Kornimate/medical-research-clean huggingface dataset:
light therapy for the treatment of back pain in pilots (lll&pilots)

Conditions: Back Pain

Summary: back pain is a common complaint among pilots. current treatments include physiotherapy and chiropractic manipulations. low-level laser irradiation (llli) in the visible to near-infrared range was shown to reduce neck and low back pain. the purpose of the study is to evaluate the efficacy of light therapy for treatment of back pain in pilots.

background: lumbar spine disorders are common conditions in pilots of various aircraft with etiology related to sub-optimal ergonomics, exposure to g-forces, the weight of the head gear and exposure to extensive vibrations. current treatments include physiotherapy and chiropractic manipulations. low-level laser irradiation (llli) is a non-ionizing, non-thermal irradiation within the visible to near infrared range of the light spectrum. llli has been used widely for alleviation of pain in inflammatory processes and acceleration of wound healing. a variety of clinical studies show that lllt in the near infrared range may be useful in the treatment of back pain. objective: to evaluate the efficacy of light therapy for treatment of back pain in pilots. study design: prospective, randomized, controlled double blind. volunteers will receive biweekly physiotherapy treatment for 3 weeks. in addition to the physiotherapy treatment, half the volunteers will receive light therapy and half sham irradiation. study evaluations will include physical examination by an orthopedic surgeon, subjective pain level by visual analogue scale, validated low back functional questionnaires, a generic functional questionnaire, and patient satisfaction scores. volunteers will be invited for evaluations at 1 and 3 months after the final treatment.

Eligibility criteria:
inclusion criteria: * pilot (current) * level of pain - moderate to severe low back pain (≥40 on the pain vas) exclusion criteria: * low back pain due to non-traumatic etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, cauda equinal syndrome). * pregnant * recent (up to 1 year) history of trauma * current chronic pain other than low back pain * physical disability that prevents the patient to lie down/get up

Keywords: photobiomodulation aviation
pregnancy and contraception education in chronic kidney disease (pace-ckd)

Conditions: CKD; Chronic Kidney Diseases

Summary: this pilot study will assess the efficacy of a pregnancy and contraception education decision aid (da) for patients with chronic kidney disease to support decisions about reproductive health, and will assess feasibility and acceptability of the intervention to inform future research project grant (r01) level studies.

60 patient participants will receive either a novel da about pregnancy and contraception in chronic kidney disease delivered by patient's nephrologist or will receive currently available educational materials based on clinic-level randomization. nephrologists will be trained to deliver the novel decision aid or will provide usual care. patients will complete a survey about pregnancy and contraception decision making and the acceptability and feasibility of the educational materials after the clinical visit. intervention nephrologists will be anonymously surveyed after all patients have completed measures, to assess acceptability and feasibility.

Eligibility criteria:
inclusion criteria: * any chronic kidney disease (ckd) diagnosis * ckd defined as abnormality in kidney structure or function for \>3 months and may be manifested by having any one of the following: i. glomerular filtration rate (gfr)\<60 milliliter/minute (ml/min)/1.73m2, or ii. a marker of kidney damage (albuminuria \>30 milligrams per gram (mg/g), abnormal kidney histology by biopsy, hematuria, structural abnormalities by imaging (e.g. polycystic kidney disease, horseshoe kidney) or electrolyte abnormalities due to tubular disorders) - able to speak and read english exclusion criteria: * patients receiving dialysis * patients who have a kidney transplant * patients that are surgically sterile (tubal ligation or hysterectomy) or currently pregnant * patients that have significant cognitive or visual impairment that limits interaction with the decision aid (da)

Keywords: pregnancy and contraception education
less neuropathy after yoga- managing diabetic neuropathy with yoga

Conditions: Diabetic Neuropathy

Summary: the long-term goal is to identify and establish effective mind-body interventions (as an aspect of complementary and alternative medicine) to improve health and quality of life (qol) for people with disabilities. preliminary data suggest that engagement in yoga is feasible and beneficial for multiple study populations, and it may relieve symptoms of neuropathy. the central hypothesis is that individuals who complete yoga will have significantly better balance, mobility, and qol after 8 weeks of yoga.

assessments completed before and after yoga. yoga was delivered twice a week for 8 weeks for one hour each session. yoga included sitting, standing, and floor postures, breath work, and meditation

Eligibility criteria:
inclusion criteria: * anyone age 18 and over with dpn from diabetes mellitus and a balance impairment. and be able and willing to attend twice weekly sessions for 8 weeks. exclusion criteria: * not have consistently engaged in yoga for greater than a year.

Keywords: yoga balance
autism in adult patients and the effects on caregivers

Conditions: Autism

Summary: background: the number of adults with autism is expected to rise significantly in the near future, due to two main reasons: first, a dramatic increase in the estimates of the prevalence of autism starting in the mid 1980s; second, the clinical diagnosis of autism was first introduced during the 1950s, and those diagnosed with autism back then are only now entering middle age. few studies, however, have focused on the outcomes of adult autistic individuals, and very little is known about the course of autism in adulthood and on the familial burden resulting from caring for an autistic adult. we therefore propose to study adult outcomes in autism, and to examine the influence of raising an autistic individual on the parents. working hypothesis and aims: the primary objectives of the study are: 1. determine clinical status and functioning of autistic adults. 2. study the influence of raising and caring for an individual with autism on the well-being of the parents.


Eligibility criteria:
inclusion criteria: * autism or autism spectrum disorder * understands the informed consent * hebrew speaker exclusion criteria: * severe acute or chronic illness * substance abuse * in control subjects: autism or autism spectrum disorder in subject or siblings * in control subjects: participating sibling

Keywords: autism spectrum disorders long-term outcomes caregiver burden birth cohort nested case-control study
leak pressure after reinforcement in gastric specimens

Conditions: Obesity

Summary: the investigators hypothesize that staple line reinforcement will result in a higher leak pressure than a non-reinforced staple line closure in the resected gastric specimens from laparoscopic sleeve gastrectomy. the primary endpoint of the study is leak pressure after various staple line treatments. the investigators will also analyze the most common site of specimen leak, association of stomach thickness to leak, association of stomach thickness to performance of the staple line techniques, and a cost analysis.

the purpose of this study is to evaluate the mechanical strength of various staple line reinforcement techniques using the resected portion of stomach in patients undergoing laparoscopic sleeve gastrectomy. the specimen will be collected at the time of surgery, the previous staple line will be excised, and a new staple line with one of the investigatory reinforcement procedures will be applied. the staple line techniques to be used in this study include non-buttressed and non-imbricated oversewing, non-buttressed and imbricated suture line, buttressed stapling, and no reinforcement (see protocol for description of each). the specimen will then be taken to the morgue where the experimental procedure will be performed within 6 hours of specimen procurement. the specimen will be attached to a catheter with a pressure monitor and blue dye will be instilled into the specimen until leakage is seen. the presence of leakage indicates failure of the staple line. detailed measurements of all specimens will be performed as will leak pressure and location in the specimen where leak occurred. the specimen will then be turned over to pathology to undergo routine pathologic examination. this experimental procedure has been used previously in published literature with animal samples, but never with human tissue. a possible reason for the lack of testing in the stomach staple line in patients after sleeve gastrectomy is that the technical aspects of bariatric surgery were developed using gastric bypass; a procedure where the stomach is divided but not excised. the investigators hypothesize that the specimens treated with staple line buttressing material will fail at a higher pressure than those without reinforcement. the investigators will also explore the location of the failure to determine if there is a consistent site of weakness. should this study yield consistent results, it would help determine a standard approach for staple line reinforcement after laparoscopic sleeve gastrectomy. additionally, should the location of the leak be consistent, this information may help drive technical changes that could decrease leak rate, an infrequent but potentially devastating risk of this and other weight loss surgeries.

Eligibility criteria:
inclusion criteria: * undergoing laparoscopic sleeve gastrectomy exclusion criteria: * undergoing a revisional procedure * subject whose specimens need clinical attention by pathology following resection (e.g. cancer biopsy) * steroid use

Keywords: bariatric surgery laparoscopy weight loss surgery staple line reinforcement
efficacy of oral famciclovir 125mg comparing to aciclovir 200 mg treatment in patients with active recurrent genital herpes

Conditions: GENITAL HERPES

Summary: recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (hsv). there are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as famciclovir and aciclovir. this is a phase iii, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with active recurrent genital herpes.

study design * open-label, prospective, parallel group, intent to treat trial * experiment duration: 5 days * 2 visits (days 1, and 5) * reduction of symptoms * adverse events evaluation

Eligibility criteria:
inclusion criteria: 1. patients must be able to understand the study procedures agree to participate and give written consent. 2. patients with clinical diagnosis of recurrent genital herpes; 3. score symptoms higher than 4; 4. negative pregnant urine test. exclusion criteria: 1. pregnancy or risk of pregnancy. 2. lactation 3. any pathology or past medical condition that can interfere with this protocol. 4. non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study); 5. patients with immunodeficiency and/or immunosuppressive disease; 6. hypersensitivity to components of the formula; 7. other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Keywords: herpes simplex virus
real-world study to evaluate the efficacy and safety of liposome irinotecan

Conditions: Colorectal Cancer; Solid Tumor

Summary: this study is a prospective, multicenter, real-world study. there are four cohorts. cohorts 1-3 include second-line, posterior-line, and neoadjuvant colorectal cancer patients, respectively. cohort 4 include patients with the exception of those with pancreatic and colorectal cancer. as this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.


Eligibility criteria:
inclusion criteria: 1. cohort 1: * patients with histologically or cytopathologically confirmed colorectal adenocarcinoma who were diagnosed with unresectable metastatic disease. * known to be pmmr/mss or mmr/ms status unknown. * prior first-line systemic oxaliplatin - and fluorouracils-based therapy for metastatic disease progressed. * patients had not received iri or nal-iri during the treatment phase of metastatic disease. * patients were scheduled to receive nal-iri plus fluorouracils or iri plus fluorouracils chemotherapy regimens as second-line systemic therapy. 2. cohort 2: * patients with histologically or cytopathologically confirmed colorectal adenocarcinoma who were diagnosed with unresectable metastatic disease; * known to be pmmr/mss or mmr/ms status unknown. * patients had received ≤ 3 lines of previous treatment for metastatic disease. * progression of metastatic disease after treatment with an iri-containing regimen (no limit on the number of iri treatment lines). * the patient had not previously received nal-iri and was scheduled to receive a systemic nal-iri containing chemotherapy regimen as palliative treatment. * have at least one measurable lesion according to recist v1.1. 3. cohort 3: * high-risk (crs score 3-5) synchronous liver metastatic colorectal adenocarcinoma with ≤5 liver metastases, confirmed by histopathology or cytopathology, and planned resection. * known to be pmmr/mss or mmr/ms status unknown. * the patient was scheduled to receive nal-iri+ oxaliplatin + fluorouracils chemotherapy regimen as neoadjuvant therapy. 4. cohort 4: * non pancreatic cancer and non colorectal cancer patients confirmed by histopathology and/or cytology. * have received at least one systemic treatment for unresectable diseases; * plan to receive a systemic treatment regimen containing nal iri; * at least one measurable lesion (according to recist v1.1); exclusion criteria: cohort 1-4: * treatment with an immune checkpoint inhibitor (e.g., pembrolizumab, nivolumab) was planned during chemotherapy. * allergy to irinotecan or liposomal irinotecan and its excipients is known. * female patients known to be pregnant or lactating. * other patients who were deemed by the investigator to be ineligible for enrollment.
mapping organ health following covid-19 disease due to sars-cov-2 infection

Conditions: COVID-19

Summary: a prospective, longitudinal, observational cohort study looking at patients following covid-19 disease using multi-parametric magnetic resonance imaging (mri) to assess the degree and prevalence of organ injury.

to date, correctly, all of the government's efforts have been dedicated to providing sufficient hospital space, and the appropriate equipment, for treating the most serious cases of covid-19. equally, enormous resource is being dedicated to developing technologies that determine who has the disease, and who has developed antibodies to it. however, patients recovering from serious disease will also pose a huge, ongoing challenge. not only are people with co-morbidities including underlying fatty liver disease, metabolic syndrome and diabetes at higher risk for complications with covid-19; but patients discharged from hospital after severe covid-19 are reported to have liver and kidney injuries, and impacts on pancreas and spleen. however, the extent of organ health/damage has not been mapped. this is a prospective, longitudinal, observational cohort study looking at patients recovering from covid-19 disease using multi-parametric magnetic resonance imaging (mri) to assess the degree and prevalence of organ injury. this proposed study aims to measure the prevalence of organ volume changes and damage in lungs, heart, kidney, liver, pancreas, spleen as assessed by mri among those having recovered, or recovering, from the sars-cov-2 infection - participants will have a final mri scan at 12 months. assessing the severity and sequelae of covid-19 in patients is crucial to enable global planning for health-care needs. the study includes up to 3 visits for mri scans and blood tests over a 12 month period. all participants will receive standard-of-care by their healthcare provider/s.

Eligibility criteria:
inclusion criteria: * male or female 18 years of age and older willing and able to give informed consent to participate in the study * recent confirmed diagnosis of sars-cov-2 rna via a polymerase chain reaction (pcr) assay (having been discharged 7 or more days from hospital). exclusion criteria: * symptoms of active respiratory viral infection: * high temperature (over 37.8c/100.04f) * cough (consistent for over an hour; 3 or more episodes in 24 hours) * the participant may not enter the study with any known contraindication to magnetic resonance imaging (including but not limited to pregnancy, a pacemaker or other metallic unfixed implanted device, metallic fragments, extensive tattoos, severe claustrophobia). * any other cause, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.

Keywords: metabolic syndrome obesity fatty liver disease
role of biomarkers in muscle pain and joint pain in patients with solid tumors receiving paclitaxel

Conditions: Arthralgia; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: learning about pain in patients with cancer receiving paclitaxel may help plan treatment and may help patients live more comfortably. studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to muscle and joint pain. purpose: this phase i trial is studying the role of biomarkers in muscle pain and joint pain in patients with solid tumors receiving paclitaxel.

objectives: primary * to determine the change in urinary prostaglandin e metabolite (pge-m) level after paclitaxel treatment in patients with a variety of solid tumor malignancies. * to determine whether a change in pge-m level correlates with paclitaxel dose. * to determine whether the change in urinary pge-m level correlates with patient reporting of pain, as measured by a visual analog scale and the brief pain inventory short form (bpi-sf). secondary * to determine whether leukotriene levels are affected by paclitaxel treatment. outline: at baseline (prior to the first dose of paclitaxel), patients complete a questionnaire about their baseline pain symptoms (including the brief pain inventory short form and the visual analog scale); cigarette smoking status and second-hand smoke exposure; and routine use of any pain medications (including nsaids, selective cox-2 inhibitors, and opioid analgesics), corticosteroids, or leukotriene antagonists (montelukast or zafirlukast). patients also complete questionnaires about their pain daily on days 2-7 after paclitaxel administration. urine samples are collected at baseline for urinary prostaglandin e metabolite (pge-m), urinary leukotriene e_4 (lte_4), and urinary cotinine levels and on day 4 for urinary pge-m and lte_4 levels.

Eligibility criteria:
disease characteristics: * solid malignancy of any type * patients must be scheduled to receive their first dose of paclitaxel at vanderbilt-ingram cancer center * any paclitaxel-containing regimen or dosing schedule is allowed patient characteristics: * not pregnant * accessible for follow-up * able to submit urine samples * able to complete questionnaires prior concurrent therapy: * see disease characteristics

Keywords: pain arthralgia unspecified adult solid tumor, protocol specific
effects of nattokinase on inflammation and cardiovascular risk markers in patients with dyslipidemia

Conditions: Cardiovascular Diseases; Dyslipidemias; Inflammation

Summary: the study aims to evaluate the effect of the nattokinase enzyme on inflammation and markers of cardiovascular risk in participants with dyslipidemia. a longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants with dyslipidemia for two months.

nattokinase has potent fibrinolytic/antithrombotic, antihypertensive, antiatherosclerotic, lipid-lowering, antiplatelet/anticoagulant and neuroprotective activities. nattokinase is capable of inhibiting platelet aggregation by blocking the formation of thromboxane and inactivating the type 1 plasminogen activator inhibitory factor. recently, it was proposed that nattokinase can attenuate oxidative stress and the inflammatory process in in vitro and animal models. however, there are no studies in dyslipidemic patients evaluating these data.

Eligibility criteria:
inclusion criteria: * both sexes; * over 18 years of age; * isolated increase in ldl-c (ldl-c ≥ 160 mg/dl); * isolated increase in triglycerides (tg ≥ 150 mg/dl or ≥ 175 mg/dl, without fasting); * increased ldl-c (ldl-c ≥ 160 mg/dl) * tg (tg ≥ 150 mg/dl or ≥ 175 mg/dl, without fasting); * reduction in hdl-c (men \< 40 mg/dl and women \< 50 mg/dl) alone or in association with an increase in ldl-c or tg. if tg ≥ 400 mg/dl. * individuals who are already using lipid-lowering therapy (statins or non-statins) will also be included. exclusion criteria: * participants with autoimmune and infectious diseases, diabetes, cancer and aids; * pregnant women; * participants using catabolic drugs or antibiotics * participants on anticoagulant medication * participants using antioxidant vitamin supplements, prebiotic, probiotic or synbiotic and who are allergic to corn or soy starch.

Keywords: nattokinase cardiovascular diseases inflammation fibrinogen