Kornimate/medical-research-clean huggingface dataset:
investigating reduction of acute heart failure readmission with lung ultrasound-preliminary trial

Conditions: Acute Heart Failure

Summary: in switzerland 15% of discharged patients are readmitted within 30 days. acute heart failure is the leading cause of hospital admission and one of the most frequent reasons for re-admission, mainly because of congestion-driven symptoms. residual congestion is noted in 10%-15% of patients at discharge and is associated with an increased risk of re-admission and mortality. lung ultrasound outperforms both chest x-ray and physical examination in detection of lung congestion. several semiquantitative scanning protocols exist for quantifying congestion. the aim of this study is to compare for the first time two widely used lung ultrasound protocols, one exhaustive (28-points) and one simplified (8-points), in real-time settings. the focus is placed on reproducibility (expert-beginner interobserver concordance), feasibility (time consumption for images acquisition and interpretation) and performance (detection of b-lines clearing) of both scores. semi-quantitative method is expected to have better feasibility with similar reproducibility and performance.


Eligibility criteria:
inclusion criteria: * diagnosis of acute heart failure on admission chart (primary or secondary diagnosis) * admission from the emergency room to a general internal medicine ward * presentation of acute heart failure according to european society of cardiology : * presence of ≥1 symptom or sign based on admission chart review and * raised value of n terminal-pro-brain natriuretic peptide (\>300 ng/l) exclusion criteria: * interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion, previous lung surgery * inability or unwillingness to give consent * presence of oligo-anuric end stage renal disease

Keywords: acute heart failure lung ultrasound
study to evaluate safety, tolerability, pharmacokinetics, and antiviral activity of voxilaprevir in adults with chronic hepatitis c virus infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly gs-9857) alone or with sofosbuvir (sof)/velpatasvir (vel) fixed dose combination (fdc) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis c virus (hcv) infection. all participants will be monitored for up to 48 weeks after the last dose.


Eligibility criteria:
key inclusion criteria: * chronic genotype 1-4 hcv infection * for cohorts 1-9, hcv rna ≥ 100,000 iu/ml at screening (no hcv rna restriction for cohort 10) * screening laboratory values within defined thresholds * use of two effective contraception methods if female of childbearing potential or sexually active male key exclusion criteria: * pregnant or nursing female or male with pregnant female partner * presence of cirrhosis * prior exposure to approved or experimental hcv protease inhibitors * co-infection with hiv or hepatitis b virus (hbv) * current or prior history of clinical hepatic decompensation * chronic use of systemic immunosuppressive agents * history of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: sustained virologic response direct acting antiviral combination therapy liver diseases digestive system diseases hepatitis, viral, human enterovirus infections picornaviridae infections rna virus infections flaviviridae infections antiviral agents anti-infective agents therapeutic uses pharmacologic actions antimetabolites molecular mechanisms of pharmacological action
metformin and esomeprazole for preterm pre-eclampsia

Conditions: Preeclampsia Severe; Preeclampsia Second Trimester; Preterm Birth Complication

Summary: a recent randomized controlled trial by cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. investigators found that extended release metformin (3g daily) can prolong gestation in women with preterm pre-eclampsia. combination metformin and esomeprazole has shown promise in the treatment of preeclampsia as both agents reduce placental and endothelial secretion of soluble fms-like tyrosine kinase 1 (sflt-1) and soluble endoglin, and reduce endothelial dysfunction.


Eligibility criteria:
inclusion criteria: individuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies * women 18 years or older * women diagnosed with preeclampsia * women with pre-eclampsia superimposed on chronic hypertension * candidates for expectant management and had no clinical indication for immediate delivery exclusion criteria: * delivery within 48hr is highly likely * maternal or fetal compromise that necessitated immediate delivery * diabetes or gestational diabetes currently on metformin therapy * contraindications to metformin, esomeprazole * baseline creatinine \>124 μmol/l * hypersensitivity to metformin or esomeprazole * metabolic acidosis * use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs) multiple gestations
blood-flow restricted exercise in inclusion body myositis

Conditions: Sporadic Inclusion Body Myositis

Summary: this study evaluates the effects of a low-intensity blood-flow restricted exerciser protocol on patient reported physical function, in patients with sporadic inclusion body myositis. the study is designed as a parallel group randomized controlled trial with a treatment group and a control group.

sporadic inclusion body myositis (sibm) is a disease characterized by skeletal muscle inflammation and severe muscle atrophy especially in the muscles in the thigh and the finger flexors. in time the muscle weakness will cause the affected person to become unable to walk and carry out basic tasks in the every day life. currently no effective treatment exist for sibm patients, however several studies indicate that exercise may be beneficial for the patients. in the resent years a lot of research attention has been directed toward low-intensity training with partial vascular occlusion as an alternative to the conventional high intensity strength training. interestingly the low-intensity blood-flow occluded training is found to be at least as beneficial in causing muscle growth as the conventional strength training but with very little mechanical load on joints and tendons. furthermore the blood-flow occluded training seem to result in a hyper-activation of muscle stem cells which play an important role in muscle regeneration. this make the blood-flow restricted training modality a very interesting treatment possibility for sibm patients because it might be able to restore and/or maintain the skeletal muscle tissue and therefore also muscle function.

Eligibility criteria:
inclusion criteria: clinical features * duration of weakness \> 12 months * weakness of finger flexors \> shoulder abductors and knee extension \> hip flexion pathologic features * invasion of nonnecrotic fibres of mononuclear cells or rimmed vacuoles or * increased major histocompatibility complex i (mhc-1) but no intracellular amyloid deposits or 15-18nm filaments exclusion criteria: * lack of gait function * co-morbidity contraindicating the use of blood-flow restricted training (previous deep vein thrombosis/pulmonary embolism or known peripheral ischemic disease). * co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled hypertension (systolic \> 160mmhg, diastolic \> 100mmhg), severe knee/hip arthritis)
safety and effectiveness study of a closed loop system maintaining patients' glucose levels during an overnight period

Conditions: Type 1 Diabetes

Summary: currently, patients diagnosed with type 1 diabetes rely on either finger stick or sensor glucose readings when making their insulin dosage decisions. designing a computerized system that mimics the way insulin is produced naturally in a person who does not have type 1 diabetes holds many challenges; all of which cannot be addressed in just one study. the purpose of the medtronic overnight closed loop study is to assess the performance of a system designed to automatically infuse the correct insulin dose during the hours that the patient is sleeping. the system consists of an insulin pump that provides insulin to the patient through an infusion set. a sensor inserted just under the patient's skin measures glucose levels and a transmitter sends this information to the pump. to enable the sensor to register the glucose information correctly, it must be set (calibrated) by a finger stick blood glucose 3-4 times a day. in the commercially released system, the physician would recommend the continuous background (basal) insulin rates and the patient would be required to make decisions regarding extra insulin (bolus) for meals or as a response to high glucose levels. in the closed loop system, a mobile control system is added to these devices. this consists of an android phone, a closed loop algorithm and a translator. this system is designed to translate the sensor information and direct the pump to provide the required dosage of insulin automatically without requiring input from the patient. reliable calibration has proved challenging, and so it is important that the system function safely, even when calibration is inaccurate. in this study, a calibration error will be introduced under very controlled circumstances. this testing will identify if the system can maintain acceptable overnight glucose levels, regardless of whether or not calibration is ideal.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of type 1 diabetes as determined by the investigator for a minimum of 36 months prior to enrollment * weight is between 50 and 120 kg * subject has used a medtronic insulin pump for at least the previous 6 months * subject has an glycated hemoglobin (a1c) value ≤ 9.0% demonstrated at the time of enrollment * subject uses a rapid-acting analogue insulin in his/her pump exclusion criteria: * female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study * subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months * subject has an exclusionary cardiac disorder

Keywords: united kingdom overnight closed loop
diagnostic strategies, risk assessment and progression of pancreatic cysts

Conditions: Pancreatic Neoplasms; Pancreas Cancer

Summary: the aims of this study are to determine the natural history of pancreatic cysts and to propose and prospectively validate a diagnostic approach and model for prediction of mucinous versus non-mucinous, and malignant versus non-malignant, pancreatic cysts using a combination of clinical, radiologic, and biomarker characteristics.

pancreatic cysts are increasingly recognized as incidental lesions due to the widespread use of cross-sectional imaging techniques such as ct and mri. twenty percent of all pancreatic cysts are non-inflammatory cystic neoplasms, many of which are mucinous, and therefore have a significant potential for malignant transformation. the primary challenge facing clinicians is the inability of current standard diagnostic tests, including imaging and standard laboratory data, to accurately and reliably discriminate neoplastic from non-neoplastic, and benign from malignant cysts, particularly in patients without symptoms. therefore, some patients with benign cysts undergo unnecessary costly surveillance and possible avoidable surgical resections, which is associated with high cost, significant morbidity and mortality, while some may not be as aggressively followed. the international association of pancreatology (iap) has published guidelines on the management of the two main types of mucinous cystic lesions: intraductal papillary mucinous neoplasms (ipmns) and mucinous cystic neoplasms (mcns). (1) although these guidelines emphasize the frequency of surveillance and outline the indications for resection, these guidelines have not yet been validated, and these guidelines presume the diagnosis of a mucinous neoplastic cyst has been confirmed prior to surgery. it is unlikely that guidelines that only use clinical and imaging will be able to accurately differentiate benign cysts from those that are pre-malignant or currently harbor malignancy. hence, there is a critical need for a diagnostic model that more accurately diagnoses neoplastic mucinous and malignant pancreatic cysts as this will improve the management of many patients with pancreatic cysts.

Eligibility criteria:
inclusion criteria: * adult patients age 18 years and older * referred for assessment of a pancreatic cyst. exclusion criteria: * medically ill patients with american society of anesthesiologists class 4 or greater. * inability to provide informed consent. * pregnancy or lactation.
mid-term outcomes of fracture odontoid management in assiut university

Conditions: Cervical Spine Fracture

Summary: the aim of this study is to evaluate and assess the mid-term outcomes of treating odontoid fracture cases admitted to the trauma unit of assiut university hospital.

odontoid fractures are common fractures of the cervical spine, accounting for 10-15% of all cervical spine fractures. it has a bimodal age distribution as it occurs in both elderly and young patients. the injury generally occurs as a result of strong flexion and extension movement in addition to axial overload. flexion generally results in anterior subluxation, while extension results in posterior subluxation. it was classified by anderson and d'alonzo classification in 1974 into three types according to the fracture location. a newer classification was introduced which offered a clearer distinction between type-ii and type-iii fractures. in this new classification, type ii fractures were further divided into 3 subtypes. the 3 subtypes are labelled a, b, and c. type ii fractures are usually treated surgically through either anterior or posterior approach depending on the fracture pattern as they are characterized by a higher rate of non-union compared to type i and iii being in a watershed level between the vertebral and the internal carotid arteries. nevertheless, the literature is still confusing about the results of anterior surgery in odontoid fractures. in a recent study by cutler et al., anterior fixation of odontoid fracture was associated with high morbidity and mortality. in another study, the most commonly reported major complications after odontoid fracture surgery in the elderly include cardiac failure, deep venous thrombosis , stroke, pneumonia, respiratory failure, liver failure, and severe infection. despite the fact that we receive and treat a large number of patients with various types of odontoid fractures in assiut university hospital, there is no consensus about the best treatment options and uncertainty about the mid and long term outcome of these treatments. in this study, the investigators will assess the mid-term outcomes (minimum of one year) to all patients with odontoid fracture who are admitted to the trauma unit in assiut university hospital regardless the treatment type.

Eligibility criteria:
inclusion criteria: * all patients with odontoid fractures presenting to assiut university hospital - department of orthopaedic and trauma surgery who have completed a minimum of 1 year follow up regardless of age, mechanism of injury, neurological status or type of treatment applied exclusion criteria: * patients who are not available for one year follow-up patients who refuse to participate in the study
comparison of coronary xience v and the cypher select+ stents in diabetic patients

Conditions: Diabetes Mellitus

Summary: in stent neointimal hyperplasia may be less in the cypher select plus stent compared to the xience v stent in diabetic patients.


Eligibility criteria:
inclusion criteria: * all diabetic patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in denmark (gentofte, rigshospitalet, odense, skejby, aalborg) can be included in the study. exclusion criteria: * the patient will not participate * the patient participates in other randomised stent studies * expected survival \< 1 year * allergy to aspirin, clopidogrel or ticlopidine * allergy to sirolimus or abt-578

Keywords: drug eluting stent diabetics intravascular ultrasound pathophysiologic (neointimal hyperplasia and peri-stent remodeling)
fuel for fun: cooking with kids plus parents and play

Conditions: Pediatric Obesity

Summary: fuel for fun: cooking with kids plus parents and play (fff), is an integrated research, extension, and education project targeting 4th grade students. its long-term goal of reducing the risk of childhood obesity will be addressed by promoting healthful food and activity environments, policies and behaviors through: 1) building and testing the efficacy of a 4th grade comprehensive school- and family-based intervention, 2) applying it to an after-school setting to broaden its reach, and, 3) disseminating both versions through outreach.

fuel for fun: cooking with kids plus parents and play (fff) is based on existing, evidence-based components: the experiential cooking with kids curriculum, the spark active recreation program; principles of behavioral economics in school cafeterias and homes; the online about eating 5-lesson module based on eating competence concepts, and a family-based fff component specifically designed for this intervention. each component addresses policy and environment in addition to behavior change at school and home. the main research project - school-based fff - will be implemented in 8 low-to-moderate income schools for two years using an asynchronous design that allows for assessment of the school-based program alone and in combination with both parent programs. changes in fruit and vegetable intake (measured by self-report, cafeteria plate waste) and activity levels (measured by self-report and accelerometry) are primary outcomes, with measured bmi as a secondary outcome. subsequent studies will involve the development of an after-school version and adoption of fff by other districts. university students will gain valuable research experience and school and extension educators will receive important childhood obesity prevention training. the project's long term goal is consistent with the united states department of agriculture (usda) goal of improving the nation's nutrition and health by promoting the development of healthy eating and activity habits in children.

Eligibility criteria:
inclusion criteria: * all students enrolled in participating classrooms are invited to participate exclusion criteria: * none

Keywords: school family fruit and vegetables cooking physical activity
comparison study of conventional poem and hybrid poem for esophageal achalasia

Conditions: Esophageal Achalasia

Summary: peroral endoscopic myotomy (poem) has recently been introduced as promising alternative to laparoscopic heller myotomy for patients with idiopathic achalasia. several technical modifications have been proposed but have not yet been tested in randomized trials.

objective: to evaluate efficacy and safety of water-jet assisted poem (wj) versus the conventional technique (c). interventions: patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for poem were randomized to either the use of erbe hybrid knife (wj group) or the conventional technique using injection and triangle tip knife interchangeably (c group). main outcome measurements: procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)

Eligibility criteria:
inclusion criteria: * with an eckardt symptom score ≥ 4 * the diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the les on established methods (barium swallow, manometry, esophagogastroduodenoscopy) * informed patient consent was obtained exclusion criteria: * severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk * pseudoachalasia * megaesophagus (diameter of \> 7 cm)

Keywords: esophageal achalasia, peroral endoscopic myotomy, water-jet assisted
efficacy study of genexol-pm and cisplatin in locally advanced head and neck cancer

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma

Summary: this clinical trial is phase ii trial for evaluating efficacy of induction chemotherapy using genexol-pm + cisplatin for locally advanced head and neck cancer. the investigators try to evaluate response rate of genexol-pm + cisplatin chemotherapy, and safety profile.


Eligibility criteria:
inclusion criteria: * locally advanced head and neck squamous cell carcinoma * oral cavity, oropharynx, hypopharynx, larynx * measurable lesion * unresectable * age 18 or more * ecog 0 or 1 exclusion criteria: * distant metastasis * pregnancy * prior chemotherapy or radiation therapy * 2ndary malignancy * other unfit medical condition
patient-centered chronic pain care

Conditions: Chronic Pain; Opioid Use; Musculoskeletal Pain

Summary: this study will adapt and scale existing ahrq-supported interoperable cds for patient-centered chronic pain care. the objective of this project is to study the adaptation and implementation of an existing interoperable cds tool for pain treatment shared decision making, with tailored implementation support, in primary care clinical settings. the central hypothesis is that tailored implementation support will increase cds adoption and shared decision making.

this study will adapt and scale the use of existing ahrq-supported interoperable cds that aids patient-centered chronic pain treatment decision making. the research will generate critical evidence on scalable strategies to implement and evaluate interoperable cds in real-world settings across different types of ehrs. the pragmatic trial will enhance the reach of interoperable cds to more diverse populations. together, these efforts will lead to important new technology and evidence that patients, clinicians, and health systems can use to improve care for millions of americans who suffer from pain and other chronic conditions.

Eligibility criteria:
inclusion criteria: * primary care patients receiving care at a participating clinic * patients with chronic non-cancer musculoskeletal pain and with a recent history of opioid use exclusion criteria: * due to the fact that the clinical decision support tool is currently available in english only, non-english speaking patients will not be eligible to participate