Kornimate/medical-research-clean huggingface dataset:
metoclopramide for post-traumatic headache. a pilot study

Conditions: Post-Traumatic Headache

Summary: post-traumatic headache is common. we are determining short and longer-term outcomes among patients treated for post-traumatic headache with iv metoclopramide.


Eligibility criteria:
inclusion criteria: * traumatic injury to the head has occurred * headache has developed within 7 days of injury to the head * headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache) * the headache must be rated as moderate or severe in intensity at the time of initial evaluation. * the plan of the attending emergency physician must include treatment with parenteral metoclopramide. exclusion criteria: * patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, parkinson's disease, use of monoamine oxidase inhibitors, and use of anti-rejection transplant medications. patients will not be excluded for pregnancy or breast-feeding.
effects of oral care in the neuroscience icu

Conditions: Ventilator Associated Pneumonia; Oral Hygiene

Summary: the purpose of this study is to compare how effective different ways of mouth cleaning are for patients in a neuroscience intensive care unit with a breathing tube in their mouth.

patients with neurological dysfunction requiring intubation and ventilation are at risk for developing ventilator acquired pneumonia. several studies have suggested that oral hygiene plays a role in the subsequent development of pneumonia for patients in the intensive care unit requiring intubation and mechanical ventilation.

Eligibility criteria:
inclusion criteria: * \> or equal 18 years old * intubated within 24hours of admission to the neuroscience icu * intubation anticipated to continue for approximately 72 hours exclusion criteria: * minors * pregnancy * acute cervical spinal cord injury * severe facial trauma * family not present for consent

Keywords: ventilator acquired pneumonia oral hygiene oral care xerostomia
study of outpatient management for promontofixation by laparoscopy

Conditions: Pelvic Organ Prolapse

Summary: laparoscopic promontofixation is becoming increasingly common and is currently the standard surgical procedure for pelvic prolapse, with few complications including exposure and mesh infection. the research hypothesis is that laparoscopic promontofixation is a relatively painless procedure and can be performed on an outpatient basis without increasing the number of postoperative complications and impairing patients' quality of life. the objective of this study is to evaluate the number of rehospitalizations after management of promontofixation by laparoscopy on an outpatient basis. to evaluate the feasibility of a postoperative h8 exit after laparoscopic promontofixation. each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.


Eligibility criteria:
inclusion criteria: * woman with promontofixation indication by laparoscopy for prolapse cure * patient's desire for outpatient management * age ≥18 years and \<70 years * absence of a major medical or surgical history that would prolong hospitalization (asa 1 or 2, absence of obstructive sleep apnea syndrome) * subject affiliated to a social security scheme * subject having signed an informed consent * availability of a caregiver, responsible and valid (for the first 48 hours after the potential early exit) at home * geographical distance less than one hour from a suitable care facility * access to a telephone or a means of transport if necessary * patient compliance * oral and written comprehension of pre- and post-operative instructions * correct housing condition * subject having been informed of the results of the prior medical examination exclusion criteria: * laparoscopic contraindication * comorbidity needs of medical supervision most of 24h * tvt-o procedure during the same surgery * mental handicap affecting autonomy * comprehension difficulties to understand the protocol * no social protection * subject with curatorship or guardianship * morbid obesity * alcohol or drugs addiction * excessive anxiety * impossibility to give the subject enlightened information (subject in emergency situation...) * pregnant woman (positive urinary pregnancy test for women of childbearing age)

Keywords: laparoscopic promontofixation outpatient management
nitrous oxide and risk of cancer recurrence after colorectal surgery: a randomized, blinded study

Conditions: Colorectal Cancer

Summary: this study was developed to test the hypothesis that the risk of colorectal cancer recurrence was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during colorectal surgery.

we conducted a 4- to 8-year follow-up of 204 patients with colorectal cancer who were randomly assigned to 65% nitrous oxide (n=97) or nitrogen (n=107), balanced with isoflurane and remifentanil. the primary outcome was the time to cancer recurrence. our primary analysis was a multivariable cox-proportional-hazards regression model that included relevant baseline variables. in addition to treatment group, the model considered patient age, tumor grade, dissemination, adjacent organ invasion, vessel invasion, and the number of nodes involved. the study had 80% power to detect a 56% or greater reduction in recurrence rates (i.e., hazard ratio of 0.44 or less) at the 0.05 significance level.

Eligibility criteria:
inclusion criteria: * subjects age 18-18 * asa status 1-3 * informed consent exclusion criteria: * acute bowel obstruction * minor colon surgery

Keywords: nitrous oxide cancer recurrence colorectal surgery
local therapy for er/pr-positive oligometastatic breast cancer

Conditions: Breast Cancer

Summary: randomized phase 2 trial to evaluate the efficacy of local therapy for oligometastasis from er/pr-positive breast cancer. the study hypothesis is that local therapy in addition to systemic therapy improves progression-free survival in comparison with systemic therapy alone.

patients with estrogen receptor/ progesterone receptor-positive oligometastatic breast cancer with disease controlled after at least six months of systemic therapy will be enrolled in the study. patients will be randomized to receive local therapy for oligometastatic sites in addition to systemic therapy or systemic therapy alone. local therapy strategies will include surgery, radiotherapy, and radiofrequency ablation.

Eligibility criteria:
inclusion criteria: * female sex * ≥ 18 years of age * histologically confirmed invasive breast cancer, with oligometastatic disease defined as one of the following criteria: 1) one to four bone lesions; 2) one to four lung and/ or hepatic lesions; 3) distant metastasis limited to ipsilateral cervical lymph nodes; 4) distant metastasis limited to contralateral axillary lymph nodes * oligometastatic sites amenable to treatment with a local therapy modality, including surgical resection, stereotactic radiotherapy, or radiofrequency ablation * estrogen receptor-positive and/ or progesterone receptor-positive breast cancer * partial response or stable disease after at least six months of systemic therapy for breast cancer * eastern cooperative oncology group (ecog) performance status 0 or 1 * measurable or non-measuble disease according to response evaluation criteria in solid tumors (recist) 1.1 * life expectancy of at least 12 weeks * for women in childbearing age, negative pregnancy test until 21 days before the date of study enrollment. * signed informed consent form * disposition and aptitude to fulfill the study protocol during the study duration exclusion criteria: * her2-positive breast cancer * progressive disease during the last systemic treatment received for metastatic disease * previous local therapy for distant metastasis * current or previous history of severe diseases, such as clinically relevant heart failure, acute myocardium infarction in the last six months, chronic obstructive lung disease, hiv infection, chronic active hepatitis b or c infection, current serious uncontrolled infections or other severe diseases that may impact patients' expected survival) * current or previous history of other invasive malignancy within the last five years, excluding non-melanoma skin cancer

Keywords: oligometastasis hormone receptor positive surgery radiotherapy radiofrequency ablation
ti pc software for analyzing longitudinal data

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to develop ti (pronounced 't-sub-i'), a personal computer program to analyze time-varying data generated by periodic patient reports, repeatedly-observed disease signs, or serial biomarkers to study chronic disease.

background: with the advent of quasi-likelihood, generalized estimating equations, and new ways to handle missing data, has come a striking increase in applicable models, perhaps more than after the 1972 introduction of the cox model for survival data. ti provided a way to analyze the data. design narrative: til provided graphics for data exploration and model validation. ti ran under most current version of windows, used civilized software's mlab as its programming language, offered context-sensitive help, a dictionary of relevant terms, identification of file entries from their screen position, and simple animation. ti permitted the user to analyze time-varying data from the two perspectives of repeated measured using a variety of models and time series where both time and frequency domain tools were provided. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
habituation to food as a risk factor for pediatric obesity

Conditions: Obesity in Children

Summary: the study is designed to assess habituation of behavioral responding for food as risk factors for increases in standardized body mass index (zbmi) over two years in non-overweight children.

cross sectional data have shown slower habituation is related to greater energy intake, and habituation is slower for overweight/obese compared to leaner youth, but it is not known whether this is a result of being overweight, or whether slower habituation is a risk factor for weight gain. the goal of this application is to study individual differences in behavioral (responding for food) habituation as risk factors for alterations in zbmi and body fat over a two year period in 200, 8 to 12 year-old non-overweight children. this project will provide the first test of the hypothesis that slow habituation to food is a risk factor for increases in zbmi in non-overweight youth.

Eligibility criteria:
inclusion criteria: * 8-12 years of age * participants will include children who are at the 50th bmi percentile and less than the 85th bmi percentile (bmi = kg/m2) at baseline. we will also include children who are below the 50th percentile, but have at least one biological parent with a current bmi ≥ 25 kg/m2. exclusion criteria: * food allergies or special diets: youth should have no dietary restrictions that could interfere with these experiments, including food allergies or religious or ethnic practices that limit food choice or medical conditions which alter nutritional status or intestinal absorption (e.g. inflammatory bowel disease). * activity restrictions: children who have activity restrictions due to medical or physical problems, such as uncontrolled exercise induced asthma or a disability requiring wheelchair use will not participate. * psychopathology, medications or sickness: children should have no psychopathology (e.g. childhood schizophrenia) or developmental disabilities that would limit participation. children will also be excluded if they are taking medications that could affect their level of activity or appetite (e.g. methylphenidate). * moderate or greater liking of study foods. children must report at least a moderate liking ( 3 or greater on a 5-point likert-type scale) of the foods used in these studies and be willing to consume them.
radiation induced cardiopulmonary injury in humans

Conditions: Thoracic; Pulmonary Injury; Heart Injuries

Summary: the purpose of the study is to assess the time, dose dependence, and fraction-size dependence of radiation (rt)-induced changes in regional lung and heart perfusion/function/structure following thoracic rt delivered using newer imrt/conformal/radiosurgery techniques. the pi hopes to develop models to better relate and predict rt-induced changes in regional lung and heart perfusion/function/structure with changes in global cardiopulmonary function. patients will undergo pre- and serial post-rt lung and heart assessments to better understand rt-induced regional heart/lung changes.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. patients who are to receive 3d-planned rt for tumor within and around the thorax. 3. patients receiving incidental rt to portions of the heart are eligible. 4. estimated minimum expected life expectancy of one year 5. able to undergo the required study-related tests for regional lung injury and regional heart injury 6. patients of child bearing potential age must have a negative pregnancy test and must agree to use appropriate birth control measures while in the study. 7. patients must be able to give informed consent. informed consent will be obtained prior to enrollment. exclusion criteria: 1. patients who are anticipated to have thoracic surgery post-rt are ineligible. 2. patients with large mediastinal/hilar tumors compressing the airways/vessels, and negatively impacting on cardiovascular function 3. pregnant or nursing women.

Keywords: radiation therapy
efficacy of focal primaquine mass administration for eliminating plasmodium vivax malaria in northern myanmar

Conditions: Malaria; Mass Drug Administration; Myanmar; Plasmodium Vivax; Primaquine

Summary: plasmodium vivax has become the predominant species in the greater mekong subregion and is a major challenge for regional malaria elimination. mass primaquine administration has played a decisive role in malaria elimination in many temperate zone countries, but its efficacy in tropical areas remains to be evaluated. this study aims to assess the efficacy of targeted primaquine mass treatment (tpt) for eliminating p. vivax malaria in northern myanmar.

this study employed a cluster-randomized crossover design in which two groups of villages received tpt at different times. in august-september 2019, group 1 received tpt (0.25 mg/kg/day primaquine base for 14 days), while group 2 was the control. in june-july 2020, group 2 received tpt, while group 1 served as the control. to evaluate the effectiveness of tpt for preventing relapses of vivax malaria, two indicators were utilized: infection prevalence at 3-month intervals estimated through cross-sectional surveys and monthly malaria incidence by passive case detection. the data were analyzed using descriptive statistics, chi-squared test, cumulative hazard function, and mixed model logistic regression.

Eligibility criteria:
inclusion criteria: * residents in study villages * male/ female * consent to participate exclusion criteria: * low hb% * g6pd deficiency * pregnant women, * breastfeeding mothers and * children under 7 years
sequential compression device on body temperature

Conditions: Hypothermia

Summary: we hypothesized that sequential compression device (scd) compression system might induce more decreases on core temperature by increasing lower extremity blood flow. and, this study investigated the effects of scd compression system on body temperature in patients during total intravenous anesthesia (tiva) with propofol and remifentanil.

anaesthesia was induced and maintained with propofol and remifentanil. during the surgery, temperature was measured and recorded using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient, respectively.

Eligibility criteria:
inclusion criteria: * asa i or ii * 20-65 year * patient who undergoing elective thyroidectomy exclusion criteria: * coronary occlusive disease * peripheral vascular disease * bmi \> 30 kg/m2 * abnormal thyroid function test * laparoscopic assisted thyroidectomy

Keywords: core temperature sequential compression device total intravenous anesthesia
asking people with psoriasis about lifestyle and eating

Conditions: Psoriasis

Summary: the apple study aims to understand if specific diet and lifestyle patterns are present in individuals with psoriasis and if these factors are correlated with psoriasis severity.

prospective participants will be invited to read an information sheet and provide informed consent. once informed consent is obtained, participants will be screened for eligibility with a short online screening questionnaire. upon successful completion, participants will be directed to start the online multiple-choice survey with questions on psoriasis, diet and lifestyle patterns and complete a 4-day diet diary.

Eligibility criteria:
inclusion criteria: adults (18 years of age or older) dermatologist diagnosis of psoriasis residents in the united kingdom (uk) fluent in english exclusion criteria: minors (17 years of age or younger) not medically diagnosed with psoriasis non-uk residents

Keywords: diet lifestyle sleep physical acitivty wellbeing
association between low back pain and quality of sleep

Conditions: Quality of Sleep; Subacute or Chronic Low Back Pain; Disability; Catastrophizing; Depression

Summary: a prospective study to assess the association between the change in quality of sleep and the change in intensity of pain in spanish patients seen for subacute or chronic low back pain. the objective is to determine the prevalence of sleep alterations, the association between quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing and depression.


Eligibility criteria:
inclusion criteria: * patients with non-specific low back pain of more than 14 days duration * seen in health centers participating in the study * who accept to participate and sign the consent form * without age limits and regardless of gender exclusion criteria: * inability to complete the questionnaires (illiteracy, dementia) * inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 years

Keywords: quality of sleep low back pain disability catastrophizing depression
a long-term study to monitor the health status of people with cystic fibrosis who took part in a previous study with bi 3720931 (lenticlair™-on)

Conditions: Cystic Fibrosis

Summary: this study is for people with cystic fibrosis who took part in a previous study with a medicine called bi 3720931. the main purpose of this study is to monitor the long-term health of participants who were treated with bi 3720931 in the previous study. participants in this study do not receive additional treatment with bi 3720931. participants who previously took bi 3720931 are in this study for 15 years. participants who previously took placebo are in the study only until it is disclosed that they were in the placebo group, after which they stop. participants who previously took bi 3720931 visit the study site about 20 times. participants visit once every 3 months during the first 2 years. after that, they visit once a year. during study visits, doctors check the health of the participants and note any health problems that could have been caused by bi 3720931. they also do lung function tests to see if bi 3720931 helps people with cystic fibrosis in the long term.


Eligibility criteria:
inclusion criteria: 1. trial participants who participated in a previous bi sponsored trial with bi 3720931 and have received any dose of bi 3720931, or matching placebo 2. signed and dated written informed consent in accordance with international council for harmonisation (ich)-good clinical practice (gcp) and local legislation prior to admission to the trial there are no exclusion criteria for enrolment into the trial.
resveratrol for the treatment of non alcoholic fatty liver disease and insulin resistance in overweight adolescents

Conditions: NAFLD; TYPE 2 DIABETES; METABOLIC SYNDROME

Summary: the current project is designed as a 30-day pilot trial to demonstrate the safety and tolerability of resveratrol therapy in overweight adolescents to decrease liver fat, and improve insulin sensitivity to prevent type 2 diabetes.

pilot study of 10 overweight or obese children with mrs determined fatty liver randomized to resveratrol or placebo. primary outcome measures include change in liver triglyceride content as determined by mrs and improvement in insulin resistance as determined by the area under the curve of glucose excursion during a 75 gram oral glucose tolerance test.

Eligibility criteria:
inclusion criteria: * 13 to \<18 years of age * bmi considered overweight (bmi \> 25 kg/m2 ) or obese (bmi \> 30 kg/m2 ) * confirmed 1h-mrs defined hepatic steatosis (\>5.5% fat/water) * parent/guardian willing and able to provide written, signed informed consent, and subjects willing to co-sign parental consent * sexually active subjects must be willing to use an acceptable method of contraception * females of child bearing potential must have a negative pregnancy test at screening. exclusion criteria: * the use of any chronic medications with the exception of oral birth control and natural health products with the exception of multivitamins. * adolescents with altered insulin sensitivity or tissue lipid content unrelated to obesity and the metabolic syndrome, including: type 2 diabetes; present or previous malignancy renal disease, hypertension (anyone who has bps over the 99th percentile for age and gender) or liver disease; * significant weight loss (10% in last six months) or enrolled in weight loss program in the six months prior to the study; * self-reported history of alcohol consumption of greater than two drinks per day and/or drinking alcohol more than once weekly; * report using non-prescription recreational drugs; * allergies or sensitivities to any of the ingredients in the investigational product or placebo; * females breastfeeding at screening or planning on becoming pregnant at any time during the study;

Keywords: pediatrics adolescents nafld spectroscopy type 2 diabetes