Kornimate/medical-research-clean huggingface dataset:
a study to learn how different amounts of the study medicine called pf-07941944 are tolerated in the body of healthy adults.

Conditions: Healthy Participants

Summary: the purpose of this clinical trial is to learn about the safety and tolerability of the study medicine (called pf-07941944) in healthy participants. this study is seeking participants who: * are male or female between the ages of 18 and 60 * are generally healthy the investigators will compare the experiences of people receiving the study medicine to those of the people who do not. this will help the investigators determine if the study medicine is safe and well tolerated. participants enrolled in part 1 will take part in this study for approximately 4 months. participants enrolled in part 2 or part 3 will take part in this study for approximately 2.5 months. study visits will take place at the study clinic. the study team will also call participants once at the end of the study over the phone.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy as determined by medical evaluation * body mass index (bmi) of 17.5 to 30.5 kg/m2 * for inclusion of japanese participants: participants who have 4 japanese biologic grandparents who were born in japan. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease * any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation * use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention. * previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). * history of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening. * part 3 only: history of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis, or adverse reaction to midazolam or other benzodiazepines. history of hypersensitivity reaction to midazolam, or any of the formulation components.

Keywords: respiratory syncytial virus (rsv)
optimizing local anesthetic concentration for continuous femoral nerve blocks

Conditions: Total Knee Arthroplasty; Knee Pain

Summary: this is a randomized, observer-masked, controlled study. subjects will be patients undergoing bilateral total knee arthroplasty (tka). one side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. the contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%. the basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. for the duration of the study, all patients will receive the current usual and customary analgesics for bilateral tka patients. all patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (pod) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. rescue opioid and route of administration will be determined by pain severity using a numeric rating scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.

the investigators propose to test the null hypothesis that differing concentrations of ropivacaine (0.1% vs. 0.4%) at an equal total dose has no impact on quadriceps muscle strength during a continuous femoral nerve block following total knee arthroplasty (tka). these results will help define the optimal concentration of local anesthetic used for continuous peripheral nerve blocks.

Eligibility criteria:
inclusion criteria: * primary, bilateral tka * age 18 years or older * postoperative analgesic pain includes bilateral continuous femoral nerve blocks exclusion criteria: * chronic, high-dose opioid use * history of opioid abuse * any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles * pregnancy * incarceration

Keywords: tka bilateral cleveland clinic ucsd catheter nerve block postoperative pain femoral catheter bilateral total knee arthroplasty bilateral femoral catheter
detection of gabhs in throat gargle

Conditions: Group A Streptococcus: B Hemolytic Pharyngitis

Summary: the objective of this study is to investigate the use of patient throat gargle as an alternative to throat swabbing for the diagnosis of pharyngitis caused by group a β-hemolytic streptococcus (gabhs) infection, also known as strep throat.

the aim of this study is to procure a detailed quantitative and qualitative analysis of gabhs present in patient throat gargle and to compare various culturing techniques and immunoassay methods for efficient and effective gabhs detection from gargle fluid. during the course of this clinical trial, the following specimen samples will be collected from each participating patient: the patient will first be asked to gargle 10-15 ml of sterile saline to obtain a gargle sample, and then the patient will be subjected to two routine standard throat swabs. these specimen samples will be properly discarded after processing and analysis.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * suspected of suffering from gabhs pharyngitis. * able to communicate with study personnel (english or hebrew). * able to understand oral and written information about the study. * willing to provide written informed consent to participate in the study. exclusion criteria: * not capable of gargling 10-15 ml fluid. * diagnosed or self-reported pregnancy. * history of dementia, cognitive impairment, or psychiatric or mental disorders.
non ablative fractional laser treatment of burn scars

Conditions: Burn Scars

Summary: background: increasing evidence appears for non-ablative fractional laser (nafl) to remodel mature burn scars. objectives: to investigate long-term clinical and histological appearance of mature burn scars after nafl-treatment. hypothesis: that nafl can modulate mature burn scars with subsequently improved cosmetic and functional appearance. methods: study patients with burn scars at trunk or extremities. side-by-side test areas are randomized to three monthly 1,540 nm nafl-treatments or control, followed by blinded evaluations at 1, 3, and 6 months using mposas (modified patient and observer scar assessment scale; 1 = normal skin, 10 = worst imaginable scar).


Eligibility criteria:
inclusion criteria: * legally competent adults aged 18-60 years * fitzpatrick skin type i-iii * burn scar 1 year or older * total scar area allowing selection of two similar side-by-side test areas of minimum 1.5 × 3 cm for study purpose exclusion criteria: * pregnancy or lactation * suntan * wounds or infections in study area * tendency to form hypertrophic scars or keloids * oral retinoids, anti-inflammatory or immunosuppressive drugs within the last six months * current anticoagulants * previous treatments in test area with laser, intense pulsed light, dermabrasion, chemical peel or filler.

Keywords: burns non-ablative fractional laser scar texture histology laser treatment erbium:glass laser meshed skin-grafts photothermolysis skin
pelvic floor consciousness in women with pelvic floor dysfunction

Conditions: Pelvic Floor Disorders

Summary: the purpose of the study is to compare the efficacy of different modalities of motor learning of pelvic floor muscle contraction in women with pelvic floor dysfunctions, considering the efficacy of the treatment as improving the specific quality of life related to pelvic floor dysfunctions and improvement of the muscular properties of the pelvic floor muscles.


Eligibility criteria:
inclusion criteria: * women diagnosed with pelvic floor dysfunction by their doctor. * women who are unable to voluntarily contract the pelvic floor muscles, quantified by the modified oxford score by a score less than or equal to 2. exclusion criteria: * women who are pregnant or women who have had a vaginal or caesarean birth in the past six months. * women whose pfd is severe, and the first indication is surgical (pop-q grade iii-iv prolapses). * women with pain in the pelvic-perineal region of 3 cm in the visual analog scale, where a score of 0 cm means no pain, and a score of 10 cm, the maximum pain that the participant can imagine. * women who have received pelvic floor physiotherapy treatment in the last 12 months. * women with any pathology that may affect the treatment (neurological, gynecological or urological), or with recurrent urinary infection or hematuria. * women with cognitive limitations to understand the information, answer the questionnaires, consent and / or participate in the study.

Keywords: motor learning pelvic floor muscles physiotherapy biofeedback consciousness
trusopt and cosopt; ocular perfusion pressure and blood flow: new long-term prospective data

Conditions: Glaucoma

Summary: to analyze cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.

to analyze cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.

Eligibility criteria:
inclusion criteria: 1. age: 30 years or older. 2. diagnosis: confirmed open-angle glaucoma in at least one eye: 1. glaucomatous visual field loss on humphrey 24-2 or 10-2 perimetry 2. glaucomatous optic disc cupping 3. agreement between two baseline exams for reliability 3. best corrected visual acuity at least 20/60 in at least one eye. 4. prior humphrey visual fields demonstrate acceptable reliability standards. exclusion criteria: 1. extensive humphrey visual field damage consisting of either a mean deviation (md) \< -15 decibels or a clinically determined threat to fixation in both hemifields. 2. evidence of exfoliation or pigment dispersion. 3. history of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy. 4. history of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis). 5. history or signs of intraocular trauma. 6. severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment. 7. any abnormality preventing reliable applanation tonometry. 8. current use of any ophthalmic or systemic steroid which may interfere with this investigation. 9. cataract surgery within the past year. 10. resting pulse \< 50 beats per minute. 11. severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Keywords: glaucoma cosopt blood flow progression
postpartum care in the nicu (pelican) transitions

Conditions: Stress Disorders, Post-Traumatic; Premature Birth; Postpartum Depression; Postpartum Anxiety

Summary: this is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (nicu), which serves a high-risk, low-income, majority black population. in addition to doula support and coordination of care in the nicu, there will be a warm handoff to a community doula to continue the support once infants leave the hospital of the university of pennsylvania (hup) nicu.


Eligibility criteria:
inclusion criteria: * hup postpartum patients who are at least 16 years old at the time their newborns' birth * infant born at hup * preterm birth \<34 weeks * english language speaking exclusion criteria: * unable to read or sign informed consent * parents of infants transferred into hup nicu * if the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks * hup postpartum patients who are less than 16 years of age at the time of their newborns' birth
smoking cessation intervention after stroke or transient ischaemic attack.

Conditions: Stroke; Transient Ischemic Attack

Summary: patients with stroke or transient ischemic attach should receive advise on smoking cessation. it is however unknown if an intensive smoking cessation program is better than ordinary advise on smoking cessation during hospitalisation for stroke or transient ischemic attack. the aim of the study was to assess if an intensive smoking cessation program made more patients stop smoking after stroke or transient ischemic attack.

patients with stroke or transient ischemic attach should receive advise on smoking cessation. it is however unknown if an intensive smoking cessation program is better than ordinary advise on smoking cessation during hospitalisation for stroke or transient ischemic attack. the aim of the study was to assess if an intensive smoking cessation program made more patients stop smoking after stroke or transient ischemic attack. patients with stroke or transient ischemic attack are admitted to the department of neurology at odense university hospital. patient who are smokers on admission and age \< 76 years, inhabitants in funen county and with symptoms developed before admission will be offered participation in the study unless they have severe stroke, stroke more than 3 weeks before admission, other severe disease or unable to participate. study participants will be randomised to either usual short advise on smoking cessation or an intensive smoking cessation program. all participants will be followed-up for 6 months with regard to smoking habits.

Eligibility criteria:
inclusion criteria: * age \< 76 years * inhabitant in funen county * acute stroke or transient ischemic attack * symptoms with onset before admission * current smoker on admission exclusion criteria: * severe stroke * current stroke onset more than 3 weeks before admission * other severe disease * unable to participate
safety and efficacy of hihep bioartificial liver support system to treat acute liver failure

Conditions: Liver Failure, Acute

Summary: this study tend to evaluate safety and efficacy of hihep bioartificial liver support system in treating acute liver failure.

liver damage remains a life-threatening syndrome. with the increasing number of patients awaiting transplantation, efforts have been made to develop extracorporeal methods to support or replace the function of the failing organ. a bioartificial liver support system has to provide the main functions of the liver: detoxification, synthesis, and regulation. it may prolonger the expected survival time of acute liver failure patients. direct reprogramming of fibroblasts to hepatic lineages could offer a new type of solution to bioartificial liver support system. the investigators have already generated human induced hepatocytes (hiheps) from fibroblasts by lentiviral expression of foxa3, hnf1a, and hnf4a. hiheps express hepatic gene programs, can be expanded in vitro, and display functions characteristic of mature hepatocytes, including cytochrome p450 enzyme activity and biliary drug clearance. hiheps can restore the liver function and prolong survival. this study tends to evaluate safety and efficacy of hihep bioartificial liver support system in treating acute liver failure.

Eligibility criteria:
inclusion criteria: * weight more than 45 kg; * age more than 18; * diagnosis of alf; * subjects must not be listed for transplant at the time of enrollment or, if listed, in the opinion of the investigator are unlikely to be transplanted within 72 hours; exclusion criteria: * acute clinical symptoms that are likely to result in death within 48 hours; * presence of sepsis or septic shock; * concomitant disease including chronic congestive heart failure, severe vascular disease, emphysema, aids, cancer; * portal hypertension; * liver dysfunction due to trauma;

Keywords: bioartificial liver acute liver failure
procellera® compared to standard of care treatment in mitigating biofilm formation in acute trauma and burn wounds

Conditions: Trauma-related Wound; Burn, Partial Thickness

Summary: the objective of the study is to evaluate procellera® , a novel fda approved antimicrobial wound dressing in a prospective, randomized, controlled clinical study. the hypothesis is that when the dressing is moistened, the low electric field created by moisture-activated elemental silver and zinc electro-couple will prevent formation of biofilm in wounds or to disrupt existing biofilm.

the healing of traumatic wounds, to include burns, can be compromised by the presence of infection so efforts are made to prevent or diagnose infection early in order to mitigate the negative impact on healing. electric stimulation has previously been shown to have both bacteriostatic and bactericidal effects in wounds. until now, administering low intensity electric field/micro-current as a therapy to mitigate biofilm infection and to improve wound healing was not feasible. in this study the investigators will use procellera® , a fda approved fabric based wireless electroceutical dressing (wed) consisting of a silver-zinc electro-couple for the prevention of wound biofilm formation. the dressing generates a low electric field (\~1v) upon activation by a moist environment, which mitigates biofilm formation and promotes wound healing. the objectives of the study are to evaluate the efficacy of a wireless electroceutical dressing to prevent the formation or disrupting existing biofilms. the investigators will conduct a prospective, randomized controlled clinical trial using the procellera® dressing compared to the standard of care. treatment sites will be randomized to either receiving procellera® or the standard of care treatment. objective measurements and assessments will be completed during subject follow-up visits for up to one month post treatment. this includes biopsies to calculate bacterial load by assessing colony forming unit (cfu) count and bacterial film visualization using scanning electron microscopy, histology, clinical assessment of infection, transepidermal water loss (tewl) and wound photography.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * willing and able to provide informed consent * participant has acute partial-thickness or full-thickness wounds caused by trauma or partial-thickness burns that are ≥ 300 cm2 in size in one contiguous area or two separate wound sites ≥ 150 cm2 each exclusion criteria: * pregnancy * prisoner * active malignancy or immunosuppressive therapy * current systemic steroid use * known allergy or sensitivity to silver or zinc * participant's proposed study wound site has any of the following conditions: * location is on the hands, face or feet * full-thickness burn wounds * exposure of visceral organs * exposure of hardware or prosthetic exposure
a study of sr58611a in the prevention of depression relapse in patients with major depressive disorder

Conditions: Depressive Disorder; Major Depression

Summary: the purpose of the study is to assess whether treatment with sr58611a can prevent relapse of depressive symptoms in patients with major depressive disorder. relapse will be assessed using the madrs scale.patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with sr58611a are randomized to continue sr58611a or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. the secondary objective is to evaluate the safety of sr58611a in patients with mdd.


Eligibility criteria:
inclusion criteria: * patients diagnosed with major depressive disorder, recurrent according to dsm-iv-tr criteria diagnostic and statistical manual of mental disorders (fourth edition) and assessed with the mini international neuropsychiatric interview (mini) * total score on the montgomery and asberg depression rating scale (madrs) \> 28 * at w12 (v7), patients will be randomized into the double-blind treatment phase if they have madrs total score \< 12 exclusion criteria: * patients with a significant risk of suicide. * patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset. * patients with a current depressive episode secondary to a general medical disorder. * patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder. * patients with severe or unstable concomitant medical conditions * patients with clinically significant abnormal laboratory value at screening * the investigator will evaluate whether there are other reasons why a patient may not participate

Keywords: depression, antidepressive agents clinical trial phase iii multicenter study