Kornimate/medical-research-clean huggingface dataset:
robot-assisted procedure versus open simultaneous resection of colorectal cancer with liver metastases

Conditions: Colorectal Liver Metastasis

Summary: the purpose of this study is to evaluate the safety and effectiveness of robot-assisted simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver metastases, and compared with the traditional open procedure.

the da vinci surgical system may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. the aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (rsrclm).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 75 years; 2. primary tumor has undergone histologically confirmed colon adenocarcinoma; colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin). 3. together with clinical or radiological evidence of stage ii (t3-4, n0, m0) or stage iii (t1-4, n1-2, m0) disease (according to the 2010 revision of the international union against cancer primary tumor, regional nodes, metastasis (tnm) staging system);liver metastasis was diagnosis by multidisciplinary (mdt) team base on liver magnetic resonance imaging (mri) and positron emission computed tomography (pet-ct). 4. performance status (ecog) 0\~1 5. adequate hematological function: neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (hb) ≥9g/dl (within 1 week prior to randomization) 6. adequate hepatic and renal function: serum bilirubin≤1.5 x upper limit of normal (uln), alkaline phosphatase ≤5x uln, and serum transaminase (either primary tumor, regional nodes, metastasis (ast) or alt) ≤ 5 x uln(within 1 week prior to randomization); 7. written informed consent for participation in the trial. 8. the liver resectability was evaluated by liver surgery of mdt team, indication including: tumor number ≤ 3; the maximum diameter of one tumor ≤ 10 cm. exclusion criteria: 1. body mass index (bmi) more than 30 kg/m2. 2. serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (child-pugh b or c), renal insufficiency (serum creatinine \>2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history. 3. history of accepting abdominal surgery. 4. liver tumor located at i or invasive the middle hepatic vein.

Keywords: minimally invasive surgery colorectal liver metastasis robotic surgery patients with resectable colorectal liver metastasis
placebo-controlled comparison of two different brands of modified-release oral dosage forms regarding safety and efficacy in children with attention deficit hyperactivity disorder (adhd) aged 6 - 14

Conditions: ADHD

Summary: currently two different brands of modified-release formulations are providing 50% immediate release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and dual peak concentrations of plasma methylphenidate. one is manufactured by novartis, the other one by medice (germany). the objective of the study is to test the hypothesis that the novartis product is superior to placebo and is clinically not inferior to the formulation manufactured by medice.

currently two different brands of modified-release formulations are providing 50% immediate release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and dual peak concentrations of plasma methylphenidate. one is manufactured by novartis, the other one by medice (germany). the objective of the study is to test the hypothesis that the novartis product is superior to placebo and is clinically not inferior to the formulation manufactured by medice.

Eligibility criteria:
inclusion criteria: patients who meet all of the following inclusion criteria will be eligible for enrollment in the study: * male and female patients aged 6-14. * patients having a diagnosis of adhd of any type according to dsm-iv criteria, as established by history, psychiatric examination and a structured diagnostic interview (kiddie-sads-present and lifetime version) * patients, whose symptoms are adequately controlled by a stable and well-tolerated dose of a immediate release methylphenidate equivalent of 20mg for one month before screening. exclusion criteria: * patients with comorbid psychiatric conditions with symptoms requiring current pharmacological treatment (e.g. major depression, psychosis). * patients who are taking any concomitant medications likely to interfere with the study drug or confound efficacy or safety assessments, e.g. * tricyclic antidepressants, buproprion, clonidine, buspirone 2 weeks before randomization. * atomoxetine 2 weeks before randomization. * fluoxetine or antipsychotics 1 month before randomization. * pemoline and amphetamines 1 week before randomization. * patients with a known non-response to methylphenidate. other protocol-defined exclusion criteria may apply.

Keywords: adhd, methylphenidate hydrochloride, modified-release
the effect of melatonin on nocturnal enuresis

Conditions: Nocturnal Enuresis

Summary: aim: to investigate the effect of melatonin in bedwetting.

design: double blind randomized placebocontrolled trial using crossover.

Eligibility criteria:
inclusion criteria: * monosymptomatic nocturnal enuresis * age 6-14 years * clinical examination normal * ≥ 3 wet nights / week due to either nocturnal polyuria with normal bladder size or reduced functional bladder capacity with normal urine output exclusion criteria: * constipation (by rome iii criteria) * day incontinence * overactive bladder (iccs 2008 classification of symptoms) * current or past history of clinical or laboratory findings that can be related to diseases or - conditions (eg pregnancy) likely to change the parameters examined, especially diseases of the kidney and urinary tract, liver or endocrine disorder. * clinical signs of urinary tract infection * hypertension, blood pressure assessed by ambulatory measurement with blood pressure cuff * set treatment with one or more drugs

Keywords: enuresis melatonin circadian rhythm children blood pressure urine production activity sleep
patients outcomes of a monofocal intraocular lens designed for monovision

Conditions: Cataract

Summary: the rationale for this observational study of a ce-marked lens is to prospectively assess the performance, safety, and patient satisfaction in a group of subjects undergoing cataract surgery with bilateral implantation of the rayone emv in a monovision configuration. in order to increase the evidence collected from real-world clinical data we are running a multicentre clinical study in several clinics of the baviera ophthalmological group. study design: prospective, observational, non-comparative.


Eligibility criteria:
inclusion criteria: * signed informed consent * availability to complete follow-up examinations up to 6 months after surgery * cataract for which removal by phacoemulsification and subsequent iol implantation was planned * cdva was expected to be better than 20/30 (+0.18 logmar) after iol implantation * iol power calculated in the range of +10.0 to +30.0 d * corneal astigmatism \< 1.50 d * candidate for refractive surgery in monovision configuration exclusion criteria: * women who were pregnant, nursing or planning to become pregnant during the study * difficulty for cooperation * inability to provide informed consent * concurrent participation in another investigational drug or device * history of ocular trauma * previous intraocular or corneal surgery * presence of ocular pathologies * subjects with diagnosed degenerative visual disorders that were predicted to cause future acuity losses to a level of 20/30 or worse * subjects who may be expected to require retinal laser treatment * other eye condition that in the opinion of the investigator prevents the subject's participation in the study. * any other condition that may be contraindicated according to the iol instructions for use.

Keywords: iol monovision patient satisfaction
convalescent plasma as treatment for acute coronavirus disease (covid-19)

Conditions: COVID-19

Summary: there is currently no effective treatment for covid-19 except best supportive care. the aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of covid-19 illness.

convalescent plasma has been shown to be safe and effective for treatment of several diseases. preliminary data indicates that it is safe and effective for treatment of covid-19. however, data is limited to small studies and case series on severely ill patients. the proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease. plasma is collected from consenting donors who have recovered from sars-cov-2.

Eligibility criteria:
inclusion criteria: * age 18 and \<81 years * active covid-19 defined as symptoms + sars cov-2 identified from upper or lower airway samples * fever ≥38.5c, admitted to a study hospital, hypoxemia defined as having a peripheral oxygen saturation below 93% (measured by pulse oximetry) and a breathing rate of \>20 breaths per minute without supplemental oxygen treatment * a negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential * written informed consent after meeting with a study physician and ability and willingness to complete follow up. exclusion criteria: * no matching plasma donor (exact matching in both the abo system and the rh system is required) * unavailability of plasma * significant growth of alternative lower airway pathogen such as streptococcus pneumoniae or haemophilus influenzae in sputum * disease duration \>8 days * estimated glomerular filtration rate \<60 (kidney failure stage iii or more) * pregnancy (urinary-hcg), breast feeding, * history of severe allergic reactions * inability to give informed consent * significantly compromised immunity.\* * compromised immunity includes but is not limited to treatment with major immunosuppressive agents including high dose corticosteroids, anti-tumor necrosis factor (tnf) agents, calcineurin inhibitors, mtor inhibitors, lymphocyte depleting biological agents, chemotherapeutic anti neoplastic agents. also patients with advanced hiv/aids, severe immunodeficiency such as hypoglobulinemia, decompensated liver cirrhosis and bone marrow transplant the last year will be excluded.

Keywords: covid-19 convalescent plasma treatment sars-cov-2 infection safety effectiveness
steroids and antiphospholipid syndrome- related pregnancy loss

Conditions: Antiphospholipid Syndrome

Summary: does the addition of steroids during the first trimester to the standard aspirin + heparin treatment reduce the miscarriage rates in women with antiphospholipid antibodies and recurrent first trimester miscarriage in those who had an unsuccessful pregnancy with aspirin + heparin?

over the last decade, the aps has emerged as most important treatable cause of recurrent miscarriages. the pathogenesis of fetal loss in this condition is still remains obscure. despite the success of aspirin + heparin treatment, some pregnant women with aps repeatedly miscarry even on treatment. the trial is designed to determine if addition of steroids has an success in these women. this is in view of recent in vitro data from our unit reporting that there is an increase decidual cytokine response in aps positive women.

Eligibility criteria:
inclusion criteria: history of 3 or more consecutive miscarriages and positive antiphospholipid antibodies on at least two occasions more than 6 weeks apart before becoming pregnant and an unsuccessful pregnancy with aspirin + heparin with a karyotype of miscarriage either unavailable or normal (46xx/ 46xy). exclusion criteria: abnormal karyotype of women or partner, previous thromboembolism, sle, diabetes mellitus, hypertension, sensitivity to aspirin, heparin and prednisolone, multiple pregnancy.
the effect of an alginate based beverage on weight loss

Conditions: Obesity; Type 2 Diabetes; Cardiovascular Disease

Summary: the project aims to examine the efficacy of a 12-week intake of alginate based ready to drink supplement on development in body weight and body composition, and risk markers for type-2 diabetes and cardiovascular disease in obese subjects.

the study consists of a parallel rct with 96 overweight/obese subjects enrolled into two treatment arms: placebo or active for 12 weeks. they will undergo examination at time points 0 and 12 weeks where a dxa scan will be performed to assess body composition and a fasting blood sample will be taken. at time points 0, 2, 4, 6, 8, 10 and 12 weeks their weight and waist circumference and number of test products not consumed will be recorded. in addition all subjects receive dietary counselling during the 12 weeks.

Eligibility criteria:
inclusion criteria: * healthy men and women * overweight to obese (bmi 28-45 kg/m2) exclusion criteria: * chronic diseases including:liver and kidney disease, including p-alanine aminotransferase (alt), p-aspartate aminotransferase (ast), gamma-glutamyltransferase (ggt), creatinine kinase and p-lactate dehydrogenase (ld)\> 2.0 times the upper limit of normal (uln) (measured at the screening at the department of human nutrition) * systemic infections and metabolic diseases that can interfere with energy balance, * diabetes or fasting blood glucose concentration\> 7.0 mm, cardiovascular disease, systolic blood pressure ≥ 160 and / or a diastolic blood pressure ≥ 100 mmhg, hyperlipidemia (total cholesterol\> 6.5 mm and triglycerides\> 5.0 mm) (measured by the screening at the department of human nutrition) * food allergies * psychiatric disorders and any clinical condition that makes the person unfit to participate in the experiment * use of dietary supplements (during the experimental period and 3 months before study start) * provision of blood for example. of donation or other scientific studies (during the trial and 3 months before study start) and hemoglobin \<7.5 mmol / l (measured at the screening at the department of human nutrition) * smoking (throughout the trial and 6 months before study start) * elite athletes (\> 10 hours strenuous exercise per week, self-reported) * women who are pregnant or breastfeeding, and post-menustruelle (self reported)
impact of perioperative shedding of the endothelial glycocalyx on short-term postoperative complication in patients undergoing robot-assisted esophagectomy

Conditions: Robotic Esophagectomy

Summary: the aim of this study was to determine whether changes in serum levels of syndecan-1 before and after surgery, which is an index related to injury of the endothelial glycocalyx layer, are associated with postoperative short-term complications and mortality in patients undergoing robotic esophagectomy.


Eligibility criteria:
inclusion criteria: 1. patients 20 years or older who undergo robotic esophagectomy exclusion criteria: 1. emergency surgery 2. if the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.) 3. chronic kidney disease (egfr \<30 ml / min / 1.73 m2) 4. pregnant and lactating women 5. use of oral anticoagulants
correlation between spinal anesthesia and perfusion index

Conditions: Inguinal Hernia

Summary: investigation of the correlation between the success of obtaining unilateral spinal anesthesia and the measurement of perfusion index (pi).

target sites for spinal anesthetics are spinal nerve roots and spinal cord. differences in the anatomy of the nerve roots may explain the variability that occurs during spinal anesthesia. spinal anesthesia is the cessation of nerve conduction for a while by injection of local anesthetic drug into the cerebrospinal fluid. it is one of the most effective and oldest regional anesthesia techniques. unilateral spinal anesthesia, on the other hand, aims to limit the distribution of the spinal block to the operated side for all operations involving only one lower extremity. reducing the dose of local anesthetic, pencil-point needles, injection speed, lateral decubitus position and non-isobaric anesthetic solution are the main factors in the formation of a unilateral spinal block. it requires slightly longer preparation time compared to standard spinal anesthesia, but provides fewer hemodynamic side effects with higher cardiovascular stability, increased postoperative autonomy and better patient acceptance. perfusion index (pi) is a numerical value showing the ratio between pulsatile and nonpulsatile blood flow. pi works by measuring changes in finger peripheral perfusion via pulse oximetry. if the procedure is successful in patients undergoing spinal anesthesia, vasodilation occurs in the lower extremities due to sympathetic nerve blockage and perfusion increases. pulse oximetry perfusion index (pi) was used in our study to indicate vasodilation associated with sympathectomy. we will examine whether the success of unilateral anesthesia in the spinal anesthesia performed in our hospital correlates with the increase of the perfusion index value measured with the finger probe, except for patient-based methods, and whether the perfusion index shows more objectively the block success than other patient-based traditional methods.

Eligibility criteria:
inclusion criteria: 1. patients who will undergo lower abdominal, urogenital, lower extremity surgery 2. patients with asa 1-2 3. patients aged 18-65 exclusion criteria: 1. patients with asa3-4 2. those with peripheral vascular disease 3. patients with a history of by-pass 4. patients with aortic stenosis

Keywords: spinal anesthesia, perfusion index
development of the drug and alcohol respiratory health test

Conditions: Respiratory Disease; Substance-Related Disorders; COPD; Asthma; Lung Cancer; Tuberculosis; Bronchitis; Pneumonia; Obstructive Sleep Apnea

Summary: the goal of this study is to develop a brief drug and alcohol respiratory health test (darht) and offer it for routine use in clinical assessment and medical reviews

respiratory diseases are highly prevalent among adults with substance use disorder. inhaling drugs are risk factors, and cigarette smoking contributes to 90% of copd cases. the substance use disorders population faces barriers to accessing healthcare, leading to under-diagnosis and including stigma, exacerbating the unmet need for effective respiratory disease management. there is no population-specific screening instrument in nhs and third sector addiction services. the lack of a validated screening tool means respiratory health symptoms may be overlooked or attributed to other causes. the aim of this trial is to develop a brief drug and alcohol respiratory health test (darht) and make it available for clinical assessment and medical reviews. the primary research question is to determine if the darht achieves satisfactory diagnostic accuracy with gold-standard spirometry. the study will be open to any enrolled adult (age \>18 years) patients at our treatment clinic (nhs secondary care) who reports inhaling (smoking) tobacco, cannabis, cocaine, opioids, or consuming alcohol in the past 28 days. volunteer and informed and consenting participants will be invited to: (1) complete a brief study questionnaire that includes the darht, then take a spirometry and pulse oximetry test; (2) return to the clinic after 3-7 day to complete the darht with a different interviewer. participants with a positive case evaluation on the darht or spirometer will be referred to primary or specialist services. the investigators will contact participants referred after 6 weeks to determine their progress and the phq-4 and eq-5d-l to evaluate changes in quality of life. the first 20 participants referred to specialist care will be invited to a lung health clinic where the investigators will offer a psycho-social intervention for advice and support.

Eligibility criteria:
inclusion criteria: 1. \>18 (no upper age limit) 2. inhalation (smoking) of tobacco, or cannabis, or cocaine, or opioids, or use of alcohol in the past 28 days 3. possession of a personal mobile phone to arrange follow-up appointments exclusion criteria: 1. reported physical health condition that would mean spirometry contra-indicated - including heart attack, unstable angina, pulmonary embolism, 2. reported surgery in the past 3 months for an eye, chest, or abdominal condition that would mean spirometry contra-indicated 3. likely inability to complete study due to criminal justice involvement with legal proceedings risking incarceration
optimizing postoperative pain control after laparoscopic colorectal surgery

Conditions: Postoperative Pain

Summary: erector spinae plane block (espb) is a novel regional block technique that was proven to have superior outcomes in relieving postoperative pain in colorectal surgeries.ketamine enhances the impact of local anaesthetics by reducing the duration and extent of motor block while shortening the onset of sensory and motor block.transdermal fentanyl patch (tfp) was better than transdermal buprenorphine in postoperative analgesia following abdominal surgeries.


Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic colorectal surgery. * american society of anesthesiologists (asa) physical status i or ii. exclusion criteria: * known allergy to one of the study medications. * skin infections at the site of the needle puncture. * hepatic, renal or cardiac dysfunction. * patients diagnosed with obstructive sleep apnoea