Kornimate/medical-research-clean huggingface dataset:
imagery in early stages of dementia

Conditions: Mental Imagery; Dementia of Alzheimer Type

Summary: the purpose of the present study is to investigate the effectiveness of mental imagery (mi) in subjects with early stage of dementia. the hypothesis of the study is that mi will have a beneficial effect in motor, cognitive and emotional state in this clinical population.

dementia is a disorder that is characterized by a decline in cognition involving one or more cognitive domains (learning and memory, language, executive function, complex attention, perceptual-motor, social cognition). the most common form of dementia in older adults is alzheimer disease (ad), accounting for 60 to 80 percent of cases. mental imagery (mi) is a technique which involves envisioning motor actions without actual execution. mi is considered an effective rehabilitative tool in athletes, parkinson's disease, and post stroke because it engages the same or similar neural systems as the actual execution of motor actions to improve gait, gait-related, and cognitive functions having as a result improvements in gait speed, stride length, tandem stance, timed up and go, clock drawing and stroop interference. the recruitment of the population will be carried out by day care centers in athens alzheimer association. a group of elderly patients with early stage of dementia, aged 65 to 95 years, will participate. information sheet and consent form will be provided to all participants. a randomized intervention study is designed to assess the efficacy of mi as therapeutic strategy for subjects with early stage of dementia and the sample will be randomized to one of the three following study groups: 1. mi and exercise program (intervention group) 2. only exercise program (control group) 3. neither mi nor exercise program (2nd control group). assessment will be obtained in three-time periods: prior to the program, middle of the program and after the program.

Eligibility criteria:
inclusion criteria: * 95 years\ 65 years * diagnosed early stage of dementia * good oral and written speech and to perform orders * both sexes * ambulatory * no other health issues in the last month exclusion criteria: * late stage of dementia * psychiatric problems * serious health problems * not able to walk

Keywords: imagery exercise dementia
observational study to evaluate long-term outcome in hip arthroplasty

Conditions: Hip Replacement; Primary, Secondary or Post-traumatic Osteoarthrosis; Femur Head Necrosis; Congenital Dislocations; Primary and Revision Surgery

Summary: this long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.

outcome data collected from this study will be used for post market surveillance (pms) and clinical evaluations on corin hip devices and will support peer-reviewed publications on products performance and safety at long term follow-up.

Eligibility criteria:
inclusion criteria: * man or woman \>18 years * subjects with indication of arthroplasty surgery with corin hip devices which are under assessment as part of this pmcf study * subjects who agreed for study participation. exclusion criteria: * subjects with existing tumour and/or particularly high surgical risk- * subjects with anaesthetic risk class iv or higher * subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.) * contraindications for arthroplasty with a corin hip devices as per product ifu

Keywords: arthroplasty hip replacement acetabular cup femoral stem
validation of combined symptom medication score (csms) in allergic patients

Conditions: Allergic Rhinoconjunctivitis; Allergic Asthma

Summary: the csms was defined by the european academy of allergy and immunology taskforce as a standardised tool to assess clinical effects of allergen-specific immunotherapy (ait). the aim of this study is to validate the csms as a tool to assess the clinical effects of depigoid ait, so that the csms can be used in future studies as a primary endpoint as well as a comparative parameter.

approximately 20% of the general public suffer from seasonal or perennial allergic rhinoconjunctivitis. the only available curative therapy is ait. the effectiveness of ait was demonstrated in numerous randomized clinical trials but comparability is difficult because of different primary and secondary endpoints. to validate the csms, adolescent (≥ 12 years) and adult patients will be observed who are allergic to house dust mites (hdm), tree or grass pollen and who were treated with depigoid. depigoid is a registered (for tree and grass pollen) respective authorized (for hdm) suspension for injection for the treatment of immediate type allergic diseases. depigoid contains depigmented and chemically modified allergen extracts, so called allergoids, derived from grass pollen, tree pollen or hdm. allergy symptoms will be documented over a time period of two years: either for two consecutive allergy seasons (for tree and grass pollen allergic patients) or for two consecutive exposure periods (september-december) for hdm allergic patients. the symptoms (4 nasal and 2 ocular symptoms) and allergy medication intake will be documented on a daily basis either using the csms questionnaire or the especially developed electronic csms+ diary application. already validated and established questionnaires will be used to validate the csms with regard to quality of life (qol) and symptom control: the rhinoconjunctivitis quality of life questionnaire (rqlq), adolescent rqlq (adolrqlq, for patients aged 12-17 years), asthma quality of life questionnaire (aqlq) and aqlq for patients aged 12 years and older (aqlq+12), the asthma control test (act), rhinitis control assessment test (rcat) and the visual analogue scale (vas).

Eligibility criteria:
inclusion criteria: - indication of an allergen-specific immunotherapy with depigoid exclusion criteria: - exclusion criteria according to the smpc

Keywords: allergy rhinoconjuctivitis combined symptom and medication score allergic asthma pollen mites
efficacy of capecitabine metronomic chemotherapy to triple-negative breast cancer

Conditions: Breast Cancer

Summary: the primary objective of this study is to compare disease-free survival (dfs) of patients with triple negative breast cancer randomised to treatment with standard adjuvant chemotherapy alone or to standard adjuvant chemotherapy followed by 1 year of capecitabine (xeloda) metronomic therapy.

triple negative breast cancer (tnbc) is an aggressive disease without tumor-specific treatment options. patients with triple-negative disease had an increased likelihood of distant recurrence and death within 5 years of diagnosis. median time to distant recurrence was significantly shorter. this study will evaluate the efficacy and safety of the addition of capecitabine to standard adjuvant therapy in patients with triple negative breast cancer. patients will be randomized to receive either standard chemotherapy (according to nccn guideline), or standard chemotherapy followed by 1 year of metronomic capecitabine (650mg/m2, twice every day). the anticipated time on study treatment is 12 months, and the target sample size is 432 individuals.disease-free survival (dfs) will be primary end point.

Eligibility criteria:
inclusion criteria: * patients must be \>=18 years of age; * the patients must be operable primary invasive breast cancer; * definitive loco-regional surgery must be completed; * primary tumor centrally confirmed as triple negative; * operable node-positive (or node-negative with tumor diameter ≥ 0.5cm); * chest, abdominal, bone imaging performed with 3 months prior to randomization must not reveal the presence of distant spread; * there are normal organ function, including bone marrow function, renal function, liver function, and cardiac function; * all patients must have signed and dated an informed consent form. exclusion criteria: * patients with bilateral breast cancer, inflammatory carcinomas; * patients with positive supraclavicular or internal mammary lymph node; * previous breast cancer history; * any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin; * pregnant or breast-feeding women; * women who are unwilling to agree to use an effective non-hormonal method of contraception during the treatment period of xeloda; * any sex hormonal therapy; * malabsorption syndrome.

Keywords: triple-negative breast cancer metronomic chemotherapy capecitabine (xeloda)
clinical trial to evaluate the effect of a probiotic product on weight

Conditions: Overweight, Obesity Grade I

Summary: the study of the intestinal microbiota and its relationship with health and disease, as well as the use of probiotics as effective alternative treatments to improve people's well-being is a field of growing research in recent years. overweight and obesity are increasingly common due to the current lifestyle, but this is not incompatible with the growing interest of the population in taking care of themselves, both physically and psychologically, and, in general, the interest in food supplements, including those based on probiotics, is increasingly common. the objective of the clinical trial is to evaluate the effectiveness of a food supplement based on probiotics to reduce body weight in 104 volunteers with overweight and type i obesity (bmi 25 - 34.9 kg/m2). this randomized, double-blind and placebo-controlled clinical trial has a 12-week intervention period, during which subjects have to take a daily dose of the product (probiotic or placebo). in this trial, anthropometric clinical data, the effect of the intervention on blood parameters and the composition of the intestinal microbiota will be analyzed.


Eligibility criteria:
inclusion criteria: * men and women aged ≥ 18 years. * body mass index (bmi) between 25.0 and 34.9 (overweight or obesity type i). * commitment to maintaining a lifestyle, including diet and sports habits, constant throughout the study. * signing of informed consent. exclusion criteria: * subjects with diabetes (type i or ii), hypothyroidism or other diseases that may promote weight gain. * presence of other serious pathologies, including cancer or autoimmune diseases, or any other that, at the medical discretion of the investigator, may influence the results of the study. * subjects who have participated in a weight loss program or who have substantially modified their lifestyle habits (diet, physical exercise) during the previous 3 months. * treatment with antibiotics in the previous 4 weeks. * consumption of products or drugs intended for weight loss or satiety control, or that may influence weight in the previous 4 weeks. * consumption of products containing probiotics in the previous 2 months. * contraindication to taking the product under investigation, or allergy or intolerance to any of its ingredients. * in the case of women: pregnancy or breastfeeding, or plans to become pregnant during the course of the study.

Keywords: probiotics overweight obesity food supplement gut microbiota
ceramide containing multivesicular emulsion application . . .

Conditions: Foot Transepidermal Water Loss in Patients in NIDDM; Foot Dryness in Patients With NIDDM

Summary: we believe that using a ceramide based foot cream two times a day for two weeks will prevent water loss and overall foot dryness in patients with non-insulin dependent diabetes.


Eligibility criteria:
inclusion criteria: * \>18 years of age * non insulin-dependent diabetes * moderate to severe xerosis of both feet \[a score of at least 4 on a scale of 0 (normal) to 8 (deep fissuring)\] * capable of understanding and signing consent form exclusion criteria: * history of ichthyosis vulgaris * known hypersensitivity to the topical product used in the study * previous use of high potency steroids (class i and ii) in past 2 week * presence of acute skin disease or infection, such as vasculitis or cellulitis * presence of foot ulcer * evidence of gangrene
a clinical study of 9mw2821 monotherapy or combined with other anticancer therapy in advanced solid tumors

Conditions: Solid Tumors

Summary: this study is a phase ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9mw2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (iec/irb/reb) approved informed consent form. 2. male or female subjects aged 18 to 75 years (including 18 and 75 years). 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. histopathological diagnosed of recurrent or locally advanced or metastatic solid tumors. 5. adequate tumor tissues submitted for test. 6. life expectancy of ≥ 12 weeks. 7. subjects must have measurable disease according to recist (version 1.1). 8. adequate organ functions. 9. sexually active fertile subjects, and their partners, must agree to use contraception during the study and at least 6 months after termination of study therapy. 10. subjects are willing to follow study procedures. exclusion criteria: 1. history of another malignancy within 3 years before the first dose of study drug. 2. ongoing clinically significant toxicities related to prior treatment. 3. grade ≥ 2 peripheral neuropathy. 4. severe or uncontrolled gastrointestinal diseases. 5. other severe or uncontrolled diseases, including severe respiratory diseases, cardiovascular and cerebrovascular diseases of clinical significance. 6. experienced clinically significant bleeding or had a clear bleeding tendency. 7. central nervous system (cns) metastasis and/or malignant meningitis. 8. clinically significant pleural, abdominal, or pericardial effusion. 9. chemotherapy or radiotherapy within 21 days prior to the first dose of study drug; 10. known sensitivity to any of the ingredients of the investigational product; history of drug abuse or mental illness. 11. pregnant and lactating women. 12. other conditions that, in the investigator's opinion, may not be suitable for the subject to be enrolled.
hyaluronic acid +hydroxyapatite vs hydroxyapatite in bone regeneration

Conditions: Bone Loss; Bone Lesion

Summary: evaluation of the effect of hyaluronic acid with hydroxyapatite versus hydroxyapatite alone on bone regeneration following enucleation of mandibular odontogenic cyst.

during cyst enucleation , there's resultant decrease in bone density especially in large defects .therefore, it may be needed for a bone grafts and bone regenerative materials to improve quality of bone .the rationale is to evaluate hyaluronic acid with hydroxyapatite as a bone quality improvement material following cyst enucleation, which would provide significant bone regeneration. hydroxyapatite is inorganic component of bone tissue used as bone graft, scaffolds, filler and cement for repair and regeneration of bone defect , and it is stimulate bone remodeling by generating surface active moieties or cell signaling process while hyaluronic acid and it's derivatives has been widely used for bone regeneration and it has a good potential for osteogenesis and mineralization

Eligibility criteria:
inclusion criteria: * patient in need of cyst removal . * both genders aged between 18-50 years . * size of lesion is ≤ 4 cm . * patients free from any systemic disease that may affect bone healing . exclusion criteria : * heavy smokers , alcohol intake . * poor oral hygiene . * patient with systemic disease that may affect bone healing . * pregnant women. * patient who are currently or have been under treatment using chemotherapy or radiotherapy * uncooperative patient .

Keywords: bone regenerarion bone graft hydroxyapatite
a clinical study on the prevention of mild to moderate intermittent asthma with chinese medicine weiyang yuping fang

Conditions: Bronchial Asthma

Summary: clinical exploring study of weiyang yuping decoction in preventing acute attacks of mild to moderate intermittent asthma based on the theory of "preventing disease from exacerbating" in chinese medicine.

based on the preliminary clinical and basic research, this project intends to highly optimize and integrate the tcm treatment of disease theory with the current methods to form two preventive treatment plans, one treatment group was given weiyang yupingfang granules orally for 1 month on the "sanfu"days and on the "sanjiu" days each year for a total of 2 months one year; the other treatment group was given weiyang yupingfang granules orally for 1 month in the first month of each quarter in the four quarters of the year, for a total of 4 months one year.; comparing the effect of prevention and treatment of mild to moderate intermittent asthma exacerbations of the two prevention methods , provides new ideas for the prevention and treatment of bronchial asthma in the future, and further improves bronchial the level of prevention and treatment of asthma.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma according to gina criteria with a documented history of at least 3 years prior to visit 1 * patients have asthma exacerbations every year * meet the diagnostic criteria for mild to moderate asthma * able to measure lung ventilation function according to ats (american thoracic society) standards * patients who have given written informed consent exclusion criteria: * medical history of life-threatening asthma including intubation and intensive care unit admission * any significant disease or disorder (e.g., cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study * pregnancy, breast-feeding or planned pregnancy during the study. * participation in another clinical study or took other research drugs during the last 30 days prior to visit 1 * known or suspected hypersensitivity to study drugs or excipient * suspected poor capability, as judged by the investigator, of following instructions of the study.

Keywords: bronchial asthma traditional chinese medicine
brief mindfulness based intervention to improve psychological wellbeing

Conditions: Stress, Psychological

Summary: our aim is to evaluate the effectiveness of virtual brief mindfulness based interventions on psychological wellbeing, resiliency, and anxiety of frontline hcp to cope for (covid19) stressors

our specific objectives are: to measure frontline hcp's level of anxiety, resilience, and how mindfulness based interventions affect anxiety and psychological resilience of hcp.

Eligibility criteria:
inclusion criteria: * covid19 frontline health care providers namely, physicians, nurses and respiratory therapist at 2 main hospitals in the eastern province of ksa exclusion criteria: 1. history of psychotic disorder, 2. substance abuse or dependence within the last 6 months 3. current severe neurotic disorder, severe depression or severe anxiety. 4. concurrent psychotherapy. 5. significant personality disorder
insomnia treatment and ema (ecological momentary assessment) outcomes

Conditions: Insomnia

Summary: the goal of this study is to examine the impact of suvorexant, an fda-approved insomnia medication, on daytime symptoms (as measured by the daytime insomnia symptoms scale: cognition, positive mood, negative mood, and fatigue/sleepiness) among older adults with insomnia. the primary hypothesis is that relative to placebo, suvorexant will improve sleep and daytime symptoms. the word "placebo" refers to a harmless pill with no therapeutic effect.

the study will take about six to eight weeks to complete. participants will have a home sleep apnea test (hsat) and complete a clinical interview. participants will also complete a baseline assessment, which will take place over one or two days (about 3 hours total). during the study, participants will complete research questionnaires and cognitive testing at baseline and post-baseline (after treatment). participants will also complete brief ema surveys (sleep diary and daytime insomnia symptoms scale) via mobile device 4 times per day for approximately 16 days; each survey will take about 2 minutes or less to complete. participants will also wear an actigraph on the non-dominant wrist. this device looks like a wristwatch and measures ambulatory movement, a validated proxy for sleep.

Eligibility criteria:
inclusion criteria: * meets diagnostic and statistical manual - fifth edition (dsm-5) diagnostic criteria for insomnia disorder. * insomnia severity index total score \>10. * insomnia symptoms must include problems with wake after sleep onset. * insomnia symptom duration \> 6 months. * baseline self-reported total sleep time \< 6.5 hours per night. exclusion criteria: * high risk for untreated organic sleep disorders other than insomnia (narcolepsy, periodic limb movement disorder, etc) as determined by structured clinical interview and investigator clinical judgment. * current diagnosis of a major untreated psychiatric disorder(s). * history of serious suicide attempt within past 5 years. * history of alcohol or substance abuse (including prescription medication abuse) within past 5 years. * heavy alcohol consumption (e.g., \>5 drinks per day or \> 14 drinks per week. * heavy caffeine use \[(\>2 cups of coffee/day (equivalent). * current tobacco or nicotine use. * history of previous allergic reaction, sensitivity, or severe side effects to sedative hypnotics. * cyp3a inhibitors. * refusal to discontinue or intention to initiate otc or other sleep aids during study period.
the natural course of trichophyton tonsurans carriage and infection: a molecular and biochemical evaluation

Conditions: Tinea Capitis

Summary: to explore carrier and infection status of t.tonsurans tinea capitis and characterize the host-pathogen interaction as it relates to the disease presentation. the general hypothesis for this study is as follows: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in trichophyton tonsurans infection.the global outcome of this investigation is to reveal potential new drug targets designed to improve treatment outcomes in these children.

tinea capitis is an overwhelmingly prevalent disease of childhood estimated to be present in approximately 1 in 20 children at any point in time with an equal number of children serving as carriers of the fungal pathogen. despite the widespread nature of the disease, the natural course of the infection remains incompletely described. the study will be driven by the following hypothesis: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in trichophyton tonsurans infection. a fungal scalp culture will be acquired from all participants using a brush culture technique. samples will be collected once a month over a two year time period.

Eligibility criteria:
inclusion criteria: * preschool aged children will be eligible. exclusion criteria: * none

Keywords: tinea capitis