Kornimate/medical-research-clean huggingface dataset:
the pharmacokinetics of anagrelide in elderly and young patients with essential thrombocythaemia (et)

Conditions: Essential Thrombocythaemia

Summary: age related differences in response to a drug could arise from variation in pharmacokinetic (pk) and/or pharmacodynamic (pd) profiles between age groups. whilst the efficacy and safety profile of anagrelide is well established through a well-documented clinical trial programme in patients of all ages, no formal studies have been carried out to investigate whether the pk profile of anagrelide and its metabolites is altered with age. this study is designed to allow comparisons to be made in terms of pharmacokinetics of anagrelide and its metabolites between elderly (≥ 65 years) and young (18-50 years) et patients


Eligibility criteria:
inclusion criteria: * young patients aged 18-50 years inclusive or elderly patients aged 65 years and over * patients must have a confirmed diagnosis of et. * currently receiving anagrelide hydrochloride at a stable maintenance dose \< 5 mg/day for at least 4 weeks. exclusion criteria: * diagnosis of any other myeloproliferative disorder. * current use of tobacco in any form (e.g. smoking or chewing) * treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study. * patients for whom use of another cytoreductive agent in addition to anagrelide is considered necessary for control of platelet count.
normotonic partial nephrectomy as novel approach in treating small renal masses

Conditions: Renal Malignant Tumor; Renal Tumor

Summary: this study evaluates novel surgical approach in treating small renal masses. half of participants will undergo hypotonic zero-ischaemia partial nephrectomy (standard of care), while the other half will undergo normotonic zero-ischaemia partial nephrectomy (experimental method).

partial nephrectomy is believed to be the gold standard for treating small renal masses (srm). the warm ischaemia and hypotonic zero-ischaemia approach are widely used techniques of care. but they have some negative effects according to renal function (rf) after surgery. we decided to compare influence of arterial blood pressure (normotension or hypotension) during partial nephrectomy on rf. a single-center prospective study comparing normotonic and hypotonic partial nephrectomy will be conducted. the design involves random allocation of eligible patients to normotonic or hypotonic partial nephrectomy group in 1:1 ratio. experimental group - normotonic partial nephrectomy (avoidance of hypotension: mean blood pressure more or equal 65 mm hg). control group - hypotonic partial nephrectomy (using medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmhg according to preliminary calculations, taking into account type i error of 5% and power of 80%, 100 patients should be included in the study. in order to compensate for data loss, the estimated sample size is increased by 10%. as a result, the total sample size is 100 +10 = 110 patients (55 patients for each group). the expected duration of the study is 36 months.

Eligibility criteria:
inclusion criteria: * suspected by computed tomography or another instrumental method renal mass * clinical stage t1-2n0-2m0-1 (distant metastases must be resectable) * indications for partial nephrectomy * eastern cooperative oncology group status 0-2 * at least 18 years of age * written informed consent exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol * pregnancy or breast feeding * medical contraindications for surgical treatment * synchronous or metachronous malignancy * non-resectable distant metastases * the patient's refusal to perform research procedures. * refusal of the patient to continue participation in the study.

Keywords: partial nephrectomy zero ischaemia renal function
combination chemotherapy before surgery in treating women with breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells and shrink tumors so they can be removed during surgery. purpose: phase i trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced, inflammatory, or large surgically removable breast cancer.

objectives: i. determine the toxicity of neoadjuvant capecitabine, cyclophosphamide, and epirubicin in women with locally advanced or inflammatory or large operable breast cancer. ii. determine the maximum tolerated dose of this regimen in this patient population. outline: this is a multicenter dose escalation study of capecitabine. patients receive neoadjuvant cyclophosphamide iv and epirubicin iv on day 1 and oral capecitabine twice daily on days 1-14. treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. projected accrual: a total of 3-33 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed carcinoma of the breast locally advanced or inflammatory disease (t4, any n or any t, n2 or n3 or t4d) or large operable disease (large t2 or t3 for which tumor shrinkage is needed) no distant metastasis on chest x-ray, liver ultrasound, or bone scan except for ipsilateral supraclavicular nodes no abnormal bone scintigrams that cannot be confirmed as benign hormone receptor status not specified patient characteristics: age: 18 to 70 sex: female menopausal status: not specified performance status: who 0-1 life expectancy: not specified hematopoietic: neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.25 times upper limit of normal (uln) sgot no greater than 2 times uln renal: creatinine no greater than 1.5 times uln cardiovascular: lvef normal by echocardiography or muga other: not pregnant or nursing fertile patients must use effective contraception no other serious uncontrolled illnesses no uncontrolled psychiatric or addictive disorders no other concurrent or prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy surgery: see disease characteristics

Keywords: stage ii breast cancer stage iiia breast cancer stage iiib breast cancer inflammatory breast cancer
evaluation of stenfilcon a versus etafilcon a

Conditions: Myopia

Summary: evaluation of two contact lenses

one week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.

Eligibility criteria:
inclusion criteria: * is at least 17 years of age and has full legal capacity to volunteer; * has read and signed an information consent letter; * is willing and able to follow instructions and maintain the appointment schedule; * is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses; * has astigmatism less than or equal to -1.00d; * is an adapted soft contact lens wearer; * demonstrates an acceptable fit with the study lenses; * has no active anterior segment disease or known ocular disease. exclusion criteria: * a person will be excluded from the study if he/she: * has never worn contact lenses before; * has any systemic disease affecting ocular health; * is using any systemic or topical medications that will affect ocular health; * has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses; * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye; * has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities; * is aphakic; * has undergone corneal refractive surgery; * is participating in any other type of clinical or research study; * has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
a phase ii study to evaluate the efficacy of tki258 for the treatment of patients with fgfr2 mutated or wild-type advanced and/or metastatic endometrial cancer

Conditions: Solid Tumors and Advanced Endometrial Cancer; Endometrial Cancer; Second-line Treatment; VEGF

Summary: this is a prospective, multi-center, open-label, single-arm, non-randomized, phase ii study to evaluate the efficacy and safety of tki258 as second-line therapy in patients with either fgfr2 mutated or wild-type advanced and/or metastatic endometrial cancer.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer with available tissue specimen (either archival tissue or fixed fresh biopsy) * female patients ≥ 18 years old * documented radiologically confirmed progression of disease after prior first-line treatment evidence of progressive disease * ecog (eastern cooperative oncology group) performance status ≤ 2 * at least one measurable lesion as per recist exclusion criteria: * previous treatment with an fgfr inhibitor * more than one line of treatment for advanced or metastatic disease * patients with uterine sarcomas, adenosarcoma, and malignant mullerian tumors * patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially curative with radiation therapy or surgery * known central nervous system (cns) metastases * malignancy within 3 years of study enrollment other protocol-defined inclusion/exclusion criteria may apply

Keywords: solid tumors, advanced endometrial cancer, endometrial cancer, second-line treatment, vegf, neoplasms, endometrial neoplasms, uterine neoplasms, female genital neoplasms, cancer, carcinoma, uterine diseases, female genital diseases, tumors, oral administration, capsules, tablets, chir258, chir-258, chir 258, tki258, tki-258, tki 258
bronchiectasis and ntm research registry

Conditions: Non-CF Bronchiectasis; Nontuberculosis Mycobacteria (NTM)

Summary: the bronchiectasis research registry is a consolidated database of non-cystic fibrosis (non-cf) bronchiectasis and nontuberculosis mycobacteria (ntm) patients from multiple clinical institutions.

the bronchiectasis research registry is a consolidated database of non-cystic fibrosis (non-cf) bronchiectasis and nontuberculosis mycobacteria (ntm) patients from multiple clinical institutions. the goal of the bronchiectasis research registry is to support collaborative research and assist in the planning of multi-center clinical trials for the treatment of ntm and non-cf bronchiectasis, a progressive, non-curable disease of the lungs, which afflicts thousands of patients. the registry will also be used to provide better insight into the study of the different types of bronchiectasis, as well as the pathophysiology of the disorder. in 2012, in collaboration with ntm info and research, inc (ntmir) and the consortium members, the copd foundation expanded the bronchiectasis research registry to enroll patients with "non tuberculous mycobacteria (ntm) only". prior to this time, the registry included individuals with bronchiectasis, with or without ntm.

Eligibility criteria:
inclusion criteria: * over the age of 18 * non-cf bronchiectasis * nontuberculosis mycobacteria (ntm) exclusion criteria: * under the age of 18 * cf bronchiectasis
healthy homes/healthy families (hh/hf) intervention in 2-1-1 callers

Conditions: Weight Change, Body

Summary: this trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number.

it is now well-established that obesity and excess weight increase the risk of cancer (i.e., colorectal and post-menopausal breast cancer), as well as other chronic diseases including diabetes, stroke, coronary heart disease, and arthritis. the world cancer research fund and the american institute for cancer research state "maintenance of a healthy weight throughout life may be one of the most important ways to protect against cancer". unfortunately, adults generally gain weight as they age. healthy homes/healthy families (hh/hf) intervention involves a tailored home environment profile and a health coach working with participants to select and implement a series of healthy actions to create a home environment more supportive of healthy eating and physical activity. the federal communications commission (fcc) designated 2-1-1 as the 3-digit number to call for information and referrals to social services and other assistance in the united states. this study will evaluate a healthy eating and weight gain prevention intervention for delivery through 2-1-1 calls.

Eligibility criteria:
inclusion criteria: * 18 to 70 years of age * able to speak english * self-report bmi of 20 and above exclusion criteria: * pregnant women * only one member per household will be enrolled

Keywords: weight gain prevention cancer prevention chronic conditions obesity healthy eating
prevalence of subacromial impingement among egyptian swimmers

Conditions: Subacromial Impingement Syndrome

Summary: in the available literature, there are no prevalence studies that show the incidence of subacromial impingement in swimmers in egypt, this should be considered as it's one of the most commonly reported injuries worldwide in swimmers. there are also no available studies to show the difference in incidence of subacromial impingement between both genders in egypt. this study is attempting to remedy both research deficits and to reduce the literature gap and to show the prevalence rate of this injury among egyptian swimmers in different age groups, to help prevent its widespread and to provide data for further investigations. this study would give the egyptian swimming federation and the ministry of youth and sports a clear idea about the prevalence rate of swimmer's shoulder at different ages in egyptian swimmers. most importantly, this study is to provide the physiotherapy community in egypt data about this injury, the rate of prevalence and how to prevent it and hopefully would help in further future studies and also to apply it in different countries.


Eligibility criteria:
inclusion criteria: * 440 swimmers (males and females) , their age between 12 - 25. * professional swimmers only. * complain of anterior shoulder pain while swimming or elevation of shoulder. * bmi will be ranged from (18.5 - 24.9 kg/m2 ). * all swimmers are under supervision and psychologically, medically stable. * all swimmers received a good explanation of the questionnaire and the given study. exclusion criteria: * any swimmer who refuse to participate in the study * uncooperative swimmers. * unprofessional swimmers. * participants who play any other sports. * exclude any previous traumatic lesion. * exclude any form of shoulder instability. * take any medication that affects pain perception as nsaids.

Keywords: swimmers swimmer's shoulder subacromial impingement
a study to assess the efficacy, safety, and tolerability of oral nora520 in adults with severe postpartum depression

Conditions: Depression, Postpartum; Postpartum Depression; Post-partum Depression; Postnatal Depression; Post-Natal Depression

Summary: the purpose of this research study is to test the study drug, nora520, as a possible treatment for severe postpartum depression (ppd). the trial aims to determine: * how well nora520 is tolerated and what side effects it may cause * if nora520 reduces depressive symptoms in subjects with severe ppd * the amount of nora520 in the blood at various times after taking the study drug; this provides information that helps determine how often nora520 should be taken * in a subset of subjects, the amount of nora520 in breastmilk at various times after taking it to determine if and how much nora520 can pass into breastmilk participate in this study will be randomly assigned to one of 3 different groups. all subjects will take the study drug for 3 days.


Eligibility criteria:
key inclusion criteria: * are willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits * are an adult female between 18 and 45 years of age, inclusive; * have either ceased lactating at screening, or if still lactating or actively breastfeeding at screening, agree to temporarily cease giving breastmilk to their infant(s) from just prior to first dose of study drug on day 1 through day 14; * have a negative pregnancy test at screening and day 1 (prior to dosing); * have had a depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery * are ≤9 months postpartum at screening. key exclusion criteria: * have a history or current diagnosis or current treatment of bipolar disorder, schizophrenia, or schizoaffective disorder; * have had recorded treatment failure of ≥2 different antidepressant classes (e.g., ssri, snri) in the current or previous episode; * are currently experiencing active psychosis per investigator assessment, or are taking typical or atypical antipsychotic medication; * have a history of suicidal behavior within 2 years; * have a history or current diagnosis of sleep apnea or narcolepsy.

Keywords: depression postpartum depression nora520 postnatal depression numom
lymphoma and t helper 2 cytokines relationship with prognostic markers

Conditions: Lymphoma

Summary: the investigators hypothesized that non hodgkin lymphoma is using t helper 2 pathways. so that the investigators decided to study of cytokines related to t helper 2 pathways. it is well known that parasites and allergic situations also use t helper 2 pathways. because that the investigators excluded the patients have parasites and allergic situations. all the patients were over 18. the investigators included the patients with non hodgkin lymphoma which new diagnosed. it is observational study. the investigators took blood before chemotherapy and four months later. the investigators did not interfere with which chemotherapy will be given to patients. this decision was belong to hematologist or oncologist who will treat the patient.


Eligibility criteria:
inclusion criteria: * newly diagnosed non hodgkin lymphoma * diffuse large b cell lymphoma and t cell lymphoma patients exclusion criteria: * under 18 age * parasitosis * allergic status

Keywords: survey, interleukin status
internet-based cbit for children with chronic tics

Conditions: Tourette Syndrome in Children; Tourette Syndrome in Adolescence; Chronic Tic Disorder

Summary: to evaluate the effect and acceptability of an internet-based comprehensive behavioral intervention for tics (icbit) in a sample of children and adolescents with tic disorders. children and adolescents (aged 8-17 years) with tourette syndrome (ts) or chronic tic disorder (ctd) and their parents will be randomly assigned to receive either an internet-based icbit or wait-list (wl).

to evaluate the effect and acceptability of an internet-based comprehensive behavioral intervention for tics (icbit) in a sample of children and adolescents with tic disorders, children and adolescents (aged 8-17 years) with tourette syndrome (ts) or chronic tic disorder (ctd) and their parents will be randomly assigned to receive either an internet-based icbit or wait-list (wl) condition in a cross over design. participants will be randomized to icbit, or to wait list, and half will cross over from wait list to icbt. two blind independent clinical evaluators will rate tic severity and comorbidity. the primary outcome measure is the yale global tic severity scale (ygtss). assessments will be performed at baseline, post-icbt or post wait list, 3-months and 6-months (post-treatment for those originally assigned to icbt) and post-icbt, 3-months and 6-months (post-treatment for those originally assigned to wait list condition). all assessments were conducted by 2 phd level independent child psychologists.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of tourette syndrome or chronic tic disorder. * yale global tic severity scale tic severity score ≥14. exclusion criteria: * change in psychotropic medication regimen during the past 6 weeks. * current diagnosis of substance abuse/dependence. * lifetime diagnosis of pervasive developmental disorder, mania or psychosis. * previous sessions of cbit.

Keywords: tics tourette syndrome
safety and tolerability of dimebon in patients on memantine, and memantine plus donepezil

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the safety and tolerability of dimebon given to alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil.


Eligibility criteria:
inclusion criteria: * alzheimer's disease * on memantine * caregiver who is willing to accompany the patient to all clinic visits exclusion criteria: * unstable medical illnesses or significant hepatic or renal disease * other primary psychiatric or neurological disorders

Keywords: alzheimers disease donepezil memantine
acute agitation in emergency psychiatry

Conditions: Agitation

Summary: the purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.

the initial treatment of acute agitation aims to reduce suffering, abort the immediate risk of harm to self or others, and prevent the use of coercive measures such a physical and mechanical restraint. with this research project, we aim to build the initial structure of a visionary platform design and to examine the efficacy, tolerability, and safety of two hitherto under-investigated compounds versus the current standard of care for acutely agitated patients when de-escalation techniques have failed. after obtaining the results of the initial phase, we plan to apply for future funding to maintain and expand the platform design with the addition of relevant experimental arms. the proposed platform design aims to anwer the question what is the best treatment for acutely agitated patients in inpatient psychiatric settings?

Eligibility criteria:
inclusion criteria: * 18-64 years * agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms * total score of ≥14 on the panss excited component (pec) * a score ≥4 on at least 1 of the 5 items of the pec * informed consent obtained prior to the occurrence of the emergency exclusion criteria: * involuntary psychiatric admission according to the danish mental health act * female patients who are breastfeeding * female patients aged \<50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives * body weight \<50 kg * extreme obesity defined as estimated bmi≥ 40 kg/m2 * clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator) * the patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator) * insufficient language skills that interfere with reading, writing, and providing written informed consent in danish or other available languages (in the opinion of the investigator) * clinical suspicion of contraindications for one of the treatment arms * use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usual treatment (i.e., additional pn sedative prescriptions) in the 4 hours before study treatment * known allergy to any of the study medications

Keywords: emergency psychiatry