Kornimate/medical-research-clean huggingface dataset:
colpopexy and urinary reduction efforts (care) protocol

Conditions: Urinary Incontinence, Stress; Uterine Prolapse; Vaginal Prolapse

Summary: pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. pelvic organ prolapse can be corrected with surgery. however, women who have this surgery may develop urinary incontinence. this study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.

many women have surgery for pelvic organ prolapse (cystocele, uterine prolapse, rectocele). women with advanced pelvic organ prolapse may experience stress urinary incontinence following surgery to repair the prolapse. development of incontinence is unpredictable. this study will determine which, if any, clinical tests are useful for predicting post-operative urinary incontinence. the study will also determine if a burch urethropexy should be performed routinely or selectively at the time of sacrocolpopexy in continent women. women with pelvic organ prolapse who are scheduled for prolapse repair will be randomized to a burch urethropexy group or to a control group. women in the burch group will undergo urethropexy at the time of prolapse repair. assessments will include a quality of life telephone interview, urodynamic testing, and physical examination. follow-up evaluations occur at 6 weeks, 3 months, and 1 and 2 years following surgery. post-operative phone interviews will occur at 3 months, 6 months, and 1 and 2 years.

Eligibility criteria:
inclusion criteria 1. eligibility for primary procedure (sacrocolpopexy) 2. eligibility for secondary procedure (burch colposuspension) 3. stage ii-iv anterior vaginal prolapse, defined as pop-q point aa at -1, 0, +1, +2, or +3 cm. 4. negative stress incontinence screen 5. negative stress incontinence screen (mesa questionnaire) exclusion criteria 1. contraindication for sacrocolpopexy or burch colposuspension. * anatomic contraindication for burch colposuspension (i.e., point aa fixed at -2 or -3 cm). * surgeon judgment that a contraindication to burch colposuspension exists. 2. anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening). 3. inability to provide informed consent or to complete testing or data collection. 4. currently pregnant.

Keywords: urinary incontinence pelvic organ prolapse stress incontinence sacrocolpopexy burch urethropexy surgical trials
immunogenicity and safety study of a new chromatographically purified vero cell rabies vaccine with id regimen and erig

Conditions: Rabies

Summary: a comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (speeda) and chromatographically purified vero cell rabies vaccine (speeda)which is filled by queen saovabha memorial institute (trcs speeda)vs. reference vaccine (purified vero cell vaccine; verorab)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

rabies is an important world health problem especially in developing countries.although the case-fatality ratio of human rabies is 100%,the disease is preventable by the modern cell-culture vaccine and rabies immunoglobulin.post-exposure rabies vaccination with the modified thai red cross intradermal(modified trc-id)regimen has been approved by who and proven to be immunogenic and effective. it represents a significant saving in vaccine cost and is now established in several developing countries. speeda,chromatography purified vero cell derived rabies vaccine,approved by thai fda on 8 april 2009 and drug registration code of speeda is 1c 90022/51. this study has a goal to determine the immunogenicity and safety of speeda and trcs-speeda (speeda which is filled by queen saovabha memorial institute)vs. reference vaccine (purified vero cell vaccine; verorab)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

Eligibility criteria:
inclusion criteria: * subjects are healthy population older than 15 years. * subjects are willing to give signed informed consents. * subjects are willing to give blood samples on recommended days. * subjects are available for follow up according to the table of administration exclusion criteria: * subjects who had received any type of rabies vaccination in the past * subjects who had received rabies immunoglobulin in the past * subjects who had known as immunocompromised hosts * subjects on steroids or any other immunosuppressant * subjects on concomitant antimalarials * subjects who have received of any blood products within the previous 3 months * subjects with history of allergy to any ingredient of the vaccine * subjects who had known as pregnancy in first recruitment

Keywords: rabies vaccine vero cells serology safety
vivaer® procedure for treatment of nasal airway obstruction study

Conditions: Nasal Airway Obstruction

Summary: the purpose of this study is to compare the vivaer procedure with radiofrequency (rf) energy to sham procedure for treatment of nasal airway obstruction (nao).

the purpose of this study is to compare the vivaer procedure for treatment of nasal airway obstruction (nao) with a sham procedure that simulates the actual procedure as closely as possible absent the delivery of radiofrequency (rf) energy to the nasal tissue.

Eligibility criteria:
inclusion criteria: 1. age 18 to 85 years (inclusively). 2. willing and able to provide informed consent. 3. willing and able to comply with the subject-specific requirements outlined in the study protocol. 4. seeking treatment for nasal obstruction and willing to undergo an office-based procedure. 5. baseline nasal obstruction symptom evaluation (nose) scale score ≥ 55. 6. nasal valve is a primary or significant contributor to the patient's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the patient has a positive response to any of the following temporary measures (based on patient history or office exam): * use of external nasal dilator strips (eg, breathe right strips) * use of internal nasal dilator cones * modified cottle maneuver (manual elevation of the lateral nasal wall using a small instrument or cotton-tipped applicator to open the nasal valve) * cottle maneuver (manual lateral retraction of the cheek to open the nasal valve) 7. dissatisfaction with medical management as judged by the patient. defined as failed medical therapy (eg, decongestants, antihistamines, and/or nasal sprays for an appropriate period of time), but a positive response to internal or external nasal dilators. exclusion criteria: 1. prior surgery of the lateral nasal wall, including cephalic resection of the lower lateral cartilage, dome division or suture plication, alar graft or spreader graft placement. 2. rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic sinus surgery (fess) within the preceding 3 months. 3. severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the patient's nasal obstruction symptoms and warranting surgical intervention. 4. any adjunctive surgical nasal procedure planned on the same day or within 6 months after the vivaer procedure. 5. known or suspected to be pregnant or is lactating. 6. participating in another clinical research study. 7. other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.

Keywords: nasal obstruction nao nasal valve dysfunction nasal airway obstruction
dose ranging study of indacaterol in japanese patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in japanese patients with chronic obstructive pulmonary disease (copd) so that optimal dose(s) could be chosen for testing in later studies.


Eligibility criteria:
inclusion criteria: * male and female japanese aged 40 to 75 years old * moderate to severe chronic obstructive pulmonary disease (copd) with smoking history of at least 20 pack years exclusion criteria: * history of hospitalization for copd exacerbation within past 6 months * use of long-term oxygen therapy * history of asthma * respiratory tract infection within past 1 month * consistently very high or low blood sugar * clinically abnormal laboratory values or significant condition * history of heart failure or heart attack within past 6 months * history of long qt syndrome or long qt interval in electrocardiogram recorded at screening other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: chronic obstructive pulmonary disease copd qab149 indacaterol long acting β2-agonist
a mhealth application as a screening tool for neonatal jaundice in filipino neonates

Conditions: Jaundice, Neonatal

Summary: the purpose of the study is to test the reliability of the picterus smartphone application in filipino neonates. a descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application

the purpose of the study is to test the reliability of the picterus smartphone application. the study is designed for filipino neonates, but implemented in other lmic. the participants include newborns with or without jaundice, gestational age \>37 weeks, age0-14days, weight \>2500 gram and absence of congenital malformations. demographic data of the neonates will be collected together with all the performed tests and it will be stored in a secured system. blood will be drawn and measure the bilirubin level of the neonates in a standard clinical routine and will be compared to the estimated bilirubin performed with the picterus smartphone application. a descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application. it will provide an answer to whether the picterus smartphone application is reliable to other populations, especially to darker skin and with high melanin content such as filipino neonates.

Eligibility criteria:
inclusion criteria: * newborns with or without jaundice * gestational age ≥ 37 weeks * age 0 - 14 days * weight 2500 to 4500 grams * absence of congenital malformations exclusion criteria: * newborns with life-threatening conditions or significant illness * newborns diagnosed with inborn errors of metabolism * jaundiced newborns that have undergone phototherapy before screening
association between drug-related cutaneous adverse events and progression free survival in patients treated with enfortumab vedotin

Conditions: Cutaneous Adverse

Summary: enfortumab vedotin (ev) is an antibody-drug conjugate (adc) targeting nectin-4. in patients with metastatic urothelial carcinoma, ev in combination with pembrolizumab (anti-pd1) provides significantly better progression-free and global survival than platinum-based chemotherapies, with the benefit observed from the first line of treatment. however, ev is associated with a high frequency of cutaneous adverse events (ae), which may be due to physiological nectin-4 expression in keratinocytes. these cutaneous toxicities include bullous/blistering toxicities and toxic epidermal necrolysis-like ae. while the association between cutaneous ae and survival has been demonstrated with anti-pd1, its association with survival in patient treated with adc remains unknown. the objective of this retrospective dual-centric study is to determine whether there is an association between drug-related cutaneous ae and progression free survival in patients treated with ev.


Eligibility criteria:
inclusion criteria: - all adult patients who have been treated with enfortumab vedotin at hôpital lyon sud or centre léon bérard and for whom follow-up data of at least 6 months are available are eligible for inclusion. to be included, patients must be willing and able to provide non-opposition consent for participation in this study and for the use of their medical data in this context. exclusion criteria: -any medical, social, or psychiatric condition that might impair the patient's capacity to provide informed consent to participate in the study and to the use of their medical data is considered an exclusion criterion
single cutting guides system for the installation of a total knee replacement

Conditions: Knee Osteoarthritis

Summary: the knee prosthesis is a validated treatment for end-stage of knee osteoarthritis, and this intervention usually provides a significant improvement in the quality of life of patients. however, a significant percentage of patients (up to 30%) are disappointed with the outcome of the intervention. one hypothesis that could explain these poor results might be the poor positioning of implants. individual cutting guides are produced after a ct scan response planning carried out according to the ct scan anatomy of each patient, and subsequently adapted to its real anatomy during surgery, thus theoretically better accuracy of the implementation over conventional techniques. it has been shown in the past that the navigation has been the gold standard in measuring the three-dimensional orientation of the implants during surgery, and this system is systematically used in the service for over 10 years.


Eligibility criteria:
inclusion criteria: * patients over 18 years * patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis. exclusion criteria: * patients under 18 years

Keywords: knee knee osteoarthritis knee replacement
g-plus (gallant, gallex and armor - post treatment follow-up study)

Conditions: Type 2 Diabetes

Summary: this is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseii/iii studies gallant, gallex and armor. in addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and adverse event recording.


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * men or women who either completed at least 6 months in a previous treatment study gallant, gallex or armor or met a pre-defined laboratory or clinical finding during participation in any of the said studies. exclusion criteria: * received open-label treatment with tesaglitazar (since this is a post-treatment study)
development of a molecular diagnostic strategy for sars-cov2 based on saliva in the context of the covid-19 pandemic

Conditions: COVID; RT-ddPCR Multiplex

Summary: the objective of the study is to develop and validate a molecular diagnostic strategy (rt-ddpcr multiplex) of covid-19 based on a saliva sample and alternative to the rt-qpcr method, in order to : 1. to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis; 2. to increase the molecular diagnostic capacity of covid-19 at the rouen university hospital; 3. and to have a method compatible with screening extended to populations at risk.


Eligibility criteria:
inclusion criteria: * person aged over 18 years presenting to the covid-19 consultation of the rouen university hospital for screening * person affiliated to a social security scheme exclusion criteria: * person objecting to participation in the research after reading information * person under the protection of justice, * person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.) * patient under guardianship or curatorship
loop-tipped guidewire in selective biliary cannulation

Conditions: Choledocholithiasis; Bile Duct Cancer; Pancreatic Cancer; Ampullary Tumor

Summary: 1. background * advanced guidewires with a u-shaped tip could effectively cross the long or multi-occlusive segment smoothly and go into the distal outflow vessel. * the guidewire looping technique is a safe and effective method for the recanalization of the occluded lesions in infrapopliteal vessels. 2. objective - to compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation. 3. design - prospective randomized trial. 4. setting: - tertiary-care medical center 5. patients - this study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography. 6. intervention - cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire 7. main outcome measurements - compare the cannulation success rate, the duration of the cannulation, immediate and late complications.


Eligibility criteria:
inclusion criteria: * age \> 19 and ability to consent * no evidence of significant cardiopulmonary or medical comorbidities precluding participation exclusion criteria: * known gastroduodenal anatomic abnormalities * coagulation disorders (international normalized ratio \> 1.5 or platelet count \< 50000 cells/cubic millimeter) * prior gastric surgery,endoscopic retrograde cholangiopancreatography * pregnancy
hemodynamic effects of chronic administration of spironolactone and/or propranolol in alcoholic cirrhotic patients

Conditions: Alcoholic Cirrhosis

Summary: the aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. the patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.


Eligibility criteria:
inclusion criteria: * indication of transjugular hepatic biopsy * alcoholic cirrhosis * presence of oesophageal varices ≤ stade 2 exclusion criteria: * renal insufficiency * natremia ≤ 135 mmol/l * vasoactive treatment in the last month before inclusion * hepatocellular carcinoma * positive hiv and hcv patients * paracentesis in the last week before inclusion * digestive bleeding in one last week * oesophageal varices stade 3 or 2 with red signs

Keywords: portal hypertension, alcoholic cirrhosis, hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol
occupational performance problems in individuals with rheumatoid arthritis

Conditions: RheumatoId Arthritis

Summary: aim: to identify the main occupational performance problems reported by individuals with rheumatoid arthritis and the relationship between these activities with work status of participants . methods: the investigators conducted a cross-sectional study with 81 patients with ra. individuals were interviewed the canadian occupational performance measure. data was described in frequencies and percentages, and the pearson's chi-square test was used to determine the asymptotic association between the occupational performance problems with work.

for this cross-sectional study, 81 patients were recruited by convenience at the clinical hospital (hc) of the universidade federal de minas gerais (ufmg), in brazil. copm was applied to identify the main occupational performance problems reported by participants. the copm is an individual measure of self-awareness about the problems faced when carrying out the activities. it identifies problems in the areas of self-care, productivity, and leisure, and measure the individual's performance and satisfaction regarding these activities

Eligibility criteria:
inclusion criteria: * over 46 years old; * diagnosed with ra by rheumatologist (american college of rheumatology); * mental competency as assessed with the mental state mini-examination; * possessed the skills to understand the instructions study. exclusion criteria * had undergone surgery in the upper limbs.

Keywords: rheumatoid arthritis human activity canadian occupational performance measure
neuroinflammation after myocardial infarction - imaging substudy

Conditions: Myocardial Infarction

Summary: the purpose of the study is to see if positron emission tomography and magnetic resonance imaging (pet/mri) with an investigational drug called \[18f\]dpa-714 will show inflammation in the brain after a heart attack. this study may help physicians and researchers better understand the role of brain inflammation in heart disease and develop new treatments to protect the brain.

the primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the pet ligand \[18f\]dpa-714 in individuals with recent ami. the basic premise is that ami leads to systemic inflammation that includes inflammation in the brain. the pet tracer \[18f\]dpa-714 binds to the 18 kda translocator protein (tspo, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. the estimates of brain tspo binding in patients with recent ami will be compared to a matched group of patients who have undergone a recent elective pci procedure.

Eligibility criteria:
inclusion criteria: 1. participation in uab irb protocol "neuroinflammation after acute myocardial infarction" (irb-300002751, pi lazar). 2. 21 years of age or older 3. . english speaking with at least 8th grade education 4. high or mixed affinity binder for tspo ligands based on genotyping for single nucleotide polymorphism (snp) rs6971. 5. admission to uab hospital for st-elevation acute myocardial infarction (ami) and treatment with percutaneous coronary intervention (pci) or undergoing elective percutaneous coronary intervention (pci) exclusion criteria: 1. contraindication to mri 2. pregnancy 3. lactation 4. serious medical co-morbidity that may interfere with participation 5. prior myocardial infarction 6. severe anemia 7. prior coronary artery bypass grafting 8. prior angioplasty and/or coronary artery stent placement (pci group only) 9. history of traumatic head injury defined by a loss of consciousness ≥30 minutes or seizure at the time of injury 10. diagnosis of major depression 11. diagnosis of dementia 12. low affinity binder for tspo ligands based on genotyping for snp rs6971.