Kornimate/medical-research-clean huggingface dataset:
understanding and appraising the new medicine service in england

Conditions: Asthma; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus, Type 2; Hypertension; Blood Coagulation

Summary: about 25% medicines prescribed for long term conditions are not taken as directed, and approximately 15% people receiving a new medicine take few, if any, doses. the new medicine service (nms) is a community pharmacy service that started in england in october 2011 which involves the pharmacist providing additional support to patients starting a new medicine for some breathing problems (asthma \& copd), high blood pressure, adult onset diabetes or medicines which reduce blood clotting. it aims to improve the way patients take their medicines improving outcomes and reducing costs to the national health service (nhs). the investigators will assess the effectiveness and cost effectiveness of the nms using a research study where some people will receive the nms, and some won't, so the investigators can look at the effect of the nms on problems with their medicines, medicines taking and use of the nhs in general. data will be collected in the east midlands, south yorkshire and london areas. the investigators will recruit 500 patients from a range of different pharmacies and follow them up at six, ten and twenty six weeks after starting their new medicine to assess effects on medicines taking behaviour, patients' reported problems with medicines, referrals to their general practitioner (gp) and use of nhs resources. the investigators will compare the data gathered from this study with that being collected routinely by all pharmacies in england to provide wider estimates of cost effectiveness. the investigators will also explore how the nms service is being implemented by pharmacies. a sample of patients from the main study will be followed in more detail. this will involve recording the consultations with the pharmacist and also interviewing patients about their experience of the service. the investigators will interview the patients gp to investigate their views of the service. the investigators will also try to understand why people decline the invitation for the nms


Eligibility criteria:
inclusion criteria: * community dwelling patients eligible for nms (aged from 14 years starting a new medicine for asthma/copd, diabetes (type 2), antiplatelet/anticoagulation or hypertension). exclusion criteria: * patients collecting a repeat prescription for a medicine (i.e. not new) for asthma/copd, type 2 diabetes mellitus (t2dm), antiplatelets/anticoagulants or hypertension * patients collecting a medicine where the only change from the previous medicine involves a dosage or formulation change only * participants who are unable to understand patient/participant study documents * participants who are unable and unwilling to provide written consent / assent
real world assessment of clinical outcome changes -including month of ramadan-for dapagliflozin in management of type ii diabetes mellitus

Conditions: Type II Diabetes Mellitus

Summary: reward is an non interventional study aims to describe the changes in the clinical outcomes of type 2 diabetes mellitus patients who are treated with dapagliflozin for a period of one year including the fasting period of ramadan

reward is a multi-center, post-authorization, prospective, open label, non-interventional, real-life, observational, cohort study. the study is to be conducted at 10-15 sites . aims to describe the changes in the clinical outcomes over 1 year as follows: 1. primary objective: to describe the change in hbalc from baseline as a parameter for blood glucose control. 2. secondary objective: to describe the changes from baseline in the following parameters: * total body weight. * total cholesterol, ldl-c, non-hdl-c and triglycerides. * systolic and diastolic blood pressures. 3. other objective: to capture the frequency \& incidence of the following reported adverse events : * hypoglycemic episodes. * volume depletion. * genital infections. * urinary tract infections. 4. exploratory objective: to describe the combined effect of the hot climate season and fasting ramadan on the level of total ketone bodies levels in t2dm subjects treated with dapagliflozin.description of outcome variables in relation to objectives and hypotheses

Eligibility criteria:
inclusion criteria: the target population will be selected according to the following inclusion criteria: * males and females participants aged 18 years and older who are diagnosed type 2 diabetic patients- (based on american diabetes association diagnostic criteria (ada), the ada defines diabetes as a fasting blood glucose (fbg) of ≥ 126mg/dl or a 2-hour glucose level post oral glucose tolerance test (ogtt) of ≥ 200 mg/dl or hbajc of ≥ 6.5%). * patients treated with dapagliflozin (as per routine care and in compliance with the locally approved prescribing information) for ≥ 4 weeks and ≤ 16 weeks prior to the recruitment date. * patients with crcl \> 60 ml/min or egfr \> 60 ml/min/1.73 m2 should be included in trial. * patients providing written informed consent. exclusion criteria: * patients with contraindications to dapagliflozin as per the locally approved prescribing information will be excluded from the study. * if participating in any clinical trial, the subject cannot take part in this study. * patients with clinically significant renal, hepatic, haematological, oncological, endocrine, psychiatric or rheumatic disease. * patients who don't have a disease with life expectancy under 1 year. * patients with crcl \< 60 ml/min or egfr \< 60 ml/min/1.73 m2 should be excluded from the trial.
homelessness prevention: psychiatric care with representative payeeship

Conditions: Mental Illness

Summary: money management is a neglected issue in maintaining persons with mental illness in the community. this randomized controlled trial (rct) assessed whether a community-based representative payee program, i.e., money management of social security and/or va benefits, coordinated with va psychiatric care (co-rp) could be more effective than customary treatment for veterans who had no representative payee.

background: money management is a neglected issue in maintaining persons with mental illness in the community. this randomized controlled trial (rct) assessed whether a community-based representative payee program, i.e., money management of social security and/or va benefits, coordinated with va psychiatric care (co-rp) could be more effective than customary treatment for veterans who had no representative payee. objectives: after 184 subjects were randomly assigned to co-rp experimental group or customary care control group, hypotheses were that the co-rp group would experience: 1) more frequent enrollment in the representative payee program, 2) improved residential status, 3) improved health-related quality of life, including less mental illness symptomatology, 4) less substance abuse, 5) improved money management. methods: six-month interviews were completed on 152 of 184 possible subjects (83%) and 12-month interviews were completed on 149 of 184 possible subjects (81%). the six and twelve-month outcomes were analyzed with analysis of covariance using data from the baseline pretest. status: completed.

Eligibility criteria:
inclusion criteria: severe mental illness; inability to manage money; va patient exclusion criteria:
a study of bimatoprost 0.01% in the clinical setting

Conditions: Glaucoma, Primary Open Angle; Ocular Hypertension

Summary: this is a study of bimatoprost 0.01% (lumigan® 0.01%) in subjects with primary open-angle glaucoma (poag) or ocular hypertension (oh) who require further treatment for elevated intraocular pressure (iop).


Eligibility criteria:
inclusion criteria: * diagnosis of primary open-angle glaucoma or ocular hypertension * determined by the treating physician to require treatment with bimatoprost 0.01%. exclusion criteria: * previous use of lumigan® 0.01%
a prospective analysis of preoperative fascia iliaca block for hip arthroscopy

Conditions: Muscle Weakness | Patient; Pain

Summary: patients undergoing arthroscopic hip surgery have been shown to have significant post-operative pain that may delay discharge, recovery, and early mobilisation. a pre-operative regional anesthesia technique, the fascia iliaca block may be an effective method for acute post-operative analgesia. this is a prospective, randomized controlled study of the preoperative fascia iliaca block for patients undergoing hip arthroscopy. the enrolled patients will be randomized to receive either a fascia iliaca block with the local anesthetic ropivacaine or to have a sham block. all patients will receive a general anesthetic for the hip arthroscopy.

arthroscopic hip surgery is used to diagnose and treat interior joint pathology. although minimally invasive in nature, patients have considerable amount of pain postoperatively, leading to prolonged recovery room stay and increased opiate requirements. the investigators performed a retrospective chart review in patients who underwent hip arthroscopy at the ucsf orthopedic institute. 89% of the patients had pain immediate after surgery requiring opioid therapy. regional anesthesia has previously been shown to reduce discomfort after hip arthroscopy. however, there is currently no safe, well-established ultrasound guided regional anesthesia technique for arthroscopic hip surgery. the fascia iliaca block has shown to decrease acute pain related with hip fractures, as well as pain related with knee arthroplasty. the ultrasound guided fascia iliaca block is easy to perform and has an excellent safety record. the investigators believe that the ultrasound guided fascia iliaca block improves pain control in patients undergoing arthroscopic hip surgery. patients will receive a sham block group or a fascia iliaca block, performed in the preoperative area. pain scores and measurement of quadriceps strength will be assessed preoperatively and postoperatively. the patient will receive a pain diary consisting of pain scores, pain medication consumption, and a brief pain inventory. within 48 hours postoperatively, an anesthesiologist will call the patient and review the patient's pain scores, pain medication consumption and brief pain inventory.

Eligibility criteria:
inclusion criteria: * age at least 18 years old * american society of anesthesia physical classification i - iii, scheduled for arthroscopic hip surgery exclusion criteria: * age younger than 18 years old * non-english speaking * contraindicated for regional nerve block (such as, but not limited to: coagulopathy, infection at site, allergy to local anesthetic) * preexisting neurologic deficits of operative limb * need for postoperative nerve function test * inability to consent due to cognitive dysfunction * chronic pain * patient refusal.
a study of ray1225 in participants with obesity

Conditions: Obesity

Summary: the main purpose of this study is to learn more about the tolerability of ray1225 in participants with obesity. the study will also explore the efficacy of ray1225. the study will last about six months for each participant.


Eligibility criteria:
inclusion criteria: 1. have a body mass index (bmi) of ≥28 kilogram per square meter (kg/m²) or ≥24 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, fatty liver disease,or hba1c ≥5.7% and \< 6.5%; 2. participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product. exclusion criteria: 1. obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity 2. with a history of diabetes or hypoglycemia; 3. have a family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia (men) syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator. 4. have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \>1 year prior to screening) 5. allergic constitution; 6. not suitable for subcutaneous injection.
renal impairment study

Conditions: Reflux; Renal Excretion

Summary: the purpose of this study is to see how quickly azd3355 is taken up in to the blood and leaves the blood in people with normal kidney function or with different degrees of reduced kidney function.


Eligibility criteria:
inclusion criteria: * provision of signed informed consent * subjects should have either normal renal function or have a moderate renal impairment or severe renal impairment exclusion criteria: * history of heart disease * unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Keywords: safety tolerability exposure healthy renally impaired subjects
evaluation of alternative transfusion triggers in hemodynamically stable, non-ventilated cancer patients

Conditions: Anemia; Blood Transfusion; Cancer; Hemoglobin; Alternative Physiological Transfusion Triggers

Summary: this is a prospective, single-center observational study conducted at the kazakh institute of oncology and radiology. the study included 107 clinically stable adult patients with cancer who required red blood cell transfusion based on a restrictive hemoglobin threshold. the aim of the study was to evaluate alternative physiological indicators of transfusion need and effectiveness. measurements included oxygen extraction ratio (o₂er), central venous oxygen saturation (scvo₂), partial pressure of oxygen in central venous blood (pvo₂), arterio-venous oxygen difference (a-vo₂diff), lactate, and veno-arterial carbon dioxide difference (δco₂). these parameters were assessed before and one hour after transfusion. for data analysis, patients were stratified into two groups based on their baseline o₂er (≤35.4% and \>35.4%) to evaluate whether higher o₂er is associated with more pronounced physiological response to transfusion.


Eligibility criteria:
inclusion criteria: * adult cancer patients (age 18 years or older) * hemodynamically stable * not requiring any form of respiratory support * presence of a central venous catheter inserted into the superior vena cava exclusion criteria: * hemodynamic instability requiring inotropic or vasopressor support * active bleeding * shock of any etiology * patient refusal to participate in the study * hematological malignancies * age under 18 years * pregnancy

Keywords: anemia red blood cell transfusion physiologic transfusion trigger alternative transfusion trigger oxygen extraction ratio central venous oxygen saturation
femoral closure versus radial compression devices related to percutaneous coronary interventions study

Conditions: Arterial Closure Device; Percutaneous Coronary Intervention (PCI); Access Site Bleeding; Adverse Cardiac Events

Summary: ferari is a single centre observational study comparing patients undergoing pci either using radial compression devices or femoral closure devices at the corresponding access site. first primary outcomes consist of the occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems second primary outcomes consist of the occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (tlr and tvr) during 30 days and 12 months of follow-up.


Eligibility criteria:
inclusion criteria: * informed consent about the study * elective pci with following indications: stable coronary artery disease, proven myocardial ischemia; cardiac arrhythmia; syncope; unstable ap defined as nstemi but without cardiac troponin elevation; nstemi; stemi * patient eligible for coronary angiography and both radial and femoral pci * requirement of using a vascular closure device (without contraindications) exclusion criteria: * inability to understand and sign the informed consent term * pregnancy * less 18 years of age * single diagnostic coronary angiography * active or high bleeding risk (thrombocytopenia \<50,000/µl) * femoral approach and pci without using a vascular closure device * other conditions hampering involvement in the study
development and validation of an instrumented ankle-foot orthosis

Conditions: Foot Drop

Summary: foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. dragging one's toes on an uneven floor or a carpet can lead to tripping and falling. turbomed orthotics inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. in order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. the instrumented orthosis will also be compared to a reference system in a validation effort.


Eligibility criteria:
inclusion criteria for patients questionnaire: * having foot drop inclusion criteria for clinician questionnaire: * being a clinician who treats foot drop patients inclusion criteria for gait analysis: * having foot drop exclusion criteria for gait analysis: * not being able to walk without a cane or a walker * having lower extremity spasticity

Keywords: ankle foot orthosis validation survey gait analysis biomecanics
a study of ly3532226 in participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to evaluate the safety and tolerability of the study drug known as ly3532226 in participants with type 2 diabetes mellitus (t2dm). blood tests will be performed to check how much ly3532226 gets into the bloodstream and how long it takes the body to eliminate it. this is a 2-part study and will last approximately 16 weeks excluding screening period for each part, respectively.


Eligibility criteria:
inclusion criteria: * participants with type 2 diabetes mellitus (t2dm) for at least 3 months before screening * have the following glycosylated hemoglobin (hba1c) levels at screening: 1. hba1c \>/= 7.0% to \</= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and 2. hba1c \>/= 6.0% to \</= 9.5% for participants treated with dipeptidyl peptidase inhibitor-4 (dpp-4) (with/without metformin) inhibitors and participants treated with metformin and sodium-glucose cotransporter-2 (sglt-2) inhibitor * participants treated with diet and exercise alone or on a stable dose of metformin for at least 3 months * participants with body weight up to 150 kilograms (kg) and body mass index (bmi) of 23.0 to 45.0 kilograms per meter squared (kg/m²) * male participants who agree to use effective methods of contraception and female participants not of childbearing potential exclusion criteria: * participants who have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening * have a clinically significant abnormality ecg * have obesity induced by other endocrine disorders such as cushing's syndrome or prader-willi syndrome * are on any glucose-lowering medications other than metformin, sglt-2 inhibitors and/or dpp4 * have received chronic systemic glucocorticoid therapy (\>2 weeks) in the past 6 months * have an average weekly alcohol intake that exceeds 21 units per week (males 65 years of age or lesser) and 14 units per week (females and males 65 years of age or older) * smoke more than 10 cigarettes, or cigarette equivalent, per day
endoscopic closure of tracheoesophageal fistulas with occluder device

Conditions: Acquired Tracheo-esophageal Fistula

Summary: endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.


Eligibility criteria:
inclusion criteria: * patients over 14 years old * benign tracheoesophageal fistulas identified through bronchoscopy; exclusion criteria: * malign neoplasia * current mechanical ventilation * immunosuppressed * current local inflammatory process at fistulas borders * other clinical risk factors
visual-spatial and visual-perceptual disorders following cerebellar strokes

Conditions: Stroke, Ischemic; Cerebellar Lesions

Summary: this study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes.


Eligibility criteria:
inclusion criteria: * signed informed consent form * being able to pass initial neuropsychological tests within 10 days after stroke exclusion criteria: * previous central neural system/psychiatric/eye disease (including severe cranial trauma) * chronic alcoholism * mri contraindication.
sup-icu renal (siren)

Conditions: Critical Illness; Acute Kidney Injury; End-stage Renal Disease; Renal Replacement Therapy; Proton Pump Inhibitor

Summary: data show that episodes of bleeding may often be observed in critically ill patients with dialysis-dependent acute renal failure (arf) on renal replacement therapy (rrt). from a clinical perspective, patients with dialysis-dependent arf and end-stage renal disease (esrd) may be considered a high risk population in regard to e.g. development of gastrointestinal (gi-) bleeding. in the current prospective subanalysis "siren" of the randomized placebo-controlled clinical trial "sup-icu" (nct02467621), the investigators seek to elucidate whether the subpopulation of critically ill patients with acute kidney injury requiring renal replacement therapy (rrt) benefit from prophylactic treatment with a proton-pump-inhibitor such as pantoprazole.


Eligibility criteria:
inclusion criteria: * please refer to sup-icu (nct02467621) trial exclusion criteria: * please refer to sup-icu (nct02467621) trial