Kornimate/medical-research-clean huggingface dataset:
the effect of propofol or sevoflurane on renal function

Conditions: Acute Kidney Injury; Anesthesia

Summary: this study investigates the role of the anesthetic agents propofol and sevoflurane on renal function in otherwise healthy patients undergoing basic back surgery.

water-sodium homeostasis is central for anyone undergoing surgery, and can therefore affect surgical outcome, level of postoperative care and the length of hospital stay. too much or too little fluid during surgery can affect the patients negatively. the kidneys play an imperative role in the regulation of water and sodium homeostasis, however there are lack of knowledge in how the anesthesia per se affects renal function. previous studies have shown that volatile anesthetic agents such as sevoflurane can cause fluid retention. why this happens is not completely known. we are now investigating the different affects of sevoflurane and propofol anesthesia on renal function in patients undergoing basic back surgery to elucidate if there is a difference in the risk of developing acute kidney injury.

Eligibility criteria:
inclusion criteria: * scheduled back surgery exclusion criteria: * american association of anesthesiology class 1-3 * american heart association class \>3 * bmi \>37 * insulin treated diabetes * pregnancy or breast feeding * sensistivity/allergy against anesthetic agents * inadequate understanding about the study * depressed kidney function and/or aki * depressed liver function * genetic malignant hyperthermia

Keywords: sevoflurane propofol
evaluating efficacy and safety of erlotinib versus gemcitabine plus cisplatin as neoadjuvant chemotherapy

Conditions: Non-small Cell Lung Cancer

Summary: the aim of this study is to investigate the efficacy and safety of tarceva versus combination of gemcitabine plus cisplatin as neoadjuvant treatment in patients with stage iiia-n1,n2 nsclc with egfr activating mutation in exon 19 or 21.

concurrent chemoradiation therapy remain the standard treatment for stage iiia disease, but its treatment-related life threaten toxicity limit its use for those patients. tarceva monotherapy have been demonstrated a significant improvement in overall survival and disease progression free survival when used for the treatment of patients with metastatic nsclc, after failure of at least one prior chemotherapy regimen. it is well tolerated without the side effects usually associated with chemotherapy. based on the encouraging results reported from the slcg phase ii study reported the efficacy of tarceva as first line treatment for metastatic nsclc with egfr mutation patients would prolong overall survival, delay disease progression and be well tolerated, mos reached 27 months, orr reached 71%. besides, with different mechanism and more tolerable than chemo, tarceva may provide an important treatment alternative for local advanced pts with egfr mutation.

Eligibility criteria:
inclusion criteria: * pathologically diagnosed of non-small cell lung cancer * diagnosed as stage iiia-ni, n2, except for t4n1m0 * the diagnosis standard of n1 or n2 is as below: * the short axis of n1 lymph node of stage iiia-n1 must be ≥ 10 mm on computed tomography, and the standard uptake value (suv) on pet-ct of n1 lymph node must be \> 2.5 exclusion criteria: * patients with prior exposure to agents directed at the her axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab) * patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy) * resection of primary malignancy
acute effects of moderate versus high intensity exercise on insulin sensitivity in gestational diabetes mellitus

Conditions: Diabetes, Gestational

Summary: exercise training is recognized as effective in preventing and treating many chronic metabolic disorders (1), and long-term exercise programmes have similar effects on glucose control as long-term drug or insulin therapy in type 2 diabetic patients (2). the precise intensity and volume of aerobic exercise needed to produce the most wanted effects on targeted risk factors for subjects at risk of/with established type 2 diabetes, is still uncertain. in this study the investigators will investigate the acute effects of a single bout of moderate versus high intensity exercise on insulin sensitivity in pregnant women with and without gestational diabetes mellitus (gdm). the investigators think that very short bouts of high intensity exercise can be a way to reduce blood glucose in these women.


Eligibility criteria:
inclusion criteria: * pregnant * gestational diabetes mellitus or normal glucose tolerance * able to exercise exclusion criteria: -

Keywords: exercise exercise therapy insulin resistance
intensive nutrition in acute respiratory distress syndrome (ards): a clinical trial (intact)

Conditions: Acute Lung Injury

Summary: the investigators propose a prospective randomized clinical trail to evaluate the impact of intensive medical nutrition therapy (imnt) in patients with acute respiratory distress syndrome (ards) or acute lung injury (ali) on short and long-term outcomes. participant's (n = 200) will be randomized to receive either standard care (sc e.g. ad lib feeding of standard food) or imnt provided early as enteral nutrition (en) and continued as intensive diet therapy tailored to maximize oral intake until hospital discharge. primary outcomes evaluated include infections while hospitalized, immune parameters (cd4 and cd8 cells, serum il-10 and leptin levels, numbers of t regulatory cells and markers for t cell anergy), days on mechanical ventilation, in the icu and hospital , and changes in fat free mass(measured by dual energy x-ray absorptiometry), weight, muscular weakness (measured as hand grip strength), fatigue (measured as distanced traveled in 6-minute walk) and pulmonary function.

this study was terminated early due to greater deaths occurring in the intervention group vs the control group. there were a total of 22 deaths, 16 in the intervention and 6 in the control.

Eligibility criteria:
inclusion criteria: adult patients (\> 18 years) with a diagnosis of acute lung injury, with viable gi function for enteral feeding - exclusion criteria: patients who are (1) transferred from another icu, (2) previously admitted to the icu during the same hospitalization, (3) do not resuscitate status or \< 12 month perceived survival due to underlying disease state (4) severely immunosuppressed, (5) immobility prior to icu admission, (6) documented neurological disease prior to admission. -

Keywords: nutrition enteral feeding parenteral feeding hospital malnutrition
contrast (sonazoid)-enhanced us as a screening tool for hepatocellular carcinoma in cirrhosis: an exploratory cross-sectional study

Conditions: Hepatocellular Carcinoma (HCC)

Summary: b-mode ultrasonography (b-us), a standard method of surveillance of hepatocellular carcinoma (hcc), has a fair sensitivity of 63% in detecting early stage hcc. sonazoid, a contrast agent for ultrasonography, has reported to have superior sensitivity in detecting focal liver lesion since it has ability of kupffer phase imaging as well as vascular phase imaging. so our aim is to compare the detection rate of early stage hcc and false referral rate of hcc between b-mode us and sonazoid-enhanced ultrasonography (s-us) within the same prospective data group. our hypothesis is that s-us has superior detection rate of early stage hcc (5%) than that of b-mode us (3%).


Eligibility criteria:
inclusion criteria: 1. patient 20 years old or older, 2. patient at high risk of hcc and is supposed to take ultrasonography, 3. patient who has no suspicious hcc on previous examinations or patient who undergoes the first surveillance, 4. patient who has liver cirrhosis proven by one of the following methods-liver biopsy (metavir score 4), identification of esophageal or gastric varix by endoscopically or radiologically, surface nodularity on ultrasonography, ct or mri, platelet count less than 100,000/mm3, serum albumin less than 3.5 g/dl, or prothrombin time higher than 1.3 inr, 5. patient without contraindication for sonazoid, 6. patient willing to sign the informed consent exclusion criteria: 1. patient on pregnancy or breast feeding, 2. patient with allergy to egg, 3. patient with left-to-right shunt, respiratory insufficiency, or severe pulmonary hypertension, 4. patient with history of hcc, 5. patient with history of malignancy other than hcc -

Keywords: hcc sonazoid ultrasonography screening
a study to describe the switching from a first- or second-line disease modifying therapy (dmt) to ozanimod in participants with relapsing remitting multiple sclerosis (rrms)

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line disease modifying therapy (dmt) to ozanimod in participants with relapsing remitting multiple sclerosis (rrms).


Eligibility criteria:
inclusion criteria: * patients with rrms according to 2017 revised mcdonald criteria * patients who switched a previous first or second line dmt to ozanimod between 4 and 12 weeks before the enrollment * patient with a mri performed within three months before the enrollment * patient eligible to ozanimod according to smpc exclusion criteria: * patients with clinical forms of ms other than rrms * patients unable to participate for various reasons * patients participating in another clinical study with an investigational product if the study considers the switching behavior as an endpoint or objective * contraindications to ozanimod according to smpc other protocol-defined inclusion/exclusion criteria apply.

Keywords: multiple sclerosis ozanimod
premolar extractions for obstructive sleep apnea in children with overjet

Conditions: Obstructive Sleep Apnea; Malocclusion

Summary: this research aims to provide pediatric patients with polysomnography (a sleep study) before and after orthodontic treatment to determine if the extraction of upper premolars for treating excessive overjet results in an increase of the ahi (apnea hypopnea index) compared to similar patients treated without upper premolar extractions.


Eligibility criteria:
inclusion criteria: * 10-15 years old * registered orthodontic patients * able to undergo routine orthodontic care and are registered to obtain an orthodontic appliance in the future. * do not have a high care need * no known hypercapnia or hypoventilation * no known allergies or nose blockages * diagnosed as class ii division i (=6mm of overjet) and bilateral class ii half cusp or unilateral class ii full cusp. exclusion criteria: * known hypercapnia or hypoventilation * patients with hypertrophic tonsils and adenoids * patients with allergies or nose blockages that interfere with breathing * patients who are not registered as orthodontic patients at research sites deemed acceptable to undergo routine orthodontic care

Keywords: orthodontic braces extraction teeth overjet
pharmacokinetic and pharmacodynamic profiles of albuterol spiromax® and proair® hydrofluoroalkane (hfa) in pediatric patients with asthma

Conditions: Asthma

Summary: the primary objective of this study is to compare the pharmacokinetic (pk) profiles of albuterol spiromax® and proair hfa after administration of a single inhaled dose of 180 mcg albuterol base from each product.

this is a single center, open-label, 2-period crossover study. the study consists of a screening visit followed by a treatment period comprising 2 treatment visits. the treatment period visits will be separated by a 4 to 14-day washout period. eligible patients will be kept overnight prior to each treatment period.

Eligibility criteria:
inclusion criteria: 1. written informed consent/assent signed and dated by the patient and/or parent/caregiver/legal guardian (as appropriate) before conducting any study-related procedure. 2. male or pre-menarchal female patient 4-11 years of age, inclusive, as of the screening visit (sv) 3. has a documented physician diagnosis of persistent asthma of a minimum of 3 months duration that has been stable for at least 4 weeks prior to the sv. the asthma diagnosis must be in accordance with the national asthma education and prevention program guidelines expert panel report 3 (epr3). 4. forced expiratory volume in 1 second (fev1) \>80% predicted for age, height and gender and race at the sv based on the pediatric population standards. 5. any patient being treated with inhaled corticosteroids (ics) must be on a lowdose regimen (200 mcg or less of fluticasone propionate per day or equivalent), which has been stable for at least 4 weeks prior to the sv and which is expected to be maintained for the duration of the study 6. has required less than 4 inhalations per week of a rescue bronchodilator (on average) for the 4 weeks preceding the sv 7. has the ability to withhold inhaled albuterol for at least 72 hours preceding each treatment visit (tv). * other criteria apply, including must weigh at least 45 pounds exclusion criteria: 1. a known hypersensitivity to albuterol or any of the excipients in the inhaler formulations (lactose, ethanol, etc.) 2. participation (receiving study drug) in any investigational drug trial within the 30 days preceding the sv or planned participation in another investigational drug trial at any time during this trial 3. history of severe milk protein allergy 4. proneness to orthostatic dysregulation, syncope, or blackouts 5. history of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza) that has not resolved within 2 weeks preceding the sv. 6. history of life-threatening asthma or that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures 7. any asthma exacerbation requiring systemic corticosteroids within 3 months of the sv. a patient must not have had any hospitalization for asthma within 6 months prior to the sv. * other criteria apply.

Keywords: persistent asthma albuterol spiromax® proair® hfa pediatric patients phase 1
a phase 1 study of ub-vv111 with and without rapamycin in relapsed/refractory cd19+ b-cell malignancies

Conditions: Lymphoma, B-Cell; Lymphoma, Non-Hodgkin (NHL); Lymphoma, Large B-Cell, Diffuse (DLBCL); Chronic Lymphocytic Leukemia (CLL)

Summary: this study is a phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of ub-vv111. the study will enroll patients with relapsed/refractory large b-cell lymphoma (lbcl) and chronic lymphocytic leukemia (cll).


Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. provides voluntary written informed consent 3. relapsed or refractory large b-cell lymphoma (lbcl) or chronic lymphocytic leukemia (cll) 4. measurable disease according to lugano 2014 criteria (lbcl) or iwcll 2018 (cll). 5. no serious concomitant diseases or active/uncontrolled infections 6. eastern cooperative oncology group (ecog) performance status of 0 or 1 7. adequate organ function 8. patients who have previously received cd19-directed therapy must have biopsy confirming cd19 expression following completion of prior cd19-directed therapy. exclusion criteria: 1. women who are pregnant or breastfeeding 2. current isolated central nervous system (cns) involvement 3. prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except car t-cell therapy in car t-exposed subjects) 4. history of or active human immunodeficiency virus (hiv) 5. active hepatitis b or c 6. systemic autoimmune or immunodeficiency diseases, except for well-controlled type i diabetes or thyroid disease 7. ongoing cns disease that would preclude neurologic assessment 8. uncontrolled angina or other acute heart disease 9. currently receiving treatment in another interventional clinical trial.

Keywords: car t cd19 chimeric antigen receptor
neuromodulation vs. electrolysis in plantar fasciitis

Conditions: Plantar Fascitis

Summary: the aim of the present study will be the implementation of two protocols in plantar fasciitis individuals: a) percutaneous neuromodulation, b) percutaneous electrolysis in plantar fascia. authors hypothesized that percutaneous neuromodulation may have benefits in: pain, quality of life, muscular structure.


Eligibility criteria:
inclusion criteria: * patiens with plantar fasciitis exclusion criteria: * lower limb disturbances * sistemic diseases * not involved in other drug or manual therapy interventions * infections

Keywords: pain plantar fasciitis ultrasound imaging quality of life
multimodal prehabilitation for surgery in the elderly: a randomised, prospective, multicenter, multidisciplinary trial

Conditions: Frail Elderly Syndrome; Major Surgery

Summary: this multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients.

postoperative complications occur in up to 50% of patients and major surgery is associated with a 20 to 40% reduction in physiological and functional capacity. the elderly have surgery 4 times more often than the rest of the population, thus in the future a major proportion of patients presenting for surgery will be older than 65 years. elderly patients have more postoperative complications, a longer convalescence and higher surgical morbidity and mortality. the number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological state, and smoking behavior. another population most probably to benefit from such a program are cancer patients with decreased functional health after cancer treatment. cancer prehabilitation affords an opportunity for the patient to improve functional status while waiting to begin treatment. this is a patient group expected to grow in the future. this is a multicenter, multidisciplinary, 2 arms (standard, n=233 vs intervention i.e. prehabilitation, n=233), randomised controlled trial (rct). the prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. this multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, morbid patients. the primary outcome is measured by the comprehensive complication index (cci). secondary outcomes are physical parameters measured by cardio-pulmonary exercise testing (cpet), grip strengh, nutritional risk score (nrs). further outcomes are amongst others smoking behavior, haemoglobin concentration, days at home at 30 days (dah30) and quality of recovery 15 (qor15).

Eligibility criteria:
inclusion criteria: * written informed consent * comorbid (≥asa 3) * pre-existing fitness deficit: at\ 33 * scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular surgery * screening at least 2 weeks prior to surgery exclusion criteria: * paralysis or patients with mobility problems (who are unable to exercise), * premorbid conditions or orthopaedic impairments that contraindicate exercise, * cognitive disabilities, * chronic renal failure (need for dialysis) * emergency procedures.

Keywords: comprehensive complication index
bupivacaine 0.125% versus bupivacaine 0.25% in superficial cervical plexus block for tympanomastoid surgeries in adults

Conditions: Surgical Field; Acute Postoperative Pain

Summary: bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. pain is also one of the most annoying complications of tympanomastoid surgeries. thus, adequate surgical field visualization is utmost important. a bloodless field allows optimal exposure and identification of vital neurovascular structures. even small bleeding, inconsequential for the patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications. the use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years. the superficial cervical plexus block (scpb) provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions. the superficial cervical plexus (scp) provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery. this is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with scpb using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery. this study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% \& 0.25% in superficial cervical plexus block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia. the investigators hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia. this prospective double-blinded study will be carried out on 60 patients between 21 to 70 years, with asa i-ii and undergoing tympanomastoid surgery. participants were equally divided into two groups: group a: patients received scpb using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). group b: patients received scpb using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline).


Eligibility criteria:
inclusion criteria: 1. adults between 21 - 70 years. 2. patients undergoing tympanomastoid surgery. 3. both genders. 4. asa physical class i and ii. exclusion criteria: 1. patient refusal. 2. uncooperative patients. 3. allergy to the drug enrolled in the study. 4. anatomical abnormality at injection site. 5. infection at injection site. 6. bleeding disorders. 7. asa physical class iii and iv patients. 8. patients having significant chronic diseases as: uncontrolled asthma, cardiovascular disorders (significant arrhythmias, severe valvular diseases, congenital heart diseases, ischemic heart disease, or cardiomyopathy). 9. renal impairment (creatinine level ≥ 2mg/dl), or uncompensated chronic liver disease.