Kornimate/medical-research-clean huggingface dataset:
patient reported outcome after bariatric surgery

Conditions: Anesthesia; Analgesia; Bariatric Surgery

Summary: prospective association study to analyse patients' outcome after bariatric surgery. outcome comprises postoperative pain, analgesia, postoperative side-effects, long-lasting pain, patients' impairment in daily living.

background bariatric surgery is a common procedure. data on patient related outcome beyond loss of body weight are scarce. the question arises which patient is at specific risk for an unfavorable outcome after bariatric surgery. objective the aim of this study is to investigate variables possibly associated with impaired outcome and increased patients' interference after bariatric surgery. which patients are at risk for clinically meaningful impaired daily living? methods patients will be enrolled in a prospective observational study. data will be collected in a registry with documentation of patient, surgery, anesthesia and analgesia related variables including preoperative status and postoperative patient reported outcome with a follow-up period up to 5 years after bariatric surgery. patients fill in standardized validated outcome questionnaires at predefined time points. the registry provides the basis for large scale analyses and benchmarks for several parameters. variables to be considered are pain scores after surgery, patient reported outcome, pain related interference after surgery (brief pain inventory), quality of life (sf-12), long-term outcome, chronic (neuropathic) postsurgical pain, bmi, psychological questionnaires, surgery and patient related variables, including genetic variants.

Eligibility criteria:
inclusion criteria: * 18 years and older * written informed consent * elective bariatric surgery * patients' ability to understand the purpose of the study exclusion criteria * no informed consent * cognitive impairment

Keywords: patient reported outcome postoperative pain pain related impairment quality of life prospective association study
repeated dermavir immunizations in hiv-1 infected treatment-naïve patients

Conditions: HIV Infection

Summary: dermavir is a synthetic pathogen-like nanomedicine. the active pharmaceutical ingredient is a single plasmid dna expressing fifteen hiv antigens that assemble to hiv-like particles. these particles are safe; replication, integration and reverse transcription deficient. dermavir is targeted to langerhans cells by topical administration with dermaprep. langerhans cells with dermavir migrate to lymph nodes and induce hiv-specific t cells that can kill hiv-infected cells. gieu006 is a phase ii randomized, placebo-controlled, dose-finding, double-blinded, multicenter study to assess the safety, tolerability, immunogenicity, and preliminary antiretroviral activity of dermavir in antiretroviral therapy naïve adults with hiv-infection.

patients were randomized into one of the following 6 arms: * arm 1: low dose dermavir (0.2 mg dna in 2 dermaprep patches, n=9) * arm 2: low dose placebo (2 dermaprep patches, n=3) * arm 3: medium dose dermavir (0.4 mg dna in 4 dermaprep patches, n=9) * arm 4: medium dose placebo (4 dermaprep patches, n=3) * arm 5: high dose dermavir (0.8 mg dna in 8 dermaprep patches, n=9) * arm 6: high dose placebo (8 dermaprep patches, n=3) dermaprep patch size: 80 cm2. dermavir standard unit per patch is 0.1 mg dna = 0.8 ml of dermavir nanomedicine. the patch sites for immunization are preferably the left or right upper back and left or right upper ventral thigh. the same skin sites should be used for all immunizations. immunization schedule (days): 0, 42, 84, and 126. the total dermavir dose: * low dose: 0.8 mg dna * medium dose: 1.6 mg dna * high dose: 3.2 mg dna dermavir immunizations were administered over an 18-week period primary endpoint: 24 weeks safety follow up: 234 weeks

Eligibility criteria:
main inclusion criteria: * hiv antibody positive * plasma hiv rna value ≥5,000 copies/ml and ≤ 150,000 c/ml * antiretroviral therapy naïve * documented cd4+ t-cell count at screening ≥400 cells/mm3 main exclusion criteria: * no skin disease * no tattoos, or changes in pigmentation at the selected skin immunization sites * no acute or chronic illness (e.g hepatitis c) * no chronic autoimmune diseases * no treatment with any immune modulating agents

Keywords: hiv vaccine immune therapy dermavir
study for treatment of chronic diabetic foot ulcers with the investigational allogeneic cell therapy product, homsc200

Conditions: Diabetic Foot; Diabetic Foot Ulcer; Diabetic Foot Ulcer Neuropathic

Summary: purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (homscs) in patients suffering from chronic diabetic foot ulcers (dfu).

a prospective, placebo controlled, partially blinded and randomized study, comprising two homsc200 dose groups (low \& high) and one placebo treated group of dfu patients (3 groups; n=8 / treatment groups and n=6/ control group). study employs a 2+2 design for dose escalation. the first two patients recruited were treated with a low dose, in a staggered manner, followed by two patients who were recruited to receive the high dose. the remaining patients (18) are randomized to receive the low dose, high dose, or placebo treatment. the assessors and patients will be blinded to the study treatments. following administration of homsc200 or placebo patients will attend on-site follow up visits for 6 months. during this period safety profile of the investigational product will be assessed as well as measurement of ulcer size. all patients, irrespective of allocated treatment, will receive routine standard of care. patients will be followed for long term safety with a phone call interview 1 year following the 6 months termination visit. optional on-site follow up visits will be offered to all patients during this time period.

Eligibility criteria:
inclusion criteria: * diagnosed with type i or type 2diabetes and with a neuropathic diabetic foot ulcer for longer than 8 weeks. * size of foot ulcer 0.5-13 cm2 * ulcer graded i by wager scale * ulcer is free of necrotic debris, exhibits no signs of clinical infection * ulcer area blood circulation meets one of the following criteria: a. palpable tibialis anterior and posterior arteries in the affected foot; b. abi range \>0.7 to \ 30mmhg exclusion criteria: * ulcer is of non-diabetic pathophysiology * the ulcer has decreased in size by \>=30% after the screening visit (week -2 to -4 before treatment) * severe hepatic deficiency * glycated hemoglobin a1c (hba1c) level of \>12% * postprandial blood sugar \> 350mg/dl * require antibiotics to treat the target wound infection within 14 days prior to treatment * evidence of current wound infection including pus drainage from wound site * severe renal failure (gfr\<30) including subject on renal dialysis * pregnant or breastfeeding * was receiving oral or parenteral corticosteroids, immunosuppressives, or cytotoxic agents prior to 4 weeks from screening * patient receiving anticoagulation therapy except for aspirin * underwent wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days prior to screening visit

Keywords: diabetic foot ulcer stem cells
long term outcomes of venous thromboembolism

Conditions: Post Thrombotic Syndrome; Chronic Thromboembolic Pulmonary Hypertension; Venous Thrombosis

Summary: this prospective observational follow-up study is designed to assess the long-term outcomes after venous thromboembolism (vte) and to assess the effect of the new oral anticoagulant (noac) rivaroxaban on the prevalence of post-thrombotic syndrome (pts). the study will not be testing any formal hypothesis.

this prospective observational follow-up study is designed to assess the long-term outcomes after vte and to assess the effect of noac (rivaroxaban) on the prevalence of pts. all patients diagnosed and treated for vte at søf from 01.01.2011 will be invited to participate in this study. newly diagnosed patients will be recruited and followed-up according to the study schedule which is based on state of the art international guidelines. first follow-up will be performed at the end of treatment period, which is usually 3 or 6 months after an event of vte, or at one year if patients will be put on permanent ac. thereafter, patients will be followed-up annually for at least 5 years or up to the end of the study, i.e for 10 years. the primary endpoints of the study are the development of pts and cteph after vte. there will be 3 visits: at 3 or 6 months depending on the duration of ac, at 2 and 5 years, in addition to a visit for tte at 6 months. remaining follow-ups will be performed by phone or by mail. all patients with pe will be examined by tte 6 months after the diagnosis of pe. those with signs of pah will be referred for further work-up to establish the presence or absence of cteph at specialized centres. patients with dvt will be evaluated for pts at 2 and 5 years and for cteph if they develop dyspnoea. as for part b of the primary objective, the study will allow inclusion of patients with previous dvt diagnosed after 01.01.11.

Eligibility criteria:
inclusion criteria: * patients with objectively verified first time dvt diagnosed after 01.01.11 for study a, or objectively verified dvt and/or pe dignosed after 01.04.14 for study b. * 18 years of age * signed informed written consent exclusion criteria: * patients who refuse to consent * patients who have been treated with other anticoagulants than thoose included in the study * patients who can not participate due to logistic reasons

Keywords: post-thrombotic syndrome chronic thromboembolic pulmonary hypertension anticoagulation rivaroxaban
study of tomotherapy hd in medulloblastoma

Conditions: Medulloblastoma

Summary: the aim of the study was to improve local control and long-term survival in children with medulloblastoma, reduce the side effects of treatment and improve quality of life.

the technical advantages of tomotherapy hd in the radiotherapy of children medulloblastoma (advantages in clinical operation and physics) were transformed into clinical advantages, and the possible mechanisms were explored.

Eligibility criteria:
inclusion criteria: * the patient was diagnosed as myeloblastoma by surgical pathology with definite pathological classification. mri of the head and spinal cord before and after operation, with definite staging; radiotherapy was performed within 28 days after surgery. exclusion criteria: * previous radiotherapy in the whole brain, whole spinal cord or primary focus; postoperative radiotherapy for more than 28 days.

Keywords: tomo irradiation
the amara (as much as reasonably achievable) study

Conditions: Liver Cancer

Summary: subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter. for the purposes of the present study, we define the amara principle in intensified regional tare as a planned irradiated tumor dose \>200gy by the partition model. the purpose of the study is to evaluate the safety and efficacy of y90 high dose radioembolization for the management of large inoperable liver tumors. in addition, to correlate the safety and efficacy with the post-treatment dosimetry analysis (by mim software inc) based on 90y-pet/ct imaging.


Eligibility criteria:
inclusion criteria: * age \>18 yr * both sexes eligible for study * patients with primary or secondary liver tumors * liver dominant disease * at least one lesion greater than 5.0 cm in maximum diameter * life-expectancy \> 3 months * flr \>40% or greater than 500mls * must be able to tolerate pre-treatment ct scan , dsa and 99mtc-maa infusion and imaging with spect/ct scan * able to schedule and tolerate post-treatment y90 pet/ct imaging * able to tolerate follow-up imaging with dynamic contrast ct liver phase or mri with liver specific contrast at 3mo, 6mo, 9mo, 1yr, 2.0 yr, and 3.0 years. exclusion criteria: * child pugh \> b * bilirubin \>2 mg/dl * albumin\<3.0 * central portal invasion * multi-focal bilobar disease * disseminated extrahepatic disease * lung shunt \>20% or a estimated lung dose \> 20 gy * focuses of extra-hepatic liver uptake. * patients that cannot tolerate addition follow-up imaging.
a study of mapatumumab in combination with paclitaxel and carboplatin in subjects with non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects with advanced non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed stage iiib or stage iv advanced primary non-small cell lung cancinoma * age 18 years or older exclusion criteria: * received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat lung cancer * received radiation therapy within 4 weeks before randomization * major surgery within 4 weeks before randomization * minor surgery within 2 weeks before randomizaiton * systemic steroids within 1 week before randomization * any grade 2 or greater neuropathy * history of severe (grade 4) hypersensitivity reaction to products containing cremophor el (cyclosporine, teniposide) * history of any infection requiring hospitalization or antibiotics within 2 weeks before randomization * known brain or spinal cord metastases * history of other cancers within 5 years before randomization * known hiv, hepatitis-b or hepatitis-c infection * pregnant or breast-feeding women * previously treated with mapatumumab

Keywords: lung cancer
silent threat: impact of preoperative albumin levels on outcomes in geriatric cancer surgery

Conditions: Neoplasms; Aged; Hypoalbuminemia; Postoperative Complications; Malnutrition

Summary: this retrospective, single-center study aims to evaluate the impact of preoperative albumin levels on postoperative outcomes in geriatric patients (aged 65 and above) undergoing cancer surgery. the study will compare postoperative complication rates, length of hospital stay, and intensive care needs between patients with hypoalbuminemia and those with normal albumin levels.

malnutrition is a significant risk factor for postoperative complications in elderly cancer patients. preoperative serum albumin is a key biomarker reflecting nutritional and inflammatory status. this study will retrospectively review the medical records of 330 geriatric patients (≥65 years) who underwent cancer surgery at dr. abdurrahman yurtaslan ankara oncology training and research hospital. patients will be grouped according to preoperative albumin levels: group 1 (\<3.5 g/dl, hypoalbuminemia) and group 2 (≥3.5 g/dl, normal). the primary aim is to compare postoperative complication rates, length of hospital stay, and intensive care requirements between these groups. the findings are expected to clarify the prognostic value of albumin and support individualized perioperative management in geriatric cancer surgery.

Eligibility criteria:
inclusion criteria: * age 65 years or older * diagnosed with cancer and underwent cancer surgery * preoperative albumin level recorded before surgery exclusion criteria: * preoperative sepsis, severe infection, or active inflammatory disease * emergency or palliative surgery * missing preoperative albumin value * incomplete medical records or follow-up data
dosing of amicar and measure of fibrinolysis by teg during cardiac surgery

Conditions: Aortic Disease

Summary: this study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and blood transfusion after cardiac surgery without increasing adverse events


Eligibility criteria:
inclusion criteria: * ability to sign informed consent * elective cardiac surgery patients undergoing primary surgery involving circulatory arrest exclusion criteria: * inability to sign informed consent * baseline hypercoagulable condition as defined in medical record * coronary disease with untreated lesions or recent coronary stent placement * severe renal dysfunction (esrd) as documented in medical record

Keywords: dilated ascending aorta
transdermal fluid removal in fluid overload

Conditions: Heart Failure; Odema

Summary: the proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant transdermal fluid removal (tfr) in heart failure patients. it seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. it also wishes to explore the patient experience of the removal.

fluid overload is distressing and is particularly prevalent in patients with vital organ dysfunction such as in kidney and heart disease. due to the patient's inability to remove excess wastes and water, these accumulate in their body fluid compartments. such excess fluid and toxins have to be removed with high dose diuretics (water tablets or injections) or by frequent dialysis. treatment with diuretics is effective initially in some patients but is fraught with risks and side effects. the retained fluid and wastes are mainly lodged within the extracellular compartment (interstitial or tissue fluid) and exert deleterious effects on cell functions. much of this excess fluid collects relatively superficially within the skin, especially in the lower extremities or other dependent body parts as oedema. the proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant transdermal fluid removal (tfr) in heart failure patients. it seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. it also wishes to explore the patient experience of the removal. principal aim of the research: to investigate whether the tfr device can remove clinically viable or relevant volumes of fluid transdermally in advanced heart failure and other patients with significant oedema. "clinically viable" volume is defined as the removal of 200ml or more of fluid in a session of up to 10 hours (or 0.43 ml/h per 1cm2 of the skin area treated with microneedles).

Eligibility criteria:
inclusion criteria: * participants aged \>18 years * diagnosis of heart failure * presence of visible oedema exclusion criteria: * inability to give consent * patient on warfarin or simthrome (acecoumarol) with international normalised ratio (inr) \>3 or other bleeding disorders * extensive skin disease, infected or broken skin over intended study area * pregnancy nb: patients with pacemakers or implantable cardiac devices (icd) may be recruited but will not have bioimpedance measurements
efficacy of faslodex in treatment of sle clinical, serologic, and molecular studies

Conditions: Systemic Lupus Erythematosus

Summary: sle(systemic lupus erythematosus) is an autoimmune disese that primarily occurs in women(9:1 compared to men). the disease is activated by genetic and environmental factors, yet the female gender is the strongest risk factor. the sex hormone estrogen has been proven in the past to be an enhancer of the immune response. estrogen serves as a ligand for two specific receptor proteins. lab studies that we have already done have shown estrogen significantly increases these two ligands in the t cells from sle females, but not in t cells from normal women. these estrogen-dependent increases are blocked by the estrogen receptor antagonist ici 182,780. the objective of this research is to investigate if ici 182,780 alters disease progression and/or activity in females with sle and may provide a new treatment for women with sle. this is based on previous work we have done.

this is a double-blind study, involving (goal) 20 women with sle. all will be premenopausal with regular menstrual cycles. patients will meet at least four of the criteria of the american colleges of rheumatology for classification of sle. disease activity will be determined by sle disease activity index called sledai scores. patients can take meds to control their disease, but none will be able to take birth control pills/patches, or hormone replacement at the time of the study. the pharmacy will be in control of the blind and 10 will get ici 182,780 (faslodex) and 10 will get placebo. lab will be drawn before each injection and a bone density will be done on injection 1 and 12, the injections will be monthly, depending on the female's cycle. a visit will be done at month 15 to evaluate sledai, and draw lab as well. each vs will have a sledai done with the clinical evaluation. the injection is 250mg/5cc, which is divided into 2 injections of 2.5cc each, given im, on day 4-10 of each cycle.

Eligibility criteria:
inclusion criteria: * premenopausal women with sle * without life-threatening manifestations * with regular menstrual cyles not on hormones of any kind exclusion criteria: for any of the following: * increase of sledai greater than 12 * if life-threatening manifestations occur * if menstruation ceases
perioperative management in gynaecological carcinoma surgery

Conditions: Gynaecological Carcinoma

Summary: this study is to determine the effect of perioperative treatment with intravenous iron and tranexamic acid on the reduction of intraoperative and postoperative rbc transfusions in gynaecological carcinoma patients undergoing abdominal surgery.

radical abdominal surgery often leads to intraoperative bleeding frequently exceeding 1000 ml and approximately 50% of women undergoing this surgery require blood transfusion. perioperative blood transfusions have been shown to increase of length of stay, surgical complications, postoperative morbidity and mortality. there are a few data on the reduction in red blood cell count (rbc) transfusions using perioperative management with intravenous iron and tranexamic acid in women with gynaecological carcinoma surgery. this study is to determine the effect of perioperative treatment with intravenous iron and tranexamic acid on the reduction of intraoperative and postoperative rbc transfusions in gynaecological carcinoma patients undergoing abdominal surgery.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * women with gynaecological carcinoma surgery with hemoglobin level between 90-120 g/i and serum ferritin \< 100 µg/i (or ferritin index \< 3.19) at recruitment * pregnancy test negative in women younger than 50 years exclusion criteria: * known hypersensitivity or allergy to ferric carboxymaltose or tranexamic acid * history or present laboratory signs of bleeding disorders, coagulopathy or thromboembolic events * history of myocardial infarction within the last year, present unstable angina or severe coronary disease * increased plasma creatinine levels above 250 µmol/i * inability to follow the procedures of the study (language problems, severe psychiatric or mental disorders) * iron overload * current administration of intravenous iron or previous intravenous iron therapy or blood transfusion within three months * date of scheduled surgery is outside 28 days after the date of recruitment * other clinically significant concomitant disease states (e.g., hepatic dysfunction, cardiovascular disease, etc.) * participation in another study with investigational drug within the 30 days * enrolment of the investigator, his/her family members, employees and other dependent persons.

Keywords: ferric carboxymaltose tranexamic acid rbc transfusion