Kornimate/medical-research-clean huggingface dataset:
dexamethasone for post uterine artery embolization pain

Conditions: Leiomyoma

Summary: the purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (a non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling of weakness following the procedure.


Eligibility criteria:
inclusion criteria: * women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids. exclusion criteria: * currently pregnant or actively attempting to conceive * those deemed mentally impaired to make their own medical decisions * previous documented allergy to dexamethasone * those currently taking daily steroids for any reason * those with diabetes or deemed to be pre-diabetic * those with contraindications for angiography * prisoners

Keywords: fibroids leiomyoma post-embolization pain dexamethasone
transplanting hepatitis c positive organs

Conditions: Hepatitis C; Awaiting Organ Transplant

Summary: this is an open-label, pilot safety and efficacy trial for adults who are active on the heart, lung, or kidney transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis c infection (hcv).

this is an open label pilot study transplanting organs from hepatitis c positive donors into hcv uninfected recipients at brigham and women's hospital. heart, lung and kidney transplant participants will be stratified into two different study arms depending on whether the donor of the organ was hcv nucleic acid amplifications technology (nat) positive or negative. in the nat positive arm, the recipients will receive a course of direct acting antivirals (daa) to begin on the day of transplant. if the donor was hcv antibody (ab) positive and nat negative, the recipients will receive close monitoring with serial hcv viral loads (vl) and will only begin treatment with daa if they develop hcv viremia.

Eligibility criteria:
inclusion criteria: * men and women who are age ≥ 18 years * active on either the cardiac, lung, or kidney transplant waiting list * willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection exclusion criteria: * hepatitis b nat or viral load positive * evidence of cirrhosis or clinically significant liver disease
using smokeless tobacco products with lower nicotine levels to reduce negative effects of smokeless tobacco use

Conditions: Tobacco Use Disorder

Summary: though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. this study will assess the effectiveness of limiting smokeless tobacco (st) nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

spit tobacco presents as many health risks to its users as smoking tobacco. it affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. long-term effects of spit tobacco use include tooth abrasion, gum recession, mouth disease, bone loss in the jaw, yellowing of the teeth, and chronic bad breath. although a significant number of st users recognize the importance of quitting, many either do not want to quit or feel it is impossible. for these individuals, tobacco reduction may be an important transitional goal, either prior to quitting, or as a treatment endpoint; however, approaches to help st users reach this goal have not been studied. this study will assess the effectiveness of limiting st nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake. participants in this open-label study will be randomly assigned to one of three treatment conditions: switching to an st brand with less concentrated nicotine and controlling for st use; switching to an st brand with less concentrated nicotine, combined with no limit on st intake; or continued use of usual st brand with no limit on intake (control group). participants in both brand-switching conditions will use st brands that have 50% less nicotine than their usual st brands for the first 4 weeks. for the next 4 weeks, participants in the brand-switching conditions will use st brands that have 75% less nicotine that their usual st brands. study visits will ocur once weekly during the 8-week treatment period. the number of participants who do not complete treatment, reduce nicotine intake, or quit completely will be assessed at week 8 and at follow-up visits, which will be held 12 and 26 weeks following the completion of treatment.

Eligibility criteria:
inclusion criteria: * not interested in quitting st use within 90 days of study entry * has been using st at least six times a day for 6 months prior to study entry * agrees to use an effective form of contraception throughout the study exclusion criteria: * current use of other tobacco or nicotine products * pregnant or breastfeeding * any unstable medical condition * use of any medication that may affect tobacco use or be affected by reduction of tobacco use * dsm-iv diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry * use of any psychotropic medications within 6 months prior to study entry

Keywords: brand switching, smokeless tobacco use
evaluation of the safety and efficacy of cosmetalife™ for the correction of nasolabial folds

Conditions: Facial Wrinkles

Summary: this is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of cosmetalife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).

patients with negative reaction skin test results will be randomized to receive cosmetalife in one nasolabial fold and control in the nasolabial fold on the opposite side of the face (split face design). each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.

Eligibility criteria:
inclusion criteria: 1. patients 18 years of age or older 2. patients with moderate nasolabial folds (3-4 wsrs scale) 3. patients willing to provide written informed consent for their participation in the study 4. patients willing to abstain from other facial cosmetic procedures through the 12 month follow-up visit exclusion criteria: 1. patients with any aesthetic facial therapy within 6 months prior to 2. patients with an any reaction to the skin test 3. patients with a history of autoimmune disorder, lidocaine reactions, allergy to heparin, other severe or chronic allergies 4. patients with a current disease state that can effect the immunoresponse, or patients on immunosuppressive therapy 5. patients with an active infection of any kind, skin disease, connective tissue disorder 6. patients who are pregnant or lactating 7. patients enrolled in another investigational clinical trial

Keywords: nasolabial folds dermal filler injectable dermal filler soft tissue augmentation
safety and tolerability of spd476 in maintaining remission in patients with ulcerative colitis.

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to test the long-term safety and tolerability of spd476 in the maintenance of ulcerative colitis remission.


Eligibility criteria:
inclusion criteria: * subjects must have completed all assessments of spd476-301 or spd476-302 end of study/early withdrawal visit * subjects who did not achieve remission at the end of study/early withdrawal visits in study 301 or 302 will be eligible to enter the acute phase; subjects who did achieve remission at the end of study visits in study 301 or 302 will be eligible to enter directly into the maintenance phase * women of childbearing potential must use an acceptable contraceptive method while on study treatment exclusion criteria: * subjects who withdrew from study 301 or 302 before study visit 3, or who withdrew due to a possible or probably related severe adverse event or serious adverse event are not eligible to enter this study
pulsed-field-ablation to treat atrial fibrillation with a novel multimodality generator

Conditions: Atrial Fibrillation

Summary: in this first-in-human clinical trial a novel generator (intellapulse), designed and built by stockert, which supports highly flexible pfa protocols as well as rf interventions will be used. for 12 months and follow-up for 12 months, after a 3-months blanking period 50 consecutive paroxysmal af patients, eligible for catheter ablation, will be enrolled.

the principal safety and efficacy of pfa have been established in previous studies, showing low compli¬cation rates, short procedure times, and non-inferior/ superior efficiency compared to thermal abla¬tion.18, 19 however, current generators available for clinical practice are not generally designed to allow both non-thermal and thermal ablation in single shot settings. moreover, modification of pfa sequences is not supported in commercially available systems. flexible, multi-modal generators that allow one to conduct pfa or rf ablation using one and the same catheter would be highly desirable, from a clinical point of view, to allow for on-the-fly decision-making in view of individual patient requirements. in this first-in-human clinical trial a novel generator (intellapulse), designed and built by stockert, which supports highly flexible pfa protocols as well as rf interventions will be used. this generator will be ce marked in q3/24. upon completion of the ethical approval process in q2/25, the 'first in human' study, exploring safety of the stockert pfa generator will be started. the trial will be a prospective single arm study at the uhz freiburg · bad krozingen and will recruit for 12 months and follow-up for 12 months, after a 3-months blanking period. 50 consecutive paroxysmal af patients, eligible for catheter ablation, will be enrolled. exclusion criteria will be age \<18 years, previous left atrial ablation, and lack or withdrawal of written informed consent. data acquisition will use an electronic case report form (redcap database). procedures will be performed using standard operating procedures (sop). in short: ablations will be performed under deep analgo-sedation and/or general anaesthesia. trans¬oesophageal echocardiography will be performed if patients present with either af or atrial tachycardia (to exclude intracardiac thrombi) or in sinus rhythm (in patients with interrupted oral anticoagulation and cha2ds2-vasc-score ≥2). atrial transseptal puncture will be performed for access to pulmonary veins (pv), using a fixed curve transseptal sheath and transseptal needle according to standard sop. pfa catheters (farawave™, boston scientific) will be utilized, as in prior work with a commercial pfa system (farapulse™, boston scientific) at the uhz. at every pv antrum, 8 pfa-pulses will be delivered in 'flower' and 'basket' configurations (delivery of additional pfa-pulses will be at operator's discretion).

Eligibility criteria:
inclusion criteria: * new onset atrial fibrillation exclusion criteria: * age \<18 years * previous left atrial ablation * lack or withdrawal of written informed consent * unable to receive ablation therapy
local and systemic oxygen saturation during 'death by squats' exercise

Conditions: Oxygen Saturation; Fatigue; Anaerobic Threshold; Quadriceps Muscle

Summary: during the exercise intervention "death by squats", which compasses body weight squats until maximum exertion, 25-30 subjects shall be tested for heart rate, the oxygen saturation of the vastus medialis and the triceps, resting and at maximum exertion blood lactate, as well as the rate of perceived exertion on the borg scale. at the end, all should indicate their primary reason for stopping (local fatigue, systemic fatigue, time constraints, motivational deficit).

subjects in this study will be measured while they are engaged in an exercise protocol until maximum exertion, each in groups of three persons. the overall duration of the study is planned from april 2023 (start of recruitment) until december 2024 (finalization of data acquisition and analysis). subjects are executing a crossfit workout which is planned as follows: every minute, participants have to perform a given number of airsquats (bodyweight squat). the first minute starts off with 10 repetitions, the remaining time can be used as a break. in minute two, 12 repetitions have to be done, in minute three 14 repetition, and so on. the subjects stick to this protocol until maximum exertion, in other words, until they are no longer able to execute the given repetitions within the actual minute. during the workout, heart rate is tracked by a 'polar' chest strap, and the oxygen saturation of the vastus medialis and the triceps are measured using the 'moxy' muscle oxygen monitor. further, at rest and at maximum exertion, a blood lactate sample is taken (ekf lactate scout). subjects rate their perceived exertion on the borg scale after quitting and indicate their primary reason for stopping (local fatigue in legs, systemic fatigue, time constraints).

Eligibility criteria:
inclusion criteria: * being moderately to severely physically active al least 2 hours/week (all types of sport are eligible) exclusion criteria: * akute infections, musculoskeletal injuries * chronic cardiovascular or pulmonary diseases (in case of uncertainty, we recommend appraisal from medical personnel)
safety observation of enterovirus 71 inactivated vaccine (vero cell) combined immunization in shanghai

Conditions: Hand, Foot and Mouth Disease

Summary: this study is an open clinical trial of the ev71 vaccine (vero cell), inactivated manufactured by sinovac research \& development co.,ltd.the purpose of this study is to evaluate the safety of ev71 vaccine (vero cell), inactivated co-administration with other vaccines

this study is an open clinical trial in children aged 6-71 months old. the purpose of this study is to evaluate the safety of ev71 vaccine (vero cell), inactivated co-administration with other vaccines.the ev71 vaccine was manufactured by sinovac biotech co.a total of 12500 subjects aged 6-71 months old were enrolled.all subjects received one dose of ev71 vaccine and one of other vaccines(such as mmr vaccine,encephalitis vaccine,mumps vaccine,inactivated poliomyelitis vaccine,influenza vaccine and so on ) at the same time.

Eligibility criteria:
inclusion criteria: * 6 months ≤ age of enrollment ≤71 months; * voluntary and self-funded completion of ev71 vaccine combined immunization with one of the other type i or ii vaccines; * the subject and/or guardian can understand and voluntarily sign the informed consent form; * subjects and their legal guardians are able to attend follow-up visits and follow all study procedures (such as cooperating in completing safety observation notes). exclusion criteria: -
transvaginal diagnostic study in women with pelvic pain

Conditions: Pelvic Pain

Summary: we propose a phase i study of laparoscopic assisted, transvaginal peritoneoscopy by using flexible endoscopy in female patients with pelvic pain. it is designed as a hybrid procedure with laparoscopy using one port for adequate safety with the ultimate goal in the future that transvaginal notes can replace therapeutic pelviscopy for this indication. the standard number of port sites for diagnostic laparoscopy is 2-3. by reducing the number and size of laparoscopic port, patients should already experience benefits from this hybrid procedure.

approximately 50% of patients with chronic pelvic pain will have a normal laparoscopy. the vast majority of women with endometriosis, chronic pelvic pain and absence of ovarian endometriomata determined by ultrasound will have revised asrm stage i or ii (peritoneal) disease with preservation of the posterior cul-de-sac. this sparing of the posterior cul-de-sac may offer a preferable route of entry for endoscopic surgery compared to the current standard of care. despite all the advantages of laparoscopic surgery, it is not free of risks and pain, and creates scars, which themselves are associated with complications such as abdominal wall hernias and adhesions. within this scenario, a new surgical procedure has emerged, called natural orifice transluminal endoscopic surgery (notes). this technique uses existing orifices of the body for introducing optical systems and surgical instruments into the peritoneal cavity by avoiding penetration of the abdominal wall. the expectations are no postoperative pain, optimal cosmesis without any visable scars and shorter recovery similar to therapeutic endoscopy.

Eligibility criteria:
inclusion criteria: * women age 18 and older who have an indication and scheduled for laparoscopic peritoneoscopy. exclusion criteria: * known pelvic adhesive disease or greater than stage ii endometriosis or sonographic evidence of endometrioma. * bmi over 30. * major comorbidities - including diabetes, myocardial infarction, congestive heart failure, stroke, history of cancer or currently undergoing chemotherapy, autoimmune disease requiring immunosuppressive or steroid therapy . * any primary bowel disease (ibd, sprue, obstruction, acute appendicitis, gastric bypass, etc.). * pregnancy. * any known pid, tuboovarian mass or abscess, or active sexually transmitted infection. * retroflexed uterus

Keywords: transvaginal peritoneoscopy
mild traumatic brain injuries in children: predicting behavioral and emotional deficits

Conditions: Post-Concussion Syndrome

Summary: the purpose of this study is to investigate the role of psychosocial factors in creating persistent post-concussive symptoms (ppcs). the researchers investigate three hypotheses: (a) do pre-injury psycho-environmental deficits predict a higher level of ppcs? (b) do socio-demographic and personal pre-injury deficits relate to (1) a more negative attribution for the child injury by their parents and (2) embracing of a more permissive and authoritarian parenting; and do these factors mediate the symptoms' preservation? (c) does cognitive-behavioral therapy (cbt) benefit to reducing ppcs emotional and behavioral symptoms?

200 children and adolescents with post concussion will be followed for 9 months, since the time of the head injury. post concussive symptoms, along emotional distress and neurocognitive deficits will be examined at 2 weeks, 4 months and 9 months since the injury, using self report questionnaires, psychological evaluation and neuropsychological tests. participants who demonstrates ppcs 4 months after the injury will be assigned either to the cognitive behavioral treatmet group (cbt) or to the treatment as ususal group(tau). the change in symptoms severity (pcs, emotional distress and neurocognitive deficits) will be compared between the two study groups in order to assess treatment efficacy.

Eligibility criteria:
inclusion criteria: * head trauma. * post-concussive symptoms diagnosis according to dsmiv. exclusion criteria: * mental retardation. * drug abuse.

Keywords: post-concussion cognitive-behavioral theray parenting
utility of the use of n-acetylcysteine associated with conventional treatment in patients with severe acute alcoholic hepatitis (maddrey> 32)

Conditions: Alcoholic Hepatitis

Summary: this study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + nac, compared to patients that only receive corticosteroids.

currently there are no drugs available to cure patients with acute alcoholic hepatitis. the only treatment available is corticosteroids, the efficacy of which is limited and not free of side effects. other drugs that can contribute to improve the situation of patients with this entity is n-acetylcysteine (nac), however, in the different studies contradictory data are obtained, therefore, different societies recommend conducting studies of greater scope to confirm the effectiveness of n-acetylcysteine and to be able to make a clear indication about n-acetylcysteines use. clinical, randomized, controlled, multicenter, parallel and open trial.

Eligibility criteria:
inclusion criteria: * men and women. * age from 18 to 75 years. * patients with acute alcoholic hepatitis according to aasld criteria or compatible liver histology. * maddrey score\> = 32. * acceptance of participation through written informed consent. exclusion criteria: * any cause of jaundice: acute hepatitis, positive hiv serology, biliary-pancreatic pathology, hemolytic anemia. * allergy or intolerance to n-acetylcysteine and / or corticosteroids. * hepatocarcinoma. * portal cavernomatosis. * portal cavernomatosis. * any disease whose life expectancy is less than 12 months. * patients with nitroglycerin and / or carbamazepine-based treatments. * patients with uncontrolled active infection. * acute kidney disease with creatinine\> 2.5 mg / dl. * uncontrolled upper gastrointestinal bleeding. * concomitant uncontrolled diseases (hbv, hcv, hiv, tb, dili, hcc or acute pancreatitis). * multiple organ failure or shock.