Kornimate/medical-research-clean huggingface dataset:
randomized comparison of distal radial versus conventional radial access for coronary angiography and intervention

Conditions: Coronary Disease

Summary: distal radial access (dtra) represents a novel site for radial artery access in interventional cardiology, there is little data compare dtra with conventional radial access (ctra) in a randomized manner. it aims to randomly compare between the new distal radial access via the snuffbox and the conventional radial access for percutaneous coronary intervention (pci) and angioplasty procedures. the objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time. candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery. procedural and post procedural outcomes and complications are being reported while patients are in hospital. all patients undergo doppler ultrasonography within 24 hours before and after the procedure, 4 weeks after procedure.


Eligibility criteria:
inclusion criteria: * patient is over 18 years of age. * patient is undergoing diagnostic coronary angiography and/or pci for the first time. * patient has provided written informed consent. * patient is willing to comply with all protocol-required evaluations during the hospitalization. exclusion criteria: * no palpable radial artery or distal radial artery. * radial artery used as a bridging vessel. * severe heart failure (nyha class iv). * severe renal insufficiency ( scr\>443umol/l). * height over 185 cm. * a ≥7f catheter may be required for operation.

Keywords: distal radial artery radial access
sirolimus vs mycophenolate with tacrolimus in simultaneous pancreas and kidney transplantation

Conditions: Diabetes Mellitus, Type 1

Summary: this is prospective randomized open single center clinical study to compare effect of sirolimus vs mycophenolate tacrolimus based protocol on pancreas and kidney graft survival in simultaneous pancreas and kidney recipients.

mtor (mammalian target of rapamycin) inhibitors represent group of immunosuppressive drugs with mechanism of t-cell blockade complementary to calcineurin inhibitors. the investigators presume that combination of sirolimus with tacrolimus will result in better survival of pancreatic and kidney grafts in simultaneous pancreas and kidney transplantations. the study is proposed as a single-center extension of eurospk 002 trial originally started in 2004 by the eurospk study group. recruitment of recipients started in 2004 with approval of eurospk 002. the patient recruitment has continued in a single center (institute for clinical and experimental medicine in prague, czech republic) using the same inclusion and exclusion criteria. the recipients of primary kidney and pancreas transplantation have been randomized into 2 arms. * in the intervention arm sirolimus is added to protocol at a dose of 5 mg immediately before transplantation, the dose is adjusted to maintained trough sirolimus trough levels between 5-10ng/ml. * in the control arm mycophenolate mofetil was added to tacrolimus. starting with 1g before transplantation, the dose has been increased to 1g bid afterwards. induction protocol at day 0. consists of atg (antithymocyte globulin)induction 8mg/kg , tacrolimus 0.05mg/kg, methylprednisolone 125mg. dosing of tacrolimus has been adjusted to maintain trough levels between 5-10ng/ml. atg was administered at 3mg/kg on days 1.-3. steroids have been gradually tapered from a dose of 20 mg prednison orally and withdrawn by 6w after transplantation.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * end stage kidney failure * negative cdc crossmatch * female patients of childbearing age must have a negative pregnancy test * patient must have signed the patient informed consent form. * patient must receive a primary simultaneous pancreas/kidney (spk) cadaver transplant, exclusion criteria: * patient is pregnant or breastfeeding. * patient is allergic or intolerant to mycophenolate mofetil, sirolimus, atg, tacrolimus * patient has malignancy or history of malignancy, with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence. * patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomization. * patient has any form of substance abuse or psychiatric disorder or condition, which invalidate communication. * severe cardiac failure or severe liver failure diagnosed at the time of transplantation
discard:characterisation of colonic polyps in vivo

Conditions: Colorectal Polyps

Summary: prospective study of accuracy of colonic polyp characterisation in vivo using high resolution white light endoscopy, narrow band imaging and chromoendoscopy.


Eligibility criteria:
inclusion criteria: 1. patients over 18 years of age, assessed as fit for routine colonoscopy 2. patients attending for screening or surveillance colonoscopy meeting the following criteria: * polyp surveillance with at least 3 adenomas or 1 adenoma\>10mm at previous colonoscopy * surveillance post colorectal cancer resection * screening with positive faecal occult blood test exclusion criteria: 1. patients with known colitis or polyposis syndromes 2. unable or unwilling to give informed consent

Keywords: colorectal cancer polyps colonoscopy advanced imaging
corneal endothelial cell injury induced by mitomycin-c

Conditions: Myopia

Summary: our study will investigate the effecacy of mitomycin-c in transepi single step photorefractive keratectomy (prk) and alcohol assisted prk


Eligibility criteria:
inclusion criteria: * age over 18 years. * primary myopia or compound myopic astigmatism. * preoperative manifest refraction spherical equivalent (mrse) within the range of -1.0 to 8 d * stable refractive error for at least 12 months before the surgery. * contact lens discontinuation for at least 3 weeks. * estimated corneal stromal bed thickness of more than 300mm at the thinnest point exclusion criteria: * unwilling to participate in the study. * previous ocular surgery * any diagnosed ocular disease * history of ocular trauma

Keywords: mytomycin
tdcs combined with treadmill training in patients with multiple sclerosis

Conditions: tDCS; Sham tDCS

Summary: this clinical trial aims to evaluate the therapeutic effectiveness of transcranial direct current stimulation (tdcs), a non-invasive technique that modulates cortical excitability, in combination with gait training in patients with multiple sclerosis (ms). the study focuses on improving balance and walking ability, which are commonly impaired in this population. a randomized, triple-blind, controlled design will be used, comparing an active tdcs group with a sham stimulation group, both receiving the same gait training protocol. outcomes will include functional and clinical measures related to mobility, balance, and fatigue. the project builds on previous meta-analytical evidence suggesting positive effects of tdcs in ms and aims to confirm these findings using an optimized stimulation protocol.


Eligibility criteria:
inclusion criteria: * ability to understand and follow instructions. * diagnosis of multiple sclerosis according to mcdonald criteria. * expanded disability status scale (edss) between 1 and 6. * stable condition in the last three months. exclusion criteria: * peripheral neurological injury of lower limbs. * metal objects in the head. * uncontrolled epilepsy. * diagnosis of psychiatric disorder. * fractures or fissures in the skull. * presence of any implanted electronic device (pacemaker, baclofen pump). * presence of ulcers in the harness attachment area. * osteoporotic fractures in the last 2 years. * height \> 190 cm. * weight \> 120 kg.

Keywords: tdcs gait multiple sclerosis gait training
technology of intracranial pressure estimation by single-channel eeg in brain disease

Conditions: Intracranial Pressure Increase; Brain Diseases

Summary: if intracranial pressure can be measured non-invasively using single-channel eeg, clinicians will be able to easily monitor changes in intracranial pressure in patients with brain diseases in the clinical setting. therefore, a more efficient treatment plan can be established and the prognosis of patients with brain disease can be expected to improve in the long term.

study objectives: 1. accuracy evaluation of single-channel eeg-based estimated intracranial pressure and actual intracranial pressure in patients with brain disease 2. it is intended to improve the accuracy by analyzing and upgrading the correlation and concordance of the single-channel eeg-based estimated intracranial pressure compared with the actual intracranial pressure measurement of the patient. study design: multi-center prospective clinical trial the study procedure was explained to the caregiver of the patient with brain disease admitted to the emergency room or intensive care unit, who was or will be implanted with an intracranial pressure monitoring device and informed consent was obtained. while the intracranial pressure monitoring device is being applied, eeg data and intracranial pressure data are simultaneously acquired by applying a single-channel eeg. eeg-based intracranial pressure prediction model and actual intracranial pressure comparison analysis are conducted to evaluate the prediction model and upgrade it.

Eligibility criteria:
inclusion criteria: * age 18 years or older * patients have had or are planning to insert an intracranial pressure monitoring device due to brain diseases * emergency room or intensive care unit of the study hospital exclusion criteria: * eeg measurement is restricted due to trauma or head deformity * the attachment of electrodes for eeg measurement interferes with the standard treatment * patients who do not agree to enroll to this study by patients or caregivers

Keywords: electroencephalogram intensive care unit intracranial pressure monitoring
fenretinide in treating patients with recurrent small cell lung cancer

Conditions: Lung Cancer

Summary: phase ii trial to study the effectiveness of fenretinide in treating patients who have recurrent small cell lung cancer. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

objectives: i. determine the efficacy of fenretinide, in terms of complete and partial response rates, duration of response, and survival, in patients with recurrent small cell lung cancer. ii. determine the toxicity of this regimen in these patients. iii. correlate the induction of apoptosis or the expression of molecular mediators of apoptosis in tumor cells with response rates, response duration, and survival in patients treated with this regimen. outline: this is an open-label, multicenter study. patients receive oral fenretinide twice daily on days 1-7. treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. patients are followed at 1 month.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed recurrent small cell lung cancer (sclc) after platinum-containing chemotherapy regimen with or without thoracic radiotherapy * limited stage or extensive stage sclc * measurable disease * at least 20 mm by conventional techniques or * at least 10 mm with spiral ct scan * no pleural effusions, bone metastases, brain metastases, or abnormal radionucleotide scans as sole evidence of disease * no symptomatic or uncontrolled brain or leptomeningeal disease * previously treated brain metastases allowed if neurologically stable patient characteristics: age: * 18 and over performance status: * zubrod 0-2 hematopoietic: * wbc at least 2,500/mm\^3 * platelet count at least 70,000/mm\^3 hepatic: * bilirubin no greater than 1.5 mg/dl * sgot no greater than 2 times upper limit of normal renal: * creatinine no greater than 1.5 mg/dl or * creatinine clearance at least 60 ml/min cardiovascular: * no symptomatic heart disease * no myocardial infarction within the past 6 months other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception for 1 month before, during, and for 2 months after study * no pre-existing retinal degenerative disease (e.g., retinitis pigmentosa or associated disorders) * no other serious concurrent illness * no other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ prior concurrent therapy: chemotherapy: * at least 3 weeks since prior chemotherapy * no more than 2 prior chemotherapy regimens endocrine therapy: * concurrent steroids allowed at stable dose radiotherapy: * no prior radiotherapy to study lesions other: * at least 3 weeks since prior systemic retinoid or carotenoid therapy * no concurrent anticonvulsants

Keywords: limited stage small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer
effect of salovum™ and spc-flakes™ on abemaciclib-induced gastrointestinal toxicity in early breast cancer

Conditions: Early-stage Breast Cancer; Diarrhea; Adverse Drug Event

Summary: the present study aims to investigate a proactive strategy including salovum™ and spc-flakes to prevent the occurrence of abemaciclib-induced diarrhea in patients with early breast cancer.

in patients with high-risk luminal breast cancer, the addition of cdk 4/6-inhibitor abemaciclib to adjuvant endocrine therapy for two years has been associated with improved disease-free survival and is now recommended from national and international guidelines as the preferred treatment strategy for this patient group. however, patients treated with abemaciclib have higher risk of diarrhea which primarily occurs during the first three months from treatment initiation and seems to impact patients' quality of life. as a result, early and proactive strategies to reduce the occurrence of diarrhea from the initiation of abemaciclib should be investigated to ensure that patients in whom adjuvant abemaciclib is recommended can complete their treatment as planned.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * histologically confirmed diagnosis of luminal breast cancer. * no clinical evidence of metastatic disease. * planned to start abemaciclib in adjuvant setting (according to current national guidelines). * signed informed consent. exclusion criteria: * contraindications to the investigational product, e g known or suspected hypersensitivity to the investigational products or expected inability to their use in accordance with the protocol. * lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the investigator. * prior exposure to abemaciclib. * prior exposure to salovum or spc-flakes. * past or present history of inflammatory bowel disease.

Keywords: early breast cancer abemaciclib induced diarrea
efficacy and safety of glucosanol in maintaining body weight

Conditions: Overweight; Obesity

Summary: to date, there is no clinical evidence on the efficacy and safety of glucosanol in maintaining weight loss beyond the study duration of 12 weeks. the rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.


Eligibility criteria:
inclusion criteria: * previously enrolled in, complied with, and completed the inq/k/003411 (glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight * age 18 to 60 years at the time of inclusion into the inq/k/003411 study * bmi between 25-35 at the time of inclusion into the inq/k/003411 study * expressed desire for weight maintenance * accustomed to 3 main meals per day * commitment to avoid the use of other weight loss products during study * females' agreement to use appropriate birth control methods during the active study period * subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply exclusion criteria: * known sensitivity to the ingredients of the device (phaseolus vulgaris or members of the fabaceae family) * history of diabetes mellitus • fasting blood glucose more than 7 mmol/l * history or clinical signs of endocrine disorders which may influence body weight (e.g. cushing's disease, thyroid gland disorders) * clinically relevant excursions of safety parameter * current use of anti-depressants * presence of acute or chronic gastrointestinal disease (e.g. ibd, coeliac disease, pancreatitis) * uncontrolled hypertension (more than 160/110 mm hg) * stenosis in the gi tract * bariatric surgery * abdominal surgery within the last 6 months prior to enrollment * history of eating disorders like bulimia, anorexia nervosa within the past 12 months * other serious organ or systemic diseases such as cancer * any medication that could influence gi functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals * pregnancy or nursing * any medication or use of products for the treatment of obesity (e.g. orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.) * more than 3 hours strenuous sport activity per week * history of abuse of drugs, alcohol or medication * smoking cessation within 6 months prior to enrolment * inability to comply due to language difficulties * presence of other factor(s) that, in the investigator's judgement, should preclude subject participation

Keywords: weight maintenance bmi body weight overweight obesity satiety
effect of vitamin d status on clinical pregnancy rates following intra cytoplasmic sperm injection

Conditions: Infertility

Summary: all patients will undergo in vitro fertilization. serum 25 (oh) d samples will be collected within1 week before oocyte retrieval. whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis. ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization. clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.

patients and methods protocol outline: the study: study site: ain shams university maternity hospital. study design: a prospective cohort study. study setting: the study will be conducted at ain shams university maternity hospital. study population: the study will include all women planned to undergo ivf due to unexplained infertility. methodology: the study will be approved by the hospital ethics committee. all included women will undergo the following: * history taking. * general and abdominal examination. * vaginal examination and assessment * pelvic ultrasound. * routine laboratory investigations including complete blood picture, hematocrit, liver and kidney function tests and coagulation profile. * preoperative senior anesthetist assessment. * hysteroscopy. all patients will undergo ivf. serum 25(oh)d samples will be collected within1 week before oocyte retrieval. whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis. ultrasound-guided fresh embryo transfer will be performed on day 5 after fertilization. clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer. measurement of outcomes 1. serum 25 (oh) d levels. 2. number of oocyte. most studies put the optimal number of retrieved oocytes between 10 and 15. 3. the implantation rate: calculated as the number of gestational sacs observed by ultrasound divided by the number of embryos transferred, multiplied by 100. 4. number of gestational sac.

Eligibility criteria:
inclusion criteria: * age between 20 and 35 years old. * body mass index between 20 - 30. * unexplained infertility . * follicle-stimulating hormone level 12 iu/l or lower (baseline level, cycle day 3). * normal hysteroscopy ( healthy uterus with no fibroids or other growths) * fresh embryo transfer of 2 or more blastocysts stage. * embryo transfer on day 5 after fertilization exclusion criteria: * women younger than 20 years old or older than 35 years old. * previous one or more failed ivf. * uncorrected congenital or acquired uterine anomalies. * other causes of infertility rather than unexplained infertility. * less than 2 embryo transfer, cleavage stager frozen embryo transfer.

Keywords: vitamin d following intra cytoplasmic sperm injection
medical thoracoscopy for diagnosing unexplained pleural effusion: a national multicenter retrospective study

Conditions: Pleural Effusion; Pleural Effusion, Malignant; Fibrinous Pleuritis

Summary: this study is a national multicenter retrospective study. patients with unexplained pleural effusion who underwent thoracoscopic or video-assisted thoracoscopic biopsy for patients in recent 10 years were retrospectively collected from multiple centers to understand the proportion and final etiological composition of pleural effusion in china.


Eligibility criteria:
inclusion criteria: patients with unexplained pleural effusion who underwent thoracoscopic or video-assisted thoracoscopic biopsy exclusion criteria: patients who cannot obtain a final diagnosis
electronic health record (ehr)-based intervention for gastroesophageal reflux disease (gerd) and chronic non-steroidal anti-inflammatory drug (nsaid) use

Conditions: GERD

Summary: the purpose of the study is to examine the impact of augmented, high-quality physician-coordinated care executed via an electronic health record (ehr)-based intervention on quality of care for gastroesophageal reflux disease (gerd) and for gastroprotection for patients on chronic non-steroidal anti-inflammatory drugs (nsaids) at increased risk for upper gi tract ulcers and ulcer related complications.


Eligibility criteria:
inclusion criteria: * eligibility as determined by criteria for participation in studies as part of the mqic * agreement of participating clinical practices to undergo training in the electronic health record (ehr) intervention designed for this study exclusion criteria: * based on voluntary participation by mqic practices, so practices were excluded if they decided to opt out

Keywords: gastroesophageal reflux disease gerd nonsteroidal anti-inflammatory drugs peptic ulcer diagnosed gerd atypical gerd symptoms chronic nsaid therapy risk for ulcer
safety and efficacy study of a0001 in subjects with friedreich's ataxia

Conditions: Friedreich's Ataxia

Summary: this is a phase 2a double-blind, placebo-controlled study with two dose levels of a0001 given twice daily for 28 days. potential subjects will be screened first to determine eligibility, after which they will be randomized to receive either a high dose of a0001, a low dose of a0001 or placebo for 28 days. eligible subjects will return within 21 days of screening for the baseline visit and randomization to one of three potential treatments. the subjects will be required to take 3 capsules of study medication in the morning with a morning meal and 3 capsules of study medication at night with an evening meal for 28 days. additional visits to the clinic are planned for day 14 and day 28, at which time a number of clinical and biochemical assessments will be done.


Eligibility criteria:
inclusion criteria: * individuals with genetically confirmed friedreich's ataxia (gaa or point mutation) * impaired glucose tolerance, measured by oral gtt exclusion criteria: * overt diabetes mellitus * presence of clinically significant cardiovascular disease