Kornimate/medical-research-clean huggingface dataset:
clinical and functional outcome of the mobilelink acetabular cup system in the short-, mid-, and longterm follow-up

Conditions: Osteoarthritis, Hip; Hip Osteoarthritis; Prosthesis Survival; Prosthesis Failure

Summary: the implantation of artificial hip joints is one of the most frequently performed surgeries. normally, patients are very satisfied with the results. the mobilelink hip prosthesis system is a ce marked medical device. this means the the safety and performance of the prosthesis ist approved. aim of the study is to collect clinical data about the outcome of the mobilelink hip prosthesis system under routine condition and to determine the satisfaction of the patients.


Eligibility criteria:
inclusion criteria: * implantation of a mobilelink acetabular cup system and a femoral stem manufactured by waldemar link * age ≥ 18 years * fully signed patient informed cons exclusion criteria: * revisions * body mass index (bmi) ≥ 40 kg/m² * patient who is foreseeable not able to understand the study and the study-related circumstances * patients who is foreseeable non-compliant to the treatment and the follow-ups * pregnant or breast-feeding women * prisoner

Keywords: mobilelink
fecal microbiota transplantation (fmt) in patients with advanced gastric cancer

Conditions: Advanced Gastric Cancer

Summary: this study is a randomized, double-blind and placebo-controlled study. the purpose of this study is to evaluate the efficacy and safety of fmt capsules combined with chemotherapy and anti-pd1/pdl1 therapy in the advanced gastric cancer.


Eligibility criteria:
inclusion criteria: voluntarily participate in this study and provide written informed consent. age ≥ 18 years , male or female. pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma. able and willing to provide tumor tissue. at least one measurable extracranial target lesion according to irecist. eastern cooperative oncology group (ecog) performance status of 0 or 1. life expectancy ≥3 months. exclusion criteria: presence of absolute contra-indications to fmt administration:toxic megacolon;inflammatory bowel disease;anatomic contra-indications to colonoscopy;colectomy patient is currently participating and receiving other study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of this study intervention. currently under any form of systemic antibiotics. has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy two weeks prior to trial treatment. patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (\> 10 mg prednisone daily or equivalent). severe anaphylactic reaction to any food (food allergies). had a severe hypersensitivity reaction to propofol. has serious concomitant illnesses. the eligibility can be granted by the treating investigator on individual bases. has hiv infection or aids-related illness. has active infection of hav, hbv or hcv. patients with a history of hepatitis b/c infection who have received anti-viral therapy and are disease free may be considered for enrollment after discussion with principal investigator. patient has received a live vaccine within 4 weeks prior to the first dose of treatment. seasonal influenza vaccines or covid-19 vaccines for injection are generally inactivated virus vaccines and are allowed. has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. females who are pregnant or breastfeeding. active central nervous system (cns) metastases and/or leptomeningeal involvement
neonatal and paediatric pharmacokinetics of antimicrobials study

Conditions: Paediatric Antimicrobial Pharmacokinetics

Summary: the aim of nappa is to develop new models to improve our understanding of how children process ('metabolise') penicillins, to help us discover if we can improve the dosing regimens used for children in the future. the study population will involve children and neonates who need a penicillin antibiotic as part of their normal national health service (nhs) care, and who also need blood tests or intravenous access. therefore the antibiotic study can be done without the need for any extra invasive procedures, and there will be no change to the medication therapy received by participants. in addition, nappa will evaluate whether it is feasible to measure antibiotic levels on a tiny drop of blood put onto absorbent paper ("dried blood spot"). this allows the sample to be stored and tested later on. nappa will compare the level of the antibiotic using this method with the level measured in the usual way, to show if this is a reliable method that could be used routinely in the future.


Eligibility criteria:
inclusion criteria: * child aged under 16 years receiving one of the specified penicillins and with intravenous access or blood test(s) as part of their routine clinical care. * informed consent form signed by parent or legal guardian. exclusion criteria: * any child or infant unlikely to survive 48 hours after recruitment. * patient known to be pregnant. * known allergy or hypersensitivity to beta-lactam antibiotics (including penicillins and cephalosporins) or beta-lactamase inhibitors. * patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ecmo) or cardiopulmonary bypass.

Keywords: infectious diseases paediatrics neonatology pharmacokinetics antimicrobials
pf-06651600 taste study.

Conditions: Healthy Participants

Summary: this is a single-blind, randomized, five (5)-period, cross-over study in healthy adult participants. a group of approximately 10 participants will assess the sensory attributes (taste and palatability) of 4 different formulations of an investigational product (pf-06651600 active pharmaceutical ingredient) and bitrex (registered) positive control in a specified sequence in 1 day.


Eligibility criteria:
inclusion criteria: * willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb) exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease infection with hepatitis b, c or hiv * participants with conditions that affect their ability to taste * participants who currently smoke

Keywords: pf-06651600 palatability bitrex taste study
new non-hormonal treatment by radiofrequency for vulvo-vaginal atrophy

Conditions: Vulvo-vaginal Atrophy; Genitourinary Syndrome of Menopause

Summary: vulvo-vaginal atrophy (vva) or genitourinary syndrome of menopause (gsm) is a common and under-reported condition associated with decreased estrogenization of the vaginal tissue the aim of this study is to evaluate safety and efficacy of " dynamic quadripolar radio-frequency" thermal treatment with vaginal dynamic radio-frequency (vdr™) and radio-frequency safety system (rss™) for the treatment of vva and gsm in postmenopausal women who either present contra-indication for menopause hormone therapy, or are not willing to use menopause hormone therapy (mht) or have failed to be helped using mht.


Eligibility criteria:
inclusion criteria: * postmenopausal women suffering of vulvo-vaginal atrophy (vva), included breast cancer survivors defined as having self-identified at least one mild to severe of the following symptoms: 1. vaginal dryness (none, mild, moderate or severe), 2. vaginal and/or vulvar irritation/itching (none, mild, moderate or severe), 3. vaginal pain associated with sexual activity (none, mild, moderate or severe) * postmenopausal women with vva confirmed by at least one of the following criteria: 1. a proportion of superficial cells ≤ 5% in the vaginal smear using a "maturation index" 2. a vaginal ph \> 5 * postmenopausal women between 40 and 75 years of age (non hysterectomized or hysterectomized). menopause will be assessed either by amenorrhea of \> 1 year and / or by follicle stimulating hormone (fsh) \> 30 ui/l and estradiol (e2) \< 20 pg/ml * they must have either a contraindication to hormonal therapies, a failure of previous use of hormonal therapies (either systemic and/or local) or must have refused to take hormonal therapy. * willing to participate in the study and sign an informed consent. exclusion criteria: * undiagnosed abnormal genital bleeding. * the administration of any investigational drug within 30 days of screening visit. * endometrial hyperplasia at biopsy performed at screening or endometrial cancer. * use of estrogens/progestins products (vaginal, oral, pellet, transdermal....) in the 4 weeks to months (depending on the product used) prior study entry. * presence of severe medical disease or neurological disease or important co-morbidities. * other gynaecological malignancies. * recent vaginal surgery . * a clinically relevant prolapse (pelvic organ prolapse-quantification system (pop-q) ≤ 2) * current urinary tract or vaginal infection or recent sexually transmitted disease * anticoagulant treatment * people with pacemakers and/or other implanted electrodes (intra-uterine device (iud) and surgical pelvic implants for sterilization are not considered as contraindication) * disabled people unable to communicate

Keywords: vulvo-vaginal atrophy dynamic quadripolar radio-frequency menopause genitourinary syndrome of menopause
peri-implant and peri-prosthetic fractures: epidemiology, morbidity, mortality, treatment and outcome analysis

Conditions: Periprosthetic Fracture of the Upper or Lower Limb; Peri-implant Fracture of the Upper or Lower Limb; Periprosthetic Fractures; Peri-implant Fracture

Summary: this study supports spanish data collection and analysis on periprosthetic and peri-implant fractures of the upper and lower limb. treatment and clinical management of this fractures are complex and goes along with complications. there will be more than 70 hospitals providing information. this study will provide evidence on which is the best treatment for every unique patient. this will help trauma surgeons and geriatricians to provide better treatments, to improve health care in our society, reducing mortality, morbidity, improving functional outcomes, and reducing costs, which in turn will be advances in trauma care.

there is no clinical evidence on which are the best treatment options for periprosthetic and peri-implant fractures of the upper and lower limb. this is a multi-center collaborative study seeking to obtain a big number of patients. data collection includes previous health status and quality of life, which is the clinical management and treatment, as well as the outcome after one month, six months and one year. the investigators will be able to define risk factors and clinical attitudes, which influence on the patient outcome. and therefore, be able to establish treatment protocols and give management recommendations based on the observed clinical evidence to improve healing indexes, morbidity and mortality, function, grade of autonomy and quality of live. main questions to be answered are: 1. which is the epidemiology of periprosthetic and peri-implant fractures and how are they treated in spain, 2. identify risk factors for complications and worse outcomes, 3. which is the morbidity and mortality, 4. influence of the fracture type and implants already placed on management and outcome, 5. influence of the treatment on patients' grade of independency, and 6. identified which are the risk factors for treatment failure.

Eligibility criteria:
inclusion criteria: * patient with the diagnose of periprosthetic fracture of the shoulder, elbow, hip or knee. or patients with the diagnose of peri-implant fracture of the scapula, humerus, forearm, pelvis, femur, patella, tibia or fibula. or patient presenting cut-out or cut-in after dhs or nail after a proximal humeral fracture. * 18 years or older exclusion criteria: * spine pp or pi fracture * pp or pi secondary to metastasis or tumoral fracture * pp or pi intraoperative fracture * pp or pi pathologic fracture * pp ankle fracture * pp or pi wrist or hand fracture * fixation failure without any new fracture line: except cut-out or cut-in after dhs or nail of a proximal humeral fracture. * pregnancy

Keywords: periprosthetic fracture peri-implant fracture mortality morbidity loosening prosthesis revision fixation osteosynthesis complication ambulate quality of life
dry eye evaluation after transepithelial prk

Conditions: Dry Eye

Summary: the aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik

prospective interventional clinical study 2 groups: group a : 20 eyes of 10 patients undergoing transepithelial prk group b: 20 eyes of 10 patients undergoing lasik using mechanical microkeratome tear break up time and schirmer 2 tests are used to evaluate severity of dry eye before surgery and 1 , 3 and 6 months postoperative follow up period : 6 months

Eligibility criteria:
inclusion criteria * myopia -1 to -6 diopters * astigmatism -0.5 to - 4 diopters exclusion criteria: * pregnancy and lactation * keratoconus * previous refractive surgery * previous herpetic keratitis

Keywords: transepithelial prk dry eye schirmer test tear break up time dry eye after advanced surface ablation technique
a study to evaluate the interaction of lx4211 and metformin in healthy subjects

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine the effects of lx4211 and metformin on each other when given at the same time as single doses to healthy human subjects.


Eligibility criteria:
inclusion criteria: * adults ≥18 to ≤55 years of age. females must be of non-childbearing potential. * body mass index (bmi)≥18 to ≤35 kg/sq m * able to provide written consent * vital signs within sponsor-defined ranges exclusion criteria: * use of any medication, including any prescription, over-the-counter, herbal tea, or other supplements within 5 days of dosing * no investigational agent or study treatment within 30 days prior to day 1. * no protein or antibody-based therapeutic agents within 3 months prior to screening * use of any tobacco product * history of bariatric surgery or any gastrointestinal surgery that may induce malabsorption * history of any major surgery within 6 months prior to screening * history of any serious adverse reaction or hypersensitivity to metformin or lx4211. * history of renal disease or significantly abnormal kidney function test * history of hepatic disease or significantly abnormal liver function test * history of any active infection within 30 days prior to day 1 * history of any surgical or medical condition or clinically significant laboratory or physical finding * positive urine glucose at screening * use of drugs or alcohol
computerized feedback in colonoscopy

Conditions: Colorectal Cancer; Healthy

Summary: in a cluster-randomized study compare if feedback from two computerized feedback systems doing a colonoscopy (cops and cors) can improve the adenoma detection rate and decrease patient discomfort.

background: approximately 4,600 persons get colon cancer annually in denmark and it is the second most common cause of cancer death. survival is highly dependent on early detection through a colonoscopy. a thorough colonoscopy is essential to detect early cancers but unfortunately the quality of colonoscopies varies widely between operators. a study of 314,872 colonoscopies performed by 136 gastroenterologists found that the adenoma detection rate (adr) ranged from 7 - 53% and was inversely associated with the risks of fatal interval cancer. the investigators have developed to tools that can generate automatic, computerized feedback in order to make a more thorough procedure and reduce patient discomfort, the colonoscopy progression score (cops) and colonoscopy retraction score (cors) objectives: the investigators predict that live-feedback from cops and cors doing a colonoscopy can improve the adr and subsequent prevent colorectal cancer. the aim of this project is to: 1. in a cluster-randomized study compare if feedback from cops and cors can improve the adenoma detection rate and patient satisfaction for individual operators and the department as a whole. 2. make an immediate measure to assess the quality of individual colonoscopy performance. materials and methodology: as a randomized controlled cluster trial following a stepped-wedge program, feedback doing a colonoscopy from these (cops and cors) will be tested compared to no feedback. three test departments consisting of three university hospital in the capital region of denmark will be included.

Eligibility criteria:
inclusion criteria: * admitted for a screening colonoscopy through the danish national screening program for colorectal cancer. exclusion criteria: incomplete procedure due to: * in cases were the cecum is not reached. * unsatisfactory bowel preparation which results in admission for a new procedure

Keywords: colonoscopy adenoma detection rate computerized feedback
deployment and evaluation of artificial intelligence software for electrocardiogram analysis and management in primary care

Conditions: Primary Care Provider; Structural Heart Disease

Summary: the daisea-ecg project aims to improve the diagnosis of heart diseases in primary care through the deepecg platform, which combines ecg-ai and echonext algorithms. this study uses a stepped wedge design, where each family medicine group acts as its own control. the fmgs will gradually transition from the control period (without ai recommendations) to the intervention period (with ai recommendations activated) in a randomized sequence. the primary objective is to compare the sensitivity of family physicians in detecting cardiac pathologies, with and without the assistance of the deepecg platform. sensitivity is defined as the proportion of patients correctly referred to cardiology or for transthoracic echocardiography (tte) among those who indeed required cardiovascular evaluation, as confirmed by an independent adjudication committee.

mathematically, sensitivity is calculated as true positive / (true positive + false negative), where true positive represents correctly referred patients and false negatives represents patients who should have been referred but were not. the secondary objectives include determining the rate of cardiovascular evaluation referrals before and after the intervention (implementation of the deepecg platform), the individual characteristics of the intervention (ppv, npv, and specificity), as well as evaluating the feasibility of implementing ai-based automatic ecg interpretation in primary care through surveys of family physicians and cardiologists. ppv: positive predictive value npv: negative predictive value

Eligibility criteria:
inclusion criteria: family physicians or nurse practitioners family physicians or nurse practitioners (nps) practicing in one of the participating fmgs. family physicians who have given their free and informed consent. patients adult patients (18 years or older). patients without follow-up in cardiology or internal medicine for cardiovascular issues (arrhythmia, heart failure, myocardial infarction, atherosclerotic coronary artery disease, valvular heart disease) or those who had a negative investigation in the past with no additional follow-up. ecg any 12-lead ecg performed with the muse ge 360 machine. ecg of adequate technical quality for interpretation (otherwise, it will be automatically rejected by the platform). - exclusion criteria: * family physicians or nurse practitioners family physicians practicing exclusively in pediatrics (patients under 18 years old). family physicians unable to follow the project guidelines.
external fixation vs. volar plate for distal radius fractures: functional outcomes

Conditions: Radius Fractures

Summary: the goal of this prospective comparative clinical trial is to evaluate the effectiveness of external fixation versus volar locking plates in the management of unstable intra-articular distal radius fractures in adults over 18 years old. the main questions it aims to answer are: does the use of a volar locking plate result in better functional outcomes, as measured by the green and o'brien scoring system modified by cooney, compared to external fixation? what are the differences in intraoperative and postoperative parameters, including complications, between the two methods? researchers will compare outcomes in two groups: one receiving external fixation and the other undergoing open reduction and internal fixation with volar locking plates. participants will: undergo surgical intervention (external fixation or orif with volar plates) performed by experienced orthopedic surgeons. follow a postoperative rehabilitation plan, including active and passive range of motion exercises. attend follow-ups at 6, 12, and 24 weeks to assess pain, range of motion, fracture union, and complications.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older. * diagnosed with recent (\<1 week) intra-articular distal end radius fractures. * willing and able to provide informed consent. exclusion criteria: * open fractures classified as gustilo grade ii or higher. * fracture avulsion or dislocation. * vascular injury associated with the fracture. * extra-articular fractures of the distal radius. * preexisting joint or carpal bone disease affecting rehabilitation. * patients unwilling to provide consent.
durvalumab as maintenance in patients who received chemoradiotherapy for unresectable stage iii nsclc: real world data from an expanded access program in brazil

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: durvalumab as maintenance in patients who received chemoradiotherapy for unresectable stage iii nsclc: real world data from an expanded access program in brazil


Eligibility criteria:
inclusion criteria: 1. patients with unresectable stage iii nsclc who completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression 2. patients who have participated in the durvalumab eap in brazil and have received at least one dose of durvalumab in the eap..

Keywords: carcinoma, non-small-cell lung