Kornimate/medical-research-clean huggingface dataset:
iltamiocel compared to placebo for chronic fecal incontinence in females with obstetric injury

Conditions: Fecal Incontinence

Summary: this study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10\^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury. half of the participants will receive iltamiocel (injections with cells) and the other half will receive placebo.

chronic fecal incontinence (fi) is the recurrent unintended passage of mucus and/or liquid or solid stool for at least 6 months. iltamiocel is an investigational cell therapy product that involves a medical procedure in which a participant's own muscle cells are collected, processed, and then injected into the tissues of the external anal sphincter. this is a double-blind randomized study, which means neither the participant, nor the study doctor will know which treatment group the participant will be in. participants who are randomly chosen to receive injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).

Eligibility criteria:
inclusion criteria: * adult female ≥ 18 years of age who has primary symptoms of fecal incontinence (fi) for at least 12 months. * history of obstetric anal sphincter injury (e.g., episiotomy, perineal tear). * failed conservative treatment (e.g., dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 6 months prior to enrollment. * must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures. exclusion criteria: * has an implanted stimulation neuromodulation system (sacral or tibial) and symptoms are unstable as determined by the physician. * is pregnant or planning to become pregnant within the next 2 years. * has known rectal sensory dysfunction (e.g., hypersensitivity or hyposensitivity). * has an obstetric anal sphincter injury (e.g., episiotomy, perineal tear) within 1 year previous to study enrollment. * patient bmi ≥ 38. * has a history of cancer in the colorectal or pelvic organs within 5 years prior to study enrollment. * any cancer that has undergone treatment within the past 12 months. * has an established diagnosis of inflammatory bowel disease (crohn's disease, ulcerative colitis) or current intestinal stoma. * has grade iii/iv hemorrhoids. * has chronic diarrhea at the time of screening. * has chronic constipation at the time of screening. * has significant pelvic floor prolapse, significant genitourinary prolapse beyond the introitus, significant symptomatic rectocele, or evidence of significant rectal evacuation disorder leading to post-defecatory leakage.

Keywords: obstetric trauma obstetric injury cell therapy anal incontinence rectal diseases intestinal diseases gastrointestinal diseases bowel incontinence
efficacy and safety study of abatacept to treat lupus nephritis

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (mmf) and corticosteroids.

double blind period: treatment, parallel assignment, double blind (subject, investigator), randomized, active control, safety/efficacy study open label period: prevention, single group assignment, open label, uncontrolled, safety/efficacy study

Eligibility criteria:
inclusion criteria: * systemic lupus erythematosus (sle) as defined by meeting at least 4 of the 11 classification criteria of the american college of rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincident. the 4 criteria need not be present at study entry * renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met isn/rps class iii or iv classification criteria \[2003\], excluding class iii \[c\], iv-s \[c\] and iv-g \[c\], or the world health organization class iii or iv classification criteria \[1982\], excluding class iiic, ivd). if the renal biopsy was performed \>3 months but ≤12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (c3 or c4) level below normal range or anti-dsdna \>upper limit of normal range. * a stable serum creatinine ≤3 mg/dl exclusion criteria: * subjects with a rise in serum creatinine of ≥1 mg/dl within 1 month prior to the screening visit * subjects with drug-induced sle, as opposed to idiopathic sle * subjects with severe, unstable and/or progressive central nervous system (cns) lupus * subjects with autoimmune disease other than sle as their main diagnosis (e.g.; rheumatoid arthritis (ra), multiple sclerosis \[ms\]) * subjects who have received treatment with cyclophosphamide within 3 months of randomization (day 1). * subjects who have received treatment with rituximab \< 6 months prior to the screening visit
native tissue repair with surgical pelvic organ pessary - an rct

Conditions: Pelvic Organ Prolapse

Summary: this is an rct looking at the primary outcome of composite success following anterior repair with native tissue at 6, 12, 24 months in two arms. one arm will be randomised to have a soft silicone pessary inserted into the vagina post operatively for three weeks and the other will not.

prolapse of the vagina is a common problem for women and varies from mildly bothersome to very problematic. about one in ten women in the developed world will require surgery for prolapse in their lifetime. the results of surgery are not perfect and some of women will develop prolapse again or not be satisfied with the result. in this study a soft silicone support (spop) is inserted into the vagina straight after prolapse surgery. women who have agreed to the study will be randomly chosen to have the spop at the time of surgery. there will be 120 patients in the study; so 60 women will have the spop inserted. the investigators think that spop will support the vagina as it heals, improving the results of surgery. there are already some studies of the spop with other surgeries that show improved results. the spop is inserted while the patient is sleeping and is removed four weeks after surgery. it is attached with two dissolving stiches to the vagina. after four weeks is will be removed in the out patient clinic without any discomfort. it is not usually painful or uncomfortable at any time. the actual surgery the women have will not be any different had they not been in the study. all the women in the study will have the normal assessment prior to their operation, and will fill out some questionnaires about their symptoms too. all women involved in the study will come back the clinic to be seen after six months, one year and two years from the date of the surgery. this is regardless of whether they had the spop or not. when the women return they will be examined and complete the questionnaires again each visit. the results of the study will be reported and published.

Eligibility criteria:
inclusion criteria: * women with symptomatic pelvic organ prolapse requiring an anterior vaginal repair at the study centre. * currently on the hospital waiting list for vaginal native tissue repair * willingness to participate * medically fit for surgery * 18 years or over * reasonable level of english to complete questionnaires * patients have not been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach exclusion criteria: * asymptomatic pelvic organ prolapse * refusal to participate * medically unfit for surgery * under 18 * unable to complete questionnaires due to poor level of english * patients has been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach
effect of locally administered morphine and bupivicaine on acute and chronic postmastectomy pain

Conditions: Acute Pain; Chronic Pain

Summary: this study investigate the effect of addition morphine to locally instillation bupivacaine on developing chronic neuropathic pain acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.

breast cancer is one of the most common cancer diagnoses in women and a significant cause of mortality and morbidity worldwide.surgical treatment indicated in most patients. persistent pain and sensory disturbances following surgery is a significant clinical problem with an average prevalence of 20-23.9%. post-mastectomy chronic pain syndrome (pmps) is defined as pain of neuropathic character located in the area of surgery and/or the ipsilateral arm, present at least 4 days per week, and with an average intensity of at least 3 on a numeric rating scale from 0 to 10. the pathological mechanisms may be related to patient characteristics, surgical technique and adjuvant therapy. although the genesis of pain is multi-factorial, sectioning of the intercostobrachial nerve (a cutaneous branch of t1-2) is the nerve lesion diagnosed most often. uncontrolled acute postoperative pain is defined as an important risk factor for the development of chronic pain. local anesthetics have been investigated in cancer breast patients through many routes; paravertebral blocks, thoracic epidurals, wound infiltration, topical lidocaine patch, and the topical application of emla( eutectic mixture of local anesthetics) cream on operation site. most of above studies suggested a better outcome in terms of reduced postoperative pain and improved patient satisfaction. opioids exert a local analgesic effect is based on several observations: • nociceptive afferent nerve fibers contain peripheral opioid receptors which are silent except in the presence of local inflammation. • morphine and its metabolites are largely undetectable systemically when applied topically to skin ulcers, suggesting the analgesic effect is local • peripheral opioid injections for local analgesia, such as intra-articular morphine after knee surgery, have been found to be effective in several trials. an effective topical opioid analgesic that could be applied to inflamed or open skin lesions would be a useful option for some patients where other options for pain relief have been exhausted.

Eligibility criteria:
inclusion criteria: * female patients with cancer breast scheduled for modified radical mastectomy with axillary dissection exclusion criteria: * allergy to the study drugs * significant cardiac, respiratory, renal or hepatic disease * drug or alcohol abuse * psychiatric illness that would interfere with perception and assessment of pain

Keywords: local morphine postmastectomy pain
gamma knife radiosurgery vs initial conservative treatment for vestibular schwannoma patients with preserved hearing, a prospective randomized study

Conditions: Vestibular Schwannoma

Summary: the effect of gamma knife radiosurgery (gkrs) on hearing loss, in patients with vestibular schwannoma (vs) and preserved hearing is still unclear. retrospective data indicate that the hearing is preserved in most patient years after the gamma knife treatment. recent prospective data suggests that radiosurgery could be a hearing preserving treatment for these patients. the main objective of this study is to evaluate if gkrs can inhibit progression of hearing loss in patients with vs. patients with preserved hearing will be offered to participate in the study and randomized ether to gkrs or initial conservative treatment for their vestibular schwannoma. they will then be followed with scheduled magnetic resonance image(mri) and audiometry and evaluated after one, three and five years after treatment.


Eligibility criteria:
inclusion criteria: 1. patients newly (\<6 months) diagnosed with vestibular schwannoma less than 20 mm in diameter. 2. vestibular schwannoma with or without evidence of growth. 3. patients between 18 and 80 years of age. 4. karnofsky performance score \>70 5. patients with vestibular schwannoma and preserved hearing according to gardner robertson class 1-2, and speech discrimination (sd) scores between 50-100% will participate in the hearing preservation part of the study. - exclusion criteria: * 1. patients with neurofibromatosis type 2 will be excluded to achieve a homogenous study population. 2. patients who had other treatments prior to the gkrs (usually microsurgery (ms), gkrs or external beam radiation) for their tumour will also be excluded for the same reason. 3. patients who are not citizens in the country where they will be followed will be excluded, to reassure the same follow up within the study population. 4. hearing loss due injury or to active ear disease, such as meniere´s disease, otosclerosis or chronic otitis media. 5. patients with poor comprehension of the the language in the country where they are followed, such that adequate performance on speech tests, are unlikely. 6. claustrophobia, making mr follow up impossible without sedation. 7. alcohol- or narcotic abuses that effect compliance to the follow up. 8. uncontrolled neoplastic disease.

Keywords: vestibular schwannoma gamma knife radiosurgery hearing preservation
pci vs. cabg in uplm-isr

Conditions: Restenosis, Coronary; Left Main Coronary Artery Disease; PTCA Left Main Artery Complications

Summary: left main (lm) coronary artery disease is associated with high morbidity and mortality owing to the large myocardial territory at risk for ischemia. evidence from randomized controlled trials supports that percutaneous coronary intervention (pci) with drug-eluting stents (des) for lm disease is an acceptable treatment strategy compared with coronary artery bypass graft surgery in patients with low or intermediate anatomic complexity. however in-stent restenosis (isr) after des in lm disease is still occurring with an incidence of 9,7%. studies comparing the percutaneous coronary intervention with coronary artery bypass grafting (cabg) in the treatment of in-stent restenosis in unprotected left main have been scarce. while surgical revascularization is considered to be the standard treatment for this kind of stent failure, owing to a high risk of perioperative morbidity and mortality, the restoration of flow with pci may be a reliable alternative. additionally, it is not clear whether re-pci is safe in these patients. therefore, the purpose of the present study was to compare long-term outcomes following pci or cabg for uplm-isr disease.


Eligibility criteria:
patients were divided into two separate cohorts for the analyses. the data included consecutive patients with ≥50% diameter uplm-isr, with or without multivessel coronary artery disease. patients with an equivalent of uplm-isr: left main distal bifurcation disease, within the proximal 5 mm of the left anterior descending artery (lad) or left circumflex artery (lcx) ostium (in the absence of significant angiographic stenosis in the left main coronary artery), were eligible. patients who had protected lm-isr, defined as the occurrence of at least one patent arterial or venous graft to the left coronary artery, other concomitant non-cabg procedure during surgery, were excluded.

Keywords: unprotected left main in-stent restenosis coronary artery bypass graft percutaneous coronary intervention
using renal elastography measurements for evaluation of glomerulonephritis patients

Conditions: Evaluation of Biopcy Proven Glomerulonephritis Patients by Renal Shear Wave Elastography

Summary: all participants will clinically evaluated by history taking, full physical examination including body weight and assessment of fluid status, and blood and urine samples for lab analysis (serum creatinine, urea, sodium, potassium, corrected calcium, phosphorous, estimated glomerular filtration rate(gfr) by cokcroft equation ((140 - age ) x body weight by kg/creatinine by µmol )complete urine analysis including microscopic examination of urine , 24 hours urinary protein , haemoglobin level . all participants will undergo renal shear wave elastography measurements. values will be obtained from the upper, middle, and lower zones of each kidney. a total of six shear wave elastography measurements will be collected to get mean elastography values (mevs) of each participant.

we will collect results of mev plus blood and urine samples of each participant then data will undergo statistical analysis to compare between mev of healthy persons and biopcy proven glomerulonephritis patients

Eligibility criteria:
a-inclusion criteria : * adult patients aged 18 years old or more * patients diagnosed as glomerulonephritis ( biopcy proven ) and not started specific tratement in assiut university hospitals b. exclusion criteria: * patient with urinary tract obstruction * patient who has gn and started corticosteroid and/or immunosuppressive drugs * patient who has congenital anomalies in renal system

Keywords: elastography
efficacy and safety of glycopyrrolate bromide of copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of chf 5259 (glycopyrrolate bromide) for the treatment of copd patients.

a multinational, multicentre, randomised, double blind, placebo-controlled, 2-way crossover study to evaluate the efficacy and safety of glycopyrrolate bromide administered via pmdi (chf 5259), for the treatment of patients with chronic obstructive pulmonary disease

Eligibility criteria:
inclusion criteria: * male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of copd * current smokers or ex-smokers * a post-bronchodilator fev1 \< 60% of the predicted normal value and a post-bronchodilator fev1/fvc \< 0.7 * positive response to the reversibility test at screening defined as change in fev1 ≥ 5%. * bdi score ≤ 10 * patients free of exacerbations for at least 1 month exclusion criteria: * pregnant or lactating women * diagnosis of asthma * patients treated for exacerbations in the 4 weeks prior to screening visit * patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as prn * patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia * known respiratory disorders other than copd * patients who have clinically significant cardiovascular condition

Keywords: chronic obstructive pulmonary disease copd
phs, lichtenstein mesh, and perfixplug for primary inguinal hernia repair - 3 years results

Conditions: Hernia, Inguinal

Summary: three different techniques for the surgical repair of groin hernias are compared. focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. three years results are presented in the study.

dissection requirements differ between various methods for inguinal hernia repair, which may effect operation times, pain response and possibly recovery time. the objectives of this study were to establish if any differences concerning these aspects could be detected after three principally different techniques for primary inguinal hernia repair. 472 men between 30 and 75 years with primary inguinal hernias were included in a prospective controlled study and randomised to lichtenstein mesh (l), perfix plug® (p) or the prolene® hernia system (phs) procedure. all patients were seen and data were collected after 2 weeks, 3 months, 1 year, and 3 years.

Eligibility criteria:
inclusion criteria: * age 30-75 years * men * primary inguinal hernia * asa i-iii exclusion criteria: * \> 75 years * females * asa iv * previous ipsi-lateral hernia surgery * drug or alchol abuse * severe illness

Keywords: inguinal hernia randomized controlled trial surgery complications surgical mesh
testing for dysautonomia in patients hospitalized for sars-cov-2 infection (covid-19) : covidans study

Conditions: SARS-CoV 2

Summary: a number of clinical features suggest the possibility of dysautonomia in patients infected with sars-cov-2 (severe acute respiratory syndrome coronavirus 2). at the same time, there is now strong experimental evidence that sars-cov-2 can cross the blood-brain barrier, probably via the olfactory nerves, and reach the brain stem, which is located in close proximity. damage to the brainstem nuclei could explain the suspected dysautonomic episodes, but also the severity of respiratory distress in infected patients, and the difficulty of ventilatory withdrawal encountered in resuscitation, potentially through damage to the ventilation control and regulation centers located in the brainstem. the objective of this study is to record the long term variability in heart rate, reflecting autonomic balance, of patients screened positive for sars-cov-2 throughout their stay in conventional care units at the saint-etienne university hospital, in order to see whether there is an autonomic imbalance at screening, whether the worsening of the autonomic imbalance precedes the worsening of the clinical condition, and how quickly the expected correction of the autonomic imbalance follows or precedes that of the disease.

in this study, patients will have a continuous recording of their heart rhythm via a holter-ecg throughout their hospitalization.

Eligibility criteria:
inclusion criteria: * major * with clinical signs of sars-cov-2 * understanding and speaking french fluently to understand the explanations and participate in the study * who have given their oral consent to participate in the study * affiliated or entitled to a social security scheme. exclusion criteria: * with a history of parkinson's disease, insulin-dependent or non-insulin-dependent diabetes at a dysautonomic stage or chronic alcoholism at a dysautonomic stage * with atrial fibrillation on the ecg trace taken at the time of their entry. * refusing to participate in the study * intubated prior to inclusion in the study * that are within the exclusion period of another research protocol * with a history of head injury, neurological pathology with a brain impact, or serious unstable somatic disease * patient under guardianship. * pregnancy woman

Keywords: covid-19 sars-cov-2 coronavirus dysautonomia
vascular and metabolic effects of vytorin

Conditions: Hypercholesterolemia

Summary: the investigator hypothesize that vytorin may improve vascular and insulin resistance in hypercholesterolemic patients


Eligibility criteria:
inclusion criteria: * hypercholesterolemia exclusion criteria: * overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (hba1c \> 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

Keywords: statins, insulin resistance