Kornimate/medical-research-clean huggingface dataset:
french national registry of patients with tetralogy of fallot and implantable cardioverter defibrillator

Conditions: Tetralogy of Fallot; Implantable Defibrillator User; Congenital Heart Disease; Sudden Cardiac Death; Ventricular Arrythmia

Summary: national french registry of patients with tetralogy of fallot and implantable cardioverter defibrillator.

inclusion criteria: * patient with tetralogy of fallot \> 18 years * implantable cardioverter defibrillator (icd) * primary or secondary prevention all french centers performing icd implantation are annually contacted to include all patients with tetralogy of fallot and icd. retrospective inclusion of cases before 2010 and prospective inclusion after 2010 with prospective follow up and annual update. all events are centrally adjudicated with collection of all baseline ecg and reviewing of endocavitary egm.

Eligibility criteria:
inclusion criteria: * tetralogy of fallot * implantable cardioverter defibrillator exclusion criteria: * age \< 18 years

Keywords: tretalogy of fallot implantable cardioverter defibrillator congenital heart disease sudden cardiac death ventricular arrhythmia
a study to evaluate the biological activity of r1507 in women with operable breast cancer

Conditions: Breast Cancer

Summary: this 2 part study will explore the pharmacodynamic effects of r1507 in breast cancer tumor cells in female patients with operable breast cancer. in the first part of the study, patients will receive a single dose of r1507, 16mg/kg iv, on day 1; pre-and post-treatment (at breast surgery on day 8) breast tissue samples will be obtained for measurement of igf-1r expression. if sufficient biological activity is demonstrated, 3 additional cohorts of patients will be entered into part 2 of the study, to receive a single dose of 9mg, 3mg/kg or 1mg/kg iv r1507, respectively. the anticipated time on study treatment is \< 3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * female patients, \>=18 years of age; * invasive, and operable, breast cancer; * ecog performance status of 0 or 1. exclusion criteria: * evidence of metastatic disease; * inflammatory breast cancer; * prior hormonal or systemic therapy for breast cancer; * prior treatment with an agent targetting the igf-1r pathway; * patients receiving concurrent radiotherapy, or who have received radiotherapy within 28 days prior to receipt of study drug.
efficacy of a mindfulness meditation program for social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the aim of this study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based program that includes "mindful exposure" to reduce anxiety and avoidance of social situations, and the buddhist practice of self-compassion aimed at reducing harsh judgment and self-criticism that is characteristic of people with social anxiety disorder.

the purpose of this pilot study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based intervention for sad (mind-sad) that incorporates the following components: training in classical mindfulness, including concentration and insight (vipassana) meditation; training in self-compassion; and mindful exposure. an exploratory aim of the study is to evaluate the effects of the mindfulness intervention on biological markers of stress reactivity, including salivary cortisoland salivary alpha-amylase. the study is a two-arm, parallel design, prospective study comparing 12 weekly sessions of mind-sad delivered in a group format versus a wait-list control (wlc).

Eligibility criteria:
inclusion criteria: * primary diagnosis of social anxiety disorder; baseline score of 30 or higher on the liebowitz social anxiety scale; baseline score of 4 or higher on the clinical global impression of severity exclusion criteria: * lifetime history of psychosis or bipolar disorder; substance abuse in the past 12 months; diagnosis of borderline or antisocial personality disorder; serious suicide risk; currently in psychotherapy; regular meditation or yoga practice in the past 12 months

Keywords: community sample
study to evaluate the safety, tolerability and the effect of bms-241027 on cerebrospinal fluid biomarkers in subjects with mild alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of the study is to evaluate safety and the pharmacodynamic effects of bms-241027 on cerebrospinal fluid (csf) tau, connectivity magnetic resonance imaging (mri), and computerized cognitive tests in mild alzheimer's disease (ad) subjects, following 9 weekly intravenous (iv) infusions of bms-241027


Eligibility criteria:
inclusion criteria: * mild ad subjects meeting national institute of neurological disorders and stroke - alzheimer's disease related disorders association(nincds-adrda) and diagnostic and statistical manual of mental disorders-forth edition, text revision (dsm-iv-tr) criteria * mini-mental state exam (mmse) score between 20 \& 26 (inclusive) * csf consistent with ad pathology * screening brain mri - normal - commensurate with age or demonstrate atrophy consistent with ad diagnosis (dx); reveal no more than mild white matter disease; up to 2 lacunar infarcts acceptable except in anterior thalamus, genu of internal capsule or basal forebrain; reveal no cortical infarcts; reveal no more than 4 microbleeds; reveal no focal asymmetric lobar atrophy or other findings suggesting primary cause of dementia is attributed to a cause other than ad; reveal no macrohemorrhages (\>10 mm) * subjects must have reliable study partners * men and women of non child bearing potentia (woncbp), ages 50-90 years exclusion criteria: * subjects with any other medical condition other than mild ad that could explain subjects' memory or cognitive deficits * subjects diagnosed with moderate or severe ad per dsm-iv criteria * subjects with a history (hx) of stroke * subjects with a hx of gi illnesses * subjects with vitamin b12 or folate deficiency * subjects with any unstable cardiovascular (cv), pulmonary, gastrointestinal (gi) or hepatic disease within 30 days prior to screening * subjects with active liver dx or history of hepatic intolerance * subjects with a geriatric depression scale score of ≥ 6 at screening * subjects treated for or have had a diagnosis of schizophrenia * subjects treated for or have had a diagnosis of bipolar disease within 3 years prior to screening * subjects with a history of generalized peripheral neuropathy
assessment of new biomarkers in the management and triage of patients with chest pain and suspicion of non st elevation acute coronary syndrome.

Conditions: Coronary Syndrome

Summary: to assess diagnostic and prognostic value of new biomarkers in patients admitted for suspicion of non st elevation acute coronary syndrome (nste acs).


Eligibility criteria:
inclusion criteria: * subjects over 18 years, * subject about having a chest pain of coronary syndrome, * subject about not having received heparin or lmwh exclusion criteria: * subject minor * subject without informed consent, * subject after receiving an anticoagulant treatment, * transplanted heart, kidney or liver
calquence cll 1l japan pms _ japan post-marketing surveillance (pms) study

Conditions: Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)

Summary: to understand the incidence of adrs of calquence capsules 100 mg (acalabrutinib) used in patients with previously untreated chronic lymphocytic leukaemia (cll) (including small lymphocytic lymphoma (sll)) in the post-marketing setting under actual use

to understand the incidence of adrs of calquence capsules 100 mg (acalabrutinib) (hereinafter referred to as "calquence") used in patients with previously untreated chronic lymphocytic leukaemia (cll) (including small lymphocytic lymphoma (sll)) in the post-marketing setting under actual use. this investigation will be conducted as the additional pharmacovigilance activity specified in the japan risk management plan (j-rmp) of calquence, in compliance with the ministerial ordinance on good post-marketing study practice (gpsp ordinance) and for the purpose of application for re-examination under article 14-4 of the law for ensuring quality, efficacy, and safety of drugs and medical devices (pmd act).

Eligibility criteria:
inclusion criteria: patients with previously untreated chronic lymphocytic leukaemia (including small lymphocytic lymphoma) who are treated with calquence for the first time will be enrolled in the study after the approval date of the sjnda for the additional indication. - exclusion criteria: none -
nimotuzumab in combination with chemoradiation for local advanced esophageal squamous cell carcinoma

Conditions: Squamous Cell Carcinoma

Summary: nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (egfr). clinical trials are ongoing globally to evaluate nimotuzumab in different indications. nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (scchn), glioma and nasopharyngeal carcinoma in different countries. the clinical phase i study of the combination of nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma (lafscc) has shown the safety and the potential efficacy of nimotuzumab. the concurrent trial is a clinical phase ii trial designed to assess the efficacy of the combination of nimotuzumab administered concurrently with chemo-radiotherapy in patients with lafscc, and to further investigate its side-effect and toxicity.

the concurrent trial is a clinical phase ii trial designed to assess the efficacy of the combination of nimotuzumab administered concurrently with chemo-radiotherapy in patients with lafscc, and to further investigate its side-effect and toxicity.

Eligibility criteria:
inclusion criteria: * joined the study voluntarily and signed informed consent form; * age 18-75 * both genders * esophageal squamous cell carcinoma confirmed by pathology * local advanced esophageal squamous cell carcinoma (t2n0m0-txnxm1a, ajcc 2002) * no radiotherapy, chemotherapy or other treatments prior to enrollment * ps ecog 0-2 * life expectancy of more than 3 months * target lesions measurable * hemoglobin（hb）≥9 g/dl * wbc≥3x109/l, neutrophils (anc )≥1.5x109/l * platelet count (pt) ≥100x 109/l * hepatic function: alat and asat \< 2.5 x uln, tbil\<1.5 x uln * renal function: creatinine \< 1.5 x uln * no immuno-deficiency * use of an effective contraceptive for adults to prevent pregnancy. exclusion criteria: * complete esophageal obstruction * deep esophageal ulcer * esophageal perforation * haematemesis * after surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy * esophageal stent or tracheal stent placed * other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years * participation in other interventional clinical trials within 30 days * pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * drug addiction * alcoholism or aids * uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * history of serious allergic or allergy * patients who are not suitable to participate in the trial according to researchers.

Keywords: nimotuzumab local advanced esophageal squamous cell carcinoma chemo-irradiation
effects of tai chi on chronic insomnia disorder combined with hyperarousal/anxiety

Conditions: Chronic Insomnia

Summary: this study focuses on individuals with chronic insomnia combined with excessive arousal/anxiety, with the main objective of investigating the effectiveness of tai chi in treating ci with excessive arousal/anxiety.

patients with chronic insomnia often experience both daytime fatigue and difficulty falling asleep at night, as well as shallow sleep and easy awakening, which is a manifestation of 24-hour excessive wakefulness. additionally, insomnia is often associated with anxiety and tension. therefore, for patients with chronic insomnia accompanied by anxiety, relieving anxiety is often an important means of treating insomnia. in recent years, an increasing number of studies have shown that tai chi has potential therapeutic value in treating mental disorders such as insomnia and anxiety. tai chi is a coordinated and unified physical and mental exercise that regulates the body's functional state through rhythmic and regular physical activities, and is combined with psychological "relaxation" activities. therefore, the investigators propose the hypothesis that tai chi training may improve chronic insomnia with excessive arousal/anxiety through intermediate pathways such as neuroendocrine, immune function, neurochemistry, etc. this study aims to explore the effects of tai chi on chronic insomnia combined with excessive arousal/anxiety, broaden new ideas for non pharmacological treatment of sleep problems, and provide data reference for the development of more precise sleep aid exercise plans in the future.

Eligibility criteria:
inclusion criteria: 1. meet dsm-5 diagnostic criteria for insomnia disorder; 2. pittsburgh sleep quality index (psqi) total score \>5; 3. age ≥18 years old with junior high school education or above; 4. voluntarily participate in this study by signing an informed consent form; and 5) hama ≥14 was required for those who had chronic insomnia disorder with anxiety symptoms. exclusion criteria: 1. people with comorbid serious physical or severe mental illnesses, suicide risk; 2. clinically diagnosed or suspected sleep breathing disorder, restless legs syndrome and sleep-wake rhythm disorder, shift workers; 3. pregnant and breastfeeding women; and 4. people who are currently undergoing any psychological treatment.

Keywords: chronic insomnia tai chi hyperawareness anxiety
does a virtual coach offer a better solution for weight reduction in ventral hernia patients with obesity?

Conditions: Obesity; Ventral Hernia

Summary: the purpose for this research is to create a mychart-enabled virtual coach that assists obese patients lose weight prior to ventral hernia surgery. researchers intend to show how the use of a virtual coach is more effective in preoperative weight reduction prior to ventral hernia repair over usual care. correspondingly, this may lower unplanned hospital readmissions. for this clinical trial, where randomization is not possible, the study team will implement the use of propensity score matching that sorts individuals into different study arms as if randomly assigned. the primary outcome is the average net amount of time-dependent weight change per group over six months. secondary outcomes are for the intervention group, patient satisfaction with the virtual coach and for both groups, quality of life. in addition, areas of social and economic disadvantage will be identified that may contribute to higher obesity rates. machine learning (ml) modeling will be used to determine the important features for weight lost over the course of the study. the impact of this work will be to demonstrate efficacy and realized workflow efficiencies within a hospital-based surgery clinic.


Eligibility criteria:
inclusion criteria: * subjects between 18 and 90 years of age with a body mass index (bmi) of 30 and above and diagnosed with obesity by the icd 10 code: e66.9 who have been evaluated by a surgeon and offered elective ventral hernia repair. also, participants must have a complete medical record that allows for all statistical calculations to be performed. exclusion criteria: * pregnant females, patients with severe mental disorders, prescribed psychiatric medications associated with weight gain, a history of a substance use disorder, patients on long-term steroid therapy, and patients with insufficient medical records.
control-iq observational (clio) post-approval study

Conditions: Diabetes Mellitus, Type 1

Summary: post-approval 522 study designed to collect primarily safety data on the us fda-cleared product, t:slim x2 insulin pump with control-iq technology (control-iq system).

post-approval study designed to collect primarily safety data on the us fda-cleared product, t:slim x2 insulin pump with control-iq technology (control-iq system), by assessing the rate of severe hypoglycemia (sh) and diabetic ketoacidosis (dka) during the first 12 months of use. secondary endpoints assessing the effectiveness of this product in real-world use by assessing the impact on patients' glycemic outcomes and user experience will also be collected. the control-iq system will be used as intended and in accordance with fda-approved labeling.

Eligibility criteria:
inclusion criteria: * patients with self-reported type 1 diabetes who have been prescribed the control-iq system. * at least 6 years of age * using humalog or novolog insulin * for females, not pregnant or planning pregnancy in the next 12 months. * agreement to use the t:slim x2 with control-iq technology, and to continue use for at least 12 consecutive months after study enrollment. * agree to provide hba1c result, obtained within the 6-month period prior to enrollment. * ability to respond to alerts and alarms, and to provide basic diabetes self-management. * patients who reside full-time in the united states. * willingness to download the t:connect mobile application to their smartphone and keep it active throughout the study. patients unable to use t:connect mobile application must be willing to manually upload their insulin pump data to t:connect every three months and at the completion of the study. * subject has read, understood and agreed to participate in the study, and has electronically signed the informed consent form (icf). exclusion criteria: * self-reported type 2 diabetes * \< 6 years of age * use of any glucose-lowering therapy other than humalog or novolog insulin * inability to respond to alerts and alarms, or to provide basic diabetes self-management. * pregnancy * subjects who have not signed the icf.
prediction of back disability in adults with low back pain

Conditions: Low Back Pain

Summary: low back pain (lbp) is one of the most enormous and challenging disorders. lbp represents a leading cause of disability worldwide. a number of variables (clinical, functional and mechanical) may predispose to back disability. clinical variables such as pain may affect the patient ability to move and also may result in muscle spasm that led to more pain and movement restriction. further, functional capabilities may affect the patient and when reduced may lead to disability. moreover, biomechanical factors such as abnormal posture creates abnormal stress and strain in many spinal structures which are considered predisposing factors for pain and disability. there is a gab of evidence to examine the relationships between those variables and to predict disability in patients with chronic nonspecific low back pain using various variables.


Eligibility criteria:
inclusion criteria: - age between 20 and 40 years, either sex, and symptoms lasting longer than three months, which imply chronicity exclusion criteria: * pregnancy, spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for lbp

Keywords: posture
clinical trial on education method of fluterol® inhalation inhaler for asthma control

Conditions: Asthma

Summary: a multi-center, randomized, open, non-inferiority, phase 4 study

a multi-center, randomized, interventional, open, phase ⅳ clinical trial on education method of fluterol® inhalation capsule 250/50 μg inhaler for asthma control in patients with partly controlled asthma

Eligibility criteria:
inclusion criteria: 1. adult at the age of 19 or older. 2. patient with partially controlled asthma (asthma control test score 16\~24) 3. written informed consent to study participation. exclusion criteria: 1. history of hypersensitivity reactions to the investigational product (fluterol®) or any of its component. 2. cardiac tachyarrhythmia. 3. contreated respiratory fungal, bacterial, or tuberculous infection. 4. moderate to severe bronchiectasis 5. planned use of the investigational product (fluterol®) as primary treatment for patients with status asthmaticus, patients with an asthmatic crisis\*, or patients with chronic obstructive pulmonary disease requiring intensive treatment. * asthmatic crisis: acute exacerbation of asthma meeting at least one of the followings. * asthma related emergency room visit or hospitalization within 2 weeks prior to screening. * administration of systemic steroids within 2 weeks prior to screening. * inhalation of rescue medication at least 10 times/day for the treatment of acute exacerbation of asthmatic symptoms within 2 weeks prior to screening. 6. administration of systemic steroids within 2 weeks prior to screening. 7. hypersensitivity reactions to lactose and milk. 8. pregnant and lactating women or women who are planning to be pregnant or who are unwilling to use appropriate methods of contraception during the study. 9. previous use of the investigational product (fluterol®) or a similar inhaler (onbrez, spiriva) at least once. 10. participation in another clinical study for drugs or medical devices to receive the investigational product or undergo a procedure using the investigational device within 4 weeks prior to participation in this study. 11. individual considered by the he investigator to be inappropriate for study participation due to other reasons.
intestinal biomarker analysis after ecp for ici colitis

Conditions: Colitis; Immune Checkpoint Inhibitor-Related Colitis

Summary: it was previously shown that ici-colitis can be treated with extracorporeal photophoresis. therefore this retrospective analysis is launched to study the chnages of immune cells in the peripheral blood and intestinal tract in an ici colitis patient cohort. the analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ici colitis receiving ecp as a treatment.

it was previously shown that ici-colitis can be treated with extracorporeal photophoresis. therefore this retrospective analysis is launched to study the changes of immune cells in the peripheral blood and intestinal tract in an ici colitis patient cohort. the analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ici colitis receiving ecp as a treatment.

Eligibility criteria:
inclusion criteria: * ici colitis exclusion criteria: * no informed consent
vaccination priming and vaccine boosting trial of allogeneic human gm-csf gene transduced irradiated prostate cancer cell vaccines (gvax® vaccine for prostate cancer)

Conditions: Prostate Cancer

Summary: the objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with gvax® vaccine for prostate cancer. clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. additionally, the antitumor effects of gvax® vaccine for prostate cancer on serum psa levels, will be evaluated and antitumor responses will be quantitated.


Eligibility criteria:
inclusion criteria: * diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by psa * no evidence of measurable metastatic disease * an ecog performance status of 0 or 1 exclusion criteria: * transitional cell, small cell or squamous cell prostate carcinomas * any previous radiation therapy, prior anti-androgens or prior investigational therapy * previous hormonal therapy of any type for prostate cancer * previous biological therapy for cancer

Keywords: prostate cancer vaccine gvax allogeneic cells