Kornimate/medical-research-clean huggingface dataset:
virtual reality for pain management in burn patients

Conditions: Pain

Summary: this study is a randomized proof-of-concept study to assess the efficacy of virtual reality (vr) vs standard of care in 50 adult patients in the new york presbyterian burn unit. the participants who are randomized to receive the virtual reality intervention will also receive opioids, which is the standard of care and is known to be effective. participants will be randomly assigned to two groups. the first group will receive vr during their painful procedure (e.g., wound dressing changes, physical therapy etc.) in addition to the standard of care. the other group will receive standard of care (and no vr).


Eligibility criteria:
inclusion criteria: * 8 years and older * patients with a burn injury and is in the burn unit at new york presbyterian * awake, alert, ambulatory * the burn comprises less than 15% total body surface area (tbsa) * the patient does not require conscious sedation such as ketamine for staple removal or wound dressing changes * the patient is able to give informed consent exclusion criteria: * diagnosis of a cognitive disorder, psychotic disorder or bipolar i as determined by self-report from previous diagnosis * current opioid abuse

Keywords: virtual reality pain management anxiety depression
efficacy and safety of dapagliflozin in preventing atrial fibrillation recurrence after catheter ablation

Conditions: Atrial Fibrillation (AF)

Summary: atrial fibrillation (af) is a common arrhythmia, particularly prevalent in the elderly population. catheter ablation is a common treatment for af, but post-ablation recurrence of arrhythmias remains a significant clinical challenge. dapagliflozin, an sglt2 inhibitor primarily used for the treatment of type 2 diabetes, has shown potential in the field of cardiology, particularly for treating heart failure patients. some studies suggest that dapagliflozin may reduce cardiac workload, improve heart function, and could even help in the management of atrial fibrillation. therefore, this study aims to explore whether dapagliflozin can reduce the recurrence of arrhythmias following atrial fibrillation catheter ablation.


Eligibility criteria:
inclusion criteria: - age: patients aged 18 years and older. presence of type 2 diabetes or heart failure. diagnosis of atrial fibrillation: confirmed atrial fibrillation through ecg or holter monitoring. first-time catheter ablation: patients undergoing their first atrial fibrillation catheter ablation. voluntary participation: patients willing to participate and sign informed consent. exclusion criteria: - presence of urinary tract infection pregnancy or breastfeeding: women who are pregnant, breastfeeding, or planning to become pregnant. allergy to dapagliflozin or similar drugs: history of allergic reactions to dapagliflozin or other sglt2 inhibitors. other contraindications to dapagliflozin: any other contraindications for dapagliflozin use. kidney function: egfr \< 45 ml/min/1.73m², with severe kidney disease.
a pharmacoeconomic study comparing the use of mycophenolate mofetil or cyclophosphamide as induction therapy in lupus nephritis patients in egypt

Conditions: Lupus Nephritis

Summary: the aim of this study is to conduct a pharmacoeconomic analysis to compare the use of mycophenolate mofetil or i.v. cyclophosphamide as induction therapy from a third party payer perspective in ln patients in the egyptian context


Eligibility criteria:
inclusion criteria: - ln patients between 18 and 65 years of age who were followed up in the department of rheumatology and rehabilitation were included during the study period. all patients fulfilled at least 4 of the 11 american college of rheumatology (acr) revised criteria for the classification of sle 21. patients were included if they had active lupus nephritis ln(ln) that was confirmed by class iii, or class iv, or class v renal biopsy and which was performed within six months of enrolment. furthermore, laboratory tests must show active nephritis demonstrated by a clinically significant high level of proteinuria, which might indicate a recent decline in renal function 22. patients with class iii or v ln must have either proteinuria (≥ 2 gm/day) or serum creatinine \> 1.3 mg/dl. patients with class iv must have either proteinuria ≥ 1 gm/day or serum creatinine \> 1.3 mg/dl 23. newly diagnosed patients who were given either iv cyc or oral mmf as induction therapy or patients who needed to be induced when flared up were included in the study. all patients signed a written informed consent form. for those below the age of 21, written informed consent was obtained from the parents. exclusion criteria: * patients were excluded from the study if they had a history of known allergy to study drugs, received previous kidney transplantation, or were on continuous dialysis for more than two weeks before the study. patients with combinations of membranous and proliferative glomerulonephritis (i.e., class iii + v or class iv + v) renal biopsies were not included. other reasons for exclusion were pregnancy and lactation, pancreatitis, current infection episode requiring iv antibiotics, severe viral infection, history of cancer, or overlapping autoimmune condition.

Keywords: lupus nephritis, immunosuppressive agents, mycophenolic acid, cyclophosphamide, healthcare costs, cost saving regimen, resource-limited setting, egypt.
celecoxib treatment for lung cancer

Conditions: Non-Small-Cell Lung Carcinoma

Summary: this proposal evaluates cyclooxygenase 2 (cox-2) inhibition as a means to decrease t regulatory cell activities and thus augment immune responses against lung cancer. the broad goal focuses on understanding how cox-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an informed approach for the use of cox-2 inhibitors in prevention and therapy for lung cancer.


Eligibility criteria:
inclusion criteria: * pathologically confirmed and surgically resectable non small cell lung cancer and subjects must be ineligible for or refuse, neoadjuvant therapy exclusion criteria: hypersensitivity to celecoxib or nsaids, previous history of gi bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency

Keywords: cyclooxygenase 2 lung cancer lymphocytes non small cell therapeutics
evaluation of the predictive and prognostic value of germ-line polymorphisms in patients with metastatic breast cancer

Conditions: Breast Cancer; Metastasis

Summary: this is a multicenter, non-randomized, prospective cohort study. the purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer. 1500 patients will be enrolled in this study. blood samples will be collected after informed consent and inclusion in the study. patients will be treated and followed according to the standards of their treating center. they will be followed during at least 5 years every 6 months for 3 years then every year.

the storm trial is designed for analysis in association with the signal study which aims to decipher the genetic risk of breast cancer displaying amplification of the her2 gene as well as resistance or toxicity to adjuvant treatments. signal study is in the process of recruiting 6000 localized breast cancer patients. the purpose of the storm trial is to create a cohort of 1500 patients with metastatic breast cancer including detailed epidemiologic and treatment data. using germ line polymorphisms in these patients and comparing them to patients with localized cancer from the signal study, the investigators will answer questions specific to the genetic influence on the prognosis of breast cancer and its response to treatments in the metastatic phase. blood samples will be collected in one 6 ml edta and one 6 ml acd tube after informed consent and inclusion in the study. to simplify the evolution of the study and to avoid all confusion, the sample collection procedures followed will be identical to those used in the signal study. as the samples are received at the biological resource center, the plasma will be aliquoted into a 500 µl tube and frozen at -80° c. dna will be extracted using standard protocols. plasma and dna will be stored in anticipation of genetic analyses. an aliquot of the dna sample will be genotyped for a panel of high-density genetic markers covering the whole genome, for genome-wide association studies. the collected plasma may also be used for analyses to determine the expression profile of proteins, alone or combined with genetic factors that allow distinguishing between groups of patients.

Eligibility criteria:
inclusion criteria: * women with a histologically proven breast adenocarcinoma, with metastatic progression diagnosed within one year (inclusion of patients who have a metastatic progression more than one year ago would favor the inclusion of patients with indolent cancer, possibly biasing the study) or locally advanced (no curative treatment) * er, pr and her2 status known * age \>= 18 years * affiliation with a social security scheme * signed informed consent exclusion criteria: * coexisting or other cancer diagnosed within the previous 5 years that may be responsible for the current metastasis * patient who cannot follow medical surveillance due to geographical, social or psychological reasons * patient included in the signal study

Keywords: germ line polymorphisms
influenza vaccine in lung transplant patients - persistence of antibodies beyond the season

Conditions: Influenza

Summary: this a sub-study of a 5-year study designed to investigate how antibody and t cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals. this study is designed to investigate influenza vaccine-induced antibodies in lung transplant patients beyond the season of vaccination.

every year influenza infection causes significant morbidity and mortality in the general population making it a serious public health concern. among those at highest risk for complications from infection are the immunocompromised. effective influenza immunization that confers protection throughout the season is critical for lung transplant recipients because in addition to aggressive immunosuppressive therapy, infection directly affects the transplanted organ. studies of influenza vaccine response rates in lung transplant patients show generally lower antibody concentrations, but acceptable influenza vaccine response rates compared with healthy individuals. however, little is known about the persistence of influenza vaccine-induced antibody concentration in either healthy or immunosuppressed populations. influenza antibody concentrations persist at seroprotective levels (defined as antibody concentrations at least 40 hemagglutination units) up to a year post vaccination. however, the investigators could find no information regarding persistence beyond one year. it is hypothesized that the high rates of persisting influenza vaccine antibody in immunosuppressed lung transplant individuals would match the rates of persisting vaccine-antibody in healthy individuals. influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (hia) annually (individual participants followed for 3 years). samples were collected at 2-4 weeks post-vaccination. seroprotection was defined as a titer of ≥ 1:40 and was compared between groups over the measured term using fisher's exact tests. \[this substudy that was originally registered to nct00205270 and subsequently registered to its own nct number for the purpose of clarity in linked results\]

Eligibility criteria:
inclusion criteria: * receiving care post-lung transplant at university of wisconsin hospital * healthy adult exclusion criteria: * allergy to eggs * moderate to severe febrile illness * active treatment for acute rejection * received season's influenza vaccine prior to enrollment

Keywords: post-lung transplant healthy immunocompromised
12 weeks of resistance band exercise impacts on metabolic syndrome progression in postmenopausal women

Conditions: Metabolic Syndrome; Dyslipidemias; Insulin Resistance; Hypertension

Summary: the purpose of this study was to examine the impacts of a 12-week resistance band exercise program on insulin resistance, blood lipid profiles, body composition, and blood pressure in postmenopausal women with obesity. thirty-six postmenopausal women participated in this study. participants were randomly allocated into the resistance band training group (ex, n = 18) or the control group (con, n = 18). the ex group performed a resistance band exercise training program 60 minutes per day, 3 times per week, for 12 weeks. the con group did not participate in any exercise, dietary, or behavioral intervention. blood glucose, insulin, homeostatic model of insulin resistance (homa-ir), blood lipids, blood pressure, and body composition were measured before and after 12 weeks of ex or con.


Eligibility criteria:
inclusion criteria: * postmenopausal (cessation of menses for at least 12 consecutive months) * abdominal obesity (waist \> 80 cm) exclusion criteria: * current smoker (smoking within 6 months of participation) * cardiovascular disease * renal disease * pulmonary disease * thyroid disease

Keywords: postmenopausal exercise
evaluate the efficacy and safety of peg-rhg-csf in patients with hemophagocytic syndrome

Conditions: Hemophagocytic Syndrome

Summary: hemophagocytic syndrome (hps), also known as hemophagocytic lymphohistiocytosis (hlh), is an immune mediated life-threatening disease. there is no uniform recommendation for salvage treatment of hlh. based on the results of current clinical trials, the marketing situation of the drug in china, and the use requirements of pegylated recombinant human granulocyte stimulating factor(peg-rhg-csf), this study was conducted in patients who received the dep rescue therapy or dexamethasone combined with vp-16 maintenance therapy. the aim of this study was to evaluate the efficacy and safety of peg-rhg-csf(jinyouli®) for the recovery of neutropenia after chemotherapy in patients with hemophagocytic syndrome.


Eligibility criteria:
inclusion criteria： 1. age ≥ 18 years old, ≤ 70 years old; 2. patients with hemophagocytic syndrome diagnosed by hlh-2004 diagnostic criteria; 3. patients who plan to receive rescue treatment or maintenance treatment; 4. the expected survival time is more than 1 month; 5. patients sign informed consent form. exclusion criteria： 1. patients who have received bone marrow or hematopoietic stem cell transplantation in the past 3 months; 2. patients with brain metastases; 3. patients who are allergic to this product or other biological products derived from genetic engineering e. coli; 4. people with mental or nervous system disorders who cannot cooperate; 5. pregnant or lactating female patients; women who refuse to accept contraceptive measures ; 6. researchers determine unsuited to participate in this trial.
reduced intensity allogeneic pbsct to treat hematologic malignancies and hematopoietic failure states

Conditions: Hematologic Neoplasms; Multiple Myeloma; Anemia, Aplastic; Hemoglobinuria, Paroxysmal; Myelofibrosis

Summary: the purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called alemtuzumab (campath®), can prevent rejection of donor blood stem cells so that those cells take hold and build a healthy new blood cell factory after transplant. the study will also look at the safety of the combination of drugs and of the transplant of peripheral blood stem cells from a healthy relative or an unrelated donor.

transplantation of related or unrelated allogeneic peripheral blood stem cells (pbscs) after administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be associated with satisfactory engraftment and acceptable post-transplant non-relapse mortality.

Eligibility criteria:
inclusion criteria: * age 50 to 75 years or age 18 to 49 with one or more of these risk factors: prior autologous, allogeneic or syngeneic hct (hematopoietic cell transplantation); not in first complete remission or first chronic phase; and/or presence of one or more medical conditions that would place the subject at high risk such as heart and kidney disease. * subjects with hematologic cancers must have received at least one previous course of chemotherapy or biological therapy. in other words, the subject cannot enroll in this trial for initial treatment of the disease. * availability of a healthy related or unrelated volunteer allogeneic donor. exclusion criteria: * eligible for another study or standard of care treatment that offers higher probability of cure or long-term control of subject's disease. * severe abnormal function of organs such as heart, kidneys, liver. * untreated or progressive central nervous system involvement by the disease. * subject is pregnant or breast-feeding. * performance score is below 50: at the least, requires considerable assistance and frequent medical care. * positive for the hiv \[aids\] virus * life expectancy less than 12 weeks with conventional treatments. * for subjects capable of having children, refusal to practice birth control while on this study and for at least 12 months after pbsct or after stopping post-transplant immunosuppressive treatments, whichever occurs later.

Keywords: hematologic malignancies lymphoma, leukemia, mds (myelodysplastic syndrome) reduced-intensity preparative regimen allogeneic peripheral blood stem cell transplant myelofibrosis or other myeloproliferative syndromes
daaoi-2 add-on treatment for treatment-resistant schizophrenia

Conditions: Schizophrenia

Summary: pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. refractory schizophrenia is still a difficult clinical issue at present. according to the n-methyl-d-aspartate (nmda) hypothesis, adjuvant nmda-enhancing agents may have therapeutic benefit. daaoi-2, a d-amino acid oxidase (daao) inhibitor, is a nmda-enhancing agent. the aim of this project is to examine the effectiveness and safety of daaoi-2 add-on treatment for treatment-resistant schizophrenia patients in a randomized, double-blind, placebo-controlled trial.

pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. refractory schizophrenia is still a difficult clinical issue at present. according to the n-methyl-d-aspartate (nmda) hypothesis, many clinical trials on nmda-enhancing agents were studied. adjuvant nmda-enhancing agents, including glycine, d-amino acids such as d-serine, and sarcosine (a glycine transporter i inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms. the aim of this project is to examine the effectiveness and safety of daaoi-2 add-on treatment for treatment resistant schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

Eligibility criteria:
inclusion criteria: * fulfill the dsm-iv criteria of schizophrenia * treatment resistant: no satisfactory response to at least two kinds of antipsychotics * remain symptomatic but without clinically significant fluctuation and the antipsychotic doses are unchanged for at least 3 months * have a minimum baseline total score of 70 on the positive and negative syndrome scale (panss) * agree to participate in the study and provide informed consent exclusion criteria: * meet dsm-iv criteria of substance (including alcohol) abuse or dependence * meet dsm-iv criteria of mental retardation * serious medical or neurological illness * pregnancy or lactation * inability to follow protocol

Keywords: treatment resistant daaoi nmda
efficacy of training programme to reduce stress

Conditions: Autism Spectrum Disorder (ASD)

Summary: this study aims to reduce stress in mothers of children with autism in saudi arabia. the researcher has designed a training programme for mothers whose children are young and just in their early stage at the autism organisations they are attending. the programme will include stress reduction tips, behavioural modification strategies for children with autism, and financial resources available to parents (how they can access government funding). the study will have two parts. part one involves conducting an experiment by dividing the participants into two groups, one group will receive the training and the other group will wait until the end of the study then they will also receive the same training. both groups will fill questionnaire at the beginning of the study, then after the first group finishes training, and then again 6 weeks later. part two of the study will involve interviewing mothers of the first group who attended the training session. they will be interviewed by the researcher asking them about their experience with the training programme and their suggestions for future improvements. mothers will be given a training manual at the beginning of the training. training involves attending five sessions, one of which is a face to face session at the autism organisation their children are attending and the other four sessions will be through a smartphone application called whatsapp which is widely used in saudi arabia.


Eligibility criteria:
inclusion criteria: * mothers aged 18 years or over * mothers of asd children who are in the early intervention stage (first year in the programme) at autism organizations in saudi arabia exclusion criteria: * mothers whose children with asd are not in the early intervention stage or did not joint autism organization * mothers who will not be willing to commence to the full duration of the trial * mothers who will not be able to use whatsapp in their smart phones
efficacy and safety of addition of il-2 to pegylated interferon alpha 2a and ribavirin in hiv/hcv coinfected patients

Conditions: HIV Infections; Chronic Hepatitis C

Summary: the purpose of this pilot study is to evaluate efficacy and safety of addition of il-2 to pegylated interferon alpha 2a and ribavirin in hiv-hcv coinfected patients non-responders after three months of standard therapy with pegylated interferon alpha 2a and ribavirin. il-2 may enhance numbers and function of cd4 t lymphocytes and specific anti-hcv immune responses and could participate to the control of hcv replication

this pilot study evaluate efficacy and safety of addition of il-2 to pegylated interferon alpha 2a and ribavirin in hiv-hcv coinfected patients non-responders after three months of standard therapy with pegylated interferon alpha 2a and ribavirin eligible patients should have cd4 cells count higher than 300/mm³ if pretreated by antiretroviral therapy or higher than 400/mm³ if naive of antiretroviral therapy, metavir score with histological fibrosis score f1, f2 or f3. recombinant il-2 will be given subcutaneously at a dose of 3 mui twice daily for 5 days every 8 weeks for 5 cycles from week 14 to week 46. this national multicenter study will enroll around 75 patients in order to give il-2 to 20 non-responders. the primary endpoint is sustained virologic response, defined by undetectable serum hcv-rna at week 72, six months after the end of therapy

Eligibility criteria:
inclusion criteria: * hiv-1 infection and hcv infection * naive of ribavirin * cd4 higher than 300 if pretreated by antiretroviral therapy or higher than 400 if naive of antiretroviral therapy * signed informed consent exclusion criteria: * cirrhosis (histological fibrosis score f4 in metavir score) * other liver disease * pregnancy

Keywords: chronic hepatitis c hiv infection interleukin-2 pegylated interferon alpha 2 a ribavirin