Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the immunogenicity, safety, and tolerability of varivax™ manufactured with a new process (v210-062)

Conditions: Varicella

Summary: this study will test the immunogenicity, safety, and tolerability of varivax™ manufactured with the varicella enhanced process (vep) compared with the varivax™ 2007 process. the primary hypotheses being tested are 1)varivax™ vep will induce varicella-zoster virus (vzv) antibody responses that are non-inferior to those induced by varivax™ 2007 process at 6 weeks after vaccination 1, and 2) varivax™ vep will induce an acceptable anti-vzv antibody response rate at 6 weeks after vaccination 1.


Eligibility criteria:
inclusion criteria: * negative clinical history of measles, mumps, rubella, varicella, and zoster exclusion criteria: * received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study * any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity * received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to require them throughout the study * history of allergy or anaphylactoid reaction to neomycin, gelatin, sorbital, egg proteins, chicken proteins, or any components of m-m-r™ ii or varivax™ * received salicylates within 14 days prior to study vaccination * exposed to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to study vaccination * received any non-live vaccine within 14 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination * received any live vaccine within 30 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination * received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to any study vaccination * fever illness (≥102.2°f \[39.0°c\]) within 72 hours prior to study vaccination * born to a human immunodeficiency virus (hiv)-infected mother * participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment
the effect of straining techniques on women and newborn

Conditions: Prolonged Second Stage of Labor; Other Specified Trauma to Perineum and Vulva During Delivery; Newborn; Vitality

Summary: purpose: to examine the effects of straining techniques on the duration of labor, perineal trauma status and newborn apgar score. method: this study is a randomized controlled trial. the straining techniques were explained to the pregnant women who gave written consent to participate in the study and were randomly assigned to groups in the latent phase (natural, spontaneous, valsalva), and the techniques were applied in the second phase of labor.

purpose: the present study was planned to determine the effects of straining techniques on the duration of labor, perineal trauma status, and newborn apgar score. method: the study, which had a randomized-controlled experimental design, was conducted in sivas numune hospital birth unit. the sampling size was calculated using power analysis. in the literature, spontaneous straining is used by pregnant women in the range of 25-81%, and valsalva -type straining has a rate of 32-75%. to represent the population of the study, sample volume was determined at =0.05 significance level, 1- =0.95 confidence interval, =0.20 error risk, and 1- =0.80 power, and the total number of individuals was determined as 354. the data of the study were collected with the "pre-evaluation form", "personal information form", "labor evaluation form", and "apgar score" created by the researchers in line with the literature data. the straining techniques were explained to the pregnant women who gave written consent to participate in the study and were randomly assigned to groups in the latent phase (natural, spontaneous, valsalva), and the techniques were applied in the second phase of labor. anova, kruskal wallis h-test, chi-square test, exact test, tamhane t2 test, and dunn test were used to evaluate the data obtained in the study. statistical significance was evaluated at a 0.05 significance level and the spss version 23.0 was used.

Eligibility criteria:
inclusion criteria: * 38-42. being at the gestational week, * having a singleton pregnancy * fetus in vertex position * being in the latent phase in the first stage of labor * planning and having a normal vaginal birth, * not having a diagnosed chronic physical disease, * not having a diagnosed psychiatric disease, * no risk of risky pregnancy or fetal anomaly, * being literate, * no communication problem * giving birth in the lithotomy position * volunteering to participate in the study exclusion criteria: * 38-42. not in the week of pregnancy, * having multiple pregnancy * fetus out of vertex position * being in the latent phase in the first stage of birth, * having a cesarean section while planning a normal vaginal delivery, * having a diagnosed chronic physical illness, * having a diagnosed psychiatric illness, * having a risky pregnancy or fetal anomaly risk, * illiteracy, * having a communication problem * giving birth in different positions * not willing to participate in the study

Keywords: labor midwife pregnant straining techniques perineal trauma apgar score
effects of microcrystalline titanium dioxide with covalently linked monovalent silver ions on complications after total hysterectomy ( istiab-0)

Conditions: Infection; Bleeding; Complication, Postoperative

Summary: total hysterectomy is one of the most performed surgical procedures in the world and it is associated with post-operative complications. the postoperative morbidity rate is estimated to vary from 3% to 8% with a readmission rate of 5-7%. the most frequent postoperative complications are urinary tract infections, wound infection of the vaginal vault, vault cellulitis, bleeding, suture dehiscence, pelvic abscess. the introduction of routine antibiotic prophylaxis has significantly reduced the risk of infectious complications, which however remains higher than other "clean" surgery, mainly due to contamination by the vaginal bacterial flora. in this scenario, the introduction of adjuvant factors acting on bacterial flora, can contribute to reduce the risk of post-surgical complications. the cationic silver ions (ag +) stabilized by covalent link with titanium dioxide (tio2), the tiab, maximizes the properties of silver by optimizing the antibiotic action and disruptive properties of the pathogenic biofilm of bacteria and fungi. thanks to these properties, tiab is able to enhance the antibiotic action by reducing the risk of antibiotic resistance and recurrent infections linked to the biofilm. re-establishing the optimal vaginal microenvironment represents a fundamental step reducing the risk of infections in the surgical site, since the vagina is a non-sterile environment populated by bacterial species that can generate biofilm and potentially infect the site of surgery. in addition to microbicidal and disruptive biofilm activity, tiab has demonstrated a direct action on tissue regeneration processes by stimulating the production of collagen and its modeling. different clinical trials have reported a cicatrizing and re-epithelializing action of tiab administered vaginally in the context of cervical conization for pathology related to hpv. without showing any notable adverse effects or a negative action on lactobacillary flora with an overall good therapy tolerance by patients. on the basis of the available evidence, the investigators conduct a randomized controlled clinical trial to determine if tiab treatment in the formulation of vaginal capsules tiagin (tiab (microcrystalline titanium dioxide with covalently linked monovalent silver ions), sodium hyaluronate, aloe barbadensis extract) is able to reduce the incidence of infectious complications, that are related to altered healing of post-hysterectomy vaginal suture.


Eligibility criteria:
inclusion criteria: * women underwent laparoscopic total hysterectomy for benign gynecological pathology exclusion criteria: * women underwent non-laparoscopic total hysterectomy * women underwent laparoscopic total hysterectomy for malignant pathology * patients with diabetes mellitus in insulin therapy * smoking patients * patients suffering from chronic rheumatic diseases or chronic diseases not in adequate control.
effects of manual diaphragmatic technique versus lateral coastal breathing exercises among copd patients.

Conditions: COPD

Summary: chronic obstructive pulmonary disease is a common, preventable as well treatable disorder, which is also one of the main reasons of high mortality and morbidity characterized by irreversible airflow limitation and has respiratory system involved. the aim of this study is to evaluate the comparative effects of manual diaphragmatic technique and lateral coastal breathing on copd patients, that these exercises will have beneficial effects or not on copd patients. manual diaphragmatic technique and lateral coastal breathing will increase the functional capacity and relieve the symptoms dyspnea, enhance the chest wall expansion.

this study will be a randomized clinical trial to determine the effects of both techniques on copd patients and disease severity in patients who falls into the inclusion criteria, who are willing to participate, patients with age limit between 45 to 65 years, gold stage ii, and patients will be excluded who have cardiac disease, abdominal or thoracic surgeries and in critical condition by taking sample of patients through non probability convenient sampling and randomly allocating them to two groups a and b out of which a will receive manual diaphragmatic techniques, b will receive lateral coastal breathing exercise up to the duration of 2 times a day, 3 days per week for up to 3 weeks. pre and post exercise outcomes will be assessed. the data will be analyzed through spss 26

Eligibility criteria:
inclusion criteria: age 45-65 years(12). both gender female and male. patients willing to be the part of the research. patients with moderate level of copd patients with gold ii stage(13). patients who response to bronchodilators patients with history of smoking(14). exclusion criteria: patients having other cardiac diseases. patients having thoracic or abdominal surgeries. exacerbation of symptoms before or during study. inability of patient to understand instructions due to mental disorder lack of medical record coronary artery disease (coronary angiography with stenting or bypass) malignant tumor patients with gastrointestinal abnormalities patients who are in critical condition

Keywords: chronic obstructive pulmonary disease lung disease dysnea chronic airflow obstruction respiratory muscle training
the greek version of the chronic pain grade questionnaire (cpgq)

Conditions: Chronic Hip Pain

Summary: the aim of the present study is to investigate and report on the psychometric properties of a greek version of the chronic pain grade questionnaire (cpgq).

the chronic pain grade questionnaire (cpgq) is designed to evaluate overall severity of chronic pain based on two dimensions, pain intensity and pain-related disability. currently, there is no reliable, valid and sensitive to change self-report instrument as brief and easy to understand and complete as the cpgq available in greek. a culturally adapted version of the cpgq would facilitate the study of chronic pain and its implications in the greek population and allow for cross-cultural comparisons. the aim of the present study is to examine the validity, reliability and responsiveness of a greek version of the cpgq in chronic hip pain sufferers.

Eligibility criteria:
inclusion criteria: * chronic hip pain (persistent or recurrent hip pain for at least 12 weeks) exclusion criteria: * severe systemic disease that is a constant threat to life * known psychiatric disorder * impaired cognition or dementia * mother language other than greek

Keywords: questionnaire hip pain
identification of biomarkers for early detection of pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is examining blood samples from patients with cancer to identify biomarkers that may help in the early detection of pancreatic cancer.

objectives: * identify specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer. * analyze serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis. outline: blood from patients is collected prior to treatment. plasma proteins are analyzed by matrix-assisted laser desorption ionization time-of-flight mass spectrometry (maldi-tof/ms) and/or electrospray mass spectrometry (esi/ms). projected accrual: a total of 120 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of pancreatic cancer * newly diagnosed disease * planning to undergo surgery or other treatment for pancreatic cancer at karmanos cancer institute or its affiliates patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage i pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer
clinical trail of transtek glass body fat analyzer

Conditions: Weight; Body Fat Disorder; Bone Mass

Summary: the clinical protocol of the clinical testing of this device: 1. objective of the test: to verify the functions and efficiency of devices. 2. test methods and procedures: comparison test. 3. dut(device under test): transtek glass body fat analyzer, model: gbf-733-w1, gbf-1012, bf-1039, bf-1041-a, and gbf-950-d. 4. comparison device: transtek glass body analyzer, gbf-950 (predicate device). 5. study endpoints: transtek devices and the predicate device are substantial equivalence. 6. statistical methodology used: description of statistical methods. 7. result: efficiencies of transtek devices and predicate device are in the same level.

hospital information the data was collected by zhongshan city people's hospital clinical investigator team at zhongshan city people's hospital, no.2 sunwen dong road, zhongshan, guangdong 528403, p. r. china. investigator: dr. stephen feng, leader; fan futao, nurse a; wu yanting, nurse b. contact dr. james zhu tel: +86 760 88823818 used equipments dut (device under test): transtek glass body fat analyzer, model: gbf-733-w1, gbf-1012, bf-1039, bf-1041-a, and gbf-950-d. reference device: transtek glass body analyzer, gbf-950 (predicate device). test protocol 1. test purpose: the aim of clinical test is to collect weight, body fat, total body water, bone mass, and muscle mass reading value which measured by dut and reference device. note: gbf-733-w1 and bf-1039 have not bone mass functions. so it just collects weight, body fat, total body water, and muscle mass data. 2. target subject: the subject database shall contain at least 25 male and 25 female subjects and all above 18 years old. patient's population analysis is bellow. 3. test procedures 1) record the name, age, and gender values of each subject. 2) let subject seated calmly for two minutes before test, dry the feet. 3) use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value. 4) for each subject, repeat 3) to get 3 pairs measurements. 5) repeat step 1) to 4) for every device (dut: gbf-733-w1, gbf-1012, bf-1039, bf-1041-a, and gbf-950-d; and reference device: gbf-950). 6) repeat step 1) to 5) for each subject. 5. note: 1. no motion and speaking are allowed during the measurement. 2. all dut use the same algorithms, have the same number of electrodes and contact the patient at the same body locations (feet), and operate on the same frequency. 3. test environment: temperature: 22±1℃; relative humidity: 40\~50%.

Eligibility criteria:
inclusion criteria: * male,female exclusion criteria: * below 18 years old

Keywords: weight body fat total body water bone mass muscle mass
phase iia study of alln-346 (engineered urate oxidase) in subjects with hyperuricemia, gout and chronic kidney disease

Conditions: Hyperuricemia; Gout; Chronic Kidney Diseases

Summary: the purpose of this phase iia study is to evaluate the safety, tolerability and pharmacodynamics of alln-346 in subjects with hyperuricemia and gout, and with mild to moderate chronic kidney disease.

this is a randomized, double-blind, placebo-controlled parallel group, multi-center phase ii clinical study or orally administered alln-346 in subjects with hyperuricemia, gout and mild to moderate chronic kidney disease over a two-week period. subjects will be enrolled in two cohorts based on estimated glomerular filtration rate (egfr).

Eligibility criteria:
inclusion criteria: * male or female, age 18 to 70 years * serum ua level ≥ 8.0 mg/dl at screening (hyperuricemia) * meets 2015 american college of rheumatology (acr)/eular criteria for gout * screening egfr of ≥60 - \<90 ml/minute/1.73 m2 for cohort a and ≥30 - \<60 ml/minute/1.73 m2 for cohort b. * concomitant medications stable for a minimum of 4 weeks prior to and during screening * body mass index (bmi) ≥ 18 and ≤ 40 kg/m2, inclusive, at screening * not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation exclusion criteria: * currently taking any oral urate-lowering medication within 2 weeks prior to screening * prior uricase therapy or exposure to recombinant uricase, such as rasburicase or pegloticase * gout flare requiring treatment within 14 days prior to or during screening * clinically significant finding during screening, any ongoing clinically significant illness requiring a clinically significant intervention or change in management within 4 weeks prior to or during screening * history of gi surgery, including gastric sleeve, roux-en-y or gastric banding (unless gastric band removed for a minimum of 12 months prior to screening * received treatment with or exposure to an investigational drug or device within 30 days - prior to or during screening * prior dosing in alln-346 clinical study * per investigator judgment, is not an ideal clinical study candidate
a study to learn about the study medicine called rimegepant in adolescents with frequent migraine

Conditions: Migraine

Summary: the purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks. rimegepant is a tablet that dissolves when you put it on or under your tongue. the study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours in the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day. participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. this will help to determine if the study medicine is safe and effective. the 1st phase of the study will last 3 months. in the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. this 2nd phase of the study will last 1 year. this will help determine if the study medicine is safe when taken for a long period. those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). home health visits may occur as well. a health check and blood sample will be conducted at all visits. participants will have to complete a daily diary to record the migraine attacks.


Eligibility criteria:
inclusion criteria: * at least a 6 month history of migraine (with or without aura) * 15 or more headache days/month * 8 or more migraine days/month * migraine lasting 4-72 hours if untreated exclusion criteria: * unrelenting headache * current psychiatric condition uncontrolled or untreated * history of suicidal behavior or the subject is at risk of self-harm * history of alcohol abuse and/or illicit drug use * history of severe drug allergy * use of more than one medication for migraine prevention/prophylaxis * participation in another clinical trial at the same time

Keywords: chronic migraine adolescents rimegepant,
identification and preservation of arm lymphatics

Conditions: Breast Cancer Related Lymphedema

Summary: controversy in axillary reverse mapping in axillary lymph node dissection (alnd) possibly results from incomplete recognition of the arm lymphatic system (als) and its compromise to oncological safety. the identification and preservation of arm lymphatics (depart) technique facilitates complete identification of als; therefore, its use may decrease the occurrence of arm lymphedema. this study aimed to examine the arm lymphedema rate, locoregional recurrence, and feasibility to perform depart in alnd. in the study group, indocyanine green and methylene blue (mb) were utilized to identify arm sentinel nodes, and 0.1 ml mb was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive. arm lymphedema, local recurrence, regional recurrence, and distant metastasis were recorded at different follow-up examinations.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older with t1-3 invasive breast cancer; * clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast; * patients who underwent mastectomy with a positive sentinel lymph node (sln); * patients who underwent breast-conserving surgery containing more than two positive slns. exclusion criteria: * neoadjuvant chemotherapy; * previous history of breast cancer.

Keywords: breast cancer axillary lymph node dissection lymphedema
acceptability of hepatitis b vaccination in general population

Conditions: Hepatitis B

Summary: the present study is conducted in order to assess the acceptability of hepatitis b vaccination in french general population before and after reimbursement of the paediatric vaccine infanrixhexa. four measurements are planned, first before reimbursement and the others at year 1, 2 and 3 after reimbursement.

the present study aims to evaluate the changes in hepatitis b immunization coverage and the acceptability thereof among parents, in the general population. this is a national, prospective, epidemiological study, comprising four measurement time-points over a three-year period, (t1 in 2009, t2 in 2010, t3 in 2011, and t4 in 2012) in order to cover the period prior to the introduction of infanrixhexa® reimbursement, the transition period, and the period following reimbursement of the vaccine. the periods between each data collection time-point will be identical, lasting a year. two age groups will be investigated at each data collection time-point: 12-15 months and 24-27 months, thus providing measurements before/after reimbursement.

Eligibility criteria:
inclusion criteria: * infants aged 12 to 15 months or 24 to 27 months inclusive at the time of the study. * with a parent or legal representative agreeing to take part in the interview. * residing in metropolitan france. exclusion criteria: * refusal to take part. * infants having lived in another country in their first two years of life.

Keywords: vaccination acceptability general population hepatitis b vaccine coverage