Kornimate/medical-research-clean huggingface dataset:
effects of total intravenous anesthesia with propofol-remifentanil versus inhalational anesthesia with sevoflurane on quality of recovery in patients undergoing transsphenoidal surgery for pituitary tumor

Conditions: Pituitary Tumor

Summary: a number of studies have compared the effects of total intravenous anesthesia(tiva) versus inhalational anesthesia on perioperative period during transsphenoidal surgery. however, they have limitations especially for the phase of recovery after anesthesia: a fragmentary assessment. quality of recovery 40 (qor-40) questionnaire was multi-dimensionally designed to assess the degree of recovery, specially after anesthesia and surgery. in this study, the investigators aim to compare the quality of recovery after inhalational anesthesia and after tiva through qor-40 questionnaire in patients undergoing transsphenoidal surgery for pituitary tumor under general anesthesia.


Eligibility criteria:
inclusion criteria: * patients over age 19 * scheduled to undergo transsphenoidal surgery for pituitary tumor * asa class i and ii exclusion criteria: * left ventricular ejection fraction \< 55% * third-degree atrioventricular block * second-degree atrioventricular block (p:qrs ratio of 3:1 or higher) * fever * history of myocardial infarction, stroke or cardiac surgery within the previous 1 year * severe neurological disease * use of sedative, opioid or sleep-inducing drugs * allergic history of any study drug * pregnancy

Keywords: anesthesia intravenous neurosurgery pituitary neoplasm postoperative period
physical performance measures for manual wheelchair users

Conditions: Spinal Cord Injury

Summary: the project is intended to modify the functional independence measure (fim) for manual wheelchair users. it will determine if the new measure is a better measure of community independence for manual wheelchair users than the fim. during the phase 1 of the study it will then use this new measure to determine whether a home exercise program increases functional independence in wheelchair users. in phases ii and iii of the study 120 manual wheelchair users will participate to test and validate the new measure and to test the effectiveness of therapeutic exercise. subjects will range in age from 20 to 79 yrs. and have a variety of disabilities.


Eligibility criteria:
wheelchair users

Keywords: wheelchair, biomechanics, aging, functional outcome, disability
safety and effectiveness of regorafenib

Conditions: Neoplasms

Summary: this study is a prospective observational cohort study. the study will be conducted in routine clinical practice settings. it is planned to enroll 1000 patients with metastatic colorectal cancer (mcrc) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. it is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. the primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. the secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by overall survival (os), progression free survival (pfs) and disease control rate (dcr). health related quality of life (hrqol) data will be collected in applicable countries.


Eligibility criteria:
inclusion criteria: * patients diagnosed with mcrc who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib. exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice

Keywords: neoplasms, colorectal
the study of the efficacy and the safety of flumatinib vs imatinib as first line treatment in patients with cml

Conditions: CML, CML-CP,MMR,TKI

Summary: a study to observe the efficacy and the safety of flumatinib vs imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia. randomized,open label,control


Eligibility criteria:
inclusion criteria: 1. men and women aged 18-75 year-old 2. eastern cooperative oncology group (ecog) performance status of 0 - 2 3. philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (ph + cp-cml) within 6 months of diagnosis 4. adequate organ function exclusion criteria: 1. received tkis drug treatment before enrollment 2. central nervous system leukemia 3. previous anti-cml therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation) 4. cardiac dysfunction 5. previous splenectomy 6. history of congenital or acquired bleeding disorders unrelated to cml 7. previous malignancy except cml 8. acute or chronic liver or severe kidney disease unrelated to cml 9. pregnant, breastfeeding, child bearing potential but failed to take effective contraception
migraine research with smartwatch application

Conditions: Migraine

Summary: this clinical, prospective study aims to evaluate the effectiveness of wearable technology in capturing real-time data to assess disease activity in patients with episodic or chronic migraine undergoing different therapy strategies, including botulinum toxin, prophylactic, and acute treatments. participants will also document migraine attacks, triggers, and symptoms through a digital migraine diary app. by combining continuous smartwatch data, the migraine diary and the implementation of questionnaires, the study seeks to provide a comprehensive understanding of how migraines and their treatments impact daily life and patient outcomes.

migraine is one of the most prevalent neurological disorders globally, significantly affecting patients' quality of life. however, due to the complexity of monitoring triggers and symptoms, determining the most effective individualized treatment regimen can be difficult. in this observational study a total of 55 patients with episodic or chronic migraines have been observed over a six-month period, with continuous data collection from both smartwatch and migraine diary app. clinical health questionnaires were completed at baseline (v1), 3 months (v2), and 6 months (v3), assessing the impact of migraine attacks on daily functioning. the data gathered from the smartwatch (withings scanwatch) includes activity-related metrics (step count, minutes of activity at various intensity levels), basic cardiovascular measurements (heart rate), and sleep data (total sleep duration, sleep quality, etc.). additionally, the migraine app allows patients to document the precise timing of migraine attacks, associated symptoms, potential triggers, and the medications taken, including their effectiveness. the mira study aims to explore the potential of wearable devices and digital health tools to systematically identify migraine triggers and physiological responses through continuous monitoring. by integrating both clinical assessments and digital data, this study seeks to provide a comprehensive, longitudinal understanding of migraine dynamics and their impact on daily life.

Eligibility criteria:
inclusion criteria: patients must meet the following criteria to be eligible to participate in the study: * ≥ 18 years of age * diagnosed migraine syndrome * possession and ability to use a smartphone (android 8.1 or later, or ios 12.3 or later) exclusion criteria: * missing informed consent * unwillingness or inability to use the smartphone app * comorbidity leading to impaired comprehension or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. the decision will be at the discretion of the investigators.

Keywords: migraine headache smartwatch wearables digital health tools
highly purified menotropin (hp-hmg) versus recombinant fsh (rfsh) plus recombinant lh (rlh) in intrauterine insemination cycles in women ≥35 years: a prospective randomized trial.

Conditions: Female Infertility

Summary: this study evaluates the effects of different therapies in ovulation induction in intrauterine insemination cycles.


Eligibility criteria:
inclusion criteria: * women with story of infertility sine causa and mild-moderate male factor * regular ovulatory menstrual cycles * bmi ≤27 kg/m2 * normal day 3 hormonal pattern * bilateral tubal patency exclusion criteria: * mono/bilateral tubal occlusion, * severe male factor * polycystic ovarian syndrome or any systemic disease or endocrine or metabolic abnormalities * pelvic inflammatory disease * endometriosis * sexual organ malformations * neoplasms or breast pathology incompatible with gonadotropin stimulation.
effectiveness and safety study of early add-on of ezetimibe with atorvastatin in very high-risk patients

Conditions: Atherosclerotic Cardiovascular Disease

Summary: this study aims to confirm the effectiveness of ezetimibe add-on therapy on ldl-c levels compared to atorvastatin monotherapy, especially in very high-risk patients. we intend to lay the foundation for a standard treatment for these patients through ezetimibe add on lipid-lowering therapy.


Eligibility criteria:
inclusion criteria: 1. patients who are ≥ 30 years old. 2. patients with very high-risk\*: clinical or unequivocal on imaging ascvd. ascvd includes previous acs (mi or ua), stable angina, coronary revascularization (percutaneous coronary intervention (pci), coronary artery bypass graft surgery (cabg), and other arterial revascularization procedures), stroke and transient ischaemic attack (tia), and peripheral arterial disease (mach f 2020). 3. patients (a) who failed to achieve their target ldl-c goals with low and/or moderate intensity statin mono therapy for ≥ 4 weeks or (b) who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment * rosuvastatin \< 10 mg, atorvastatin \< 40 mg, and all dose of pitavastatin, simvastatin, lovastatin, pravastatin, and fluvastatin (team g 2020). 4. patients with ldl-c levels ≥ 70 mg/dl 5. patients who are willing to maintain tlc throughout the study. 6. patients who are willing to provide written informed consent prior to study enrollment. exclusion criteria: 1. patients with hypersensitivity to ezetimibe, atorvastatin or any of its inactive ingredients. 2. patients with active liver disease or unexplained persistent elevations of hepatic transaminase levels. (aspartate transaminase (ast) or alanine transaminase (alt) \> 3 x upper limit of normal (uln)). 3. patients who have predisposing conditions with muscle disease (i.e., rhabdomyolysis or myopathy) or neuromuscular disease. 4. patients with myasthenia gravis. 5. female patients who are pregnant or have a potential to be pregnant and nursing. 6. patients who are taking glecaprevir and pibrentasvir. 7. patients with hereditary problems of galactose intolerance, lapp lactase deficiency, or of glucose-galactose malabsorption. 8. patients with disease known to influence serum lipids or lipoproteins excluding dyslipidemia. 9. patients with a history of cancer within 5 years. 10. patients whose life expectancy is less than 6 months due to their medical conditions. 11. patients with any condition or situation that might pose a risk to the participant or interfere with participation in the study. 12. patients who have received any investigational medicine within 12 weeks of written informed consent or are going to receive during the clinical trial period. 13. patients who are judged to be difficult to conduct clinical trials according to the judgment of the investigator.

Keywords: very high-risk patients' atherosclerotic cardiovascular disease (ascvd)
cross-over multicentre study in adolescents

Conditions: Overweight; Hyperlipidemia

Summary: the main objective of this study is to evaluate the effects of two diets with different glycemic index and fibre content on glucose metabolism and plasma lipid profile of 80 adolescents in 4 european centres. secondary objectives are to evaluate the effects of the two standardized diets on selected hormones and variables linked to inflammatory status.


Eligibility criteria:
inclusion criteria: * age 13-16 yrs * written informed consent * menstrual cycle for at least 6 months * overweight exclusion criteria: * taking part simultaneously in another research trial * involvement in physical training (\>4 h/week of vigorous physical activity) * any dietary treatment in the previous two months * body weight changes \> 3 kg in the previous two months * gastrointestinal diseases, irritable bowel syndrome, or positive history for recurrent gastrointestinal symptoms such as nausea, vomiting, bloating, epigastric pain, abdominal pain, abdominal discomfort, flatulence, severe constipation * kidney diseases * type 1 or type 2 diabetes * thyroid or other hormonal diseases * other secondary causes (including illnesses) of hyperlipidemia or altered glucose metabolism * severe hyperlipidemia (total cholesterol \> 300 mg/dl or triglycerides \>300 mg/dl) * severe hypertension * positive history for eating disorders * any regular drug treatment * any food allergy and intolerance

Keywords: adolescence overweight dietary fiber glycemic index healthy lifestyle
clinical evaluation of no needle dental anesthesia compared to syringe anesthesia delivery

Conditions: Local Anesthesia Injection Pain

Summary: the purpose of the study is to evaluate two different ways to administer the numbing solution. one is with a conventional needle and syringe the other method iontophoresis is a machine that supplies a weak current through electrodes that touch your teeth. both methods use an anesthesia solution to make your teeth numb but the iontophoresis system contains no needle and the delivery device does not penetrate the gum.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age at the time of consent subject is able to provide their own informed consent subject has a minimum 24 teeth/subject and 6 teeth per quadrant subject has an approximal plaque index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents subject must be able to speak and understand english subject is able and willing to return for all scheduled study visits subject to able to make dental appointments subject should not be a pregnant female subject meets the level-i or level-ii classification criteria of the american society of anesthesiologists (asa) physical status classification system for dental patient care exclusion criteria: * subject has any of the following: * rampant caries * chronic periodontitis * salivary gland dysfunction subject is unable, for any reason, to tolerate the procedure time required to place the restorations subject has unacceptable oral hygiene (e.g., chronic moderate to heavy plaque accumulation along the gumline) subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study subject is using a whitening agent at any time during this study. subject has history of allergic reaction to anesthetic medications subject with uncontrolled systemic disease or conditions subject is having acute or chronic myofascial pain or neuropathic conditions subject taking long-term analgesics for their systemic conditions subject presenting with acute dental pain subject requiring iv sedation or nitrous oxide sedation or oral sedation for anxiety

Keywords: local anesthesia
a study of patupilone in patients with advanced solid tumors and varying degrees of hepatic function

Conditions: Advanced Malignancies; Tumors

Summary: patients who participated in the core epo2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.


Eligibility criteria:
inclusion criteria: * completion of the core study is required for participation in the extension. * 18 years of age or older * world health organization (who) performance status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work. * life expectancy of 3 months or more * patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist exclusion criteria: * severe and/or uncontrolled medical disease * known diagnosis of human immunodeficiency virus (hiv) infection * presence of any other active or suspected acute or chronic uncontrolled infection * severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease * history of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ other protocol-defined inclusion/exclusion criteria may apply.

Keywords: epo patupilone solid tumors
a study to evaluate safety and efficacy of amz002 treatment, compared with vigabatrin in participants with infantile spasms

Conditions: Spasms, Infantile

Summary: the main purpose of this study is to evaluate the efficacy of amz002 compared to vigabatrin in participants with newly diagnosed infantile spasms (is).


Eligibility criteria:
inclusion criteria: * participant has been diagnosed with is within 6 weeks prior to screening. diagnostic criteria include both clinical spasms and an eeg pattern consistent with hypsarrhythmia or significant abnormality compatible with is * participant has normal renal function as defined by an estimated glomerular filtration rate (egfr) greater than \[\>\] 60 milliliter/minute (ml/min)/1.73 m\^2, calculated as egfr = 0.413 × (height \[centimeter (cm)\]/serum creatinine \[milligrams per deciliter {mg/dl}\]) * participant's legally authorized representative (that is \[i.e.\], parent or guardian) must provide written informed consent obtained per institutional review board (irb) policy and requirements, consistent with the international council for harmonisation (ich) * participant's parent/guardian is able to understand and willing to comply with study procedures and restrictions exclusion criteria: * participant has been diagnosed with tuberous sclerosis * participant has acute illness considered clinically significant by the investigator within 30 days prior to screening * participant has a diagnosis of recent systemic fungal infection; history of ocular herpes simplex; history of or current peptic ulcer; uncontrolled hypertension or congestive heart failure; or any other condition that would be significantly impacted by the study drug * participant has a preplanned surgery or procedure(s) that would interfere with the conduct of the study * participant has received any prior treatment for is * participant has been previously treated with adrenocorticotropic hormone (acth), corticosteroids, or vigabatrin for seizures; * participant has been previously treated with a course of corticosteroids for an indication other than seizures within 30 days prior to screening * participant has a known or suspected allergy to acth or vigabatrin or any component of amz002 or vigabatrin * participant has used any other investigational drug within 30 days or 5 half-lives prior to the first dose of amz002 or vigabatrin (whichever is longer) * participant' s parent/guardian is unable to provide written informed consent and/or to complete the daily diary * participant has any other disease, condition, or therapy that, in the opinion of the investigator, might compromise safety or compliance, preclude the participant from successfully completing the study, or interfere with the interpretation of the results

Keywords: amz002 vigabatrin seizures electroencephalograms infantile spasms west syndrome central nervous system diseases epileptic syndrome
c-reactive protein as a predictor for airway hyper-responsiveness

Conditions: Asthma

Summary: background: increased serum high sensitivity c-reactive protein (hs-crp) has been associated with airway inflammation in asthma and may serve as a surrogate marker for the presence of airway hyper-responsiveness (ahr) in this set-up. this study was designed to evaluate the predictive value of hs-crp for ahr assessed by metacholine challenge test (mct), in adults with suspected asthma.


Eligibility criteria:
inclusion criteria: * subjects that were referred to metacholine challenge test exclusion criteria: * age \< 18
efficacy and safety of ertapenem sodium (mk-0826) following colorectal surgery in chinese adults (mk-0826-056)

Conditions: Infection; Surgical Site Infection

Summary: the purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection following elective colorectal surgery in chinese adults. this study is designed to demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this participant population.


Eligibility criteria:
inclusion criteria: - participant is scheduled to undergo elective colon or colorectal surgery by laparotomy that is scheduled in advance with adequate time prior to surgery to complete preoperative bowel preparation. - participant is a chinese adult between the ages of more than 18 years old and less than 81 years old. - participant is highly unlikely to conceive. exclusion criteria: * participant is undergoing emergency colon or colorectal surgery. * participant requires a second planned colorectal surgery or other surgery requiring antibiotic prophylaxis within the 4-week follow-up period. * participant is undergoing laparoscopic-assisted surgery. * participant is undergoing an isolated rectal procedure. * participant has a decompensated intestinal obstruction. * participant has active inflammatory bowel disease involving the colon (i.e., ulcerative colitis or crohn's disease). * participant is scheduled to undergo an elective colorectal procedure for revision of a previous operation involving a large bowel resection. * participant has a bacterial infection at the time of surgery. * participant requires or is anticipated to need the administration of other (nonstudy therapy) systemic antimicrobial therapy within 1 week prior to surgery or at any time during this study. * participant is anticipated to receive either antibiotic or antiseptic peritoneal lavage during the surgery. * participant has a history of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to ertapenem sodium, ceftriaxone sodium, metronidazole, penicillin, or any cephalosporin, beta(β)-lactam, or nitroimidazole agents. * participant is breast feeding or plans to breast feed prior to the completion of the study period. * participant has neutropenia. * participant with immunosuppression due to an underlying disease, chronic immunosuppressive therapy, or use of high-dose corticosteroids. * participant has a rapidly progressive or terminal illness. * participant is considered unlikely to survive through the expected 4-week study period.

Keywords: colorectal surgery