Kornimate/medical-research-clean huggingface dataset:
tislelizumab plus folfox versus pof in the treatment of locally advanced: a multicenter, open-label, randomized phase iii studyunresectable or metastatic gastric/gastroesophageal junction adenocarcinoma

Conditions: Gastric Cancer

Summary: to compare the efficacy and safety of tislelizumab combined with folfox or combined with pof in the treatment of locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma with cps≥1


Eligibility criteria:
inclusion criteria: * patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction. * 18-70yeas. * ecog ps 0-1. * no previous chemotherapy (perioperative chemotherapy, six months after fluorouracil alone or one year after oxaliplatin or a combination of taxoid and fluorouracil can be included), radiotherapy or immunotherapy. * with normal marrow, liver and renal function: a hemoglobin (hgb) of ≥100g/l (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/l; a platelet count of ≥100×109/l; a total bilirubin (tbil) of ≤1.5 upper normal limitation (unl); a creatinine (cr) of ≤ 1.5 unl; a creatinine clearance rate ≥ 50ml/min (cockcroft-gault); a alanine aminotransferase (alat) and aspartate aminotransferase (asat) of ≤2.5 unl or ≤5 unl in case of liver metastasis. * life expectancy ≥3 months. * with normal electrocardiogram results and no history of congestive heart failure. * with normal coagulation function: activated partial thromboplastin time (aptt), prothrombin time (pt) and inr, each ≤ 1.5 x uln. * female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of tislelizumab until 8 weeks after discontinuing study drug. male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug. * with written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors. * have a known pd-l1 cps/mmr (or msi) /her2(fish) test result, or have sufficient samples for relevant testing. exclusion criteria: * patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer. * patients with brain or central nervous system metastases, including leptomeningeal disease. * pregnant (positive pregnancy test) or breast feeding. * serious, non-healing wound, ulcer, or bone fracture. * significant cardiac disease as defined as: unstable angina, new york heart association (nyha) grade ii or greater, congestive heart failure, history of myocardial infarction within 6 months evidence of bleeding diathesis or coagulopathy. * history of a stroke or cva within 6 months. * clinically significant peripheral vascular disease. * hiv-positive, active hepatitis b or c (hbv, hcv); * inability to comply with study and/or follow-up procedures. * patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial. * her2-positive (ihc 3+ or 2+/fish+) patients.
validation of an allergic rhinitis control test in children

Conditions: Allergic Rhinitis

Summary: allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. several tools exist for assessing control of allergic rhinitis, but none has been validated in teenagers or in children. a study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (arct) in patients from 12 years of age. we propose to adapt arct adult to pediatric population from 5 to 11 years old.


Eligibility criteria:
inclusion criteria: * patients aged 5 to 11 years old, consulting a practitioner for an allergic rhinitis * parents formulated their study participation agreement by signing the consent form. exclusion criteria: * patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatment.

Keywords: allergic rhinitis
to assess with ezefeno tab. in patients with dyslipidemia and t2dm

Conditions: T2DM (Type 2 Diabetes Mellitus); Dyslipidemias

Summary: the goal of this randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. the primary endpoint are: * major adverse cardiovascular events within 48 months of the trial duration * microvascular events within 48 months of the trial duration

a prospective, randomized, open-label, parallel, multicenter, active-drug-controlled clinical trial to assess the long-term efficacy and safety of combined therapy with ezefeno tab. in patients with dyslipidemia who do not achieve adequate control of non-hdl-c levels even with moderate-intensity monotherapy.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes diagnosed by american diabetes association criteria * age ≥ 19 years * non-hdl-c ≥100 mg/dl, tg ≥200, \<500 mg/dl on moderate-intensity statins * with cardiovascular risk factor exclusion criteria: * pregnant or breastfeeding women * uncontrolled hyperglycemia(more than 12.0% for subject treated with anti-diabetic treatment.) * patient with myopathy and rhabdomyolysis * ast/alt more than 3 uln * clinical evidence of genetic disorders such as galactose intolerance, lapp lactose deficiency, and/or glucose-galactose malabsorption
the effect of therapeutic touch on exam anxiety

Conditions: Test Anxiety

Summary: aim: this study was planned to determine the effect of therapeutic touch applied to nursing students on test anxiety. method: students who met the inclusion criteria were divided into therapeutic touch and control groups using the randomization method. after the groups were determined, the students filled out the introductory information form and the state exam anxiety scale. 30 minutes before the exam, therapeutic touch was applied to each of the students, who were divided into groups, for 20 minutes. no application was made to the control group, and they were told to wait in the classroom where the group was waiting as they wished.immediately after the application was completed, the scale was re-applied to both groups.

test anxiety is a condition that has cognitive, emotional and physiological aspects and causes unwanted and disturbing emotions during the exam. it can inhibit the mental perception needed to do well on an exam, as well as the clear thinking skills and memory needed to study effectively.the person may feel anxious, worthless or disorganized, experience rapid heartbeat, headaches and stress; they may compare themselves with their peers due to test anxiety. test anxiety can hinder educational success and negatively impact students' skill development and academic performance. nursing education is a highly stressful process that includes theoretical and practical learning and teaching experiences. this situation further increases students' anxiety levels. studies have found that nursing students' test anxiety is higher than other university students.i t is known that many complementary methods are used to reduce anxiety. therapeutic touch, which is one of the energy-based practices, is one of them. when the literature is examined, it can be seen that therapeutic touch has been studied on symptoms such as anxiety, fatigue, sleep quality, comfort and pain in different sample groups, but there is no study on test anxiety.therefore, this study was planned to determine the effect of therapeutic touch applied to nursing students on test anxiety.

Eligibility criteria:
inclusion criteria: * to be over 18 years of age, * to know turkish and to agree to participate in the research * being a fourth year nursing student * not having received any energy therapy (reiki, therapeutic touch) before exclusion criteria: * presence of existing psychiatric illness, * using anxiolytic and antidepressant medications

Keywords: therapeutic touch nursing care test anxiety
postoperative identification of tumor cells at the lumpectomy site of patients with early breast cancer

Conditions: Breast Cancer

Summary: for early breast cancer, local surgery followed by breast radiation is a standard local treatment. it has been found that the original primary tumor site, the lumpectomy site, is the commonest location of local relapse. the researchers think that such relapse occurs because of persistent tumor cells (ptcs) at the lumpectomy site even when conventional pathology reports indicate complete resection with clear margins. the researchers propose to analyze the lumpectomy fluid (seroma) of patients who are one to six weeks post-surgery for the presence or absence of tumor cells using new technology. results of this study may help identify women who may have increased local relapse risk beyond that suggested by conventional pathology and clinical features; it may also help identify women at very low risk of local relapse who could avoid any additional treatment after local surgery.


Eligibility criteria:
inclusion criteria: 1. women with pathologic stage i to iib invasive mammary breast cancer. 2. tumor size over 1 cm. 3. patient age 50 years or younger. 4. primary tumor non-lobular. 5. primary tumor non-low grade or oncotype dx score \> 18. 6. patient is six weeks or earlier post-lumpectomy. 7. seroma is clinically palpable and symptomatic causing discomfort and/or swelling of the lumpectomy site or re-excision of the lumpectomy site is planned.
elastography and thermography plantar fasciopathy assessment after radiofrequency stimulation in a sporty population

Conditions: Plantar Fascia; Contracture

Summary: 448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.

plantar fasciopathy pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers and sport populations. many factors have been proposed as the cause of pain, however there are no studies analysing possibilities of preventing foot injuries by using a radiofrequency stimulus. the use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment looking for improve the quality of the tissue is still to be explored. the hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the shoulder will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured. all interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

Eligibility criteria:
inclusion criteria: * age between 18-50 years --sporty people with at least 3 days of training per week and presenting an upper limb dominance exclusion criteria: * suffer from any painful shoulder condition. * history of significant shoulder trauma, such as fracture or ultrasonography * clinically suspected partial thickness cuff tear, following the classification of wiener and seitz. * recent shoulder dislocation in the past two years
safety and efficacy of ldv/sof fixed-dose combination (fdc) ± ribavirin in hcv genotype 1 subjects

Conditions: Chronic Hepatitis C Virus

Summary: this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) with or without ribavirin (rbv), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis c virus (hcv) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of hcv.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years, with chronic genotype 1 hcv infection * hcv rna equal to or greater than 10,000 iu/ml at screening * cirrhosis determination; a liver biopsy may be required * screening laboratory values within defined thresholds * use of two effective contraception methods if female of childbearing potential or sexually active male exclusion criteria: * pregnant or nursing female or male with pregnant female partner * current or prior history of clinical hepatic decompensation * hepatocellular carcinoma (hcc) or other malignancy (with exception of certain resolved skin cancers) * chronic use of systemic immunosuppressive agents * history of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Keywords: hcv genotype 1 (gt-1) hcv sustained virologic response direct acting antiviral combination therapy gs-7977 gs-5885 ribavirin open label sofosbuvir treatment-naïve protease inhibitors pi
irrigation of chronic subdural hematomas - is more better?

Conditions: Hematoma, Subdural, Chronic

Summary: there are numerous reported ways to treat chronic subdural hematomas (csdh) and practice is still differing considerably between departments. except for a recent randomized controlled trial (rct) that found that postoperative subdural drainage was better than no drain, there is no higher level evidence. another recent rct did not replicate these findings, but the study was severely underpowered. aim of this population based study is to compare clinical results (reoperation rates, complications, perioperative death, and survival) between neurosurgical departments treating csdh with different treatment policies.


Eligibility criteria:
inclusion criteria: * all patients treated with evacuation of primary chronic subdural hematoma(csdh) from 2005 through 2010 at st.olav university hospital * all patients treated with evacuation of primary chronic subdural hematoma(csdh) from 2005 through 2010 at university hospital north norway * all patients treated with evacuation of primary csdh from 2006 through 2010 at karolinska university hospital (not 2005 due to practical reasons since major changes occurred in electronic surgery protocols 2005). exclusion criteria: * chronic subdural hematoma in arachnoid cyst(s) * previous csdh surgery * external hydrocephalus (hydrocephalus with cerebrospinal fluid (csf) in the subdural space rather than in the ventricles) * csdh due to previous intracranial surgery (within 6 months).

Keywords: surgery trephining drainage therapeutic irrigation subdural space postoperative complications mortality
a study to evaluate the efficacy and safety of imsidolimab (anb019) in the treatment of participants with acne vulgaris

Conditions: Acne Vulgaris

Summary: efficacy and safety of imsidolimab in participants with acne vulgaris

this is a phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adolescent and adult participants with acne vulgaris (av). this study also will characterize the pharmacokinetic (pk) profile of imsidolimab and explore the immune response to imsidolimab in participants with av.

Eligibility criteria:
key inclusion criteria: * diagnosis of moderate to severe facial av * facial iga) score of 3 (moderate) or 4 (severe) * at least 20 and no more than 100 inflammatory lesions on the face * no more than 100 non-inflammatory lesions on the face. * no more than 5 nodules (≥5 millimeter \[mm\]) on the face key exclusion criteria: * a participant with acne fulminans or conglobate or secondary acne will be excluded.

Keywords: li-36 receptor interleukin 36 imsidolimab
effect of raspberry on gut microbiota and metabolic syndrome

Conditions: Gut Microbiota; Metabolic Syndrome

Summary: there is growing evidence that nutritional intervention with dietary polyphenols can positively modulate the gut microbiota to improve cardiometabolic health. whether the beneficial effects of raspberry on obesity and the metabolic syndrome can be linked to their potential impact on the gut microbiota and intestinal integrity remains speculative at this time. moreover, the mechanisms of action underlying health benefits associated to raspberry consumption are still unknown. the investigators are thus proposing to combine the study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity of raspberry can play a role in the prevention of obesity-linked metabolic syndrome in a clinical setting.


Eligibility criteria:
inclusion criteria: * men and premenopause women in good health * caucasians * at least one of the following : bmi between 25 and 40 kg/m2 or waist circumference ≥ 80 cm for women and ≥ 94 cm for men * at least one of the following : tg ≥ 1.35 mmol/l or fasting insulinemia ≥ 42 pmol/l exclusion criteria: * metabolic disorders (hypertension, diabetes, hypercholesterolemia) * regular use of medication affecting study parameters * use of natural health product in the last 3 months * use of antibiotics in the last 3 months * nicotine users * allergy or intolerance for raspberries * raspberry taste aversion * more than 2 alcohol drinks par day * particular dietary habits (vegetarism, gluten-free diet, cetogenic diet...) * weight change of more than 5% in the last 3 months * surgery in the last 3 months or planed during the study

Keywords: raspberry diet
colonoscopy in the prone position for patients with bmi greater than 30

Conditions: Obesity

Summary: in the united states, colonoscopy has become the most commonly used screening test for colorectal cancer. colonoscopy is typically performed with the patient starting in the left lateral decubitus position, however there is little data to support this practice and starting position is variable amongst individual gastroenterology physicians. the investigators plan to randomize patients with body mass index \>30 that are presenting to the university of virginia for colonoscopy to either the prone or left lateral decubitus position. the investigators will then record and compare cecal intubation times as well as amount of sedation used and complications to help determine which position is superior for this patient population.

patients that have been scheduled for colonoscopy will undergo chart review. patients who meet inclusion criteria will be invited to participate at the time consent is obtained for the colonoscopy. participants will then be randomized to one of two colonoscopy starting positions. after randomization, patients will begin the colonoscopy in either the prone position or left lateral decubitus position. it is common practice to re-position the patient during endoscopy (including supine and prone positions) and some endoscopists commonly employ prone starting position for obese patients, although there is no estimate in the literature as to the prevalence of this practice. no additional interventions will be performed for research purposes. during the colonoscopy, the endoscopist will be allowed, as usual, to adjust patient position as needed to complete the procedure. cecal intubation time, amount of sedation used, and any intra-procedural complications (hypoxia, hypotension, etc) will be recorded for data analysis. this information is standardly recorded in the procedure report in the patient's medical record. the study will not affect any interventions performed during the colonoscopy such as polyp removal or biopsies as, clinically indicated. per endoscopy unit protocol, patients will be monitored in the recovery area and discharged home with supervision. the study requires no further direct patient interaction after the colonoscopy is completed. charts will be reviewed at 30 days to assess for any delayed and unexpected complications.

Eligibility criteria:
inclusion criteria: * bmi \>30 * undergoing screening or diagnostic colonoscopy with conscious sedation exclusion criteria: * pregnant women (self reported). * cognitively impaired patients * history of colonic resection * cannot lay in prone position * history of colon malignancy * procedure aborted due to inadequate bowel prep * severe pulmonary problems (including baseline oxygen use) * inability to provide consent for themselves

Keywords: colonoscopy
validation of a questionnaire that identifies the reasons for non-adherence to existing growth hormone therapy

Conditions: Growth Hormone Deficiency in Children

Summary: the aim of the study is to examine the suitability, the so-called validation, of a questionnaire, with which one can grasp the reasons why injections of growth hormones are omitted by patients ("non-adherence"). participants are treated with growth hormone and are therefore eligible to take part in the study. study doctor will ask participants to answer questionnaires. two times within 14 days. the first time participants answer during the routine visit to the practice / clinic and the second time at home. there are no risks associated with participating in the study as it does not affect participant's medical treatment.


Eligibility criteria:
inclusion criteria: - children/adolescents, male or female, aged 8 to 18 years who self-inject gh as well as their parents/legal guardians or parents/legal guardians who administer gh to a child/adolescent, male or female, from birth to 18 years - the child/adolescent is on prescribed daily ght due to idiopathic growth hormone deficiency (ghd), multiple pituitary hormone deficiency (mphd/organic ghd), small for gestational age (sga) or turner syndrome (ts) for at least 6 months before screening visit - signed informed consent obtained by parent/legal guardian and child/adolescent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) exclusion criteria: - mental incapacity, unwillingness or language barrier of participant precluding adequate understanding or cooperation - previous participation of participant in this study. participation is defined as having given informed consent in this study - treatment of child/adolescent with any investigational drug within 30 days prior to enrolment into the study