Kornimate/medical-research-clean huggingface dataset:
high medium-chain triglyceride nutritional support in infants with biliary atresia

Conditions: Biliary Atresia; Infant; Nutrition Support; Medium-chain Triglyceride

Summary: this study is a prospective, single center and observational open clinical study.

biliary atresia (ba) is a significant disease leading to liver failure in infancy, with ba accounting for 50% of infant liver transplantation cases. many ba children experience complications related to malnutrition, particularly during the first year of life. these complications are primarily characterized by reduced muscle mass and structural protein, impaired bone mineralization, diminished fat reserves, and deficiencies in vitamins and trace elements. some studies have indicated that oral administration of specialized medium-chain triglycerides (mct) and branched-chain amino acids fsmp with polysaccharides still result in malnutrition and growth retardation among ba children, necessitating enteral nutrition support treatment through tube feeding. the american association for the study of biliary atresia conducted a study on the prognosis of 104 children with biliary atresia after kasai surgery across six clinical centers. they found that the key period for changes in growth rate occurred six months post-surgery, with faster-growing children exhibiting better prognoses compared to those with slower growth rates. active nutritional therapy can enhance the prognosis of children with biliary atresia, particularly before and after kasai surgery within the initial six-month period following surgery. currently, there is no standardized process for using foods for special medical purpose in china nor any regulations governing the addition and monitoring of trace elements and vitamins. therefore, this study aims to improve overall outcomes for children with biliary atresia through standardized nutrition assessment procedures as well as education, intervention, and follow-up measures.a total of 300 hospitalized patients were enrolled, all of whom received high mct formula nutritional support following the kasai operation, in order to investigate the impact of high mct formula on the nutritional status and growth of children with biliary atresia after undergoing the kasai procedure.

Eligibility criteria:
inclusion criteria: the kasai procedure for infants with biliary atresia under the age of 3 months. exclusion criteria: * complicated with cirrhosis, hepatitis, or other hepatic disorders; * complicated with other systemic serious diseases (such as congenital multiple malformations, chromosome abnormalities)

Keywords: biliary atresia kasai portoenterostomy nutrition support medium-chain triglyceride
mitomycin-c injection therapy in refractory esophageal stricture

Conditions: Esophageal Stricture

Summary: intralesional mitomycin-c (mmc) injection has recently been introduced to resolve refractory benign esophageal stricture mostly in children. the investigators aimed to evaluate the clinical efficacy of endoscopic postdilation intralesional injection of mmc in adults with refractory benign esophageal stricture.

the participnts who have refractory benign esophageal stricture even after five or more sessions of bougination are prospectively enrolled. a submucosal needle injection of 4ml of a mmc preparation (0.5mg/ml) is endoscopically done with a 0.5ml of eight each injection mainly into the tearing esophageal wall, after esophageal bougie dilation is done upto 14mm in diameter. and then, repeated bouginations combined with mmc injection are done with the interval of eight weeks upto 3 times, if dysphagia symptoms recurr with dysphagis score 3 or more. initial and overall clinical success rates are evaluated with drug and procedure-related complication rates during the follow-up period of at least 1 year.

Eligibility criteria:
inclusion criteria: * aged more than 29 year and less than 75 year * refractory benign esophageal stricture who had the symptoms of dysphagia score suggested by mellow et al greater than 3 (0: able to eat a normal diet, 1: able to eat some solid food, 2: able to eat some semi-solids only, 3: able to swallow liquids only, 4: complete dysphagia) exclusion criteria: patients who have at least one of following conditions were excluded from our study * malignant esophageal stricture * multiple sites of esophageal stricture * pregnant or breast feeding status * clinical deterioration not tolerated to endoscopic procedures * esophageal motility disorders * esophageal leakage or fistula * hypersensitivity to mitomycin c * bleeding tendency due to thrombocytopenia or clotting disorders

Keywords: esophageal stricture mitomycin c endoscopy
data collection on the ati neurostimulation system: spg stimulation for cluster headache

Conditions: Cluster Headache

Summary: the primary objectives of the registry are to: 1. monitor the transfer of the ati neurostimulation system and its safety/clinical performance to a larger number of centers in the post market phase and 2. collect additional evidence to support reimbursement and clinical acceptance and long term follow up


Eligibility criteria:
inclusion criteria: * subject meets ce marked labeling for cluster headache. * subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of the investigator. * subject agrees to maintain current preventive headache medication regimens (no change in type, frequency or dose except to manage tolerability) from study enrollment through the completion of the therapy evaluation period. * subject has the ability to read, comprehend and to reliably record information as required by the protocol. * subject is able to provide written informed consent prior to participation in the study. exclusion criteria: * subject has had a change in type, dosage or frequency of taking preventive headache medications \< one (1) month prior to study enrollment. * per the ce marked labeling: in the opinion of the investigator, subject has bony facial deformities, inappropriate surgical anatomy or has had facial surgery in the surgical area on the same side as the planned surgery that would prevent the proper placement of the ati neurostimulator. * subject has other significant pain problem that might confound the study assessments in the opinion of the investigator.
universal cancer peptide-based vaccination in metastatic nsclc

Conditions: Metastatic Non-small Cell Lung Cancer

Summary: ucpvax is a therapeutic vaccine based on the telomerase-derived ucp designed to induce strong th1 cd4 t cell responses in cancer patients. three doses of ucpvax (0,25 mg, 0,5 mg and 1 mg) will be tested in this phase i/ii study by using continuous reassessment method (crml) dose escalation design model. the phase i is a dose escalation study designed to evaluate safety of use of ucpvax and to estimate its maximum tolerated dose (mtd). the phase ii is a dose deescalation designed to evaluate the immunogenicity of ucpvax according to the dose level.

ucpvax study is a prospective multicenter phase i/ii study: 54 patients with metastatic nsclc will be enrolled in 5 centers in france. a translational research program will be performed to better define the eligibility criteria and predictive biomarkers needed for randomized phase ii and phase iii trials.

Eligibility criteria:
inclusion criteria: * written informed consent * histologically or cytologically confirmed nsclc (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other) * stage iiib not amenable to radiotherapy or stage iv cancer according to the tnm classification (7th edition) or recurrent nsclc after surgery not amenable to loco-regional therapy. * pre-treated with at least 2 or 3 lines of treatment (including immunotherapy). chemoradiation for stage iiib disease is considered as one treatment line. * at least one measurable lesion by ct scan or mri based on recist criteria version 1.1 * performance status 0 or 1 on the ecog scale * life-expectancy \> 3 months * adequate hematological, hepatic, and renal function exclusion criteria: * prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years * symptomatic brain metastases. patients with controlled brain metastases after radiation therapy or with asymptomatic brain metastases may be included. * history of active autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease...) * patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed) - - positive serology for human immunodeficiency virus (hiv) or hepatitis c virus (hcv); presence in the serum of the antigens hbs * participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment * pregnancy or lactating patients. * patients with any medical or psychiatric condition or disease, * patients under guardianship, curatorship or under the protection of justice.

Keywords: cancer immunotherapy cd4 t lymphocyte helper telomerase
lamictal bipolar observational study

Conditions: Bipolar Disorder

Summary: this is multi-center, prospective, observational stud. this study is designed to evaluate the rate of non-serious rash in korean bipolar i patients.


Eligibility criteria:
inclusion criteria: * a subject will be eligible for inclusion in this study only if all of the following criteria apply: * provides written informed consent * male or female age 18 years or older a female subject is eligible to enter and participate in the study if she is of; * non-childbearing potential * childbearing potential, has a negative pregnancy test at screen * diagnosis of bipolar i disorder using dsm-iv criteria exclusion criteria: * a subject will not be eligible for inclusion in this study if any of the following criteria apply: * previous or current treatment with lamotrigine * presence of a clinically significant psychiatric or physiologic comorbidity, including significant substance abuse, severe depression or mania which is of an unstable or progressive nature that could, in the opinion of the investigator, interfere with participation in this study * presence of untreated thyroid disease * have active suicidality or homicidality, history of recent suicide attempts within the past year, or, in the investigator's opinion, a marked risk for suicide * history of severe hepatic or renal insufficiency or significant hematologic disease or other significant medical or psychiatric condition that would interfere with subjects' participation in the study * currently participating in another clinical trial, or plans to enroll in another trial while participating in this study * currently pregnant or is breastfeeding

Keywords: korean bipolar i disorder non-serious rash lamotrigine
clinical validation of a novel classification for predicting surgical complexity in mandibular wisdom teeth surgery

Conditions: Impacted Third Molar Tooth; Tooth Extraction Status Nos

Summary: the study evaluates and validates a new classification proposed by juodzbalys and daugela in 2013 predicting the complexity of impacted mandibular third molars surgical extraction, comparing it with other two, scientifically approved (pell and gregory, winter) classifications.

the extraction of mandibular impacted wisdom teeth is the most widespread surgical procedure performed in oral surgery. there are many situations indicating the extraction of those teeth as well as risks and protective factors that may contraindicate it. a reliable classification predicting the complexity of the surgical procedure and the related risk of complications would greatly help the surgeon in the diagnostic phase. the aim of the study is to evaluate if the classification proposed by juodzbalys and daugela in 2013 could be effective in predicting the complexity of impacted mandibular third molars surgical extraction, and to compare its effectiveness with commonly used pell and gregory, winter classifications. a blind expert surgeon will assess postoperatively all cbcts (cone beam computed tomographies) and opgs (orthopantomographs) not older than 12 months, and will assign the score for each extracted tooth for the three classification (juodzbalys and daugela - pell and gregory - winter). duration of the surgical procedure, assessment of the surgical technique and of intra- and post-operative complications will be considered as the main parameters to evaluate surgical difficulty. vas (visual analogue scale) pain score and nsaid (nonsteroidal anti-inflammatory drug) pills count taken by each patient of the 7 days postoperative period will be also evaluated. statistical unit analyzed will be the single tooth. it should be noted that if a single patient has a bilateral impacted tooth to be extracted it will be randomly selected only one to be analyzed. patients will be divided into two groups according to juodzbalys and daugela classification score (x\<9≤y), two groups according to each predicted extraction difficulty to pell gregory (x\<class 2b≤y) and winter (x\<horizontal impaction≤y) classifications.

Eligibility criteria:
inclusion criteria: * male and female patients with an age comprised between 16 to 90 years * healthy patients ( asa (american society of anesthesiologists) physical status index ≤ 2) * cbct and/or opg performed not before than 12 months before surgery * complete roots formation of 38 or 48 at cbct and/or opg examination * signed informed consent exclusion criteria: * smoking \> 10 cigarettes per day * presence of any neoplastic lesion (benign or malignant), clinically or radiologically evaluable, at the site or close to the impacted tooth * presence of any radiolucent lesion \>1 cm at impacted tooth level

Keywords: third molar classification inferior alveolar nerve lingual nerve injuries mandibular canal
absorbable screws to treat anterior-superior iliac spine avulsion fractures

Conditions: Fractures, Bone; Pediatrics

Summary: there is some debate over the best treatment for anterior-superior iliac spine (asis) avulsion fractures although conservative treatment can be applied when there are no neurological symptoms. open reduction and internal fixation can be performed for dislocations exceeding 1.5 cm, or in patients requiring a short period of convalescence, although a second operation is subsequently required to extract osteosynthetic material. in this paper, we introduce the use of absorbable screws as a new fixation material for the second round of surgery.

to investigate the feasibility of absorbable screws as a new fixation material for the treatment of asis avulsion fractures in children and adolescents.the investigator plan to retrospectively analyzed 59 patients diagnosed with asis avulsion fractures in our hospital between jan 2009 and dec 2016. these patients were divided into two groups: group a (conservative group) and group b (absorbable screws). group a received conservative therapy involving bed rest with the affected lower extremity positioned with the hip and knee in flexion to ensure minimal tension of the muscles attached to the asis avulsion fracture. group b received open reduction and internal fixation with fixation by absorbable screws. six weeks and three months after treatment, all patients were assessed for range of motion (rom) and by x-ray as they returned to activity. one week after treatment, the american academy of orthopaedic surgeons (aaos) lower limb and hip score was used to evaluate hip function; the same scores were also determined during follow-up at 1, 3, 6 and 12 months postoperatively.

Eligibility criteria:
inclusion criteria: * avulsion fracture of the asis * new fractures exclusion criteria: * old avulsion fractures * delayed fractures * multiple fractures.
pmcf study on the safety, performance and clinical benefits data of the zimmer® reconstruction system

Conditions: Acetabulum Fracture; Pelvic Ring Fracture

Summary: the study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. the purpose of this study is to confirm safety, performance and clinical benefits of the reconstruction system (implants and instrumentation) when used for temporary internal fixation and stabilization of fractures during the normal healing process. the primary objective is the assessment of performance by analyzing fracture healing. the secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. relation of the events to implant, instrumentation and/or procedure should be specified. subjects' outcomes will also be assessed.

the reconstruction system is especially used to stabilize pelvic ring and acetabulum fractures. one site will be involved in this study. the aim is to include a maximum of 83 consecutive series cases who received the zimmer reconstruction system at the azienda ospedaliero universitaria senese (siena, italy) between 2010 and 2018. all potential study subjects will be required to participate to the informed consent process. baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. in addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected retrospectively.

Eligibility criteria:
inclusion criteria: patients having received the zimmer reconstruction system for temporary internal fixation and stabilization of fractures during the normal healing process exclusion criteria: * off-label use * patients under the age of 18 * severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position * infection * metal sensitivity or intolerance * severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation * sternal or spinal fractures * anatomical location in which the device would interfere with nerves, blood vessels, or other vital structures * patients with inadequate soft tissue coverage at the implant site

Keywords: acetabulum fracture pelvic ring fracture medical device clinical benefits safety performance post market clinical follow up study
a study to evaluate the safety and immune responses to fluzone® vaccination

Conditions: Influenza

Summary: to describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. to describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

safety will be assessed throughout the trial period. using antigens provided by aventis pasteur inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.

Eligibility criteria:
inclusion criteria : * age of 18 years or greater. * ambulatory. * in reasonably good health as assessed by the investigator. * available for duration of the study (21 days + 2d). * willing and able to meet protocol requirements. * willing and able to give informed consent. exclusion criteria : * self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde. * an acute illness with or without fever (temperature \>100.4°f) in the 72 hours preceding enrollment in the trial. * clinically significant findings in vital signs (including temperature \>100.4°f) or review of systems. * self-reported history of severe adverse event to any influenza vaccine. * vaccination against influenza in the 6 months preceding enrollment in the study. * any vaccination in the 14 days preceding enrollment in the study or scheduled between visit 1 and visit 3. * participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study. * immunosuppressive therapy including long-term (\> 2 weeks) systemic corticosteroids or cancer therapy within the past 3 months or ongoing. * receipt of blood or blood products within the 3 months preceding enrollment in the study. * diabetes * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine (e.g., existing severe chronic illness such as pulmonary disorders, cardiovascular disorders, chronic blood disorders, etc.). * person deprived of freedom by an administrative or court order (having legal or medical guardian). * for women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.

Keywords: influenza fluzone®
is a woolen cap effective in maintaining normothermia in preterm infants during kangaroo mother care?

Conditions: Neonatal Temperature; Kangaroo Mother Care

Summary: the aim of the present study is to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (lbwi) during kangaroo mother care (kmc).

background: neonatal hypothermia is an important challenge associated with morbidity and mortality. preventing neonatal hypothermia is important in high resource countries, but is of fundamental importance in low resource settings where supportive care is limited. kangaroo mother care (kmc) is a low-cost intervention that, whenever possible, is strongly recommended for temperature maintenance. during kmc, the world health organization (who) guidelines recommend the use of a cap/hat, but its effect temperature control during kmc remains to be established. in the hospitals participating to the projects of the non-governmental organization cuamm, kmc represents a standard of care, but the head of the babies often remains uncovered due to local habits or to the unavailability of a cap. objective: the aim of the present study will be to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (lbwi) during kmc. methods: this is a multicenter (three hospitals), multi country (three countries), prospective, unblinded, randomized clinical trial of kmc treatment with and without a woolen cap in lbwi. after obtaining parental consent, all infants with a birth weight \<2500 g and candidate to kmc will be assigned to kmc with woolen cap or to kmc without cap group in a 1:1 ratio according to a computer-generated randomized sequence. the primary outcome measure will be the temperature in the normal range (36.5-37.5°c) in course of kmc during the first week of life. in all participants, axillary temperature will be measured with a digital thermometer 4 times per day. in addition, maternal and room temperature will be recorded. secondary outcome measures will be: episodes of apnea; sepsis; mortality before hospital discharge; in-hospital growth; age at discharge.

Eligibility criteria:
inclusion criteria: * birth weight \<2500 g (and) * candidate to kmc treatment (and) * parental consent; a written informed consent will be obtained by a member of the neonatal - team involved in the study from a parent or guardian before kmc treatment exclusion criteria: * major congenital malformations * twins * parental refusal to participate to the study