Kornimate/medical-research-clean huggingface dataset:
intervention using vitamin d for elevated urinary albumin treated with losartan in diabetes (ideal)

Conditions: Diabetic Nephropathies

Summary: this study is a single center open-label randomized controlled trial designed to evaluate the efficacy of calcitriol plus losartan therapy in subjects with type ii diabetes and macroalbuminuria.

the investigators propose to test the efficacy and safety of a combined regimen of calcitriol and losartan in subjects with type ii diabetes (t2dm) with macroalbuminuria. should the investigators study confirm the hypothesis that the proposed novel regimen is superior to the current practice of renin-angiotensin-aldosterone system blockade, the study would significantly advance the care of subjects with type ii diabetes and kidney disease in qatar and worldwide. in this regard it is worth noting that the prevalence of end stage renal disease in qatar is 202 subjects per million population. this would translate into fewer subjects requiring dialysis or transplantation, an enormous benefit to individuals and society.

Eligibility criteria:
inclusion criteria: 1. diagnosis of t2dm requiring treatment with at least one oral hypoglycemic medication or insulin 2. macroalbuminuria as defined as the presence of a uacr greater than 300 mg/gm creatinine (30 mg/mmol creatinine) on two occasions in the last six months 3. estimated egfr of 30 to 90 ml/min/1.73 m2 exclusion criteria: 1. positive pregnancy test or planning pregnancy in the subsequent 18months (if female) 2. serum calcium \> 2.45 mmol/l (9.8 mg/dl) 3. serum phosphorus \> 1.78 mmol/l (5.5 mg/dl) 4. serum potassium \> 5.5 mmol/l (5 meq/l) 5. parathyroid hormone \ 500 pg/ml 6. hemoglobin a1c \> 12% 7. 25-oh vit d \> 50 ng/ml 8. poorly controlled hypertension defined as systolic blood pressure \>= 180 mm hg or diastolic blood pressure \>= 110 mm hg 9. history of kidney stones 10. history of severe disease like chronic liver disease 11. active malignancy 12. active granulomatous diseases like turburculosis and sarcoidosis 13. recent diagnosis of acute renal failure within 3 months of screening visit 14. likelihood of renal replacement therapy within 1 year 15. history of parathyroidectomy 16. currently taking calcitriol or 1,25-dihydroxyvitamin d analog 17. currently taking calcitonin, bisphosphonates, cinacalcet, teriparatide, glucocorticoids or other drugs that may affect calcium or bone metabolism (subjects may be taking calcium containing phosphate binder or other phosphate binder. subjects may also be taking stable dose of estrogen/progestin) 18. history of osteoporosis or other bone disorder requiring calcitriol therapy 19. history of allergic reaction to calcitriol, paracalcitol, hectoral, or other 1,25-dihydroxyvitamin d analogs 20. history of allergic reaction to losartan or any other angiotensin receptor blocker therapy 21. evidence of drug or alcohol abuse
ocular-hypertensive response to topical steroids in children after bilateral strabismus surgery

Conditions: Intraocular Pressure

Summary: this study aims to compare the effects of topical (rimexolone versus dexamethasone) on the iop in children under 13 years of age who underwent bilateral strabismus surgery, and to compare the effects of topical (rimexolone versus fluorometholone) on the iop in the children under 13 years of age who underwent bilateral strabismus surgery.

children under the age of 13 years undergoing bilateral strabismus surgery in cairo university hospitals (cairo university specialized pediatric hospital and kasr al ainy hospital). will be randomized using simple randomization method, computer software for randomization, into two equal groups: * first group: one eye is randomized to receive topical 0.1% dexamethasone, whereas the fellow eye will receive topical 1% rimexolone four times per day for 2 weeks. * second group: one eye is randomized to receive topical 0.1% fluorometholone, whereas the fellow eye will receive topical 1% rimexolone four times per day for 2 weeks. iop will be measured on the day before operation using the tono-pen®. three reliable measurements will be obtained from each eye and the mean will be taken. iop will be measured at postoperative weeks 1, 2, 3, 4 and 6 using the tono-pen®.

Eligibility criteria:
inclusion criteria: * children younger than 13 years of age. * children who underwent bilateral recession strabismus surgeries. * preoperative iop of 21.00 mmhg or less, with a cup-disc ratio of 0.3 or less. * the absence of systemic disease and ocular disease (apart from strabismus) in both eyes. * children who can comply with the iop measurements using the tono-pen®, as no type of anesthesia will be used, except for the topical anesthesia. exclusion criteria: * patients that are 13 years of age or older. * children who need resection muscle surgeries, surgeries for the vertical, or the oblique muscles. * preoperative iop of more than 21.00 mmhg, or a cup-disc ratio of more than 0.3 * family history of glaucoma or high myopia. * a history of steroid usage in the past year. * failure to comply with iop measurements or the follow-up schedule.

Keywords: intraocular pressure topical steroids strabismus
a study of treatment with ro6864018 in virologically suppressed participants with chronic hepatitis b virus (hbv) infection

Conditions: Hepatitis B, Chronic

Summary: this randomized, multicenter, partially double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects of treatment with ro6864018 in virologically suppressed participants with chronic hbv infection.


Eligibility criteria:
inclusion criteria: * chronic hepatitis b infection * positive test for hbsag for more than 6 months prior to randomization * hbsag titer greater than or equal to (\>/=) 250 international units per milliliter (iu/ml) at screening * treatment with any nucleoside/nucleotide analogue for \>/= 1 year with ongoing entecavir and/or tenofovir treatment at randomization and for at least 3 months prior to randomization * hbv dna less than (\<) 90 iu/ml for at least the preceding 6 months * hbeag positive at randomization and for at least 6 months prior to randomization exclusion criteria: * pregnant or lactating women * documented history of hbv genotype d * history or other evidence of bleeding from esophageal varices * history of decompensated liver disease, chronic liver disease other than hbv infection, or any evidence of metabolic liver disease * positive test for hepatitis a, hepatitis c, or human immunodeficiency virus (hiv) * documented history of hepatitis d infection * history of or suspicion of hepatocellular carcinoma * history of immunologically mediated disease * history of organ transplantation * history of thyroid disease * significant acute infection
the predictor of respiratory discomfort after the shoulder arthroscopic surgery

Conditions: Shoulder Arthroscopic Surgery

Summary: the investigators applied upper airway ultrasonographic examination focusing the measurement of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate the change of upper airway anatomy before and after the surgery. the investigators also tried to find any findings of ultrasonographic examination that could reliably predict the dyspnea or airway compression after extubation. the investigators tried to compare the ultrasonographic findings with those of chest radiograph to validate the measurements of the ultrasonographic examination. a cuff leak test was preformed to evaluate its ability to predict the upper airway obstruction in shoulder arthroscopic surgery.

during shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the shoulder and trachea, compressing the upper airway. although the extravasation is generally reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or life-threatening complications. an endotracheal tube is the most reliable method of securing the airway from airway obstruction during a shoulder arthroscopy surgery. however, since the airway may become obstructed after extubation, airway patency should be verified before extubation. direct visualization of the larynx or trachea using laryngoscopy or bronchoscopy is difficult due to the presence of the tracheal tube. a cuff leak around the tracheal tube in a cuff-deflated condition is suggested to be a predictor of successful extubation. however, its reliability has been questioned in adult patients. a cuff leak could be affected by paratracheal pressure, which is thought to be elevated during shoulder arthroscopy. in a recent study, it was shown that laryngeal ultrasound can be a reliable, non-invasive method for the evaluation of laryngeal morphology or predicting post-extubation stridor. the investigators applied upper airway ultrasonographic examination focusing the measurement of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate the change of upper airway anatomy before and after the surgery. the investigators also tried to find any findings of ultrasonographic examination that could reliably predict the dyspnea or airway compression after extubation. the investigators tried to compare the ultrasonographic findings with those of chest radiograph to validate the measurements of the ultrasonographic examination. a cuff leak test was preformed to evaluate its ability to predict the upper airway obstruction in shoulder arthroscopic surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair) exclusion criteria: * patients with airway anomaly * patients with anticipated difficult airway * patients with hemodynamic unstability * patients with severe cardiopulmonary disease

Keywords: shoulder arthroscopic surgery dyspnea airway diameter
a prospective, observational trial on the diagnostic and prognostic of lm

Conditions: Lung Neoplasms; Meningeal Carcinomatosis

Summary: the primary purpose of this study is to compare the positive rate between the cell-free dna and cytological examination of cerebrospinal fluid in advanced lung cancer with leptomeningeal metastases.


Eligibility criteria:
inclusion criteria: 1. patient who was confirmed primary lung cancer by pathologic histology or cytology 2. adult patients (≥18 years and ≤75 years). ecog performance status 0 or 1.life expectancy of at least 12 weeks. 3. clinical symptoms and imaging tests are highly suspicious of advanced lung cancer with leptomeningeal metastases 4. without contraindications to lumbar puncture exclusion criteria: 1. patients who have primary benign or malignant brain tumor and metastatic malignant brain tumor 2. patients who have contraindications to lumbar puncture 3. serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease

Keywords: lung cancer leptomeningeal metastases cell-free dna
fat to lean mass ratio and its effect on low back pain and permanent functional disability.

Conditions: Low Back Pain, Mechanical

Summary: the study was conducted for people who suffer from excess fat mass and their age is over 18 years will be calculated with g\*power will be used body composition analyzer to calculate the percentage of fat.

cross-sectional study was applied. data was collected through a questionnaire (oswestry disability index arabic version). fat percentage was taken by body composition analyzer.

Eligibility criteria:
inclusion criteria: * excess fat mass * age must be over 18 years. exclusion criteria: * people under the age of 18. * low back pain not associated with increased fat mass.
managed access programs for abl001, asciminib

Conditions: Chronic Myeloid Leukemia in Chronic Phase

Summary: the purpose of this registration form is to list all managed access programs (maps) related to abl001, asciminib


Eligibility criteria:
inclusion criteria: 1. an independent request was received from a licensed physician. 2. the patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment. 3. the patient is not eligible or able to enrol in a clinical trial or continue participation in such trial. 4. there is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. 5. the patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable). 6. provision of the product will not interfere with the initiation, conduct, or completion of a novartis clinical trial or overall development program. 7. managed access provision is allowed per local laws/regulations

Keywords: chronic myeloid leukemia cml cml-cp asciminib abl001
abdominal massage to prevent postoperative ileus after colorectal surgery

Conditions: Colorectal Surgery

Summary: post operative ileus refers to an disrupt in normal gastrointestinal motility responsible of nausea and vomiting. it occurs in about 15-20% of colorectal surgeries. some preventive measures have been included in the enhanced recovery after surgery program such as early mobilisation and enteral feeding or minimal invasive approach. abdominal massage is not widely applied amongst general surgery team and is not part of the recommendation. this technique refers to profound manœuvrers of visceras through abdominal palpation and breathing, and has been used as part of the local protocol of grenoble alps university hospital for many years with satisfactory results. no complications have been reported. various studies have evaluated the value of physiotherapy and massage for resumption of normal bowel function. a study from rouen university hospital demonstrated that a mechanical stress to the cuteaneous tissue by lpg cellu m50® machine would reduce pain and lower the time to first flatus. similar results were obtained after cardiac surgery. in a preclinical study on operated rats, abdominal massage also improved normal bowel function recovery. physiotherapist plays a key role in rac. their action on respiratory function (movement of diaphragm) and musculoskeletal system (early walking) allows a faster recovery and a reduction of time of hospitalization. even though the results on time to first flatus and anxiety seem interesting, deep abdominal massage has never been evaluated.


Eligibility criteria:
inclusion criteria: * adult patients \>18years (homme et femme de plus de 18 ans) * elective patients undergoing colorectal surgery with intestinal anastomosis (colectomy, anterior resection, intestinal resection or stoma closure) without protective stoma creation in an enhanced recovery after surgery program * able to give the consent * affiliated to social security exclusion criteria: * mental disorders * cutaneous infection on the abdomen * pregrancy and breast feeding * patients unable to give their free consent (incarcerated, legal protection measures)
pilot study for a national screening for familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia

Summary: a pilot study to study the feasibility of the screening of familial hypercholesterolemia within the setting of the legal medical visits at primary school. the pilot study shall evaluate whether this screening set-up is efficient to detect patients having familial hypercholesterolemia, detect further patients by an adjacent cascade screening of family members, to deliver treatment to these patients and to provide this screening in a cost-effective manner.

pilot study evaluating the feasibility of a screening for familial hypercholesterolemia. cross-sectional design. primary outcome percentage of screened school children with confirmed familial hypercholesterolemia participants all children, who attend a public primary school in the city of luxembourg and are enrolled in the cycle c2.2 (age of 7-8 years; 3rd medical visit at school), cycle c3.2 (age 9-10 years, 4th medical visit at school) and cycle 4.2 (age 11-12 years, 5th medical visit at school) will be invited to participate. expected number of invited children is around 1600 children/year. recruitment will take place during the school year 2021/2022 and 2022/2023. the parents/caregivers of these children will receive written information about the screening. they will receive as well a questionnaire on the family history of premature cardiovascular events and known fhc disease. without informed consent, the child cannot be included in the screening program. all children with signed informed consent will have a finger prick for a capillary blood test in the setting of their medical school exam by an external study nurse (not the school nurse) all data (pseudonymised) on each participant will be entered in the online data base for further analysis.

Eligibility criteria:
inclusion criteria: 1. attending primary school in the city of luxembourg and invited for the legal medical visit exclusion criteria: 1. no parental informed consent
effect of maternal obesity on labour induction in postdate pregnancy

Conditions: Obesity; Induced; Birth

Summary: this study investigate the progression of labour in 144 normal weight pregnant women (bmi \ 30) , not in labor admitted for induction of labor. these women are to be investigated for success of induction of labor.

* this prospective study will be conducted for 144 obese and 144 non obese ), post date (\>41 wks), not in labor. * woman is classified as obese if bmi \>=30. * prolonged pregnancy was defined as delivery on or after (41+0 weeks) of gestation. * first informed consent will be obtained. * determination of gestational age * proper history taking, general and abdominal examinations will be done then digital examination will be performed to determine bishop score. * and obstetric u/s scan will be done and by which the following data will be obtained : * fetal biometry * fetal heart activity * presentation * localization of the placenta. * amount of amniotic fluid. * exclude multifetal pregnancy. * induction of labor will be done using vaginal misoprostol according to the estimated bishop score.

Eligibility criteria:
inclusion criteria: * pregnant woman. * post date \>= 41 weeks. * absent onset of labor. * patient acceptance to join the study after signing an informed consent. exclusion criteria: * placenta previa and or vasa previa. * previous caesarean section(cs). * multiple gestation * any patient who will refuse to be a part of the study. * intra- uterine fetal death (iufd).
electronic skin surface brachytherapy for cutaneous basal cell and squamous cell carcinoma

Conditions: Cutaneous Basal Cell; Squamous Cell Carcinoma

Summary: the purpose of this study is to assess the effectiveness of electronic skin surface brachytherapy (essb) for early stage basal or squamous cell carcinoma of the skin using a new device. this new device is nucletron's esteya electronic skin surface brachytherapy system. the investigators want to understand what effects, good and/or bad this device for delivering brachytherapy has on your skin cancer. the investigators also want to assess the safety, cosmetic results, the effects that essb has on quality of life and to correlate skin imaging with clinical response to essb.


Eligibility criteria:
inclusion criteria: * men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years * histopathologic diagnosis of basal or squamous cell carcinoma * clinical stage t1n0m0 (by ajcc 2010 criteria) °basal cell carcinoma with morpheaform, sclerosing, mixed, infiltrative or micronodular features must be ≤1 cm * low risk pathologic features (by ajcc 2010 criteria) * eastern cooperative oncology group (ecog) performance status of 0-3 (appendix c) * able and willing to complete the skindex16 and skin cancer index (must be able to speak english) * ability to provide informed consent exclusion criteria: * bcc/scc that was previously treated (ie, recurrent bcc/scc) * bcc/scc in region adjacent to or overlapping with region of prior radiotherapy * bcc/scc on irregular surface (ie, target area not flat) * bcc/scc adjacent to or overlapping with burn or scar * bcc/scc in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow) * bcc/scc in area with compromised lymphatic drainage or vascular supply * bcc/scc within 3 cm of another treated or untreated bcc/scc * inflammatory process in target area * collagen vascular disease (lupus, scleroderma, rheumatoid arthritis) * diabetes that is poorly controlled * genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans) * receipt of treatment with another investigational device or drug * receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector) * high likelihood of protocol non-compliance (in opinion of investigator)

Keywords: skin brachytherapy 14-001
impact mrsa -pcr on patient management

Conditions: MRSA Bacteremia

Summary: staphylococcus aureus represents one of the most met germs, with escherichia coli, during bacteremia. microbiologist distinguish at aureus s. two profiles of resistance in beta-lactamines: s. aureus sensitive to the methicillin ( sasm) and the s. aureus resistant to the methicillin ( sarm). with the implementation of the maldi-tof, it is now possible to identify the origin responsible of the bacteremia the day of the positivity of the hemoculture ( j0) and to set up a treatment with adapted antibiotic, which, in the case of a sepsis to aureus s., is the vancomycine. ye it was demonstrated, that the use of the vancomycine on the sasm increased the average duration of stay and a more important rate of relapse. the pcr sarm was organized in the ghpsj in 2014. it allows from the day of the positivity of the hemoculture ( j0), to determine the phenotype of resistance of s. aureus.


Eligibility criteria:
inclusion criteria: * hemoculture positive to staphylococcus aureus methicillin sensitive exclusion criteria: * positive test to staphylococcus aureus methicillin sensitive but not hospitalized.
post market surveillance to evaluate the effectiveness the polaris deformity spinal system

Conditions: Spinal Deformity

Summary: the purpose of this post market surveillance validation is to document the performance and clinical outcomes of the polaris deformity spinal system \& trivium 3d spinal deformity correction system.

the purpose of this post market surveillance validation is to document the performance and clinical outcomes of the polaris deformity spinal system \& trivium 3d spinal deformity correction system. we have extended the study tol collect further outcomes data at the 12 month time point.

Eligibility criteria:
inclusion criteria: * 200 subjects at 10 clinical centers. * all subjects undergoing spinal fusion surgery between the levels of t1- ilium (thoracic 1 to ilium) * all subjects are skeletally mature with spinal deformity. * risser score must be ≥ 3. * subjects or their representative must be willing and able to give informed consent and assent (if applicable). * subjects who do not meet any of the following contraindications: spinal infection or inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over the operative site, open wounds local to the operative area, any case not described in the specific indications exclusion criteria: * any subject who does not meet the inclusion criteria

Keywords: scoliosis kyphosis spinal deformity curvature lordosis