Kornimate/medical-research-clean huggingface dataset:
telemedicine for patients with chronic respiratory insufficiency

Conditions: Chronic Respiratory Failure

Summary: in unstable patients needing oxygen and/or home mechanical ventilation, a nurse-centred tm programme (supported by continuous availability of a call centre and a pulsed oxygen system) is cost/effective saving health care resources.

background: integrated care and strict follow up have been recommended for frail patients with chronic respiratory failure (crf) discharged at home. objectives: to evaluate impact and costs on health care resources of a telemedicine programme (tm) for severe patients discharged at home with oxygen and/or home mechanical ventilation (hmv) with a high risk of hospital readmission. design: prospective randomised controlled trial. setting: respiratory rehabilitation unit s. maugeri foundation between may 2004 and march 2007. participants: 240 crf patients will be randomised into an intervention group (tm) and a control group, which received current usual care (educational plan, 3 months outpatient visits). interventions: one year tm with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing. main outcome measures: survival, admissions to emergency room (er), hospitalisations, urgent general practitioner (gp) calls, home relapses; probability to remain free from the above events will be also compared among groups. tm and health care system costs as customer satisfaction will be also collected.

Eligibility criteria:
inclusion criteria: * crf patients discharged from respiratory unit with home mv exclusion criteria: * severe co morbid conditions, i.e. lung cancer or other advanced malignancies, and extremely severe neurological disorders (with impaired cognitive status, ability to understand medical instructions, dementia or severe psychiatric illness) * logistical limitations due to extremely poor social conditions, such as illiteracy or no telephone access at home * being admitted to a nursing home * lack of caregiver when ventilated invasively (i.e. tracheal cannula with sounds uncertain) to allow a contact between care team and family * refusal to give informed consent

Keywords: copd als telemedicine mechanical ventilation integrated care strict follow up impact and costs on health care resources telemedicine programme home mechanical ventilation (hmv) frail patients chronic respiratory failure (crf)
study of intranasal clonazepam in adult subjects with epileptic seizures

Conditions: Epilepsy

Summary: evaluate the safety and efficacy of intranasal clonazepam in subjects with epilepsy.


Eligibility criteria:
inclusion criteria: * diagnosis of refractory epilepsy * no nasal conditions that would preclude the use of intranasal product exclusion criteria: * subject with a clinical significant unstable medical abnormality * subject currently or regularly taking clonazepam
a trial comparing the effect of pravastatin and rosuvastatin on atherosclerosis progression measured by carotid intima media thickness in patients with coronary artery disease after biolimus eluting stent (nobori®) implantation: cpr imt

Conditions: Coronary Artery Occlusive Disease

Summary: current consensus papers recommend statin medication to reduce low density lipoprotein (ldl) cholesterol level less than 100mg/dl (optional 70mg/dl) in patients with coronary artery disease. however, there is lack of solid evidence whether a specific kind of statin have the superiority against other statins in clinical outcomes. furthermore, recent data have showed that several kinds of statin could have an adverse effect on glucose metabolism and increase the risk of development of diabetes. carotid intimamedia thickness (cimt) is a surrogate marker of atherosclerosis to predict long term cardiovascular outcomes in not only general population but also patients with established coronary artery disease. consequently, we will evaluate the efficacy of high dose of pravastatin on cimt, comparing with moderate dose of rosuvastatin in patients with established coronary artery disease. additionally, we will assess the clinical outcomes of pravastatin after percutaneous coronary intervention as well as adverse outcomes including insulin resistance and new onset diabetes compared with rosuvastatin. our main hypothesis is that pravastatin 40mg would be non-inferior to rosuvastatin 20mg regarding cimt at 1 year follow up.


Eligibility criteria:
inclusion criteria: * patients ≥ 20 years old * patients with coronary artery disease who are candidate for coronary revascularization with des implantation. * significant coronary de novo lesion (stenosis \> 70% by quantitative angiographic analysis) * patients eligible for statin treatment (initial ldl cholesterol \>70mg/dl or patients taking lipid-lowering agent) exclusion criteria: * severe hepatic dysfunction (3 times normal reference values) * pregnant women or women with potential childbearing * life expectancy \< 1 year

Keywords: statin cimt bes
the medical management in patients exposed to weapons of mass destruction

Conditions: Chemical Injury; Chemicals; Intoxication; Acute Respiratory Distress Syndrome; Distress Respiratory Syndrome; Medical Emergencies

Summary: observation study measuring medical response in contaminated environment.

this is an ongoing multicentric observational study that aims to assess the medical response to chemical, biological, radiological, nuclear, explosive (cbrne) events during the last five (5) decades (i.e.: 1970-2020), and in any future cbrne attack that might occur within the next 15 years (i.e.: 2021-2036). of note, the data collection will be performed retrospectively and after sites review ethic board (reb) approval.

Eligibility criteria:
inclusion criteria: i. a cbrne attack caused at least one casualty who required the assistance of the participating health care system (e.g.: physicians, nurses, paramedics and other health-care specialists of a medical facility) during a medical extraction from the incident site until admission to a medical facility; ii. patients are eligible if they were exposed to the cbrne attack; iii. medical information concerning the cbrne exposures, even if partial, is accessible to health care professionals for the purposes of filling out the online case report form (ecrf); iv. participants must be able to complete the online case report form in english; and v. the approval of an ethics review board is obtained by each medical centre participant. exclusion criteria: a negative response to any of the inclusion criteria results in an exclusion.

Keywords: cbrne defence acute settings pre-hospital settings decontamination protection respiratory insults treatments
survey on the reproductive and child-rearing situations of patients with severe mental disorders

Conditions: Schizophrenia and Schizoaffective Disorder; Bipolar Disorder (BD)

Summary: severe mental disorders represent a major public health concern, imposing substantial disease burden and adversely affecting multiple dimensions of patients' lives, while also creating intergenerational impacts on their offspring and families. existing evidence suggests that children of affected patients demonstrate elevated vulnerability to various physical and psychological challenges during developmental stages. currently, china lacks systematic data regarding reproductive patterns and child-rearing practices among patients with severe mental disorders. to address this knowledge gap, investigators are conducting a multicenter epidemiological survey across ten representative cities and regions nationwide. this study aims to comprehensively examine the reproductive history, child-rearing circumstances, and family socioeconomic status of this population. the findings will establish a crucial foundation for subsequent analytical epidemiological investigations and intervention studies, while informing evidence-based mental health policy formulation. the study population consists of registered patients (aged 18-59 years) in the national severe mental disorder management system who meet diagnostic criteria for: schizophrenia, bipolar disorder, paranoid personality disorder, schizoaffective disorder, epilepsy-induced mental disorders, or intellectual disability-associated mental disorders. eligible participants must have documented childbirth history (including miscarriage, preterm, and term deliveries).


Eligibility criteria:
inclusion criteria: * patients who meet the diagnostic criteria for schizophrenia, bipolar disorder, paranoid personality disorder, schizoaffective disorder, mental disorders caused by epilepsy, or mental disorders associated with intellectual disabilities, and are registered in the management system for severe mental disorders * aged 18-60 years * patients who had a history of childbirth (childbirth history includes miscarriage, preterm birth, and full-term birth). exclusion criteria: * do not agree to participate in the survey.
prospective trial of the bilevel positive airway pressure (by boussignac) in emergency department of non-invasive patients presenting with acute hypercapnic respiratory failure

Conditions: Acute-on-chronic Respiratory Failure

Summary: the purpose of this study is to determine whether the new boussignac-system of non-invasive ventilation is as good as the conventional non-invasive system in patients presenting with acute hypercapnic respiratory failure.


Eligibility criteria:
inclusion criteria: * 7,25 ≤ ph ≤ 7,35 * paco2 ≥ 45 mmhg exclusion criteria: * ph \< 7,24 * incapable of collaboration

Keywords: non-invasion ventilation boussignac
cog-fun ageing participation-centered, health promotion for older adults

Conditions: Subjective Cognitive Decline (SCD)

Summary: the goal of this feasibility study is to test the feasibility of a group intervention program based on health management principles for older adults with subjective cognitive decline (scd). scd is a condition where individuals feel that their memory is worsening, although standard tests do not detect it. this perceived memory decline can lead to negative feelings and self-perception, causing people to withdraw from meaningful activities. this study aims to answer three main questions: 1. is the intervention feasible in terms of fidelity, adherence, and participant satisfaction? 2. are the assessments used sensitive enough to identify the unique challenges faced by the scd population and detect changes after the intervention? 3. what are the preliminary effects of the intervention on participants' perceptions of how scd affects their daily life, mental health, and quality of life? participants will: 1. take part in 14 weekly group sessions focused on managing the challenges of living with scd and improving participation in daily activities. 2. complete assessments before and after the intervention to measure their satisfaction with the program, and track changes in their perceptions of daily life, mental health, and quality of life.


Eligibility criteria:
inclusion criteria: * self-reported memory changes, * a score of 23 or higher on the montreal cognitive assessment (moca) * proficiency in hebrew to participate fully in a hebrew-speaking group. exclusion criteria: * presence of a significant health condition that affects functioning * residence in a medical institution or nursing home * current participation in another scd treatment

Keywords: occupational experience participation cognitive functional interventions functional decline
a study of ds-8500a in japanese subjects with type 2 diabetes mellitus receiving sitagliptin

Conditions: Type 2 Diabetes Mellitus

Summary: the objectives of the study is to evaluate the efficacy and safety of ds-8500a compared with placebo in patients with type 2 diabetes mellitus (t2dm) receiving sitagliptin.

in patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of ds-8500a are to be evaluated after 28-day multiple oral administration of ds-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.

Eligibility criteria:
inclusion criteria: * japanese patients with type 2 diabetes * patients aged ≥ 20 years at the time of informed consent * patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus * patients who have hba1c ≥ 7.0% and \< 9.0% exclusion criteria: * patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis * patients receiving or requiring treatment with insulin * patients with a body mass index (bmi) of \< 18.5 kg/m2 or ≥ 35.0 kg/m2 * patients with clinically evident renal impairment (estimated glomerular filtration rate \[egfr\] of \< 45 ml/min per 1.73 m2) or clinically significant renal disease * patients with fasting plasma glucose ≥ 240 mg/dl

Keywords: type 2 diabetes mellitus sitagliptin adult phase 2
receptor occupancy of iti-007 using positron emission tomography (pet) in patients with stable schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to determine the relationship between iti-007 dose, plasma levels and brain receptor occupancy in patients with stable schizophrenia.


Eligibility criteria:
inclusion criteria: * patients with schizophrenia who are drug-free with regard to their antipsychotic medication * in clinical remission and free from acute exacerbation of their psychosis * in good health exclusion criteria: * clinically significant medical conditions considered inappropriate for trial participation
fitness intervention trial for stroke

Conditions: Stroke

Summary: the objective of this study is to evaluate, among persons who have completed the restorative phase of stroke and have ceased rehabilitation, the relative effectiveness in improving functional exercise capacity of two programs for continued care, a home-based general fitness training program using stationary cycling and a disability targeted, home-based exercise program to enhance mobility and walking competency. capacity compared with the "walking" group and that consequently the cycle group will achieve a higher quality of life. a secondary objective is to explore factors associated with compliance with the exercise regimens. previous research has indicated that cognitive-affective-behavioural profile is related to exercise activity in a number of populations including sedentary adults, older adults and patients with cardiovascular disease. as we anticipate that one of the mechanisms by which the cycling will result in an outcome better than the more traditional type of disability tailored exercise program is through greater compliance, this second objective is very relevant. this study will also address the impact of regular exercise on cardio-vascular risk factor profile.

the specific clinical hypothesis to be tested is that, over a one year period, persons assigned to the general fitness "cycle" group will experience a greater increase in functional exercise

Eligibility criteria:
inclusion criteria: * verified stroke requiring hospital admission (based on clinical and radiological evidence) * ability to walk a minimum of 10 meters independently, using an aid or orthotic, with or without supervision, * less than one year since the last cerebrovascular event at the time of recruitment, * discharge from active rehabilitation (usually around 3 to 4 months post-stroke but not less than 1 month) into the geographic study area of greater montreal and greater halifax. exclusion criteria: * severe cognitive deficits as evaluated by the telephone version of the mini-mental state examination such that the subject does not understand their participation in the study, * receptive aphasia as evaluated by the canadian neurological scale48 or the treating speech therapist, * illness or disability precluding participation in either rehabilitation intervention. * failure to pass a standard cardiology orientated history and physical examination complemented by a baseline screening exercise stress test

Keywords: stroke rehabilitation walking
assessment of blood and follicular fluid immune cell constitution in patients undergoing in vitro fertilization

Conditions: Infertility, Female

Summary: the etiology of infertility in the majority of patients with poor response to ovarian stimulation remains unknown. this study will investigate the role of immune cells (t cells, b cells, dendritic cells and nk cells), that constitute the immune system which normally fights infection and cancer. we, the investigators, have found that specialized nk cells that help with new blood vessel formation, are found in the fluid surrounding the egg during ivf, only in patients with good response to ovarian stimulation. we now wish to expand our studies and correlate our findings to ovarian blood flow , as measured by 3d ultrasound and to the presence of other cells in the immune system.


Eligibility criteria:
inclusion criteria: * age 27-43 years * diagnosis of infertility due to endometriosis, severe male factor, tubal occlusion. * patient undergoing ivf exclusion criteria: * body mass index (bmi) \> 38 kg/m2 * abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography * any current use of systemic steroid medication or any infertility treatment within 3 months of study enrollment. * any contraindication to being pregnant and carrying a pregnancy to term. * any ovarian or abdominal abnormality that may interfere with adequate tvs evaluation. * absence of one or two ovaries * clinically relevant systemic disease (e.g., insulin-dependent diabetes, adrenal dysfunction, organic intracranial lesion, polycystic ovarian syndrome, hyperprolactinemia, or hypothalamic tumor) or serious illness (neoplasia). * history (within past 12 months) or current abuse of alcohol or drugs. * administration of any investigational drugs within three months prior to study enrollment. * any medical condition that may interfere with the absorption, distribution, metabolism or excretion of the study drugs, gastrointestinal diseases, mal absorption syndromes and liver dysfunction * unexplained gynecological bleeding. * ejaculated sperm is not sufficient for icsi * patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study. * abnormal coh screening blood done for both partners, including: prolactin, thyroid stimulating hormone, hiv serology, hepatitis b and c serology, rubella, group and screen and syphilis serology prior to participation in study. * unwillingness to give written informed consent. previous entry into this study or simultaneous participation in another clinical trial.
mivideo - video visit summary for cancer patients

Conditions: Colorectal Cancer

Summary: cancer patients about to begin chemotherapy receive large amounts of information regarding their prognosis, how chemotherapy improves their prognosis, and the usual side effects of the chemotherapy during their first visit to the oncologist. prior studies have documented that less than half of this information is retained after the visit, making it difficult for patients to participate in their care and difficult for them to enlist the help of their social support. the mivideo project allows the physician to create a custom 5-minute summary video summary of a pre-chemotherapy clinic visit and upload it to a secure web site. the video will emphasize the major points of the forty-five minute office discussion, allowing patients to review the physicians' recommendations and share the information and recommendations with others. by providing the patient with this re-cap of their visit, the investigators hope to engage them more actively in their cancer treatment. making the information available to friends and family can also help a patient receive both intellectual and emotional support during the course of treatment. the primary endpoint of this study is improvement of patient care, not research activity. primary hypothesis: creating a 5-minute video summarizing information about diagnosis, stage, chemotherapy treatment plan, and anticipated side effects for patients starting chemotherapy for colon cancer will not significantly lengthen the pre-chemotherapy clinic visit as compared to visits that do not include video production.


Eligibility criteria:
inclusion criteria: * age 18-80 * diagnosis of colon cancer with treatment plan to include chemotherapy * sufficient command of english language to read and understand consent and survey forms * working email address and access to the internet (computer, tablet, smartphone) to view treatment summary video exclusion criteria: * previous history of chemotherapy or cancer (excepting in situ cancers) * history of drug or alcohol abuse or unmedicated mental or psychiatric disorder * medical history or diagnosis of debilitating medical disorder such as progressive muscle paralysis, advanced cardiac, respiratory, or renal disease, or aids
the study of molecular risk panels (70-gene assay) in chinese breast cancer patients

Conditions: Chinese

Summary: this study is experimental and will prospectively assess the proportion of patients in the two (2) mammaprint risk categories in patients of chinese descent.

the incidence of breast cancer in chinese women is lower than that of a western population. breast cancer is the most common cancer in chinese women and the incidence is rising. moreover there are more premenopausal women with breast cancer where the breast cancer incidence peaks in the forties and the postmenopausal rise in incidence is less commonly seen. as the genetic predisposition to breast cancer is increasingly understood, it has been suggested that the differences in breast cancer incidence in different ethnic populations is potentially due to interactions between lifestyle and genetic characteristics. to date, the use of agendia's gene expression assays in chinese women has not been studied. in this study, the feasibility of the gene-expression prognostic assays for risk assessment in this specific group will be assessed. moreover, the specific molecular characteristics and potential biomarkers will be studied, focusing especially on the large group of premenopausal breast cancer patients.

Eligibility criteria:
inclusion criteria: * females aged 18 year to 70 year, * diagnosis of stage i or stage ii (excluding those involving more than 3 lymph nodes) breast cancer * chinese descent exclusion criteria: * stage ii breast cancer with more than 3 positive lymph nodes

Keywords: chinese women breast cancer