Kornimate/medical-research-clean huggingface dataset:
effect of enteral docosahexaenoic acid administration in children with acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia; Malnutrition

Summary: the purpose of this study is to evaluate if enteral docosahexaenoic acid (dha) administration during the first three months of treatment reduces the deterioration of nutritional status, treatment toxicity and early mortality in children with acute lymphoblastic leukemia.

cancer is often associated with malnutrition.the most of children with cancer loss weight, and 50-80% of patients with cancer experience morbidity and mortality as a result of progressive wasting. as a consequence of malnutrition, patients with cancer may have a poorer outcome, reduced effectiveness of chemotherapy and increased risk of chemotherapy-induced toxicity compared to those who are well nourished at diagnosis. on the other hand, in the recent years, there has been increased focus on the role of long chain polyunsaturated fatty acids and their effect on prevention and treatment of several diseases. the results of animal studies and adults with cancer have demonstrated that the consumption of long chain polyunsaturated fatty acids can slow the growth of cancer, increase the efficacy of chemotherapy and reduce loss weight and the side effects of the chemotherapy. beneficial effects of enteral long chain polyunsaturated fatty acids has been reported in adults with cancer. however, in children with cancer the scientific reports are scarce; therefore, is necessary to evaluate if the long chain polyunsaturated fatty acids administration in children with acute lymphoblastic leukemia has the same effects on clinical and nutritional outcomes that have been previously showed by different studies in adults with cancer.

Eligibility criteria:
inclusion criteria: * children with acute lymphoblastic leukemia diagnosis * authorization from both parents or legal guardian for recruiting of the child into the study with consent signed form after the purpose and procedures have been explained * must be able to swallow capsules of dha or placebo * malnutrition exclusion criteria: * patients had received radiotherapy or chemotherapy * parents who decide to decline of the study

Keywords: docosahexaenoic acid nutritional status acute lymphoblastic leukemia long chain polyunsaturated fatty acids n-3 fatty acids remission-induction phase
response to medical therapy in inflammatory bowel disease patients carrying-out a prescribed exercise programme

Conditions: Inflammatory Bowel Diseases

Summary: the investigators propose the use of a 20 week physician-derived exercise programme will lead to an improvement in physical fitness which will in turn lead to an increase in muscle mass, a reduction in visceral obesity resulting in an improvement in biologic response, disease biomarkers (including a reduction in circulating pro-inflammatory cytokines), fatigue scores and quality of life.

after completion, the investigators expect to describe the significant impact that exercise has on ibd disease control, response to biologics, modification of pro-inflammatory cytokine levels, quality of life and fatigue scores.

Eligibility criteria:
inclusion criteria: * 18 years of age or above. * confirmed moderate to severe inflammatory bowel disease based on endoscopic evaluation, clinical scoring tools and faecal calprotectin. * be able to provide written informed consent. * stable dose of steroids. * physically able to complete an exercise programme. * healthy controls. exclusion criteria: * inability to participate in the exercise program (unable to perform 6mwt, unable to attend for assessment of parameters at any time point). * an uncontrolled cardiovascular condition such as unstable angina, uncontrolled cardiac arrhythmias, uncontrolled symptomatic heart failure or symptomatic severe aortic stenosis. * a significant musculoskeletal condition, neurological condition, mental illness or intellectual disability that restricts participation in a physical exercise program. * pregnancy. * healthy controls with underlying inflammatory conditions.
metformin and congenital nephrogenic diabetes insipidus

Conditions: Diabetes Insipidus

Summary: the purpose of this study is to determine whether metformin can increase urine concentration (osmolality) and decrease the amount of urine in patients with congenital nephrogenic diabetes insipidus (ndi).

nephrogenic diabetes insipidus (ndi) is a genetic disease. patients with this disease make large amounts of urine because their kidneys don't hold on to water. the large amount of urine means that patients need to urinate very frequently. they are also at increased risk for dehydration if they don't drink enough. the large amount of urine can sometimes damage their bladders and kidneys. there are some medicines that may help these patients urinate less, but they are not very effective. there is evidence in animal studies that a medication called metformin may help patients with ndi urinate less.

Eligibility criteria:
inclusion criteria: * males with a documented mutation in the vasopressin type 2 receptor (v2r) * willing to provide consent and/or assent as appropriate * capable of providing urine samples as dictated by the protocol exclusion criteria: * urinary incontinence * subjects who have heart disease, liver disease, diabetes, cancer, or other significant disease other than nephrogenic diabetes insipidus (ndi) * subjects with significant renal dysfunction (defined as a calculated glomerular filtration rate (gfr) \<80 ml/min/1.73 m\^2) * subjects with acquired ndi

Keywords: congenital nephrogenic diabetes insipidus
thermal imaging compared to skeletal survey in children below 2 years

Conditions: Fracture; Abuse Physical

Summary: when a child less than 2 years old attends the emergency department (ed) with an injury, carers should offer an explanation. when there is no explanation or if the explanation is inconsistent \& because the child cannot say what happened, the doctor will need to consider all possible causes including child abuse. to help exclude abuse, the doctor will request x-rays of all the child's bones to make sure there are no other unexplained fractures. this requires up to 20 x-rays, which are called a skeletal survey. even if there are no fractures, some or all of the x-rays will be repeated in the following 7-21 days, because by that time any fractures will have started to heal and so are easier to see than on the first skeletal survey. it means that if a doctor is worried about abuse, the child may need to have up to 40 x-rays, which amounts to a significant radiation dose (more than 6 months of natural uk background radiation) \& increases the child's lifetime risk of getting cancer. 79 to 97 out of 100 skeletal surveys performed are normal. while it is of paramount importance to identify if a child is being abused, it is also important to minimise radiation dose. a camera which detects light and heat given off by the body has shown promise in some areas of medical practice. we plan to compare the results from the camera to those of the skeletal survey in 40 children below 2 years of age attending our hospital over a 6-month period. we hope to demonstrate that this technology can be used to further select children who should have a skeletal survey, reducing radiation dose in children without missing those who are being abused and sending them home to be abused again.


Eligibility criteria:
inclusion criteria: * children between 1 month and 2 years of age having initial/follow-up skeletal survey for investigation of suspected abuse * healthy control children exclusion criteria: * 1. informed consent withheld by main carer/guardian for the skeletal survey (court order would then be issues) 2. informed consent for participation in the research study withheld 2. situations where informed consent cannot be obtained (e.g. inability of carer/guardian to understand written english) 3. postmortem cases (inclusion of the demised would unduly complicate the consent process for this small pilot study)
a study in opioid-experienced, non-dependent recreational drug users to determine the abuse potential and safety of cl-108 tablets administered via the oral route

Conditions: Pain; Nausea; Vomiting

Summary: the purpose of this study is to assess the abuse potential of cl-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (apap) tablets and placebo in non-dependent, recreational opioid users.

the purpose of this study is to assess the abuse potential of cl-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (apap) tablets and placebo in non-dependent, recreational opioid users; to assess the cognitive and behavioral effects of cl-108 tablets following oral administration relative to hydrocodone/apap tablets and placebo in non-dependent, recreational opioid users; and to assess the safety of orally administered cl-108 tablets relative to hydrocodone/apap tablets and placebo in non-dependent, recreational opioid users.

Eligibility criteria:
inclusion criteria: * bmi within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at screening) * healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ecg findings, vital signs measurements, and laboratory results at screening, as judged by the investigator * current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year exclusion criteria: * drug or alcohol dependence within the last 12 months (except nicotine) * subjects who had ever been in treatment for substance use disorders (except smoking cessation * history of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results * history or presence of hypotension, judged to be clinically significant based on investigator judgement

Keywords: pain nausea vomiting
surgical complication and microbiome changes in colorectal surgery

Conditions: Anastomotic Leak; Microbial Colonization

Summary: the microbiome, the collection of microorganisms that live in our gut, plays an important role in maintaining our health, proper nutrient absorption, nutrient turnover and immunity. after birth, a symbiotic relationship develops with the strains of bacteria that colonise our gut, and the presence and proportion of bacteria is individualised and highly variable. a healthy bacterial flora is essential for the cells of the intestinal mucosa. glycoproteins in the cell surface mucus coat are important nutrients for bacteria, while some bacterial strains supply mucosal cells with nutrient molecules (e.g. short-chain fatty acids) that are their essential energy source. an abnormal change in the proportion of bacterial strains that make up the microbiome, dysbacteriosis, in which pathogenic bacteria proliferate at the expense of members of the normal flora, can cause a number of pathologies. nutrient supply to the cells of the mucosa is reduced, making them more vulnerable and leading to various pathological conditions. the microbiome and the essential nutrients they produce have also been found to play an important role in wound healing. a decrease in the diversity of the microbiome, an increase in the relative number of pathogenic bacteria and a decrease in the proportion of 'beneficial' bacteria increases the risk of surgical complications of infection and suture failure.

a number of risk factors have been identified that increase or decrease the risk of anastomotic leak. the risk of anastomotic failure is increased by anastomosis (lower third) close to the anus, tumour size greater than 5cm in colorectal carcinoma, surgical complications, smoking, diabetes, male gender, overweight, malnutrition (protein deficiency), heart disease requiring anticoagulation, time to surgery, american society of anaesthesiologist score, neoadjuvant treatment, corticosteroid use. the risk of suture failure is reduced by mechanical lining, intravenous and oral non-absorbable antibiotics. the microbiome also appears to have an impact on suture failure: lower diversity of bacteria in intraoperative specimens and an increase in the number of mucin-degrading bacteroidaceae or lachnospiraceae strains may be associated with higher anastomotic failure.

Eligibility criteria:
inclusion criteria: * circular stapled anastomosis * planned surgery with colo-colic anastomosis * no passage disorder, as it is confirmed at the first medical examination * not allergic to antibiotics * can receive a bowel preparation * no proximal excluded intestine, i.e., the bowel preparation may be successful (ileostomy) exclusion criteria: * treated with antibiotics within 2 weeks before randomisation * allergic to any of the medicines used * under 18 years of age * have suffered from abdominal sepsis within 6 months prior to recruitment * pregnancy or breastfeeding * been treated with steroids * any form of chronic immunosuppression

Keywords: colorectal surgery anastomotic leak surgical site infection microbiome oral antibiotic prophylaxis
influence of acute daily workload changes on low-frequency fatigue morning scores

Conditions: Fatigue Intensity

Summary: in recent years, the increased demands of both training and competition have heightened the need of load monitoring among soccer players. however, adopting metrics that comprehensively capture the intricacies of neuromuscular fatigue remains a challenge. assessing low-frequency fatigue may contribute to fill this gap, as it provides an objective measure to evaluate muscle function readiness. thus, the aim of this study was to examine whether variability in low-frequency fatigue morning scores are related to training external load acute changes throughout the in-season microcycle.


Eligibility criteria:
inclusion criteria: * elite soccer players exclusion criteria: * injured athletes

Keywords: fatigue low-frequency fatigue soccer
self-management supported telerehabilitation in children and adolescents with juvenile idiopathic arthritis

Conditions: Telerehabilitation; Juvenile Idiopathic Arthritis; Self-Management

Summary: juvenile idiopathic arthritis (jia) is the most common chronic rheumatic disease of unknown etiology in childhood. jia covers several different subgroups and is predominantly manifested by peripheral arthritis. joint swelling, effusion, tenderness, pain in jia; causes functional limitations, fatigue and quality of life disorders. chronic inflammation limits the patient's daily activities and productivity. self-management is defined as an individual's ability to manage their symptoms, treatment, lifestyle changes, and the psychosocial and cultural consequences of health conditions. good self-efficacy and coping skills reduce the health and financial burden on the individual as well as on health care, benefiting society in general. telerehabilitation is the dissemination of rehabilitation services through communication technologies. in the literature, it is seen that the studies on internet-based exercise applications are limited. in the studies, people were encouraged to physical activity with an internet-based application and the benefits of being active were given within the scope of patient education, and it was reported that the level of physical activity effectively improved as a result. it can also increase endurance, has been reported to be safe and feasible. in our study, unlike the literature, the self-management program and exercise applications will be integrated into the internet-based telerehabilitation method, based on the fact that the exercise practices in jia are effective in disease management and improvement of symptoms. therefore, in our study; the effectiveness of telerehabilitation-based exercise methods to be applied additionally synchronously and asynchronously to self-management education in children and adolescents with jia on pain, disease activity, functional status, fatigue, quality of life, psychosocial status, self-efficacy and satisfaction will be examined and compared.


Eligibility criteria:
inclusion criteria: * having been diagnosed with juvenile idiopathic arthritis according to ilar diagnostic criteria * 8-18 years old * agreeing to do the exercises throughout the study * stable symptoms and medications * internet and computer access exclusion criteria: * be younger than 8 years old * surgical or arthroscopic operation in the last 1 year * having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise * presence of active synovitis and arthritis * active vestibular disease * family and patient's inability to adapt to the assessment * having a psychiatric illness that affects cooperation * having heart failure and lung pathology at a level that will affect activities of daily living
peri-capsular nerve group and supra inguinal fascia iliaca block for analgesia and ease of positioning during neuraxial anesthesia in hip fracture patients

Conditions: Spinal Anesthesia; Hip Fractures

Summary: severe pain associated with fractured hip often results in difficulty during positioning for spinal anesthesia (sa). among many regional analgesic techniques, the fascia iliaca compartment block (ficb) is popular among anesthesiologists to provide immediate as well as postoperative analgesia in hip fractures. recently, the pericapsular nerve group (peng) block has been proposed to provide effective analgesia in hip fracture patients. however, comparative studies between peng and ficb are lacking.


Eligibility criteria:
inclusion criteria: * 40 years and above with hip fracture with persistent pain and scheduled for surgery under spinal anesthesia (sa) exclusion criteria: * any contraindications to sa or peripheral nerve blocks, history of ischaemic heart disease, patients on opioids for chronic pain and patients with significant cognitive impairment. patients who had no pain while sitting by themselves (resting pain less than 4 on nrs) for sa without any support were also excluded.
evaluation of rapid virologic response among hcv patients treated with pegintron and rebetol in brazil (study p05427)

Conditions: Hepatitis C, Chronic; Hepatitis C

Summary: the objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (rvr) after 4 weeks treatment with pegintron and rebetol. the study will also assess whether rvr is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).


Eligibility criteria:
inclusion criteria: * willing to participate in the study and sign the informed consent form * established hcv infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction \[pcr\] test) * can be treatment-naïve, have retreatment, or co-infected with hiv * be under treatment with pegintron in combination with ribavirin, starting up to 14 days before the screening visit exclusion criteria: * participants who have not confirmed their willingness to participate in the study or have refused to sign the free and informed consent form * prior treatment with pegintron (combined with ribavirin or not) * history of alcohol abuse in the past 6 months * decompensated liver disease * severe heart disease * decompensated thyroid disorder * neoplasia * type 1 diabetes mellitus - uncontrolled or hardly controlled * seizures - uncontrolled * primary immune deficiency * men and women not using appropriate contraceptive methods * pregnancy or lactation * for participants co-infected with hiv: hiv-related opportunistic disease in the past 6 months or cd4 count lower than 200 cells/mm\^3
phase i randomized, placebo-controlled, double-blind, dose ranging study, safety, tolerability and immunogenicity

Conditions: Clostridium Difficile Infection; Clostridium Difficile Diarrhea

Summary: this phase i, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of c. difficile vaccine. population: healthy male and female adults, 18 to 55 years old.

this was a phase i, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of c. difficile vaccine. the study was conducted in healthy male and female adults, 18 to 55 years old. subjects was randomly assigned on day 0 to receive one of two doses of c. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).

Eligibility criteria:
inclusion criteria: * adult males or females, 18 - 55 years in good general health exclusion criteria: * evidence of current c. difficile infection, as determined by a positive stool c. difficile cytotoxin assay at screening * evidence of any previous antibiotic-associated diarrhea caused by any etiology including c. difficile that required medical intervention or medication * active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.

Keywords: clostridium difficile diarrhea clostridium difficile toxoid vaccine