Kornimate/medical-research-clean huggingface dataset:
statistical analysis plan for the sano-trial: neoadjuvant chemoradiotherapy followed by surgery versus active surveillance for oesophageal cancer

Conditions: Esophageal Cancer; Active Surveillance; Neoadjuvant Chemoradiotherapy; Surgical Oncology

Summary: an active surveillance approach is proposed after completion of neoadjuvant chemoradiotherapy (ncrt) for carcinoma of the oesophagus. in this sano (i.e. surgery as needed for oesophageal cancer) approach, surgical resection is offered only to patients in whom a locoregional regrowth is highly suspected or proven, without distant dissemination. such an organ-preserving strategy can have great advantages, but is only justified if long-term survival is non-inferior to that of the current standard trimodality approach comprising neoadjuvant chemoradiotherapy followed by standard surgery. the aim of this study is to assess the (cost-)effectiveness (including non-financial costs and survival) of active surveillance for patients with squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction.


Eligibility criteria:
inclusion criteria: * patients who underwent or are planned to undergo neoadjuvant chemoradiotherapy according to cross and are planned to undergo potentially curative surgical resection for histologically proven oesophageal or junctional squamous cell carcinoma or adenocarcinoma are eligible. whenever pathology is inconclusive but a multidisciplinary expert group concludes oesophageal carcinoma because of radiologically or endosonographically highly suspected lesions, patients are eligible for the study. * age ≥18; * written, voluntary, informed consent. exclusion criteria: * language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires; * non-fdg-avid tumour at baseline pet-ct scan; * initial treatment with endoscopic resection.
the role of 5% lidocaine patches in the pain control of hepatocellular carcinoma patients receiving radiofrequency ablation

Conditions: Liver Cancer; Post Ablation Syndrome

Summary: background: this study aims to test whether 5% lidocaine patches can reduce radiofrequency ablation-induced pain. methods: the study will enroll patients with hepatocellular carcinoma and schedule a radiofrequency ablation procedure. 200 patients will be invited to allocate randomly into study or control groups: pretreatment with a 5% lidocaine patch (lidotopⓡ) (group a); pretreatment with a placebo patch (group b); the skin patch is applied before radiofrequency ablation (rfa) while admission, and is changed every day till discharge. pain severity is evaluated by a visual analog scale using a 10-point scale recorded by a study nurse before rfa and after the procedure. the demographic data, hepatocellular carcinoma characteristics, analgesics usage, patient satisfaction with pain control, and visual analog scale will be compared between the two groups. anticipated results: pretreatment with 5% lidocaine patches is an effective and straight method of reducing radiofrequency ablation-induced pain to reduce analgesics usage and improve patient satisfaction with pain control.


Eligibility criteria:
inclusion criteria: 1. adults diagnosed with liver cancer (hcc) by a physician and eligible for radiofrequency cautery (rfa). 2. age is \> = 18 years. 3. whether there is cirrhosis combined with cirrhosis, the child-pugh score of those with cirrhosis must score \< 8 points. 4. communicative and able to express pain sensations. exclusion criteria: 1. those who are allergic to lidocaine. 2. those who suffer from skin diseases or have wounds on the abdomen that cannot be patched.

Keywords: hepatocellular carcinoma radiofrequency ablation lidocaine patch
us-guided ilioinguinal blocks versus local infiltration

Conditions: Pain, Postoperative

Summary: injection of local anesthetic drugs is an effective way to freeze (block) nerves to achieve loss of sensation during surgery and satisfactory pain control afterwards. many studies have shown that nerve block is associated with higher degree of success in controlling pain after open inguinal hernia repair. nerve block can be administered by a single injection with a long acting local anesthetic agent using ultrasound guidance. this study is to compare different techniques for freezing the nerves responsible for pain after open inguinal hernia repair. patients will be randomized to one of two groups. in the first group, participants will receive ultrasound-guided nerve block following induction of general anesthesia but prior to surgical procedure. in the second group, participants will receive local anesthetic injection directly into the wound by the surgeon prior to closure. the investigators will assess the level of pain control for 48 hours after the surgical procedure. patients will be provided with additional medications for pain relief if necessary. the investigators will also contact participants to follow-up with regard to possible chronic groin pain after 3 months following the surgical procedure.

populations. it is well-known that inguinal hernia surgery can lead to significant degree of acute perioperative pain. at the same time, patients undergoing inguinal hernia operation are at increased risk to develop chronic neuropathic groin pain. in the literature, several approaches to prophylaxis and treatment of perioperative pain have been described including: infiltration of local anesthetics by surgeons, ilioinguonal/iliohypogastric nerve blocks, neuroaxial blockade, and caudal block in pediatric petients. recent studies have shown that ultrasound guided ilioinguinal/iliohypogastric nerve block is associated with increased level of safety, improved success rate, and reduction in dose of local anesthetic required compared to the "blind" technique. the aim of our study is to investigate the role of ultrasound guided ilioinguinal/iliohypogastric nerve block in prevention of perioperative and persistent neuropathic pain following open inguinal hernia repair in comparison with infiltration of local anesthetics by surgeons. in the first randomized group of patients we will perform ultrasound guided ilioinguinal/iliohypogastric nerve block using the same types and amount of local anesthetics. in the second group, patients will receive infiltration of the same type and amount of local anesthetics by surgeons.

Eligibility criteria:
inclusion criteria: * asa 1-3 * both gender * 18 years and older * informed consent exclusion criteria: * asa 4 and more * lack of informed consent * patients with history of chronic pain * patients on regular opioids * history of allergic reaction to local anesthetics * medication or non-medication induced bleeding diastasis * infection at the site of injection * patients with bilateral hernias * linguistic difficulties
a study to investigate the safety and tolerability of npsp558, for the treatment of adults with hypoparathyroidism - a clinical extension study in hungary

Conditions: Hypoparathyroidism

Summary: this study is designed to evaluate the effect of 6-months of treatment with npsp558 in reducing requirements for supplemental oral calcium and active vitamin d, while maintaining stable total serum calcium levels in adult subjects with hypoparathyroidism.

subjects either must have previously completed npsp558 study cl1-11-040 (replace) including 24 weeks of active therapy and 4 weeks of follow-up to week 28 prior to enrolling in this study or have enrolled in replace and dropped out during optimization, but currently meet inclusion/exclusion criteria for replace.

Eligibility criteria:
inclusion criteria: patients who meet all the following inclusion criteria can be enrolled into this study: 1. signed and dated informed consent form (icf) before any study-related procedures are performed 2. previously completed 24 weeks of therapy and 4 weeks of follow-up in the replace study, or enrolled in replace and dropped out during optimization, but currently meet inclusion/exclusion criteria for replace 3. able to perform daily sc self-injections of study medication (or have a designee perform injection) via a multidose injection pen into the thigh 4. willingness and ability to understand and comply with the protocol 5. women who are: (1) postmenopausal defined as 12 months amenorrhea with appropriate serum follicle stimulating hormone (fsh) levels (\> 40 iu/l); (2) surgically sterilized; or (3) of childbearing potential with a negative pregnancy test at screening and who consent to use two acceptable methods of contraception for the duration of the study, with pregnancy testing at every scheduled visit during the treatment period . female partners (who are of childbearing potential) of male study patients must also use acceptable forms of contraception during their partner's participation exclusion criteria: patients who meet any of the following exclusion criteria at baseline (visit 1) are not eligible for enrollment in this study: 1. any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of npsp558 2. any disease or condition in the opinion of the investigator that has a high probability of precluding the patient from completing the study or where the patient cannot or will not appropriately comply with study requirements 3. pregnant or lactating woman

Keywords: pth 1-84 hypoparathyroidism npsp558 parathyroid hormone 1-84
an extension of istradefylline in north american parkinson's disease patients who have completed study 6002-int-001

Conditions: Parkinson's Disease

Summary: this is an, open-label, long-term safety extension for patients in north america who have completed the prior istradefylline study 6002-int-001.

patients with parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-int-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.

Eligibility criteria:
inclusion criteria: * completion of study 6002-int-001 * not of childbearing potential exclusion criteria: * cancer within 5 years of enrollment * alt/ast levels \> 2.5 times uln

Keywords: parkinson's disease levodopa end of dose wearing off off time
prophylactic antibiotic treatment for hand lacerations involving flexor and/or extensor tendon

Conditions: Hand Laceration; Tendon Involved; Clean Laceration; No Bone Involved

Summary: the investigators assume that simple hand lacerations involving flexors or extensors tendons, do not require prophylactic antibiotic treatment to prevent wound infection.

hand lacerations are divided to "complicated" which involves tendons, nerves, bones, and joints, and "simple" which involves only cutaneous and subcutaneous tissue. prophylactic antibiotic should not be given in a clean simple lacerations, and should be given when a bone is involve (open fracture). but there is not enough data, weather prophylactic antibiotic treatment should be given when only tendons are involved. the investigators will examine 2 groups of 30 patients each with clean hand lacerations involving tendons. one group will be treated with prophylactic antibiotic and the other wont be treated, randomly. the investigators assume that the rate of wound infection wont be different between the 2 groups.

Eligibility criteria:
inclusion criteria: * hand laceration * tendon involeved * clean laceration * no bone involved exclusion criteria: * pregnant * children * immunocompremised patients * "dirty" lacerations

Keywords: lacerations tendons antobiotic
hemangioma growth during the first 6 months of life

Conditions: Hemangiomas of Infancy

Summary: one of the most important and unique characteristics of infantile hemangiomas is their dramatic growth during early infancy. most hemangiomas are either absent at birth or barely evident as a small scratch or bruise-like area. a recent study emphasized how early hemangioma growth occurs. in this study by 3 months of age, hemangiomas had reached 80% of their final size, and by 5 months of age, 80% had already stopped growing. unfortunately the average age when most infants are seen by specialists is often at 5 months of age or later, a time when most growth is already completed. researchers at the university of california, san francisco, the medical college of wisconsin, and at the mayo clinic are interested in studying hemangioma growth at even earlier ages, before 3 months of age, which is before most patients are ever seen by dermatologists or other specialists. for this study are requesting that parents of children older than 3 months of age with hemangiomas send us a series of photographs of their child which demonstrates this early growth. ideally the photographs would show your child (including the area of the hemangioma of course) at weekly or every other week intervals up until age least 3 to 6 months of age. this will probably not be difficult if the hemangioma is on the face but we would be interested in other body locations as well, if available. we are using these photographs to analyze early hemangioma growth patterns, to see if there is a period of especially rapid growth, and to help determine if there is a specific time before which specialty referral should occur. we are interested in all sizes of hemangiomas, from small to large. of greatest importance is that the photos be at frequent intervals (every 1 to 2 weeks is ideal) and of sufficient quality to be able to evaluate the appearance of the hemangioma.


Eligibility criteria:
inclusion criteria: * children older than 3 months of age who have or have had a diagnosis of an infantile hemangioma. the parents of these children will be able to provide us with frequent (weekly to biweekly) photographs of the patient's hemangioma(s) during the first 3-6 months of life. * these hemangiomas must have a superficial component that can be seen. parents must consent to the use of their child's photographs in this study. exclusion criteria: * current age less than 3 months. patient who do not have an infantile hemangioma (as determined by the investigators). patients whose photographs are not of sufficient quality or frequency in order to be evaluated for this study.

Keywords: infantile hemangioma
comparison of heparin types; efficacy and safety

Conditions: Coronary Artery Disease

Summary: heparin, a blood thinner, is used routinely in open-heart surgery. do different brands of this drug have differing clinical effects despite both having exactly the same regulation and marketing specifications?


Eligibility criteria:
inclusion criteria: * will be undergoing cardiopulmonary bypass for coronary artery disease * has provided written informed consent exclusion criteria: * allergy or intolerance to heparin

Keywords: heparin coronary artery bypass graft surgery anti-coagulation efficacy
preoperative i.v. iron substitution in patients with colon cancer

Conditions: Colon Cancer

Summary: about 70% of colon cancer patients are anemic. preoperative anemia in patients with colorectal cancer is associated with both impaired disease-free survival and overall survival. the purpose of this study is to compare the effects of preoperative iv iron substitution on postoperative recovery in preoperatively anemic (male hb \<130, female hb \<120) and iron deficient colon cancer patients in a prospective setup. as a primary outcome, the effect of iv-iron substitution on postoperative complications is investigated.

randomized preoperative iron substitution for patient with iron deficient anemia

Eligibility criteria:
inclusion criteria: * age\> 18 years * dg: colon ca * the planned measure: the colon resection * men: hb \<130, women: hb \<120 and iron deficiency (elevated tfr, low trfesat or low ferritin) exclusion criteria: * hyperreactivity for ferinject * haemochromatosis * refusal for participation

Keywords: postoperative complications
evaluation of corrected carotid flow time variations during passive leg lift to predict response to filling.

Conditions: Organ Failure, Multiple

Summary: patients hospitalized in intensive care often require intravenous administration of fluid in order to optimize the functioning of the heart and thus ensure perfusion of vital organs such as the kidneys, the brain or the digestive tract. however, it is necessary to find the right balance in fluid intake because it has been shown that excessive administration has a negative impact on patient survival, the length of their stay in intensive care or the duration of invasive mechanical ventilation.the passive leg lifting maneuver is regularly used to determine which patients should be infused with these large volumes (the patient's chest is placed in a horizontal position and the legs are elevated at 30 ° by tilting the bed for 2 minutes ). to be interpreted, this maneuver requires the presence of invasive devices (bloody arterial pressure catheter, picco monitor) or an operator experienced in cardiac ultrasound.our study aims to evaluate an easy-to-use, non-invasive tool widely available in intensive care and emergency departments (carotid vascular doppler ultrasound) to assess the response to a passive leg lifting maneuver. . the measurements are taken before and after a passive leg lifting maneuver and then before and after a filling decided before inclusion by the doctor responsible for the patient.


Eligibility criteria:
inclusion criteria: * equipped with a picco2® continuous cardiac output monitoring device * for which the practitioner in charge of the patient decides to administer a volume expansion exclusion criteria: * patients whose rhythm is non-sinus * who have expressed their refusal to participate in the protocol * contraindicated to passive leg lifting maneuvers (deep vein thrombosis, htic, bmi\> 40 or\> 14, spinal instability) * pregnant women and patients clinically suspected of abdominal compartment syndrome
effect of clustered nursing interventions on physiological response in critically ill patients

Conditions: Mechanically Ventilated Patients

Summary: to determine physiological responses related to clustered nursing interventions among critically ill patients.

clustered nursing interventions are defined as group of interventions more than six for each patient in one nursing interaction.the study was conducted on 80 mechanically ventilated adult patients admitted to intensive care units of alexandria main university hospital and damanhour medical national institute. the most common procedures provided by nurses in direct care for those patients were vital signs measurements, central venous pressure measurement, suctioning, feeding, laboratory sampling, general care, repositioning, and administration of medications. physiological parameters measured were end-tidal carbon dioxide using capnography, vital signs using bed side monitor, and oxygen saturation using pulse oximeter.

Eligibility criteria:
inclusion criteria: * adult patients of both sex, aged 18 years and over * mechanically ventilated for ≥ 48 hours. exclusion criteria: * lung disorder (eg, copd, asthma, lung cancer, pneumonia, ards) * pregnancy.

Keywords: clustered nursing interventions
genetic predictors of response to acupuncture for cancer-related fatigue among breast cancer patients after chemotherapy

Conditions: Breast Cancer

Summary: genetic predictors of response to acupuncture for cancer-related fatigue among breast cancer patients after chemotherapy.

cancer related fatigue(crf) in patients with breast cancer has a great impact on their quality of life and treatment compliance. many studies suggest that acupuncture has certain therapeutic effects on fatigue. in this clinical trial, we treated patients with acupuncture to alleviate their fatigue symptoms. currently, studies have shown that cancer related fatigue in breast cancer patients is related to some biological factors. while acupuncture is used to treat fatigue, we will collect blood samples from patients for fatigue related single nucleotide polymorphisms（snp）. based on crf related biological factors, our study aims to screen snps that related to crf related biological factors to guide electroacupuncture in the treatment of cancer-related fatigue and establish a prognostic model.

Eligibility criteria:
inclusion criteria: 1. the patient was diagnosed with breast cancer.; 2. breast cancer patients diagnosed with cancer related fatigue are included in our clinical study; 3. voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent); 4. patients with previous local recurrence were eligible, but not patients with distant metastasis； 5. the basic indexes were consistent, and the blood routine and ecg were normal. exclusion criteria: 1. the exclusion criteria were patients with needle phobia; 2. low platelet count (\<50 000); co-morbidity with a bleeding disorder; co-morbidity with thyroid dysfunction; pregnancy; haemoglobin levels \<10 g/dl and haematocrit \<30; anaemia on active pharmacological treatment or receiving blood transfusion or steroids； 3. life expectancy \<6 months； 4. lymphoedematous limbs.

Keywords: single nucleotide polymorphisms breast cancer cancer-related fatigue acupuncture
the impact of malnutrition on immune responses to tuberculosis

Conditions: Malnutrition, Child; Tuberculosis

Summary: the aim of this study is to assess immune responses to mtb in children with mam compared to well-nourished children and to evaluate the impact of a nutrition intervention on these immune responses.

immune dysfunction in malnourished children is poorly characterised. the aim of this study is to assess immune responses to mycobacterium tuberculosis (mtb) in children with moderate acute malnutrition (mam) compared to wellnourished children and to evaluate the impact of a nutrition intervention on these immune responses. innate and adaptive immune responses to mtb will be characterised in four groups: 1) mam children with tb disease; 2) wellnourished children with tb disease; 3) mam children with latent tb infection; 4) well-nourished children with latent tb infection. a range of assays to compare innate, adaptive and functional immune responses to tb between groups will be performed. whether nutritional supplementation improves immune function in mam children remains uncertain. hence, children in all four groups will be followed up during 6 months of tb therapy/chemoprophylaxis. mam children will receive 12 weeks of concomitant ready-to-use supplementary food, to evaluate longitudinal changes in innate and adaptive immune function, monocyte:lymphocyte ratio and mycobacterial growth inhibition. the results of this study will provide data to understand the reasons for infection susceptibility in malnourished children and provide a proof-of-concept that nutritional rehabilitation promotes immune rehabilitation. it will also provide a proof-of concept for use of nutritional supplementation as adjust therapy in tb disease

Eligibility criteria:
inclusion criteria: * age 12-60 months * hiv-negative * bcg vaccinated * moderate acute malnutrition (whz -2 to -3 or muac 115 - 125mm ± haz \<-2) * tb disease * latent tb infection exclusion criteria: * inclusion criteria not met * severe acute malnutrition (whz\<-3; muac\<115mm; bilateral oedema) * severe anaemia (hb: \<7g/dl) * chronic infection (hiv, hepatitis b or c) * chronic disease (e.g. crohn's disease) * feeding problems (eg cerebral palsy) that prevent ingestion of rusf * known nut allergy * mdr tb disease and contacts of mdr tb adults

Keywords: malnutrition moderate acute malnutrition immunology