Kornimate/medical-research-clean huggingface dataset:
fast track protocol after radical cystectomy and urinary diversion: a randomised controlled trial.

Conditions: Bladder Cancer

Summary: we will design a randomized controlled single center study in which we will compare 2 groups of patients, 1 with standard perioperative protocols and another one in which we will apply fast track protocols in patients after radical cystectomy and urinary diversion .

study hypothesis: fast track protocol after radical cystectomy reduces the length of hospital stay and the early postoperative complications relative to the traditional perioperative care regimen. purpose of the study: 1. to evaluate the the perioperative efficacy, safety and benefits of fast track protocol implementation after radical cystectomy and to optimize perioperative patient care for the benefit of "fast-track" surgery. 2. to evaluate early complications in patients with bladder cancer who will be subjected to radical cystectomy and urinary diversion. study groups: group 1: fast track group (105 patients). group 2: conventional perioperative care group (105 patients). study design: the design of the research will be a prospective randomised, open-label, controlled study on 210 consecutive patients with bladder cancer who will be subjected to radical cystectomy and urinary diversion. all the patients will sign an informed consent. length of stay, dietary issues, and return of bowel function, readmission rates and complications will be evaluated. study setting/location: the study will be conducted in a single tertiary centre, urology and nephrology centre in mansoura, egypt. the study will be carried out on patient with bladder cancer who will be subjected to radical cystectomy and urinary diversion. study duration: the study will last about 2 and half years. randomisation: randomization will be performed using computer generated, sequentially numbered random tables. ratio of assignment to groups is 1: 1. allocation concealment and blinding: we are well aware that it is very difficult to properly blind trials comparing surgical treatments. allocation of patients to treatment groups will be self-evident following randomization and blinding of patient groups and observers will not be possible. so, our trial will be a randomised, open-label, controlled trial. type of analysis: intention-to-treat analysis is planned in this trial. we will include all patients randomized to the fast track group regardless of their adherence and compliance to the early recovery after surgery (eras) items.

Eligibility criteria:
inclusion criteria: * patients undergoing radical cystectomy and urinary diversion surgery including orthotopic neobladder and ileal loop conduit exclusion criteria: 1. radical cystectomy performed in an emergency setting 2. patients who refused fast track protocol 3. mental illnesses

Keywords: eras (early recovery after surgery) radical cystectomy
tramadol for labor analgesia: a placebo controlled randomised control trial

Conditions: Tramadol for Labor Analgesia

Summary: tramadol for labor analgesia: a low risk placebo controlled randomised control trial

investigators will administer 100mg tramadol or 2ml distilled water through intramuscular route in a blinded manner. visual analogue score will be assessed in the beginning and every hour till four hours. patient satisfaction, safety outcomes, duration of 1st and 2nd stage of labor, proportion of women experiencing nausea, vomiting and increased sleepiness, postpartum haemorrhage,apgar score at 5 minute, need for nicu admission wiil be assessed at the end

Eligibility criteria:
inclusion criteria: * delivering for first time(nulliparous) * well established labor ( 3 or more contractions in a span of ten minutes * cervical dilation of 4 cm or more * \>= 80% effacement of cervix exclusion criteria: * any medical disorder- diabetes,hypertension * obstetric high risk factors
respiratory support in severe chronic obstructive pulmonary disease exacerbation

Conditions: COPD Exacerbation

Summary: preliminary studies have shown that nppv can avoid tracheal intubation in 40% to 60% patients who have severe exacerbation of copd. recently, large-scale comparative effectiveness research (cer) also found that compared with invasive ventilation, nppv can reduce mortality rates. but there's no high-quality clinical studies which can confirm this. therefore, investigators believe that nppv can avoid intubation in patients with severe exacerbation of copd in icu with perfect monitoring conditions and reasonable human resource allocation, in order to reduce imv-related complications and improve patients' outcomes.

in part of the patients who were aecopd with ph \<7.25 , preliminary studies have shown that nppv can avoid tracheal intubation in 40% to 60% patients, and also reduce the incidence of vap. recently, large-scale comparative effectiveness research (cer) also found that compared with invasive ventilation, nppv can reduce mortality rates. at present, there's no high-quality clinical studies which can confirm this, and clinical guidelines do not have a recommendation on the use of nppv in these patients. therefore, investigators believe that nppv can avoid intubation in patients with severe exacerbation of copd in icu with perfect monitoring conditions and reasonable human resource allocation, as well as the progress of medical technology in nppv in recent years, in order to reduce imv-related complications and improve patients' outcomes.

Eligibility criteria:
inclusion criteria: * aecopd; exclusion criteria: * refuse to engage in the study; * have been included in other study.

Keywords: copd exacerbation noninvasive positive ventilation invasive positive ventilation severe high flow nasal cannula
human epididymis protein 4 in women with severe preeclampsia / hellp syndrome

Conditions: Preeclampsia

Summary: pre-eclampsia seems to be associated with a four to five times increase risk of later microalbuminuria and ckd which might suggest a possible direct renal damage from pre-eclampsia


Eligibility criteria:
inclusion criteria: 1. pregnant women 18-35 years old. 2. fulfilling the criteria for diagnosis of sever preeclampsia. 3. fulfilling the criteria for diagnosis of hellp syndrome exclusion criteria: 1. diabetes mellitus 2. preexisting renal disease. 3. chronic hypertension 4. rheumatologic diseases 5. adnexal mass.
estimation of glomerular filtration rate (gfr) in patients with type 2 diabetes mellitus.

Conditions: Diabetes Mellitus; Diabetic Nephropathy

Summary: the purpose of the present study is to evaluate bias, precision and accuracy of new cystatin c and creatinine based equations for gfr estimation compared with 51cr-edta (chromium-51 labeled ethylenediamine tetraacetic acid) measured gfr in patients with diabetes.

the purpose of the present study is to evaluate bias, precision and accuracy of new cystatin c and creatinine based equations for gfr estimation compared with 51cr-edta measured gfr in patients with diabetes. additional, we will check which equation detects better the reduction of renal function over the time, in patients with diabetes. finally, we will investigate if cystatin c levels can be influenced by factors other than gfr

Eligibility criteria:
inclusion criteria: * type 2 and type 1 diabetes mellitus exclusion criteria: * patients with other type diabetes: gestational, exocrine pancreatic defects, endocrinopathies, drugs * patients with end-stage renal disease, cardiac failure, hepatic failure, malignancies, immunosuppression, pregnant, diabetic ketoacidosis
safety and cost-effectiveness study of single port laparoscopic cholecystectomies

Conditions: Cholecystolithiasis

Summary: many feasibility studies have been published on single port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. the purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.

design: * prospective randomized controlled trial * population analysis based on intention to treat * patient and data analyzer blinded (double-blind trial) outcomes observed: * primary: pain * secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, co2 consumption nbr of patients included: 260 port used: triport, olympus

Eligibility criteria:
inclusion criteria: * cholecystolithiasis * age 18 to 75 y.o. * bmi \< 35 exclusion criteria: * immunodeficiency * choledocholithiasis * previous uppergi open surgery

Keywords: cholecystolithiasis cholecystectomy laparoscopic surgery single port
sore throat after intubation using glidescope with stylet and bougie

Conditions: Postoperative Sore Throat

Summary: this is a prospective double-blinded clinical trial aiming to compare the incidence and severity of sore throat after laparoscopic cholecystectomy when using two different techniques of intubation using glidescope

the first technique is loading the endotracheal tube on a stylet the second technique is sliding the endotracheal tube over a bogie that is dragged into the trachea at both techniques, the investigators are using glidescope

Eligibility criteria:
inclusion criteria: * asa i, ii undergoing laparoscopic cholecystectomy under ga exclusion criteria: * anticipated difficult intubation
repeat quadratus lumborum block to reduce opioid need in patients after pancreatic surgery

Conditions: Pancreatic Carcinoma

Summary: this phase ii trial studies how an additional anesthetic nerve block, called a quadratus lumborum block, works to reduce the need for opioids in patients after pancreatic surgery. giving an additional regional anesthetic after surgery may hasten the weaning process, reduce the need for opioid medications upon discharge, and reduce the risk of opioid dependence.

primary objective: i. to use a phase ii randomized controlled trial to compare the intervention of a second regional anesthetic block (quadratus lumborum \[ql\] block) versus usual care (single intraoperative ql block) to increase the proportion of opioid-free pancreatic cancer survivors at discharge after potentially curative surgery. outline: patients are randomized to 1 of 2 arms. arm 1: patients undergo ql block before surgery and receive standard of care multimodal pain control after surgery. arm 2: patients undergo ql block before surgery and receive multimodal pain control. patients then undergo a second ql block on day 4 after surgery and continue to receive standard of care. after completion of study treatment, patients are followed up at 1 month, 3 months, 6 months, and 1 year after surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing elective open pancreatic resection for potentially curative intent (pancreaticoduodenectomy or distal pancreatectomy) who would otherwise be treated with ql block + iv-pca converted to oral pain meds (non-narcotic bundle + opioid pain pill). exclusion criteria: * patients with current or past substance (drug or alcohol) abuse disorder. * laparoscopic or minimally invasive surgery.
effects of walking and heating on vascular function in diabetic patients

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: the purpose of the present study is to determine the effects of increased walking and lower body heating on leg vascular function in patients with type 2 diabetes (t2d).

the notion that habitual aerobic exercise increases insulin-induced vasodilation is largely founded on rodent studies, hence the urgent need for human studies, especially in patients with type 2 diabetes (t2d). for example, it remains unknown if increased walking, the most common form of physical activity, enhances skeletal muscle vasodilator actions of insulin in t2d. in addition, the molecular mechanisms by which exercise improves vasoreactivity to insulin have not been examined in humans. the investigators propose that in t2d patients who are sedentary (i.e., the vast majority), increased leg blood flow with walking or local heating signifies a vital strategy to correct vascular insulin resistance. this study will establish whether increased physical activity and associated hemodynamic forces (e.g., shear stress) are a direct form of vascular medicine in humans.

Eligibility criteria:
inclusion criteria: patients with type 2 diabetes who are overweight and obese (bmi 25-50 kg/m2), 35 to 65 years of age, and sedentary (\<60 minutes structured exercise/week). healthy volunteers without type 2 diabetes: 18 to 65 years of age. exclusion criteria: 1. cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke; 2. renal or hepatic diseases; 3. active cancer; 4. autoimmune diseases; 5. immunosuppressant therapy; 6. excessive alcohol consumption (\>14 drinks/week for men; \>7 drinks/week for women); 7. current tobacco use; 8. pregnancy; 9. mobility limitations; 10. foot ulcers; 11. diabetic neuropathy 12. uncontrolled hypertension (\>=180 systolic / 100 diastolic mmhg)
computed guided prolotherapy versus conventional prolotherapy

Conditions: Temporomandibular Joint Disorders; Orofacial Pain

Summary: the aim of that study is to compare between conventional prolotherapy and computed guided prolotherapy in treatment of temporomandibular joint (tmj) internal derangement.

this study will include patients with tmj internal derangement with signs and symptoms of pain, clicking and limited mouth opening .the study will be held in oral and maxillofacial department, faculty of dental medicine, al-azhar university, assiut branch. internal derangement of the joint will be confirmed by magnetic resonance image (mri). patients included in this study will be divided randomly into two equal groups by the aid of financial coins. group i: patients will be conventionally injected into the superior space of tmj by injectable prf by the aid of the surface facial landmarks where the patient will seated comfortably at 45° angle on the dental chair with the head turned toward the unaffected side. the target site will be prepared and disinfected with betadine. the points of needle insertion will be marked on the skin according to a line will be draw from the middle of the tragus of the ear to the outer canthus of the eye and entry points will be marked along this cantho-tragal line which will correspond to the glenoid fossa and will be marked 10 mm from the mid-tragus and 2 mm below the line. group ii: patients will be injected into the superior space of tmj with i- prf by the aid of specific ct-planned 3d-printed surgical guide, which will lead the needle insertion, and the accuracy of the needle insertion into the superior space of the tmj will be assessed. preparation of i-prf: the cubital area of the patient arm will be disinfected with betadine and the blood will be drawn from the patient cubital vein into plain tubes (vaccutainers) under aseptic conditions .the loaded tubes will be centrifuged at 750 rpm for 3 minutes and the i-prf will be aspirated into a plastic syringe to be ready for injection into the superior space of the tmj of patients of each group.

Eligibility criteria:
inclusion criteria: * bilateral or unilateral tmj internal derangement. * no response to conservative treatments (soft diet, occlusal splint, muscle relaxants, non-steroidal anti-inflammatory drugs, or movement restriction). * ability to undergo mri or ct scans without contraindications. exclusion criteria: * those with systemic diseases (polyarthritis or rheumatoid diseases). * individuals with neurologic disorders. * patients with a history of condylar fracture or previous tmj injections. * those with head and neck cancer. * completely edentulous patients (lacking teeth). * individuals with implanted metal or medical devices. * patients with developmental and congenital disorders of the tmj.

Keywords: tmd temporomandibular joint disorders prolotherapy of tmj guided arthrocentesis
effectiveness of the suboccipital inhibition technique in patients with mechanical neck pain

Conditions: Neck Pain; Myofascial Pain

Summary: the project is based on checking the effectiveness of the technique of suboccipital inhibition in patients with mechanical neck pain. suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. then the fingers slowly leads upward to contact the occipital condyles. at this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull. in this technique the investigator would be carrying out the relaxation of the suboccipital muscles: lower rectus capitis posterior, superior oblique head straight back and head higher. it is a technique used very often but without knowledge about the time needed for implementation. in several studies that have used the technique it has been maintained for 2.4 or 10 minutes without agreeing how long is necessary. the study will consist of three groups formed by patients with mechanical neck pain that they applied the technique two, four or ten minutes and a control group of patients with mechanical neck pain. the four groups were measured before and after treatment the pain threshold to pressure by algometer and conduct the test repositioning of the head to show any changes after application of the technique.


Eligibility criteria:
inclusion criteria: 1. men and women of full age . 2. ≥ 15/50 rating in the neck disability index 3. participants with good adhesion to the study . 4. participants who have signed informed after appropriate informed consent. exclusion criteria: 1. cancer , inflammatory , infectious , vascular , neurological and metabolic processes. 2. patients who are under medical treatment. 3. patients with psychiatric illnesses. 4. women : pregnancy. 5. patients who have not signed the informed consent.

Keywords: neck pain suboccipital inhibition physical therapy
observational registry of transoral incisionless fundoplication (tif) for gastroesophageal reflux disease (gerd)

Conditions: Gastro Esophageal Reflux

Summary: this observational registry aims to: 1) record the tif interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (ppis) and on the gerd-health related quality of life (hrql) and reflux symptom index (rsi) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of tif success, identifying the subpopulation who may effectively benefit from tif.

after being evaluated according to the clinical indication for the treatment of symptomatic gastro-esophageal reflux disease (gerd with esophageal or extraesophageal symptoms) by transoral incisionless fundoplication (tif) and, thus, being treated by tif using the esophyx device, all patients giving specific informed consent will enter a 3-year enrollment registry with a 5-year follow-up for each patient through post-tif routine practice visits and examinations.

Eligibility criteria:
inclusion criteria for enrollment: * clinical indication to undergo transoral incisionless fundoplication (tif) with the esophyx device for treatment of chronic gastro-esophageal reflux disease; * availability for prolonged follow-up (5 years) after tif at san raffaele hospital; * signed informed consent for participation in the observational registry. exclusion criteria for enrollment: * absence of clinical indication to undergo transoral incisionless fundoplication (tif) with the esophyx device for treatment of chronic gastro-esophageal reflux disease; * unavailability for prolonged follow-up (5 years) after tif at san raffaele hospital; * no signed informed consent for participation in the observational registry.

Keywords: fundoplication endoscopy, digestive system gastro esophageal reflux
thrust versus non-thrust manipulation in chronic low back pain

Conditions: Low Back Pain; Mechanical Low Back Pain; Backache

Summary: this study aims to verify the effects of thrust versus non-thrust manipulation on pain, trunk proprioception and postural stability in subjects with chronic low back pain.

forty individuals with chronic low back pain will be randomly assigned, by a researcher not involved in data collection, to two treatment groups: thrust manipulation (side-lying rotational manipulation standardized to the l4-l5 level) or non-thrust manipulation (side-lying grade iii rotational non-thrust manipulation). a single treatment session will be provided. outcome measurement will be conducted immediately after the treatment session. data will be collected by a blinded assessor. between-group differences will be calculated by constructing mixed linear models following an intention-to-treat principle.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * chronic low back pain (pain lasting for at least 12 weeks) * nprs ≥ 3 exclusion criteria: * previous surgery or fracture at the lumbar spine * pregnancy * inflammatory disorders * symptoms distal to the gluteal line * having received manipulative treatment in the past four weeks

Keywords: low back pain thrust manipulation spinal manipulation joint mobilization non-thrust manipulation proprioception postural stability baropodometry
a study to investigate the effect of 0.003% ar-15512 on subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: the purpose of this study is to evaluate the effect of ar-15512 ophthalmic solution 0.003% (0.003% ar-15512) on ocular surface characteristics of subjects with dry eye disease (ded).

qualified subjects will enter a 14-day run-in period, followed by a 13-week randomized treatment period, for a total individual duration of participation of approximately 15 weeks. during the run-in period, subjects will administer artificial tears (refresh® classic) as one drop in each eye twice daily. this is a phase 3b study.

Eligibility criteria:
key inclusion criteria: * have a previous history of ded, clinician diagnosed or patient reported, within the previous 6 months prior to the screening visit. * have used artificial tears for ded symptoms within 2 months prior to the screening visit. * corrected visual acuity equal to or better than logarithm minimum angle of reflection (logmar) +0.7 (snellen equivalent equal to or better than 20/100), as assessed by early treatment of diabetic retinopathy study (etdrs) scale in both eyes at both the screening and baseline visits. * good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history. * other protocol specified inclusion criteria may apply. key exclusion criteria: * history or presence of any ocular disorder or condition (other than ded) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety. * current evidence of other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease which the investigator believes may interfere with study findings or interpretation. * history of ocular surgery within 1 year prior to the screening visit; history of corneal transplant in one or both eyes. * use of contact lenses in either eye within 7 days prior to the screening visit or planned use during the study. * regular use, as assessed by the investigator, of lid hygiene or heat masks within 14 days prior to the screening visit or any planned use during the study. * use of lid heating therapy or meibomian gland probing/therapeutic expression within 1 year prior to the screening visit or anticipated during the study. * other protocol-specified exclusion criteria may apply.

Keywords: dry eyes eye drops