Kornimate/medical-research-clean huggingface dataset:
adjuvant hyperthermic intraperitoneal chemotherapy (hipec) versus no hipec in locally advanced colorectal cancer (apec study)

Conditions: Locally Advanced Colorectal Cancer

Summary: this study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (hipec) with raltitrexed or oxaliplatin versus no hipec in locally advanced colorectal cancer

peritoneum is one of the common sites of metastasis in advanced stage colorectal cancer patients, resulting in a poor prognosis. hyperthermic intraperitoneal chemotherapy (hipec) is effective to colorectal peritoneal metastasis and may play a significant role in reducing the risk of metachronous peritoneal metastasis among patients with locally advanced colorectal cancer. oxaliplatin is routinely used for hipec in the europe and raltitrexed may be another ideal drug for hipec. the present phase ii multicenter, randomized controlled trial is designed to evaluate the efficacy and safety of adjuvant hipec with raltitrexed or oxaliplatin versus no hipec in locally advanced colorectal cancer.

Eligibility criteria:
inclusion criteria: * joined the study voluntarily and signed informed consent form * eastern cooperative oncology group performance status of 0 to 1 * life expectancy of more than 5 years * colorectal adenocarcinoma / mucinous adenocarcinoma / signet ring cell cancer confirmed by histopathology * stage t4nanym0 cancer; or stage t3nanym0 mucinous adenocarcinoma / signet ring cell cancer / adenocarcinoma with partly mucinous adenocarcinoma or signet ring cell cancer * r0 resection of colorectal cancer * neutrophils (anc) ≥ 1.5×10\^9/l, platelet count (pt) ≥ 100× 10\^9/l, hemoglobin (hb) ≥ 80 g/l, hepatic function: alt and ast ≤ 2.5 times upper limit of normal (uln) and tbil ≤ 1.5 times uln, renal function: creatinine ≤ 1.5 times uln * use of an effective contraceptive for adults to prevent pregnancy exclusion criteria: * rectal cancer below peritoneal reflection (≤ 8cm above the anal verge) * other malignant tumors within the past 5 years, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived from radical treatment * severe adhesion of peritoneal cavity impossible to separate * abdominal infection * allergic to raltitrexed, 5-fu, and oxaliplatin; dihydropyrimidine dehydrogenase (dpd) enzyme deficiency * uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * drug addiction, alcoholism or aids * impossible to tolerate the operation due to severe cardiac, lung, and vascular diseases * pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives

Keywords: locally advanced colorectal cancer hyperthermic intraperitoneal chemotherapy
effect of liver mscs in blood of patients with liver disease.

Conditions: Decompensated Cirrhosis

Summary: liver mscs or adult derived human liver stem/progenitor cells (adhlscs) infusions are currently being developed as a therapeutic medicinal product for the treatment of different liver defects. nevertheless, a main concern for clinicians and health authorities is the risk of therapy-induced thrombosis, which has been reported in several patients after intravenous infusion. previous studies showed in fact that most mscs express a procoagulant activity. adhlscs could be used to treat acute de-compensated cirrhotic patients due to their immunomodulatory and anti-fibrotic effects. however in these patients, disturbances of coagulation and haemostasis are common and result in profound haemostatic alterations that can lead to thrombosis as well as to bleeding complications. the aim of this study is to evaluate the effect of adhlscs in cirrhotic blood compared to control blood.


Eligibility criteria:
inclusion criteria: * acute de-compensated cirrhotic patients exclusion criteria: * anticoagulant treatment except for prophylactic heparin treatment * coagulopathy * thrombosis * cancer
trial of miltefosine in cutaneous leishmaniasis (brazil)

Conditions: Treatment of Cutaneous Leishmaniasis in Brazil.

Summary: the hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - glucantime®).


Eligibility criteria:
inclusion criteria: * newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (pcr) methods or by intradermal skin testing (montenegro test). * number of lesions: 1 to 5 ulcerative lesions. * lesion´s diameter: 1 to 5 cm. * disease duration: up to three months. exclusion criteria: safety concerns: * thrombocyte count \<30 x 109/l * leukocyte count \<1 x 109/l * hemoglobin \<5 g/100 ml * asat, alat, ap \>3 times upper limit of normal range * bilirubin \>2 times upper limit of normal range * serum creatinine or bun \>1.5 times upper limit of normal range * evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary) * immunodeficiency or antibody to hiv * any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, hiv, or other major infectious diseases * lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months lack of suitability for the trial: * negative parasitology (aspirate/smear)or negative montenegro test * any history of prior anti-leishmania therapy * any condition which compromises ability to comply with the study procedures * concomitant serious infection other than cutaneous administrative reasons: * lack of ability or willingness to give informed consent (patient and/or parent / legal representative) * anticipated non-availability for study visits/procedures

Keywords: cutaneous leishmaniasis miltefosine meglumine antimoniate l. braziliensis, l. guyanensis
evaluation of intravenous cardene(nicardipine)and labetalol use in the emergency department

Conditions: Hypertensive Urgency

Summary: the purpose of this study is to compare the safety and efficacy of cardene i.v. to labetalol administered intravenously for the management of hypertension in the emergency department setting.

more than 3 million patients yearly receive an intravenous antihypertensive agent in the us. despite this large number of critically ill patients treated annually, little research exists in the area of acute severe hypertension, specifically hypertensive emergency, a serious condition that contributes to morbidity and mortality. two agents that are commonly used to treat acute hypertensive crisis include labetalol and nicardipine. cardene may provide benefits in titration and has shown to have lower dosage adjustments compared to labetalol. nicardipine has also shown a decreased need for additional antihypertensives when compared to labetalol in patients with stroke in a neurological icu.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * systolic blood pressure ≥180 mm hg on 2 consecutive readings(10 minutes apart)presenting in the emergency department (ed) exclusion criteria: * use of any investigational drug within 1 month prior to emergency department (ed) * pregnant or breast-feeding females * contraindications or allergy to beta-blockers and calcium channel blockers (see fda approved labeling for nicardipine intravenous and labetalol) * subjects with decompensated congestive heart failure (chf) or with a known left ventricular ejection fraction (lvef) \<35% * history of stroke within 30 days * known liver failure * suspected myocardial infarction * suspected aortic dissection * suspected cocaine overdose * concurrently receiving other intravenous (i.v.) hypertensive medications

Keywords: hypertension emergency department nicardipine labetalol hypertensive emergency hypertensive urgency
effects of lymph drainage on patients with axillary web syndrome

Conditions: Movement Disorders

Summary: effects of a physical therapy program combined with manual lymphatic drainage on shoulder pain and function, quality of life, lymphedema incidence in breast cancer patients with axillary web syndrome following axillary dissection: a randomized controlled trial.

this study's objective is to assess the effectiveness of physical therapy (pt) combined with manual lymphatic drainage (mld) on shoulder pain and function, lymphedema, visible cords, and quality of life (qol), compared to physical therapy alone, in subjects with breast cancer and suffering of axillary web syndrome (aws).

Eligibility criteria:
inclusion criteria: * had a breast cancer dissection with lymphadenectomy and/or sentinel lymph node biopsy and a subsequent appearance of aws (diagnosed by physical examination and also by using the screening test aws (st-aws)) \[35\]. * suffering of pain that exceeds 6-8 points (measured by the numeric rating scale (nrs)) in the region of the cording on the upper/lower arm, elbow, and dorsum site, and * have visible or palpable cords in the arm or breast. exclusion criteria: * suffering of both acute thrombosis and lymphedema, * suffering of skin issues like infections or musculoskeletal conditions like adhesive capsulitis, rheumatoid arthritis, pectoral muscle tightness, and diseases of the rotator cuff, and/or * having cording that doesn't involve an arm and only affects the chest or side of the thorax.
a study to evaluate the effect of food on the pharmacokinetics of sotagliflozin and to explore the relative bioavailability in healthy subjects

Conditions: Diabetes Mellitus

Summary: primary objective: to evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects. secondary objectives: * to evaluate the effect of food on the single-dose pharmacokinetics of the main metabolite (sotagliflozin 3-o-glucuronide) relative to a fasted state in healthy adult male and female subjects. * to investigate the relative bioavailability of sotagliflozin tablet to oral solution under fasting conditions * to evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted conditions in healthy adult male and female subjects.

the study duration per subject will be 26 to 83 days and will consist of a screening period of 2-28 days, a treatment period of 6 days each for periods 1, 2 and 3, a washout between treatment periods of 1-14 days, and follow up visit 10-15 days after the last investigational medicinal product administration in period 3.

Eligibility criteria:
inclusion criteria : * healthy male and female subjects, between 18 and 55 years of age, inclusive, at the time of screening. * body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female; body mass index between 18.0 and 30.0 kg/m2, inclusive. * certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination), vital signs, ecg, and clinical laboratory parameters. exclusion criteria: * any history or presence of clinically relevant illness at screening, which could interfere with the objectives of the study or the safety of the subject's participation. * frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month). * blood donation any volume, within 2 months before inclusion. * symptomatic postural hypotension. * presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * history or presence of drug or alcohol abuse. * smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study. * if female, pregnancy, breast-feeding. * any medication (including st john's wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
tachosil paediatric liver trial (tc-019-in)

Conditions: Liver Diseases

Summary: the overall objective is to assess the haemostatic efficacy and safety of tachosil for control of local bleeding in paediatric patients undergoing surgical resection of the liver with our without segmental liver transplantation.


Eligibility criteria:
inclusion criteria: 1. has the parent(s)/legal guardian given informed consent according to local requirements before any trial related activities? 2. is the child above 4 weeks and below 6 years of age? 3. has at least segmental resection (anatomical/non-anatomical) of the liver and primary haemostatic treatment been performed? or has resection of the liver and placement of a segmental liver graft and primary haemostatic treatment been performed? 4. is only minor, i.e. oozing, or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)? all inclusion criteria must be answered "yes" for a child to participate in the study. exclusion criteria: 1. was the child retransplanted or had liver transplantation in combination with other organs? 2. was there anamnestic or laboratory evidence of congenital coagulation disorders including haemophilia a or b and von willebrand disease? 3. has the child a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin? 4. has the child fulminant hepatic failure, portal vein thrombosis or anamnestic or clinical evidence of cirrhotic condition of the liver, including cirrhosis due to genetic deficiency of a1 - antitrypsin? 5. did the child undergo an emergency operation? 6. does the child participate in another clinical trial during the intra-operative phase? 7. has any serious surgical complication occurred? 8. has any fibrin glue haemostatic (including tachosil ® ) been used on the target wound before the planned application of tachosil ® ? to participate in the study all exclusion criteria must be answered "no" for a child having segmental resection. for a child having total hepatectomy and placement of a segmental liver transplant criteria 4 and 5 can be answered "yes".

Keywords: surgical resection of the liver with or without segmental transplantation
analysis of current situation and evaluation of trauma treatment training in china

Conditions: Train Accident Involving Explosion, Passenger Injured; Train Collision With Streetcar, Pedestrian Injured; Trauma Injury; Train Accident Involving Burning, Passenger Injured

Summary: this study will rely on the training course of ctct project to conduct standardized training for trauma practitioners in china. and the quality of training will be stratified research; continuously improve the quality of trauma treatment and improve the prognosis of trauma patients.


Eligibility criteria:
all ctct participants from different administrative districts of china registered for standardized and procedural ctct curriculum . all trainees have finished the general survey of personal background, trauma care status in local hospitals and pre-training tests of trauma knowledge. after ctct curriculum and hifidelity trauma simulation training, they were also needed to finish post-training test about the initial evaluation of various kinds of traumas. the pre- and post-training examination were constantly about trauma evaluation of major trauma patients. inclusion criteria: trainees who attended on ctct curriculum. exclusion criteria: rejection for supplying training information, in-completed ctct training information, lack of pre- and/or post-training scores.

Keywords: trauma training trauma care
improvised explosive device (ied) level blasting of human blood with slosh prevention

Conditions: Brain Injuries

Summary: to monitor changes in indicators of red cell damage such as extracellular hemoglobin, potassium (k-abl), and lactate dehydrogenase (ld) post blast exposure.

traumatic brain injury (tbi) causes significant morbidity and mortality, accompanied by high related costs. recent hypotheses concerning the pathophysiology of tbi invoke strain shear theory and cavitation theory. the invbestigators propose to test the importance of the latter by directing blast waves into containers that are either partially or completely filled with blood and measuring markers of lysis. these experiments are designed to better understand the demonstrated effectiveness of mild jugular compression according to the principle of the queckenstedt maneuver to reduce the likelihood of tbi by filling up the compliance of the cranial space. a device (c-collar) is being developed by q30 labs, llc (q30), to accomplish this effect.

Eligibility criteria:
inclusion criteria: * • normal healthy volunteer * able to provide written consent * must be 18 years or older exclusion criteria: * • unable to provide written consent * recent penetrating brain trauma (within 6 months) * under the age of 18 years
lymphatic function in patients with secondary tricuspid valve regurgitation

Conditions: Lymphatic Insufficiency; Heart Failure; Edema

Summary: the study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls. the study will use t2 weighted mri, near-infrared fluorescence imaging, and plethysmography to examine the above-mentioned question.

the study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls. subjects will be examined at one occasion using t2-weighted mris to evaluated lymphatic anatomy and near-infrared fluorescence imaging for evaluation of superficial peripheral lymphatic function. finally, the capillary filtration rate will be estimated using plethysmography.

Eligibility criteria:
patients: inclusion criteria: * patients with moderate to severe tricuspid regurgitation * age ≥18 years * informed consent exclusion criteria: * reduced ejection fraction (\<50%) * congenital heart disease * left sided valve disease * mri contraindications (all metal implants, cochlear implants, pacemakers etc.) * claustrophobia * peripheral edema * bmi\>30 * age\<18. controls: inclusion criteria: * healthy * age ≥18 years * age, gender and weight matched with included patients. exclusion criteria: * cardiovascular disease * mri contraindications (all metal implants, cochlear implants, pacemakers etc.) * claustrophobia * peripheral edema * bmi\>30 * age\<18.
a safety, tolerability, pharmacokinetics and efficacy study of gb261 in b-cell nhl and cll.

Conditions: B Cell NHL; CLL

Summary: this is a phase 1/2 study of gb261 in participants with relapsed or refractory b-cell nhl and cll. the study will consist of a dose-escalation stage(phase 1), an expansion stage(phase 2a) and phase 2b stage where participants will be enrolled into indication-specific cohorts.


Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status of 0 or 1 2. cd20+ b-cell non-hodgkin lymphoma or cll who have relapsed or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival 3. adequate hepatic, hematologic, and renal function exclusion criteria: 1. burkitt lymphoma, lymphoplasmacytic lymphoma or b lymphoblastic leukemia 2. prior treatment with systemic anti-lymphoma therapy within 4 weeks or five half-lives of the drug (which is shorter) prior to the first gb261 infusion 3. history of auto-sct or car-t therapy in the past 180 days and/or with any of protocol specified conditions 4. prior allo-sct or allogeneic car-t 5. prior solid organ transplantation 6. autoimmune disease with the exceptions specified in the protocol 7. history of central nervous system(cns) lymphoma or other cns disease 8. significant cardiovascular or pulmonary disease 9. hepatitis b or c or human immunodeficiency virus (hiv) 10. pregnant or lactating or intending to become pregnant during the study

Keywords: b cell nhl, phase 1/2,gb261,bispecific antibody,cd20/cd3
study evaluating ekb-569 in advanced colorectal cancer

Conditions: Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Summary: this non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered ekb-569 in subjects with advanced colorectal cancer. patients must have been previously treated with a fluoropyrimidine (5-fu or capecitabine) and either oxaliplatin or irinotecan (given concurrently or as separate regimens). the primary objective of the study is to assess the clinical activity of ekb-569 administered orally as a second-line or later stage treatment in subjects with advanced colorectal cancer. secondary objectives include: * to further evaluate the safety of ekb-569 * to explore additional clinical activity parameters * to explore subject survival * to evaluate the pharmacokinetics of ekb-569 * to assess subject reported outcomes ekb-569 will be administered orally as a single-agent. eligible subjects will take ekb-569 daily as long as they do not have progressive disease and are tolerating treatment.


Eligibility criteria:
inclusion criteria: * signed and dated, institutional review board (irb) or independent ethics committee (iec)-approved informed consent form before any protocol-specific screening procedures * previous histologic diagnosis of adenocarcinoma of the colon or rectum * egfr expression by immunohistochemical analysis (must be \> or = 20% positive tumor cells in prior tumor biopsy specimens) exclusion criteria: * chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas). * prior epidermal growth factor receptor-targeting therapy * known central nervous system (cns) metastases

Keywords: advanced colorectal cancer colorectal carcinoma colorectal tumors neoplasms, colorectal
cross-sectional study to investigate the effects of chronic obstructive pulmonary disease on daily life activities

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to investigate the effects of chronic obstructive pulmonary disease (copd) on daily life activities in patients with copd and also to determine the socio-demographic profile, daily life style and needs of the patients with copd.


Eligibility criteria:
inclusion criteria: * diagnosis of copd * outpatient treatment for any reason * current or ex-smoker exclusion criteria: * an exacerbation of copd that still lasts or that was experienced within last 3 months * history of asthma and/or allergic rhinitis * the presence of another important respiratory disease

Keywords: copd