Kornimate/medical-research-clean huggingface dataset:
effects and consequences for mother and child from treatment for depression

Conditions: Pregnancy; Moderate Depression

Summary: this study targets women with moderate depression during pregnancy. we aim to investigate the direct effect of the newborn child and the long term consequences on the cognitive developement on children who´s mother has been treated with cbt alone or in combination with antidepressants.

the primary objective is to study the direct neonatal effects and the long-term consequences on cognitive development in children prenatal exposed to maternal sertraline treatment compared to exposure to maternal depression treated with only icbt.

Eligibility criteria:
inclusion criteria: 1. female \> 18 years old 2. pregnant, gestational week 9-21. 3. verified moderate depression according to scid-i with or without concomitant anxiety disorder. 4. signed informed consent 5. able to understand the swedish language orally and in written and able to use the internet for the icbt, including having succeded in filling out online questionnaires 6. are willing to participate to all study visits 7. plans to give birth at the department of obstetrics at karolinska university hospital, huddinge or at additional study site such as norrland university hospital (nus), umeå exclusion criteria: * 1. known drug or alcohol abuse 2. serious psychiatric disorder such as psychosis, bipolar disorder, severe personality disorder, adhd/add, autism or mental retardation) and severe melancholic or psychotic depression. 3. known idiosyncrasy to zoloft or allergy to one of the zoloft excipients 4. ongoing medication with ssri, snri, tca, mood-stabilizers, antiepileptic drugs ,psychotropic drugs, tramadol, propafenon, tolbutamid, flekainid, psychostimulants and atomoxetine, insulin or steroids 5. any severe somatic disease that necessitate regular treatment with systemic steroids, severe heart and lung disease, kidney disease, liver disease, diabetes mellitus, or epilepsy with drug treatment. 6. women who either during screening or treatment on self-assessment forms (madrs-s: 4 or more points on question about suicidal ideation (question 9)) report symptoms of severe suicidal thoughts or suicide plans will be contacted for structured suicide risk assessment by telephone (by experienced staff from the unit for internet psychiatry according to clinical routine). if judged necessary patients will be booked for psychiatric assessment by study nurse. if acute assessment or care is judged necessary, referral to psychiatric emergency departments will be made according to the same routine as in regular care. also women, who contact the study personal and report symptoms of suicidal thoughts or suicide plans will receive psychiatric assessment as specified above. women who according to psychiatric assessment have a high suicidal risk will be excluded from the study. these women will be actively transferred into necessary psychiatric treatment as usual. 7. other factors that are clinical significant and could jeopardize study results or its intention, as judged by study psychiatrist or study obstetrician

Keywords: women
dornase alfa therapy for ventilator associated lung infections in the neonatal intensive care unit (nicu)

Conditions: Pulmonary Infections

Summary: to evaluate the effect of dornase alfa on preterm and late preterm neonates with ventilator associated pulmonary infections. dornase alfa has been effective in the treatment of pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. the bacteria causing pulmonary infections in cystic fibrosis patients is similar to those infecting preterm infants. the investigators expect that dornase alfa therapy will improve recovery from ventilator associated pulmonary infections in preterm infants.


Eligibility criteria:
inclusion criteria: * infants less than 38 weeks gestation and over 7 days of age * infants with a ventilator associated pulmonary infection, defined as intubated infants who have moderate to heavy white blood cells (wbcs) on tracheal aspirate, organisms on tracheal aspirate gram stain, a positive endotracheal tube culture, a chest x-ray with infiltrate, consolidation or atelectasis, an increase in oxygen (fio2) requirement and whom the clinical team decides to treat with systemic antibiotic therapy exclusion criteria: * extremely ill infants not expected to survive * critically ill infants requiring high frequency ventilation * infants with congenital pneumonia * infants with congenital malformations of the respiratory system (e.g. congenital diaphragmatic hernia, cystic adenomatoid malformation or tracheo-esophageal fistula) cyanotic congenital heart disease, chromosomal abnormalities and infants with a positive newborn screen for cystic fibrosis

Keywords: ventilator associated pulmonary infections
ace-inhibitor effects on total hip and knee arthroplasty patients

Conditions: Adverse Effects of Angiotensin-converting-enzyme Inhibitors; Hypotension

Summary: the purpose of this study is to determine the effects of angiotension converting enzyme inhibitors (ace-i) during surgery and in the immediate postoperative period for patients undergoing elective total hip or knee arthroplasty.


Eligibility criteria:
inclusion criteria: * patients electing to undergo primary or revision total hip or knee arthroplasty * currently taking an ace-i exclusion criteria: * trauma patients * immunosuppressed patients (hiv/aids, organ transplant recipients, chemotherapy patients, chronic steroid use) * patients with history of severe hypertension related illness such as hypertension associated with stroke or myocardial infarction * patients in who continuation of their ace-i is expressly mandated by their prescribing physician
virtual reality (vr) self-hypnosis software

Conditions: Musculoskeletal Pain; Neuropathic Pain; Neuralgia

Summary: this single-site study of self-hypnosis software using an off-the-shelf virtual reality (vr) device (oculusgo™) to determine the software's safety, usability, and preliminary efficacy in pain relief for hiv-associated chronic pain patients. this is funded under the i prism funding through mount sinai innovations.

the study will be done in two phases - phase a is the development of the software by the study team and the engineers targeted to be completed by 4/15/2024. testing will occur with only the study team. no participants will be involved in the testing phase. phase b is the participant enrollment phase targeted to start 5/20/2024. a request for fda exemption of a non-significant risk combination device has been submitted and granted.

Eligibility criteria:
patient eligibility inclusion criteria: * adults age ≥18 * confirmed diagnosis of hiv, currently on a stable antiretroviral regimen ≥ 90 days. * documentation of chronic pain associated with hiv for≥90 days * stable pain management regimen ≥90 days, or no pain treatments ≥90 days * average pain intensity of 3 or greater on the nrs of the mean daily scores reported between visit 1 and visit 2 * access to the internet via smartphone, computer, or tablet 7. fluent in english * capable of giving informed consent and willingness to comply with study procedures. exclusion criteria: * a co-occurring medical or psychiatric condition which would make participation in the study or complicate measurement of changes associated with the intervention. * concurrent participation in another investigational protocol for pain treatment * a psychiatric disorder, medical condition, or other life circumstance, which in the opinion of the pi, would contraindicate attendance at sessions, or make it unlikely that the participant could successfully complete the study procedures. * current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological conditions contraindicating the use of virtual reality devices. * a medical condition predisposing prospective participant to nausea or dizziness 6. lack of stereoscopic vision or severe hearing impairment * injury to eyes, face, or neck that impedes using the vr device * if participant has access to personal vr gear for gaming or other purposes at home, participant fails to agree not to use these personal vr gear during the course of the protocol. * currently pregnant or planning to become pregnant during the study period

Keywords: hiv chronic pain self-hypnosis virtual reality software non-drug treatment for chronic pain
effect of spirulina on serum hyaluronic acid in beta thalassemic children with hepatitis c

Conditions: Beta Thalassemia Major

Summary: thalassemics can develop liver fibrosis because of iron overload and hepatitis c infection. the latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus c infection. hyaluronic acid serum levels correlate with histological stages of liver fibrosis in hepatitis c patients, so it has a good diagnostic accuracy as a non invasive assessment of fibrosis and cirrhosis.there is evidence that suggests spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.


Eligibility criteria:
inclusion criteria: * multitransfused beta thalassemic children with and without super added hepatitis c virus (hcv) infection diagnosed by serological detection of hcv antibodies and hcv rna by polymerase chain reaction. exclusion criteria: * liver decompensation child younger than 3 years patients with hepatitis b infection
a safety and tolerability study of arformoterol tartrate inhalation solution in pediatric subjects

Conditions: Asthma

Summary: to determine the safety and tolerability of arformoterol tartrate in children with asthma

a randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age with asthma. this study was previously posted by sepracor inc. in october 2009, sepracor inc. was acquired by dainippon sumitomo pharma., and in october 2010, sepracor inc's name was changed to sunovion pharmaceuticals inc.

Eligibility criteria:
inclusion criteria: * male and female * between age 2 and 11, inclusive, at the time of consent * weight equal to or greater than 15 kg * history of physician-diagnosed asthma of at least 2 years duration for children age 6 and older, and at least 1 year duration for children 5 and younger. exclusion criteria: * female subject who is pregnant or lactating. * subject who has a history of hospitalization for asthma within one year, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial. * subject with any history of life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures. * subject with a history of cancer. * subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders. * subject with a history of cigarette smoking or use of any tobacco products.

Keywords: asthma respiratory tract diseases
liraglutide improve cognitive function in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: patients with diabetes are susceptible to dementia, but regular therapy fails to reduce the risk of dementia. in previous observational study, the investigators found that liraglutide can improve cognitive function in patients with t2dm through a metabolism-independent pathway. here the investigators aim to further verify such effects through a randomized, controlled study.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus exclusion criteria: * t2dm with acute diabetic complications; * type 1 diabetes; * other diseases affecting cognitive function (e.g., congenital dementia, brain trauma, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, renal dysfunction); * alcohol abuse, mental illness, and psychoactive substance abuse; * history of thyroid disease; * any surgical or medical conditions that could significantly influence the absorption, distribution, metabolism, or excretion of interventional drugs; * unwillingness to provide informed consent.

Keywords: type 2 diabetes mellitus cognitive function liraglutide functional near-infrared spectroscopy metabolic changes
inspiratory muscle training after gastroplasty

Conditions: Obesity

Summary: the purpose of this study is to assess the effect of post-operative inspiratory muscle training on muscle strength and endurance in patients with obesity submitted to gastroplasty.

gastroplasties, like other major abdominal surgeries, induce mechanical changes in the lungs and decreases of the respiratory muscle strength in the post-operative periods. depending on the occurrence of pre-existing disturbs, obese patients may exhibit severe declines of respiratory function after these surgeries. post-operative respiratory physiotherapy is a valuable intervention, involving a set of techniques aimed to expand pulmonary volumes and to improve arterial oxygenation, leading to decreases on the development of atelectasis and pneumonias. it induces faster recovery of respiratory function and reduction of lung complications, what may be particularly important in high-risk patients like over-weighted subjects. there are scanty data about the role of respiratory muscle training in the post-operative period. this is particularly true regarding inspiratory muscle training of obese patients submitted to gastroplasties.

Eligibility criteria:
inclusion criteria: * gastroplasty patients presenting body mass index (bmi) ≥ 35 kg/m2; * weighting ≤ 60 kg/m2; * capable of fulfilling the experimental protocol. exclusion criteria: * acute or chronic pulmonary disease; * smoking; * post-operative mechanical ventilation for more than 48 hours; * presence of lung complications; * need for surgical re-intervention during the study period.

Keywords: obesity gastroplasty respiratory muscle training muscle strength physical therapy
study of asthma phenotypes and pharmacogenomic interactions by race-ethnicity (sapphire)

Conditions: Asthma

Summary: inhaled corticosteroids (ics) are considered first-line treatment for persistent asthma, yet little is known about the genetic factors that influence response to this therapy. this study seeks to quantify response to ics therapy in african american and white patients, as well as look for genetic markers that predict treatment response.

inhaled corticosteroids (ics) are considered first-line therapy for the management and control of patients with persistent asthma. use of inhaled steroids has been associated with improved lung function, diminished symptoms, and fewer exacerbations. however studies show considerable inter-subject variability in ics response. it has also been estimated that corticosteroid resistance accounts for half of all asthma-related health care costs. therefore, identifying factors associated with ics response is both clinical and economically important. african-american patients have been understudied with respect to genetic predictors of asthma controller medication response, and to date there have been no sufficiently powered genome-wide association studies of ics treatment response among african american individuals with asthma. this issue is of particular importance, since african-american individuals are disproportionately affected by asthma-related complications. in this proposal, we seek to identify novel genetic loci associated with ics treatment responsiveness (defined by the change in asthma control test score) among african american individuals treated with beclomethasone dipropionate (bd) for 6 weeks. we will attempt to validate loci identified in the discovery set by 1) reassessing these variants for their interaction with ics treatment on asthma exacerbations in a separate group of african american individuals with asthma, and 2) by reexamining the genetic association with change in asthma control among similarly treated (i.e., treatment with 6 weeks of bd) european americans with asthma.

Eligibility criteria:
inclusion criteria for discovery group: * age 12-56 years * physician diagnosis of asthma (identified by using encounter data prior to screening and by the survey administered at the clinic visit) * bronchodilator reversibility on pulmonary function testing (i.e., improvement in baseline fev1 of \>12%) * african-american/black self-reported race-ethnicity exclusion criteria for discovery group: * smoking in the preceding year or \<10 pack-year smoking history total * pregnant at the time of enrollment or intending to get pregnant during the 6-week treatment period * oral or inhaled corticosteroid use in the 4 weeks preceding enrollment * prior diagnosis of chronic obstructive pulmonary disease or emphysema * prior diagnosis of congestive heart failure * self-reported race not african-american/black or hispanic ethnicity (these groups could be included in replication/validation group)

Keywords: inhaled corticosteroids asthma pharmacogenomics genome wide association study admixture mapping continental population groups
comprehensive genomic profiling and next generation functional drug screening for patients with aggressive haematological malignancies

Conditions: Advanced Lymphoma; Refractory Lymphoma; Refractory Leukemia; Refractory Acute Myeloid Leukemia; Refractory T-Cell Lymphoma

Summary: exalt-2 is a prospective, randomized, three arm study for treatment decision guided either by either comprehensive genomic profiling, next generation drug screening or physician's choice


Eligibility criteria:
inclusion criteria: * patient is suffering from aggressive haematological disease and has undergone at least two lines of previous therapies and/or has undergone at least one previous therapy and no standard treatment is available in the specific disease setting and disease specific guidelines recommend treatment in studies. * duration of last response is less than 6 months defined as first day of last treatment to date of relapse, the response duration has to be available with dates (dd/mm/yyyy) for initiation of and relapse to previous treatment. * best response to previous treatment has to be available. * the patient is able to give written informed consent and wishes to undergo further therapy * further therapy is medically feasible * tumor cell-containing samples can be obtained exclusion criteria: * current participation in another experimental clinical trial * performance status does not allow participation (ecog ˃ 1) * pregnancy, tested at screening * patient suffers from classical or nodular, lymphocyte predominant hodgkins lymphoma. * other malignoma, diagnosed \<1a before inclusion (except localized squamous cell carcinoma of the skin, surgically curable melanoma of the skin, basal cell carcinoma of the skin)

Keywords: personalized medicine
the tele-taking charge after stroke randomized controlled feasibility trial

Conditions: Stroke/Brain Attack

Summary: take charge is a novel, community-based treatment for stroke developed to harness a person's self-determination. two prior clinical trials with 572 stroke survivors showed that take charge improves quality of life, independence, and social participation up to a year after stroke. take charge has also been shown to be overall cost-saving to the health system and is a useful adjunct to standard care after stroke. because of the covid-19 pandemic, a lot of healthcare has moved into a telehealth approach. the simplicity of take charge may lend itself to being effective if delivered by telehealth, allowing greater access for people with stroke in rural communities. improving the care we provide in underserved regions of the country is important to help the health of canadians. we are proposing a new study, working closely with the researchers who ran the previous take charge studies. the goal of this feasibility clinical trial is to learn about tele-take charge in adults with stroke who live in southern alberta. the main questions it aims to answer are: * is delivering take charge by telehealth feasible? * is take charge by telehealth acceptable to this population? participants will meet with facilitators online via zoom at 4 to 16 weeks after stroke, and be randomized to receive either: * two tele-take charge sessions six weeks apart * one control tele-education session. researchers will compare the tele-take charge and control groups to see if there are any differences in outcome measures. these differences will help researchers to estimate the number of participants that will be needed for a larger, multi-centred effectiveness trial.

for adults diagnosed with acute stroke who are discharged to community living (non-institutionalized), we wish to evaluate whether delivering two take charge sessions by telehealth is (1) acceptable to the population of southern alberta, and (2) feasible to do. subjects will be randomly assigned to receive either two tele-take charge sessions or one tele-education session (life after stroke video) by telehealth (the active control). the primary feasibility outcome will be recruitment rate. secondary outcomes will be measured by a blinded outcomes assessor at 6 and 12 months, either by e-questionnaire or by telephone. those who received tele-take charge will also be asked to complete an acceptability questionnaire, and will be invited to take part in an in-depth interview about their experience as part of a qualitative substudy.

Eligibility criteria:
inclusion criteria: * discharged with diagnosis of stroke to non-institutionalised community living situation * answering 'no' to the question 'are you fully recovered from your stroke?' (i.e., modified rankin score \[mrs\] must be \> 0) * able to access video calling with a smartphone, computer, or other device exclusion criteria: * major comorbid illness that would dictate functional outcome at 12 months or life expectancy \< 12 months * pre-stroke dependency (mrs \> 2 before index stroke)

Keywords: self-determination rehabilitation