Kornimate/medical-research-clean huggingface dataset:
treatment effects of chinese medicine (yi-qi-qing-jie herbal compound) combined with immunosuppression therapies in iga nephropathy patients with high-risk of esrd

Conditions: IgA Nephropathy at High Risk of Developing ESRD

Summary: the tcm-wine study is a single-center, prospective, double-blind randomized placebo-controlled trial. based on optimal supportive care, the trial is aiming to assess superiority with regard to renal protection and reduction of severe treatment-related adverse events of yi-qi-qing-jie formula (yqf) combined therapy compared with immunosuppression monotherapy in high-risk igan.

the investigators plan to randomize 60 participants with biopsy-proven igan to a yqf combined group (yqf compound combined with prednisolone, and cyclophosphamide if necessary) or an immunosuppression group (placebo-yqf combined with prednisolone, and cyclophosphamide if necessary). the two groups will enter a 48-week in-trial treatment phase and receive post-trial follow-up until 50% (30/60) have a composite endpoint or have been followed for 3 years (study completion). all patients will receive optimal supportive care.

Eligibility criteria:
inclusion criteria: 1. patients who maintain regular follow-ups at guang'anmen hospital, agree to participate, and provide informed consent; 2. biopsy-proven iga nephropathy, with recent progression to high-risk igan\*; 3. egfr 15 to 60 ml/min/1.73 m2, calculated with the use of ckd-epi creatinine equation 2009. * high-risk igan: persistent proteinuria ≥ 1 g/d despite at least 8 weeks of optimal supportive care \[maximally tolerated ras blocker which refers to no symptomatic hypotension, no hyperkalemia, and serum creatinine increased by not more than 30% of baseline, blood pressure control meeting targets (135/85 mmhg or lower), and dietary management (sodium intake less than 6 g/d, protein intake of 0.6-0.8 g/kg/day, and low-fat diet)\], the mean annual egfr decline rate (egfr-slope) \>10 ml/min per 1.73 m2 per year, while needing to restart immunosuppressive therapy; or egfr\<60 ml/min/1.73 m2 at the first diagnosis. exclusion criteria: 1. secondary igan; 2. comorbidity of other primary or secondary glomerular diseases; 3. comorbidity of severe primary diseases such as cardiovascular, hepatic, cerebral, and hematopoietic system diseases or mental disorders; 4. allergy or intolerance to the experimental medication (e.g., ras blockers, prednisolone, cyclophosphamide, yqf compound and its placebo compound); 5. contraindications to immunosuppression therapy-acute and chronic infectious diseases, malignancies, leukopenia, thrombocytopenia, gastrointestinal hemorrhage, ulcers of stomach or duodenum, post-transplantation; 6. pregnant or lactating women; 7. unwilling to participate in this study, failure to accept or tolerate chinese medicine compound; 8. history of alcohol or drug abuse; 9. poor compliance, loss to follow-up; 10. participation in another clinical investigation.

Keywords: iga nephropathy immunosuppressive therapy yi-qi-qing-jie herbal compound high-risk igan traditional chinese medicine
a study to analyze the effect of acupuncture on mobility and quality of life in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this two-center study is to examine the effectiveness of acupuncture treatments in addressing mobility deficits, sensorimotor impairment, and quality of life (qol) limitations in persons with multiple sclerosis (ms). it is hypothesized that acupuncture will result in an improvement in these limitations.

this research study will examine the effects of acupuncture on various symptoms experienced by persons with ms. persons with ms often use acupuncture as a way of controlling the symptoms of the disease. however, there is little research on whether or not acupuncture has any effect on ms symptoms related to movement. this study intends to look at the effects of acupuncture treatment on walking, balance, and mood in persons with ms.

Eligibility criteria:
inclusion criteria: * diagnosis of ms * ability to walk unaided for 6 minutes with or without assistive device exclusion criteria: * bleeding precautions * trypanophobia * inability to lie still for 30 minutes * active cancer, current exacerbation, and history of previous acupuncture treatment
trial using integuseal as microbial sealant for arterial bypass surgery on lower extremities

Conditions: Arterial Obstructive Diseases

Summary: the purpose of this study is to prove a reduction of postoperative wound infections after direct preoperative use of a microbial sealant in the form of integuseal for vascular procedures on lower extremities.


Eligibility criteria:
inclusion criteria: * planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft exclusion criteria: * secondary procedures and suprainguinal procedures

Keywords: integuseal microbial sealant infection prophylaxis postoperative wound infection arterial bypass surgery
studies on aldosterone and vascular function

Conditions: Inflammation

Summary: a randomized crossover trial to determine the effects of sodium loading and aldosterone infusion on endothelial function in normal subjects.


Eligibility criteria:
inclusion criteria: * healthy subjects age \>18 years exclusion criteria: * any chronic medical disease or chronic use of medications

Keywords: vascular endothelium nitric oxide aldosterone vascular biology
assessing the histological quality of biopsy samples obtained with multibite forceps

Conditions: Helicobacter Pylori Infection; Celiac Disease

Summary: biopsies are routinely taken during endoscopy and colonoscopy in order to facilitate histological analysis of various disease processes. the current practice of obtaining biopsies involves taking a maximum of two biopsies at a single time (ie. with a single pass). when investigating certain diseases, such as celiac disease, there is a need to obtain several biopsies (sometimes greater than 6) and the current practice of taking one to two biopsies at a time can lengthen endoscopy time. this study investigates a new approved multiple bite forceps that has the ability to retrieve six biopsies during a single pass which could reduce endoscopy time and improve diagnostic yield. this study will assess the histological quality of multiple biopsies when taken with the multiple bite forceps compared to the standard double bite forceps. this multiple bite forcep is approved for clinical use in canada.

this will be a prospective randomized noninferiority study that will take place at hotel dieu hospital. based on a statistical power calculation, a total of 100 patients are required for enrollment. enrollment will take place at the outpatient endoscopy suite at hotel dieu hospital. patients will be reviewed for eligibility as per the inclusion and exclusion criteria and those deemed eligible will consent for participation. members of the research time will attempt to contact patients two to three weeks prior to their schedule endoscopy for consent. if unable to reach them after two attempts, they will then be consented for their participation during the day of their endoscopy at hotel dieu hospital. once enrolled in the study, each patient will be randomly allocated to one of two groups (group a and group b) using a computer randomizer generator. the aim is to have equal numbers in both groups (ie. 50 patients in each group). participants in group a will have their biopsies during endoscopy taken with the conventional double bite forceps. on the other hand, participants in group b will have their biopsies taken with the multiple bite forceps. each patient in both groups will have at least six biopsies taken. in both groups, biopsies will be taken for assessment of h. pylori and/or celiac disease. patients recruited will be those who would require these biopsies to be taken regardless of this study. the samples will be sent to pathology where two independent expert gastrointestinal pathologists will examine the slides and grade each specimen using a five-point scale. the overall histological score given to samples will then be assessed to compare those retrieved with the multiple bite forceps and conventional forceps.

Eligibility criteria:
inclusion criteria: * patients who were referred for outpatient upper endoscopy at hotel dieu hospital requiring biopsies to investigate for celiac disease or h. pylori infection. exclusion criteria: * patients with clinical or endoscopic evidence of gastric mucosal atrophy.

Keywords: biopsy histological quality endoscopy forceps
assessment of bifocal and prismatic bifocal spectacles for myopia control in children

Conditions: Myopia

Summary: 1. to determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression. 2. to study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children. 3. to investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.


Eligibility criteria:
inclusion criteria: * age: 8 to 13 years * myopia: -1.00 to -5.00 d * myopia progression: at least 0.50 d/yr * astigmatism and anisometropia: not more than 1.50 d * distance monocular visual acuity: 6/6 or better * near monocular visual acuity: 0.4 m or better * stereoacuity: not more than 40 sec of arc at 40 cm exclusion criteria: * strabismus * ocular diseases

Keywords: myopia, bifocal, children
cognitive stimulation in daily activities for people living with early to middle stage dementia

Conditions: Dementia; Dementia, Mild; Dementia Moderate

Summary: the goal of this study is to test the effect of cs-adl is on people living with early to middle stage dementia. the study also aims to evaluate the feasibility of conducting larger-scale research of cs-adl. the main questions it aims to answer are: * what is the effect of cs-adl on the ability of people with early to middle stage dementia to carry out their everyday activities? * what is the effect of cs-adl on the memory, mood, communication, and quality of life of people living with early to middle stage dementia? what is the feasibility of conducting large-scale research of cs-adl? participants will take part in a group program that lasts 7 weeks, with one session per week, lasting two hours. participants will take part in rewarding and stimulating activities, for example discussion, reminiscence, music, and practical activities such as baking, cooking, gardening. participants will be asked to complete a variety of questionnaires before and after taking part in the group. researchers will compare a group receiving cs-adl to a group receiving their usual care, to explore whether cs-adl works well in comparison to typical treatment provided by the health services.


Eligibility criteria:
inclusion criteria: * participants must have a formal diagnosis of major neurocognitive disorder (dementia) as per the dsm-v criteria. * participants must have a mild-to-moderate cognitive impairment as classified by the montreal cognitive assessment (moca). * participants must have some ability to communicate and understand communication, determined by a score of 1 or 0 on questions 12 and 13 of the clifton assessment procedures for the elderly-behaviour rating scale. * participants must be able to see and hear well enough to participate in the group. exclusion criteria: * individuals with severe dementia, i.e., an mmse\<10, will be excluded as most cs interventions are not applicable for those with severe cognitive impairment. * participants will be excluded if they have significant uncontrolled disruptive behaviours. * premorbid diagnosis of a learning disability. * a significant physical illness/disability that may affect participation during intervention sessions or assessments.

Keywords: cognitive stimulation occupational therapy randomised controlled trial activities of daily living adl
sepsis: from syndrome to personalized care

Conditions: Sepsis Syndrome; Sepsis; Sepsis, Severe; Septic Shock

Summary: this is a prospective, observational study designed to examine the performance of biomarkers, molecular biological methods and other analysis in blood from patient with suspected sepsis in the emergency department, as well as identidying novel sepsis endotypes. around 1500 patients will be enrolled.

the study will prospectively include adult patients (\>18 years) with suspected sepsis admitted to oslo university hospital, ullevål (ouh-ullevål). patients admitted to the emergency department and managed by the medical rapid response team or the sepsis rapid response team are considered eligible for inclusion. informed consent will be collected at the emergency department if possible, or within few days, by a clinical investigator or a study nurse. the investigators aim to include 1500 patients treated by the sepsis rapid response team or medical emergency team for possible sepsis. patients classified to have had other conditions than sepsis in the post hoc assessment will be used as controls. the inclusion period will be 3 years.

Eligibility criteria:
inclusion criteria: * admitted to emergency department ouh, ullevål. * managed by the medical rapid response team or the sepsis rapid response team exclusion criteria: * not given informed consent by patient or next of kin (if patient is not able to)
antistaphylococcal betalactam and emergence of resistance

Conditions: Bacterial Resistance; Methicillin-Sensitive Staphylococcus Aureus Infection

Summary: antistaphylococcal penicillins are recommanded as first-line agent in methicillin-suceptible staphylococcus aureus bacteraemia. several studies in progress are investigating the efficacy and safety of cefazolin compared with antistaphylococcal penicillins. cefazolin has broader spectrum than antistaphylococcal penicillins. the hypothesis of this project is that cefazoline could be responsible for a higher rate of bacterial resistance. the aim is to study the association between the emergence of bacterial resistance and the consumption of cefazolin and antistaphylococcal penicillins.


Eligibility criteria:
inclusion criteria: french hospitals which have collected their consumption and resistance data on the french national database named consores (from 2019 to 2022) exclusion criteria: * none

Keywords: cefazolin antistaphylococcal penicillins methicillin-sensitive staphylococcus aureus infection bacterial resistance
how tka implants affect muscle quality and activity during daily living and immunological response

Conditions: Osteoarthritis, Knee; Inflammation Knees

Summary: this study compares two total knee replacement implants to asses muscle function and quality, and the immune response to the implants. 30 patients will receive the smith and nephew journey ii implant, while 30 patients will receive the zimmer nexgen lps-flex implant. 15 healthy controls will also be recruited and compared.

patients will undergo biomechanics testing while they complete sit-to-stand, stand-to-sit, lateral step down, level walking, and single leg balance tasks up to 1 month before surgery, and 6 and 12 months after surgery. they will also undergo mri imaging up to 1 month before surgery and 12 months after surgery to assess muscle quality. a secondary outcome will also be to analyze the immunological response in the patients who received femoral components made of oxidized zirconium versus contemporary components made of cobalt chrome. fifteen healthy controls will also participate in the study and will undergo the biomechanical, mri and blood draws at a single visit.

Eligibility criteria:
inclusion criteria: * the participants receiving a knee implant must requiring a total knee replacement exclusion criteria: * any degenerative conditions (other than osteoarthritis at the affected knee) impacting joints of the lower extremities * bilateral knee replacements * previous joint replacement at the affected knee * any other past or present conditions that may impact gait * any active infection and any diagnosed conditions that may affect the local and systemic immune response (e.g., rheumatoid arthritis, hiv infection, lupus, pregnancy, and thrombocytosis) * bmi and waist circumference (wc) will be another exclusion criterion since both bmi and wc are associated with health problems and gait abnormalities. any patient with both bmi \> 35 kg/m2 and a wc \> 102 cm in men or \> 88 cm in women will be excluded from the study. healthy controls inclusion * controls must not suffer from lower extremity injuries or joint conditions that might alter gait dynamics exclusion * bmi and waist circumference (wc) will be another exclusion criterion since both bmi and wc are associated with health problems and gait abnormalities. any patient with both bmi \> 35 kg/m2 and a wc \> 102 cm in men or \> 88 cm in women will be excluded from the study
trpc6 characterization to predict and prevent chemotherapy related cardiomyopathy and heart failure with breast cancer

Conditions: Breast Carcinoma; Cardiomyopathy; Congestive Heart Failure

Summary: this study examines trpc6 in predicting and preventing chemotherapy related cardiac toxicity and heart failure in patients with breast cancer. cardiac toxicity, changes in heart function is a well-recognized complication of certain cancer related therapies. understanding these changes may allow early intervention against therapy-related cardiac toxicity and also identify novel therapeutic targets to protect patient long-term cardiac health. studying samples of blood from patients with breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (dna), identify biomarkers related to cardiac toxicity, and prevent the development of therapy-induced cardiac toxicity in patients receiving chemotherapy.

primary objective: i. characterize trpc6 risk variants for doxorubicin-related cardiotoxicity in prospectively collected samples from breast cancer patients. outline: this is an ancillary-correlative study. patients undergo collection of blood samples at time of enrollment. patients who develop cardiac toxicity may undergo additional collection of blood samples. patients' medical records are also reviewed.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * any breast cancer patient initiating doxorubicin/other anthracycline and patients receiving trastuzumab without doxorubicin/anthracycline in the neoadjuvant/adjuvant setting * an understanding of the protocol and its requirements, risks, and discomforts * the ability and willingness to sign an informed consent * diagnosed with therapy related cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment or completed chemotherapy with no cardiotoxicity at least two years post treatment or patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. this will include doxorubicin chemotherapy, or trastuzumab. * healthy, non-pregnant, adult subjects who weigh at least 110 pounds exclusion criteria: * inability on the part of the patient to understand the informed consent or be compliant with the protocol * anemia with hemoglobin less than 8 * patients not willing to undergo a blood draw * patients with stage iv or distant metastatic breast cancer
transctunaous pulsed radiofrequency therapy in carpal tunnel syndrome

Conditions: Peripheral Neuropathy; Chronic Pain

Summary: the aim of this study is to examine the effect of transcutaneous pulsed radiofrequency current in the treatment of carpal tunnel syndrome.

carpal tunnel syndrome (cts) is the most common peripheral neuropathy. wrist splint is the first-line treatment option for cts. pulsed radiofrequency therapy is used in the treatment of chronic pain. 60 carpal tunnel syndrome patients diagnosed with electroneuromyelography will be included in the study. 30 patients will wear wrist splints for 1 month. in the other 30 patients, pulsed radiofrequency current will be given through the wrist median nerve trace. rf current will be applied through transcutaneous pads. it will be applied once a week for a total of 2 sessions, 8 minutes each. boston carpal tunnel syndrome questionnaire with visual analog scale (vas) will be applied to all patients before and after the treatment at 1 week and 1 month. our aim is to compare the effectiveness of wrist splint and pulsed rf therapy.

Eligibility criteria:
inclusion criteria: * carpal tunnel syndrome detected by electroneuromyography * positive tinel sign exclusion criteria: * thenar muscle atrophy * weakness in the abductor pollicis brevis muscle

Keywords: carpal tunnel syndrome pulsed radiofrequency treatment transcutaneous pulsed radiofrequency
intervention of hiv, drug use and the criminal justice system in malaysia

Conditions: Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome; Opiate Addiction; Drug Dependence

Summary: the purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (holistic health recovery program) or both (methadone and holistic health recovery program) has on reducing hiv-related risk behaviors and illicit drug use among opioid-dependent, hiv-infected individuals in prison when given 90 to 180 days prior to leaving prison.


Eligibility criteria:
inclusion criteria: * hiv-infected * clinical diagnosis of opioid dependence * fluent in bahasa malaysia or english * within 90 to 180 days of release from prison * planning to live in klang valley region after release from prison * able to provide informed consent exclusion criteria: * pregnancy or planning to become pregnant (female only)
the effectiveness of titanium-prepared platelet-rich fibrin on angiogenic biomarkers in gingival crevicular fluid

Conditions: Chronic Periodontitis; Intrabony Periodontal Defect

Summary: this study investigates the effect of titanium-prepared platelet-rich fibrin (t-prf) treatment on the angiogenic biomarkers in gingival crevicular fluid (gcf) in infrabony defects of patients with chronic periodontitis. in each patient, the infrabony defect of one side of arch was designated as control group (allograft), while the infrabony defect on the contralateral side of same arch was designated as test group (allograft+t-prf).

platelets are the cells initiating the wound healing and also supporting it by secreting various growth factors actively. these growth factors released by platelets act the increase of connective tissue healing, bone regeneration and repair, fibroblast mitogenesis, wound angiogenesis and the activation of macrophages by stimulating cell proliferation signals. titanium-prepared, platelet-rich fibrin (t-prf), is a new platelet concentrate, is formed in titanium tubes may be more efficient to activate platelets in comparison with glass tubes.the titanium tubes is utilized to refrain any inverse effects of glass tubes and also silica.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic periodontitis * the presence of two or three-wall intrabony defects≥3 mm deep along with an interproximal probing depth ≥5 mm after non-surgical periodontal therapy exclusion criteria: * systemic illnesses * any medications known to affect the outcomes of periodontal surgery * pregnancy and lactation

Keywords: angiogenesis bilateral infrabony defect flap surgery titanium-prepared, platelet-rich ﬁbrin