Kornimate/medical-research-clean huggingface dataset:
recombinant human il-18 and ofatumumab after pbsct for lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to test the safety of rhil-18 combined with ofatumumab to see what effects (good and bad) it has on subjects and their non-hodgkin's lymphoma.


Eligibility criteria:
inclusion criteria: * patients who have undergone high-dose therapy and autologous pbsct for treatment of cd20+ lymphoma. * patients must be between 2-6 months post-transplantation at the time of study registration. * patients must have at least stable disease (no overt progressive disease) at the time of study registration. * laboratory values must be within protocol specified ranges. * females of childbearing potential must have a negative pregnancy test. * females of childbearing potential and males must use an effective method of contraception from the time of consent until at least 365 days following discontinuation of protocol therapy. exclusion criteria: * patient must not have obvious clinical progression of lymphoma after pbsct as determined by the treating physician. * cannot be positive for hepatitis b surface antigen, hepatitis b core antibody or hiv antibody. * no major or uncontrolled comorbid conditions as determined by the treating physician: history of ventricular arrhythmias requiring drug or device therapy; uncontrolled angina or symptomatic congestive heart failure; • severe or uncontrolled infection requiring systemic antibiotic or antifungal therapy or active hepatitis c infection; severe or uncontrolled psychiatric illness. * no known leptomeningeal involvement by lymphoma or current metastatic brain disease. * no corrected qtc interval \> 480 msec. * no known or suspected hypersensitivity to ofatumumab or sb-485232 that in the opinion of the investigator is a contraindication to their participation in the study. * no systemic (oral or parenteral) corticosteroids within 14 days of study entry. * not receiving concurrent chemotherapy, biologic therapy, radiotherapy, or other investigational therapy. * no previous treatment with sb-485232 or ofatumumab. * no history of other malignancy except for adequately treated non-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. * no diabetes mellitus with poor glycemic control (documented hemoglobin a1c \>7% within 4 weeks prior to study entry).
reliability of the preoperative work-up in patients submitted to surgery for cystic neoplasms of the pancreas

Conditions: Pancreatic Cystic Neoplasms

Summary: prospective, observational, cohort study to evaluate the reliability of preoperative work-up of patients submitted to surgery for pancreatic cystic neoplasms, in a tertiary referral center. a comparison between the preoperative diagnostic suspicion and the final pathologic report will be done.


Eligibility criteria:
inclusion criteria: * diagnosis of pancreatic cystic neoplasms * indication to surgery exclusion criteria: * pregnancy, breastfeeding
woundvac in obese patients undergoing lumbar surgery

Conditions: Obesity; Lumbar Spine Surgery

Summary: this is an open label, randomized clinical trial of closed-incision negative-pressure therapy to decrease post-operative wound complications in patients with bmi ≥35kg/m2 after posterior lumbar spine surgery.

methods: study design: prospective open-label randomized clinical trial of cinpt in obese patients. subjects will be randomized in a 1:1 to standard of care (soc) and cinpt. study arms: (1) standard of care (2) cinpt sample size: based on 30% incidence of wound complications in obese patients undergoing lumbar spine surgery, a sample size of 124 (62 in each cohort) will be needed to detect a decreased incidence of 10% with an α of 0.05 and β of 0.2. randomization: randomization will be done with varying blocks of 4, 6 and 8 using opaque sealed envelopes. procedures: all patients will receive standard pre operative prophylactic antibiotics with 2g - 3g cefazolin or 1g clindamycin (if patient has known penicillin allergy) based on weight 60 min before incision is made. they will be clipped if needed before being prepped. each patient will be prepped with alcohol and then either duraprep, chloraprep, or betadine. after the procedure is complete, a subfascial and subcutaneous closed suction drain will be placed in the wound prior to closure. 1 to 3 gram of vancomycin powder will be placed in the wound. the wound is closed with #1vicryl for the fascial layer followed by 2-0 vicryl for the subcutaneous layer followed by 3-0 or 4-0 monocryl. in the soc group, skin glue, steri-strips, sterile gauze and tegaderm will be applied to the wound. in the cinpt group, a cinpt dressing will be placed and attached to a compact portable negative pressure unit to deliver 125mmhg continuous pressure for 5 to 7 days. all patients will receive standard wound care instructions before hospital discharge. patients will return to the clinic in 6±1 days for a wound check and removal of the cinpt. primary endpoint: the primary endpoint is the occurrence of a wound complication. a wound complication can include a local inflammatory reaction, wound dehiscence, skin blistering/necrosis, stitch abscess or incision and drainage for hematoma seroma, deep or superficial infection

Eligibility criteria:
inclusion criteria: * adult patients aged ≥18 years old * patients undergoing posterior lumbar fusion with or without interbody fusion * body mass index of ≥35kg/m2 * able to provide informed consent * no prior lumbar spine surgery exclusion criteria: * presence of skin infection or any systemic infection * known allergy or sensitivity to silver or acrylic adhesive * fragile peri-incisional skin * patients on anti-coagulation and/or platelet aggregation inhibitors
avf volume blood flow reduction in hd patients

Conditions: Chronic Kidney Disease Stage 5; Heart Failure

Summary: heart failure with preserved / high cardiac output is a well-known syndrome in patients with high-flow arteriovenous fistula (avf). however, the threshold for classifying an avf as high-flow is currently undefined. cardio-fistular recirculation (cfr) is often used as a criterion, with values greater than 25-30% considered cardiotoxic and associated with adverse outcomes. additionally, cfr is one of the few easily modifiable risk factors through surgical reduction of avf volume blood flow (qa). the study aimed to evaluate the extent of involution of heart structural and functional changes following qa reduction in patients with heart failure and cfr \> 25%.


Eligibility criteria:
inclusion criteria: * signed informed consent * age \> 18 years * ckd 5d * native arteriovenous fistula or vascular graft * heart failure with preserved co (nyha i-iv ) * cardio-fistula recirculation ≥ 25% * ekt/v \> 1.2 * absence of arrhythmias (except grade i av block) * absence of valvular disease (except mitral regurgitation i-ii) * arteriovenous fistula blood flow reduction surgery exclusion criteria: * death * kidney transplantation * conversion of vascular access to central venous catheter * withdrawal of informed consent
dose-ranging study for miconazole oil for treatment of otomycosis

Conditions: Otomycosis

Summary: the purpose of the study is to evaluate the efficacy and safety of active treatment (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with fungal infection (otomycosis) of the external ear.

miconazole, an imidazole antifungal agent, is commonly used for different types of fungal skin infections, such as candida, ringworm, jock itch, athlete's foot, nail fungus, vaginal yeast infections, and oropharyngeal candidiasis. the 2% formulation of miconazole is commonly used for dermatophytic infections. the mechanisms of action of miconazole against fungi in general appear to be applicable to fungi associated with otomycosis, in that miconazole has been demonstrated to have activity in vitro against some clinical isolates of fungi associated with human otomycosis in the us. miconazole targets the cytochrome p450-dependent enzyme 14-α-sterol demethylase, an enzyme that is also involved in mammalian cholesterol synthesis, resulting in inhibition of ergosterol biosynthesis in the cell membrane of the fungal organism. because ergosterol is an important component of the cell membrane, inhibition of its synthesis inhibits fungal cell growth. in addition to its activity toward the enzyme 14-α-sterol demethylase, miconazole also leads to increased reactive oxygen species in fungal organisms, which appears to result in fungicidal activity.

Eligibility criteria:
inclusion criteria: * uncomplicated otomycosis of the external ear only, age more than 2 year exclusion criteria: * pregnancy * other dermatoses or conditions of the ear that may interfere with the evaluation of otomycosis, including concomitant otic infections (including bacterial infection) that require antimicrobial treatment, disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s) * tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated * previous surgery affecting the ear(s) that will be treated, except for prior tympanostomy tube(s) that had been removed and had completely healed * previous use of medicated treatments for otomycosis or participation in another investigational study within 28 days of study entry * previous use of any systemic antifungal therapy, warfarin, and immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry * recurrent otomycosis that had been unresponsive to previous antifungal treatment * known hypersensitivity to any of the components in the test formulation
a combined neurofeedback-tms intervention for alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: the goal of this clinical study is to test the effectiveness of a supplemental fmri neurofeedback and/or tms intervention in individuals seeking treatment for alcohol use disorder. after an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include tms and mri. participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two mri follow-ups at 6 and 12 months.


Eligibility criteria:
inclusion criteria: 1. age 19-65 2. receiving treatment for alcohol use disorder exclusion criteria: 1. mri contraindications 1. presence of metal in the body that would make having a 7t mri unsafe (including facial tattoos) 2. claustrophobia, such that individual would be unable to stay in the mri for up to 1 hr 3. hearing loss, including tinnitus, that might be made worse by mri or tms 2. tms contraindications 1. has ever had a seizure, or has a family history of epilepsy 2. taking medications or substances that lower the seizure threshold 3. implanted devices that are in the head or rely on physiological signals 4. history of neurological disease, such as stroke or brain tumor 5. head injury with loss of consciousness greater than 30 minutes 6. actively withdrawing from alcohol 3. family history of schizophrenia or presence of psychotic symptoms

Keywords: treatment seeking alcohol tms neurofeedback supplemental intervention heavy drinking problems with drinking
clinical trial to evaluate the efficacy and safety of ckd-390 tablet

Conditions: Chronic Hepatitis B

Summary: a multicenter, randomized, double-blind, parallel design, phase iii clinical trial to evaluate the efficacy and safety of ckd-390 tablet

a multicenter, randomized, double-blind, parallel design, phase iii clinical trial to evaluate the efficacy and safety of ckd-390 tablet and viread® tablet in chronic hepatitis b patients subjects will receive either a single oral dose of the test formulation(ckd-390) or a oral dose of the reference formulation(viread).

Eligibility criteria:
inclusion criteria: 1. male or female older than 19 years at the time of screening 2. patients who have chronic hepatitis b disease are taken viried for 6 months 3. patients who show hbv dna undetected(less than 20 iu/ml) 4. patients who show positive hbsag 5. patients who show positive hbeag or negative hbeag 6. patients who fully understand the clinical trials after in-depth explanation, decided to join the clinical trials by their will and signed inform consent exclusion criteria: 1. patients who are not taken any anti-viral agents except viread tab 2. patients who have hepatitis c (hcv), hepatitis d (hdv), or human immunodeficiency virus (hiv) 3. patients who have seroperitoneum, icterus, hepatic encephalopathy, variceal hemorrhage or patients with following value at screening * total bilirubin \> upper normal limit x 1.5 * prothrombin time(inr) \> upper normal limit x 1.5 * platelets \< 75,000/ul * serum albumin \< 3.0g/dl 4. patients who are estimated to have hepatocellular carcinoma (hcc) through imaging examination or showed alpha-fetoprotein(afp) more than 50ng/ml 5. patients who show creatinine clearance \< 50 ml/min by calculating cockcroft-gault equation 6. patients with disease like heart failure, renal failure, pancreatitis that investigators consider ineligible for this study 7. patients who have other hepatic diseases like hematochromatosis, wilson's disease, alcoholic cirrhosis, autoimmune hepatic diseases, α-1 antitrypsin deficit syndrome 8. patients with genetic disease like galactose intolerance, lapplactase deficiency, glucose-galactose malabsorption 9. history of malignant tumor within 5 years 10. patients who take any other investigational product within 30 days 11. patients who have to administer immunosuppressants or nephrotoxic drugs, hepatotoxic drugs for period of clinical trial 12. pregnant, breast-feeding and childbearing age who don't use adequate contraception 13. patients who receive an organ transplant or bone marrow transplant or are going to received surgury 14. history of allergic reaction to the investigational product 15. patients that investigators consider ineligible for this study

Keywords: chronic hepatitis b tenofovir ckd-390
evaluation of serum mif level in sle patients

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosis (sle) is a chronic autoimmune disease characterized by production of autoantibodies and the deposition of immune complexes, affecting a wide range of organs. the clinical onset of sle derives from the interaction between genetic predisposition and environmental, immunological and hormonal factors, with a strong predilection for women of childbearing age. sle is usually diagnosed in young women in the third decade of life and represents the leading cause of systemic disease with secondary kidney involvement. lupus nephritis (ln) occurs in \~50% of patients with sle and is the most common, but not the only, cause of kidney injury in sle. ln typically develops early in the disease course, generally within the first 6 to 36 months, and may be present at initial diagnosis. macrophage migration inhibitory factor (mif) is a pleiotropic inflammatory cytokine with regulatory roles in innate and adaptive immunity and is implicated in the pathogenesis of autoimmune diseases including sle. mif actively participates in multiple stages of the inflammatory response, acting on cells directly and/or potentiating the effects exerted by other stimuli. mif overcomes the inhibitory effects of glucocorticoids on tnf alpha, il-1 beta, il-6, and il-8 production. mif is implicated in the pathogenesis of other autoimmune diseases including rheumatoid arthritis (ra), type 1 diabetes, multiple sclerosis and guillain barré syndrome.


Eligibility criteria:
inclusion criteria: * adult sle patients \>18 years * fulfilled the 2012 systemic lupus international collaborating clinics (slicc) criteria exclusion criteria: * patients with overlap syndrome, pregnancy, active infection, diseases other than sle that might produce abnormal proteinuria. * individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, scleroderma, mixed connective tissue disease).
online self-help for depressed patients awaiting psychotherapy

Conditions: Major Depressive Disorder

Summary: patients with major depression who are on a waiting list for psychotherapy usually suffer from considerable symptoms. online self-help is one potential way to alleviate this suffering. the investigators want to study if patients awaiting psychotherapy benefit from online-self help. the investigators therefore randomly assign patients to either online self-help or no intervention and assess their depressive symptoms on a regular basis. the investigators hypothesize that online self-help will be superior to no intervention in alleviating depressive symptoms in depressed patients awaiting psychotherapy.


Eligibility criteria:
inclusion criteria: * major depressive disorder * stable medication * 18yrs. or older exclusion criteria: * current psychotherapy * acute suicidality * unavailability of internet connection
investigation of the effects of bariatric surgery on taste reward in humans

Conditions: Obesity

Summary: the investigators hypothesize that some of these changes in the reduced appetite after surgery may be due to alterations in taste. the aim is to compare obese patients before and after bariatric surgery (gastric bypass and banding) to define the reward value of sweet, fatty and vegetable/fruit taste in obese individuals, and how this changes after surgery.

severe obesity is associated with excessive food eating and appetite. bariatric surgery (also known as 'obesity surgery' or 'weight loss surgery') is a well known treatment for severely obese individuals. the way in which these operations achieve weight loss is not fully understood. the investigators hypothesize that some of these changes in the reduced appetite after surgery may be due to alterations in taste. the aim is to compare obese patients before and after bariatric surgery (gastric bypass and banding) to define the reward value of sweet, fatty and vegetable/fruit taste in obese individuals, and how this changes after surgery.

Eligibility criteria:
inclusion criteria: * bmi of 18-25 for normal weight volunteers * bmi of \>30 for obese patients exclusion criteria: * pregnancy * breast feeding * substance abuse * consumption of more than 3 alcoholic units per day * severe psychiatric illness * lack of understanding of test instructions * diabetes mellitus * chronic medical conditions making a general anaesthetic unsafe * allergy to stimulus ingredients * active smoking

Keywords: taste bariatric surgery food preferences reward progressive ratio task
memantine augmentation in obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this study is to determine whether memantine is safe and effective when used as an augmentation to standard treatment for obsessive-compulsive disorder (ocd).

the purpose of this study is to determine whether memantine (namenda), in doses up to 20 mg/day, will be effective in treating the ocd of adult patients who have not responded to their ocd medication. memantine is not fda approved for ocd, but is approved for the treatment of alzheimer's disease. memantine appears to work by regulating the activity of glutamate, one of the brain's specialized messenger chemicals, which may play a role in ocd. all patients in the study will receive memantine; no one will receive placebo.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * suffering from ocd * y-bocs score of 18 or greater * taking a therapeutic dose of an anti-ocd medication specified in the protocol exclusion criteria: * diagnosed with a mental disorder other than ocd * taking tiagabine or pregabalin * having had a previous trial of memantine * receiving therapy for ocd * substance abuse in the last 6 months * personality disorders sufficiently severe to interfere with study participation
photography or video in assessing breast reconstruction?

Conditions: Breast Neoplasms; Breast Reconstruction

Summary: current qualitative methods of assessing the aesthetic result following breast reconstruction are known to be poor. the investigators believe that real time digital video footage followed by expert panel review would be a superior method of qualitative assessment of breast cancer reconstruction aesthetics. this has never been studied before.

breast cancer is the commonest cancer to affect women in the uk. current guidelines state that; disease permitting, all females due to undergo mastectomy for breast cancer should be offered reconstruction. this usually takes place in the form of implant based reconstruction, regional flap based reconstruction +/- implant or free autologous tissue based reconstruction. traditional methods of subjectively assessing the aesthetic outcome of any of the forms of breast surgery have been shown to be poor and the assessment of immediate reconstructions a cumbersome task. the qualitative part of the assessment usually relies on standardised clinical photographs and panel ratings. four to six photographs are usually taken of the patient and their reconstruction from different angles. these photographs are then shown to an expert panel (usually consisting of healthcare professionals familiar with breast reconstruction). a large degree of both inter and intra-observer bias exists when comparing standardized photographs. the results from expert assessment of cosmesis often do not correlate to the patients opinion with regards to the cosmetic outcome of their reconstruction due to the static nature of clinical photography it does not capture the effect which movement and gravity play on a reconstructed breast in comparison to a normal breast. a large volume of information can be captured from a short digital video clip in comparison to a single photograph. the potential advantages of digital video assessment over photography are only beginning to be explored with regards to aesthetics in other fields associated to medicine.9 however this has never been trialed with regards to breast cancer reconstruction. we believe that real time digital video footage would be a more valuable tool in the assessment of breast reconstruction. we believe that there may be more accurate correlations between patient's satisfaction and panel opinion and that there will be less inter and intra-observer discordance

Eligibility criteria:
inclusion criteria: * female patient * minimum 18 years of age * due to attend for nipple areola complex tattooing * previous unilateral breast reconstruction following mastectomy exclusion criteria: * male patient * bilateral breast reconstruction * reconstruction less than 1year ago * breast reconstruction not following breast cancer excision

Keywords: breast reconstruction