Kornimate/medical-research-clean huggingface dataset:
a multicenter efficacy study of a diclofenac+menthol gel in subjects with ankle sprain

Conditions: Pain

Summary: this phase iii pivotal efficacy study will assess efficacy and onset of pain relief of mfc51123 gel vs. placebo and mfc51123 gel vs. 1% diclofenac gel and 3% menthol gel in participants with an ankle sprain to support topical mfc51123 gel registration.

this is a multi-center, randomized, double-blind, repeat-dose, placebo-controlled, parallel-group trial in participants with ankle sprain. eligible participants will be randomly assigned to one of four treatment groups (1% diclofenac plus 3% menthol gel, 1% diclofenac plus 0.09% menthol gel, 3% menthol gel or placebo gel with 0.09% menthol). treatment will be self-administered by participants four times daily on an out-patient basis. participants will rate pain intensity score (nrs) at rest and on movement, pain relief score (prs) and cooling and soothing sensations. after leaving the clinic, participants will continue to complete scheduled pain intensity and pain relief assessments and answer questions about cooling sensation by answering questions in a paper diary card. the investigator (or designee) will measure the ankle swelling via the 'figure-of-eight' method on treatment days 1 (at baseline), 3, 7 and 10. participants will continue treatment until they are pain free or for up to 10 days, whichever occurs first. at the end of the treatment, participants will be assessed for function of the injured joint by the investigator. in addition, the participants will evaluate treatment satisfaction, sensory features of the gel and provide a global assessment of the treatment by using a questionnaire.

Eligibility criteria:
inclusion criteria: * age: 16-65 years * good general and mental health * grade i or grade ii acute sprain of the lateral ankle within 24 hours of visit 1, a pain intensity score of the ankle sprain that is ≥ 5 as measured on an 11-point numerical rating scale, and a peri-malleolar edema (sub-malleolar perimeter difference of ≥ 20mm between injured and uninjured ankle * females of child-bearing age practicing a reliable method of contraception exclusion criteria: * pregnant or breast-feeding females * if participant has treated the ankle sprain with treatment such as oral or other topical pain relief medications, massage or physical therapy since experiencing the ankle sprain * acute or chronic pain disorders, which may confound the study pain evaluations * participant has has injury to both ankles or to both medial and lateral ligaments of the same ankle * known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications * participant has a medical history of renal or hepatic disease, a current active peptic ulcer or a history of upper gastrointestinal bleeding or perforation related to previous nsaid therapy
the sister study: genetic and environmental risk factors for breast cancer

Conditions: Breast Cancer

Summary: the sister study is prospectively examining environmental and familial risk factors for breast cancer and other diseases in a cohort of 50,884 sisters of women who have had breast cancer. such sisters have about twice the risk of developing breast cancer as other women.

the sister study is prospectively examining environmental and familial risk factors for breast cancer and other diseases in a cohort of 50,884 sisters of women who have had breast cancer. such sisters have about twice the risk of developing breast cancer as other women. the frequency of any relevant genes and shared risk factors will also be higher. studying sisters enhances our ability to understand the interplay of genes and environment in breast cancer risk and to identify potentially preventable risk factors. we assess exposures before the onset of disease, thus avoiding biases common to retrospective studies. the assembled cohort has created a framework from which to test new hypotheses as they emerge. cancer-free sisters aged 35-74 were recruited nationally. enrollment was completed july 2009 with 50,884 women fully enrolled. participants have enrolled from all 50 states and puerto rico. the cohort is now being followed actively. cohort members are occasionally invited to participate in add-on studies, which sometimes include asking participants to invite their family members to provide information. data on potential risk factors and current health status were collected with telephone interviews and self-completed questionnaires. blood, urine, and environmental samples were collected and banked for future use in nested studies of women who develop breast cancer (or other diseases) and a sample of those who don't. the cohort is being followed prospectively for 10 or more years. annual questionnaires update medical history and changes in exposures. about 300 new cases of breast cancer are expected to occur in the cohort each year. analyses are ongoing and assess the independent and combined effects of environmental exposures and genetic polymorphisms that affect estrogen metabolism, dna repair, and response to specific environmental exposures. future analyses will focus on known and potential risk factors (e.g. smoking, occupational exposures, alcohol, diet, obesity) and include measurement of phthalates, phytoestrogens, insulin, growth factors, micro-nutrients, and genes. women who develop breast cancer during the study are followed to assess the role of environment and genes in healthy survival following diagnosis and treatment. the cohort will also be used to explore risk for other diseases (e.g. heart disease, osteoporosis, other hormonal cancers, and autoimmune diseases) that are important for women.

Eligibility criteria:
inclusion criteria: women who are eligible for the sister study: * have a sister (living or deceased) who had breast cancer * ages 35-74 * never had breast cancer themselves * live in the united states the sister study is currently recruiting sisters of women diagnosed with breast cancer nationwide.

Keywords: breast cancer sisters
intramedullary calcium sulfate antibiotic depot

Conditions: Open tíbia Fracture; Osteomyelitis Tibia; Tibial Fractures

Summary: the goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. the main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.

this research is a randomized clinical trial aimed to reduce the frequency of fracture related infections following open tibia fracture. the proposed test methods for infection reduction is use of an antibiotic depot placed inside the bone at the time of final fracture treatment. this is in addition to standard of care wound care, fracture fixation with intramedullary nailing, and peri-operative systemic antibiotics. this prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing. the target population for the proposed study is patients with severe open tibia fractures (type ii or iii) who require definitive fixation with intramedullary nail recruited form one of the participating sites during the index hospitalization. one group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation, while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot. participants will be followed for 12 months (data capture includes patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).

Eligibility criteria:
inclusion criteria: * patients 18 years and older * type ii or iii open tibia fracture requiring definitive fixation with intramedullary nail exclusion criteria: * less than 18 years of age * allergy to vancomycin or tobramycin * hypercalcemia * unable to speak english or spanish * no email, phone, or other point of contact * pregnant and lactating women * prisoner

Keywords: antibiotic depot
coaching children with anxiety and autism through telehealth

Conditions: Autism; Autism Spectrum Disorder; Anxiety

Summary: this study will examine a telehealth parenting intervention to reduce anxiety in 20 families of children between 4 and 8 years old with autism and anxiety. caregivers and children complete 12 telehealth treatment sessions. caregivers and children will complete pre tests, post tests, and 3 month followup assessments that include observations, heart rate monitoring, and caregiver ratings.

this study will examine the feasibility and initial efficacy of a telehealth adaptation of a parenting intervention to reduce anxiety (coaching approach behavior leading by modeling; calm) amongst 20 families of children between 4 and 8 years old with autism and anxiety. our time limited telehealth-delivered adaptation of calm is called cat (coaching children with anxiety and autism through telehealth). the study will utilize an open trial design with pre, post, and 3-month follow-up assessments including observational measures, physiological measures, and caregiver ratings.

Eligibility criteria:
inclusion criteria: * child participants must: * be between 4:0-8:11 years old * have clinically significant caregiver-report symptoms of anxiety on the parent-rated anxiety scale for asd (pras-asd) * have a primary anxiety concern on the anxiety disorders interview schedule for autism spectrum and developmental disorders: parent version (adis/asa) * have an asd diagnosis made by a qualified diagnostician * have a cognitive level of 48 months on the wechsler preschool \& primary scale of intelligence-fourth edition (wppsi-iv; ages 2:6-7:7) or the wechsler intelligence scale for children-fifth edition (wisc-v; ages 6:0-16:11) caregiver participants must: * have access to a computer, tablet, or phone with a camera and wi-fi access exclusion criteria: * primary concern other than anxiety as measures on the adis/asa
emdogain minimally invasive surgical technique

Conditions: Periodontitis

Summary: the aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with straumann emdogain as an adjunct (test treatment) or without straumann emdogain (control treatment).

the aim of the study will be achieved through the following primary and secondary objectives. the primary objective is to evaluate the regenerative potential of straumann emdogain by comparing the change in clinical attachment level from baseline to 12 months between the test and control arms. the regenerative potential of straumann emdogain will also be assessed by comparing the changes in gingival margins, changes in average probing pocket depth, changes in full mouth plaque score, changes in bleeding on probing, and changes in root dentin hypersensitivity from baseline to 12 months between the test and control arms.

Eligibility criteria:
inclusion criteria: * subjects must have voluntarily signed the informed consent form before any study related procedures * subjects must be males or females who are 18-85 years of age * subjects must have moderate to severe chronic, generalized periodontitis with pockets of 5 mm - 8mm probing depth in at least 2 pockets per contralateral quadrants in one arch (study teeth) * subjects must be committed to the study and the required follow-up visits * subjects must be in good general health as assessed by the investigator exclusion criteria: * subjects taking or intending to take any medications during the duration of the study that will potentially affect healing and inflammation * subjects who are currently heavy smokers (defined \>10 cigarettes per day or \>1 cigar per day) or who use chewing tobacco * subjects being treated with systemic antibiotics or subjects that were treated with systemic antibiotics within 3 months prior to treatment in this study * subjects with uncontrolled diabetes * subjects that are immunocompromised or immunosuppressed * subjects that cannot provide informed consent * subjects with drug or alcohol abuse * subjects that have undergone periodontal root planing or periodontal surgery in the last 6 months * subjects that are pregnant * subjects with necrotizing periodontitis or periodontitis related to systemic disease * teeth with pockets with probing depth ≥ 9 mm will not classify as study teeth * teeth with pockets or defects with furcation involvement will not classify as study teeth * teeth with mobility degree \> 1 without splint will not classify as study teeth * subjects with test and control sites in the two quadrants on adjacent teeth * patients with compromised health conditions such as diabetes, systemic diseases, high dose steroid therapy, bone metabolic diseases, radiation or immune-oppressive therapy, and infections or vascular impairment at the surgical site * subjects with conditions or circumstances, in the opinion of the investigator , which would prevent completion of study participation or interfere with analysis of study results
perix: comparison of efficacy between placement of epidural catheters x-ray guided and los technique

Conditions: Postoperative Pain; Postoperative Complications; Pancreatic Cancer; Haemodynamic Instability

Summary: the use of epidural catheters for postoperative analgesia in pancreatic surgery is recommended by the guidelines of the eras society. some studies claim it may expose to hemodynamic alterations that may compromise outcome and increase postoperative complications, attributable to a malfunction of the catheter itself, often linked to a bad positioning, since this is usually positioned with los technique. our hypothesis is that a positioning made using the radiographic guide the day before the intervention can significantly reduce the number of catheter's dysfunctions.

about 30% of epidural catheters are reported to have hypo or hyper functioning behaviour. this has and impact on postoperative pain control and can affect also surgical and global outcome since it is known that a malfunctional catheter carries an increased complication's rate. our hypothesis is that rx-guided positioning can reduce the incidence of catheter malfunction afrom 30 to 15 %.

Eligibility criteria:
inclusion criteria: * scheduled for open pancreatic surgery * asa \< = 3 exclusion criteria: * scoliosis * coagulation abnormalities * antiplatelet drugs (except asa) * history of back surgery * anticipated need of icu stay

Keywords: epidural catheter postoperative pain los
effect of phototherapy in individuals with temporomandibular disorder.

Conditions: Temporomandibular Disorder.

Summary: the present study aims to evaluate the effect of phototherapy with the combination of different sources of light on pain, activity of temporal and masseter muscles, bilateral and joint mobility in subjects with tmd. it will be made a randomized, placebo-controlled and double-blind clinical trial. individuals participate with myogenic temporomandibular disorder, being allocated into 4 groups randomly and stratified by the method of sealed envelopes. the results will be evaluated using: rdc/tmd, digital caliper, electromyography, and visual analog scale and algometry. the protocols will be used in a single session and will be evaluated in four different moments. the variables that will be investigated are pain, muscle activity and joint mobility. the analyses of the data will be performed by adopting a significance level of 5%.


Eligibility criteria:
inclusion criteria: * 18 to 40 years. * female volunteers. * diagnosis of myogenic tmd pain must masseter presenting moderate to severe according to the rdc / tmd. * display body mass index (bmi) less than 25 kg/m2 to standardize the sample. * in addition, volunteers must submit scores of pain greater than 3 cm according to the visual analog scale masticatory muscles. exclusion criteria: * history of neurological disorders. * chronic neck pain resulting from a traumatic incident. * chronic musculoskeletal condition. * medical diagnosis of fibromyalgia; systemic disease. * connective tissue disorder. * having undergone physical therapy use of analgesic, muscle relaxant.

Keywords: temporomandibular disorders, electromyogram, modalities of physiotherapy, temporomandibular dysfunction syndrome, lasers.
ephedrine vs phenylephrine - ecg changes

Conditions: Spinal Anesthesia; Pregnancy

Summary: ecg changes during caesarean section are common. incidence of st depression on the ecg is up to 81% in some studies. although this may indicate inadequate oxygen supply to the heart muscle (myocardial ischaemia) many other theories have been suggested including air entering the circulation from the placental bed, high heart rate, hormone or nervous system influences and spasm of the coronary blood supply. perioperative st depression often reflects an imbalance between heart muscle oxygen supply and demand. at the time of delivery, high heart rate is common and there is a further increase in the amount of blood the heart has to pump every minute due to blood coming back to the circulation from the placental bed. this increases oxygen demand and most st changes are seen at the time of delivery or within 30 minutes. the clinical significance of these changes is much debated, and apart from a few case reports do not appear to be associated with poor heart muscle function or ischaemia (lack of oxygen supply). management of the mother's blood pressure during caesarean section has changed greatly in recent years. intermittent boluses of ephedrine, given when blood pressure is low, have been replaced with prevention of low blood pressure and phenylephrine has become the drug of choice. ephedrine increases heart rate and contractility of the heart muscle and is likely to increase oxygen demand. phenylephrine reduces heart rate while maintaining blood pressure which may result in a more favorable oxygen supply demand ratio. the investigators aim to compare the incidence of ecg changes if the mother's blood pressure is maintained with phenylephrine as compared to ephedrine. to see if these ecg changes are associated with myocardial ischaemia, the investigators will perform troponin t analysis after delivery. troponin t is a molecule released by ischaemic heart muscle.


Eligibility criteria:
inclusion criteria: 1. able to give written informed consent 2. \>37/40 weeks gestation 3. singleton pregnancy 4. elective caesarean section under spinal anaesthesia 5. in good general health (american society of anesthesiology category 1 or 2, fit and well or with mild systemic disease that has no impact on physical activity ) exclusion criteria: 1. circulatory disease (eg pre-existing hypertension) 2. cardiac disease/medications (e.g. angina, cardiomyopathy, b blocker medication) 3. pregnancy related disease (eg pre-eclampsia) 4. diabetes pre-existing the pregnancy 5. hyperthyroidism 6. renal disease 7. closed-angle glaucoma 8. patients on monoamine oxidase inhibitors 9. in active labour 10. emergency caesarean section 11. fetal abnormalities 12. contraindications to spinal anaesthesia 13. height \>6 feet/180cm / height \<5 feet/150cm 14. body mass index (bmi) \ 35

Keywords: spinal anaesthesia phenylephrine ephedrine ecg changes caesarean delivery myocardial ischaemia cardiac output hypotension
additional mailed fit kits

Conditions: Colorectal Cancer Screening

Summary: this study aims to assess whether sending patients in a county health care system additional fit kits can increase the fit kit return rate enough to warrant the extra cost. to do this, the health system mailed a random subset of patients ages 60 to 75 a fit kit in november 2024 in addition to sending patients an annual fit kit mailing. this work analyzes the return rate of mailed fit kits within 60-days of the november mailing.

this study aims to assess whether sending patients in a county health care system additional fit kits can increase the fit kit return rate enough to warrant the extra cost. to do this, patients ages 60 to 75 due for colorectal cancer screening, who had not received a fit kit in the previous 3 months but had completed one sometime in the past and had an assigned primary care provider, were randomized to be sent a fit kit in november of 2024 or to usual care. usual care includes an annual fit kit mailing. we will analyze the successful return rate of mailed fit kits within 60-days of the november mailing.

Eligibility criteria:
inclusion criteria: * age 60-74 * due for colorectal cancer screening; * not sent a fit kit in the past 3-months; * previously successfully returned a fit kit. exclusion criteria: * under age 60 or over age 74; * incarcerated; * not due for colorectal cancer screening; * sent a fit kit in the past 3-months.

Keywords: fecal immunochemical test (fit) cancer screening
impact of palmitoylethanolamide (pea) in the management of oro-facial pain

Conditions: Oral-facial Pain

Summary: pain is the most common symptom faced by dentists, whether acute (pulpitis, acute periodontitis, post-surgical, etc.) or chronic (chronic periodontitis, muscle pain, tmj disorders, bms, olp, etc.). the success of therapy depends on the reduction and management of pain. therefore, over the past few years, the need has emerged, also in relation to the aging population, to analyze new molecules with pain-relieving activity and with low risk of inducing side effects and interactions with other drugs; capable of bringing about the reduction of oro-facial pain; and that lend themselves to prolonged use. palmitoylethanolamide (pea) is a bioactive lipid mediator similar to endocannabinoids (ecbs) that has been observed to have anti-inflammatory, analgesic, anticonvulsant, antimicrobial, antipyretic, antiepileptic, immunomodulatory, and neuroprotective activities. the objective is to clinically study, through a clinical trial, the pain-relieving and anti-inflammatory properties of a pea-containing nutraceutical agent in the management of patients with orofacial pain, both neuropathic and nociceptive in nature.

a double-blind placebo-controlled study was conducted to evaluate the efficacy of palmitoyletinolamide (pea) and determine the statistical significance of its action. 40 patients with both acute and chronic orofacial pain were divided into two groups: study group given a nutraceutical agent containing pea and a control group given a placebo. a three-month follow-up will be conducted.

Eligibility criteria:
inclusion criteria: * good general health condition, * presence of diffuse or localized oro-facial pain of nociceptive nature or postoperative pain, * presence of diffuse or localized oro-facial pain of neuropathic nature for at least 1 month. exclusion criteria: * allergies, * debilitating systemic diseases, * pregnancy status * severe cognitive impairment