Kornimate/medical-research-clean huggingface dataset:
dragon iii: neoadjuvant chemotherapy (flot versus sox) for gastric cancer

Conditions: Gastric Cancer; Chemotherapy Effect

Summary: safety and efficacy study of neoadjuvant chemotherapy (flot versus sox) for gastric cancer patients in high volume center of china

dragon iii research, neoadjuvant chemotherapy (flot versus sox) for gastric cancer, is an investigator initiated; phase ii, open label, randomised controlled study. this study will be conducted and analyzed by the gastrointestinal department（unit iii）of the ruijin hospital and the project is supported by the institute of digestive surgery, shanghai, which is a state key research center. this study will be monitored by the clinical research center of the ruijin hospital (official body which is responsible to guide and monitor all types of research at ruijin hospital). primary endpoint and secondary endpoint is described above. the aim of this study to obtain preliminary result and further conduct a large scale multi-center randomised controlled trial(rct) study.

Eligibility criteria:
inclusion criteria: * histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction. * clinical stage: ctnm: stage iii or above * performance status: eastern cooperative oncology group (ecog) ≤ 2 (normal to symptomatic but in bed less than half the day) * clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function. * written informed consent exclusion criteria: * clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia * confirmed distant metastases * locally advanced inoperable disease (clinical assessment) * relapse of gastric cancer * malignant secondary disease * prior chemo or radiotherapy * inclusion in another clinical trial * known contraindications or hypersensitivity for planned chemotherapy

Keywords: neoadjuvant chemotherapy perioperative chemotherapy systemic chemotherapy flot sox gastric cancer
effect of prp as therapy for shoulder osteoarthritis

Conditions: Shoulder Osteoarthritis

Summary: patients with shoulder osteoarthritis are suffering from pain and disabilities which lead to difficulties in life. the presence of platelet-rich plasma as regenerative therapy which helps in healing of damaged tissues like ligaments and joint might be of great benefit in managing such conditions.

primary and secondary osteoarthritis of the shoulder occurs due to destruction of the articular surface of the humeral head and glenoid , patient mainly presented with pain and decreases in the range of motion . treatment of shoulder osteoarthritis is often controversial and is typically based on the patient's age, the severity of symptoms, and level of activity, radiographic findings, and medical comorbidities. the new era of management include regenerative therapy ,platelet-rich plasma (prp) is one of the regenerative therapy that prove its effect as injections of a concentration of a patient's own platelets to accelerate the healing of injured tendons, ligaments, muscles and joints.

Eligibility criteria:
inclusion criteria: * patient's age: from 21 years. * acute symptoms on a background of at least a 3-month history of chronic pain or swelling of the shoulder joint with radiological confirmed (x-ray or mri) * mild or moderate osteoarthritis of the shoulder joint according to the samilson-prieto classification. * numerical rating scale for pain scores greater than five on a 10 scale exclusion criteria: * under 21 years of age * severe osteoarthritis according to the samilson-prieto classification. (figure 1) * neuropsychiatric disorders. * immunocompromised patients. * active infection or malignancy at the joint. * pregnancy and breastfeeding. * patients may have thrombocytopenia, bleeding disorders, or on anticoagulant therapy. * shoulder surgery within 3 months or inflammatory arthritis; previous infection of the shoulder joint.
the effects of rhus coriaria l. on serum lipid levels of patients with hyperlipidemia

Conditions: Hyperlipidemias

Summary: coronary heart disease and stroke are two main causes of human deaths and is directly related to increased levels of plasma lipids.high total cholesterol and low high density lipoprotein cholesterol concentrations are often associated with endothelium dysfunction and inflammation, which can be followed by atherosclerosis. rhus coriaria l. (rhus) with the public name of "somagh" is a plant species in the anacardiaceae family that is used as a food supplement, spice in middle east region (iran, turkey and arabic countries). in a double blind randomized placebo-controlled clinical trial, the investigators want to evaluate the effects of somagh (rhus coriaria l.) on serum lipid levels of patients with hyperlipidemia.

rhus (somagh) is found in temperate and tropical regions worldwide, often growing in areas of marginal agricultural capacity. rhus is used as an herbal remedy in traditional medicine because of its assumed analgesic, antidiarrhetic, antiseptic, anorexic and antihypergylcemic properties. the fruits of rhus contain flavonols, phenolic acids, hydrolysable tannins, anthocyans and organic acids such as malice, citric and tartaric acids. some studies have shown that polyphenols could have beneficial effects on cardiovascular disease and cancer and could be regarded as bioactive compounds with a high potential health-promoting capacity. phenolic compounds inhibit lipid peroxidation, scavenge the superoxide anion and hydroxyl radical, and enhance the activities of detoxifying enzymes.moreover, the hypocholesterolemic action of dietary polyphenols has been reported. the hypocholesterolemic effect of rhus fruit powder and its components have been reported previously in rabbits and mice.

Eligibility criteria:
inclusion criteria: * age: 20-65 years * serum triglyceride \>150mg/dl and/or total cholesterol \>= 240mg/dl exclusion criteria: * serum triglyceride \> 500 mg/dl * serum ldl-cholesterol at level which need drug treatment according to the patient risk categories (ncep-atp iii) * diabetes mellitus * hypo. or hyperthyroidism * any systemic illnesses e.g. liver cirrhosis, acute or chronic renal failure, heart failure * use of drugs: ocps, lipid lowering agents, thiazides * pregnancy * alcoholism * history of allergic reaction to somagh

Keywords: rhus cholesterol triglycerides lipids medicine, traditional herbal medicine
a study of the safety, tolerability, and pharmacokinetics of multiple-ascending dose basimglurant in healthy subjects and in patients with major depressive disorder (mdd)

Conditions: Major Depressive Disorder, Healthy Volunteer

Summary: the study will assess the safety, tolerability, and pharmacokinetics of basimglurant compared to placebo after multiple ascending oral doses for up to 22 days in healthy subjects and in patients with mdd on stable selective serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitor (snri) background therapy.


Eligibility criteria:
inclusion criteria: * 18 to 65 years of age, inclusive * body weight at least 50 kg * healthy male or female subjects (healthy cohorts) * body mass index (bmi) 18 to 30 kg/m\^2, inclusive (healthy cohorts) * nonsmoker for at least 90 days prior to dosing (healthy cohorts) * primary diagnosis of mdd without psychotic features (mdd cohort) * bmi 18 to 35 kg/m\^2, inclusive (mdd cohort) * current partial response to ongoing ssri or snri antidepressant treatment at an adequate dose and for at least 4 weeks (mdd cohort) * clinical global impression of severity (cgi-s) score 3 or greater (mdd cohort) * other regimens stable for at least 8 weeks prior to screening (mdd cohort) exclusion criteria: * pregnant or lactating women * history of alcohol or substance abuse in the past 6 months * hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) * clinically relevant electrocardiogram (ecg) abnormalities or a personal or family history of congenital long qt syndrome * participation in an investigational study within 90 days of screening * blood donation over 500 ml within 3 months of screening * hypersensitivity to any study medication or excipients * psychotic symptoms or comorbid mood disorder * significant suicide risk * major illness within 1 month before screening, or febrile illness within 1 week (healthy cohorts) * average alcohol consumption of more than 2 units per day (healthy cohorts) * multi-drug therapy for depression including antidepressants or adjunctive medications (mdd cohort) * prior use of basimglurant (mdd cohort) * cigarette use of greater than 1 pack per day (mdd cohort)
oral etrasimod versus placebo for the treatment of moderately to severely active ulcerative colitis in adult japanese participants (elevate uc 40 japan)

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult japanese participants with moderately to severely active ulcerative colitis (uc). this study is an extension of study apd334-302 (nct03996369). participants will continue with the same blinded treatment assigned in study apd334-302 for a total treatment duration of 52 weeks (12 weeks in study apd334-302 plus 40 weeks in study apd334-308).


Eligibility criteria:
inclusion criteria: participants with moderately to severely active ulcerative colitis (uc) are eligible to enroll into this study if they fulfill all of the following: * must have completed the week 12 visit of study apd334-302 * ability to provide written informed consent or assent (parent or legal guardian must provide consent for a participant \< 20 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. enrollment of participants \< 20 years should be conducted only if acceptable according to local laws and regulations. * both men and women subjects agree to use a highly effective method of birth control if the possibility of conception exists exclusion criteria: participants who meet any of the following exclusion criteria will not be eligible for enrollment into the study: * if the investigator considers the participant to be unsuitable for any reason to participate in the study * participants requiring partial or total colectomy during the apd334-302 study * participants requiring treatment with prohibited concomitant medications

Keywords: ulcerative colitis etrasimod apd334 uc
alternative approaches for nausea control

Conditions: Nausea

Summary: 216 chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. participants will be randomized to one of three study arms: arm 1: control; arm 2: expectancy-neutral handout + expectancy-neutral mp3+ acupressure bands; arm 3: expectancy-enhancing handout + expectancy-enhancing mp3 + acupressure bands. hypothesis: acupressure bands provided with the relaxation mp3 will be effective in controlling chemotherapy-induced nausea

earlier research has shown that the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy. the present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. all patients will receive a standardized antiemetic regimen. arm 1: control; arm 2: expectancy-neutral handout + expectancy-neutral mp3+ acupressure bands; arm 3: expectancy-enhancing handout + expectancy-enhancing mp3 + acupressure bands. the investigators hypothesize that acupressure bands provided with the relaxation mp3 will be effective in controlling chemotherapy-induced nausea. the two versions of the handout and mp3 are being examined to determine what is the most effective way to deliver the intervention.

Eligibility criteria:
inclusion criteria: * be female. * have a diagnosis of breast cancer, any stage. * be chemotherapy naïve and about to begin her first course of chemotherapy. * be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. they are: 1. chemotherapy regimen: doxorubicin/cyclophosphamide. antiemetic regimen: aprepitant + palonosetron + dexamethasone on day 1 and aprepitant + dexamethasone on days 2 \& 3. 2. chemotherapy regimen: doxorubicin/cyclophosphamide/docetaxel. antiemetic regimen: aprepitant + palonosetron + dexamethasone on day 1 and aprepitant + dexamethasone on days 2 \& 3. 3. chemotherapy regimen: docetaxel/carboplatin. antiemetic regimen: palonosetron on day 1 + dexamethasone on days 1, 2, \& 3. 4. chemotherapy regimen: docetaxel/cyclophosphamide. antiemetic regimen: palonosetron on day 1 + dexamethasone on days 1, 2, \& 3. note: fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron. * have a response of \> 3 or greater on a question assessing expected nausea as assessed on a 5-point likert-scale anchored at one end by 1 = "i am certain i will not have this," and at the other end by 5 = "i am certain i will have this." * be able to read english (since the assessment materials are in printed format). * be 18 years of age or older and give written informed consent. exclusion criteria: * have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist. * be receiving concurrent radiotherapy or interferon.

Keywords: nausea quality of life chemotherapy expectancy
self-injection and self-management

Conditions: Food Allergy

Summary: the purpose of the present study is to determine if asking adolescent patients (ages 13-17) to self-inject an empty syringe into their thigh during routine clinic visits results in increased reported comfort with self-injection, reduced anxiety regarding self-injection and food allergy management for both patient and caregiver(s), and in greater perceived likelihood of epinephrine self-injection, in the event of an emergency.

the purpose of the present study is to determine if asking adolescent patients (ages 13-17) to self-inject an empty syringe into their thigh during routine clinic visits results in increased reported comfort with self-injection, reduced anxiety regarding self-injection and food allergy management for both patient and caregiver(s), and in greater perceived likelihood of epinephrine self-injection, in the event of an emergency. forty participants, in total, will be recruited during routine visits to an outpatient allergy clinic. half of all participants will be randomized to the behavioral self-management intervention; whereby patients will insert a needle attached to an empty syringe into their thigh (simulating an injection of epinephrine); the other half of participants will be randomized to the control condition, and will be encouraged to speak to their physician about self-injection, but will not undergo the self-injection protocol. prior to randomization, baseline measures will be collected on patient's comfort with epinephrine self-injection. following the self-injection protocol and/or the discussion of self-injection with the physician, all participants will complete immediate post-intervention questionnaires at clinic about comfort with self-injection, health care management and anxiety. one month following the clinic visit, all patients will be sent a follow-up questionnaire that will include items identical to the ones completed at immediate post-intervention.

Eligibility criteria:
inclusion criteria: * patients seen in the outpatient clinic and their caretakers (no inpatients). * patients must have been diagnosed with food allergy and previously prescribed self-injectable epinephrine. * patients between the ages of 13-17 years old. * parent consent and child assent. exclusion criteria: * patients and caregiver(s) who have been diagnosed with cognitive barriers that prevent them from understanding the study, as determined by either: a previously diagnosed mental retardation or inability to repeat the study protocol at the time of consent.

Keywords: food allergy self-management epinephrine self-injection ntervention adolescents
impact of patient education on benzodiazepine use in the elderly

Conditions: Anxiety; Insomnia

Summary: the overall goal of this research is to develop and test strategies to decrease potentially inappropriate medication use among the elderly.

specifically, the purpose of the study is to determine whether direct patient education is effective in decreasing benzodiazepine use in seniors.

Eligibility criteria:
inclusion criteria: * men and women * full benefit members living in a sash facility * 60 years old or older * using at least 1 active short/medium/long acting benzodiazepine at time of recruitment exclusion criteria: * inability to provide consent * inability to communicate in english * diagnosis of severe mental illness, dementia, seizure disorder

Keywords: education geriatric benzodiazepine prevalence
the study is observational and retrospective: lifestyle, bmi and activity physical.

Conditions: Breast Cancer; Body Weight Change

Summary: the goal of this observational-retrospective study is to learn about the long-term effects of a lifestyle intervention inclusive of dietary counselling and physical activity advice, on body weight in female breast cancer survivors who took the intervention in previous years compared to those who did not take it. the main question it aims to answer is: does a long-term lifestyle intervention help to control body weight 5 years after breast cancer diagnosis? participants are asked to answer online survey questions about their anthropomethry, clinical conditions, socio-economical status, dietary habits, physical activity levels, quality of life, sleep quality and pshycological distress.

investigators will use data from 428 women with a 5-yr primary diagnosis of bc (stages i-iii at ages ≥30 \<75 anni). half of this sample (n=214) who followed integrated lifestyle treatment of behavioral modification of diet and physical activity conducted by pascale institute since 2016; the other half (n=214) will be patients who were eligible to participate but did not for logistic reasons. the present study aims to enroll 428 women with prior primary diagnosis of breast cancer. half of the patients (n = 214) had previously followed the lifestyle treatment of dedica trial on the modification of eating and physical activity habits (eudract n. 2015-005147-14) conducted by the oncologic institute pascale in naples (italy) since nov 2016; the other half of the patients were 214 who had refused to participate in the aforementioned trial for reasons unrelated to serious health conditions or progression of the disease.

Eligibility criteria:
inclusion criteria: 1. surgery for primary breast cancer performed at least 5 years prior to the interview. 2. women who have joined the dedica trial or who have refused to participate for reasons not related to serious health conditions or disease progression. 3. those who are able to sign the informed consent. exclusion criteria: 1. age \<30 years. 2. primary diagnosis of metastatic breast cancer. 3. diagnosis of other malignancies prior to the diagnosis of breast cancer. 4. those who are unable to sign the informed consent or who deny to be contacted by telephone.

Keywords: lifestyle study
retrospective observational study diana study

Conditions: Major Depressive Episode

Summary: this non-interventional study (nis) is intended to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion. this will address unmet medical needs of patients with a depressive episode related to rdd (icd-10, version 2010), who have failed to respond adequately to initial treatment with an antidepressant and contribute to an understanding of the usual approaches that physicians adopt to monitor initial treatment efficacy in rdd (recurrent depressive disorder). the study will also focus on second-line therapy in hard to treat patients, describing the different pharmacotherapeutic strategies.


Eligibility criteria:
inclusion criteria: 1. female or male aged between 18 and 65 years inpatients and outpatients diagnosed with an episode of major depression relating to rdd (icd-10, version 2010) during the period from january 1, 2012 till september 30, 2013 3. initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 weeks 4. initial treatment changed because of a suboptimal response at physician's discretion, which is clearly documented in the patient's medical chart. exclusion criteria: patients currently participating in any other clinical or non-interventional trial, or have completed their participation with the last 30 days. 2. patients with current psychiatric or general medical conditions which require concomitant use of lithium, thyroid hormones, or atypical antipsychotics 3. patients with unstable general medical condition. 4. patients who were pregnant or were suspected to be pregnant during the period when a patient had received treatment for mde (major depressive episode).

Keywords: recurrent depressive disorder depression depressive episode atypical antipsychotics