Kornimate/medical-research-clean huggingface dataset:
linear ii - lme-159 evaluation of a multi-electrode linear type ablation catheter

Conditions: Cavotricuspid Isthmus Dependent Right Atrial Flutter

Summary: the linear ii study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the multi-electrode linear type ablation catheter and the performance of the product when used for the treatment of symptomatic cti (cavotricuspid isthmus) dependent right atrial flutter.


Eligibility criteria:
inclusion criteria: * at least one symptomatic episode of typical cti dependent right atrial flutter documented by 12 lead ecg, holter monitor, transtelephonic event monitor, telemetry strip, or implanted device. * age 18 years or older. exclusion criteria: * previous typical cti dependent right atrial flutter ablation * uncontrolled heart failure or nyha function class iv * mi within the past 2 months * any cardiac surgery (i.e. cabg) within the past 2 months * subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) * awaiting cardiac transplantation or other cardiac surgery within the next 6 months * documented thromboembolic event (including tia) within the past 12 months * significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * active illness or active systemic infection or sepsis * unstable angina * history of blood clotting or bleeding abnormalities * contraindication to anticoagulation (eg, heparin or warfarin) * life expectancy less than 6 months * presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation * presence of a condition that precludes vascular access * women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation * currently enrolled in another device, biologics, or drug study * contraindication for use of the investigational catheter, as indicated in the respective instructions for use

Keywords: endocardial ablation atrial flutter cavotricuspid isthmus
evaluating the efficacy of artesunate-mefloquine and the relative roles of resistance genetic markers

Conditions: P. Falciparum Malaria; P. Falciparum Malaria Mixed Infection

Summary: this is a retrospective non randomized cohort to evaluate efficacy of mas3 on patients with uncomplicated p. falciparum malaria or mixed infection (p. falciparum + a non-falciparum species). the review of patients' records and blood samples will be performed for patients treated at the clinics of shoklo malaria research unit from the period of january 2003 to december 2013.

the objective of this study is to evaluate the day 42 pcr adjusted cure rate of mefloquine-artesunate (mas3) in patients with p. falciparum study procedure clinic and patient records and log books will be reviewed and the following clinical information will be extracted: vital signs especially the temperature, clinical signs and symptoms, blood slide and haematocrit result and findings of physical examination (anaemia, jaundice, liver, spleen etc). as a routine, these data were recorded on the clinic patient record and malaria smear microscopy logbook accordingly (which will be regarded as the source documents in this analysis). these source documents will be reviewed and stored specimen will be analysed after getting the permission from the director of shoklo malaria research unit, the university of oxford tropical research ethical committee (oxtrec)and the faculty of tropical medicine ethics committee (ftmec). these data will be extracted and transcribed into the case record forms and entered into microsoft access. during the data extraction, the unique id will be assigned to each patient whereas the patients' name will neither be entered into database nor disclosed in the analysis process (ie: the data will be anonymised).

Eligibility criteria:
inclusion criteria: * patients of any age and sex who received treatment for uncomplicated malaria and followed up between january 2003 to december 2013 * symptomatic of malaria infection, i.e. history of fever or tympanic temperature ≥37.5°c * microscopically confirmed asexual stages of p. falciparum ≥ 5/500 wbc (alone or mixed with non- p. falciparum species) * received fully supervised treatment of mefloquine-artesunate exclusion criteria: * pregnant woman * p. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells signs or symptoms indicative of severe malaria29 * mefloquine treatment within the 60 days preceding the current episode of malaria * splenectomy patients will be excluded from the efficacy analysis if they didn't finish the 3 days treatment of mefloquine artesunate but still kept in intention-to-treat population.

Keywords: retrospective studies clinical efficacy
does the national health insurance card allow us to predict antibiotic resistance?

Conditions: Urinary Tract Infection Empiric Antibiotic

Summary: the objective is to determine if data from the national insurance health card (giving antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk of antibiotic resistance and to identify population groups for which probabilistic antibiotics regimen of urinary tract infection could be simplified


Eligibility criteria:
inclusion criteria: * national health insurance card available * community acquired urinary tract infection exclusion criteria: * incapacity to accept an inform consent * hospitalized acquired urinary tract infection * national health insurance card non available
crocus sativus extract impact in metabolic control of patients with diabetes mellitus type 1

Conditions: Diabetes Mellitus, Type 1; Diabetes type1

Summary: administration of 4 strain of probiotics, prebiotic, magnesium and crocus sativus extract in a sachet to people with diabetes mellitus type 1 for 6 months

double blind placebo controlled randomized trial: a sachet of a combination of 4 strains of probiotics (lactobacillus rhamnosus, bifidobacterium animalis lactis, bifidobacterium breve, bifidobacterium longum), fructooligosaccharides, magnesium and saffron extract was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.

Eligibility criteria:
inclusion criteria: * people with diabetes mellitus type 1 (with diabetes duration over 1 year) (adults \<18 years old) wearing a continuous glucose monitoring system with or without an insulin pump exclusion criteria: * pregnant * people with diabetes mellitus type 2 * breastfeeding women * people with liver disease * people with chronic kidney disease (over stage 3) * people with allergy in crocus sativus * people that consume everyday herbs or supplements * people on anti platelet treatment not for prevention

Keywords: diabetes mellitus type 1 diabetes type 1 saffron saffron extract continuous glucose monitoring
zinc, mental health, and school performance in guatemalan schoolchildren

Conditions: Depression; Anxiety

Summary: this study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in guatemala.

mental health problems are an important cause of dysfunction throughout the world, accounting for 8.1% of the global burden of disease. the need for interventions that can prevent mental health conditions, particularly among children, cannot be overemphasized. this study will determine whether zinc supplementation improves the mental health and school performance among children in guatemala. participants will be randomly assigned to receive daily supplements of either zinc or placebo for 6 months. participants will be assessed at study entry and after the 6-month treatment. participants and their parents and teachers will complete questionnaires about the participants' symptoms of depression and anxiety, concentration and activity levels, school performance, and any environmental stressors to which the participants may be exposed to.

Eligibility criteria:
inclusion criteria: * attend a public school in specific guatemalan community and has thorough and up-to-date school records * currently in 2nd to 6th grade * parent or guardian willing to provide informed consent exclusion criteria: * any illness that may affect participants' zinc levels * any chronic illness * history of cancer

Keywords: zinc dietary supplements nutritional supplements child mental health school guatemala
advance care planning for older latinos with chronic illness

Conditions: Patient Engagement; End of Life; Chronic Disease; Communication

Summary: the goal of this study is to test the feasibility of a randomized controlled trial to learn about implementation of an intervention model, advance care planning i plan (acp-i plan), among older latinos with chronic illnesses in community settings.

the goal of this study is to test the feasibility of a randomized controlled trial to learn about implementation of an intervention model, advance care planning i plan (acp-i plan), among older latinos with chronic illnesses in community settings. the questions of this study seek to explore implementation of the intervention model: 1. to evaluate feasibility, acceptability, and preliminary impact of acp-i plan to improve ad documentation and increase engagement in acp communication with family and providers among older latinos with chronic diseases (cancers and non-cancers); and 2. to evaluate implementation of acp-i plan in a community setting and examine further need for adaption. participants will be randomized into two groups: 1. acp education consisting of * a brief social work screening, * an educational pamphlet, * advance directive forms (in english and spanish), and * community resource materials (i.e., handout); and 2. acp education plus counseling consisting of * motivational interviewing * decisional support, and * patient navigation to address barriers we anticipate that acp-i plan will be feasibly and acceptable. participants who receive acp-i plan will show 1) greater likelihood of documenting an ad, 2) greater importance of and concern for engaging in acp communication with family members and providers, and 3) reduced distress at 4-week post intervention.

Eligibility criteria:
inclusion criteria: * 50 years old or older * latino/latina or hispanic? * have 1 or more chronic health conditions exclusion criteria: * schizophrenia * schizoaffective disorder * dementia * alzheimer's disease

Keywords: latino advance care planning advance directive
the effectiveness of individualised bone density feedback and osteoporosis education in premenopausal women

Conditions: Osteoporosis

Summary: the purpose of this study is to determine whether giving women feedback concerning their bone mineral density, combined with either an information leaflet or group education concerning osteoporosis changes women's behavior and/or bone density.

fractures due to osteoporosis are a major public health problem. bone density is one of the major predictors of these osteoporotic fractures and is the result of the amount of bone gained in early life (i.e peak bone mass) and subsequent bone loss. cigarette smoking, physical inactivity and inadequate calcium intake are widely regarded as risk factors for osteoporosis (as well as for other common diseases for the former two). despite this information being widely available and actively promoted, the prevalence of these risk factors in the population remains unacceptably high. in women (mean age 33) taking part in a study of the determinants of bone mass in children, we recently reported substantial change in these behaviours at 12 months follow-up when women received an information leaflet and individualised bone density feedback. these women were highly selected and it is unclear if this response is representative of all women. with this study, we aim to test whether individualised bone density feedback, combined with either an information leaflet or small group education will change women's osteporosis preventive behaviors and/or bone density. specifically, we aimed to test the following hypotheses: 1. women are more likely to change calcium intake and physical activity if their bmd is low. 2. group education (in the form of the osteoporosis prevention and self management course) will be more efficacious at changing these lifestyle behaviours than an information leaflet alone. 3. bone density feedback and educational intervention have independent effects on behavior and bmd change. 4. women who improve their physical activity or dietary calcium intake will have a change in bone mass over 2 years that is 0.34-0.54% per annum better (depending on site and lifestyle factor) than those who do not alter their behaviour.

Eligibility criteria:
inclusion criteria: * women aged between 25 and 44 years of age exclusion criteria: * previous had measurement of bone densitometry * thyroid disease * renal failure * malignancy * rheumatoid arthritis * history of hysterectomy * hormone replacement therapy * were pregnant or planning pregnancy within 2 years of study entry * lactating.
evaluation of novel cone-beam ct for guidance and adaptation of precision radiotherapy

Conditions: Lung Cancer; Liver Cancer; Breast Cancer; Other Cancer

Summary: this is a feasibility study investigating the image quality of a new, high-performance cone beam ct (cbct) used for on-couch imaging during radiotherapy treatments.

this study focuses on potential benefits of a high performance cone beam ct (cbct) image guidance system for improved precision in the delivery of radiotherapy. cbct is currently used during radiation therapy to align the patient to their original treatment plan to increase the precision of radiation delivery. current cbct imaging technology requires approximately a minute to acquire an image. in order to acquire images with sufficient quality to allow accurate targeting, the patient may need to perform multiple breath hold maneuvers to "freeze" the motion of tumors that move with the breathing cycle (e.g. lung, liver, and breast tumors). the new high-performance cbct can acquire an image in approximately 6 seconds, potentially enabling acquisition of images with a single breath hold. improved motion compensation algorithms used in image reconstruction may allow acquisition of good quality images even while a patient is not holding their breath. the methodology for the subject's treatment setup, ct simulation, treatment planning, image guidance and treatment delivery will be determined by the subject's treatment team and is not specified by this study. enrollment in the study may occur after treatment delivery has started but must be prior to the fifth fraction. following completion of informed consent to participate in this study, high-performance cbct imaging will be scheduled immediately before or after one of the subject's first five scheduled radiation treatment fractions. two research cbct images will be acquired, one with breath hold, the other with free breathing. with minimal disruption for participating patients, this study will enable a comparison of (i) the subject's treatment planning fan-beam ct and (ii) the conventional cbct acquired on an existing treatment unit with (iii) the high-performance cbct. image quality of the high performance cbct image data will thereby be compared to both a best-case standard (fan-beam) and the status-quo for on-couch imaging to isolate and identify improvements.

Eligibility criteria:
inclusion criteria: * subject is scheduled for treatment on one of the five truebeam platforms at the ns health qe2 site. * subject is receiving radiation therapy using a breath-hold technique (for example, lung, liver and left breast cancers). exclusion criteria: * patient is pregnant or has plans for pregnancy during the period of treatment. * patient is unwilling to consent to participating to the study, or for whom informed consent is not possible.
a trial of tolerogenic immunosuppression in highly sensitized renal transplant recipients

Conditions: Kidney Diseases

Summary: comparison between campath induction and monotherapy with tacrolimus vs thymoglobulin induction and triple drug maintenance using tacrolimus, mycophenolate, and steroids.

recent reports suggest that it might be possible to induce a state of tolerance in solid organ transplantation. so called "tolerogenic immunosuppression" involves induction with lymphocyte depleting antibodies followed by monotherapy with calcineurin inhibitors, cyclosporin or tacrolimus. the proposed study aims to evaluate a protocol of immunosuppression induction with lymphocyte depleting antibody campath given prior to graft reperfusion, followed by tacrolimus monotherapy in highly sensitized patients (pra \>14% or past historical =/\>50% and/or multiple renal transplants) undergoing renal transplantation, and compare it with the current standard protocol at utmb which employs induction with thymoglobulin given over 4 days followed by 3 drugs: tacrolimus, mycophenolate and steroids. in both groups of patients the target tacrolimus levels will be the same i.e, between 10 to 15ng/ml, soon after the transplant. in the campath gro up, tacrolimus will be tapered after 3 months in patients who do not have rejection and appear to be developing donor specific tolerance.

Eligibility criteria:
inclusion criteria: 1. males and females aged 18-75 years. 2. recipients of multiple kidney transplants 3. patients with a pra \>14% and/or a past historical pra greater or equal to 50%. 4. females of childbearing potential must have a negative pregnancy test prior to inclusion. 5. patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained. exclusion criteria: 1. patients with a history of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin. 2. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation,confirmed by a positive human chorionic gonadotropin(hcg) laboratory test. 3. patients who are hiv positive. 4. patients with symptoms of significant somatic or mental illness or evidence of current drug and/or alcohol abuse.

Keywords: kidney transplant tolerance induction high panel reactive antibody (pra) kidney recipients
a safety and effectiveness study of acetaminophen extended release (3900 mg/day) and ibuprofen (1200 mg/day) in the treatment of pain associated with ankle sprains.

Conditions: Sprains and Strains; Pain

Summary: the purpose of this study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that of 400 mg ibuprofen given three times daily for nine days for the signs and symptoms of (grade i and grade ii) lateral ankle sprains.

the objective of this randomized, double-blind, parallel-group study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that of 400 mg ibuprofen given three times daily for nine days for the signs and symptoms of grade i and grade ii lateral ankle sprains. the primary efficacy endpoint is the change from baseline (day 1) to day 4 in the subjects' pain upon walking. safety assessments consist of the monitoring of adverse events and assessments of the ankle injury during the course of the study. two hypotheses are examined using a step down approach. the first hypothesis is that acetaminophen extended release is not inferior to ibuprofen in relieving the pain associated with (grade i or grade ii) lateral ankle sprains. if acetaminophen extended release is not inferior to ibuprofen in relieving the pain associated with grade i or grade ii lateral ankle sprains, the second hypothesis is that acetaminophen extended release is superior to ibuprofen in relieving the pain associated with grade i or grade ii lateral ankle sprains. two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day for nine days or two ibuprofen 200 mg caplets, taken by mouth, three times a day for nine days

Eligibility criteria:
inclusion criteria: * have had an ankle sprain within 24 hours of study entry * have ankle pain when walking * have not recently used non-steroidal, anti-inflammatory drugs (nsaids), other pain relieving medications (including acetaminophen) or medicines that could interfere with the assessment of effectiveness * if female, must not be pregnant or breastfeeding exclusion criteria: * ankle sprain was the second ankle sprain within six months * both ankles were sprained * ankle sprain occurred on the same side of the body as a knee injury * ankle injury requires bed rest, hospitalization, surgical intervention, or use of a non-removable rigid cylindrical cast * subject reports severe or very severe pain at rest on a five-point scale of none, mild, moderate, severe or very severe

Keywords: ankle sprain acetaminophen extended release, ibuprofen
role of rehabilitation for the repair of pelvic floor injuries associated to vaginal delivery identified by 3/4d transperineal ultrasound

Conditions: Pelvic Floor Disorders; Ultrasound Therapy; Complications; Physical Disorder; Obstetric Labor Complications

Summary: summary: (objective, design, scope of the study, subjects of study, instrumentation, results, conclusions) objectives: to evaluate if the physiotherapy treatment in pelvic floor dysfunctions, identified by transperineal ultrasound 3 / 4d, in postpartum improve the tone and functionality of pelvic floor. design: post-authorization, prospective, longitudinal randomized intervention study scope: full-term deliveries at the university hospital. subjects of study: full-term primiparous and full-term pregnancies with pelvic floor lesion, identified by transperineal ultrasound 3 / 4d, which are randomized between the physiotherapy treatment of pelvic floor and the non-work. variables: primary variable: assess the improvement in contractility / tone, evaluation by manometry and assess the anatomical improvement of the area of ?? the genital hiatus, stay by transperineal ultrasound 3 / 4d. secondary variables: identify the levator ani muscle injury rate, estimate the sonographic changes in the levator ani muscle through rehabilitation. analyze the improvement of the symptoms associated with the public organic prolapse and evaluate the improvement of the quality of life. data analysis: to detect a difference of 10% in the reduction of the size of the index between the study groups (not intervened / intervened) after 6 months of intervention, standard deviation 10%, error-alpha 5%, error- beta 10% (p90%) we need 23 women in each group. assuming a loss of 10% in the follow-up, the final size would be 52 women, 26 per group.


Eligibility criteria:
inclusion criteria: * vaginal delivery * cephalic presentation * primiparity * at term gestation (37-42 weeks) * no prior pelvic floor corrective surgery * written informed consent exclusion criteria: * pregnancies with severe maternal or fetal pathology