Kornimate/medical-research-clean huggingface dataset:
pilot studie of lipiodol demarcation of the tumour in bladder cancer

Conditions: Bladder Cancer

Summary: rationale: bladder tumours are often not visible on x-ray based image-modalities during planning and treatment of radiotherapy. purpose: to determine if a single contrast (lipiodol) demarcation of the bladder tumour before treatment is feasible and visible on multiple x-ray based image-modalities during radiotherapy.

to exploit the potential of modern radiotherapy (rt), it is important to localize and follow the target precisely during treatment. since the bladder tumour can usually not be identified on conventional ct-scan, a fiducial or contrast marking system is warranted. the iodized oil, lipiodol is a well-known contrast media used mainly for lymphography and hysterosalpingography. local lipiodol demarcation has been used for localisation of tumours in the lung, prostate and seminal vesicles visualised on computed tomography (ct) and fluoroscopy. purpose: to evaluate the feasibility of tumour demarcation using the contrast agent lipiodol in adaptive image-guided rt of bladder cancer. visibility on ct, cone-beam ct, mri and on-board imaging will be evaluated.

Eligibility criteria:
inclusion criteria: * histologically confirmed primary muscle invasive transitional cell carcinoma of the bladder. t1-4a, n0-1, m0. * non-operable or refuse operation. * eligible for curative radiotherapy. * oral and written informed consent. * fertile women must have a negative pregnancy test before inclusion or use contraceptive pills or intrauterine device. * ongoing beta blocker treatment is paused before lipiodol injection. exclusion criteria: * known metabolic disorder (hyperthyroidism, goiter) * allergy towards iodine. * pregnancy / breast-feeding * performance status ecog \> 2

Keywords: bladder cancer radiotherapy tumour delineation markers
a relative bioavailability study of setrobuvir tablet formulation versus reference setrobuvir capsule formulation in healthy volunteers

Conditions: Healthy Volunteer

Summary: this open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule formulation in healthy volunteers. subjects will be randomized to one of four treatment sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule formulation with or without a high fat meal, with a washout period of at least 14 days between treatments.


Eligibility criteria:
inclusion criteria: * healthy male and female adults, 18 to 55 years of age inclusive * body mass index (bmi) 18.0 - 30.0 kg/m2 * healthy status defined as absence of clinically significant acute or chronic condition as determined by complete medical history and physical examination * females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception as defined by protocol during treatment and for at least 3 months after the last dose of study drug * non-smokers or use of \< 10 cigarettes (or equivalent nicotine-containing product) per day * negative results on following screening laboratory test: urine drug screen, urine alcohol screen * willing and able to consume the study-specified meal on day of dosing exclusion criteria: * pregnant or lactating women, or males with female partners who are pregnant or lactating * history of current alcohol abuse and/or other drug addiction \</= 2 years prior to enrollment in the study * participation in other clinical studies within 60 days prior to study randomization * positive for hepatitis b, hepatitis c or hiv infection
operative versus non-operative treatment for mild to moderate hallux valgus deformity

Conditions: Hallux Valgus Deformity

Summary: the goal of this randomized controlled trial is to investigate operative treatment versus conservative treatment in participants suffering from mild to moderate hallux valgus deformity. the main question it aims to answer are; is surgery superior to conservative treatment? the participants will be randomized in to two groups, operative and conservative group. investigators will compare the groups measuring the clinical results using the patient-reported outcome measure (prom) manchester-oxford foot questionnaire (moxfq), visual analog scale (vas), likert scale 0-5. participants will be observed for a period og two years.

randomized controlled trial (rct) investigating the patient reported outcome after operative or conservative treatment in mild to moderate hallux valgus deformity. in this rct study participants will be divided into operative group, non-operative group where the treatment will be orthopedic aids/wide shoes. the participants will be evaluated 6 months, 1 year and 2 years after starting the treatment. the clinical results will be evaluated using patient reported outcome measures (proms). primary aim: investigating the clinical result by prom (manchester oxford foot questionnaire) secondary aim: investigating the radiological results according to newer and traditional parameters. operative group -correction achieved, residual rate. conservative group -progression of deformity. statistical power calculations have been made within the research group. calculations are based on the main outcome moxfq, with the power of 80 and confidence interval 95%. the investigators concluded that a sample size of 49 participants will be needed to perform a regression analysis. to account for loss to follow-up (estimated 20%),120 participants (60 per group) will be recruited.

Eligibility criteria:
inclusion criteria: * painful hallux valgus deformity * hallux valgus angle \<35 degrees * intermetatarsal angle \<15 degrees * 18-80 years exclusion criteria: * advanced osteoarthritis in first metatarsophalangeal joint * rheumatic diseases * pregnancy * drug abuse * severe psychological disorder * lack of compliance * language barrier
safety of mk0928 on insomnia in the elderly (0928-005)(completed)

Conditions: Insomnia

Summary: the purpose of this trial is to study the safety of mk0928 on insomnia in the elderly.

the duration of treatment is 1 year.

Eligibility criteria:
inclusion criteria: * diagnosis of insomnia
a retrospective, blinded validation of a host-response based diagnostics

Conditions: Fever; Respiratory Tract Infections; Urinary Tract Infections; Gastroenteritis; Arthritis, Infectious

Summary: this is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (ivd) assay that will include samples that were previously collected from febrile pediatric patients. the investigated assay measures the levels of a few host-related, blood-based, bio-markers that will be integrated into a single score. based on this score, each patient will be classified into one of three categories: (i) bacterial immune response, (ii) viral immune response, and (iii) marginal immune response. the assay prediction and the patient diagnosis will than be unveiled and compared to determine their level of concordance.


Eligibility criteria:
inclusion criteria: the infectious disease samples should also fulfill the following criteria: * the patient had a peak temperature ≥38°c (and) * symptoms initiated ≤ 7 days before sampling the non-infectious disease control group will include: * patients with a non-infectious disease exclusion criteria: * another infection episode during the last 3 weeks before sampling * congenital immune deficiency (cid) * a proven or suspected hiv-1, hbv, hcv infection * active hematological malignancy * current treatment with immune-suppressive or immune-modulating * other illnesses that affect life expectancy and/or quality of life
a study of daratumumab

Conditions: Multiple Myeloma

Summary: the purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain janssen research and development (r\&d) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. certain long-term safety data will continue to be collected from study participants.


Eligibility criteria:
inclusion criteria: * participants must be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain janssen research and development (r\&d) studies or receiving other study treatment in a janssen r\&d daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis continue to benefit from study treatment, not have experienced disease progression or unmanageable toxicity while receiving daratumumab, not have met the withdrawal criteria set forth in the parent study, and have had the last dose of study treatment within the previous 3 months * investigator's assessment that the benefit of continued study treatment will outweigh the risks * a female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study * a male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment * must sign an informed consent form (icf; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study * willing and able to adhere to the lifestyle restrictions specified in this protocol exclusion criteria: * has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment * any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab investigator brochure (ib) and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide) * vaccinated with an investigational vaccine (except for coronavirus disease \[covid-19\])or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment
impact of bacterial resistance on healthcare costs for hospitalized patients with complicated intra-abdominal infections

Conditions: Complicated Intra-Abdominal Infection

Summary: the objective of this study is to estimate the costs of empiric antibiotic therapy and hospitalization costs for patients with a complicated intra-abdominal infection, and to assess the impact of treatment failure of initial antibiotic empiric therapy on pharmacological and total healthcare costs for these patients in greece.

every patient diagnosed with complicated intra-abdominal infections will enter the study, until the pre-specified number of patients is reached. patients diagnosed with any of conditions mentioned below (inclusion criteria) will enter the study, until the pre-specified number of patients is reached.

Eligibility criteria:
inclusion criteria: * a recorded primary diagnosis of a complicated intra-abdominal. infection (ciai) and a procedure involving a laparotomy, laparoscopy, or percutaneous drainage of an intra-abdominal abscess the study will be a prospective, multi-centre, epidemiological study of patients (aged \> 18 years) diagnosed with a complicated intra-abdominal infection and who received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess. ciai's will include the following conditions/ diagnoses: * gastric ulcer with perforation; * gastric ulcer with hemorrhage and perforation; * duodenal ulcer with perforation; * duodenal ulcer with hemorrhage and perforation; * peptic ulcer with perforation; * peptic ulcer with hemorrhage and perforation; * gastrojejunal ulcer with perforation; * gastrojejunal ulcer with hemorrhage and perforation; * acute appendicitis with generalized peritonitis; * acute appendicitis with peritoneal abscess; * peritonitis; * abscess of intestine; * fistula of intestine, excluding rectum and anus; * ulceration of intestine; * perforation of intestine; * abscess of liver; or * acute cholecystitis with perforation. the initial antibiotic regimen will be defined as all iv antibiotics newly received either on the day immediately prior to laparotomy or laparoscopy or percutaneous drainage of an intra-abdominal abscess, or on the day of these procedures, given that the use of these procedures prior to initiation of iv antibiotic regimens in complicated iais , which is increasingly common, is likely reflective of prophylaxis. exclusion criteria: * patients not signing an informed consent form. * patients participating in another interventional study.

Keywords: health care costs intra-abdominal infection
preoperative localization of sentinel lymph node in breast cancer patients by novel computed tomography-lymphography guided technique

Conditions: Breast Cancer

Summary: a question is raised about the possibility of accurate localization of the sln (sentinel lymph node) detected by ctlg (computed tomography lymphography) which offers a detection rate of 100% in many studies in oncology center, mansoura university (ocmu), the surgical oncology unit had a previous experience in using charcoal for localization of non-palpable suspicious breast lesions and it showed promising results in comparison to traditional localization methods in addition, we had another study using silver wire for localization of breast masses before neoadjuvant therapy. in the study, the investigators will study the usage of both methods as preoperative localization methods for the sln detected by ct lymphography in breast cancer patients the investigators suppose that this method can offer two main advantages over the traditional sln intraoperative methods which are; saving operative time needed for the intraoperative procedure as well as solving the problem of the need for complex logistic preparations especially for the usage of radioisotope method.


Eligibility criteria:
inclusion criteria: * node negative early breast cancer exclusion criteria: * • unfit patients for general anaesthesia * previous axillary surgery * history of breast surgery or incisional biopsy compromising the breast lymphatic drainage. * known hypersensitivity to the dye * patients with clinically positive or suspicious axilla * pregnant females

Keywords: sentinel lymph node biopsy
serum cholesterol reduction efficacy of biscuit with plant stanol ester

Conditions: Dyslipidemias; Hypercholesterolemia; Hyperlipidemias

Summary: efficacy of plant stanols as esters on ldl-cholesterol reduction is well documented. ldl-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.


Eligibility criteria:
inclusion criteria: * mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l) * fasting serum triglyceride levels below 3.0 mmol/l * normal liver, kidney and thyroid function * no lipid lowering medication * no history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (cabg), percutaneous transluminal coronary angioplasty (ptca) within the previous 6 months, diabetes, temporal ischemic attack and malignant diseases exclusion criteria: * alcohol abuse (\> 4 portion/per day) * pregnancy * use of plant stanol and plant sterol products and equivalent cholesterol lowering products, though the ones who have discontinued the consumption of these products minimum 3 weeks before the beginning of the study, can be included
a randomized study of surgery vs no surgery in patients with mild asymptomatic primary hyperparathyroidism

Conditions: Hyperparathyroidism

Summary: objectives: i. assess the efficacy of surgery vs no surgery in patients with mild asymptomatic primary hyperparathyroidism. ii. assess the quality of life, morbidity, and mortality of these patients.

protocol outline: this is a randomized, multicenter study. patients are stratified by gender. patients are randomized to receive surgery or follow up without surgery. patients receive parathyroidectomy (current standard care) or long term follow up without parathyroidectomy. quality of life is assessed before the study and then every 6 months. all patients are followed every 6 months until death.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- histologically diagnosed mild asymptomatic primary hyperparathyroidism persistent albumin adjusted serum calcium between 10.1-11.5 mg/dl for at least 3 months intact parathyroid hormone greater than 20 pg/ml no other cause for hypercalcemia no family history of primary hyperparathyroidism, primary endocrine neoplasia, or hypocalciuric hypercalcemia bone mineral density of the forearm no greater than 2.0 sd units below the expected value for sex, age, and race no phalangeal subperiosteal resorption on hand x-rays --prior/concurrent therapy-- radiotherapy: no history of childhood irradiation to head and neck surgery: no thyroid disease requiring surgical intervention other: no prior glucocorticoid or anticonvulsant drug therapy concurrent thiazide diuretic therapy for hypertension must be changed to nonthiazides --patient characteristics-- menopausal status: at least 5 years postmenopausal renal: at least 2 years since prior nephrolithiasis creatinine no greater than 1.5 mg/dl creatinine clearance at least 70% (age adjusted) cardiovascular: no unexpected finding on echocardiogram that will interfere with surgical intervention other: living within 150 mile radius of downtown detroit no concurrent participation in other clinical trials no concurrent polyuria, polydipsia, anorexia, nausea, or vomiting at least 12 months since prior pancreatitis no concurrent symptomatic peptic ulcer disease no objective muscle weakness no history of nontraumatic vertebral or hip fractures no vertebral compression fractures no urolithiasis on x-ray of abdomen

Keywords: disease-related problem/condition endocrine disorders hyperparathyroidism quality of life rare disease
comparing laparoscopic and open surgery for pancreatic carcinoma

Conditions: Pancreatic Carcinoma; Laparoscopic; Pancreaticoduodenectomy

Summary: background: pancreatic cancer (pc) is one of the most aggressive malignant neoplasms with poor outcomes. pancreatoduodenectomy (pd) is the only curative treatment for pc. minimally invasive surgery has been progressively developed, first with the advent of hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues are currently being debated, including the superiority between total laparoscopic pancreaticoduodenectomy (tlpd)and the open pancreaticoduodenectomy (opd). studies comparing these two surgery techniques are merging and randomized controlled trials (rct) are lacking but clearly required. methods/design: tjdbps07 is a multicenter prospective, randomized controlled, trial comparing tlpd and opd in pancreatic cancers. a total of 200 patients with pancreatic cancer underwent pd will be randomly allocated to the tlpd group or opd group with an enhanced recovery after surgery (eras) pattern. the trial's aim is to exploring the overall survival (os), disease free survival (dfs) and quality of life. the duration of the entire trial is seven years including prearrangement, a presumably five-year follow-up and analyses. discussion: despite the fact there are several rcts comparing minimally invasive pancreaticoduodenectomy (mipd) and open approach or lpd versus opd. this trial will be the first comparing tlpd and opd in a large multicenter setting. tjdbps01 trial is hypothesized to assess whether tlpd has superiority over opd in recovery and other aspects.


Eligibility criteria:
inclusion criteria: 1. age between 18 years and 75 years. 2. histologically confirmed pdac or clinically diagnosed pdac by an mdt without histopathologic evidence. 3. patients feasible to undergo both lpd and opd according to mdt evaluations. 4. patients understanding and willing to comply with this trial. 5. provision of written informed consent before patient registration. 6. patients meeting the curative treatment intent in accordance with clinical guidelines. exclusion criteria: 1. patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs. 2. patients requiring left, central or total pancreatectomy or other palliative surgery. 3. preoperative american society of anaesthesiologists (asa) score ≥ 4. 4. history of other malignant disease. 5. pregnant or breast-feeding women. 6. patients with serious mental disorders. 7. patients treated with neoadjuvant therapy. 8. patients with vascular invasion and requiring vascular resection as evaluated by the mdt team according to abdominal imaging data. 9. body mass index \> 35 kg/m2. 10. patients participating in any other clinical trials within 3 months.

Keywords: pancreatic carcinoma laparoscopic pancreaticoduodenectomy survival
clinical evaluation of the mandibular mini-implant overdenture

Conditions: Stabilization of a Full Lower Denture; Edentulism in Lower Jaw; Lower Denture Made Within Last Few Years

Summary: stabilization of existing full lower dentures by means of mini-dental implants (mdi). to test whether 4 mini-implants placed at the front of the lower jaw can stabilize an immediately-modified existing lower denture.

to test whether the percentage of case successes of these lower dentures supported by 4 mdis is equal to or greater than 95% at 1 year. success is defined as a denture supported by implants that is functioning in the way it was intended.

Eligibility criteria:
inclusion criteria: * completely edentulous with last tooth extraction 2 years ago or longer. * patients requesting implant stabilization of existing lower conventional denture. * adequate space in anterior mandible for placement of 4 mdi implants. * able to maintain adequate oral hygiene and keep dentures clean. * healthy enough to have minor surgical procedures. * have adequate understanding of written and spoken english or french. * capable of providing written informed consent. exclusion criteria: * not enough room in mandibular bone for implant height. * has acute or chronic symptoms of parafunctional disorders. * history of radiotherapy to orofacial region. * are or have been taking bisphosphonate iv or other medications (to be evaluated by the researcher). * health conditions that may jeopardize treatment (to be evaluated by the researcher). * unable or unwilling to return for evaluations or study recalls.

Keywords: edentulous edentulism lower denture mini dental implant imtec mdi denture stabilization case success rate of overdentures stabilized by mdi general satisfaction of patients with this treatment oral health-related quality of life of these patients cost estimates