Kornimate/medical-research-clean huggingface dataset:
impact of associated abdominal injuries on clinical and operative outcome in pelvic injuries

Conditions: Pelvic Ring Fracture; Acetabular Fracture; Abdominal Trauma; Polytrauma

Summary: pelvic fractures are severe injuries which require advanced orthopedic surgical skills to treat. on the other hand, abdominal injuries are severe injuries, which might require quick general surgical treatment. the combination of both injuries is a challenge for orthopedic surgeons, as the abdominal injury might lead to a delayed surgical treatment of the pelvic fracture. whether an associated abdominal injury influences the quality of care of pelvic fractures, is aim of this registry study.

the german pelvic registry of the german trauma society is a multicenter prospective registry which collects data of patients with pelvic injuries since 2003. beside demographic data (including concomitant injuries) allowing for epidemiological evaluations of the development of surgical care in these patients, namely the operative care is focus of this registry. beside the chosen procedure or surgical approach, this includes both intraoperative data like time until operation, duration of the procedure or intraoperative blood loss and reduction parameters (pre- and postoperative fracture steps). the clinical course is recorded also including overall morbidity, overall mortality and osteosynthesis-related complications. the influence of a concomitant abdominal trauma on the quality of care regarding operative parameters like reduction quality or the clinical course in pelvic injuries has not been investigated yet. the investigators therefore retrospectively analyze the prospective consecutive data of patients from the multicenter german pelvic registry of the german trauma society in the years 2003 - 2017. demographic, clinical and operative parameter were recorded and compared in two groups (isolated pelvic fracture vs. combined abdominal/pelvic trauma).

Eligibility criteria:
inclusion criteria: * pelvic fracture exclusion criteria: * no agreement to participate in the registry

Keywords: pelvic trauma pelvic ring fracture acetabular fracture abdominal trauma polytrauma reduction quality
pacap-38 infusion in patients with cluster headache

Conditions: Cluster Headache

Summary: a randomized, double-blinded, two-way crossover study investigating the headache inducing capabilities of pacap-38 in patients with cluster headache. forty-five patients (15 episodic patients in cluster, 15, episodic patients in remission and 15 chronic cluster headache patients) are expected to participate. each patients will on two separate study days in a randomized way receive an infusion of pacap-38 and vip over 20 minutes followed by an observation period of 70 minutes. blood samples for investigation of vip, pacap38; cgrp, nse, histamine and tryptase will be drawn at fixed time-points during experiment.


Eligibility criteria:
inclusion criteria: * episodic or chronic cluster headache according to international classification of headache disorders * age 18-65 years * weight 50-100 kg * if women of childbearing potential, then must use safe contraceptives exclusion criteria: * episodic tension-type headache \> 15 days per month * other primary headache disorders, except tension-type headache \< 5 days per month * episodic cluster headache patients outside cluster must be completely headache free a minimum of 8 hours prior to experiment * episodic cluster headache patients in cluster and chronic cluster headache patients must be completely headache free a minimum of 4 hours prior to experiment * current or recent use (30 days) of injected or oral corticosteroids * pregnant or lactating women * a history or clinical signs of hypertension (bp \> 150mmhg systolic / 100mmhg diastolic) * a history or clinical signs of hypotension (bp \<90 mmhg systolic / 50mmhg diastolic) * a history of cardiovascular or cerebrovascular disease * a history of psychiatric disease or substance abuse * a medical history or clinical signs of disease that according to investigator would preclude participation in the study
a study to evaluate etrasimod treatment in adolescents with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine the safety, efficacy, and pharmacokinetics (pk) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to \< 18 years of age). participants who will complete the total 52-week treatment period will have the opportunity to continue in a long-term extension (lte) period of up to 4 years (5 years after study enrollment).


Eligibility criteria:
inclusion criteria: * have a diagnosis of ulcerative colitis (uc) that is moderately to severely active * participants are permitted to be receiving a therapeutic dose of select uc therapies exclusion criteria: * severe extensive colitis * diagnosis of crohn's disease (cd) or indeterminate colitis or the presence or history of a fistula consistent with cd * diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Keywords: pharmacokinetics adolescents active ulcerative colitis apd334
sleep and resistance exercise

Conditions: Sleep Deprivation

Summary: introduction: despite the awareness of the importance of sleep in our lives, especially for athletes, the consequences of poor rest on sports performance are not well understood. furthermore, the interaction between complete and partial sleep deprivation over one night and sleeping the usual hours for each person remains unclear. objectives: the aim of this study is to evaluate the effects of sleep deprivation on the production of strength, power, and muscular endurance according to sex (men vs. women) and type of exercise (bench press vs. squat). additionally, the study will analyze the effects of sleep deprivation on perceived fatigue, mood, dietary habits, electrical activity, resting metabolic rate (rmr), and maximal fat oxidation (mfo).


Eligibility criteria:
inclusion criteria: * age between 18 and 35 years. * body mass index (bmi) \&lt; 25 kg/m². * resistance-trained individuals (more than 2 years of structured training). * healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising. * participants must be able to perform the tests described in the following section. exclusion criteria: * history of neuromuscular diseases, heart disease, or conditions that may affect liver or muscle metabolism. * use of drugs, stimulants, or sports supplements that could interfere with the dietary supplement used in the study. * sedentary habits (less than 150 minutes/week of moderate exercise). * having undergone prolonged periods of physical inactivity in the 6 months prior to the study. * engaging in strenuous exercise within 48 hours prior to the tests. * failure to replicate the same food intake on both experimental days. * consumption of caffeine or any other stimulant the day before the tests.
evaluation of the effects of an exogenous phytase on iron absorption from lns added to complementary foods

Conditions: Iron Deficiency

Summary: previous studies on iron absorption have focused on the effects on the addition of iron absorption enhancers like ascorbic acid and edta to a meal and more recently the enzymatic phytic acid removal through phytase. the investigators want here to investigate the effects of fat on iron absorption with and without the addition of exogenous phytase as a potential iron absorption enhancer in lipid nutrient supplements (lns) products compared to micronutrient powder(mnp) products. furthermore the investigators will evaluate the effects of lipids- on iron absorption to induce the ileal brake by ingestion of a fat emulsion prior to a meal. increasing the caloric density of a meal by increasing its fat content might enhance iron absorption by delaying gastric emptying, gastric acid secretion and increasing fe stomach residence time.


Eligibility criteria:
inclusion criteria: reproductive age females 18-45 years * normal body mass index (17.5-25 kg/m2) * no intake of mineral/vitamin supplements 2 weeks before and during the study * no metabolic or gastrointestinal disorders * no food allergies or other chronic disorders or eating disorders assessed by self-report * having received full oral and written information about the aims and procedures of the study * willing to comply with the study procedure * having provided oral and written informed consent exclusion criteria: * regular intake of medication (except oral contraceptives) * blood donation or significant blood loss (accident, surgery) over the past 4 months * currently participating in another clinical trial or having participated in another clinical trial during the last 30 days prior to the beginning of this study * former participation in a study involving administration of iron stable isotopes * subject who cannot be expected to comply with study protocol * pregnancy or lactation
investigational study with the bd posiflush™ safescrub on nads

Conditions: CRBSI - Catheter Related Bloodstream Infection

Summary: this study is an investigational study to evaluate the safety and performance of the bd posiflush™ safescrub on needleless access devices.

this study is being conducted to generate clinical data to support the performance and safety of bd posiflush™ safescrub. the study data will be used for regulatory submission in eu.

Eligibility criteria:
inclusion criteria: 1. any patient (≥18 years of age) in a high acuity hospital medical or surgical unit regardless of gender, with an eligible in-situ vascular access device and with a needleless access device (nad). this includes patients who have a current vad, whether it is newly placed or long-term access as part of their routine medical care. eligible in-situ vascular access devices are peripheral intravenous catheters (pivcs), peripherally inserted central catheters (piccs), central venous catheters (cvcs) and implanted venous access ports. eligible nads are stopcocks, y-sites, and needle-free connectors. 2. expected to be available until 2 accesses are completed and for any periodic observation upto 15 min after each access. 3. able and willing to provide informed consent or legal authorized representative (lar) authorized to give consent on behalf of the participant. exclusion criteria: any patient in whom observation might interfere with medical care or create undue hardship as determined by the patients care team. * patients under the age of 18. * patients suffering hypernatremia and fluid retention, when the administration of sodium or chloride could be clinically detrimental as determined by the study investigator. * patients with a known allergy to any of the followings as determined by the study investigator: * any of the components or materials of bd posiflush™ safescrub device or bd posiflush™ sp syringe, or * 0.9% sodium chloride solution * pregnant or breastfeeding women * urine pregnancy test will be required for all women of childbearing age who want to participate in the study
barriers and facilitators to vegetable intake

Conditions: Overweight; Obese

Summary: the purpose of this study is to find out why people do or do not eat vegetables.

the dietary guidelines for americans (dga) stress the importance of a diet high in fruits and vegetables (fv) to achieve health benefits. despite the recommendations, adherence is low; only 12% of the population meets the recommendation for fruits and even less of the population (9%) meets the recommendation for vegetables. recently, it was found that vegetable consumption increased when individuals were provided the recommended daily amounts while participating in a clinical study, but returned to pre-study low levels when vegetables were no longer supplied. this result suggests that habitual consumption of fv is strongly regulated by behaviors influenced by social, environmental, and/or individual factors. therefore, identifying regulatory factors of vegetable consumption will greatly assist in developing successful strategies to increase vegetable intake to achieve health benefits. the overall objective of this study is to examine both barriers and facilitators to adherence to consuming dga-recommended amounts of vegetables in participants who completed a randomized controlled trial with provided vegetables or who were in a control group, using the nominal group technique (ngt).

Eligibility criteria:
inclusion criteria: * participant in nct02585102 who gave permission to be contacted for a follow-up study. exclusion criteria: * did not participate in nct02585102. * participant in nct02585102 who did not give permission to be contacted for a follow-up study.

Keywords: vegetable intake
neuroimaging predictors of antidepressant treatment outcome

Conditions: Depression

Summary: current medical therapies for depression take weeks to achieve full efficacy, and are ineffective in many patients or cause intolerable side effects, emphasizing the need for a deeper understanding of depression and its treatment. identifying early brain biomarkers of treatments responses seems necessary to improve antidepressant treatment outcome. in this study we aim to detect early brain responses to a fast acting antidepressant-like treatment administered intravenously during a real-time neurofeedback functional magnetic resonance imaging (mri) task to predict antidepressant treatment outcome in depression. at completion of the neuroimaging task, participants will enter a placebo-controlled clinical trial with a selective serotonin reuptake inhibitor (ssri).


Eligibility criteria:
inclusion criteria: inclusion criteria will include hamilton depressive rating scale (hdrs) scores \>15 and snaith-hamilton pleasure scale scores (shaps) \> 7. exclusion criteria: suicidal ideation, comorbid conditions that are medical, neurological or psychiatric, pregnancy, use of hormones (including birth control) or use of psychotropic agents. we will only permit certain past anxiety disorder diagnoses, including generalized anxiety, panic, agoraphobia, social phobia. we will also exclude left-handed individuals and patients who have used any centrally acting medications, nicotine, or recreational drugs within the past 2 months.
intravenous immunoglobulin in prevention of preterm neonatal sepsis

Conditions: Neonatal Sepsis

Summary: majority of healthcare authorities believe that due to the methodological weakness and small number of patients in conducted therapeutic trials, the evidences are insufficient to support the efficacy of intravenous immunoglobulin (ivig) in prevention of preterm neonatal sepsis. the objective of this research is to determine the effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis.


Eligibility criteria:
inclusion criteria: * born alive before 37 weeks of pregnancy (preterm neonates) * under 2500 g at birth exclusion criteria: * lethal anomaly * congenital heart disease * torch infection * severe asphyxia
the effect of black currant on postprandial glucose metabolism

Conditions: Postprandial Hyperglycemia; Prediabetic State

Summary: the study examines the effect of black currant on glucose and insulin concentrations after a meal. in addition, the cytokine and free fatty acids levels are of interest.

the study examines the effect of black currant on glucose and insulin concentrations after a meal. healthy (n= 30) volunteers are recruited to participate in four consecutive visits in the research laboratory, when four meals are served in randomised order. meals are: black currant puree, black currant and quinoa based snack, quinoa base and liquid containing glucose, fructose and sucrose. the meals contain the same amount of carbohydrates. in addition to glucose and insulin concentration, cytokine and free fatty acid concentrations are measured after each meal.

Eligibility criteria:
inclusion criteria: * age: 25-65 years * bmi: 20-28 kg/m2 * perceived health status: good exclusion criteria: * fasting glucose: \> 7.0 mmol/l * ldl-cholesterol: \> 3.0 mmol/l * total cholesterol: \> 6.5 mmol/l * blood pressure : \> 160/100 mmhg * weight change of \> 5% during previous 6 months or active weightreduction * no serious chronic diseases * one exception of the exclusion criteria maybe accepted after the md consideration

Keywords: berries black currant glucose glycemia quinoa
virtual walking intervention for neuropathic pain in spinal cord injury

Conditions: Spinal Cord Injuries; Neuropathic Pain

Summary: the purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with chronic spinal cord injury.

many people with sci experience neuropathic pain. neuropathic pain is often described as sharp, burning, or electric. 'traditional' treatments often do not do a good job of reducing neuropathic pain. therefore, it is important to see if 'non-traditional' treatments might work. scientists think that neuropathic pain occurs in sci because the sensations coming from the eyes and up the spinal cord to the brain do not match what the brain thinks it told the body to do. this 'mis-match' may result in changes in the brain that make neuropathic pain possible. virtual reality walking reduces this 'mis-match.' it does this by creating the 'illusion' that the person is walking. the brain then thinks it is telling the body to walk and the information coming from the eyes matches its instructions. this 'matching' may reverse the brain changes that made neuropathic pain possible. the current study is specifically focused on individuals whose sci has been classified as complete (asia a).

Eligibility criteria:
inclusion criteria: the study will recruit individuals with complete injury (american spinal injury association \[asia\] classification a) with lumbar, paraplegic, or low tetraplegic (c5-c7) injury. additional criteria will include: 1. must have persistent np symptoms that are of daily severity of at least 4/10 for 3 or more months 2. must endorse more than 2 items on a 7-item spinal cord injury pain instrument, scipi 3. must be 18 years of age or older 4. must be more than one year post-injury to begin study (can be screened at an earlier time for eligibility) 5. must have mobile connectivity with usable service 6. must be stable on pain medication for 1 or more months 7. must be cleared on the vrwalk physical activity clearance scale 8. must not have motion sickness that interferes with daily life exclusion criteria: 1. individuals with injury levels between c1 and c4 2. individuals under the age of 18 3. individuals who were injured within the past year 4. individuals who cannot comprehend spoken english 5. individuals who are in prison 6. individuals who are blind 7. individuals who experience severe motion sickness
study of kw-6002 (istradefylline) for the treatment of parkinson's disease in patients taking levodopa

Conditions: Parkinson's Disease

Summary: the purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the off state in patients with advanced parkinson's disease (pd) treated with levodopa. patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.


Eligibility criteria:
inclusion criteria: 1. be willing and able to give written informed consent 2. uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd 3. pd stages 2-4 in the off state for modified hoehn and yahr scale 4. on levodopa/dopa-decarboxylase inhibitor for at least one year 5. taking at least three doses and \>=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization 6. predictable end of dose wearing off 7. able to satisfactorily complete hauser based 24-hour patient parkinson's diary 8. have an average of two hours of off time on 24-hour diaries 9. on a stable regimen of any other anti-parkinson's drugs for at least four weeks before randomization 10. on a stable dose of domperidone for at least 14 days before randomization exclusion criteria: 1. taking any excluded medications 2. neurosurgical treatment or transcranial magnetic stimulation for pd 3. diagnosis of cancer within 5 years 4. diagnosis of clinically significant illness of any organ system 5. diagnosis of dementia or mini-mental status examination score of 23 or less 6. history of drug or alcohol abuse or dependence within the past two years 7. history of psychosis 8. history of significant drug allergies 9. taking anticonvulsants for seizures 10. history of neuroleptic malignant syndrome 11. pregnant or lactating females

Keywords: parkinson's disease levodopa end of dose wearing off off time
validation of the start back screening tool in the military

Conditions: Low Back Pain; Lumbago; Radiculopathy; Intervertebral Disc Disorder

Summary: this is a trial to validate the use of the start back screening tool (sbst) in the military health system for patients with low back pain presenting to primary care.

subjects with low back pain presenting to primary care will be enrolled in a study that aims to evaluate the utility of the sbst for providing risk-stratified care. the concept of this approach revolves around matching treatment to patients based on their risk for developing chronic disability from back pain. those at low risk receive less treatment, and those at high risk need more specialized treatment, that includes psychosocially-focused and cognitive considerations. this approach will be compared to usual care, where general practitioners carry out the course of action they think best for each patient, without any other guidance. patients will be followed for 1 year.

Eligibility criteria:
inclusion criteria: 1. males and females who are between the ages of 18-50 years old 2. primary complaint of lbp for any duration, with or without associated radiculopathy 3. can speak and understand english 4. be willing and able to give full, informed written consent exclusion criteria: 1. red flags: any potentially serious or systemic disorders (e.g., cauda equina compression, inflammatory arthritis, compression fracture, malignancy, infection, severe neurological progression), serious illness or comorbidity 2. spinal surgery in the past 24 months 3. current pregnancy (or within the last 6 months) 4. already receiving treatment (other than primary care) for this episode of lbp 5. inability to attend regular treatment sessions 6. pending litigation or a medical evaluation board

Keywords: low back pain risk-stratified care