Kornimate/medical-research-clean huggingface dataset:
reirradiation with concomitant chemotherapy after salvage surgery for recurrence of head and neck cancer in irradiated area

Conditions: Recurrence of Head and Cancer in Irraiated Area

Summary: interest of a reirradiation with concomitant chemotherapy after salvage surgery for recurrence of head and cancer in irradiated area : a multicentric phase iii randomized trial


Eligibility criteria:
inclusion criteria: * head and neck squamous cancer * both sexes * \>=18 years * recurrence treated by surgery and initially treated by radiotherapy * with written informed consent at entry time exclusion criteria: -
study of hucns-sc subretinal transplantation in subjects with ga of amd

Conditions: Age-Related Macular Degeneration

Summary: a fellow eye controlled study of hucns-sc sub-retinal transplantation in subjects with bilateral ga amd. all subjects will be assigned to hucns-sc transplantation.

a fellow eye controlled study of hucns-sc sub-retinal transplantation in subjects with bilateral geographic atrophy (ga) age-related macular degeneration (amd). all subjects will be assigned to hucns-sc transplantation. all subjects will be followed for efficacy and safety for 12 months. an independent data monitoring committee (idmc) will review adverse events for the duration of the study.

Eligibility criteria:
inclusion criteria: * ga associated with amd in both eyes. total area of ga determined by fundus autofluorescence. * bcva of 20/320 or better in each eye at screening assessment exclusion criteria: * prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center. * retinal or macular disease of any other cause in either eye. * diagnosis of glaucoma in either eye. * uncontrolled intraocular pressure in either eye * compromised renal function defined as egfr \ 0.3 is spot urine collection. * history of or active autoimmune disease. * previous organ, tissue or bone marrow transplantation. * seropositive for hiv, hepatitis b or c, or cmv igm
comparing minisling to tension free vaginal tape in mangement of stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. the aim of this study is to test the hypothesis that the single incision mini-sling placed in the "u" position is not inferior to tvt in this patient population.


Eligibility criteria:
inclusion criteria: * patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse exclusion criteria: * patients with overactive bladder on urodynamic study. * patients with voiding dysfunction. * patients with intrinsic sphincteric deficiency. * patients with previous anti-incontinence surgery. * patients on anti-coagulant therapy. * immune-compromised patients (dm, patients on corticosteroids treatment). * refusal of surgery.

Keywords: stress urinary incontinence tension free vaginal tape single incision minisling midurethral sling
vitamin d supplementation in pcos patients

Conditions: PCOS

Summary: to assess whether vitamin d supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not

this study is double blinded randomized controlled study conducted at tanta university hospitals in the period from april 2019 to march 2022. patients and methods: one hundred twelve patients were recruited and randomly allocated into 2 groups; study group with vitamin d supplementation and control group without vitamin d supplementation.

Eligibility criteria:
inclusion criteria: * pcos * infertile * vitamin d deficient exclusion criteria: * age less than 20 and more than 35 * non pcos patients * obese patients * previous ovarian surgery * previous oophrectomy of one ovary

Keywords: pcos vitamin d supplementation ovulation pregnancy
safety monitoring for a novel 3d printed mandibular advancement device

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to evaluate the safety profile of the novel oral appliance (oa )device and to assess patient comfort of the novel oa device.


Eligibility criteria:
inclusion criteria: * no history of obstructive sleep apnea * no active jaw joint pain * no active moderate to severe periodontal disease * presence of 12 teeth per arch exclusion criteria: * presence of severe bruxism

Keywords: oral appliance sleep apnea hypoxia
voriconazole (vfend) special investigation (regulatory post marketing commitment plan)

Conditions: Scedosporium Infection

Summary: to collect the efficacy and safety information of voriconazole related to their appropriate use in daily practice.


Eligibility criteria:
inclusion criteria: male or female patients who are prescribed voriconazole (vfend) for deep mycosis on scedosporisis. exclusion criteria: subject who have been prescribed voriconazole (vfend) for deep mycosis on aspergillus, candidasis,cryptococcal infections not involving scedosporisis.

Keywords: systemic mycosis scedosporium infection scedosporisis japanese voriconazole vfend regulatory post marketing commitment plan.
heat therapy and omega 3 on cardio-metabolic health

Conditions: Hypertension

Summary: currently, controlled studies are lacking which test the benefits of: 1) ω3 pufa; and 2) heat therapy on improving vascular-metabolic-microbiota health in hispanic american populations. the investigator's objective is to determine if this modality (heat therapy i.e., warm water immersion, hot tubs) combined with dietary interventions (increased fish and/or fish oil intake) may be feasible treatments to improve cardiovascular risk factors and reduced comorbidities in hispanic populations.

in a double-blind, placebo-controlled design, participants will be randomized to the following experimental treatments: 1. 4 g omega 3 daily for 12 weeks combined with 6 weeks of heat therapy 2. placebo pill daily for 12 weeks with 6 weeks of heat therapy (ht) non-obese healthy will only serve as controls and enroll in placebo and neutral control therapy conditions. ht will entail 14 consecutive days of 1.5 hours passive heating (increase internal temperature 1.2°c above baseline), followed by 4 weeks of ht, 3 days per week.

Eligibility criteria:
inclusion criteria: * bmi\>30-40, * fasting glucose 100-125, * blood pressure 130-139/80-89, * hispanic american, * age 18-65 years exclusion criteria: * non-hispanic, * bmi\ 40, * fasting glucose \ 125, * blood pressure \ 139 systolic, \>90 diastolic, * age \ 65 years
computerized screening, brief intervention, and referral to treatment in primary care

Conditions: Substance Use Disorder

Summary: this is a randomized, controlled clinical trial to evaluate the effect of a computerized screening, assessment, and brief intervention on substance use in patients recruited from a primary care clinic. study participants will be assigned to one of the following 4 study groups: computerized health screening alone (standard care) (sc); computerized assessment-only intervention (ca); computerized assessment followed by a computer-directed motivational intervention (caci); or computerized assessment followed by a therapist-delivered motivational intervention (cati). data regarding substance use, medical and psychosocial functioning, and economic outcomes will be collected. the investigators hypothesize that patients randomized to caci and cati will be more likely to report drug abstinence at the 3-month follow-up visit and will show greater reductions in drug use at 1, 3 and 6 months follow-up than patients assigned to ca or sc. similarly, patients in the caci and cati groups will report greater reductions in hiv risk behaviors, lower rates of medical and psychosocial problems, and increased economic gains at the 6-month follow-up. in addition, patients in the assessment only intervention (ca) will have outcomes superior to those found for sc patients. a cost-effectiveness analysis will also be done comparing economic costs associated with ca, caci and cati and their relationship to substance use reductions and related improvements in medical and psychosocial outcomes at the 6 month follow-up.


Eligibility criteria:
inclusion criteria: * 18 - 65 years * primary care clinic patient exclusion criteria: * pregnant

Keywords: substance use drug use drug abuse
results of adjunctive intraoperative bevacizumab injection on trabeculectomy outcome

Conditions: Glaucoma

Summary: the purpose of this study is to evaluate the adjunctive effect of intratenon bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (iop).

prospective interventional clinical trial single center, outcome assessor-masked, active control, randomized controlled trial

Eligibility criteria:
inclusion criteria: * primary open angle glaucoma with primary mmc-trabeculectomy indication exclusion criteria: * combined phacoemulsification with trabeculectomy * no more than 6 month of cataract surgery before trabeculectomy * revised trabeculectomy * active uveitic glaucoma * neovascular glaucoma * par planar vitrectomy * conjunctival surgery * allergy to bevacizumab or mitomycin c * ischemic heart disease * cerebrovascular disease * renal failure * liver failure

Keywords: trabeculectomy bevacizumab intraocular pressure
improved automatic cpap algorithm to treat obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea (OSA)

Summary: the purpose of this study is to compare a modified autoset algorithm running on research hardware versus the traditional autoset algorithm running on an s7 autoset spirit. the study will determine if the modified autoset algorithm reacts appropriately to obstructive apnoeas and hypopnoeas and provides suitable levels of positive airway pressure compared to the s7 autoset spirit. the hypothesis is that the modified autoset algorithm will be more efficacious than the traditional autoset algorithm

subjects in the trial will spend 2 nights in a sleep laboratory being monitored with a full montage polysomnograph (psg) with each of the algorithms providing positive airway pressure therapy. the psg records eeg, emg, eog, patient airflow, respiratory effort, blood oxygen saturation, and body position. in a randomised order each subject will spend one night being treated by the modified autoset algorithm and a second night being treated by the traditional autoset algorithm. the subjects will be blinded to which therapy they are receiving and the scorer of the psg will also be blinded to which therapy is being used.

Eligibility criteria:
inclusion criteria: * psg-confirmed diagnosis of osa, showing an apnoea-hypopnoea index (ahi) of at least 15 events/hr and an obstructive apnoea index (oai) of at least 5 events/hr. * on cpap therapy (fixed pressure or autocpap) for at least 1 month. * using a resmed mask (this requirement applies only to phase 2 of the trial) without significant discomfort for at least 2 weeks. * age between 18 and 70 years. * written informed consent. exclusion criteria: * unstable medical condition, including unstable angina, myocardial infarction within previous 6 months, cardiac failure nyha grades iii and iv, epilepsy, psychiatric disturbance. * respiratory insufficiency, defined as arterial co2 greater than 50 mm hg during the daytime or arterial oxygen saturation less than 90% when asleep and breathing room air on effective cpap therapy. * recent severe epistaxis. * history of spontaneous pneumothorax. * history of regurgitation of gastric contents during sleep. * unable to give written informed consent.
women helping women - lung cancer screening

Conditions: Lung Cancer

Summary: the women helping women lung cancer screening (whw-l) study will be conducted to develop a scalable, easy to apply community-based intervention to increase rates of lung cancer screening and follow-up in high-need/low-resource populations, based on a transtheoretical stages of change theoretical model. the investigators will test the feasibility of using community health workers to recruit (aim 1) and partner with 60 community members (aim 2) within 6 months, to take the steps to consult with a doctor, schedule screening, and/or attend screening (aim 3) \[84 people may be screened for the study assuming some don't continue}.chws will use the healthstreet 12,000+ cohort to identify current or former female smokers (adults 50 to 77 years old) with a smoking history of 25 pack-years who could benefit from ldct screening for lung cancer and will facilitate steps in their screening receipt. all participants will benefit from the standard intervention; additionally, a random sample of 30 will receive the enhanced chw intervention (e-chw-i). the investigators hypothesize that women who may be at higher risk of lung cancer due to lack of knowledge, access, and resources will take steps to receipt of ldct in both interventions, with those receiving the enhanced intervention more likely to take these steps. ultimately, such an intervention could lead to a lower lung cancer burden in the target population


Eligibility criteria:
inclusion criteria: * women who are 50 to 80 years old * 20+ pack-years of smoking history * live within 45 miles of uf health shands hospital or in duval county, specifically the 12,000+ healthstreet cohort exclusion criteria: * women outside the acceptable age range * insufficient smoking history * women who live outside the 45 miles of uf health shands hosptial or not in duval county not in the healthstreet system
rapid postoperative recovery pathway in adolescent idiopathic scoliosis.

Conditions: Scoliosis Idiopathic

Summary: the study will evaluate the clinical outcomes of an intra- and postoperative fast-track protocol in patients undergoing instrumented posterior arthrodesis surgery for adolescent idiopathic scoliosis.


Eligibility criteria:
inclusion criteria: * ages 14-18 years * iagnosis of adolescent idiopathic scoliosis requiring an instrumented posterior arthrodesis surgical procedure * males and females. exclusion criteria: * spinal infection * neoplastic diseases * heart disease * hypersensitivity to tranexamic acid * history of coagulopathy and/or previous thromboembolic events * severe renal failure

Keywords: scoliosis
incidence and severity of neuropsychiatric adverse events of efavirenz given as a stepped dosage vs. the usual dosage

Conditions: HIV-1 Infection; HIV Infection

Summary: background: neuropsychiatric side effects (npses) occur in a significant proportion of subjects after initiation of efavirenz (efv) and may limit its use in certain patients. objectives: to evaluate the incidence and severity of npses and antiviral efficacy of efv given as a stepped dosage over 2 weeks versus the usual dosage. methods: randomized, double blind, multicentric clinical trial in which a progressive dosage (arm a: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was compared with conventional administration (arm b: 600 mg qd from the first day). all patients received additional treatment with 2 nrtis. the incidence and intensity of npses and sleep disorders were assessed using a likert-type scale specifically designed. efficacy was assessed by percent of virological failures.


Eligibility criteria:
inclusion criteria: * age older than 18 years * hiv-1 infection * women of child-bearing age: negative pregnancy test * ability to understand and sign a written consent form exclusion criteria: * pregnancy.. * illegal drug or methadone use. * major psychiatric disease antecedents or starting new psychotropic agents in the last 4 weeks * concomitant treatment with rifamycins, protease inhibitors or drugs which interfere the pharmacokinetic of efavirenz. * hepatic insufficiency

Keywords: hiv efavirenz central nervous system adverse effects
mapping obesity-related subtypes and interconnected clusters

Conditions: Obesity; Overweight (BMI &gt; 25)

Summary: in the netherlands, about half of all adults are currently living with overweight. this number is expected to rise to as much as 64% by the year 2050, especially among younger adults aged 18 to 44. overweight and obesity increase the risk of chronic conditions such as heart disease, diabetes, and joint problems. however, there is no single cause behind these issues. instead, they result from a complex combination of factors - including nutrition, physical activity, sleep, stress, income, environment, and even air quality. these factors often influence each other and vary from person to person. this study aims to better understand these patterns and connections. by analyzing large sets of data, researchers are identifying different subtypes of people with overweight or obesity. these subtypes reflect groups of individuals who share similar personal, lifestyle, and environmental characteristics. understanding these differences makes it possible to develop more personalized lifestyle advice and support. that way, care and prevention efforts can be better tailored to what people actually need and what works best for them in practice. experts from various fields are helping interpret the results, so that scientific insights can be translated into practical solutions for individuals, communities, and healthcare settings.

overweight and obesity are increasingly prevalent in the netherlands. obesity-related health issues are complex and influenced by multiple interacting variables, including personal behaviors, socioeconomic status, environmental characteristics, and health conditions. this study seeks to validate and enrich the results of an ongoing exploratory data analysis by involving experts in the interpretation of identified factor clusters related to bmi categories. this mixed methods study includes a quantitative component (an online survey) and a qualitative component (expert panel group discussions). experts are recruited through purposive and snowball sampling and participate in interpreting variable clusters, assessing associations, and drawing conclusions on implications for further research and practical application.

Eligibility criteria:
inclusion criteria: * researchers or professionals with expertise in obesity, lifestyle, environment, psychosocial or medical factors; * experience in data interpretation and/or public health; * able to communicate in dutch; * willing to participate in the online survey and/or expert panel meeting exclusion criteria: * no relevant domain expertise; * inability to give informed consent

Keywords: overweight obesity prevention lifestyle data-driven clusters
integrative medicine for pain in patients with advanced cancer trial (impact)

Conditions: Cancer Pain

Summary: the purpose of this study is to compare the long-term effectiveness of acupuncture versus massage in people living with advanced cancer. the study will test how the two approaches compare in helping people with pain and its related symptoms and improving quality of life.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years or older * having a diagnosis of the following: stage iii or iv lung cancer; any stage pancreatic cancer; unresectable cholangiocarcinoma; unresectable liver cancer; unresectable ampullary or peri-ampullary cancer or other stage iv gastrointestinal cancer; stage iii or iv ovarian or fallopian tube cancers or other stage iv gynecologic cancer; stage iv breast cancer; stage iii testicular cancer; stage iv genitourinary cancer; stage iii or iv sarcoma; stage iv melanoma; stage iii or iv head/neck cancer; stage iv endocrine cancer; or hematological malignancies (lymphoma, myeloma, and leukemia) * be ambulatory (karnofsky functional score of ≥ 60) * having musculoskeletal pain, defined as regional (joints, extremities, back, neck) or more generalized (fibromyalgia or chronic widespread pain); patients with a neuropathic component to their pain that involves the extremities or back will be eligible. * having musculoskeletal pain for at least 1 month * having had pain for at least 15 days in the preceding 30 days * having a pain rating of 4 or greater in worst pain on a 0-10 numerical rating scale in the preceding week * having an expected prognosis of greater than six months as judged by the treating oncologist or study physician exclusion criteria: * having a platelet count \<15,000 * cognitive impairment precluding response to study assessments * unwilling to accept random assignment * unwilling to commit to the 26-week study time period * have non-musculoskeletal pain syndromes (headache, facial pain, chest pain, visceral abdominal pain) if these are the sole source of pain but can be present as co-morbid conditions as long as a patient has a primary musculoskeletal pain condition defined as above.

Keywords: acupuncture massage impact 19-341
arterial calcification in the diabetes

Conditions: Diabetic Vascular Diseases; Arteriosclerosis Obliterans; Monckeberg Medial Calcific Sclerosis

Summary: the blood concentration of the protein rankl could be predictive of the calcification of the leg arteries, which is a major complication occurring during diabetes. the objective of the diacart study is to show that blood rankl concentration predict the progression of calcification of the leg arteries in diabetic patients, independently of other cardiovascular risk factors.

introduction: peripheral arterial disease (pad) is the primary major amputation risk factor in diabetes. the pad is particularly common among diabetic patients at high cardiovascular risk (20-30% of coronary patients have pad). the calcification of atherosclerotic plaque and media leg arteries contributes to narrowing of the arterial lumen and exposes the diabetic patient to critical limb ischemia. the receptor rank (receptor activator for nuclear factor κ b) and its ligand rankl form a complex which initially was described as being involved in bone metabolism by activating osteoclasts but the rank / rankligand system could also be involved in the process calcification and arterial obstruction, especially in the lower limbs. currently there is anti-rankl antibody used in humans that could possibly slow down this process. but it is necessary to prove the involvement of this system in pad in diabetic patients at high cardiovascular risk before proposing a therapeutic trial. assumptions: the concentration of rankl could be predictive of calcification of leg arteries in diabetes main objective: to show that serum rankl concentrations predict the progression of calcification of the leg arteries in diabetic patients, independently of other cardiovascular risk factors. secondary objectives: * to show the link between other proteins of bone remodeling, markers of inflammation and glycation, and calcification of leg arteries. * measuring the rate of calcification leg arteries. * phenotype diabetic patients who have the highest rate of calcification. primary outcome: predictive power of serum rankl concentration at t0 on the progression of calcification of leg arteries between t0 and t24 months. methodology: prospective observational study. the calcium score of leg arteries will be evaluated by a scanner at t0 and 24 months. inclusion criteria: * type 2 diabetes * women over 60 * men over 50 years * men and women with known coronary artery disease non-inclusion criteria: * severe renal failure * immunodeficiency * acute infectious or inflammatory disease * history of bypass surgery or sub-popliteal angioplasty number of subjects required: 188 patients will be included. total study duration: 24 months inclusion period: 24 months

Eligibility criteria:
inclusion criteria: * type 2 diabetes * women over 60 * men over 50 years * men and women with known coronary artery disease non-exclusion criteria: * severe renal failure * immunodeficiency * acute infectious or inflammatory disease * history of bypass surgery or sub-popliteal angioplasty

Keywords: type 2 diabetes arterial calcification mediacalcosis calcium score