after infection

Conditions: Zika Virus

Summary: in this prospective observational study the investigators will report on 20 male subjects with proven who-classification zika infection. these subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of zika virus (zikv) in semen over time.

in this prospective observational study the investigators will report on 20 male subjects with proven who-classification zika infection. these subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of zika virus (zikv) in semen over time. knowledge of the possible presence, infectivity and persistence of zikv in semen will provide evidence-based data for 1. estimating of the risk of sexual transmission of zikv in the general population 2. antenatal guidelines for the prevention of sexual transmission of zikv to the fetus 3. advising couples on the length of time that pregnancy should be avoided in women wishing to conceive after their partner's zikv infection 4. strategies to prevent transmission of zikv infection through assisted reproductive treatment (art) 5. advice on gamete cryopreservation 6. optimising investigations for diagnosis of zikv in males.

Eligibility criteria:
inclusion criteria: * male aged 18-50 years * zikv symptoms within the preceding thirty days * confirmed zikv infection (who criteria) * able to ejaculate to produce a semen sample exclusion criteria: • current urological malignancy
relative potency of inhaled corticosteroids

Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Summary: to investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.


Eligibility criteria:
inclusion criteria: * sputum eosinophilia \>3% * adults age 18-70 years * history of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months. * fev1 ≥ 60% predicted * steroid naive or on not more than 500 µg a day of beclomethasone or equivalent. * able to give written informed consent exclusion criteria: 1. recent asthma or copd exacerbation (as judged by the clinician) due to respiratory infection within the last month 2. relevant seasonal allergen exposure within 4 weeks or within the course of the study 3. treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks 4. other respiratory diseases 5. women who are pregnant or unwilling to use appropriate contraception during the study 6. unable to withhold short-acting ß-agonist treatment for 6 hours before visit

Keywords: eosinophilic bronchitis with asthma eosinophilic bronchitis without asthma
mr-guided laser ablation of prostate bed recurrences

Conditions: Prostate Tumors

Summary: the purpose of this study is to see if mr-guided laser ablation can effectively treat prostate tumor recurrences.


Eligibility criteria:
inclusion criteria: * patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa referred to urology and/or interventional radiology for treatment. * surgery is not a desirable alternative therapy at the time of enrollment * radiation therapy has failed or not indicated or can be safely postponed * tumor size ≤ 5 cm at its largest diameter * tumor does not encompass the rectal wall or external urethral sphincter * performance status is ecog 2 or better in adults * patient is able to undergo mri exclusion criteria: * patients with pacemaker or defibrillator