Kornimate/medical-research-clean huggingface dataset:
hera fib registry for patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the single-center hera afib registry was created to assess real-world prevalence, demographic characteristics and management of patients with atrial fibrillation (af) in the era of novel oral anticoagulant regimes (noac) presenting in the emergency department (ed) of university of heidelberg

hera afib is a single-center retrospective registry which enrolled consecutive cases presenting with atrial fibrillation at the emergency department of university hospital of heidelberg. clinical parameters and characteristics for cases were assessed retrospectively. follow-up was performed via review of medical reports, phone calls and postal queries. outcome parameters included rates for all-cause mortality, non-hemorrhagic stroke, myocardial infarction and major bleeding.

Eligibility criteria:
inclusion criteria: * documented atrial fibrillation * availability of at least one hstnt measurement exclusion criteria: * lost to follow-up
the effect of platelet-rich plasma in subjects with androgenetic alopecia

Conditions: Androgenetic Alopecia

Summary: the purpose of this study is to evaluate the effect of autologous platelet-rich plasma (prp) in the treatment of androgenetic alopecia. this is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with moderate androgenetic alopecia. approximately 30 subjects will be randomized into the study. the study is designed as an 18-month study consisting of 2 phases. this study was a pilot study designed to determine feasibility of this procedure. subjects currently living in the chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.


Eligibility criteria:
inclusion criteria: 1. males or females ≥ 18 years old and ≤55 years old 2. subjects are in good health as judged by the investigator. 3. diagnosed with by a dermatologist with moderate androgenetic alopecia. 4. subject is seeking treatment for androgenetic alopecia. 5. subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year. 6. subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator. exclusion criteria: 1. other than androgenetic alopecia, evidence of another skin condition affecting the treatment area that would interfere with clinical assessments. 2. subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study. 3. willing to refrain from washing hair or using hair product 24 hours before and after treatment visits 4. history of a clinically significant hematologic disorder as determined by the investigator. 5. subjects currently receiving anticoagulant or anti-platelet therapy. 6. subjects on daily aspirin therapy for cardiovascular disease. 7. subjects with chronic nsaid use, unable to wean off. 8. subject is known to be hiv positive. 9. history of recurrent facial or labial herpes simplex infection 10. history of hypertrophic scars or keloids 11. known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc. 12. subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent 13. pregnant or breast feeding 14. uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations. 15. subjects who are unable to understand the protocol or give informed consent.
intracervical lidocaine gel for iud insertional pain

Conditions: Pain

Summary: the intrauterine device (iud) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. women can experience high levels of pain when the iud is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method. this study will randomly (like flipping a coin) assign women who have chosen the iud as their contraceptive into two groups. one group will have lidocaine anesthetic gel placed into their cervix prior to having the iud inserted; the other will have an inert gel placed into their cervix instead. the level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease iud insertional pain

the intrauterine device (iud) is a highly effective, long-acting, reversible method of contraception used by approximately 8% of women in the developed world. in the united states, historically candidates for iuds were monogamous, parous women. recent research has shown that both copper and levonorgestrel iud use is safe and effective in nulliparous women. nulliparous and parous women can experience significant amounts of pain during iud insertion. concerns about insertional pain could be a barrier to iud initiation women and their healthcare providers. this study will recruit women at either the family planning clinic or the offices of columbia university family planning practice who desire the copper or levonorgestrel iud for birth control. women who consent to participating in the study will be randomized to two groups: one group will receive 2% lidocaine gel placed in the cervix prior to iud placement and the other group will receive a placebo inert gel. the primary objective of this study is to compare the pain scores on a 10cm visual analogue scale in the two groups after tenaculum placement (placing an instrument on the cervix to stabilize it), uterine sounding (measuring of the uterus) and at speculum removal; these are standard procedures during iud insertion. secondary outcomes include provider assessment of the patient's pain, patient's level of satisfaction with the insertion, and whether any adverse events such as nausea/vomiting, fainting, or iud insertion failure occurred.

Eligibility criteria:
inclusion criteria: * self-select either a paragard or mirena iud and are appropriate for insertion as determined by their provider * age 18-45 * speak english or spanish exclusion criteria: * lidocaine allergy * first trimester abortion or miscarriage in the previous six weeks * second trimester abortion or miscarriage in the previous 12 weeks

Keywords: iud lidocaine gel
a study of vaniprevir (mk-7009) in participants with chronic hepatitis c infection after participation in other vaniprevir studies (mk-7009-028)

Conditions: Hepatitis C, Chronic

Summary: this study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon (peg-ifn) and ribavirin (rbv) to participants with chronic hepatitis c virus (hcv) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (mk-7009-004, nct00518622; mk-7009-007, nct00704405; mk-7009-009, nct00704184; and mk-7009-029, nct00954993).


Eligibility criteria:
inclusion criteria: * participant has participated in a prior vaniprevir clinical trial * participant agrees to use acceptable birth control method during treatment exclusion criteria: * more than one year has passed since the participant was determined to be eligible for enrollment in protocol 028 * participant discontinued vaniprevir and/or peg-ifn and/or rbv in the prior study due to a safety or tolerability issue * participant received any investigational therapy for hcv after participating in the prior study

Keywords: hepatitis c
acute posttraumatic osteomyelitis in patients with high-energy tibial fractures and biomarkers

Conditions: Osteomyelitis Tibia; Surgical Site Infection

Summary: the present trial was aimed to identify which biomarkers could be associated in perioperative period after surgical treatment of tibial fracture to the development of pom.

early diagnosis of acute posttraumatic osteomyelitis (pom) is of vital importance for avoiding devastating complications. diagnosing pom is difficult due to the lack of a highly specific and sensitive test, such as in myocardial infarct, stroke and intracranial bleeding. serum inflammatory markers, c-reactive protein (crp), procalcitonin (pct), white blood cells (wbc) can support clinical findings but they are not able to differentiate between inflammatory response to infection and the host response to non-infection insult with high specificity and sensitivity. the prospective nonrandomised cohort study included 86 patients after high-energy injury to the shin requiring primary surgical treatment (open or closed reduction and internal fixation of tibial fracture). values of the biochemical and immunoinflammatory profile were measured on admission (add), first postoperative day (pod1) and fourth-postoperative day (pod4). the objectives of the study were to investigate that the biochemical and immunoinflammatory profile could facilitate postoperative monitoring, guide the antibiotic treatment and timing of revision surgery.

Eligibility criteria:
inclusion criteria: * high-energy injury to proximal, shaft or distal tibia, * tibial fracture requiring primary surgical treatment /orif exclusion criteria: * ankle fracture, * patella fracture, * avulsion fracture of the knee, * malignant neoplasm and pathological tibial fracture, * systemic autoimmune disease of connective tissue, * immature patients under 15 years of age (children), * immunocompromised patients.

Keywords: osteomyelitis tibial fracture cytokines pct crp albumin
support tool for families of high-risk children with heart disease during hospital admission and after discharge

Conditions: Heart Disease Congenital

Summary: the goal of this study is to pilot the "support tool" in the nemours cardiac center to assess acceptability and feasibility. this tool will be offered to 5 high-risk families, and they will be asked to complete a survey. in addition, healthcare providers including bed-side nurses and cardiologists will be asked to complete a survey to assess the feasibility of the tool.

despite advances in the care of children with heart disease, those affected often remain in need of complex care after hospital discharge. multiple medications, tube feeds, and medical equipment are a few of the care needs parents face upon leaving the hospital. unsurprisingly, many parents report problems in the transition of care from the hospital to the home. clinical providers express frustration related to challenges with family education and communication around the time of discharge. research is required to identify intervention strategies to improve parent/ caregiver confidence with caring for their child after discharge and reduce unintended resource utilization after discharge including clinical deterioration, unplanned 30-day readmissions, emergency department (ed) visits and nonadherence to outpatient appointments. in aim 1 of the study, the investigators identified the modifiable barriers, perceived needs, and opportunities for intervention to support parents/ caregivers in meeting the care needs of the high-risk child with heart disease after discharge by conducting semi-structured qualitative interviews with parents/ caregivers and healthcare personnel. and based on participants' responses, the investigators developed a support tool to improve parent/ caregiver comfort with caring for the high-risk child and improve post discharge outcomes. the objective of this study is to pilot this support tool in 5 high-risk families in nemours cardiac center and assess the acceptability and feasibility based on their experience.

Eligibility criteria:
parent/caregiver group- inclusion criteria: • parents of a child with congenital heart disease and planned discharge from the nemours cardiac center. exclusion criteria: • non-english and non-spanish speaking families. the healthcare providers group is pre-identified and they will be invited to provide feedback through semi-structured qualitative interviews only. they will not receive any intervention. their participation will be voluntary.
efficacy and safety of gsk3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate

Conditions: Arthritis, Rheumatoid

Summary: this study \[contrast 1 (201790: nct03980483)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of gsk3196165, in combination with methotrexate (mtx), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (ra) who have had an inadequate response to mtx. the study will consist of a screening phase of up to 6 weeks followed by a 52-week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive gsk3196165 150 milligrams (mg) subcutaneous (sc) weekly, gsk3196165 90 mg sc weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with mtx. participants who, in investigator's judgement will benefit from extended treatment with gsk3196165, may be included in the long-term extension study \[contrast x (209564: nct04333147)\]. for those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.


Eligibility criteria:
key inclusion criteria * \>=18 years of age * has had ra for \>=6 months and was not diagnosed before 16 years of age * has active disease, as defined by having both:\* * \>=6/68 tender/painful joint count (tjc), and * \>=6/66 swollen joint count (sjc) * has at least 1 bone erosion present on hand/wrist or foot radiographs * has had an inadequate response to mtx, despite currently taking mtx 15-25 mg/week\*\* oral or injected * if surgical treatment of a joint has been performed, that joint cannot be counted in the tjc or sjc. * a lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to mtx or per local requirement. key exclusion criteria * has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections. * has received prior treatment with an antagonist of gm-csf or its receptor or janus kinase (jak) inhibitors (either experimental or approved) * has received prior treatment with a biologic disease-modifying antirheumatic drug (dmard) which has been discontinued due to an inadequate response.

Keywords: rheumatoid arthritis gsk3196165 otilimab tofacitinib methotrexate placebo
effects of creatine supplementation in women with knee osteoarthritis and fibromyalgia

Conditions: Knee Osteoarthritis; Fibromyalgia

Summary: the purpose of this study is to determine whether creatine associated or not to exercise training can improve physical performance in patients with knee osteoarthritis and fibromyalgia.


Eligibility criteria:
inclusion criteria: * fulfill acr criteria of knee osteoarthritis * fulfill acr criteria of fibromyalgia exclusion criteria: * athletes * drugs stable for at least three months before entering the study * no limitations to resistance training
predictive factors for failure or success of endoscopic treatment of superficial colorectal tumors

Conditions: Superficial Colorectal Tumors

Summary: to evaluate the long-term complete remission rate (\> 12 months) after endoscopic treatment of early neoplastic colorectal lesions.

intra-mucous colorectal neoplasia lesions (or even with minimal mucosal infiltration), formerly treated surgically, are increasingly treated endoscopically. the ipc as a center for interventional endoscopy has been taking care of these lesions for several years. resection techniques have diversified since the 2000s (polypectomy, monobloc or piecemeal mucosectomy, submucosal dissection ... etc) and the endoscopy team has developed its various techniques within the institute ; practice has evolved and has not been studied or evaluated in recent years. the purpose of this study is to evaluate practices and to compare results with the literature, and to identify predictive factors for the failure or success of endoscopic treatment of these early neoplastic lesions.

Eligibility criteria:
inclusion criteria: * patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified vienna classification during the last 5 years at the institute. exclusion criteria: * adenomas with low grade dysplasia * endoscopic control not available

Keywords: endoscopic resection colorectal adenomas colorectal adenocarcinomas
biktarvy for non-occupational post-exposure prophylaxis (npep)

Conditions: HIV Prevention

Summary: study will evaluate the safety and tolerability of once daily biktarvy for 28 days for prevention of hiv infection in hiv-1-seronegative adults after high-risk sexual contact. (non-occupational post exposure prophylaxis - npep)

non-randomized, open label single arm trial conducted at fenway health as a single site. 100 subjects will be enrolled following a high risk sexual exposure in which hiv exposure is a concern. each person will be provided with detailed informed consent and if they agree, will receive a 28 day regimen of bic/f/taf (biktary) in a single fixed-dose tablet. subjects will be seen for 3 visits over a period of four months in which assessments will be done to evaluate safety of product, tolerability of product and hiv status. all subjects will be compared to historical controls in the previous one daily tdf-based npep studies which were conducted at fenway health.

Eligibility criteria:
inclusion criteria: 1. \> age of 18 at time of first visit. 2. hiv uninfected 3. willing and able to provide written informed consent. 4. willing and able to provide adequate locator information. 5. willing and able to return to all study visits. 6. willing to participate in all study procedures. 7. childbearing age: willing to use contraception for as long as they are on study medication plus 7 days after. (appendix a: list of approved contraception). 8. possible sexual exposure to hiv-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure. a possible exposure could include: 1. condomless anal, vaginal, oral, or mucosal (e.g. conjunctival) exposure to ejaculate from a partner who is hiv-1 infected or high risk for hiv infection and of unknown hiv-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage); or 2. condomless penile exposure to cervicovaginal secretions or anorectal secretions from a partner who is hiv-1 infected or high risk for hiv infection and of unknown hiv-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage) exclusion criteria: 1. an active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures. 2. pregnancy and/or breastfeeding. 3. people who are actively trying to become pregnant. 4. acute or chronic hepatitis b infection. 5. acute or chronic renal disease. 6. creatinine clearance at or below 30 ml/min (cockcroft-gault0 known intolerance or allergy to tenofovir disoproxil fumarate, tenofovir alafenamide, emtricitabine, or bictegravir. 8. currently taking or plans to take prohibited medication while enrolled in the study. (appendix b: complete list of prohibited medications). 9. non-english speakers.

Keywords: post-exposure-prophylaxis
the effect of locomotor training on children with incomplete spinal cord injuries

Conditions: Spinal Cord Injuries

Summary: --participation open to all canadian residents-- the purpose of this study is to address how well children with incomplete spinal cord injuries of greater than 12 months duration who remain non-functional ambulators improve through body weight assisted treadmill training (bwatt).

in the past, this type of treatment has been offered to adults living with a spinal cord injury, but only recently has it been extended, in the us, to children so affected. numerous trials indicate that bwstt does improve human gait patterns in adults. as children have more neuroplasticity than adults, we believe they should respond well to bwstt. the bwstt uses a counterweight harness system to unload the patient's body weight while he or she is on a treadmill. the patient's legs are manually moved by trained therapists through the human gait cycle while maintaining a correct upright posture. functional and social re-integration outcome assessments are administered before and after each treatment period. the aim, this year, is to recruit five children who have been living with a spinal cord injury for at least 12 months. the 12-month timeframe was chosen to limit any gait improvement from spontaneous recovery as well as to ensure medical stability. the study will be conducted over a nine-week period. there are two three-week training sessions separated by a three-week rest period. the bwstt therapy will be held twice daily for 30 minute sessions. the children and their families return home between the two training periods and are allowed to continue any conventional physiotherapy program they started prior to participating in the study. outcomes will be re-evaluated during the second three-week training period.

Eligibility criteria:
inclusion criteria: * children between the ages of 4-18 with incomplete asia c or d spinal cord injuries at least 12 months before study enrolment * non-ambulatory or 'exercise only' ambulators with or without assistive devices * normal motor and cognitive development up to time of injury * medical stability exclusion criteria: * other neuromuscular disease * contraindication to weight bearing on lower extremities * pressure sores where harness would be applied * uncontrollable hypotension when upright * lower limb contractures impeding range of motion necessary for ambulation * prior enrolment in a bwatt program * unable to commit to intervention for duration of protocol

Keywords: incomplete spinal cord injuries walking treadmill training