Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of a small aperture extended depth of focus intraocular lens

Conditions: Cataract; Presbyopia

Summary: the purpose of this study is to determine the safety and effectiveness of the ic-8 iol implanted in one eye and a monofocal or monofocal toric iol implanted in the fellow eye in accordance with the indication.

eligible patients will complete up to 12 study visits over a 12-month period. all subjects will complete a preoperative examination of both eyes to assess study eligibility: operative visit (each eye) and up to 9 postoperative visits (day 1 - each eye, week 1 - each eye, month 1 - each eye or combined, month 3 - both eyes, month 6 - both eyes, and month 12 - both eyes). the first eye must meet specific qualification criteria in order to proceed with iol implantation in the second eye. the second eye should be implanted within 45 days of the first eye.

Eligibility criteria:
inclusion criteria: 1. minimum 22 years of age; 2. able to comprehend and have signed a statement of informed consent; 3. availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits; 4. planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber iol implantation in both eyes; 5. cataractous lens changes as demonstrated by best-corrected visual acuity (bcdva) of 20/40 or worse either with or without a glare source present; 6. potential for postoperative bcdva of 20/25 or better in each eye 7. clear intraocular media, other than cataract. exclusion criteria: 1. requiring an ic-8 intraocular lens outside the available spherical power range 2. pharmacologically dilated pupil size less than 6 mm in either eye; 3. inability to achieve stable keratometric readings for contact lens wearers 4. irregular astigmatism in either eye; 5. preoperative corneal astigmatism \> 1.50 diopters in either eye 6. active or recurrent anterior segment pathology 7. presence of ocular abnormalities other than cataract as specified in the protocol 8. diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication; 9. congenital cataracts; 10. previous corneal or intraocular surgery 11. history of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention; 12. systemic conditions as specified in the protocol; 13. patient is pregnant, plans to become pregnant, or is lactating 14. concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.

Keywords: cataract intraocular lens
aliskiren in patients with idiopathic membranous nephropathy

Conditions: Idiopathic Membranous Nephropathy

Summary: the goal of this proposal is to conduct a pilot study to access the antiproteinuric effect of aliskiren in patients with idiopathic membranous nephropathy. patients will be treated for 3 months with aliskiren aiming to achieve the maximum tolerated dose and blood pressure (\>100 but \ 75% of the readings).

in patients with nephrotic syndrome, including patients with membranous nephropathy (mn), conservative therapy consists of restricting dietary protein intake, and controlling blood pressure (target blood pressure is ≤ 125/75 mmhg), hyperlipidemia, and edema. angiotensin-converting enzyme inhibitors (acei) and/or angiotensin ii receptor blockers (arb) are effective anti-hypertensive agents that can reduce proteinuria and slow progression of renal disease in both diabetic and nondiabetic chronic nephropathy patients and for these reasons they are the preferred agents to treat hypertension in proteinuric renal diseases. recent studies suggest that renin inhibition with aliskiren may be renoprotective and reduce proteinuria in patients with type 2 diabetes. similar observations have also been reported in patients with membranous nephropathy and proteinuria in the range of 1-3 g/24h. these observations suggest that aliskiren may have powerful antiproteinuric. however, it is important to emphasize, that none of the patients in these studies had proteinuria greater than 3.0 g/24h. thus, the antiproteinuric effect of aliskiren in patients with heavy proteinuria (e.g. \>4g/24h) is unknown.

Eligibility criteria:
inclusion criteria * idiopathic mn proven by diagnostic kidney biopsy. * age ≥18 years but ≤ 80 years. * proteinuria as measured by urinary protein/urinary creatinine \> 4.0 on a spot sample aliquot from a 24-hour urine collection. * estimated gfr ≥ 30 ml/min/1.73m\^2 using the 4 variable modification of diet in renal disease (mdrd) equation. exclusion criteria * age \<18 years. * estimated glomerular filtration rate (gfr) \ 3.0 mg/dl. * patient must be off prednisone, calcineurin inhibitor or mycophenolate mofetil for \> 1 month and alkylating agents for \> 6 months. * patients with presence of active infection or a secondary cause of mn (e.g. hepatitis b, hiv, systemic lupus erythematosus (sle), medications, malignancies). * type 1 or 2 diabetes mellitus. patients who have recent history of steroid induced diabetes but no evidence of diabetic nephropathy on renal biopsy performed within 6 months of entry into the study are eligible for enrollment. * pregnancy or nursing for safety reasons. * acute renal vein thrombosis documented prior to entry by renal us or ct scan. * previous therapy with aliskiren

Keywords: membranous nephropathy aliskiren proteinuria, glomerulonephritis
safety, tolerance and pharmacokinetics of anidulafungin in immunocompromised children ages 2-17

Conditions: Neutropenia

Summary: anidulafungin is a medicine being developed for treatment of adults with certain kinds of fungal infections. this study is evaluating anidulafungin in children and adolescents who have fever and a low white blood cell count (neutropenia).

anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

Eligibility criteria:
* children ages 2-17 years with fever and neutropenia. * the expected duration of neutropenia should be 10 days and due to cytotoxic chemotherapy or aplastic anemia.

Keywords: neutropenia fever febrile neutropenia
safety and efficacy of the sore throat lozenges to treat acute sore throats

Conditions: Tonsillopharyngitis; Respiratory Tract Infection Viral

Summary: aim of this study is to investigate safety and efficacy of a. vogel sore throat lozenges for the treatment of of acute sore throats

75 patients aged 12-75 years with acute sore throats (symptoms not older than 48 h) were recruited by the study site/cro via local general practitioners and are allocated to acute treatment with a. vogel sore throat lozenges. the patients who are confirmed to meet the study entry criteria and after having given written informed consent will be assigned to receive a study treatment according to study procedures described in the study plan. the patients will visit study site twice. at the first visit (visit 1) a screening will be performed to finally decide if patient will be included/excluded in the study. then he or she will be taking one single lozenge under supervision of the investigating physician and acute efficacy/safety ratings recorded before intake and repeatedly every 15 minutes for 90 minutes after intake of first lozenge. he or she will be supplied with the remaining 19 lozenges in a bottle and provided with patient diaries for home recording of efficacy/safety. after four days (max 5 days) or until complete resolution of symptoms the patients were obliged to return to the study centre for final visit 2. daily ratings of efficacy/safety was done by the patient once in the morning and once in the evening. daily dosage was 5 lozenges per day every 3rd hour during daytime. at final visit 2, patients will be evaluated physically by the physician at the study centre and again assessed for safety/efficacy parameters. at last, patients returned their patient diaries and remaining study medication before compensation is handed out and patients finally excluded from the study.

Eligibility criteria:
inclusion criteria: * men and women aged 12-75 years * acute pharyngitis or tonsillitis with the following symptoms: sore throat, inflammation of the pharynx and/or tonsils * start of painful disease with the last 48 hours before study inclusion * tonsillopharyngitis score bigger than or equal to 6 (s.attachment) * willingness to give blood samples and three viral throat swabs * written informed consent exclusion criteria: * pharyngitis or tonsillitis more than 48 hours before study start (inclusion) * intake of analgetically active medication within the last 12 hours prior to study start (inclusion) * use of local sore throat medications within the last 4 hours prior to study start (inclusion) * patients with symptoms of a primary bacterial pharyngitis or a bacterial superinfection * severe medical condition (tumors, uncontrolled hypertension, heart insufficiency, immunosuppressive diseases etc.) * systemic use of corticosteroids in the last month prior to study inclusion * allergies to substances used in the tablet * pregnancy or lactation * participation or inclusion in one or more clinical trials within the last 30 days
an observational study to learn more about ntrk gene fusion positive in solid tumor in japan

Conditions: Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion

Summary: this is an observational study in which data from the past of people with solid tumors harboring an ntrk gene fusion in japan are studied. in observational studies, only observations are made without specified advice or interventions. advanced or recurrent solid tumor harboring an ntrk gene fusion is a rare type of solid cancer caused by specific changes in the genes called ntrk gene fusion, and which has spread to nearby tissues and/or lymph nodes or has returned. due to this change in the gene, an altered protein known as a trk fusion protein is made, which can cause cancer cells to grow and survive. the main purpose of this study is to learn more about ntrk gene fusion in people in japan. to do this, researchers will collect information on the number or percentage of japanese people with ntrk gene fusion in any solid tumor. the data will come from the national database called c-cat. they will cover the period from june 2019 until january 2023. besides this data collection, no further tests or examinations are planned, and no visits are required in this study.


Eligibility criteria:
inclusion criteria: * patients with any solid tumor and genome profiling results exclusion criteria: * none
femoral arterial access with ultrasound trial

Conditions: Vascular Access Complications; Cardiac Catheterization; Peripheral Vascular Disease

Summary: this study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography.

cardiac catheterization is conventionally performed with femoral arterial access using a combination of arterial pulse palpation, anatomical landmarks, and fluoroscopic landmarks to guide needle insertion. vascular access complications including hematoma formation, retroperitoneal bleeding, and arterial dissection are the most common types of adverse events associated with cardiac catheterization, and have been associated with insertions above and below the level of the common femoral artery. real-time ultrasound assistance for central venous catheter placement has been proven in multiple studies to reduce complications, and has been recommended by the agency for healthcare research and quality as a "top 11 highly proven" patient safety practice. this recommendation has not yet been extended to arterial access, due to a lack of studies to date. however, ultrasound assistance is licensed for and commonly utilized for arterial access, especially in difficult patients. in a pilot study of 71 procedures performed by the lead researcher, ultrasound guidance was associated with an improved 1st pass success rate (83% vs 47%, p=0.002), reduced risk of accidental venipunctures (0% vs 25%, p=0.002), and greater overall success in common femoral artery cannulation (89% vs 69%, p=0.048) as compared with the fluoroscopic control. this study is a multicenter prospective randomized trial to generalize the above findings with more patients studied, a larger number of operators, and across several centers. similar to the previous study, the ultrasound will be used real-time to visualize the femoral vein, femoral artery, and needle tract as the needle is inserted, to guide the needle towards the appropriate location in the artery. the time for insertion, number of passes, complications, and position of the insertion catheter on the femoral angiogram will be analyzed in the setting of patient factors including age, body mass index, and presence of peripheral vascular disease.

Eligibility criteria:
inclusion criteria: * adults age 18 and over * patients undergoing left heart catheterization or peripheral arterial angiography from the retrograde femoral approach * willingness and ability to sign consent form * scheduled to have procedure performed by operator trained in the ultrasound technique exclusion criteria: * access from a site other than the common femoral artery * nonpalpable femoral pulses * creatinine \> 3.0 mg/dl, unless already on dialysis * prisoners * pregnant women * unable or refusal to sign consent form * patients undergoing emergent cardiac catheterization for st segment elevation myocardial infarction or unstable acute coronary syndrome * equipment unavailable

Keywords: ultrasound guidance vascular access vascular complications
effects of travoprost on neovascular glaucoma

Conditions: Neovascular Glaucoma

Summary: prostaglandin analogues have not been used in the treatment of neovascular glaucoma because of suspicious lack of efficacy. this study aims at assessing the effect of travoprost on neovascular glaucoma.


Eligibility criteria:
inclusion criteria: * neovascular glaucoma of known cause * older than 18 years * previously submitted to retinal photocoagulation * under medical treatment to glaucoma exclusion criteria: * need of antiglaucomatous surgery * previous ocular surgery in the last 6 months * pregnancy

Keywords: neovascular glaucoma travoprost
bradykinesia subscale administered alone versus regular administration: psychometric properties

Conditions: Parkinson's Disease

Summary: the purpose of this study is to examine whether scores on questionnaires that rate how much parkinson's disease (pd) has slowed movements of the body differ when the order of the questions are changed. the consistency and accuracy of the questionnaires will also be examined. it is hypothesized that there will not be a difference.


Eligibility criteria:
inclusion criteria: 1. male or female at least 30 years of age 2. willing to be assessed using the motor examination section of the updrs and the spes/scopa motor evaluation 3. patients must be willing and able to give written informed consent prior to performing an study procedures 4. be in the "on" state (only for patients who fluctuate between "on" and "off" states) exclusion criteria: 1. absence of bradykinesia at the time of assessment 2. hoehn and yahr stage not available from patient's chart or not assessed between 3 and 180 days prior to clinic visit 3. has received and experimental drug within the last thirty (30) days

Keywords: parkinson's disease movement disorders unified parkinson's disease rating scale short parkinson's evaluation scale scales for outcomes in parkinson's disease motor evaluation schwab and england activities of daily living bradykinesia psychometrics order effects hoehn yahr aging assessments
leaf - low energy in atrial fibrillation

Conditions: Atrial Fibrillation; Atrial Tachyarrhythmia

Summary: the purpose of the study is to demonstrate the efficiency on at / af prevention and termination of a new algorithm contained in the medtronic at500 antitachycardia device in patients with conventional pacemaker indications.

aim. more than 30% of patients (pts) implanted with a pacemaker are known to have atrial tachyarrhythmias (at) despite medical treatment and about 20% of pts experience at prior to implant. the medtronic at500tm is a new dddrp pacemaker with extended memory and features designed for preventing and terminating at. the objective of this european multi-center prospective crossover and randomized study is to evaluate efficacy of this device for decreasing at burden, improving qol and reducing symptoms and costs. method. 243 pts are implanted with the at500tm and followed at 1, 7 and 13 months after implant. all patients are selected for a dual chamber pacemaker indication plus at least two episodes of at in the last 12 months. one month after implantation patients are randomized either to a six month therapy phase (activation of preventive and atp pacing) or a six month observation phase (no at prevention nor therapy). crossover (co) takes place at seven months after implant and the endpoint is reached at 13 months. symptom checklist and qol questionnaires are completed by pts at enrollment and after the two randomization periods. at each follow-up, a save to disk (std) of device-stored at episodes is performed and hospitalization, visits and/or other examinations are reported for future cost evaluation.

Eligibility criteria:
inclusion criteria: * acc/aha class i or ii indication for dual chamber pacing and two symptomatic atrial fibrillation or flutter episodes in the three months prior to implant as well as ecg documentation of at least one episode in the prior year. exclusion criteria: * patients with permanent/persistent af, an indication for an implantable cardioverter defibrillator or class iv heart failure.

Keywords: atrial fibrillation atrial tachyarrhythmia pacing electrophysiology
mitochondrial oxygraphy on subcutaneous and peri-visceral adipose tissue: influence of body composition

Conditions: Digestive Organs--Cancer; Bariatric Surgery Candidate; Parietal Region Trauma

Summary: the objective of this study is to adapt the oxygraphy technique on human adipocytes and to characterize respiration measurements according to patients' body mass index and white adipose tissue localization (subcutaneous vs visceral).

during digestive surgery: oncological and bariatric surgery, it is possible to collect a small volume of subcutaneous and epiplonic adipose tissue (10-20 cc). we wish to collect these samples in order to develop the technique of oxygenography on permeabilized adipocytes. in order to characterize these measurements, they will be related to the clinical data of the patients usually collected in the framework of the preoperative assessment including the body mass index (bmi). the measured adipocyte data will thus be normalized to three bmi classes: ≤ 20, \> to 20 \< 30, and ≥ to 30 kg∙m-2. primary end point is to validate the measurement of mitochondrial respiration under oxidophosphorylating conditions by determining indicators of the distribution of mitochondrial respiration values (mean, standard deviation, skewness, kurtosis, coefficient of variation) as a function of patients' body mass index.

Eligibility criteria:
inclusion criteria: * patients undergoing oncological, bariatric, parietal surgery * patients able to give an informed consent * patients affiliated to an health care insurance * patients aged over 18 exclusion criteria: * patients under guardianship, curatorship or deprived of freedom * pregnant or breastfeeding women * participation refusal * patients under chemotherapy * patients with peritonitis and infectious parietal processes

Keywords: mitochondria oxygraphy adipose tissue body mass index digestive surgery
anxiety and depressive symptoms in placenta previa / accreta

Conditions: Anxiety Depression; Placenta Previa

Summary: placenta previa is an obstetric complication which is associated with depression and anxiety. as little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother

placenta previa is an obstetric complication with a prevalence of 5.2 per 1000 pregnancies. placenta previa is associated with maternal morbidity and mortality. the delivery carries a risk of bleeding, emergency hysterectomy, organ damage and even death. during admission, counselling is done for the possible need for delivery at any time and the need for life saving hysterectomy. hysterectomy is a tough and difficult choice for patients, and the subsequent emotional process is often associated with depression, severe and prolonged feelings of sadness, diminished interest in activities and in sexual intercourse. similarly, severe adverse psychological outcomes, including post-traumatic stress disorders, have been reported as a result of traumatic birth events. antenatal depression and anxiety occur in approximately 13% and up to 21.7% of women, respectively. rates of antenatal depression among women hospitalized for obstetrical risk can be as high as 19%. research about the responses to a diagnosis of placenta previa is scarce. a study found increased anxiety score in women diagnosed with placenta accreta spectrum. other studies focussed on the post-trauma stress associated with hysterectomy versus uterine conservation. as little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother.

Eligibility criteria:
inclusion criteria: * patient diagnosed to have placenta previa or accrete * plan to deliver baby in assiut women health hospital * willing and able to participate exclusion criteria: * pre-existing psychological disorders * severe medical complications * severe obstetric complications * fetal abnormality