Kornimate/medical-research-clean huggingface dataset:
acute hip fracture study in patients 65 years or greater

Conditions: Hip Fractures

Summary: this is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to investigate the safety, tolerability, and efficacy of vk5211 after 12 weeks of treatment. males and females ≥65 years old who are ambulatory and recovering from a hip fracture will be eligible for participation 3-7 weeks post-injury.


Eligibility criteria:
inclusion criteria: * males or females ≥65 years old who are recovering from a hip fracture (occurring 3-7 weeks prior) with no residual surgical issues will be eligible for participation. exclusion criteria: * pathological fracture (e.g. fracture due to paget's disease of bone, malignancy, etc.). fracture due to postmenopausal osteoporosis is not considered pathological for this trial.
solx gold shunt versus control implant: randomized trial for refractory glaucoma

Conditions: Glaucoma; Glaucoma, Open Angle

Summary: study objective: to establish the substantial equivalence of the solx gold shunt to commercially available aqueous shunts, specifically the ahmed™ glaucoma valve model fp7, in the ability to reduce intraocular pressure (iop) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.

this protocol is a randomized, controlled, multi-center, outpatient study to compare the iop lowering ability and safety profile of the solx gold shunt to the selected, commercially available aqueous shunt product (i.e., control shunt model fp7 ahmed™ glaucoma valve flexible plate™) for a period of up to one year. extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. follow-up beyond one year will be expected unless other patients with solx gold shunt implants in earlier phase studies outside the us clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the fda.

Eligibility criteria:
inclusion criteria: * primary open-angle, pseudoexfoliative, or pigmentary glaucoma * age 21 or over * refractory glaucoma, with iop \>21 mmhg on medications and failed prior incisional glaucoma surgery * detectable visual field defect (negative md score) * written consent * available for up to 24 months follow-up exclusion criteria: * either eye with va worse than count fingers * recent angle closure glaucoma episode * uveitic glaucoma, iridocorneal endothelial (ice) syndrome, traumatic glaucoma, or neovascular glaucoma * other significant ocular disease, except cataract * active ocular infection * expected ocular surgery in next 12 months * no suitable quadrant for implant * systemic corticosteroid therapy \> 5 mg/day prednisone * intolerance to gonioscopy or other eye exams * mental impairment interfering with consent or compliance * pregnancy * known sensitivity to anticipated medications used at surgery * significant co-morbid disease * concurrent enrollment in another drug or device study

Keywords: glaucoma shunt ocular implant gold trabeculectomy
undislocated distal both-bone forearm fractures in children

Conditions: Fracture; Forearm; Distal; Child; Treatment

Summary: we create a randomized clinical trial between above- and below elbow cast to find out what kind of treatment is optimal for undislocated both-bone distal forearm fractures.

children who arrive at the emergency unit with a undislocated both-bone distal forearm fracture will be asked to join the trial. after informed consent, a randomization between 2 kinds of cast will be done. outpatient clinic visits till a follow-up of 6 months. during these visits we will investigate: consolidation and dislocation on x-ray, function of both arms, complains in daily living and complications.

Eligibility criteria:
inclusion criteria: * both-bone forearm fracture * distal * undislocated * age \< 16 years exclusion criteria: * fracture older than 1 week * no informed consent * refracture * open fracture (gustillo 2 and 3) * both fractures type torus

Keywords: fracture forearm distal child treatment
reduction of infection in neonatal intensive care units using the evidence-based practice for improving quality

Conditions: Nosocomial Infections

Summary: this 4-year cluster randomized controlled trial aims to determine whether implementation of evidence-based practice for improving quality (epiq) method can reduce hospital-acquired infection in chinese neonatal intensive care units (nicus).

following randomization into two groups, the intervention nicus (n = 12) will receive training in the epiq method and then develop, implement, and document evidence-based practice changes to reduce hospital-acquired infection. compliance with practice changes and neonatal outcomes will be monitored. nicus will receive quarterly feedback on their progress, as well as access to implementation support. control nicus (n = 12) will collect neonatal data and continue to provide standard care. study subjects will be all preterm infants born at \<34 weeks' gestation and admitted to participating nicus during the trial (estimated n = 5,200 per year). data analysis will be conducted to compare neonatal outcomes and health-care resources used between the intervention and control groups.

Eligibility criteria:
inclusion criteria: * infants born at \<34 weeks' gestation * admitted to the participating nicus within 7 days after birth * admitted to the participating nicus between may 1, 2015 and april 30, 2018 exclusion criteria: * infants with major congenital anomalies * infants who are moribund on admission (a decision is made to provide only palliative care)

Keywords: intensive care, neonatal nosocomial infections quality improvement
a single-arm trial of atezolizumab/platinum/etoposide for the treatment of advanced large-cell neuroendocrine cancer of the lung

Conditions: Large Cell Neuroendocrine Carcinoma of the Lung

Summary: this phase ii clinical trial evaluates the efficacy, safety and tolerability of atezolizumab in addition to standard of care chemotherapy (platinum/etoposide) in lcnec.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (lcnec) without curative treatment options (patients with mixed histology are eligible if lcnec is the predominant histology i.e. ≥50%) 3. previously untreated with systemic therapy (note: patients relapsing after curative radio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 months after discontinuation of curative treatment) 4. planned treatment with carboplatin or cisplatin and etoposide (soc) 5. ecog performance status: 0-2 6. age ≥18 years 7. measurable disease according to recist v1.1 8. adequate organ function defined as: 1. alat/asat ≤2.5x uln or ≤3.5x uln in case of liver metastases 2. bilirubin ≤1.5x uln or ≤2.5x uln in case of liver metastases 3. creatinine ≤1.5x uln or creatinine clearance according to cockroft-gault \>60 ml/min 4. neutrophils ≥1 gpt/l, platelets \>50 gpt/l unless caused by bone marrow carcinosis exclusion criteria: 1. symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks) 2. severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment) 3. severe uncontrolled infection 4. prior treatment with either atezolizumab or other immune checkpoint inhibitor 5. any prior treatment for metastatic disease

Keywords: lung cancer lcnec neuroendocrine carcinoma
a feasibility study of confocal microendoscopy in the evaluation of gastrointestinal neoplasia -project 1

Conditions: GERD; Barrett's Esophagus

Summary: the overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. this is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this fda-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower gi tract. the confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.


Eligibility criteria:
inclusion criteria: * patient 18 years or older * colonoscopy for screening or surveillance of polyps or disease of colon * anoscopy because of suspected or known anal dysplasia or neoplasia exclusion criteria: * patient unable to provide informed consent * patient found unfit for standard colonoscopy or anoscopy with biopsies

Keywords: barrett's esophagus confocal microendoscopy
effects of virtual museum visit on pain, fatigue, and anxiety in patients receiving chemotherapy

Conditions: Chemotherapy Effect; Pain Cancer; Fatigue; Anxiety

Summary: symptom management is the most important aspect of clinical cancer care. virtual reality-based interventions can be used to improve cancer patients' experiences with medical treatment, with their distraction-based effects. the aim of this study was to determine the effects of virtual museum visits with virtual reality glasses on pain, fatigue, and anxiety in patients receiving chemotherapy. the study included a museum visit with virtual reality glasses during the procedure in addition to routine treatments for patients in the intervention group. patients in the control group were given only their routine treatments. data will be collected using the personal information form (pif), hirai cancer fatigue scale, visual analog scale (vas) and beck anxiety scale (baö). in the first interview, the patient was also presented with virtual museum options and the museums he/she wanted to visit were listed. in addition, the patients in the intervention group were shown virtual museums with 53 different themes on the website prepared by the general directorate of information technologies of the ministry of culture and tourism, which is located on the website ''https://sanalmuze.gov.tr'' belonging to the ministry of culture and tourism, and the museums they wanted to visit in each session according to their preferences were listed. in the meantime, the intervention group was explained how to use the virtual glasses and they will be tested. one week after the first test, the patients in the intervention group will visit a virtual museum on the theme preferred by the patients using virtual glasses for an average of 20 minutes for a total of five consecutive weeks. in the fifth virtual tour session, which is the third and last application session, measurements (visual analog scale, hirai cancer fatigue scale and beck anxiety scale) will be administered. the control group will not receive any intervention other than routine treatment.the museum visit applied to the intervention group will also be applied to the control group after the study is completed, taking into account the ethical dimension.


Eligibility criteria:
inclusion criteria: * the inclusion criteria of the sample were having received at least one course of chemotherapy and continuing chemotherapy * having not visited a virtual museum with vr glasses before, * having no difficulty in communicating, * having no mental problems, being 18 years of age or older, * agreeing to participate in the study exclusion criteria: * the exclusion criteria of the sample were having not received chemotherapy or having completed treatment. * having stage iv cancer * having difficulty seeing and communicating. * being under the age of 18 * the desire to withdraw from the study.
para aortic lymphadenectomy : always ?

Conditions: Cervical Cancer

Summary: cervical cancer affects more than 3000 new cases per year in france. the treatment of stage ib3 to iva cervical cancer is based on concomitant radio-chemotherapy. the irradiation volumes are based, according to current recommendations, on imaging examinations and / or on the results of a laparoscopic para-aortic lymphadenectomy (pal). there is some risk of false negatif with the pet/ct. for this reason, most of the time, pal is offered when there is no pathological paraaortic lymph node on pet/ct. the investigators suppose that this staging surgery could be avoid when no pathological pelvic nodes are identified on pet/ct. the investigators use a retrospective study, to analyse histological report of systematic pal, comparing to results of pre-operative pet/ct.


Eligibility criteria:
inclusion criteria: - patients with : * locally advanced cervical cancer, * who undergone pal * with pre operative pet ct, between january 2015 and december 2019 exclusion criteria: - patients aged under 18

Keywords: locally advanced cervical cancer, more than ib3 stage figo 2018 para aortic lymphadenectomy laparoscopy pet/ct
an extension study of mom-m281-004 to evaluate the safety, tolerability, and efficacy of m281 administered to patients with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of m281 in participants with generalized myasthenia gravis (gmg)


Eligibility criteria:
participants must be ≥18 years of age with a documented history of generalized myasthenia gravis (gmg) and clinical signs/symptoms of gmg, not pregnant or breastfeeding, previously participated in the mom-281-004 study, had no major eligibility deviations or other major protocol deviations or not met any of the stopping criteria or discontinued study drug in the mom-m281-004 study for any reason other than the need for rescue therapy as specified in the mom-m281-004 study. additional, more specific criteria are defined in the protocol.

Keywords: m281 generalized myasthenia gravis
envision® surface evaluation

Conditions: Pressure Ulcer

Summary: this observational study will acquire initial clinical practice utilization and product safety data for the envision® surface.

this is a single site, open label, observational study to acquire initial clinical practice utilization information, product safety, and wound healing data, as defined by changes in wound volume and/or surface area, for patients with pressure ulcers placed on this surface.

Eligibility criteria:
inclusion criteria: * subject weight \< 400 lbs. subject has stage ii, iii, or iv pressure ulcer on weight bearing aspect of the body subject estimated length of stay at least 7 days subject ability to provide informed consent exclusion criteria: * inability to provide informed consent

Keywords: pressure ulcer
the turkish version of the aofas hallux mtp-ip

Conditions: Foot Deformity; Hallux Deformity; Assessment, Self; Orthopedic Disorder

Summary: the american orthopedic foot and ankle society hallux metatarsophalangeal-interphalangeal joint scale (aofas hallux mtp-ip) is originally developed in english to evaluate the pain, function and alignment in patients with hallux deformities. the purpose of this study is to translate and cross-culturally adapt the aofas hallux mtp-ip scale into turkish and investigate its psychometric properties.

the american orthopedic foot and ankle society hallux metatarsophalangeal-interphalangeal joint scale (aofas hallux mtp-ip) is originally developed in english to evaluate joint function in patients with elbow stiffness. the purpose of this study is to translate and cross-culturally adapt the aofas hallux mtp-ip scale into turkish and investigate its psychometric properties. approximately seventy patients with hallux deformities will be included. for cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. within a 5-to-7-day period after the first assessment, the participants will complete the turkish version of aofas hallux mtp-ip (aofas hallux mtp-ip-t) to evaluate test-retest reliability. cronbach's alpha (α) will use to assess internal consistency. the correlation with the turkish version of the manchester-oxford foot questionnaire (moxfq) and short form-12 will be determined to check the validity.

Eligibility criteria:
inclusion criteria: * aged between 18 and 65 years * diagnosis of hallux deformities * continuing follow-up and treatment in the orthopedic service * being able to follow simple instructions * being able to read and write in turkish exclusion criteria: * having any cardiovascular diseases, neurological disorders, rheumatic diseases, or psychiatric diseases * having peripheral nerve injury, peripheral neuropathy, or sensory loss in the lower extremity * having heterotopic ossification, myositis ossification, or post-traumatic ankylosing in the lower extremity * fracture, non-healing wound, or infection in the lower extremity
evaluation of morphofunctional and baropodometric changes in pregnant women

Conditions: Pregnancy Related; Foot Diseases

Summary: pregnancy causes physiological and biomechanical changes in the female body, such as weight gain and hormonal changes, which can affect the structure and function of the foot and ankle. these adaptations can influence gait, balance and stability. however, the temporal evolution of these changes in the foot and ankle before, during and after pregnancy is not well documented. this study aims to characterize and quantify these changes, as well as their impact on foot function, with the aim of contributing to the prevention and management of podiatric and orthopedic problems in pregnant women.

pregnancy causes physiological and biomechanical changes in the female body, such as weight gain and hormonal changes, which can affect the structure and function of the foot and ankle. these adaptations can influence gait, balance and stability. however, the temporal evolution of these changes in the foot and ankle before, during and after pregnancy is not well documented. this study aims to characterize and quantify these changes, as well as evaluate their impact on foot function, thus contributing to the prevention and management of podiatric and orthopedic problems in pregnant women. the general objective of this study is to evaluate the morphofunctional and baropodometric changes of the foot and ankle in pregnant women from the pre-gestational period to the postpartum period. specific objectives include determining changes in foot and ankle size and width at different stages, assessing foot function using the aofas (ankle and foot outcome score), fpi (foot posture index) and ffi (foot function index) indices, analyzing plantar pressure distribution and baropodometric changes, and correlating morphofunctional and baropodometric changes with weeks of gestation and maternal weight.

Eligibility criteria:
inclusion criteria: 1. healthy women between 20 and 35 years old. 2. if pregnant, they must be in the first trimester of pregnancy (before week 12). 3. absence of chronic or acute pathologies that may interfere with the analysis of biomechanical variables (arthritis, vascular or metabolic problems). 4. not having had previous foot or ankle surgeries. exclusion criteria: 1. women with multiple pregnancies (twin or multiple pregnancies increase biomechanical variations). 2. conditions that affect gait or foot structure (arthritis, neuropathies, or other orthopedic problems). 3. history of previous foot or ankle injuries that may alter measurements.

Keywords: pregnancy foot diseases postural balance foot morphology
effect of ganglionar electrical stimulation on central arterial pressure

Conditions: Heart Failure; Chagas Disease

Summary: this study will evaluate the applications of ganglionar electrical stimulation in patients with chagas disease and ischemic heart failure patients.

a crossover randomized controlled study will be developed with 3 groups: healthy older, ischemic heart failure and chagas disease. this individuals will be randomized in two groups: tens and placebo (same stimulus without electrical output) with 48 hrs between the interventions.

Eligibility criteria:
inclusion criteria: * ischemic and chagas disease previously diagnosticated * age above 40 years old exclusion criteria: * no vascular disease * no recent surgery * no recent infections

Keywords: autonomic nervous system neuromodulation exercise pulmonary oxygen kinetics oxygen uptake
research for individualized therapeutics in rare genetic disease

Conditions: Rare Genetic Disease; Undiagnosed Diseases

Summary: the purpose of this research study is to identify individuals that have a rare genetic disease without an adequate therapeutic strategy that might be treatable with drug developed to target the disease-causing genetic alteration.


Eligibility criteria:
inclusion criteria: * has mayo clinic or other medical health system id, or another unique identifier. * able to provide informed consent. * individual must have evidence of a genetic disorder as determined by a provider or genetic counselor with causative or likely causative genetic variants identified by molecular testing. * genetic variants must be hypothesized to be targetable using antisense oligonucleotide drugs (such as: knockdown gain of function alterations, increase protein production for reduced function alterations, or modulate mrna splicing to correct abnormal splicing, promote normal splicing, or return reading frame to an out-of-frame transcript to restore function, etc.) based on current acceptable understanding of aso mechanisms of action and tissue/organ targeting efficiency. * biological family member of an enrolled individual. * would be able to travel to a mayo clinic site for ongoing treatment should a therapeutic be developed. * treatment at the individual's current disease state would likely provide benefit based on current clinical data and understanding of the progression of the disease. -or- * biological family member of an enrolled individual * able to provide informed consent or has a lar available to provide informed consent exclusion criteria * individuals who have situations that would limit compliance with the study requirements. * institutionalized (i.e. federal medical prison).
detection of herpesvirus dna (cmv, ebv, hhv-6 and hsv) in colonic tissue: impact on ulcerative colitis flare-up

Conditions: Colitis, Ulcerative

Summary: flare-up of ulcerative colitis (uc) is characterized by the inflammation of colon mucosa that requires the use of immunosuppressive therapies. in previous studies, the active role of cytomegalovirus (cmv) has been demonstrated, with a correlation between the cytomegalovirus dna ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive lines of immunosuppressive therapy (roblin et al., am j gastroenterol 2011). the main aim of this monocentric prospective study is to evaluate the dna viral load by qpcr (polymerase chain reaction) of 3 herpesviruses (epstein-barr virus, herpes virus 6 and herpes simplex) together with that of cmv in colonic mucosa depending of the local inflammation (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to severe uc flare-up (mayo score \>6 with endoscopic score higher or equal than 2). the viral load will also be correlated to the mayo endoscopic score and the response to immunosuppressive drugs (steroid and anti-tnf (tumor necrosis factor) monoclonal antibodies).


Eligibility criteria:
inclusion criteria: * age\>18 years * voluntary to participate to the study * flare-up of ulcerative colitis with mayo score \>6 * ability to receive steroid or anti-tnf therapy * agree the rectosigmoidoscopy and the therapies exclusion criteria: * age \<18 years * pregnancy * disagree the rectosigmoidoscopy or the therapies * participation to the evaluation of a new therapy * colectomy (partial or total) * contraindication of steroid or anti-tnf therapy * anticoagulant drugs

Keywords: ulcerative colitis inflammation immunosuppressive drugs herpesvirus qpcr colonic mucosa