Kornimate/medical-research-clean huggingface dataset:
a 12-week digital physical activity programme, with or without physical education support for type 2 diabetes patients.

Conditions: Diabetes Mellitus, Type 2

Summary: investigation into the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with t2dm using hba1c testing.

primary objective: investigate the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with t2dm using hba1c testing. secondary objective: evaluate the effects on cholesterol (ratio of high density lipids to low density lipids), resting heart rate, and body mass index after a 12 week physical activity programme. monitor step counts and sleep patterns during a 12 week physical activity programme.: methods: using a rct is intended to implement dependent variable inductive research into a 12-week e-health physical activity (pa) programme with or without physical education support focusing on the blood glucose control in patients with t2dm. recruitment of 60 patients from hospital out-patient clinics, community diabetic departments, and. nhs patients from general practitioners.

Eligibility criteria:
inclusion criteria: * a diagnosis of t2dm in the last 3 years. * age 18+ years. * uses the english language as a primary or secondary language with the ability to read and write. * lives in the united kingdom. * has no medical reason preventing participation in regular physical activity. * has a smart phone with access to the internet. exclusion criteria: * physical inability to participate in 12 weeks of physical activity. * cardiac or cardiovascular surgery in the past 6 months. * musculoskeletal issues that could be aggravated whilst participating in regular physical activity. * presently participating in a weight loss programme. * unable to commit to the 12-week feasibility study.

Keywords: hba1c cholesterol resting heart rate
propofol versus midazolam and fentanyl for diagnostic and screening colonoscopy in patients with advanced liver disease

Conditions: Liver Cirrhosis

Summary: prospective, randomized-controlled trial (rct) comparing the use of propofol and traditional sedation (midazolam and fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. the investigators' working hypothesis is that the use of propofol will be translated in a shorter recovery and discharge times with a higher patient satisfaction and a decrease in general complications in the context of patients with advanced liver disease.


Eligibility criteria:
inclusion criteria: * consecutive patients older than 18 and younger than 75 years with advanced liver disease, defined by the presence of liver fibrosis at least f3 and higher in the metavir score or with established cirrhosis (child pugh a, b and c) exclusion criteria: * patients with significant cardiorespiratory disease i.e. advanced respiratory, renal and heart failure (asa class iii or higher except for patients with decompensate liver cirrhosis), obstructive sleep apnea or those with mild degree of liver fibrosis (less than f3)
treatment of melasma with stabilized kligman preparation associated or not with pulsed dye laser

Conditions: Melanosis

Summary: melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on the face. treatment is difficult and to date the best treatment option is the combination of hydroquinone, retinoic acid and steroids combined in topical daily application (called kligman's trio). q-switched pigmentary lasers are usually ineffective and can induce post inflammatory hyperpigmentation (pih). intense pulsed light can sometimes improve melasma but also induce pih which limit their use. recently, pulsed dye laser were demonstrated to be effective in treating some pigmentary defects. associating blanching cream with hydroquinone to prevent pih after laser or intense pulsed light has been already reported with success. the objective of the study is to compare in a prospective intra individual comparative trial the association of pulsed dye laser plus stabilized kligman's trio to kligman's trio alone. the secondary objective was to study the frequency and the intensity of the potential side effects including pih.


Eligibility criteria:
inclusion criteria: * pregnant women or breastfeeding. * skin type 5 or 6. exclusion criteria: * known allergy to the compounds of the kligman preparation. * refusal to put very high protection sunscreen during the study. * concomitant use of topical products that might have an effect on melasma (topical steroids, retinoids, etc...)
home phototherapy for term newborns with icterus

Conditions: Neonatal Hyperbilirubinemia

Summary: the study is designed as a randomised controlled multicenter study.the primary aim is to investigate if home phototherapy improves parent-child bonding compared to if treatment is performed at the hospital. the investigators will also istudy how home phototherapy is perceived by the parents, impact on breastfeeding and parents stress levels, if the method can be implemented etc. patients are included at 5 hospitals in sweden. the plan is to include 250 term newborns with neonatal icterus at a level that needs phototherapy treatment.

background: almost half of all newborns develops jaundice, due to elevated levels of bilirubin. if levels are high phototherapy is needed to reduce the levels of bilirubin. presently most children with neonatal jaundice in sweden receives phototherapy admitted to hospital. there is fiberoptic equipment available that can be used at home to treat the newborns. aim: primary aim is to investigate if parent-child bonding is improved with home phototherapy compared to phototherapy performed at the hospital. method:the study is designed as a randomised controlled multicenter study. eligible parents and newborns are randomised to either treatment at home or at the hospital. demographic data about the newborn such as for example apgar score, gender, time of birth etc are registered. at time of discharge parents answers questionnaires such as for example the postpartum bonding questionnaire (pbq), the edinburgh postnatal depression scale (edps), the swedish parenthood stress questionnaire etc. parents experiences from home phototherapy will also be investigated through semistructured interviews. parents will asked to answer questionnaires at the time of discharge as well as at 4-months after discharge. analysis of data will be performed by using conventional parametric and non-parametric statistical methods. the results of the study will be reported as scientific articles and as part of a thesis.

Eligibility criteria:
inclusion criteria: * gestational age w36-42. * age of newborn 48 hours or more. * level of bilirubin 300-400 µmol/l exclusion criteria: * immunisation. bilirubin \>400 µmol/l. asphyxia. ongoing infection, weightloss \> 10%, other severe disease, parents who don´t speak swedish, parents that are not expected to be able to handle the home phototherapy equipment

Keywords: home phototherapy parental bonding
design and evaluation of care environment and technology at pediatric radiotherapy

Conditions: Pediatric ALL; Radiotherapy Side Effect

Summary: the purpose of the study is to evaluate the effect of changes in the care environment in pediatric radiotherapy. the definitions of the changes is a part of the study, and is constructed in collaboration with the institute of design at umeå university. the implementation is however not part of the study, but done as part of clinical routine. the study consist of two parts, where the first 1.5 years are a control phase where the changes are designed and also function as a baseline period. the following 1.5 years are the case period where the changes that are accepted for clinical implementation are implemented. the impact of the changes are evaluated using surveys and interviews of both parents and children

the purpose of the study is to evaluate the effect of changes in the care environment in pediatric radiotherapy. the definitions of the changes is a part of the study, and is constructed in collaboration with the institute of design at umeå university. the implementation is however not part of the study, but done as part of clinical routine. the study consist of two parts, where the first 1.5 years are a control phase where the changes are designed and also function as a baseline period. the following 1.5 years are the case period where the changes that are accepted for clinical implementation are implemented. the impact of the changes are evaluated using surveys and interviews of both parents and children. interviews of the personnel regarding their experiences of the study and the changes is performed after the finalization of the case period.

Eligibility criteria:
inclusion criteria: * radiotherapy treatment exclusion criteria: -

Keywords: pediatric radiotherapy
using a voice output communication aid to facilitate language development in young children with asd

Conditions: Autistic Disorder

Summary: it was proposed that in order to teach these children to use a voice output communication aid (voca), it should be introduced through a play-based situation using parents as the primary interventionist.

the research will test the effectiveness of using the communication board to improve the frequency of communication and social engagement for these children, and the level or sophistication of that engagement. the study will test the effectiveness of using the communication board in a variety of settings and a variety of practitioners. the study will have sites in and near jonesboro, arkansas.

Eligibility criteria:
inclusion criteria: criteria for inclusion included a diagnosis of autism and agreement of the parents to participate and use the voca at home. exclusion criteria: not diagnosed with autism spectrum disorder

Keywords: autism spectrum disorders voice output communication
comparing 0.5 mg dutasteride vs placebo daily in men receiving androgen ablation therapy for prostate cancer

Conditions: Prostate Cancer

Summary: patient on an intermittent androgen deprivation protocol for biochemical recurrence after radical local therapy for prostate cancer,the addition of continuous dutasteride treatment, significantly prolongs the duration of the off treatment interval and time to androgen independence.

the study is to assess the effect of therapy with repeat oral daily dosing of dutasteride 05 mg on the length of the off treatment interval in men receiving intermittent androgen therapy for localized prostate cancer.

Eligibility criteria:
inclusion criteria: * able to give informed consent * age_\>45and\<_80 * histological confirmed adenocarcinoma of prostate * has received external beam radiation,brachytherapy or radical prostatectomy for the treatment of prostate ca * candidate for intermittent androgen ablation * minimum of 3 psa values above nadir taken at least 1 month apart * serum testosterone \>_250ng/dl,ecog 0 or 1 * negative bone scan within 12 months of visit 1 * able to swallow and retain oral medication exclusion criteria: * previous treatment with chemotherapy * hormonal therapy with in last year * glucocorticoid with in last 3 months * lhrh analogues with in previous year * ketoconazole * non steroidal anti-androgens with in previous year * concurrent or previous use of finasteride dutasteride 5a reductase inhibitor anabolic steroids * over the counter or herbal prep such as saw palmetto selenium or vitamin e within last year * may not be receiving any other investigational drug with in last 30 days * evidence of distant metastases * has received adjuvant or neoadjuvant ablation in past 12 months * unstable serious co-existing medical condition * abnormal liver and kidney functions * previous malignancy not including curative treated basal cell carcinoma of skin with in 5 years and bladder cancer with in past 2 years * known hypersensitivity to any 5a-reductase inhibitor or to any drug chemically related to dutasteride * known hypersensitivity to bicalutamide.
difference between inhalation anesthesia and total intravenous anesthesia in free flap surgery

Conditions: Surgery

Summary: the purpose of this study is to compare the difference between total intravenous anesthesia to inhaled anesthesia in free flap surgery.

the aim of this study is to perform a randomized controlled trial to examine the effects of different anesthetics on intraoperative hemodynamic stability during free flap surgery and postoperative complications

Eligibility criteria:
inclusion criteria: patients who need head and neck cancer excision and free flap reconstruction surgery exclusion criteria: 1. preoperative cognitive dysfunction, nyha chf \> iii or lvef \< 30% 2. preoperative documented obstructive or restrictive lung disease 3. liver cirrhosis; severe chronic renal insufficiency (gfr \< 30 ml·min-1·1.73 m-2.) 4. peripheral arterial occlusive disease expected to be a contraindication for picco catheter insertion 5. active cardiac arrhythmias that were assumed to preclude valid assessment using arterial pulse contour analysis 6. anticipated bilateral femoral arterial and central venous catheterization when the jugular and subclavian veins were not available due to surgical extent

Keywords: inhalation,intravenous anesthesia
hr070803 in combination with oxaliplatin, s-1 versus nalirifox as adjuvant therapy for pancreatic cancer

Conditions: Efficacy and Safety

Summary: the purpose of this study is to evaluate the efficacy and safety of hr070803 in combination with oxaliplatin plus tegafur compared to hr070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5fu/lv) treatment as adjuvant therapy in patients with resected pancreatic cancer.

study design/ evaluation criteria main criterion: efficacy. the main criterion is the 1-year disease-free survival rate. disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. patients without event at the time of analysis will be censored at the date of last follow-up visit. secondary criteria include overall survival. os is defined as the time from date of randomization until the date of death from any cause. patients who are still living at the time of analysis will be censored at the date of last follow-up visit. secondary criteria also include the disease-free survival. tolerance patients evaluable for toxicity must have received one investigational drug.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (r0 and r1). 2. ecog performance status 0 or 1. 3. life expectancy of greater than or equal to 6 months. 4. full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery. 5. the number of lymph nodes dissected during resection ≥ 15. 6. able and willing to provide a written informed consent. exclusion criteria: 1. patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor; 2. presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma. 3. ca19-9 exceeding normal value within 14 days prior to enrollment. 4. prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma. 5. severe infection (\> ctcae grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment; 6. patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) patients with nyha class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
a new supplement for the immune response to hpv infection

Conditions: HPV Infection

Summary: the purpose of this study is to evaluate whether a supplement in which ellagic acid plus annona muricata are combined, may modulate the immune response to high risk hpv infection. sixty women will be enrolled in a randomized, controlled study, having a histological diagnosis of l-sil correlated with high rish hpv types infection. main outcome measure is the activation of onco suppressor protein by the supplement and secondary outcome is the clearance of hpv infection in the treated group.


Eligibility criteria:
inclusion criteria: * women with high risk hpv infection * histological diagnosis of l-sil exclusion criteria: * women with no high risk hpv infection * women without histological diagnosis of l-sil

Keywords: hpv, l-sil
efficacy of a multimodal brain health intervention for older african americans

Conditions: Cognitive Impairment, Mild; Cognitive Decline

Summary: this study tests the feasibility, acceptability, and efficacy of a multimodal intervention (walking, social engagement, and reminiscence), including the use of wearable digital biomarkers, for cognitively healthy and mildly cognitively impaired african americans aged 65 and older.

cognitively healthy and mildly cognitively impaired participants engage in up to 8 weeks of baseline data collection and 4-16 weeks of triadic neighborhood walking using a group tablet device to access pre-programmed 1-mile routes. gps (global positioning system)-triggered historical images of local black culture and history along the route prompt conversational reminiscence about portland, oregon's historically black neighborhoods. digital biomarker technology (a continuously worn actigraph watch and an unobtrusive under-the-mattress sleep sensor) and weekly online surveys via a study chromebook assess feasibility, acceptability, efficacy, and health outcomes. intermittent discussions and check-ins with participants, and observational sessions will be used to elicit participant feedback.

Eligibility criteria:
inclusion criteria for walkers: 1. self-identified african american, 2. age \> 65 years old 3. reside or resided for \>10 years in portland's historically black neighborhoods (to be familiar with memory markers about this area), 4. able to ambulate independently. 5. meeting cognition criteria 1. participants with mci (mild cognitive impairment) will meet criteria consistent with the criteria outlined by the nia-alzheimer's association workgroup 2. participants without cognitive impairment will have a montreal cognitive assessment (moca) score \> 24 (and not meet mci criteria). participants' cognitive function should allow them to get to and from walk locations independently or with minimal assistance. 6. cognitive function allows independent (or minimally assisted) travel to and from walk locations 7. in-home reliable broadband internet (for weekly online surveys). 8. ability to read, speak, and understand english exclusion criteria: 1. self-reported or clinically diagnosed dementia 2. significant disease of the central nervous system 3. severely depressed (ces-d score \> 16), significantly symptomatic psychiatric disorder 4. advanced cardiovascular disease that would make walking difficult, including history of congestive heart failure 5. unstable insulin-dependent diabetes mellitus, received diagnosis type 1 diabetes, started insulin within past 3 months, hospitalized for hypoglycemia within past 6 months.

Keywords: social engagement neighborhood walking reminiscence physical activity african american mild cognitive impairment
effects of azithromycin on airway oxidative stress markers in patients with bronchiectasis

Conditions: Bronchiectasis

Summary: the mechanism by which macrolide antibiotics have immune modifying effects independent from its antibacterial activity has not been well established. in the present work, the investigators will analyze the effect of long-term treatment with azithromycin (250 mg three times per week during three months) on airway oxidative stress markers in exhaled breath condensate of adult patients with stable non-cf bronchiectasis.

the mechanism by which macrolide antibiotics have immune modifying effects independent from its antibacterial activity has not been well established. in the present work, we will analyze the effect of long-term treatment with azithromycin (az) on airway oxidative stress markers in exhaled breath condensate of adult patients with stable non-cf bronchiectasis. patients will be randomized in an open label model to receive az 250 mg three times per week during three months or nothing.dyspnea (borg scale), exacerbations (nº) in the last three months, sputum volume (cc), sputum colour (15-point scale), and health related quality of life (questionnaire st.george) will be measured in both groups before and after treatment. lung function, sputum culture, ct scan (bhalla score) and inflammatory markers in blood (esr, pcr),exhaled air (nitric oxide,) and exhaled condensed air (ph, nitrites, isoprostane) will be assessed before and after treatment. relationships between clinical and inflammatory markers will be studied

Eligibility criteria:
inclusion criteria: * previous diagnosis of bronchiectasis based on lung hrct and clinical symptoms * clinically stable in previous four weeks without exacerbations * informed consent exclusion criteria: * bronchiectasis secondary to cystic fibrosis, pulmonary surgical processes, immune deficiency, emphysema, allergic bronchopulmonary aspergillosis or diffuse interstitial pulmonary diseases * intolerance to macrolides or severe liver disease.

Keywords: bronchiectasis oxidative stress markers airway inflammation
urinary 8-isoprostane is elevated in acute childhood asthma

Conditions: Childhood Asthma; Oxidative Stress

Summary: oxidative stress is seen in children with asthma, but is hard to measure. the investigators exploring the utility of using a commercially available assay to measure oxidative stress in the urine in asthmatics. additionally, the investigators will attempt to prove that oxidative stress is higher in children with acute asthma compared to those with stable asthma and that this stress is also higher in children with more severe clinical asthma exacerbations compared to less severe ones.


Eligibility criteria:
inclusion criteria: group 1 1. patients aged 4-18 years 2. known stable asthmatics on no medications or with no medication changes in 3 weeks prior to enrollment 3. no asthma hospitalizations in past 3 months 4. parent available to consent group 2 1. patients aged 4-18 2. known asthmatic, admitted to stony brook university hospital for status asthmaticus 3. parent available to consent exclusion criteria: 1. any child with documented fever within 24 hours of study entry 2. any child with a known current history of tracheo- or bronchomalacia 3. any child with known clinical or laboratory evidence of shock (see below) 4. any child with history of documented immunodeficiency, rheumatologic disease, cystic fibrosis, or renal dysfunction (see below) 5. any child with a current or recent (less than 1 year) history of tracheostomy 6. any child with a known genetic abnormality 7. any pregnant child 8. any child with a history of autism 9. any child whose parent/caregiver is unable to give informed consent

Keywords: childhood asthma oxidative stress urinary 8-isoprostane