Kornimate/medical-research-clean huggingface dataset:
evaluation of the effect of flow rate on swallowing function in young infants

Conditions: Deglutition Disorders in Infants; Bottle Feeding

Summary: the purpose of this study is to evaluate the effect of nipple flow rate on swallowing function in infants less than 3 months corrected age (up to 11 weeks and 6 days) who have been referred for videofluoroscopic swallow study.

feeding difficulties are common in infants born premature and with medical complexity, particularly those with congenital heart disease. one of the most common strategies for managing feeding difficulties is changing the milk flow rate of the bottle nipple. milk flow is the rate at which milk transfers from the bottle to the infant's mouth. during swallowing, the vocal folds must close to prevent aspiration of fluid into the airway. when milk flow is fast, the infant must swallow frequently to clear the bolus of fluid and prevent aspiration; this is done at the expense of respiration. when the milk flow rate is slowed, the infant can swallow less frequently, allowing better integration of respiration, and has more time to coordinate an effective swallow. while there is some very limited evidence that slower milk flow rate improves feeding in infants born premature and with congenital heart disease, the underlying mechanisms for improvement of feeding remain unknown. this project will be the first to evaluate the effect of milk flow rate on swallowing function under fluoroscopy to better understanding how swallowing changes under different conditions of flow in young infants. this research will provide the evidence needed to support the use of this simple intervention (i.e., changing the flow rate) in infants at risk for feeding difficulty and swallowing dysfunction.

Eligibility criteria:
inclusion criteria: * infant less than 3 months corrected age * must be referred for video fluoroscopic swallow study (vfss) at boston children's hospital exclusion criteria: - infant unsafe to trial all study conditions as determined by clinician(s) conducting the vfss.
mother-to-infant bonding and prematurity are associated with sensory processing at 12 months of age

Conditions: Preterm; Sensory Disorder; Attachment Disorder

Summary: establishing a strong bond between mother and infant is crucial for fostering healthy relationships in the future. this research sought to investigate the correlation between mother-to-infant bonding and sensory processing, as well as the connection between prematurity and sensory processing in 12-month-old infants.

at the age of four months, mothers will utilize the mother-infant attachment scale (mibs) to evaluate the bonding between themselves and their infants. subsequently, at 12 months old, the sensory processing abilities of the infants will be assessed using the test of sensory functions in infants (tsfi). the study will encompass both preterm and term-born children.

Eligibility criteria:
inclusion criteria: preterm children with a gestational age \<34 weeks term children with a gestational age between 37 and 41 weeks exclusion criteria: * infants with chromosomal defects, metabolic or neuromuscular disease, * hydrocephalus, cerebral palsy, congenital heart disease,
fatigue and skeletal muscle impact in severe axial spondyloarthritis

Conditions: Spondyloarthritis, Axial; Fatigue; Exercise Capacity

Summary: axial spondyloarthropathy (spa) is the most common inflammatory rheumatism (1% of the general population) with important medico-economic consequences. fatigue is a major feature of sa. it can be defined as a feeling of reduced muscle capacity, lack of energy and exhaustion. the fatigue reaches an abnormally high level (fatigue severity score (fss) ≥4, called severe fatigue in this protocol) in more than two thirds of patients with sa. skeletal muscle repercussions are present during sa. it is characterized by a decrease in exercise capacity independently of pain and ankylosis but is associated with a decrease in strength and muscle mass, the importance of which varies from one study to another. the link between fatigue (subjective sensation) and the skeletal muscular impact (objective) of sa has never been studied.

this work will: 1. study for the first time the implication of the objective skeletal muscular impact in fatigue during sa. 2. better characterize the skeletal muscle impact of sa; 3. characterize the evolution of the fatigue and the muscular impact under targeted therapy

Eligibility criteria:
inclusion criteria: * axial sa according to the asas criteria; * targeted therapy naïve patients * indication to start a targeted therapy; * initiation of targeted therapy ≤ 15 days before inclusion * ≥ 18 years old, no upper age limit; * subject affiliated to a social health insurance reimbursement; * subject able to understand the aims and risks of the research and having signed a dated and informed consent * subject informed of the results of the preliminary medical examination * woman in childbearing age: negative beta-hcg test and effective contraception; * sufficient understanding of french to follow the protocol. exclusion criteria: * targeted therapy in progress for \> 15 days prior to inclusion * contraindication to the use of targeted therapy * systemic corticosteroids in the 15 days preceding the v0 visit * associated extramuscular inflammatory disease (s) (excluding ocular and cutaneous involvement) eg chronic inflammatory bowel disease * associated fibromyalgia (questionnaire score first ≥5) achieved during the v0 visit * history of coronary artery disease: exercise angina, acute coronary syndrome and / or coronary angioplasty, * history of lower extremity arterial disease: vascular claudication and / or lower extremity angioplasty * copd * neuromuscular pathology * insufficiency of organ (renal, hepatic pulmonary heart) * sleep apnea * impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject, etc.) * subject under the protection of justice * subject under guardianship or curatorship * breastfeeding * pregnancy * subject in exclusion period defined by another clinical study or participating in a study likely to impact the results of the research

Keywords: axial spondylarthritis fatigue targeted therapy exercise capacity sarcopenia
gabapentin premedication to reduce postoperative pain for pediatric tonsillectomy

Conditions: Tonsillitis; Tonsillectomy

Summary: the purpose of this pilot study: 1) to examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg given 2) to record the time to first analgesic postoperatively and 3) to compare wong baker and the 0-10 numeric pain distress scale scores at 12, 24 and 48 hours postoperatively. we hypothesize one 15mg/kg (up to 600mg) dose of gabapentin will decrease mean narcotic amounts in mg/kg compared to participants who do not receive preoperative gabapentin and will demonstrate a decreased mean time to first analgesic as well as to lower mean pain scores for each age group at 12, 24 and 48 hours.

this double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing t/as from a regional healthcare organization. patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. both control and test group will receive the standard narcotic regimen intraoperatively. additionally, young children will receive instruction for tylenol and motrin postoperatively while teenagers will receive a narcotic prescription. outcome measurements include: mean tylenol mg/kg, motrin mg/kg and narcotic mg/kg use. additional measurements: mean time to first analgesic. phone interviews with the research nurse for three days postoperatively will elicit pain scores at 12, 24 and 48 hours postoperatively.

Eligibility criteria:
inclusion criteria: * participants age 3-18 years * asa class 1 or 2 * elective tonsillectomy/adenoidectomy * outpatient setting. exclusion criteria: * bmi \>40kg/m2 * history of renal insufficiency, chronic pain * allergy to gabapentin * history of developmental delay

Keywords: pain relief non-narcotic pain relief
under-correction in refractive accommodative esotropia

Conditions: Accommodative Esotropia

Summary: in most clinics, physicians reduce diopter of hyperopic glasses in older patients with accommodative esotropia. however, there are risks of decompensation in that practice. the authors are going to try measure the change of stability of eye alignment after reducing diopter of hyperopic glasses.

inclusion criteria : patients with accommodative esotropia at initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5d). outcome measure : follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. at every visit, symptoms such as asthenopia, diplopia, or blurred vision will be documented and ocular examinations, including visual acuity and ocular alignment status for distance and near will be performed. tests of fusion and stereoacuity will be performed at the 1-month, 3-month, and 6-month follow-up visits.

Eligibility criteria:
inclusion criteria: * patients with accommodative esotropia * older than 24 months exclusion criteria: * unstable eye alignment * older than 18 years

Keywords: accommodative esotropia
colorectal cancer (crc) surveillance tool: cognitive and pilot testing

Conditions: Colorectal Cancer

Summary: the goal of this research study to help develop a tool to assist patients in making decisions about care during treatment for colorectal cancer. information collected during this study will be saved to help develop future studies about patient decision making in cancer treatment.

cognitive testing phase: if participant agrees to take part in this study, participant will take part in a one-on-one interview where participant will be asked questions about participant's health and the disease. this is called the cognitive testing phase. notes about the interviews may be kept so that the responses can be reviewed later by the study doctor and research staff.the interview may take from 45-60 minutes to complete. pilot testing phase: participant may be asked to take part in the next phase of the study called the pilot testing phase. if participant takes part in this phase, participant will have a second one-on-one interview. the interview will last from 45-60 minutes. participant may also be asked to complete a questionnaire about the disease, what participant understands about it, and the treatment plan recommended for participant. participant will also be asked to give participant's opinion about colorectal cancer follow-up materials. if participant is asked to complete it, the questionnaire will be completed during the interview, in person. the questionnaire will take 35-45 minutes. collection of information: information may be collected from participant's medical record about participant's health, participant's treatment, basic information like participant's age and participant's gender, and the disease. information will not be collected from all participants. length of study participation: if participant takes part in the cognitive testing phase only, participation in this study will end when participant has completed the interview. if participant takes part in the pilot testing phase, participation in this study will end when participant has completed the second interview and questionnaire if participant was asked to complete it. this is an investigational study. up to 100 participants will be enrolled in this study. all will take part at md anderson.

Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. able to read and speak english 3. patient undergoing follow-up for curative resection of stage i-iv colon or rectal cancer 4. there will be no exclusion on the basis of gender or race. exclusion criteria: n/a

Keywords: colorectal cancer crc colorectal cancer surveillance decision support tool interviews questionnaire survey
clinical study to investigate the efficacy and safety of sjp002 ophthalmic solution in patients with dry eye syndrome.

Conditions: Dry Eye Syndromes

Summary: this study is to evaluate the efficacy and safety of sjp002 ophthalmic solution compared to placebo in patients with dry eye syndrome.


Eligibility criteria:
inclusion criteria: * age over 19. * must meet all criteria listed below at least in one eye. 1. fluorescein corneal staining score ≥ 2 2. schirmer test ≤ 10mm in 5 mins 3. tear break-up time ≤ 10 secs exclusion criteria: * ocular disorder that may confound interpretation of study results. * wearing contact lenses 72 hrs prior to screening visit and unwilling to avoid wearing contact lenses for the duration of the study period. * history of laser-assisted in situ keratomileusis (lasik) or similar type of corneal refractive surgery within 12 months prior to screening visit, and/or any other intraocular surgery within 90 days prior to screening visit. * female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test. * participation in other studies within 30 days of screening visit.
can fasting ramadan in the third trimester in pregnancy affects the fetal growth.

Conditions: Fasting; Fetal Growth Retardation, Antenatal (Disorder)

Summary: prospective comparative cohort study including 159 pregnant women at the third trimester recruited from the antenatal clinic at el-demerdash outpatient clinic, and followed up during the holy month of ramadan (from 18th june to 16th july 2015). the patients recorded their pattern of fasting during ramadan then grouped into three groups a, b, c regarding fasting state a- non fasting group b- partially fasting group c- totally fasting group .

many pregnant muslims women fast during ramadan since fasting during ramadan is one of the five pillars of islam and is a central part of muslim culture, many women may fear a loss of connection with their communities or would feel guilty if they did not observe ramadan. each year, about 400 million out of 1 billion muslims do this duty. such tasks like eating, drinking, and smoking are forbidden from sunrise until sunset. fasting during pregnancy has been always considered as a debatable condition. many women ask their obstetricians if fasting is safe for their baby or not? there have been many studies on metabolic changes and different aspects of human health during and after ramadan .but there have been few studies on the effect of fasting on pregnancy outcome and there are also some controversies in the findings of different studies. all mothers within the age range of 20 - 35 years and in the 3rd trimester pregnancy (starting from 28 weeks) which is going to be calculated according to the date of the last menstrual period \& confirmed ultrasonically, normal healthy women with average body mass index (bmi) and women included have no medical disorder. women who fulfilled the eligibility criteria were subjected an ultrasound fetal biometry every 2 weeks till delivery and assess fetal weight after delivery.

Eligibility criteria:
inclusion criteria: * age from 20 - 35 years. * third trimester pregnancy (starting from 28 weeks) which is going to be calculated according to the date of the last menstrual period \& confirmed by ultrasonography. * normal healthy women with average body mass index (bmi). normal range (18.5 to 25). * women included have no medical disorder. exclusion criteria: * history of systemic disorder. * smoking narcotics or alcohol use. * have previous history of fetal loss. * multiple pregnancies.
postoperative subq pain control for spinal fusion surgery

Conditions: Spine Fusion; Surgery; Pain, Postoperative

Summary: post-operative pain following lumbar spine fusion is frequently difficult to manage and can lead to increased doses of opiate pain medications to control pain. in this study, the use of subcutaneous local anesthesia will be studied to determine its efficacy at reducing post-operative pain following spinal fusion surgery.

for patients randomized to the experimental or to the placebo groups, two subcutaneous catheters will be tunneled under the skin with large hollow-bore needles along the entire length of the incision on either side prior to closure. these catheters will deliver study drug (0.25% marcaine) directly into the incision. they will be affixed to the skin with steri-strips. the catheters will then be attached to a drug delivery pump at 2ml/hour and will be removed prior to discharge.

Eligibility criteria:
inclusion criteria: * patient 18 years of age or greater * surgery to be done at banner university medical center-tucson * elective surgeries only * lower thoracic or lumbar fusions only - posterior approach * postero or posterolateral instrumented fusions with or without interbody graft * transforaminal interbody fusions * must be able to cooperate in the daily vas assessment exclusion criteria: * patients under 18 years of age * prisoners * pregnant women * hypersensitivity to infusion medication * deformity correction cases requiring osteotomies * surgical fusion in acute phase for traumatic injury * anterior lumbar interbody fusion, direct lateral interbody fusion procedures
targeted axillary dissection after neo-adjuvant chemotherapy

Conditions: Breast Cancer

Summary: currently most breast cancer patients with confirmed axillary lymph node metastasis (cn1) at diagnosis are candidates for neoadjuvant chemotherapy (nac). the increased utilization of nac can be attributed to practical clinical advantages. the increasing use of nac has, however, introduced questions regarding appropriate loco-regional management, including the optimal surgical approach to the axillary lymph nodes. according to current guidelines, patients presenting with cn1 disease and treated with nac, still undergo axillary lymph node dissection (alnd). in forty percent of these patients, however, the investigators see a nodal complete pathological response (ypn0). in certain subgroups, triple negative breast cancer and her2 amplified breast cancer, this percentage is even higher. the investigators would like to lessen surgical morbidity by performing a targeted axillary dissection. the investigators place a clip in the biopsy-proven lymph node metastasis at diagnosis. after nac, the investigators perform a dual agent sentinel node procedure and remove the clipped node during the same surgery. when these lymph nodes are microscopically tumor-free, the investigators can abolish an alnd. targeted axillary dissection after nac for cn1 disease seems to have acceptable false negative rates in previous trials. the investigators would like to further define patients where an alnd can be safely omitted.


Eligibility criteria:
inclusion criteria: * patients diagnosed with ct1-3n1m0 breast cancer, histopathologically confirmed. * age greater than or equal to 18 years and less than or equal to 85 years. * necessity and agreement to neoadjuvant chemotherapy exclusion criteria: * previous surgery ipsilateral axillary or radiation ipsilateral axillary / chest. * extranodal metastases m1 * cn2-3 status * breast cancer with direct invasion of chest wall and / or skin ct4 * disease progression (clinical /radiological) under neoadjuvant treatment * pregnancy * presence of a pacemaker in the ipsilateral chest wall
protein balance in protein supplemented elderly patients: acute study with protein-tracer-techniques

Conditions: Elderly

Summary: the aim of this study is to investigate potential protein synthesis effects of whey protein high in leucine compared to whey protein with normal leucin content in elderly patients in a acute crossover setting. we will use the method of a 2 x 3 h tracer infusing protocol with 15nphenylalanine along with blood samples and muscle biopsies.

background: improved muscle function/strength will enhance the quality of life of the more frail elderly population. dietary proteins and amino acids act as anabolic substrates in muscles in elderly people. in particular the amino acid leucine is suggested to have an impact on muscle protein synthesis. in collaboration with the danish dairy company arla foods we will use their conventional whey protein and leucine enriched whey protein in an acute study on elderly patients. our aim is to examine the acute effects of supplementation with whey protein high in leucine compared to whey protein with normal leucine content on muscle protein synthesis and protein balance in elderly patients. methods: we include 10 elderly patients, age 60-85 years in a randomized crossover study. the subjects will be recruited from the osteoporosis section at the department of endocrinology at aarhus university hospital. the subjects are their own controls in 2 x 1 day interventions a: whey protein high in leucine and b: whey protein with normal leucine content. interventions are conducted with a 4 week washout period between them. on the intervention day postprandial protein synthesis rate will be measured over 2 x 3h using a tracer infusing protocol with 15nphenylalanine along with blood samples and muscle biopsies. for analyzing steps of signaling in muscle protein synthesis initiated by leucine mammalian target of rapamycin (mtor) and sites downstream from mtor is quantified using western blotting. whole body protein kinetics are calculated using the formula q=i\*ei/ep-i

Eligibility criteria:
inclusion criteria: - healthy elder people exclusion criteria: * liver and kidney disease. * known diabetes or hgb1c ≥6,5% (≥48mmol/l). * severe heart disease (nyha-class \>2). * oral corticosteroid treatment within the last 3 month. * participation in other intervention studies within the last 4 weeks.
psma pet/ct for prostate cancer

Conditions: Prostate Cancer

Summary: prostate cancer is the most frequently occurring male cancer in belgium. patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker prostate specific antigen (psa) within the first few years. in these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. in so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.


Eligibility criteria:
inclusion criteria: * patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging. exclusion criteria: * age: \<18 years * physically or mentally unfit to perform the sequential procedures * refusal of patient to be informed about accidental findings on scans * patients with heart failure if ejection fraction \< 45% (phase 2 trial) * history of anaphylactic shock after administration of visipaque ct contrast (phase 2 trial)

Keywords: prostate cancer biochemical recurrence 18f-pet imaging