Kornimate/medical-research-clean huggingface dataset:
interaction study of clopidogrel 300/75 mg given alone or with omeprazole 80 mg 12 hours apart in healthy subjects

Conditions: Healthy

Summary: primary objective: * assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on adenosine diphosphate (adp)-induced platelet aggregation when given either alone in the morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours interval in healthy male and female subjects secondary objectives: * compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone alone in the morning, or in association with omeprazole in the evening at a 12-hours interval

the total study duration per subjects is 8-9 weeks broken down as follows: * screening: 2 to 21 days before the first dosing * period clopidogrel/placebo: 7 days including 5 days treatment * period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment * washout between periods: at least 14 days period after last dosing respect to clopidogrel treatment * end of study: at 7 to 10 days after the last dosing

Eligibility criteria:
inclusion criteria: healthy subject, * as determined by medical history, physical examination including vital signs and clinical laboratory tests. * with a body weight between 50 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a body mass index (bmi) between 18 and 30 kg/m² exclusion criteria: * evidence of inherited disorder of coagulation/hemostasis functions * smoking more than 5 cigarettes or equivalent per day * abnormal hemostasis screen * unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration * any contraindication to clopidogrel and/or omeprazole the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
examining the efficacy of scapular exercises on pain and function i̇n patients with lateral epicondylitis

Conditions: Lateral Epicondylitis

Summary: we aimed to investigate the effect of scapular exercises on pain and functioning in patients with lateral epicondylitis to achieve a more accurate result by using little-used emg between scapula and elbow muscles in the literature besides ongoing classical measurements and evaluations.

thirty patients who participated in the study were randomly divided into two groups. first group (n=15), conventional physiotherapy program and exercise, second group (n=15), in addition to the conventional physiotherapy program and exercises, scapula exercises were applied. patients were evaluated before and after treatment by vas, algometer, hand dynamometer, emg, uefs, prtee and dash questionnaires.

Eligibility criteria:
inclusion criteria: * cases diagnosed with lateral epicondylitis by the physician and decided to receive conservative treatment * not receiving nsaid or other medical treatment * untreated lateral epicondylitis for the last 6 months * cases with age range 18-75 * patients with pain and tenderness for at least 3 months exclusion criteria: * people with pacemakers or cardiac arrhythmias * tumoral disease * pregnant women * head and neck, elbow, scapula joint pathologies * acute infection * nerve or nerve root compression * other musculoskeletal problems

Keywords: lateral epicondylitis electromyography pain scapula
evaluation of safety and efficacy of ave5530 as add-on to ongoing high doses of statins in patients with primary severe hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the present study is assessing the efficacy and safety of ave5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment. the main objective is to evaluate the effects of the association ave5530+statin on ldl-c level reduction after 12 weeks of treatment. the effects of ave5530 on other lipid parameters will be assessed as secondary objectives.

the two doses of ave5530 tested in this study are 25 mg and 50 mg taken in the evening, with dinner dosing. the study will include a pre-randomization phase up to 6 weeks, a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.

Eligibility criteria:
inclusion criteria: * adults with severe primary hypercholesterolemia and cholesterol levels not controlled on ongoing stable statin treatment at maximum doses. exclusion criteria: * ldl-c levels \> 250 mg/dl (6.48 mmol/l) or \< 100 mg/dl (2.59 mmol/l) * triglycerides \>350 mg/dl (3.95 mmol/l) * conditions / situations such as: * presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels * active liver disease * recent history of congestive heart failure, of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or unstable or severe peripheral artery disease * positive test for hepatitis b surface antigen and/or hepatitis c antibody or known to be human immunodeficient virus (hiv) positive * pregnant or breast-feeding women, * women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the investigational product the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
remineralizing potential of biomimetic scaffolds on enamel white spot lesions

Conditions: White Spot Lesion

Summary: the modern concept in caries treatment focuses on the non-invasive approach and on the biomimetic remineralization of early non-cavitated white spot carious lesions. recently developed biomimetic scaffolds attempt to remineralize the dental tissues and are more regenerative than reparative.


Eligibility criteria:
inclusion criteria: * patients who at least have 1 white spot lesion. * no systemic diseases or taking any medication affecting salivary flow. * patients with good oral hygiene measures. * patients with moderate caries risk assessment. * post orthodontic wsls with international caries detection and assessment system (icdas ii) scoring criteria (1-2). exclusion criteria: * participant in another trial. * developmental non carious lesion (enamel hypoplasia and dental fluorosis). * presence of abnormal oral disease, or medically compromised patients. * participants who had evidence of reduced salivary flow or significant tooth wear. * allergy to milk products or other drug allergies.
transcranial direct current stimulation in the treatment of dyslexia.

Conditions: Dyslexia

Summary: the present study grounds on the absence of evidence-based treatment in individuals with dyslexia. at this topic, the present study will explore the potential effect of transcranial direct current stimulation (tdcs) over parieto-occipital brain regions, cerebral areas usually disrupted in individuals with dyslexia. tdcs will be administered without concomitantly training. therefore, the investigators hypothesized that active tdcs over parieto-occipital areas will enhance reading skills in children and adolescents with dyslexia. on the contrary, sham tdcs (placebo) over parieto-occipital areas will not have significant effect on reading. further, both active and sham tdcs will be safe and well-tolerated.

the study design is randomized stratified, cross-over, double-blind, placebo-controlled. children and adolescents with dyslexia will be selected and randomly assigned to two different groups: 1. active tdcs over parieto-occipital areas + sham tdcs over parieto-occipital areas (active-sham tdcs); 2. sham tdcs over parieto-occipital areas + active tdcs over parieto-occipital areas (sham-active tdcs). in this project, the investigators will work to understand whether a brain-based intervention, with the use of tdcs without combined training, can enhance reading in individuals with dyslexia. the protocol will allow the investigators to: 1. testing the efficacy of stand-alone tdcs in enhancing reading in individuals with dyslexia; 2. testing the critical role of brain regions (parieto-occipital areas) usually involved in reading and disrupted in dyslexia; 3. predicting outcomes based on reading-related skills; 4. investigating the safety and tolerability of tdcs; the overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in dyslexia.

Eligibility criteria:
inclusion criteria: * children and adolescents with dyslexia (dsm-5, apa 2013) * iq ≥ 85 exclusion criteria: * having a comorbidity with an important medical conditions; * having neurological diseases; * having epilepsy o family history of epilepsy; * receiving a treatment for dyslexia in the previous three months before the baseline screening;

Keywords: tdcs transcranial direct current stimulation transcranial electric stimulation developmental dyslexia specific learning disorders treatment
exercise plus activity strategy training for osteoarthritis

Conditions: Osteoarthritis

Summary: purpose: to study the effects of two different rehabilitation programs for people with osteoarthritis of the hip or knee. hypothesis 1: participants who received activity stratgey training will report less pain and physical disability at 8-weeks and 6-months follow-up. hypothesis 2: participants who receive activity strategy training will have a greater increase in physical activity as measured by a wrist-worn accelerometer. hypothesis 3: participants who receive activity stratgey training will report greater improvements in health-related quality of life.

we are testing the effectiveness of a targeted intervention for older adults with hip and/or knee osteoarthritis (le-oa) using an occupational therapy treatment approach to promote activity engagement. we believe that it is necessary to tailor this intervention to the specific needs of older adults with le-oa. based on the literature, exercise is a necessary component of an intervention for older adults with le-oa. however, this should also be coupled with an activity strategy training (ast) component designed to promote lifestyle changes and thus more lasting effects. the ast component is based on occupational therapy principles and will include behavioral and environmental strategies to increase activity engagement.

Eligibility criteria:
inclusion criteria: * minimum age of 62 years * meet acr clinical criteria for either hip or knee oa * ambulatory (with or without assistance) * requiring assistance or report difficulty in \>=1/4 activities of daily living * ability to speak english exclusion criteria: * knee/hip surgery within the previous 9 mos. * current participation in physical/occupational therapy * any contraindication to exercise activities * cognitive impairment * inability to provide informed consent

Keywords: pain activities of daily living symptoms self-management
a study to evaluate food effect on ono-5920/ym529 intermittent formulation

Conditions: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases

Summary: the aim of the study is to evaluate the effects of food intake on the plasma concentration profile of yno-5920/ym529 in post menopausal women.


Eligibility criteria:
inclusion criteria: * post menopausal women (at least 2 years after menopause) * body weight: more than 40.0 kg and less than 70.0 kg * bmi: more than 17.6 and less than 30.0 exclusion criteria: * receives investigational drug within 120 day before the study * blood donation before the study * with abnormal laboratory values

Keywords: ono-5920 ym529 minodronic acid food effect
the effectiveness and safety of human lumbar puncture assist device (lpat)

Conditions: Meningitis; Encephalitis; Guillain-Barré; Subarachnoid Hemorrhage; Intracranial Neoplasm; Intracranial CNS Disorder

Summary: the purpose of this study is to proof and investigate the effectiveness and safety of the invented device named "human lumbar puncture assist device (lpat)" as an assist tool to be utilized to improve the success rate of performing lumbar puncture (lp), avoid side effects from multiple punctures, avoid excess radiation if the lp need to be done under fluoroscopy, and need to obtain none traumatic tap for better csf analysis.

"human lumbar puncture assist device (lpat)" was invented as an assist tool to be utilized to improve the success rate of performing lumbar puncture (lp), avoid side effects from multiple punctures, avoid excess radiation.

Eligibility criteria:
inclusion criteria: patients age 12 years and older who need lumbar puncture (lp) for diagnostic purposes or patients already underwent lp but failed to obtain cerebrospinal fluids i.e. "unsuccessful tap" exclusion criteria: patients younger than 12 years of age
using a motivational interviewing (mi) informed text messaging program to lower blood sugar in diabetic patients.

Conditions: Type II Diabetes Mellitus

Summary: despite advances in medical therapy for diabetes, significant numbers of patients fail to achieve adequate blood glucose control. diabetic patients who engage in more self-care behaviors have better glycemic control, as measured by hba1c. patient "activation", defined as the knowledge, skills, beliefs, and behaviors to manage a chronic disease, is key to the performance of these self-care behaviors. there is a growing literature on diabetes behavioral change interventions; however interventions are often developed and implemented without consideration of patients readiness to engage in lifestyle changes. additionally, patient-tailored interventions require intensive clinical and financial resources, making them difficult to integrate into clinical practice. mobile text messaging (sms) programs have been successfully used to promote smoking cessation, alcohol cessation, and weight loss in diverse patient populations. sms interventions for diabetes have also been developed, but they have been designed primarily to provide feedback on blood glucose management, rather than to motivate behavioral change. the few studies that included motivational content as a primary feature, did not tailor their intervention to a patient's readiness for change or rigorously describe their motivational intervention, and show limited efficacy. to address these concerns, we will perform a three-month randomized controlled pilot study to develop and test a motivational interviewing (mi)-informed sms intervention tailored to patient level of activation for patients with poorly controlled type ii diabetes.


Eligibility criteria:
inclusion criteria: * age 18 or older * type ii diabetes * poorly controlled diabetes (hba1c \>8 x 2 measurements, with goal \< 8) exclusion criteria: * pregnancy * non-english speaking or reading
resminostat (4sc-201) in relapsed or refractory hodgkin's lymphoma

Conditions: Hodgkin's Lymphoma

Summary: the purpose of this study is to determine whether resminostat (4sc-201) is effective and safe in the treatment of relapsed or refractory hodgkin's lymphoma.


Eligibility criteria:
main inclusion criteria: * patients must have histological or cytological evidence of hodgkin's lymphoma (all subtypes are acceptable) * patients must have relapsed or refractory hodgkin's lymphoma (hl) defined as relapse following initial therapy or lack of response to first line therapy and treatment with second-line (salvage therapy). patients may have also undergone high-dose chemotherapy with autologous stem cell transplantation at least 12 weeks prior to study entry * patients must have measurable anatomical disease present on ct scan * patients must have an ecog performance score of 0, 1 or 2 main exclusion criteria: * patients who have received previous treatment with an hdac inhibitor * patients who have undergone allogeneic hematopoietic stem cell transplantation * patients with known or suspected involvement of the cns by hl * patients treated with agents known to prolong the qt interval or with a confirmed qtcf \> 450 msec * patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current psa \< 0.1 ng/ml; or cervical intraepithelial neoplasia * patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness that could preclude their participation in the trial, pose an undue medical hazard or interfere with the interpretation of the trial results, including, but not limited to, patients with congestive heart failure (nyha class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring \> 2 medications for adequate control; diabetes mellitus with \> 2 episodes of ketoacidosis in the preceding 12 months

Keywords: hodgkin's lymphoma hdac 4sc-201 resminostat phase ii
a study of ramucirumab (ly3009806) in healthy participants

Conditions: Healthy

Summary: this study evaluates a new formulation of ramucirumab, a drug approved for several types of cancer. in this study of healthy participants, a small amount of ramucirumab will be given by injection either into a vein or just under the skin. study doctors will measure the amount of ramucirumab in the bloodstream. side effects and tolerability will be documented. the study will last for about 16 weeks for each participant, including screening and follow up. screening is required within 28 days prior to entering the study.


Eligibility criteria:
inclusion criteria: * overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion) * have a body weight greater than or equal to (≥)70 kilograms (kg) and body mass index (bmi) of 18 to 32 kilogram per square meter (kg/m ²), inclusive * have normal blood pressure, pulse rate, electrocardiogram (ecg), and blood and urine laboratory test results that are acceptable for the study exclusion criteria: * are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study * have previously participated or withdrawn from this study * have or used to have health problems or laboratory test results or ecg readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * had blood loss of more than 500 milliliters (ml) within the previous 30 days of study screening
eribulin as a second-line treatment in triple-negative advanced breast cancer

Conditions: Breast Cancer; Metastatic Breast Cancer; Triple Negative Breast Cancer

Summary: multicenter, retrospective and prospective, cohort, observational study evaluating the clinical efficacy and tolerability of eribulin as second-line treatment in accordance with the indications authorized by aifa in patients with triple negative advanced breast cancer in a real world setting.

the study, multicenter, retrospective and prospective, cohort, observational, describes the modalities of treatment with eribulin as a second line therapy for triple negative breast cancer and "clinical outcomes" in a population real-world, evaluating any differences with the results obtained in clinical trials. therapeutic sequences will also be evaluated with the aim of providing a photograph of the choices made in clinical practice in this historical moment characterized by rapid evolution of new molecules available to clinicians. a total of at least 200 patients with triple negative advanced breast cancer treated with eribulin as second line will be enrolled in the retrospective or prospective cohort. enrollment period will last 2 years. pseudoanonymized data will be collected in a electroctronic database (redcap cloud); here the list of the main variables collected: * patient registration * demography * pregnancy test * past history and habits of the patient * previous antineoplastic therapy * anamnesis close to entering the study * vital signs and ecog performance status (who) * blood chemistry tests * recist 1.1 baseline and re-evaluations * 12 lead ecg evaluation * eribulin cycles * adverse events * previous and concomitant medications * end of study the retrospective analysis of the choices made in clinical practice and the benefits obtained from the second therapeutic lines could provide important data to favor the definition of prospective randomized studies, and guide the clinician towards a better therapeutic path.

Eligibility criteria:
inclusion criteria: * performance status according to ecog equal to 0-2 * locally advanced or triple negative metastatic breast cancer (hr- and her2-) confirmed histologically * progressing after first-line chemotherapy for advanced disease * previous anthracyclines and taxanes therapy (in an adjuvant, neoadjuvant or metastatic), unless the patient is ineligible to receive such treatments * treatment with eribulin mesylate since 2017, in accordance with aifa indications * adequate haematological, renal and hepatic function, as per clinical practice * written informed consent exclusion criteria: * breast cancer her2 + or hr + * treatment with eribulin in the context of clinical studies * patients unsuitable for treatment with eribulin * diagnosis of other malignancies in the two years prior to enrollment, with one exception of adequately treated localized basal cell or squamous cell carcinomas of the skin o cervical carcinomas undergoing curative treatment

Keywords: breast cancer triple negative second line eribulin real world
the effect of preoperative hemotologic markers on postoperative long-term and short-term outcomes for laparoscopic gastrectomy

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to explore the effect of preoperative hemotologic markers on postoperative long-term and short-term outcomes for laparoscopic gastrectomy.

a prospective cohort study will be performed to explore the effect of preoperative hemotologic markers on postoperative long-term and short-term outcomes for laparoscopic gastrectomy.the evaluation parameters are perioperative clinical efficacy, postoperative complications and 3-year survival and recurrence rates.

Eligibility criteria:
inclusion criteria: * age from 18 to 75 years * primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * ct2-4a, n0-3, m0 at preoperative evaluation according to the american joint committee on cancer (ajcc) cancer staging manual seventh edition * no distant metastasis is observed. and the spleen, pancreas or other adjacent organs are not involved by the tumor. * performance status of 0 or 1 on eastern cooperative oncology group scale (ecog) * american society of anesthesiology score (asa) class i, ii, or iii * written informed consent exclusion criteria: * women during pregnancy or breast-feeding * severe mental disorder * history of previous upper abdominal surgery (except laparoscopic cholecystectomy) * history of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * enlarged or bulky regional lymph node envelop important vessels * history of other malignant disease within past five years * history of previous neoadjuvant chemotherapy or radiotherapy * history of unstable angina or myocardial infarction within past six months * history of cerebrovascular accident within past six months * history of continuous systematic administration of corticosteroids within one month * requirement of simultaneous surgery for other disease * emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * fev1\<50% of predicted values