Kornimate/medical-research-clean huggingface dataset:
effect of teriparatide on fracture healing in patients with incomplete atypical femur fractures

Conditions: Non Displaced Atypical Femoral Fractures

Summary: atypical femur (thigh bone) fractures (affs) are uncommon low-trauma fractures which often occur without warning, are highly debilitating, and are slow to heal. as physicians learn more about them, affs are increasingly being identified prior to a total break. however, there's no evidence on the best way to treat these non-displaced affs. one option is teriparatide, an osteoporosis medication that can build new bone. investigators will conduct a double blind randomized placebo controlled trial to examine whether teriparatide use in aff patients with an incomplete break will help accelerate fracture healing and prevent surgical intervention. co-primary outcomes include change in womac scores from baseline to 12 months and number of participants requiring surgical intervention at 12 months. investigators will recruit 60 women and men over the age of 30 who have experienced an incomplete aff. participants will be randomly assigned to either teriparatide (20 mcg/day) or placebo (using an identical injection pen) for up to 2 years. as affs are highly debilitating, a trial examining the use of teriparatide in this population is urgently needed.


Eligibility criteria:
inclusion criteria: i. female or male; ii. over the age of 30; iii. experienced an incomplete aff that satisfies the diagnostic criteria as set forth by the american society for bone and mineral research (asbmr) international task force on affs: 1. atraumatic or low trauma incomplete stress fractures, defined as fractures sustained with minimal force, such as a fall from standing height; 2. from distal to the lesser trochanter to proximal to the supracondylar flare along the femoral shaft. 3. radiographic confirmation of aff features is required for a definitive diagnosis. incomplete aff features include cortical thickening, cortical beaking, and lucency line. patients with cortical beaking without lucency line can be included. exclusion criteria: i. peri-prosthetic fractures, ii. high trauma fractures, iii. pathological fractures secondary to metastases or metabolic bone diseases other than osteoporosis, iv. fractures that are not confirmed by radiological investigations, v. contraindication to use of teriparatide such as: 1. pregnant or nursing mothers, or women who are planning on pregnancy within 1 year of completing teriparatide therapy, 2. hypersensitivity to teriparatide, 3. severe renal impairment, 4. multiple myeloma, 5. active cancer in past 5 years (other than non-melanoma skin cancer), 6. primary hyperparathyroidism, 7. hypercalcemia, 8. paget's disease or other conditions that may increase the risk for osteosarcoma, 9. prior radiation therapy involving the skeleton, vi. concomitant use of other osteoporosis therapies including bisphosphonates or denosumab (except calcitonin). aff patients with complete fractures on the contralateral side or patients with secondary osteoporosis will not be excluded.
nac for head trauma-induced anosmia

Conditions: Anosmia; Head Trauma

Summary: this study will compare administration of n-acetyl cysteine (nac) versus placebo for the treatment of olfactory loss due to head injury. the hypothesis is that treatment with nac acutely after head injury will result in improved olfactory function


Eligibility criteria:
inclusion criteria: * admitted to ryder trauma center for observation acutely following head injury (i.e. concussion), with documented hyposmia or anosmia by university of pennsylvania smell identification test (sit). * male or female, aged 18 years or older * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * ability to take oral medication and be willing to adhere to the nac regimen * for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of nac administration exclusion criteria: * severe trauma requiring ongoing inpatient treatment beyond 48 hours * pregnancy (based on urine screening) or lactation * known allergic reactions to components of nac, such as mucomyst * currently taking nitrates such as nitroglycerine and/or isosorbide regularly * currently taking azathioprine (imuran) or cyclophosphamide (cytoxan) * known diagnosis of cystinuria (renal condition in which cysteine supplement should be avoided) * febrile illness within 1 week * treatment with another investigational drug or other intervention within 3 months * active sinonasal disease by imaging and/or nasal exam, i.e. rhinosinusitis, nasal polyps * adults unable to consent * prisoners, employees or subordinates * individuals who are not yet adults (infants, children, teenagers). this population is excluded because efficacy has not yet been established in adults.
observational study on skeletal ewing's sarcoma

Conditions: Ewing Sarcoma of Bone

Summary: observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by skeletal ewing sarcoma

the ewing sarcoma treatment is based on chemotherapy, surgery and radiotherapy. chemotherapy, performed with a combination of several drugs, is given as primary treatment before surgery. surgical intervention must be performed in all cases in which it is possible to obtain an excision with free margins and with acceptable functional deficits. however, when, after surgery in case of incomplete resection, post-operative radiotherapy is used, in order to reduce the risk of local recurrence as much as possible. subsequently in the local treatment, a phase of maintenance chemotherapy is foreseen, the intensity of which is modulated according to the response to induction therapy. the treatments are carried out with different programs for patients with localized disease or metastatic disease and derive from clinical trials carried out in the last 30 years. these results are the result of national and international prospective trials which, precisely due to the rarity of the disease, took many years to execute, and it is significant to know that randomized studies were in very limited numbers, as almost all the studies were represented by studies of uncontrolled phase ii improving treatments requires the expansion of knowledge on the biological behavior of this tumor and the acquisition of as much information as possible deriving from clinical experience. for this reason, pending the definition of a new prospective randomized trial, which will take time (approximately two years) to be made operational, it is considered useful from a scientific point of view to prospectively collect data relating to new cases of ewing's sarcoma 'bone.

Eligibility criteria:
inclusion criteria: 1. diagnosis of ewing's sarcoma of the bone 2. diagnosis of ewing-like sarcoma (round cell sarcoma with fusion of the ewsr1 gene with others not of the ets family, sarcoma with cic rearrangement or sarcoma with bcor rearrangement) 3. diagnosis of extraosseous ewing's sarcoma for patients 4. age at diagnosis \<50 years 5. assessment of the extent of the disease at onset in accordance with the european society of medical oncology guidelines 6. patients or parents oe guardians of minors who have given their written informed consent to participate in the study exclusion criteria: 1. presence of comorbid factors who can compromise the compliance of the treatment plan or the evaluation of the outcomes, including but not limited to organ pathologies that contraindicate the use of chemotherapy and psychological or social conditions that do not allow for adequate compliance treatment or adequate follow-up

Keywords: ewing sarcoma
effects of insulin treatment on postprandial platelet activation in patients with non-insulin-dependent diabetes mellitus (niddm)

Conditions: Type 2 Diabetes Mellitus; Postprandial Hyperglycemia

Summary: the postprandial phase in diabetic patients is characterized by a rapid increase in blood glucose levels, increase in platelet aggregation, ldl oxidation and over production of thrombin. the aim of the study is to determine whether meal induced platelet activation is related to post-prandial hyperglycemia, and can be attenuated by good postprandial glucose control with rapidly acting insulin in patients with t2dm.

each patient is admitted in the fasting state, on 3 different occasions . blood glucose levels are normalized using intravenous infusion of insulin aspart , to a blood glucose level of 6-7 mmol/l. 15 minutes after normalization ,and right before a standardized meal, the patient is given a subcutaneous injection of insulin aspart 0.1 u/kg, 0.2 u/kg or placebo. the order of injections in the cross over study is randomized and blinded to the patient and to the investigators. the patient eats the meal and is followed up for 90 minutes after completion of the meal. blood tests for platelet function and other parameters are taken at 3 main points: 1. before glucose normalization. 2. 15 minutes after glucose normalization, and right before the meal. 3. 90 minutes after the meal. platelet function is evaluated by flow cytometry in whole blood (p- selectin expression, fibrinogen binding,aggregate formation: platelet- leukocyte, platelet-platelet, platelet-monocyte). agonists that are used for platelet activation in flow cytometry are the thromboxane analogue u46619, adp, and a collagen peptide that activates gpvi. platelet adhesion is measured by the impact cone and platelet analyser.

Eligibility criteria:
inclusion criteria: * type ii diabetes mellitus. * antecubital forearm veins allowing technically good sampling for platelet studies. * hba1c 6-9 % (mono-s method). * below 70 years exclusion criteria: * history of a cardiovascular disease; ischemic heart disease, stroke, peripheral vascular disease. * acute or chronic renal or liver disease * contraindication to insulin treatment * treatment with glitazones, sulphonylurea, antiplatelet drugs, * thrombocytopenia \<150 x109/l.

Keywords: niddm platelet activation postprandial hyperglycemia insulin
influence of relaxing breathing before each station of an objective structured clinical examination

Conditions: Performance Anxiety; Stress; Coping Skills

Summary: sobjective and structured clinical examinations (osces) has been incorporated recently in the certification process as a final national undergraduate ranking examination. this exam is an additional major stressor for medical students. the aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing occuring during rotation of the osce stations just before the start of the next upcoming osce station, in medical student, during the osce.

stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. objective and structured clinical examinations (osces) has been incorporated recently in the certification process as a final national undergraduate ranking examination. this exam is an additional major stressor for medical students. stress coping strategies could be implemented to help them better prepare for this examination. the aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing as a coping interventions occuring during rotation of the osce stations just before the start of the next upcoming osce station, in medical student, during the osce.

Eligibility criteria:
inclusion criteria: * all volontary medical students of the second cycle that came for their exam during the sessions of june 2024 from the university of lyon (medecine est) exclusion criteria: * no exclusion criteria
long term follow-up study with keppra xr (levetiracetam xr) for partial seizures

Conditions: Epilepsy

Summary: to provide continued treatment of keppra xr (levetiracetam xr) and to assess the long term safety of keppra xr in subjects with partial onset seizures.


Eligibility criteria:
inclusion criteria: * subjects who were randomized into study n01280 \[nct00419094\], and completed the 2 week up titration period exclusion criteria: * subjects who did not meet the inclusion/exclusion criteria for n01280 \[nct00419094\] * subjects who were discontinued prior to the end of titration period

Keywords: keppra xr levetiracetam xr long term partial seizures
colorectal cancer screening assessment study

Conditions: Colorectal Cancer

Summary: this study, led by the american samoa community cancer coalition's indigenous samoan partnership to initiate research excellence (inspire) and the uh cancer center's project team including dr. cassel, will utilize a community-based and culturally relevant process to assess the uptake of fecal occult blood testing (fobt) using tailored colorectal cancer patient education materials for those with inadequate health literacy. our primary outcomes include: 1) process to develop "suitable" and "comprehensible" health promotion materials for populations in english and samoan with various health literacy levels, 2) commitment to use the fobt colocare home kit, and 3) use of a fobt colocare home kit.

utilizing the behavioral model of health services use as a conceptual framework and the evidence-based program "against colorectal cancer in our neighborhoods" (accion) for the latino population in texas as a guide, the proposed study will conduct a randomized controlled trial of indigenous samoan participants (n=312), age≥ 50 recruited using respondent-driven sampling (rds). this design will compare use of non-tailored instruction for completing colocare fobt home-kits (n=156) versus the experimental condition, using a colocare fobt home-kit with instructions tailored to low health literacy and to enhance crc-knowledge attitudes and behavior (kab) - (n=156). our goal is to test the influence of tailored materials on timely completion of crc screening using the colocare fobt.

Eligibility criteria:
inclusion criteria: 1. resident of america samoa 2. over age 50 3. have not been diagnosed or treated for colon cancer 4. is not high risk for crc by having family history or diagnosed with irritable bowel syndrome 5. can read and speak english and samoan (can provide written informed consent) 6. have a home address and working phone 7. is willing to provide information on their health behaviors exclusion criteria: * persons who indicate they speak or read and write samoan or english less than well

Keywords: health literacy screening
a safety and efficacy trial of stannsoporfin in neonates with hyperbilirubinemia

Conditions: Hyperbilirubinemia, Neonatal

Summary: it is a normal process in the human body for red blood cells to die, which makes bilirubin. bilirubin is cleared away through the liver. some babies are born with livers that don't work well enough yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice). this means there is too much bilirubin in the body. it can be dangerous if a baby's bilirubin gets too high. phototherapy is what they call the lights they shine on newborn babies to help the liver get rid of bilirubin. this study tests an experimental drug to see if it can reduce how much bilirubin is being made in the first place.

the purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and effective in the treatment of hyperbilirubinemia in hemolyzing neonates.

Eligibility criteria:
inclusion criteria: babies may only participate if they meet all the following criteria: * is a term or late preterm baby * is at risk for protocol-defined hemolytic disease * weighs at least 2500 g (5.5 lbs) * has total serum bilirubin (tsb) a specified amount lower than the phototherapy threshold for the age * has parents/guardians who are willing to follow light precautions and sign informed consent exclusion criteria: the following criteria will make a baby not eligible to participate: * needs medications that may prolong the qt interval * has family history or risk factors for long qt syndrome, sudden infant death syndrome, or porphyrias * has an apgar score of 6 or below at age 5 minutes * has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results

Keywords: hemolysis
pretest probability of infectious endocarditis for appropriate criteria regarding transesophageal echocardiography in tertiary care facilities (pro endocarditis echo-study)

Conditions: Infective Endocarditis

Summary: infective endocarditis is a potentially lethal disease that has undergone major changes over the last decades. the duke criteria are recommended for evaluation of probability of presence of infective endocarditis by current esc guidelines. however, since the introduction of duke criteria in 1994, characteristics of patients presenting with potential infective endocarditis have substantially changed, especially in tertiary care facilities, towards a high proportion of patients with immune deficiency (caused by illness or medically induced), critically ill patients, patients with prosthetic valves and patients with long-lasting intensive care treatment. likewise, with the increasing interventional therapy of structural heart disease and device implantation in older and multi-morbid patient cohorts, the frequency of endocarditis on prosthetic material and devices increased over the last decades. while duke criteria overall misclassify a substantial proportion of patients with endocarditis, duke criteria are difficult to apply in these patients because of lower sensitivity. therefore, several modifications of the duke criteria have been proposed. in addition, the uncertainty regarding potential infective endocarditis of treating physicians due to clinical characteristics of their patients leads to an increase in requests for transthoracic and transesophageal echocardiography, overcoming echocardiography laboratories. in the present study the investigators aim to identify (i) the precision of the duke score in predicting presence of infective endocarditis in patients examined at the echocardiography laboratory of the west german heart center (ii) determine characteristics, not including echocardiography that are associated with increased risk of infective endocarditis, justifying transesophageal echocardiography examination and (iii) establish scoring algorithms to help treating physicians to assess the risk of endocarditis in severely diseased patient cohorts prior to echocardiography examinations and to avoid unnecessary echo exams.


Eligibility criteria:
inclusion criteria: * patients referred for echocardiographic assessment of suspected endocarditis exclusion criteria: * unwillingness to participate.
the impact of a caffeinated sports drink on performance

Conditions: Dehydration; Dehydration Related to Exercise

Summary: caffeine is known to enhance physical and mental performance, but few beverages combine caffeine with electrolytes and carbohydrates to enhance exercise performance. this study evaluates a caffeinated electrolyte-glucose drink's effect on endurance, strength, and cognition. using a repeated-measures, cross-over design, 20 trained cyclists will complete one familiarization and four randomized 3-hour experimental trials (liquid i.v.™ energy multiplier, hydration multiplier, sugar-free hydration multiplier, and water). each trial includes 2 hours of cycling in a warm environment (32ºc), followed by strength and cognitive assessments. cycling performance, capillary blood, urine, and expiratory gases will be collected.

each subject will complete 5 trials (1 familiarization and 4 experimental) consisting of approximately 2 hours cycling in a warm environment (90ºf), followed by strength assessment and cognitive assessment via questionnaire. each trial will be identical, with the only difference being the type of drink consumed during each trial. the first trial will be for familiarization without any blood sampling. the rest of the trials will be completed in a randomized order and the drink consumed cycling endurance exercise performance the exercise test will consist of a series of three consecutive cycling sets in a warm environment (90ºf), with each series consisting of: 1. a 30-min submaximal ride (50% maximal power as determined from the initial) 2. a 5-km time trial race-like performance effort. during each 30 min submaximal rides participants will drink a total 500 ml of fluid spread out during the 30 min. during the 5 km performance test the participants will drink 25 ml of fluid at the end of each kilometer. at regular intervals throughout the exercise task, body weight, blood samples, respiratory gasses, and perceptual data will be collected. see study schematic provided below for specific measurement timepoints. upon completion of the cycling task subjects will moved to another room with cool temperature (70ºf), where strength and cognitive function will be assessed to determine the influence of each beverage on indices of exercise performance and fatigue.

Eligibility criteria:
inclusion criteria: * age 18-55 * healthy and injury-free (muscle, skeletal) for greater than 2 months * active cyclists who train at least 3 times per week * body mass index (bmi) range of 18.5-30 kg/m2 exclusion criteria: * • history of caffeine sensitivity * cancer diagnosis during the last 5 years * pregnancy * history of renal disease, hypertension * history of a heat stroke * use of testosterone therapy * adults who are unable to consent (impaired decision-making capacity)

Keywords: caffeine sports drinks hydration
paired acute invasive/non-invasive stimulation trial

Conditions: Chronic Pain

Summary: chronic pain patients with implanted dorsal root ganglion stimulators will be randomized to receive transcranial direct current stimulation (tdcs) to the motor cortex, magneto-encephalographically (meg) localized stimulation or sham stimulation to identify therapeutic efficacy of paired central and peripheral neuromodulation.


Eligibility criteria:
inclusion criteria: * patients who are willing and able to give consent to the study. * male or female, aged 18 years or above with diagnoses of chronic pain. * treatment includes spinal cord stimulation, dorsal root ganglion stimulation, or peripheral analgesic stimulation. exclusion criteria: * patients who do not wish to be in the study. * patients with metallic intracranial implants. * patients with extreme language barrier that cannot understand the purpose of the study despite the use of an interpreter