Kornimate/medical-research-clean huggingface dataset:
clinical impact of cardiac photon counting ct

Conditions: Coronary Artery Disease

Summary: the purpose of this research trial is to determine whether images taken using a photon counting detector ct scanner (pcd-ct) after the patient has received a drug that makes the heart work harder provide clinically important information about the severity of suspected coronary artery disease compared to ct imaging performed without using the drug that causes the heart to work harder.

this study will focus on demonstrating the benefits of pcd-ct for clinical indications and findings where the improved spatial and temporal resolution, decreased quantum and electronic noise, improved spectral imaging capabilities, and increased iodine signal are expected to benefit the diagnosis and characterization of cad and myocardial perfusion defects.

Eligibility criteria:
inclusion criteria: * patients referred for coronary artery cardiac ct imaging or nuclear medicine or mri cardiac perfusion within the department of radiology or cardiology. * patients who are able and willing to sign the informed consent will be enrolled * negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient). exclusion criteria: * patients unable to provide written informed consent * pregnancy * egfr ≤ 30 * history of prior moderate or severe contrast reaction includes: unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis. * any history of required premedication prior to iodinated contrast administration. * patients that consent to participation but do not undergo their clinically-indicated, contrast-enhanced ct, or nuclear medicine or mr perfusion scanning for any reason (e.g., bad iv, infiltration, reaction, change in indication). * patients experiencing atrial fibrillation, premature ventricular contractions or other heart rhythm abnormalities * hospitalized patients or patients under care in the emergency department specific exclusion criteria only for participation in the cardiac stress test arm of this study (requiring administration of regadenoson): * anything by mouth within three hours of the examination * known hypersensitivity to regadenoson, adenosine, or dipyridamole. * active ongoing wheezing or poorly controlled asthma or copd (hospitalized within last month or receiving treatment for flair within last month). * second (type i or ii) or third degree atrioventricular (av) block or sinus node dysfunction unless patient has functioning artificial pacemaker. * ingested greater than 4 oz. of caffeine within the last 12 hours. * currently experiencing unstable coronary syndrome. * uncontrollable seizures within the last 3 months

Keywords: coronary ct angiography cardiac stress imaging photon counting ct cardiac ct
influence of somatuline autogel 120mg on post-operative drainage after total mesorectum excision for rectumcarcinoma

Conditions: Rectal Carcinoma

Summary: total mesorectal excision (tme) is a precise dissection of the rectum and all para-rectal lymph nodes within the mesorectal envelope. it is becoming universally recognized and accepted as the standard technique for surgical excision of rectum carcinomas. tme results in lowest rates of local recurrence, especially when combined with pre-operative chemo-radiotherapy. especially after pre-operative chemo-radiotherapy, the post-operative drainage may be important. the quick decrease of this drainage will enable the early mobilisation of the patient and may shorten the time of hospitalization. if this decrease in fluid production can be achieved, it will have a positive effect on the quality of life of the patient and will ensure health economic savings by reduction of hospitalization time and resources. somatostatin analogues have shown to be able to decrease the secretion of numerous types of bodily fluids. the aim of this study is to investigate if lanreotide autogel 120mg is capable to reduce the fluid discharge in patients that underwent a tme for rectumcarcinoma. lanreotide autogel 120mg compared to placebo, administered post-surgery on the fluid discharge in the drain of the patient that underwent a total mesorectum excision (tme) for rectal carcinoma. patient planned to have a tme will be asked to participate in the study. when they have provided written informed consent, they will be randomized 1:1 to receive either placebo or lanreotide autogel 120mg. drain fluid will be checked for hematocrit daily post-surgery. once hematocrit levels of the drain fluid are \ 10% in his drain fluid for a period of 5 days, this patient can not be randomized.


Eligibility criteria:
inclusion criteria: * male and female patients * 18-75 years * written informed consent to participate the study * scheduled to have a total mesorectal excision (tme) for rectumcarcinoma exclusion criteria: * patients with a known intolerance for somatostatin analogues, lanreotide or any of it's excipients * patients younger than 18 years * patients unable to provide written informed consent * patients who received somatostatin or any of it's analogues the last 30 days before the start of the study * pregnant and breast-feeding women * women not using contraception

Keywords: rectal carcinoma
lymph fluid and blood collection for identification of novel biomarkers

Conditions: Adenocarcinoma of the Breast

Summary: the objective of this study is to identify and validate metastasis protein markers in lymph collected from women with metastatic breast cancer. we will examine peripheral blood for the presence of these identified markers in order to develop a user friendly clinical test to detect metastasis and to evaluate response to therapy.

the goal of the study is to identify node-negative breast cancer patients who are unlikely to benefit from adjuvant chemotherapy, thus saving them from the adverse effects of unnecessary treatment. we propose to identify and validate protein markers that can determine breast cancer recurrence and metastasis, based on an approach our group has recently found highly promising for biomarker discovery. the objective of our research is to identify and validate metastasis protein markers in lymph collected from vessels exiting from the primary tumor and prior to their entry into sentinel lymph node in women with metastatic breast cancer. realizing that this novel procedure cannot be adopted for routine clinical use, we will examine the peripheral blood for the presence of these identified markers in order to develop a user friendly clinical test to detect metastasis and to evaluate response to therapy.

Eligibility criteria:
inclusion criteria: * women, age greater than or equal to 18, with histologically and/or cytologically confirmed diagnosis of adenocarcinoma of the breast with metastatic (node positive) and/or non-metastatic (node negative) breast cancer. * no prior chemotherapy treatment. * women, age greater than or equal to 18, with carcinoma in situ that opted for mastectomy. * able to provide informed consent and hipaa authorization. exclusion criteria: * hormone therapy in the past six months. birth control pill use is allowed. * history of radiation therapy to the chest. * previous or current use of aromatase inhibitor (ai) or selective estrogen receptor modulator (serm) medication. * history of chemotherapy for breast or other cancers. * pregnant or breast-feeding.

Keywords: lymph fluid collection
evaluation of the modified vista technique using alb-prf vs ctg in the treatment of multiple miller class iii recessions

Conditions: Gingival Recession

Summary: treatment of miller class iii rt2 gingival recession using modified vista technique using connective tissue graft vs albumin prf

treatment of gingival recession is an important element in the treatment of periodontitis this study covers clinical evaluation of using the modified vista technique with using albumin-prf vs connective tissue graft in the treatment of miller class iii / rt2 for root coverage outcomes

Eligibility criteria:
inclusion criteria: * 18 years old good oral hygiene exclusion criteria: * smokers patients with poor oral hygiene

Keywords: gingival recession, plastic surgery, soft tissue management
postoperative nausea and vomiting: ramosetron plus aprepitant vs palonosetron plus aprepitant

Conditions: Postoperative Nausea and Vomiting

Summary: the purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.

the purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy. study is performed during 24 hours after surgery.

Eligibility criteria:
inclusion criteria: * non smoking, female patients, scheduled for laparoscopic cholecystectomy exclusion criteria: * patients with gastrointestinal disorder, * patients with allergies to any study medication, * patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery
allopurinol in functional impairment (alfie) trial: 'improving muscle strength'

Conditions: Sarcopenia

Summary: sarcopenia is defined as the presence of low muscle mass and either decreased muscle strength or function. it is increasingly becoming a significant cause of frailty, loss of independence and physical disability in ageing western populations. recent experimental evidence has revealed that skeletal muscle is particularly susceptible to damaging molecules that result in oxidative stress and that oxidative stress plays a prominent role in the development and progression of sarcopenia. the investigators have previously shown that the xanthine oxidase inhibitor allopurinol is able to abolish vascular oxidative stress and improve endothelial function in cohorts such as optimally treated chronic heart failure and chronic kidney disease. recently, the investigators have also shown that allopurinol improves exercise tolerance and time to st-depression in optimally treated coronary artery disease, suggesting that allopurinol could also exert its effects through atp and/or oxygen sparing mechanisms. therefore, we propose a randomised double blind placebo-controlled parallel group trial of allopurinol in patients with primary sarcopenia using mr-spectroscopy and flow mediated dilatation to investigate the possible mechanisms that underlie this exciting possibility

this section will be completed once the study is officially recruiting

Eligibility criteria:
inclusion criteria: age 65 and over 6-minute walk distance \<400m exclusion criteria: documented history of peripheral arterial disease. pre-existing diagnosis of severe heart failure (lvef\<35%). malignancy under active treatment (excluding basal cell carcinoma). severe copd (physician diagnosis). intolerance to allopurinol. individuals with active acute gout currently taking allopurinol; or those who have stopped taking allopurinol ≤1month previously for this condition. on long term high dose steroids (eq. prednisolone\>10mg/day due to risk of steroid induced myopathy and osteoporosis). immobility that would render the patient incapable of doing the short physical performance battery test (sppb) or 6mwt. patients who have participated in any other clinical drug trial within the previous 30 days will be excluded. cognitive impairment precluding informed consent. any other considered by a study physician to be inappropriate for inclusion.

Keywords: sarcopenia allopurinol xanthine oxidase mr spectroscopy
comparison of m-tapa and tap blocks on postoperative analgesia in laparoscopic inguinal hernia surgeries

Conditions: Post Operative Pain

Summary: the goal of this study is to compare the analgesic efficacy of m-tapa block and tap block in patients undergoing laparoscopic inguinal hernia surgeries.

there will be three randomized groups: group control (no any block, n=30) group m-tapa (n=30), group tap (n=30). all patients will have standard general anesthesia. group m-tapa patients will receive bilateral m-tapa block with 0.25% bupivacaine (total volume of 40 ml). group tap patients will have bilateral lateral-tap block with 0.25% bupivacaine (total volume of 40 ml). all blocks will be performed at the end of the surgery, before awakening the patients. all patients in the study will receive 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. all patients will have ibuprofen 3x400 mg in postoperative 24 hours (maximum dose 1200 mg/day). numerical rating scale (nrs) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol will be administered as a rescue analgesic in all patients.total tramadol consumption will be calculated.

Eligibility criteria:
inclusion criteria: * adult patients older than 18 years of age who will undergo laparoscopic inguinal hernia under general anesthesia and will be american society of anesthesiologists (asa) i-ii-iii according to the asa risk classification. exclusion criteria: * patients who did not give consent, * patients with coagulopathy, * patients with signs of infection at the block application site, * patients using anticoagulants, * patients with local anesthetic drug allergies, * patients undergoing open surgery, * patients with unstable hemodynamics, * patients who could not cooperate during postoperative pain assessment

Keywords: m-tapa tap block laparoscopic inguinal hernia regional anesthesia postoperative pain
effect of self-monitoring of blood glucose in patients with type 2 diabetes mellitus not using insulin

Conditions: Diabetes Mellitus, Type 2

Summary: self-monitoring of blood glucose (smbg) is one of the important instruments in diabetes management. most patients with type 1 diabetes and patients with type 2 using insulin, frequently measure their blood glucose in case of possible hypoglycemia, but also to evaluate the insulin treatment and get information about how to change the insulin regimen, if necessary. without smbg it is almost impossible to achieve this goal. the purpose of this study is to determine if self-monitoring in patients with type 2 diabetes not using insulin results in better glycemic control.

study objectives: primary: what is the effect of smbg in patients with type 2 diabetes who are not using insulin on glycemic control (as measured with glycosylated hemoglobin (hba1c)? secondary: what is the effect of smbg in patients with type 2 diabetes who are not using insulin on the following parameters: * health status * diabetes related complaints * patient satisfaction * cumulative incidence of (necessity to start) insulin therapy / maximum dosage of oral blood glucose lowering drugs * dosage of oral blood glucose lowering drugs * bodyweight (bmi) two treatment protocols are proposed. treatment a consists of self-monitoring of blood glucose and treatment b consists of usual care. patients in the a-group are instructed to measure their blood glucose values 4 times a day (1 fasting plasma glucose concentration and 3 post-meal glucose concentrations), two times a week, on one week day, and one weekend day (no more, no less). patients should record these glucose values in a diary. patient will get one page with information in dutch. no further education than for handling the device and interpreting the values is given, so that besides this intervention, there will be no differences compared with the control group like other forms of education. the duration fo the trial will be 12 months.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c 7 - 8,5% at previous and present annual check-up * use of 1 or 2 different oral blood glucose lowering drugs * in case of two oral blood glucose lowering drugs, they should not both have a maximum dosage * sufficient knowledge of the dutch language to understand the requirements for the study exclusion criteria: * change in oral blood glucose lowering drugs in the past three months * use of insulin * use of device for self-monitoring of blood glucose at the start of the study, or in the preceding 6 months

Keywords: diabetes mellitus, type 2 blood glucose self-monitoring life style
a research study looking at new protein-based tablets in healthy men - oral formulation ii

Conditions: Healthy Volunteers; High Cholesterol

Summary: in this study, the study drug 'nnc0385-0434' will be tested in 3 different tablet formulations. these formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). participants will only receive 2 of the 3 tablet formulations. the treatments participants get are decided by chance. participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). the study will last up to 96 days. only men can participate in this clinical study.


Eligibility criteria:
inclusion criteria: * male * aged 18-64 years (both inclusive) at the time of signing informed consent * body mass index between 20.0 and 32.0 kilogram per meter square (both inclusive) * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * known or suspected hypersensitivity to study interventions or related products * use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening * any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol * presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator * history of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
safe and effective sedation in chronic alcoholic patients underwent diagnostic endoscopic procedures: study comparing midazolam and propofol with midazolam

Conditions: Chronic Alcoholism

Summary: sedative endoscopic examination using sedative premedication has been undertaken to induce conscious sedation for comfortable and painless endoscopy. midazolam has been most widely used as a sedative premedication because it has lots of advantages, such as a short half-life, a faster onset of sedation and an excellent sedative hypnotic effect. however, midazolam has been used regardless of whether or not alcohol although using midazolam in chronic alcoholics is related to paradoxical reaction, characterized by increased talkativeness, emotional release, excitement, and excessive movement. in recent years, propofol has been used safety and effectively in sedative gi endoscopy because of its potent hypnotic effect and its ultrashort pharmacokinetic profile. therefore, the present study was conducted to compare the safety and efficacy of bps (propofol in combination with midazolam) with conventional sedation (midazolam) in chronic alcoholic patients undergoing diagnostic gi endoscopic procedures.


Eligibility criteria:
inclusion criteria: * age ≥ 20 * ecog ≥ 2 * patient who consents to enroll the trial exclusion criteria: * age \< 20 * pregnant or lactating women * american society of anesthesiology (asa) physical status class v * chronic pulmonary disease * history of allergic to propofol * history of complication of sedation endoscope * liver failure or hepatic encephalopathy * who didn't consented to enroll the trial

Keywords: sedation endoscopy midazolam propofol chronic alcoholics
fostamatinib for treating acute respiratory distress syndrome (ards) in hospitalized adults

Conditions: Acute Respiratory Distress Syndrome; ARDS

Summary: this study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ards).

this is a randomized, double-blind, placebo-controlled phase 2 study for long-term evaluation of fostamatinib for the treatment of adult patients with acute respiratory distress syndrome. subjects will be randomly assigned 1:1 to either standard of care treatment plus fostamatinib or standard or care plus placebo. th study drug will be taken twice daily for 14 days. the primary objective will be to evaluate drug safety in hospitalized patients with severe ards. other objectives include assessment of the efficacy and clinically relevant endpoints, such as mortality and effects on resolution of this disease entity. the ability of fostamatinib to impact the short term and long term outcomes for patients with ards will be directly evaluated.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * subject (or legal representative) provides informed consent to study participation. * subject (or legal representative) understands and agrees to comply with planned study procedures. * hospitalized with acute respiratory failure from ards with ratio of partial pressure of arterial oxygen to fraction of inspired oxygen pao2/fio2 of 200 mm of hg or less with positive end expiratory pressure (peep) equal to or higher than 5 cm of h2o and requiring invasive mechanical ventilation or extracorporeal support. * functional respiratory imaging (fri) compatible ct scan of the chest within the prior 7 days. * duration of invasive mechanical ventilation \< 10 days. * females of childbearing potential must agree to be abstinent or seek a highly effective form of contraception from the time of enrollment through 30 days after the last day of study drug. exclusion criteria: * severe hepatic impairment (child-pugh class c). * abnormal liver function tests (ast or alt \> 3x uln or ast or alt \> 3x uln) * pregnant or nursing. * participation in any other clinical trial, or receipt of an investigational medicinal product within 30 days prior. * known concomitant life-threatening disease with a life expectancy \< 6 months. * known hypersensitivity to fostamatinib. * uncontrolled hypertension (systolic blood pressure \> 160 mmhg or diastolic blood pressure \> 100 mmhg). * neutrophil count \< 1000/ul * death expected within 72 hours * received a live vaccine in the last 30 days * those who were cognitively impaired or mentally disabled prior to acute illness * patients with acute coronary syndrome, ejection fraction \<30%, or active unstable arrhythmias
diet intervention in food sensitive patients with iga nephropathy

Conditions: IGA Nephropathy

Summary: the purpose of this study is to assess whether a tailored diet, eliminating antigens to which iga nephropathy patients have demonstrated sensitivity, will have an effect on proteinuria, renal function and other immunological variables.


Eligibility criteria:
inclusion criteria: * above 18 years * iga nephropathy (igan), verified by biopsy * proteinuria \> 1 g/24 h * having signed informed consent form exclusion criteria: * participation in another clinical trial * patients with celiac disease * introduction of an angiotensin-converting enzyme (ace) inhibitor or angiotensin ii receptor blockers (arb) during the last three months prior to inclusion * patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months