Kornimate/medical-research-clean huggingface dataset:
medtronic enterra ii neurostimulator

Conditions: Gastroparesis

Summary: humanitarian device: authorized by federal (u.s.a.) law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

description the medtronic enterra ii model 37800 neurostimulator is a programmable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system. these components comprise the implantable portion of the medtronic enterra ii system. the operation of the neurostimulator is supported by a clinician programmer. the neurostimulator (figure 1) operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation, through the implanted lead system. a wide range of noninvasively programmable parameters and stimulation modes are available. the neurostimulator provides current parameter information, via telemetry, when used with the clinician programmer. system components * neurostimulator: medtronic enterra ii model 37800 * controlling devices: medtronic model 8840 clinician programmer with model 8870 application card. model 8527 printer optional. * lead: medtronic enterra model 4351 unipolar lead

Eligibility criteria:
inclusion criteria: * chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years. exclusion criteria: * organ transplant * organic obstruction * pseudo-obstruction * prior gastric surgery * scleroderma * amyloidosis * history of seizures * peritoneal or unstable dialysis * chemical dependency * pregnancy * primary eating or swallowing disorders * psychogenic vomiting * implanted electronic medical devices * age \ 70 years

Keywords: nausea vomiting
the bridge project

Conditions: Borderline Personality Disorder

Summary: the bridge project: a feasibility randomised controlled trial of brief, intensive assessment and integrated formulation for young people (age 14-24) early in the course of borderline personality disorder.

this project is the first step in testing a new intervention programme, called bridge (brief, intensive assessment and integrated formulation), for young people early in the course of borderline personality disorder (bpd). the bridge project will help us find out whether we can do a much bigger study in the future that will tell us whether bridge works well. bpd is characterised by long standing difficulty in managing emotional responses, personal relationships, impulse control and self-image. research shows that individuals with bpd may experience discrimination and resulting stigmatisation by both the public and health care professionals. many adolescents and young people with complex needs and high suicide risk are left under-diagnosed and untreated. as a result, young people with bpd are frequently not in education or training and experience challenging relationships with friends and families. the overall aim of the study is to assess the possibility of providing a treatment programme for young people with bpd symptoms in the general population, who may or may not be accessing any mental health services. first, we need to see whether young people are comfortable with random allocation to bridge (and service as usual) or service-as-usual (alone) (a bit like tossing a coin). second, we need to find out whether enough young people want to be involved. third, whether we can find out the information we need about them and can follow up enough young people later. the proposed study will try to find these things out, so that we can design a future, bigger, study to find out whether bridge is good value for young people with bpd.

Eligibility criteria:
inclusion criteria: * cut off score of 11 out of 15 on the self-reported scid-ii bpd questionnaire and subthreshold (3 or 4 out of 9 domains) or threshold (5 and above out of 9 domains) criteria on the scid-ii dsm-v (bpd module) * age 14-25 exclusion criteria: * currently receiving psychological/counselling /psychotherapeutic treatment for bpd * has received psychological/counselling/psychotherapeutic intervention for over 8 sessions in the last 3 months * severe or profound intellectual disability, that would preclude full engagement in talking therapy * receiving intensive psychiatric treatment at the time of study entry, for conditions such as acute psychosis or severe eating disorder * non-english speaking
trial of repeated analgesia with kangaroo care

Conditions: Pain; Development

Summary: mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. there is a recent accumulation of data, being analyzed by ourselves in a cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as kangaroo mother care (kmc), is effective in diminishing pain response during a single painful procedure. while evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. current guidelines recommend sweet taste for minor painful procedures. although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. the combination of kmc and sucrose is marginally more potent, but again, long term use remains unstudied. aims. to test the repeated efficacy in diminishing pain from heel lance of kmc compared to usual care (sucrose), and of kmc in combination with sucrose by examining each condition at least three times during nicu stay. a secondary aim is to compare these interventions on neurodevelopment at discharge from the nicu.


Eligibility criteria:
inclusion criteria: * less than 36.0 weeks gestational age * mother is generally available to provide kangaroo mother care exclusion criteria: * narcotic analgesics * surgery in past 48 hrs * major congenital anomalies

Keywords: pain preterm neonate sucrose kangaroo mother care
intra-arterial lidocaine for pain control post uterine fibroid embolization

Conditions: Uterine Leiomyomas

Summary: uterine artery embolization (uae) is a minimally invasive treatment for women with symptomatic fibroids. it is similar to hysterectomy in term of satisfaction and symptoms improvement, with fewer complications and at lower cost. however, the majority of women undergoing ufe experience important pain after the procedure despite optimal analgesia, with one third reporting pain equal or worse than labor. pain is the more common cause of prolonged hospital stay or readmission. there is need for a simple, efficient way to reduce post-procedural pain. for this prospective randomized study, the hypothesis is that an anesthetic drug, lidocaine, injected in the uterine arteries diminishes pain post-ufe. patients will be randomized in 3 groups: control, lidocaine injected during embolization, and lidocaine injected after embolization. pain will be evaluated using a validated scale at 4h and 24h post-intervention. hospital length-of-stay and total narcotic dose administered will be evaluated in the three groups. this is the first canadian study evaluating lidocaine use for pain control in ufe patients. results will be transferable to clinical practice, considering the use of lidocaine is simple and cost is negligible. it could have a great impact on pain management in women undergoing ufe in all practice settings.


Eligibility criteria:
inclusion criteria: * indication for uterine fibroid embolization: bulk symptoms, pain or heavy menstrual bleeding attributed to fibroids, with imaging confirmation; * patient must be able to provide written, informed consent exclusion criteria: * documented of allergy or intolerance to lidocaine or other amide-type anesthetics; * personal or familial history of malignant familial hyperthermia; * documented history of second or third atrio-ventricular heart block * contra-indication to uterine fibroid embolization : active infection, suspected malignancy, coagulopathy, pregnancy or desire to preserve fertility, large pedunculated sub-serosal fibroid. * history of previous uterine fibroid embolization.

Keywords: uterine fibroid embolization leiomyoma lidocaine pain
simidis: azacitidine and beta erythropoietin treatment in patients with myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: the primary objective is to evaluate the efficacy of the treatment in response rate terms. otherwise this study wants to evaluate the safety of the treatment.

a total of up to 30 patients diagnosed of myelodysplastic syndrome red cell transfusion dependent with low or intermediate -1 risk will be included. the patients will be evaluated at scheduled visits in up to three study periods: pre-treatment, treatment and follow up. the pre-treatment includes screening and baseline visits. after providing informed consent, patients will be evaluated for study eligibility. during treatment period patients will be evaluated once a month although biochemistry and haematology parameters will be evaluated every 2 weeks. if an erythroid response after 24 weeks is determined, a extension treatment will be carry out without disease progression.

Eligibility criteria:
inclusion criteria: 1. must voluntary sign the informed consent. 2. age ≥ 18 years. 3. must be able to comply with the protocol requirements 4. patient recently diagnosed with myelodysplastic syndrome red cell transfusion dependent with low or intermediate -1 risk according ipss criteria. 5. red cell transfusion dependent anemia. 6. el patient has to be able to complain with the protocol visits. 7. women and man must accept to use high efficacy anticonceptive methods exclusion criteria: 1. pregnancy or breast-feed women. 2. patients previously received treatment with azacytidine . 3. patients previously received treatment with erythropoietin agents. 4. proliferative chronic myelomonocytic leukaemia (leukocytes ≥ 12000/ml). 5. patient with a previous clinical history of another cancer (except for basocellular carcinoma or spinocellular carcinoma in situ of cervix or breast) except if the patient is free of symptoms during ≥ 3 years. 6. cytotoxic chemotherapy or experimental agents usage for myelodysplastic syndrome treatment during 28 days. 7. previous haematopoietic transplant. 8. mielosupresion and antitumoral treatment during the previous 28 days. 9. the following laboratory data: absolute neutrophil count \ 2.0 mg/dl (177 mmol/l) aspartate transaminase (ast) or alanine transaminase (alt ) \> 5 x the upper limit of normal. total bilirubin: \> 2 mg/dl 10. patients with b12 vitamin, folic acid and ferrum deficiency. 11. patient with positive vih-1. 12. any other organic or mental illness that could make impossible to sign the inform consent or involve risk to the patient. 13. patient has hypersensitivity previous to beta ,azacytidine, erythropoietin and/or mannitol.

Keywords: myelodysplastic syndrome red cell transfusion dependent
dpbrn prevalence of questionable occlusal caries lesions

Conditions: Dental Caries

Summary: the purpose of this study was to investigate the process involved when making decisions about the diagnosis and treatment of questionable lesions, as well as determine if there is any association between lesions progression (or depth, if opened) and clinical characteristics and baseline risk assessment.

the term"questionable" is defined as a tooth with no cavitation (no continuity break in the enamel) and no radiographic radiolucencies, but the presence of caries is suspected due to roughness, surface opacities, or staining. the characteristics of these lesions and the patient's baseline caries risk were examined. there have been very few studies regarding questionable lesions, virtually no clinical evaluations of the progression of questionable lesions over time, and no studies depicting the prevalence of these lesions. since carious lesions have the ability to arrest and possibly reverse, determining how often these lesions are being seen in practice and learning more about their characteristics and patient risk assessment are important steps in order to manage these lesions without unnecessary surgical intervention.

Eligibility criteria:
inclusion criteria: * patients needed to have at least one permanent tooth with a questionable lesion. this means that subjects were at least 6 years old because that is when the permanent first molar typically erupts. exclusion criteria: * patients under 6 years old * patients 6 years old and older who do not have a questionable lesion

Keywords: assessment questionable caries
the effect of alpha linolenic acid intake on patients with elevated glycemic status

Conditions: Elevated Blood Sugar

Summary: the findings of previous experiments suggested that alpha linolenic acid (ala) has been linked to anti-hyperglycemic, and reducing the risk of diabetes.this is a randomized double-blind cross-over trial, aims to study the effect of ala on glycemic status and human metabolism. firstly, the investigators will investigate the efficacy of ala on improving the indexes of glucose metabolism. secondly, next generation sequencing (ngs), ultra-high performance liquid chromatography-tandem mass spectrometric (uplc-ms/ms) and gas chromatography-mass spectrometry detection will be conducted to explore the role of ala on gut microbiota as well as metabolites. thirdly, single nucleotide polymorphism will be genotyped by time-of-flight mass spectrometry to find the gene-environment interaction effect.


Eligibility criteria:
inclusion criteria: * fasting blood glucose 6.1-8.4mmol /l; * hba1c 5.7-7.0%; * ogtt 2h or postprandial blood glucose 7.8-11.1 mmol/l; * patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well. exclusion criteria: * under 30 years old or over 75 years old; * suffering from severe obesity, thyroid disease, or other serious diseases, such as mental illness; * take nutritional supplements, such as fish oil capsules, perilla seed oil and flaxseed oil capsules, for nearly one month; * intake more than 20g walnuts per day or more than 100g fatty fish per week in the last month; * daily cooking oil is linseed oil or rapeseed oil and other α -linolenic acid rich vegetable oil; * have been diagnosed with type 2 diabetes and are currently receiving insulin injection; * allergic to the content of intervention; * failure to eat the tested sample as prescribed and affect the efficacy or safety judgment.
evaluation of gynecological acceptability of 3 health care products

Conditions: Atrophic Vaginitis; Vaginal Disease

Summary: the research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. the subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.

at this study, 70 female participants, 18 to 70 years, healthy with complaints of vaginal dryness used the 3 investigational product, each one by 9 days. between the changes of product use, there were 4 days of wash out. at the 9th day, the participants answered assessment questionnaire.

Eligibility criteria:
inclusion criteria: * health volunteers * non-injured mucosa in the test region; * agreement to adhere to study procedures and requirements and attend the institute on the day(s) and time(s) determined for the evaluations; * ability to consent to their participation in the study; * age from 18 to 70 years old; * female participants; * vaginal dryness (slight minimum) - according to questions from the gynecologist. exclusion criteria: * pregnancy or breastfeeding; * skin pathology in the area of application of the product; * diabetes mellitus type 1; insulin-dependent diabetes; presence of complications due to diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma; * current use of the following medications for topical or systemic use: corticosteroids, immunosuppressants and antihistamines; * skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis; * history of reaction to the category of the tested product; * other diseases or medications that may directly interfere with the study or endanger the health of the research participant.
comparative effectiveness of myofacial release vs cupping therapy on quality of life in restless leg syndrome with knee o.a.

Conditions: Restless Leg Syndrome With Knee OA; Sleep Disorder

Summary: the aim of this study is to determine effectiveness of myofascial release and cupping therapy on quality of life in restless leg syndrome with knee osteoarthritis. holding this aim, a randomized control trial will be conducted at physiotherapy out patient department of dow institute of physical medicine and rehabilitation. the subjects will first be screened by the principal investigator, physiotherapist, using the criteria of international restless leg syndrome study group (irlssg). each selected subject will go for random allocation in one of the two treatment groups with different interventions with the help of a computer-generated randomization sheet. the group a will be provided with myofacial release whereas the group b will receive cupping therapy while cryotherapy and passive lower limb stretches (hamstring and calf muscles) will be applied to both the groups as standard treatment. assessment will be done at baseline and will re-evaluate at the post intervention session through an assessment form. physical therapist but not the principal investigator will assess who will be unaware to the type of intervention administered. outcome measures will be pittsburgh sleep quality index, visual analog scale for pain assessment, restless leg syndrome quality of life questionnaire (rls-qol), international restless leg syndrome study group rating scale (irlssg rs) and passive straight leg raise (pslr). total 12 sessions will be given for duration of 4weeks on alternate days.


Eligibility criteria:
inclusion criteria: 1. grade 2, 3 and 4 knee oa by the kellgren lawrence classification 2. bilateral or unilateral both knee oa 3. age 40 to 70 years 4. patients who were meeting the international restless leg syndrome study group (irlssg) eligibility criteria exclusion criteria: 1. patients with cognitive dysfunction 2. rheumatoid arthritis 3. patients with neurological disorders 4. medical conditions covering (cardiovascular disease, neurological disorders, severe psychiatric illness or pregnancy)

Keywords: restless leg syndrome knee oa cupping therapy myofacial release
application of machine learning algorithms to identify optimal candidates for primary tumor resection in patients with metastatic non-small cell neuroendocrine tumors

Conditions: Lung Cancer - Non Small Cell

Summary: this study was based on public use data from the seer database. the study did not require informed consent from the seer registered cases, and the authors obtained limited-use data agreements from seer.

this study utilized publicly available data from the seer (surveillance, epidemiology, and end results) database, which is a comprehensive source of information on cancer statistics in the united states. the authors did not need to obtain informed consent from individuals whose cases are registered in the seer database because the data is anonymized and is meant for public use. instead, the authors acquired limited-use data agreements with seer, which are legal contracts that allow researchers to access and use specific datasets under certain conditions while ensuring that the privacy of the individuals in the database is maintained. this agreement outlines the terms of data use, ensuring that the researchers adhere to guidelines for the ethical handling of data while still enabling them to conduct their research.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis of non-small cell neuroendocrine carcinoma * known surgical information exclusion criteria: * small cell lung cancer * age less than 18 years

Keywords: lung cancer machine learning non-small cell neuroendocrine tumor
high-dose quinapril versus low-dose quinapril plus amlodipine in the treatment of high-risk hypertensive patients

Conditions: Hypertension

Summary: the purpose of this study is to compare the impact of two blood pressure lowering treatments (high dose quinapril versus low dose quinapril plus amlodipine) on variations in heart rate over 24 hours.


Eligibility criteria:
inclusion criteria: * patients with a documented history of hypertension defined as: sbp \> or = 140 mmhg or dbp \> or = 90 mmhg if hypertension untreated or patients currently treated for hypertension. * documented cad or diabetes or impaired glucose tolerance * sinus rhythm principal exclusion criteria: * previous intolerance or allergic reaction to an ace inhibitor, an arb or dihydropyridine calcium channel blocker * history of angioedema or cough related to previous ace inhibitor use. * systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 110 mmhg in untreated patients * systolic blood pressure \> 160 mmhg or diastolic blood pressure \> 100 mmhg in patients currently treated by an ace inhibitor or an arb * creatinine clearance \< 30 ml/min * significant liver dysfunction * current serum potassium \> or = 5 mmol/l or a history of marked ace inhibitor or arb induced hyperkalemia resulting in either a serum potassium \> or = 5.5 mmol/l or a life-threatening adverse event. * history of hf or known lvef \< or = 45% * bilateral renal artery stenosis (or unilateral if only one kidney) * unstable angina, myocardial infarction or coronary revascularization within the last 3 months. * connective tissue disease or chronic inflammatory condition * active malignancy * active infection in the last 2 weeks * inability or any contraindication to perform an exercise test.

Keywords: blood pressure hypertension renin aldosterone heart rate variability
outcomes of resection at different times between the end of neoadjuvant treatment and surgery

Conditions: Neoadjuvant Chemoradiotherapy; Rectal Tumor; Surgery; Surgery--Complications

Summary: neoadjuvant radio-chemotherapy (nrct) represents a milestone in the treatment of selected rectal tumours. ideal time interval between the end of nrct and surgery is still debated; a 6-8 weeks time interval is considered optimal, but shorter or longer intervals have been associated with better oncological outcomes. moreover, there is a lack of data about clinical postoperative outcomes and different time intervals after the end of nrct. here, effect that different time intervals have on postoperative complications with particular regard to the anastomotic dehiscence have been evaluated. methods one hundred-sixty-seven patients underwent surgery after long-course nrct. three different time intervals were considered: (0-42; 43-56; \>57 days).

neoadjuvant radio-chemotherapy (nrct) represents a milestone in the treatment of selected rectal adenocarcinoma. even though a 6-8 weeks' time interval after the end of nrct and surgery is considered ideal, the optimal time for surgery is still controversial.

Eligibility criteria:
inclusion criteria: - patients with rectal adenocarcinoma who underwent to resection after combined nrct at university campus bio-medico di roma from january 2005 to march 2015. to evaluate the anastomotic dehiscence were excluded patients undergone to abdomino-perineal resection (apr) and 4 patients for whom data were not available.