Kornimate/medical-research-clean huggingface dataset:
study of cilofexor in adults with primary sclerosing cholangitis

Conditions: Primary Sclerosing Cholangitis

Summary: the primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (psc).


Eligibility criteria:
key inclusion criteria: * diagnosis of large duct psc * liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage f0 - f3 fibrosis in the opinion of the central reader * individual has the following laboratory parameters at the screening visit, as determined by the central laboratory: * platelet count ≥ 150,000/mm\^3 * estimated glomerular filtration rate (egfr) ≥ 30 milliliter/minute (ml/min), as calculated by the cockcroft-gault equation * alanine transaminase (alt) ≤ 8 x upper limit of the normal range (uln) * total bilirubin \< 2 mg/dl, unless the individual is known to have gilbert's syndrome or hemolytic anemia * international normalized ratio (inr) ≤ 1.4, unless due to therapeutic anticoagulation * negative anti-mitochondrial antibody key exclusion criteria: * current or prior history of any of the following: * cirrhosis * liver transplantation * cholangiocarcinoma or hepatocellular carcinoma (hcc) * ascending cholangitis within 30 days of screening * presence of a percutaneous drain or biliary stent * other causes of liver disease * current or prior history of unstable cardiovascular disease * current moderate to severe inflammatory bowel disease (ibd) (including ulcerative colitis, crohn's disease, and indeterminate colitis) note: other protocol defined inclusion/exclusion criteria may apply
the monet - study: mr mammography of nonpalpable breast tumors

Conditions: Breast Neoplasms

Summary: the purpose of this study is to determine whether performing mri of the breast will improve breast cancer management by reducing the number of biopsies and in case of malignancy allowing one-stage surgical excision of the tumor.

each year 7000 women present with nonpalpable suspicious breast lesions on mammography in the netherlands. in the usual care situation, these lesions are detected by mammography and ultrasonography and pathologically characterized by analysis of large core needle biopsy material. in case of malignancy, these lesions are surgically removed. first, a wire is placed in the breast with the tip of the wire within 1 cm of the tumor and then the surgeon follows the wire and removes the lesion. unfortunately about 25% of women require more that one surgical procedure to remove all tumorous tissue. this is caused by incorrect presurgical diagnosis of the extent and invasiveness of the disease (multifocality, multicentricity, lymph node involvement). we hypothesize that mr mammography will improve presurgical diagnosis and differentiation of lesions and thereby decrease the number of invasive surgical procedures (primary outcome) and number of invasive biopsies (secondary outcome).

Eligibility criteria:
inclusion criteria: * patients with a nonpalpable, mammographically suspicious breast lesion (bi-rads 3, 4 or 5) * referred for large core needle biopsy * 18 to 75 years exclusion criteria: * previous breast surgery or radiation therapy of the breast less than 9 months before mr mammography * pregnant or lactating * claustrophobia or adiposity ( \> 130 kg) * general contraindications for mri * unable to maintain prone position for one hour * medically unstable patients

Keywords: magnetic resonance imaging breast neoplasms diagnostic trial
nature-based sensory stimulation on pain levels

Conditions: Fibromyalgia

Summary: this randomized controlled trial aims to evaluate the effect of a single session intervention based on a nature-based stimulation program in patients with fibromyalgia

all participants will continue to receive their usual pharmacological treatment as previously established by the andalusian public health system. the intervention will comprise interaction tasks with biotic and abiotic agents for 30 minutes.

Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia syndrome (acr criteria 2016). * chronic widespread musculoskeletal pain symptoms (\>1 location using the widespread pain index). * high-intensity pain (vas ≥ 4), at least 3 days a week for the previous 3 months. * if currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment * over 18 and less than 65 years old (labour active). * ability to speak and understand english or spanish. exclusion criteria: * acute or temporal pain * severe cognitive impairment, detected by the mini-mental state examination (score \<24 out of 30 points) * severe mental disorders in acute phase or symptomatic phase * behavioural alterations as this may interfere in their participation * severe intellectual disability * other severe or medically unstable diseases interfering with the project participation * co-occurrence of neuropathic pain * other disorders that may cause pain * pregnant or breast-feeding * drug abuse within the past year.

Keywords: fibromyalgia nature-based activities pain dimensions multisensory stimulation quantitative sensory testing
evaluation of transcutaneous electrical stimulation in post stroke dysphagia

Conditions: Oropharyngeal Dysphagia; Deglutition Disorders

Summary: oropharyngeal dysphagia induces aspirations which could be responsible of aspiration pneumonia and denutrition. it could be present in the majority of central neurological disease (degenerative or vascular disease), which explains that it is the first case of mortality in stroke. two pilot studies realised by our research group aimed to demonstrate that sensitive transcutaneous electrical stimulation could improve swallowing coordination and reduce aspirations. this technique could be used at home. the aim of this study is to demonstrate that sensitive electrical stimulation could improve oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in seven centers. sensitive electrical stimulation will be applied either as active stimulation, either as a placebo. active electrical stimulation will be realised at 80 hz during 30 minutes, under motor threshold and above sensitive threshold. it will be administrated via surface electrodes over the hyoid bone. patients will be separated by randomisation. patients will be evaluated before and after 6 weeks of use. methods will evaluation questionnaire, clinical examination and videofluoroscopy. the time of use will also be collected. we wish to demonstrate that transcutaneous electrical stimulation is able to improve oropharyngeal dysphagia in stroke.


Eligibility criteria:
inclusion criteria: * age between 18 and 85 years * no contraindication to electrical stimulation * oropharyngeal dysphagia from 8 weeks diagnosed by videofluorosocpy with penetration aspiration scale \> 3 or a residue ≥ 50% * due to an hemispheric stroke * patients able to understand the videofluroscopy and questionnaires * for women in age of procreation, to have a contraception, a pregnacy test will be done if not * able to swallow (a nasogastric tube is not a contraindication to participate) exclusion criteria: * pregnancy or breast feeding * psychiatric illnes * swallowing disorders before the stroke * contraindication to electrical stimulation
online ltp+cacbt for treating depression in british mothers of african/caribbean heritage

Conditions: Postnatal Depression

Summary: the pilot trial aims to test the feasibility, acceptability and cultural appropriateness of online ltp+cacbt for treating postnatal depression and to improve the mental health and wellbeing of mothers and their children in the uk.

participants who scored 5 or above on patient health questionnaire (phq-9) will be would be recruited and randomly assigned into one of two groups (experimental or controlled). experimental groups will receive the online ltp+cacbt treatment - the intervention will consist of a total of 12 group training sessions (approx. 60 minutes each). the controlled groups will receive 'placebo effects' in the form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. each of the two groups (both experimental and controlled) will be comprised of approximately 10 mother-child pairs per sub-group.

Eligibility criteria:
inclusion criteria: * 18 years and above * a mother with a child (0-3 years) from the african and/or caribbean heritage * able to provide full consent for their participation * a resident of the uk * able to complete a baseline assessment * score 5 or above on patient health questionnaire (phq-9) exclusion criteria: * less than 18 years * medical disorder that would prevent participation in a clinical trial such as tuberculosis or heart failure * temporary residents are unlikely to be available for follow up * active suicidal ideation or any other severe mental disorder * non-residents of the uk * unable to consent * patients currently undergoing severe mental health treatment * unable to speak the english language fluently * other significant physical or learning disability
implementation of a telehealth palliative care model for persons with dementia

Conditions: Palliative Care; Dementia

Summary: grounded in the reach-effectiveness-adoption-implementation-maintenance (re-aim) model, this study will assess the implementation outcomes of the nurse practitioner (np) delivered telehealth palliative care consultation in post-acute care (pcc-pac) intervention for persons living with dementia (plwd) and their care-partners newly admitted to nursing homes (nhs) for post-acute care.

this single arm embedded pragmatic pilot clinical trial will provide data to assess the implementation outcomes of the nurse practitioner (np) delivered telehealth palliative care consultation in post-acute care (pcc-pac) intervention among 30 persons living with dementia (plwd) and their care-partners newly admitted to one nursing homes (nh) for post-acute care.

Eligibility criteria:
inclusion criteria: stakeholders: * (1) pc provider * (2) social work (sw) nh champions * (3) post-acute care unit nursing staff and providers (including medical directors) * (4) nh leadership, information technology staff * (5) plwd and their care partner(s). person living with dementia (plwd) * documented dementia diagnosis * admitted for post-acute care * age ≥ 60 years * if unable to participate in a conversation or lacking capacity to make healthcare decisions as determined by the nh staff/providers, a care partner who can act as a surrogate decision maker in the pcc-pac. exclusion criteria: stakeholders: -plwd who receives the intervention plwd: * planned discharge within 48 hours of screening * currently receiving hospice care

Keywords: dementia palliative care telehealth nursing homes
prasugrel monotherapy reduced dose in acute and chronic coronary syndrome patients after percutaneous coronary intervention (promote)

Conditions: Coronary Arterial Disease (CAD); Percutaneous Coronary Intervention (PCI)

Summary: rationale: dual antiplatelet therapy, consisting of aspirin and a p2y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (pci). however, this therapy is also associated with a higher risk of bleeding. given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing pci with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight. objective: assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after pci in acute and chronic coronary syndrome patients (acs and ccs). study design: open-label, single-centre, randomized controlled trial pilot. study population: patients undergoing successful pci due to acute or chronic coronary syndrome. intervention: a once-daily reduced dose of 5 mg prasugrel for 6 months in ccs patients and for 12 months in acs patients, preceded by a loading dose of 60 mg prasugrel after pci, administered without concomitant use of aspirin. main study parameters/endpoints: the primary endpoint is net adverse clinical events (nace), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as bleeding academic research consortium type 2, 3 or 5.


Eligibility criteria:
inclusion criteria: * acute coronary syndrome * chronic coronary syndrome * successful pci exclusion criteria: * known allergy or contraindication for prasugrel, including active pathological bleeding severe liver disease (defined as child pugh class c) * current indication for oral anticoagulant therapy (oac) * indication for ongoing dapt (e.g. pci ≤ 6 months for ccs or acs ≤ 12 months) * pregnancy or breast-feeding women * participation in another trial with an investigational drug or device * recent or ongoing strong cyp3a4 inhibitor or inducer therapy (e.g. clarithromycin, ketoconazole, carbamazepine or rifampicin)
infusion rate and volume kinetics for hyperoncotic albumine in healthy subjects

Conditions: Edema Secondary

Summary: treatment with colloidal solutions has during long time been a cornerstone within intensive care. lately there has been a shift from synthetic colloids to natural albumine. one of these solutions is the hyperoncotic "albumin 20%". there are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known. in this study the main object is to study with what rate hyperoncotic albumin should be administered. rapidly 30 minutes or slower 120 minutes.

difference in volume expansion as well as fluid recruitment from the tissues depending on infusion rate is of interest. plasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of tissue fluid is measured as a combination of plasma volume expansion and urinary output. healthy individuals are asked to refrain from eating and drinking the night before the study. two hours before study start, the subjects may take a sandwich and a glas to drink. after 15 minutes of rest baseline blood samples are taken. subjects are randomised to receive two rates of albumin solution (albumin 20%) 3 ml/kg bodyweight at two separate occasions. once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. between the two infusions there will be an interval of 3 to 20 weeks. randomization is performed to chose which rate the subjects start with. 6 in each group (total 12). during each occasion15 blood samples are collected, during a 6 hour period. hemoglobin, plasma sodium, colloid osmotic pressure and albumin are analysed. the total volume of blood collected will be 170 ml at each occasion when an albumin infusion is given. urinary output is measured and urinary sodium content is measured. liberal fluid intake is recommended the same day and the next.

Eligibility criteria:
inclusion criteria: - healthy, without allergies and with the age 18 years or above exclusion criteria: * heart failure * signs of kidney injury/failure * severe allergies * pregnancy
adelphi primary sjogren's syndrome (pss) disease specific programme (dsp)

Conditions: Sjogren's Syndrome

Summary: sjogren's syndrome is a chronic autoimmune disease characterized by sicca (dryness) symptoms of the mouth and eyes. this autoimmune disease is less commonly studied and there are no licensed treatments to treat the underlying cause of disease and current management is based on clinical experience and/or small clinical studies. this study is based on dsp methodology, a multinational, cross-sectional, multi-sponsor survey of robust real-world data. dsp methodology collects quantitative market research data. the pss dsp will survey a sample of approximately 230 to 325 rheumatologists and their prospectively consulting pss subjects in france, germany, italy, spain and the us. the data will be collected via physician interviews, physician workload questionnaires, detailed patient record forms (prfs) to be completed by physicians, and a self-completion questionnaire by pss subjects. the data collected using this method includes subjective and objective evidence, clinical information about individual patients, their disease and their treatment. this dsp will follow three key phases: preparatory phase, data collection phase and data processing/analysis phase.


Eligibility criteria:
inclusion criteria: physician eligibility criteria: * primary physician specialty identified as rheumatologist * physicians who currently treat 7 or more pss subjects in a typical month * physicians who are actively involved in the management and treatment decisions of pss subjects subject eligibility criteria: * subjects with a diagnosis of sjogren's syndrome in the opinion of the rheumatologist in the absence of systemic lupus erythematosus (sle), rheumatoid arthritis (ra) or systemic sclerosis. * for main sample (6 subjects per rheumatologist) * subjects with age \>=18 years and with confirmed diagnosis of pss and are currently, or have previously, exhibited disease activity in one or more of the categories: fever of non-infectious origin, lymphadenopathy/lymphoma, glandular swelling/enlarged parotid gland, arthralgia/synovitis, erythema/vasculitis/purpura, pulmonary involvement, renal involvement, myositis, peripheral nervous system involvement, central nervous system involvement, cytopenia of autoimmune origin (with neutropenia) and/or anemia and/or thrombocytopenia and/or lymphopenia, hypocomplementemia and/or hypergammaglobulinemia and/or cryoglobulinemia or hypogammaglobulinemia and/or ever received immunosuppressant or biologic treatment. * for oversample (1 subject per rheumatologist) * subjects with age \>=18 years and with confirmed diagnosis of pss that fit the following criteria: has never exhibited disease activity in any of the categories above, moderate or severe fatigue (in the opinion of the rheumatologist) exclusion criteria: * not applicable

Keywords: belimumab disease specific programme rheumatologist benlysta primary sjögren's syndrome adelphi pss dsp
safety and efficacy of adalimumab to methotrexate and placebo in subjects with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: placebo-controlled study comparing the safety and efficacy of adalimumab to methotrexate and placebo in subjects with moderate to severe chronic plaque psoriasis


Eligibility criteria:
inclusion criteria: * subject was age 18 or older and in good health (investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis * subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents. * subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections. * male subjects must hve been vasectomized or practicing birth control. exclusion criteria: * previous systemic anti-tnf therapy. * prior use of mtx. * known hypersensitivity to the constituents of adalimumab. * systemic therapy for psoriasis for at least 4 weeks prior to baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment. * topical psoriasis therapy for at least 2 weeks prior to baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only. * use of tanning beds, excessive sun exposure, or phototherapy (uvb, uva), for at least 2 weeks prior to baseline. * use of puva for at least 4 weeks prior to baseline. * use of oral or injectable corticosteroids during the study. * subject considered by the investigator, for any reason, to be an unsuitable candidate for the study. * female subject who is pregnant or breast feeding or considering becoming pregnant.

Keywords: psoriasis adalimumab
prospective clinical study of unilateral or bilateral implantation of intraocular lens in cataract patients

Conditions: Cataract

Summary: this is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral implantation of intraocular lens（iols） in cataract patients.

the subjects will undergo uneventful phacoemulsification and implantation of iol. the subjects will be divided into two groups . the unilateral cataract patients in the group 1 will undergo unilateral surgery, and the bilateral cataract patients in the group 2 will undergo bilateral surgery. iol may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition. in each group, the subjects will be divided into three subgroups according to the type of the iols.compare binocular functional vision and the satisfaction of patient between the two groups at postoperative 3 months.compare binocular functional vision and the satisfaction of patient with different iols among the subgroups.

Eligibility criteria:
inclusion criteria: * patients with unilateral or bilateral age related cataracts * regular corneal topography and preoperative corneal astigmatism ≤ 0.75 diopter exclusion criteria: * pregnant or nursing women * in the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, marfan syndrome, etc.) * pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.) * history of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis. * patients with history of ocular trauma or prior ocular surgery including refractive procedures * postoperative visual acuity of worse than 0.2 logmar in any eye * patients using systemic or ocular medication that affect visual acuity. * patients participating in other clinical trials during the study.

Keywords: unilateral cataract binocular functional vision multifocal intraocular lenses