Kornimate/medical-research-clean huggingface dataset:
biomarkers serum collection methodology pilot study

Conditions: Hemophilia A

Summary: the purpose of this study is to compare the standard collection of whole blood in tiger top tubes for serum collection versus a collection method of added fviii to whole blood samples in the hemophilia population for routine biomarker assays to ensure reliable assay results.

20 adults with severe hemophilia a seen in one htc site for routine blood drawing will be consented for discard blood sampling. half of the whole blood discard will be placed in a tiger top test tube, and half of the whole blood discard sample will be placed in a red top test tube containing exogenously added recombinant human fviii concentrate \[advate, baxter immuno\] to assure an end concentration of once iu per cc of whole blood. both whole blood specimens will be allowed to coagulate at room temperature and then will be centrifuged to prepare serum. the separated serum from each type of collection test tubes will be aliquoted into eppendorf tubes (a minimum of two aliquots per sample) at a volume of 150 microliters. aliquoted serum samples will be stored at -70 degrees centigrade and shipped on dry ice to synarc labs. a panel of standard ctx bone resorption assays will be preformed in duplicate on the two differently processed serum specimens obtained from each subject. results will be analyzed for inter-subject variability using stored age-matched samples provided by synarc and intra-subject variability will also be analyzed.

Eligibility criteria:
inclusion criteria: * severe hemophilia a exclusion criteria: * if they are not diagnosed with severe hemophilia a.

Keywords: severe hemophilia a hemophilia a patients serum collection vs a method of added fviii to blood samples
acute preoperative pain and chronic post-surgical pain in emergency surgery

Conditions: Chronic Postsurgical Pain; Acute Pain; Emergency Surgery; Opioid; Postoperative Pain; Risk Factors

Summary: studies evaluating postoperative pain as a risk factor for cpsp are almost exclusively carried out in the context of scheduled surgery. as a result, the preoperative pain studied as a risk factor for chronicity is essentially a state of pain that has persisted for several weeks or even several months. in emergency surgeries, patients are subject to acute preoperative pain of varying intensity and the duration of which may vary by a few days. a few studies have highlighted the intensity of acute preoperative pain as a factor favouring moderate to severe postoperative pain. at this point, no study has addressed the long-term consequences of this intense preoperative pain the emergency context. an evaluation in the field of emergency surgery, where the preoperative pain is often intense and limited in time, would enable us to identify more precisely the impact of acute pain on the incidence of cpsp. the investigators are hypothesising that the occurrence of cpsp at 3 months in patients undergoing emergency orthopaedic or abdominal surgery is associated with acute preoperative pain.


Eligibility criteria:
inclusion criteria: * age ≥18 years old. * emergency orthopaedic and/or abdominal surgery. * informed consent. * affiliation to a social security scheme exclusion criteria: * intraoperative complications that are life-threatening or require the surgical procedure to be discontinued. * post-operative intensive care unit admission. * ambulatory surgery. * endoscopic surgery. * repeat surgery at the same site in less that 3months. * pregnant or breast-feeding patients. * patients under guardianship or deprived of liberty. * patients suffering from psychiatric pathologies. * patients suffering from neurodegenerative pathologies. * patients for whom self-assessment of pain using a numerical scale (0-10) cannot be carried out (non-communicative patients, non-french-speaking patients, and so on).

Keywords: risk factors chronic postsurgical pain acute pain emergency surgery opioid postoperative pain
mechanical ventilation in brain-injured patients

Conditions: Brain-injury; Stroke; Subarachnoid Haemorrhage; Traumatic Brain Injury; Structural Coma

Summary: protective ventilation (association of a tidal volume \< 8 ml/kg with a positive end expiratory pressure) is poorly used in severe brain-injured patients. moreover, a systematic approach to extubation may decrease the rate of extubation failure and enhance outcomes of brain-injured patients. we hypothesized that medical education and implementation of an evidence-base care bundle associating protective ventilation and systemic approach to extubation can reduce the duration of mechanical ventilation in brain-injured patients.

a before/after study design will be used. the before period (control phase) will consisted of all consecutive patients with severe brain-injury who were admitted to the participating icus. during the interphase, all physicians, residents, physiotherapists and nurses will receive a formal training for the processes and procedures related to the 2 point bundle: protective ventilation and systematic approach to extubation (according to recommendation for the use of tidal volume \< 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmh20 (centimeter of water) and extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cought). the after period consisted of all consecutive severe brain-injured patients admitted to the participating icus after the formal training.

Eligibility criteria:
inclusion criteria: * adult patients (traumatic brain-injured, subarachnoid hemorrhage, stroke or other) * brain injury (glasgow coma scale ≤ 12 associated with at least one anomaly related to an acute process on head tomographic tomodensitometry * mechanical ventilation for more than 24 hours exclusion criteria: * early decision to withdraw care (taken in the first 24 hours in icu), * death in the first 24 hours
efficacy and safety of odanacatib in postmenopausal women previously treated with oral bisphosphonate (mk-0822-076)

Conditions: Osteoporosis

Summary: the purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (bmd) over time in female participants who have received at least 3 years of bisphosphonate therapy. it was hypothesized that odanacatib treatment would increase femoral neck bmd relative to placebo after 24 months.


Eligibility criteria:
inclusion criteria: * postmenopausal for ≥5 years (defined as no menses for at least 5 years or at least 5 years post bilateral oophorectomy). * prior or current treatment with oral bisphosphonate therapy (i.e., alendronate, risedronate, ibandronate) for postmenopausal osteoporosis for ≥3 years. * bmd t-score at any hip site (femoral neck, trochanter, or total hip) ≤-2.5 and \>-3.5 as assessed by dual-energy x-ray absorptiometry (dxa) without a history of a prior fragility fracture. for participants with a history of a prior fragility fracture (except hip fracture), bmd t-score can be ≤-1.5 and \>-3.5 at any hip site. * serum 25-hydroxyvitamin d level of ≥20 and ≤60 ng/ml within 90 days of the time of randomization. exclusion criteria: * evidence of a metabolic bone disorder other than osteopenia or osteoporosis * history or current evidence of hip fracture. * history of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. * active parathyroid disease. participant with a documented history of parathyroid disease can be considered for inclusion if she has normal parathyroid hormone (pth) at screening. * history of thyroid disease not adequately controlled by medication. * current treatment with anti-seizure medication, with indices of calcium metabolism not within normal limits. * prior treatment with strontium-containing products; intravenous bisphosphonates; cathepsin k inhibitors; rank ligand inhibitors; fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks. * use of following medications within the 6 months prior to the screening visit: activated vitamin d; estrogen, with or without progestin, at a dose high enough to have systemic effects; raloxifene or other selective estrogen receptor modulator (serm), tibolone or any aromatase inhibitor; sub-cutaneous calcitonin (note: use of intranasal calcitonin is allowed at any time); anabolic steroid; pth (1-34 or 1-84); growth hormone; systemic glucocorticoids (≥5 mg/day of prednisone or equivalent) for more than 2 weeks; cyclosporine for more than 2 weeks. * concurrent use of cancer chemotherapy or heparin; protease inhibitors for human immunodeficiency virus (hiv) treatment; and vitamin a (excluding beta carotene) \>10,000 iu daily, unless willing to discontinue this dose during the study. * current treatment with cytochrome p450 3a4 (cyp3a4) inducers or treatment with cyp3a4 inducer within 4 weeks of screening.
fear and anxiety level in dental patients during the covid-19 pandemic

Conditions: Fear; Anxiety; COVID-19

Summary: psychological support may be needed to help patients in the face of emotional disturbances that may be associated with the outbreak and to help them accomplish their fear and anxiety. due to the increasing fear of covid-19 transmission during the pandemic, patients may develop treatment avoidance behavior in dental practices. if the fear and anxiety levels of the patients can be determined, it may be easy to offer special approaches to them.

officially, the first covid-19 case in turkey was diagnosed on march 10, 2020. to ensure social isolation, cities were locked down with residents to stay at home to prevent disease transmission. a very large part of the population may experience frustration, stress, and irritability while in isolation. due to the prolonged lockdown and covid-19 associated fear, the covid-19 pandemic, which threatens people's physical health and lives, is likely to trigger a wide variety of psychological problems such as anxiety and depression by increasing their stress levels. the risk of cross-infection in dentistry has been described as considerably high due to close physical contact between dental professionals and patients, and aerosols production during routine dental treatments. in this uncertain process, patients remain undecided about attending their dental appointments. their concern is associated with the risk of getting infected and transmitting the disease to family members. all these factors may increase the mental stress of patients. the essential purpose of this study is to evaluate the covid-19 fear and anxiety level, covid-19 knowledge status, and information sources in dental patients in turkey during the pandemic period.

Eligibility criteria:
inclusion criteria: * willing to participate with providing informed consent; * age ≥18 years * able to understand and read \& write the turkish language. exclusion criteria: * not willing to participate with providing informed consent; * age\<18 years * not able to understand and read \& write the turkish language

Keywords: covid-19 pandemic covid-19 fear anxiety
clinical trial evaluating iti-007 as an adjunctive therapy to lithium or valproate for the treatment of bipolar depression

Conditions: Bipolar Depression

Summary: the study will evaluate the efficacy and safety of iti-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with bipolar i or bipolar ii disorder having a major depressive episode.


Eligibility criteria:
inclusion criteria: * male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of bipolar i or bipolar ii disorder * experiencing a current major depressive episode * treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms exclusion criteria: * any subject unable to provide informed consent * any female subject who is pregnant or breastfeeding * any subject judged to be medically inappropriate for study participation
a study to assess the short term efficacy of intravenous ibandronate (bondronat) in participants with metastatic bone pain due to breast cancer

Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis

Summary: this study will assess the short term efficacy of ibandronate (6 mg intravenous \[iv\]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. all participants will receive an iv infusion of ibandronate on days 1, 2, and 3, and pain response will be measured on days 1-7. the anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.


Eligibility criteria:
inclusion criteria: * female participants greater than or equal to (\>=) 18 years of age * breast cancer with bone metastases * pain score of \>=4 on worst pain scale of brief pain inventory (bpi) * stable analgesic regimen. exclusion criteria: * participants who have received a bisphosphonate within 3 weeks of start of trial * radiotherapy to bone within 4 weeks of enrolment * hypersensitivity to ibandronate * central nervous system (cns) or meningeal metastases
study of prediction of ovarian reserve in yong breast cancer patients treated with chemotherapy

Conditions: Breast Cancer

Summary: the purpose of this study is to predict the ovarian reserve, especially premature ovarian insufficient (poi), in young breast cancer patients during chemotherapy treatment using ultrasensitive anti-müllerian hormone (amh) detection method.

young breast cancer women are often treated with adjuvant chemotherapy and neoadjuvant chemotherapy regiments include cyclophosphamide, anthracyclines and a taxane. these treatments can adversely affect ovarian function across the lifespan, causing premature menopause, infertility, and poi. amh is currently the most robust marker of prediction of ovarian injury in cancer patients during chemotherapy in compare with other sexual hormone marker (such as follicle stimulating hormone (fsh), inhibin b) and ovarian volume, and is a more convenient way of prediction of ovarian reserve compare antral follicle count (afc). but most of the patients' amh levels become undetectable (using common amh kits) after several cycle of chemotherapy, and some of these patients' amh levels will maintained at a low level after chemotherapy, while others will recover. using the ultrasensitive amh detection method is expected to accurately assess the ovarian reserve during the chemotherapy treatment, predicting the risk of ovarian failure, and providing patients with ovarian and fertility function protection recommendations, such as using gnrha regents during treatment and providing assisted reproductive technology consultants.

Eligibility criteria:
inclusion criteria: 1. female 18-50 years. 2. suffering from breast cancer. 3. treated with adjuvant or neoadjuvant chemotherapy. 4. having regular menstrual cycle before chemotherapy. exclusion criteria: 1. bilateral oophorectomy or ovarian irradiation before enrollment. 2. prior chemotherapy. 3. oral contraceptives before enrollment. 4. pregnancy or lactation.

Keywords: breast cancer chemotherapy ovarian reserve
deploying poke within intermountain healthcare

Conditions: Newborn; Infection

Summary: to assess the impact of poke on babies, the investigators will longitudinally track outcomes before and after implementation at intermountain healthcare's five nicus. process outcomes will include the number of total pokes per baby and the number of painful pokes per baby, each measured at both the patient-level and nicu-level. clinical outcomes will include hospital acquired infections, length of stay, and mortality. financial outcomes will include total variable costs and backfill rate. the effect of poke on each of these outcomes will be measured using multivariable regression analysis with appropriate distributional families and interaction terms.

poke was developed and implemented at dixie regional medical center's neonatal intensive care unit (nicu) over the past 10 years to eliminate waste and reduce harm in healthcare. poke is a combination of a unique culture and process, with a supporting database, that is designed to guide and inform care decisions while minimizing pokes. the program utilizes an implementation framework, educational materials, electronic health records (ehr), and decision support analytics. poke's initial deployment showed extremely promising results for intermountain, which included: (1) eliminating 11,000 pokes per year (a 50% reduction in overall pokes), (2) realizing $940,000 per year in cost savings (a 28% reduction of overall cost), (3) reducing length of stay by 2 weeks per average stay (a 21% reduction in length of stay), and (4) eliminating hospital acquired infections (i.e., central-line associated bloodstream infection and ventilator-associated pneumonia), translating into 10 lives saved and a $5.2m savings over a decade. poke will now be deployed and routinized within all intermountain healthcare nicus and be developed as a commercial product for external customers. to assess the impact of poke on babies, the investigators will longitudinally track several outcomes before and after implementation at intermountain nicus. process outcomes will include the number of total pokes per baby and the number of painful pokes per baby, each measured at both the patient-level and nicu-level. clinical outcomes will include hospital acquired infections, length of stay, and mortality. financial outcomes will include total variable costs and backfill rate.

Eligibility criteria:
inclusion criteria: * all babies in intermountain healthcare nicu exclusion criteria: * none

Keywords: nicu poke length of stay infection neonates
efficacy and safety study of products based on tribulus terrestris, l. in men with oligospermia

Conditions: Oligospermia

Summary: efficacy and safety of products based on tribulus terrestris, l. in men with oligospermia. it is expected that the benefits of investigational products outweigh the risks that will be mitigated or carefully managed by the study team.


Eligibility criteria:
inclusion criteria: 1. - male; 2. - ages 25 and 60; 3. - diagnosis of oligospermia; 4. - with sexual partner; 5. - indication of drug treatment with steroid hormones, precursors or analogues. exclusion criteria: 1. - severe oligospermia 2. - anatomical change 3. - previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues; 4. - bmi 35; 5. - participant who presents liver enzyme and creatinine values above the upper limit of normality; 6. - history of testicular cancer, or prostate cancer or any other condition that carries risks in this case increased testosterone; 7. - hypersensitivity to any ingredient present in the formulation; 8. - any criteria or clinical history that, in the investigator's opinion, could compromise the well-being and participant safety; 9. - proven infertility of the partner; 10. - history of genetic disorder; 11. - history of psychiatric disorder, serious or decompensated illness or any situation that, investigator's discretion, puts the participant's safety at risk; 12. - active cancer at the discretion of the investigator; 13. - participants with pregnant and breastfeeding partners; 14. - cycling and horse riding more than 3 hours per week; 15. - alcoholism characterized by the inability to control alcohol consumption according to who "drinker excessive, whose dependence on alcohol is accompanied by mental, health and physics, relationships with others and social and economic behavior". source: https://www.cancer.gov/publications/dictionaries/cancerterms/def/alcoholism; 16. - smoking greater than half a pack per day or equivalent.
power production in older adults with knee osteoarthritis

Conditions: Osteo Arthritis Knee

Summary: knee osteoarthritis is an important cause of functional disabilities at old age. previous research has demonstrated that individuals with knee osteoarthritis have reduced knee-extensor strength in comparison to healthy individuals. however, rapid power production declines more than strength as a consequence of ageing and is more predictive of functional capacity. however, limited research has investigated whether individuals with knee osteoarthritis have reduced ability to develop strength and power rapidly on top of reduced maximal strength capacities, which is the primary aim of the current study.


Eligibility criteria:
inclusion criteria: group with knee osteoarthritis: - diagnosed with knee osteoarthritis based on rx. exclusion criteria: healthy group: * systematic engagement in (resistance) exercise in the 12-months prior to participation * cardiovascular disease * neurological disorders * cognitive malfunctioning * severe knee or hip problems group with knee osteoarthritis: * systematic engagement in (resistance) exercise in the 12-months prior to participation * cardiovascular disease * neurological disorders * cognitive malfunctioning * severe hip problems

Keywords: knee osteoarthritis power production functional capacity
the effect of exercise on menstrual symptoms

Conditions: Menstrual Problem

Summary: the aim of this study is to contribute to the determination of the relationship between exercise and menstrual symptoms and to create an alternative for non-pharmacological coping methods with menstrual symptoms.

the type of research is randomized controlled trial. an average of 50 people who do not have exercise habits will participate in the study, and two randomized groups will be formed as exercise group and control group. everyone will be asked to fill in the menstruation symptom scale, the menstruation distress scale, the pittsburgh sleep quality scale, the fatigue severity scale, the international physical activity scale, the personal information form prepared by us, and the voluntary and consent form during their menstrual period. the duration of the study will cover 3 (three) menstrual periods of the individuals. at the beginning and end of the study; they will be asked to fill in the pittsburgh sleep quality scale, fatigue severity scale, international physical activity questionnaire short form, menstruation symptom scale and menstruation distress complaint list.

Eligibility criteria:
inclusion criteria: * women between the ages of 18-50 whose menstrual cycle continues, * those who have emotional or physical problems during menstruation periods, * those whose menstrual cycle is between 21-40 days on average exclusion criteria: * those with chronic disease * those with a diagnosed gynecological disease, * those who receive any medical treatment, * persons with dysmenorrhea and anemia. * people who exercise regularly.

Keywords: sleep menstruation stress