Kornimate/medical-research-clean huggingface dataset:
belide: better living with non-memory-led dementia

Conditions: Dementia

Summary: around 48 million people worldwide 1 live with dementia, of whom 3.9 million start with symptoms before the age of 65 (young-onset dementia). most of the people presenting with young-onset dementia and some people with later onset dementia develop non-memory led dementias such as the atypical forms of alzheimer ́s disease (ad)or frontotemporal dementia (ftd). despite the proven benefits of educational programmes and skill training for caregivers, families of people with non-memory led dementias encounter fewer opportunities to receive this type of support. this is a significant gap in care considering that many people with young-onset non-memory led dementia are in their 50s or early 60s, which carries additional challenges about employment, financial stability, and childcare responsibilities. finding suitable information and resources is less likely due to the lower prevalence of these phenotypes, their consequent geographical spread, and their atypical symptoms. caregivers demands for more phenotype-specific support suggest that tailored provision of education and training is a gap in the provision of care in these types of dementia. the aim of this study is to: 1. determine the effectiveness of the better living with non-memory dementia educational programme for caregivers in improving psychological outcomes \[ws1\]; and 2. conduct a mixed methods process analysis to elucidate mechanisms of change, barriers and facilitators to access and implementation as well as perceived benefits and costs \[ws2\]. the design is a randomised waiting list control trial with an 8-week intervention and 6-month follow-up comparing intervention to standard care with embedded process analysis. the intervention comprises a virtual onboarding session with a facilitator, 6 learning modules (including module-end real-life tasks to put skills into practice) and up to two further virtual check-in sessions with the facilitator. intervention adaptation, adaptation to design and selection of primary outcome measures was based on feasibility work.


Eligibility criteria:
inclusion criteria: 1. adults (18+) who self-identify as an unpaid carer (partners, children, friends, etc.) of someone with ppa, pca or bvftd who is not living in a full-time care facility. 2. the care recipient must have a confirmed diagnosis of dementia (through self- report of the carer, to reflect the 'real world' application of the intervention). 3. able to give informed consent. 4. good comprehension of written english. 5. access to the internet. 6. having a minimum amount of input in the care of the person with dementia (weekly contact). exclusion criteria: 1. carers of people living with dementia in full time care facility. 2. carers of a people with severe dementia in terms of large impact on activities of daily living. -
functional electrical stimulation cycling for managing mobility disability in people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: mobility impairment is one of the most common, poorly managed, and life altering consequences of ms. current therapies for managing ms do not prevent the long-term accumulation of mobility impairment, highlighting the need for alternative strategies that prevent or slow progressive mobility disability. the proposed trial will test the efficacy and lasting effects of functional electrical stimulation (fes) cycling as an exercise-based rehabilitation strategy for managing mobility impairment and associated consequences in ms.

the study is an assessor-blinded rct for examining the efficacy and lasting effects of 24 weeks of supervised fes cycling exercise compared to passive leg cycling on mobility and secondary outcomes in people with ms with mobility impairment. participants who meet the eligibility criteria will undergo the informed consent process and baseline assessment. participants will then be randomized to either the fes or passive leg cycling program. following baseline assessment, participants will complete a 24-week leg cycling program, with a mid-point assessment at 12 weeks. at 24 weeks, participants will undergo a post-intervention assessment. following a 12-week follow-up period, participants will undergo a final assessment. each participant will be involved in the study for approximately 10 months.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * relapse free in the past 30 days * stable course of disease-modifying therapies over the past 6 months * ability to communicate in english * willing to come to the university of ottawa to complete testing and training sessions * edss score 5.0 - 7.0 * asymptomatic based on a physical activity pre-participation screening tool exclusion criteria: * presence of any contraindication to fes including epilepsy, a pacemaker, implanted defibrillator, unstable fracture, or pregnancy * diagnosis of other neurological condition(s) * participation in fes cycling exercise or other mobility-based exercise rehabilitation program within the past 6 months * current use of dalfampridine within the past month

Keywords: exercise multiple sclerosis mobility
leflunomide treatment for men1 patients - the lumen1 trial

Conditions: MEN1 Gene Mutation

Summary: multiple endocrine neoplasia type 1 (men1) is an autosomal dominant disorder due to mutations in the tumor suppressor gene men1 with the corresponding gen product menin. men1 is characterized by the occurrence of parathyroid, pancreatic islet and anterior pituitary tumors which can release excessive amounts of hormones (= functional active tumors). other tumors (e.g. carcinoid tumors, adrenocortical tumors, meningiomas, facial angiofibromas, collagenomas, lipomas) have also been described. there is no geno-phenotype correlation but the disease occurs after a second hit of the corresponding gene within the endocrine organ leading to an uncontrolled growth. men1-patients have a decreased life expectancy, mainly due to pancreatic neuroendocrine tumors (pnets) which are often multiple and more aggressive than in non-men1 patients. to date, no prophylactic treatment exists to prevent tumor development in this hereditary disease. leflunomide has been used as a treatment for rheumatoid arthritis for many years. it is a potent inhibitor of the dihydroorotate dehydrogenase (dhodh). according to some preclinical studies, leflunomide showed antineoplastic activities in several malignancies, including prostate, breast, bladder, multiple myeloma, leukemia, and lymphoma. a recent study identified an interaction between men1 mutation and dhodh inhibition. in this study, leflunomide selectively killed men1 deficient cells in vitro, prevented the occurrence of pancreatic tumor development in xenograft models and led to tumor regression / stabilisation in three men1 patients with advanced aggressive pancreatic neuroendocrine tumors. accordingly, leflunomide could be used as a new treatment option for patients with known men1 germline mutation and associated endocrine disease. the aim of this study is, therefore, to evaluate the antitumor effect of leflunomide treatment on men1-associated tumors in patients with known men1-syndrome.


Eligibility criteria:
inclusion criteria: * adult (≥18 years) patients with known pathogenic or likely pathogenic men1-germline mutation and at least 1 associated tumor lesion or hormonal syndrome exclusion criteria: * uncontrolled arterial hypertension, defined as blood pressure \>160/100 mmhg * impaired kidney function, defined as creatinine clearance \<50ml/min * impaired liver function, defined as bilirubin or liver transaminases \>3 times upper normal range * cytopenia, defined as one or several of the following: hemogloin \<100 g/l, leucopenia \<2x109/l, thrombocytopenia \<100x109/l
laparoscopic adrenalectomy versus radiofrequency ablation

Conditions: Hyperaldosteronism; Conn Syndrome; Adrenocortical Adenoma

Summary: this is a prospective randomized controlled study comparing laparoscopic adrenalectomy (la) versus image-guided percutaneous radiofrequency ablation (rfa) in treating aldosterone-producing adenoma. the objectives of this study are to 1. compare the short-term outcomes of la and rfa in treating aldosterone-producing adenoma. 2. compare the treatment success rates of la and rfa during follow-up for primary aldosteronism.


Eligibility criteria:
inclusion criteria: 1. hypertensive individuals 2. biochemically confirmed primary aldosteronism 3. radiologically confirmed unilateral adrenal adenoma ≤3cm exclusion criteria: 1. bilateral adrenal disease 2. multiple adrenal tumors 3. other concomitant adrenal diseases 4. potentially malignant adrenal tumors as shown on imaging 5. uncorrected coagulopathy 6. surgically unfit for general anaesthesia 7. prior open abdominal surgery

Keywords: hyperaldosteronism adrenocortical adenoma adrenalectomy catheter ablation
changes in serum creatinine levels can help distinguish hypovolemic from euvolemic hyponatremia

Conditions: Hyponatremia; Hypovolemia; SIADH

Summary: retrospective study that analyzes the changes in serum creatinine as a tool to correctly classify the volemic status volemic status (euvolemia vs hypovolemia) of the patients with hyponatremia.

this study evaluates the usefulness of the changes in serum creatinine in differentiating between euvolemia and hypovolemia in hyponatremic patients. changes in serum creatinine were retrospectively analyzed . the latter was calculated subtracting the serum creatinine value of eunatremia from that of hyponatremia, and was categorized as an increase when it was "positive", or "decrease/no change" when it was negative or equal to zero. the percentual change in serum creatinine was also calculated. two groups of patients were selected for the current study. first group was conformed by patients with hypovolemic hyponatremia, and second group by patients with euvolemic hyponatremia. data from eunatremia as well as the hyponatremic episode were collected. both groups were matched in receiver operating characteristic curve analyzes where both arithmetical and percentual changes in serum creatinine were assessed and cut-off points were selected for an additional odd ratio analysis.

Eligibility criteria:
inclusion criteria: * patients with hypovolemic hyponatremia secondary to any cause * patients with euvolemic hyponatremia caused by syndrome of inappropriate antidiuresis * complete clinical volemia assessment during hyponatremia. * presence of serum creatinine measured in eunatremia as well as in hyponatremic episodes. exclusion criteria: * pregnants. * patients with a prior history of diabetes, advanced chronic kidney disease (glomerular filtrate rate below 30 ml/min), cirrhosis, or heart failure were excluded. * patients with hypervolemic hyponatremia.

Keywords: hyponatremia diagnosis serum creatinine; hypovolemic hyponatremia euvolemic hyponatremia siad
medical expulsive therapy post-swl for renal stones

Conditions: Urologic Diseases; Urolithiasis; Stone, Kidney

Summary: to evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-swl in patients with renal stone less than 20 mm


Eligibility criteria:
inclusion criteria: * renal stone ≤ 20 mm. * lower calyceal stone ≤ 15 mm exclusion criteria: * women with known or suspected pregnancy or breastfeeding. * history of alpa-blockers (more than 7 days prior to study participation) * history of ureteral stricture * multiple (that is more than 2) stones * stone in solitary kidney (either anatomically or functionally). * presence of urinary sepsis. * estimated glomerular filtration rate \< 30 ml/min * contraindication or allergy to tamsulosin
study of arimoclomol in patients diagnosed with gaucher disease type 1 or 3

Conditions: Gaucher Disease, Type 1; Gaucher Disease, Type 3

Summary: multicenter, doubleblinded, randomized placebo-controlled study of arimoclomol in patients with gaucher disease type 1 or 3

evaluating the response of 3 dose levels of arimoclomol on various pharmacodynamic biomarkers in blood and cerebrospinal fluid as indicators of enhanced gba in gaucher disease type 1 or 3.

Eligibility criteria:
key inclusion criteria: * be able to understand and voluntarily sign informed consent * a diagnosis gd, either type 1 or type 3 * for gd3 at least 1 neurological symptom * age ≥ 4 years and ≤ 60 years at the time of enrolment * plasma or serum chitotriosidase activity greater than 3 times the upper limit of normal. key exclusion criteria: * recipient of a liver transplant or planned liver transplantation during the course of the study. * splenectomy within 4 months of study entry or planned splenectomy during the course of the study. * severe liver damage. * severe renal insufficiency. * body weight \< 10 kg. other inclusion and exclusion criteria may apply

Keywords: gaucher disease
the effect of prognostic factors on the success of full pulpotomy in permanent mature molars with irreversible pulpitis

Conditions: Pulpitis - Irreversible

Summary: this study aims to evaluate the effect of prognostic factors, such as the degree of pulpal inflammation and the radiographic caries depth, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis.

* patients with mature permanent molars diagnosed with irreversible pulpitis will be enrolled in the study. * the pre-operative pulpal status will be assessed using the american association of endodontists (aae) classification and wolters classification. * pre-operative radiographs will be taken, and radiographic caries depth will be assessed. * an artificial intelligence software will process the pre-operative x-rays to assess the presence of carious pulp exposure. the diagnostic accuracy of the software will be evaluated by comparing its readings with clinical findings of pulp exposure after caries removal. * the patients will be randomized to receive either full pulpotomy or conventional root canal treatment. * the patients will be followed up for 1, 3 and 6 months to assess clinical and radiographic success.

Eligibility criteria:
inclusion criteria: * mature permanent molars with irreversible pulpitis. * presence of bleeding pulp tissues from all canals. * the tooth is not periodontally compromised. exclusion criteria: * non-vital teeth. * uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent. * molars with immature roots.

Keywords: irreversible pulpitis full pulpotomy artificial intelligence
a smartphone based, titrated exercise solution for patients with parkinson's disease in daily life: pilot study

Conditions: Movement Disorders; Parkinson Disease

Summary: the aim of this pilot randomized controlled trial is to test whether it's feasible to increase participants' step counts within four weeks with a developed motivational smartphone application. if this is feasible, then we can proceed to test the app in a large, long-term randomized clinical trial.

rationale: exercise affords health benefits for people with parkinson's disease (pd), but implementing exercise in daily life remains challenging. moreover, many training programs are not very scalable. the investigators take an important step forward by developing and studying an innovative and fully decentralized smartphone-based program to increase long-term physical activity in people with pd in daily life. objective: the aim of this pilot study is to investigate whether the developed smartphone app can increase physical activity in people with pd for a short period of time (one month). the secondary aim is to study the usability and enjoyment of the app and the potential effects of an increase in physical activity on physical fitness, motor- and non-motor functioning. study design: pilot double-blind randomized controlled intervention study. study population: a total of 30 dutch people with pd who have no other medical conditions that markedly hamper mobility, no cognitive impairments that make it difficult to use a game on the smartphone and possess a suitable smartphone, will be recruited. intervention: participants will be randomized into one of three groups. all groups will be encouraged to increase their physical activity level, measured in step counts on the participants' own smartphone, with a different percentage: (a) an increase in step count of 10% (active control group, n = 10), (b) in increase in step count of 50% (experimental group 1, n = 10), or (c) an increase in step count of 100% (experimental group 2, n = 10), compared to their baseline level.

Eligibility criteria:
inclusion criteria: 1. idiopathic pd 2. hoehn and yahr 1-3 3. able to understand the dutch language 4. able to walk independently 5. less than 30 minutes of sports/outdoor activities per day (lasa physical activity questionnaire, lapaq) 6. less than 7,000 steps/day during 1-week baseline exclusion criteria: 1. weekly falls in the previous 3 months 2. medical conditions that hamper mobility 3. living in a nursing home 4. cognitive impairments that hamper use of the motivational app on the smartphone (montreal cognitive assessment, moca \<26) 5. not in the possession of a suitable smartphone (iphone 5s or newer with ios 10 or higher or android 4.1 or newer)

Keywords: physical activity walking exercise parkinson disease locomotion motivational application
cogecig: cognitive functioning and electronic cigarette

Conditions: Tobacco Abuse Smoke

Summary: the aim of the present study is to compare cognitive scores (attention, executive function and working memory) of different e-cigarette strength with usual cigarettes.

the study is randomised cross-over trial designed to compare: 1) cognitive performances levels for four different e-cigarette strength. participants will be requested to abstain from smoking and alcohol from 20:00 on the night before each study day and from food and caffeine for at least 1 h before the session. on arrival at the study centre, carbon monoxide (co) will be measured in participants' expired breath. if co will be \>15 parts per million (ppm), the assigned study treatment will be allocated; however, if co was \>15 ppm or they will report smoking in the previous 12 h, participants will be rescheduled wherever possible to a subsequent session. on the first study day, participants will be randomised to use one of five ordered conditions: electronic nicotine delivery device (endd) (fourth generation) containing nicotine 2,4%; electronic nicotine delivery device (endd (second generation) containing nicotine 7,4 mg; electronic nicotine delivery device (endd containing nicotine 9 mg; electronic nicotine delivery device (endd nicotine free; their usual cigarette. additionally participants will be trained to use an electronic cigarette. the following tests will be completed at the each visits: continuous performance test - ax version (cpt-ax), wisconsin card sorting test( wcst), working memory test (n-back).

Eligibility criteria:
inclusion criteria: * 20 regular smokers (smoking ≥ 15 factory-made cigarettes per day for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days, co \> 10 parts per million ) will be recruited from the local hospital staff in catania, italy. exclusion criteria: * people who reported recent myocardial infarction, angina pectoris or other serious medical conditions (diabetes mellitus, severe allergies, poorly controlled asthma or other airways disease, poorly controlled psychiatric disorders or current chemical dependence other than nicotine) and * pregnancy, * breastfeeding, * blood pressure \> 180 mm hg systolic and/or 100 mm hg diastolic, * weight \ 120 kg, or * current use of any other smoking cessation medications
candonilimab (ak104) plus preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma (escc)

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this is a prospective, single-arm, open-label，multi-center, phase ii study, aiming to evaluate the efficacy and safety of ak104 combined with preoperative chemotherapy in patients with locally advanced escc.

eligible patients first receive ak104 (10mg/kg, iv, q2w) for one cycle in the induction period, and then patients receive ak104 (10mg/kg, iv, q3w) combined with nab-paclitaxel (130mg/m2 ivgtt d1，d8, q3w) and carboplatin ((auc=5) d1，q3w) for 2 cycles. after neoadjuvant therapy of 3 cycles, patient will undergo preoperative evaluation. for patients who can be performed for r0 surgery, surgery wil be performed in 4 to 6 weeks. patients who do not achieve pathological complete response (pcr) will receive ak104 (10mg/kg, iv, q3w) as adjuvant therapy until disease progression or intolerable toxicity for up to 12 months. patients who achieve pcr after surgery will be enrolled in observational follow-up.

Eligibility criteria:
inclusion criteria: 1. voluntarily signing a written informed consent form; 2. males or females aged ≥ 18 to ≤ 70 years; 3. ecog score 0-1; 4. pathologically diagnosed thoracic esophageal squamous cell carcinoma; 5. no distant metastasis after imaging examination, and esophageal cancer can be resected or potentially resectable with stage ct1b-ct2n+m0 or ct3-ct4a anyn m0 or ct2n0m0 high-risk (lymphovascular invasion or tumor ≥3 cm or hypo-differentiation) (ajcc 8th edition ctnm stage); 6. not received prior antitumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, etc. for esophageal cancer); 7. life expectancy is greater than 6 months; 8. at least one measurable tumor lesion per recist v1.1; 9. major organ functions are adequate; exclusion criteria: 1. patient has received previous antitumor therapy (chemotherapy, radiation, surgery or immunotherapy); 2. cervical or thoracic esophageal cancer is \< 5 cm from the cricopharyngeal muscle; 3. patients are or are expected to be at significant risk of esophageal perforation, fistula, and major bleeding; 4. imaging during the screening period showed that the tumor surrounded or invaded important blood vessels or organs (such as the heart and pericardium, trachea, aorta, superior vena cava, etc.) or there was obvious necrosis or cavity, and the investigator determined that entering the study would cause bleeding risk; participants at risk of developing oesophageal or oesophageal fistula; 5. patients with a history of other malignant diseases in the last 5 years，unless complete resolution or no additional treatment is required (exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervix, or breast carcinoma in situ)； 6. pregnant or nursing women； 7. patients with known or suspected active autoimmune disease; 8. patients with a history of myocarditis, cardiomyopathy, malignant arrhythmias; 9. other patients are not eligible for enrollment assessed by investigators;

Keywords: ak104 preoperative chemotherapy surgery
crisaborole for chinese and japanese subjects (≥2 years of age) with mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of crisaborole ointment, 2% in chinese and japanese subjects with mild to moderate atopic dermatitis involving at least 5% treatable bsa. eligible subjects will be randomized in a 2:1 ratio to one of 2 treatment groups (crisaborole bid, vehicle bid, respectively).


Eligibility criteria:
inclusion criteria: - is male or female 2 years and older at the screening visit/time of informed consent/assent diagnosed with mild-moderate ad (according to the criteria of hanifin and rajka), of at least 5% bsa. exclusion criteria: * has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non ad dermatological conditions and known genetic dermatological conditions that overlap with ad, such as netherton syndrome) or clinically significant physical examination finding at screening that in the pi's or designee's opinion may interfere with study objectives. * has participated in a previous crisaborole clinical study.