Kornimate/medical-research-clean huggingface dataset:
biofreedom stent versus orsiro stent: sort out ix

Conditions: Ischaemic Heart Disease

Summary: the aim of the danish organization for randomized trials with clinical outcome (sort out) is to compare the safety and efficacy of the polymer-free biolimus-eluting biofreedom stent with a biodegradable-polymer sirolimus-eluting orsiro stent in a population-based setting, using registry detection of clinically driven events

sort out ix is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the polymer-free biolimus-eluting biofreedom stent with a biodegradable-polymer sirolimus-eluting orsiro stent in treating atherosclerotic coronary artery lesions. patients will be enrolled by the investigators and randomly allocated to treatment groups after diagnostic coronary angiography and before percutaneous coronary intervention. block randomization by centre (permuted blocks of random sizes (2/4/6)) will be used to assign patients in a 1:1 ratio to receive the polymer-free biolimus-eluting biofreedom stent (biosensors) or the biodegradable-polymer sirolimus-eluting orsiro stent (biotronik). a web based trial partner randomization system will be used.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent. exclusion criteria: * life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, biolimus or sirolimus; participation in another randomized trial; or inability to provide written informed consent.

Keywords: coronary drug eluting stents outcomes
a pilot study to evaluate barhemsys for the prevention of postoperative nausea and vomiting in the bariatric surgery population

Conditions: Post Operative Nausea and Vomiting

Summary: to assess the effectiveness of amisulpride to treat post operative nausea and vomiting (ponv) and to assess the effectiveness of amisulpride to prevent ponv following bariatric surgery.

this is a phase iii/iv, randomized, placebo-controlled, patient-blinded cross-over pilot study to evaluate the effectiveness of amisulpride in the treatment and prevention of post operative nausea and vomiting (ponv) in adult patients, 18-65 years of age, at a single surgery site in the pacific northwest who are undergoing bariatric surgery. approximately 100 patients will be randomized in a 1:1 ratio to receive a single intravenous dose of amisulpride (5mg iv single dose) or a placebo (saline control, 1ml iv single dose) at the induction of anesthesia. those who initially receive placebo will undergo an additional randomization in the post-anesthesia care unit (pacu) to receive a dose of amisulpride (10mg iv single dose) or placebo (saline control, 2ml iv single dose) in a 1:1 ratio as first line treatment for ponv.

Eligibility criteria:
inclusion criteria: * the study will recruit adult patients (age 18-65) scheduled for bariatric surgery. additional inclusion criteria include asa class i-iii and patients who plan to be inpatient for at least 24 hours. included surgeries: robotic, laparoscopic or open roux-en-y robotic, laparoscopic or open gastric sleeve robotic, laparoscopic or open gastrectomy robotic, laparoscopic or open revision gastric bypass exclusion criteria: * pregnant or breastfeeding * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. * congenital qtc abnormalities * current use of droperidol * parkinson's disease * allergy to barhemsys * gfr \&lt; 30 ml/min/1.73m2 * emergency surgery or add-on cases

Keywords: post operative nausea and vomiting bariatric surgery bariatric barhemsys amisulpride
mulligan rotational movement versus medial gapping technique in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis is a progressive degenerative and non-inflammatory joint disorder. due to the extensive use and stress placed on knee joint, it is a common site for painful disorders such as knee osteoarthritis. it is seen that medial side of knee is most commonly affected because of weight bearing on medial side. symptomatically, the knee joint is most commonly affected in osteoarthritis because it requires support, high mobility, and insufficient internal stability. osteoarthritis of the knee joint affects three parts of the knee joint (medial, lateral, and patellar-femoral joints) and develops slowly, usually over 10-15 years, interfering with daily activities slow and gentle movements like tai chi, isometric, iso-kinetic and isotonic exercises are considered helpful in increasing joint range of motion and physical function. stretching and aquatic therapy can also decrease pain and enhance joint flexibility. the aim of this study is to compare the effects of mulligan rotational movement vs medial gapping technique on pain, range of motion and disability in knee osteoarthritis. this study will be a randomized control trial and will be conducted in riphah clinics and lgh. the study will be completed within the time duration of six months. non-probability convenient sampling technique will be used to collect the data. those who will meet the inclusion criteria will be recruited in the group. the sample size of patients with knee osteoarthritis will be taken in this study to find the effects of mulligan rotational movements vs. medial gap technique, aged between 20-40 years, will be allocated to an intervention or control group. the scales used for recording findings will be goniometer, visual analogue scale and modified disability index. subjects will randomly divide into control group called group a taking mulligan therapy and interventional group called group b taking median gapping technique. 12 sessions over 6 weeks were performed on both groups. data analysis will be done by spss version 25.


Eligibility criteria:
inclusion criteria: * post-traumatic stiffness of knee * restricted range of knee flexion * patients with restricted rom and with grade 3 or more than three power of knee muscle exclusion criteria: * patients with hyper mobile and unstable joints * joint infection and loosening, * soft tissue injuries around knee joints and * other complications of post-fracture

Keywords: mulligan rotational movement medial gapping technique pain range of motion knee osteoarthritis
auriculotherapy in the cares to the premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: premenstrual syndrome (pms) is a collection of physical and emotional symptoms related to a woman's menstrual cycle. these symptoms occurring only during the luteal phase of the menstrual cycle that are of sufficient severity to interfere with some aspects of life of these women, reflecting also in interpersonal relationships, workplace and in their productivity. for these reasons, this research was conducted with the nursing staff of the samaritan hospital in order to verify the effectiveness of auricular acupuncture to alleviate some of the symptoms of pms.

the chinese auriculotherapy is a intervention used by chinese traditional medicine in order to balance the body energy and to treat several kind of diseases using semipermanent needles in specific points of the auricular pavilion.

Eligibility criteria:
inclusion criteria: 1. belong to the nursing staff 2. present at least one behavioral or physical symptom that is self-perceived as related to the symptoms that precede menstruation (irritability, depression, fatigue, headache, breast tenderness, swelling, anxiety, insomnia, crying spells, changes in appetite) 3. voluntary participation in the study 4. availability of time for submission to the sessions exclusion criteria: 1. medical license or vacation during the period of the research. 2. pregnancy

Keywords: premenstrual syndrome physical distress behavioral changes
emergency room visits and older patients (er2)

Conditions: Emergencies; Length of Stay

Summary: today's population is living longer than prior generations. senior patients, defined as 65 years or older, are therefore increasing in number, and representing a larger number of hospitalized patients. thus, assessing and addressing the needs of the growing number of older er users is essential. the overall objective of the study is to examine the feasibility and the epidemiology of two screening tools ("programme de recherche sur l'intégration des services pour le maintien de l'autonomie" (prisma-7) and emergency room evaluation and recommendations (er2)) used in the emergency room of jewish general hospital to screen older patients (i.e.; ≥65 years) at risk of adverse health events. a prospective observational cohort design will be used for the study's two phases; phase 1- assessment and phase 2- assessment as well as recommendations.


Eligibility criteria:
inclusion criteria: * age ≥ 65 years. * unplanned er visits. exclusion criteria: * death within the 24 hours of first visiting er. * palliative care due to er visit.
beverly-c: an observational study of avastin (bevacizumab) in first-line treatment in elderly patients with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this observational study will evaluate the efficacy and safety of avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy in elderly patients (\>/= 65 years of age) with newly diagnosed metastatic colorectal cancer. patients will be followed until disease progression, death, withdrawal of consent, discontinuation of physician-patient relationship or study closure, whichever comes first.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 65 years of age * patients with newly diagnosed metastatic colorectal cancer starting first-line treatment with avastin in combination with fluoropyrimidine-based chemotherapy according to the approved hungarian summary of product characteristics * patients suitable for avastin treatment as assessed by the treating physician exclusion criteria: * any contraindications to avastin treatment according to the hungarian summary of product characteristics
the relationship between serum psa levels and wbc, delta neutrophil index (dni) and other hematological parameters

Conditions: Prostate Infection; Prostate Disease; Prostate Cancer

Summary: purpose: to find the correlation between hemogram parameters and delta neutrophil index(dni) and serum psa in patients presenting with the diagnosis of acute prostatitis. material-metod: serum psa levels and hemogram parameters of patients who came to the urology outpatient clinic in january 2018 and may 2022 and were diagnosed with prostatitis were collected retrospectively.

serum psa levels and hemogram parameters of patients who came to the urology outpatient clinic in january 2018 and may 2022 and were diagnosed with prostatitis were collected retrospectively. wbc, neutrophil, lymphocyte, neutrophil-lymphocyte ratio, delta neutrophil index (dni), plt, rdw, and mpv values were determined in the hemogram parameters. serum total psa and free psa values of the patients were also checked. urine culture, urinary ultrasound, and antibiotic therapy

Eligibility criteria:
inclusion criteria: acute prostatitis male - exclusion criteria: prostate cancer chronic prostatitis other urinary infections, -

Keywords: prostatit
curative d2 vs d1 lymphadenectomy in operable gastric carcinoma

Conditions: Gastric Cancer

Summary: gastric carcinoma is the second most common cause of cancer-related deaths and its main treatment modality if potentially curable is surgery but the optimal surgical resection is controversial. the aim of the current study was to assess the outcomes of curative d2 compared to d1 gastrectomy of operable gastric carcinoma regarding postoperative morbidity and mortality, disease recurrence and survival rates.

80 consecutive patients with potentially operable gastric carcinoma were randomized via concealed envelopes into 2 groups (each included 40 patients), group i managed by radical gastrectomy with d1 lymphadenectomy while group ii managed by radical gastrectomy with d2 lymphadenectomy . both groups were compared regarding postoperative mortality, morbidities, tumor recurrence and 2 years survival rates.

Eligibility criteria:
inclusion criteria: * histologically confirmed gastric carcinoma * potentially operable gastric carcinoma without evidence of distant metastasis exclusion criteria: * complicated gastric cancer (obstructed or perforated) * locally irresectable tumor * previous or coexisting cancer * prior gastric surgery or neoadjuvant chemotherapy * contraindication for major surgery

Keywords: operable gastric cancer d2 vs d1 lymphadenectomy surgical and oncologic outcomes
buspirone, in combination with amantadine, for the treatment of levodopa-induced dyskinesia

Conditions: Parkinson's Disease; Dyskinesias; Movement Disorders

Summary: the primary objective of this study is to evaluate the efficacy of buspirone in combination with amantadine in reducing levodopa-induced dyskinesia (lid) in patients with parkinson's disease (pd).

plan: we will perform a randomized, placebo-controlled, double-blind, two-period cross-over study to evaluate the safety, tolerability, and efficacy of a novel treatment combination for lid in pd. methods: eligible subjects who consent to participate in this study will be randomized to one of two sequences of treatment interventions during the baseline visit. each treatment sequence includes placebo and buspirone interventions. after randomization, each participant will titrate up on study drug for two weeks ending in 30 mg/day. at the end of each two week study drug period, the participant will then have a study visit at the va portland health care system that includes safety monitoring, adverse event monitoring, drug compliance, and several measurements of lid.

Eligibility criteria:
inclusion criteria: * parkinson's disease diagnosis * currently taking a levodopa containing medication for parkinson's disease * mild to severe dyskinesia * currently taking between 200-500 mg of amantadine daily for treatment of levodopa-induced dyskinesia with insufficient suppression levodopa-induced dyskinesia. * stable medication regimen for at least 4 weeks prior to study. exclusion criteria: * currently receiving any other treatment for levodopa-induced dyskinesia, including but not exclusive to deep brain stimulation. * not able to follow verbal commands * not able to stand unsupported for at least 60 seconds * not able to answer a patient questionnaire about their symptoms of parkinson's disease and dyskinesia. * have proprioceptive deficits. * have a history of hepatic impairment * currently have severe renal impairment * currently have any other medical or psychiatric diagnosis that would preclude their ability to safely participate in the study. * significant cognitive impairment * pregnancy * breast-feeding * unable to swallow study drug (capsule)
evaluate the performance of journey ii cr in tka populations

Conditions: Arthroplasty; Replacement; Knee

Summary: background: the journey ii cr total knee system consists of femoral component made from oxidized zirconium (oxinium) purpose: post-market evidence generation for journey ii cr total knee system objectives: evaluate the performance of journey ii cr tka in apac populations evaluate the impact of patella resurfacing on the outcomes of journey ii cr tka research participants / locations: a total of up to 480 knees' information will be collected in up to 15 sites in india, china mainland, hong kong, singapore, thailand and japan there will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.


Eligibility criteria:
inclusion criteria: * subjects with degenerative osteoarthritis. * subject is planning to have tka using journey ii cr. * subject is able and willing to provide voluntary consent to study participation. * subject is 18-80 years old (inclusive) \* (\* for japan, the minimum inclusion age is 20 years old.) exclusion criteria: * subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis. * previous surgeries including hto, uka or tka on the subject knee. * subject is pregnant or breast feeding or those at a child-bearing age planning to become pregnant during the follow up. * subject does not meet the indication or is contraindicated for journey ii cr's ifu.

Keywords: osteoarthritis total knee arthroplasty (tka)
safety and immunogenicity study of the venezuelan equine encephalomyelitis vaccine

Conditions: Venezuelan Equine Encephalomyelitis

Summary: this study is designed to determine safety of and immune response to venezuelan equine encephalomyelitis vaccine, live, attenuated, dried tc-83, ndbr-102 (tc-83).


Eligibility criteria:
inclusion criteria: * at least 18 years old * vee prnt80 \< 1:10 before immunization. * (females) negative serum pregnancy test on same day before vaccination. not planning pregnancy for 3 months. * actively enrolled in the sip * at risk for exposure to virulent vee virus (with up-to-date risk assessment). * up-to-date (within 1 year) physical examination/tests. * sign and date the approved informed consent. * willing to return for all follow-up visits. * agree to report adverse event (ae) up to 28 days after vaccination. exclusion criteria: * over age of 65 years. * clinically significant abnormal lab results including evidence of hepatitis c, hepatitis b carrier state, or elevated liver function tests. * history of immunodeficiency or current treatment with immunosuppressive medication. * (females) currently breastfeeding. * confirmed human immunodeficiency virus (hiv) titer. * family history (first degree relative, but not elderly parent with late onset) diabetes, personal history gestational diabetes, or confirmed elevated fasting serum glucose (\> 125 mg/dl). * serious allergic reaction to guinea pigs/guinea pig products. * any known allergies to components of the vaccine. * a medical condition that in the judgment of the principal investigator (pi) would impact subject safety (i.e-vaccination and or exposure to another alphavirus). * administration of any vaccine within 28 days of tc-83. * any unresolved aes resulting from a previous immunization.

Keywords: encephalitis,vee
standardized nutritional management of pediatric patients with solid tumors

Conditions: Tumor, Solid; Children; Nutritional Intervention

Summary: the purpose of this study is to establish a standardized nutrition intervention procedure for children with solid tumors, and to explore the effectiveness and clinical applicability of standardized nutrition management and short peptide-based enteral nutrition intervention for improving the nutritional status of children with malignant solid tumors. after admission, patients in the intervention group will receive standardized nutrition management provided by a nutrition support team composed of dietitians, nutritionists, clinicians, and nursing teams. basic information, including diet, enteral and parenteral nutrition, nutritional status and clinical data, will be collected during the study.


Eligibility criteria:
1. male and female, age 0-18 years old 2. pathological diagnosis is malignant solid tumor with untreated initial onset
caffeine disposition after inhalation

Conditions: Healthy

Summary: the purpose of this study is to determine how fast caffeine gets into your body with a product called aeroshot™. aeroshot™ is a lipstick sized device that you slide open and then put your mouth over the opening and inhale. a fine powder containing 100 mg of caffeine is deposited on your tongue and the inside of your mouth. caffeine will be absorbed through the membranes in your mouth or swallowed and then absorbed in your stomach. we will compare the absorption of caffeine after using the aeroshot™ with the absorption after drinking an energy drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in your blood. you will also be asked to fill out some scales to measure the effects you feel after the caffeine dose. we hypothesize that caffeine absorption after inhalation will be faster than after an energy drink.


Eligibility criteria:
inclusion criteria: * healthy volunteer * non-smoker exclusion criteria: * take chronic medication * co-existing diseases * platelet count less than 100,000/ul (per microliter) * acute or chronic psychiatric condition * consume more than 300 mg of caffeine per day * participated in another study within last 30 days or donated blood in last 6 weeks

Keywords: caffeine pharmacokinetics pharmacodynamics
near-infrared fluorescence imaging as a supportive tool for localisation of deep infiltrating endometriosis during laparoscopy

Conditions: Pelvic Endometriosis; Endometriosis Outside Pelvis

Summary: the aim of the study is to establish a new and more accurate method to visualize the peritoneal changes caused by endometriosis using indocyanine green mediated fluorescence imaging. the hypothesis is that indocyanine green, a fluorescent dye that has wide applications throughout medicine in identifying vascularity of tissues and neovascularization, could facilitate the localization and excision of endometriotic lesions exploiting the hypervascularization due to the chronic inflammation

patients were recruited within the clinical routine after indication for laparoscopy under consideration of the inclusion and exclusion criteria. the first abdominal and pelvi's inspection was made using direct laparoscope visualization under white light conditions. all areas suspected of peritoneal endometriosis were classified as white, black and red lesions and recorded together with their anatomic location in the surgical record for the purposes of subsequent extirpation. after the first visual inspection the patient was administered with 0.05 - 0.25 mg /(kg bw) indocyanine green intravenously. the indocyanine green imaging mode of the olympus indocyanine green imaging system was activated and suspected areas in indocyanine green imaging mode were recorded with their corresponding appearance in white light mode. if suspected areas were visible either in white light or indocyanine green imaging mode, specific sample has been taken from these areas. in addition control biopsy specimens from inconspicuous peritoneum has been taken.

Eligibility criteria:
inclusion criteria: * suspected endometriosis with necessity for laparoscopic confirmation and resection * regular menstrual cycles exclusion criteria: * patients younger than 18 years and older than 50 years at time of operation * subject with previous history of adverse reaction or allergy to indocyanine green, iodine, shellfish or iodine dyes * documented allergy to sulfur containing compounds * history of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green * subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests (total bilirubin increased by factor 1.5 than normal and/or serum glutamic oxaloacetic transaminase increased by factor 2 than normal) * subject has uremia, serum creatinine (\> 2.0 mg/dl) * subject has severe coronary heart disease (instable angina pectoris) * pregnant or breast-feeding women * subject actively participating in another drug, biologic and/or device protocol * the presence of medical conditions contraindicating general anesthesia or standard surgical approaches * subject has any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure

Keywords: indocyanine green deep infiltrating endometriosis near-infrared vision occult endometriosis invisible endometriosis