Kornimate/medical-research-clean huggingface dataset:
compare immunogenicity & safety of 2 formulations of gsk biologicals' dtpa-hbv-ipv/hib vaccine given in healthy infants

Conditions: Diphtheria; Hepatitis B; Poliomyelitis; Tetanus; Acellular Pertussis

Summary: in this study, infants will be randomly allocated into three groups: * one group of subjects will receive dtpa-hbv-ipv/hib vaccine (new formulation) * the second group of subjects will receive dtpa-hbv-ipv/hib vaccine (current formulation) * the third group of subjects will receive dtpa-hbv-ipv vaccine the study will be double-blind for the two groups receiving the dtpa-hbv-ipv/hib vaccine (new or current formulation). the study will be single-blind for the group receiving dtpa-hbv-ipv vaccine.

a study to compare the immunogenicity \& safety of 2 formulations of glaxosmithkline (gsk) biologicals' dtpa-hbv-ipv/hib vaccine given in healthy infants at 3,4 \& 5 months age. the immunogenicity \& safety of dtpa-hbv-ipv vaccine will also be evaluated in a 3rd group of subjects subjects in the group that will receive dtpa-hbv-ipv/hib vaccine (current formulation) will be the control group for the group that will receive dtpa-hbv-ipv/hib vaccine (new formulation)

Eligibility criteria:
"inclusion criteria: * a healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination. * infant born to known hepatitis b surface antigen (hbsag) seronegative mother (documented laboratory result of hbsag assay from the maternal blood sample is available). * born after a normal gestation period (between 36 and 42 weeks). * written informed consent obtained from the parent or guardian of the subject. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * any chronic drug therapy to be continued during the study period. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose. * previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b and/or haemophilus influenzae diseases. * known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b and/or haemophilus influenzae diseases since birth. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. "
factors influencing occurrence of hilar biliary stricture in case of bile duct injury

Conditions: Bile Duct Injury

Summary: the bile duct injury is a complication that occurs mainly after the cholecystectomy. bile duct stricture is one of complications of this unwitting iatrogenic injury, the outcomes of surgery in this case are worse when the level of the stricture is above the helium. so what are factors influencing the occurrence of this high level bile duct obstruction ?

the objective of this study was to answer a simple question, what are the factors influencing the occurrence of high level -called hilar biliary stricture? to answer this question, a retrospective study was carried out on the files of patients operated for biliary stenosis after operative trauma of the bile ducts in our department over a period from january 2010 to may 2018. only patients operated in biliary stricture (grade e strasberg) was included. a univariate and muntivariate logistic regression analysis was performed to determine the factors influencing the occurrence of hilar stenosis. data entry and analysis was done using spss v20.0 software.

Eligibility criteria:
inclusion criteria: * all cases with biliary stricture following an operative bile duct injury. exclusion criteria: * cases of biliary stricture following an non operative bile duct injury (blind or penetrating abdominal trauma , radiological or endoscopic maneuvers). * cases of biliary stricture following hepatectomy

Keywords: bile duct injury surgery laparoscopy cholecystectomy bile duct stricture
management of metastatic colorectal cancer: a clinical and patient perspective

Conditions: Metastatic Colorectal Cancer

Summary: a real world evidence prospective cohort study in the management of metastatic colorectal cancer: a clinical and patient perspective


Eligibility criteria:
inclusion criteria: * age ≥ 18 * diagnosis of mcrc * having had two disease progressions since diagnosis of first metastasis that led to first systemic treatment. exclusion criteria: * currently participating in an investigational clinical trial (thus it does not apply to observational cohort studies) * currently being treated for other cancer(s) * not having mental capacity and/or ability to participate in the study

Keywords: real worl evidence
emtricitabine for naive chinese chronic hepatitis b patients

Conditions: Hepatitis B, Chronic

Summary: this study evaluates generic emtricitabine(ftc) in chinese naive chronic hepatitis b patients. patients were divided into 2 groups: hbeag positive chronic hepatitis b(chb)group and hbeag negative chronic hepatitis b(chb)group.

generic emtricitabine(ftc) has been approved for treatment of naive chronic hepatitis b(chb) patients in china. yet data are limited for this agent. the investigators design this trial to test the effect of ftc in chinese chb which including naive hbeag positive and negative chb patients. response guided therapy strategy is adopted for patients who can not achieve hbv dna negativity at week 24 ftc treatment, which means ftc and adefovir are combined for these patients.

Eligibility criteria:
inclusion criteria: * hbsag positive for more than 6 months * hbeag positive patients: hbv dna ≥ 5log10 copies/ml * hbeag postive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4 * hbeag negative patients: hbv dna ≥ 4log10 copies/ml * hbeag postive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4 * nucleoside/nucleotide naive paitents exclusion criteria: * diagnosed hcc with afp and ultrasound, ct or mri * creatine \>130μmol/l or ccr \< 70ml/min * hemoglobin \<100g/l * neutrophils \<1.5e+9/l * plt\<80e+9/l * coinfected with hav,hev,hcv,hdv or hiv * ana \> 1:100 * uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer * drug abuse or alcohal addiction * previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine * long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial * underwent liver transplantation or liver transplantation in schedule * allergic to nucleoside or nucleotide analogues * preganency or in breastfeeding

Keywords: hepatitis b, chronic emtricitabine adefovir dipivixil hbeag
patient educational video for pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: this is a single-blinded, randomized controlled trial investigating if a patient educational video on pelvic organ prolapse improves patient understanding of this pelvic floor disorder and satisfaction in their healthcare decision making for its management.

this is a randomized controlled trial. participants will be randomized either to watch a pre-visit educational video on pelvic organ prolapse (pop) in addition to routine physician counseling (intervention group) or routine physician counseling alone (control group). the counseling physician will be blinded. all participants will complete a pre-visit survey that includes the prolapse and incontinence knowledge - pop (pikq-pop) and a demographics questionnaire. the pikq-pop has been validated to assess for patient knowledge of pop. those randomized to the intervention group will take a brief survey after watching the video asking if they had any technical issues with the video and confirming they watched the video. at the end of all initial clinic visits, participants will complete a post-visit survey that includes the validated satisfaction with decision scale for pelvic floor disorders (sds-pfd) to assess the primary outcome of change in patient decision satisfaction. the sds is designed to assess satisfaction with a treatment decision. the sds was modified into the sds-pfd to be specific for women making decisions regarding surgical treatment for pelvic floor disorders. to assess the secondary outcomes of change in decision conflict and pop knowledge, the post-visit survey will also include a validated decision conflict scale (dcs) and the pikq-pop. the dcs was developed to evaluate the effect of health care decision aids and decision-supporting interventions on decision uncertainty. the physician will also complete a counseling survey at the end of the visit to assess their perception of patient comprehension and their ease of counseling. after undergoing their chosen management option, participants will also complete a post-management survey in follow up which will include the sds-pfd and pikq-pop.

Eligibility criteria:
inclusion criteria: * initial evaluation for symptomatic pop * age greater than or equal to 18 years old * reliable access to text or e-mail exclusion criteria: * pregnant women * presence of cognitive disability * non-english speaking patient or requiring interpreter assistance * women with a history of prior pelvic organ prolapse therapy, i.e. pelvic floor physical therapy, pessary, or surgical repair
effect of vocal exercise after botulinum toxin injection for spasmodic dysphonia

Conditions: Spasmodic Dysphonia; Dystonia

Summary: studies have suggested that voluntary muscle exercise in the hand and face after botulinum toxin injection may enhance the clinical effects of the toxin. exercise may speed up the absorption of the toxin by the nerves and enhance the clinical response. this study will explore the effect of exercise on botulinum toxin injections for spasmodic dysphonia (sd).

sd is a rare voice disorder that usually starts when individuals are in early adulthood and occurs in two common forms: adductor and abductor (aronson, 1968, brin et al., 1992, schweinfurth et al., 2002). adductor is the more common form (aronson, 1985, blitzer et al. 1998). with adductor sd, patients have been described as "trying to talk whilst being choked" (critchley, 1939). the spasmodic hyperadduction of the vocal folds is associated with strained-strangled, rough voice quality and sudden intermittent voice arrests (aminoff, dedo, \& izdebski, 1978, blitzer \& brin, 1992, hillel, 2001, izdebski 1992, ludlow, nauton, \& bassich, 1984, woodson, zwirner, murry, \& swenson, 1991). on the other hand, the intermittent or continuous abduction of the vocal folds linked with abductor sd results in breathy or whispered voice quality with sudden intermittent voice arrests (aronson, 1985, hillel, 2001, and zwitman, 1979). local injection of botulinum toxin is an effective treatment for spasmodic dysphonia and the national academies of otolaryngology and neurology has endorsed the toxin as the treatment of choice for adductor spasmodic dysphonia. consequently, this treatment is widely used. the clinical benefit of the botulinum toxin is related to muscle weakness in the vocal folds and the benefit lasts from 6 weeks to 6 months. studies have suggested that voluntary muscle exercise in the hand and face after botulinum toxin injection may enhance the clinical effects of the toxin (chen, scott, \& smith, 2002; chen et al., 1999; kim et. al 2003;. exercise may speed up the absorption of the toxin by the nerves and enhance the clinical response. you are invited to take part in a research study to learn more about the effect of exercise on botulinum toxin injections for spasmodic dysphonic. this project will examine whether or not exercise performed immediately following botulinum toxin injection affects the clinical benefit received from the injection.

Eligibility criteria:
inclusion criteria: 1. diagnosis of adductor spasmodic dysphonia 2. receiving ongoing botulinum toxin injections for a minimum of 1 year 3. improvement in voice to at least 70% following each of the last three injections exclusion criteria: 1. other neurological disorder 2. other dystonia 3. upper respiratory infection in the last two weeks 4. analgesia at time of injection 5. illiterate 6. under 18 years of age

Keywords: spasmodic dysphonia botulinum toxin vocal exercise
observational post-authorization studies carboplatin, paclitaxel and bevacizumab

Conditions: Nonsquamous Nonsmall Cell Neoplasm of Lung

Summary: this is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line therapy in patients with non-squamous advanced non-small cell lung cancer.

this is a observational study prospectively followed post-authorization.

Eligibility criteria:
inclusion criteria: 1. patients should sign inform consent before inclusion in the study that specifies that the clinical treatment entails consent for the analysis of biological samples of tumor and blood. 2. histologically confirmed diagnosis of advanced non small-cell lung carcinoma, non-squamous cell 3. patients age 18 years or more 4. patients will be candidates to received a first line of chemotherapy of carboplatin, paclitaxel and bevacizumab as the best therapeutic option. 5. evidence of measurable disease per response evalutation criteria in solid tumors (recist) 6. patients must be avalaible for clinical follow-up 7. patients with the following hematologic/biochemical values: * absolute neutrophil count anc \> 1500/µl. * platelets \> 100.000 /µl. * hemoglobine \> 10 g/dl. * bilirrubin \< 1.5 mg/dl. * aspartate aminotransfereasa (ast) and alanine transaminase (alt) ≤ 3 x lsn, except in case of hepatic metastases: upper 5 x lsn * creatinine clearance ≥ 45 ml/min. exclusion criteria: 1. previous treatment for advanced disease. chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neadjuvant treatment 2. history of haemoptysis (defined as at least half a teaspoon's emission of red blood) in the 3 months prior to inclusion 3. evidence by ct of tumor cavitations, or tumours invading or abutting major blood vessels 4. known or suspected brain metastases non-treated. 5. major surgery within 28 days of starting treatment. 6. minor surgery within 24 hours before starting the treatment. 7. non-controlled hypertension (systolic \> 150 mm hg and/or diastolic \> 100 mm hg). 8. patients with coronary disease or uncontrolled arrhytmia, uncontrolled cerebrovascular disease and other clinical conditions that, in judgment of the investigator, contraindicate the patient's participation in the study. 9. history or evidence of bleeding diathesis or hereditary coagulopathy. 10. contraindication or suspected allergy to the products under investigation in the study:: paclitaxel, carboplatine or bevacizumab. 11. patients who are pregnant or breasfeeding. women of childbearing potencial must have a negative pregnancy test performed within 7 days before the onset of treatment. 12. substance abuse of clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance

Keywords: first line treatment non small cell lung cancer, non squamous
spyglass ds peroral cholangioscope guided ll or ehl versus bml for endoscopic removal of complicated bile duct stones

Conditions: Biliary Stones

Summary: this study aims to compare the overall rate of endoscopic clearance of complicated bile duct stones by spyglass ds peroral cholangioscopy guided holmium:yag laser/electrohydraulic lithotripsy versus conventional bml.

currently, complicated bile duct stones are removed during endoscopic retrograde cholangiopancreatography (ercp) by conventional mechanical lithotripsy, which means using a metal wire basket to capture the stone and crush it to make it easier to remove. this is successful in approximately 70% of patients, with the success rate inversely correlated to the size of the stone. unsuccessful stone removal would require additional endoscopic, percutaneous or surgical interventions. spyglass ds peroral cholangioscope-guided holmium:yag laser/electrohydraulic lithotripsy is a recent alternate method for managing complicated bile duct stones. also performed during ercp, a thin flexible camera (called spyglass ds peroral cholangioscope) is inserted into the bile duct to visualize the stone which can then be targeted by a laser beam for fragmentation (also known as laser lithotripsy). the smaller pieces are then removed. direct comparisons of these procedures' efficacy however have not been performed. the purpose of this study is to compare the efficacy and safety of spyglass ds peroral cholangioscope-guided holmium:yag laser/electrohydraulic lithotripsy (the laser arm) versus conventional basket mechanical lithotripsy alone (the conventional arm) for fragmentation and clearance of complicated bile duct stones.

Eligibility criteria:
inclusion criteria: * patients with complicated biliary stones * patients older than 18 years old * patients where informed consent can be obtained exclusion criteria: * patients who cannot give informed consent * patients under 18 years old * pregnant or lactating patients * patient with altered gastrointestinal/biliary anatomy * patients with distal cbd malignant stricture from intrinsic or extrinsic causes * patients with ongoing cholangitis or biliary pancreatitis * patient with refractory bleeding tendencies (platelet count \ 1.5 despite correction with platelet or fresh frozen plasma transfusions) * patients with intrahepatic segmental stones * patients with contraindications to endoscopy due to comorbidities

Keywords: spyglass ds laser lithotripsy endoscopic retrograde cholangiopancreatography
changes of pelvic floor functions in women at different postpartum time

Conditions: Pelvic Floor Disorders

Summary: the main purpose of this study was to observe the pelvic floor muscle strength abnormalities of cesarean section and vaginal delivery at different time points within six months after delivery without any intervention. it was a prospective observational study, and the main study population was healthy postpartum women. regular follow-up was conducted at 6 weeks, 9 weeks, 3 months, 4 months, 5 months and 6 months postpartum. the follow-ups included gynecological examination, pelvic floor electrophysiological indexes (category i and ii muscle fiber strength and fatigue), questionnaire (ici- q-sf, oabss, udi-6), and pelvic floor ultrasound. the incidence of pelvic floor muscle strength abnormality at different postpartum time points was statistically analyzed, the high-risk factors of postpartum pelvic floor function abnormality caused by pregnancy and delivery were analyzed, and the general rules of the natural development of pelvic floor function were observed.


Eligibility criteria:
inclusion criteria: * 1)age: 20 \~35 years old; 2) first parturients registered in the obstetrics department of our hospital; 3) no medical complications before pregnancy, no ui and pop (according to the standard of pop-q stage); 4) no obstetric complications; 5) the patients agreed to conduct the study and signed the informed consent. exclusion criteria: * 1) patients with uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity shall be determined by the researcher to affect clinical research compliance; 2) follow up the patients with difficulty.
use of human dehydrated amnion chorion allograft in laryngectomy/pharyngectomy

Conditions: Larynx Cancer; Pharynx Cancer; Pharyngocutaneous Fistula

Summary: this trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.

this study is to determine if intra-operative use of amnio-fix improves post-operative patient healing outcomes after laryngectomy and/or pharyngectomy.

Eligibility criteria:
inclusion criteria: 1. subject is scheduled to undergo laryngectomy and/or pharyngectomy procedure due to oncological indication 2. subject is age 18 or older 3. subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study exclusion criteria: 1. subjects currently enrolled in or planning to enroll in another clinical trial 2. subjects with a known history of poor compliance with medical treatments 3. subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment 4. subjects that have any significant medical condition(s) that, in the opinion of the investigator, would interfere with protocol evaluation and participation 5. subject has undergone previous pharyngeal reconstructive surgery 6. pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study or are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
coca-cola's clinical effects on gastric phytobezoars

Conditions: Bezoars

Summary: consecutive patients suffering from gastric phytobezoars were divided into 3 groups (group 1, group 2 and group 3) according to the phytobezoars' formation time and each group was further subdivided into control and intervention group according to whether coca-cola was admitted. all patients in intervention group dieted coca-cola whereas patients in control group refused to drink coca-cola and had willing to receive the emergently gastric fragmentation.

consecutive patients were enrolled and were divided into group 1(the formation time of phytobezoars was less than 7 days), group 2(the formation time of phytobezoars was from 7 days to 14 days) and group 3 (the formation time of phytobezoars was more than 14 days) according to the formation time of phytobezoars and each group was subdivided into control group (who refused to diet coca-cola and chose emergent fragmentation with gastroscopy) and intervention group (who had a willing to diet coca-cola) from 1st jan, 2017 to 1st dec 2021. the current protocol was approved by the medical ethics committee of the affiliated hospital of qingdao university (qyfywzll 26293). the patients in intervention group all dieted coca-cola to treat gastric phytobezoars, 250ml-500ml/2 h till to sleeping time according to personal health conditions and life habits. pay more attention to the stools and assess if the bezoars had excreted. the coca-cola dieting period of intervention group 1 was 3 days, intervention group 2 was 5 days and intervention group 3 was 7 days. the patients would go through an endoscopy once the coca-cola dieting therapy was over. the patients who chose emergently endoscopic fragmentation was enrolled in control group. all patients endorsed the digital informed consent and bring the medical records before endoscopy. statistical analysis was performed with spss version 22(ibm, inc. armonk, ny, usa). anova or independent samples t-test was used for analysis of continuous variables. p \< 0.05 was taken as statistical meaning.

Eligibility criteria:
inclusion criteria: * diagnosed by abdominal ct or gastroscope; * years older than 12; * no contraindications; * have willingness to diet caco-cola to treat gastric bezoars; * choose the emergent endoscopy whose bezoar formation time are more than 2 weeks; exclusion criteria: * gastroscopy contraindications; * choose the emergent endoscopy whose bezoar formation time are shorter than 2 weeks; * years younger than 12 years;

Keywords: rct bezoars cola lithotripsy gastroscopy