Kornimate/medical-research-clean huggingface dataset:
evaluation of immunogenicity, reactogenicity and safety of herpes simplex (gd) candidate vaccine with/without adjuvant

Conditions: Prophylaxis Herpes Simplex

Summary: the purpose of the phase iia study in healthy hsv seropositive and hsv seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gd) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * between 18 and 40 years of age * written informed consent * female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study. * good clinical condition as evidenced by history taking and physical examination exclusion criteria: * history of persistent hepatic, renal, cardiac or respiratory diseases. * clinical signs of acute illness at the time of entry into the study. * seropositive for antibodies against the human immunodeficiency virus (hiv). * pregnancy, lactation. * treatment with corticosteroids or immunomodulating drugs. * simultaneous participation in another clinical trial. * any previous history of allergy. * any concomitant vaccination or administration of immunoglobulin during the study period. * any abnormal laboratory value among the tests performed at screening

Keywords: herpes simplex herpes simplex vaccine
minimally invasive surgery of the gastro-esophageal junction

Conditions: Achalasia; Paraesophageal Hernia; GERD; Epiphrenic Diverticula; Zenker's Diverticulum

Summary: this study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (misgej). patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following misgej. hospital charts will also be reviewed on an annual basis to assess patient health outcomes.


Eligibility criteria:
inclusion criteria: * all patients at the ottawa hospital undergoing minimally invasive surgery of the gej exclusion criteria: * less than 18 years of age.

Keywords: gastro-esophageal junction minimally invasive achalasia paraesophageal hernia gerd epiphrenic diverticula zenker's diverticulum all minimally invasive surgeries of the gastro-esophageal junction
clinical trial to evaluate the efficacy and safety of da-8031 in male patients with premature ejaculation

Conditions: Premature Ejaculation

Summary: this study is designed to evaluate the efficacy and safety of da-8031 and to decide the optimal dose of da-8031 in male patients with premature ejaculation after oral administration on-demand. the investigators hypothesized that newly-developed da-8031 would effect in delaying ejaculation in patients with premature ejaculation (pe). design: placebo-controlled, randomized, double-blind, double-dummy, parallel group, fixed dose design


Eligibility criteria:
inclusion criteria: * male patients aged with premature ejaculation for more than 6 months. * pedt score ≥ 11 exclusion criteria: * iief-ef domain ≤ 21 * serum creatinine ≥ 2.5 mg/dl * ast, alt \> 3\*upper limit of normal * subjects with hypotension(sbp/dbp\ 180/100mmhg) * subjects with chronic depression, psychiatric or schizophrenia, * subjects with alcohol, drug or substance abuse
imatinib response in patients with chronic myeloid leukemia (cml) in function of abl polymorphisms

Conditions: Leukemia, Myeloid, Chronic-Phase

Summary: the main objective of this study is to evaluate the existence of a relationship between the presence of certain abl polymorphisms (or haplotypes) upon cml diagnosis and the occurrence of primary resistance to the treatment of cml by imatinib.

the first secondary objective of this study is to identify, in patients not responding to treatment, possible changes in the polymorphisms of interest during the course of the disease, reclassifying such polymorphisms as mutations. the second secondary objective is to compare the control patients in terms of polymorphism frequency on the nonpathological abl fraction.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan inclusion criteria for all cml patients * patients diagnosed with cml * treatment with imatinib in first-line monotherapy and this for at least 12 months * rna and / or cdna used for diagnosis correctly stored in the biobank inclusion criteria for cml patients already having undergone a follow-up visit at 12 months * rna and / or cdna used for diagnosis/follow-up correctly stored in the biobank * cytogenetic results are available * absence of itk mutation for the primary resistance subgroup * validated compliance inclusion criteria for the optimal response group: * bcr-abl typing is less than 0.1% at 12 months inclusion criteria for the primary resistance group * bcr-abl typings is \>1% and/or philadelphia+ is greater than 0 inclusion criteria for the control population * absence of hematologic malignancy exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has a contraindication for a treatment used in this study exclusion criteria for cml patients already having undergone a follow-up visit at 12 months * known or suspected cause for resistance (dose reduced due to intolerance, digestive disease responsible for malabsorption ...) exclusion criteria for the control population * history or suspicion of hemopathy

Keywords: abl polymorphisms
system accuracy and user performance of blood glucose monitoring systems for self-testing in managing diabetes mellitus

Conditions: Diabetes

Summary: the aim of this test is to determine the system accuracy and user performance evaluation of three blood glucose monitoring systems. for system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.


Eligibility criteria:
inclusion criteria: * subjects with type 1 or type 2 diabetes and healthy subjects * signed and dated informed consent form * for small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy) or insulin pump therapy (continuous subcutaneous insulin infusion) exclusion criteria: * pregnancy or lactation period * severe acute illness that in the opinion of the investigating physician might confound the results of the test or which could result in a risk to the patient caused by the test * mental incapacity or language barriers precluding adequate compliance with the test procedures * severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the patient caused by the test * legal incompetence or limited legal competence * dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center) * for user performance evaluation: subjects having used the test systems before themselves or having participated in a study with these blood glucose monitoring systems * for system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease- or impaired hypoglycaemia awareness

Keywords: blood glucose monitoring system system accuracy
impact of continuous positive airway pressure on the treatment of acute asthma exacerbation

Conditions: Acute Asthma

Summary: this current study aimed to demonstrate the effectiveness of the addition of cpap to the current conventional therapy in terms of airway obstruction improvement in acute asthma patients.

continuous positive airway pressure (cpap) is widely used in providing ventilator support. however, its role in an acute asthmatic attack is uncertain. the purpose of this study was to compare the efficacy of cpap when used in addition to conventional therapy with conventional therapy alone in the management of acute asthma exacerbation.

Eligibility criteria:
inclusion criteria: * aged over 18 years * known asthmatic patients visiting ed with acute exacerbation * had given their written informed consent. exclusion criteria: * smoking history * chronic obstructive pulmonary disease * required intubation * instability of hemodynamic or arrhythmia * unable to perform pefr * facial abnormality * pulmonary infiltration * pregnancy.

Keywords: bronchial disease asthma continuous positive airway pressure (cpap) bronchoconstriction
benefits of group psychotherapy programs in the treatment of obesity

Conditions: Obesity; Psychotherapy; Psychotherapy, Group

Summary: obesity has reached pandemic proportions in recent years, affecting not only the physical health, but also the mental health, of obese people. according to spain's national health survey 2011-12, the prevalence of obesity in the adult population of spain was 17%, having increased by 2.5% since 2006. therefore, a constant and worrying increase in the prevalence of obesity is being observed, which is having a great impact, both individually, in terms of health and quality of life, and socially, inter alia, by raising health expenditure due to increased morbidity. in this context, the desirability of a comprehensive approach that includes psychological intervention in attending obese patients (rev cochrane, 2006), has been given greater prominence. paying attention to the emotional and psychopathological aspects related to obesity has proven to be an action that could have positive impact on obesity intervention models. the aim of this project is to measure, through a clinical trial, the efficacy of a psychotherapy group program for obesity patients who are attended by the consulting endocrinologist at the infanta leonor hospital (madrid). the impact of body mass index, psychological wellbeing, psychopathology and quality of life of two experimental study groups will be compared, one a control group of patients that follows the standard treatment, the other an experimental group that follows not only the standard treatment, but also the psychotherapy group intervention program.


Eligibility criteria:
inclusion criteria: * age older than 18 and younger than 65. * body mass index of 30 or higher. * candidate to a specific obesity treatment. * accept psychological attention. * able to understand and consent participation. * able to speak, write and read in spanish. * committed to assist weekly for 6 months non-inclusion criteria: * obesity related to a non- stabilized hormonal disorder. * severe mental disorders requiring specific treatment resources. * cognitive or sensitive deficits. * having had bariatric surgery within last 2 years. exclusion criteria: * pregnancy during treatment * bariatric surgery during treatment * addictive disorder as a principal diagnosis.

Keywords: obesity psychotherapy psychotherapy group
placement of antibiotic powder in wounds during the emergency room

Conditions: Open Fracture

Summary: this is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.

open fracture injuries are highly susceptible to infection and infection-related complications. the current routine treatment for these injuries includes the use of systemic iv antibiotics. however, open fracture injuries often have compromised blood supply, reducing the amount of antibiotic that reaches the target tissue while increasing risk of injury to non-target organs. this trial aims to evaluate the effectiveness of early application of a topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual treatment, in reducing the risk of infection seen in these injuries.

Eligibility criteria:
inclusion criteria: * subject or legal authorized representative (lar) is willing and able to provide written informed consent. * adult 18 years of age or older. * open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula. * 24 hours or less has elapsed from the estimated time of injury to study intervention. exclusion criteria: * time from injury \> 24 hours. * subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility. * subject or lar speaks neither english nor spanish. note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur). * high-potency antibiotic powder or solution applied to the wound prior to enrollment. simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted. * documented allergies or serious reactions to vancomycin. history of uncomplicated "red man syndrome" will not be considered a reason for exclusion. * pregnant subjects. if the subject is a female of childbearing potential, and she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment. * prisoners. * participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.

Keywords: infection vancomycin topical antibiotic antibiotic prophylaxis
comparison of the effectiveness of high-intensity and low-intensity laser therapies in primary knee osteoarthritis

Conditions: Primary Knee Osteoarthritis

Summary: our primary goal is to investigate the advantages of low-intensity laser therapy (lllt) and high-intensity laser therapy (hilt) over conventional therapy in patients with knee osteoarthritis (oa), our secondary goal is to investigate the advantages of hilt and lllt; to compare its analgesic effects, its effects on functional status and quality of life, and its effects on femoral cartilage thickness.

in the study, those who applied to ankara city hospital physical therapy and rehabilitation hospital outpatient clinic between 01.10.2020-01.10.2021, were between the ages of 55-75, were diagnosed with primary knee oa according to the american rheumatology association, stage 2-3 knee according to kellgren and lawrence radiological classification. with oa; 72 volunteer patients with knee pain with a visual pain score of 4 and above for at least 3 months were included. the study was designed as a prospective, randomized, controlled, single-center. patients were randomly divided into 3 treatment groups. conventional treatment including hotpack therapy, transcutaneous electrical nerve stimulation (tens), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients in the first group, conventional treatment and hilt were applied to 24 patients in the second group, and conventional treatment and lllt were applied to 24 patients in the third group. all groups were evaluated clinically and ultrasonographically at the beginning of the treatment, at the end of the treatment and at the 3rd month after the treatment.

Eligibility criteria:
inclusion criteria: * age range of 55-75 years * primary knee oa diagnosis according to acr (american college of rheumatology) and knee oa classified as stage 2-3 according to the kl (kellgren-lawrence) radiological classification * visual pain score of 4 or higher for knee pain lasting for at least 3 months exclusion criteria: * patients with secondary knee oa * patients who have undergone surgical operations related to the knee joint * patients with pathology in the hip and/or ankle on the same side * patients who have received intra-articular corticosteroid, hyaluronic acid, or prp injections in the knee joint in the last 6 months * patients who have received physical therapy for the knee region in the last 6 months * patients with serious systemic diseases such as malignancy, congestive heart failure, or chronic obstructive pulmonary disease * patients with insufficient cognitive function

Keywords: osteoarthritis, low level light therapy, high level light therapy,muscle skeletal; ultrasonography
efficacy and safety of different hyaluronic acid tear substitutes formulations in evaporative dry eye

Conditions: Dry Eye

Summary: the objective of the study is to compare the efficacy and safety of different hyaluronic acid tear substitutes formulations in patients with evaporative dry eye. for this purpose, a randomized, single-blind clinical trial has been designed.


Eligibility criteria:
inclusion criteria: 1. self-reported history ded. 2. ocular surface disease index (osdi) \> 13 points. 3. non-invasive tear film break-up time (nibut) \< 10 s. 4. schirmer test (st) without anesthesia ≥ 5 mm. 5. mgd grade \> 1. for mgd, the sirius device (cso, florence, italy) was used, which determines mgd grade based on loss area of meibomian glands (lamg). mgd grade was scored from 0 to 4 (mgd grade 1 = lamg \< 25%; mgd grade 2 = lamg ≥ 25% and \< 50%; mgd grade 3 = lamg ≥ 50% and \< 75%; mgd grade 4 = lamg ≥ 75%). exclusion criteria: 1. abnormal lid anatomy, including active blepharitis, and active lid margin. 2. all corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies. 3. active ocular allergies. 4. vectored thermal pulsation (vtp) intense pulse light (ipl), quantum molecular resonance (qmr), or other procedure to treat ded within the previous 6 months. 5. intraocular surgery or laser ocular surgery within the previous 6 months. 6. use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs. 7. systemic autoimmune diseases. 8. contact lens wearers. 9. pregnant or lactating women. 10. patients who did not understand or comprehend the informed consent.
a molecular and functional brain imaging study in individuals with down syndrome and healthy controls following single dose rg1662

Conditions: Healthy Volunteer, Down Syndrome

Summary: this single-center, single-blind, placebo-controlled, parallel-group study with crossover component will evaluate the gabaaalpha5 receptor expression, occupancy and functional connectivity in the brains of individuals with down syndrome and healthy controls following single dose rg1662. participants will receive a single dose of placebo before the imaging session (pet and mri), and a single dose of rg1662 before the second imaging session.


Eligibility criteria:
inclusion criteria: healthy controls and individuals with down syndrome: * male and female adults, 18 to 40 years of age * body mass index (bmi) 18 - 40 kg/m2 inclusive * females of child-bearing potential and males with female partners of child-bearing potential must agree to use two medically approved methods of contraception, one of which must be a barrier method, for the duration of the study and for 4 months after the last study drug administration * clinical laboratory values within normal limits or abnormalities considered not significant by the investigator and sponsor; individuals with thyroid disease may be included in the study provided they are euthyroid and stable on treatment for at least one month prior to screening individuals with down syndrome must also meet the following: * diagnosis of down syndrome confirmed by karyotype; subjects may have free trisomy 21 or robertsonian translocations; mosaic down syndrome will be excluded * individuals must have a parent or other reliable caregiver who agrees to accompany the inidvidual to all clinic visits, provide information about the individual as required by protocol, and be willing to give informed consent exclusion criteria: * regular smoker (\>5 cigarettes or equivalent: 3 cigars, 6 cigarillos, 3 pipes per day) * concomitant disease or condition or any clinically significant finding at screening that could interfere with, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study * severe head trauma or cns infections (e.g. meningitis) * history of epilepsy or seizures other than benign febrile convulsions of childhood * any confirmed significant allergic reactions against any drug, anaphylaxis or severe environmental allergies as judged by the investigator * positive for hepatitis b, hepatitis c or hiv infection * positive urine test at screening or at follow-up for drugs of abuse, or positive alcohol breath test at screening and prior to dosing * previous inclusion in research and/or medical protocol involving nuclear medicine, pet or radiological investigations with significant radiation burden (as defined by protocol) * pregnant or lactating women * individuals with evidence or meeting clinical diagnosis of dementia