Kornimate/medical-research-clean huggingface dataset:
medication use and quality of life among older people (pilot)

Conditions: Quality of Life; Reduction, Harm

Summary: this project will provide new evidence on how to optimize medication use among older people with limited life expectancy. this will be done by testing whether a patient-centered deprescribing intervention, focused on aligning medical treatment with patients' preferences, can improve quality of life among older people with limited life expectancy. this registration concerns the initial pilot study.

in a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. this registration concerns the initial pilot study. all patients included in the pilot study will receive the intervention (that is, the pilot study will not include randomization). the intervention will comprise a series of consultations between the patient and general practitioner (gp) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process. the process can be summarized in seven steps: during an initial consultation (1: consultation 0), the gp assesses patient eligibility. if the patient would like to participate, a project nurse subsequently visits the patient at home (2: home visit) for retrieval of informed consent as well as baseline measurements. during the next consultation (3: consultation 1), the patient and gp discuss how the patient feels about his/her medical treatment, and the gp provides the patient with written material for the patient to prepare prior to the next consultation. the patients prepares (4: preparation) by considering and verbalizing his/her goals of care and treatment preferences. simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the gp on which drugs can be continued and deprescribed, respectively. during the next consultation (5: consultation 2), the patient and gp discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. during a new consultation (6: consultation 3), the patient and gp follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. if needed, subsequent consultations (7: consultation x) are planned until the patient and gp consider the patient's medical treatment optimal.

Eligibility criteria:
inclusion criteria: * aged ≥80 years * take ≥8 different medications * have a life expectancy of \<2 years, estimated via the surprise question ("would you be surprised if this patient died within 1-2 years?") by the general practitioner * have a mini-mental state exam (mmse) score of ≥15 * are able to provide informed consent exclusion criteria: * not able to communicate * does not speak and understand danish

Keywords: deprescribing polypharmacy guideline
effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with age-related macular degeneration

Conditions: Macular Degeneration

Summary: the effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with age-related macular degeneration.

there is observational data in the current literature suggesting that the intake of foods high in marine sources of omega-3 fatty acids, such as fish, may lower the risk of developing age-related macular degeneration (amd). a large prospective study is underway to determine whether oral supplementation with 1 gram of omega-3 fatty acids is beneficial for subjects with dry amd. the purpose of our study is to evaluate the change in serum omega-3 index (blood level of omega-3 fatty acids) after 1 gram of omega-3 fatty acid supplementation versus 2 grams.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study. * have areds category 3 or 4 disease. * category 3: many medium sized drusen or one or more large drusen in one or both eyes * category 4: geographic atrophy or choroidal neovascularization in one eye. exclusion criteria: * women of child-bearing age with positive urine pregnancy tests or desire to conceive during the course of the study. * patients with a known fish allergy. * patients currently taking supplementation with omega-3 fatty acids and have an omega-3 index of greater than 4%.

Keywords: amd vision loss omega-3 supplement age related macular degeneration
a survey about hot flashes in women going through the menopause

Conditions: Menopause; Vasomotor Symptoms

Summary: this study is an online survey of women in and around menopause with moderate to severe hot flashes. menopause, a normal part of life, is a time after a woman's last period. hot flashes often occur during menopause. they can disrupt a woman's daily life. this study is about collecting information only. there will be no treatment in this study. this study will provide information about how many women have moderate to severe hot flashes in menopause. it will also provide details on women's experiences with hot flashes. women from brazil, canada, nordic europe, and mexico will take part in this study. the women in this study will already be taking part in consumer panels. women will be contacted based on their age. they will be asked if they would like to take part in this study. firstly, the women will answer questions about whether they are in menopause or are getting close to menopause. they will also be asked how severe their hot flashes are. from their answers, some women will be asked to complete an online survey. these will be women who are in menopause and have moderate to severe hot flashes. they will provide more details about how hot flashes have impacted their lives. also, they will answer questions on how hot flashes affect their quality of life. finally, they will answer questions about their experiences when they visited their doctor about their hot flashes.


Eligibility criteria:
inclusion criteria (primary outcome measure): - post-menopausal women inclusion criteria (secondary outcome measure): * women currently experiencing, or have experienced in the last month, moderate to severe vms symptoms (i.e. minimum of 1 moderate to severe hot flushes per day over the last month) * peri-menopausal and post-menopausal women exclusion criteria (primary outcome measure): * women with current breast cancer treatment * women treated with anti-estrogens, aromatase inhibitors or gonadotropin-releasing hormone (gnrh) agonists/antagonists for cancer or any other medical condition. additional exclusion criterion for secondary outcome measures will be: - mild vms symptoms only

Keywords: menopause vasomotor symptoms
survivor stories: impact on cancer patients' quality of life and follow-up

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate in a randomized controlled trail, an innovative cancer communication strategy to help african american breast cancer patients cope with a variety of challenges during and after treatment and to better adhere to recommended treatment guidelines and follow-up care.

disparities in incidence and mortality between african americans and caucasians for a number of cancers have been well documented. this study builds on previous work in st. louis to overcome barriers to access to breast screening, identifying and addressing factors associated with access to care once diagnosed, and factors contributing to delay in diagnosis and completion of therapy. african american breast cancer patients randomly assigned to the intervention arm of the trial will have access to the survivor stories tablet, a tablet computer, on which they will browse an archive of 1-3 minute videotaped survivor stories about five topics: coping, relationships, experiences with the health care system, follow-up care, and quality of life (qol) living with breast cancer. patients will have the tablet for two weeks after enrollment in the study, and again at 6 and 12 months. patients in the control arm will receive usual care.

Eligibility criteria:
inclusion criteria: * african american women * first primary ductal carcinoma in situ (dcis) or stages i, ii, or iii invasive breast cancer. exclusion criteria: * prior dcis or breast cancer diagnosis * stage iv or metastatic breast cancer * planned to receive a double mastectomy * non-english speaking, * having known psychiatric or neurologic disorders * being cognitively impaired according to weighted error scores on the orientation-memory-concentration test * being unwilling or unable to give consent

Keywords: race disparities breast cancer quality of life treatment adherence
efficacy study of dietary intervention and weight loss in improving psoriasis

Conditions: Psoriasis

Summary: this is a multicenter randomized controlled clinical trial evaluating the impact of a structured non pharmacological intervention consisting in intensive weight reduction (qualitative and quantitative changes in diet associated with physical exercise) compared to an intervention based on a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic plaque psoriasis * bmi \> 25 kg/m² * patients under systemic treatments for psoriasis or candidates for such treatments exclusion criteria: * diagnosis of other type of psoriasis or psoriatic arthritis * patients under local treatments or candidates for such treatments * patients expected to have poor compliance at follow-up evaluation

Keywords: psoriasis
evaluation of the performance of a rapid pregnancy diagnostic test.

Conditions: Pregnancy Related; Diagnostic; Emergencies; Pelvic Pain; Metrorrhagia

Summary: the aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to improve the medical care of patients in emergency room.

the most current gynecological consultations in emergency unit first lead to a pregnancy diagnostic test. the gold standard used is the diagnostic test based on determination of the β-human chorionic gonadotropin concentration. but this assay need time and expect women to wait for hours. a 5-minutes pregnancy diagnostic test has been developed in france. a 62-patients study showed that results obtained with the rapid test were correlated with results obtained with the test based on determination of the β-human chorionic gonadotropin concentration. the purpose of this study is to evaluate the efficiency of the 5-minutes pregnancy diagnostic test realized in emergency room, in comparison with the blood determination of the β-human chorionic gonadotropin concentration which is only tested in medical laboratory. a little amount of total blood sample used for gold standard test will be used to assess sensibility, specificity, positive or negative predictive values of the rapid pregnancy diagnostic test.

Eligibility criteria:
inclusion criteria: * adult women who are in genital activity * women who are in emergency unit to consult for metrorrhagia and/or pelvic pains. * lack of intrauterine gestational sac determined using endo-vaginal ultrasound * women who need a diagnostic test using the β-human chorionic gonadotropin blood test. exclusion criteria: * previous pregnancy diagnostic assessed using the β-human chorionic gonadotropin blood test. * patients included in an ovarian stimulation program for infertility * ectopic gestational sac in which there is an embryo with a cardiac activity determined with ultrasound. * patient objecting to participate in the study * minor * persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
investigation of the added value of a big toe hinged brace for the treatment of hallux rigidus

Conditions: Hallux Rigidus

Summary: comparison of the added value of a rehabilitation brace to standard rehabilitation by physiotherapy


Eligibility criteria:
inclusion criteria: * hallux rigidus exclusion criteria: -
a dose-finding phase iib study with azd0865 and esomeprazole in gerd patients without erosive esophagitis.

Conditions: GERD Without Erosive Esophagitis

Summary: the primary objective is to compare the efficacy between three doses of azd0865 (25, 50 and 75 mg). the secondary objectives are to compare the efficacy between the three doses of azd0865 and esomeprazole 20 mg and to evaluate the safety and tolerability of azd0865.


Eligibility criteria:
inclusion criteria: * identification of their main symptom as heartburn defined as a burning feeling behind the breastbone. * have at least a 6-month history of heartburn and at least 4 days of episodes of heartburn with at least overall moderate intensity during the last 7 days prior to visit 1. * have an absence of mucosal breaks in the esophagus, as defined by the la classification, at the visit 1 endoscopy. * have provided informed consent. exclusion criteria: subjects with current or historical evidence of the following conditions are excluded from the study: * erosive esophagitis. * esophageal columnar metaplasia (barrett's esophagus) of 1.0 cm or greater. * esophageal stricture. * primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia. * systemic sclerosis (scleroderma). * irritable bowel syndrome (ibs), i.e. upper abdominal discomfort or pain that in the opinion of the investigator is likely to be due to ibs or fulfilling two or more of the criteria: relieved by defecation, associated with change in frequency of stools, associated with change in form (appearance) of stools. * inflammatory bowel disease. * zollinger-ellison syndrome. * gastric ulcer, duodenal ulcer or duodenal erosions within the last 3 months subjects with i) history of significant or ii) current significant or unstable: * cardiovascular diseases or cardiac chest pain. * cerebrovascular diseases, such as cerebral ischemia, infarction, haemorrhage, or embolus. * diabetes mellitus. stable diabetes controlled on diet, oral agents or insulin is acceptable. * pulmonary, renal, pancreatic or liver diseases or any other serious disease as judged by the investigator to interfere with the evaluation of the current study. * malignant disease (except for minor superficial skin disease). * generalised bleeding disorders.

Keywords: gerd without erosive esophagitis
glycemic and insulinemic response with different sources of soluble fiber in patients type 2 diabetes mellitus

Conditions: Dietary Modification; Diabetes Mellitus Type 2; Insulin Tolerance; Diabetic Blood Glucose Monitoring

Summary: to compare the acute effect of soluble fiber intake from foods or supplement after a common meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. the hypothesis is a meal with a high content of soluble fiber from food determines glycemic and insulinemic response similar to a meal with a high content of soluble fiber from supplement sources.

three breakfasts (high amount of fiber from diet food sources - hfd, high amount of soluble fiber from guar gum supplement - hfs and usual amount of fiber -uf), isocaloric and similar distribution of carbohydrates, proteins and lipids, the order of breakfasts randomly determined. meals hfd and hfs have the same amount of fiber from different sources, origin in food and supplement respectively. meal uf consist of the same foods meal hfs, but without the use of soluble fiber supplement and white bread instead of rye bread (low fiber content in relation to meals hfd and hfs). the supplement (sachet 5g - fiber mais ®: 60% guar gum and 40% inulin) will be added to the plain water to meal hfd.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes * body mass index (bmi) \<= 35 kg / m² * hemoglobin a1c (hba1c) \<= 9% exclusion criteria: * serum creatinine \>2.0 mg/dl * digestive diseases (e.g. malabsorption) * severe autonomic neuropathy (presence of symptomatic postural hypotension, gastroparesis, diabetic diarrhea) * recent cardiovascular event * cachexia * psychiatric disorder with impairment of understanding * participating in other research protocol

Keywords: dietary fiber dietary supplements type 2 diabetes postprandial period plasma insulin plasma glucose area under curve soluble fiber
safety and efficacy study of gynevac lactobacillus vaccine in the treatment of bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: to investigate the efficacy (therapeutic response) of gynevac vaccination following a 5-shot treatment period in patients with bacterial vaginosis, based on the nugent score and the amsel criteria


Eligibility criteria:
inclusion criteria: * adult premenopausal females, 18 years and older. * mentally competent patients that can comply with the study protocol and are able to complete and keep or study related material (patient diaries, etc.). * signed and dated written informed consent. * clinical diagnosis of bv according to amsel criteria * gram stains nugent score ≥7 or nugent score 4-6 with the presence of clue cells * patient does not need an anti-infective treatment which would be required for specific treatment of vaginosis or to prevent the development of acute vaginitis and which may affect treatment outcome of bv. * negative pregnancy test at screening. exclusion criteria: * patients with other infectious causes of vulvovaginitis (e.g. vaginal candidiasis, trichomonas vaginalis). * patients with another vaginal or vulvar condition, which would confound the interpretation of clinical and or therapeutic response. * patients who received antifungal or antimicrobial therapy (systemic or intravaginal), as part of standard clinical practice, or clinical trial, within 14 days of randomization. * patients who are diagnosed with a chronic inflammatory disease (rheumatoid arthritis, psoriasis, crohn's disease, coeliac disease, spondyloarthritis rheumatica etc.) * women who are scheduled to be under treatment during the study period for cervical intraepithelial neoplasia (cin) or cervical carcinoma. * pregnancy or lactation. * patients with known hypersensitivity to formaldehyde. * patients undergoing antibiotic treatment. * patients with acute polyarthritis, known serious cardiac, liver, kidney diseases or unstable diabetes mellitus. * known abnormalities of the blood circulation or of the haemopoietic system. * use of any investigational drug within 30 days from randomization. * patients who do not abstain from use of intravaginal products for at least 7 days prior to study randomization (e.g. douches, female deodorant sprays, spermicides, condoms, tampons, and diaphragms). patients should also refrain from using intravaginal products 3 days prior to each study visit. * patients who do not abstain from vaginal intercourse during at least 3 days prior to each study visit.

Keywords: bacterial vaginosis gynevac lactobacillus vaccine
sarcopenia and physical performance in hemodialysis patients

Conditions: End Stage Kidney Disease

Summary: many systems such as the cardiovascular, pulmonary, musculoskeletal, hematological, immunological, gastrointestinal, central nervous system are affected due to decreased kidney function. the aim of this study was to investigate the relationship between physical performance and sarcopenia, peripheral muscle strength, activities of daily living, cognitive functions, physical activity level, fragility, pain in hemodialysis patients.

a high prevalence of sarcopenia has been reported in end stage kidney disease. the incidence of sarcopenia increases with age. muscle atrophy is caused by an imbalance between the anabolic and catabolic processes in chronic kidney disease. sarcopenia and physical inactivity progress synergistically. decreased physical performance is associated with sarcopenia. in hemodialysis patients, daily physical activity level and physical performance decrease. cognitive impairment is common in chronic kidney disease. uremic toxins can cause a decrease in cognitive function. one of the most important problems associated with hemodialysis is pain and pain negatively affects functional capacity and quality of life.

Eligibility criteria:
inclusion criteria: * having been diagnosed with end stage kidney disease * receiving hemodialysis for more than 3 months * being clinically stable * volunteering to participate in the research exclusion criteria: * having an orthopedic disease that may affect functional capacity * having cardiac event in the past 3 months

Keywords: sarcopenia pain physical performance
efficacy study of evt 201 in the treatment of elderly patients with daytime sleepiness

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study is to determine whether a compound known as evt 201 is effective in treating elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.


Eligibility criteria:
inclusion criteria: * diagnosis of primary insomnia according to dsm-iv * over the last three months for at least 5 nights per week, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours * a history of sleepiness, tiredness or unintentional napping during the daytime attributed to to poor sleep at night * able to attend the sleep center for five nights (two consecutive nights on two occasions and one night on one occasion)over a five week period * willing and able to complete a sleep diary and questionnaires exclusion criteria: * clinically significant or unstable medical condition that may interfere with sleep * major psychiatric disorders (other than insomnia) such as depression, schizophrenia, bipolar disorder * history of myocardial infarction, cardiac failure or clinically significant dysrhythmias in the previous 2 years or clinically significant ecg abnormalities at screening * history of substance abuse * disorders that interfere with drug pharmacokinetics * history of cancer, except basal cell carcinoma * use of hypnotics, anxiolytics, antidepressants, anticonvulsants, over-the-counter sleep aids, histamine-1 receptor antagonists (except for loratadine and fexofenadine), beta-adrenergic blockers (except for atenolol), respiratory stimulants and decongestants, systemic steroids, narcotic analgesics, any other compound which might impact sleep-wake function, or medication used for the treatment of parkinson's disease such as dopamine agonists and l-dopa (e.g., sinemet, madopar or requip) * use of hypnotics within the 2 weeks preceding the screening period or within five half-lives of the medication, whichever is longer * consuming ≥ 350 mg per day of xanthine-containing food or beverages * smoking ≥ 10 cigarettes per day and/or unable to refrain from smoking without distress or discomfort for the duration of visits to the sleep laboratory (i.e.≥ 20 hours) * body mass index \> 34 kg/m2; * performing night work or rotating shift work during the past month * traveling across \> 3 time zones in the past 2 weeks * participation in another trial of an investigational product or device within the previous 30 days * known allergy or sensitivity to benzodiazepines