Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic study of 2 doses of atv/r od + 2 nrtis in thai hiv-1 infected patients

Conditions: HIV Infections

Summary: several studies from hiv-nat have demonstrated high nevirapine, indinavir, saquinavir and lopinavir/r levels when compared to caucasian patients. until now, the pharmacokinetics of atazanavir have not been explored in a thai population. we postulate that atv levels, as with other pis, are higher in thai people. therefore, the level of atv in atv/rtv 300/100 od may be higher than the acceptable range and could be associated with atv related toxicity.

we are interested in once daily atv/rtv 200/100 mg od because of the convenience, reduction in atv doses which may improve adherence while reducing toxicity and cost. there are limited prospective studies evaluating pharmacokinetic and long term efficacy and safety of atazanavir/ritonavir once daily dose in combination of nrtis in hiv-1 pretreated patients. we believe that the pk parameters of atv/rtv given at 200/100mg daily in thai patients will be equivalent to the atv/rtv 300/100mg once daily dosing in caucasian patients when combined with 2nrtis, and that the once daily regimen will have better safety, tolerability profile, and cost saving while maintaining good cd4 and vl outcome. if, the pharmacokinetic profile of atv/rtv 200/100 mg od + 2nrtis is in acceptable range or comparable with standard dose of atv/rtv 300/100 mg od, long term efficacy will be explored later.

Eligibility criteria:
inclusion criteria: * written informed consent * adults hiv patients currently using atv/rtv 300/100 mg od plus 2 nrtis * hiv rna \< 50 copies/ml exclusion criteria: * inability to understand the nature and extent of the study and the procedures required. * alt/ ast more than 5x upper limit * relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion. * use of concomitant medication that may interfere with the pharmacokinetics of atazanavir, and ritonavir * history of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study. * active drug abuse or heavy alcoholic drinking * history of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study. * active drug abuse or heavy alcoholic drinking

Keywords: atazanavir/ritonavir pharmacokinetic of atv/r200/100 od+2nrtis
volar plate injury: a comparison of two splinting methods

Conditions: Volar Plate Injury of the Proximal Interphalangeal Joint

Summary: which splinting method produces the best outcomes (in range of movement, pain and function) in the non-operative treatment of stable volar plate injuries in adults? the volar plate is a ligament located at the middle knuckle (proximal interphalangeal joint - pipj) of the finger. it is commonly injured through hyperextension, for example a ball hitting the fingertip. current treatment in the hand therapy unit involves splinting the injured joint dorsally (on the back of the finger) into 20⁰ flexion (bent) using thermoplastic material. however, there is a potential risk of developing permanent stiffness of the pipj into straightening, once the volar plate ligament heals. to reduce this risk, the study aims to investigate if using a volar (on the front of the finger) gutter splint in 0⁰ flexion (straight), which still prevents hyperextension, achieves better outcomes. there is no existing high-quality evidence comparing these two methods. this is a randomised controlled trial. for the purposes of this study, the current treatment of a 20° dorsal block splint will act as the control group. the intervention group will be the volar gutter splint group. a convenience sample will be used and all patients (over 16 years old) presenting to the mid yorkshire hospitals nhs trust's hand therapy unit will be invited to participate in the study, with consideration to inclusion/exclusion criteria. participants will be randomised into one of two groups through the use of a random number generator. the outcomes assessed will be range of movement, pain and function. these will be measured at initial assessment, four and twelve weeks. these are all average normal time intervals that patients are seen. each splint is worn for four weeks and participants will receive standardised advice, exercises and treatment.


Eligibility criteria:
inclusion criteria: 1. all stable volar plate injuries. 2. aged 16 and older. 3. male and female. 4. acute presentation within 2 weeks of injury. 5. all ethnic groups speaking english. exclusion criteria: 1. vulnerable patient groups or those lacking capacity. 2. previous injury or pathology involving the same digit. 3. surgical intervention 4. unstable proximal interphalangeal joint. 5. concomitant tendon or additional bony injury outside the traditional eaton classification types of volar plate injury. 6. the dash outcome measure is available and validated in 27 languages. however, those who do not speak/understand english well will unfortunately be excluded. this is an educational project and therefore there is no funding to use a translator service. 7. volar plate injuries are just as common in children and teenagers as adults. but under 16s will be excluded from this study as the dash questionnaire has only been assumed valid in adults. there is no research investigating its use in younger age-groups.

Keywords: volar plate splint proximal interphalangeal joint palmar plate hyperextension injury
probiotic treatment for prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: a whole new research area studying the function of intestinal microorganisms, also known as gut microbiota, has emerged during the last decade. as a result, dietary supplementation with specific bacteria (or probiotics) holds great promise as a therapeutic strategy for a wide range of diseases, from obesity to anxiety and depression, all of which are major characteristics of prader-willi syndrome (pws). the main objective of the current proposal is to determine the effects of bifidobacterium animalis subsp. lactis (strain bpl1) supplementation in children and young adults with pws. specifically, participants will receive placebo or bpl1 for 6 months, and then this phase will be followed by a 6-month extension period in which all participants will receive bpl1. this study will allow us to 1) determine the effects on fat mass and glucose metabolism; and 2) explore the effects on mental health symptoms by studying potential structural changes in the brain by magnetic resonance imaging (mri) as well as using a number of psychiatric questionnaires.


Eligibility criteria:
inclusion criteria: * diagnosed with prader-willi syndrome with genetic confirmation * on a stable diet and medication regimen for at least the last two months before enrollment exclusion criteria: * current enrollment in or discontinuation within the last 30 days from a clinical trial * patients with bariatric surgery in the last two years * patients with type 2 diabetes on insulin therapy * presence of other medical problems that would preclude study participation * unsuitable for inclusion in the study in the opinion of the investigator
microrna diagnostics in subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: the purpose of this study is to compare the profile of microrna in cerebrospinal fluid from patients suffering subarachnoid hemorrhage with and without delayed cerebral ischemia.

in this study of patients suffering an aneurysmal subarachnoid hemorrhage (sah) we would like to investigate the pathophysiological mechanisms that lead to the phenomenon delayed cerebral ischemia (dci). we will accomplish this through analyzing the profile of microrna expression in the cerebrospinal fluid of sah patients treated with extraventricular drainage. at first we wish to compare the expression of 376 specific microrna between 12 patients developing dci (group 1) and 12 patients without dci (group 2) in cerebrospinal fluid drawn on day 5 after ictus. secondly specific micrornas of interest in which the expression differs between group 1 and 2 are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course. should we find no differently expressed specific micrornas we will compare the expression of microrna in group 1+2 with group 3. in addition, some of the patients as part of another clinical trial (nct01447095 ) will have established invasive neuromonitoring including microdialysis. it is our intention to develop a method for analyzing microrna in this microdialysate. dci as defined by vergouwen et al in stroke 2010;41(10):2391-2395: "the occurrence of focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the glasgow coma scale (either on the total score or on one of its individual components \[eye, motor on either side, verbal\]). this should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, ct or mri scanning of the brain, and appropriate laboratory studies."

Eligibility criteria:
inclusion criteria: * patient admitted to the neurointensive care unit with aneurismal subarachnoid hemorrhage * external ventricular drainage with 5 days of ictus * age \> 18 years exclusion criteria: * glasgow coma score (gcs) continuously \< 7 during the first 5 days following ictus * a known and proven complication (rebleeding, clip/coil complication, cardiopulmonal complication requiring full sedation, ventriculitis e.g.) leads to a gcs \< 7 thereby preventing the detection of dci.

Keywords: delayed cerebral ischemia microrna cerebrospinal fluid subarachnoid hemorrhage
comparison of effects virtual reality and short foot exercises on balance and performance in pes planus

Conditions: Virtual Reality

Summary: virtual reality exercises have become increasingly popular in recent years. after the increase in usage areas in daily life, its use in healthcare has become widespread. flatfoot is one of the orthopedic problems with high prevalence, especially in young individuals. in the literature, conservative treatment methods of flat soles are mentioned as exercise, shoe modifications, and orthotic methods. in the study, it is planned to investigate whether individuals with flat-footed virtual reality exercises contribute to conservative treatment. the aim of this study was to investigate the effect of virtual reality exercises on individuals with pes planus.

to show whether virtual reality exercises will contribute to decrease of flat footing, improvement of balance and increase of performance of individuals with flat foot.

Eligibility criteria:
inclusion criteria: * have pes planus, * volunteer for this study, * climb 10 stairs independently, * can stand one single leg exclusion criteria: * history of trauma, fracture or operation of the foot, knee, and hip that will affect the foot * having visual, hearing and mental problems that prevent participation in virtual reality exercises, * being diagnosed with orthopedic or neurological problems that prevent standing on a single leg

Keywords: virtual reality foot posture navicular drop short foot exercise
mindfulness-based therapy in chronic tinnitus

Conditions: Chronic Tinnitus

Summary: in the present randomized waiting-list-controlled study the investigators examined a specific manualized mindfulness-based therapeutic approach in the treatment of chronic tinnitus.

in the current randomized waiting-list-controlled pilot study, we investigate a new manualized therapeutic approach, which is based on mindfulness- and body-psychotherapy and which has been specifically developed for the treatment of tinnitus patients (tinnitus atemtherapie; http://www.maria-holl.de/). essential components of the treatment program include mindfulness, meditation, selfmassage, and breathing exercises. these components are intended to help patients use their inner resources to accept responsibility for themselves, become more self-sufficient and develop symptom acceptance.

Eligibility criteria:
inclusion criteria: * chronic tinnitus (duration ≥ 6 months) * german speaking * subjective tinnitus exclusion criteria: * instable medical conditions * objective tinnitus

Keywords: mindfulness-based therapy chronic tinnitus;
symptom management for irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the objective of this study is to test the efficacy of a symptom management treatment strategy, acupuncture/moxibustion (acu/moxa), to improve the symptoms associated with irritable bowel syndrome (ibs) in adults.


Eligibility criteria:
inclusion criteria: * men and women 18 to 70 years of age. * diagnosis of ibs based on rome iii criteria. * complete symptom diaries and return completed diaries at all sessions. exclusion criteria: * history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology. * alarm symptoms according to rome iii. * individuals currently receiving other types of complementary therapies. * individuals with an acute medical condition requiring acute medical attention.
bolus pouch feed study

Conditions: Cancer; Neurological Disorder; Gastrointestinal Dysfunction; Oral Complication; Stroke

Summary: the primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.

bolus enteral tube feeding (termed 'bolus feeding') is an increasingly common method of providing nutritional support to home enterally tube fed (hetf) patients, particularly those who are more active and/or require greater flexibility in their feeding regimen. however, current methods of bolus feeding are complex to administer, messy, may be unhygienic, and require and lead to a significant amount of plastic waste. therefore, there is a clear need for a simpler and optimised way to provide bolus feeds. the aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life, ease of use, liking, compliance, gastrointestinal tolerance, nutritional intake, anthropometry and safety. this is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.

Eligibility criteria:
inclusion criteria: * ≥16 years of age * using or requiring an enteral tube feed as part of nutritional management plan * using or about to use bolus tube feeding methods at least once daily * expected to receive at least 400 kcal/day from the intervention feed * written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign. exclusion criteria: * parenteral nutrition contributing more than 70% of total energy requirements * patients with major hepatic dysfunction (i.e., decompensated liver disease) * patients with major renal dysfunction \[i.e., requiring filtration or stage 4/5 chronic kidney disease (ckd)\] * patients receiving inpatient care * participation in other clinical intervention studies within 2 weeks of this study * adults lacking mental capacity to consent * allergy to any study product ingredients * investigator concern regarding ability or willingness of patient to comply with the study requirements.
atricure exclusion of the laa in patients undergoing concomitant cardiac surgery

Conditions: Left Atrial Appendage Exclusion

Summary: prospective, non-randomized trial to evaluate the safety and efficacy of the laa exclusion device (clip) for the exclusion of the laa via epicardial tissue approximation.


Eligibility criteria:
inclusion criteria: 1. subject is greater than or equal to 18 years of age. 2. subject has any one of the following risk factors and is thought to benefit from laa occlusion: * chads score \> 2 * age \> 75 years * hypertension and age \> 65 years * previous stroke * history of atrial fibrillation (any classification) 3. subject is scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or placement, tricuspid valve repair or replacement, coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) maze procedure, patent foramen ovale (pfo), atrial septal defect (asd) repair with the device deployed while on or prepared for cardio-pulmonary bypass support. 4. subject is willing and able to provide written informed consent. 5. subject has a life expectancy of at least 1 year. 6. subject is willing and able to return for scheduled follow-up visits. exclusion criteria: 1. previous cardiac surgery 2. thrombus in the laa/la which cannot be evacuated prior to placement of the clip. 3. patients requiring surgery other than cabg and/or cardiac valve and/or surgical maze procedure and/or pfo closure and/or asd repair. 4. nyha class iv heart failure symptoms 5. need for emergent cardiac surgery (i.e. cardiogenic shock) 6. creatinine \>200 µmol/l 7. laa is not appropriate for exclusion based on intraoperative evaluations 8. current diagnosis of active systemic infection 9. renal failure requiring dialysis or hepatic failure 10. a known drug and/or alcohol addiction 11. mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study 12. pregnancy or desire to get pregnant within 12-months of the study treatment 13. preoperative need for an intra-aortic balloon pump or intravenous inotropes 14. patients who have been treated with thoracic radiation 15. patients in current chemotherapy 16. patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases. 17. patients with known connective tissue disorders

Keywords: left atrial appendage laa atrial fibrillation afib af stroke tia
tmao and atherosclerosis in hiv

Conditions: Carotid Artery Plaque

Summary: in the present study, the investigators sought to prospectively examine the associations of plasma levels of tmao (trimethylamine oxide), choline, betaine, dimethylglycine, and sarcosine with risk of incident carotid artery plaque, assessed by repeated b-mode carotid artery ultrasound imaging over a 7-year period, in women and men with and without hiv infection from the wihs (women interagency hiv study) and macs (multicenter aids cohort study).


Eligibility criteria:
inclusion criteria: * participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013). exclusion criteria: * a history of coronary heart disease, individuals with prevalent diabetes or prevalent carotid artery plaques at baseline
frailty and the elderly in martinique

Conditions: Elderly People With Polypathology or Disabilities

Summary: this was a prospective multicenter cohort study of elderly people admitted to the acute care for elders in martinique. they were followed up to 36 months. it aimed to study the adverse outcomes. in all, 287 subjects were included. they were 85+/-6 years, and mainly women (61%).

the safma cohort was an ad hoc study formed into the recruitment of the acute care for elders in the geriatric department of martinique university hospitals. the inclusion of subjects ran from january 1st 2012 to june 30th 2012. to be eligible, patients had to be 75 or over and hospitalised for acute condition. each patient was visited by a specialist in geriatrics familiar with the survey procedures. in the course of this interview, patients were informed about the study, prior to signing the consent form. if the clinical status and/or the cognitive status of the patient did not enable informed consent, the interviewer referred to the subject's representative. follow-up was performed by visits and telephone interview till 36 months.

Eligibility criteria:
inclusion criteria: * age of 75 years or over * admitted to acute care for elders * consent to participate exclusion criteria: * impossibility to perform the tests * refusals to participate
simultaneous care: linking palliation to clinical trials

Conditions: Solid Tumor; Lymphoma

Summary: this is a multi-site randomized control trial taking place at six cancer centers. uc davis is the lead site. additional performance sites include the city of hope medical center, fred hutchinson cancer center at the univ. of washington, usc norris cancer center, ucsd cancer center, and johns hopkins cancer center. clinical trial patients and their caregivers who are randomized to the intervention arm of the study are scheduled for three educational sessions. the sessions focus on teaching problem solving skills based on the cope problem solving model.

the project introduces and evaluates the effects of a simultaneous care education intervention, using the cope model (creativity, optimism, planning and expert information) developed by d'zurilla and nezu, as one of its key components for cancer patients in phase i, ii and iii clinical trials. the scei team will use the cope problem solving educational model to instruct patients on how to problem solve and manage challenges associated not only with the investigational therapy, but also the psychosocial issues that arise from cancer diagnosis, disease progression, treatment, and disease or treatment related symptoms. the educational intervention also sets up a system for regularly contacting the patient and caregiver in order to reinforce what is taught. patients and caregivers randomized to the intervention arm will receive three education sessions. patients and designated caregiver will be asked to complete the set of measurement tools approximately every 30 days while enrolled in the study.

Eligibility criteria:
inclusion criteria: * english speaking, must have caregiver who is willing to participate, must be entering a phase 1-3 oncology clinical trial. must be able to complete first educational session on or before treatment start date. solid tumor or lymphoma only. exclusion criteria: * non-english speaking, no caregiver available, unable to complete first educational session on or before treatment start date.

Keywords: problem solving psychosocial support