Kornimate/medical-research-clean huggingface dataset:
clinical study of divozilimab in patients with systemic scleroderma

Conditions: Systemic Scleroderma

Summary: the study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.the study will enroll adult patients of both sexes diagnosed with active systemic scleroderma according to the acr/eular 2013 criteria with a modified rodnan skin score (mrss) of 10 to 20. in patients having signs of ild, the forced vital capacity (fvc) should be at least 40 % of the due value. subjects will be randomized to divozilimab or placebo group.


Eligibility criteria:
inclusion criteria: * diagnosis of "systemic scleroderma" in accordance with the acr/eular 2013 classification. * modified rodnan skin score (mrss) from 10 to 20. * fvc ≥ 40 % of the due value. exclusion criteria: * induced scleroderma. * silicone implants/protheses. * digital ulcers with signs of infection or indications for any amputation. * blood biochemistry or hematological abnormalities at screening. * fev1/fvc \< 0.7 and fev1\< 50 % at screening. * history of threatment with anti-cd20 monoclonal antibodies.
phase iii randomized trial of adjuvant xp chemotherapy and xp/rt for resected gastric adenocarcinoma

Conditions: Gastric Cancer; Surgery

Summary: the objective of the trial is to compare disease-free survival between adjuvant capecitabine/cisplatin alone vs capecitabine/cisplatin with radiotherapy (chemoradiation) in curatively resected gastric cancer patients.

although gastrectomy is the only potentially curative treatment in gastric cancer patients, the overall survival results remain unsatisfactory. the main factor accounting for high mortality rate is the relapse after surgical resection. during the past few decades, the principle of combined modality treatment has been developed and applied in practice for various solid tumors and gastric cancer has not been an exception. in an attempt to prevent recurrence and increase the cure rate of gastric cancer patients after surgery, multiple studies using variable modalities have been undertaken. one of the landmark study in adjuvant trials was the intergroup study int-0116, which reported a significant improvement in survival with the use of chemoradiation therapy after gastric resection of stage ib to iv gastric cancers. thereafter, the chemoradiation therapy has gained popularity and has been increasingly recognized as a standard of care in u.s. nevertheless, the result from int-0116 study has been challenged by the fact that the surgical treatment applied in the trial was gastrectomy with limited lymph node dissection (d0 or d1) in 90% of cases. therefore, it is debatable whether adjuvant chemoradiation therapy can confer survival benefit in patients with extensive lymph node dissection. it is still disputable if chemoradiotherapy after d2 can improve the results of d2 alone. thus, the assessment of the effect of adjuvant chemoradiotherapy in d2 resected gastric cancer is essential.

Eligibility criteria:
inclusion criteria: 1. histologically proven gastric adenocarcinoma 2. ≥ d2 resection 3. stage ib(t1n1,t2bn0), ii, iiia, iiib, iv(t4,n3 포함, m1 lymph node 제외) 4. 18 ≤ age ≤ 75 5. ecog 0-2 6. no distant metastasis 7. adequate bone marrow functions (anc ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl) 8. adequate renal functions(serum creatinine ≤ 1.5mg/dl) 9. liver functions (serum bilirubin ≤ 1.5mg/dl, ast/alt ≤ 3 times(normal value) 10. written informed consent exclusion criteria: 1. previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer 2. active infection requiring antibiotics 3. pregnant, lactating women 4. psychiatric illness, epileptic disorders 5. concurrent systemic illness not appropriate for chemotherapy 6. resection margin (+) 7. pathologic stage ia 8. history of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma 9. m1 lymph node (+) 10. d0, d1 resection

Keywords: gastric cancer radiotherapy postoperative therapy chemotherapy
relative importance of cardiovascular risk factors and echocardiographic parameters affecting left atrial strain

Conditions: Heart Failure, Diastolic; Heart Failure, Preserved Ejection Fraction

Summary: the goal of this observational study is to learn about left atrial reservoir strain in patients with heart failure with preserved ejection fraction. the main questions it aims to answer are: * usefullness of lars as a predictor of high hfa-peff diagnostic algorithm scores (≥5) * the relative importance of lars in variables including each component of hfa-peff and traditional cardiovascular risk factors.


Eligibility criteria:
inclusion criteria: * participants with icd-10 code of heart failure (i50) from august 2021 to july 2022 * 20-year-old or higher age * participants who are available to measure left atrial reservoir strain exclusion criteria: * left ventricular ejection fraction \<50% * supraventricular arrhythmia (e.g. atrial flutter/fibrillation, atrial tachycardia) * participants who are given pacemaker or icd implantation procedure

Keywords: left atrial reservoir strain hfa-peff la strain heart failure with preserved ejection fraction (hfpef)
transversalis fascial plane nerve block in iliac crest bone graft

Conditions: Upper Limb Surgery; Iliac Crest Bone Harvest

Summary: hand or wrist surgery often requires the use of bony material in order to accomplish any associated reconstructive aspects required for the surgery. the iliac crest is often used as the source of bone for such surgery and harvesting from this site is performed simultaneously with the hand/wrist surgery. in terms of anesthesia, patients typically receive a supraclavicular nerve block for the hand/wrist surgery, and a general anesthestic for the bone graft, though spinal block may also be performed. this study will look at the use of a transversalis fascia plane (tfp) nerve block (ie, to numb the nerves going to the iliac crest) in combination with a general anesthetic to see if post-operative pain and opioid consumption is reduced using the tfp block.


Eligibility criteria:
inclusion criteria: 1. asa physical status i-iii 2. 18-85 years of age, inclusive 3. weight 50kg+ 4. scheduled for elective upper limb surgery, which can be solely performed under a brachial plexus block, and requiring an icbg exclusion criteria: 1. contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area) 2. pregnancy 3. history of alcohol or drug dependency/abuse 4. history of long term opioid intake or chronic pain disorder 5. history of significant psychiatric conditions that may affect patient assessment 6. failure of upper extremity block 7. previous iliac crest bone grafting 8. history of severe pelvic and hip conditions that could interfere with the long-term functional assessments of the study 9. inability to understand the informed consent and demands of the study.

Keywords: supraclavicular nerve block regional anesthesia transversalis fascia plane block ultrasound guided opioid consumption iliac crest bone harvest hand surgery wrist surgery upper limb surgery combined with iliac crest bone harvest.
use of biosimilar nivestim® to prevent chemo-induced neutropenia. real life study

Conditions: Chemotherapy-Induced Neutropenia

Summary: the aim of this study is to describe in real-life conditions the determinants of use of gcsf (granulocyte colony-stimulating factor) nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.

this is a longitudinal, observational, prospective, multicentre, cohort study, conducted in france among a representative sample of public and/or private hospital-based oncologists. data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations: * baseline visit: prescription of nivestim®. * follow-up visit: during the first cycle of chemotherapy after the first course of nivestim®. * final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.

Eligibility criteria:
inclusion criteria: * patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour. * patients for whom the oncologist has decided the initiation of g-csf biosimilar treatment (nivestim®) in primary or secondary prophylaxis. * patients informed about the computer processing of their medical data and their right of access and correction. exclusion criteria: * patients with contraindication of use of nivestim®. * patients with haematological malignancy including myelodysplasia and chronic myeloid leukemia treated or untreated. * patients participating or having participated in the previous month in a clinical trial. * patients refusing to participate in this study.
geriatric assessments in senior adults with multiple myeloma

Conditions: Multiple Myeloma

Summary: this study will evaluate the prevalence of geriatric syndromes in older adults with multiple myeloma, examine relationships between baseline geriatrics syndromes and initial treatment selection, and examine risk of functional decline. relationship between baseline geriatric questionnaires and initial treatment selection in older adults with newly diagnosed multiple myeloma. feasibility of subjects completing the carg geriatric assessments at baseline, 3 months and 6 months. comorbidities or dependence in iadls at baseline predict decline in functional status at 6 months of follow-up in older adults with newly diagnosed multiple myeloma.


Eligibility criteria:
inclusion criteria: * patient must have a diagnosis of multiple myeloma by imwf criteria: diagnosis must have occurred within 3 months of study enrollment. * patient must be ≥ 65 years of age. * patient's life expectancy must be ≥ 6 months. * patient must be willing to complete follow-up assessments. * patient must be able to understand and willing to sign a written informed consent document. exclusion criteria: * patient must not have a diagnosis of smoldering myeloma. * patient must not have concomitant amyloidosis.
the relaxation vs. retreat study

Conditions: Stress; Ageing; Wellbeing

Summary: the purpose of this research study is to examine whether a short term meditation intervention can improve health, mood, and biological markers of cellular stress and aging in novice and experienced meditators compared to controls.

there are 3 parts to this research study, part a, b, and c. in part a, participants complete a brief online questionnaire sent to them via email by the study coordinator. during part b of the study, participants stay at la costa resort in carlsbad, ca for 6 nights and participate in a meditation retreat being held at the resort, or stay at the resort without participating in the retreat. during their stay, participants attend two in-person research assessments throughout the week. assessments will be 4 days (96 hours) apart for all participants and will include a fasting blood draw, body measurements, and self-report questionnaires. part c of the study includes a brief online questionnaire that is completed 1 month after participants leave la costa resort. this study includes 3 groups: a group of "novice meditators" from the greater san diego region that are randomized into either the 1) relaxation (control) group or 2) retreat group. the third group is comprised of self-selected "experienced meditators" who are already enrolled in the retreat. in total, 99 participants were recruited for this study. the retreat group stays at la costa resort and attends a 6 day meditation retreat intervention as well as completes all research study assessments and questionnaires. the relaxation (control) group stays at la costa resort for 6 nights, but does not attend the meditation retreat. they attend once daily lectures on science topics and complete all research study assessments and questionnaires. the experienced retreat group participants have an ongoing meditation practice and have enrolled themselves in the april 2013 meditation retreat. all of the experienced meditators attend the meditation retreat and complete all research study assessments and questionnaires.

Eligibility criteria:
inclusion criteria: * healthy * women * age 30-60 * "novice meditator" (meditates for 30 minutes per week or less) or "experienced meditator" (meditates at 40 or more per week and for more than 6 months, and are self-selected/enrolled in the retreat) exclusion criteria: * current or history of a major medical condition (such as cancer, heart disease, autoimmune disease, diabetes) * smokers (have not smoked regularly for the past 6 months) * currently taking antidepressants * post traumatic stress disorder * currently taking hormone replacement therapy or birth control pills

Keywords: telomerase telomere length psychological stress amyloid beta proteins meditation
peep vs. zeep in out-of-hospital-cardiac-arrest

Conditions: Ventilation Therapy; PEEP, Occult; CPR; Cardiac Arrest (CA)

Summary: out-of-hospital cardiac arrest (ohca) remains a major cause of mortality, with low survival probabilities to hospital discharge. despite the frequent use of airway management and mechanical ventilation during resuscitation, there is limited evidence regarding the optimal ventilation strategy to improve oxygen delivery and patient outcomes. the present study aims to investigate the effects of positive-end-expiratory-pressure (peep) set at 5 mbar compared to zero-end-expiratory-pressure (zeep) on the return of spontaneous-circulation (rosc) in adult patients with ohca.

this is a prospective, multicenter, cluster-randomized controlled trial conducted across emergency medical services (ems) in the regions of guetersloh, minden-luebbecke and osnabrueck. adult patients (\>= 18 years) with ohca who are undergoing mechanical ventilation through an airway device will be enrolled. the clusters (regional district) will be randomized into two groups: one group will receive ventilation with peep set at 5 mbar (intervention group), while the other group will receive ventilation with zeep (control group). the study's primary endpoint is the rate of rosc. secondary endpoints include rate of re-arrest, death during pre-hospital care phase, hospital admission during ongoing resuscitation, hospital admission with spontaneous circulation, peripheral oxygen saturation and end tidal co2 at hospital admission.

Eligibility criteria:
inclusion criteria: * adults \>= 18 years * non-traumatic ohca * mechanical ventilation via airway device exclusion criteria: * patients \< 18 years, * traumatic cause of ohca, * no cardiac arrest, withholding of resuscitation (e.g. do-not-resuscitate orders)

Keywords: cardiac arrest positive end-expiratory pressure zero end-expiratory pressure ventilation randomized controlled trial emergency medicine resuscitation cpr
deep sequencing of the breast cancer transcriptome

Conditions: Breast Cancer

Summary: this project is a pilot study designed to investigate transcriptional regulation in breast cancer. although the main focus of the present study will be triple negative breast cancer where all of the clinically relevant receptors - estrogen receptor (er), progesterone receptor (pr) and herceptin (her2) - are absent, all breast tissue biospecimens, including normal and mammary dysplasia, stored in the uams tissue bank, procured from outside collaborators or purchased from commercial vendors will eventually be investigated. we will use high throughput molecular profiling techniques such as microarrays and next generation sequencing to correlate gene expression and gene expression regulation with clinical parameters such as tumor size, time to relapse and overall survival.


Eligibility criteria:
inclusion criteria: * there is no inclusion criteria. this study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. no subjects will be enrolled. exclusion criteria: * there is no exclusion criteria. this study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. no subjects will be enrolled.

Keywords: identify novel genes and predict putative proteins in breast cancer. find biomarkers that can be used for early detection, diagnosis, and prognosis.
pediatric antibiotic associated diarrhea

Conditions: Diarrhea

Summary: diarrhea is one of the side effects of antibiotics. antibiotic associated diarrhea can be encountered between two hours to two months after starting of antibiotics. the purpose of the study is to determine incidence,risk factors and severity of pediatric antibiotic associated diarrhea in turkey.

antibiotic associated diarrhea is a common adverse effect, occurring about 5-30% of patients either early during treatment or up to two months after the cessation of the treatment. the frequency differs according to the definition of diarrhea, the inciting antimicrobial agent and the host factors such geriatric age, immunosuppression, prolonged hospitalization. almost all agents, especially the the ones acting on anaerobes may cause diarrhea. clinical presentations range from mild diarrhea to fulminant pseudomembranous enterocolitis. in turkey still data about antibiotic associated diarrhea is not enough. incidence and the factors that effect severity are not known.

Eligibility criteria:
inclusion criteria: * the parents and the child who give consent * the children who are treated for the acute infections in the outpatient clinics and whole treatment is completed in the outpatient clinics. * children who are born mature, for the children who are younger than 1 year of age. exclusion criteria: * the parents and child who do not give consent * children who have primary and secondary immunosuppressive states. * children who had abdominal/gastrointestinal tract surgery in the past. * children who had used probiotics/prebiotics in the last one month period. * children who had used antibiotics in the last one month period. * children who has accompanying gastrointestinal symptoms. * children who are using anti-acid treatment at the time of involvement.

Keywords: outpatient clinics oral antibiotics diarrhea
registry on luma vision's verafeye system (enlight)

Conditions: Atrial Fibrillation; Left Atrial Appendage Closure; Atrial Arrhythmia

Summary: the objective of the study is to compile real-world data on the use of the verafeye system in standard of care atrial fibrillation (af) ablation procedures and left atrial appendage closure (laac) procedures.


Eligibility criteria:
key inclusion criteria: * subject is 18 years of age or of legal age to give informed consent specific to state and national law at the time of consent * subjects is indicated for an atrial fibrillation ablation and/or a left atrial appendage closure procedure with the verafeye system as navigation and imaging system, per physician discretion; * subject is able to understand and willing to provide written informed consent * subject is able and willing to complete all study assessments at an approved clinical investigational center key exclusion criteria: * subjects who have undergone a previous cardiac ablation for the treatment of paf/laa closure * subject where placement of verafeye imaging catheter is technically not feasible per physician discretion * pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure) * unrecovered/unresolved adverse events from any previous invasive procedure * subjects who are currently enrolled in another study (except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments)
tiotropium respimat administration with and without aerochamber disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: copd patient on tiotropium respimart divided into two group, group a given aerochamber and group b without aerochamber enroll in the study for total 18 week .

1. copd patient who is on tiotropium respimart and other inhalers continued. 2. those fullfill inclusion criteria will be randomized into two group. 3. to do baseline cat score and sgrq questionnaires with lung function test. 4. assess inhaler technique with and without aerochamber. 5. teach proper inhaler technique by templates and demonstrate to patients. 6. group a given aerochamber and group b without aerochamber enroll in the study for total 18 week . 7. first phase for 8 week after that 2 week of washout periode (without aerochamber both arm). 8. then group a without aerochamber and group b with aerochamber continue with all inhalers for 8 week. 9. followed up at 8th , 11th and 18th week to assess inhaler techniques ,lung function test and do cat score, and sgrq questionnaire. 10. analysis data

Eligibility criteria:
inclusion criteria: 1. copd patients under respiratory clinic ukm follow up * patients who are with stable copd (no exacerbation past 2 months) * age same and more than 40-year-old 2. patient able to perform inhaler medication 3. patient able to perform technically acceptable pulmonary function test exclusion criteria: 1. drug hypersensitivity 2. bronchial asthma 3. significant disease that may influence patient's ability to participate in the study. 4. unable to provide signed informed consent 5. mental condition rendering the subject unable to understand the nature, scope and the possible consequences of the study.
inhibitory effect of propofol on perineal pruritus in patients undergoing day surgery

Conditions: Pruritus Vulvae

Summary: objective: to investigate the inhibitory effect of different doses of propofol on perineal pruritus induced by dexamethasone sodium phosphate injection in women, with a view to providing clinical reference for comfortable clinical care in day surgery. methods: one hundred and fifty patients with asa classification i or ii undergoing elective day surgery were randomly divided into six groups of p1, p2, p3, p4, p5 and d1, with 25 cases in each group. before administration of dexamethasone, propofol injection 0.1 mg/kg, 0.2 mg/kg, 0.3 mg/kg, 0.4 mg/kg and 0.5 mg/kg were given intravenously in groups p1, p2, p3, p4 and p5, respectively (injection rate was 5 s), followed by 30 s of intravenous dexamethasone sodium phosphate 10 mg in all five groups; 5 ml of saline was given in group d1, and 30 s after that, dexamethasone sodium phosphate injection was given (injection speed was 5s in all five groups). the perineal itching, the onset and duration of itching, the visual analogue score (vas) of itching, the sleep disorder sedation score (ramsay score) and the occurrence of adverse reactions were recorded in the five groups.


Eligibility criteria:
inclusion criteria: age 18-65 years old asa classification i-ii grade body mass index (bmi) 18-30kg/m2 exclusion criteria: patients with paresthesia or pruritus drug and alcohol abuse allergies to lipid drugs and contraindications; corticosteroids are cautious patients hyperlipidemia patients during pregnancy and lactation mental diseases, communication disorders patients who use hormones for a long time