Kornimate/medical-research-clean huggingface dataset:
evaluation of the rectal reflex using anal acoustic reflectometry

Conditions: Pelvic Floor Dysfunction

Summary: anal acoustic reflectometry (aar) is a reliable and reproducible technique that has been studied in our department over the last 6 years. sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. by gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. this assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles. the gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. however, it has limitations. in previous studies aar has shown promise in the assessment of faecal incontinence and, that unlike manometry, it has been able to distinguish between different types of incontinence. the recto-anal inhibitory reflex (rair) is a normal response when the rectum fills with faeces, fluid or air, whereby there is a change in the pressures within the anal canal to determine the type of contents. this can be absent or altered in patients who have difficulty in opening their bowels. the rair is currently measured by anal manometry using a 4.9mm catheter, resulting in an anal canal which is already partially opened prior to the measurement, and potentially distorted. aar is considered a catheter free technique as the balloon has a cross-sectional area of only 0.4mm2 when collapsed. the investigators propose to measure the rair using a 1.7mm diameter catheter alongside the aar balloon to determine the effect that its placement has on the recorded parameters of aar. this aims to improve our understanding of the opening and closing of the anal canal in response to distension of the rectum.


Eligibility criteria:
inclusion criteria: 1. adults over 18 years old 2. have capacity to consent to the study 3. patients with pelvic floor dysfunction. exclusion criteria: 1. minors under the age of 18 years old 2. patients who lack capacity to consent 3. patients with known rectal tumours and proctitis 4. asymptomatic patients

Keywords: faecal incontinence obstructive defaecation rectal prolapse
natrunix in hla-b27 positive subjects with axial spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: double-blind, placebo-controlled, randomized trial of natrunix in combination with standard of care in patients with axial spondyloarthritis

this is double-blind, placebo-controlled, randomized trial examining natrunix in combination with standard of care. qualified subjects will be consented and screened for study eligibility and enrollment. enrolled subjects will be randomized in a 2:1 ratio to receive either 400 mg natrunix or placebo. all subjects who enter the study must be on a stable background standard of care (soc) that they were receiving for at least 8 weeks prior to study enrollment. enrolled subjects must meet 2009 assessment of spondyloarthritis international society (asas) classification criteria for axial spondyloarthritis, be hla-b27 positive, and have active disease as defined by a basdai score ≥4 or an asdas-crp \>2.1. subjects will receive once weekly injection of natrunix or placebo in addition to soc for 12 weeks. the study will conclude after 12 weeks followed by a 12-week open label extension phase and one-week follow-up.

Eligibility criteria:
inclusion criteria: 1. positive for hla-b27 and have at least 2 additional spa features or positive for hla-b27 and has radiological evidence of sacroiliitis from either x-ray or mri from patient's medical records. 2. must have active disease at screening, according to either bath ankylosing spondylitis disease activity index (basdai), with disease severity of ≥ 4 or asdas-crp (ankylosing spondylitis disease activity score - c reactive protein) ≥ 2.1 3. subject must be dmard naive, including those who previously declined dmard treatment options, or previously discontinued dmard treatment after initial trial of no more than 12 total weeks exclusion criteria: 1. history of treatment with natrunix 2. have received any prior, or are currently receiving, treatment with opiates, csdmards, biologic dmards, jak inhibitors, or other immunomodulatory agents for more than 12 weeks at any point prior to enrollment or within 12 weeks prior to enrollment 3. treatment with more than one csdmard (such as methotrexate and sulfasalazine etc.) , biologic dmard (such as etanercept and infliximab etc.), jak inhibitor (such as tofacitinib and upadacitinib etc.), or any combination thereof prior to enrollment currently requiring regular dosing regimen corticosteroids (excluding prn dosing) treatment with biologics that target cd20 (rituximab or any other anti-cd20 antibody) prior to enrollment 4. clinically significant laboratory abnormalities per pi's discretion 5. positive for active hiv, hepatitis b or c
a comparison of pregabalin (lyrica®) to placebo in pain relief after photorefractive keratectomy (prk) surgery

Conditions: Postoperative Pain

Summary: the purpose of this study is to compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.

study subjects will be taken from a standard group of typical candidates for prk surgery including active duty and dod (department of defense) beneficiaries. prior to being approached for the study, all patients will have had a previous desire for surgery and had a pre-operative evaluation indicating healthy ocular status. patients scheduled for prk surgery will be briefed on the purpose of the study and invited to participate at the preoperative appointment. after the consent process, patients will be randomized in a 1:1 fashion to receive either oral pregabalin 75mg twice daily or placebo for pain control, in addition to the standard care treatment of as needed percocet and tetracaine ophthalmic drops. subjects will be evaluated daily for 4 days post-operatively for subjective pain assessment, adverse drug events and compliance, use of concomitant medications as well as monitoring of healing time. quality of life will be measured at baseline and post-op day 2 when the peak of pain is anticipated. analysis will be performed to detect an approximate 10% improvement in pain scores. secondary outcomes will include measuring healing time, quality of life and use of rescue medications.

Eligibility criteria:
inclusion criteria: * healthy ocular status * stable preoperative refractive anisometropia * consented to the prk surgical procedure exclusion criteria: * pregnant or breastfeeding * diagnosed with autoimmune disease or diabetes * patients with a known adverse reaction or hypersensitivity to gabapentin or pregabalin * patients only desiring prk on one eye * patients with history of drug use/abuse/addiction * patients who are on chronic pain medications * patients currently taking anti-epileptic, antidepressant and/or anti-psychotic medications * patients with a history of suicidality * patients with chronic renal insufficiency (defined as estimated creatinine clearance less than 30ml/min or scr ≥ 2.0) 10) patients who have experienced angioedema, or have heart failure

Keywords: photorefractive keratectomy excimer laser prk pain, postoperative pregabalin
osteopathic procedure on pain in palliative care

Conditions: Pain

Summary: the culture of the palliative is anchored more and more in france. in 2009, nearly 9 out of 10 french people (89%) believe that palliative care can reduce the suffering of people at the end of their lives. despite the rise of palliative care in france, their access is not homogeneous between regions. in 2010, it is estimated that 2 french out of 3 likely to receive palliative care could not access it. palliative care remains essential at the end of the patient's life, as well as for the family and caregivers. the french government has put in place three national palliative care development programs: 2002-2005, 2008-2012, 2015-2018. the last program has unlocked a budget of 190 million euros for their development. it has been estimated from social security reimbursements, that the costs per patient over their last years of life are 26,000 euros, for a total of 13.5 million euros. one of the most important aspects of palliative care is the comfort of the patients as well as their feelings in the care. in order to best meet the expectations of cancer patients, some offer early palliative care that is effective in improving both the quality of life of the patient and its life expectancy. osteopathy is a manual alternative medicine whose goal is to restore the lack of mobility of tissues. it can be used as a complementary treatment when a specific support is put in place. the purpose of this study is to examine the effectiveness of osteopathy in the reduction of pain in adult patients in palliative care.


Eligibility criteria:
inclusion criteria: * major patient (age\> 18) male or female * patient hospitalized or admitted to a day hospital that can be followed * eva between 40/100 and 60/100 * signed informed consent exclusion criteria: * patients requiring a modification of analgesic molecule during the study. * clinical stability of the patient estimated during the duration of the study.

Keywords: palliative osteopathy
safety study of univers® revers shoulder prosthesis

Conditions: Rotator Cuff Tear Arthropathy

Summary: the primary safety objective is to demonstrate that severe device-related complication (serious adverse device effect = sade) occur within 2 years after prosthesis implantation at a rate of less than 2%. such adverse events include (but are not limited to) revisions due to dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical repair.

reverse shoulder arthroplasty and its principles are still recognized today as the gold standard for treatment of degenerative arthropathy of the shoulder associated with an irreparable tear of the rotator cuff. the new arthrex univers® revers shoulder prosthesis shows a large and narrow range of components, whether it is a stem, cup, spacer, inlay or glenosphere. adjustment can be done in very small steps to match anatomic and biomechanic needs. the arthrex univers revers shoulder prosthesis is the only device up to date that can be configured in two different inclination angles without any limitation in component use. this multicentre case-series has the goal to evaluate whether patients with rotator cuff tear arthropathy benefit from the univers® revers shoulder prosthesis in terms of low complication risk, as well as high function and quality of life.

Eligibility criteria:
inclusion criteria: * patient aged 18 years and over * patient with primary omarthrosis or secondary osteoarthritis associated with insufficiency in the centering function of the rotator cuff and • willing and able to give written informed consent to participate in the study including all follow-up examinations exclusion criteria: * previous ipsilateral shoulder arthroplasty * acute shoulder trauma * post-traumatic secondary osteoarthritis * rheumatoid arthritis * general medical contraindication to surgery * known hypersensitivity to the materials used * tumour / malignoma * any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) * bacterial infection at the time point of operation * recent history of substance abuse * legal incompetence * pregnancy or * participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study

Keywords: rotator cuff tear arthropathy inverse prosthesis safety universe reverse
antiplatelet resistance research in patients with peripheral arterial revascularization

Conditions: Vascular Diseases

Summary: in coronary pathology, persistent platelet hyperresponsiveness under antiplatelet therapy, which is often referred to as "antiplatelet resistance," is predictive of increased risk of thrombotic recurrence as well as hyper-inhibition of this aggregation may be predictive of a hemorrhagic risk. but no study has shown that the adaptation of treatment based on platelet aggregation tests has a benefit: the management of antiplatelet treatments through the search for antiplatelet resistance (apr) is not recommended by the european society of cardiology (esc) in the context of coronary angioplasty (iiia), while this is a common practice in neurovascular pathology.

in peripheral arterial disease, several studies have shown that the existence of an apr is predictive of the occurrence of thrombotic events but not all. the investigators can therefore ask the question of the benefit of adaptation of antiplatelet therapy by biological monitoring to prevent the recurrence of thrombotic events. the platelet aggregation tests used mainly concern aspirin, via stimulation with arachidonic acid, or anti-p2y12 (clopidogrel, ticagrelor, prasugrel), via stimulation with adenosine diphosphate (adp). for the latter, a test via the measurement of the phosphorylation of a cytoplasmic protein called "vasp" is also used routinely, making it possible to further clarify the existence of platelet resistance to anti-p2y12. within the vascular medicine department, any discovery of a potential resistance to the anti-platelet treatment of a patient requires a therapeutic adaptation to overcome this phenomenon of "resistance", and to improve the phenomenon of anti-aggregation

Eligibility criteria:
inclusion criteria: * patients older than 18 years * all patients who were hospitalized in the vascular medicine department and who received a search for antiplatelet resistance between april 2014 and november 2017. exclusion criteria: * opposition to participation in the study * absence of follow-up after antiplatelet resistance testing

Keywords: antiplatelet resistance peripheral arterial revascularization
opioid & steroid use following tonsillectomy in pediatric patients

Conditions: Pain, Postoperative

Summary: the purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy. patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,nsaids or 2) opioids/acetaminophen/nsaids alone. all drugs are prescribed per approved fda labeling. children between the ages of 4-17 will be considered for enrollment. participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.


Eligibility criteria:
inclusion criteria: * age 4-17 years at time of surgery * scheduled for tonsillectomy or adenotonsillectomy surgery exclusion criteria: * prior history of intracapsular tonsillectomy * previous diagnoses of down syndrome or developmental delay * presence of gastrostomy (g) tube * a contraindication to steroids or steroid usage within 30 days prior to surgery including diabetes, allergy to steroid, already on chronic steroid, immune deficiency * active infection or concurrent operative procedures at the time of surgery * unable to read or speak english * pregnant or breastfeeding females
dynamx bioadaptor implantation for the treatment of complex coronary lesions

Conditions: Coronary Artery Disease; Chronic Total Occlusion of Coronary Artery; Bifurcation of Coronary Artery; Multi Vessel Coronary Artery Disease; Long Lesions Coronary Artery Disease

Summary: the aim of the dynamite study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of dynamx drug-eluting coronary bioadaptor system implantation in complex coronary lesions.


Eligibility criteria:
inclusion criteria: presence of complex coronary lesions defined as follows: * long lesions (\>28 mm); * cto, a total occlusion of duration more than 3-months; * lesions involving a bifurcation, defined as a division with a side branch large enough to be stented (i.e. \>2.25 mm); * patients requiring 4 or more stents * reference vessel diameter: \>2.25 mm to \<4.0 mm exclusion criteria: * age under 18 years old; * significant co-morbidity precluding clinical follow-up; * a positive pregnancy test in women with child-bearing potential; * contra-indication to dual anti-platelet therapy; * thrombocytopenia \<100,000/ul; * major surgery planned which will lead to discontinuation of antiplatelet therapy; * in-stent restenosis; * treatment of saphenous vein graft; * cto with long sub-intimal tracking (\> 20 mm).
nasopharyngeal carcinoma (npc) axitinib

Conditions: Recurrent or Metastatic NPC

Summary: this is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety of single-agent axitinib in recurrent or metastatic npc patients who failed at least one line of platinum based chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of nasopharyngeal carcinoma (npc) (either at initial diagnosis or at recurrence). * patients with recurrent or metastatic npc that has progressed following one line of prior platinum-based chemotherapy. * disease must be not amenable to potentially curative radiotherapy or surgery. * measurable disease according to recist. * age 18 or above; ecog performance 0 or 1. * adequate bone marrow, renal and hepatic reserve. exclusion criteria: * presence of local recurrence * presence of neck lymph node recurrence invading vascular structure; * presence of central lung lesions involving major blood vessels; * history of hemoptysis or epistaxis within 4 weeks; * preexisting uncontrolled hypertension defined as more than 140/90 mmhg despite adequate medical therapy; * gastrointestinal abnormalities, including inability to take oral medication or malabsorption syndrome; * concurrent use or anticipated need for treatment with known potent cyp3a4 inhibitors or cyp3a4 /cyp1a2 inducers.
albumin-bound paclitaxel combined with gemcitabine first-line inoperable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this study aims to further observe and evaluate whether the three-week administration of albumin-bound paclitaxel combined with gemcitabine is equivalent to the four-week administration in the treatment of inoperable locally advanced or metastatic pancreatic cancer

pancreatic cancer is a common clinical malignant tumor of the digestive system, and its incidence is gradually increasing worldwide.the prognosis is poor and the mortality rate is high, accounting for about 7% of cancer deaths.albumin-bound paclitaxel is a good first-line treatment for pancreatic cancer. it has the advantages of high dose, high tumor tissue distribution, high efficacy, and low toxicity.it is hoped that the low-dose intensity can achieve the same clinical efficacy as the high-dose intensity, which provides strong evidence for the clinical choice of low-dose intensity.

Eligibility criteria:
inclusion criteria: 1. age: ≥18 years old, no gender limit; 2. inoperable locally advanced or metastatic pancreatic cancer patients (except islet cell carcinoma) diagnosed by pathology or histology; 3. the patient has not undergone standard systemic treatment in the past, or more than half a year after the end of postoperative treatment.for those who have undergone major surgery or radiotherapy, the interval must be more than 4 weeks and their metastases have not received any local treatment including radiotherapy, chemotherapy, surgical treatment, etc.; 4. at least one measurable lesion (ct scan of tumor lesions with long diameter ≥ 10 mm, ct scan of lymph node lesions with short diameter ≥ 15 mm, and scan thickness not greater than 6 mm); 5. the main organs are functioning normally, that is, they meet the following standards:routine blood examination: hb≥90g/l (no blood transfusion within 14 days);anc ≥1.5×109/l;plt ≥100×109/l;biochemical examination: alb≥29 g/l (without alb in 14 days), tbil \<1.5 times the upper limit of normal (uln);alt and ast≤3uln, accompanied by liver metastasis, then alt and ast\<5×uln;cr ≤1.5×uln or creatinine clearance rate ≥60ml/min; 6. the subject voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up exclusion criteria: 1. pregnant or lactating women; 2. patients suffering from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 3. those who have been confirmed to be allergic to the test drug albumin-bound paclitaxel and gemcitabine or its excipients. 4. the patient has clinically significant ascites; 5. those who have experienced arterial/venous thrombosis within six months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 6. patients with active hepatitis b or c; 7. doctors think it is not suitable for inclusion.
efficacy of endoscopic transantral surgical approach in the repair of orbital blow-out fractures

Conditions: Orbital Floor Fracture

Summary: aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach versus traditional trans-orbital surgical approach (control group) in orbital blow out fractures in terms of postoperative clinical and digital radio-graphical assessments.

(n.m) operator, data entry \& corresponding author; assistant lecturer , surgery department . (i.e) main supervisor, data monitoring \& auditing; professor, surgery department. (r.h) co-supervisor, data entry \& auditing; lecturer, surgery department . (am) assistant lecturer, surgery department .faculty of oral \& dental medicine cairo university outcome assessors and data collection. (ya) assistant lecturer of surgery department , faculty of oral and dental medicine - cairo university , for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents. intervention: preoperative preparation: preoperative cone beam ct. a clearance from the ophthalmology department after examination of papillary reflexes, motility restriction and measurement of the visual acuity. laboratory investigations: blood picture, liver functions, kidneys functions,coagulation profile informed consent signed by the patient. (nm and rh) will perform all procedures under general anesthesia . intervention :endoscopic trans-maxillary (through the maxillary sinus) surgical approach. control group: traditional trans-orbital surgical approaches. follow up clinically and radio-graphically for 6 months.

Eligibility criteria:
inclusion criteria: 1. patients with unilateral/bilateral orbital blow out fractures. 2. positive forced-duction test. ( to ensure the muscular entrapment). exclusion criteria: 1. medical condition affecting bone healing. 2. medically compromised conditions, not proper candidate for general anesthesia. 3. tumor case encroaching on the orbital floor. 4. pathological orbital blow out fractures. 5. allergy/ metal hypersensitivity.

Keywords: endoscopic, trans-antral, subciliary