Kornimate/medical-research-clean huggingface dataset:
whipple procedure: standard of care vs. thunderbeat

Conditions: Pancreatic Neoplasms; Bile Duct Carcinoma

Summary: the whipple procedure is the standard method for therapy for cancerous tumors, inflammation, and stenosis (narrowing) near the head of the pancreas. this is a prospective study to assess whether or not use of the thunderbeat™ device may decrease blood loss and postoperative morbidity (the presence of illness or disease). the findings will then be compared to patients whose whipple procedure will be performed using conventional dissection and hemostasis techniques.

as the pancreas is fed by many vessels, it is necessary to use lots of ligatures, clips and sutures for hemostasis after dissection. this dissection technique is very time consuming and requires numerous changes of instruments. the devices the investigators currently have available for use in the operating suite are enseal and ligasure. a new type of surgical scissors that delivers ultrasonically generated frictional heat energy and electrically generated bipolar energy simultaneously, known as the thunderbeat™ (olympus, japan), is now an available alternative for dissection and hemostasis. thunderbeat™ was provided fda clearance in march 2012 for use in open, laparoscopic, and endoscopic surgery, or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed. the thunderbeat™ device provides the first integration of both bipolar and ultrasonic energies delivered simultaneously from a single multi-functional instrument. this integration provides the surgeon the ability to rapidly cut tissue with ultrasonic energy and to create reliable vessel seals with bipolar energy without having to change devices. the current is provided by a special generator and contains a very high capacity with a low voltage. the body's proteins, such as collagen and elastin, are converted so a permanently sealed zone results. as the tissue between the branches is sealed, lateral thermic tissue damages can be limited to a minimum. several authors have described a tendency of reduced intraoperative blood loss with bipolar energy devices. other trials show reduced operating time when a bipolar device is utilized in several surgical procedures, such as thyroid, hepatic, urologic, hemorrhoidectomy and gynecology surgery. correct dissection in the operating field is very important to avert secondary bleeding or other complications, which might cause re-operation or elevate the patients' morbidity and mortality.

Eligibility criteria:
inclusion criteria: * scheduled to undergo an elective open or laparoscopic whipple procedure * at least 22 years of age. * karnofsky performance status greater than or equal to 80%. * able to understand and willing to sign a written informed consent document. exclusion criteria: * pregnant or breastfeeding. * surgeon's opinion at the time of dissection that the subject's well being (e.g. bleeding or other independent acute health problems) would be compromised.

Keywords: whipple procedure
an extended access program (eap) for participants who have completed rufinamide study e2080-g000-303

Conditions: Lennox Gastaut Syndrome

Summary: this is an extended access study for participants who have completed rufinamide study e2080-g000-303 to continue to have access to rufinamide until it becomes commercially available in poland or until no participants remain in the eap.


Eligibility criteria:
inclusion criteria: * participants who were on rufinamide treatment and have completed study e2080-g000-303 in poland. exclusion criteria: * participants were randomized to the other antiepileptic drug (aed) treatment group in study e2080-g000-303.

Keywords: central nervous system e2080 rufinamide epilepsy seizures brain diseases
local tolerability and safety of povidone k25 eye drops (artificial tears containing povidone) versus placebo in healthy volunteers

Conditions: Healthy

Summary: instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. povidone k25 eye drops (povidone) is an isotonic solution containing povidone to simulate normal tears viscosity. safety and local tolerability of povidone k25 is evaluated in healthy volunteers in comparison to placebo eye drops.


Eligibility criteria:
inclusion criteria: * healthy subjects * older than 18 years * ocular discomfort less than 20 mm on 100 mm visual analogue scale (vas) prior to treatment exclusion criteria: * known hypersensitivity to any of the constituents of the medications * known allergic disposition (e.g. hay fever) * wearing of contact lenses * any kind of current eye disease (e.g. dry eye) additional exclusion criteria are defined in the protocol

Keywords: artificial eye drops tolerability healthy volunteers povidone healthy subjects
anc1 study impact of a geriatric and nutritional evaluation for the malnutrition and malnutrition risk screening in patients over 70 years with colorectal surgery.

Conditions: Colorectal Tumor

Summary: malnutrition priori a major abdominal surgery is frequent and increases morbidity and mortality. the management of malnutrition has an impact in reducing postoperative complications. however malnutrition is rarely detected and guidelines infrequently followed. recovery time and nutritional evaluation in elderly patients are major criteria in their postoperative management. identifying malnutrition or malnutrition risk is fundamental to its treatment. it is therefore unsurprising that many validated tools for nutrition risk screening and nutrition assessment exist for the clinician to use in assisting with the accurate identification, referral and treatment of patients who are malnourished or at risk of malnutrition. and nutritional management must be adapted and based on this evaluation and evolution of the general status (guidelines grade a). a geriatric evaluation based on a screening of preoperative malnutrition should allow a better implementation of the european society of parenteral and enteral nutrition (espen) guidelines.

assessing the impact of a geriatric action (team mobile geriatrics, emg, or if the geriatric facility team when it does not have emg) on the rate of nutritional support perioperative elderly subjects (≥ 70 years) who underwent a colorectal cancer according to espen recommendations and sfnep.

Eligibility criteria:
inclusion criteria: * aged ≥ 70 years * colorectal or tumor resection with/without synchronous metastases exclusion criteria: * emergency resection of colorectal tumor * unresectable colorectal tumor with/without synchronous metastases

Keywords: vulnerable nutrition cancer colorectal tumor
levosimendan efficacy for veno-arterial ecmo weaning: a retrospective study

Conditions: Cardiogenic Shock

Summary: failure of weaning from ecmo is a serious complication, reaching an incidence between 29 and 58%. inotrops are frequently used to help separating patient from ecmo. levosimendan is an ino-dilatatory medication and was used in different clinical settings. the aim of this study was to evaluate the benefit with levosimendan when used in weaning process.


Eligibility criteria:
inclusion criteria: * age over 18 * patient requiring the need for short-term assistance * patient who has agreed to use his medical data for research purposes exclusion criteria: * refusal to participate in the study * non-weaning attempts due to a death under assistance or a relay by a long-term assistance or heart transplant * non-cardiac indications of assistance (indication of pulmonary replacement) * subject under guardianship or curatorship

Keywords: levosimendan veno-arterial ecmo weaning
a study evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of crovalimab as adjunct treatment in prevention of vaso-occlusive episodes (voe) in sickle cell disease (scd)

Conditions: Sickle Cell Disease

Summary: this study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of voes in participants with scd.


Eligibility criteria:
inclusion criteria: * body weight \>=40 kg. * male or female with confirmed diagnosis of hbss (scd genotype of sickle cell anemia) or hbsβ0 (scd genotype of sickle cell beta zero thalassemia). * two or more (\>=2) to \<=10 documented voes in the 12 months prior to randomisation. * if receiving concurrent scd-directed therapy, the participant must have been on a stable dose for a minimum of 3 months prior to study enrollment. there should be no plans to modify the participants' dosing throughout the study duration, other than for safety reasons. * if receiving erythropoietin, the participant must have been prescribed this medication for the preceding 3 months and be dose-stabilised for at least 3 months prior to study enrollment. * vaccination against n. meningitides serotypes a, c, w, and y and vaccinations against h. influenza type b and s. pneumonia. * participants who have been vaccinated (partially or in full) against sars-cov-2 with a locally approved vaccine are eligible to be enrolled in the study, 3 days or longer after inoculation. * adequate hepatic and renal function. * for women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 10.5 months after the final dose of study treatment. exclusion criteria: * history of hematopoietic stem cell transplant. * participating in a chronic transfusion program and/or planning on undergoing an exchange transfusion during the duration of the study. * history of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment. * received active treatment on another investigational trial within 28 days (or within five half-lives of that agent, whichever is greater) prior to screening visit, or plans to participate in another investigational drug trial. * hemoglobin \<6 g/dl. * known or suspected hereditary complement deficiency. * active systemic bacterial, viral, or fungal infection within 14 days before first drug administration. * presence of fever (\>=38 degrees celsius) within 7 days before the first drug administration. * immunised with a live attenuated vaccine within 1 month before first drug administration. * pregnant or breastfeeding, or intending to become pregnant during the study or within 10.5 months after the final dose of study treatment. * known hiv infection with documented cd4 count \<200 cells/microliter within 24 weeks prior to screening. * history of n. meningitidis infection within the prior 6 months.

Keywords: vaso-occlusive episodes pain crisis
the impact of the routine aminophylline administration following regadenoson stress on spect myocardial perfusion

Conditions: Coronary Artery Disease

Summary: the investigators developed a modified regadenoson nuclear stress test of the heart that incorporates an aminophylline injection following regadenoson (the assuage protocol). the modified (assuage) protocol has been associated with fewer side effects and was better tolerated by patients. this study will investigate whether the modified regadenoson stress protocol (assuage) produces blood flow pattern to the heart similar to that of a standard regadenoson stress protocol. in proven to be the case, the assuage protocol has the potential to be used on a wide scale instead of the current standard protocol.

patients who had regadenoson stress nuclear stress test of the heart will be invited to return to undergo a modified nuclear stress using the modified (assuage) protocol. images from the original scan will be compared to those from the second scan to determine whether the blood flow pattern is similar between the two scans.

Eligibility criteria:
inclusion criteria: * patients who have had a qualifying regadenoson stress myocardial perfusion imaging (regadenoson nuclear stress test). exclusion criteria: * inability to provide an informed consent * known allergic reaction to aminophylline or regadenoson * systolic blood pressure \< 90 mmhg * unstable abnormal heart rhythm * pulmonary edema * acute coronary symptoms, myocardial infarction within 48 hours * active dipyridamole, aminophylline or theophylline use * pregnancy * any contraindication to aminophylline according to the drug's package insert: uncontrolled seizure disorder, sepsis with multi-organ failure and liver impairment

Keywords: regadenoson aminophylline assuage myocardial perfusion imaging (mpi)
a phase i clinical study, randomized, single-blind, placebo-controlled, multiple doses, dose escalation study of the safety, tolerability and pharmacokinetics of donepezil patch in healthy male subjects.

Conditions: Alzheimer Disease

Summary: study of the safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects


Eligibility criteria:
inclusion criteria: * bmi : more than 19 ㎏/㎡, less than 27 ㎏/㎡ * systolic blood pressure : more than 90, less than 140 (mmhg) * diastolic blood pressure : more than 60, less than 100 (mmhg) exclusion criteria: * evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease. * a history of skin disease or skin graft * hypersensitivity to donepezil or piperidine derivatives or any of the excipients. * a known or suspected history of drug or alcohol dependency or abuse * patients who have participated in another clinical study within 60 days. * whole blood within 60 days, apheresis within 30 days, transfusion within 30 days * heavy alcohol intake(more than 21 units/week) * heavy smoker(more than 10 cigarette/day) * abnormal clinical laboratory values which are judged clinically significant by the investigator. * any condition that would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.
treosulfan-tmi conditioning and rapamycin gvhd prophylaxis before allo-hsct

Conditions: Irradiated Bone Marrow; Transplant-Related Hematologic Malignancy; Leukemia, Acute; Multiple Myeloma; Graft Vs Host Disease

Summary: trramm-tmi is a phase i trial to evaluate the feasibility and efficacy of an original sequential tmi/trramm (total marrow irradiation/treosulfan-rapamycin-mycophenolate mofetil) schedule in patients with hematological malignancies in advanced stage of disease undergoing an allogenic stem cell transplant (sct). the aim is to determine the maximum tolerated dose of tmi when combined with conditioning chemotherapy to transplant according to trramm schedule.


Eligibility criteria:
inclusion criteria: * patients with haematological malignancies such as * any acute myeloid leukemia (aml) beyond complete remission (cr) 1 * any acute lymphoblastic leukemia (all) beyond cr1 * multiple myeloma (mm) at any relapse/progression, except refractory disease * mm with unfavourable cytogenetic profile at diagnosis * mm with less than a partial response (pr) after induction therapy * karnofsky index ≥ 80 % * adequate contraception in female patients of child-bearing potential. * written informed consent * availability of one of the following: * a matched related or unrelated donor (mrd or mud) exclusion criteria: * a hematopoietic cell transplantation-specific comorbidity index \> 4 * active non-controlled infectious disease at the moment of inclusion * active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection * impaired liver function (bilirubin \> 2.0 x upper normal limit; transaminases \> 3.0 x upper normal limit) * impaired renal function (creatinine-clearance \ 1.5 x upper normal limit). * pleural effusion or ascites \> 1.0 l * pregnancy or lactation * known hypersensitivity to treosulfan and/or fludarabine and/or rapamycin * non-co-operative behaviour or non-compliance * psychiatric diseases or conditions that might impair the ability to give informed consent * previous spinal cord radiotherapy with dose ≥ 45 gy equivalent
effects of a probiotic on body weight

Conditions: Obesity

Summary: probiotics administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. recently, probiotics consumption was proposed to reduce fat mass and body weight in rodents (lee hy. et al. 2006; hamad em. et al. 2009) as well as abdominal fat in human (kadooka y, 2010). the mechanisms explaining the effects of probiotics in weight control are not well understood. the primary objective of the clinical trial is to investigate whether a consumption of a probiotic formula when compared to an intake of a placebo, is associated with a greater reduction of body weight.


Eligibility criteria:
inclusion criteria: * age: between 18 and 55 years old * weight: 30.0 kg/m2 ≤ bmi ≤ 39.9 kg/m2 * non smokers * good general health * a 2 weeks probiotics washout period prior to treatment initiation exclusion criteria: * under antibiotics or treatments (medication or nutritional program) affecting body weight or glucose control for the last 3 months * currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study * pregnant women, women who have given birth in the past year, women planning pregnancy in the next 6 months or menopausal women * excessive consumption of products enriched in probiotics (\> 4 servings per week). * history of drug or alcohol (\> 2 drinks daily) abuse * abnormal thyroid hormone levels * intake of medication that could affect body weight and/or energy expenditure * family history of type 2 diabetes in first degree relatives * allergy to the ingredients in the study product and placebo * participant with anaemia * participant with a recent history of large weight fluctuations (e.g., \> 10 kg in the past year * immune-compromised conditions * participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain * participant with co-morbidity associated with obesity: * hypertension (≥ 140/90 mm hg) * current use of antihypertensive medications, depression * prediabetes (fasting glucose \>100mg/dl) * family history of premature coronary artery disease * ldl \> 2.0 mmol/l * hdl \< 1.3 mmol/l * smoking * obstructive sleep apnea * type 2 diabetes * cardiovascular disease.

Keywords: probiotics, weight control, body composition
health professional exposure assessment to covid-19

Conditions: COVID-19

Summary: understanding the sars-cov2 epidemic is a major public health issue, both in the community and in the hospital sector. because of their central position in the management of patients infected with covid-19, hospital staff may be considered at high risk of infection. the development of serological tests makes it possible to reliably document a contamination, symptomatic or not, that is more than 3 weeks old. these tests, combined with clinical questioning of the symptoms, make it possible to determine the proportion of asymptomatic infections whose impact in the transmission of this disease appears to be major. the duration of the presence of the antibodies that are hoped to neutralize after infection with cov2-sars remains uncertain. documenting the evolution of antibody levels and their monitoring in a population at high risk of re-exposure to cov2-sars is a major issue in understanding this disease and in assessing the risk of infection among healthcare workers.

this is a multi-center, prospective, interventional, low-risk, low-constraint, biological collection study to assess the exposure of health care workers to covid-19. three blood samples will be taken at day 1, month 3 and month 6. the blood samples will be stored in a serum biological collection. a prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at d1, m3 and m6. in the event of the appearance of symptoms between samples, a self-questionnaire will be completed by the participating personnel as well as an invitation to screening by rt-pcr sars cov2 according to standard practices in force at the national level as well as an additional serological test.

Eligibility criteria:
inclusion criteria: * staff on duty in the health facility * eligible to be drawn * beneficiary subject affiliated or entitled to a social security scheme exclusion criteria: * minor patient * refusal to participate * patient under guardianship * patient under guardianship
a study to efficacy and safety of sph4336 monotherapy or in combination with cadonilimab in patients with advanced solid tumors.

Conditions: Advanced Solid Tumors

Summary: this is a randomized, open-label, phase ib/iia study to evaluate the efficacy and safety of sph4336 monotherapy or in combination with cadonilimab in the patients with selected advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. subjects voluntarily participate in this study and sign informed consent. 2. expected survival ≥3 months. 3. patients with advanced solid tumors (including advanced well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment. 4. according to recist v1.1, participants in the dose expansion phase must have at least one measurable lesion. 5. the laboratory test results meet the organ function requirements before starting the study treatment. 6. prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss/pigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. the toxicity of the risk is not subject to this limitation. 7. subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug. exclusion criteria: 1. taking anti-tumor traditional chinese medicines at the time of signing the icf. 2. had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery. 3. had a history of other malignancies before starting the study. 4. history of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; nyha class ≥ii; qtcf≥ 470 ms; lvef≤ 50%. 5. diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study. 6. previous history of organ transplantation. 7. before starting the study, hbsag positive patients with hbv dna \> 500iu/ ml or 2500 copies /ml or the lower limit of the study center detection, or hcv antibody positive patients with hcv rna positive, or known hiv-infected patients, or known active tuberculosis. 8. accompanied by any other serious, progressive, or uncontrolled disease. 9. subjects with a known history of immune-related adverse events that the investigator determined could not be included. 10. history of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product. 11. women who are pregnant or breastfeeding. 12. any other reason for which patients are ineligible for the study as assessed by the investigator.