Kornimate/medical-research-clean huggingface dataset:
immunogenicity of the 9vhpv vaccination 2-dose regimen among children 4 to 8 years old

Conditions: Human Papilloma Virus

Summary: this study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vhpv) vaccine separated by 12 months (months 0, 12).

study participants will include 150 boys and girls aged 4-8 years (total, 75 boys and 75 girls) to receive 2 doses of the 9vhpv vaccine at 0 and 12 months. patients will be recruited by age-group to achieve balanced enrollment of 15 girls and 15 boys per year of age. the investigators will examine the immunogenicity profile in this cohort, for which titers will be analyzed one month after dose 2 (month 13) and at month 60. though clinical efficacy cannot be assessed in young children because of limited exposure to human papillomavirus (hpv), this descriptive study will allow the investigators to understand whether the 9vhpv vaccine in younger patients provides immunogenicity similar to that shown for the 9-14 and 16-26 age groups who have received the 9vhpv vaccine.13 this study will require an ind for the use of the hpv vaccine in children younger than 9 years. immunogenicity will be measured by examining serum antibodies of all participants using a competitive luminex immunoassay (clia).15 month 60 serology will be by clia and igg lia assays. the antibody response testing will be performed at merck research laboratory. the goal of this study is to explore whether a 2-dose 9vhpv vaccine regimen with dosage separated by 12 months is immunogenic among children aged 4-8 years. the primary outcome will be geometric mean titers (gmt) for hpv6, hpv11, hpv16, hpv18, hpv31, hpv33, hpv45, hpv52, and hpv58 antibodies at months 13 and 60. results will allow the investigators to qualitatively compare immunogenicity in individuals vaccinated at age 4-8 years to known immunogenicity in 9vhpv recipients vaccinated at ages 9-14.13 knowledge of whether vaccination in this age group is sufficient to induce high-level protective antibody titers through 4 years after the second dose will support further efficacy studies in a larger randomized trial of a 2-dose 9vhpv regimen for children aged 4-8 years.

Eligibility criteria:
inclusion criteria: 1. children aged 4-8 years old 2. receives care at the boston medical center or one of the affiliated community heath centers 3. naïve to hpv vaccine exclusion criteria: 1. a history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic reaction to yeast 2. immunocompromised/previous immunosuppressive therapy 3. thrombocytopenia or other coagulation disorder

Keywords: gardasil 9 immunogenicity children
study of ace-031 in subjects with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this study is to determine if ace-031 is safe and well-tolerated in boys with duchenne muscular dystrophy (dmd) and to select the optimal doses of ace-031 in terms of safety and pharmacodynamic (pd) activity for designing future studies. \[note: this study was terminated based on safety data\]

ace-031, a soluble form of the human activin receptor type iib, was administered once every 2 to 4 weeks by subcutaneous (sc) injection to boys with dmd. dose levels and regimens for this multiple-dose study were based on data from the initial clinical studies in healthy subjects in which doses of 0.02 to 3 mg/kg sc were evaluated. a total of 24 subjects were enrolled into the study; 18 received ace-031 and 6 placebo. all subjects were treated for a period of 12 weeks.the pharmacodynamic effects of ace-031 treatment were assessed by a battery of motor function test that included the 6-minute walk test, the 10-minute walk/run test, the 4-stair climb test and the gower maneuver (gw). muscle strength was assessed by hand-held myometry and fixed system testing. body composition (i.e., spine bmd, lean mass, and fat mass) was assessed by whole body and lumbar spine dxa scans. pulmonary function was assessed by forced vital capacity (fvc), maximal inspiratory pressure (mip) and maximal expiratory pressure (mep). ace-031 safety was evaluated through observation of the incidence and severity of adverse events.

Eligibility criteria:
inclusion criteria: * diagnosis of dmd confirmed * ambulant * corticosteroid therapy for at least one year prior to study day 1 and on a stable dose and schedule for at least 6 months prior to study day 1 * evidence of muscle weakness by clinical assessment exclusion criteria: * any previous treatment with another investigational product within 6 months prior to study day 1 * any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that is not related to dmd * inability to perform a whole body dual x-ray absorptiometry (dxa) scan
efficacy of acupuncture and moxibustion treatment in patients with active crohn's disease

Conditions: Crohn's Disease; CAM

Summary: the purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active crohn's disease. meanwhile, we are aim to observe the content of inflammatory factors and neurotransmitter before and after acupuncture and moxibustion therapy.

the purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active crohn's disease. meanwhile, we are aim to observe the content of inflammatory factors and neurotransmitter before and after acupuncture and moxibustion therapy. through treating active crohn's disease by acupuncture and moxibustion therapies for 12 weeks, we are aim to observe the efficiency and the probably change of inflammatory factors and neurotransmitter of colonic mucosa and we may elucidate the mechanism of the efficiency of acupuncture and moxibustion therapy.

Eligibility criteria:
inclusion criteria: * age 18-70 years; * crohn's disease activity index \[cdai\]\>150 and \<450; * not taking any medication or taking salicylates, prednisone ( dose≤ 15mg and at least have taken a month ), after entering the study the dose remained constant; * not taking immunosuppressive agents or use " with " biological preparations within 3 months prior to entering the study * signing a written informed consent form. exclusion criteria: * severe crohn's disease patients or patients in remission ( cdai \> 450 or \< 150 ); * the pregnancy or lactation period patients ; * patients associated with heart, brain, liver, kidney and hematopoietic system disease; * the psychiatric patients; * patients with other serious diseases.

Keywords: crohn's disease,acupuncture,moxibustion,inflammation factors
cyclobenzaprine in muscle cramps with liver cirrhosis

Conditions: Liver Cirrhosis

Summary: - cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. it is one of the best-studied drug for this application.

although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. several agents as vitamin e, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking. - cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. it is one of the best-studied drug for this application.

Eligibility criteria:
inclusion criteria: * liver cirrhosis and has frequent muscle cramps exclusion criteria: * allergy to cyclobenzaprine * encephalopathy. * receiving antidepressant drugs
ultra-sounded guided regional blockade for lipoma excision

Conditions: Lipomas

Summary: there is limited information on using the ultrasonography for block placement concerning lipoma excision. a new type of regional blockade, performed under ultrasound, can ensure proper block placement with accurate local anesthetics deposition. investigators hypothesized that ultrasound guidance can reduce the number of needle passes to complete the block placement. investigators will compare namely ultrasound guided regional blockade and traditional method regarding the number of needle passes to complete the block placement.

50 patients between the ages of 18 and 60 years with american society of anesthesiologists (asa) physical status i-iii, scheduled for superficial subcutaneous lipoma (sized from 5 to 7 cm) excision will be enrolled in prospective comparative randomized clinical study. patients will be randomized into two groups: u (n = 25), in whom regional blockade was performed using us-guidance; and c (n = 25), in whom regional block was performed using the traditional method. patients will be randomly assigned on a one-to-one ratio. randomization will be performed by means of a computer generated random-numbers table. group allocation will be concealed in sealed opaque envelopes that will not opened until patient consent had been obtained. all patients will be pre-medicated with oral diazepam (7.5 mg) 30 min before the procedure, and iv fentanyl (50 ug) will be administered 5 minutes before placement of the block. before the procedure, an iv access and standard monitoring of electrocardiogram (ecg), noninvasive blood pressure (nibp), and peripheral oxygen saturation (spo2) will be established. primary outcome includes the number of needle attempts (number of skin punctures and needle redirections) needed to complete the block placement. it will be documented by an investigator blinded to the aim of the study. patient demographics, duration of surgery, patient's asa physical status and other study outcomes will be documented by independent investigators who were not involved in the block placement procedure and were blinded to the group assignment.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 60 years * american society of anesthesiologists (asa) physical status i-iii * superficial subcutaneous lipoma excision surgery (sized from 5 to 7 cm) * able to provide informed consent * consent to participates * single procedure exclusion criteria: * unable to consent * do not consent to participate * patients with local infections in the skin over lipoma * patients with history of allergy to local anesthetics * more than one procedure is being performed at the same setting

Keywords: ultrasound regional blockade lipoma
proximal humerus fracture dislocation direction and avascular necrosis

Conditions: Proximal Humeral Fracture; Dislocation; Dislocation Shoulder; Avascular Necrosis; Avascular Necrosis of Humerus

Summary: the purpose of the study is to see if there is a connection between a proximal humerus fracture dislocation direction and the likelihood of developing avascular necrosis. utilizing a retrospective cohort from the last ten years we hope to bring consenting patients back for a single visit to have x-rays and complete patient reported outcome measures to assess for evidence of avascular necrosis.

the incidence of proximal humerus fractures continues to increase and is among one of the more common fractures seen in the adult population. proximal humerus fracture dislocations, however, are less common. despite the decreased prevalence, fracture dislocations have unique challenges with respect to obtaining an anatomical reduction and more frequently involve an open surgical reduction. in addition, depending on other fracture characteristics, there are various treatment options for the fracture itself. while fracture dislocations ultimately lead to increased avn and revision surgery, further discussion surrounding the direction of dislocation and how it may influence overall outcomes has not been addressed in the previous literature. the study design utilizes a retrospective cohort from the last ten years, by asking patients who have had a previously surgically treated proximal humerus fracture dislocations to come back to the surgeon's private clinic to complete a single visit assessment. during this assessment the consenting participant will receive x-rays and complete patient reported outcome measures. in conjunction, these will be utilized to assess overall function and the existence of avascular necrosis.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * patients who underwent operative fixation of proximal humerus fracture dislocation at royal columbian hospital between january 2011 and july 2021 * willing and able to consent and complete patient reported outcome measures * willing and able to follow the protocol and attend a follow-up visit * able to read and understand english or have an interpreter available exclusion criteria: * skeletally immature patients * patient with pathological fractures * patients who have had previous operative fixation of proximal humerus * patients treated non-operatively * patients presenting outside of the study duration window * patients treated by a non-participating surgeon * deceased patients * patients unable to complete patient reported outcome measures * patients declining to come back to the clinic for updated x-rays * dementia * incarceration
emergency coronary artery bypass graft in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: a retrospective study investigating the early outcome of emergency cabg post mi in patients who were operated at saud al babtain cardiac center.

a retrospective study of surgical patients who underwent coronary artery bypass graft for acute myocardial infarction between december 2013 and february 2018 determining outcomes on morbidity and mortality.

Eligibility criteria:
inclusion criteria: * patients with post cardiogenic shock who underwent cabg * =/\> 17 years old exclusion criteria: * patients other than post cardiogenic shock who underwent cabg or any cardiac surgeries * \<17 years old

Keywords: cabg
single pre-operative radiation therapy (sport) for low risk breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.


Eligibility criteria:
inclusion criteria: * female aged 60 years or older. * invasive ductal carcinoma. * unifocal disease. * tumors less than 2cm. * no clinical evidence of nodal disease. * estrogen receptor status (er) positive. * her2 negative. exclusion criteria: * age less than 60 years. * brca 1 and/or brca 2 mutation. * tumour histology limited to lobular carcinoma only. * neoadjuvant hormonal manipulation or chemotherapy. * more than one primary tumour in different quadrants of the same breast. * inability to view tumor on imaging.

Keywords: breast cancer early breast cancer partial breast irradiation preoperative radiation
a personalized and interactive web-based health care innovation to advance the quality of care

Conditions: Implantable Defibrillator User; Distress

Summary: this study evaluates the clinical efficacy and cost-effectiveness of the acquire-icd care innovation as add-on to usual care as compared to usual care alone in patients with an implantable cardioverter defibrillator.


Eligibility criteria:
inclusion criteria: * patients with a first-time icd or crt-d * ≥18 years of age exclusion criteria: * subcutaneous icd * upgrade from a pacemaker to icd or crt * history of psychiatric illness other than affective/anxiety disorders * cognitive impairments (e.g. dementia) * left ventricular assist device (lvad) or upcoming lvad implant * under evaluation or on the waiting list for heart transplantation * no e-mail address * inability to manage or cope with computer technology * insufficient knowledge of the danish language * participation in other randomized controlled trials unless of a technical nature * irresponsible to ask patient to participate according to gcp

Keywords: information empowerment
study of idalopirdine in patients with mild - moderate alzheimer's disease treated with donepezil

Conditions: Alzheimer's Disease

Summary: to establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate alzheimer's disease (ad).

the study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 30 mg/day or 60 mg/day as adjunctive therapy to donepezil 10 mg/day, and a 4-week safety follow-up period following study completion or withdrawal from treatment.

Eligibility criteria:
inclusion criteria: * the patient has a knowledgeable and reliable caregiver. * the patient is an outpatient. * the patient has probable ad. * the patient has mild to moderate ad. * stable treatment with donepezil. * the patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, or be surgically sterile. * the patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, or must have been surgically sterilised prior to the screening visit. exclusion criteria: * the patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than ad. * the patient has a diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) axis i disorder other than ad. * the patient has evidence of clinically significant disease. * the patient's donepezil therapy is likely to be interrupted or discontinued during the study. * the patient is currently receiving memantine or has taken memantine within 2 months prior to screening. other inclusion and exclusion criteria may apply.
university of michigan / wayne state chronic pain study

Conditions: Chronic Musculoskeletal Pain

Summary: this study is designed to determine if a brief educational program can alter the attitudes and knowledge of individuals with chronic back pain, which is likely to be non-structural in nature. individuals will be randomly assigned to an experimental condition (performs written educational and emotional awareness exercises) or a control condition (completes a general health activities questionnaire). comparisons will be made to assess the degree of centralized pain features and functional improvements at 1-month follow-up. a 10-month follow-up as a secondary endpoint is also planned.


Eligibility criteria:
inclusion criteria: * english-speaking adults ages 18 years or older with internet access who are referred to the university of michigan health service physical medicine and rehabilitation spine program identified the physician with chronic nonspecific back pain (longer than 3 months) or fibromyalgia. degenerative changes seen on imaging are considered nonspecific. alternatively, enrolled in the university of michigan health research volunteer pool with a profile that includes chronic low back pain or fibromyalgia. exclusion criteria: * any signs of a serious underlying condition (cancer, infection, cauda equine), spinal stenosis or radiculopathy, or other specific spinal cause (vertebral compression fracture or ankylosing spondylitis). those patients who are being considered for an interventional spine procedures or surgical consults would not be included in this study. * individuals receiving or applying for compensation or disability, the inability to provide written informed consent, severe physical impairment (e.g. blindness, deafness), co-morbid medical condition limiting function (e.g. malignant cancer), the use of illicit drug use, or a psychiatric condition that would limit judgment.
controlling the mental health for a better response to treatment in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the project aims to implement the internet of thing (iot) platform of the san raffaele hospital (osr) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists.

this is a prospective, single-center observational study involving patients with an established diagnosis of uc who are currently receiving standard care and eligible for advanced therapies at the san raffaele hospital (osr). the estimated sample size for the 1-year project is 150 uc patients eligible for advanced therapy. this study aims to understand the relationship between environmental factors, dietary composition, and altered intestinal permeability that contribute to flares in uc patients by leveraging internet-of-things (iot) technologies. these subjects will be asked to answer a series of questions about feelings and thoughts via the mobile app each month. the mobile app was developed and designed following the open source researchkit framework. the questionnaire based on the perceived stress scale (pss) will be created thanks to the collaboration between the gastroenterologist and psychologists of the san raffaele hospital (osr). the pss is a classic stress assessment tool. finally, all this data will be integrated thanks to the bioinformatic tool based on machine learning. all analyzes will be performed and stored in a dedicated cloud service (https://www.heroku.com/), which will make the project feasible and easy to manage.

Eligibility criteria:
inclusion criteria: - patients in whom the ulcerative colitis has been diagnosed and eligible for advanced therapies patients will be asked to sign an informed consensus before filling out the questionnaire. exclusion criteria: - patients in whom the ulcerative colitis has not been diagnosed. all those who have not signed previously informed consensus.
effect of re-education on rebleeding rate after endoscopic treatment in liver cirrhosis

Conditions: Liver Cirrhosis; Esophageal Varices Bleeding; Gastric Variceal Bleeding; Bleeding

Summary: a prospective, randomized controlled study on whether re-education after discharge can reduce the rebleeding rate after endoscopic treatment of esophageal and gastric varices in patients with liver cirrhosis

after receiving esophageal variceal ligation and （or） gastric fundus variceal sclerotherapy, patients with outside hospitalthe rate of bleeding due to liver cirrhosis shall be re-educated outside the hospital, including diet, drugs, anticoagulation of portal vein thrombosis,regular endoscopic treatment, reexamination , nutrition, etc. the patients were divided into the first treatment group and the more thanonce treatment group according to whether they had received endoscopic treatment in the past

Eligibility criteria:
inclusion criteria: * esophageal and / or gastric varices ； * liver cirrhosis ； * patients receiving endoscopic treatment (esophagogastric variceal sclerosis and/or ligation) ； * all subjects or their guardians must sign the subject consent form before entering the test exclusion criteria: * patients with mental illness, severe hearing loss and unable to take care of themselves ; * asa score ≥ grade iv at discharge ; * hepatic encephalopathy ≥ stage ii; * patients with liver cancer; * pregnant and lactating women; * patients who cannot sign informed consent
safety, efficacy of chadox1 ncov-19 vaccine: rapid systematic review and meta analysis

Conditions: ChAdOx1 nCoV-19 Vaccine

Summary: since the beginning of covid-19 pandemic, a safe and effective vaccine against infection and development of acute respiratory syndrome coronavirus 2 (sars-cov-2) is needed control of the wide spread of covid-19 and reduce death rates throughout the world. many clinical trials investigated the immunogenicity of different proposed vaccine including the first distributed vaccine; the chadox1 ncov-19 vaccine and there is a need to analyze the results of published clinical trials.


Eligibility criteria:
inclusion criteria: * participant who received 2 doses of chadox1 ncov-19 vaccine exclusion criteria: * non vaccinated person

Keywords: safety efficacy immunogenicity covid-19 vaccine