Kornimate/medical-research-clean huggingface dataset:
band versus ring for tricuspid regurgitation

Conditions: Tricuspid Regurgitation

Summary: tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly. however, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. this study aims to prospectively compare the efficacy and long term outcomes of flexible band versus rigid ring annuloplasty for the correction of tricuspid regurgitation.


Eligibility criteria:
inclusion criteria: * 1. subject must be 18 years and 80 years at time of consent and must not be a member of a vulnerable population. * 2. subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure. * 3. subjects with moderate or greater tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (tte) and/or transesophageal echocardiogram (tee). * 4. subjects with moderate tricuspid regurgitation will only be included in the trial if moderate tricuspid regurgitation is accompanied by a tricuspid annular diameter of ≥ 40mm as measured by echocardiography. * 5. isolated functional symptomatic tricuspid regurgitation of moderate to severe or greater, with annular dilatation of ≥ 40mm; * 6. requirement for concomitant left heart valve surgery; * 7. requirement for concomitant coronary artery surgery; * 8. requirement for concomitant atrial fibrillation surgery; * 9. available and able to return to the study site for post-procedural follow-up examination; exclusion criteria: * 1. patient unable or unwilling to provide informed consent; * 2. subjects with mild tricuspid regurgitation; * 3. emergency surgery; * 4. prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure; * 5. subjects with percutaneous coronary intervention within prior 30 days prior to enrollment; * 6. subjects with presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year; * 7. subjects with permanent or temporary pacemaker implantation; * 8. subjects with severe, irreversible pulmonary hypertension in the judgment of the investigator; * 9. history of mitral/tricuspid endocarditis within the last 12 months; * 10. subjects with contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated; * 11. subjects with bleeding or coagulation disorders (e.g. active peptic ulcer or active gastrointestinal bleeding); * 12. female patient is pregnant (urine hcg test result positive) or lactating; * 13. subject is currently participating in another clinical trial that has not yet completed its primary endpoint; * 14. subjects with left ventricular ejection fraction (lvef)≤20%.
diet, obesity and cardiovascular risk study

Conditions: Cardiovascular Diseases; Obesity

Summary: controversy exists about the role of dietary glycemic index (gi) and fat content and cardiovascular risk. our aim was to assess the long term effects of altering dietary gi, carbohydrate, and fat on body weight, lipids, glucose homeostasis, and c reactive protein (crp) in overweight and obese subjects. men and post-menopausal women with body mass index values between 28-38 kg/m2 were placed on an isoweight average american diet for 5 weeks, then randomized to one of 4 diets which differed in gi, carbohydrate and fat content with calorie restriction for 12 weeks. the same diets were continued for 5 weeks under isoweight conditions, and in the free-living state for 48 weeks.


Eligibility criteria:
inclusion criteria: * bmi 28-28 kg/m2 * male or postmenopausal female 45-65 yr exclusion criteria: * abnormal thyroid, liver, kidney function * abnormal hemoglobin * ldl-cholesterol ≤ 100 mg/dl * fasting triglycerides ≥ 400 mg/dl * diabetes or on medication for diabetes * chronic illness * elevated blood lipids
circulating plasmablast in diagnosis and relapse prediction of igg4-rd

Conditions: Plasmablast/Plasma Cells in Diagnosis of IgG4-RD; Plasmablast/Plasma Cells in Relapse Prediction of IgG4-RD

Summary: 300 igg4-rd patients, 200 other autoimmune diseases, 60 igg4-rd mimickers and 100 healthy controls were enrolled. circulating plasmablast/plasma cells were detected of all patients at baseline and healthy controls. igg4-rd patients were followed up every 3-6 months. circulating plasmablast/plasma cells were also detected at disease remission and relapse. igg4-rd patients' clinical data and laboratory parameters were collected.

300 igg4-rd patients, 200 other autoimmune diseases, 60 igg4-rd mimickers (pancreatic cancer, cholangiocarcinoma, vasculitis, lymphoproliferative diseases, inflammatory bowel disease, kimura disease) and 100 healthy controls were enrolled. peripheral blood samples of 5-10 ml were collected from all patients and healthy controls. serum was separated for elisa detection. circulating plasmablast/plasma cells were detected of all patients at baseline and healthy controls. igg4-rd patients were followed up every 3-6 months. circulating plasmablast/plasma cells were also detected at disease remission and relapse. igg4-rd patients' clinical data and laboratory parameters were collected. data were analyzed to evaluate plasmablast/plasma cells in diagnosis and relapse prediction of igg4-rd.

Eligibility criteria:
inclusion criteria: * igg4-rd patients fulfilled the 2011 comprehensive diagnostic criteria of igg4-rd (2011). other autoimmune disease and igg4-rd mimickers fulfilled the corresponding diagnostic criteria. exclusion criteria: * patients in pregnancy or preparing to pregnancy, patients with active infection, including hiv, hcv, hbv, tb, et al.

Keywords: igg4 related disease plasmablast/plasma cells diagnosis relapse
heartstart hs1 defibrillator* event registry

Conditions: Sudden Cardiac Arrest

Summary: a prospective study on the performance and safety of the heartstart onsite (model m5066a) \& heartstart home (model m5068a) defibrillator device data.

the objective of this pmcf (post market clinical follow-up) prospective collection of post-event data registry is to confirm the safety and performance as expressed in the energy delivery by the heartstart hs1 defibrillator (heartstart onsite and home models in north america) in the population for the device's intended use in reference to its commercial labeling, and in relationship to the type of pads attached to the device.

Eligibility criteria:
inclusion criteria: * have been suspected of a circulatory arrest for any cause. * have had heartstart hs1 defibrillator with electrodes: adult smart pads cartridge \[ref: m5071a\], infant/child smart pads cartridge (ref:m5072a) applied to their body and powered up with hs1 battery (model m5070a), regardless of whether a defibrillation shock was delivered exclusion criteria: * subjects will be excluded if any of the following are present: * aed or pad use other than the heartstart hs1 defibrillator with above referenced philips electrode pads. note: use of a device other than the philips heartstart hs1 aed does not preclude enrollment if the aed or an advanced life support defibrillator was used after the heartstart hs1 aed. * aed used for training purposes.

Keywords: aed post -market cardiology
measuring forces during chiropractic treatment

Conditions: Low Back Pain

Summary: the insight pilot study will measure forces applied by a doctor of chiropractic (dc) during the delivery of a specific, manually based chiropractic treatment for participants with low back pain.

low back pain (lbp) is a well-recognized health problem. one common manual therapy available for the treatment of lbp is spinal manipulation (sm), which can be separated into 2 categories: high-velocity low-amplitude (thrust) and low-velocity (non-thrust) sm according to their force-delivery profiles. one commonly utilized non-thrust sm technique is the flexion-distraction procedure. several studies have reported manually applied forces during thrust sm; however, the forces used during non-thrust sm, specifically those used with flexion-distraction treatment are still unknown. the results of this pilot study will provide preliminary information on treatment forces and sample size justification for future full-scale trials, while also ascertaining the feasibility of the study protocol and patient recruitment methods for such trials.

Eligibility criteria:
inclusion criteria: * able to demonstrate the necessary abilities (english language, literacy) needed to provide informed consent without the assistance of another person (e.g., a proxy, spouse, family member or other support person) * self-reported low back pain (acute, subacute or chronic) at the time of examination and enrollment exclusion criteria: * weight \> 300lbs * spinal pathology or conditions contraindicating study procedures or compromising participant safety * inflammatory arthropathy involving the spine (e.g. ankylosing spondylitis, rheumatoid arthritis) * spinal fracture in the past 6 months * other conditions requiring referral (e.g. self-reporting alcohol/substance dependence or abuse, unstable spinal segments, and cauda equina syndrome) * pregnant or planning to become pregnant within the next 5 weeks * unable to tolerate study procedures safely * altered mental capacity * sensitivity to adhesives used in the study * uncontrolled hypertension * co-morbidity requiring simultaneous clinical management that compromises ability to deliver study procedures or assess the participant's heath status or poses as a scheduling burden * retention of legal advice or seeking a health-related insurance claim * compliance concerns (e.g. scheduling conflicts, moving from the quad city area, unwilling to undergo required study procedures or receive treatment from study doctor(s)) * quebec task force classification of 10 or 11: (chronic pain syndrome, visceral/infectious source of lbp)
quickly eradicate hepatitis c in patients undergoing renal transplant with 4 weeks of glecaprevir/pibrentasvir

Conditions: Kidney Failure; Hepatitis C; Kidney Disease, Chronic

Summary: this is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic daa therapy in kidney transplantation to prevent the transmission of hepatitis c virus infection from an hcv-positive donor kidney to an hcv-negative recipient.

the goal of this study is to determine if the administration of glecaprevir and pibrentasvir (g/p) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of hcv infection in hcv negative recipients receiving transplanted kidneys from hcv rna positive donors.

Eligibility criteria:
inclusion criteria (recipient) 1. met mgh transplant center criteria and already listed for kidney transplant with stage 5 ckd / esrd (egfr \<15 ml/min/1.73m2 or on renal replacement therapy) 2. must agree to birth control. women must agree to use birth control in accordance with mycophenolate risk evaluation and mitigation strategy and at least one barrier method 3. no evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team 4. able to sign informed consent inclusion criteria (deceased donor) 1. detectable hcv nat test 2. kdpi score is less than ≤ 0.850 3. traditional donor selection criteria met - acceptable for transplantation per usual evaluation exclusion criteria (recipient) 1. pregnant or nursing (lactating) women 2. hbv positivity (ag or dna) 3. any contra-indication to kidney transplantation per mgh transplant center protocol 4. any signs or symptoms of clinically significant chronic liver disease per transplant center physician 5. inability to discontinue any medication with a known drug-drug interaction as listed in the g/p package insert exclusion criteria (deceased donor) 1. confirmed hiv 2. confirmed hbv positive (surface antigen or hbv dna positive) 3. any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

Keywords: kidney transplant kidney failure hcv hepatitis c
treatment of peri-implant mucositis by sodium hypochlorite gel and cross-linked hyaluronic acid gel

Conditions: Peri-implant Mucositis; Mucositis Oral

Summary: the aim of the study is to evaluate the potential of the combination of a sodium hypochlorite-based gel and a hyaluronic acid-based gel as an adjuvant to non-surgical mechanical debridement (nsmd) in the treatment of mucositis, after 6 months of follow-up. after a meticulous selection, patients will be randomly assigned to test (sodium hypochlorite-based gel + nsmd + hyaluronic acid-based gel ) or control (nsmd) group. all clinical parameters will be recorded and the final evaluation will be performed.

the aim of the study is to evaluate the clinical results of the combination of a sodium hypochlorite-based gel (naocl gel) and a cross-linked hyaluronic acid-based gel (ha gel) as an adjuvant to non-surgical mechanical debridement (nsmd) in the treatment of mucositis, after 6 months of follow-up (clean \& seal concept). following the selection through inclusion and exclusion criteria, all patients will be randomly assigned to test naocl-based gel + nsmd + ha-based gel) or control (nsmd) group. patients will be recruited at department of periodontology (univeristy of naples "federico ii") and at department of periodontology (university of budapest "semmelweis"). subsequently, after recording of the clinical parameters (bop, fmps, fmbs, pd), in the test group a naocl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. furthermore, mechanical therapy (nsmd) will be performed by means of an ultrasonic scaler with a plastic tip. finally, ha-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle. conversely, control group will be treated only through the nsmd. all clinical parameters (bop, fmps, fmbs, pd) will be recorded again after 6 months for the final evaluation. data analysis will be performed using statistical software.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * non-smokers and smokers ( ≤ 10 cigarettes/day); * presence of at least 1 implant in mucositis, clinically and radiographically detected; * the implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown, 3-element bridge), cemented or screwed. exclusion criteria: * cancer patients; * uncontrolled diabetic patients; * prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months; * pregnant or breastfeeding patients; * implants that support mobile prosthetic products; * implants in peri-implantitis, detected clinically and radiographically.

Keywords: hyaluronic acid peri-implant mucositis sodium hypochlorite
integrated community case management study in eastern province, zambia

Conditions: Malaria; Diarrhea; Pneumonia

Summary: this study will provide important evidence to the ministry of community development, mother and child health (mcdmch) and the ministry of health (moh) on how to effectively implement iccm with a focus on improving both the flow of supplies to chws as well as the quality of their supervision and mentorship. the overall aim will be to determine whether improvements in supplies for community health workers (chws) and strengthened supervision result in improved early and appropriate treatment for children with malaria, pneumonia, and diarrhea in rural zambia when compared to chws offering iccm without this logistics and supervision support.

the main objective of this study is to strengthen the delivery of integrated community case management (iccm) of malaria, diarrhea, and pneumonia in chadiza and chipata districts of eastern province, through mhealth supported improved supply chain management of iccm commodities and enhanced supportive supervision of iccm-trained chws.

Eligibility criteria:
inclusion criteria: * age \<5 years * treatment for an iccm condition (malaria, pneumonia, or diarrhea) by a chw * willingness of the child's caregiver to provide informed consent exclusion criteria:

Keywords: integrated community case management mobile health (mhealth) rapid diagnostic test artemether-lumefantrine amoxicillin zinc oral rehydration solution (ors) district health information system 2 (dhis2) iccm-dhis2 zcahrd
evaluation of ronnie gardiner method in individuals with parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is typically associated with cognitive and movement related functional disabilities. one commonly described cognitive complaint is the ability to do several things simultaneously, defined as dual or multiple tasking. the ronnie gardiner method (rgm) is a rhythm and music based rehabilitation intervention that includes components that will train this ability specifically in addition to postural control, motor learning, movement ability and general cognitive function. the aim with the present randomized controlled single-blinded trial is to evaluate the rgm with main focus on dual-task performance, compared to a control group, in individuals with pd. the control group will continue with everyday activities, including ordinary exercise activities, with no additional activity. both groups will be evaluated pre-, post-, and after 3 months post intervention. following outcome measures will be analyzed: 1. dual task performance (motor-motor, and motor-cognitive) 2. level of physical activity, motor function and balance 3. cognitive function including memory and spatial function 4. health-related quality of life, fear of falling, and freezing of gait 5. qualitative interviews from focus group discussions

patients with parkinson's disease at the neurological department of university hospital of linköping are included and randomized to either the rhythm and music based rehabilitation method ronnie gardiner method or to a control group with no other activity other than everyday activities including habitual exercise. timed up and go (tug) cognitive and tug manual will be used to evaluate dual-task performance. the intervention will take place twice weekly for twelve weeks in a neurological rehabilitation facility, and will be led by a highly skilled physiotherapist with ten years of practice from the ronnie gardiner method.

Eligibility criteria:
inclusion criteria: * parkinson's disease, stage 1,5 to 4 on the hoehn \& yahr scale, community dwelling, stable medication, being able to walk at least 10 meters, being able to transport to the intervention facility, being able to follow instructions in swedish exclusion criteria: * parkinsonism of other origin, color blindness, severely impaired vision or hearing

Keywords: physical therapy modalities dual-task performance parkinson's disease active music therapy physical activity
eus-b-fna in the diagnosis of malignant parenchymal lung lesions

Conditions: Lung Cancer

Summary: the aim of this study is to evaluate the diagnostic accuracy, safety and tolerability, predictors of success of eus-b-fna in the diagnosis of malignant parenchymal lung lesions. the investigators will also evaluated the adequacy of samples obtained for molecular analysis in patients with non-small cell lung cancer (nsclc)

lung cancer is by far the leading cause of cancer death among both men and women worldwide. non-small cell lung cancer (nsclc) represents about 80-90% of all lung cancers. endoscopic ultrasound with bronchoscope fine needle aspiration (eus-b-fna) is a safe and accurate technique that has been mostly described for the diagnosis and the mediastinal nodal staging of nsclc, as a complementary technique to endobronchial ultrasound trans-bronchial needle aspiration (ebus-tbna) or when ebus-tbna may be difficult and/or contraindicated for clinical reasons (e.g. excessive cough, respiratory failure etc). few retrospective studies evaluated the sensitivity and the safety of this technique in the diagnosis of parenchymal pulmonary lesions suspected for lung cancer, in contact or adjacent to the esophagus. few data are available on the adequacy of the samples obtained by eus-b-fna for molecular analysis in nsclc. the main predictors of success are still unclear. the primary aim of this prospective study is to evaluate the diagnostic accuracy of eus-b-fna in the diagnosis of malignant parenchymal lung lesions. the investigators will also evaluate the safety and tolerability of the technique, the main predictors of success and the adequacy of samples obtained for molecular analysis in patients with nsclc

Eligibility criteria:
inclusion criteria: * adult patients with a lung parenchymal lesion suspected for malignancy, in contact or adjacent to the esophagus at the ct scan (with or without mediastinal lymph adenopathies), requiring a pathological diagnosis: * which can not be sample by bronchoscopy/ebus-tbna or * with a previous not diagnostic bronchoscopy/ebus-tbna or * with clinical/anesthesiological contraindications to bronchoscopy/ebus-tbna or * with a previous nodal eus-b-fna not diagnostic/not adequate at the rose * patients with lung parenchymal lesions who are able to sign the informed consent for the study participation exclusion criteria: * patients with lung parenchymal lesions of known etiology; * patients with lung parenchymal lesions in whom bronchoscopic ultrasound-guided trans- esophageal needle aspiration is contraindicated; * patients with lung parenchymal lesions who refuse/are not able to sign the informed consent for the study participation

Keywords: lung cancer endoscopic ultrasound eus-b-fna molecular analysis rapid on-site evaluation