Kornimate/medical-research-clean huggingface dataset:
resection versus transcatheter arterial chemoembolization for hepatocellular carcinoma with solitary huge tumor

Conditions: Carcinoma, Hepatocellular; Survival Rate

Summary: this clinical trial aims to compare hepatectomy with transarterial chemoembolization (tace) for hepatic cellular cancer with solitary huge tumor (≥5cm). all patients will be divided into two group.one group will receive hepatic resection, while an another equivalent group patients will be treated with transarterial chemoembolization.

hepatocellular carcinoma (hcc) is the most common primary malignant tumor of the liver.for barcelona clinic liver cancer (bclc) stage b patients，especially those with solitary huge tumor (≥5cm) ，the better therapy between hepatic resection and transarterial chemoembolization remains controversial despite extensive studies。 from now on, we prospectively collected patients with solitary huge hcc who received hepatectomy or tace. of the 200 patients，100 patients were surgically treated and the others underwent tace。after the treatment, patients received routine follow-up with physical examination, serum α-fetoprotein (afp) level and ultrasonography at 3-month intervals for the first year and then every 6 months.the end of follow-up was determined as either the time of last follow-up (july 2019) or death. the overall survival，including 1, 2 and 3-year overall survival rates，will be analyse. all data are collected prospectively.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hepatic cellular carcinoma. * patients with solitary huge tumor (≥5cm）of hepatic cellular carcinoma (hcc) detected by serum alpha fetoprotein (afp) and ct or mri. * patients without hepatic vein or bile duct invasion and extrahepatic metastasis. * patients without surgical contraindication. * patients with child a or b liver function and indocyanine green retention rate at 15min (icgr15) \< 10% before treatment. * laboratory examination: haemoglobin (hb)\>100g/l, white blood cell (wbc) \> 3000/ml, blood platelet counts (plt) \> 8×10\*10/l before treatment. * patients without severe esophagogastric varices before treatment. * patients with hbv，hbv dna≤100, 000 copy/ml. * all of the patients has written consent for this research. exclusion criteria: * patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis. * patients with surgical contraindication. * patients with child c grade liver function before treatment. * patients with other malignancy. * .patients treated with hepatic resection or tace before this treatment. * patients with severe esophagogastric varices or refractory ascites or coagulation dysfunction before treatment.

Keywords: hepatocellular carcinoma hepatic resection tace solitary huge tumor overall survival
dornase alpha versus hypertonic saline for lung atelectasis in non-cystic fibrosis patients

Conditions: Atelectasis

Summary: despite the lack of trials proving the efficacy of dnase in non cystic fibrosis patients, it is currently heavily used in this population. in fact, per evidence of barcode scanning via meditech computer system at ou medical center 93% of the dnase prescribed in 2005 was for non cystic fibrosis patients with an estimated yearly cost of $341,968.15.in vitro studies showed that the effect of dnase was minimal on sputum viscosity when compared to hypertonic saline . furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic fibrosis. we hereby propose a prospective randomized trial to compare the efficacy of hypertonic saline, dnase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis, mechanically ventilated patient.


Eligibility criteria:
inclusion criteria: 1. patient on invasive mechanical ventilation 2. new onset (\<48 hours) lobar or multilobar lung atelectasis based on cxr exclusion criteria: 1. asthma 2. severe copd (fev1\<30%) 3. pneumothorax or massive pleural effusion, thought to be causing the atelectasis 4. lobar atelectasis secondary to compressive tumor. 5. severe hypoxemia (pao2/fio2 \< 75) 6. hemodynamic instability 7. cystic fibrosis patients 8. allergy to dnase 9. patients on acetylcysteine 10. pregnant women

Keywords: atelectasis
a study of capecitabine (xeloda) in the adjuvant treatment of participants with resected colon cancer

Conditions: Colorectal Cancer

Summary: this study will evaluate the safety and tolerability of capecitabine (xeloda) in participants who have undergone surgery for colon cancer. oral xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. the anticipated time on study treatment is 24 weeks, and the target sample size is 70 individuals.


Eligibility criteria:
inclusion criteria: * adults at least 18 years of age * curative surgery for stage iii colon cancer, performed 4 to 8 weeks before study entry exclusion criteria: * macroscopic or microscopic residual tumor * evidence of metastatic disease including tumor cells in ascites * previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer * active cardiovascular disease * other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix * malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
regional anesthesia for breast surgery

Conditions: Breast Cancer

Summary: patients scheduled for mastecotmy will be randomized to receive either an ultrasound-guided double space paravertebral block or a pecsii + parasternal block. in both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only. postoperative, all patients will receive a morphine pca. they will follow at 6, 12, 24 months for persistent postoperative surgical pain (ppsp) and cancer recurrence.

patients scheduled for mastecotmy with or without axillary dissection, will be randomized to receive preoperative either an ultrasound-guided double space paravertebral block or a pecsii + parasternal block. in both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only. all the patients also received a general anesthesia induced by propofol and esmeron for endotracheal intubation and desflurane for maintaining. sensory block by ice and pinprick test application and maximum spread after 40' from la injection will be registered. postoperative, all patients will receive a morphine pca, ketorolac 30 mg/12h and paracetamol 1g each 8h. morphine consumption will be registered. patients will follow at 6, 12, 24 months for persistent postoperative surgical pain (ppsp) and cancer recurrence.

Eligibility criteria:
inclusion criteria: * patients scheduled for radical mastectomy for cancer. * age \> 18 y-o * written informed consent exclusion criteria: * bilateral surgery * opioids user * bmi \> 35 * postoperative intensive care

Keywords: breast cancer, regional anesthesia, cancer recurrence
effect of bariatric surgery on mechanisms of type 2 diabetes

Conditions: Obesity; Type 2 Diabetes

Summary: the purpose of this study is to determine the effects of bariatric surgery on blood sugar control and underlying mechanisms that contribute to type 2 diabetes in men and women with a bmi between 27 and 42. sixty subjects will be randomized to either undergo the roux-en-y gastric bypass operation or intensive medical, dietary and exercise management.

obesity and type 2 diabetes mellitus (t2dm) are two of the greatest public health problems of the 21st century. lifestyle changes and pharmacotherapy, which are mainstay treatments for t2dm have had limited success. more intensive lifestyle weight management such as in the look ahead trial reported an 8.6% weight loss after 1 year, while the diabetes prevention program reported a 7% weight loss after 2 years, and a 58% decrease in the risk of developing t2dm. in contrast,we have observed a 31% weight loss together with 83% remission of t2dm in severely obese patients after roux-en-y gastric bypass (rygb) surgery. however, direct evidence of the glycemic benefits of bariatric surgery from randomized control trials is lacking; there is no clear consensus that rygb surgery is a good treatment option for moderately obese t2dm patients; and the mechanisms responsible for reversing t2dm after surgery remain unclear but may involve pancreatic insulin secretion and skeletal muscle and hepatic insulin resistance. the objective of this application is to evaluate the effects of rygb surgery on glycemic control and underlying mechanisms that contribute to t2dm in obese subjects (bmi: 30-40 kg/m2). our central hypothesis is that rygb surgery will reduce hyperglycemia via reversal of beta-cell dysfunction and decrease hepatic and peripheral insulin resistance. the approach requires a 12-month randomized controlled trial. the rationale is based on data showing that rygb lowers fasting and postprandial glucose, and increases the glp-1 response to a meal. however, the therapeutic efficacy of rygb surgery in obesity-related t2dm needs to be demonstrated in a randomized trial.

Eligibility criteria:
inclusion criteria: * candidate for general surgery * 18 to 60 years old * bmi 27-43 * type 2 diabetes * willing to participate in either study arm * understand and comply with requirements of each arm * not pregnant * willing to use reliable birth control for duration of study exclusion criteria: * prior bariatric surgery of any type * prior complex abdominal surgery * abdominal, thoracic, pelvic, obstetrical surgery within last 6 months * significant cardiovascular disease * kidney disease with a creatinine greater than or equal to 1.8 mg/dl * chronic liver disease except for nafld/nash * celiac, malabsorptive, inflammatory bowel disorders * psychiatric disorders requiring 3 or more medications * pregnancy * cancer except squamous or basal cell skin cancer or cancer in remission * anticoagulation therapy that can't be stopped for surgery * clotting disorders * severe pulmonary disease

Keywords: obesity type 2 diabetes
effectiveness of a patient therapeutic education program in improving pain management

Conditions: Pain Cancer

Summary: pain is one of the most feared and burdensome symptoms experienced by cancer patients. its prevalence has been estimated by inca1 in 2012 at 48% in patients undergoing cancer treatment, and unrelieved pain is directly associated with significantly reduced quality of life (qol)2. a large part of cancer pain undertreatment can be attributed to patient-related barriers. patient barriers are multifactorial and often result from a lack of knowledge about cancer pain and its self-management. they mainly consist of misconceptions about opioids and their side effects, nonadherence, and reluctance to alert health care providers to unrelieved pain. patient education enables people with chronic disease to manage their illness, and has been considered in the field of cancer research as an important strategy to achieve optimal pain control. in basse-normandie french region, the "health regional plan, pain aspect" has identified the theme " pain education program " as a priority. the main endpoint is the decrease of pain interference with daily life (using the brief pain inventory). the experimental group, consisting of cancer pain patients, will benefit from the education program by previously trained health care providers. it will be compared with the control group, consisting with patients whose pain will be conventionally managed before the professional training in therapeutic education.


Eligibility criteria:
inclusion criteria: * patient suffering from a cancer which diagnosis has been established since at least 1 month * patient who suffers from pain related to the pathology or its treatment: * receiving an analgesic treatment since at least 1 month * moderate to severe pain intensity in the previous week : average pain score greater than 4 (on a 0-10 numerical rating scale), or pain leading to insomnia or 4 daily breakthrough pain, which interferes with daily activities * patient with a life expectancy \> or = 6 months * health compatible with the pep requirements (who performance scale \> or = 2) * patient v 18 years old * patient able to understand, speak and read french * patient without cognitive dysfunctions * patient with a signed informed consent before inclusion in the study exclusion criteria: * primary central nervous system or cerebral metastases * disorders of higher functions documented * evolutionary psychiatric pathology * drug user * abuse of alcohol exceeding who recommendations * refusal of participation
effects of transcranial direct current stimulation (tdcs) in the management of suicidal ideation

Conditions: Depression and Suicide

Summary: the main objective of this study is to demonstrate that 15 transcranial direct current stimulation (tdcs) sessions of 30 minutes at 2 ma intensity are effective to reduce suicidal ideation

after being informed about the study and potential risks, all patients giving written informed consent will undergo a screening visit to determine eligibility for study entry. patient who meet the eligibility requirements be able to start the 15 tdcs sessions at the rate of one session per day. after the last session, patients will perform three follow-up visits on d19, d49 and d79

Eligibility criteria:
inclusion criteria: * age over 18 years * written informed consent * diagnosis of recurrent or isolated depressive episode according to dsm iv criteria (a.p.a. 1994). * stable antidepressant treatment for 3 weeks * madrs score ≥ 20 * ssi score \> 3 * subject affiliated to a health insurance system * woman with effective contraception and agreeing to maintain it throughout the study period. exclusion criteria: * depression with psychotic features axis i (dsm iv) co-morbid diagnosis of schizophrenia, alcohol and/or other substance dependence (or abuse) (lifetime) * patient who has already undergone an electroconvulsive therapy course for the current episode and does not respond to this treatment * patient deprived of liberty * patient with high suicide risk (item 10 madrs \> 4) in the absence of hospitalization * contraindication to tdcs: intracerebral metallic implant (with the exception of dental implants), cardiac pacemaker, active or non-implanted devices in the region of the head, acute eczema in the planned stimulation area * pregnant, parturient or breastfeeding woman * simultaneous participation in another interventional research

Keywords: tdcs
palbociclib plus letrozole for postmenopausal women with hr(+) her2(-) advanced breast cancer for whom letrozole is deemed appropriate

Conditions: Advanced Breast Cancer Female

Summary: the purpose of this study is to provide access to palbociclib in mexico and in selected latin american countries before it becomes commercially available to patients with hr positive/her2-negative abc who are appropriate candidates for letrozole therapy.


Eligibility criteria:
inclusion criteria: * adult women with proven diagnosis of advanced adenocarcinoma of the breast (locoregional recurrent or metastatic disease). * women who are not of childbearing potential. * er-positive and/or progesterone receptor (pgr)-positive tumor based on local laboratory results (test as per local practice). * her2-negative breast cancer based on local laboratory results (test as per local practice or local guidelines). * patients must be appropriate candidates for letrozole therapy. * eastern cooperative oncology group (ecog) performance status 0-2. * adequate bone marrow function. * adequate liver function * adequate renal function. exclusion criteria: * known hypersensitivity to letrozole, or any of its excipients, or to any palbociclib excipients. * current use of food or drugs known to be potent inhibitors or inducers of cyp3a4 isoenzymes within 7 days prior to study entry. * prior treatment with any cdk inhibitor. * previous participation in a palbociclib clinical study. * participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation. * qtc \>480 msec; history of qt syndrome, brugada syndrome or known history of qtc prolongation, or torsade de pointes. * high cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina and severe cardiac dysrhythmias in the past 6 months prior to enrollment. * diagnosis of any second invasive malignancy within the last 3 years prior to enrollment. note: patients with adequately treated basal cell or squamous cell skin cancer, a history of intraepithelial neoplasia or in situ disease (eg, carcinoma in situ of the cervix or melanoma in situ) may enter. * active uncontrolled or symptomatic brain metastases. previously treated and clinically stable, brain metastases are permitted. * other severe acute or chronic medical or psychiatric conditions. * patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are pfizer employees directly involved in the conduct of the study.

Keywords: palbociclib, ibrance, breast cancer
implementation of the s'tim serious-game for rehabilitation of dysexecutive disorders (s'tim)

Conditions: Dysexecutive Syndrome; Serious Game

Summary: this study proposes to improve the management of dysexecutive syndrome by a serious game (sg) in addition to the usual management including work in occupational therapy and neuropsychology.


Eligibility criteria:
inclusion criteria: * french-speaking male or female patient at least 18 years old * patient suffering from recent disorders (less than 6 months) of executive functions * patient with sufficient mobility of the upper limb (mobility of the dominant upper limb greater than 70 °) to interact with the device. * patient affiliated or beneficiary of a social security scheme * patient having signed the free and informed consent. exclusion criteria: * patient participating in another clinical study * protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision, * pregnant or breastfeeding woman, * patient hospitalized without consent. * patient with unstable psychiatric disorders * patient with comprehension disorders (alexia, visual agnosia, illiteracy, not understanding the language, etc.) * patient with executive function disorders greater than 6 months * negligent hemi patient * patient not familiar with the french language * patient with major neuro-visual disorders.
aspirin versus metformin in pregnancies at high risk of preterm preeclampsia: a 3-arm randomized controlled trial

Conditions: Preeclampsia

Summary: this is a prospective, multicenter, randomized controlled, double-blind trial of three treatment arms: (1) aspirin 75 mg/day vs. (2) aspirin 150 mg/day vs. (3) aspirin 75 mg/day with metformin 1.5 g/day from the first trimester to compare the incidence of preterm preeclampsia with delivery at \<37 week's gestation between the treatment arms, in order to determine the optimal therapeutic intervention for the prevention of preterm preeclampsia among chinese women at high-risk of preeclampsia.

all women with singleton pregnancies who are attending for their routine hospital visit at 11-13 weeks' gestation will be invited to undergo screening for preeclampsia. we use a bayes theorem-based method that combines maternal characteristics, medical and obstetric history together with mean arterial pressure (map) and serum placental growth factor (plgf) level. women who are deemed high-risk following first trimester combined screening (cutoff corresponding to a screen positive rate of 10%, e.g ≥1 in 80) will be invited to participate in the 3-arm randomized controlled trial.

Eligibility criteria:
inclusion criteria: * singleton pregnancies * live fetus at 11-13 weeks' gestation * high-risk for preterm preeclampsia at 11-13 weeks by the algorithm combining maternal characteristics, medical and obstetric history, map and serum plgf * informed and written consent exclusion criteria: * age \<18 years old * multiple pregnancies * treatment with low-dose aspirin and metformin at the time of screening * pregnancies complicated by major fetal abnormality identified during the first trimester * women with learning difficulties, or serious mental illness * bleeding disorders such as von willebrand's disease * active peptic ulceration or gastrointestinal bleeding * hypersensitivity to aspirin, metformin hydrochloride and other biguanides * treatment with long term nonsteroidal anti-inflammatory medication * hyperemesis gravidarum * renal, liver or heart failure * a serious medical condition * concurrent participation in another drug trial or at any time within the previous 28 days * any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.

Keywords: preterm preeclampsia aspirin metformin
treatment of congenital stationary night blindness with an alga containing high dose of beta carotene

Conditions: Night Blindness

Summary: to assess the effect of oral administration of the alga dunaliella bardawil containing approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual functions patients with congenital stationary night blindness {fundus albipunctatus).


Eligibility criteria:
inclusion criteria: * written informed consent to participate in the study. * men or women aged 18 years or older * diagnosed with fundus albipunctatus 1. isolated rod response markedly reduced (less than 20% of normal)after 20 minutes dark adaptation and improved by 50% after 2 hours 2. negative maximal response (a wave to b wave ratio less than 2) 3. retinal midperipheral white dots (more than 3000 dots) exclusion criteria: * current smokers. * current use of vitamin a/ beta carotene supplements. * active arterial disease within 3 months of study entry such as unstable angina, myocardial infarction, transient ischemic attack (tia), stroke, and coronary artery bypass graft (cabg) surgery. * history of malignancy, except basal or squamous cell skin carcinoma. * pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception. * uncontrolled hypertension defined as either resting diastolic blood pressure of \>95mmhg (taken from the mean of 3 readings) or resting systolic blood pressure of \> 180 mmhg. * history of alcohol abuse or drug abuse, or both. * active liver disease or hepatic dysfunction as defined by elevations of 2.0 times the uln in any of the following liver function tests: alt, ast or bilirubin. * serum cpk \> 2.0 times uln in visit 0 * tsh above the normal range. * newly diagnosed diabetes within 3 months. * patient plans to engage in vigorous exercise or an aggressive diet regimen. * uncontrolled endocrine or metabolic disease. * participation in another investigational drug study within 4 weeks of entry into this study. * serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. * serum creatinine \> 2.0 mg/dl before the treatment phase, +3 proteinuria in urine dipstick, or a history of renal transplantation before the treatment period. * subject whose hormone replacement therapy (hrt) or oral contraceptive therapy (oct) was initiated within the 3 month prior to enrollment. * forbidden medications: the combination of ppar alpha agonists-fibric acid derivatives, ppar gamma agonists.

Keywords: beta carotene visual functions fundus albipunctatus night blindness