Kornimate/medical-research-clean huggingface dataset:
screening women at high genetic risk for ovarian cancer

Conditions: Ovarian Cancer

Summary: rationale: screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer. purpose: screening trial to determine the best procedure to detect ovarian cancer in women who have a high genetic risk for developing ovarian cancer.

objectives: * determine an optimal screening procedure for ovarian cancer, in terms of the most appropriate screening test, criteria for interpretation of results, and screening intervals, in women at high genetic risk for developing ovarian cancer. * determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women. * assess the feasibility of screening this high-risk population in terms of compliance rates. outline: patients undergo transvaginal ultrasonography of the ovaries (scheduled for the early follicular phase, day 3-6 of the menstrual cycle) and ca 125 measurement annually. blood samples are collected every 4 months for analysis of ca 125 levels and novel markers. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 5,000 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * first-degree relative (mother, sister, or daughter) of an affected member of a high-risk family defined as one of the following: * family containing 2 or more individuals with ovarian cancer who are connected by first-degree relationships * family containing 1 individual with ovarian cancer and 1 individual with breast cancer and under 50 years of age at the time of diagnosis who are connected by first-degree relationships * family containing 1 individual with ovarian cancer and 2 individuals with breast cancer and under 60 years of age at the time of diagnosis who are connected by first-degree relationships * family containing an affected individual with a mutation of one of the known ovarian cancer predisposing genes * family containing 3 individuals with colorectal cancer with at least 1 individual under 50 years of age at time of diagnosis and 1 individual with ovarian cancer who are connected by first-degree relationships * families where affected relatives are related by second-degree relationships through an unaffected intervening male relative who has an affected daughter are allowed patient characteristics: age: * 35 and over performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * no prior bilateral oophorectomy other: * no concurrent participation in other ovarian cancer screening trials

Keywords: ovarian epithelial cancer
nurse-led reminder program for the prevention of cardiovascular diseases

Conditions: Hypertension; Cardiovascular Disease

Summary: a number of strategies have been evaluated to improve the prevention and control of the main cardiovascular (cvd) risk factors. nursing telephonic and tele-counseling individualized lifestyle educational programs were found to improve blood pressure (bp) control and adherence to healthy lifestyle. this study aims at evaluating for the first time the efficacy of a nurse-led reminder program through email (nrp-e) to improve cvd risk factors among hypertensive adults. participants will receive usual care and a guideline-based educational program on bp control and healthy lifestyle habits. subjects in the nrp-e group will also receive weekly email alerts and phone calls from a nurse care manager for 6 months. emails contain a reminder program on the compliance with a healthy lifestyle based upon current guidelines for cvd prevention. follow-up visits will be scheduled at 1, 3 and 6 months after enrollment; randomization will be made centrally and blood samples will be evaluated into a single, accredited laboratory.


Eligibility criteria:
inclusion criteria: * to be eligible, all subjects had to be hypertensive (on active treatment for hypertension, or systolic blood pressure ≥ 140 mmhg; or * diastolic blood pressure ≥ 90 mmhg). * speaking and reading italian, * having a active phone number and an email address, and * providing a signed informed consent. exclusion criteria: * mental illness; * nursing home institutionalization; * pregnancy; * previous cardiovascular major events, non-modifiable cardiovascular risk-factors (i.e. diabetes).
supportive periodontal therapy under antiresorptive therapy

Conditions: Periodontitis; Antiresorptive Drugs

Summary: this observational study investigates the one-point in time and course of clinical periodontal and dental parameters during supportive periodontal therapy in patients under and without antiresorptive medication.


Eligibility criteria:
inclusion criteria: * patients undergoing supportive periodontal therapy (spt) after completing anti-infectious therapy (ait) in the section of periodontology, clinic of conservative dentistry, university hospital heidelberg * regular attendance to spt (no interruption of interval of more than one year) * existing radiographs (orthopantomogram or dental status) of up to six months before ait * art-group: patients on antiresorptive medication (underlying diseases: osteoporosis, cancer diseases) * understanding of participation in this study and given informed consent exclusion criteria: * patients \< 18 years * patients who underwent radiation therapy * pregnancy
pharmacokinetic study of opc-1085el ophthalmic solution in healthy male adult volunteers

Conditions: Glaucoma; Ocular Hypertension

Summary: opc-1085el ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in opc-1085el ophthalmic solution by formulating the combination drug will be determined.


Eligibility criteria:
inclusion criteria: * subjects who are considered medically healthy per investigator's judgment exclusion criteria: * subjects with ocular conditions as defined by the protocol * subjects with intraocular pressure: \<10 or ≥22 mmhg
evaluation of the impact of an amoxicillin and amoxicillin/clavulanic acid resistant probiotic on key clinical outcomes in children treated with amoxicillin or amoxicillin/clavulanic acid

Conditions: Bacterial Infections

Summary: amoxicillin or amoxicillin/clavulanic acid antibiotic therapy has been shown to be associated with disrupting the microbiota population particularly bifidobacterium, which may have further gi clinical implications. the present randomized clinical trial is aimed to assess if probiotic bifidobacterium breve prl2020 can help modulate the bifidobacterium population and its clinical implications after antibiotic amoxicillin or amoxicillin/clavulanic acid antibiotic therapy.

treatment with amoxicillin or amoxicillin/clavulanic acid is one of the most common antibiotic therapies used against various infections both in children and adults. these antibiotics can create an imbalance in the intestinal microbiota, altering its structure with a reduction in bacterial richness and, more specifically, in the abundance of bifidobacteria. this opened the window for further evaluations of the effect of this antibiotic combination on the composition of gut microbiota. the alteration can lead to intestinal symptoms such as pain, bloating, abdominal distension, flatulence, diarrhea, and constipation. in study by l. mancabelli et al. (2021), bifidobacterium breve prl2020 has shown greatest resistance to amoxicillin and amoxicillin/clavulanic acid. currently available scientific data, however, have not yet analyzed the ability of b. breve prl2020 to counteract the reduction of bifidobacteria that may occur in the human gut during the antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid, and neither its ability to avoid the consequent clinical relapse. the purpose of this randomized, controlled, prospective, single-center, non-profit study will be to evaluate the efficacy and safety of the administration of bifidobacterium breve prl2020 in pediatric patients (\> 4 years of age), treated with the antibiotic amoxicillin or amoxicillin/clavulanic acid, in the improvement of the symptoms due to the pharmacological treatment and in the contrast of the fall of the bifidobacterium cluster.

Eligibility criteria:
inclusion criteria: * children aged between 4-12 years, of either gender, with a bacterial infection and the use of antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid under a physician's prescription. * informed written consent from legal guardian exclusion criteria: * use of antibiotics within 3 months prior to enrolment
dialysis weaning in intensive care units (dialysis stop)

Conditions: Acute Kidney Injury

Summary: evaluation of daily urinary urea excretion, to guide renal replacement therapy weaning, in intensive care units. the objective is to show that remove the dialysis catheter, once daily urinary urea excretion is greater than 1.35 mmol/kg/d, would increase more than 3 days the number without dialysis catheters, and thus without dialysis, the first 28 days after insertion. daily urinary urea excretion = urea (mmol/l) x diuresis (l/d) / weight (kg).

daily urinary excretion of urea may provide a safe and reproducible renal replacement therapy withdrawal criterion, according to a recent french study (citations). a rate greater than 1.35 mmol/kg/d would predict a weaning success of 97.1% at 1 week. this criterion is influenced by the use of diuretics, and is easily accessible and achievable. daily urinary urea excretion is representative of the recovery of renal function. the french study establishing this new withdrawal criterion was monocentric and retrospective. however, we changed our practices as soon as we became aware of them. french multicentric (bordeaux university hospital, libourne, pau and bayonne hospitals) study, before and after: * period before: patients who were dialysed in the intensive care units of bordeaux, libourne, pau and bayonne, from november 2013 to november 2015. * period after: patients selected prospectively in the 4 hospitals. when diuresis \> 100 ml/d, an urinary ionogram is realized daily. measurement of urinary urea excretion every day. ablation of the catheter as soon as daily urinary urinary excretion \> 1.35 mmol/kg/d. measurement of daily urinary excretion the following 3 days.

Eligibility criteria:
inclusion criteria: * all patients \> 18 of age, who have a renal replacement therapy, in intensive care unit, * with a diuresis \> 100 ml/d. exclusion criteria: * patients still presenting "hard" criteria for rrt: metabolic acidosis with ph \ 5l 02 or 50% fio2 for sp02 \> 95%) objectified by echocardiography; k\> 5.5 mmol/l after treatment * renal transplantation * long-term chronic kidney injury or short-term dialysis project (arteriovenous fistula created). * acute kidney injury secondary to thrombotic microangiopathy * acute kidney injury secondary to an obstacle even if dialysed * rrt started for toxic cause without ira (lithium,...)
meibomian gland dysfunction treatment

Conditions: Meibomian Gland Dysfunction; Dry Eye

Summary: the purpose of this study is to evaluate the effectiveness of treatments for meibomian gland dysfunction.


Eligibility criteria:
inclusion criteria: * evidence of meibomian gland obstruction in both eyes * dry eye symptoms per deq-5 exclusion criteria: * active ocular infection * previous lipiflow treatment * beginning new oral or other systemic medications within prior 3 months * beginning new or changing dosages of ocular medications within prior 3 months * previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 months * habitual contact lens wear in prior 3 months * women who are pregnant or nursing

Keywords: dry eye meibomian gland dysfunction lipiflow
ifuse torq for the treatment of sacroiliac joint dysfunction

Conditions: Sacroiliac Joint Dysfunction; Sacroiliac; Fusion; Sacroiliac Disorder; Sacroiliac Joint Pain

Summary: staci is a prospective, multicenter, study of sij fusion using the ifuse torq implant system.

staci is a prospective, multicenter, study of sij fusion using the ifuse torq implant system. the goal of the study is to demonstrate the effectiveness of the device for its intended use.

Eligibility criteria:
inclusion criteria: 1. age \> 21 at time of screening 2. patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care 3. diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption) 4. baseline oswestry disability index (odi) score of at least 30% 5. baseline sij pain score of at least 5 on 0-10 numerical rating scale 6. bmi \< 35 7. patient has signed study-specific informed consent form exclusion criteria: 1. asa score 4 or 5 2. severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture 3. other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other hla-associated spondyloarthropathy), tumor, infection, acute fracture 4. cluneal neuralgia 5. previous sij implant placement, including allograft 6. anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement 7. history of recent (\<1 year) major trauma to pelvis 8. previously diagnosed or suspected severe osteoporosis (defined as prior t-score \< -2.5 or history of osteoporotic fracture). 9. chronic rheumatologic condition (e.g., rheumatoid arthritis) 10. current diagnosis of fibromyalgia 11. known allergy to titanium or titanium alloys 12. current local or systemic infection that raises the risk of surgery 13. patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation 14. currently pregnant or planning pregnancy in the next 2 years (self-reported) 15. patient is a prisoner or a ward of the state. 16. known or suspected active drug or alcohol abuse, including opioids 17. diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation 18. currently participating in another interventional clinical trial
a multilevel approach for improvement in screening of colorectal cancer in rural communities, the screen to save trial

Conditions: Colorectal Carcinoma

Summary: this clinical trial determines the feasibility of a multilevel approach to improve colorectal cancer screening within two rural regions of the fred hutchinson cancer research center/university of washington consortium catchment area. the catchment area is the greater puget sound region (13 counties). these rural counties have the highest overall rates of cancer incidence and mortality in the area; rural/small town residents in the catchment area had the lowest rates of meeting mammogram, pap, and colorectal screening recommendations. this study involves observational data and questionnaire assessments to determine if an online version of the evidence-informed national colorectal cancer screening program, known as "screen to save (s2s)" and a fecal immunochemical test (fit) kit distribution are acceptable and accessible to patients. fit kits may help doctors find colorectal cancer sooner, when it may be easier to treat.

outline: participants receive s2s online screening education and fit kit for sample collection. after completion of study intervention, patients are followed up at 3 months.

Eligibility criteria:
inclusion criteria: * age 45 years or older or \< 45 years old with family history of crc * speak and read english or spanish * current resident in clallam county * currently non-adherent to crc screening recommendations exclusion criteria: * age \< 18 years old
examination of the effectiveness of suvorexant in improving daytime sleep in shift workers

Conditions: Sleep Disorder, Shift-Work

Summary: the purpose of this study is to test the hypothesis that ingestion of the wake-inhibiting drug suvorexant 30 minutes prior to daytime sleep initiation in individuals working overnight shifts will significantly improve both objective (total sleep time, sleep efficiency, wake after sleep onset) and subjective (sleep quality) measures of daytime sleep.


Eligibility criteria:
inclusion criteria: * aged 20-60 (older individuals excluded due to altered sleep-related circadian signaling) * males and females * shift worker * minimum of three months of prior shift work * will work minimum of four nights per week or 32 hours of night shift per week during study * "night work" defined as having at least six hours of work occurring between 8 pm and 8 am and no longer than 12 hours on shift * presence of dsm-5 defined circadian rhythm sleep-wake disorder: shift work type * insomnia (se \< 88%) during attempted daytime sleep or excessive sleepiness during nocturnal wake exclusion criteria: * currently or planning to become pregnant * currently breastfeeding * inadequate opportunity (\<7 hours) for daytime sleep after shift work * use of sleep aids during the study period. includes as needed or continuous use of prescription, non-prescription, and naturopathic pharmacotherapies * diagnosis or detection (during study) of sleep disordered breathing (ahi\>10) on home sleep testing; referral to clinical sleep program will be offered * diagnosis of narcolepsy * restless legs syndrome * \>600 mg caffeine intake per night shift or use of prescription stimulant medication during night shift * rotational or irregular work shifts during study * use of digoxin for six months prior to or during study * use of strong (e.g., etoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan) or moderate (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil) cyp3a inhibitors or cyp3a inducers (e.g., rifampin, carbamazepine, phenytoin) for six months prior to or during study * severe hepatic impairment * unstable or severe medical or psychiatric condition
cryoplasty climb-registry

Conditions: Critical Limb Ischemia; Peripheral Arterial Occlusive Disease

Summary: in 5 belgian hospitals, the data of 100 cli-patients receiving the cryoplasty technique to treat their infrapopliteal arterial lesions will be collected. the treatment occurs strictly according the "instructions for use" of the ce-approved device (polarcath peripheral dilatation system, boston scientific) and only data are collected that have been made available conform the standard the standards of care for these patients.


Eligibility criteria:
inclusion criteria: * symptomatic cli male or female patients with at least 1 atherosclerotic diseased infrapopliteal artery. if patients present with more than 1 diseased vessel, only the vessel with the best distal run-off providing the foot with blood, will be assessed following treatment with the polarcath peripheral dilatation system (boston scientific) and analysed for registry purposes. patients will be considered eligible for inclusion into the registry if satisfying the product dfu specifications.

Keywords: cli critical limb ischemia infrapopliteal cryoplasty
the effect of h. pylori infection on iron metabolism

Conditions: Iron Deficiency Anemia; Helicobacter Pylori Infection

Summary: the purpose of this study is to determine if helicobacter pylori (h. pylori) gastritis results in abnormal iron metabolism in patients with iron deficiency anemia (ida), and to determine if this is due to strain variations in the h. pylori organism.

there is suggestive evidence that h. pylori gastritis (without peptic ulcer disease) is a cause of ida. there have been individual case reports and case series describing patients with refractory ida that resolved following successful h. pylori treatment. the effect of h. pylori on iron metabolism will be studied through specific aims: 1. to assess whether h. pylori results in abnormal oral iron absorption 2. to assess if differences in h. pylori strains are associated with iron deficiency due to: a. genetic differences in h. pylori strains or b. differences in the pattern of gastritis which could be due to host, bacterial or environmental factors 3. to assess if h. pylori infection results in storage of iron in the gastric mucosa and an elevated gastric iron concentration. the study will consist of three aspects: 1. determining whether oral iron absorption is abnormal for h. pylori-positive ida patients, and comparison of oral iron absorption for h. pylori positive and negative ida patients. this will also include an experimental component in which oral iron absorption will be repeated after h. pylori treatment for h. pylori-infected ida subjects (and after an equivalent time period for h. pylori negative controls to exclude changes in iron absorption that occur over time). 2. comparison of h. pylori strain characteristics for ida patients and non-anemic h. pylori-infected controls. characterization of h. pylori strains will include: genetic analysis using a whole genome microarray technique that assesses the presence or absence of h. pylori genes, evaluation of expression of genes related to iron metabolism, and comparison of pattern of gastritis (pan gastritis vs. antrum-predominant). 3. determination of whether h. pylori stores a significant quantity of iron in the gastric mucosa in vivo. this will be assessed by measuring the iron concentration in mucosal biopsy specimens and comparing results for h. pylori-infected ida patients to h. pylori-uninfected ida controls.

Eligibility criteria:
inclusion criteria: * age \> 18 years * iron deficiency anemia (ida) defined as: hgb \< 14 g/l for men and 12 g/l for women, and a serum ferritin level less than 45 ug/l exclusion criteria: * obvious non-gi cause of blood loss * chronic renal failure (bun\>60, creatinine \> 4) * hemolytic anemia, thalassemia, aplastic anemia * known alcoholism or cirrhosis of the liver * regular use (\>3x weekly) of nsaids * prior gastric resection * celiac disease * known gi or hematologic malignancy * known inflammatory bowel disease

Keywords: anemia, iron-deficiency helicobacter pylori
continuous theta burst stimulation as potential biomarker of levodopa-induced dyskinesias in parkinson's disease

Conditions: Parkinson Disease

Summary: the primary endpoint of the study is to identify a neurophysiological biomarker (absence of synaptic depotentiation at primary motor cortex , measured as change in the amplitude of motor evoked potentials recorded at the dorsal first interosseus muscle after administration of neurophysiological ctbs depotentiation protocol) as predictor of the development of levodopa-induced dyskinesia in patients with parkinson's disease.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of idiopathic parkinson's disease according to movement disorder society (mds) criteria; * age between 30 and 80 years; * ongoing therapy with levodopa; * fulfillment of requirements for the application of transcranial magnetic stimulation (tms), assessed by completion of the tms screening questionnaire. exclusion criteria: * patients unable to give informed consent; * cognitive impairment (mmse ≤ 24); * history of epilepsy; * pregnant women.