Kornimate/medical-research-clean huggingface dataset:
physical rehabilitation evaluation and optimal physical therapy (pre-opt)

Conditions: Breast Cancer

Summary: phase 1: the investigators will conduct a prospective study to quantify the association between axillary web syndrome (aws) and metastatic disease and chronic morbidities such as lymphedema, shoulder dysfunction, and pain comparing women (i) with aws and (ii) without aws in two cohorts of women. (n=200) phase 2: this is a randomized controlled trial to 1) quantify the effects of (i) physical therapy compared to (ii) a control group in individuals with aws following breast cancer surgery related to physical activity and physical impairments such as lymphedema, shoulder motion, function, and pain (n=44, 22 in each group). funding to progress to phase 2 of this trial has been obtained. it is anticipated 120 subjects participating in phase 1 will be screened for eligibility for phase 2 (separate consent and eligibility from phase 1).


Eligibility criteria:
inclusion criteria: * age ≥ 18 * patients (female or male) with a tissue diagnosis of non-invasive or invasive breast cancer * planned surgical breast cancer treatment (lumpectomy or mastectomy) with a minimum removal of one axillary lymph node by sentinel node biopsy. contralateral prophylactic mastectomy or bilateral mastectomy is allowed. * voluntary written consent signed before performance of any study-related procedure not part of normal medical care exclusion criteria: * patients (patients unable to travel easily to the university of minnesota medical center for post-surgery visits). * synchronous bilateral breast cancer * presence of a medical complication that would prevent the patient from being able to participate in the study, such as terminal cancer * previous history of upper extremity deep vein thrombosis * breast cancer surgery without lymph node removal
exteriorized versus in situ uterine repair at cesarean delivery

Conditions: Vomiting; Nausea; Pain; Hypotension; Tachycardia

Summary: this study was undertaken to compare the two techniques (exteriorized vs in situ) of uterine repair with respect to patient comfort, hemodynamic changes, surgical time and blood loss, in patients undergoing elective cd under a strictly standardized spinal anesthetic. we hypothesized that in situ uterine repair would be more comfortable for the patients.

uterine repair during cesarean delivery can be done either by exteriorizing the uterus and replacing it into the abdominal cavity after the completion of a double layer closure, or by suturing it in situ. exteriorization of the uterus has been shown to decrease blood loss during cesarean delivery when compared to in situ repair. however, at the same time, it is thought to be uncomfortable for the patient with respect to intraoperative nausea, vomiting and pain. intraoperative nausea and vomiting in patients who receive regional anaesthesia for cesarean section is a complex multifactorial problem arising from anesthetic and non-anesthetic causes. additionally, it can influence hemodynamic stability. the study was a prospective, randomized and single blinded study. it compared the effects of exteriorization of the uterus and in-situ repair during cesarean delivery with respect to patient's comfort, hemodynamic changes, uterine contractility and blood loss in patients under spinal anesthesia. all low risk patients undergoing elective c-delivery under spinal anesthesia were considered for this study. spinal anesthesia was performed in the sitting position with 10-12 mg of 0.75% hyperbaric bupivacaine, mixed with 100 mcg of preservative free morphine and 10 mcg of fentanyl. any drop in blood pressure was treated with 100 mg of phenylephrine titrated to maintain systolic blood pressure within 10% of the baseline values throughout the procedure. oxytocin was used judiciously, in aliquots of 0.5 iu. obstetricians were asked to allow assisted spontaneous delivery of placenta rather than manual extraction. during surgery, patient's complaints of nausea, vomiting, pain or any discomfort were recorded.

Eligibility criteria:
inclusion criteria: * healthy pregnant women scheduled for elective cesarean delivery exclusion criteria: * asa iii or iv patients * patient with conditions that predispose to uterine atony and post partum hemorrhage

Keywords: cesarean delivery spinal anesthesia nausea vomiting pain
effects of sustained reading on the ocular surface

Conditions: Dry Eye Syndromes; Sjogren's Syndrome

Summary: this research is being done to to see if changes in visual reading function correlate with changes in optical and retinal image quality. we hypothesize that changes and deterioration in tear film quality and dynamics may have a negative effect on reading function. people with or without dry eye syndrome may enroll.


Eligibility criteria:
general inclusion criteria for all subjects will include: * ages 50 to 89 years * capacity to give informed consent. * self-reported literacy (i.e. a "yes" answer to the question "have you learned how to read?") additional inclusion criteria for the dry eye group will include both of the below: * a previous diagnosis of dry eye syndrome by an eyecare specialist * ocular surface disease index total scoring of 13 or above additional inclusion criteria for the sjögren's syndrome group will include: - a previous diagnosis of sjögren's syndrome by an immunology specialist, per acr criteria 22 additional inclusion criteria for normal control subjects will include: * no previous history of dry eye diagnosis * ocular surface disease index total scoring of 12 or under * total corneal and conjunctival staining score of 0 exclusion criteria will include: * a binocular vision below 20/25 (with habitual correction) * any ocular surgery within the last 3 months. * mental issues, illiteracy, or language problems which might possibly interfere with reading ability * history of taking or current use of topical prescription anti-inflammatory eyedrops (including, cyclosporine and steroids as well as any glaucoma eyedrops). subjects who are willing to discontinue their treatment for at least a period of 30 days can be placed on a "wash out period" as per the discretion of the investigator and subject safety, and be eligible at the end of this period, given all other criteria have been met. otherwise, subjects on these medications will be excluded.

Keywords: dry eye disease sjogren's syndrome tear film ocular surface aqueous tear deficiency
the relationship of crp/albumin ratio level and prognosis in pregnant covid-19 patients

Conditions: Corona Virus Infection; Pregnancy; Infection

Summary: the crp/albumin ratio (car) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. recent studies have shown that the crp/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. with this study it is aimed to investigate the effect of crp/albumin ratio in predicting the severity and prognosis of the disease in pregnant patients with more severe covid-19 infection.

pregnant women are more susceptible to viral infections affecting the respiratory tract than non-pregnant women. similar to non-pregnant patients, covid-19 infection occurs with non-specific symptoms in pregnant patients. a computed tomography (ct) scan of lungs and several laboratory parameters are used to predict the prognosis of this infection, which starts with non-specific findings. although it has been demonstrated that low-dose lung ct can be used safely in pregnant women, both clinicians and pregnant women tend to avoid tomography imaging due to its teratogenic effects the crp/albumin ratio (car) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. it is an indicator of both the inflammatory state and the nutritional state, simultaneously. recent studies have shown that the crp/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. with this study it is aimed to investigate the effect of crp/albumin ratio in predicting the severity and prognosis of the disease in pregnant patients with more severe covid-19 infection.

Eligibility criteria:
inclusion criteria: * covid pcr test positive patients * pregnant exclusion criteria: * covid pcr test negative * missed data
semi-blunt needles: is outcome better?

Conditions: Chronic Hemodialysis Patients; Vascular Abord: Native Arterio-venous Fistula; Buttonhole Cannulation

Summary: the aim of this observational study in patients chronically hemodialyzed by a native arterio-venous fistula is to determine the impact of the use of semi-blunt needles on the quality of the punction. the investigators have observed that cannulation with blunt needles (button-hole method) is sometimes difficult and the use of a sharp needle may be necessary, with consequently more hematomes and infections. our hypothesis is that canulation with semi-blunt needles would be easier than with classical blunt needles, and consequently the use of sharp needles would become less frequent. inclusion criteria and study design are detailed below.


Eligibility criteria:
inclusion criteria: * chronic hemodialysis patients * aged 18 years or more * dialyzed by a native arterio-venous fistula * cannuled by buttonhole method with blunt needles exclusion criteria: * acute hemodialysis * puncture with 14g needles * puncture with a sole needle * arterio-venous grafts * patients transferred from another centre

Keywords: blunt needles semi-blunt needles buttonhole cannulation method
tiotropium/salmeterol inhalation powder in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objectives of this study are to assess bronchodilator efficacy as determined by fev1, the effect on dyspnoea as determined by the bdi/tdi, the effect on health status as determined bt the sgrq and the effect on copd exacerbations


Eligibility criteria:
inclusion criteria: main: diagnosis of copd post-bronchodilator fev1\<80% predicted and fev1/fvc\<70% predicted exclusion criteria: main: significant other diseases then copd recent mi any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year hospitalisation for cardiac failure during the past year history of asthma
individualized maternal milk fortification for feeding the preterm infants

Conditions: Metabolic Syndrome

Summary: neonatal nutrition has to face a contradictory and conflicting nutritional regimen like a high percentage of amino acids from the first day of life in order to achieve normal neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia, increased visceral fat) that this type feeding, in conjunction with complexity of prematurity, is likely to cause. current study aims to investigate is whether individualized fortification of breast milk protein, based on the mother's milk protein content and targeting the recommended daily protein requirements, is associated with better nutrition, growth, biochemical and endocrine markers associated with the nutrition of preterm low birth weight neonates, compared to the standard fortification of human milk.

proteins are of the most important macromolecules in living organisms participating in almost all biological processes. premature infants are forced to adapt to a new (extrauterine) environment where supply of nutrients, including amino acids, from mother ceases abruptly. consequently, the aim of neonatologist is the appropriate, quantitatively and qualitatively nutritional support, to promote brain development, achieve normal endocrine and metabolic function, maintain a growth rate similar to the intrauterine one avoiding extrauterine growth restriction during postnatal period and at the same time encouraging the analogue modulation of body composition (increased muscle mass, decrease body fat, hydration). malnutrition or inadequate nutrition of preterm infant which remains undiagnosed and without proper treatment could have serious consequences on psychomotor development and metabolic activity. indeed, 75% of low birth weight premature infants exhibit extrauterine growth restriction at discharge, even when they have achieved growth equal to the considered satisfactory, ie 15g/kg/day. beyond anthropometrics differences between preterm and full-term newborns, body composition varies as well. preterms have higher percentage of body fat and decreased muscle mass at term time compared with full term neonates. however, it has not been clarified whether this differentiation is harmful predisposing to chronic diseases later in childhood or adult life (eg. obesity, metabolic syndrome).

Eligibility criteria:
inclusion criteria: * infants with gestational age ≤ 34weeks * very low birth weight (≤ 1500g) exclusion criteria: * maternal health problems contradicting breastfeeding * genetic or chromosomal abnormalities * metabolic contraindications for increased amount of protein

Keywords: preterm neonate tailored fortification nutrition maternal breast milk composition
cardiac cath lab staff radiation exposure

Conditions: Coronary Artery Disease; Chronic Total Occlusion of Coronary Artery; Percutaneous Coronary Intervention

Summary: the objective of this randomized safety and observational study is to demonstrate corpath grx chronic total occlusion pci is safe, and that cardiac catheterization laboratory staff have no additional exposure to radiation when compared to conventional manual chronic total occlusion pci procedures without added procedure time.

this is prospective, dual-arm, randomized, multi-center, observational study comparing patient outcomes and staff radiation exposure in chronic total occlusion pci procedures through 48 hours post procedure or hospital discharge, whichever occurs first.

Eligibility criteria:
inclusion criteria: * cto lesion, successfully crossed with conventional manual techniques; * the investigator deems the procedure appropriate for robotic-assisted cto pci with the corpath grx system; * individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure; * the subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. exclusion criteria: * failure/inability/unwillingness to provide informed consent, or * cardiogenic shock; or * perforation which requires treatment (e.g. covered stent, coil and other embolization techniques, or pericardiocentesis).
physical activity guidelines for people with spinal cord injury (sci)

Conditions: Spinal Cord Injury

Summary: the first evidence-based physical activity guidelines for people with spinal cord injury were released in march, 2011. this project will evaluate the implementation of the new physical activity guidelines in a community exercise setting in hamilton, ontario. the investigators hypothesize that persons who follow the guidelines will experience increased aerobic fitness and muscle strength. the investigators also hypothesize that participants will find the guidelines easy to follow and that their self-efficacy for participating in physical activity will be improved following the study period.


Eligibility criteria:
inclusion criteria: * adults with spinal cord injury who have been given clearance to exercise by their primary care physician (or healthcare team) exclusion criteria: * ventilatory support * inability to voluntarily participate in upper body exercises * inability to communicate in english * ongoing infection * unstable autonomic dysreflexia

Keywords: spinal cord injury physical activity physical fitness
safety and efficacy study using abt-335 (investigational drug) in combination with atorvastatin, to study the effects on thickening of the blood vessel wall in patients with abnormal lipid (fat) levels in the blood

Conditions: Coronary Artery Disease; Coronary Heart Disease; Dyslipidemia

Summary: the primary purpose of this study is to test the effect and safety of once daily abt-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.


Eligibility criteria:
inclusion criteria: * patients with mixed dyslipidemia * qualifying cimt thickness exclusion criteria: * patients with certain chronic or unstable medical conditions. * patients with unstable dose of medications or receiving coumadin, cyclosporine, or certain other medications * pregnant or lactating women or women intending to become pregnant * patients with diabetes mellitus that is poorly controlled
the possible effects of roflumilast on obesity related disorders

Conditions: Obesity; PreDiabetes

Summary: evaluation of the possible effects of roflumilast on weight, glucose and lipid metabolism, insulin resistance, oxidative stress and inflammatory process in prediabetic obese subjects.


Eligibility criteria:
inclusion criteria: 1. prediabetic patients (fasting blood glucose between 100 mg/dl and 125 mg/dl or hba1c within the range 5.7% and 6.4%). 2. obese subjects (bmi ≥30 kg/m2 and \<40 kg/m2). exclusion criteria: 1. patients with morbid obesity (bmi \> 40 kg/m2). 2. patients already on weight lowering agents or weight loss program. 3. history or current diagnosis of major depressive disorder or other psychiatric disorders that in the opinion of the investigator would make participation unsafe for the participant. 4. moderate to severe liver disease (child-pugh b or c), renal disease, thyroid disease, cardiovascular disease, peripheral vascular disease or coagulopathy. 5. women will be excluded from our study if they are pregnant, breastfeeding, currently on contraceptive pills or if they plan to become pregnant prior to the end of the study. 6. patients on medications that can interfere with glucose or lipid metabolism (e.g. hypoglycemic agents, corticosteroids, anti-hyperlipidemics, non-selective β-blockers thiazides, etc.) and subjects with organic causes of obesity. 7. diabetic patients and patients with any inflammatory disease. 8. smokers. 9. patients on cytochrome p450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, etc.)
the collar post anterior cervical spine surgery study

Conditions: Cervical Radiculopathy; Cervical Myelopathy

Summary: the anterior cervical discectomy and fusion (acdf) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. however, there is currently no high quality evidence available to support the routine use of post-operative bracing after acdf; further, braces are expensive and have been associated with a variety of local complications. in summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after acdf, places the surgeon and the patient in a precarious position. our randomized trial comparing the impact of 6 weeks of post-operative bracing with a rigid cervical collar vs. no post-operative bracing, on a variety of clinical and radiological outcomes, for adult patients with cervical radiculopathy and/or myelopathy undergoing single or multi-level acdf.

the anterior cervical discectomy and fusion (acdf) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. however, there is currently no high quality evidence available to support the routine use of post-operative bracing after acdf; further, braces are expensive and have been associated with a variety of local complications. in summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after acdf, places the surgeon and the patient in a precarious position.

Eligibility criteria:
inclusion criteria: 1. between the ages of 18 and 80; 2. presenting with cervical radiculopathy and/or myelopathy to one of the study centers; 3. deemed appropriate by the attending surgeon involved for a one, two or three level plated acdf or a one-level acdf with a standalone interbody cage; and 4. able to cooperate in the completion of all study consents, forms and documents. 5. participants who are able to speak, read and write at an elementary school level exclusion criteria: 1. those with previous cervical surgery; 2. those undergoing single or multi-level plated acdf for a diagnosis related to malignancy, infection or trauma; 3. those undergoing a single or multi-level plated acdf augmented with a posterior cervical fusion or posterior cervical decompression and fusion; 4. those undergoing a multi-level non-plated acdf; 5. those undergoing acdf at greater than three levels, and; 6. those with a pre-existent neurological or mental disorder which would preclude accurate evaluation and follow-up.
nutraceutical on hyperuricemia

Conditions: Hyperuricemia

Summary: the aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin, bromelain and l-carnosine (uricemin®) can reduce uric acid levels in subjects with values between ≥ 6 and \< 7 mg/dl after 3 months of therapy.

the aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin, bromelain and l-carnosine (uricemin®) can reduce uric acid levels in subjects with values between ≥ 6 and \< 7 mg/dl after 3 months of therapy. patients will be randomized to uricemin® or placebo for three months. we will evaluate body weight, fasting plasma glucose (fpg), lipid profile, uricemia (ua), high-sensitivity c-reactive protein (hs-crp) at baseline and after 3 months since the study start. treatment tolerability will be assessed evaluating transaminases, and creatinine, and all adverse events will be recorded.

Eligibility criteria:
inclusion criteria: * patients with uric acid levels between ≥ 6 and \< 7 mg/dl * patients not taking hypouricemic agents (both pharmaceuticals or nutraceutical agents) exclusion criteria: * patients with previous gout attack * patients with impaired hepatic function * patient with impaired renal function * patients with gastrointestinal disorders * patients with current or previous evidence of ischemic heart disease, heart failure, or stroke * patients with weight change of \> 3 kg during the preceding 3 months * patients with history of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse. * patients taking (within the previous 3 months) hypouricemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, antidepressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics * women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.