Kornimate/medical-research-clean huggingface dataset:
minimal clinical important change of the turkish versions of the fabq tks, and pcs in patients with chronic neck pain

Conditions: Neck Pain; Kinesiophobia; Fear of Movement

Summary: to investigate the reliability and sensitivity of the fear-avoidance beliefs questionnaire, tampa kinesiophobia scale, and pain catastrophizing scale in patients with chronic nonspecific neck pain undergoing multidisciplinary rehabilitation and to determine the most appropriate minimally clinically significant difference values in order to increase confidence in their use in clinical practice and research for this patient population. therefore, the current study aims to evaluate the answerability and minimal clinical significance of the turkish versions of the fear-avoidance beliefs questionnaire, tampa kinesiophobia scale, and pain catastrophizing scales in patients with non-specific chronic neck pain.

to investigate the reliability and sensitivity of the fear-avoidance beliefs questionnaire, tampa kinesiophobia scale, and pain catastrophizing scale in patients with chronic nonspecific neck pain undergoing multidisciplinary rehabilitation and to determine the most appropriate minimally clinically significant difference values in order to increase confidence in their use in clinical practice and research for this patient population. therefore, the current study aims to evaluate the answerability and minimal clinical significance of the turkish versions of the fear-avoidance beliefs questionnaire, tampa kinesiophobia scale, and pain catastrophizing scales in patients with non-specific chronic neck pain.

Eligibility criteria:
inclusion criteria:a definitive diagnosis of chronic nonspecific neck pain (documented history of neck pain lasting more than twelve weeks without a recognizable, specific pathoanatomical cause of the pain) * good turkish communication skills * both genders must be between the ages of 18 and 65, * agreeing to participate in the research and signing the voluntary consent form exclusion criteria: * systemic disease, cognitive impairment (mini mental state examination \<24), * recent (\<12 weeks) myocardial infarction, cerebrovascular accident * rheumatoid arthritis, neurological disorders, radiculopathy, infection, tumor, osteoporosis, vertebral fracture, trauma and surgery in the cervical region. * having previously received any exercise therapy and/or pain neuroscience training. * refusal of treatment or failure to comply with treatment (
randomized and multicenter study to evaluate a customizable support breast cancer material

Conditions: Breast Cancer; Knowledge, Attitudes, Practice; Patient Empowerment; Patient Satisfaction

Summary: the goal of this clinical trial is to evaluate if a customizable support material allows to improve the knowledge about the stage and subtype of the disease, as well as the indicated treatments, in comparison with a non-customizable support material among patients with breast cancer. the main question it aims to answer is: • what is the impact of delivering a customizable support material so that patients with breast cancer know and remember the stage and subtype of their disease, as well as the indicated treatments, compared to non-customizable support material? participants in the intervention group will be provided customizable support material while those in the standard group will receive a non-customizable material.

in the present investigation, it is planned to carry out a prospective, multicenter study, randomized and blinded to the statistician. patients with a recent diagnosis of cm and who are scheduled to have their first consultation in which their options will be discussed of treatment to participate in the study. to those who agree to participate and sign the informed consent, the protocol coordinator of each center will randomly assign them to the intervention group or the standard group (in a 1:1 ratio) before the appointment medical. the intervention group will receive customizable support material while the standard group will receive a non-customizable material (annex 2). additionally, you will be instructed to the intervention group that the support material received can be filled with the information discussed with the medical team. the protocol coordinator will obtain sociodemographic data and clinicopathology of the medical records of the participants. after the next visit follow-up, the coordinator will apply to both groups questionnaires about the knowledge of the patient about his own disease, satisfaction with the support material received and perceived ability to participate in discussions about their treatment, and the comprehension of written materials (chlt-6). after one month, both groups will respond knowledge questionnaires to assess long-term information retention, disease uncertainty (sf-muis) and satisfaction with medical information provided (eortc-qlq-info25).

Eligibility criteria:
inclusion criteria: * women with a recent diagnosis of primary breast cancer treated at the participant centers * women who will receive information about their options for the first time treatment * provision of informed consent to participate in the study exclusion criteria: * patients who have already started systemic treatment for breast cancer * patients with medical records not available for data collection

Keywords: breast cancer patient education written information shared decision making latin america
a comparison of mometasone to advair in patients with milder persistent asthma

Conditions: Asthma

Summary: the research hypothesis for the proposed study asks the question, can asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, advair® in control of mild persistent asthma? the purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (asmanex®) is comparable to combination therapy with advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.


Eligibility criteria:
inclusion criteria: * subjects 18 to 65 years of age * a \>2 year history of asthma * fev1 \> 80% for subjects currently using advair®. exclusion criteria: * severe asthma * current smokers * pregnant or breast-feeding women * other chronic significant illnesses
effects of cognitive training on speech perception

Conditions: Hearing Loss; Deafness and Auditory Perception

Summary: in this study, the investigators are testing whether cognitive training can lead to improvements in speech perception for individuals with hearing loss. individuals will complete 20 hours of cognitive training that is designed to improve cognitive abilities such as short term memory and attention. the investigators predict that cognitive training that improves the cognitive abilities affected by hearing loss will improve speech perception.


Eligibility criteria:
inclusion criteria: * able to come to dalhousie university, halifax, nova scotia, canada for study visits * adults (50 years or older) with mild to moderate hearing loss * access to an internet-connected device that is able to use flash media, basic computer skills * medically stable participants * not currently taking medication that may affect brain function (e.g., anti-anxiety medication) * normal or corrected-to-normal vision exclusion criteria: * participants with neurological conditions such as epilepsy or concussions will be excluded for safety reasons * participants who are not native english speakers (materials used in the study are only in english) * participants who are unable to provide consent * participants with impaired cognition (assessed with the montreal cognitive assessment) * participants with high accuracy on the speech perception in noise task at the second study visit (to eliminate participants who may be performing at ceiling level)

Keywords: hearing loss speech perception cognitive training cognitive fitness memory, short-term
an efficacy, safety, and tolerability study for ta-7284 in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to demonstrate the efficacy, safety, and tolerability of ta-7284 compared with placebo in patients with type 2 diabetes.

type 2 diabetes mellitus (t2dm) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. various classes of orally administered antihyperglycemic agents have been developed for the treatment of t2dm and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, resulting in high rates of morbidity and mortality in the diabetic population. this is a randomized, double-blind, placebo-controlled, parallel-group study to demonstrate the efficacy, safety, and tolerability of ta-7284 compared with placebo in patients with t2dm, who are not optimally controlled on diet and exercise. the primary study hypothesis is that the study drug will be superior to placebo as assessed by the change in hba1c from baseline. the patients will receive tablets of ta-7284, or placebo, once daily for 12 weeks.

Eligibility criteria:
inclusion criteria: * aged from 20 to 80 years inclusive on the day of informed consent; * patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period; * patients with hba1c of ≥6.5% and ≤9.5% (according to the japan diabetic society \[jds\] criteria) on the start day of the run-in period; exclusion criteria: * type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, cushing's syndrome, etc.); * past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage iii or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy); * fasting blood glucose of \>270 mg/dl on the start day of the run-in period or at week 2 of the run-in period; * egfr of \<60 ml/min/1.73 m2 on the start day of the run-in period; * systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg on the start or end day of the run-in period; * history of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period; * concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease; * past or current history of malignant tumor; however, this criterion shall not apply to those who have been free of relapse for at least 5 years even with a history of malignant tumor. * past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms; * pregnant women, lactating mothers, or women of childbearing potential; * any condition that subjects are assessed to be ineligible by the investigator (sub investigator).

Keywords: ta-7284 jnj-28431754 canagliflozin type 2 diabetes mellitus sodium glucose co-transporter (sglt2 inhibitor)
adherence, improvement measure (aim) system

Conditions: Patient Compliance; AIDS

Summary: in this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing phr that uses cellular phone short message service (sms) reminders and patient responses to the reminders. we will compare adherence rates in both arms as assessed by antiretroviral medication concentrations in hair samples and self-report; clinical outcomes will also be compared in the two arms. the project will examine medication adherence for antiretroviral medications and treatments of common conditions such as depression, hypertension, diabetes and hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * older than 18 * evidence of hiv-1 infection, based on patient's medical history or results of laboratory tests * detectable viral load, based on patient's medical record * receiving primary medical care at the aids program at sfgh * able and willing to give informed consent to be randomized to study arms * willing to use the patient portal * has a cell phone with ability to receive and send unlimited sms texts, patient of the hiv/aids clinic at ward 86, sfgh exclusion criteria: failure to meet inclusion criteria -

Keywords: hiv, antiretroviral, adherence, sms, cell phone
testosterone in metastatic renal cell carcinoma patients

Conditions: Metastatic Renal Cell Carcinoma

Summary: purpose to determine efficacy and safety of testosterone in male patients with metastatic renal cell carcinoma and fatigue receiving targeted therapy or checkpoint inhibitors.

fatigue is a frequent symptom of metastatic renal cell carcinoma (rcc), and most common adverse event of targeted and immunotherapy. in phase 3 pivotal studies, 56% (9%, grade 3-4), 54% (11%, grade 3), 37% (10%, grade 3-4) and 20% (2%, grade 3) of patients had fatigue during the therapy of cabozantinib, sunitinib, axitinib or pazopanib, respectively. 59% (14%, grade 3) and 31% (5%, grade 3) of patients treated with lenvatinib/everolimus and everolimus had fatigue in registrational trials. finally, 33% (2%, grade 3-4) of patients that received nivolumab had fatigue in checkmate 025 study. testosterone may help to relieve fatigue associated with the use of tyrosine kinase, mtor or checkpoint inhibitors. additionally, testosterone could impact on poor prognostic factors of rcc (anemia, ecog performance status, serum calcium). this will be first clinical trial which evaluates safety and efficacy of testosterone in rcc patients.

Eligibility criteria:
inclusion criteria: 1. histologically proven clear cell renal cell carcinoma; 2. ct-confirmed metastatic measurable disease; 3. first-line sunitinib or pazopanib treatment with fatigue; 4. low level of testosterone; 4. male, 18 years and older; 5. normal psa level exclusion criteria: 1. prostate and other cancers history 2. hypothyroidism 3. history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., new york heart association class iii or iv)
care canadian als riluzole evaluation

Conditions: Amyotrophic Lateral Sclerosis

Summary: evaluate the efficacy of riluzole 50-mg bid defined by comparing the percentage of riluzole-treated subjects who experienced death, permanently assisted ventilation (pav) or tracheostomy, to a group of recent historical controls for the treatment of amyotrophic lateral sclerosis (als).


Eligibility criteria:
inclusion criteria: * diagnosis of als confirmed by the following definition: (a)"probable" or "definite" amyotrophic lateral sclerosis (als) according to the el escorial criteria(b)"peripheral" onset form (limb involvement) or a "bulbar" form of als with a duration of five years, based on inquiry for the earliest symptoms of the disease * a subject who simultaneously presents with bulbar and peripheral signs at onset of als disease should be stratified to the bulbar onset group. the neurologic progression of such subjects matches that of the bulbar onset als subjects. * pulmonary function: forced vital capacity (fvc) must be 3 60% at study entry. * females of childbearing potential must be documented to be using acceptable birth control methods such as an iud or oral contraceptives. exclusion criteria: * previous treatment with riluzole * tracheostomy, or expected to undergo a tracheostomy within two months after study inclusion * signs of clinical dementia and/or major psychiatric disorders * serious concomitant disease or handicap likely to interfere with the subject's assessments or impact on the subject's survival * a multiple conduction block has been shown on nerve conduction studies by electromyogram the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
roman: phase 3 trial investigating the effects of gc4419 on radiation induced oral mucositis in head/neck cancer patients

Conditions: Oral Mucositis

Summary: the purpose of the phase 3, clinical study is to determine if gc4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (imrt) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.


Eligibility criteria:
inclusion criteria: * squamous cell carcinoma of the head and neck * treatment plan to receive imrt delivered as single daily fractions of 2.0 to 2.2 gy with a cumulative radiation dose of 60-72 gy * treatment plan to receive standard cisplatin monotherapy * age 18 years or older * eastern cooperative oncology group (ecog) performance status ≤ 2 * adequate hematologic, renal and liver function * negative serum pregnancy test * use of effective contraception exclusion criteria: * tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands * metastatic disease * prior radiotherapy to the region of the study cancer or adjacent anatomical * prior induction chemotherapy * receiving any approved or investigational anti-cancer agent other than those provided for in this study * concurrent participation in another interventional clinical study * inability to eat soft solid food at baseline * malignant tumors other than hnc within the last 5 years * active infectious disease excluding oral candidiasis * presence of oral mucositis at baseline * known history of hiv or active hepatitis b/c * female patients who are pregnant or breastfeeding * known allergies or intolerance to cisplatin and similar platinum-containing compounds * requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure

Keywords: oral mucositis superoxide dismutase mimetic cisplatin intensity-modulated radiation therapy chemoradiation om imrt head and neck cancer squamous cell carcinoma scc oral cavity oropharnyx mouth sores avasopasem mangenese
clevidipine in the perioperative treatment of hypertension (eclispe-snp)

Conditions: Hypertension

Summary: the purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. approximately 250-500 patients with perioperative hypertension undergoing coronary artery bypass grafting (cabg), off-pump coronary artery bypass (opcab) or minimally invasive direct coronary artery bypass (midcab) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or sodium nitroprusside.

the primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, mi and renal dysfunction in the clevidipine and sodium nitroprusside treatment groups from the initiation of study drug infusion through postoperative day 30. secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (bp) lowering effect and additional safety variables.

Eligibility criteria:
prerandomization inclusion criteria: * provide written informed consent before initiation of any study related procedures. * be at least 18 years of age * be scheduled for coronary artery bypass grafting (cabg), off pump coronary artery bypass (opcab), minimally invasive direct coronary artery bypass (midcab) surgery, and/or valve replacement/repair surgery prerandomization exclusion criteria: * women of child-bearing potential (unless they have a negative pregnancy test) * recent cerebrovascular accident (within 3 months before randomization) * known intolerance to calcium channel blockers * known or suspected hypersensitivity to sodium nitroprusside * allergy to soybean oil or egg lecithin (components of the lipid vehicle) * pre-existing permanent ventricular pacing * any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial * participation in another therapeutic drug or therapeutic device trial within 30 days of starting study postrandomization inclusion criteria: * determined to be hypertensive perioperatively as determined by the investigator

Keywords: perioperative hypertension
can 3d kinematic parameters assess the symptomatic and functional severity of koa?

Conditions: Osteoarthritis,Knee

Summary: there is little study focusing on kinematic parameters in the assessment of the symptomatic and functional severity of knee osteoarthritis (koa). the purpose of this study is to evaluate the correlations between kinematic parameters and the severity of symptoms and functions in patients with koa.


Eligibility criteria:
inclusion criteria: 1. age\> 50 years 2. body mass index\<30; 3. confirmed radiographically and assessed according to kl score; 4. knee pain in their knees at least three months; 5. absolute medial compartment koa according to atlas criteria13; 6. able to walk unaided exclusion criteria: 1. history of knee surgery; 2. corticosteroid or sodium hyaluronate injection within 6 months; 3. neuropathic arthropathy or rheumatoid arthritis; 4. any other muscular or neurological diseases that affected the condition of the lower limbs; 5. any treatments or training (e.g. kneepad) to improve the symptoms of koa; 6. history of foot/ankle/hip injury or disease; 7. unable to walk independently; 8. history of heart disease; 9. lateral koa according to atlas criteria13; 10. body mass index\> 30; 11. age\> 90 years; 12. unable to finish the procedure

Keywords: osteoarthritis, knee womac gait kinematics
national covid-19 surveillance physicians

Conditions: Antibody COVID-19

Summary: the investigators will analyze the presence of antibodies against sars-cov2 in physicians working in emergency and intensive care medicine and in those who treat covid 19 patients.


Eligibility criteria:
inclusion criteria: * qualified as physician exclusion criteria: * none
phase 2a study of iw-9179 to treat functional dyspepsia

Conditions: Dyspepsia; Functional Gastrointestinal Disorders

Summary: the objectives of this study are to determine the safety and efficacy of iw-9179 administered to patients with functional dyspepsia (fd).


Eligibility criteria:
inclusion criteria: * patient meets rome iii criteria for functional dyspepsia (fd) * patient has a normal esophagogastroduodenoscopy (egd) either during the screening period or within 2 years of the screening visit * patients who either: 1. have not used a proton pump inhibitor (ppi) within 4 weeks of the screening visit, or 2. have used a ppi at a stable dose for at least 4 weeks prior to the screening visit; * patient meets symptom severity criteria in the pretreatment period * patient is fluent and literate in dutch, french, or english exclusion criteria: * patient meets criteria for gastroesophageal reflux disease (gerd, stable regimen of ppis acceptable), constipation, diarrhea, lower abdominal pain, or gastroparesis * patient has a history of inflammatory bowel disease, chronic pancreatitis, small intestinal bacterial overgrowth, celiac disease, lactose intolerance, polycystic kidney disease, interstitial cystitis, or scleroderma * any significant neurological disease or a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable; complete remission of other cancers for 5 years or longer is also acceptable) * history of active alcoholism or drug addiction within 12 months prior to the screening visit * hospitalized for a psychiatric condition or has made a suicide attempt during the two years before the screening visit * any organic or structural disease that can cause abdominal pain or discomfort