Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy of a single brief intervention of mindfulness to reduce stress response in a social stress task paradigm

Conditions: Mindfulness; Fibromyalgia; Stress

Summary: this study is a double-blinded randomized controlled trial with two arms, comparing a recorded mindfulness intervention to a control psycho-education audio. it is a monocentric study that will take place in centre hospitalier universitaire vaudois (chuv), a primary teaching hospital in lausanne, switzerland. patients will be randomized 1:1 to the brief mindfulness intervention vs neutral audio intervention. the investigators involved in recruitment and testing will be blind to the intervention condition. a collaborator that is not involved in this study will prepare a coded randomized sequence of audio assignments, uploaded in redcap. the audio will be played on a laptop or mp-player with a noise cancelling headset.


Eligibility criteria:
inclusion criteria: * we plan to recruit adult female patients (\>18 years old) suffering from fibromyalgia (fms), with chronic pain (more than 6 months), willing and able to give informed consent. specifically, patients must fulfil the criteria of the american college of rheumatology (2010) by having the following combination of scores at the widespread pain index (wpi) and the severity score (ss) : * wpi score is ≥7 and the ss score is ≥ 5 or * wpi score is comprised between 3 to 6 and the ss score ≥9 * and no other condition explaining the painful syndrome exclusion criteria: * insufficient french language skills * unstable psychiatric co-morbidity: major depression with current suicidal risk, unstable psychotic disorder, unstable psychotropic medication (stable=more than 3 month under the same dose). * somatic co-morbidity that could interfere with physiological monitoring/stress tolerance: such as cardiac malformation, recent myocardial dysfunction, cardiac transplantation, or cardiac treatment (pacemaker, antiarrhythmic drugs, muscarinic receptor blockers, ace inhibitors or any that would induce a modification in hr) * contraindication to sensors positioning (local skin damage or allergies) * substance use disorder (alcohol, drugs). * refusal to listen to an audio recording of mindfulness
an exploratory tumor biopsy-driven study to understand the relationship between biomarkers and clinical response in patients with head and neck cancer receiving regn2810 (anti-pd-1)

Conditions: Recurrent Squamous Cell Carcinoma of Head; Recurrent Squamous Cell Carcinoma of Neck; Metastatic Squamous Cell Carcinoma of Head; Metastatic Squamous Cell Carcinoma Neck

Summary: this study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.


Eligibility criteria:
key inclusion criteria: 1. histologically confirmed diagnosis of recurrent and/or metastatic scchn (squamous cell carcinoma of the head and neck) with no curative options with at least 1 lesion that is measurable by response evaluation criteria in solid tumors (recist) 1.1 criteria and accessible for biopsies. primary tumor sites of oral cavity, oropharynx, larynx, or hypopharynx are included. 2. have failed/are refractory to at least first line chemotherapy or deemed unsuitable candidate for first line chemotherapy due to medical co-morbidities or patient preference 3. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 4. adequate hepatic function 5. adequate renal function 6. adequate bone marrow function 7. provide signed informed consent 8. willing and able to comply with clinic visits and study-related procedures key exclusion criteria: 1. ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse event (iraes) 2. prior treatment with an agent that blocks the programmed death-1/programmed death-ligand 1 (pd-1/pd-l1) pathway 3. prior treatment with other immune modulating anti-cancer agents 4. untreated or active brain metastases or spinal cord compression 5. immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of regn2810 6. prior treatment with idelalisib other protocol-defined inclusion/exclusion criteria will apply
interface selection for adaptive servo ventilation

Conditions: Central Sleep Apnea; ASV

Summary: the purpose of this study is to compare the effects of nasal and oronasal interfaces during asv treatment on sleep efficiency and sleep architecture. therefore, patients starting treatment with asv, will be randomized between two groups. in the first group, patients will use a nasal interface during the first night and an oronasal interface during the second night. in the second group, patients will use an oronasal mask first and a nasal mask during the second night. the results of this trial will have major impact on future clinical practice as it would deliver prediction rules to choose the correct interface immediately.


Eligibility criteria:
inclusion criteria: * patients with central sleep apnea, not responding to treatment with cpap * indication for treatment with asv exclusion criteria: * patients \< 18 years old
the international imaging registry in liver cirrhosis (baveno-vi spss group).

Conditions: Liver Cirrhosis; Portal Hypertension; Hepatic Encephalopathy

Summary: the purpose of this study is to perform a multicentre registry of cirrhotic patients who had been submitted to an imagining technique in recent years (angio-ct scan or abdominal mri), in order to collect anatomical and clinical information. the main objective will be focused on the study of portosystemic shunts and their relation with portal hypertension. patient with liver cirrhosis submitted to an abdominal angio-ct scan or a mri from year 2010 to 2014 will be included in the study. the chosen imaging technique will be angio-ct preferably, but mri data will also be available. patients will be identified in every hospital by means of the registry of coded diagnoses and the lists of complementary tests performed. clinical and radiological data of every patient will be collected. the clinical variables will be obtained from reviewing the patient clinical history. the radiological parameters will be gathered by means of the systematic review of the angio-ct or mri.


Eligibility criteria:
inclusion criteria: * liver cirrhosis * an evaluable imaging test (angio-ct or mri) performed by any reason in the study period (from january 2010 to december 2014) exclusion criteria: * presence of previous surgical shunts * prior liver transplant * neurological or psychiatric disorder that do not permit to establish the diagnosis of hepatic encephalopathy * presence of hepatocellular carcinoma beyond milan criteria * terminal disease

Keywords: portosystemic shunt hepatic encephalopathy portal hypertension liver cirrhosis
italian registry chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: itarecipe is a multicenter national registry designed to study the diagnosis and evolution of chronic pancreatitis

chronic pancreatitis (pc) is a relatively rare disease (45/100,000 population) in italy, with heterogeneous aetiology, clinical history and treatment. patients need to be treated by different specialists, but almost always the gastroenterologist is central in diagnosis and treatment. the study will be the first national registry, prospective and will collect data on the history of the disease and its outcomes. data will be collected through an electronic data collection form (e-crf) that the sponsor (aisp) will make available to the participating centres. patients enrolled will be both new diagnoses or follow-up visits of patients with a diagnosis already made no more than 1 year before the signing of informed consent for the study in question: only data on the diagnosis and follow-up visits prior to the signing of the informed consent will be collected retrospectively (no more than one year). data from patients visited in the centres included in the study will be collected prospectively. in addition to the first visits, data will also be collected on follow-up visits that are scheduled according to the clinical need of each patient, which differ according to the stage of the disease

Eligibility criteria:
inclusion criteria: * age \>/= 12 years; * diagnosis "definite" or "probable" according to the "m-annheim" criteria; * first evidence of diagnosis within 12 months of enrolment. exclusion criteria: * age \< 12 years; * history of known disease with certainty for \> 12 months.

Keywords: chronic pancreatitis surveillance chronic pancreatitis chronic pancreatitis diagnosis chronic pancreatitis therapy
effectiveness and safety of chinese medicine to treat hand, foot, and mouth disease

Conditions: Hand, Foot, and Mouth Disease

Summary: the study is aimed to evaluate the effectiveness and safety of xiyanping injection,a traditional chinese medicine (tcm), in the treatment of severe type of hand, foot, and mouth disease (hfmd).

by adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of a traditional chinese medicine, xiyanping injection,for treatment of hfmd, and to provide scientific evidence for the construction of tcm methods in treating hfmd.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of severe hand-foot-mouth disease patients according to hand-foot-mouth disease treatment guidelines 2010 issued by china's ministry of health; more than 1/3 patients should be diagnosed by etiological examination. * less than 24 hours of occurrence of fever and/or occurrence of tetter or herpes. * age of 1-13 years. * patients or their guardians agree to participate in this study and signed the informed consent form. exclusion criteria: * complicated with other diseases such as neurogenic pulmonary edema, cardiopulmonary failure. * complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc. * with history of allergies on traditional chinese medicine. * patients who using glucocorticoids for based diseases. * patients who having history of hemolysis. * patients or their guardians suffering from psychiatric diseases. * attending other clinical studies on hfmd after diagnosed.

Keywords: hfmd traditional chinese medicine xiyanping
psychosocial treatment intervention in persons newly diagnosed with rheumatoid arthritis or diabetes

Conditions: Diabetes Mellitus; Arthritis, Rheumatoid; Coping Skills

Summary: the aim of this study is to evaluate the results of psychosocial treatment in patients with newly diagnosed rheumatoid arthritis and/or diabetes.

research and clinical experience show that adaptation to chronic disease is affected by individuals' psychological and social situations and subjective experiences of threat to identity, autonomy, and life. it is important to identify persons whose psychosocial situation and reaction to the diagnosis is such that they may not be able to adjust to the illness or take adequate responsibility for adherence to treatment. the purpose of this study is to identify such at-risk persons, and with the help of psychosocial treatment, strengthen their resistance resources and help them work through emotional and social problems that hinder adequate adaptation and adherence to treatment. beginning in 2001, 200 consecutive patients between 18 and 65 years who are newly diagnosed with either rheumatoid arthritis (n = 100) or diabetes (n = 100) at the karolinska hospital, solna, sweden, will be included in the study. each person will be interviewed by a medical social worker about their psychosocial situation and possible problems. every other patient with psychosocial problems will be offered intensive, personalized psychosocial treatment. the rest of the patients with problems will be given minimal required measures. the psychosocial well-being and medical situation of all patients (intensive treatment group, minimal treatment group, and the group without need of psychosocial measures) will be followed for 2 years and evaluated at the conclusion of that time.

Eligibility criteria:
inclusion criteria: * newly diagnosed diabetes (within one month of receiving diagnosis) * newly diagnosed rheumatoid arthritis(within one month of receiving diagnosis) * patient at the endocrinological or rheumatical clinic at the karolinska university hospital, solna, sweden exclusion criteria: * patients previously diagnosed with diabetes (had been diagnosed more than a month ago) * patients previously diagnosed with rheumatoid arthritis (had been diagnosed more than a month ago) * inability to speak swedish well enough to fill in standard questionnaires

Keywords: diabetes mellitus arthritis, rheumatoid psychosocial aspects patient adherence social work coping behavior coping skills adaptation, psychological
clinical effectiveness of enteric coated(e.c.) anise-oil on irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: colpermin ® (peppermint oil) is used in the treatment of irritable bowel syndrome but peppermint (mentha x piperita) isn't native in iran. so in this study the enteric-coated of anise-oil will formulate and use in treatment of irritable bowel syndrome with pain and bloating.

the purpose of this study is to assess the efficacy of enteric-coated anise-oil capsules comparing with placebo and colpermin® for treatment of ibs patients. 120 patients with confirmed ibs with non-response criteria selected. in this double blind pilot study, the patients and researchers will be blinded about receiving drug, placebo and active allocation. patients will be randomized into group a (anise-oil ec capsule 187 mg daily, for 4 weeks), group b (placebo capsule once daily, for 4 weeks) and group b (colpermin® capsule once daily, for 4 weeks). at the end of therapy (4 weeks) and at baseline (first), 2 weeks after receiving drug, placebo and colpermin® ibs load, will be evaluated and compared between groups.

Eligibility criteria:
inclusion criteria: * meeting the rome iii modular questionnaire * patients with 50 years were required to have a colonoscopy performed within the previous 5 years * patients under the age of 50 years were required to have a sigmoidoscopy performed exclusion criteria: * unable or unwilling patients to use an acceptable method of birth control * pregnant or nursing females * previous gastrointestinal or abdominal surgery (except for common causes unrelated to ibs) * organic disorder of the large or small bowel (e.g. ulcerative colitis, crohn's disease) * mechanical obstruction * unexplained significant weight loss or rectal bleeding * diagnosis of any medical condition associated with constipation (other than ibs) * cancer * abnormal laboratory tests * abuse of alcohol or drugs

Keywords: pimpinella anisum l. peppermint oil irritable bowel syndrome
comparison of different acceleration modes of transcranial magnetic stimulation

Conditions: Treatment Resistant Depression (TRD)

Summary: to compare the efficacy and safety of 6 times a day, 10 times a day acceleration mode and sham stimulation intervention for trd, and to explore the antidepressant mechanism of accelerated mode, so as to provide a more simple and effective rapid treatment plan for trd patients.


Eligibility criteria:
inclusion criteria: 1. the current episode met the dsm-5 diagnostic criteria for major depression, without psychotic symptoms of the first or recurrent drug-free depressive subjects 2. after a full course of treatment with two or more antidepressants, the patient had no response, and the level of treatment resistance was moderate to severe as assessed by the maudsley staging method 3.24-item hamilton depression scale score ≥20 4.the age ranged from 18 to 45 years, both sexes 5.right handed 6.written informed consent was obtained and patients volunteered to participate in the study and be evaluated. exclusion criteria: * 1. comorbidity with other mental disorders, including schizophrenia, mental retardation, substance dependence, etc. 2. suffering from serious or unstable physical diseases 3, pregnant, lactating women, women of childbearing age screening period urine hcg test results are positive 4. subjects with metal objects in the body or other contraindications to mri scanning 5. there are other conditions considered by the investigator to be inappropriate for participation in the clinical trial.
efficacy and safety study of individualized and standardized acupuncture treatment for knee osteoarthritis

Conditions: Osteoarthritis Knee

Summary: the purpose of this study is to verify the efficacy and safety of acupuncture treatments (individualized, standardized acupuncture) for patients with knee osteoarthritis (oa).

the investigators targeted the patients with knee oa. after treatment in 4 groups - individualized acupuncture treatment, standardized acupuncture treatment, sham-needle treatment, and waiting groups - the investigators will compare the effects of pain relieving and daily performing improvement. so the investigators will confirm the efficacy of acupuncture, and further the best treatment method. in addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

Eligibility criteria:
inclusion criteria: 1. at least 20 years of age, but below 80 years of age 2. knee pain from oa in one or both knees in the last 3 months or more 3. presence of knee oa diagnosed by an orthopedist based on american college of rheumatology classification criteria 4. knee pain from oa in one or both knees rated \> 4 cm on a 10 cm visual analog scale (vas) 5. an understanding of the objectives and methods of the clinical trial, and willingness in completing the consent form. 6. those who are reliable and willing to cooperate in this test, and obey the restrictions for the next 3 months exclusion criteria: 1. trauma to or surgery on the knee(s) within 6 months prior to enrollment, causing pain or functional problems 2. a history of prolotherapy, injection of hyaluronic acid or cortisone within the last 3 months 3. a physical or laboratory finding indicating infection, presence of an autoimmune disease, or inflammatory arthritis 4. serious organic disease, and severe dysfunction due to the medical illness (e.g. arrhythmia, angina pectoris, stroke, asthma, etc.) 5. more severe pain in regions other than the knee joint. 6. pregnant 7. when researchers evaluate that it is not appropriate to participate in this clinical test

Keywords: knee osteoarthritis acupuncture sham acupuncture
bone microstructure by using hr-pqct in long courses after gastrectomy

Conditions: Osteoporosis; Sarcopenia; Gastric Cancer

Summary: osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. the aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (hr-pqct) in the long course after gastrectomy. in total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

the patients after gastrectomy loss appetite and decrease the weight. total gastrectomy especially cause severe sarcopenia and metabolic change. osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. the primary tools for assessing volumetric density and bone structure are quantitative computed tomography (qct) and more recently, high-resolution peripheral quantitative computed tomography (hr-pqct). however the validation of osteoporosis with hr-pqct in the long course after gastrectomy remain elusive. the aim of the present study was to evaluate osteoporosis by using hr-pqct in the long course after gastrectomy. in total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

Eligibility criteria:
inclusion criteria: * at least 5 years have elapsed since dg or tg due to gastric cancer * provide signed informed consent exclusion criteria: * pregnancy * current use of the following osteoporosis agents; teriparatide, denosumab, and bisphosphonate * hyperthyroidism * hyperparathyroidism * present malignancy (except in situ carcinoma) * any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy * other diseases which affect bone metabolism * any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures * received \> 3 months (or equivalent) of osteoporosis treatment * currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
the effect of avandia on the late asthmatic response

Conditions: Asthma

Summary: this study is to investigate the effects of avandia on the asthmatic response.


Eligibility criteria:
inclusion criteria: * mild asthmatic treated with short-acting beta agonists only, non-smoker. exclusion criteria: * inability to abstain from medications other than short-acting beta agonists and paracetamol. * recent administration of steroids. * recent respiratory infection or exacerbation of asthma.

Keywords: asthma avandia inflammation
establishment and application of early postoperative activity plan for patients after hemi-laminectomy for lumbar spinal tumor resection

Conditions: Tumor of Spinal Cord

Summary: objective to construct the related early activity program for patients with lumbar intraspinal tumor after hemilaminectomy, and evaluate the postoperative limb function exercise according to the content of the program. in order to improve the self-care ability and quality of life of patients, reduce postoperative complications, shorten the average length of stay, reduce hospitalization expenses and improve patient satisfaction. objective to evaluate the efficacy and safety of establishing early activity program after hemilaminectomy for patients with lumbar intraspinal tumors


Eligibility criteria:
inclusion criteria: 1. patients with primary benign intraspinal tumors at the level of l1-l5 who underwent semi laminectomy; 2. the age of the patients ranged from 14 to 80 years old; 3. the gcs score was 15 points, and the lower limb muscle strength was more than or equal to grade 3 before operation; the patients agreed to the operation and were willing to accept and cooperate with the concept of early rehabilitation nursing and related measures; exclusion criteria: 1. patients with rapid development of disease, difficult to exclude malignant tumors, and non neoplastic lesions in spine or spinal canal; 2. have a history of severe hypertension, heart disease or other mental illness; 3. patients with major organ damage or coagulation dysfunction; 4. the patients and their family members had poor communication and compliance; 5. there are factors that may progress or worsen the patient's condition (such as uncontrolled infection, severe respiratory disease, pulmonary infection, etc.);

Keywords: early rehabilitation training