Kornimate/medical-research-clean huggingface dataset:
botulism outbreak in thailand (episode ii)

Conditions: Botulism

Summary: a second botulism outbreak in northern thailand was reported in 2006. 192 people were exposed to raw meat and the gut of deer, 83 suffered from diarrhea. of these 5 developed respiratory failure, 1 impending respiratory failure. we analysed the clinical findings and electrophysiologic findings in this second episode of large botulism outbreak in northern thailand.

preliminary report northern thailand's big botulism outbreak occurred again on 30 june 14, 2006, \[16.00pm\] affecting 83 from 192 people who exposed to raw dear meat and gut \[1 night preserved with ice pack of whole body of dear before disection and distribution \]. of these, 3 developed respiratory failure, 1 developed impending respiratory failure, 83 of 192 whom developed fatique and diarrhea after ingestion of raw dear meat and gut on 26-30 june 2006. 3 patients were refered to 2 high facility hospitals for severe respiratory failure. physical examination of 3 patients in icu of chiang kum general hospital revealed ptosis \[3/3\] mild ophthalmoparesis \[2/3\] proximal muscle weakness \[2/3\] abdominal paradoxical respiration \[3/3\] pupil dilate \[1/3\] and negative inspiratory pressure \[nip\] less than 15 mmhg \[3/3\] were observed. neurological electrophysiologic study of 2 patients revealed low amplitude compound muscle action potential \[cmap\] of abductor digiti minimi \[adm\] muscle with decrement response after repetitive stimulation with low frequency \[3hz\], increment response of adm muscle after stimulation with high frequency \[10hz, 20hz, and 30hz.\].the electrophysiologic findings support diagnosis of presynaptic neuromuscular dysfunction with respiratory failure, botulism is most likely diagnosis. after treated with botulinum antitoxin \[on july,1 ,2006 \[mixed-type botulinum antitoxin --donated from japan at nan hospital's botulisum outbreak on march 14,2006\], 3 patients in icu showed improvement of over all clinical outcomes. active survey by ministry of public health of thailand and cdc-usa to identify the high risk patient who may develop respiratory failure , and immunologucal vs microbiological diagnosis were performed. this outbreak may be the second hit of botulisum in the northern thailand but less amount of severe cases was observed.

Eligibility criteria:
inclusion criteria: * ate the deer meat and/or the gut from chiang kum district, after june 26,2006 * clinical botulism or respiratory failure who need ventilator assistance * the staff of referring hospital willing to participate in the thai botulism study group exclusion criteria: • patients who did not eat deer meat and or the gut from chiang kum district

Keywords: food borne botulism
the effect of a multi-component weight management program on appetite, food preference and body weight

Conditions: Overweight; Obesity; Sedentary Lifestlye

Summary: the aim of the current study is to demonstrate that a commercial weight management diet (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy intake during ad-libitum meals and over a full day. we further seek to demonstrate the sustainability of this effect following 12- week weight loss on the weight management program. * we hypothesise that formulated (low energy) meals will lead to decreased hunger, greater fullness and reduced desire to eat compared to standard meals. * we hypothesise that the commercial weight management program will lead to greater weight loss compared to control program. * we hypothesise that formulated meals (high consumer acceptance) will improve hedonic control over eating (lower wanting for high fat food) * we hypothesise that the commercial weight management program will improve hedonic control over eating (reduced experience food cravings)


Eligibility criteria:
inclusion criteria: * bmi of 28 - 45 kg/m2 * reporting an interest in weight loss, not actively participating in a commercial weight loss program, * not increased physical activity levels in the past 2-4 weeks * able to eat most everyday foods and fruits and vegetables * written informed consent to be given exclusion criteria: * significant health problems that could cause confounding effects between intervention and control. * taking any medication or supplements known to affect appetite or weight within the past month and/or during the study * pregnant, planning to become pregnant or breastfeeding * history of anaphylaxis to food * known food allergies or food intolerance * smokers and those who have recently ceased smoking * participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters * those who have previously taken part in a commercial weight loss program in the last 6 months? . * participants who work in appetite or feeding related areas * participants unable to consume foods used in the study * participants who have had bariatric surgery * participants with a history of eating disorder * presence of untreated hypothyroidism * inability to fully comply with intervention or study procedures * insufficient english language skills to complete study questionnaires
chronic indwelling foley and catheter associated trauma (cif-cat) study

Conditions: Bladder Infections and Inflammations

Summary: to determine whether an indwelling low profile kohli atraumatic catheter causes less macro-morphologic inflammation and edema to the bladder mucosa than a traditional indwelling foley catheter as assess by computerized image analysis.

the kohli atraumatic catheter similarly aims to reduce bladder mucosal trauma with its low profile pancake shaped balloon versus the ovoid balloon of a traditional foley catheter. the kohli atraumatic catheter has a short, opened-ended tip that minimally protrudes through a patented low-profile donut-shaped balloon. the combination of the low profile and reduced tip length prevents the catheter from contacting the bladder walls and thereby minimize disruption of the bladder surface mucus layer and trauma to the urothelium - theoretically reducing the chance of bacterial invasion. a trial in which sheep were randomized to a traditional indwelling foley catheter or a prototype kohli atraumatic catheter demonstrated a dramatic reduction in both bladder wall trauma and edema. the ulcerated area dropped from 7.2% to 1.8% (75%) and the edema from 26.9% to 13.0% (52%). statistical analysis to compare the effects of 2 catheter types, data will be analyzed using the general linear models tools from sas/stat software and presented as means ± standard error of the mean. the model will include 2 catheter types, inflamed vs non-inflamed areas, and their interactions.

Eligibility criteria:
inclusion criteria: * men or women older than age 18 * indwelling foley urinary catheter for at least 30 days prior to entry with anticipation for continued indwelling urinary catheterization for at least 30 days after entry into the study. exclusion criteria: * inability to provide informed consent * unwilling or medically inappropriate for cystoscopy

Keywords: bladder mucosal trauma
to assess the pharmacokinetics of azd1656 and its metabolite in type 2 diabetes mellitus patients

Conditions: Glucose Lowering

Summary: to assess the pharmacokinetics of azd1656, and its metabolite, in type 2 diabetes mellitus patients with varying degrees of renal impairment and to compare the results with those in patients with normal renal function.


Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of t2dm for at least 1 year, treated with any oad or insulin * calculated mdrd gfr based on s-creatinine at enrollment should fall within any of the 4 categories: mild , moderate, severe normal exclusion criteria: * clinically significant progression of current disease or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the ip * clinically significant neuropathy according to the investigator. however subjects with diabetic neuropathy which is not clinically significant according to the investigator may be included.

Keywords: diabetes
co-infusion of neurotensin and glp-1 effects on appetite and food intake.

Conditions: Obesity

Summary: co-infusion of neurotensin and glp-1 effects on appetite and food intake.

neurotensin (nt), a gut hormone and neuropeptide, and glp-1, as well a gut hormone, increases in circulation after bariatric surgery in rodents and humans and inhibit food intake in mice. studies in rodents have shown that a glp-1 receptor agonist and long acting neurotensin inhibit food intake. this study investigates whether the synergistic anorexic effects of neurotensin and glp-1 agonism suggested by animal studies can be translated.

Eligibility criteria:
inclusion criteria: * informed consent * above 18 years of age * normal hemoglobin concentration * 28\<bmi\<40 kg/m2 exclusion criteria: * diabetes mellitus * truncal vagotomy * resection of intestine (apart from appendectomy) * tobaccos use * nephropathy (serum-creatinin\>130 micromolar or/and albuminuria) * liver disease (alanine transaminase or/and aspartate transaminase\>2 times normal range.) * treatment with medication that cannot be paused in 12 hours * allergy towards latex or plastic * bleeding disorder

Keywords: neurotensin glucagon like peptide-1 (glp-1)
ultrasounds evaluation of asymptomatic perimandibular muscles treated with dry needling

Conditions: Asymptomatic State; Temporomandibular Joint; Masticatory Muscles

Summary: the articular disc of temporomandibular joint and three muscles of the cervico-facial region (temporal, masseter, sternocleidomastoid) are evaluated by means of sonographic images to observe and measure their dimensions' changes after a dry needling intervention. the participants are asymptomatic subjects and will be randomly divided in 2 groups: half of them are treated on the right side of the face, while the other half on the left side. our hypothesis is that ultrasonography can reveal changes in the structures measured on the treated side.

the trial is designed as a before-and-after study conducted on asymptomatic subjects. the aim is to assess temporomandibular joint and three perimandibular muscles (temporal, masseter, sternocleidomastoid) by means of rehabilitative ultrasound imaging, carried out by a novice clinician. these evaluations are performed before and after a dry needling treatment directed to the tree studied muscles of one side of the face. the side to be treated is randomly assigned by using a computer-generated randomization process, the other side is used as control. one month after the treatment sonographic images are taken by the novice clinician and by an expert one. the aim is to assess the reliability of ultrasonography comparing the results of their assessments.

Eligibility criteria:
inclusion criteria: * age major then 18 years * must be asymptomatic in the face/head region at the time of the visit and in the previous 6 months. exclusion criteria: * pregnancy * medical history of systemic disease * current pharmacological therapy * history of recurrent headache and/or neck pain * presence of orofacial pain or temporomandibular symptoms assessed with the dc/tmd (diagnostic criteria for temporomandibular disorders) * current use of a bite during sleep

Keywords: ultrasonography dry needling physical therapy
lingzhi for cancer children

Conditions: Pediatric Cancers

Summary: ganoderma lucidum (lingzhi) is a traditional chinese medicine which is widely used as a means to 'strengthen immunity' among patients with cancers. however, there is no published randomized controlled clinical trial on its efficacy and safety despite the many in vitro studies on its anti-viral, anti-oxidative, anti-tumour, radioprotective, hepato-protective and immunomodulatory effects. this study was a randomized, double-blind, placebo-controlled, parallel clinical trial that investigated the benefits and safety of ganoderma lucidum (lingzhi) in treating children with cancers. patients were randomized to receive identical capsules of either lingzhi or placebo for six months. the primary outcome was the general paediatric quality of life score. secondary outcomes included immune functions, infection-related morbidities, complete blood counts and serum biochemistry, and overall and event-free survival.

alternative and complementary medicine are widely used in treating children with cancers. a population-based survey in british columbia revealed that they were used by 42% of the respondents. among chinese in hong kong, traditional chinese medicine (tcm) is also widely practiced. some 60% of the population had consulted tcm practitioners at one time or another. tcm use could be dated back to more than five thousand years ago, and written records were available for over two thousand years. tcm is considered to be an integral part of the chinese culture. in our experience, tcm is believed to be commonly used to 'strengthen immunity and promote health' among local children with cancers, despite the lack of well-designed study to prove its usefulness. ganoderma lucidum (ling zhi) is a mushroom long-used in china for a broad range of disorders. its use is common in the general population and among both adults and children with a wide range of malignancies. however, there is no randomized controlled trial to support its clinical efficacy and safety. therefore, we conducted this clinical trial of ganoderma lucidum (ling zhi) among hong kong children with cancers.

Eligibility criteria:
inclusion criteria: * male and female patients aged 2-18 years * acute lymphoblastic leukaemia who completed induction chemotherapy and pending maintenance chemotherapy treatment * solid tumours completed chemotherapy * aute myeloid leukaemia who completed induction and consolidation chemotherapy treatment * all patients and their parents signed informed written consent exclusion criteria: * relapsed cancer patients * received traditional chinese medicine (tcm) treatment within preceding one month * could not swallow capsules * syndromal disorders (e.g. down syndrome) * history of hypersensitivity reaction to lingzhi or any tcm * significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular or allergic diseases * in the judgement of investigators were unable to comply with study protocol requirements

Keywords: randomized controlled trial lingzhi immune functions quality of life survival
safety study of tenapanor for the treatment of pediatric patients (6 to less than 18 years old) with ibs-c

Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)

Summary: open-label long-term safety study of tenapanor in pediatric patients with ibs-c.

open-label long-term safety study of tenapanor in pediatric patients with ibs-c. eligible patients who complete the parent study will have an option to enroll in this study. patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg bid or 25 mg bid per guidance in protocol after a patient's first week on the assigned dose. patients will also return for study visits approximately every 6 weeks for safety assessments.

Eligibility criteria:
inclusion criteria: 1. ≥6 and \<18 years old at enrollment of either parent study 2. patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the investigator 3. females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence). 4. subject is ambulatory 5. written informed consent by parent/guardian/ legally authorized representative (lar) and a willingness of both subject and parent/guardian/lar to participate in the study as it is described exclusion criteria: 1. patient discontinued prematurely from the parent study. 2. any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy 3. pregnant or lactating women 4. if, in the opinion of the investigator, patient is unable or unwilling to fulfill the requirements of the protocol
vagus nerve stimulation titration protocol to improve tolerance and accelerate adaptation

Conditions: Epilepsy; Seizures

Summary: post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study to determine the number of patients achieving their final assigned vns therapy dose settings in patients with drug-resistant epilepsy who are being treated with adjunctive vns therapy using new titration protocols.

post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study is designed to determine which vns therapy titration paradigm allows more patients to achieve a therapeutic dose within a specified time frame. additionally, the study will collect data on the acute tolerability and clinical outcomes for patients with drug-resistant epilepsy treated with adjunctive vns therapy employing three different titration paradigms.

Eligibility criteria:
inclusion criteria: 1. patients must agree to be treated with vns therapy. the decision to treat with vns therapy must have been made independent of and prior to participation in the study. 2. patients must be 12 years or older and have partial onset seizures or must follow the indication for use statement for vns therapy. 3. patient and/or caregiver must be able and willing to give accurate side effect reports, global impressions data and complete study instruments with minimal assistance throughout the study. 4. patient or legal guardian understands study procedures and voluntarily signs an informed consent and health insurance portability and accountability act (hipaa) authorization in accordance with institutional policies. in the event the patient is under the age of 18, the patient will also be required to sign an assent affirming agreement to participate in research according to local irb requirements. 5. patient must be taking at least 1 anti-epileptic drug treatment exclusion criteria: 1. patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy. 2. patient is expected to require mri using a body coil for transmission of rf during the clinical study. 3. patient has a progressive neurological condition (e.g. brain tumor etc.). 4. in the investigator's opinion, the patient or legal guardian is unable to comply with the frequency of clinic visits during the study. 5. patient is currently using an investigational device or pharmacologic medication not approved by the fda. 6. patient was previously implanted with vns therapy. 7. in the investigator's opinion, the patient is considered a suicide risk or is otherwise not a good candidate for this study. 8. patient/caregiver is unable to complete the required study follow-up visits and assessments.

Keywords: vagus nerve stimulation ascend vns titration to improve tolerance and accelerate adaptation
electronic cigarettes in daily dependent smokers

Conditions: Substance Withdrawal Syndrome; Nicotine Dependence

Summary: the aim of this study is to measure nicotine cue- and withdrawal-induced craving in current smokers under four distinct conditions: after smoking a conventional cigarette, an electronic cigarette (e-cigarette) containing nicotine, an e-cigarette without nicotine, and after taking a nicotine lozenge. participants will be asked to attend four morning study visits after overnight smoking abstinence. standardized questionnaires will be used to assess changes under each condition, allowing for the investigation of the efficacy of e-cigarettes in reducing craving by replacing the behavioral component of smoking with minimal risk of adverse effects.

many addiction models postulate stimuli to be linked with nicotine intake and reward after prolonged use. as such, smoking becomes more heavily based in habit, initiated by cues. craving has been found to be a crucial component of continued smoking and relapse in response to various environmental and behavioral cues. electronic cigarettes (e-cigarettes) are new smoking products emerging in consumer markets that often mimic conventional tobacco cigarettes. e-cigarettes commonly include a cartridge, a heating element, a puff sensor, and a battery. when a user draws on the device, the heating element is activated and the cartridge fluid is vaporized. users then inhale the aerosol containing droplets of the vaporized fluid. this study will empirically assess the efficacy of e-cigarettes in alleviating craving by replacing the behavioral component of smoking. using standardized questionnaires, intra-subject changes in cue- and withdrawal-induced craving after smoking an e-cigarette without nicotine will be compared with that after either smoking a conventional cigarette, an e-cigarette with nicotine, or taking a 4mg lozenge.

Eligibility criteria:
inclusion criteria: * current daily smoker * smoke minimum of 10 cigarettes per day * fagerstrom test of nicotine dependence score equal or greater than 3 * never used an e-cigarette prior to the study * no intention to quit smoking within the next 3 months * able to provide written informed consent * able and willing to attend scheduled appointments exclusion criteria: * any serious medical or unstable psychiatric problems requiring treatment * pregnancy or lactation

Keywords: electronic cigarettes lozenge nicotine tobacco dependence withdrawal
effects of singing in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to investigate the effects of the practice of singing for a long period of time on pulmonary function data, quality of life, and dyspnea sensation of patients with copd in stable clinical conditions. as singing is a type of respiratory training, the study hypothesis is that singing would improve maximal respiratory pressures, dyspnea sensation, and overall quality of life of these patients.

thirty copd patients in stable clinical conditions are going to be randomized in two groups: the first one is going to have singing classes for six months; the other one is going to have classes of general manual arts for a similar period of time. the patients of both groups are going to perform spirometry, measurements of maximal respiratory pressures and answer the health related quality of life questionnaires sf-36 and saint george's before the beginning of practice and after 6 months.both singing and manual arts practices are going to be administered one hour a week by specialized teachers.

Eligibility criteria:
inclusion criteria: * diagnosis of copd according gold criteria * stable clinical conditions for the previous two months exclusion criteria: * severe comorbidities other than copd * hypoxemia with partial arterial oxygen pressure lower than 50 mmhg * incapacity to come to the research center in a weekly basis.

Keywords: copd pulmonary function respiratory muscle dyspnea quality of life