Kornimate/medical-research-clean huggingface dataset:
individualized carbohydrate intake strategy to improve blood glucose control

Conditions: Type 1 Diabetes

Summary: the objective of this study is to test whether an individualized carbohydrate intake based on weight and pre physical activity glucose level is more effective than usual camp care to improve glucose control in children and adolescents engaging in team sports (basketball, soccer, hockey) during a summer camp. at the enrollment interview, in addition to collecting patient's information (age, sex, diabetes duration, recent a1c, type of treatment, insulin doses body weight, concomitant diseases, diabetes complications and history of severe hypoglycemia), a continuous glucose monitoring system (freestyle libre) will be installed by a nurse. at least, eight sports sessions per participant are planned for this study. in a randomized order, the individualized carbohydrate intake will be applied during at least 4 interventions sport sessions while at least 4 with matching types of sports will be used as control sessions. two sport sessions are routinely scheduled at the camp each day; from 9h:30 to 10h:30 and from 11h:00 to 12h:00. for intervention sessions that involve individualized carbohydrate intake, the freestyle libre will be scanned 0-10 minutes before the start of the team sport. carbohydrates will then be given in the amount of 0.5g/kg for glucose levels between 4.5 to 7.0 mmol/l and 0.25g/kg for glucose levels between 7.1 to 10.0 mmol/l and none will be given if glucose levels are between 10.1 and 15.0 mmol/l. when glucose levels are below 4.5 mmol/l or above 15.0 mmol/l, the camp staff will take care of hypoglycemia/hyperglycemia treatment. during control sessions, as per camp routine care, there will be no measurement of glucose levels before the start of physical activity.


Eligibility criteria:
inclusion criteria: 1. males or females between the 7 and 16 years of old. 2. clinical diagnosis of type 1 diabetes for at least 6 months. 3. using continuous subcutaneous insulin infusion therapy or multiple daily injections. 4. hba1c ≤ 12.0%. 5. practicing team sports (soccer, basketball, hockey, tennis) at the summer camp. exclusion criteria: 1. clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. 2. severe hypoglycemic episode within two weeks of inclusion in the study. 3. using the medtronic 670g insulin pump as a treatment mode 4. current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). stable doses of inhaled steroids are acceptable. 5. acute disease in the last 3 months that would affect ability to do physical activity. 6. other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).

Keywords: exercise physical activity carbohydrates hypoglycemia
j-pouch colorectal anastomosis or straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor

Conditions: Colorectal Cancer; Gastrointestinal Complications; Perioperative/Postoperative Complications

Summary: rationale: it is not yet known whether a j-pouch colorectal anastomosis is more effective than a straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor. purpose: this randomized clinical trial is studying j-pouch colorectal anastomosis to see how well it works compared with straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.

objectives: primary * to assess whether the incidence of major anastomotic leak after low anterior resection, in patients with rectal cancer, is reduced by using the j-pouch reconstruction vs straight colorectal anastomosis. secondary * to compare the global anastomotic leak (major and minor) rate, the incidence of other complications in addition to anastomotic leak, and the functional outcome and the quality of life in these patients. * to describe, in the j-pouch reconstruction group, the feasibility of the colonic j-pouch. outline: ths is a multicenter study. patients are stratified according to clinical center, gender (male vs female), and neoadjuvant treatment types. patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical straight stapled colorectal anastomosis. * arm ii: patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical j-pouch stapled anastomosis reconstruction. quality of life is assessed periodically using eortc quality of life questionnaires (eortc qlq-c30 and -cr38), and the mskcc bowel function questionnaire. after completion of study treatment, patients are followed at 1, 6, 12, and 24 months.

Eligibility criteria:
disease characteristics: * histologically confirmed rectal adenocarcinoma meeting the following criteria: * mid and/or low rectal cancer * tumor site ≤ 11 cm from anal verge * must have a temporary stoma (ileostomy or colostomy) * must be scheduled for a total mesorectal excision with a low anterior rectal resection and mechanic colorectal anastomosis that is potentially curative or with a microscopic residual resection (r0-r1) * no locally recurrent disease * no distant metastasis patient characteristics: * must be able to understand the study prior concurrent therapy: * no prior handsewn coloanal anastomosis * no prior colonic resection * no prior surgery for local recurrence

Keywords: perioperative/postoperative complications gastrointestinal complications adenocarcinoma of the rectum stage i rectal cancer stage ii rectal cancer stage iii rectal cancer
american ginseng for the prevention of moderate-severe fatigue in breast cancer patients

Conditions: Cancer Related Fatigue; Breast Cancer Female

Summary: among the symptoms referred by cancer patients, cancer related fatigue (crf) is one of the most disabling symptom with a relevant impact on the quality of life. crf can occur before, during and after anti-cancer treatment. the aim of the present study is to verify the efficacy of american ginseng in preventing or reducing the intensity of moderate-severe crf in breast cancer women receiving adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.

cancer related fatigue (crf) can occur before, during and after anti-cancer treatment. in fact, up to 40% of patients report fatigue at diagnosis, 80%-90% during chemotherapy and radiotherapy, respectively and 20%-50% in the post-treatment phase. all cancer patients should be screened for the presence of crf at the first oncological visit and subsequently during and after the anticancer therapies. if the patient refers crf, it could be quantified with one of the validate instruments available; the possible determinants could be identified and corrected if possible, to reduce their impact on patients cr. the most evaluated pharmacological treatments of crf include psychostimulants (methylphenidate, modafinil, armodafinil) and dexamethasone. non-pharmacological treatments include physical exercise, psychological therapies and complementary therapies such as agopuncture, yoga, ginseng. the aim of the present study is to verify the efficacy of american ginseng in preventing or reducing the intensity of moderate-severe crf in a homogeneous population of breast cancer women submitted to adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.

Eligibility criteria:
inclusion criteria: * submitted for the first time to adjuvant chemotherapy with anthracyclines and cyclophosphamide after surgery for breast cancer; * not presenting crf or at least with o al massimo crf lieve (nrs \< 4); * 18 year old, who have given written informermed consent; * who accept to use adequate contraceptive methods, if they are of child-bearing potential. exclusion criteria: * previously submitted to chemotherapy; * with concomitant not-correctable alterations, present before chemotherapy, possible determinants of fatigue (nrs ≥ 4), such as anemia, not well controlled pain, insomnia, electrolyte imbalance, dehydration, anorexia/cachexia, hepatic, renal or heart failure, adrenocortical failure, neurological deficit, hypothyroidism, not-controlled diabetes mellitus; * submitted to raitherapy during the 15 days before the randomization; * presenting moderate-severe fatigue (nrs ≥ 4) at basaline; * receivind opioids or corticosteroids (except if admimistered at phisiological doses or to prevent emesis on the chemotherapy day); * with with blood cell count \< 3000/mm3, platelets \< 70000 mm3, hemoglobin \< 8 g/dl; * unable to understand the procedures of the study or to collaborate with them; * pregnant or breastfeeding.

Keywords: american ginseng cancer related fatigue breast cancer female
a study to evaluate alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: participant has a history of rrmm, and must: * part a: have previously received ≥ 3 prior lines of anti-myeloma therapy. * part b and part c: have received 1 to 3 prior lines of anti-myeloma therapy. exclusion criteria: • must not have previously received alnuctamab or mezigdomide. note: other protocol-defined inclusion/exclusion criteria apply
a study of ramucirumab (ly3009806) in children with refractory solid tumors

Conditions: Pediatric Solid Tumor; Refractory Tumor; Recurrent Tumor; CNS Malignancies

Summary: the main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (cns) tumors.


Eligibility criteria:
inclusion criteria: * part a: participants with recurrent or refractory non-cns solid tumors * part b: participants with recurrent or refractory cns tumors * measurable or evaluable disease * no other therapeutic options * performance status: karnofsky ≥50% for participants \>16 years and lansky ≥50 for participants ≤16 years exclusion criteria: * active or recent history of serious bleeding events * active or recent history of gastrointestinal perforations, ulcers, fistulas or abscesses * active or recent history of hypertensive crisis or hypertensive encephalopathy * active non-healing wound or bone fracture * history of solid organ transplant

Keywords: relapsed pediatric solid tumors unspecified childhood solid tumor brain and central nervous system tumors
prospective use of awake endoscopy for inspire activation

Conditions: Obstructive Sleep Apnea

Summary: the aim of this study is to examine a new method of device configuration for the inspire upper airway stimulator. first, the investigators will attempt to determine optimal configuration by quantifying changes in upper airway size with different implant configurations using awake nasal endoscopy. the configuration/voltage that results in the greatest increase in upper airway size and is tolerated by the patient will be selected. participants will then undergo a sleep study so that increased airway size may be correlated with changes in sleep study parameters including ahi and oxygen desaturation index (odi). airway size and sleep study parameters using the standard device configuration (+-+)/voltage will be compared to airway size and sleep study parameters using the test, or "optimal," configuration/voltage to determine the usefulness of awake endoscopy in activation of the inspire device.


Eligibility criteria:
inclusion criteria: * patients with moderate to severe osa who have undergone inspire uas implantation by the principal investigator * must have symptoms of osa prior to inspire implantation * ahi between 15 and 65, where central and mixed apnea is 25% or more, and the level of collapse is in the soft palate area bmi less than 32 * age 18 or above exclusion criteria: * significant central sleep apnea * presence of other sleep disorders * history of neurologic or neuromuscular disease * historical or present substance abuse * bleeding disorders * autoimmune diseases that increase risk of nasal trauma such as wegener's, sarcoidosis, etc. * pregnancy
manipulative treatment of children with neck and back pain

Conditions: Neck Pain; Back Pain

Summary: the purpose of this study is to determine the effect of manipulative treatment of children with neck and back pain. because manipulation is the most frequently used treatment of musculoskeletal complaints in children, and an increasing number of danish children see a chiropractor, it appears obvious to start the search for evidence by examining the effect of this treatment.

parents receive text messages \[sms) on a weekly basis inquiring about the child's musculoskeletal pain as well as amount and types of sport during leisure time the past week. following a report of pain, the parents will be interviewed by phone by a member of the clinical team, consisting of two licensed physical therapists and two licensed chiropractors, for a thorough description of the complaint. based on this, the interviewer determines whether the complaint is negligible or whether the child should be seen by a member of the clinical team, in which case the child will be examined at his or her school. at this examination, the child will be evaluated for inclusion and exclusion criteria.

Eligibility criteria:
inclusion criteria: * pain in neck or back equal to or greater than 3 on an 11-box numerical rating scale for more than three days. exclusion criteria: * if a serious pathology or injury is suspected, the child will be referred to a secondary care sports injury center for diagnostic work-up and/or imaging. * handicaps which prevents normal physical activity.

Keywords: manipulative treatment children neck pain back pain effect adolescence advise exercise
evolution of aqueous flare in rhegmatogenous retinal detachments treated with gas or silicone oil tamponade.

Conditions: Retinal Detachment

Summary: to examine and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (rrd), in 4 groups of patients : * group 1 : 48 eyes primarily treated with gas tamponade * group 2 : 11 eyes primarily treated with silicone oil tamponade * sub-group g1rg : 8 eyes among group 1 treated with gas after relapse * sub-group g1rs : 3 eyes among group 1 treated with silicone oil after relapse


Eligibility criteria:
inclusion criteria: * adult patients * patients who underwent surgery for rhegmatogenous retinal detachment (silicone or gas tamponade) * aqueous flare measurement carried out preoperatively and postoperatively at 2-4 weeks and 3 months exclusion criteria: * diabetic retinopathy * glaucoma * non rhegmatogenous retinal detachment * active uveitis * pseudoexfoliation syndrome.

Keywords: aqueous flare retinal detachment
effect of plum-blossom needle vs. tropicamide eye drops on juvenile myopia

Conditions: Myopia

Summary: the purpose of this study is to determine whether plum-blossom needle is effective in the treatment of juvenile myopia and compare the efficacy with tropicamide eye drops.

plum-blossom needle is a historical treatment technology of traditional chinese medicine, and has been applied to ophthalmic diseases, such as myopia and glaucoma, for nearly one hundred years.

Eligibility criteria:
inclusion criteria: * the result of retinoscopy is myopic refractive error, near visual acuity and other visual functions must be normal * distance visual acuity can be corrected to normal using negative spherical or cylindrical lenses * myopia diopter spherical lenses must be ≤-3.00 d which measured under cycloplegia * subjects must be between 8 and 20 years of age exclusion criteria: * diopter spherical lenses be \>-3.00 d , or uncorrected distance visual acuity \<0.1, or pathologic myopia with eye complications * diopter spherical lense ≥1.50 d or cylindrical lenses ≥1.00 d, as measured under cycloplegia * the affected eyes have other diseases which affect the determination of acupuncture efficacy * subjects with serious systemic diseases, such as cerebrovascular, liver, kidney, hematopoietic system, and psychiatric diseases * longterm use of other related drugs or treatments, which have not been terminated * parents or subjects refuse to participate this trial * participating other ongoing clinical trials

Keywords: juvenile traditional chinese medicine plum-blossom needle
study of the effect of fostamatinib upon cutaneous inflammation in the setting of hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: a 16 week exploratory, proof of concept study to evaluate the effect of fostamatinib (12 weeks of treatment) upon cutaneous inflammation in hidradenitis suppurativa.

sample size: 20 patients study duration: 16 weeks primary endpoints: alterations in gene expression profiling, cell counts (cd3+, cd11c+, neutrophil elastase+, cd20+, cd138+) at week 4 compared to baseline. alterations in gene expression profiling, cell counts (cd3+, cd11c+, neutrophil elastase+, cd20+, cd138+) at week 12 compared to baseline. secondary endpoints: safety and tolerability (grade 2/3 adverse effects); changes in disease activity (measures by an count and ihs4 scoring). study procedures clinical examination, patient questionnaires, skin biopsy, blood draw, medical photography

Eligibility criteria:
inclusion criteria: * moderate to severe (hurley stage 2 or 3) hidradenitis suppurativa as determined by the pi exclusion criteria: * uncontrolled hypertension (systolic blood pressure \[bp\] ≥135 mmhg and/or diastolic bp ≥85 mmhg), unstable angina, congestive heart failure of new york heart association classification iii or iv, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia) at screening. * history of myocardial infarction within 3 months prior to screening. * shock or hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine at screening or at randomization. * renal function impairment with creatinine clearance \<30 ml/min at screening (estimated glomerular filtration rate will be calculated using the modification of diet in renal disease equation). * liver function impairment with aspartate aminotransferase/alanine aminotransferase \>=3x the upper limit of normal or bilirubin \>2x the upper limit of normal at screening. * neutrophil count \<1000/µl at screening. * history of an allergic reaction or hypersensitivity to the study treatment or any component of the study treatment formulation. * has documented hiv infection or documented, active hepatitis b or hepatitis c infection. * women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. * individuals with concurrent use of systemic antibiotics/ oral retinoids/ systemic immunosuppressants (those with prior use of these medications must have conducted a washout period of 4 weeks or 5 half-lives of the drug, whichever is longer). * any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.

Keywords: fostamatinib hs tavalisse
treatment of pilonidal cyst with holmium laser

Conditions: Pilonidal Cyst

Summary: observational study on the treatment of pilonidal cyst with holmium laser. single-centre retrospective study of medical data from patients' medical records

from the medical records of a series of patients treated for pilonidal cysts with holmium laser: 1. primary objective: to assess the rate of healing at 1 month after holmium laser treatment (healing being defined as no dressing) 2. secondary objectives: to assess the following: * healing rate at last follow-up (1 month after surgery) * recurrence rate at last follow-up (1 month after surgery) * consumption of \>1 level analgesics in the week and month following the procedure * duration of nursing care

Eligibility criteria:
inclusion criteria: * patient aged 18 years or older, who has been informed of the research; * patient with a pilonidal cyst treated with holmium laser during a scheduled procedure. exclusion criteria: * patient under legal protection, guardianship or curatorship; * patient who has indicated his opposition to the use of his data. * patient undergoing emergency surgery for an abscess
effects of a computerized physician order entry (cpoe)-based inpatient insulin protocol on glycemic outcomes

Conditions: Diabetes Mellitus

Summary: retrospective cross-sectional study measuring the impact of a computer=based insulin correction protocol and nursing inservicing on diabetes outcomes

this study is a retrospective cross-sectional study at one institution, where the investigators compared diabetic patients admitted to medicine services from march-april 2006 (before cpoe was implemented) to patients admitted from october-november 2007 (one year after cpoe implementation). capillary blood glucose values, hemoglobin aic, diabetes medication profile and demographic data were obtained to compare between groups. the investigators hypothesized that a computer-based protocol that emphasizes basal-bolus and correctional insulin orders and excludes sliding scale, in conjunction with nursing personnel inservicing, improves outcomes.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetes mellitus exclusion criteria: * admitted to non-medicine hospital services

Keywords: inpatient computer physician order entry diabetes mellitus