Kornimate/medical-research-clean huggingface dataset:
acute cardiac ischemia in women in the aci/tipi trial

Conditions: Heart Diseases; Cardiovascular Diseases; Angina Pectoris; Myocardial Ischemia

Summary: to conduct a series of five inter-related studies on acute cardiac ischemia (aci) in women.

background: acute cardiac ischemia (aci), including acute myocardial infarction (ami) and unstable angina pectoris, is the leading cause of death in women in the us. despite growing interest in ischemic (coronary) cardiac disease in women, little research has focused on women in the most common site of aci initial evaluation and care: the emergency department (ed). improving medical care quality and outcomes for aci in women will require an understanding of gender's influence on initial ed presentation, diagnosis, triage, treatment, and outcomes.the detail of prospectively-collected data and number of patients available for this project with the resulting large statistical power (while savings the cost of the $1.8 million aci-tipi trial data collection effort) and the experience of the cchsr in over a decade of related studies of factors influencing the triage, treatment, and outcome of ed patients with aci, provide this project with substantial promise of new and useful results. design narrative: the five studies included. study i: were women's emergency department (ed) presentations of aci different from men's? study ii: were there differences between women and men in the ed diagnosis and triage of patients with chest pain and other symptoms suggestive of aci? study iii: were there differences between women and men in the use of non-invasive and invasive treatments among patients presenting to the ed with aci? study iv: were there significant differences between women and men in medical outcomes during the acute event and within 30 days following ed presentation with aci? study v: had differences between women and men in their ed presentation, diagnosis, and/or triage for chest pain or other symptoms compatible with aci changed over the past 10-15 years? in studying the impact of gender, these studies also included analyses for primary and interaction effects related to patient sociodemographic features, ed presenting clinical features, physician type and training, hospital type and ed setting, health insurance type, and include adjustments for patients' probabilities of having aci as well as their likelihood of acute cardiac mortality. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
computer-delivered intervention for individuals with obesity and elevated anxiety sensitivity

Conditions: Obesity; Anxiety Sensitivity; Eating; Physical Activity

Summary: the proposed study will design and evaluate a computerized-delivered single-session anxiety sensitivity reduction program (i.e., anxiety sensitivity training; ast). the ast will be designed to achieve three primary aims: (1) provide psycho-educational information on as and its consequences, (2) present psycho-educational information on the relationship between as and obesity-related health behavior correlates, and (3) offer concrete, evidence-based strategies to facilitate motivation to change their obesity-related lifestyle behaviors.

the primary goal of the research study is to investigate the efficacy of a brief, computer-delivered transdiagnostic intervention that addresses anxiety sensitivity to reduce emotional eating, eating expectancies, food cravings, binge eating, perceived barriers to engage in physical activity, anxiety/depressive symptoms, severity of daily fatigue and increase perceived benefits to engage in physical activity, exercise self-efficacy, willingness to use adaptive coping strategies, and perceived physical health functioning. to address this aim, the investigator's will implement a randomized controlled trial that will employ a longitudinal experimental design and involve five stages: (a) online pre-screener; (b) baseline survey consisting of a pre-intervention assessment (eligibility) and random assignment to a one-session computer-delivered intervention (active versus control); (c) 1-week follow-up survey; (d) 2-week follow-up survey; (e) 1-month follow-up survey.

Eligibility criteria:
inclusion criteria: * have a body mass index of at least 30 * endorse elevated anxiety sensitivity defined as an asi-3 score of 17 or greater exclusion criteria: * any anticipated matters that would interfere with participating in the study * not being fluent in english

Keywords: anxiety disorders depression anxiety sensitivity obesity eating physical activity exercise
a multi-centre observational study of the axium neurostimulator as a treatment for chronic pain

Conditions: Chronic Pain

Summary: 08-smi-2012 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available axium neurostimulator in the management of intractable, chronic pain.


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years old 2. subject is able and willing to comply with the follow-up schedule and protocol 3. chronic, intractable pain for at least 6 months 4. failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain 5. average baseline pain rating of 60 mm on the visual analog scale in the primary region of pain 6. in the opinion of the investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device 7. subject is able to provide written informed consent exclusion criteria: 1. female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control 2. escalating or changing pain condition within the past month as evidenced by investigator examination 3. subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days 4. subject has had radiofrequency treatment of an intended target drg within the past 3 months 5. subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump 6. subject is unable to operate the device 7. subjects currently has an active infection 8. subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device 9. subject has participated in another clinical trial within 30 days 10. subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 11. subject has been diagnosed with cancer in the past 2 years
status of superficial esophageal cancers treated by endoscopy "oesofare"

Conditions: Superficial Esophageal Cancers

Summary: in 2013, esophageal cancer was the 9th cause of cancer in the world and the 6th in terms of cancer mortality. the prognosis of this cancer varies according to geographical areas, but in europe and the usa, the 5-year survival rate has risen from less than 5% in the 1960s to around 20% in the 2000s. in the united states, however, the survival rate has risen from 5% in the 1960s to around 20% in the 2000s. increased the detection of premalignant lesions and early stages may improve prognosis. the presence of esophageal cancer is determined by endoscopy, biopsy and histological confirmation. however, endoscopic techniques (mucosectomy and sub mucosal dissection) are also used as curative treatment for early esophageal lesions. now, due to the low number of diagnoses of esophageal tumours at the superficial stage, few studies are available in europe on the efficacy of these endoscopic techniques and on the complications resulting from their use. similarly, little is known about the complications of endoscopic techniques and about therapeutic strategies for managing these superficial lesions. in particular, no data are available concerning the adequacy between the treatment proposed in multidisciplinary consultation meetings and the actual management of patients. our study is therefore fundamental to make an inventory of superficial esophageal cancers treated by endoscopy, and their management

this fundamental study will therefore best describe current french practices for the management strategy of esophageal cancers after endoscopic treatment. consequently, the interests of this study, national inventory, are multiple: 1. list a significant number of endoscopic treatments. in particular, by sub mucosal dissection in france, in order to strengthen scientific evidence of its efficacy, to assess its feasibility and complication rate. 2. describe the therapeutic strategies currently in place during endoscopic treatment, 3. evaluate the adequacy between the proposed upstream management of the endoscopic procedure by scp and the actual management.

Eligibility criteria:
inclusion criteria: * male or female over 18 years of age * patient with histologically proven high-grade esophageal cancer (adenocarcinoma or squamous cell carcinoma) or dysplasia * patient with digestive endoscopy for endoscopic resection (mucosectomy or submucosal dissection) of a cancerous lesion (adenocarcinoma or squamous cell carcinoma) of the esophagus or high-grade dysplasia. * patient who received the study briefing note and agreed to participate exclusion criteria: * failure to perform the endoscopic procedure * patient under guardianship or guardianship or under judicial safeguard measure * pregnant woman * patient with prior treatment for esophageal cancer.

Keywords: superficial esophageal cancer endoscopic mucosectomy submucosal dissection therapeutic strategy
effect of singing in abdominal surgery patients

Conditions: Abdominal Pain; Anxiety

Summary: patients who have undergone abdominal surgery are given a prompt in the postoperative period and asked to sing the song they remember. vital signs, pain and anxiety levels are measured before and after singing.

this study is of a randomized controlled type. patients who have undergone abdominal surgery are divided into experimental and control groups in the early postoperative period. no intervention is made to the control group by the researchers. vital signs, pain and anxiety levels are measured half an hour apart as pre-test and post-test. patients in the experimental group are given a prompt in the postoperative period and asked to sing the song they remember. pre-test before singing and post-test after singing, vital signs, pain and anxiety levels are measured. it is expected that singing will calm patients, stabilize their vital signs, and reduce anxiety and pain.

Eligibility criteria:
inclusion criteria: * abdominal surgery patiens * 18 and more than age exclusion criteria: * no abdominal surgery patients * under 18 age

Keywords: signign anxiety pain vital signs abdominal surgery patients
comparison of knee kinematics for subjects implanted with either a conformis or traditional knee implant

Conditions: Osteoarthritis

Summary: a better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (tkas) and to help design a prosthesis that most closely approximates the normal knee. previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. more recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a tka. conformis has attempted to follow a clearly different path than the major orthopaedic companies. they have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. the hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized conformis tka and 25 patients implanted with a traditional tka design to determine if there are any kinematic differences between these tka designs.

each subject will be asked to perform five activities in one continuous sequence: (1) stand up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep knee bend. subjects will be video recorded from the waist down while performing the activities. the speed level of each trial will be based on the comfort level of the patient. the fluoroscopic images will be stored digitally for subsequent analysis on secure servers and workstations at the university of tennessee.

Eligibility criteria:
inclusion criteria: * at least 6 months post-op with no other surgical procedures conducted within the past 6 months * between 40-70 years of age * body weight of less than 250lbs * bmi of less than 38 * pregnant females will be excluded * tka patients will be judged clinically successful with an american knee society score of greater than 90 * must have 100 degrees post-op passive flexion with no ligamentous laxity or pain * participants must be able to walk on level ground without aid of any kind and ascend/descend stairs without assistance. * all potential subjects will have either a personalized conformis™ tka or a traditional tka manufactured by an orthopaedic company other than conformis. * patients from the physician's list who do not meet the study requirements will not be considered. * patients must be willing to sign the informed consent and hipaa forms to participate in the study. * patients must be between 160cm (5'3) and 193cm (6'4) tall.

Keywords: kinematics knee joint
vr for joint attention support in asd

Conditions: Autism Spectrum Disorder

Summary: the overall objective of this study is to determine the effectiveness of the floreo vr joint attention module in improving social communication skills in children with asd. an additional objective is ongoing investigation of the tolerability of the product and the extent of potential adverse effects of floreo vr, if any.

the study will be a phase ii randomized controlled trial in which the floreo vr joint attention module is the intervention being evaluated. floreo is a mobile application that offers a supervised virtual reality experience for individuals with asd. the application provides a 3d immersive scene for google cardboard-compatible smartphones and a wifi paired supervisory overview that can run on smartphones or tablets. the therapeutic content will consist of a learning module focused on joint attention. this joint attention learning module will include separate learning cards (lcs) that address specific subskills necessary to develop appropriate joint attention. each learning card will consist of a virtual reality environment in a safari-themed setting, complete with animals designed to draw the learner's attention when necessary. the product will be implemented at the children's spot by a therapist working with a client during the course of a therapy session. the intervention arm participant would engage in one or two vr episodes during a scheduled session. each episode would last no more than 5 minutes. if two episodes are done in a day, there is a mandatory break of at least 3 minutes in between them. the sessions would occur two days per week, with at least two days in between sessions to allow the eyes time to rest. there are 15 total vr sessions in the protocol, and completion of all study sessions would take 8 weeks. the control condition is treatment as usual, that is, regularly scheduled therapy.

Eligibility criteria:
inclusion criteria: * documented asd diagnosis, between 7 and 17 years of age exclusion criteria: * history of seizures, migraines, vertigo, psychosis
microcurrent for healing autogenous skin donor sites

Conditions: Burns

Summary: this single-center, prospective, randomized, and controlled study evaluated the efficacy of silver-coated dressing with active microcurrent in comparison to silver-coated dressing with sham microcurrent on wound-closure time for autogenous skin donor sites.

the specific aims of the study are to evaluate the impact of active versus sham direct microcurrent application to silver nylon dressings in the treatment of donor sites for partial thickness thermal injuries. the primary endpoint is wound-closure time (re-epithelialization of 90% or more of wound surface). a secondary endpoint was infection. exploratory assessments of clinical outcomes, including inflammation, and pain medication (type, dosage, route, timing) will also be conducted.

Eligibility criteria:
inclusion criteria: * between 18-65 years of age * burn less than 30% total body surface area * burns not involving donor site area * you need skin grafting to cover burns * agree not to use other electronic devices that generate current during your study participation * agree to come back for follow up visits at least every other day after discharge from hospital until donor site is healed exclusion criteria: * you have an illness that may affect how your wound heals such as diabetes, blood clotting disorder, cirrhosis, liver failure, peripheral vascular disease * you are taking medications that could affect how your wound heals such as steroids, plavix, coumadin * you have an infection of the skin or your bloodstream * you are pregnant or nursing * you are sensitive or allergic to silver or nylon * your burn wounds are more than 30% of your total body surface area * your site was previously harvested for grafting * you have an implantable pacemaker device

Keywords: burns donor site healing microcurrent
implementation study to describe and compare retention rate and adherence to adjuvant therapy with ribociclib with and without usage of mobile application in patients with hr+ her2-negative stage ii and iii breast cancer in real-world practice

Conditions: Breast Cancer

Summary: this study is designed to evaluate the effect of using the application on the adherence of patients with luminal her2- breast cancer (bc) stage ii-iii to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (ai). the purpose of the app is to increase adherence to treatment by informing patients about the risks of relapse and adverse event prevention and treatment.


Eligibility criteria:
inclusion criteria: 1. female and male patients with histologically verified and radically treated stage ii-iii hormone receptor positive her2-negative breast cancer; 2. age ≥ 18 at the time of initiation of ribociclib therapy; 3. patients who were prescribed ribociclib + ai (±gnrh agonist for premenopausal men and women) not earlier than 28 days before signing the informed consent; 4. it is allowed to start adjuvant hormone therapy with ai (±gnrh agonist) not earlier than 12 months before the start of ribociclib; 5. provision of written informed consent. exclusion criteria: 1. patients participating in any interventional clinical study at the time of signing the informed consent; 2. patients receiving active treatment for malignant neoplasms other than bc at the time of enrollment.

Keywords: breast cancer
effectiveness and safety study of peripheral balloon dilatation catheter in percutaneous transluminal angioplasty(pta) procedure

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to determine whether the peripheral balloon dilatation catheter (trade name: iris) is safe an effective in pta procedure.


Eligibility criteria:
inclusion criteria: * age: 18 yrs - 80 yrs. * patients with iliac and / or femoral artery atherosclerotic lesions * rutherford grade of 1-5; * target lesion stenosis≥70% (visual estimation) (proportion of trans-atlantic inter-society consensus(tasc) b, c and d grade lesions not less than 60% ) * patients being able to understand the purpose of the test, and being volunteered to participate in and sign the informed consent. exclusion criteria: * patients not suitable for receiving interventional surgeries of lower limb arteries for treatment; * patients require intervention of lesions besides unilateral iliac and femoral artery lesions at the same time; * patients have been involved in clinical trials of other drugs or medical devices within the past three months; * patient is unable or unwilling to participate in this trial; * patients with serious heart and brain, liver and other vital organs failure; * patients with life expectancy less than 6 months; * pregnant women.
the influence of psychobiological adversity to children and adolescents with type 1 diabetes

Conditions: Type 1 Diabetes; Stress

Summary: the aims of this study are two fold: to show whether there is an increased environmental or genetic susceptibility to stress in patients with t1d and whether it influences diabetes management. and to develop a strategy for the assessment and treatment of patients with t1d and an increased risk for development of psychopathology under stress.

lately, a marked increase in the incidence and earlier age of onset of type 1 diabetes (t1d) has been noted. these observations could also be connected to an increased prevalence of stressful experiences and a lowered stress tolerance in some children. the way a person responds to stress is determined by the interplay of genetic and environmental factors. environmental experiences at specific times of development have been shown to shape individual's hypothalamic-pituitary-adrenal axis (hpa axis) stress response. it is known, that early development of central nervous system is critically dependent on child's interaction with the environment (experience dependent maturation), especially to the attachment to caregivers (most often the mother). appropriate caregiving is connected to lower basal cortisol levels in children and a more stable hpa axis response after the exposure to stress. any circumstances that disturbed the formation of the attachment to the primary caregiver (e.g. complications at delivery, psychosocial stressors affecting the mother or mother's postpartum depression) resulted in higher hpa axis responsiveness to stress in the affected children. changes in individual genes have also been shown to influence a person's susceptibility to stress and risk for the development of stress-induced psychopathology.

Eligibility criteria:
inclusion criteria: * informed consent signed by a parent/legal guardian and informed assent signed by the study participant prior study entry * diagnosed with type 1 dm prior to signature of patient informed consent (pic) (for the t1d group). * age between 8-15 years old (inclusive) at signature of pic * treated by the investigator's centre prior signature of pic (for the t1d group). * willing to undergo all study procedures exclusion criteria: * any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, crohn's disease, ulcerative colitis, mb addison disease) * any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol (e.g. intellectual disability).

Keywords: type 1 diabetes children and adolescents stress genetic factors psychological background