Kornimate/medical-research-clean huggingface dataset:
behavioural profiling of disease-related cognitive and motor impairment in pd

Conditions: Parkinson Disease; Medication; UPDRS; Motor Function; Cognitive Impairment; Depression; Impulsive; Levodopa

Summary: in this project, patients with parkinson's disease (pd) will be characterized by measuring cognitive and motor function and relation to effect of levodopa. participants will be patients with parkinson's disease and healthy controls. it will be investigated if there is a difference between patients with a good measured levodopa response and with a poor measured response.

the patients with parkinson's disease will be included from the outpatient clinic at the department of neurology at bispebjerg frederiksberg hospital and healthy controls will be found among relatives or volunteers through research ads. patients will be asked to pause dopaminergic medication for 6 half times.then a baseline examination will be performed in the morning in a non-medicated state (off), using unified parkinson's disease rating scale (updrs), the montreal cognitive assessment (moca) and computerized cognitive testing. baseline screening for depression with beck depression inventory (bdi) and for impulsivity with questionnaire for impulsive-compulsive disorders in parkinson's disease-rating scale (quip). an acute levodopa challenge will be performed with patients receiving 200/25 mg dispersible levodopa/benserazide. after an hour updrs and cognitive computerized tests are repeated. this is estimated to take about 3½ hours to complete. in healthy controls a neurological examination, bdi and moca will pe performed. the updrs motor test is videotaped. a specialist will later evaluate the motor function blinded. the participants will be asked to participate in the bispebjerg frederiksberg (bfh) biobank, bfh-2017-114, (isuite nr.: 05991) at bispebjerg frederiksberg hospital for future research. an exact calculation of power is difficult to calculate as the project includes a broad range of correlations. numeric data will be analysed using the student's t-test (when normal distribution is met) or wilcoxon rank sum test (when normal distribution is not met). binary data will be analysed using the fishers exact test.

Eligibility criteria:
inclusion criteria: * age of minimum 18 * diagnosis of pd * be able to cooperate, understand and participate in the project * signed informed consent, including consent to being included in the biobank exclusion criteria: * dementia * treatment with anti-dopaminergic medication.
comparison of motor functions and quality of life according to feeding type in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy.

the aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy. children will be divided into two groups: children with oral feeding and children with non-oral feeding, according to functional oral intake scale. gross motor function classification system will be used for classify children according to gross motor function, gross motor function measurement will be used for evaluate gross motor functions, and parent-reported pediatric quality of life inventory will be used for evaluate quality of life of children. to measure caregivers' anxiety and depression levels will be assessed by using beck depression inventory and beck anxiety inventory. parametric or non-parametric tests will be applied according to the variables distribution. through this analyses, determination of the difference between feeding type groups and other categorical and continuous variables will be decided.

Eligibility criteria:
inclusion criteria: * children who were diagnosed with cp * aged between 5-18 years * must have cooperation * feed by orally or non-orally exclusion criteria: * having other accompanying neurodegenerative diseases. * acute respiratory tract infection * complications of enteral feeding
outcomes from home in patients recovering from major gynecologic cancer surgery: measuring symptoms and health-related quality of life

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cancer; Uterine Cancer; Vaginal Cancer; Vulvar Cancer

Summary: this study is being done to see if most patients are willing and able to report how they are feeling after surgery using the internet, and if this information can help doctors and nurses detect concerning symptoms after surgery. this study uses a special new website called webcore. patients can logon to webcore and answer questions about how they are feeling. then, doctors and nurses can look at this information during clinic appointments. we are doing this study to see if webcore is a helpful way for us to keep track of information about how patients are feeling and quality of life. if webcore is helpful, we will use it in the future to collect more information about patients' symptoms and quality of life. we can use what we learn to help find better ways of helping patients to prepare for what they will go through while they recover from surgery.


Eligibility criteria:
inclusion criteria: * participants must be 18 years or older * participants must be able to provide informed consent * participants must be scheduled to undergo laparotomy for presumed or known gynecologic cancer * the assessments were designed and validated in english and are not currently available in other languages. translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. therefore, participants must be able to communicate in english to complete the tests. participants must be able to speak and read english fluently * participants must have access to a home computer, have a personal email account, and check email at least once weekly by self-report exclusion criteria: * patients who have a cognitive or psychiatric deficit resulting in an inability to provide meaningful informed consent, as judged by the consenting professional, and/or as noted in the medical record * patients who are undergoing pelvic exenterative surgery (with the exception of patients undergoing modified pelvic exenteration in the context of debulking for ovarian or uterine cancer).

Keywords: gynecologic cancers quality of life 08-155 surgery
an observational study to assess the risk of out-of-hospital sudden cardiac death in users of domperidone, users of proton pump inhibitors, and users of metoclopramide

Conditions: Death, Sudden, Cardiac

Summary: the purpose of this observational study is to assess the risk of out-of-hospital sudden cardiac (heart) death (scd) associated with current use of domperidone compared to current use of a proton pump inhibitor (ppi), current use of metoclopramide, or non-use of any of these medications.

this is a population-based, retrospective (a study in which the exposures and outcomes occurred before the study began), and nested case-control study (a study in which the patients with the study outcome \[cases\] and comparison patients without that outcome \[controls\] are observed to assess their exposure to the medication being studied \[domperidone, ppi's and metoclopramide\]). the data will come from the united kingdom's clinical practice research datalink. the study will estimate the rate of scd during periods of exposure to each of the study medications, and during periods of exposure to none of them; and the ratios of these rates. it will also use a "case-crossover" analysis (in which each case serves as his/her own control) to re-estimate these rate ratios in a manner that takes account of personal characteristics such as obesity or smoking that may affect the study findings and are incompletely recorded in the database.

Eligibility criteria:
inclusion criteria: - patients registered in english practices whose data are linkable to hospital episode statistics (hes) and office for national statistics, uk (ons). patients are required to have at least 1 year in the clinical practice research datalink before they can enter the study exclusion criteria: * patients with a diagnosis of cancer other than non-melanoma skin cancer * patients from practices not linkable to hes and ons data * patient time corresponding to the period between hospital admission date and 30 days after discharge date

Keywords: death, sudden, cardiac risk of sudden cardiac death domperidone proton pump inhibitors (ppi) metoclopramide observational study
rapid ventricular pacing during cerebral aneurysm surgery: a study concerning the safety for heart and brain

Conditions: Cardiac Pacing, Artificial; Aneurysm, Brain; Arteriovenous Malformations, Cerebral

Summary: rapid ventricular pacing (rvp) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. rvp results in an adequate fall in blood pressure which presents as an on-off phenomenon. however it is not clear whether repetitive periods of pacing are harmless for the patient. silent cardiac and cerebral infarcts may be undetected. the investigators will study the safety of rvp, particularly for the heart and the brain.

rapid ventricular pacing (rvp) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. rvp results in an adequate fall in blood pressure which presents as an on-off phenomenon. the technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (avms) and can be lifesaving in the case of an intraoperative bleeding or rupture. in a former study blood pressure and clinical outcome were used as study parameters. however it is not clear whether repetitive periods of pacing are harmless for the patient. silent cardiac and cerebral infarcts may be undetected if only clinical outcome is taken as a study parameter. the investigators will study the safety of rvp, particularly for the heart and the brain, using magnetic resonance imaging, brain oxygenation (sct o₂) evaluated by near-infrared spectroscopy and troponin levels. the purpose of this study is to evaluate the effect of repetitive periods of rvp on the oxygenation of the heart and brain using magnetic resonance imaging, sct o2 (3) and troponin levels (4) both markers for ischemia damage.

Eligibility criteria:
inclusion criteria: * elective cerebral aneurysm clipping surgery * arteriovenous malformation surgery * craniotomy * american society of anesthesiologists 1,2 and 3 exclusion criteria: * cardiac abnormalities * coronary heart disease * valvular heart disease * pregnancy
radiolabeled monoclonal antibody therapy in treating patients with recurrent or persistent metastatic colorectal cancer

Conditions: Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer

Summary: phase i trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent metastatic colorectal cancer. radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer

primary objectives: i. determine the maximum tolerated dose of iodine i 131 monoclonal antibody cc49-deltach2 (deleted ch2 region) in patients with colorectal cancer. ii. determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and conjugate stability of this drug in these patients. iii. determine the ability of this drug to localize to tumor sites in these patients. iv. determine the immune response in patients treated with this drug. outline: this is a dose-escalation study. patients receive a tracer dose of iodine i 131 monoclonal antibody cc49-deltach2 iv on day 1 and a therapy dose over 30 minutes on day 8. cohorts of 3-5 patients receive escalating doses of iodine i 131 monoclonal antibody cc49-deltach2 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity. patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease progression.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic adenocarcinoma of the colon or rectum * not amenable to surgical resection * recurrent or persistent disease after standard surgery, radiotherapy, and chemotherapy, including fluorouracil and irinotecan * tag-72 positive * performance status - ecog 0-2 * wbc greater than 3,500/mm\^3 * platelet count greater than 125,000/mm\^3 * hemoglobin greater than 10 g/dl * no nucleated rbc or significant teardrop rbc morphology * bilirubin less than 1.5 mg/dl * sgot/sgpt less than 4 times normal * hepatitis b surface antigen negative * creatinine less than 2.0 mg/dl * hiv negative * no other malignancy within the past 5 years except basal cell skin cancer * no allergy to iodine * no detectable antibody to monoclonal antibody cc49 * not pregnant or nursing * fertile patients must use effective contraception * at least 3 weeks since prior immunotherapy and recovered * no prior bone marrow or stem cell transplantation * no other concurrent immunotherapy * see disease characteristics * at least 3 weeks since prior chemotherapy and recovered * no concurrent chemotherapy * see disease characteristics * at least 3 weeks since prior radiotherapy and recovered * no prior radiotherapy to more than 25% of red marrow * no concurrent radiotherapy * see disease characteristics * at least 3 weeks since prior surgery and recovered
the impact of creative interventions on symptoms of postnatal depression (cohort study)

Conditions: Depression, Postpartum

Summary: post-natal depression (pnd) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the uk alone. however, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the uk do not have a strategy for treating pnd, and flaws in the current pharmacological and psychological treatment models. consequently, research into promising psychosocial interventions such as music is critical to developing new paradigms for treating pnd. this project is an ambitious programme of research that investigates links between the mental health of women in the later stages of pregnancy and first 9 months post birth and their use of psychosocial interventions including music.

the study uses an online questionnaire to achieve a cross-sectional view of the mental health of women across england in the final stages of pregnancy and the first 9 months post birth, how much and in what ways music is used by these women, and whether there are any associations between music and mental health. the study aims to recruit between 1,000 and 5,000 women to take the anonymous questionnaire. however, women who complete the questionnaire while still pregnant will be invited to complete three further questionnaires shortly post-birth and 3 months later to gather longitudinal data to analyse change across pregnancy into post-birth (aiming for 500 of the 1,000 undertaking this repeated measurement). phase a of the study will be open to nhs sites around england to take part.

Eligibility criteria:
inclusion criteria: * women who are more than 28 weeks pregnant or up to 9 months post-birth exclusion criteria: * outside the limits of the number of weeks pregnant/post birth * living outside england * refusal to participate

Keywords: depression mental wellbeing motherhood music alternative therapies
changes in physical, cognitive and emotional function 5 and 10 years after aneurysmal subarachnoid hemorrhage (asah)

Conditions: Subarachnoid Hemorrhage

Summary: the current study is a continuation of the study "effect of early rehabilitation in patients with acute asah" which was approved by the regional committee for medical research ethics, south-east norway, archive number 2011/2189, clinical trials number 0925-0586 (clinical trials gov. identifier nct01656317). the original study was a prospective, controlled, interventional study comprising patients managed at the neuro-intermediate ward following repair of a ruptured intracranial aneurysm in 2011-2012. 157 patients signed the informed consent form and were included in the study. patients were assessed in the acute phase, as well as a 3 and 12 months post ictus. the main research goal of the present study will be to assess physical, cognitive and emotional function 5 and 10 years after asah in the 2011-2012 population. in addition we will also describe quality of life and work-status along with the time-course of recovery from the acute sage after asah to the chronic phase.


Eligibility criteria:
inclusion criteria: * patients with asah treated at oslo university hospital in 2011-2012 * only patients with signed informed consent form and thereby included the project "effect of early rehabilitation in patients with acute subarachnoid hemorrhage" (regional committee for medical research ethics, south-east norway, archive number 2011/2189, clinical trials number 0925-0586, clinical trials gov. identifier nct01656317) will be asked to participate. exclusion criteria: * patients with asah treated at oslo university hospital in 2011-2012 who did not sign an informed consent form in the project "effect of early rehabilitation in patients with acute subarachnoid hemorrhage" (regional committee for medical research ethics, south-east norway, archive number 2011/2189, clinical trials number 0925-0586, clinical trials gov. identifier nct01656317)

Keywords: cognitive function quality of life
iron interventions and non-transferrin-bound iron (ntbi) in women

Conditions: Iron Deficiency

Summary: the overall goal of this research is to develop safe and effective iron interventions that can be administered without production of plasma non-transferrin-bound iron (ntbi: iron in the systemic circulation not bound to the iron-transport protein transferrin). the appearance of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after oral administration of iron supplements in doses similar to those used in the pemba trial. this research project will (i) confirm the appearance of plasma non-transferrin-bound iron after administration of an iron supplement like that in the pemba trial (\~1 mg fe/kg body weight, without food), and then determine the effects on production of plasma non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of giving the supplemental iron (\~1 mg fe/kg) with the standard rice meal, and (iii) of giving a lower dose of iron (\~0.1 mg fe/kg) - like that used in home fortification - with the standard rice meal.


Eligibility criteria:
inclusion criteria: * non pregnant * non lactating * apparently healthy women exclusion criteria: * chronic disease * pregnancy * lactation

Keywords: ntbi iron absorption
effectiveness of autologel therapy in diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: the aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which diabetic foot ulcers (dfu) will be treated using autologel and case-matched against a concurrent cohort of patients receiving undefined usual and customary care (ucc) as provided in up to 30 u.s. wound registry research network (uswrrn) centers.

autologel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. prospective observational studies of the effectiveness of autologel have demonstrated promising results in regard to the healing of dfus, including severe wagner grade 3 and 4 ulcers. the aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which diabetic foot ulcers will be treated using autologel to determine the time to heal at 12 weeks. comparison will be made with a case-matched concurrent cohort of patients receiving undefined usual and customary care (ucc).

Eligibility criteria:
inclusion criteria: 1. medicare/medicaid eligible 2. ≥18 years of age 3. type i or ii diabetes requiring medical treatment as determined by the physician 4. the largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a wagner 1-5 dfu (see appendix 9 for wagner classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces) 5. for subjects with potentially multiple eligible dfus, the largest ulcer will be selected there must be at least 4 cm between the index ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure) 6. debrided ulcer size between 0.5 cm2 and 50 cm2 7. demonstrated adequate offloading regimen 8. duration ≥ 1 month at first visit 9. subject must be willing to comply with the protocol, which will be assessed by enrolling clinician. exclusion criteria: 1. subjects known to be sensitive to autologel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin 2. presence of another wound that is concurrently treated and might interfere with treatment of the index wound by autologel (malignancy in nearby wound) 3. ulcer not of dfu pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology) 4. any malignancy other than non-melanoma skin cancer 5. subjects who are cognitively impaired and do not have a healthcare proxy 6. serum albumin of less than 2.5 g/dl 7. plasma platelet count of less than 100 x 109/l 8. hemoglobin of less than 10.5 g/dl 9. subject has inadequate venous access for repeated blood draw required for autologel administration.

Keywords: non healing wound
strategy for left main coronary bifurcation lesion ii

Conditions: Coronary Artery Disease

Summary: in patients with unprotected left main (lm) true bifurcation lesion (cohort a), elective 2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion. in patients with unprotected lm non-true bifurcation lesion (cohort b), 1-stent technique with mandatory final kissing ballooning is superior to 1-stent technique without kissing ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.


Eligibility criteria:
inclusion criteria: 1. age ≥20 years 2. left main bifurcation lesion on coronary angiography 3. significant myocardial ischemia main vessel (left main coronary artery and left anterior descending artery) and/or side branch (left circumflex artery) diameter stenosis \> 75%, or diameter stenosis 50-75% with angina and/or objective evidence of ischemia in the non-invasive stress test 4. significant size of the main branch (left anterior descending artery) and side branch (left cirmflex artery) - the reference diameter of both branches ≥ 2.5 mm by visual estimation exclusion criteria: 1. the patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, biolimus 2. patients who have received des implantation in the target lesion prior to enrollment

Keywords: angioplasty transluminal percutaneous coronary