Kornimate/medical-research-clean huggingface dataset:
validity of the turkish version of the profile fitness mapping neck questionnaire for patients with neck pain

Conditions: Pain; Neck Pain; Evaluations, Diagnostic Self; Assessment, Self

Summary: as patients improve on one parametric result, the results on the other parametric may worsen, but the total score may not be affected. for this reason, it would be useful to make measurements that evaluate all the parameters of the patients. thus, it would be more advantageous to score both pain and symptoms separately, as well as activity limitations. therefore, neck specific surveys are needed to meet this need. for this reason, this study was planned to determine the validity of the questionnaire named "profile fitness mapping neck questionnaire" in patients with neck pain.

the translation of the original version of "profile fitness mapping neck questionnaire" to turkish will be translated by two independent professional translators. afterwards, a person without a medical history and a native english speaker will be translated into english again. once the translation stages are complete, the translators will be brought together to discuss the two versions of the questionnaire. then the final state will be translated into the main language of the questionnaire and the compliance will be checked. first of all, people who have been suffering from low back pain for at least six months will complete the "profile fitness mapping neckquestionnaire", "neck disability index", "sf-36 health related quality of life questionnaire" and "visual analog scale". seven days after the questionnaire, the "profile fitness mapping neck questionnaire" will be completed again.

Eligibility criteria:
inclusion criteria: * neck pain for more than six months during activity or rest * having a problem with the neck based on clinical examination and story exclusion criteria: * having neurological problems * having vestibular or cerebellar problems
prospective study to evaluate a digital regimen for fibromyalgia management: an extension study

Conditions: Fibromyalgia

Summary: this study is designed as a 9-month extension of the original study (prosper-fm). the purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia.


Eligibility criteria:
key inclusion criteria: * participant has completed participation in the prosper-fm study and was assigned to the digital act arm * participant is willing and able to comply with all protocol-specified requirements key exclusion criteria: * based on the investigator's judgment, any new diagnosis of acute or chronic disease/condition since participant's enrollment in prosper-fm study that may impact the outcome of this study * severe depression at the final visit of the prosper-fm study (measured by bdi-ii) * increased risk of suicide on the basis of the investigator's judgment or the columbia-suicide severity rating scale ("c-ssrs") at the final visit of the prosper-fm study
evaluation of smell and taste in fibromyalgia

Conditions: Fibromyalgia

Summary: patients diagnosed with fibromyalgia syndrome according to 2016 acr criteria and 18-70 years old healthy subjects will be included in the study. their smell and taste will be assessed with sniffin sticks and taste strips. besides they will be evaluated for quality of life, anxiety, depression, and alexithymia.


Eligibility criteria:
inclusion criteria: * 18-70 years of fibromyalgia patients * giving informed consent * knowing how to write and read in turkish exclusion criteria: * mentally retarded patients * psychiatric disorders (bipolar disorder, schizophrenia etc.) * severe organ failure (kidney, liver, heart failure) * history of head trauma * any disorder associated with smell and taste functions

Keywords: fibromyalgia smell taste
study to evaluate the efficacy and safety of oral ct1812 in participants with geographic atrophy (ga) secondary to dry age-related macular degeneration (amd).

Conditions: Age-Related Macular Degeneration

Summary: this is a phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered ct1812 compared to placebo in participants with ga associated with dry amd.

this is a phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered ct1812 compared to placebo in participants with ga associated with dry amd. participants ≥50 years old diagnosed with ga secondary to dry amd and who meet all inclusion criteria and none of the exclusion criteria will be included in the study. the study will randomize up to 246 participants in a 1:1 manner (123 participants per treatment group) to receive a single daily dose of either ct1812 (200 mg) or placebo across approximately 40-50 sites. following a screening period of up to 60 days, the total expected duration of participant participation in the study will be 108 weeks (104-week treatment period followed by a 28-day \[4-week\] post treatment safety follow up period).

Eligibility criteria:
inclusion criteria: 1. age ≥50 years at time of informed consent. 2. bcva of 24 letters or better using early treatment diabetic retinopathy study (etdrs) charts at screening. 3. stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening. exclusion criteria: 1. ga due to causes other than dry amd. 2. any history or current evidence of exudative ("wet") amd. 3. retinal disease other than dry amd. 4. any ophthalmologic condition that prevents adequate imaging of the retina as judged by the study site or central reading center. 5. intraocular surgery (including intraocular lens implantation surgery) within 3 months prior to randomization. 6. any ophthalmic condition that will or is likely to require surgery during the study period. 7. hypersensitivity to fluorescein. 8. suspected or known allergy to any components of the study treatments. 9. history of vitrectomy surgery, submacular surgery or any other surgical intervention for dry amd. 10. history of glaucoma filtering surgery or corneal transplant in the study eye. 11. history of central serous retinopathy in either eye.
the inter-rater reliability of the turkish version of aphasia rapid test for stroke

Conditions: Aphasia

Summary: the aphasia rapid test (art) is a bedside aphasia screening test developed originally in french. the purpose of this study is to assess the inter-rater reliability of the turkish version of the art in stroke patients.

the aphasia rapid test (art) was developed and validated originally in french to evaluate language skills in post-stroke patients (azuar et al., 2013). it is a 26-point scale that takes less than 3 minutes to administer. the simplicity of the art allows it be used bedside in acute post-stroke patients with little to no training needed. the items needed to administer the art are also easy to access in healthcare settings (e.g., watch, pen, doctor's coat). although the art is not a diagnostic test, it is beneficial for tracking progress and determining prognosis in stroke patients. the original art was designed similar to the nih stroke scale (nihss), a widely-used test in stroke patients. the nihss which assesses many areas of functioning (level of consciousness, gaze, visual ability, facial palsy, motor and sensory ability, limb ataxia, language, dysarthria, and extinction and inattention) was chosen because of its sensitivity to early changes in neurological status and high prognostic accuracy (http://www.nihstrokescale.org). the art is an expanded version of the language section of the nihss. the total possible points on the art is 26, which indicates the highest level of impairment. the test begins with the patient being asked to follow two one-step commands (up to two points each), a complex command (up to 3 points), repeat three nouns (up to 6 points), repeat a simple sentence (up to 2 points), and name three simple objects (up to 6 points). the next item requires a rating of dysarthria by the examiner (up to 3 points). on the final item, the patient is asked to name as many animals as they can think of in one minute (up to 4 points). with the exception of items 1a, 1b, and 6, there are no time restrictions on the test. the purpose of the present study is to translate the original art into turkish to provide an efficient method for the evaluation of language skills in post-stroke turkish-speaking patients and to assess its inter-rater reliability.

Eligibility criteria:
inclusion criteria: * left mca infarct due to cva * right hand dominant * turkish as first language * cva within the last 10 days exclusion criteria: * right or bilateral brain lesion * previous stroke * psychiatric disorder * other neurological disorder * cognitive impairment * endotracheal entubation prohibiting responses to test

Keywords: stroke aphasia reliability
efficacy of a mobile-based multidomain intervention to improve cognitive function and health-related outcomes among older korean adults with a high risk of dementia

Conditions: Cognitive Decline; Cognitive Impairment, Mild; Aging; Dementia

Summary: this study investigated the efficacy of the silvia program, a mobile-based multidomain intervention, to improve cognitive function and health-related outcomes of older adults with a high risk of dementia. we compare its effects to a conventional paper-based multidomain program on various health indicators related to risk factors of dementia.


Eligibility criteria:
inclusion criteria: 1. experiencing subjective cognitive decline, 2. had a smart phone and could use it, and 3. understood the purpose and process of this study. exclusion criteria: 1. major psychiatric disorders 2. dementia, 3. degenerative brain diseases 4. severe or unstable heart diseases 5. neurological or psychological diseases that affected cognitive functioning 6. severe vision or hearing impairment, 7. current participation in a cognitive training program 8. does not know how to use mobile devices.
rivaroxaban acs specialist cohort event monitoring study

Conditions: Acute Coronary Syndrome

Summary: rivaroxaban is a medicine which reduces the formation of blood clots. acute coronary syndrome (acs) comprises a range of disorders, including heart attack and unstable angina, caused by a sudden reduction in blood flow to part of the heart muscle. this study aims to collect information on the use of rivaroxaban and its safety when used by patients for the prevention of atherothrombotic (plaque rupture leading to a blood clot) events following acs, during the first three months after starting. this study was requested by the european regulatory body (ema) which is responsible for the use and safety of medicines. it will last for approximately 3 years and is a national study covering the whole of england and wales. the study aims to recruit 1193 patients who have been prescribed rivaroxaban and antiplatelet therapy and 1193 patients who have been prescribed alternative dual antiplatelet therapy for the secondary prevention of atherothrombotic events following acs. each patient will only be monitored for the first 13 weeks after hospital admission for acs. patients who choose to take part will complete a consent form. the patient's care team will be asked to complete a baseline questionnaire about the patient at the time the medicine is given and a further questionnaire up to 16 weeks later, specifically asking about the patient's experiences whilst on the medication. if anything unusual is reported during the observation period, the care team may be asked to fill out a followup questionnaire. with the patient's consent, the study team will also inform the patient's general practitioner (gp) of their participation in the study and will ask the gp to complete an abridged questionnaire from the patient's medical records. the study team will analyse and aggregate the data, carefully protecting patient confidentiality, to classify adverse events of interest, in particular bleeding events.


Eligibility criteria:
inclusion criteria: * age 18 years or above * patients newly prescribed rivaroxaban in any combination with standard oral antiplatelet therapy for the indication of secondary prevention in patients after acs * patients prescribed dual antiplatelet therapy (contextual cohort) for the indication of secondary prevention after acs * patients have provided signed, informed consent exclusion criteria: * patients prescribed with oral anticoagulants including rivaroxaban within 6 months prior to the index date for any indication * patients commenced rivaroxaban between date of market launch (28th october 2014) for the indication of secondary prevention after acs and study start (18th september 2015)

Keywords: acute coronary syndrome
red cell distribution with to lymphocyte ratio in cardiac surgery

Conditions: Cardiac Surgery

Summary: it is aimed to investigate whether red cell distribution with (rdw) to lymphocyte ratio (rlr) can predict early comorbidity among cardiac surgery patients.

there are important developments in the field of cardiac surgery due to advances in medical treatments, surgical techniques, intraoperative anesthesia management, and postoperative intensive care. on the other hand, the proportion of high-risk patients has increased due to the increasing number of elderly patients with comorbidities presenting for cardiac surgery. it is important to analyze outcomes such as postoperative morbidity and mortality, due to concerns about the quality of life of patients after cardiac operations, the recommendations of current eras protocols, and the shortening of intensive care unit length of stay. complications such as cardiac, pulmonary, renal, and neurological disorders, infections such as pneumonia or sepsis, and prolonged stay in the intensive care unit and hospital are indicators of not only the quality of care but also the quality of life after cardiac surgery. therefore, it is important to determine the perioperative risk factors that cause postoperative morbidity. various outcome prediction models are used for cardiac surgery, such as the cardiac anesthesia risk assessment score, tuman score, tu score, and the european system for cardiac operative risk assessment score, which uses preoperative factors to predict the postoperative outcomes. it is known that intraoperative factors such as cpb duration, aortic cross-clamp time, surgical technique, and serum lactate levels are associated with postoperative morbidity. recent studies suggest that inflammatory and immune imbalance may play an important role in postoperative complications. studies point to new parameters derived from preoperative complete blood count as potential biomarkers of inflammation and oxidative stress. many markers such as neutrophil/lymphocyte ratio, mean platelet volume (mpv) or rdw alone have been studied in cardiac surgery. the ratio of red cell distribution width (rdw) to lymphocyte (l) has been popular in recent years as an indicator of poor prognosis, especially in oncological patients. however, this marker has not yet been evaluated in terms of morbidity or mortality in cardiac surgery patients. the main purpose of this study; to investigate the rdw/l ratio as an early morbidity marker in cardiac surgery patients.

Eligibility criteria:
inclusion criteria: * adult patients undergoing open-heart surgery with cardiopulmonary bypass exclusion criteria: * re-operations * emergency operations * patients with preoperative renal failure * patients with preoperative hematological problems * patients with preoperative infection * patients with preoperative immunological disease * patients using preoperative steroids

Keywords: red cell distribution width lymphocyte postoperative complications cardiac surgery
placebo-controlled trial with glyti-m among children with attention deficit hyperactivity disorder (adhd)

Conditions: ADHD

Summary: although psychostimulant is the first line of drug to treat attention deficit hyperactivity disorder, (adhd), actually there are 10-20% adhd patient do not response well to current medication. most of parents of children with adhd in taiwan dislike to use psychostimulant. we expect that glyti-m will have better efficacy than placebo to reduce adhd symptoms. this study will also help us to understand the mechanism of adhd and give a way to develop new drug and also a more possible way to treat adhd children under 6 years old.

the accumulated neuro-image, hereditary and animal studies showed the correlation between glutamate transport dysfunction and adhd psychopathology. however, there is limited clinical trial to testify the effect of modulating the nmda receptor function of glutamate to treat adhd. glyti-m is an endogenous glycine transporter i inhibitor, and it acts on the glutamatergic synapse to modulate the neurotransmission of n-methyl-d-aspertate (nmda) receptor. this study aims to explore the effect of glyti-m among children with adhd.

Eligibility criteria:
inclusion criteria: * fulfill the criteria of adhd according to the diagnostic and statistic manual, fourth edition (dsm-iv). * subjects and parents agree to participate in the study and provide informed consent. exclusion criteria: * autism, mental retardation. * inability to follow protocol.

Keywords: adhd glyti-m
a study of attr-01 in participants with select epithelial solid tumours

Conditions: Solid Tumor, Adult

Summary: attr-01 is the experimental drug being studied in the attest clinical trial. the drug is made from a common cold virus that has been changed to only infect and multiply in cancer cells. this virus delivers an immune therapy drug into the cancer that is intended to promote a participant's own immune system to attack the cancer. the first part of this trial (sub-protocol a) is a phase 1 trial including dose escalation and expansion at one or more doses. it is the first time that attr-01 will be given to humans. if an optimal dose is identified, additional sub-protocols will be added by to further elicit whether attr-01 may successfully treat cancer. expanded access is not available.


Eligibility criteria:
inclusion criteria: * consenting male and female adults (18 years of age) with select solid epithelial tumour indications known to have high frequency (75 percent) of αvβ6 integrin receptor expression as detailed in the applicable sp. * received and failed/intolerant of standard of care (soc) therapy where eligible (not including neoadjuvant). * tumour lesion (not previously irradiated), suitable for safe pre- and post-treatment biopsies. * measurable disease by response evaluation criteria in solid tumours (recist) version 1.1. * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1. * minimum life expectancy anticipated to be greater than three months * willing to undertake appropriate measures of hygiene to prevent any spread of virus and protection of vulnerable individuals. * adequate organ function. * compliant with requirements for prior treatment washout and contraceptive measures applicable to genetically modified organisms (gmos) and cancer therapies * prior immune checkpoint antibody therapies as single agents or in combination with other anti-cancer agents is permissible. exclusion criteria: * significant degree of fibrotic disease, including autoimmune diseases (e.g. systemic lupus, rheumatoid arthritis) or idiopathic and occupation-related pulmonary fibrosis. * known prior history of intolerance to anti-programmed cell death protein 1 (pd-1) and/or anti-pd-l1 immunotherapy due to toxicity. * has any of the comorbid conditions listed in the detailed protocol exclusion criteria.
time restricted eating for the treatment of type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: innovative lifestyle strategies to treat type 2 diabetes (t2dm) are critically needed. at present, daily calorie restriction (cr) is the main diet prescribed to patients with t2dm for weight loss. however, many patients find it difficult to adhere to cr because calorie intake must be vigilantly monitored every day. in light of these problems with cr, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. this diet is called "time restricted eating" (tre) and involves confining the period of food intake to 6-8 h per day. tre allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. recent findings show that tre is effective for weight loss and improved glycemic control in patients with obesity and prediabetes. however no long-term randomized controlled trial has examined whether tre is safe and effective for patients with obesity and t2dm. this study is a 6-month randomized, controlled trial that aims to compare the effects of tre (eating all food between 12:00 pm to 8:00 pm, without calorie counting), versus cr (25% energy restriction daily), and a control group eating over a period of 10 or more hours per day, on change in body weight (%), glycemic control, and cardiometabolic risk factors, in adults with obesity and t2dm.


Eligibility criteria:
inclusion criteria: * age 18-80 years * bmi between 30 and 50 kg/m2 * previously diagnosed with type 2 diabetes * hba1c between 6.5 and 11% * sedentary or lightly active exclusion criteria: * hba1c below 6.5 or greater than 11% * have a history of cardiovascular disease * history of eating disorders (anorexia, bulimia, or binge eating disorder) * not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4%) * eating within less than a 10 hour window at baseline * perimenopausal (menses does not appear every 27-32d) * pregnant, or trying to become pregnant * night shift workers * smokers