Kornimate/medical-research-clean huggingface dataset:
implementation of a rehabilitation technology in orthopedic and neurological rehabilitation to increase therapy dosage: an exploratory study

Conditions: Arthroplasty; Neurologic Disorder

Summary: rehabilitation technology is more and more implemented in conventional therapy to increase the dosage of therapy and/or increase patient's motivation towards therapy. in orthopedic as well as neurological rehabilitation it is important to exercise with enough intensity and repetitions to improve functional performance in activities of daily life, and consequently quality of life. at the moment, not all (rehabilitation) technologies are adapted towards the wishes and needs of both patients and therapists for everyday use in the clinical setting. also, not all technologies are fit for independent use by the patients. researcher of pxl have developed a kinect-based system (i.e. i-act) for rehabilitation and performed supervised research with i-act in neurological and musculoskeletal rehabilitation, and older adults. within this research, patients will exercise with i-act under supervision of their therapist during weekdays, but in the weekends they will be motivated by the medical staff to perform their exercises with i-act. the medical staff will be present for safety reasons, but the patient is asked to use and exercise with i-act as independent as possible. the aim of this research is to explore to which extend i-act is suitable for semi-independent use by patients in orthopedic or neurological rehabilitation.


Eligibility criteria:
inclusion criteria: * age over 18 years old * post-operation of arthroplasty (hip or knee), or official medical diagnosis of stroke or parkinson's disease * understand dutch instructions * patient at st-trudo ziekenhuis * experiencing problems in functional performance exclusion criteria: * neglect * spasticity (brunström fugl-meyer \< 50) * cognitive disfunction (mini mental state examination \< 24) * visual impairment (blind, cataract, etc.) * persons who are not able to exit electric wheelchair

Keywords: rehabilitation technology
evaluation of wound management with negative pressure dressing versus standard dressing after revision arthroplasty.

Conditions: Prosthesis-related Infections; Wound Complications; Joint Diseases; Musculoskeletal Diseases

Summary: the purpose of this study is to determine the efficacy of a negative pressure wound therapy (npwt) system after revision total knee and hip arthroplasty in patients at high risk for infection. it is hypothesized that the use of npwt system (i.e., prevena) in high risk patients prevents wound complications and decreases reoperation rates.

one of the primary causes of un-planned readmission following lower extremity arthroplasty procedures is infection. continuous wound drainage poses a serious risk for infection and is often initially treated with absorbent dressings and/or oral antibiotics. comorbidities such as obesity, diabetes and tobacco abuse predisposes to wound complications and therefore infection after these procedures. npwt has proven to be effective for postoperative drainage and decreases the risk for infection or further reoperation. this prospective randomized trial will involve 160 patients at high risk for infection undergoing revision total knee or hip arthroplasty; 80 patients will be randomly selected to be treated with the npwt system (prevena) and randomly selected to be treated with the current standard of care wound dressing (control group). patients will be enrolled at a single site of the cleveland clinic health system (main campus).

Eligibility criteria:
inclusion criteria: * scheduled revision total hip or knee arthroplasty procedure * presence of one of the following: body mass index (bmi) greater than 35, use of blood thinners other than acetylsalicylic acid (asa) after surgery, peripheral vascular disease, depression, diabetes mellitus, current tobacco use, history of prior infection, current use of immunomodulators or steroids, current history of cancer or hematological malignancy, rheumatoid arthritis, renal failure or dialysis, malnutrition, liver disease, transplant status, or hiv. exclusion criteria: * patient lives \>100 miles from hospital * patient is \< 18 years old * silver allergy

Keywords: revision total knee arthroplasty revision total hip arthroplasty negative pressure wound therapy system (npwt) drainage
obstetric outcome in pregnancies treated with laparoscopic cerclage

Conditions: Pre-Term; Cervical Insufficiency

Summary: preterm birth is a leading cause of neonatal mortality and morbidity. cervical insufficiency is one factor implicated in the complex mechanisms involved in spontaneous preterm birth. trans-abdominal insertion of a cervical cerclage suture can be used to treat cervical insufficiency. growing evidence support that laparoscopic cerclage procedures are safe and effective. still, many aspects of the laparoscopic cerclage remains uncertain. therefore, the investigators plan to study the obstetric outcome from the first and subsequent pregnancies after laparoscopic cerclage in a danish cohort from aarhus university hospital in a 10 years' period.

please see attached study protocol for further desricption.

Eligibility criteria:
inclusion criteria: * persons who underwent laparoscopic cerclage at aarhus university hospital, denmark between may 2011 and may 2021 exclusion criteria: * persons who had their laparoscopic cerclage performed subsequently to a trachelectomy.
nortriptyline for idiopathic gastroparesis

Conditions: Idiopathic Gastroparesis

Summary: the principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.


Eligibility criteria:
inclusion criteria: * age 21 through 65 years old at registration * documentation of delayed gastric emptying on gastric emptying scintigraphy within 2 years of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours * symptoms of gastroparesis for at least 6 months (does not have to be contiguous) prior to registration with gastroparesis cardinal symptom index (gcsi) score of 21 or greater * negative upper endoscopy or upper gi series within 2 years of registration exclusion criteria: * normal gastric emptying confirmed with scintigraphy * diabetic gastroparesis or post-surgical gastroparesis including fundoplication * another active disorder which could explain symptoms in the opinion of the investigator * history of significant cardiac arrhythmias and/or prolonged qtc * history of seizures * use of narcotics more than 3 days per week * use of tricyclic antidepressants for refractory symptoms of gastroparesis within 6 weeks prior to randomization * use of strongly anticholinergic medications * use of calcium channel blockers * use of erythromycin * clear history of failed trial of nortriptyline use for gastroparetic symptoms * symptoms of primary depression or suicidal ideation * contraindications to nortriptyline: 1. hypersensitivity or allergy to any tricyclic antidepressant drug 2. concomitant therapy with a monoamine oxidase inhibitor (maoi) 3. recent myocardial infarction 4. glaucoma * pregnancy or nursing * any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study * use of a g tube, j tube,or a central catheter for nutrition * use of a gastric electrical stimulator * failure to give informed consent

Keywords: idiopathic gastroparesis
17% salicylate versus 17% salicylate-ethyl pyruvate for plantar foot warts

Conditions: Warts

Summary: plantar warts on the sole of the foot are among the most common warts seen in podiatry clinics. some patients are readily cured by simple standard of care treatments that include wart debridement (trimming or excision) and application of 17% salicylate (commercially known as compound w)or by other treatments that may be painful and affect mobility. no treatment is consistently effective and most patients fail treatment multiple times. ethyl pyruvate (ep)is a common food additive noted to be 'generally regarded as safe' that may improve the activity of salicylate in wart treatment by improving the ability to penetrate and/or persist in the skin. the use of 17% salicylate with the addition of ep may improve cures of common foot plantar warts in subjects who also be receiving other standard-of-care treatment.


Eligibility criteria:
inclusion criteria: * evidence of skin plantar wart(s) exclusion criteria: * iodine allergy

Keywords: warts salicylic acid ethyl pyruvate
the association between epidural labor analgesia and pregnancy outcomes

Conditions: Labor Pain; Pregnancy Outcomes; Psychological Disorder

Summary: labor analgesia can alleviate intrapartum pain, in the importance of the delivery is very obvious.but some researches think labor analgesia may affect the progress of labor, increase the cesarean section rate.this research adopts the epidural anesthesia to study labor analgesia effects on delivery outcomes and long-term emotional and psychological effects on the mothers. besides, we also want to study the effect of exercise during pregnancy on the mode of delivery.


Eligibility criteria:
inclusion criteria: healthy and full term pregnant women exclusion criteria: the pregnant women with complications

Keywords: epidural labor analgesia length of labor stage fetal outcomes maternal outcomes postpartum depression exercise
a correlation between hair cortisol levels and the development of post traumatic stress disorder (ptsd)

Conditions: Post Traumatic Stress Disorder

Summary: this observational study follows subjects who have been exposed to a traumatic event and are at risk of developing ptsd symptoms. participants are recruited within six hours of a traumatic event, and, starting from the recruitment session, are then examined on six set points of time within a period of thirteen months. the examinations include both biological studies of cortisol in hair, blood and saliva, and psychological examinations and questionaires that assess the development and severity of ptsd symptoms. the novel method of sampling hair cortisol allows investigators to retroactively estimate the mean levels of blood cortisol during the tree months prior to the sampling. the study aims at further illuminating the correlation between cortisol levels both prior and following a traumatic event, and the development and severity of ptsd symptoms


Eligibility criteria:
inclusion criteria: * age 18-70. * experienced a traumatic and were at risk (or perceived risk) of serious injury to themselves or others in their surroundings. * signed an informed consent form. exclusion criteria: * age under 18 or over 70. * severe or complex physical injury, such as severe head trauma, massive burns or injuries that require surgery under full anesthesia. * a personal history of psychotic state or ptsd. * pregnancy * weight below 45 kg or over 120 kg. * hair shorter than 1.5 cm.
genes in predicting outcome in patients with esophageal cancer treated with cisplatin, radiation therapy, and surgery

Conditions: Esophageal Cancer

Summary: rationale: studying samples of tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict a patient's response to treatment. purpose: this laboratory study is looking at genes to see if they can predict outcome in patients with esophageal cancer treated with cisplatin, radiation therapy, and surgery.

objectives: * correlate patient outcomes with neoplastic cell genotypes, specifically 18 single nucleotide polymorphisms (snps) in 16 major genes involved in platinum metabolism and disposition and dna repair, in patients with esophageal cancer treated with neoadjuvant cisplatin-based chemoradiotherapy followed by surgical resection on clinical trial ecog-1201. * correlate patient outcomes with neoplastic cell genotypes, specifically loss of heterozygosity, in these patients. * correlate patient outcomes with normal (germline) cell genotypes, specifically snps related to platinum metabolism and disposition and dna repair. * compare the predictive ability of neoplastic vs germline cell genotypes. outline: this is a retrospective, cohort, multicenter study. neoplastic and normal (germline) cells are collected from pretreatment and post-treatment specimens using laser-capture microdissection. single nucleotide polymorphisms are examined by real-time pcr. loss of heterozygosity is assessed by analyzing short tandem repeat markers in neoplastic and germline tissue.

Eligibility criteria:
disease characteristics: * diagnosis of adenocarcinoma of the esophagus * stage i-iv disease * received cisplatin-based treatment on clinical trial ecog-1201 patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: adenocarcinoma of the esophagus stage ii esophageal cancer stage iii esophageal cancer stage iv esophageal cancer stage i esophageal cancer
pilot study to assess the use of spy elite for assessment of amputation healing

Conditions: Wound Healing; Lower Extremity Amputation; Above Knee Amputation; Below Knee Amputation

Summary: the purpose of the study is to evaluate the use of the spy elite system to assess real-time tissue perfusion of lower extremity amputation sites and to develop parameters to predict healing of amputations at the time of surgery. this is a pilot study to see if the spy elite system is capable of recording accurate measurements on amputation sites to allow some correlation to healing. if this study shows promise for the device, the investigators would plan a larger study in which the data would be assessed in the operating room at time of acquisition and revision performed if needed based on the findings.

the pilot study is a prospective cohort study of consented subjects who require below knee or above knee amputation. the study will start with 18 subjects to assess proof of concept. if a correlation is identified, then a new proposal will be submitted with a larger cohort. our hypothesis is that the spy elite system can help identify areas of poor tissue perfusion at the time of lower extremity amputation, and predict future potential wound healing complications. primary outcome variables include wound healing at 30 days, and intra-operative imaging of amputation sites using the spy elite system. secondary outcome variables include level of amputation, 30-day wound healing complications, readmission rate, need for revision, and subject demographics and co-morbidities. subjects who agree to participation will undergo the amputations in the operating suite as per routine. the spy elite system will be implemented after final wound closure and prior to dressing placement. a single injection of 10 mg of indocyanine green will be administered, followed by 10 ml bolus of normal saline as per manufacturer ifu and recommendations (attachments b, c, d). recording from the spy elite device will be saved for analysis. also, a digital photograph of the surgical wound will be saved for comparison. no changes in operative management based on spy elite system will take place in this study. at subjects routine 30-day follow up appointment, wounds will be assessed for complications, a digital photograph of the incision will be saved, and secondary endpoints will be obtained. possible correlations between perfusion values from the spy elite system recording and wound healing will be analyzed by the investigators. the values will not be known until after the photos are taken and the investigators compare ischemic areas to normal areas based on the collected photographs.

Eligibility criteria:
inclusion criteria: * all patients \>= 18 years of age requiring below knee amputation (bka) or above knee amputation (aka) cared for by the vascular surgery service will be assessed for eligibility. exclusion criteria: * subjects with a history of allergies to iodides or iodinated contrast agents, pregnant or nursing women, subjects who are unable to provide consent, and prisoners will be excluded.
study of cm313 in subject with iga nephropathy

Conditions: IgA Nephropathy

Summary: this is a randomized, double-blind, placebo-controlled phase ii clinical study evaluating the safety and efficacy of cm313 (sc) in subjects with iga nephropathy


Eligibility criteria:
inclusion criteria: 1. able to comprehend the research study and voluntarily signing the informed consent form (icf). 2. renal biopsy report supporting diagnosis of primary igan within 8 years prior to the screening visit. 3. estimated glomerular filtration rate (egfr) \>=30 milliliter per minute per 1.73 square meter (ml/min/1.73m\^2) at screening. 4. receiving stable background therapy for igan (angiotensin-converting enzyme inhibitor \[ace-i\] or angiotensin receptor blocker \[arb\]) for 12 weeks prior to screening. exclusion criteria: 1. secondary igan (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies). 2. known or suspected hypersensitivity to excipients used in cm313. 3. rapidly progressive glomerulonephritis (rpgn), defined as a decrease of egfr by more than 50% within 3 months prior to baseline visit and/or formation of crescents in more than 50% of glomeruli in renal paracentesis specimens. 4. confirmed acute kidney injury (aki) within 4 weeks prior to baseline visit. 5. receipt of live attenuated vaccine within 30 days prior to the baseline visit or plan to receive such a vaccine during the study; receipt of novel coronavirus vaccines within 7 days prior to study drug administration. 6. history of transplantation (any solid organ transplant, including renal transplant, bone marrow transplant, etc.) or plan to undergo transplantation during the study. 7. history of severe recurrent or chronic infection. 8. current malignancy or history of malignancy during the previous 5 years, except adequately treated basal cell or squamous cell carcinomas of the skin or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix.
evaluation of the effectiveness of delirium preventive care protocol

Conditions: Delirium

Summary: the prospective, randomized controlled experimental trial investigates the effectiveness of delirium preventive care protocol for hip fracture patients.

the aim of this prospective, randomized controlled experimental trial is to evaluate the effectiveness of delirium preventive care protocol on pain, functional status, sleep quality and delirium prevention in patients with hip fracture. this research was conducted at a training and research hospital's orthopedics and traumatology department. the study sample was compromised of 80 patients with hip fracture. intervention and control groups were applied after block randomization. study data was collected by using patient information form, mini-cog test, confusion assessment method, visual analogue scale, barthel index, mini nutritional assessment-short form and richards campbell sleep questionnaire. the patients in the intervention group were provided with nursing care in accordance with the delirium preventive care protocol developed with the support of literature. in the control group, routine nursing care was provided in line with the clinical procedure. the data was analyzed by using number, percentage, mean, standard deviation, median, interquartile range, student's t test, mann-whitney u test, pearson's chi square test, fisher corrected chi-square test, anova test, paired sample t test, friedman test, wilcoxon test and cronbach α coefficient.

Eligibility criteria:
inclusion criteria: * planned surgery for hip fracture, * 65 years and older, * no communication problems in turkish, * without cognitive impairment, * patients who volunteered to participate in the study exclusion criteria: * patients who could not be evaluated by the investigator before the operation * patients with dementia and mini-cog test less than 3 points * patients with a history of cerebrovascular accident * patients with severe comorbidity

Keywords: care protocol delirium nursing care hip fracture
step it up cf: stimulating improved health and well-being in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: step it up cf: stimulating improved health and well-being in cystic fibrosis using integration of fitness technology and port cf. a pilot in integration of wearable fitness tracker data with existing health data provided by cf foundation patient registry (port cf)

cystic fibrosis patients who are willing to use an activity tracker for 3 months are invited to participate. analysis of activity patterns and sleep patterns will be analyzed and compared to their lung function and general health as part of the routine cf center care visits during the study period.

Eligibility criteria:
inclusion criteria: * adults with cystic fibrosis * age \>18, cystic fibrosis exclusion criteria: * a potential subject who meets any of the following exclusion criteria is ineligible to participate in the study. * those unable to commit to at least 3 months follow up for cf care from enrollment at study cf center. inability to speak and understand english. * those patients without dedicated access to a smartphone, tablet, or computer with internet for syncing device and completing patient diary. * those patients unwilling to sign an informed consent form.
brain mechanism and intervention of executive-control dysfunction among gambling disorder

Conditions: Transcutaneous Electric Nerve Stimulation; Gambling

Summary: the investigators assume that transcranial alternating current stimulation (tacs) could improve gambling disorder patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. this study intends to test the effect of tacs treatment. three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism.

gambling disorder is become a major social and public health problem in china. executive-control dysfunction is the main symptom of behavioral addiction like gambling disorder. previous studies have demonstrated the relationship between cognitive dysfunction and prefrontal-ventral striatum pathway. studies have shown that abnormal phase synchronization and phase-amplitude coupling (pac) induced the impairment of cognition, and transcranial alternating current stimulation (tacs) could improve executive-control function by adjusting the abnormal synchronization. however, it has not been verified among gambling disorder patients. the investigators assume that tacs could improve gambling disorder patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. this study intends to test the effect of tacs treatment. three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism. this study will provide a practical and theoretical basis for developing a novel treatment for gambling disorder.

Eligibility criteria:
inclusion criteria: * aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests * meet dsm-5 (diagnostic and statistical manual of mental disorders，dsm) diagnostic criteria for gambling disorder * have gambled for at least one year (at least once a week) * normal vision and hearing, or within the normal range after correction * agree to cooperate in the follow-up evaluation * no metal implantation in the head, no history of nerve problems or head injury, and no skin sensitivity exclusion criteria: * have severe cognitive impairment, such as a history of head trauma, cerebrovascular disease, epilepsy, etc. * have used drugs promoting cognitive function in the last 6 months * have impaired intelligence (intelligence quotient\<70) * abuse or dependence of psychoactive substances (except nicotine) in the last 5 years