Kornimate/medical-research-clean huggingface dataset:
virtual therapeutic garden for depressive symptoms

Conditions: Depressive Symptoms; Depression; Anxiety

Summary: this study evaluates the addition of virtual therapy intervention in the treatment of depression in the elderly. half of the participants will receive virtual reality treatment as an addition to physical exercises and psychoeducation, while the other half will receive physical exercises and psychoeducation alone.

depressive disorders are frequent and can either first be manifested at a younger age and recurrent during later life or have an onset beyond 60 years (late-life depression). the multifactorial genesis of depression in old age includes psychosocial, vascular and metabolic factors and requires multimodal and multi-professional therapy including physical activity and psychosocial interventions. however, there is still a percentage of older people who do not show improvement in depressive symptoms. in recent years, various types of virtual reality are gaining in popularity, primarily because of the availability and ease of use. a systematic review from 2018 concluded that vr treatment had moderate to large effects in anxiety and depression, compared to controls and it could be another effective choice available to clinicians and patients. therefore, the aim of this project was to evaluate the effectiveness of virtual therapy in the elderly, in whom the previous multimodal therapeutic program has not brought the expected results.

Eligibility criteria:
inclusion criteria: * gds≥10 or hads-a≥8 or hads-d≥8 exclusion criteria: * cognitive impairment (mmse\<24); * aphasia and a serious loss of sight or hearing that makes it impossible to assess cognitive functions based on mmse; * contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment); * substance abuse; * participation in another therapeutic project or individual psychotherapy; * antidepressant treatment;

Keywords: virtual reality depression anxiety mental health elderly rehabilitation virtual garden
endovascular aortic repair with sac embolization for the prevention of type ii endoleaks (the evar-se study)

Conditions: Abdominal Aortic Aneurysm; Endoleak

Summary: beyond a certain threshold diameter, abdominal aortic aneurysms (aaa) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (evar). the latter involves implantation of a stent-graft and thereby exclusion of the aaa from the blood circuit. small vessels supplying parts of the bowel or the spine are regularly covered. in a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the aaa, referred to as type ii endoleak (t2el). occurrence of t2el is associated with complications like aaa growth or even rupture. secondary interventions to treat t2el often fail and may be highly invasive. various risk factors for t2el have been described. this enables prediction whether a patient is at high risk for t2el after evar. deployment of metal coils in the aneurysm sac as part of the evar procedure can reduce the risk for t2el.the present study aims to assess the efficacy of sac embolization during evar to prevent t2el.


Eligibility criteria:
inclusion criteria: * age ≥18 years * infrarenal aaa ≥50 mm maximum diameter * indication for evar within ifu of company * presence of one or both high risk criteria on ct-a: ≥5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) or \<40% thrombus at largest aaa diameter exclusion criteria: * ruptured aaa * fenestrated or branched evar * concomitant iliac artery aneurysm * non-ability to adhere to the fu protocol * lack of consent * pregnancy

Keywords: abdominal aortic aneurysm endoleak endovascular aortic aneurysm repair coiling endoleak type ii
covid-19 - study of the kinetics of the immune response during the intensive care unit stay in adult patients infected with sars-cov-2: multicentric non interventional study

Conditions: Intensive Care Unit; SARS-Cov-2

Summary: infection with the sars-cov-2 coronavirus (covid-19) has recently been identified as a pandemic due to the speed and global scale of its transmission. in auvergne-rhône-alpes region (aura), the epidemic began in february 2020 and the number of infected people is still important. between 15 and 20% of covid-19 patients develop an acute respiratory distress syndrome (ards) leading to their hospitalization in intensive care. their clinical progression can be rapidly harmful with the development of severe ards associated with an increased risk of death. preliminary data on the immune response of covid-19 patients describe the induction of a moderate inflammatory response and the occurrence of major progressive lymphopenia over time associated with potential immunosuppression. up to 50% of secondary infections are reported in deceased covid-19 patients. however, no prospective study has exhaustively described the kinetics of the immune response of covid-19 patients in intensive care. the precise description of the immune response over time in adult patients with a proven infection with the sars-cov-2 virus and the study of the relation between this response and the increased risk of organ failure (severe ards), death or nosocomial infection will allow us to better understand the pathophysiology of the immune response induced by covid-19 in order to (i) identify new therapeutic strategies targeting the host response in patients in intensive care (ii) to develop biological markers to stratify patients for future clinical trials evaluating these immunoadjuvant treatments in covid-19.


Eligibility criteria:
inclusion criteria: 1. man or woman aged 18 or over, 2. hospitalization in intensive care for sars-cov-2 pneumopathy, 3. first hospitalization in intensive care unit, 4. positive diagnosis of sars-cov2 infection carried out by pcr or by another approved method in at least one respiratory sample, 5. sampling in the first 24 hours after admission to intensive care unit (d0 / d1) feasible, 6. patient or next of kin who has been informed of the terms of the study and has not objected to participating. exclusion criteria: 1. pregnant or lactating woman, 2. person placed under legal protection,
a single session community-based body empowerment session

Conditions: Body Image

Summary: this present study will examine the effectiveness of a single session, virtually delivered body empowerment program for decreasing participants thin ideal internalization. the intervention asks participants to identify cultural norms surrounding appearance and attractiveness, then challenge these ideals. participants will answer questions about thin ideal internalization before and after the program.

a body empowerment program rooted in the psychological theory of cognitive dissonance has been shown to be effective to reduce the value of the thin beauty ideal. this theory proposes that humans are motivated to maintain consistency in their beliefs and actions, and inconsistencies will result in psychological discomfort (or cognitive dissonance). a shift in beliefs or actions is required to resolve this discomfort and maintain consistency. however, the accessibility of this program is lacking. the proposed study will examine the effectiveness of a single session, virtually delivered body empowerment program designed to create cognitive dissonance by asking participants to identify cultural norms surrounding appearance and attractiveness, then challenge these ideals through a series of interactive activities in a fully virtual, self-paced module. challenging these ideals (e.g., identifying how ideals represent very narrow identities and are informed by oppressive value systems, stating the psychological costs of trying to change your body to match ideals) theoretically creates cognitive dissonance in those who have internalized the value of pursuing those ideals. this dissonance is resolved through a reduced investment in the ideals and then hypothesized to lead to more positive attitudes about body image, dieting, and other unhealthy weight control behaviors. the program consists of a single 45-minute self paced, interactive, virtual module. primary assessments will be completed at pre-intervention and post-intervention.

Eligibility criteria:
inclusion criteria: * 18+ years of age * able to reliably access internet * can speak and read english * completed the body empowerment program exclusion criteria: * none

Keywords: body image eating disorder psychological wellbeing weight stigma social stigma digital health
association between p0.1 and extubation failure in adult patients with acute hypoxemic respiratory failure. a multicenter prospective cohort study

Conditions: Ventilator Weaning

Summary: the goal of this observational study is to learn about the effect of the occlusion pressure during the first 100 miliseconds (p01) over the extubation failure in participants receiving mechanical ventilation for acute respiratory failure. the main question it aims to answer is: are high p0.1 values (≥3 cmh2o) measured 30 minutes after starting a spontaneous breathing trial associated with extubation failure in adult patients who were intubated for acute hypoxemic respiratory failure?


Eligibility criteria:
inclusion criteria: * patients over 17 years of age * patients receiving invasive mechanical ventilation for more than 24 hours * patients who have been ventilated for acute hypoxemic respiratory failure * patients who overcome a pve * patients who, after overcoming the pve, meet the conditions to be extubated immediately after, according to the team of treating professionals who conduct the weaning * patients who are in their first attempt at extubation exclusion criteria: * tracheostomized patients * patients with neuromuscular disease (for example: guillain barré, * myasthenia gravis, amyotrophic lateral sclerosis, etc.) * patients with a decision not to reintubate

Keywords: respiration, artificial positive-pressure respiration
efficacy and mechanism of action of methenamine hippurate (hiprex™) in women with recurring urinary tract infections.

Conditions: Urinary Tract Infections

Summary: the purpose of this study is to measure the concentration of formaldehyde in the urine of women with recurrent urinary tract infections on hiprex; and then, assuming its urinary presence is confirmed at the proper acid urinary ph, evaluate if such a therapy has favorable effects in decreasing the rate of recurrent urinary tract infections over time.


Eligibility criteria:
inclusion criteria: 1. female 2. age 50 - 85 3. have rutis (at least 2 utis within the past 6 months or 3 within the past year) - exclusion criteria: 1. being on antibiotics at baseline (i.e. suppressive therapy or antibiotic therapy for urinary or non-urinary infections) 2. neurogenic bladder condition 3. using urinary catheters (including foley catheter, intermittent catheterization, and suprapubic catheter) 4. uncontrolled diabetes (hba1c \> 9) 5. chronic renal failure defined as serum creatinine \> 1.5 mg/dl 6. history of liver disease 7. patients from out of town, in whom follow-up will not be possible 8. pregnancy 9. allergy to hiprex 10. inability to take hiprex reliably at home, such as having psychosis, dementia, or swallowing disorders 11. non-english speakers -
ipt-g for mums with postpartum depression

Conditions: Postpartum Depression

Summary: postpartum depression is a very common and costly illness with numerous, long-term deleterious effects for women, their offspring and families; yet most women are not treated. group ipt delivered virtually offers women a 1st-line, low-cost intervention that overcomes existing treatment barriers. to test its acceptability and effectiveness, a rct will be conducted to compare virtually delivered group ipt immediately to usual care in women in ontario canada who have postpartum depression.

depression during pregnancy and in the first year following delivery affects 15-20% of women. left untreated, these disorders increase the risk of future depressive episodes, postpartum depression in their partners, as well as emotional, behavioural, and cognitive problems in offspring. unfortunately, up to 85% of these women will not receive treatment, which is estimated to cost the province of ontario upwards of $6 billion annually. there is significant stigma surrounding perinatal depression which can result in less help-seeking by women, as well as a lack of awareness about available non-medication treatment options among both physicians and patients, even though most women prefer psychotherapy over medication. despite the very strong evidence base for ipt, relatively few clinicians are trained to deliver ipt. rather than travelling to tertiary care centres, the delivery of group psychotherapy virtually via telemedicine or zoom allows women anywhere in the province to access this highly effective first-line treatment, thereby increasing access for women with perinatal depression and improving outcomes for mothers, babies, and families in ontario. study objective: to compare the effectiveness of virtual group ipt to usual care in women with postpartum depression symptoms for reducing depression symptoms and anxiety, improving mother-infant attachment, and increasing social support, functioning, and quality of life. study design: rct population: postpartum women, aged 18 or older, with a baby under a year old intervention: 12 weeks (15 sessions - 12 acute, 3 maintenance sessions) of group ipt delivered virtually via zoom comparison: 12 weeks of usual care followed by group ipt outcomes: pre-treatment versus post-treatment change in depression symptoms, anxiety, acceptability, mother-infant bonding, social support \& functioning, and quality of life. all women in the study will be able to access care as usual from their physicians and other therapists throughout the study.

Eligibility criteria:
inclusion criteria: * age 18 years or older * postpartum with baby under 1 year * score greater than or equal to 10 on the edinburgh postnatal depression scale (epds) exclusion criteria: * active alcohol or substance use disorder * bipolar disorder * borderline personality * antisocial personality * ptsd * psychosis

Keywords: postpartum perinatal depression depressive disorder
effectiveness of cryotherapy on the fatigue of patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the aim of the study is to evaluate the effectiveness of partial-body cryotherapy (pbc) on the symptoms of patients with multiple sclerosis during a rehabilitation stay.

multiple sclerosis (ms) is a chronic heterogeneous disease with an unpredictable clinical course. symptoms can include paralysis, ataxia, spasticity, incontinence and fatigue syndrome. fatigue is considered to be the most prevalent and disabling of the symptoms at all stages of the illness and its occurs in 70-80% of patients. this characteristic of the disease directly impacts the quality of life of patients, affecting their social and physical well being. physical rehabilitation is often prescribed in the management of ms, and is recognized to improve modifiable impairments in ms. however, the benefit of physical activities may be limited by heat stress also named uhthoff syndrome frequently observed in patients with ms. cryotherapy is commonly used as a method to relieve pain and inflammation without marked side effect in respect to contraindication. however well designed studies on pbc in patients with ms are still too sparse. the investigators propose to evaluate the effectiveness of pbc on the symptoms of ms patients during a rehabilitation stay in out- or inpatients.

Eligibility criteria:
inclusion criteria: * men and woen over 18 years old and under 65 years old * with multiple sclerosis * 0-6 points in the expanded disability states scale (edss) * with ms in remission (at least 6 months since the last relapse) * able to understand and respect the protocol and its requirement * who signed the consent prior to any other procedure protocol exclusion criteria: * major patients under guardianship/curators/legal protection * pregnant patients * patients with contraindication for cryotherapy * patients unable to complete the entire program * patients with substantial change in pharmacological treatment the month before the start of the study

Keywords: cryotherapy fatigue quality of life spasticity quality of sleep depression symptoms
the medical college of georgia play project: exercise dose and insulin sensitivity in obese children

Conditions: Obesity; Type 2 Diabetes Prevention; Executive Function (Cognition)

Summary: the study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other cardiovascular risk factors in overweight elementary schoolchildren. the hypothesis is that the more exercise a child does, the more benefit he or she will gain in reducing the risk of diabetes and other cardiovascular diseases. an ancillary study examined effects on cognition and achievement.

the study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on insulin response to the oral glucose tolerance test, body composition, fitness, lipid profile, inflammation and other metabolic syndrome components in overweight elementary schoolchildren. blinded psychological assessments of cognition and achievement were obtained.

Eligibility criteria:
inclusion criteria: * overweight, sedentary children * black or white race * attending specific schools in augusta, ga area from which this study is recruiting exclusion criteria: * unable to participate in testing or vigorous exercise program * diabetes * taking medication that would affect study results * sibling enrolled in project

Keywords: prevention children diabetes overweight obesity metabolic syndrome exercise insulin resistance female male black, african-american white, caucasian cognition executive function
expanded access treatment protocol ca204-143

Conditions: Multiple Myeloma

Summary: the objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at u.s. sites where licensed physicians determine clinical need.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria * men and women 18 years and older. * active, relapsed or refractory multiple myeloma by imwg (international myeloma working group) criteria as assessed by the treating physician and have received one prior line of multiple myeloma therapy. * prior lenalidomide exposure is permitted only if they fulfill all of the following:. i) were not refractory to prior lenalidomide defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. patients progressing on lenalidomide maintenance dose are eligible for enrolment. a. patient did not discontinue lenalidomide due to a grade ≥ 3 related ae. exclusion criteria * active plasma cell leukemia (defined as either 20% of peripheral wbc comprised of plasma/cd138+ cells or an absolute count of 2 x 109/l). * all adverse events of any prior chemotherapy, surgery, or radiotherapy not resolved to nci ctcae (v. 3.0) grade ≤ 2. * significant cardiac disease as determined by the treating physician including cardiac amyloidosis. * hiv infection or active hepatitis a, b, or c. * history of participation in elotuzumab studies ca204-004, ca204-006 or ca204-009. * inadequate recovery from prior surgery or prior myeloma therapy. if prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (gvhd). * any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient. * certain abnormal physical or laboratory findings. * hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation, or recombinant protein. * other protocol-defined inclusion/exclusion criteria apply.
cervical stiffness measurement in cervical insufficiency

Conditions: Pregnancy Related; Cervical Insufficiency; Preterm Birth

Summary: the goal of this cross sectional study is to evaluate the differences in cervical stiffness between patients who present for cerclage placement versus normal pregnancies. the central hypothesis is that women for whom a cerclage is indicated will have cervical stiffness measurements lower than normal controls. cervical stiffness will be objectively measured by the closing pressure pcl using the pregnolia measurement device. this is performed during a speculum exam by placing the measurement probe on the ectocervix. in current clinical care, there is no objective measurement of cervical stiffness. an accurate measurement of cervical stiffness that correlates with clinical outcome will advance the field. successful completion of the current study will spark future studies that correlate cervical stiffness pcl in a prospective study.


Eligibility criteria:
inclusion criteria: 1. pregnant women over 18 years of age. 2. singleton gestation. 3. gestational ages between 12w0d and 22w6d. 4. candidates for cerclage 5. normal controls, which will be matched to cerclage subjects by gestational age and parity exclusion criteria: 1. multiple gestation pregnancy. 2. pregnancy complications: premature rupture of membranes, placental abruption, placenta previa/accreta. 3. chorioamnionitis 4. preterm contractions 5. history of cervical surgery (leep, trachelectomy, conization). 6. mullarian anomaly 7. known carrier or hiv or hepatitis b/c 8. active genital infection 9. communication problems (cognitively impaired adults unable to give consent) 10. cerclage placement already performed this pregnancy
effects of cholecalciferol supplementation in patients with chronic heart failure and low vitamind d levels

Conditions: Heart Failure; Vitamin D Deficiency

Summary: the purpose of this study is to determine whether cholecalciferol supplementation in patients with chronic heart failure and low vitamin d levels improves: 1. performance at six minutes walking test 2. echocardiographic parameters 3. neurohormonal imbalance


Eligibility criteria:
inclusion criteria: * heart failure diagnosis according to european society of cardiology guideline criteria * age \> 60 years old * 25(oh) vitamin d level \< 30 ng/ml * clinical and therapeutic stability for one month (nyha class ii or iii) exclusion criteria: * chronic use of anticonvulsants or barbiturates, steroids, thiazides, aluminium or magnesium, colestipol or cholestyramine * glomerular filtration rate lower than 30 ml/min/1.73 m2 according to mdrd equation * nephrolitiasis, sarcoidosis or hypercalcemia * recent (three months) acute coronary syndrome or stroke or major vascular surgery * reduced life expectancy due to other diseases (active neoplasms, liver cirrhosis...)