Kornimate/medical-research-clean huggingface dataset:
42-day repeat oral dose study of akb-6548 in participants with chronic kidney disease and anemia

Conditions: Anemia; Kidney Disease

Summary: the purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered akb-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.


Eligibility criteria:
key inclusion criteria: * 18 to 79 years of age, inclusive * chronic kidney disease (egfr \<60 ml/min), not yet on dialysis * hemoglobin (hgb) ≤ 10.5 g/dl * transferring saturation ≥ 20% * ferritin ≥ 50 ng/ml key exclusion criteria: * body mass index \>42 * red blood cell transfusion within 12 weeks * androgen therapy within the previous 21 days prior to study dosing * therapy with any approved or experimental erythropoiesis stimulating agent (esa) within the 11 weeks prior to the screening visit * participants meeting the criteria of esa resistance within the previous 4 months * individual doses of intravenous iron of greater than 250 mg within the past 21 days * aspartate aminotransferase or alanine aminotransferase \>1.8x upper limit of normal (uln) * alkaline phosphatase \>2x uln * total bilirubin \>1.5x uln * uncontrolled hypertension * new york heart association class iii or iv congestive heart failure * myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing

Keywords: anemia chronic kidney disease ckd chronic renal insufficiency renal impairment erythropoietin safety efficacy tolerability pharmacokinetics
the use of adaptive proximal scaphoid implant (apsi): long term follow-up

Conditions: Scaphoid Non-union Advanced Collapse (SNAC Wrist)

Summary: scaphoid proximal pole fracture with avascular necrosis is a complex surgical problem. in some cases, it's possible to perform a scaphoid hemiarthroplasty with an adaptative proximal scaphoid implant (apsi), made of pyrocarbon, replacing the necrotic proximal pole. apsi allows an early mobilization of the wrist, an optimal recovery of strength and a rapid return to normal daily and work activities without limitations. this implant delays palliative and more invasive surgical treatments in patients that are generally young with high functional demands. the investigators have performed a long-term follow up (with a mean follow-up of 17 years) of the early cases of apsi implant performed, starting from 1999. radiographic and clinical strength recovery, along with subjective outcomes, have been shown to be good, with a rapid return to daily and work activities, indicating that apsi implants are a good alternative to traditional and invasive techniques.


Eligibility criteria:
inclusion criteria: * patients who underwent apsi implant surgery in the period from december 1999 to december 2016, with surgery performed via dorsal or volar approach in the case of previous surgical access; * collection of informed consent to the processing of personal data by the patients contacted in order to be included in the study. exclusion criteria: * patients for whom it was not possible to obtain informed consent to the processing of personal data.

Keywords: osteoarthritis arthroplasty scaphoid fracture pyrocarbon bone implant
assessment of the impact of probiotics on biofilm formation on removable acrylic dentures

Conditions: Mandibular Prosthesis User

Summary: the aim of this study is to evaluate the effect of pip toothbrush cleaner® on the microbial composition and candida albicans colonization of denture biofilm formation. additionally, its effect will be compared to that of cleansing tablets.

therefore the present study intended to compare a probiotic denture cleaning protocol with the current protocols. it was aimed to examine, in institutionalized older individuals with removable complete dentures, if the microbial composition and c. albicans colonization of the denture biofilm differs when overnight stored in a probiotic cleaning product compared to water or a cleanser. additionally the influence of brushing on these protocols was investigated.

Eligibility criteria:
inclusion criteria: * reside in a home for elderly * fully edentulous in lower and upper jaw * removable denture wearer in lower and upper jaw * good oral health exclusion criteria: * current or history of corticosteroid treatment within the 3 months prior to the study * current or history of antimicrobial treatment within the 3 months prior to the study * inability to provide informed consent * inability to comply with the study requirements * heart disorders persons with a high risk for an unfavourable prognosis of bacterial endocarditis will be excluded. this applies to patients with prosthetic heart valves, history of infectious endocarditis, cyanogenic congenital heart disorders (including palliative shunts and connections), completely recovered congenital disorders that were treated less than 6 months ago, treated congenital heart disorders with residual defect, and valvulopathy after heart transplantation.

Keywords: edentulous patients with full
randomized controlled study of the effectiveness of iv fluid infusion in patients with acute ischemic stroke (ivis)

Conditions: Ischemic Stroke

Summary: to study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours.

this study aims to find the effect of early iv fluid administration to patients with acute ischemic stroke on the neurological outcome and to determine the side effects of intravenous fluids. due to its cost effectiveness and wide accessibility, the possible application or use of iv fluid infusion as first line treatment can aide in the treatment of more acute ischemic stroke patients worldwide. this novel information will aide physicians with more comprehensive understanding of the efficacy of utilizing iv fluid in future treatment plans for patients with acute ischemic stroke.

Eligibility criteria:
inclusion criteria: 1. age from 18-80 years 2. nihss ≥ 1 3. diagnosis of acute ischemic stroke within 72 hours from stroke onset 4. enrollment into the study within 24 hours after hospital arrival 5. urine specific gravity level \< 1.030 6. patient consent exclusion criteria: 1. patients receiving \> 40 ml/hr iv fluid infusion over 3 hours 2. acute ischemic stroke caused cardiogenic embolism 3. urine specific gravity ≥ 1.030 4. large cerebral infarction area 1. infarction \> 1/3 of middle cerebral artery area 2. infarction \> 1/2 of cerebellar hemisphere 5. nhiss ≥ 18 6. previous or current episode of atrial fibrillation 7. previous or current episode congestive heart failure 8. previous echocardiogram with ejection fraction \< 40% 9. previous or current episode of dilated cardiomyopathy 10. abnormal renal function gfr ≤ 60% or serum creatinine ≥ 2 11. modified rankin scale before acute ischemic stroke ≥ 2 12. patients receiving intravenous thrombolysis 13. npo with need for iv fluid 14. iv fluid infusion needed from any other causes 15. patients with poor prognosis with life expectancy \< 90 days 16. patients involved in other ongoing clinical studies

Keywords: acute ischemic stroke intravenous fluid ้hydration
retrospective analysis on large incisional hernia in high risk patients

Conditions: Incisional Hernia; Large Incisional Hernia

Summary: large incisional hernia (lih) is a challenging condition where the abdominal wall is hopelessly compromised. nowadays the best treatment option in this particularly frail subset of patients is a major issue. the auhtors proposed the clinical experience with an innovative approach with the composite free lateral polypropylene prosthesis (flapp®) mesh fashioned as "neoperitoneum" analyzing its feasibility and short/medium term results.


Eligibility criteria:
inclusion criteria: * symptomatic patients with midline large incisional hernia exclusion criteria: * lateral incisional hernias * collagen diseases * patients who recently have undergone chemotherapy and/or radiation therapy * patients with acquired immunodeficiency
effectiveness of oral insulin in unstable type 1 diabetes patients

Conditions: Brittle Type I Diabetes Mellitus

Summary: the intent of the proposed study is to assess the potential of oral insulin to mitigate diabetic instability and reduce the frequency and severity of hypoglycemic episodes in patients with type 1 diabetes. restoring hepatic glycogen stores is critical for the normalization of counter-regulation to hypoglycemia in these patients. oral insulin can provide a means to increase portal insulin levels, shift the ratio of insulin/glucagon in favor of glycogenesis while sparing the patient the risk of hypoglycemia due to peripheral hyperinsulinemia


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * male or female aged 18-50 years inclusive * body weight between 50-100kg and bmi between 18 and 30 kg/m2 * diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia * no other medical problems exclusion criteria: * history or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug * positive pregnancy test or lactation * lack of family support * unwilling or unable to follow the study protocol * concurrent medical problems
intensive management of pressure and volume expansion in patients with subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: the purpose of our study is to determine how well triple-h works and how safe it is. the investigators are hoping to determine the effects of starting the therapy early and to explore if hypervolemia and/or hypertension are beneficial, and what the optimal target ranges are.

efficacy of triple-h therapy.

Eligibility criteria:
inclusion criteria: 1. age more than or equal to 18 years 2. aneurysmal sah of any clinical grade 3. head computed tomography demonstrating sah 4. cerebral angiography revealing the presence of cerebral aneurysm(s) in a location that explains the sah 5. treatment of aneurysm with clipping or coiling must be carried out prior to randomization and within 72 hours of bleeding 6. signed consent by study participant or applicable legal representative within 72 hours after sah exclusion criteria: 1. history of traumatic sah 2. non-aneurysmal sah as indicated by no demonstrable aneurysm by cerebral angiography 3. presence of an unsecured intracranial aneurysm(s) at risk of rupture that in the opinion of the investigator would compromise the safety of the patient or the quality of the data 4. delayed referral with clipping/coiling greater than 72 hours after the initial bleeding 5. time of symptom onset cannot be reliably determined 6. intracranial hypertension (icp \>25 mm hg) at the time of screening 7. history within the past six months and/or physical findings on admission of decompensated congestive heart failure (nyha functional class iii or iv, or objective class c or d) 8. acute, evolving or recent myocardial infarction 9. cardiac arrhythmia or second and third degree atrio-ventricular block causing hemodynamic instability 10. chronic renal failure requiring dialysis 11. suspected or confirmed pregnancy 12. non english speaking 13. a condition that would preclude the performance of the neurobehavioral test battery due to a prior diagnosis of alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation 14. severe terminal disease with life expectancy less than 6 months 15. refusal of consent
treating obstructive sleep apnea using targeted hypoglossal neurostimulation

Conditions: Obstructive Sleep Apnea; OSA; Apnea; Apnea, Obstructive; Apnea, Obstructive Sleep; Apnea+Hypopnea; Hypopnea, Sleep

Summary: multi-center, open-label, prospective, randomized clinical trial of the aura6000(r) system for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.

all qualifying subjects will be implanted. subjects will be randomized 2:1 in favor of stimulation therapy (active group). randomization will occur following implant and prior to the month 1 visit. the active group will start stimulation therapy at month 1. the control group may continue with their current sleep apnea treatment until month 7, and will receive stimulation therapy beginning at month 7 +1day. (all subjects are excluded from use of pap or surgical treatments after enrollment through month 13) safety and efficacy will be evaluated at month 7, and again at month 13.

Eligibility criteria:
abbreviated: additional criteria may apply: inclusion criteria: * diagnosis of moderate to severe osa * declines to use or does not tolerate pap therapy exclusion criteria: * respiratory, cardiac, renal disease or other co-morbid conditions * bmi \> 35 kg/m2 * specific psg criteria outlined in the protocol

Keywords: osa snoring obstructive sleep apnea cpap pap
trial comparing outpatient flexible to rigid cystoscopy in females

Conditions: Pain

Summary: the primary purpose of this study to assess patient pain scores comparing rigid to flexible cystoscopy in females; to assess post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures; to assess physician perception of patient pain or discomfort with flexible or rigid cystoscopy.

this will be a prospective randomized trial study in order to determine to compare rigid and flexible cystoscopy in female patients. patients will be recruited from ou physicians pelvic and bladder health clinic. patients receive an information leaflet describing the procedure prior to their appointment. all procedures are performed by the attending physician. procedures performed by residents and/or fellows are excluded from this study. the vulva is cleaned with antiseptic solution and 10 ml of xylocaine 2% is be instilled into the urethra before the endoscope was introduced. a 16 f flexible cysto urethroscope (storz, culver city, ca) is used for flexible cystoscopy. when rigid cystoscopy is performed, a 17f, 70° scope (storz, culver city, ca) is used to enable optimal visualization of the lateral bladder wall in those with previous continence surgeries. the investigator may choose to use a 30° scope when appropriate. cystoscopy is commenced by recording a postvoid residual ensuring appropriate bladder emptying prior to filling. filling is performed with continuous saline infusion until the maximum tolerated capacity or 300 ml. (whichever was reached first). a standard systematic approach was adopted to ensure global assessment of the vesical surface. this included the bladder dome, the bladder neck, bladder trigone, sidewalls and ureteral orifices. the urethroscopy portion of the procedure is performed last. when performing rigid cystoscopy, a 0° degree lens is used for this portion of the procedure.

Eligibility criteria:
inclusion criteria: * patients with the following indications for outpatient cystourethroscopy: 1. microscopic hematuria or 2. voiding dysfunction, or recurrence of urinary incontinence, or 3. history of recurrent bacterial cystitis * age \>18 * patient willingness to enroll * patient able to read and understand an english language self- administered questionnaire. exclusion criteria: * severe detrussor overactivity * interstitial cystitis or chronic urethral or bladder pain * acute urinary tract infection * urinary retention defined as a post void residual \>120cc * pregnancy or planning pregnancy within the next 3 months * prior urethral surgery * dementia or inability to complete questionnaires

Keywords: flexible cystoscopy rigid cystoscopy bladder outcome assessment pain measurement
pilot study on rutin combined with tislelizumab and gc (gemcitabine and cisplatin) as neoadjuvant therapy for platinum-refractory muscle-invasive bladder cancer

Conditions: Muscle Invasive Bladder Cancer

Summary: this trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and gc(gemcitabine and cisplatin) in platinum-refractory muscle-invasive bladder cancer patients. key research questions include: 1. whether rutin regulates epigenetic mechanisms in tumor cells from platinum-refractory bladder cancer patients and modulates the tumor immune microenvironment. 2. evaluating the safety and adverse events of the combination treatment in platinum-refractory bladder cancer patients. 3. assessing the disease control rate in platinum-refractory bladder cancer patients receiving this therapy. patients with mibc who exhibit no response (stable disease or progressive disease) after two cycles of neoadjuvant gc chemotherapy will receive two cycles of rutin combined with tislelizumab and gc. safety and adverse events will be assessed after each cycle of combinational treatment. therapeutic response will be evaluated by contrast-enhanced mri, and surgical decisions (transurethral resection, partial cystectomy, or radical cystectomy) will be made by two senior urologists. epigenetic alterations and the changes in immune microenvironment will be analyzed post-treatment.


Eligibility criteria:
inclusion criteria: * patients with ct2-ct4n0m0 muscle-invasive bladder cancer (mibc) * no response after 2 cycles of gc neoadjuvant chemotherapy * no prior use of systemic immunotherapy or target therapy * tumor is measurable according to new response evaluation criteria in solid tumours: revised recist guideline * ecog (zps, 5-point scale) 0-1 exclusion criteria: * age less than 18 years * patients with severe cardiac, cerebral, hepatic, or renal disease * severely malnourished patients * patients with mental illness and those without insight and unable to express exactly * combined with malignant tumors of other organs * systemic infectious diseases
cpr quality between flexible stretcher and standard stretcher in ohca

Conditions: Out-of-hospital Cardiac Arrest

Summary: this study aims to compare the quality of emergency medical services cardiopulmonary resuscitation between flexible stretcher and standard stretcher during ambulance transport to hospital among out-of-hospital cardiac arrest patients.

background: cardiopulmonary resuscitation (cpr) during ambulance transport in asia has been known to be ineffective for quality and unsafe for emergency medical services(ems)providers. small elevators in high rise buildings are the most serious barriers to provide high quality cpr due to too long stretcher cart to enter in the elevators. we developed flexible stretcher cart to be safely used in small elevator through reducing the length of the stretcher. this study aims to compare the quality of ems cpr between flexible stretcher and standard stretcher during transport to hospital. method: this is a before and after-trial in a metropolis ems. study targets are adult out-of-hospital cardiac arrest (ohca), excluding evident death cases, pregnancy, dnr cases, and too big or too small body size for stretcher cart or mechanical cpr devices. in the before period, the standard stretcher will be used for manual cpr using standard cpr protocol. in the after period, the flexible stretcher will be used with mechanical cpr devices after 3 cycles of standard manual cpr. individual and utstein risk factors will be collected. main outcomes are no-flow fraction (nff) measured by defibrillators (x-series) and safety will be measured on mechanical error, transportation error, patient injury and ems provider injury. sample size were 24 cases for before (12 cases) and after (12 cases) trial from 80% power and 0.05 of alpha error for expecting 20% quality difference (30% nff inflexible stretcher and 50% nff in standard stretcher) expected impact: the study will be expected to find the benefit of flexible stretcher cart during cpr in small elevators. this findings will contribute to revise the asian ems protocol for improving quality of cpr.

Eligibility criteria:
inclusion criteria: * all ems-assessed ohca in (3-4) selected districts in seoul * 18 years or older of age exclusion criteria: * do-not-resuscitation cases or ohca occurring in result of terminal diseases * signs of evident death (decapitation, evident livor mortis or rigor mortis) * pregnant * physique too large for mechanical cpr device application * chest deformation or injury * ems cpr quality not assessed by the defibrillator * return of spontaneous circulation (rosc) before scene departure * cardiac arrest cases during transport

Keywords: emergency medical services resuscitation
an observational study to assess change in disease activity and use of upadacitinib tablets in adolescent and adult participants with moderate to severe atopic dermatitis in real world

Conditions: Atopic Dermatitis

Summary: atopic dermatitis (ad) is a skin condition that may cause a rash and itching due to inflammation of the skin. this study will assess how effective upadacitinib is in treating ad. upadacitinib is an approved drug for treating ad. approximately 300 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in france. participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * physician confirmed diagnosis of atopic dermatitis or atopic eczema at baseline. * symptom onset ≥1 year prior to baseline. * initiation of upadacitinib treatment for ad is indicated and prescribed per local label. * the decision to prescribe upadacitinib is made prior to and independently of study participation. * participants who can understand and who are willing and able to complete the questionnaires, with parental support as required for adolescents. * participants (or legal representatives for adolescents) with a smartphone/tablet with internet access and willing to download the dedicated application to complete the questionnaires via this application. * participants (and legal representatives for adolescents) who have been informed verbally and in writing about this study before inclusion, and who do not object to their data being processed. * participants (and legal representatives for adolescents) able to understand and communicate with the investigator. exclusion criteria: * participation in a clinical trial assessing an investigational drug, concurrently or within the last 30 days. * prior treatment with upadacitinib.

Keywords: atopic dermatitis ad upadacitinib rinvoq