Kornimate/medical-research-clean huggingface dataset:
impact of vitamin c on endothelial function and exercise capacity in fontan-palliated patients

Conditions: Fontan Procedure; Hypoplastic Left Heart Syndrome; Tricuspid Atresia

Summary: in this study, investigators will evaluate the effect of vitamin c on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to fontan physiology. the hypothesis is that vitamin c will result in improved exercise tolerance and endothelial function in patients who have undergone the fontan operation, compared to placebo.

recent evidence suggests that after fontan operation, single ventricle patients have impaired function of the vascular endothelium due in part to abnormalities in nitric oxide signaling. endothelial dysfunction may contribute to the development of congestive heart failure and exercise intolerance that have been well-documented in fontan patients. therapeutic interventions to improve endothelial function in adults with heart failure have mainly focused on increasing the synthesis or decreasing the degradation of nitric oxide. we propose a randomized, prospective, placebo-controlled trial of vitamin c, an antioxidant that protects no deactivation, in subjects with single ventricular anatomy after fontan palliation. the specific aims of this study are to compare no signaling, endothelial function and exercise capacity in fontan subjects to that of a control group that is frequency-matched to case subjects by age and sex, and to assess no signaling, endothelial function and exercise capacity in fontan subjects after 4 weeks of oral vitamin c (or placebo) therapy. these results have particular importance because improving the endothelial response in fontan patients has the potential to reduce the risk of developing congestive heart failure and improve exercise capacity. furthermore, assessing endothelial function and the effects of therapies aimed at improving vascular health may be generalizable to many other chronic pediatric conditions associated with increased cardiovascular risk such as obesity, diabetes mellitus, and hypertension.

Eligibility criteria:
inclusion criteria: * 8-25 years of age * fontan-palliated patient exclusion criteria: * new york heart association (nyha) classes iii or iv * diabetes mellitus * family history of premature coronary artery disease * use of sildenafil or other pulmonary artery vasodilators * prior cardiac arrest (outside the first 24-hours postoperatively) * life-threatening dysrhythmias * severe ventricular dysfunction * severe av valve regurgitation * pregnancy * severe renal or hepatic impairment
cognitive-behavior therapy for young adults with bipolar disorder

Conditions: Bipolar Disorder

Summary: the aim of the study is to develop and pilot test a cognitive-behavioral (cbt) intervention for young adults, ages 18-24 with bipolar disorder. the 14-week intervention focuses on improving management of bipolar disorder, reducing involvement in high-risk behaviors, and enhancing psychosocial functioning. the intervention also focuses on issues specific to transition-age youth. the study includes two phases: in phase 1, the intervention will be developed, refined, and openly piloted with several participants. in phase 2,the investigators will conduct a randomized clinical trial, in which 40 participants will be randomized either to receive the intervention right away, or to a 14-week waitlist condition. participants will be evaluated at baseline, week 5, week 10, and week 14 of the study period, as well as at 3- and 6-month follow up, using measures of mood symptoms, high-risk behaviors, drug and alcohol use, and psychosocial functioning.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar spectrum disorder (bipolar i, bipolar ii, or bipolar nos disorder) * ages 18-24 years * able to understand the nature of the study as well as potential risks and benefits * in treatment with a physician or nurse-practitioner for their bipolar disorder, or willing to seek and obtain such treatment if needed. exclusion criteria: * concurrent cognitive-behavioral psychotherapy * documented mental retardation * pervasive developmental disorder * current serious medical illness * inability to participate in the intervention because of acuity of symptoms * current drug or alcohol dependence (other than marijuana dependence)

Keywords: bipolar disorder cognitive behavior therapy alcohol abuse drug abuse high risk behaviors medication adherence psychosocial functioning
usefulness and efficacy of telemonitoring of patients with copd

Conditions: COPD

Summary: a substantial number of people with copd suffer from exacerbations, which are defined as an acute worsening of respiratory symptoms. to minimize exacerbations, telehealth has emerged as an alternative to improve clinical management, access to health care, and support for self-management. the study objective was to map the evidence of telehealth/telemedicine for the monitoring of adult copd patients after hospitalization due to an exacerbation.

chronic obstructive pulmonary disease (copd) is a major public health problem due to its high prevalence along with high morbi-mortality. indeed, it is the third leading cause of all-cause death worldwide. copd is marked by the onset of acute exacerbations (aecop), which accelerate the progression of the disease, the decline in respiratory function resulting in poor quality of life with a worse survival. therapeutic education of patients concerning treatment compliance and avoidance of exacerbating factors is one of the means of preventing aecopd. education sessions usually occur during during consultations and hospitalizations. face-to-face visits with health professionals can be hindered by severity of copd, geographic distance and limited access to health care services. telemonitoring patients with copd could improve delivery of health care, reduce exacerbations, improve quality of life, and results in lower rates of hospitalisation. however, it is unclear whether providing telehealth care improves outcomes of patients with copd. this trial aimed to assess the usefulness and efficay of telemonitoring patients with aecop

Eligibility criteria:
inclusion criteria: * patients aged over 18 years old with prior diagnosis of copd according to gold criteria exclusion criteria: * dementia * pregnancy * reluctance or self-declared inability to engage in the study * simultaneous participation in another trial involving a therapeutic or non-therapeutic intervention that will interfere with the primary and secondary endpoints of this study.

Keywords: exacerbation hospitalization telemonitoring acute
chemotherapy combined with immunotherapy in her 2 insertion or amplification advanced nsclc

Conditions: Non Small Cell Lung Cancer

Summary: this study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus pd-1 antibody in her 2 insertion or amplification.

main enrolled criteria: her2 insertion advanced nsclc her 2 amplification advanced nsclc failed with standard chemotherapy no history of pd-1/ pd-l1 antibody using

Eligibility criteria:
inclusion criteria: * ≥18，advanced non-squamous non-small cell lung cancer confirmed by histopathology * her 2 insertion or amplification * first diagnosis and treatment * treatment plan is chemotherapy or chemotherapy plus pd-1 antibody exclusion criteria: * patients received antitumor treatment before * patients with contraindication of chemotherapy * pregnant or breast feeding women
feasibility study of the taïso practice in parkinson's disease

Conditions: Parkinson Disease

Summary: this is a pilot study of descriptive and analytical, prospective feasibility, monocentric, longitudinal with 6 months of bi-weekly practice of taïso in patients with parkinson's disease with mild to moderate postural instability. the intervention is planned over 6 months (25 consecutive weeks) for the whole project of the patient group. patients are included in the month before the start of the treatment of the intervention. four standardized evaluation sessions are conducted: a first evaluation during the first week of taiso and then every 8 weeks (2 months, 4 months and 6 months). incident collection and fitness assessment tests are performed by the physical trainer while the balance and are performed by a physiotherapist. the quality of life assessment and the mds-updrs ii rating are performed during the inclusion visit and then the final study visit (within 2 weeks) after 6 months of practice) with the coordinating neurologist. an evaluation of incidents is also carried out during this end-of-study visit.


Eligibility criteria:
inclusion criteria: * age ≥18 and \<85 years old, * parkinson's disease diagnosed by a neurologist, treated and sensitive to dopaminergic treatment without limitation of the duration of the disease since the date of diagnosis, * patient with mild to moderate postural instability (equivalent to grade 2.5 and 3 on the hoehn and yahr scale), * naive patient of any practice of taiso, * patient available to perform the taïso program planned in the study, * patient with written informed consent exclusion criteria: * patient with a contraindication to the practice of sport * pregnant woman, parturient and breastfeeding mother * patient deprived of liberty by administrative or judicial decision * patient admitted to a health or social facility for purposes other than that of research * adults under guardianship or trusteeship or unable to express consent * patient not affiliated to a social security system * patient already participating in a therapeutic research protocol that aims to improve physical or mental abilities

Keywords: taïso physical therapy exercice therapy parkinson disease
nurtured in nature

Conditions: Postpartum Depression; Pregnancy Related; Environmental Exposure

Summary: the investigators pilot test a nature coach intervention in a population of postpartum women, to increase the amount of time people spend outside in local nature, with the goal of preventing postpartum depression.

postpartum depression (ppd), characterized by feelings of sadness, irritability, and fatigue following the birth of a child, occurs in 10-15% of women. ppd peaks within the first 2-3 months following delivery, but can occur anytime in the first year, representing one of the most common complications of childbearing. the consequences go beyond impaired functioning for the woman, and include harmful effects on the cognitive and emotional development of the woman's infant. despite this, many women are undiagnosed and do not get adequate treatment. living near and spending time in green space is associated with a host of mental health benefits, including reduced depression and improved well-being. research has shown that women who live near more green space have improved birth outcomes such as higher birthweight infants. despite the growing body of evidence linking nature with improved mental health, spending time in green space is not a standard health promoting tool to address mental illness. behavioral economics concepts have been used successfully in promoting other preventative health behaviors such as physical activity and healthy eating.

Eligibility criteria:
inclusion criteria: * 18 years old and older * delivery of a living child * ambulatory * live in west or southwest philadelphia * have a smart phone * able to understand and respond to an oral interview in english exclusion criteria: * baby in neonatal intensive care unit * mother has not been in intensive care unit pre/post-delivery * gestational age less than 37 weeks * department of human services involvement
autonomic cardiovascular control for elderly surgery patients

Conditions: Delirium

Summary: the purpose of this study is to study aspects of autonomic cardiovascular control and the level of stress hormones and inflammatory markers in saliva or serum, in elderly patients exposed to elective, major abdominal surgery, with or without postoperative delirium, to explore the hypothesis that delirium may be the result of aberrant stress responses.

patients admitted for elective, major, abdominal surgery will be tested with a head-up tilting to 20 degrees for 15 minutes preoperatively and again on the second postoperative day. haemodynamic variables will be registered by the device taskforcemonitor which monitors heart rate (hr), electrocardiography (ecg), blood pressure and stroke volume continuously and non-invasively. background variables (including demographics, comorbidity and simple cognitive tests) and daily variables (including delirium assessments) will be registered. blood and saliva samples will be drawn preoperatively and postoperatively to measure levels of stress hormones and inflammatory markers.

Eligibility criteria:
inclusion criteria: * patients 65 years or older scheduled for abdominal surgery at oslo university hospital exclusion criteria: * absence of a valid informed consent or assent, or consent from a legal proxy * patients with atrial fibrillation or a pacemaker rhythm * polyneuropathy * current treatment with beta-blockers, calcium-blockers or cholinesterase inhibitors * competing research project

Keywords: delirium autonomic cardiovascular control abdominal surgery tilt-test
rfviia in ich in patients treated with anticoagulants or anti-platelets

Conditions: Intracerebral Hemorrhage

Summary: evaluation of efficacy and safety of recombinant factor viia versus standard therapy in preventing early haematoma growth in spontaneous acute intracerebral haemorrhage in patients treated with oral anticoagulants or antiplatelets agents

intracerebral hemorrhage (ich) is the deadliest, most disabling, and least treatable form of stroke. approximately 40% of patients die within 1 month of ich onset, and two-thirds of survivors never regain functional independence. though guidelines for supportive care exist, there is currently no treatment that has been shown in a randomized-controlled trial to definitely improve outcome after ich. hematoma volume is a critical determinant of mortality and functional outcome after ich, and early hematoma growth may be an important cause of early neurological deterioration. considerable clinical interest has been given to the relationship between antiplatelet and antithrombotic treatment and ich. the reported incidence of major bleeding events in patients undergoing antithrombotic treatment is 5-11/1,000 patients/year, while the overall range of hemorrhages is about 62/1,000 patients/year.in the patients treated with antithrombotic drugs (oral anticoagulants or antiplatelets agent) the incidence rate of ich has been shown higher than in the general population. moreover, the mortality rate for both spontaneous and post-traumatic events is higher in antithrombotic treated patients than in controls. \[14,15\] rfviia has been successfully used to control ich in patients with hemophilia or other coagulation disorders, and can arrest intraoperative bleeding and reverse coagulopathies in patients undergoing neurosurgical procedures.\[19\] rfviia has also been reported to prevent or minimize refractory bleeding in non-coagulopathic patients.

Eligibility criteria:
inclusion criteria: * ich in patient on treatment with one of the following: * a)oral anticoagulant (inr upper than 1,4 at enrollment * b) aspirin, whatever dosage * male or female subjects, age \> 18 years. * informed consent exclusion criteria: * inr below 1.4 for patients on oral anticoagulants. * patients with secondary ich related to infarction, tumor, cerebrovenous thrombosis, thrombolysis. * planned neurosurgical intervention. * any history of haemophilia or other congenital or acquired coagulopathy requiring specific antihemorrhagic treatment. * acute myocardial ischaemia or acute thrombotic stroke (within one year). * septicemia, intravascular disseminated coagulation. * pregnancy. * limb amputation due to vascular disease or claudication within last 30 days. * known or suspected allergy to the trial product or related products. * participation in other trials within the previous year.

Keywords: intracerebral hemorrhage oral anticoagulants antiplatelet agents recombinant activated factor vii
an educational and exercise program as secondary prevention of recurrent lower back pain in healthcare workers

Conditions: Acute Low Back Pain

Summary: at lyon university medical center, back problems are the leading cause of sick leave. the course of lower back pain is usually relatively short (recovery occurs within 4 to 6 weeks in 90% of cases). however, about 5-10% develop chronic lower back pain. although this is a relatively small group, the economic consequences are enormous (accounting for 70 to 80% of the total cost of lower back pain). nowadays, some very general training sessions are offered to workers at lyon university medical center, irrespective of their lower back pain status. these very general training sessions are mostly preventive and primary in nature (like back school program) despite the fact that these people already have a history of lower back pain, the main risk factor of recurrence and chronic pain. since the 1980, some multidisciplinary functional restoration programs have been advised as a strategy for secondary and tertiary prevention of lower back pain. the purpose of this randomized controlled trial is to assess the effectiveness of physical exercise combined with an educational program and self-led exercise for lyon university medical center workers with lower back pain. we hope this intervention will reduce the risk of recurrence and chronic lower back pain.


Eligibility criteria:
inclusion criteria: * all healthcare workers in the 4 hospital sites * history of acute or subacute lower back pain in the 3 past years exclusion criteria: * history of surgery for spinal fractures * history of lumbosacral arthrodesis * history of surgical intervention or discal hernia, more than 2 levels or more than twice * radiculalgia with sign of motor deficit, or radiculalgia with a positive lasègue sign * eligible for enrollement in a functional restoration program for lower back pain * ongoing low back pain (lumbago) * psychosocial or behavioural impairment * unstable cardiac disease * inability to fill out the questionnaires and scales (inability to understand french) * pregnancy

Keywords: low back pain recurrence chronic low back pain educational program physical therapy home exercise compliance
effects of a legal support program on women experiencing domestic violence

Conditions: Domestic Violence; Anxiety; Depression; Stress

Summary: intimate partner violence (ipv) is a major public health concern. worldwide, 1 in 3 women have experienced domestic abuse/ violence in their lifetime. in most cases, family lawyers, advocates are first contact before the police. if the children are involved, finding the legal options become the priority for women before leaving the abuser. the purpose of this study was to compare the effectiveness of the help (health, education legal support program) intervention among ipv survivors.


Eligibility criteria:
inclusion criteria: * female survivors of intimate partner violence * 18 years old or older * gives informed consent exclusion criteria: * diagnosed mental health condition * terminally ill * chronic condition * on psychiatric medication * sexual assault
giant cell arteritis: improving use of ultrasound evaluation

Conditions: Giant Cell Arteritis

Summary: giant cell arteritis (gca) is an inflammatory disease causing new, unaccustomed headache in the elderly and which can lead to blindness in 20-30% of untreated cases. the study group have previously shown that ultrasound is a viable non-invasive alternative to temporal artery biopsy in diagnosing gca. however, there is significant variation in ultrasound assessment (measuring a dark "halo" around the abnormal blood vessels) between sonographers in different centres, requiring a labour intensive and time consuming training programme. the study group propose to standardise the training programme, and use ultrasound and clinical evaluation to define changes occurring over time and with treatment in patients with a diagnosis of gca made based on ultrasound changes alone. the study group will explore the use of algorithms to automate or semi-automate image interpretation.

objectives and project plan: * project purpose: the purpose of the project is to develop the technology to reliably acquire and analyse ultrasound images through the use of a training programme which are comparable to those from scanning by an expert sonographer in the diagnosis (i.e. as a diagnostic tool) and monitoring of patients with gca following treatment (i.e. as a response indicator), and patient stratification according to initial or early scan changes to determine the most appropriate treatment (i.e. as a prognostic tool). * end point: the end point will be the production of an effective training programme which can be used to obtain reproducible accurate ultrasound images of the temporal artery which can be automatically analysed and used in real time in the management of patients with suspected or confirmed giant cell arteritis. * milestones: the project is in 3 phases. in phase 1 (0-12 months) the study group will create a bank of images for training from healthy volunteers and patients with gca; in phase 2 (13-18 months) the study group will test the programme on sonographers assessing patients with gca; in phase 3 (19-42 months) the study group will acquire serial images, clinical data, serum and plasma from cohorts of patients with newly diagnosed and flaring gca so that they can analyse and develop new software algorithms. the study group can use images already acquired from a previous diagnostic study in gca, and test the algorithms on the new cohorts..

Eligibility criteria:
inclusion criteria: * healthy volunteer or * patient with a suspected diagnosis of gca but found not to have gca * recent diagnosis of gca within 1 month or * suspected flare of gca within one month * ability to provide written informed consent exclusion criteria: * unable to provide written informed consent

Keywords: ultrasound