Kornimate/medical-research-clean huggingface dataset:
reduced volume of neck prophylactic irradiation in nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma; Radiotherapy; Complications

Summary: this is a multi-center, non-inferiority, open-label, randomized controlled phase iii clinical trial in primary diagnosed nasopharyngeal carcinoma (npc) patients without distant metastasis. the purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.


Eligibility criteria:
inclusion criteria: * newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (who ii/iii); * all genders, range from 18-70 years old; * ecog score 0-1; * clinical stage i-iva (ajcc/uicc 8th); * not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy); * no contraindications to chemotherapy or radiotherapy; * adequate organ function: white blood cell count ≥ 4×109/l, neutrophile granulocyte count ≥ 1.5×109/l, hemoglobin ≥ 9g/l, platelet count ≥ 100×109/l; alanine aminotransferase or aspartate aminotransferase \< 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (cockcroft-gault formula); * sign the consent form. exclusion criteria: * neck lymph nodes exist skipping metastasis; * distant metastases; * keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma; * have or are suffering from other malignant tumors; * participating in other clinical trials; * pregnancy or lactation; * have uncontrolled cardiovascular disease; * severe complication, eg, uncontrolled hypertension; * mental disorder; * drug or alcohol addition; * do not have full capacity for civil acts.
an open label phase 2 extension study of higher dose sialic acid-extended release (sa-er) tablets and sialic acid-immediate release (sa-ir) capsules in patients with glucosamine (udp-n-acetyl)-2-epimerase (gne) myopathy

Conditions: GNE Myopathy; Hereditary Inclusion Body Myopathy (HIBM)

Summary: the safety objectives of the study are to: evaluate additional long-term safety of sa-er treatment of participants with gne myopathy previously treated with sa-er at dose of 6g/day (part i); evaluate the safety of 12g /day sa (delivered by 1.5g of sa-er tablets and 1.5g of sa-ir capsules 4 times per day) in the treatment of participants with gne myopathy (part ii) over a 6 month treatment period; evaluate the safety of sa treatment at both 6g/day and 12 g/day (part iii \[sa-er/sa-ir\] and part iv \[sa-er\]).


Eligibility criteria:
inclusion criteria: * enrollment in, and successful completion of the ux001-cl201 (nct01517880) protocol or (for 10 treatment naïve subjects): * have a confirmed diagnosis of gne myopathy * aged 18 -65 years of age, inclusive * able to walk ≥ 200 meters and \< 80% of predicted normal during the 6-minute walk test (6mwt; orthotics and assistive devices allowed) * must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures * must be willing and able to comply with all study procedures * sexually active subjects must be willing to use an acceptable method of contraception while participating in the study * females of childbearing potential must have a negative pregnancy test at baseline and be willing to have additional pregnancy tests during the study. females considered not of childbearing potential include those who have been in menopause for at least two years, or have had tubal ligation at least one year prior to baseline, or who have had total hysterectomy exclusion criteria: * use of any investigational product (other than sa-er tablets) to treat gne myopathy * ingestion of n-acetyl-d-mannosamine (mannac) or similar sa-producing compounds * pregnant or breastfeeding at baseline or planning to become pregnant (self or partner) at any time during the study * has had any hypersensitivity to sa or its excipients that, in the judgment of the investigator, places the subject at increased risk for adverse effects * have any co-morbid conditions, including unstable major organ-system disease(s) that in the opinion of the investigator, places the subject at increased risk of complications, interferes with study participation or compliance, or confounds study objectives.
the fine motor dexterity under dual task in parkinson's disease

Conditions: Fine Motor Skill Dysfunction; Parkinson Disease

Summary: this study was planned to investigate the contribution of dual task interference on dexterity related adl disability in patients with parkinson's disease. we hypothesised that the dual task interference is an indicator of dexterity related adl difficulties.

we planned this study as a cross sectional trial. 53 patients with parkinson's disease will be evaluated under 2 different task by nine hole peg test. besides this assessment the cardinal symptoms (bradykinesia, tremor, rigidity) will be evaluated to determine their contribution on the adl performance.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease according to the criteria of the united kingdom brain bank by neurologist * age 50-90 range * having sufficient cognitive status according to the mini mental status evaluation (24 or above from the mini mental test) exclusion criteria: * having orthopedic and neurological disorders affecting hand function, * having sensory problems, * having diabetus mellitus

Keywords: hand function, dual task, parkinson disease, activities of daily living
transverse abdominis plane block versus ilioinguinal-iliohypogastric block for analgesia following hysterectomy

Conditions: Postoperative Pain

Summary: the investigators hypothesis that ilioinguinal iliohypogastric nerves block could provide a potent modality of postoperative pain control as compared to transverse abdominis plane block in open abdominal hysterectomy

aim of the work the aim of the study is to compare between the analgesic effect of transverse abdominis plane block and ilioinguinal-iliohypogastric block following open abdominal hysterectomy objectives * to compare between the analgesic effect of transverse abdominis plane block and ilioinguinal-iliohypogastric block for postoperative analgesia following open abdominal hysterectomy * to measure the incidence of complications following both blocks as hematoma, block failure, infection at injection site sample size: our primary outcome is the time to first rescue analgesia request. in a previous study, the meantime to first rescue analgesia was 10.58 ± 2.35 hours (6). the investigators calculated a sample size that could detect a mean difference of 20% between both study groups. medcalc software version 14 (medcalc software bvba, ostend, belgium) was used to calculate the sample size.38 patients( 19 patients per group) at least were estimated to have a study power of 80% and an alpha error of 0.05. this number will be increased to 42 patients (21 patients per group) to compensate for possible dropouts. sample size calculation was performed guided by the power of 80%, confidence level of 95%. statistical analysis: for data analysis, the statistical package for social science (spss) software, version 26 for microsoft windows (spss inc., chicago, il, usa) will be used. the chi-squared test will be used to examine categorical data, which will be given as frequency (percent). the shapiro-wilk test will be used to verify for normality in continuous data, and the results will be provided as mean (standard deviation) or median (interquartile range) as appropriate. depending on the data's normality, the unpaired t-test or the mann whitney test will be used to assess it. repeated measures will be examined using analysis of variance (anova), with posthoc pairwise comparisons using the bonferroni tests. a p value less than 0.05 will be considered statistically significant.

Eligibility criteria:
inclusion criteria: * participants will be adult patients (18-65 years) * asa i-ii * scheduled for elective open tah exclusion criteria: * patient refusal * any known allergy to local anesthetic * patients with neurological, psychological disorders or those lacking cooperation * patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion. * patients with bleeding disorders defined as (inr \>2) and/ or (platelet count \<100,000/µl) * patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement
the effects of radiation in reconstructed breasts

Conditions: Breast Cancer

Summary: the primary objective of this study is to use lr imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.

immediate breast reconstruction following mastectomy has become an increasingly popular and accepted treatment option among breast cancer patients. this change in practice has resulted in a significant number of patients who undergo radiation therapy after breast reconstruction. following irradiation, the reconstructed breast often experiences fibrotic contracture, volume loss, altered pigmentation, or some combination thereof, producing an asymmetric and aesthetically compromised result. the effects of radiation on reconstructed breasts as well as the implications that such changes have for timing of reconstructive surgery, post-operative management and surveillance imaging are topics of growing importance in plastic surgery, radiology and surgical oncology.

Eligibility criteria:
inclusion criteria: * female patients between 18 and 90 years of age. * patients with a diagnosis of unilateral breast cancer who elect to undergo bilateral mastectomy with immediate free flap reconstruction. * patients must also have a locally advanced tumor that requires adjuvant radiation therapy following reconstruction. exclusion criteria: * women who do not undergo immediate, bilateral breast reconstruction using a free flap. * women who do not require unilateral, adjuvant radiation therapy * women who are pregnant * women who have altered renal function, defined as a personal history of diabetic, hypertensive or autoimmune nephropathy and/or on routine preoperative testing are found to have a serum creatinine greater than or equal to 1.3

Keywords: breast cancer bilateral mastectomy immediate breast reconstruction locally advanced unilateral breast cancer bilateral mastectomy for prophylaxis
assessment of pain during intramuscular injection delay in adult psychiatry

Conditions: Delayed Antipsychotic Treatment, Pharmacological Factors and Individual Factors

Summary: since psychiatry is still too often confronted with a dichotomy between psyche and soma, the assessment of pain and anxiety at rmi is still rarely done (willer et al., 1982). the objective of this exploratory study is to evaluate the influence of pharmacological factors (type of injected molecules, injection frequency, injection site, treatment duration, treatment dose, time since last injection) and individual about the pain perceived when injecting antipsychotic therapy (diagnosis, sex, age, weight, duration of illness, level of anxiety, psychiatric and somatic comorbidity, insight). in the future, this study will develop a suitable procedure to limit pain and anxiety during rmi. taking these dimensions into account will probably allow a better compliance of patients for this type of care, and thus a decrease in the number of relapses in the long term.


Eligibility criteria:
inclusion criteria: * patients (males, females) * over the age of 18 * hospitalized or outpatient * patient affiliated with social security, state medical aid (ame) * with prescription of antipsychotic delay by intramuscular injection * french language mastered * given oral consent to pass the self-assessment scales exclusion criteria: * patients on long-term analgesic treatment, daily * patients with chronic pain with or without analgesic treatment * patient not communicating * pregnant woman, parturint and nursing mother * person deprived of liberty by judicial or administrative decision * minor and person subject to legal protection: guardianship or curatorship

Keywords: pain -injection
a clinical trial of two educational strategies in cardiovascular health in child population

Conditions: Obesity; Cardiovascular Diseases

Summary: aim: to evaluate the effectiveness of two strategies in cardiovascular risk in children 2º grade in the community of madrid. design: cluster-randomized trial with blinded evaluator scope and subjects of study: children of both sexes enrolled in 2º grade in public schools in the community of madrid. rate exclusion criteria intervention: schools were randomly assigned to two groups: an experimental group that the investigators organized a concert teaching focused on messages cardio, a second group or control group to which they will host a healthy breakfast as it has been offering the community of madrid . measurements: the primary end result is the increase of correct answers on a standardized test to be administered before and after the activity. secondary outcomes will be, improving the same questionnaire at 6 months and reduced overall weight and center from before the intervention at 6 months of it.


Eligibility criteria:
inclusion criteria: * 2º grade of primary school students present the day of the activity, whose parents had signed the informed consent to participate in the study and with no exclusion criteria at the moment of the intervention exclusion criteria: * students with food allergies or intolerances. * students with severe hearing impairment (not corrected). * students whose parents didn´t sign the informed consent to participate in the study. * students with a poor understanding of oral and written language. * to have previously received healthy breakfasts interventions or educational concerts.

Keywords: obesity cardiovascular diseases prevention paediatrics
delayed rewarming for neuroprotection in infants following cardiopulmonary bypass surgery

Conditions: Post-Op Complication

Summary: this is an unblinded, single center, randomized study of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming intervention or to the standard of care (strict normothermia).

control group: the congenital heart surgery will be performed according to usual practice with the degree of intra-operative hypothermia determined by the cardiothoracic surgeon based on the anticipated complexity of the case. following completion of the surgical procedure, the infant will be rapidly rewarmed on cpb at a rate of 0.2 to 0.3°c per minute to a normothermic temperature of 36.5°c. infants in this group will be given a single weight-based 15 mg/kg dose of intravenous tylenol in the operating room (or) by the anesthesiologist as the chest is being closed. the infant will be transported to the pediatric intensive care unit (picu) for routine post-operative monitoring. if the infant develops a fever, ice packs will be applied to the axilla and groin per usual routine and removed once the fever has abated. experimental group: partial rewarming will occur on cpb to 35°c. during the last hour of surgery, the infant's temperature will be maintained at 35°c while the chest is closed by using a bairhugger and lowering the room temperature. transfusions of packed red blood cells, fresh frozen plasma and cryoprecipitate will not be automatically warmed. infants will be given a single 15 mg/kg dose of iv tylenol in the or. the infant will be transported to the picu at 35°c and placed on the temperature-regulating blanket. the infant will be incrementally rewarmed with increases in temperature of 0.3°c every 2 hours for 6 hours, then 0.2°c every 2 hours for 6 hours to the goal temperature of 36.5°c. once the infant is stable, eeg will be performed for 48 hours to screen for seizures. the pi will interpret the eeg every 6-8 hours. the infant will remain on the blanket at 36.5°c for another 12 hours. the blanket and esophageal temperature probe will then be removed a total of 24 hours after surgery was completed.

Eligibility criteria:
inclusion criteria: 1. diagnosis of congenital heart disease requiring congenital heart surgery on bypass 2. age less than 6 months at the time of surgery 3. intra-operative hypothermia less than or equal to 35°c exclusion criteria: 1. concern for underlying coagulation disorder such as hemophilia 2. death in the operating room 3. inability to wean of cardiopulmonary bypass at conclusion of surgery

Keywords: therapeutic hypothermia
adherence to the antiemesis national comprehensive cancer network (nccn) guideline

Conditions: Gynecologic Cancer; Chemotherapy-induced Nausea and Vomiting

Summary: this study aims to investigate the adherence to the antiemesis nccn guideline in chinese patients of gynecologic malignancies, who are given chemotherapy treatment. the risk of chemotherapy induced nausea and vomiting (cinv) is calculated by the questionnaire supported by the website "cinv risk assessment" (http://www.riskcinv.org/).


Eligibility criteria:
inclusion criteria: * good performance status * aged 18 years or older * signed an approved informed consents exclusion criteria: * not meeting all of the inclusion criteria
use of ngs cell-free pathogen test for identification of low risk fever & neutropenia in pediatric patients

Conditions: Neutropenia; Fever

Summary: febrile neutropenia is a common complication in pediatric oncology patients. standard of care requires admission of all patients for intravenous antibiotics until cultures are negative, patients are afebrile and there are signs of bone marrow recovery. this often results in prolonged hospital admissions with significant financial costs, decreased quality of life and potential secondary infections. more recent data suggests it may be possible to identify a "low risk" group that can be discharged prior to signs of bone marrow recovery. at this time, researchers have been unable to identify a model that is safe for early discharge across institutions.

1. conduct a pilot study to determine the feasibility of using the karius assay to risk stratify pediatric oncology patients admitted with febrile neutropenia. this will provide preliminary data for a larger study which would randomize patients to early discharge vs. usual care. 2. evaluate the klaasen and spog clinical decision rules with and without the karius assay to predict patients at low risk for adverse infectious outcomes during admission. adverse infectious outcome will be defined as: positive blood or urine culture, radiographic evidence of infection, admission to the intensive care unit or death. 3. model potential cost savings of early discharge for patients deemed low risk for an adverse infectious outcome.

Eligibility criteria:
inclusion criteria: 1) pediatric oncology patients, aged 1-22, treated at lucile packard children's hospital (lpch) exclusion criteria: 1. relapsed disease 2. acute lymphoblastic leukemia during induction 3. acute myeloid leukemia during any phase of treatment 4. philadelphia-chromosome positive all 5. down syndrome 6. patients who have received an allogeneic stem cell transplant.
rebalance: compassion focused therapy in a transdiagnostic health group

Conditions: Psychological Adjustment; Compassion; Chronic Disease

Summary: this study evaluates the use of group compassion focussed therapy in a population with various and/or multiple long term health conditions. a multiple baseline, single case experimental design will be used with a view to evaluate changes in psychological adjustment and compassion. daily data and weekly questionnaire batteries will be collected across a baseline period and ten weeks of group intervention. participants will be those already referred to the group by a clinician as part of their routine care.


Eligibility criteria:
inclusion criteria: * experiencing difficulties adjusting to one or more chronic physical health condition(s) * willing and motivated to attend a nine-week group facilitated in english * exhibit sufficient interpersonal skills and impulse control to allow them to engage with group members without disrupting group dynamics * able to provide informed consent exclusion criteria: * moderate or severe impairment of cognitive function * primary problem related to drug or alcohol misuse * actively suicidal or experiencing an acute deterioration in their mental health including experiencing an acute psychotic episode
subthalamic nucleus stimulation with directional leads on patients with parkinson disease at fluctuations and dyskinesia stage

Conditions: Parkinson Disease; Subthalamic Nucleus Stimulation; Directional Electrodes

Summary: patients with subthalamic nucleus have to go through a lot of examinations and tests, before and after surgery which is difficult, sometimes painful, for the patient. the investigators used to chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator. the investigators can chose the plot using a software (guide xt), which can delete the exhausting test. the investigators would like to study the non inferiority of this tool to choose the best plot .


Eligibility criteria:
inclusion criteria: * age : \>18y * all patient with parkinson disease eligible for sub thalamic surgery (capsit criterias) in chu amiens exclusion criteria: * patient doesn't consent

Keywords: parkinson disease subthalamic nucleus stimulation directional electrodes
efficacy and safety study of nktr-181 in opioid-naive subjects with low back pain

Conditions: Low Back Pain; Chronic Pain

Summary: the purpose of this study is to determine whether a new opioid molecule, nktr-181, is effective for the relief of moderate to severe chronic low back pain as compared to a placebo.

this is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-control treatment of twelve weeks. during the double-blind treatment period, this study will evaluate the analgesic effect of nktr-181 versus placebo in patients with moderate to severe chronic low back pain.

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-nursing female aged 18 to 75 years old * clinical diagnosis of moderate to severe, chronic non-neuropathic low back pain for at least six months * not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics * opioid analgesia is necessary * currently taking no more than 10 mg morphine sulfate equivalents per day of short acting opioids for 14 days prior to entry * females of child bearing potential must be using a highly effective form of birth control. all subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug. * willing and able to provide informed consent exclusion criteria: * taking extended release or long-acting opioids within 6 months * history of hypersensitivity, intolerance, or allergy to opioids * compression of spinal nerve root; spinal fracture, tumor, or abscess * surgical procedures on the low back in the last 12 months or facet nerve root block or radiofrequency ablation in the last 3 months * untreated moderate to severe sleep apnea