Kornimate/medical-research-clean huggingface dataset:
total ankle replacement: clinical and radiological outcomes

Conditions: Ankle Arthritis

Summary: this retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from january 2011 to march 2026, evaluating the results both clinically and radiographically.

the aim of this study is to evaluate radiographically and clinically using clinical and radiographic outcomes . few studies exist in the literature and rarely report fix-bearing and mobile-bearing prosthetics \[1-4\]. therefore the data related to this study can be considered a reference in the literature. patients who performed and will perform ankle prosthesis surgery from january 2011 to march 2026 and who underwent a clinical evaluation (also using questionnaires and scores) and radiographic evaluation. the clinical data and radiological parameters were collected together with the visits and the procedures prescribed according to the clinical routine of the department.

Eligibility criteria:
inclusion criteria: * males and females * age ≥ 18 years at the time of surgery * patients who underwent ankle replacement surgery from january 2011 to march 2026 exclusion criteria: - age \< 18 years at the time of surgery
effects of electrical baroreflex stimulation on sympathetic activity, renal hemodynamics, and insulin sensitivity

Conditions: Hypertension

Summary: electrical stimulation of carotid baroreceptors (baropacing) acutely decreases arterial pressure in patients with refractory hypertension. the reduction in blood pressure seems to be mediated through sympathetic inhibition with concomitant reduction in the activity of the renin-angiotensin system. indeed, switching on and off the stimulation is accompanied by decreases and increases in central sympathetic vasoconstrictor outflow, respectively. plasma renin concentration also decreases with acute electrical baroreflex stimulation. in some patients chronic baropacing is associated with long-term blood pressure reduction. however, there is sparse information as to the relative contribution of blood pressure regulating systems to account for the acute and chronic effects of baropacing. sympathetic, renal, and vascular mechanisms are of special interest. furthermore, technical aspects of electrical baroreflex stimulation may play a role, e.g. worsening of the electrical contact between the stimulating electrodes and the baroreceptor afferents. this study is designed to answer the following primary questions: 1. does chronic electrical stimulation of carotid baroreceptors inhibit sympathetic vasoconstrictor tone also in the long-term? 2. does sympathetic vasoconstrictor tone increase on switching off chronic baropacing? such an increase would confirm electrical integrity of the system and proper contact to the baroreceptor afferents. 3. does acute electrical baroreflex stimulation decrease renal vascular resistance? 4. does acute electrical baroreflex stimulation influence glucose delivery to skeletal muscle and change insulin sensitivity? the study follows an open-label observational design and it is planned to recruit up to 30 patients over 3 years.


Eligibility criteria:
inclusion criteria: subjects meeting all of the following criteria will be considered for enrollment in the study: * adult patients having an implanted device for electrical baroreflex stimulation. * signed written informed consent. exclusion criteria: subjects meeting all of the following criteria will be excluded from the study: resy study - protocol version: december 20, 2010 8 * subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. * mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. * subject unlikely to comply with protocol, e. g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study. * pregnancy. breast-feeding. * history of hypersensitivity to inulin or paraaminohippurate or to drugs with a similar chemical structure have to be excluded from the constant-infusion procedure. * history of drug or alcohol abuse. * blood donation of more than 500 ml during the previous 3 months (men) or 6 months (women).
comparison of atomoxetine versus placebo in children with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this is a two-arm, parallel, randomized, double-blind, placebo-controlled phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with attention-deficit/hyperactivity disorder (adhd) treated in an inpatient, day-patient and outpatient setting in germany. core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based continuous performance test. following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. in the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.


Eligibility criteria:
inclusion criteria: * male or female patients who are at least 6 years of age, and who will not have reached their 13th birthday * diagnosis of adhd * normal intelligence * able to swallow capsules exclusion criteria: * weight less than 20 kg or more than 60 kg at study entry * prior treatment with atomoxetine * history of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months * history of severe allergies or multiple adverse drug reactions * cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, qt prolongation, inherited cardiac disorders
the value of advanced mr imaging in gynecological tumors and benign uterine fibroids

Conditions: Gynecologic Tumor

Summary: this research is being done to test new mri methods called magnetic resonance fingerprinting and q-space trajectory imaging in gynecological abnormalities. the purpose of this research study is to evaluate if these new mri methods can give additional information in characterizing gynecological tumors compared with conventional mri.

magnetic resonance imaging (mri) is a safe and painless test that uses a magnetic field and radio waves to produce detailed images of the body's organs and structures. this research is being done to test new mri methods called magnetic resonance fingerprinting (mrf) and q-space trajectory imaging (qti) in gynecological abnormalities. the purpose of this research study is to evaluate if these new mri methods can give additional information in characterizing gynecological tumors compared with conventional mri in this research study, the investigators are: * investigating the use of mr imaging in gynecological tumors on imaging quality and comparison of tumor or fibroid structures and normal anatomy * investigating whether new mri methods could help in characterizing the tumor and give information about the expected outcome

Eligibility criteria:
inclusion criteria: * participants with suspected or histologically confirmed diagnosis of primary or recurrent gynecological cancer including uterine endometrial, cervical, vaginal, vulvar, ovarian, and smooth-muscle tumors undergoing routine clinical standard of care pelvic mri * control subjects with benign fibroids undergoing routine clinical standard of care pelvic mri * age ≥ 18 years * ecog performance status of ≤ 2, based on treating physician's discretion (appendix a) * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * contraindication to mri identified by the mr procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other mr non-compatible device or implant * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * adults unable to consent * non-english speaking subjects * pregnant women * prisoners

Keywords: gynecologic tumor
real time early warning model and mobile medical assistant system for the impact of air pollution on aecopd disease

Conditions: COPD

Summary: objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (copd) caused by air pollution, and develop the corresponding mobile medical assistant system. through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with copd.

objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (copd) caused by air pollution, and develop the corresponding mobile medical assistant system. through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with copd.

Eligibility criteria:
inclusion criteria: * patients aged \> 40 and \ 30%, who were no exacerbation of symptoms in the 6 weeks preceding the study, were included in the study. exclusion criteria: * patients who were diagnosed with other chronic respiratory diseases, including bronchial asthma, bronchiectasis and lung abscess. * patients with near-terminal illness, congestive heart failure (nyha iii-iv), or cannot record cat score timely were excluded.
how to predict postoperative complications after early laparoscopic cholecystectomy for acute cholecystitis: the chole-risk score

Conditions: Cholecystitis, Acute

Summary: acute calculous cholecystitis (acc) is the most common complication of gallstone disease, and laparoscopic cholecystectomy is the gold standard treatment. several prospective studies have demonstrated that same-admission, early lc (elc), for acc is safe when compared with delayed lc (dlc). however, there is still controversy on the indication of elc in high risk patients with important comorbidities, in cases of severe inflammation of the gallbladder and in patients with acc and suspicious of a choledocholithiasis. the advantages of elc in high risk patients with severe comorbidities have been recently questioned, with tokyo guidelines 2018 (tg18) proposing an initial conservative management of this cases, assessing the benefit of elc according to specified criteria. however, the recent chocolate trial, demonstrated the advantages of elc over an initial conservative management. performing an elc for acc can be a straightforward procedure for an on-call general surgeon or a very challenging procedure even for experienced hepatopancreaticobiliary (hpb) laparoscopic surgeon, depending on disease features, surgeons experience, centres volumes and resources available. deciding whether the elc should be performed by the on-call team or by hpb surgical team, or whether the operation should be delayed are still matter of debate in daily practice. several preoperative scores assessing the risk of difficult cholecystectomy have been proposed, but they were mainly focused on elective procedures and on risk of conversion to open cholecystectomy or other intraoperative complications. they did not asses the risk of post-operative complications in a subgroup of patients, for whom, indication to elc by the on-call general surgeon is still questionable according to the more recent guidelines.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older diagnosed with acute calculous cholecystitis. * consecutive patients undergoing early laparoscopic cholecystectomy between january 2013 and december 2018 during admission for the acute episode. * minimum 30-day post-operative follow-up. * asa ≤ 3. exclusion criteria: * presence of another concomitant pathology of the bile duct (choledocholithiasis, cholangitis, pancreatitis, biliary peritonitis). * aetiology other than cholelithiasis (amythiasis, malignancy). * patients with severe sepsis, immunosuppression and pregnancy. * additional abdominal surgical procedure. * asa 4.

Keywords: acute cholecystitis cholecystectomy gallbladder
a study to characterize adverse events occurring within one day of tegsedi administration to adult participants with hattr-pn

Conditions: Hereditary Transthyretin Amyloidosis With Polyneuropthy

Summary: the objective of the study was to characterize adverse events (aes) occurring within one day of tegsedi administration to adult participants with hattr-pn overall and in individual participants with respect to time course of ae onset, vital sign changes, preventive measures, treatment required, risk factors, and subsequent adverse outcomes.


Eligibility criteria:
inclusion criteria: 1. satisfy one of the following: 1. united states (us) participants: adult participants (≥ 18 years old) diagnosed with hattr-pn and prescribed tegsedi according to the united states prescribing information (uspi). 2. canadian participants: adult participants (≥ 18 years old) diagnosed with stage 1 or stage 2 hattr-pn and prescribed tegsedi according to the canadian product monograph (cpm). 2. must have given written informed consent for participation in this study. 3. must provide access to their previous medical records. 4. are about to initiate or have recently initiated treatment with tegsedi and have not received more than 9 doses in total. 5. be willing to complete required testing and report any aes and/or changes in medications. 6. satisfy one of the following: 1. females: non-pregnant and non-lactating; abstinent, or if engaged in sexual relations of childbearing potential, participant is using an acceptable contraceptive method from time of signing the informed consent form (icf) until 13 weeks after the last dose of tegsedi administration 2. males: abstinent or if engaged in sexual relations with a female of childbearing potential, participant is utilizing an acceptable contraceptive method from the time of signing the icf until 13 weeks after the last dose of tegsedi administration exclusion criteria: * none

Keywords: hereditary transthyretin amyloidosis hattr-pn hattr amyloidosis
evaluating a telehealth treatment for veterans with hepatitis c and ptsd

Conditions: Chronic Disease; Hepatitis C; Stress Disorders, Post-Traumatic

Summary: the main objective of this proposal is to develop and test the efficacy of two interventions (a telehealth and face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with hcv and ptsd. it is hypothesized that

patients with comorbid diagnoses of hcv and ptsd may experience increased risk of diminished quality of life, given that ptsd is associated with poor self-care and medical non-compliance. to date, no systematic efforts to improve quality of life in this high-risk population have been documented. the main objective of this proposal is to develop and test the feasibility and efficacy of two cognitive-behavioral interventions (a telehealth intervention and a face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with hcv and ptsd. a secondary objective is to evaluate the cost effectiveness of the interventions. i plan to develop the interventions, pilot test them, and deliver the refined treatments to veterans with hcv and ptsd. participants will be 70 patients from va boston who meet study criteria. assessment will occur at pre-treatment, post-treatment, and 3- and 6-month follow-up. assessments will measure quality of life, self-care, motivation to engage in healthcare, and psychological distress. analyses will examine study feasibility, the effects of the treatment conditions, and the cost effectiveness of the interventions. it is hypothesized that the telephone and face-to-face intervention will improve outcomes, as compared to treatment as usual, but that the participants will be more satisfied with the telephone intervention. in addition, it is predicted that the telephone condition will be cost effective as compared to the face-to-face intervention

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hepatitis c * clinical diagnosis of posttraumatic stress disorder * need to have access to a telephone exclusion criteria: * life threatening or acute illness * current alcohol or substance dependence * currently prescribed interferon treatment * no access to a telephone

Keywords: rehabilitation telecommunication
chlorhexidine caps for clabsi prevention in hemodialysis: a pilot randomized controlled trial

Conditions: Vascular Access Complication; Device Related Infection; Device Related Sepsis; Catheter Infection; Catheter Complications; Catheter-Related Infections; Catheter Related Complications; Hemodialysis Catheter Infection; Hemodialysis Catheter-associated Infection; Hemodialysis Complication

Summary: the goal of this clinical trial is to compare a chlorhexidine antimicrobial barrier cap in patients requiring hemodialysis treatment to the standard hemodialysis caps currently used within the metro north kidney health service. the main questions to answer are: * study feasibility * occurrence of infectious complications related to renal central venous catheters participants will be randomly allocated to receive either of the below hemodialysis caps to cover their hemodialysis catheter hub: * the standard hemodialysis cap used at the royal brisbane and women's hospital, or * the intervention hemodialysis cap containing chlorhexidine inside it researchers will compare standard and chlorhexidine hemodialysis caps to see if the presence of chlorhexidine improves the occurrance of infectious complications related to the hemodialysis catheter.

this study is a single-centre, two-arm, parallel group randomized controlled trial (rct) to test the effectiveness, safety, impact of device application on health-related quality of life measures, and cost-effectiveness of clearguard™ hd antimicrobial barrier caps in patients receiving hemodialysis. setting and sample: the echo-hd will be undertaken at the metro north kidney health service (mnkhs), royal brisbane and women's hospital in queensland, australia. sample size: the investigators will recruit 60 patients with 30 patients per arm. the purpose of the pilot study is to assess research project feasibility and inform the design of a large scale powered rct. viechtbauer et al. (2015) determined that a sample size of 59 participants is sufficient to detect a problem with a 5% probability of occurrence.

Eligibility criteria:
inclusion criteria: * age≥18 * able to provide informed consent * kidney failure requiring a tunnelled cvc for treatment (haemodialysis) * 21 days bsi free * no known allergy to chlorhexidine and/or nylon and/or polypropylene. exclusion criteria: * current clabsi * known allergic to chlorhexidine and/or nylon and/or polypropylene. * patients on an end-of-life pathway * people with a cognitive impairment and/or intellectual disability

Keywords: hemodialysis catheter randomised controlled trial antimicrobial barrier caps vascular access device hemodialysis catheter caps chlorhexidine cap central venous catheter cvc clabsi central line associated blood stream infection
comparison of efficacy on healing, and safety of two dressings urgotul and tullegras ms on surgical acute wounds.

Conditions: Surgical Acute Wounds

Summary: evaluation of non-inferiority on healing rates of two dressings urgotul and tullegras ms in the treatment of surgical acute wounds.


Eligibility criteria:
inclusion criteria: * male or female subject. * aged 18 to 75 years * with a planned surgery: * of abdominal location * leading to an acute wound of a maximum total length ≤ 18 cm (corresponding to 2 investigational products) * absence of clinical sign suggestive of worsened wound (assessed only at the randomization visit) * followed-up in surgery department * written and signed informed consent obtained * affiliated to the french social security system or equivalent. exclusion criteria: * underlying pathology that may interfere with wound healing in the opinion of the investigator (human immunodeficiency virus \[hiv\], cancer, immunodeficiency disease, generalized infection, systemic disease ...). the presence of low-risk prostate cancer according to the amico classification (1) (psa\<10 ng/ml and gleason's score \< 6 and clinical grade t1c ou t2a) or a grade t1 (a or b) n0m0 renal cancer which requires surgery without adjuvant therapy (radiotherapy, chemotherapy, hormonal therapy...), in a patient whose general condition is preserved without significant comorbidity or signs of malnutrition are not considered as a non- inclusion criteria * inadequately controlled diabetes (glycosylated hemoglobin \> 8%) * hypo or hyperthyroidism * intake of a systemic treatment with glucocorticoids or immunosuppressives * known allergy to one of study dressings components * participation in a clinical trial in the month prior to his/her inclusion in the study * pregnancy or breastfeeding or of childbearing potential and saying not to use contraception.

Keywords: non-inferiority randomized tullegras urgotul healing surgical acute wounds pain
study of de-108 ophthalmic solution in patients who are scheduled for cataract surgery

Conditions: Cataract Surgery

Summary: the purpose of this study is to evaluate superior efficacy of de-108 ophthalmic solution to that of levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery.


Eligibility criteria:
inclusion criteria: * those who are scheduled for cataract surgery exclusion criteria: * those who with suspected ocular infections based on clinical findings in the study eye. * those who have any eye disease other than cataract which requires treatment in the target eye. * those who have a history of allergy to the drugs to be used during the clinical study (such as fluoroquinolones, topical anesthetics and povidon iodine) * those who need to wear contact lenses during the study period