Kornimate/medical-research-clean huggingface dataset:
effects of massage therapy on peripheral neuropathy and quality of life

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: the aim of this randomized controlled experimental study was to determine the effect of massage applied to colorectal cancer patients receiving chemotherapy on peripheral neuropathy and quality of life.

the aim of this randomized controlled experimental study was to determine the effect of massage applied to colorectal cancer patients receiving chemotherapy on peripheral neuropathy and quality of life.investigation was carried out between february 2012- may 2013 with 52 patients meeting study criteria and receiving chemotherapy in akdeniz university outpatient chemotherapy unit (28 study group, 24 control). massage therapy group:the experimental group patients were given a series of effleurage, petrissage and surface fraction types of classical massage on local parts of they're body-below, elbow-frontal arm-hand (20 minutes) and below knee-leg (lower part)-foot (20 minutes) two days of treatment of 16 times total.the patients in the massage group received 16 sessions of classical massage performed by the research nurse, who had classical massage training and certification.baseline, patient characteristics , peripheral neuropathy symptoms, neuropathic pain, cancer and chemotherapy-related symptoms, and quality of life were completed. peripheral neuropathy symptoms, cancer, and chemotherapy-related symptoms were assessed at each cycle (2th, 4th, 6th, 8th,10th,12th,14th, 16th. week- (two-week intervals)). neuropathic pain and quality of life were measured at 4, 10, and 16 weeks. at week 16 (2 weeks after the intervention), the grade of peripheral sensory neuropathy was determined. control group: the patients received routine care. baseline, patient characteristics , peripheral neuropathy symptoms, neuropathic pain, cancer and chemotherapy-related symptoms, and quality of life were completed. peripheral neuropathy symptoms, cancer, and chemotherapy-related symptoms were assessed at each cycle (2th, 4th, 6th, 8th,10th,12th,14th, 16th. week (two-week intervals)). neuropathic pain and quality of life were measured at 4, 10, and 16 weeks. at week 16 (2 weeks after the intervention), the grade of peripheral sensory neuropathy was determined.

Eligibility criteria:
inclusion criteria: * over 18 years old * have a diagnosis of colorectal cancer * receiving folfox-4 chemotherapy protocol * to receive a maximum of 4 cycles of folfox-4 chemotherapy * platelet values over -100.000/mm3 * no obstacle to massage application exclusion criteria: * previously been diagnosed with polyneuropathy, * has been diagnosed with diabetes, * is addicted to alcohol, * has been amputated at the extremities, * has a skin infection and skin integrity disorder, * has megaloblastic anemia, uses anticoagulants, * takes drugs that hide or affect neuropathy findings * has had massage therapy within the last month.

Keywords: peripheral neuropathy, chemotherapy massage life quality colorectal cancer
immunogenicity and safety of glaxosmithkline biologicals' infanrix™-ipv+hib vaccine

Conditions: Poliomyelitis; Tetanus; Acellular Pertussis; Diphtheria; Haemophilus Influenzae Type b

Summary: this study is designed to evaluate the safety and immunogenicity of infanrix™-ipv+hib vaccine when administered as a primary vaccination course to healthy korean infants at 2, 4 and 6 months of age.


Eligibility criteria:
inclusion criteria: * a male or female between, and including, 42 and 69 days of age at the time of the first vaccination. * born after a gestation period of 37 to 42 weeks inclusive. * subjects who the investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol. * written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis b and bacillus calmette-guérin vaccination; or planned administration during the study period, with the exception of hepatitis b and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the dtpa vaccine. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and hib vaccination or disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * family history of congenital or hereditary immunodeficiency. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * major congenital defects or serious chronic illness. * history of any neurological disorders or seizures. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * acute disease and/or fever at the time of enrolment.

Keywords: primary vaccination combination vaccine south korea
non-interventional study related to fixed lama/laba/ics triple therapy

Conditions: COPD

Summary: this is a prospective non-interventional trial to measure the health related quality of life of patients with chronic obstructive pulmonary disease (copd) on a fixed lama/laba/ics triple therapy (trimbow®) and characterisation of determinants of treatment adherence.

the primary goal of copd therapy is the prevention of exacerbations and clinical deterioration. to achieve these goals, treatment adherence (i.e. taking medication as prescribed) is important. however, non-adherence (not taking medication as prescribed) is common in copd and can be affected by lifestyle changes or use of multiple inhalers. the effects of trimbow® on patients' health related quality of life, adherence and clinical outcomes have not been assessed in a uk real-world setting. this non-interventional trial aims to collect data from copd patients under routine care over a 6 month period, for whom their doctors has decided to prescribe trimbow® as per the authorised indication. we plan to investigate any changes in quality of life, as well as changes in lung function and the need for any additional therapy over 6 months. we also plan to investigate the adherence or reasons for non-adherence to trimbow® as used in everyday routine.

Eligibility criteria:
inclusion criteria: 1. patients with moderate to severe copd (with and without concomitant asthma) 2. physician decision to start therapy with trimbow as per its current marketing authorisation; the treatment decision should be made independently from participation in this non-interventional trial 3. patients with at least one copd exacerbation within the previous 12 months 4. patients willing and able to sign informed consent for use of their pseudonymised clinical data within the present non-interventional trial exclusion criteria: 1. patients hospitalised due to an exacerbation of their copd within the last 4 weeks prior to enrolment 2. participation within an interventional clinical trial within 30 days prior to enrolment into the present non-interventional trial
endocan levels at polycystic ovary syndrome and periodontal inflammation

Conditions: Polycystic Ovary Syndrome; Inflammation Gum; Cytokines

Summary: periodontal diseases are chronic inflammatory disease occurred by the interaction between pathogenic microorganism and the host defense. polycystic ovary syndrome (pcos) is a reproductive and metabolic disease associated with increased risk of cardiovascular events. endocan is a proteoglycan secreted mainly by endothelial cells under the control of inflammatory cytokines. periodontal diseases, including gingivitis, are common chronic infectious diseases caused by predominantly pathogenic microorganisms that colonize the subgingival area and cause local and systemic elevations of proinflammatory cytokines such as interleukin-6 (il-6). several lines of evidence established the association between periodontal and systemic diseases, including metabolic syndrome, diabetes, and cardiovascular disease. because of the fact that both periodontal disease and pcos are associated with systemic inflammation and insulin resistance, these two disorders may be linked through a common pathophysiologic pathway. a number of studies have indicated a possible relationship between pcos and periodontal inflammation. despite common risk factors, including oxidative stress, the relationship between chronic periodontitis (cp) and pcos remains unclear. the aims of the study were to determine serum and saliva endocan and il-6 levels and to evaluate the correlation between these two biomarker in women with periodontal disease and pcos.


Eligibility criteria:
inclusion criteria: * newly diagnosed pcos patients * never smokers * had no history of systemic disease * bmi\<25 kg/m2 * participants had ≥20 teeth present. exclusion criteria: * pregnancy * lactation * hemoglobin a1c (hba1c) ≥ 6.5% * 2-h oral glucose tolerance test (ogtt-2h) ≥200 * cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors * using antibiotics and antiinflammatory within the past 6 months * periodontal treatment within the past 6 months
membrane blue versus infracyanine green

Conditions: Macular Pucker; Macular Hole

Summary: to compare possible toxicities of membrane blue and infracyanine green in vivo by macular function and peripheral visual field.


Eligibility criteria:
inclusion criteria: * macular pucker or macular hole exclusion criteria: * any other retinal disease

Keywords: macular pucker macular hole membrane blue infracyanine green peripheral visual field
a study to evaluate the safety and pharmacokinetics of ag2304 compared to coadministration of ag23041 and ag23042

Conditions: Pharmacokinetics

Summary: the objective of this study is to evaluate the pharmacokinetic characteristics of ag2304 in healthy subjects.

to evaluate the pharmacokinetic characteristics and safety profiles of ag2304 compared with coadministration ag23041 and ag23042 after a single oral dose administration in healthy korean subjects under fasting conditions.

Eligibility criteria:
inclusion criteria: * a healthy adults aged 19-65 years at the time of screening * subjects who are deemed eligible based on the screening tests exclusion criteria: * subjects who have taken the investigational drug within 6 months prior to the first dose * other exclusions have been applied
study of efficacy and safety of voretigene neparvovec in japanese patients with biallelic rpe65 mutation-associated retinal dystrophy

Conditions: Biallelic RPE65 Mutation-associated Retinal Dystrophy

Summary: the purpose of this study is to provide safety and efficacy data for voretigene neparvovec, administered as subretinal injection, in japanese patients with biallelic rpe65 mutation-associated retinal dystrophy.

this is an open-label, single-arm study to evaluate the safety and efficacy of bilateral subretinal administration of voretigene neparvovec in japanese patients with biallelic rpe65 mutation-associated retinal dystrophy. assessments will include full-field light sensitivity threshold testing, visual fields, visual acuity, vector shedding, immunogenicity and adverse events. participants will be monitored for 5 years after treatment.

Eligibility criteria:
inclusion criteria: * japanese participants with biallelic rpe65 mutation-associated retinal dystrophy; molecular diagnosis of rpe65 mutation must be confirmed by a novartis designated laboratory in japan. * age four years or older. * visual acuity worse than 20/60 (both eyes) and/or visual field less than 20 degrees in any meridian as measured by a iii4e isopter or equivalent (both eyes). * sufficient viable retinal cells as determined by non-invasive means, such as optical coherence tomography (oct) and/ or ophthalmoscopy. must have either: * an area of retina within the posterior pole of \> 100 µm thickness shown on oct, or * ≥ 3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole, or * remaining visual field within 30 degrees of fixation as measured by a iii4e isopter or equivalent exclusion criteria: * any prior participation in a study in which a gene therapy vector was administered. * participation in a clinical study with an investigational drug in the past 6 months from screening visit. * known hypersensitivity to any of the study treatments including excipients or to medications planned for use in the peri-operative period. * unable to reliably perform the fst assessment. * use of retinoid compounds or precursors that could potentially interact with the biochemical activity of the rpe65 enzyme in the past 6 months from screening visit. * prior intraocular surgery within 6 months from screening visit. * prior use of any medicines that, in the opinion of the investigator, may have caused retinal damage (e.g., sildenafil or related compounds, hydroxychloroquine, chloroquine, thioridazine, any other retino-toxic compounds) * pre-existing eye conditions or complicating systemic diseases that would preclude the planned surgery or interfere with the interpretation of study. complicating systemic diseases would include those in which the disease itself, or the treatment for the disease, can alter ocular function.

Keywords: ltw888 voretigene neparvovec biallelic rpe65 mutation-associated retinal dystrophy japanese patients
intellicycletm 2.0 improved patient-ventilator asynchrony during psv

Conditions: Automatic Adjustmen of Inspiratory Triger and Cycling-off

Summary: pressure support ventilation use expiratory triggering sensitivity (esense) to transfer inspiration to expiration, the value of esense is fixed. that may lead to asynchrony between humans and ventilators, making people uncomfortable and prolonging weaning time. furthermore，trigger delay or inffective trigger happens frequently during insppiratory triggering. the ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, intellicycletm 2.0. it will make the transforming more synchrony with humans. the objectibe of the present study is to detect the effect of automatic adjustmen of inspiratory triger and cycling-off based on waveform on patient-ventilator interation.

this is a physiological cross-over study. enrolled patient with different baseline respiratory mechanics, for example ards patients with low compliance, copd patient with high airway resistance and postoperative patients with almost normal compliance and airway resistance. patients are ventilated with psv+ automatic adjustmen of inspiratory triger and cycling-off based on waveform, psv with fixed inspiratory and expiratory and nava in two different levels of support. the demographic characteristics, diagnosis, formerly medical history, ventilator indications, ventilator data, other respiratory treatments, patient-ventilator interation, work of breathing, eadi, will be recorded.

Eligibility criteria:
inclusion criteria: postoperation patients 1. receiving invasive mechanical ventilation due to operation 2. abdominal surgery, orthopedic surgery or gynecological surgery 3. without respiratory system comorbidity 4. able to sustain psv more than 1 h with inspiratory support ≤ 15 cmh2o. copd and ards patients 1. receiving invasive mechanical ventilation due to acute respiratory failure 2. able to sustain psv more than 1 h with inspiratory support ≤ 15 cmh2o. exclusion criteria: 1. age \ 85 years, 2. tracheostomy at time of inclusion, 3. contra-indication for nasogastric tube insertion (e.g. history of esophageal varices, gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 7 days, inr ratio \> 1.5 , aptt \> 44 s, history of leukemia), 4. neuromuscular disease affecting spontaneous breathing (e.g. history of acute central or peripheral nervous system disorder or neuromuscular disease with irregular spontaneous rhythm), 5. hemodynamic unstable (heart rate \> 140 beats/min, vasopressors required with ≥ 5 μg.kg-1.min-1 dopamine/ dobutamine, or ≥ 0.2 μg.kg-1.min-1 norepinephrine), 6. sedation level richmond agitation-sedation scale (rass) ≤ -2 or ≥ 2, 7. lack of informed consent and patients included in other intervention study.

Keywords: patient-ventilator interation automatic adjustmen of inspiratory triger and cycling-off neurally controlled ps
adherence to hiv treatment postpartum: the implications of transitions among women living with hiv in south africa

Conditions: HIV; Pregnancy Related

Summary: despite high levels of adherence motivation during pregnancy, hiv treatment adherence and engagement in care is difficult for women in the postpartum period. supporting women during the transition from pregnancy to postpartum is imperative to sustaining hiv treatment adherence during this period. the investigators are conducting a small scale pilot study of a behavioral transition theory-based intervention to support art adherence and engagement in art services among pregnant and postpartum women living with hiv.

prevention of mother-to-child transmission (pmtct) efforts have reduced the rates of vertical transmission to 2.7%, however, optimal antiretroviral therapy (art) adherence remains a difficult goal to reach, particularly postpartum. longitudinal qualitative research reveals a variety of facilitators and barriers to the transition from pregnancy to postpartum including employment/financial concerns, logistical concerns around childcare and breastfeeding, worries about vertical transmission and difficulties bonding. this intervention draws on the growing cadre of community health workers within the south african health care system and transition theory to develop a behavioral intervention to support women living with hiv through the transition from pregnancy to postpartum. the investigators are conducting a small scale pilot study to compare the impact of a transition theory-based intervention to enhanced standard of care on self-reported art adherence and engagement in art services among pregnant and postpartum women living with hiv.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. hiv positive status (based on clinic records) 3. confirmed pregnant (based on clinic records) and estimated to be 23-34 weeks gestation (clinic records or self-report) 4. currently prescribed art 5. planning on remaining a resident of cape town for at least 6 months postpartum 6. ability to speak isixhosa or english 7. able to provide informed consent exclusion criteria: * failure to meet any of the inclusion criteria * significant pre-existing psychiatric comorbidity at enrolment that may impact ability to consent according to the judgement of study personnel (including cognitive impairment or known psychotic disorder) note: mothers will not be withdrawn from the study following foetal complications or death

Keywords: hiv pregnancy postpartum south africa
uvb-311nm after initial slow response to adalimumab in psoriasis

Conditions: Psoriasis

Summary: adalimumab, a fully human anti-tumor necrosis factor (tnf) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. however, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (pasi) of 75% or greater, now being considered as gold standard for treatment efficacy. in this study we aim to determine in a randomized half-side comparison whether additional narrowband uvb-311nm phototherapy accelerates and improves the clearance of psoriatic lesions in adalimumab-treated patients after initial slow response.

patients with moderate to severe psoriasis who have received treatment with adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) for at least 6 weeks without a pasi reduction of 75% or greater qualify for the study. adalimumab is continued and uvb-311nm phototherapy is added at 6 weeks or thereafter one a randomized body half (left or right; head exempt) 3 x per week until complete response (defined as reduction in pasi to \ 90%, \> 75% and/or 50% between body sites.

Eligibility criteria:
inclusion criteria: * psoriasis patients with pasi reduction of less than 75% after at least 6 weeks of treatment with adalimumab. exclusion criteria: * pregnancy or lactation * history of skin cancer * presence of or history of malignant skin tumors * dysplastic melanocytic nevus syndrome * antinuclear antibodies (ds-dna, ro/ssa, la/ssb) * autoimmune disorders such as lupus erythematosus or dermatomyositis * photosensitive diseases such as porphyria, chronic actinic dermatitis, xeroderma pigmentosum, basal cell nevus syndrome, and others * general poor health status

Keywords: psoriasis biologic adalimumab narrowband uvb phototherapy half-side comparison
dermacyd breeze (lactic acid) pocket br - photo evaluation

Conditions: Hygiene

Summary: to demonstrate the absence of photoirritation and photosensitization potential of the product dermacyd breeze (lactic acid) pocket br.


Eligibility criteria:
inclusion criteria: * age between 18 and 60 years old; * phototype skin ii and iii; * integral skin test in the region; * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; exclusion criteria: * lactation or gestation; * use of antiinflammatory and/or immunosuppression drugs 15 days before the selection; * diseases which can cause immunity decrease, such as hiv, diabetes; * use of drug photosensitizer; * history of sensitivity or irritation for topic products; * active cutaneous disease which can change the study results; * history of photodermatosis active; * family or personal antecedent of cutaneous photoinduced neoplasias; * presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium; * intense solar exposure in the study area; * use of new drugs or cosmetics during the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.