Kornimate/medical-research-clean huggingface dataset:
a phase iii clinical trial of a haemophilus influenzae type b (hib) conjugate vaccine

Conditions: Haemophilus Influenza

Summary: haemophilus influenza type b (hib) remains a serious global health threat associated with high mortality and morbidity in young children. in china, the overall impact of hib-related infections and the extent of coverage of hib conjugate vaccines are unclear.generally, vaccination has been considered the most effective way to prevent infection against hib.in order to evaluate safety and immunogenicity of a haemophilus influenzae type b (hib) conjugate vaccine developped by chengdu olymvax biopharmaceuticals inc. a phase iii clinical trial is planned to conduct in healthy infants and children in china.

haemophilus influenza type b (hib) remains a serious global health threat associated with high mortality and morbidity in young children. in china, the overall impact of hib-related infections and the extent of coverage of hib conjugate vaccines are unclear.generally, vaccination has been considered the most effective way to prevent infection against hib.in order to evaluate safety and immunogenicity of a haemophilus influenzae type b (hib) conjugate vaccine developped by chengdu olymvax biopharmaceuticals inc. a randomized, positive-controlled, non-inferiority phase iii clinical trial is planned to conduct in healthy infants and children in china.

Eligibility criteria:
inclusion criteria: * healthy children aged 3-5 months/ 6-11 months/ 1-5 y for each age group * without vaccination history of hib conjugate vaccine * one of his/her guardians is able to understand and sign the informed consent * subjects' guardian can and will comply with the requirements of the protocol * subjects with temperature \<=37.0°c on axillary setting exclusion criteria: * subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease * subject who is allergic to any ingredient of the vaccines * subject with damaged or low immune function which has already been known * subject who had a hib disease medical history * subject with acute febrile illness or infectious disease * major congenital defects, developmental disorders or serious chronic illness * thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection * subject who has serious allergic history * subject with other medical history not suitable for vaccination such as difficulty for blood collection * any prior administration of immunodepressant or corticosteroids in last 6 months * any prior administration of blood products in last 3 months * any prior administration of other research medicine/vaccine in last 30 days * any prior administration of any attenuated live vaccine in last 14 days * any prior administration of subunit or inactivated vaccines in last 7 days, such as pneumococcal vaccine * any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or his/her guardian's signature on informed consent
detection and/or evaluation of dense breast abnormalities using tomosynthesis and digital mammography

Conditions: Breast Neoplasms; Breast Abnormalities

Summary: the purpose of this study is to compare 3d mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.


Eligibility criteria:
inclusion criteria: * females 30 years of age or older. * dense breasts. * has undergone clinical two view mammogram and diagnostic breast imaging evaluation. * suspicious or palpable mass and scheduled for biopsy. exclusion criteria: * pregnant or lactating women. * prior personal history of breast cancer. * prior breast augmentation with implants or silicon injection. male patients. * no two view mammogram as part of breast imaging evaluation. * breast density of almost entirely fatty/scattered fibroglandular densities.
bioactive restorative material in non-carious cervical lesions

Conditions: Cervical Lesion

Summary: evaluating the clinical performance of a bioactive restorative materiel (cention n) placed in non-carious cervical lesions (nccls) with no preparation and 1-step adhesive system or, with preparing a gingival retentive groove and no adhesive system.

cention n is a relatively new restorative material that is known to be the first commercially available bioactive resin composite. the manufacturing company recommends using cention n with 1-step adhesive system in non-retentive cavities, or with no adhesive system in retentive cavity preparations. this study was designed to evaluate the clinical performance of this material in non-carious cervical lesions by comparing it to rm-gic (fuji ii lc). information about oral and tooth brushing habits along with detailed information about the characteristics of each nccl, gingival status, and preoperative sensitivity will be collected for each patient.

Eligibility criteria:
inclusion criteria: * good general health * with at least 20 teeth under occlusion * should have three or more nccls which share the characteristics of being deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility exclusion criteria: * poor oral hygiene * severe periodontitis * severe bruxism habits * xerostomia

Keywords: non-carious cervical lesions (nccls) composite restorations bioactive restorative material (cention n) adhesive
impact of preventive and therapeutic zinc supplementation programs among young children

Conditions: Zinc Deficiency; Diarrhea; Malaria

Summary: zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency or in a higher dose for 10-14 days as part of the treatment of diarrhea. it is important to determine how best to integrate programs designed either to prevent zinc deficiency or to treat diarrhea. the overall objective of this project is to determine the most effective approach to prevent zinc deficiency and treat diarrhea, such that a single approach could provide the maximal beneficial impact on the health and nutritional status of young children and greatest simplicity of implementation.

this is a single-center cluster- and household-randomized, partially masked, community-based efficacy trial of zinc supplementation. the study sample consists of 5 study groups in one region, with 34 clusters randomly assigned to 3 types of intervention communities. communities will be randomly assigned to 1) early intervention communities, 2) later intervention communities, 3) non-intervention communities. within each intervention cluster, children will be randomly assigned to the intervention group at the household level. children aged 6-27 months at enrollment will be eligible. the study duration is 12 months. the investigators will assess the relative impact of daily preventive zinc supplementation (7 mg zinc/d for one year), intermittent preventive supplementation (10 mg zinc/d for 10 days every three months for one year), and zinc treatment during episodes of diarrhea (20 mg zinc/d for 10 days beginning with each episode of diarrhea during one year). outcomes that will be assessed include the incidence and duration of all episodes of diarrhea, the incidence of malaria, physical growth, and (in a sub-group) biochemical indicators of zinc, iron and vitamin a status.

Eligibility criteria:
inclusion criteria: * 6-27 months of age * plan to remain in study area for 1 year exclusion criteria: * evidence of congenital abnormalities and chronic infection * severe anemia and severe acute malnutrition * consumption of micronutrient supplementation including zinc

Keywords: zinc supplementation diarrhea management zinc deficiency malaria
process versus outcomes incentives for lipid management

Conditions: Diabetes; Cardiovascular Disease

Summary: in a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of cvd and who have elevated ldl cholesterol levels by testing process versus outcomes financial incentives. participants will use electronic pill bottles that continuously monitor statin adherence. the primary outcome will be change in ldl cholesterol over 12 months.


Eligibility criteria:
inclusion criteria: * individuals at high risk of a cardiac event, specifically one of the following: * individuals with clinical ascvd (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an ldl greater than or equal to 100 mg/dl ; * individuals with diabetes (between the ages of 40-75) with an ldl greater than or equal to 100 mg/dl; * individuals without clinical ascvd or diabetes with ldlc with an ldl greater than or equal to 100 mg/dl and estimated 10-year ascvd risk 7.5%; * individuals without clinical ascvd or diabetes with ldl cholesterol 190 mg/dl * a prescription filled for a statin medication within the last 12 months (derived from pharmacy records); * low medication adherence on self-report completed during enrollment exclusion criteria: * under 18 years old * a contraindication to further statin use or have suffered statin side effects, such as myopathy * will not or cannot give consent * a history of active or progressive liver disease * participating in another clinical trial with related aims * co-morbidities likely to lead to death within a short period (e.g. metastatic cancer)
obstetric and perinatal outcomes of women with covid-19

Conditions: Pregnant Women

Summary: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) is currently spreading rapidly around the globe, causing a major public health issue. there is currently very few data about the impact of covid-19 on pregnancy, and potential in utero infection. this is a prospective observational study of covid-19 diagnosed pregnant patients. this objective is to examine the impact of covid-19 during pregnancy on the rates of obstetric and perinatal complications.

clinical manifestations of covid-19 can range from a benign upper respiratory tract infection to severe acute respiratory distress syndrome (ards), fatal in 1% of cases. however, pregnant women and their fetuses could particularly be vulnerable to the infection, as shown by previous human coronavirus outbreaks (sars-cov and mers-cov). cases will be recruited among all pregnant women aged \>18 years old who have tested positive for covid-19 and are followed in a maternity belonging to the french south regional perinatology network. voluntary physicians will refer eligible participants to the study-coordinating center at aphm university hospital. the participants will be followed by phone after having provided an informed consent. clinical symptoms, laboratory and imaging findings, maternal and perinatal outcomes will be recorded.

Eligibility criteria:
inclusion criteria: * pregnant women * able to give informed consent * diagnosed with covid-19 exclusion criteria: * patients refusing to participate in the study * patients who do not speak french well enough to benefit from clear and intelligible information
biological standardization of allergen extracts of pollens of betula pendula, phleum pratense and mite extract of dermatophagoides pteronyssinus

Conditions: Allergy

Summary: allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. many factors such as the biovariability, differences in extraction process and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. genetic diversity of affected people adds another level of complexity. in order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. therefore, the system for biological standardization mainly used in europe still is the biological calibration of in-house reference preparations (ihrp). the method has been adopted by the nordic council on medicines as the nordic biological unit, histamine equivalent potency (hep) or skin prick test (spt) value. the aim of this procedure is to estimate the biological activity of allergen extracts. the activity of an allergen extract is defined as 10,000 diagnostic biological units (dbu) per ml (1 spt per ml), when the extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned. the present study aims to standardize the allergen extracts of betula pendula, phleum pratense and dermatophagoides pteronyssinus by using this method. * trial with medicinal product


Eligibility criteria:
inclusion criteria: * positive clinical history with inhalant allergy to at least one of the allergen to be standardized. * at least one positive prick test (mean wheal diameter = 3mm) when tested with already standardized extracts of the allergens under investigation. * positive prick test (wheal diameter =3 mm) to histamine 10 mg/ml * age: 18-60 years * written informed consent exclusion criteria: * diseases or medications, influencing the skin tests or that contradict the correct conduct and evaluation of the study. * pregnancy, skin irritations, drug and alcohol abuse and participation in another clinical trial within the last 30 days
methacholine challenge test (mct) in healthy adults

Conditions: Hyperreactive Airway Disease

Summary: knowledge of methacholine challenge test (mct) and impedance oscillometry (ios) is limited. only three studies have included adult patients, and none of these with healthy controls. the three studies have combined ios and spirometry in the same test, although it is not recommended to perform ios after a test that requires deep breathing, e.g. fev1 measurement. deep breathing is considered to affect the impedance via reduced tone in the smooth muscle.

asthma is a common chronic disease that is characterized by a history of variable respiratory symptoms and variable expiratory airflow limitation, and usually associated with airway hyperresponsiveness. in general, fev1 is used to test for airway hyperresponsiveness (ahr), and a 20% decrease after methacholine challenge test (mct) is considered a positive test. there is increasing recognition that the small airways are involved in 40-80% of patients with asthma, and the function of these airways is overlooked (the "silent zone") when measuring fev1, which mainly reflects the function of the central airways. small airway dysfunction (sad) can be assessed by ios where pressure applied to the airways at a range of frequencies, and components of respiratory resistance and reactance are measured. resistance at 5 hz (r5) and 20 hz (r20), respectively, represent total airway resistance and proximal airway resistance. the difference between these two values can be calculated (r5-r20). high r5-r20 and low reactance at 5 hz (x5) indicate the presence of sad. knowledge of mct and ios is limited. only three studies have included adult patients, and none of these with healthy controls. these studies have combined ios and spirometry in the same test, although it is not recommended to perform ios after a test that requires deep breathing, e.g. fev1 measurement. deep breathing is considered to affect the impedance via reduced tone in the smooth muscle. the investigators have the following objectives for these studies: 1. to determine the ios response to mct in healthy adults. 2. to investigate whether spirometry (fev1) carried out in relation to mct influences ios by comparing the ios response to mct performed with and without spirometry in healthy adults.

Eligibility criteria:
inclusion criteria: * forced expiratory volume in the 1. second (fev1) \>80% * fev1/fvc-ratio \>0,7 * feno \<25 pbb * oxygen saturation (sato2) \>95% * negative methacholine challenge test = drop in fev1 less than 20% exclusion criteria: * any lung disease * lung symptoms * medicine for lung disease * tobacco smoking * ex-smokers with more than 5 package years * bmi (body mass index) \>40 kg/m2

Keywords: ios oscillometry spirometry bronchial hyperreactivity
repair of inguinal hernia

Conditions: Inguinal Hernia

Summary: the aim of this study is to compare the outcomes of open versus laparoscopic approaches for inguinal hernia surgery and provide evidence-based guidance to the selection of the most appropriate operative technique.


Eligibility criteria:
inclusion criteria: male patient \> 18 years of age • primary groin hernias requiring surgical intervention that are eligible for both open and laparoscopic repair. exclusion criteria: * emergency procedures . * asa score \> 2. * irreducible inguinoscrotal hernia . * local or systemic infection . * other abdominal hernias being operated at the same time or planned operated during follow up. previous surgery which has impaired the sensation in the groin area . * bmi \> 40 kg/m2. * known disease which impairs central or peripheral nerve function . * concurrent malignant disease . * chronic pain which requires daily medication . • mental disorder which requires daily medication .
nonmyeloablative stem cell transplant in elderly

Conditions: Hematological Malignancies

Summary: the study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of fludarabine and total body irradiation in patients older than 60 years of age

a total of 35 patients with hematological malignancies were treated with fludarabine (30 mg/m2 x 3-5 days) and 200 ccy tbi followed by allogeneic hematopoietic stem cell transplantation (hsct) from a matched-sibling donor. neutrophil recovery occurred in 89% of the patients at a median time of 15 days. on day +30, 10 patients had \> 95% donor chimerism, and 21 patients had mixed chimerism. the cumulative probabilities of grade ii-iv acute gvhd and chronic gvhd were 51% and 84% respectively. transplant-related mortality at 100 days and 1 year was 5% and 9% respectively. the probabilities of 1-year overall (os) and progression-free survival (pfs) were 55% and 47% respectively. the estimated 1-year probability of os and pfs for patients in early disease stages were 87% and 74% respectively , which were significantly higher than the survival and pfs estimates of 12% obtained in patients with advanced disease stages at the time of transplant

Eligibility criteria:
inclusion criteria: * patients with myeloid or lymphoid malignancy who were \> 60 years old potentially treatable with stem cell transplant exclusion criteria: * lack of an hla-identical sibling donor
study of nab-paclitaxel (abraxane®) treatment in patients with metastatic breast cancer in routine clinical practice

Conditions: Breast Neoplasms

Summary: this is a national, multicenter, retrospective, observational post-authorization study (epa-od) study. the study will be conducted by reviewing the medical records of patients up to the start of the study. in each case, only data from before the start of the study will be obtained in order to ensure they are retrospective in nature, thus reflecting the regular use of nab-paclitaxel in clinical practice and avoiding interference with the physician's clinical practice. to ensure the observational nature of this study, these data will be collected whenever they are available in the patient's medical record, and so no diagnostic or therapeutic intervention outside regular clinical practice will be used.

this is a national, multicenter, retrospective, observational post-authorization study (epa-od) study. investigators will include all consecutive adult patients diagnosed with her2-negative mbc who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014). these patients must meet all the inclusion criteria and none of the exclusion criteria established in this protocol. the primary objective is to describe the effectiveness of nab-paclitaxel in terms of response in early lines of chemotherapy for metastatic breast cancer in routine clinical practice. this study plans to collect data retrospectively, provided they are available in the patient's medical record and according to routine clinical practice.

Eligibility criteria:
inclusion criteria: * women ≥18 years of age. * confirmed diagnosis of mbc (stage iv). * breast adenocarcinoma confirmed histologically. * her2-negative according to the american society of clinical oncology (asco) and anatomical pathology (cap) criteria for the detection of her2 in breast cancer. * patients who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease in her2-negative breast cancer during the period 2012-2014 (3 years) and who have received at least one cycle of treatment. * ability to give informed consent, preferably in writing or orally in front of a witness, before the start of data collection (if it is able to be given). exclusion criteria: * patients with any medical or psychological disorder which in the investigator's opinion might compromise the ability of the patient to give their informed consent. * patients who have received treatment with nab-paclitaxel combined with other chemotherapy agents or anti-angiogenic drugs or tumor-targeting drugs with anti-tumor activity. * patients who have taken part in any clinical trial (interventional) during the study period.

Keywords: breast cancer metastatic breast cancer nab-paclitaxel abraxane observational retrospective amber
prospective trial for examining hematuria using computed tomography

Conditions: Urothelial Carcinoma; Renal Cell Carcinoma; Renal Cyst; Renal Stone

Summary: the primary objective is to evaluate whether one-phase nephrographic ct (experimental) is sufficient to detect urothelial cell carcinoma in patients with hematuria compared to the traditional four-phase ct (control).

responsible centers oslo university hospital, aker. division of radiology and nuclear medicine. study type: prospective clinical trial study design: one sample paired proportion, non-inferiority study with a 7.5% non-inferiority limit. investigational product: one phase nephrographic ct (experimental arm) vs. four-phase ct (control arm) objective:the primary objective is to evaluate whether one-phase nephrographic ct (experimental) is sufficient to detect urothelial cell carcinoma in patients with asymptomatic macroscopic hematuria compared to the traditional four-phase ct (control). primary endpoints: the difference in accuracy between the experimental- and control arm. there will also be a secondary reading in order to asses interobserver variability for both the experimental and the control arm sample size: 250 patients

Eligibility criteria:
inclusion criteria: * asymptomatic macroscopic hematuria referred to ctu before cystoscopy * \>18 years old exclusion criteria: * symptomatic urinary tract infection relieved by antibiotics * patients referred to ctu after cystoscopy * cystoscopy within the last 6 months * symptomatic stone disease * macroscopic hematuria after recent catherization or instrumentation * microscopic hematuria * previous history of urothelial cell carcinoma * known staghorn calculi * allergy to iodine contrast media * impaired renal function (egfr \< 30m/min/1.73m2) * unable to provide consent for any reason * for any reason, do not wish to participate in the study