Kornimate/medical-research-clean huggingface dataset:
working well with back pain (feasibility rct of vocational rehabilitation)

Conditions: Low Back Pain

Summary: back pain has a major impact on people's ability to work. health professionals need to know how they can best use their limited resources to address the occupational needs of people with chronic low back pain. vocational rehabilitation is the process that helps people with health problems to stay at, return to and remain at work. this study comprises the second phase of a three year study of back pain and vocational rehabilitation. the first phase gathered data from patient interviews and postal surveys of gps and gp practice managers. these findings have been used to inform this second phase; a feasibility randomised controlled trial. the participants will be thirty employed people with back pain who have been offered an nhs rehabilitation programme, and who are concerned about their ability to work with low back pain. those who consent will be randomised into two groups. one group will receive routine rehabilitation. the other will receive routine rehabilitation plus an individually tailored vocational intervention carried out by the researcher. following the trial, individual interviews will be carried out with each of the participants by an independent researcher. an economic study will evaluate the possibility of measuring the cost-effectiveness of the intervention. the hypothesis is that an enhanced vocational intervention plus routine rehabilitation will be more effective in improving patients' work ability than routine rehabilitation alone.


Eligibility criteria:
inclusion criteria: * low back pain * offered routine rehabilitation * employed * concern about work ability due to low back pain * referral by gp in south nottinghamshire exclusion criteria: * not fluent in english

Keywords: vocational rehabilitation work ability low back pain
along-term study of opc-262 in patients with type 2 diabetes

Conditions: Diabetes, Type 2

Summary: the purpose of this clinical study is to evaluate the safety of opc-262 (2.5 mg and 5 mg) in patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate the efficacy of opc-262


Eligibility criteria:
inclusion criteria: * patients who completed study 262-09-001 (namely, patients who visited the hospital at visit week 24） * patients who are capable of giving informed consent prior to participating in this clinical study * patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period) exclusion criteria: * patients who withdrew from study 262-09-001 * patients who experienced serious adverse events that the relationship with the study drug was not denied in study 262-09-001 * patients who experienced serious adverse events that the relationship with the study drug are denied in study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study * patients who met the exclusion criteria of study 262-09-001 during the study period of study 262-09-001 * female patients who wish to become pregnant during the study period of study 262-09-002 or within 4 weeks after the study * patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
markerless image guidance using intrafraction kilovoltage x-ray imaging

Conditions: Lung Cancer

Summary: this trial will investigate the feasibility of the markerless tumour tracking technology.

markerless tumour tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. eligible patients will be implanted with fiducial markers, which act as the ground truth for evaluating the accuracy of markerless tumour tracking. the patients will undergo the current standard of care radiotherapy, with the exception that kilovoltage x-ray images will be acquired continuously during treatment delivery to enable markerless tumour tracking.

Eligibility criteria:
inclusion criteria: * is willing to comply with all trial procedures and intends to provide written informed consent for participation in this trial. * patients undergoing external beam radiotherapy. * histologically proven stage i nsclc or oligometastatic lung metastases (3 or less). * mri/4d-ct prior to insertion of fiducial markers. * patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by lmo or cardiologist). * ecog performance status 0-2. * a maximum of three metastases to the lung from any non-haematological malignancy. multiple metastases will be treated separately. * 1 cm ≤ tumour diameter in any dimension ≤ = 5 cm. * the distance between the tumour centroid and the top end of the diaphragm is \<=10 cm. exclusion criteria: * patient has low respiratory performance as evaluated by the physicians. * previous high-dose thoracic radiotherapy. * less than one fiducial marker implanted in the lung. * fiducial markers are too far from the tumour centroid (\>9 cm). * cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators). * targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment. * women who are pregnant or lactating. * unwilling or unable to complete quality of life questionnaires.

Keywords: lung cancer nsclc oligometastases
anti-infective effect of non-surgical treatment with and without photodynamic therapy on initial peri-implantitis

Conditions: Peri-implantitis

Summary: photodynamic therapy (pdt), also known as photoradiation therapy, phototherapy, or photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated by exposure to light of a specific wavelength in the presence of oxygen. in recent years, pdt has been introduced as an important novel disinfection therapy in the field of implant dentistry. the inactivation of microorganisms using pdt has been defined as antimicrobial pdt. pdt has the potential to be an alternative of antibiotics, especially for the treatment of localized infections and oral biofilm. pdt is unlikely to cause bacterial-resistance and is equally effective against antibiotic-resistance and antibiotic-susceptible bacteria. inconsistent results have been reported regarding the potential role of pdt as an adjunct to mechanical debridement in the management of peri-implant infection. thus, the aim of the present trial is to investigate the treatment effect of non-surgical treatment with and without photodynamic therapy on initial peri-implantitis.


Eligibility criteria:
inclusion criteria: 1. male and female subjects, ages over 18. 2. subjects with at least one implant with initial peri-implantitis: ppd of 4-6mm combined with bop+, bone loss of 0.5-2mm on peri-apical radiographs compared to the time point of restoration placement. 3. availability for the 12 month duration of the study. 4. good general health (asa classification i-ii). 5. signed informed consent form. exclusion criteria: 1. medically compromised subjects (asa classification iii-v) 2. pregnant or lactating females. 3. peri-implant mucositis defined as the absence of radiographic marginal bone loss between restoration placement and pre-screening review. 4. subjects treated for \>2 weeks with any medication known to affect soft tissue condition (e.g. phenytoin, calcium antagonists, cyclosporin, coumadin and non-steroidal anti-inflammatory drugs) within 1 month of the baseline examination. 5. unwilling to participate in the study.

Keywords: photodynamic therapy
rate of catheter colonization and risk of bloodstream infection during use of two different central venous catheters (cvc)

Conditions: Bacteriaemia; Catheter Related Bloodstream Infection

Summary: the use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. certofix® protect is a catheter with a surface modified in order to reduce colonization by bacteria. this clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, certofix® protect, with that of the non-coated standard catheter certofix®.

central venous catheters are an essential part of patient management in the icu (intensive care unit). the use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. many catheters become colonized with bacteria but only a proportion of colonised catheters go on to cause bacteriemia and sepsis. it is currently impossible to prospectively identify which of the catheters will become colonized and lead to sepsis. various types of antiseptic or antimicrobial vascular catheter coatings have been developed. studies showed that the coated catheters were effective in limiting the catheter colonization rate and that they may decrease the risk of catheter-related bloodstream infections. the "certofix protect" was developed by b.braun to reduce the risk of catheter related infections. it is a catheter with a modified surface that consists of a high molecular weight polymer which is non-covalently linked to the polyurethane catheter material. this clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, certofix® protect, with that of the non-coated standard catheter certofix®.

Eligibility criteria:
inclusion criteria: * patients with probable icu stay * patient's first or second catheter placement during actual hospital stay * anticipated indwelling central venous catheter period \>= 3 days (jugular vein, subclavian vein) * \>= 18 years of age * written informed consent of patient or independent physician prior to the participation; in this case: written informed consent after recovery if possible exclusion criteria: * the catheter will not be placed in the femoral vein * inflammation of the skin at the site of puncture prior to puncture * known hypersensitivity to any of the components (i.e. polyhexanide or related substances such as chlorhexidine) * participation in another clinical trial * emergency insertion of catheter in the field

Keywords: central venous catheter cvc coated catheter bacteriaemia bloodstream infection
shape up kids fitness ancillary

Conditions: Childhood Obesity

Summary: the overall objective of this study is to quantify the decision-making process and underlying biases around leisure activity behaviors using the activity preference assessment (apa), a novel psychological task. the investigators plan to validate the apa against objectively measured sedentary and physical activity time, and examine its potential to predict health-related outcomes in children and adolescents. the shape up kids fitness ancillary protocol will add exercise testing, cognitive and behavioral measures, accelerometry, and questionnaires to the existing shape up kids primary study dataset.

the investigators will enroll 60 boys and girls (50% female) between the ages of 8-17 years into this pilot and feasibility ancillary study. the aims of this study are to validate and test the reliability of the activity preference assessment (apa), as described below. aim 1: to examine the convergent validity of the apa against habitual physical and sedentary activity time measured objectively by seven days of accelerometry, as well as leisure activity choices during a 30-minute free-choice play period. aim 2: to examine the criterion validity of the apa against concurrent measures of body composition, cardiometabolic health indicators, aerobic fitness, and physical strength. aim 3: to measure the test-retest reliability of apa outcomes through repeated measures separated by approximately one week. exploratory aim: to investigate patterns or clusters of activity preferences through exploratory factor analysis of activity liking vas scores.

Eligibility criteria:
inclusion criteria: * eligible for the shape up kids primary study * height ≥ 4 feet 8 inches * body weight \< 350 lbs exclusion criteria: * american college of sports medicine (acsm) contraindications to exercise testing (i.e., medical history of cardiovascular or pulmonary conditions, physical conditions that affect the ability to exercise)

Keywords: cardiorespiratory fitness sedentary behavior physical activity decision-making cardiometabolic risk factors
improving antiretroviral therapy adherence through urban gardening and nutritional counseling in the dominican republic

Conditions: HIV

Summary: this pilot study proposes to develop, implement, and evaluate the feasibility, acceptability and preliminary effectiveness of a culturally appropriate, multi-component intervention combining peer nutrition counseling with sustainable urban gardening among people with hiv in the dominican republic. the overall hypothesis is that this combined intervention will improve adherence to antiretroviral therapy (art) and virologic suppression among food insecure hiv+ individuals with suboptimal adherence.

the purpose of this pilot clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of a culturally appropriate, multi-component intervention that targets food insecurity and nutritional health with the ultimate goal of improving antiretroviral therapy adherence and virologic suppression for people with hiv in the dominican republic. through an initial phase, we conducted formative research on dietary patterns and locally available foods and, together with our preliminary research on nutritional counseling and urban gardening, developed a multi-component nutrition intervention to address food insecurity among people with hiv that integrates culturally-appropriate, peer-led nutritional education with a sustainable urban garden component. during the clinical trial phase, we will enroll 120 hiv+ adults with food insecurity and suboptimal adherence in 2 hiv clinics (60 participants in the intervention clinic and 60 participants in the control clinic) and will evaluate the feasibility, acceptability and preliminary effectiveness of urban gardening plus peer nutritional counseling on improving virologic suppression and art adherence in both the short (month 6) and longer terms (month 12). we will also explore preliminary intervention effects on potential mediators (food security, nutritional status, internalized hiv stigma, and social support). as one of the first studies to develop a sustainable food production approach with peer nutrition counseling among people with hiv, key products will include: 1) an easy-to-use peer nutritional counseling curriculum and urban gardens training materials; 2) pilot data on the feasibility, acceptability, and effects of our intervention on primary outcomes and potential mediators; and 3) if results are promising, an r01 application to conduct a fully-powered cluster randomized controlled trial that examines effects across a larger number of clinics in the dominican republic.

Eligibility criteria:
inclusion criteria: * hiv+ and on art * has moderate or severe household food insecurity * has detectable viral load (\>50 copies) and/or suboptimal adherence to art exclusion criteria: * does not meet above criteria

Keywords: food insecurity nutrition treatment adherence
effect of omega-3 fatty acid on neurobehavioral status of children with autism spectrum disorder: a randomized, double-blind, placebo controlled trial

Conditions: Autism Spectrum Disorder

Summary: this study is conducted to assess whether omega-3 fatty acid improves neurobehavioral staus of children with autism spectrum disorder and whether there is any correlation of this improvement with reference range of omega-3 fatty acid.

autism spectrum disorder (asd) is a complex neurodevelopmental disorder of children with lifelong impacts. who estimates the international prevalence of asd in 2022 at 1 in 100 children. till date, no pharmacological treatment has been proven effective for asd. this proposed study is an effort to explore whether omega-3 fatty acid supplementation produces improvement in neurobehavioral symptoms of asd. this study will be a randomized, double-blind, placebo-controlled trial.a total of sixty four (64) asd patients attended in the outpatient department of ipna, bsmmu will be selected for the study according to inclusion and exclusion criteria. diagnosis of asd will be made by dsm-v (diagnostic and statistical manual of mental disorders, 5th edition). after completion of necessary formalities including informed consent of the patients, each participant will be assessed by translated and validated bangla version of aberrant behaviour checklist (abc-parents rated). omega-3 fatty acid ( docosahexaenoic acid, dha and eicosapentaenoic acid, epa) level in plasma will be measured in hplc. 32 patients having dha and epa within reference value and 32 patients below the reference value will be selected. then participants of each group will randomly be assigned into two groups: intervention group and control group. the intervention group patients will receive omega-3 fatty acid 1 gm softgel once daily for 8 weeks at or below 25 kg and 1 gm softgel twice daily for 8 weeks above 25 kg making a total dose of 2gm/day. on the other hand, patients in control group will receive 1 placebo softgel of 1 gm once daily for 8 weeks at or below 25 kg and twice daily above 25 kg. after 8 weeks of therapy each participant will be assessed once again by bangla version of abc and plasma level of dha and epa will be measured.

Eligibility criteria:
inclusion criteria: fulfills diagnosis of asd by meeting dsm-5 diagnostic criteria. written parental consent for participation. age of children: 2-18 years. sex: all. - exclusion criteria: those taking omega-3 fatty acid or fish oil at present. known allergy to fish or fish oil. diagnosed with a psychotic disorder (e.g. schizophrenia) or mood disorder, including depression or bipolar disorder.
sedentary behaviour and subjective well-being

Conditions: Sedentary Behaviour

Summary: this study will investigate the relationship between sedentary behaviour and subjective well-being among a sample of university students. eligible participants will fill out an online survey with questions assessing their sedentary behaviour, physical activity, subjective well-being, life satisfaction, depression, anxiety, and demographic variables.

an electronic survey will be used to assess outcomes of interest (i.e., demographics, sedentary behaviour and physical activity history, subjective well-being, life satisfaction, depression, and anxiety). the survey will be created and hosted on sosci survey. interested participants will contact the investigators and will be sent a personal link to access the survey. upon following the link, participants will answer inclusion/exclusion criteria and give electronic consent. upon confirming consent and eligibility, participants will complete the survey. upon completion of the survey, participants will be thanked and offered an entry into a draw.

Eligibility criteria:
inclusion criteria: * currently a full-time student enrolled at western university * are 18 years of age or older * are able to read and write in english * have access to a computer with internet exclusion criteria: * part-time enrollment or currently on a leave of absence from full-time studies at western university

Keywords: sedentary behaviour subjective well-being university students
a comparison of two color contact lenses in habitual clear contact lens wearers

Conditions: Myopia; Refractive Error

Summary: the purpose of this study was to evaluate overall satisfaction with air optix® colors as compared to freshlook® colorblends contact lenses.


Eligibility criteria:
inclusion criteria: * willing and able to sign informed consent document. if under legal age of consent, legally authorized representative must also sign informed consent document. * able to achieve best corrected visual acuity (bcva) of 20/25 (snellen) or better in each eye at distance. * manifest cylinder less than or equal to 0.75 diopter in each eye. * wear contact lenses within protocol-defined specifications. * require spherical contact lenses within the available range of powers. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any eye condition that contraindicates contact lens wear. * any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions. * moderate or severe ocular findings upon examination. * any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops. * habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment. * previous corneal or refractive surgery or irregular cornea. * eye injury or surgery within the last 6 months (excluding placement of punctal plugs). * monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens. * history of intolerance or hypersensitivity to any component of the test articles. * other protocol-defined exclusion criteria may apply.

Keywords: color contact lenses refractive error myopia
use of safety behaviors in exposure therapy for arachnophobia

Conditions: Specific Phobia; Arachnophobia; Spider Phobia

Summary: this study examines the impact of safety behaviors (i.e., unnecessary protective actions) on outcomes of exposure therapy for spider phobia. researchers will compare exposure therapy with (a) no safety behaviors, (b) safety behaviors faded toward the end of treatment, and (c) unfaded safety behaviors.

some studies suggest that safety behaviors might undermine the efficacy of exposure therapy (powers et al., 2010), whereas other studies suggest that there is no difference in exposure therapy outcomes whether or not safety behaviors are used (deacon et al., 2010). mixed findings could be explained by the parameters of safety behaviors use, such as whether they are used throughout the full course of therapy or faded toward the end of therapy. this will be the first study to directly compare the impact of faded and unfaded safety behaviors on exposure therapy outcomes. specifically, researchers will randomize participants with a fear of spiders to receive exposure therapy (a) without safety behavior use, (b) with faded safety behavior use, and (c) with un-faded safety behavior use. researchers will compare each condition's impact on fear reduction and on the tolerability/acceptability of treatment.

Eligibility criteria:
inclusion criteria: * fluent in english * displays sufficiently high fear of spiders, as indicated by responses on (a) a self report questionnaire (the fear of spiders questionnaire) at prescreening, and (b) behavioral avoidance tests at baseline exclusion criteria: * younger than 18 years old

Keywords: exposure therapy safety behaviors arachnophobia spider phobia specific phobia