Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, and immunogenicity of v419 given concomitantly with prevnar 13™ and rotateq™ (v419-005)

Conditions: Bacterial Infections; Virus Diseases

Summary: this is a study to assess the safety, tolerability, and immunogenicity of v419 (pr5i) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of daptacel™, prevnar 13™ and pedvaxhib™ at 15 months of age. the study will determine whether subjects who receive v419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.


Eligibility criteria:
inclusion criteria : * participant is a healthy infant * participant has received one dose of monovalent hepatitis b vaccine prior to or at 1 month of age exclusion criteria : * participant has received more than one dose of monovalent hepatitis b vaccine or hepatitis b based combination vaccine prior to study entry * participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, or any combination of the above * participant has had a fever ≥38.0°c (≥110.4°f) within 24 hours of study enrollment * participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated, live virus vaccine) within 30 days prior to study enrollment, except for inactivated influenza vaccine which will be permitted 15 days or more prior to enrollment * participant has hepatitis b surface antigen (hbsag) seropositivity (by medical history) * participant has a history of haemophilus influenzae type b, hepatitis b, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection

Keywords: diphtheria tetanus whooping cough (pertussis) poliomyelitis hepatitis b infection haemophilus influenzae type b infection
cryolipolysis and subcision for treatment of cellulite

Conditions: Cellulite

Summary: this study intended to investigate and compare the changes that may occur in response to cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. the cryolipolysis cooling device used is fda approved for skin cooling, but still investigational in the treatment of cellulite. it has previously been used for fat reduction on love handles or back fat. during cryolipolysis, the system drew fat tissue into an applicator then exposes the extracted fat tissue to cold temperatures. the cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite. subcision is a process used to treat scars left behind by acne or other skin diseases and has been noted to improve moderate to severe cellulite. subcision is a simple surgical procedure that is performed by inserting a specially designed needle under the skin after local numbing medication is injected. the needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. this study was a pilot study designed to determine feasibility of these procedures.


Eligibility criteria:
inclusion criteria: * healthy female patients 18-60 years of age with more than one evident depressed lesion of cellulite on the upper thighs and/or buttocks. * all subjects must have the affected areas that show the mattress phenomenon spontaneously when standing or while both lying and standing (stage 2 or 3 of nurnberger-muller grading scale of cellulite7). * 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: * pregnant or lactating * subjects who are unable to understand the protocol or to give informed consent. * subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder. * subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria. * subjects who have active skin disease or skin infection in treatment area. * subjects who are allergic to lidocaine or prilocaine. * subjects who are allergic to both cephalexin (and penicillin) and levofloxacin (or another quinolone antibiotic). * subjects who have history of abnormal scarring.

Keywords: cellulite cryolipolysis zeltiq subcision
efficacy and safety of masitinib versus placebo in the treatment of als patients

Conditions: Amyotrophic Lateral Sclerosis

Summary: the objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of amyotrophic lateral sclerosis (als).

masitinib is a selective, oral tyrosine kinase inhibitor with neuroprotective capability demonstrated via numerous preclinical studies. two of masitinib's main cellular targets are the mast cell and microglia cell. it is well-established that mast cells play a prominent role in neuroinflammatory processes. microglia, resident immune cells of the central nervous system (cns), also constitute an important source of neuroinflammatory mediators and may have fundamental roles in numerous neurodegenerative disorders. the development of masitinib in als is therefore based on the pharmacological action of masitinib in microglia cells and mast cells, thereby slowing microglial-related disease progression, reducing neuro-inflammation, and modulating the neuronal microenvironment in both central and peripheral nervous systems. this is a multicenter, double-blind, randomized, placebo-controlled, parallel-group (two ascending dose titrations of masitinib and matching placebo), comparative study of oral masitinib in the treatment of patients with amyotrophic lateral sclerosis (als).

Eligibility criteria:
main inclusion criteria include: * patients diagnosed with laboratory supported probable, clinically probable or definite als according to the world federation of neurology revised el escorial criteria * patient with a familial or sporadic als * als disease duration from diagnosis no longer than 24 months at the screening visit * patient treated with a stable dose of riluzole (100 mg/day) for at least 12 weeks days prior to the baseline visit * patient with an alsfrs-r score progression between onset of the disease and screening of \> 0.3 per month, confirmed with an alsfrs-r score progression of ≥ 1 point during a 12-week run-in period between screening and randomization. * patient with a score, at screening, of at least 26 overall, including a score of at least 3 on item #3 and at least 2 on each of the 12 alsfrs-r individual component items and with a score, at randomization, of at least 2 on each of the 12 alsfrs-r individual component items main exclusion criteria include: * patient with dementia or significant neurological, psychiatric, systemic or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results * patient with a fvc \< 60% predicted normal value for gender, height, and age at screening and baseline * pregnant, or nursing female patient

Keywords: amyotrophic lateral sclerosis als tyrosine kinase inhibitor lou gehrig's disease charcot's disease motor neuron disease mnd
cerebral blood flow and metabolism during hypoxia and endotoxemia

Conditions: Hypoxia; Endotoxemia; Healthy

Summary: the objective of the present protocol is to study whether a low level of oxygen in the blood will affect the immune response to as well as cerebral blood flow and metabolism during an infection and, conversely, whether the acute systemic and cerebral physiologic response to hypoxia is modified by an ongoing inflammatory response.

the combination of acute infection and a low level of oxygen in the blood is a common phenomenon. thus, acute hypoxia may complicate severe infections including severe sepsis. conversely, healthy persons who ascend to moderately high altitudes, which will be associated with a lowering of the inspired oxygen level, may sustain an infection. even so, it is unknown whether hypoxia modifies the systemic inflammatory response, or, conversely, whether the reaction to hypoxia is influenced by the presence of systemic inflammation. the present protocol aims to measure global cerebral blood flow, metabolism and net flux as well as the systemic response in healthy volunteers who are subjected to either normobaric hypoxia alone (n=12), low-dose iv endotoxin infusion alone (n=12), or a combination of endotoxin infusion and normobaric hypoxia (n=12).

Eligibility criteria:
inclusion criteria: * healthy nonsmoking male * age 18-45 yrs exclusion criteria:

Keywords: sepsis hypoxia altitude sickness endotoxin cytokines cerebral blood flow cerebral metabolism reactive oxygen species
a clinico-pathologic study of primary mediastinal b-cell lymphoma

Conditions: Primary Mediastinal B-Cell Lymphoma

Summary: a non-profit study designed with the aim of analysing the phenotype and molecular characteristics (central review) and evaluating prospectively the role of pet-scans in the management of primary mediastinal lymphoma treated with conventional approaches.


Eligibility criteria:
inclusion criteria: * primary mediastinal diffuse large b-cell lymphoma, cd20 positive. patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum. * no prior treatment of lymphoma. patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms. * any stage of disease. * age at least 18 years. * fit to receive chemotherapy with curative intent. * able and willing to give informed consent, and to undergo staging including pet scanning * willingness to comply with an appropriate contraceptive method in women of childbearing potential or men. exclusion criteria: * evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease. * impairment of bone marrow function (wbc \<3.0x109/l, anc \<1.5x109/l, plt \<100x109/l), unless due to involvement by lymphoma. * major impairment of renal function (serum creatinine \>2x upper normal) or liver function (asat/alat \>2,5 upper normal, total bilirubin \>2,5x upper normal), unless due to lymphoma involvement. * known hiv infection. patients will not be tested routinely. * pregnant or lactating women. * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Keywords: primary mediastinal b-cell lymphoma positron emission tomography
endoscopic treatment of complex anal fistulas

Conditions: Anal Fistula

Summary: this is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by video-assisted anal fistula treatment (vaaft) compared to fistulectomy and sphincter reconstruction as standard surgical procedure.

the surgical treatment of complex fistulas is difficult and ideally aims to completely heal the fistula and prevent recurrence without affecting the anal sphincter function. the definitive surgical treatment options include transsphincteric fistulectomy and sphincter repair, intersphincteric ligation of the fistula tract (lift), transanal advancement flap and cutting seton suture. all the methods caries a relative high recurrence and complication rate including the risk of anal incontinence .transsphincteric fistulectomy and primary reconstruction of the anal sphincter has been reported to have a healing rate between 90 - 95,8 %, recurrence rate of 7,1-9,7 % and 5-30 % experience incontinence in varying degree. video-assisted anal fistula treatment (vaaft) is a novel sphincter saving procedure for treating complex anal fistulas and recently introduced with promising early results with a healing rate of 74-87.1 % after 1 year. the procedure can be done as a day-case surgery with the ability of precise identification of the fistula tract, including the presence of secondary branches. the method includes an endoscopic debridement and closure of the internal opening. only few scientific reports of the method has been published and only with short term results, and there is a need of validating the efficacy of this procedure in a prospective randomized trial. there are few randomised controlled trials in the literature on the treatment of complex anal fistulas treatment and there is no conclusive evidence of which method is the best. furthermore the knowledge of changes in quality of life and functional results in terms of standardized continence evaluation and manometric studies are either contradictive or simply lacking after the surgery for anal fistulas. the aim of this study is to conduct a randomized clinical trial to compare vaaft (mini invasive and sphincter-saving) with the traditional transsphincteric fistulectomy and primary reconstruction in terms of recurrence rate, manometric and functional changes as well as changes in quality of life.

Eligibility criteria:
inclusion criteria: * patients with complex transsphincteric anal fistulas \>18 yrs old. exclusion criteria: * crohns fistulas * signs of suppuration or/and branching. * malignancy within 5 yrs. * previous radiotherapy of the abdomen and pelvis. * current immune- suppressive treatment.

Keywords: vaaft anal fistula sphincter reconstruction
maternal determinants of immunity to influenza

Conditions: Vaccination; Infection; Maternal-Fetal Relations; Influenza; Immunoglobulins

Summary: the overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.

the study compares immune responses to influenza vaccination between a group of pregnant women and a group of non-pregnant controls women. specifically, the study has three aims: 1. to compare the quality of antibodies induced by influenza immunization in pregnant and non-pregnant women; 2. to identify immune predictors of vaccine responses in pregnant women and compare them to the determinants of vaccine responses in non-pregnant women; 3. to identify immune predictors of the transfer of maternal antibodies to the newborn following influenza immunization during pregnancy;

Eligibility criteria:
inclusion criteria: * age over 18 and under 40 years. exclusion criteria: * grade iii/iv anemia * human immunodeficiency virus (hiv) infection * active bacterial infection * opportunistic infection (tuberculosis, cytomegalovirus (cmv), toxoplasmosis, etc) * inability to understand the nature and extent of the study and the procedures required * current or recent use of immunosuppressive drugs (corticosteroids, anti-tumor necrosis factors (anti-tnf), methotrexate, etc) * active neoplasia
nitropaste in breast reduction

Conditions: Gynecomastia; Delayed Wound Healing

Summary: the purpose of this study is evaluate the effect of nitroglycerin paste on wound healing and scarring. previous research has shown that nitroglycerin paste can improve the blood flow to a wound, which may be associated with better wound healing, and ultimately, better scarring.

this will be a single-center, patient-blinded, (breast) randomized trial utilizing nitroglycerin paste on their breast reduction scar. the study team aims to randomize 100 patients, or 200 breasts. each patient will receive treatment, but the breast that received treatment will be random. this will allow for a control breast to compare to. patients will be followed for 12 months postoperatively to observe wound healing.

Eligibility criteria:
inclusion criteria: * patients who are female and transmen * undergoing bilateral breast reduction via mount sinai plastic surgery clinic * reduction must be performed via wise incisional pattern exclusion criteria: * patients who are male or transwomen * patients who are under 18 years of age

Keywords: nitroglycerin paste scarring necrosis wound healing breast breast reduction
expanding exercise programming for veterans through telehealth

Conditions: Arthritis

Summary: the goal of this study is to evaluate the acceptability and feasibility of a group telehealth exercise program for veterans with lower extremity osteoarthritis (oa). methods: this is a randomized pilot trial where veterans (n=50) receive a group telehealth exercise program (3 months), followed by an exercise maintenance phase (6 months) that includes either text messaging alone or text messaging plus group telehealth exercise booster sessions. the primary outcomes for this study are feasibility and acceptability of the intervention. feasibility will be assessed through number and source of referrals, recruitment, and retention. acceptability will be assessed through surveys and interviews for participants and providers addressing reasons for participation, satisfaction, perceived appropriateness, and overall experience containing likert scales and both yes/no and open-ended questions. exploratory outcomes, assessed at multiple time points during the course of the study, will measure changes in the western ontario and mcmaster universities osteoarthritis index (womac) and changes in performance measure and physical activity assessed remotely through individual telehealth sessions. data will be collected at baseline, 3-, 6-, and 9-month follow-up.


Eligibility criteria:
inclusion criteria: * diagnosis of symptomatic knee or hip oa * veterans at eastern colorado healthcare system primary care clinics with at least one va visit within the past year * physically inactive (add definition) exclusion criteria: * no telephone access * hip or knee surgery or acute meniscus or anterior cruciate ligament tear in the past six months * recent hospitalization for cardiovascular/cerebrovascular event * serious mental health condition or behavioral issues precluding participating in group exercise * terminal illness * motor neuron diseases * severely impaired hearing, vision, or speech * non-english speaking * current participation in another oa or exercise intervention or lifestyle change study * other self-reported or study team/primary care physician deemed health condition that would prohibit participation in the study * no primary care physician visit in past 12 months * pregnant women * insufficient internet connectivity to participate in group telehealth

Keywords: osteoarthritis exercise maintenance telehealth group exercise text messaging
web-based genetic research on parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to examine how genes and environment affect risk for parkinson's disease.

23andme has created a web-based parkinson's research initiative to understand the genetic associations found between parkinson's patients' dna and their disease. to learn more, visit: https://www.23andme.com/pd/. you can participate in this research initiative without leaving home. if you are eligible to participate, we will send you an in-home 23andme dna kit at no cost. we will ask you short online surveys (15-20) about your parkinson's journey, symptoms, and response to treatment. enrollment is on-going and open to individuals who have been diagnosed with parkinson's disease and are residents of the u.s. participants receive access to ancestry information and uninterpreted genetic data. participants will also receive regular updates on our research efforts and findings.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease by a physician exclusion criteria: * diagnoses other than parkinson's, including: * progressive supranuclear palsy (psp) * multiple system atrophy (msa) * shy-drager syndrome * spinal cerebella ataxia (sca) * atypical parkinsonism * parkinsonism due to medications, drug-induced parkinsonism * vascular parkinsonism * frontotemporal dementia with parkinsonism

Keywords: parkinson's genetic online gwas genome wide association
essential oils for electrocautery

Conditions: Anxiety

Summary: the purpose of this study is to assess whether essential oil aromatherapy could improve or eliminate the smell of burnt flesh from electrocautery and subsequently mitigate patient anxiety and discomfort during dermatologic skin surgery. this is a randomized clinical trial. approximately 210 electrocautery participants will be randomized to receive sham control/no aromatherapy or aromatherapy. patients will be asked to complete a questionnaire after completion of the procedure to assess their experience. this study was a pilot study designed to determine the feasibility of this procedure. subjects currently living in the chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.


Eligibility criteria:
inclusion criteria: 1. \>18 years of age 2. receiving same day cutaneous surgical procedure that requires electrocautery per protocol 3. in good general health as assessed by the investigator 4. participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study exclusion criteria: 1. surgery site incompatible with the patient holding a handheld aromatherapy device (physician discretion) 2. subject unwilling to sign an irb approved consent form 3. participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
neurocognitive rehabilitation after hip replacement

Conditions: Hip Osteoarthritis

Summary: the purpose of the study is to evaluate the effectiveness of an approach based on neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language), not required in a traditional approach proprioceptive, in order to obtain a more complete and long-lasting recovery.


Eligibility criteria:
inclusion criteria: * presence of symptomatic unilateral primary hip osteoarthritis treated with surgical replacement with a posterior-lateral approach and the use of a non-cemented prosthesis (press-fit). all the implants are composed of a stem symax (stryker-howmedica) and a ceramic head with coupling ceramic-ceramic and are implanted by the same surgeon. exclusion criteria: * different diagnosis from hip osteoarthritis (eg. fracture) * concomitant osteoarthrosis of the hip or knee with gait restrictions * lameness for more than six months * central nervous system or peripheral nervous system disorders * systemic inflammatory disorders (eg. rheumatoid arthritis) * systemic infectious disorders * cognitive impairment * neoplastic disorders * surgical revisions * intraoperative complications * suspected hip replacement infection * hip replacement with endoprosthesis.

Keywords: hip replacement neurocognitive rehabilitation womac questionnaire
evaluating a website for parents of injured children

Conditions: Acute Post-Traumatic Stress Disorder

Summary: the purpose of the current protocol is to evaluate the ability of the aftertheinjury website to increase parent knowledge and skills.

the purpose of the current protocol is to evaluate the ability of the aftertheinjury website to increase parent knowledge and skills. primary objective is to compare website condition vs control with regard to (a) immediate parent learning outcomes and (b) coping assistance provided by parents as reported at 6 wks. secondary objective is to compare conditions as above with regard to child and parent pts symptoms at 6 wks.

Eligibility criteria:
inclusion criteria: 1. children age 6 through 17 who sustained an injury within the past 2 months and their parents. 2. have access to the internet at home (for stage 3 only) exclusion criteria: 1. parent does not read or understand english 2. child's injury is due to participation in organized sports 3. child's injury is due to suspected abuse or family violence