Kornimate/medical-research-clean huggingface dataset:
impact of adjuvant hormone therapy on bone and cardiovascular risk

Conditions: Breast Cancer

Summary: breast cancer is the most frequently observed cancer in women in france.the mortality rate is still decreasing with a decrease of 1.6% per year between 2010 and 2018, explained by the improvement in available treatments.for patients with breast cancer expressing hormone receptors, treatment with tamoxifen or anti-aromatase can have the risk of the cancer coming back.however, these treatments have many side effects, including the risk of osteoporosis and metabolic disorders with anti-aromatases; and arterial and thromboembolic accidents with tamoxifen.these effects have been well studied while taking hormone therapy.however, very few studies have analyzed the impact of these treatments after stopping them in women who have had non-metastatic hormone-sensitive breast cancer and uncertainties persist on the evolution of the health risk after initial treatment.


Eligibility criteria:
inclusion criteria: * adult patients who had t1-t3, n0-n2, m0 breast cancer * patients referred to the menopause center in the context of their breast cancer who were included in the original study evaluating the bone impact of hormone therapy carried out between 2010 "bone and cardiovascular impact of adjuvant hormone therapy for cancer non-metastatic breast " * patient who has given her consent for the study (written or verbal) after clear and fair information exclusion criteria: * metastatic breast tumor * absence of adjuvant hormone therapy for patients whose tumor did not express hormone receptors * patients who have died since the last assessment * protected adult patient (guardianship, curatorship, safeguard of justice)
the relationship between sense of coherence and wound healing.

Conditions: Wound Heal; Sense of Coherence

Summary: the study aimed to investigate the relationship between sence of coherence (soc) and surgery-related oral wound healing. the study was consisted of one hundred and sixty patients of both sexes (female,male) who were scheduled for oral surgery. pre-operatively the patients were asked to complete a questionnaire designed to measure their sense of coherence (soc). the wound healing was evaluated after 4 days, 14 days and 6 weeks after surgical operation. the results were analyzed statistically.

many factors play a role in wound healing (wh) including physiologic factors. the concept of sense of coherence (soc), reflects an individual's capacity to respond to stressful situations. high soc scores indicate a strong soc, and individuals with strong soc are reported to tolerate stress better. additionally, a strong soc has been associated with fewer symptoms and significantly fewer issues related to oral condition. the aim of this study is to evaluate the relationship between soc and wound healing following oral surgery. the study included 160 patients of both sexes (female,male). an informed consent form was obtained from all participants. pre-operatively the patients were asked to complete a questionnaire designed to measure their sense of coherence (soc). a blinded operator, who was not involved in the operation, recorded all data of the patients pre-operatively. all patients were undergone oral surgery. all surgical procedures were performed by the second maxillofacial surgeon. the first blinded operatoand conducted postoperative measurements. the wound healing was evaluated after 4 days, 14 days and 6 weeks after surgical operation. to evaluate of wound healing, a scale named inflammatory proliferative remodeling (ipr) scale was used. according to this scale, patients were recalled 3 days, 14 days and 6 weeks after surgical operation. the third blinded researcher was responsible for the analysis data.

Eligibility criteria:
inclusion criteria: * adult patients aged between 18-65 years * patients classified as american society of anesthesiologists (asa) physical status asa i * patients scheduled to undergo oral surgery exclusion criteria: * not consenting to participate * intake of steroid, bisphosphonate or immune-suppressive medication * receiving radiotherapy in the head and neck area * pregnancy * inability to self-evaluate, and inability to communicate verbally and in writing.
safety and feasibility of tdcs to enhance auditory rehabilitation in cochlear implant recipients

Conditions: Hearing Loss

Summary: this study aims to evaluate the safety and feasibility of transcranial direct current stimulation (tdcs) in combination with home-based auditory training therapy in cochlear implant (ci) patients. changes in speech perception performance will also be evaluated.

participants will complete a 4 week web-based auditory training program while wearing a transcranial direct current stimulation device (tdcs). the customized auditory training program will be completed at home, in 20 - 30 minute sessions at least five times a week for four weeks. a customized learning and practice plan will be provided along with instructions on use of the tdcs device. tdcs is a non-invasive brain stimulation technique that delivers low-intensity current via electrodes on the scalp to modify neuronal excitability in the underlying cortex. the tdcs system has customizable headgear with disposable, snap-in electrodes that are easy to apply at home without assistance. speech and hearing assessments will be completed prior to the start of auditory training, at the end of the 4 week training session, and again 6 months later.

Eligibility criteria:
inclusion criteria: * age \>/= 18 years of age * patients with a unilateral cochlear implant device in use for a minimum of 1 year * sentence recognition scores (azbio) below 65% and/or word recognition scores (cnc) are below 75% in the implanted ear for \> one year following cochlear implantation. * ability to access internet to conduct computer-based auditory trainings and weekly video visits with study team weeks 2-5 exclusion criteria: * non-english speaking * diagnosis (documented or self-reported) of a psychiatric or neurologic condition, or any other comorbidities that may interfere with the study or increase the level of risk (such as dementia, seizures, legal blindness, brain tumor) * implants, other than ci, above collar bone level that may interact with delivery of tdcs * inability to or unwillingness to use electronic devices/computers, participate in video visits, or make required visits

Keywords: cochlear implant
thoracic epidural analgesia versus rectus sheath block versus surgeon infiltration with liposomal bupivacaine or standard bupivacaine for post-operative pain control after cystectomy

Conditions: Cystectomy

Summary: the purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder).

the purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder). by collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (feeling sick to your stomach, feeling drowsy/sleepy, blockage/lack of movement in the intestines, inability to completely empty the bladder, unusually slow or shallow breathing). the specific aim of this study is to compare the difference between the pain control methods in achieving the following: 1. decreased opioid requirements 2. improved postoperative vas pain scores 3. decreased opioid side effects (nausea, sedation, ileus, respiratory depression) 4. decreased hospital length of stay (los)

Eligibility criteria:
inclusion criteria: * patients undergoing cystectomy for bladder cancer * asa class 1, 2, 3 or 4 * age 18 or older, male or female * desires regional anesthesia for postoperative pain control exclusion criteria: * any contraindication for thoracic epidural. * history of substance abuse in the past 6 months. * patients on more than 30mg morphine equivalents of opioids daily. * any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery. * known allergy or other contraindications to the study medications (acetaminophen, gabapentin, bupivacaine, hydromorphone). * postoperative intubation. * any patient with history of neuropathic bowel or bladder dysfunction
goal-directed therapist-guided play-based intervention in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: abstract objective: this study planned to examine the effect of goal-directed therapist-guided play-based intervention (gd-tg-pbi) on occupational performance, occupational satisfaction and functional performance in children with diplegic cerebral palsy (dcp). materials and methods: this study was designed as a randomized controlled trial. 34 children with dcp (14 boys; 20 girls) who received routine therapy included to the study. all children were classified according to the gross motor function classification system (gmfcs) and the manual abilities classification system (macs). participants were randomly divided into two groups: the gd-tg-pbi group (number =17; mean age: 7.70±2.25 years) and the control group (number =17; mean age: 7.41±2.06 years). both groups received routine therapy twice a week for 45 minutes per session during 8 weeks; while the gd-tg-pbi group received gd-tg-pbi additional to routine therapy twice a week for 45 minutes per session during 8 weeks. occupational performance and satisfaction were determined with the canadian occupational performance measure (copm), and functional performance was evaluated with the pediatric evaluation of disability inventory (pedi). the copm and pedi were performed before and after the intervention for both groups. di̇fferences between copm and pedi values before and after the intervention calculated, additionally the effect size of each parameter calculated.


Eligibility criteria:
inclusion criteria: * the inclusion criteria of the study were a spastic dcp diagnosis, being aged 4-12 years, gross motor function classification system (gmfcs) level i, ii or iii, and manual ability classification system (macs) level i or ii, and ability to follow verbal instructions. exclusion criteria: * the exclusion criteria were mental retardation diagnosis, additional treatment other than neurodevelopmental treatment (ndt), surgical intervention or botulinum toxin injection in the last six months, diagnosis of psychiatric disorder accompanying cp, vision and/or hearing problems affecting participation.

Keywords: play, child, intervention
comparison of insulin mix25 versus mix50

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine the efficacy and safety of insulin lispro mix25 (lm25) compared to insulin lispro mix50 (lm50) as an insulin starter in participants with type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * have a diagnosis of type 2 diabetes mellitus (t2dm) for at least 6 months * have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, glinide, or dipeptidyl peptidase iv inhibitor, or any combination of these * have a qualifying hemoglobin a1c (hba1c) value ≥7.0% and ≤11.0% at screening * have a body mass index (bmi) ≥18.5 and \<35.0 kilogram per square meter (kg/m²) * have given written informed consent to participate in the study in accordance with local regulations and the ethical review board (erb) governing the study site exclusion criteria: * have a diagnosis of type 1 diabetes * have had more than 1 episode of severe hypoglycemia within the 6 months before screening * have any of the following cardiovascular conditions within 3 months prior to screening: acute myocardial infarction, new york heart association (nyha) class iii or class iv heart failure, or cerebrovascular accident (stroke) * have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase levels ≥3.0 times the upper limit of the reference range at screening, as determined by the central laboratory * have an estimated creatinine clearance (crcl), cockcroft-gault formula \<30 milliliter per minute (ml/min), as determined by the central laboratory at screening * have evidence of a significant, active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator * have an active or untreated malignancy or have been in remission from a clinically significant malignancy for \<5 years * have any other condition (such as, known drug or alcohol abuse or a psychiatric disorder) that may prevent the participants from following and completing the protocol * are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
bovine vs. human milk-based fortifier study

Conditions: Very Low Birth Weight Infant (<1250g)

Summary: most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal nutrient reserves and elevated nutritional requirements which may contribute to poor outcome. adding nutrients to human milk improves their nutritional status and growth, but it is unclear if adding bovine protein-based fortifiers as is the current standard of care has some unintended negative consequences to neonates. infants will be randomized to have their feeds (mother's own milk or pasteurized donor breastmilk) nutrient enriched with a human milk-based fortifier or a bovine protein-based fortifier and will be followed in hospital to assess feeding tolerance, growth, gut inflammation, mother's milk and infant gut microbiome, and neonatal morbidity and mortality.


Eligibility criteria:
inclusion criteria: * \<1250g birth weight * parent(s) or guardian(s) agree to use donor breastmilk if own mother's milk supply is insufficient exclusion criteria: * infant receives formula or a nutrient fortifier prior to randomization * \>day 14 at the time of enrollment and enteral feeds have not commenced * infants with major congenital or chromosomal anomalies that could impact growth * enrollment in another research study affecting nutritional management during the feeding intervention * reasonable potential that the infant will be transferred to a neonatal intensive care unit where the study protocol will not be continued
demonstrating efficacy of jogo for the treatment of tremor

Conditions: Functional Neurological Disorder

Summary: this research is being done to determine the effectiveness of a new treatment, called jogo, for patients with functional tremor (ft). jogo is a biofeedback device that has been shown to help patients with several conditions, e.g., chronic pain, migraine, and parkinson's disease (pd)-related tremor. jogo provides biofeedback by using wireless adhesive stickers, called surface electromyography, to get information about muscle activity. this information is then used to modify symptoms through a series of training sessions with a physical therapist and individual practice.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of functional tremor diagnosed by a mayo clinic florida movement disorders specialist. * must have access to reliable internet video. exclusion criteria: * cognitive impairment (montreal cognitive assessment greater than 26). * currently taking any of the following medications to treat tremor: primidone, gabapentin, zonisamide, any non-selective beta blocker, any benzodiazepine. * exposure to tremorgenic drugs or drug with withdrawal states within 30 days prior to the study start. * direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor. * known history of other medical or neurological conditions that may cause or explain subject's tremor, including, but not limited to: parkinson's disease, dystonia, cerebellar disease, traumatic brain injury, alcohol abuse or withdrawal, mercury poisoning, hyperthyroidism, pheochromocytoma, head trauma or cerebrovascular disease within 3 months prior to the onset of essential tremor, multiple sclerosis, polyneuropathy, family history of fragile x syndrome. * prior mr-guided focused ultrasound or surgical intervention (e.g., deep brain stimulation, ablative thalamotomy or gamma knife thalamotomy). * botulinum toxin injection in the 6 months prior to screening. * use of medication(s) in the past month that might produce tremor or interfere with the evaluation of tremor, such as, but not limited to: cns-stimulants, lithium, amiodarone, metoclopramide, theophylline, and valproate. * regular use of more than two units of alcohol per day. * sporadic use of a benzodiazepine, sleep medication or anxiolytic to improve sleep performance. stable use at a consistent dose is allowed if tremor persists against the background of regular medication use. * current treatment with any investigational therapy for tremor.

Keywords: functional tremor
a study to evaluate the long term safety and efficacy of bimekizumab in subjects with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis


Eligibility criteria:
inclusion criteria: * in the opinion of the investigator, the subject is expected to benefit from participation in an open label extension (ole) study * subject completed as0008 without meeting any withdrawal criteria * female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception * male subjects with a partner of childbearing potential must be willing to use a condom when sexually active exclusion criteria: * female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (imp). male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose * subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry * subjects who meet any withdrawal criteria in as0008. for any subject with an ongoing serious adverse event, or a history of serious infections (including hospitalizations) in the lead-in study, the medical monitor must be consulted prior to the subject's entry into as0009

Keywords: bimekizumab ankylosing spondylitis as
alpha-1-antitrypsin-deficiency in covid-19

Conditions: Covid19

Summary: the blood concentrations of alpha-1-antitrypsin are monitored during covid-19. the clinical course of patients that received aat infusion for clinical indication is monitored.

the blood concentrations of alpha-1-antitrypsin are monitored during covid-19. the clinical course of patients that received aat infusion for clinical indication is monitored. clinical outcomes, blood inflammatory markers, and virus load are monitored.

Eligibility criteria:
inclusion criteria: * infection with sars-cov2 * age over 18 years exclusion criteria: * unability to consent * invasive ventilation
minimally invasive surgery vs standard posterior approach in the treatment of developmental idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: this is a randomized trial with 1:1 allocation. the aim of the study is to evaluate clinical and radiographic outcomes in patients with developmental age idiopathic scoliosis treated with mini invasive scoliosis surgery (mis) technique versus posterior spinal fusion (psf) technique through clinical and radiographic evaluations.

patients with developmental age idiopathic scoliosis will be included in a randomized trial in which one group of patients will be treated with mini invasive scoliosis surgery technique , and one group will be treated instead with traditional posterior spinal fusion arthrodesis. the study design involves a noninferiority evaluation, assuming that mis does not produce inferior results to the classic technique from the point of view of curve correction. this result would be important, because with equal curve correction success, the risk/benefit balance for minimally invasive surgery is superior, as it reduces the risk of transfusion and postoperative pain. the results of this study could therefore give important guidance for surgeons on choosing the optimal treatment for patients. patients will be evaluated by clinical examination, before the surgical procedure and at subsequent follow-ups as per clinical practice: at 2, 6, 12, 24, 60 months after treatment by medical personnel. during the selection visit, patients will also be evaluated with radiographic examination for measurements necessary to decide the indication for surgical treatment. the patient also undergoes postoperative radiographic examination before discharge, as well as at follow-ups at 2, 6, 12, 24, and 60 months.

Eligibility criteria:
inclusion criteria: 1. patients with ais 2. age between 12 and 25 years; 3. site of scoliotic curve: thoracic and/or lumbar; 4. preoperative radiographic range of the main scoliotic curve between 40° and 70° according to cobb; 5. ability and consent of patients/parents to actively participate in the study and clinical follow-up. exclusion criteria: 1. patients already treated surgically for scoliosis; 2. site of the scoliotic curve: cervical; 3. patients with scoliosis other than adolescent idiopathic scoliosis; 4. patients who do not fall within the described parameters; 5. unbalanced sagittal profile; 6. patients unable to consent or perform follow-ups. 7. pregnant women.

Keywords: posterior spinal fusion mini invasive scoliosis surgery adolescent idiopathic scoliosis randomized trial
the use of penile vibratory stimulation to decrease spasticity following spinal cord injury

Conditions: Spinal Cord Injury; Muscle Spasticity

Summary: the purpose of this study is to determine the effect of penile vibratory stimulation on the muscle spasticity of men with chronic spinal cord injury.

spinal cord injury can result in mild to severe muscle spasms that can both inhibit functional capability and increase the likelihood of injury due to fall. anecdotal reports and a recent study suggest that triggering the ejaculatory reflex in men with vibratory stimulation can result in a significant decrease in spasm activity over a period of 2 to 42 hours. this study examines the effects of penile vibratory stimulation on spasticity when conducted daily in the home setting.

Eligibility criteria:
inclusion criteria: diagnosed with a traumatic spinal cord injury * level of injury is at t6 or below * injured at least 6 months prior to study enrollment * male, aged 18 to 70 years * spasticity to a degree that either anti-spasticity medications have been or are being used or current spasticity is at 2 or greater on the ashworth scale specifically for the quadriceps muscle group (knee flexion) exclusion criteria: * medical instability * subjects may not use cialis * use of viagra, levitra, caverject, or vacuum constriction devices is restricted to no less than 8 hours prior to daily vibratory therapy * recent history of autonomic dysreflexia secondary to sexual stimulation * presence of intrathecal baclofen pumps * inability or unwillingness to use the therapy daily

Keywords: penile vibratory stimulation muscles spasticity spasms ferti care vibrator antispasmotic treatment