Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of fibrin sealant (fs 4iu) for skin graft fixation and wound healing in subjects with burn wounds

Conditions: Burns

Summary: the purpose of this study is to assess if fibrin sealant 4iu is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds. each subject receives staples as well as fs 4iu on comparable treatment sites.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from either the subject or the subject's legally acceptable representative prior to screening activities * male or female age \>= 6 and \<= 65 years of age * total burn wounds measuring \<= 40% tbsa to include a deep partial thickness/full thickness area requiring autologous split thickness sheet skin grafts * the selected test area consisting of a contiguous, deep partial thickness/full thickness burn wound between 2% and 8% tbsa, which can be divided into two approximate halves or two bilateral wounds (each measuring between 1% and 4% tbsa) * females of child-bearing potential with a negative urine or serum pregnancy test on admission * able and willing to comply with the procedures required by the protocol exclusion criteria: * conductive electrical burns and chemical burns * digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites * circumferential burns are excluded as a test area * 4th or 5th degree burns * test area with infection as determined clinically by the investigator prior to surgery * venous or arterial vascular disorder directly affecting a designated test area * known immune deficiency disorder, either congenital or acquired * chronically malnourished as determined clinically by the investigator prior to surgery (investigators are responsible for determining subjects are chronically malnourished during the screening process. investigators should take into consideration the following parameters: medical history and physical appearance, the subject's body mass index, and any significant laboratory findings) * severe respiratory problems or concurrent head trauma at hospital admission * any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study * known or newly diagnosed diabetics requiring insulin * any other acute or chronic concurrent medical condition(s) that in the investigator's opinion are a contraindication to skin grafting and study participation * known or suspected hypersensitivity to bovine protein * concurrent participation in another clinical trial in which an investigational agent is used. (subjects must not have been enrolled in another clinical trial within 30 days of enrolling in this trial).
thoracic epidural analgesia and bilateral erector spinae plane block on postoperative pain in open heart surgeries

Conditions: Pain, Postoperative; Respiratory Complication

Summary: postoperative pain negatively effects respiratory functions in open heart surgeries. the aim of the study is to compare the effects of thoracic epidural analgesia (tea) and erector spinae plane block (espb) on postoperative pain and respiratory functions in patients undergoing open heart surgery with sternotomy

thoracic epidural catheter was inserted to patients in group t at the t4-t5 vertebra level before induction of general anesthesia. and then local anesthetic infusion was started until postoperative 48. hours. bilateral erector spinae plan block was applied with total 40 ml of local anesthetic solution to patients in group e at the t4-t5 vertebra level before induction of general anesthesia. the control group was infused with 1 mcg/kg/min fentanyl during the surgery. in the postoperative period, 1 g paracetamol was infused 4 times a day. all patients underwent general anesthesia with the same method and medications. tramadol/diclofenac was administered to patients with a pain score (nrs) above 4. nrs and tidal volumes (tv) of the patients were measured at 0, 2, 6, 12, 24, 36 and 48. hours after extubation. postoperative mechanical ventilation durations, intensive care unit and hospital stays, additional analgesic needs and respiratory complications of the patients were recorded.

Eligibility criteria:
inclusion criteria: * has asa ii-iv score * having open heart surgery exclusion criteria: * having a psychiatric illness * using analgesic medication due to chronic pain * uncooperative

Keywords: thoracic epidural analgesia erector spinae plane block heart surgery
trial to assess the efficacy of the comfort plug™in preventing urinary incontinence (comfort study)

Conditions: Urinary Incontinence

Summary: validation study: a prospective, non-randomized, single arm trial to assess the efficacy of the comfort plug™ in preventing urinary incontinence in male subjects with post prostatectomy urinary incontinence (comfort study)

this is a first-in-human, device assessment, feasibility study to assess the safety, effectiveness, comfort and usability of the prototype comfort plug™ for controlling urinary incontinence in male subjects. no drug treatment will be administered.

Eligibility criteria:
inclusion criteria: 1. male 18 years of age or older 2. at least 6 months post radical prostatectomy for localized prostate cancer 3. cystoscopic evaluation of the lower urinary tract within 12 months of screening 4. eastern cooperative oncology group (ecog) 0 or 1 performance status 5. evidence of moderate to severe urinary incontinence as assessed by the investigator, requiring protective garments or pads 6. post-surgical prostate specific antigen (psa) \<0.04 exclusion criteria: 1. inability to insert the comfort plug™ into his own urethra and remove it 2. history of significant incontinence prior to radical prostatectomy 3. evidence of incomplete bladder emptying post radical prostatectomy 4. recurrent , refractory bacteruria 5. urethral stricture disease. 6. history of meatal stenosis or phimosis 7. history of any other malignancy except basal cell skin cancer 8. planned radiotherapy for post prostatectomy residual disease within the next 90 days 9. evidence of neurogenic bladder dysfunction 10. multiple sclerosis or previous spinal cord trauma/pathology resulting in any neurologic deficit that, in the opinion of the investigator, might compromise the outcome 11. ongoing constipation 12. use of anticoagulant or antiplatelet medications excluding low-dose acetylsalicylic acid (asa) 13. hemophilia 14. any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve 15. currently receiving successful medical treatment for incontinence. 16. the usage of male urethral slings 17. planning to travel by airplane during the course of the study
efficacy and tolerability of flunarizine for the treatment of schizophrenia: comparison with haloperidol

Conditions: Schizophrenia

Summary: flunarizine is a calcium channel blocker traditionally used for the treatment of vertigo and migraine. it also has the mechanism of action associated with antipsychotic activity (d2 receptor blockade), but has never been tested as such. the investigators hypothesis is that flunarizine can be an atypical antipsychotic.

the main advantage of flunarizine over other d2 receptor blockers is its long half-life, so that it may be administered weekly or may delay relapse if medication is interrupted.

Eligibility criteria:
inclusion criteria: * dsm-iv schizophrenic or schizoaffective patients between 18 and 55 years old with a panss score above 45. exclusion criteria: * clinical disease * pregnancy * drug dependence (except for nicotine) in the past month and history of being refractory to at least 2 antipsychotics taken appropriately.

Keywords: flunarizine schizophrenia antipsychotic
cardiac arrest incidence and outcome among patients with covid-19 in french icus

Conditions: Sars-CoV2; Covid-19

Summary: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) is responsible for the novel coronavirus disease 2019 (covid-19) pandemic. among covid-19 complications, in-hospital cardiac arrest (ihca) was reported with a very poor outcome in a retrospective single-center study (0,7% of 30 days survival with good neurological outcome among ihca patients with a resuscitation attempt), related to its natural course and management. the incidence of unexpected in-icu cardiac arrest (icuca) due to covid-19 is still unknown. additionally, outcome of covid-19 patients admitted in icu for an out-of-hospital cardiac arrest (ohca) is also undescribed. the objective this study is : * to report the incidence of icuca among patients hospitalized in french icu for covid-19. * to report morbidity and mortality among covid-19 patients admitted alive in icu for an ohca or an ihca. the secondary objective is to assess outcome and identify risk factors of icuca occurrence among patients admitted for covid-19.

retrospective and prospective multicentric observational registry in french intensive care units (icu) including all consecutive adult patients admitted in icu with a documented sars-cov-2 disease : * for an out-of-hospital or an in-hospital cardiac arrest (ohca and ihca respectively) * or presenting an unexpected in-icu cardiac arrest (icuca) patients characteristics, cardiac arrest history and patients outcome will be recorded according to utstein recommendations. patients presenting an expected cardiac arrest in icu related to withdrawal of life sustaining therapies (wlst) will be excluded.

Eligibility criteria:
inclusion criteria: * patients admitted in intensive care unit with a documented sars-cov-2 disease * for an out-of-hospital or an in-hospital cardiac arrest * or an in-hospital cardiac arrest * or presenting an unexpected in-intensive care unit cardiac arrest exclusion criteria: * age under 18 y.o * expected in-intensive care unit cardiac arrest related to withdrawal of life sustaining therapies. * withdrawal of patient or next-of-kin informed consent

Keywords: novel coronavirus disease 2019 (covid-19) severe acute respiratory syndrome coronavirus 2 (sars-cov-2) out-of-hospital cardiac arrest in-hospital cardiac arrest unexpected cardiac arrest intensive care unit
the health of competitive fitness athletes

Conditions: Resting Metabolic Rate; Bone Mineral Density, Low, Susceptibility to; Body Image; Perfectionism; Depression; Eating Disorder; Exercise-Related Amenorrhea; Exercise Addiction; Binge Eating; Dietary Amenorrhea; Dietary Deficiency

Summary: fitness athletes emphasize the value of staying lean, muscular and defined, and motivates and inspires followers through social media. we want to study the effect of such lifestyle on selected aspects of psychological and physical health in female fitness athletes, and compare the outcomes to a healthy, physically active female population.

little is known about the mental and physical health effect from following the modern, idealized fitness lifestyle. the lifestyle is characterized by selective and restrictive eating behavior, strength training and use of supplements. the athletes emphasize the value of staying lean, muscular and defined, and motivates and inspires followers through social media. this study will recruit and observe a group of competitive female fitness athletes over their typical 3 month dieting period when preparing for contest. before their contest diet is initiated, the athletes will be screened on selected aspects of psychological and physical health. the screening is repeated two weeks prior to their first seasonal contest, and then finally one month post-contest season. during the diet period of 3 months, the athletes answers brief questionnaires by email on eating- and training behavior and on mood, while also reporting dietary intake by telephone interview. recreational physically females, not planning to do any fitness contest, will be recruited to serve as a parallel control group. they will perform the same physical and psychological screening, and answer the same questionnaires throughout the fitness contest diet period.

Eligibility criteria:
inclusion criteria: * fitness athletes: planning to compete in fitness sport during spring or fall 2017 * controls: being regular physically active (exercise \>2 times/week during last year) with a bmi between 17,5-30 exclusion criteria: * controls: having competed in fitness sports previously or planning to do in the future, or working as a personal trainer. * not able to meet at the norwegian school of sport sciences for baseline and follow up screenings. * being pregnant or nursing * metabolic related diseases

Keywords: body composition bone mineral density binge eating eating disorder exercise dependency depression perfectionism body building drive for muscularity drive for leanness
role of intima-media thickness in determining arteriogenic erectile dysfunction

Conditions: Erectile Dysfunction

Summary: erectile dysfunction.

the intima media thickness is increasingly used as a surrogate end point of vascular outcomes in clinical trials aimed at determining the success of interventions that lower risk factors for atherosclerosis and associated diseases (stroke, myocardial infarction and peripheral artery diseases, like disease of cavernosal artery). the investigators hypothesized that the imt of cavernosal artery would add to the predictive value of vasculogenic erectile dysfunction risk and outcomes. this study seeks to evaluate these hypotheses with our experience, investigating the predictive accuracy of cavernosal doppler ultrasound findings for discriminating patients with vasculogenic erectile dysfunction.

Eligibility criteria:
inclusion criteria: * erectile dysfunction patients exclusion criteria: * penile trauma.
follow-up of patients with previous sars-cov-2 infection: long-term damage assessment

Conditions: COVID-19

Summary: people affected by sars-cov-2 infection, whether patients have developed mild forms or a severe form of the disease, complain of nonspecific and entirely new symptoms or complain about the persistence pf them.investigators intend to follow over time the post-infectious phase of patients discharged from sub-intensive care unit. the aim is to identify symptoms and their frequency of presentation in the sars-cov-2 population in the post-acute period.


Eligibility criteria:
inclusion criteria: * patients over 18 exclusion criteria: * patients under 18

Keywords: long-covid post-covid sars-cov2
preoperative chemoradiotherapy for locally advanced resectable gastric adenocarcinoma

Conditions: Gastric Adenocarcinoma

Summary: gastric cancer is a high incidence in asia, and one of the leading cause of death in korea. a cure rate is improving due to early diagnosis. however, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40 \~ 67%. therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. the purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.

gastric cancer is a high incidence in asia, and one of the leading cause of death in korea. a cure rate is improving due to early diagnosis. however, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40 \~ 67%. therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. the purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.

Eligibility criteria:
inclusion criteria: 1. age ≥ 20 years old 2. histologically confirmed gastric adenocarcinoma 3. clinical stage : resectable gastric cancer * advanced confirmed (egd) * extramural infiltration\> 1 mm (ct) * positive serosa invasion (eus) 4. eastern cooperative oncology group performance status 0 or 1 5. no prior chemotherapy and radiotherapy 6. measurable lesion or evaluable lesion according to response evaluation criteria in solid tumors version 1.1 criteria 7. patients with adequate organ function 8. signed informed consent exclusion criteria: 1. metastasis esophageal invasion \> 3cm 2. inoperable peritoneal seeding disease determined by exploratory laparotomy 3. t4b invading the surrounding organs 4. lymph node metastasis outside the celiac trunk lymph node and splenic lymph node 5. uncontrolled viral infections (hiv, hbv, hcv) 6. pregnant or lactating women, women of childbearing potential not employing adequate contraception 7. severe hypersensitivity reactions to s-1, cisplatin 8. subjects with uncontrolled clinically significant cardiovascular medical history, uncontrolled infection or complication 9. other co-existing malignancies or malignancies diagnosed within the last 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix
outcomes of the plhiv with suboptimal viral suppression to injectable long-acting antiretrovirals

Conditions: HIV-1-infection; Non-Adherence, Medication

Summary: this study aims to determine whether people living with hiv (plhiv) with suboptimal medical adherence can achieve better viral suppression with long-acting antiretrovirals (la) compared to all-oral antiretrovirals.

this is an open-label, multi-center, randomized, active-controlled, superiority trial on 40 adult subjects who had been diagnosed to have hiv infection for at least 12 months before enrollment but with suboptimal viral suppression despite antiretroviral treatment (art), with the latest hiv-1 viral load ≥ 200 copies/ml. participants' eligibility will be assessed through a review of their medical records, and individuals with established resistance to cabotegravir or rilpivirine will be excluded. enrolled participants will then be randomized 1:1 to either "delayed switch to la treatment group" or "immediate la treatment group" on enrollment. the "delayed switch to la treatment group" will also switch to la on week 24. the proportion of participants with hiv-1 rna \<200 copies/ml at week 24 in the two study groups will be compared. psychologic assessments including self-stigma and depression assessment will also be performed on day1, at week 24 and week 52.

Eligibility criteria:
inclusion criteria: * willing to sign the written informed consent form for male and female participants aged 18 and above. * at the time of enrollment, diagnosed with hiv infection for a minimum of 12 months. * under oral antiretroviral treatment (art), which can be irregular or interrupted, with the most recent viral load ≥ 200 copies/ml. * body weight ≥ 35kg. * willing to maintain contact with the research team throughout the study (provide accurate and reachable phone numbers, social accounts like line, or reliable contact information of family or friends). * willing to receive gluteal (buttocks) drug injections. * willing to transition back to oral medication or follow the recommended treatment prescription according to the then-current national treatment guidelines after discontinuation of long-acting injectable drugs. exclusion criteria: * for those currently undergoing oral antiretroviral therapy, who have started or restarted oral art for less than six consecutive months before screening. * previously undergone hiv drug resistance testing and known to have resistance mutations to either cabotegravir or rilpivirine. * unable to commit to maintaining contact with the research team throughout the study. * individuals who cannot receive treatment for hepatitis b during the period of transitioning to long-acting injections, if they are hepatitis b carriers. * individuals with buttock fillers. * women who are planning to become pregnant, pregnant, or currently breastfeeding.

Keywords: hiv-1, non-adherence
a phase 2 study to evaluate dnth103 in adults with generalized myasthenia gravis (magic)

Conditions: Myasthenia Gravis, Generalized

Summary: the purpose of this phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of dnth103 in participants with generalized myasthenia gravis (gmg).

the study includes the following periods: * screening (up to 10 weeks) * randomized, blinded, controlled treatment (rct) period (13 weeks) * open-label extension (ole) period (optional) for eligible participants (52 weeks) * safety follow-up (40 weeks)

Eligibility criteria:
inclusion criteria: 1. must have given written informed consent before any study-related activities are carried out. 2. adult males and females, 18 to 75 years of age (inclusive) at screening. 3. weight range between 40-120 kg at screening. 4. diagnosis of gmg by the following tests: acetylcholine receptor antibody (achr ab) positive, and one of the following: i. history of abnormal neuromuscular transmission test; ii. history of positive anticholinesterase test; iii. clinical response to acetylcholinesterase inhibitors. 5. myasthenia gravis foundation of america (mgfa) class ii-iva 6. myasthenia gravis activities of daily living (mg-adl) score of 6 or more 7. vaccination against n. meningitidis with the quadrivalent meningococcal vaccine, and where available, meningococcal serotype b vaccine within 3 years prior to, or at the time of, initiating study drug. 8. female participants must: be of non-childbearing potential, or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception. 9. male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm exclusion criteria: 1. history or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant 2. prior history (at any time) of n. meningitidis infection. 3. positive test results for active human immunodeficiency virus (hiv-1 or hiv-2), hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) antibodies during screening. 4. any thymic surgery/biopsy within 1 year of screening. 5. any known or untreated thymoma. 6. any history of thymic carcinoma or thymic malignancy. 7. concurrent or previous use of the following medication within the time periods specified below. 1. rituximab within 6 months (180 days) prior to randomization (day 1); 2. intravenous immunoglobulin (ivig) and plasma exchange (plex) within 4 weeks (28 days) prior to randomization (day 1). 8. participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent.