Kornimate/medical-research-clean huggingface dataset:
an evaluation of a fibrillar collagen dressing to treat chronic, stalled lower-extremity wounds

Conditions: Wound

Summary: patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. the powder dressing will be used in accordance with its label. after cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. patients will visit the clinic twice a week to have the powder re-applied. wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. concurrent standard of care, such as compression for venous ulcers, will be provided.


Eligibility criteria:
inclusion criteria: * has one of the following types of wounds below the knee: diabetic ulcers, pressure ulcers, venous ulcers, ulcers of mixed-vascular origin, traumatic wounds, or post-surgical wounds * wound has been present for at least four weeks * wound is free of necrotic tissue or debridement practices will take place prior to initial visit in order to remove necrotic tissue * wound has failed at least one wound care treatment * wound size is between 1 and 100 square centimeters * patient has adequate circulation as demonstrated by biphasic or triphasic doppler waveform, measured within three months prior to study enrollment. if monophasic on exam, then non-invasive tests must display ankle brachial index greater than 0.8 and no worse than mild disease on segmental pressures. * wound is confirmed as being free of infection and absence of osteomyelitis exclusion criteria: * pregnant, planning to become pregnant during the study timeframe, or breast feeding * unable or unwilling to receive porcine collagen * wound is infected or presence of osteomyelitis * allergy or sensitivity to collagen * inability, in the opinion of the investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol
evaluating system accuracy and user performance of omnitest® blood glucose monitoring systems for self-testing in managing diabetes mellitus

Conditions: Diabetes

Summary: the aim of this study is to determine the system accuracy and user performance evaluation of the mentioned bgm systems by gaining a sufficient amount of measured data from capillary blood.


Eligibility criteria:
inclusion criteria: * male or female subjects with type 1 or type 2 diabetes, for the evaluation of system accuracy also healthy subjects * age ≥ 18 * signed and dated informed consent form * for small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy - i.c.t.) or insulin pump therapy (continuous subcutaneous insulin infusion - c.s.i.i.) exclusion criteria: * pregnancy or lactation period * severe acute illness that, in the opinion of the investigating physician, might confound the results of the test or which could result in a risk to the subject caused by the test. * severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the subject caused by the test. * mental incapacity or language barriers precluding adequate compliance with the test procedures * legal incompetence or limited legal competence * dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the clinical research centre) * for user performance evaluation: subjects having participated in a study with omnitest® 5 before. * for system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease or impaired hypoglycaemia awareness * anamnestically relevant amounts of interfering substances in the blood, following labelling in the instructions for use as reviewed and evaluated by a physician during screening.

Keywords: blood glucose monitoring system system accuracy
intermittent automated devices for labor analgesia in emilia romagna

Conditions: Labor Pain

Summary: the study aims to determine whether the use of automated intermittent devices for labor analgesia could prevent the increase of instrumental deliveries, with same analgesia. moreover it will evaluate if automated devices can allow a reduction of health-care burden.

epidural analgesia is recognized as the most effective technique to control labor pain, although its possible adverse events. continuous epidural administration of local anesthetics can stabilize the analgesic block and reduce the anesthesiologists' workload but is associated with an increase in operative vaginal delivery. epidural intermittent boluses performed by anesthetist are associated to reduction of dosages, but they could provide insufficient analgesia and they involve the constant anesthetist's presence in the operating room. this is a multicenter randomized controlled trial with two arms, funded by grant of regione emilia romagna, in which we will compare two different epidural analgesia protocols: anesthesiologist's supervised versus intermittent boluses with pcea.

Eligibility criteria:
inclusion criteria: 1. nulliparous women at full-term pregnancy single fetus and vertex presentation, hospitalized for harbingers of labor and cervical dilation less than 5 cm 2. numeric rate scale \> 5 exclusion criteria: 1. patients aged under 18 years 2. patients with ongoing administration of oxytocin 3. patients with no indications to epidural analgesia 4. patients with inability to place the epidural catheter for technical difficulty 5. patients with parenteral administration of opioids 6. multiparous women 7. patients unable to understand the objectives and procedures of the study

Keywords: epidural analgesia patient controlled analgesia obstetric outcome
fludeoxyglucose f 18 pet/ct scans in predicting therapy response in patients with stage iiia non-small cell lung cancer undergoing chemoradiation

Conditions: Stage IIIA Non-small Cell Lung Cancer

Summary: this clinical trial studies fludeoxyglucose f 18 (fdg) positron emission tomography (pet)/computed tomography (ct) in predicting chemoradiation therapy (crt) failure in patients with stage iiia non-small cell lung cancer (nsclc). diagnostic procedures, such as fdg pet/ct, may help predict crt failure. comparing diagnostic results during crt may help doctors predict a patient's response to treatment and help plan the best treatment

primary objectives: i. to determine whether early response of the research positron emission tomography (pet)-computed tomography(ct) scan measured by change in standard uptake value (suv)max relative to baseline scan can predict induction chemoradiation therapy (crt) failures sooner than post-treatment pet-ct scan. ii. to determine the optimal timing for 18fdg pet-ct that best predicts for induction crt failure. secondary objectives: i. to correlate early 18 fludeoxyglucose (fdg) pet-ct response metrics with pathologic response, progression-free survival separately for: induction crt failures vs. non-failures, or overall survival separately for induction crt failures vs. non-failures. outline: patients are randomized to 1 of 3 groups. patients undergo a baseline fdg pet/ct scan and receive standard radiotherapy (rt) for 28 fractions with concurrent chemotherapy. group a: patients undergo a fdg pet/ct scan between rt fractions 5-6 (before course 2 of chemotherapy). group b: patients undergo a fdg pet/ct scan between rt fractions 10-11 (before course 3 of chemotherapy). group c: patients undergo a fdg pet/ct scan between rt fractions 15-16 (before course 4 of chemotherapy). approximately 6 weeks after completion of crt, patients undergo a fdg pet/ct scan and undergo standard tumor resection. after completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Eligibility criteria:
inclusion criteria: * all patients with marginally resectable iiia (n2) nsclc undergoing induction crt will be eligible for this imaging trial; patients will be screened by the chest tumor board for entry * undergoing or plan to undergo induction chemoradiation exclusion criteria: * poorly controlled or uncontrolled diabetes mellitus, with blood glucose \> 200 mg/dl * have allergies or medical contra-indications to fdg or intravenous (iv) contrast * medical contra-indications to obtaining ct or pet scans * pre-authorization denial of coverage by insurance providers of clinical staging and restaging pet-ct scans
a comparison of valganciclovir and ganciclovir in the treatment of cytomegalovirus (cmv) of the eyes

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to investigate the efficacy and safety of rs-79070 when used as induction therapy in patients with newly diagnosed peripheral retinitis. to assess the effects of induction and maintenance level dosing of rs-79070 on cmv viral load, estimated by plasma cmv pcr. to assess the pharmacokinetics of ganciclovir following administration of rs-79070 in the target population.


Eligibility criteria:
inclusion criteria: * documented aids diagnosis * newly diagnosed peripheral cmv retinitis * more than 3 weeks of previous therapy for cmv retinitis
egm analysis in idiopathic outflow tract ventricular arrhythmia

Conditions: Ventricular Outflow Tract Tachycardia

Summary: investigate the value of unipolar and bipolar electrograms (egm) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (otva).

the proposed study aims to evaluate the predictive value of using reversed polarity in adjacent bipolar egms (bi-rp method) and unipolar egm with qs morphology (uni-qs method) for identifying successful ablation site, and evaluate the feasibility of enhancing uni-qs method's performance by using its morphology characteristics such as descending slope and symmetry.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo ablation for idiopathic otva * have the ability to provide informed consent for study participation. exclusion criteria: * be currently participating in any other investigational study * be less than 18 years of age * be pregnant * has any other conditions that are not suitable for catheter ablation (including but are not limited to active whole-body infection or sepsis, coagulation or hemorrhage disorder history)
assessing tissue remodeling in the skin using sfi (skin fluorescence imaging)

Conditions: Skin Lesion; Melanoma (Skin); Mole

Summary: the goal of the sfi is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin

the goal of the sfi is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin. sfi analyzes the topical staining of the skin surface using the orl-1 dye to reveal the presence of remodeling in the skin, together with the visible feature characteristics. the system provides a biometric score corresponding to the dye staining, a structural score, and a composite sfi score to quantify the presence of tissue remodeling and the process of melanocytic transition in the skin.

Eligibility criteria:
inclusion criteria: 1. subjects with a pigmented skin lesion recommended for a skin biopsy. 2. a lesion that is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the mds. 3. at least 21 years old. 4. written, signed, and dated informed consent 5. scheduled for a primary excision/biopsy as part of the clinics soc. exclusion criteria: 1. lesion is less than 1 centimeter from the eyes. 2. lesion is on the palms of the hands or soles of the feet. 3. mucosal lesion. 4. ulcerated lesion. 5. subject is pregnant or planning to become pregnant during the study period. 6. patients who are mentally or physically unable to comply with all aspects of the study. 7. any subject undergoing chemotherapy. 8. any lesion that has been treated with local anesthesia such as lidocaine prior to enrollment that would confound study results.

Keywords: melanoma nevus mole atypical nevi
feasibility of an early progressive strength exercise programme for acute achilles tendon rupture

Conditions: Achilles Tendon Rupture

Summary: the aim of this study is to investigate the feasibility of an early progressive exercise program for patients with achilles tendon rupture treated non-surgically. the outcomes will concern the patient's acceptability of the intervention, adherence to the intervention and safety of the healing tendon.

regardless of choice of either surgical or non-surgical treatment, long-term muscular deficits and a decreased function after achilles tendon rupture is found up to 10 years later. the majority of the patients are of working age and a deficit in physical performance will have impact on returning to work and sports. there has been promising results in treatments using early functional rehabilitation during the first eight weeks of treatment after both surgical and non-surgical treatment, but few studies has examined the effect of the exercises on its own. in general, descriptions of the exercise programs are lacking important information such as type, time of application, frequency, intensity and progression of the exercises. the primary aim is to test the feasibility of an early progressive exercise program for patients with achilles tendon rupture treated non-surgically. feasibility in this study will be defined as successful patient acceptability and compliance of the exercise intervention.

Eligibility criteria:
inclusion criteria: * acute achilles tendon rupture treated non-surgically * diagnosed and treatment initiated within 3 days of injury * age 18-65, able and willing to participate in the intervention * able to speak and understand danish exclusion criteria: * insertional achilles tendon rupture on calcaneus or rupture in the musculo-tendinous junction of the triceps surae * previous achilles tendon rupture or other conditions in either leg causing lower leg disability (pain, deficits in strength or range of movement) * treated with fluoroquinolones or corticosteroids within the last 6 months * diabetes * severe medical illness: asa score higher than or equal to 3. (asa: american society of anesthesiologists physical status classification system)
evaluation of pet/mri in patients with pancreatic adenocarcinoma

Conditions: Adenocarcinoma Pancreas

Summary: this study will use pet/mri in patients with adenocarcinoma of the pancreas to identify hidden metastatic disease or identify patients with borderline or locally advanced disease.

patients will receive a pet/mri scan within 6 weeks of their standard of care imaging. there is no maximum number of scans for research. the number of scans depends on each patient's treatment plan.

Eligibility criteria:
inclusion criteria: * presence of suspicious lesion of the pancreas consistent with pancreatic adenocarcinoma. cytological confirmation is not required. * patients preparing to receive therapy for pancreas cancer, including patients enrolled in nct01413022 * patient must be 18 years or older * patient must have a life expectancy of more than 6 months and performance status of 2 or less * patient must be able to understand and willing to sign an approved written informed consent document * women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the length of the study * patients enrolled in the clinical trials.gov# nct01413022 trial must meet both studies eligibility criteria. exclusion criteria: * patient must not have had prior resection for pancreatic adenocarcinoma. * patient must not have a history of other malignancy less than or equal to 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix * patient must not be unable to receive a pet-mri scan due to renal function, allergy or other problem with receiving or tolerating an mri scan, etc. all patients will fill out a standard mri screening form. * patients must not have a blood glucose of greater than or equal to 200mg/dl at the time of pet-mri or if a patient is diabetic and glucose is not controlled. at the discretion of the pi and the authorized user and with their approval prior to 2-\[18\]fluoro-2-deoxy-d-glucose (fdg) injection, patients with blood glucose ≥ 200 mg/dl may participate in the study. * patient must not be pregnant and/or breast feeding

Keywords: adenocarcinoma imaging pet mri
insole on morton's neuroma

Conditions: Morton Neuroma

Summary: objective: the aim of the present study was to assess the effectiveness of insole with metatarsal support on pain in patients with morton's neuroma and the impact of this insole on function, load distribution in the plantar region, gait variables, quality of life and satisfaction with insole use. methods: a randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. seventy-two patients with morton's neuroma were randomly allocated into a study group and control group. one week following the baseline evaluation, the study group received insole with metatarsal support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color and density. the groups were evaluated after 6, 12 and 24 weeks of insole use. the following assessment parameters employed: pain when walking and at rest (end); quality of life (sf-36); foot function (ffi and fhsq); six-minute walk test (6mwt) and foot pressure analysis using the am cube footwalk pro program.


Eligibility criteria:
inclusion criteria: * patient with clinical and radiological diagnosis (magnetic resonance or ultrasound) of morton's neuroma. * pain in the foot with vas between 3-8 cm to walk. * over 18 years. * no distinction of sex * agree to participate of the study and sign the informed consent form. exclusion criteria: * other symptomatic musculoskeletal diseases in mmii. * symptomatic diseases of the central and peripheral nervous system. * diabetes mellitus. * rigid deformities on foot. * use of insoles in the last three months. * physiotherapy in the last three months. * infiltrations on foot and ankles in the last three months. * previous or expected surgery in the next twelve months. * allergy to the material of the insole. * mental deficiency. * geographic inaccessibility .- use of corticosteroids or nsaids in the last month

Keywords: insole morton neuroma pain function
use of integrated pet/ct as a first line staging and re-staging technique in oncologic patient.

Conditions: Lung Cancer

Summary: positron emission tomoscintigraphy (pet) and contrast computed tomography (ctmdc) are diagnostic methods widely used in the staging and restaging of neoplastic diseases. in recent years, pet tomographs have been implemented, integrating a ct scanner into the pet tomograph (pet/ct): these tomographs are able to simultaneously acquire the function/metabolism study (pet) and the morgfostructural study (ct). numerous clinical studies have demonstrated the added diagnostic value of pet/ct compared to pet with consequent effect on the choice of treatment type. in addition to the potential clinical value deriving from the simultaneous execution of the two diagnostic methods, it is necessary to consider the possibility of a reduction in indirect costs deriving from the reduction of days of work lost and costs related to transport, both for the patient and for any companions. the aims of this multicenter observational study are: 1. evaluate the diagnostic accuracy of pet/ct, contrast-enhanced ct and contrast-enhanced pet/ct+ct performed in a single examination session (single staging) in cancer patients (patients suffering from lymphoma and lung cancer). 2. evaluate any psychological, quality of life and economic benefits deriving from carrying out the two diagnostic procedures in a single examination session.


Eligibility criteria:
inclusion criteria: * patients suffering from lung cancer or lymphoma in which the two diagnostic investigations mentioned (pet and contrast-enhanced ct) are part of the routine diagnostic-therapeutic program of the disease in question; * patients suffering from lung cancer will be in the stage of primary neoplasm staging; * patients suffering from lymphoma will be evaluated both in the disease staging phase at onset and re-evaluation after radio-chemotherapy treatment. exclusion criteria: * patients with contraindications to performing investigations with contrast medium.
3d ultrasound myocardial mechanical wave measurements

Conditions: Chronic Primary Mitral Regurgitation

Summary: primary mitral regurgitation (mr) is a frequent disease that can ultimately lead to heart failure. primary mr represents the second most prevalent cause of cardiac valve surgery in high income countries. progressive myocardial fibrosis due to chronic volume overload is recognized as a pathophysiological substrate of altered lv function in primary mr. as fibrosis leads to increased myocardial stiffness, ultrasound mechanical wave propagation measurements within the myocardium could provide important clinical information. natural mechanical wave velocity (mwv) imaging, using high-frame-rate (hfr) echocardiography has emerged as a promising tool to evaluate myocardial stiffness. the objective is study is to evaluate the correlation between the lv myocardial stiffness (as assessed by 3d ultrasound myocardial mwv mapping) and myocardial interstitial fibrosis as measured using cmr (myocardial extracellular volume measure)

after being informed about the study. all patients giving written informed consent will undergo in a routine practice: 1. echocardiography (2d/3d), 2. cmr imaging, 3. electrocardiogram 24 hours monitoring, 4. blood sampling including brain natriuretic peptide measurement, 5. symptom-limited combined exercise echocardiography and oxygen uptake measurements

Eligibility criteria:
inclusion criteria: * severe primary mr patients (effective regurgitation orifice area ≥ 40mm²) with class i indication for surgery (symptoms and/or altered conventional parameters of lv function) (n=10 patients) * severe primary mr patients (effective regurgitation orifice area ≥ 40mm²) without class i indication of surgery (n=20 patients) * mild to moderate primary mr patients as defined by effective regurgitation orifice area ≥ 20mm² and \< 40mm² (n=10 patients) exclusion criteria: * permanent atrial fibrillation * acute primary severe mr * secondary mr * previous cardiac surgery of any kind * other severe left sided valvular disease * coronary artery disease * congenital cardiac disorder

Keywords: primary mitral regurgitation high frame rate ultrasound imaging cmr myocardial fibrosis