Kornimate/medical-research-clean huggingface dataset:
pneumococcal conjugate vaccine 13 (prevnar13®) in children who are solid organ transplant recipients (sot)

Conditions: Infection in Solid Organ Transplant Recipients

Summary: the purpose of this study is to determine the safety and long-term immunogenicity of the 13-valent pneumococcal conjugate vaccine in children who are solid organ transplant recipients.

the purpose of this study is to determine if a booster dose of 13-valent pneumococcal conjugate vaccine (pcv13) is safe and results in a measurable and durable immunologic response against pneumococcal subtypes present in the vaccine in solid organ transplant recipient (sot) children. pneumococcal infections are amongst the most common infections seen in immunocompromised children. infection by streptococcus pneumoniae is one of the most frequently observed infection in immunocompromised children. pneumococcal polysaccharide vaccines (ppv) have been licensed in the u.s. for over 40 years. in contrast, pneumococcal conjugate vaccines are immunogenic and efficacious in normal infants and children, and offer hope of reducing pneumococcal infections in immunocompromised children. however, conjugate pneumococcal vaccine can only protect against a limited number of the 90 pneumococcal serotypes. it is reasonable to anticipate that the introduction of pcv13 may help reduce the chances of severely immunocompromised children getting pneumococcal infections. many of these children have been previously immunized with a full series of a 7-valent pneumococcal conjugate vaccine. these children will benefit from an additional dose of the new 13-valent vaccine. the degree to which sot-recipient children are protected by prior immunizations and are responsive to new immunizations is still largely undefined. this study aims to expand the knowledge regarding the safety and immunogenicity of pcv13 immunization in this growing and vulnerable population.

Eligibility criteria:
inclusion criteria: * are 12 to 59 months of age. * have received a solid organ transplantation requiring ongoing immunosuppression. * have been receiving immunosuppressive agents for at least 3 months. non-steroidal anti-inflammatory agents, g-csf, erythropoietin and inhaled corticosteroids are not considered immunosuppressive agents for the purposes of this study. * expect to be able to complete the study injection and follow-up. * have parent or guardian's consent. * have received at least 3 doses of an approved pcv7 and/or pcv13 vaccine series. exclusion criteria: * have received any inactivated vaccine within 4 weeks, or any live vaccine within 6 weeks of entering the study. * have had an allergic reaction or a serious side effect after receipt of any previous immunization to pneumococcal vaccines, or to other routine childhood immunizations. * have any other condition that would make receiving study vaccine inadvisable. * have other diseases of the immune system. * have any other disease or previous surgery that would interfere with study treatment. * are likely to have bleeding disorders.
study to assess medi -578 in patients with osteoarthritis (oa) of the knee

Conditions: Osteoarthritis; Pain

Summary: the purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of medi-578, a monoclonal antibody, in patients with osteoarthritis of the knee. it will also be evaluated how medi-578 is absorbed and distributed through the body.


Eligibility criteria:
inclusion criteria: * patients with painful osteoarthritis of the knee. * the pain from the knee must exceed pain experienced from any other condition. * patients must be willing and able to discontinue all current analgesic treatment. exclusion criteria: * any other form of arthritis than osteoarthritis. * presence of neuropathic pain, or fibromyalgia, or wide spread chronic pain not related to osteoarthritis. * significant abnormalities on the clinical examination that may interfere with the study or present a safety risk to the patient, as judged by the investigator.

Keywords: anti-ngf oa pain
comparison of medifast's 5 & 1 plan to a food-based plan of equal calories

Conditions: Obesity

Summary: portion-controlled meal replacements have been shown to be an effective weight control strategy in overweight and obese individuals. thus, the investigators plan to evaluate the effect of medifast's 5 \& 1 program compared to an food-based diet plan of equal calories on the following indices: weight loss and maintenance of weight loss, satiety during weight loss, changes in biochemical markers of inflammation and oxidative stress following weight loss, and compliance and retention rates.


Eligibility criteria:
inclusion criteria: * adult males and females (age between 18 and 65) * obese (bmi \>=30.0 kg/m2 and \<50.0 kg/m2) * non-smokers * no known food allergies to wheat, gluten, soy or nuts * \<14 alcoholic beverages per week * willing and able to give informed consent * not currently using appetite-affecting medications (e.g ssris, steroids, ritalin) * not pregnant or lactating * primary care physician's permission for weight loss, normal labs and electrocardiogram (ekg) within past 1 year exclusion criteria: * actively dieting * eating attitudes test (eat) \> 30 * chronic uncontrolled health problems (not including obesity or diabetes) * pacemaker or other internal electronic medical device * schizophrenia, history of bipolar disorder, current major depressive disorder * dependence on alcohol or sedative-hypnotic drugs (e.g. benzodiazepines) * cognitive impairment severe enough to preclude informed consent * taking weight loss or appetite-suppressant medications * taking appetite affecting medications (e.g. ssris, steroids, ritalin) * food allergies to wheat, gluten, soy, or nuts * pregnant or lactating

Keywords: obesity weight loss meal replacements inflammation oxidative stress visceral fat
effect of laser therapy on vaginal tissue

Conditions: Pelvic Floor Disorders; Vaginal Atrophy

Summary: pelvic floor disorders, including prolapse, incontinence, and vulvovaginal atrophy decrease the quality of life of every fourth woman. recent therapy including habits change, rehabilitation, surgery, or hormonal replacement is not possible in all patients. laser therapy is currently being proposed as an alternative. laser therapy was brought to the gynecological field from dermatology, where it is used for facial rejuvenation (wrinkles) and treatment of other skin abnormalities. in dermatology, the laser has proven its efficacy at the molecular and histological levels. however, this concept was brought to gynecology without comparable confirmation. the skin and vagina have a different structures, therefore effects of laser may differ. patient satisfaction with the clinical effects of laser has been reported. however, based on recent reviews and sheep studies knowledge about histological and other effects is limited. the goal of this study is to gain knowledge about the histological, biomechanical effects and molecular effects of laser on vagina. control samples were collected from women undergoing colporrhaphy. the laser group underwent laser treatment prior to the surgery. the gained knowledge may improve laser protocols and in the future maybe laser therapy will become standard treatment in urogynecology.


Eligibility criteria:
inclusion criteria: * pelvic organ prolapse stage ii (cystocele ba ≥ -1) * planned surgical treatment (anterior colporrhaphy) * menopausal exclusion criteria: * surgical treatment at a location of interest * use of systemic or vaginal estrogens within last 12 months
does a drain tube influence the postoperative epidural haematoma for lumbar biportal endoscopic surgery?

Conditions: Drain Tube Influence the Postoperative Epidural Haematoma

Summary: the purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (poseh) in biportal endoscopic spinal surgery (bess) procedures for decompression of lumbar spinal stenosis.

how to reduce the rate of poseh after lumbar spinal surgery is an obvious concern for spine surgeon. wound drains were recognized as effective methods and typically used to prevent the development of symptomatic epidural hematomas after spinal surgery. however, whether range prophylactic postoperative drainage after spinal decompression for the prevention of poseh is still controversial. although there have been many studies focusing on the potential associations between wound drains and poseh after lumbar spinal surgery, a prospective study focusing on the role of drains in minimally invasive surgery of bess for lumbar spinal decompression has been rare. in present study, our team sought to investigate the influence of wound drains for poseh and provide clinical evidence for the selection of drainage in bess procedures for the decompression of lumbar spinal stenosis.

Eligibility criteria:
inclusion criteria: all patients with two level lumbar stenosis and neurogenic claudication with or without lumbar radiculopathy were eligible for inclusion. exclusion criteria: patients were excluded if radiography revealed lumbar instability (motion of \>3mm at the level of listhesis), if they had had previous lumbar spinal surgery, or they had american society of anesthesiologists (asa) class ⅳ or severe systemic disease.

Keywords: spinal epidural hematoma decompression surgery lumbar spinal stenosis
positive effects of daily consumption of bread enriched with hydroxytyrosol on the results of a 12-week dietary intervention on subjects with type 2 diabetes mellitus and overweight/ obesity

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: hydroxytyrosol is a phenolic compound drawn from the olive tree and its leaves as a by-product obtained from the manufacturing of olive oil and has antioxidant and antidiabetic effects. the use of ht extract in food products is a good strategy to improve their nutritional quality. however, this extract has a strong odour and flavour, so it is important to be encapsulated for the odour and flavour to be covered up. the purpose of the study is to investigate the effects of regular consumption of bread enriched with ht on biochemical parameters (blood glucose and cholesterol levels).

subjects with type 2 diabetes mellitus and overweight/ obesity will participate in the present study. they will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of bread enriched with hydroxytyrosol. the effects of the dietary intervention on biochemical parameters (blood glucose and cholesterol levels) and body weight reduction will be examined.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * bmi : 25-40 kg/ m-2 * normal exercise and dietary habits * weight stable for at least 3 months before enrollment exclusion criteria: * hba1c \> 8.5% * pregnancy * chronic medical illness * regular intense exercise * alcohol consumption (\> 2 drinks/day)
trem-1 pathway activation in covid-19

Conditions: Covid19

Summary: severe acute respiratory syndrome-corona virus-2 infection results in a mild infection in most of the patients. however, 15-20% require hospitalization, and among them, 15-20% will develop acute respiratory failure, leading to their admission in intensive care unit. there are no accepted predictive criteria for aggravation. severe forms of coronavirus induced disease-19 (covid-19) are the consequence of endotheliopathy, and hyperinflammatory and pro-coagulant state. the triggering receptor expressed on myeloid cells-1 (trem-1) is an immunoreceptor that acts as an amplifier of the inflammatory response. trem-1 is expressed on myeloid and endothelial cells. its activation leads to endothelial activation and damage, hyperinflammatory, and pro-coagulant state. trem-1 activation is associated with poor outcome during septic shock and myocardial infarction. we here aim at investigating the relationship between trem-1 pathway activation and clinical degradation and outcome of covid-19 hospitalized patients.


Eligibility criteria:
inclusion criteria consecutive covid-19 hospitalized patients for less than 3 days exclusion criteria: no consent pregnancy protected populations
impact of fitbit plus weight management program on physical activity and metabolic disease in obese adolescents

Conditions: Obesity

Summary: this study is evaluating the feasibility and efficacy of using fitbit charge hr devices to remotely track the physical activity of obese pediatric patients who are concurrently enrolled in a comprehensive weight loss intervention program. patients will receive fitbit devices and will be called weekly to review their average daily steps and heart rates. patients will receive the fitbit either at the beginning of classes or upon completion of classes. patients will then be followed remotely and called weekly for 12 additional weeks after completing classes. the two groups will be compared to examine for differences.

patients will be randomly assigned into one of two groups. in the first group, patients will undergo an already established multidisciplinary weight loss intervention program and will also wear fitbit charge hr devices. their data will be regularly uploaded to their fitbit dashboard, and this information will be reviewed by the study team.

Eligibility criteria:
inclusion criteria: * enrollment in the healthy kids, healthy weight assessment and intervention program * bmi greater than or equal to the 95th percentile exclusion criteria: * compromising medical condition that prevents physical activity (sickle cell disease, severe asthma, fractures, etc) * severe intellectual disability * history of smoking * current use of atypical antipsychotics, stimulants

Keywords: fitbit obesity pediatrics
cardiac rehabilitation program in peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: the main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (cr) in patients with peripheral arterial disease (pad) after successful revascularization. this study will also test if cr improves quality of life and health outcomes in pad patients.


Eligibility criteria:
inclusion criteria: * patients with pad post-revascularization (stent, angioplasty, or bypass). * patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures. exclusion criteria: * below or above the knee amputation. * underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard cr protocols at the university of kansas medical center (kumc). * unfavorable short term prognosis and limited life expectancy (\<2 years) * awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned). * prior history of having dropped out of cr without completing. * unwilling to consent for all aspects of cr or study participation. * unable to come for cr (this will exclude patients who live far away or have no means to travel to the cr facility). * pregnancy

Keywords: revascularization blocked arteries leg arteries leg pain
palliative steroeotactic body radiotherapy vs palliative standard radiotherapy in patients with advanced head and neck cancer

Conditions: Advanced Head and Neck Cancer

Summary: this study is being done to answer the following question: does stereotactic body radiation therapy (sbrt) provide better cancer control compared to standard radiation therapy (rt) for those with advanced head and neck cancer?

stereotactic body radiation therapy, or sbrt, is a cancer treatment that more precisely delivers radiation to the tumour area with less radiation going to unaffected areas around the tumour. it uses fewer treatments of higher doses compared to standard radiation therapy. this study is being done to find out if this approach is better than the usual approach for advanced head and neck cancer. the usual approach is defined as care most people get for advanced head and neck cancer.

Eligibility criteria:
inclusion criteria: * histologically confirmed mucosal squamous cell carcinoma (scc) of the head and neck arising from at least one of the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary * stages t0-t4/n0-n3 * must be considered unfit for curative intent rt as determined by the treating oncologist(s) * geriatric 8 score \<14 (see appendix vi for g8 screening tool) * patient must be ≥18 years of age * ct or mri of the head and neck within 8 weeks prior to randomization * chest ct or x-ray. pet ct is permitted if ct is of diagnostic quality. * eastern cooperative oncology group (ecog) performance status 0-3 * participants of childbearing potential must have agreed to use a highly effective contraceptive method during protocol therapy. * patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational treatment are eligible for this trial. exclusion criteria: * patients with nasopharyngeal carcinoma. * prior systemic therapy (including immunotherapy). * prior radiotherapy to the head and neck excluding superficial radiotherapy for head and neck skin cancer that does not overlap with current protocol treatment. * prior head and neck cancer excluding skin cancer. * patients with tumour locations/at risk of sbrt toxicity, including glottic/subglottic larynx, t4 hypopharynx, post-cricoid, cervical esophagus, circumferential pharyngeal involvement, extension/proximity to brain/optic structures, any single tumour mass \>8 cm (in one dimension), \>2 nodal levels (level 1a/b not counted). * gross tumour poorly visualized on ct/mri. * definitive radiological or clinically evident distant metastases. * scleroderma/crest syndrome.
trial to assess implementation of new research in a primary care setting (trains)

Conditions: General Practice (GP), Primary Care Settings

Summary: in england and wales, unscheduled care for school-aged children with asthma significantly increases after their return to school in september, a trend linked with decreased asthma preventer prescriptions during the summer holidays. the pleasant study found that a reminder letter from gps to parents of children with asthma led to a 30% increase in prescription uptake during august and reduced unscheduled medical visits from september to december. the trains trial will now assess if informing gps of pleasant findings would lead to its implementation. this pragmatic cluster randomised implementation trial will use routine data from clinical practice research datalink (cprd).


Eligibility criteria:
inclusion criteria: * inclusion criteria of practices practices inclusion criteria 1- general practices who are currently contributing part of the cprd in england. * inclusion criteria of children with asthma inclusion criteria for the data extraction from cprd: 1- school-aged children with asthma aged between 4 to 16 years old as of 1st september 2021 with a coded diagnosis of asthma who have been prescribed asthma medication in the last 12 months. exclusion criteria: * practice exclusion criteria: 1. general practices that are not in england. 2. general practices that are not included in the cprd. 3. practices that cease to be part of the cprd during the intervention time without contributing to the primary outcome. 4. practices that merge during the intervention (where the merging practices were in different study arms). * exclusion criteria of children with asthma: 1. school-aged children with asthma under 4 and over 16 years old as of 1st september 2021. 2. children with no asthma diagnosis 3. children with asthma who have not received a prescription for asthma medication. in the last 12 months
total mesorectum excision with left colic artery preservation for the treatment of rectal cancer

Conditions: Rectal Cancer

Summary: a randomized controlled clinical trial to compare the short and long term outcomes of left colic artery preservation for the treatment of rectal cancer

rectal cancer is one of most frequently diagnosed cancers and one of the leading causes of cancer death around the world. surgery remains the main treatment for rectal cancer. anastomosis leakage (al) is an unresolved, devastating and lethal complication after rectal cancer surgery and remains to be a serious difficulty for surgeons despite its causes, preventions and treatments having been extensively studied. to achieve a radical dissection of lymph nodes, it is necessary to remove the central lymph nodes at the root of inferior mesenteric artery(ima) trunk.from the perspectives of lymph nodes dissection and tension-free anastomosis, it is preferred to perform a high ligation of ima. however, there is still a controversy whether ima should be high ligated or not. the argument mainly focuses on whether this performance will compromise the blood perfusion of the proximal limb of the anastomosis leading to the occurrence of al. some studies suggested that a high ligation did not increase the rate of al. there are still many surgeons prefer the transection of ima distal to the left colic artery(lca) with the intention to preserve a good blood supply of the left colon after the performance of lymph node dissection around ima. some studies suggests that the preservation of lca in anterior resection for mid and low rectal cancer is associated with lower rates of al. further investigations are needed to resolve the controversy. in this study, eligible patients will be randomly allocated to receive total mesorectal excision (tme) for rectal cancer either by a high ligation of ima without preservation of left colic artery or a low ligation of ima with preservation of left colic artery. postoperative complications, including anastomosis leakage, anastomosis bleeding, will be recorded. patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.

Eligibility criteria:
inclusion criteria: * patients suitable for curative surgery over 18 years old; * american society of anesthesiologists(asa) grade i-iii; * pathological diagnosis of rectal adenocarcinoma; * patients suitable for abdominalperineal resection * informed consent; * no history of familial adenomatous polyposis, ulcerative colitis or crohn's disease. exclusion criteria: * pregnant patient; * history of psychiatric disease; * use of systemic steroids; * simultaneous multiple primary colorectal cancer; * preoperative imaging examination results show:1. tumor involves the surrounding organs and combined organ resection need to be done;2. distant metastasis;3. unable to perform r0 resection; * history of any other malignant tumor in recent 5 years; * patients need emergency operation: mechanic ileus, perforation.

Keywords: left colic artery rectal cancer
supplementation of critical nutrients in a plant-based diet

Conditions: Deficiency, Vitamin; Vegan's Anemia (Vitamin B12 Deficiency); Deficiencies Micronutrient

Summary: 500 participants of the vegan/vegetarian congress vegmed are to be included, which should answer once (cross-sectional study) a medicine socio-behaviorist questionnaire on the topic "supplementation of critical nutrients in a plant-based diet" at the vegmed congress on 21/04/2018. the aim of the study is to understand how experts in this field behave and whether actions taken follow official recommendations.


Eligibility criteria:
inclusion criteria: * participants of the vegmed congress (berlin, april 2018) * expertise of the respondent in the field of nutritional medicine * presence during the oral education to participate in the survey exclusion criteria: n/a