Kornimate/medical-research-clean huggingface dataset:
laparoscopic gas pressure and postoperative pain score

Conditions: Postoperative Pain; Laparoscopy

Summary: aim of the study is to determine the effect of different laparoscopic intraoperative intraabdominal gas (co2) pressures on the extent of postoperative pain scores.

in this study investigator planned to randomize patients into three groups ; in the first group abdominal entrance pressure will be 15 mmhg and intraoperative pressure will be 15 mmhg too ; in the second group again entrance pressure will be 15 mmhg , intraoperative pressure will be 12 mmhg ; and in the thirth group both entrance and intraoperative pressures will be 12 mmhg. during operation intraoperative mean pressures will be recorded every 15 minutes , also end tidal co2 pressures will also assesed by the anesthesiologist. every participant will take , same standard analgesics ; 2 mg/kg contramal and 1 gr i.v. paracetamol at the end of the operation ; except the ones who has allergy to these analgesics. at postoperative 6 th and 24 th hours patients will be asked to execute the visual analogue score (vas) form to assess the pain . only patients with benign gynecologic pathologies will be included in to the study and informed consent forms will be taken from all participants.

Eligibility criteria:
inclusion criteria: * benign gynecologic pathologies which requires laparoscopic surgery exclusion criteria: * patients who has malign gynecologic pathologies

Keywords: postoperative pain intraabdominal laparoscopic gas pressure
transcatheter or surgical aortic valve replacement in all-comers with severe aortic valve stenosis

Conditions: Aortic Valve Stenosis

Summary: the purpose of this study is to determine that transcatheter aortic valve replacement (tavr) with sapien 3 is superior to traditional surgical aortic valve replacement(savr) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis.


Eligibility criteria:
inclusion criteria: * age must be at least 19 and less than 75 years old * severe aortic valve stenosis with echocardiographically derived criteria: mean gradient \> 40mmhg or jet velocity greater than 4.0 m/s and an initial aortic valve area (ava) of ≤ 0.8 cm2. echocardiogram must be within 3 months of the date of the procedure * patient is symptomatic from his/her aortic valve stenosis, as demonstrated by nyha class ii or greater. * the patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site. exclusion criteria: * life expectancy \<1 year due to medical illness * suspected malignancy * inoperability evaluated by surgeon * concomitant severe coronary artery disease not amenable for percutaneous coronary intervention * concomitant severe mitral valve or significant aorta disease requiring surgery * active bacterial endocarditis within 6 months of procedure * leukopenia (wbc\<3000 cell/ml), acute anemia (hgb\<8g/dl), thrombocytopenia (platelet \< 50000 cell/ml) * intracardiac thrombus * a known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure. * native aortic annulus size \ 25 mm as measured by echocardiogram. * expectation that patient will not improve despite treatment of aortic stenosis * patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Keywords: transcatheter aortic valve replacement tavr tavi savr
amlodipine in the prevention and treatment of iron overload in patients with thalassemia major

Conditions: Thalassemia; Iron Overload

Summary: this study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. the study will follow 60 patients with thalassemia major: 30 will receive amlodipine and 30 will serve as controls receiving placebo in a randomized double-blind fashion. patients will be monitored through one year. monitoring will occur through the measurement of blood ferritin as well as live and heart t2\* by mri initially, at 6 and 12 months.


Eligibility criteria:
inclusion criteria: 1. patients with thalassemia major with at least 6 years of age undergoing iron chelation therapy. 2. no anticipated changes in chelation regimen for the next 12 months 3. completed and signed informed consent exclusion criteria: 1. pregnancy 2. advanced class iii/iv heart failure or lvef \< 0.35% (by mri) 3. formal contra-indications to mri (pacemakers, cerebral aneurysm metal clips, etc). 4. advanced heart av block

Keywords: magnetic resonance imaging thalassemia iron overload
intraoperative local anaesthetic and postoperative pain

Conditions: Postoperative Pain

Summary: background: intraoperative wound infiltration with local anaesthetic is commonly used. apart from the obvious immediate action it has been supported that a possible down regulation of pain receptors may lead to longer effects. our aim was to compare the use of local anaesthetic versus placebo in order to assess if indeed there is a late beneficial effect. materials and methods: we will conduct a rct involving 400 consecutive general surgery patients randomized in 2 groups: group a= placebo, group b= wound infiltration with ropivacaine 10%. we will record the preoperative and postoperative pain for the 1st week as well as the type and quantity of the analgesia used during the study period. hypothesis : patients who receive intraoperatively wound infiltration with local anaesthetic have lower pain during the 1st postoperative week and require less pain killers .


Eligibility criteria:
inclusion criteria: * patients with conditions that require surgery ( general surgery) * must be able to comprehent the questions , fill documents, communicate well with the doctors * patients who will have at least one surgical incision under general or regional anaesthesia exclusion criteria: * patients who could not comprehend well * patients who remained intubated even for one postoperative day * patients who were discharged the day of the operation
biomarkers in samples from patients with b-cell acute lymphoblastic leukemia

Conditions: Leukemia

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. purpose: this research study is studying biomarkers in samples from patients with acute lymphoblastic leukemia enrolled on ecog-2993 clinical trial.

objectives: * to identify micrornas that behave as oncogenes or as tumor suppressor genes in b-lineage acute lymphoblastic leukemia (all) in vitro and in vivo. * to examine if single microrna or signatures of microrna correspond to different clinical outcomes in cytogenetically distinct b-all groups. outline: rna from archived samples are analyzed for microrna expression profile in vitro and in vivo.

Eligibility criteria:
disease characteristics: * samples from patients enrolled on ecog-2993 * samples from patients with recurrent cytogenetic abnormalities other than bcr-abl, including mll/af4, e2a/pbx1, and tel/aml1 patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: adult acute lymphoblastic leukemia in remission b-cell adult acute lymphoblastic leukemia
effects of legume intake on cardiovascular risk factors among adults at risk for diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this randomized cross-over study was designed to investigate the effects of legume enriched diet consumption on cardiovascular risk factors among first degree relatives of diabetic patients.


Eligibility criteria:
inclusion criteria: * subjects aged more than 30 years * no history of chronic diseases * no use of blood glucose lowering drugs be wiling to participate to study exclusion criteria: * do not follow study protocol * incidence of chronic diseases during the study * to start use of blood glucose lowering drugs or to change dose and type of current medications
a web-based calculator predicts heterogeneous frailty trajectories

Conditions: Gastric Cancer

Summary: to explore the predictive factors of frailty trajectories and develop a web-based nomogram among gastric cancer survivors.

the aims of this study are to explore the predictive factors of frailty trajectories in gastric cancer patients more comprehensively based on the health ecology theory and to construct a clinically convenient web-based prediction calculator, so as to screen high-risk frailty elderly gastric cancer patients at an early stage in clinical practice, and thus to implement early interventions to improve the prognosis.

Eligibility criteria:
inclusion criteria: * diagnosed with gastric cancer by endoscopy or pathology; * age ≥60 years old; * radical gastrectomy was proposed; * be able to communicate simply in writing and verbally. exclusion criteria: * combined with other sites of malignant tumors; * combined with severe heart, liver, lung, and renal insufficiency; * recent using hormones, immunosuppressants; * with physical disabilities.

Keywords: gastric cancer
a phase 1/2 study of ba3071 in patients with solid tumors

Conditions: NSCLC; Melanoma

Summary: the objective of this study is to assess safety and efficacy of ba3071 in solid tumors

this is a multi-center, open-label study designed to evaluate the safety, tolerability, pk, immunogenicity, and antitumor activity of ba3071. phase 2 is open and currently recruiting patients with: 1. melanoma - 1l 2. nonsquamous or recurrent nsclc (type iib, iiia, iv) with single or any combination of the following mutations: kras mutation stk11 mutation keap1 mutation pd-l1 tumor proportion score (tps) \<1%

Eligibility criteria:
inclusion criteria: * patients must have measurable disease. * age ≥ 18 years * clta-4 blocking-antibody naïve * adequate renal function * adequate liver function * adequate hematological function * have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * patients must have single or any combination of the following mutations: kras, stk11, keap1 and/or pd-l1 tps \<1% * patients must be eligible for surgery (nsclc stage iib-iiia only) exclusion criteria: * patients must not have clinically significant cardiac disease. * patients must not have known non-controlled cns metastasis. * patients must not have a history of ≥ grade 3 allergic reactions to mab therapy as well as known or suspected allergy or intolerance to any agent given during this study. * patients must not have had major surgery within 4 weeks before first ba3071 administration. * patients must not have known human immunodeficiency virus (hiv) infection, active hepatitis b and/or hepatitis c. * patients must not be women who are pregnant or breast feeding.

Keywords: metastatic cancer first line melanoma first line nsclc; 1l nsclc treatment refractory melanomas nonsquamous stage iv nonsquamous recurrent 1l nsclc systemic treatment naive nonsquamous stage iib nonsquamous stage iiia kras stk11 keap1 pd-l1 tumor proportion score (tps) <1%
study on the burden of influenza-related hospitalizations and emergency room (er) visits in children in spain

Conditions: Influenza

Summary: this study aims to quantify the inpatient and er visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ari) and/or isolated fever, with or without laboratory-confirmed influenza.

the total medical cost associated with each hospitalization or er visit will also be calculated at the end of this study. the study will be conducted from october, 2010, until may, 2011. each subject will be followed-up for 21-30 days via telephone. the follow-up medical chart review will preferably be performed within 7 days after the telephone contact.

Eligibility criteria:
inclusion criteria: * subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol. * a male or female \<15 years of age at the time of study entry. a subject will become ineligible on his/her 15th birthday. * signed informed consent from the parents or guardians of the subject and signed assent from children ≥ 12 years old. * presenting with a sudden onset clinical process comprising : * isolated fever defined as: oral temperature ≥ 37.5°c / axillary temperature ≥ 37.5°c / rectal temperature ≥ 38°c / tympanic temperature on oral setting ≥ 37.5°c / tympanic temperature on rectal setting ≥ 38°c without an obvious cause. and/or * ari defined as one or more of the following symptoms: sore throat, coryza, cough, breathing difficulties. exclusion criteria: • children in foster care.

Keywords: influenza children hospitalizations spain burden
reversal of right ventricular steatosis in pulmonary hypertension

Conditions: Pulmonary; Hypertension; Steatosis; Right Ventricular Failure

Summary: the goal of this study is to elucidate the relationship between myocardial right ventricular triglyceride content (steatosis) and right ventricular dysfunction in participants with pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty acid treatment.

the investigators propose to treat 30 participants that are identified as having elevated myocardial triglyceride content (defined as greater than 0.50%) on cardiac mri with 4 grams of omega-3 fatty acids daily for six months with a primary end point of reducing right ventricular steatosis and a secondary endpoint of improving rv systolic function. the investigators hypothesize that right ventricular steatosis by cardiac mri will be associated with the degree of right ventricular systolic function by cardiac mri. in the subset of participants with elevated baseline steatosis who are treated with a lipoprotective strategy, the investigators hypothesize that six months of therapy with omega-3 fatty acids will reduce myocardial steatosis and improve right ventricular systolic function.

Eligibility criteria:
inclusion criteria: * adult men and women \> 30 years of age with a diagnosis of pulmonary hypertension (defined as mean pulmonary arterial pressure ≥25 mmhg at rest on right heart catheterization) exclusion criteria: * contraindication to mri (e.g., metallic hazards or allergy to gadolinium) * renal dysfunction (egfr \< 60 ml/min/1.73m2 as estimated by the modified diet in renal disease formula) * high risk features for nephrogenic systemic fibrosis (solitary kidney or prior renal transplant) * active pregnancy or breastfeeding (determined by urinary pregnancy test before cmr) * weight \> 550 lb or waist diameter \> 70 cm (limits for our siemens verio cmr system) * fish allergy
acl reconstruction with simple and double bundle technique using two different implants for graft fixation

Conditions: Knee Injuries; ACL Tear; ACL Injury; Sports Injury

Summary: in this study our objective is to compare two tibial acl graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.

in this study our objective is to compare two tibial acl graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports. this is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant. primary outcome is graft ligamentization assessed in mri images at 4-6 months

Eligibility criteria:
inclusion criteria: isolated acl injury for more than six weeks by physical examination and confirmed by magnetic resonance, adult non-elderly (18 to 60 years), nonobese (body mass index within the normal range) exclusion criteria: intraoperative complications requiring change in technique of reconstruction and / or anesthesia during surgery, patients undergoing cartilage piercing procedures ( such as microfractures) and / or meniscus suture, those with allergies to medications administered during anesthesia, surgery and / or post-operative patients with tourniquet time of more than two hours and patients who did not sign the consent form
cognitive-behavioral intervention to increase the practice of responsive feeding and maintain healthy weight in infants

Conditions: Prevention Childhood Obesity

Summary: introduction: childhood overweight and obesity in mexico is a serious public health problem. perceptive eating is a factor in the prevention of obesity and occurs when the caregiver recognizes the signs of hunger and satiety, responds in a timely manner to these needs. however, its implementation is often a challenge for parents. studies show that there is low knowledge and self-efficacy, as well as erroneous beliefs about food. teaching perceptive eating can lead to: the development of healthy eating habits, generate warm environments in which the interaction between parents and children is strengthened and promote self-regulation of hunger and satiety sensations and prevent overweight and obesity. interventions on responsive feeding for the prevention of healthy weight in infants under six months of age are null in mexico. objective: to evaluate the effect of the intervention: \&#34;identify and respond\&#34; aimed at mexican mothers to increase the practice of responsive feeding and maintain a healthy weight in children under 6 months of age. methodology: the present study will be a pilot clinical trial type intervention study because the preliminary effect will be evaluated where the experimental group will receive the intervention aimed at increasing the practice of responsive feeding , there will be randomization of repeated measurements by virtue of which measurements will be made at three times: before the intervention (baseline) and follow-up (post-test 3 and 6 months later). the sample consisted of 72 mothers with children younger than 6 months for each group (n=144).


Eligibility criteria:
inclusion criteria: * mother/child dyad, apparently healthy. * minimum of 12 hours postpartum and/or cesarean section. * mother who knows how to read and write. * mother who has a smartphone. * mother with internet access. * mother who agrees to participate in the study. exclusion criteria: * hospital stay of the mother/child dyad for more than 7 days after birth. * child-related exclusions: * gestational age under 37 weeks (sdg). * presence of a congenital anomaly. * physical disability that could affect feeding (e.g., cleft palate, cleft lip). * low birth weight (\< 2,500 g).

Keywords: infants responsive feeding
different modalities in reducing airborne particulate concentrations during agp for health volunteers

Conditions: Transmission, Patient-Professional

Summary: several clinical procedures have been described as aerosol generating procedure (agp), including nebulization, high-flow nasal cannula oxygen therapy, noninvasive ventilation, and bronchial hygiene treatment, etc. however, the understanding on the transmission risk of these treatments is still unclear, particularly the methods to reduce the airborne particulate concentrations during these treatments are still lacking. this study is aimed to compare different modalities in reducing airborne particulate concentrations during these aerosol generating procedures, in order to find the most effective method to reduce particle concentrations, ultimately to decrease the transmission risk and protect health care providers.


Eligibility criteria:
inclusion criteria: • ages 18-65, male or female exclusion criteria: * chronic lung disease, including asthma, copd, etc. * upper airway anatomical abnormities * pregnancy * uncontrolled diabetes, hypertension, or untreated thyroid disease * has any of the following symptoms in the last 21 days: sore throat, cough, chills, body aches for unknown reasons, shortness of breath for unknown reasons, loss of smell, loss of taste, fever at or greater than 100 degrees fahrenheit. * covid-19 test positive within 21 days.

Keywords: aerosol generating procedure high-flow nasal cannula nebulization aerosol therapy
comparison of new combination inhaler (flutiform hfa mdi 100/10 µg) versus fluticasone & formoterol administered alone in patients with asthma

Conditions: Asthma

Summary: to compare the efficacy and safety of the fixed combination asthma drug flutiform hfa mdi with its two components administered alone, fluticasone propionate and formoterol fumarate, in adult and adolescent patients with mild to moderate asthma.


Eligibility criteria:
* ages eligible for study: 12 years and above * genders eligible for study: both * prior steroid use: steroid-requiring or steroid-free inclusion criteria: * history of asthma for at least 12 months * for steriod-requiring patients, documented use of inhaled corticosteroid for at least 4 weeks prior to screening visit * for steroid-free patients, no history of inhaled steroid asthma medication for at least 12 weeks prior to screening visit * demonstrate fev-1 of 60-85% of predicted normal values at screening and baseline visit * documented reversibility of 15% within 12 months of screening or at screening visit (15% increase from pre-fev-1 levels following albuterol inhalation or nebulized albuterol administration) * symptoms of asthma during run-in * females of childbearing potential must have a negative urine pregnancy test at screening and baseline visits. females are eligible only if they are not pregnant or lactating, and are either sterile, or using acceptable methods of contraception. * must otherwise be healthy * provide written informed consent. wishes of minors must be respected. exclusion criteria: patients will not be eligible for the study if they meet any of the following criteria: * life-threatening asthma within the past year or during the run-in period. * history of systemic corticosteroid medication within 3 months before the screening visit. * history of omalizumab use within past 6 months. * history of leukotriene receptor antagonist use, e.g., montelukast, within past week. * current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. * upper or lower respiratory infection within 4 weeks prior to screening visit or during run-in period. * significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease \[copd\], cystic fibrosis, bronchiectasis). * known human immunodeficiency virus (hiv)-positive status. * smoking history equivalent to "10 pack years". * current smoking history within 12 months prior to screening visit. * current evidence or history of alcohol and/or substance abuse within 12 months prior to screening visit. * patients who are confined in institution.

Keywords: asthma fluticasone propionate formoterol fumarate pressurized metered dose inhaler hydrofluoroalkane mild to moderate asthma