Kornimate/medical-research-clean huggingface dataset:
applicability of syncope guidelines in cataluña

Conditions: Brief Loss of Consciousness

Summary: the aim of syncat study is to study the level of adherence of the centers in cataluña tu the syncope guidelines esc2009 for the diagnosis and treatment of syncope and the impact that following them can have in the prognosis of these patients.

the aim of syncat study is to analyze the level of adherence of syncope guidelines esc2009 for the management, diagnosis and treatment of syncope in a specific territory with similar health structure, the region of cataluña in spain that includes aprox. 7,000,000 inhabitants, including different complexity level of hospitals and the impact that following guidelines can have in the prognosis of these patients.

Eligibility criteria:
inclusion criteria: * each patient that comes from the emergency room and/or in office doctors visit (internal medicine, cardiology, neurology...) with transient loss of conscience (t-loc) exclusion criteria: * patients younger than 15 years old * pregnant women

Keywords: tloc
a patient-centered communication tool (ur-goal) versus usual care for older patients with acute myeloid leukemia, their caregivers, and their oncologists

Conditions: Acute Myeloid Leukemia

Summary: the objective of this study is to conduct a pilot randomized trial to evaluate the preliminary efficacy of the ur-goal tool in improving sdm and communication between 100 older patients with aml and their oncologists.

the investigators have developed a patient-centered communication tool (university of rochester-geriatric oncology assessment for acute myeloid leukemia or ur-goal) that 1) conducts assessments of fitness, 2) elicits patient values via best-worst scaling, and 3) elicits preferences for prognostic information and assesses prognostic awareness. the tool also includes an aml educational video. the investigators have refined the tool based on feedback from stakeholders consisting of older patients with cancer, caregivers, and oncologists. this was further adapted in a qualitative study of 15 older patients with aml. in a single arm pilot study, the investigators have demonstrated feasibility of recruiting older patients with newly diagnosed aml to a single arm study, as well as their caregivers and oncologists.

Eligibility criteria:
inclusion criteria: patients 1. age ≥60 years 2. newly diagnosed aml or being worked up for possible aml 3. able to provide informed consent 4. agreement of their oncologist to participate in the study 5. english-speaking if patients screen positive for cognitive impairment on the mini-cog test performed as part of the baseline assessment, they can still enroll if they are able to provide informed consent and have decision making capacity as determined by their treating oncologist caregivers 1. selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 21 or older\] with whom the patient discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") can be eligible for the study. a caregiver need not be someone who lives with the patient or provides direct hands-on care. a caregiver can be any person who provides support (in any way) to the patient 2. able to provide informed consent 3. english-speaking oncologists 1. a practicing oncologist 2. at least one of their patients are recruited to the study 3. english-speaking

Keywords: acute myeloid leukemia communication shared decision making older adults geriatric hematology
a study to evaluate efficacy and safety of subcutaneous abatacept with steroid treatment compared to steroid treatment alone in adults with giant cell arteritis (gca)

Conditions: Giant Cell Arteritis

Summary: to investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of giant cell arteritis in adults.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * new headache (new onset or new type of localized pain in the head) * elevated esr (≥ 50 mm/h by the westergren method) or crp ≥ 1 mg/dl * temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries) * temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells * large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells or characteristic changes of large vessel stenosis or aneurysm secondary to gca as seen by arteriography (magnetic resonance imaging/ magnetic resonance angiography), ultrasound (eg, halo sign on color duplex sonography), or ct scan * patients must be treated with prednisone or prednisolone of 20-60 mg/day (prednisone equivalent) and be on a dose between 20-60 mg/day for at least 2 weeks prior to enrollment into the study exclusion criteria: * rheumatic disease other than gca such as takayasu's arteritis, granulomatosis with polyangiitis (wegener's), rheumatoid arthritis, systemic lupus erythematosus * patients with unilateral blindness (partial or complete) or who have unstable or recurrent visual symptoms attributable to gca within 4 weeks of randomization * patients with a history of dissection of aorta * patients with a history of myocardial infarction, stroke or transient ischemic attack attributable to gca within the 3 months of screening * patients who have been treated with intravenous ("pulse") doses of glucocorticoids defined as methylprednisolone \> 1000 mg/day if given within 6 weeks of randomization * patients who will require oral or iv glucocorticoid treatment during the trial for conditions other than gca * patients at risk of tuberculosis other protocol defined inclusion/exclusion criteria could apply
detection of gastrointestinal bleeding in intensive care patients via biosensor watch

Conditions: Gastro Intestinal Bleeding

Summary: the purpose of this study to improve methods of monitoring and diagnosing gastrointestinal bleeding via the e4 wristband, a biosensor watch.

the annual occurrence of gastrointestinal (gi) bleeding is approximately 150 per 100,000 in the us and accounts for 300,000 hospitalizations per year with a death rate of 5%. qualitative assessments of blood tests monitoring patients with or are thought to have gi bleeding can lack accuracy and objectivity, delaying conformation of the bleed through endoscopy. early endoscopies have been linked to more favorable outcomes for patients with heavier gi bleeding and earlier discharge times for patients with less severe gi bleeding. additionally, laboratory values are not documented at regular intervals, which makes identifying when gi bleeding exactly occurred difficult. in this study, the investigators aim to improve methods of monitoring and diagnosing gi bleeding via the e4 wristband, a biosensor watch. using data from the e4 wristband, the investigators will train a model to recognize gi bleeding through analyzing the heart rate and skin conductance of both patients with gi bleeding and who may have gi bleeding while they are not bleeding and while they are bleeding. monitoring both types of patients while they are and are not bleeding will help the model discern which vital signs are critical. additionally, the investigators will be using blood tests and other traditional methods of diagnosis to create a standard for vitals that characterize gi bleeding. if the e4 wristband is successfully able to accurately identify when a patient is experiencing gi bleeding, then speed of gi bleeding detection and the ability to monitor gi bleeding will dramatically increase, leading to quicker discharge times, reduced risk of rebleeding, and a lower death rate for afflicted patients.

Eligibility criteria:
inclusion criteria: * patients with a history of gastrointestinal bleeding and/or showing the symptoms of gastrointestinal bleeding. exclusion criteria: * patients who are not showing the symptoms of gastrointestinal bleeding and/or do not have a history of gastrointestinal bleeding.

Keywords: biosensor watch e4 wristband intensive care unit gi bleeding
vasopressin injection versus misoprostol during hysteroscopic myomectomy in reducing blood loss and operation time.

Conditions: Submucous Leiomyoma of Uterus

Summary: a prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .

this was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group a) 20 patients transcervical intramyoma vasopressin injection and (group b) 20patients with vaginal misoprostol is used .

Eligibility criteria:
inclusion criteria: * symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy * grade 0 and grade 1 submucous myomas * less than 5 centimeters in diameter exclusion criteria: * patients with grade 2 submucous myoma or more * patients with submucous myomas larger than 5 cm in diameter * postmenopausal women * patients received gnrh analogue in last 6 months * patients with anticoagulant therapy * patients with endometrial premalignant or malignant pathologies * patients with cardiovascular diseases, asthma or impaired kidney functions
effects of home base whole-body vibration in osteoarthritis. (vibe-rx2)

Conditions: Whole Body Vibration; Osteo Arthritis Knee

Summary: the purpose of this proposal is to understand how the vibrant health ultimate whole-body vibration (wbv) machine affects pain and inflammation in older adults. the investigators' hypothesize that sub-acute (12 weeks) wbv will lead to improvement in the level of knee pain and improve vascular function via a decrease in systemic inflammation.

knee osteoarthritis (ko) is a leading cause of disability and medical cost. whole body vibration (wbv) has emerged as an exercise alternative that may be more tolerable than traditional forms of exercise, such as treadmill walking/running or cycling. similar to traditional exercise, research supports that wbv can be very beneficial for your health. in fact, a single bout of wbv increases circulating concentrations of inflammatory markers. wbv is safe and effective, wbv training has been conducted in obesity, elderly, patients with diabetes, patients with lung disease, as well as patients with knee osteoarthritis.

Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritic knee pain for at least 6 months. * mean and women * ages 40-75 years old exclusion criteria: * \ 75 years old * history of balance issues * history of falls * epilepsy * pregnancy * the use of whole-body vibration in the past 6 months * previous knee surgery within last 3 years * unable to stand for at least 20 minutes (for whole body vibration training)
teen health choices & wellness

Conditions: Health Behavior; Wellness, Psychological; Substance Use

Summary: the goal of this observational study is to learn more about changes in health, wellness, and substance-use behaviors as teenagers get older. participants, ages 13 to 16, will be asked to use a smartphone application developed for this research study. participants will also come to brown university or meet via video conference to answer questions about specific behaviors, choices, and feelings that may change over time.


Eligibility criteria:
inclusion criteria: 1. be age 13 to 16 years 2. engage in a target health behavior on at least one recent occasion 3. speak, read, and understand english or spanish 4. live in or near rhode island exclusion criteria: 1. lifetime history of moderate or severe substance use disorder or treatment, excluding nicotine use disorder 2. current psychotic symptoms or active suicidality (i.e., intent in the past 30 days)
combining myoci with memory reactivation to improve motor recovery after stroke

Conditions: Stroke

Summary: this study will examine the combination of myoelectric computer interface (myoci) training with targeted memory reactivation (tmr) in chronic stroke survivors. the study aims to determine whether this training-plus-sleep combination will generalize to improve arm motor function over an extended training protocol in stroke survivors.


Eligibility criteria:
inclusion criteria: * age at enrollment is 21 or older * hemiparesis from first ever stroke affecting arm movement at least 6 months prior to screening * severe to moderate motor impairment (fma-ue of 7-40) * at least some voluntary shoulder and elbow muscle activation exclusion criteria: * inability to follow instructions of the myoci task * visual impairment (such as hemianopia) preventing full view of screen * anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the nih stroke scale extinction and inattention subtest) * participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study * inability to understand or follow commands in english due to aphasia or other reason * diffuse or multifocal infarcts in both hemispheres * substantial arm pain preventing participation for 90 minutes a day * spasticity treatment (pharmacological or botox) within last 3 months * ferromagnetic implants that are mri incompatible

Keywords: sleep
efficacy and safety of metformin plus biphasic insulin aspart 30 in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in south america. the aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin nph on blood glucose control in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * currently treated with insulin nph or are insulin-naive * body mass index (bmi) below 35.0 kg/m2 * hba1c between 7.5-11.0% exclusion criteria: * participation in any other clinical trial involving investigational products within the last 3 months * history of drug or alcohol dependence * known impaired hepatic function * known or suspected allergy to human insulin nph, insulin aspart or any component of the composition
epics-8: reasons for emergency department utilization by patients with non-urgent conditions

Conditions: Non-urgent Emergencies

Summary: epics-8: reasons for emergency department utilization by patients with non-urgent conditions: emergency departments (eds) are an important interface between primary and secondary health care sectors in germany. the number of outpatient visits in the ed´s is still increasing. the reasons for ed utilization by patients with non-urgent conditions are nearly unknown in germany and will be investigated in this project.

epics-8: reasons for emergency department utilization by patients with non-urgent conditions: emergency departments (eds) are an important interface between primary and the secondary health care system in germany. the number of outpatient visits in the ed´s is still increasing. the reasons for ed utilization by patients with non-urgent conditions are nearly unknown in germany and will be explored in this project. epics-8 is a pilot study to establish a research structure for the linkage of ed-data with data of the primary health care sector. data linkage will be conducted for patients with the manchester triage system categories blue, green and yellow. a secondary aim of the epics-8 study is to develop a valid questionnaire for the assessment of reasons for ed utilization by non-urgent patients. primary objective: establishing of a research structure for the linkage of inhospital-data with data from the primary health care system. records of 5,000 patients who attended one of the two eds at the charité university medicine berlin will be linked to primary health care data. secondary objectives: 1. development and testing of a questionaire for the identification of reasons for emergency department utilization by patients with non-urgent conditions (n=100) 2. characterization and quantification of non-urgent emergencies 3. explorative analysis of patient pathways and influencing factors for ed-visits with non-urgent conditions.

Eligibility criteria:
eligibility criteria for record linkage: * age\>= 18 years * outpatients * mts-triage category blue, green or yellow * treatment in one of the two participating eds eligibility criteria for questionnaire pretest: inclusion criteria: * age\>= 18 years * outpatients * mts-triage category blue, green or yellow * treatment in one of the two participating eds * eligibility to understand the study purposes and give written informed consent exclusion criteria: * dementia * no sufficient german language skills * patients with legal representatives
operation worth living project with suicidal soldiers at ft. stewart

Conditions: Suicidal Ideation Active; Suicidal and Self-injurious Behavior

Summary: this is a randomized controlled trial comparing the use of new clinical intervention (the "collaborative assessment and management of suicidality--cams") versus enhanced care as usual for suicidal soldiers who are seen at outpatient mental health clinics at ft. stewart ga.

this is a randomized controlled clinical trial of 148 suicidal active-duty us army soldiers. participants were randomized to on-site providers who were trained in the collaborative assessment and management of suicidality (cams) vs. providers doing their own routine care--referred to as enhanced care as usual (e-cau) within an outpatient military treatment center. the cams rating scale (crs) was used to reliably verify fidelity between treatment conditions and the adherence by cams providers to the model. participants received informed consent to be randomly assigned to treatment arm and were ask to complete study assessments at baseline, 3 months, 6 months, and 12 months after the start of treatment. recruitment is complete and all study assessments were completed as of march 2016. the study is in a second year of no cost extension; outcome data analyses and moderator analyses are currently underway to develop manuscripts for submission to peer-review scientific journals.

Eligibility criteria:
inclusion criteria: * active duty army personnel at fsga * significant suicidal ideation * soldier is appropriate under fsga policies * consent at baseline and follow up * consent to randomization and being digitally recorded exclusion criteria: * significant psychosis, cognitive or physical impairment to not give consent * judicially ordered treatments

Keywords: suicide assessment intervention cams
cll therapy approaches in russia

Conditions: Chronic Lymphocytic Leukemia

Summary: this is going to be a non-interventional study (nis). assessment of variables will be carried out using data on patient's treatment in real-life clinical setting. patients should be enrolled into study after evaluation of eligibility criteria by the investigator. no additional procedures besides those already used in the routine clinical practice will be applied to the patients. treatment assignment will be done according to the current practice. evaluation of efficacy and safety of any approaches used for cll/sll treatment is not the primary objective of this study, though there is no treatment of interest. study procedures will comply with all the local regulatory requirements regarding ae reporting (pharmacovigilance). it is planned to enroll approximately 6000 patients (suggested number of patients on ww\~1000 pts, 1l\~2750 pts, rr\~2250 pts) during the course of study's prospective part, it is planned to carry out at approximately 5 visits: (if unscheduled visit performed - the information should be filled on nearest visit). * baseline visit: icf signing, initial patient's data input will be done retrospectively, for patients who are already monitored by investigational site. * interim visits (crf will be filled every 6 months for therapy receiving patients and every 12 months for ww patients; if a patient transitions from ww to therapy, his/her crf will be filled every 6 months; all patient's visits should be planned according routine practice and investigator's judgement on individual basis). * final visit (data collection on 24 months after enrollment): patient's data input will be done for previously enrolled patients (data update)


Eligibility criteria:
inclusion criteria: * age ≥18 years * ability and willing to sign the icf * diagnosed cll/sll (including watch and wait stage of disease) according to russian clinical guides exclusion criteria: * patients without cll/sll diagnosis * age \<18 years * patients who refused/did not sign the icf

Keywords: chronic lymphocytic leukemia
a study to evaluate the efficacy and safety of jkb-122 in patients with nash and fibrosis

Conditions: Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Summary: a double-blind placebo controlled randomized phase 2 study to determine if jkb-122 compared with placebo resolves nash on liver biopsy and improves fibrosis

this is a phase 2 study in which jkb-122 is given once daily for 52 weeks to subjects with nonalcoholic steatohepatitis (nash) with fibrosis who have biopsy reading more than nas 4 with a fibrosis reading more than 1 and no cirrhosis. subjects will be at least 18 years of age, either male or female.

Eligibility criteria:
inclusion criteria: 1. is male or female, 18 years to 70 years of age. 2. if female of childbearing potential, must not be pregnant or breastfeeding and either postmenopausal (no menses for previous 12 months) or using an effective method of birth control (e.g., oral contraceptives, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy plus a barrier method). 3. is diagnosed with non-alcoholic steatohepatitis (nash) nas \>4.0 4. compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol: 5. subjects taking lipid lowering agents should keep their dose stable during the study. 6. stable use of insulin sensitizing agents (ppars, sglt2 inhibitors, or glp-1 agonists for 6 months prior to screening liver biopsy). 7. is capable of understanding and signing the informed consent document. if subject is unable to sign the informed consent form, then the subject's legal representative or guardian may provide written consent per local regulations. 8. agrees to comply with protocol requirements. exclusion criteria: 1. has human immunodeficiency virus (hiv) or is hepatitis b or c positive. 2. has history of liver cirrhosis. 3. has glycated hemoglobin (hba1c ) greater than 9%. 4. binge drinking as drinking 5 or more alcoholic drinks 5. significant alcohol consumption 6. is being treated with any prescription narcotic drug (including transdermal delivery systems). 7. has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold. 8. has unstable and uncontrollable hypertension (\>180/110 mmhg). 9. has received other therapies for nafld in the last 4 weeks prior to the screening visit (day -7). 10. requires concomitant use of or treatment with opioids or other excluded drugs such as hepatotoxic medications. 11. has received other investigational agents within 30 days prior to the screening visit (day -7). 12. has either autoimmune or genetic liver disease. 13. alpha- fetoprotein greater than 20 mcg/l. has impaired renal function (i.e. serum creatinine clcr \< 60 ml/min). 14. subjects who gained or lost weight greater than 5 kg in the past 3 months. 15. any form of chronic liver disease other than nash 16. suspected or confirmed cirrhosis. -