Kornimate/medical-research-clean huggingface dataset:
medical therapy versus balloon sinus dilation for patients with chronic rhinosinusitis

Conditions: Sinusitis

Summary: this post-market study aims to compare health outcomes for chronic rhinosinusitis (crs) patients treated with balloon sinus dilation (bsd) versus continued medical management.


Eligibility criteria:
inclusion criteria: * males and females aged 19 or greater * diagnosis of chronic rhinosinusitis (crs) * failure of appropriate medical management * radiographic evidence of inflammation of the paranasal sinuses * surgical candidate * willing and able to read and sign the informed consent form and remain compliant with the protocol and study procedures * able to read and understand english exclusion criteria: * not suitable for balloon dilation for all peripheral sinuses that require treatment * clinically significant illness that may interfere with the evaluation of the study * patients involved in other clinical studies 30 days prior to study * pregnant or lactating females * patients unable to adhere to follow-up schedule or protocol requirements
fluoroscopic analysis of pfc cr 150 versus standard pfc cr total knee arthroplasty implants in deep flexion

Conditions: Knee Osteoarthritis

Summary: the investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. in the study arm, the implant used was a sigma cruciate retaining (cr) press fit condylar (pfc) 150, which is a high flexion knee system designed to combine function with wear resistance. it can accommodate up to 150 degrees of knee flexion. in the cohort arm, the implant used was the standard sigma cr which can accommodate up to 120 degrees of flexion.

both sets of patients will undergo routine post-operative follow up in clinic. the study involves patients who had their surgery more than 2 years ago. we assess their range of movement using fluoroscopy. they are asked to perform lunges, squats and climbing up and down 3 steps. the fluoroscopic images are then analysed to assess their individual range of movements.

Eligibility criteria:
inclusion criteria: * all patients who underwent total knee replacement surgery who received either the pfc cr 150 knee implants or the pfc cr standard knee implant * surgery more than 2 years * able to walk, climb stairs exclusion criteria: * knee stiffness with less than 100 degrees of knee range of movement * patients who required revision surgery * patients who received an all polyethylene tibial insert * patients who received rotating platform tibial tray

Keywords: knee osteoarthritis
transvaginal appendectomy

Conditions: Appendicitis

Summary: the purpose of this study is to determine the feasibility and safety of transvaginal appendectomy and determine and compare the postoperative pain and quality of life after surgery to standard laparoscopic transabdominal appendectomy.


Eligibility criteria:
inclusion criteria: * ultrasound or ct-based diagnosis of acute or chronic appendicitis * asa classification 1 or 2 exclusion criteria: * bmi \>35 * on immunosuppressive meds or immunocompromised * on blood thinners or aspirin or abnormal coagulation tests * h/o ectopic pregnancy, pid or endometriosis * prior open abdominal surgery or transvaginal surgery * with diffuse peritonitis * evidence of abscess * retroflexed uterus * non english speaking

Keywords: appendicitis surgery laparoscopy natural orifice transluminal surgery
study of su011248 plus gefitinib (iressa) in patients with advanced renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: to assess the maximum tolerated dose and overall safety and tolerability of sunitinib \[su011248\] administered in combination with gefitinib (iressa) for the treatment of patients with metastatic renal cell carcinoma (phase 1). to assess antitumor activity of the combination of gefitinib and sunitinib (phase 2).


Eligibility criteria:
inclusion criteria: * histologically confirmed renal cell carcinoma with metastases * evidence of unidimensionally measurable disease * failure of 1 prior immunotherapy or no prior systemic therapy for metastatic rcc exclusion criteria: * rcc without any clear (conventional) cell component * history of or known brain metastases * uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry
effect of prehabilitation on the lean mass index (imm) in eras programm.

Conditions: Colo-rectal Cancer; Nutrition Disorders

Summary: the implementation of prehabilitation in patients operated on for colon cancer in a multimodal rehabilitation regimen improves the values of the "lean body mass" or lean mass index, positively influencing the results of clinical, analytical and radiological nutritional values pre- and postoperatively and in morbi-mortality, recovery, average stay and re-entry rates.


Eligibility criteria:
inclusion criteria: * it is considered that the subject suffers a confirmed diagnosis of colon cancer and is going to undergo surgery on a scheduled basis under a rhmm program. * the subject is ≥ 18 years of age. * the subject can perform any of the two proposed treatments. * preoperative staging txnxm0. * the patient has voluntarily signed and dated an informed consent document (ic), approved by an independent ethics committee (ceic) before participating in the study. exclusion criteria: * patients with rectal cancer. * the study doctor determines that the subject is not eligible to participate. * the subject can not give informed consent to participate in the study. * the subject can not perform the pre-habilitation. * non-acceptance or impossibility of following rehabilitation protocol multimodal * the subject was previously scheduled at the time of the inclusion of the nutritional supplement study, whether it is different or the same that would be scheduled at this time * subjects who have received previous radiochemotherapy, hiv, gestational stage, psychiatric, with crf who are undergoing renal replacement techniques, urgent surgery, with intestinal obstructions, with uncontrolled infections, urgent surgery, distant metastasis, asa iv, advanced liver failure, severe coagulation disorder, severe hyperlipidemia and hyperglycemia or difficult to control. * subject has renal or hepatic impairment (gfr \<60ml / m or ast / alt 3 x upper limit of normal).

Keywords: colon cancer eras nutrition
effect of metformin on vascular and mitochondrial function in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: insulin resistance (ir) is an important contributor to increased cardiovascular disease risk in type 1 diabetes (t1d). the purpose of this study is to measure the effect of metformin on insulin sensitivity, vascular function and compliance, and mitochondrial function in t1d. the long term goal is to identify novel non-glycemic approaches to managing cardiovascular disease risk in t1d. the results of this study may validate a novel approach to t1d treatment that could significantly improve current management of cardiovascular disease risk in this high risk population.


Eligibility criteria:
inclusion criteria: * age 20-59 years of age, * type 1 diabetes based on antibody-positivity, rapid persistent conversion to insulin requirement after diagnosis, absent c-peptide, or dka at diagnosis, or a clinical course consistent with t1d, * hba1c 6.0 - 9.5, and * willing and able to commit to two 6 week-long periods of blinded medication followed by hyperinsulinemic euglycemic clamp, vascular testing, and muscle biopsies. exclusion criteria: * any comorbid condition associated with: * inflammation, * insulin resistance, or * dyslipidemia including: 1. cancer, 2. heart failure, 3. active or end stage liver disease, 4. kidney disease, or 5. rheumatological disease; * tobacco use; * pregnancy or women who are breastfeeding; * steroid use; * scheduled strenuous physical activity \>3 days a week; * angina, known cad, or any other cardiovascular or pulmonary disease; * a history of copd or asthma; * presence of systolic blood pressure \>190 at rest or \>250 with exercise, or diastolic pressure \>95 at rest or \>105 with exercise; * untreated thyroid disease; * proteinuria (urine protein \>200 mg/dl) or a creatinine \> 1.5 mg/dl (males) or 1.4 mg/dl (females), suggestive of severe renal disease; * severe proliferative retinopathy; * niacin treatment; * administration of experimental agent for t1d within 30 days prior to screening; * recent (prior 6 months) or current metformin or thiazolidenedione use; * hypoglycemia unawareness or recurrent severe hypoglycemia (no symptoms of hypoglycemia with fsbs\ 1 per week); * weight instability (weight change \>5% in last 6 months); * history of any organ transplant, including islet cell transplant; * current or prior infection with hiv, hepatitis b or hepatitis c or hepatic -insufficiency (ast or alt \> 2x the upper limits of normal); * any condition, medical or otherwise that would, in the opinion of the investigator, prevent complete participation in the study, or that would pose a significant hazard to the subject; * history of substance abuse within the 12 months prior to screening.

Keywords: diabetes insulin metformin vascular vessels type 1
rapid sequence intubation with rocuronium in elderly patients

Conditions: Rapid Sequence Induction; Rapid Sequence Intubation; Rocuronium

Summary: with the prolongation of life expectancy, the frequency of surgical intervention and anesthesia increases in elderly patients. the rapid sequence intubation(rsi) technique is preferred in patients with aspiration risk and who will undergo general anesthesia, especially in the pandemic period, to reduce or eliminate the aerosolization of respiratory secretions. the use of rocuronium at a dose of 1 mg/kg in rsi also causes prolongation of the recovery of neuromuscular block. this study aimed to compare the intubation conditions and train-of-four count(tofc) 1-2 times of the rocuronium doses with priming according to ideal body weight(ibw), corrected body weight(cbw), and total body weight(tbw) in rsi of patients aged \>65 years.

the number of elderly patients (\>65 y) increases, and a large proportion of these patients will require surgery and anesthesia at some point. changes in the neuromuscular junction, organ systems, and cardiac output that occur with aging cause changes in response to neuromuscular blockers. one of the reasons for rapid sequence intubation(rsi) preference is to reduce or eliminate aerosolization of respiratory secretions during general anesthesia and airway manipulation in surgical cases during the pandemic period. guidelines regarding this subject recommend securing the airway quickly with rsi, and it is reported that aerosol production would decrease with this method. this study aimed to compare the intubation conditions and the train-of-four count (tofc) 1 and 2 response times of the patients aged 65 and above, who were administered rocuronium at a priming dose (0.06 mg/kg) according to ideal body weight(ibw), corrected body weight(cbw), and total body weight (tbw) before induction, followed by administration of 0.94 mg/kg rocuronium 3 minutes after the anesthesia induction and intubated 45 seconds later.

Eligibility criteria:
inclusion criteria: * elective abdominal surgery * age \> 65 years * asa i-ii -iii exclusion criteria: * patient with history of allergy to rocuronium * body mass index \> 35 kg/m2 * patient who had history of difficult intubation or high possibility of difficult intubation * neuromuscular disease * kidney failure (gfr \< 30 ml/dk/m2)

Keywords: rapid sequence induction and intubation rapid sequence intubation rocuronium geriatrics
active breathing coordinator-based vs visionrt-based deep inspiration breath-hold for radiation for breast cancer

Conditions: Breast Cancer

Summary: female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of active breathing coordinator (abc)-assisted and visionrt-assisted deep inspiration breath-hold (dibh).

female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of abc-assisted and visionrt-assisted dibh. residual motion during breath-hold will be quantitatively assessed using mv fluoroscopy from the treatment beam itself (i.e., no additional radiation dose). the dosimetric impact of residual motion on organs at risk (heart and lung) will be assessed by applying rigid and/or deformable displacements to the planning ct images, computing the 3d dose map and comparing with the original planned dose map.

Eligibility criteria:
inclusion criteria: * women with diagnosis of breast malignancy * women whom requires left chest wall post-mastectomy radiation with or without bolus * age ≥ 18 years. * performance status ecog \</=3 * women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately ability to understand and the willingness to sign a written informed consent. * patient must be able to maintain a 30 second breath hold. * conventional chest wall radiation delivery dose of 50.4 gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints) exclusion criteria: * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
measuring brain activity of school age children

Conditions: Perinatal Hypoxia; Dopamine; Neurobehavioral Manifestations

Summary: this observational study will investigate whether differences in birth events and oxygen levels during the newborn period affects the brain activity of children during the middle childhood years.

the investigators will conduct an observational study comparing two groups of children to determine whether differences in birth events and oxygen levels during the newborn period lead to structural and functional impairment within the brain's dopaminergic pathways and the cortical regions innervated by those pathways. the dopaminergic system is involved in modulating motor control and cognitive function. using magnetic resonance diffusion tensor imaging, structural integrity of dopaminergic circuits will be quantified and compared in post-hypoxic former preterm children versus healthy control children born at term closely matched by age/sex/race. functional activity during executive function tasks will be quantified and compared in post-hypoxic former preterm children versus healthy control children born at term using functional magnetic resonance imaging-blood oxygen level dependent (fmri-bold). assessment of motor function (grooved pegboard task) will also be performed.

Eligibility criteria:
inclusion criteria: 1. for study group children: birth gestational age between 23-28 weeks and birth weight appropriate for gestational age (aga) with available oxygen saturation level data recorded continuously from the first day of life to 8 weeks postnatal age (n=11) 2. for healthy control children: birth gestational age ≥ 38 weeks gestation and birth weight appropriate for term gestation (n=10) matched by age/sex/race to participating cohort children. 3. born in years 2005-2009 (age range will be 8-15 years during the funding period) 4. ability of the child to provide assent, with the parent/legal guardian able to provide written informed consent for study procedures. 5. sensory and motor capability to complete study tasks (i.e. grooved pegboard test). mental development index must be \> 80 at 2-year-old follow-up for preterm cohort. exclusion criteria: 1. past history of concussion requiring medical treatment to avoid confounding of mri data 2. current diagnosis of autism. 3. child who suffers from claustrophobia (per parent report). 4. unable to participate in neuroimaging due to claustrophobia, or medical contraindication to mri including any implanted medical device, dental braces, surgical clips for aneurysms in the head, heart valve prostheses, electrodes or other metallic objects, pregnancy. 5. healthy control children who were treated in the neonatal icu in the newborn period for breathing difficulties. 6. healthy control children who were hospitalized for breathing problems in the first 3 months of infancy.

Keywords: hypoxia, brain neural networks magnetic resonance imaging
the effect of adding nalbuphine to intrathecal morphine on analgesic efficacy and side effects after cesarean section

Conditions: Postoperative Pain

Summary: the primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and morphine related side effects post- cesarean delivery.

the study will be performed in assiut university hospitals, after obtaining approval from the local ethics committee and written informed patient consent. all patients will have a peripheral iv cannula 18 g inserted; standard non-invasive monitors will be applied. all the patients will be preloaded with 10 ml/kg ringer's lactate solution intravenous. intrathecal block under strict aseptic conditions will be performed in sitting position at l3-4 or l4-5 inter-spinous space with 25g pencil-point spinal needle. all patients will receive intrathecal 10 mg of 0.5% hyperbaric bupivacaine.

Eligibility criteria:
inclusion criteria: * female patients * age between 16 to 40 years * asa physical status i - ii exclusion criteria: * infection at the site of injection. * coagulopathy or other bleeding diathesis. * preexisting neurologic deficits. * history of hypersensitivity to any of the given the drugs. * inability to communicate with the investigator and the hospital staff. * history of chronic opioid us
scalpel versus electrocautery for surgical skin incision in open carpal tunnel release

Conditions: Carpal Tunnel Syndrome

Summary: the use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. this study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (octr).

the use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. this study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (octr).

Eligibility criteria:
inclusion criteria: * age 18 - 60 years * scheduled to undergo open carpal tunnel release (octr) by a study group member * gives informed consent * diagnosis of chronic carpal tunnel syndrome exclusion criteria: * -any current underlying systemic illness or condition that may affect wound healing (e.g. diabetes or chronic vascular disease) * history of severe systemic or focal illness (e.g. previous myocardial infarction, chronic obstructive pulmonary disease) * chronic skin condition in the affected upper limb (e.g. psoriasis) * pregnancy * inability to comprehend the consent form (in finnish) or inability to give consent * previous surgery or scar in the palmar aspect of the affected wrist * recurrent carpal tunnel syndrome * previous significant trauma of the affected upper extremity (including distal radius fracture) or suspicion of acute onset carpal tunnel syndrome
effects of different exercise training on atrial function in hypertension

Conditions: Hypertension; Coronary Artery Disease

Summary: the study aim is to compare the effects produced by two different exercise training modalities on atrial function evaluated by speckle-tracking echocardiography on hypertensive patients with coronary artery disease. 50 males patients will be randomized to interval training or combined training the latter including both aerobic and resistance exercises. the training period will last 12 weeks. the protocol will provide two different assessment of atrial function: -acute: after a single session of exercise; - 12 weeks: at the end of exercise training protocols.

this is a prospective randomized two- arms, single-blinded, parallel trial evaluating the effects of two different exercise training modalities on atrial function, assessed by speckle-tracking echocardiography, on hypertensive patients with coronary artery disease. first endpoint will be: between-groups comparison of exercise-induced changes on peak atrial longitudinal strain (pals). secondary endpoints will be: exercise-induced changes on diastolic function and left ventricular strain. we will include 50 patient with hypertension and underlying coronary artery disease, evaluated for entering a cardiac rehabilitation program. patients that will be judged suitable for the study will be randomized, with a 1:1 ratio, to interval training (it) or combined training (ct) the latter including both aerobic and resistance exercises. each patient will undergo three visits. at visit 1 in which patients will perform a first echocardiography with evaluation of the acoustic window and an ergometric test (for excluding myocardial ischemia and for establishing the training intensity); visit 2- acute evaluation- :patients will undergo an echocardiographic assessment before and within 30 minutes after a single exercise session (alternatively interval or combined training according to the randomization code). visit 3: at 12 weeks all patient will perform a final echocardiography evaluation and a second ergometric test. patients of both groups will exercise three times/week for 12 weeks. each exercise session will last 45 minutes

Eligibility criteria:
inclusion criteria: * hypertension; * coronary artery disease; * age over 45 years; * male gender exclusion criteria: * secondary hypertension; * significant heart valve diseases; * hypertrophic cardiomyopathy; * signs and/or symptoms of myocardial ischemia during an ergometric test; * uncontrolled arrhythmia; * neurological and or orthopedic conditions contraindicating or limiting exercises; * significant chronic obstructive pulmonary disease (fev1 \<50%), * symptomatic peripheral arterial disease

Keywords: atrial function; hypertension; coronary artery disease
comparing different routes and doses of phytonadione (vitamin k) for reversing warfarin treated patients with hip fracture before surgery

Conditions: Bleeding; Complications

Summary: it is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical intervention is the preferred treatment. any delay in operating on such patients would inevitably increase their risk of developing complications. one of the reasons for such unintentional delay would be the hypercoagulative status of patients taking warfarin. the chest 2008 guidelines suggest reversing warfarin with vitamin k for patients who need urgent operation. the aim of this study is to compare different roots and doses of vitamin k.


Eligibility criteria:
inclusion criteria: * hip fracture patients on warfarin exclusion criteria: * pregnancy * vitamin k sensitivity

Keywords: hip fracture warfarin vitamin k phytonadione inr level