Kornimate/medical-research-clean huggingface dataset:
comparison study on topical anesthetic agents (lmx4 and blt) prior to fractional skin resurfacing

Conditions: Pain

Summary: the purpose of this research study is to test which topical anesthesia: lmx4 (lidocaine 4%) or blt (benzocaine 20%, lidocaine 6%, and tetracaine 4%) is more effective in reducing discomfort during treatment with the fraxel dual 1550/1927 (solta medical, hayward, ca). no studies have been done on the effectiveness of lmx4 versus blt using the fraxel dual, although individually lmx4, blt, and the fraxel dual have been studied extensively. the hypothesis is that there will be no clinical difference between the two topical anesthetics.

lasers can be effectively utilized for facial rejuvenation, reduction of photoinduced rhytides, and dyschromia. topical anesthetics are used to minimize the discomfort associated with laser induced thermal pain. there are currently several formulations of topical anesthesia. however, studies comparing the products are limited especially for the new formulations that claim increased efficacy and faster onset. lmx4 (ferndale laboratories, ferndale, michigan) is over the counter topical anesthesia. it is 4% lidocaine that has been formulated into multilamellar vesicles containing several lipid bilayers. this unique liposomal-based delivery system has been reported to deliver a greater concentration of drug. this results in a longer duration of activity and faster onset of action without requiring occlusion.4 liposomes assist with drug penetration because the skin is lipid bilayer that can encapsulate the drug. blt is a compounded topical anesthetic containing 20% benzocaine, 6% lidocaine, and 4% tetracaine. it is commonly prescribed as topical anesthesia. all blt products will be compounded at the university physicians center pharmacy to ensure safety and uniformity. anecdotally, some physicians claim it is the topical anesthesia of choice prior to laser surgery. the objective of the study is to evaluate the clinical efficacy of topical anesthetic compounds prior to fractional skin resurfacing.

Eligibility criteria:
inclusion criteria: * at least 28 subjects will be included in this study. * subjects capable of giving informed consent. * patients 18 years of age and older will be included in this study. * any patient seeking fraxel dual1550/1927 (solta medical) treatment on the face for rhytids, photoaging, hyperpigmentation, and acne scarring at the hershey medical center dermatology clinics will be asked to participate. exclusion criteria: * age \<18 * allergy to lidocaine or tetracaine * women who are pregnant or breast-feeding * patients with cardiac or respiratory disease, seizure disorders, or neuropathy * patients currently taking anxiolytics and opiates

Keywords: topical anesthetics laser resurfacing
characteristics of a maxillofacial prosthesis consultation within assistance publique - hopitaux de paris

Conditions: Head and Neck Neoplasm; Cleft Palate; Cleft Lip

Summary: patients treated with maxillofacial prosthesis have loss of maxillary and/or mandibular substances. few data are available on quality of life of these patients and its association with some of their socio-demographic, medical and clinical characteristics.

patients treated with maxillofacial prosthesis have loss of maxillary and/or mandibular substances (oral-nasal or oral-sinusal communication, removal of the soft palate, removal of part of the lower jaw). these losses are mainly due to the surgical consequences of cancers of the upper aerodigestive tract, trauma or sequelae of labio-palate clefts. depending on the etiology of substance loss, there are 3 main therapeutics: surgical approach, radiotherapy and chemotherapy. the effects of these treatments are functional, aesthetic and psychological. the functions impacted are chewing, phonation, ventilation and swallowing. few data are available on quality of life of these patients and its association with some of their socio-demographic, medical and clinical characteristics (drug use, type of maxillo-mandibular loss of substance, disorder(s) associated with substance loss, ...). this study investigates the socio-demographic, medical and quality of life characteristics of maxillofacial prosthesis consultation's patients (department of dentistry, ghps) and the potential associations between quality of life and some of these characteristics.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. patients consulting for maxillofacial prosthesis management (dental department, pitié-salpêtrière hospital group) 3. information and collection of the patient's non-opposition to participation in the research 4. good written and oral comprehension of the french language exclusion criteria: 1. under guardianship or curatorship 2. cognitive disorders: confounding, impaired memory, attention, reasoning and/or judgment

Keywords: head and neck neoplasm cleft maxillofacial prosthesis
risk factors for lower extremity overuse injuries in jump-landing athletes

Conditions: Landing Biomechanics; Fatigue

Summary: in this prospective study, male jump-landing athletes (volleyball and basketball) will be screened pre-season and followed for one consecutive season. pre-season screening consists of 3d biomechanical analysis of standardized (such as drop vertical jump) and sports-specific jumps (such as stop-jump) before and after a high-intensity, intermittent exercise protocol and clinical field tests (such as force measurements).


Eligibility criteria:
inclusion criteria: * volleyball and basketball players * elite and non-elite * male * healthy exclusion criteria: * symptoms or complaints of lower extremity acute of overuse injuries in the past 3 months * history or surgery of the lower extremities * history of fractures of the lower extremities
a multicenter study of active specific immunotherapy with oncovax® in patients with stage ii colon cancer

Conditions: Stage II Colon Cancer

Summary: oncovax® is the first cancer vaccine that both prevents cancer recurrence and addresses the diversity of cancer cells. in this pivotal randomized, multicenter phase iiib study in patients with stage ii colon cancer, oncovax is designed to use a patient's own cancer cells to mobilize the body's immune system to prevent the return of colon cancer following surgery.

oncovax is an active specific immunotherapeutic (asi) stimulating a patient's immune response to autologous (patient-specific) tumor cells. it is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for stage ii colon cancer. within 35 days following surgery, patients are immunized with oncovax to prevent disease recurrence, which is incurable and occurs in up to 35% of patients. patients are given three vaccinations once per week for three weeks, followed by a booster vaccination after six months. a previously completed phase iii trial published in the lancet showed that oncovax cut the risk of recurrence by 61% in patients with stage ii colon cancer. the primary endpoint is disease-free survival: defined as the time from curative surgery to the objective test confirming tumor recurrence or death due to any cause. the secondary endpoints are overall survival and recurrence-free-interval. an interim analysis will be performed at a significance level of 0.005 once 2/3 of anticipated events have occurred, resulting in a significance level of 0.0483 at the end of the study. a total of 550 patients is planned, randomized 1:1 to receive oncovax® plus surgery (n=275) or surgery alone (n=275).

Eligibility criteria:
inclusion criteria: * patients must have stage ii (iia = t3n0m0, iib = t4an0m0, iic = t4bn0m0) disease. * patients must have undergone curative resection and have no evidence of residual or metastatic disease. * following curative resection patients must have a cea within normal limits. if elevated prior to resection, it must return to normal within 21 days post surgery and prior to randomization. exclusion criteria: * patients with prior radiation therapy or chemotherapy or a prior malignancy of any type will be excluded. however, subjects with prior, curatively-treated squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix will be eligible for participation in this study. * patients with more than one malignant primary colon cancer will be excluded.
quality of life and pain changes due to drg stimulation for chronic pain

Conditions: Spinal; Nerve Root, Pain; Pelvic Pain; Regional Pain Syndrome; Chronic Pain Syndrome; Complex Regional Pain Syndromes

Summary: active study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain.

objectives the primary objective is changes in pelvis and/or lower limb pain following dorsal root ganglion (drg) stimulation. pain levels will be determined using a 10-point visual analog scale (vas) with 10= extreme pain and 0= no pain. the null hypothesis is there will be no change in the subjects' self-reported pain levels from baseline to 52 weeks post-stimulator implantation. the alternate hypothesis is a significant change in pain levels. secondary objectives include changes in physical health, quality of life, and pain-related prescription medication usage. each subject's overall quality of life will be measured with the national institute of health's promis global health survey v1.2. physical activity changes will be assessed using the nih promis pain interference 6a sf v1.0 and pain intensity 3a scale v1.0. finally, patients will be asked the name, dosage, and frequency of use of any pelvic and/or lower limb pain-related prescription medications they are currently using. design and outcomes this is a prospective observational single-arm study to access the primary outcome variable of pelvic and/or lower limb pain intervention and duration there will be no study intervention. subjects will only be monitored and evaluated for pre and post-operative pain, physical activity levels, quality of life, and medication use. subjects will be followed for 12 months following their drg stimulation implant surgery. sample size and population this study will last for 4 years starting july 1, 2017. there will be no maximum subject population size. we aim for a minimum population size of 500 in order to give statistical significance with results. subjects will be stratified by area of chronic pain.

Eligibility criteria:
inclusion criteria: * prescribed orthopedic surgery or procedure by their healthcare provider. * previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief. * willing and able to adhere to the protocol of the study including the survey timeline. * between the ages of 18-85 years. exclusion criteria: * inability or unwillingness to give written informed consent.

Keywords: dorsal root ganglion
transcranial direct current stimulation on the risk of falls and lower limb function for acute stroke

Conditions: Stroke

Summary: transcranial direct current stimulation (tdcs) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. the purpose of this study was to compare the effectiveness of three different montages of tdcs (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.

this is a randomized sham-controlled trial reported following the 2010 consort guidelines. the subjects were randomly allocated into 1 of 4 groups in a double-blinded parallel study design. each patient received 10 sessions (5 consecutive days for 2 weeks) of real or sham stimulation at 2 ma intensity and current density equivalent to 0.05 a/m2.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute stroke * able to walk 10m independently * high risk of falling exclusion criteria: * severe functional limitations * cognitive impairment
a study of obexelimab in patients with warm autoimmune hemolytic anemia (saphiare)

Conditions: Warm Autoimmune Hemolytic Anemia

Summary: this study aims to examine the efficacy and safety of obexelimab in participants with warm autoimmune hemolytic anemia (waiha).

this study consists of a 6-month open label safety and dose confirmation run-in period (srp), 6-month randomized control period (rcp), and an additional 1-year open-label extension (ole) period. to enter the screening period (day -28 to day -1) in the srp or rcp, patients must have a clinical diagnosis of primary or secondary waiha due to an underlying autoimmune disorder, have failed at least 1 prior waiha treatment regimen, and have a hgb level of ≥ 7 to \< 10 g/dl with at least one sign or symptom of anemia. for the srp only, patients with secondary waiha due to underlying lymphoproliferative disease may be eligible if they are receiving stable treatment. all patients in the srp or rcp are allowed to continue up to 2 failed waiha therapies throughout the 24-week study. on day 1 of the srp, patients receive obexelimab administered as subcutaneous (sc) injections. on day 1 of the rcp, patients will be randomized in a ratio of 1:1 to receive either obexelimab or placebo administered as subcutaneous (sc) injections. patients must return to the study site for the first 5 weeks and then every 2 weeks thereafter. patients will undergo assessments for efficacy, safety, pk, pd, and immunogenicity during the 24-week srp or rcp. following the 24-week srp or rcp, patients will have the opportunity to receive obexelimab for up to 52 weeks in the open label extension (ole) period. including screening and follow-up, the maximum duration of participation in this study for an individual patient is 81 weeks (i.e., 28-day screening, 24-week srp or rcp, 52-week ole, and an 8-week follow-up).

Eligibility criteria:
inclusion criteria: 1. males and females, ≥ 18 years of age 2. clinically diagnosed with waiha for at least 3 months and currently receiving treatment for waiha or have previously received treatment for waiha. 3. diagnosis of primary or secondary waiha documented by a positive direct antiglobulin test specific for anti-igg or anti-iga. 4. failed at least 1 prior waiha treatment regimen. 5. at least one sign or symptom of anemia as assessed by the investigator at screening. 6. other inclusion criteria apply. exclusion criteria: 1. have cold antibody aiha, cold agglutinin syndrome, mixed type (i.e., warm, and cold) aiha, or paroxysmal cold hemoglobinuria. 2. have any other associated cause of hereditary or acquired hemolytic anemia. 3. for the rcp only, patients with secondary waiha not due to autoimmune disorders, including lpds. 4. received a transfusion within 2 weeks prior to randomization. 5. use of b cell-depleting, b cell-targeted, or other biologic immunomodulatory agents within the 6 months prior to randomization. 6. received iv ig or epoetin alfa within 6 weeks prior to randomization. 7. receiving more than 2 concomitant medications for the treatment of waiha. 8. other exclusion criteria apply.

Keywords: warm autoimmune hemolytic anemia waiha
patients with non-st-segment elevation acute coronary syndrome

Conditions: Myocardial Infarction

Summary: there are two types of acute coronary syndrome (acs): acs with persistent st segment elevation (acs st +) and acs without st segment elevation (non-st + acs). the incidence of non-st + acs is increasing and currently accounts for the majority of myocardial infarction (mi) hospitalizations, while that of st + acs is declining. complications of mi, which include rhythm and conduction disturbances, are mainly associated with acs st +. it is recognized that these complications can occur during non-st + acs, but with less frequency. this frequency is not clearly established, and has been the subject of few studies. recent studies in this direction suggest that the frequency of rhythmic complications is low during non-st + acs. however, the data collected concerns inter-hospital transport. the aim of the study is to estimate the frequency of occurrence of potentially fatal rhythmic complications in patients admitted to the emergency room and to the cardiology department for non-st + acs.


Eligibility criteria:
inclusion criteria: * adult patient (≥ 18 years old) * man or woman * patient admitted to the emergency department (su) or to the cardiology department at the nhc between january 1, 2019 and december 31, 2020 * patient whose main diagnosis retained at the end of hospitalization is a non-st + acs * patient who did not express his opposition to the reuse of his data for scientific research purposes. exclusion criteria: * subject having expressed opposition to participating in the study * subject under guardianship, curatorship or safeguard of justice

Keywords: acute coronary syndrome acs st segment elevation myocardial infarction
safety and efficacy of mem 1003 versus placebo in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine in a 12-week treatment study if mem 1003 is a safe and effective treatment for patients with mild to moderate alzheimer's disease.

alzheimer's disease is the leading cause of dementia and one of the most common diseases of the aging population. it is a chronic brain disease that involves gradual memory loss, decline in the ability to perform routine tasks, disorientation, difficulty in learning, loss of language skills, impairment of judgment, and personality changes in affected individuals. the neurodegenerative nature of the disease eventually leads to the failure of other organ systems and death. perturbations in calcium homeostasis in the central nervous system, such as those associated with alzheimer's disease and aging as well as stroke and head trauma can result in an increase in intracellular levels of calcium (ca2+). increased levels of ca2+ may lead to cellular dysregulation and cell death. the role of calcium in these neurodegenerative processes led to the hypothesis that controlling calcium levels may be beneficial, particularly where progressive neuronal damage results in cognitive dysfunction and memory loss. mem 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central nervous system activity. it inhibits l-type ca2+ channels and within the anticipated human dosing range has more benign cardiovascular effects than other dhp l-type calcium channel modulators.

Eligibility criteria:
inclusion criteria: * standardized mmse score of 10 to 24 points * diagnosis of probable alzheimer's disease * magnetic resonance imaging or computed tomography examination compatible with ad * modified hachinski ischemia score of less than or equal to 4 * currently receiving no ad therapy or currently receiving donepezil, rivastigmine, or galantamine exclusion criteria: * head injury associated with cognitive impairment * history of vascular dementia stroke, transient cerebral ischemic episodes, major depression, major psychotic disorder, or symptomatic postural hypotension * treatment for alzheimer's disease other than donepezil, rivastigmine, or galantamine; tacrine is not permitted in the last 30 days or memantine in the last 90 days * treatment with calcium channel blockers or any investigational medications within the prior 30 days

Keywords: cognition alzheimer's cognitive impairment
bioequivalency study of 100 mg cilostazol tablets under fasting conditions

Conditions: Intermittent Claudication

Summary: the objective of this study was the bioequivalence of a roxane laboratories' cilostazol tablets, 100 mg, to pletal® tablets, 100 mg (otsuka pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to cilostazol or any comparable or similar product.
diagnostic efficacies of sonazoid-ceus and eob-mri in patients with high risk of hcc

Conditions: Hepatocellular Cancer; Liver Cirrhoses; Diagnoses Disease

Summary: hepatocellular carcinoma (hcc) is the fifth most common cancer. patients with hccs usually have a poor prognosis. hepatocarcinogenesis is an intricate and multistep process. detecting and staging early hcc in patients with liver cirrhosis are still challenging for imaging techniques. contrast-enhanced ultrasonography (ceus) and gadoxetic acid-enhanced magnetic resonance imaging (eob-mri) are widely used in clinical practice. eob-mri has advantages of high detecting rate for small lesions, high sensitivity of hepatobiliary phase and extensive image information. sonazoid has the advantage of offering a unique post-vascular phase, also called the kupffer phase. therefore, malignant tumors with few or no kupffer cells appear as contrast defects, with respect to the relatively well-enhanced surrounding liver in the postvascular phase. the diagnostic efficacies of these two imaging methods have not been well studied. therefore, the purpose of this study is to compare the efficacies of sonazoid-ceus and eob-mri in patients with high risk of hcc, and to compare the detection ability for malignant tumors by kupffer phase and hepatobiliary phase.


Eligibility criteria:
inclusion criteria: 1. patients are at high risk for hcc. 2. the ages of patients are between 18 and 80. 3. patients are with solid liver lesion(s) detected by us: if a patient has a solitary tumor, the size of the tumor is less than or equal to 5 cm; if a patient has multiple lesions, the sizes of the tumors are less than or equal to 3 cm and the number of lesions is less than or equal to 3. 4. patient is able and willing to receive ceus and eob-mri examinations within 30 days. 5. patient signs the informed consent. - exclusion criteria: 1. patient is with lesions confirmed by pathology or follow-up, or hemangiomas. 2. patient is with lesions already undergoing local treatment, including thermal ablation or tace. 3. patient is with severe cardiopulmonary insufficiency. 4. patient is a pregnant or breastfeeding women. 5. patient is considered to be unsuitable to participate in the study.

Keywords: hepatocellular carcinoma sonazoid contrast-enhanced ultrasound eob-mri diagnostic efficacy