Kornimate/medical-research-clean huggingface dataset:
safety and reactogenicity of glaxosmithkline (gsk) biologicals' ipv vaccine (poliorixtm) in toddlers

Conditions: Poliomyelitis

Summary: the study will evaluate the safety and reactogenicity of poliorixtm given as a single booster dose to chinese children at 18-24 months of age.


Eligibility criteria:
inclusion criteria: * a male or female toddler between, and including, 18 and 24 months of age at the time of the booster vaccination. * subjects who received three doses of opv as primary vaccination in the first year of life as per chinese recommendations. * subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study. * written informed consent obtained from the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster 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 booster vaccination * administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of dtp and/or hib vaccine(s). * administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination, or planned administration during the study period. * 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 * previous booster vaccination against poliomyelitis since the end of the primary vaccination series. * history of poliomyelitis disease. * history of seizures or progressive neurological disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * major congenital defects or serious chronic illness. the following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met: • current febrile illness or axillary temperature \> 37.0 ºc or other moderate to severe illness within 24 hours of study vaccine administration.

Keywords: poliomyelitis vaccines ipv
imaging the pathogenesis of cerebral small vessel disease

Conditions: Ischemic Stroke; Hypertension; Hyperlipidemias; Diabetes

Summary: cerebral small vessel disease (csvd) can lead to vascular cognitive impairment and dementia (vcid). the hallmark of csvd is the appearance and progression of white matter hyperintensities (wmh) on mri. the goal of this study it to recruit and follow individuals at risk for wmh progression and use serial mri scanning to gain insights into the pathogenesis of csvd.

vascular cognitive impairment and dementia (vcid) which is attributed in large part to cerebral small vessel disease (csvd) is prevalent in patients with a history of stroke and vascular risk factors. the hallmark of csvd is white matter hyperintensities (wmh) seen on t2-weighted mri. the initial amount, and rate of progression, of wmh is tied closely with the development and progression cognitive deficits. it is hypothesized that one of the early pathologic features in the normal appearing white matter (nawm), before it progresses to wmh is disruption of the blood-brain barrier (bbb) and loss of micro-structural integrity. the purpose of this study is track the progression of wmh using multiple mri biomarkers looking at bbb disruption (dce, dsc, asl), micro-structural changes (multi-shell dti), and macrostructural changes (flair, swi, t1) to better understand the pathogenesis of csvd. patients with a history of a stroke, at least one vascular risk factor, and evidence of csvd on mri may be eligible for this study. we will follow 50 patients with 3 mris performed over 1.25 years

Eligibility criteria:
inclusion criteria: * clinical or radiographic evidence of ischemic stroke * one vascular risk factor (hypertension, hyperlipidemia, or diabetes) * evidence of cerebral small vessel disease on mri exclusion criteria: * inability to complete 3 research mri scans over 1.25 years

Keywords: cerebral small vessel disease vascular cognitive impairment and dementia white matter hyperintensities blood-brain barrier vascular risk factors ischemic stroke
national clinical and biological sarcoma database : an initiative of the french sarcoma group

Conditions: Sarcoma

Summary: the bcb sarcomes database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (french expert network dedicated to the management of bone sarcomas \[resos\] / french expert network dedicated to the pathology of sarcomas \[rreps\]), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (resos / french expert clinical network for sarcomas \[netsarc\]), collecting multidisciplinary tumor boards (mdtb) data of patients nationwide, and the third (conticabase / bone / gist) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples. primary objectives of bcb-sarcomes are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients' outcomes. with the financial support of the french national cancer institute \[institut national du cancer \[inca\]).


Eligibility criteria:
inclusion criteria: * sarcoma exclusion criteria: -

Keywords: patterns of care access to care survival experts' network
study on the correlation and consistency of measuring biologic drug plasma concentrations based on different detection methods

Conditions: Inflammatory Bowel Diseases

Summary: in recent years, biologics (such as infliximab, adalimumab, vedolizumab, and ustekinumab) have shown great potential in the treatment of inflammatory bowel disease (ibd), transforming the traditional treatment model for ibd. despite achieving good efficacy, some patients do not respond to biologics, which may be related to low drug concentrations in the blood. guidelines recommend therapeutic drug monitoring (tdm) during the treatment of ibd. currently, many commercial testing methods are available to detect the trough levels of biologics; however, data on the diagnostic accuracy and practicality of these methods remain limited. this study compares the detection of blood samples from ibd patients after administration using elisa, pica, and clia methods, aiming to provide more accurate guidance and evidence for tdm in chinese ibd patients undergoing biologic therapy.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older; diagnosed with inflammatory bowel disease according to the 2019 european ecco-esgar guidelines; who have not previously received any biologic therapy or, based on the treating physician's judgment, require treatment with infliximab (ifx), adalimumab (ada), vedolizumab (vdz), or ustekinumab (ust) . exclusion criteria: * patients who refuse treatment with infliximab, adalimumab, vedolizumab, or ustekinumab for various reasons, or those with contraindications; patients currently using antibiotics or who have been in contact with probiotics/antibiotics in the past month; those with concomitant active autoimmune diseases, active tumors, etc.; those with severe oral diseases; patients experiencing other diseases unrelated to inflammatory bowel disease during treatment but may affect the efficacy of inflammatory bowel disease treatment; pregnant or lactating women; those deemed unsuitable for participation in this study by the investigator's judgment.
immuno-effect of tα1 for stage i nsclc

Conditions: Non Small Cell Lung Cancer

Summary: to explore the effect of thymosin alpha 1 (tα1) on postoperative peripheral blood circulating tumor cells and immunosenescence in patients with early-stage non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * pathologically confirmed stage i (per ajcc 8th edition) invasive nsclc * resectable tumor * undergoing lobectomy and systemic lymph node dessection * without a previous history of malignant tumors or other concurrent malignancies * naïve to any anticancer therapies or other immunostimulatory agents * eastern cooperative oncology group (ecog) performance status (ps) score 0-1, with cardiac, pulmonary, hepatic, cerebral, and renal functions capable of withstanding surgery * aged ≥18 years and ≤75 years * having signed written informed consent and capable of adhering to the visit schedule and related procedures outlined in the study protocol exclusion criteria: * with a pathologically confirmed non-invasive nsclc, including preinvasive lesions, small cell lung cancer, and benign lesions * post-diagnostic use of immunosuppressive medications or other immunostimulatory agents * with known or suspected active autoimmune disease * allergic to thymopeptides * with other uncontrolled serious illnesses or having acute or chronic conditions that may confound test outcomes, including active severe clinical infections ( \&gt;nci-ctcae grade 2 infection); diagnosed with epilepsy requiring antiepileptic treatment; on renal dialysis; with non-healing wounds, ulcers, or fractures; with a history of arteriovenous thrombotic events, including cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, within six months prior to the first dose

Keywords: nsclc thymosin alpha1 ctc immunosenescence
using hiv risk assessment tool to promote hiv testing among men who have sex with men

Conditions: HIV/AIDS; HIV Infections; Social Media

Summary: the objective of the study is to evaluate the effectiveness of a hiv risk assessment tool to promote hiv testing and to reduce high risk sexual behaviors among men who have sex with men (msm). it hypothesizes that the social media-based hiv risk assessment tool can increase 20% hiv testing proportion during the six months follow-up period.


Eligibility criteria:
inclusion criteria: * male at birth. * having had homo-sexual behaviors (anal/oral) in the past 6 months before enrollment. * an age of 18 years or older. * living in beijing, china. * self-reporting hiv negative or unknown. * willingly participating into the baseline survey and the six months follow ups. * agreeing not to share the research link to others. * owning a mobile phone and having had downloaded the social networking application blued before enrollment. exclusion criteria: * not accepting blood sampling within the study period. * reporting injecting drugs use in the past six months before enrollment. * being currently involved in other hiv behavioral interventions for msm. * having a specific plan to leave from beijing in the next 6 months. * self-reporting female. * other reasons the investigators deem make participation either detrimental to the participants or the study.

Keywords: hiv risk assessment hiv testing unprotected anal intercourse social medica
bioburden and usability evaluation of a nasal prototype cpap mask

Conditions: Obstructive Sleep Apnea

Summary: aim and hypothesis: the purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system. the mask system will be assessed according to objective data recordings and user questionnaires. it is hypothesised that the prototype mask components will not pose a health risk (with regards to bioburden and impedance) and that the mask system will pass usability objectives to adequately deliver cpap treatment.


Eligibility criteria:
inclusion criteria: * participants willing to give written informed consent * participants who can read and comprehend written and spoken english * participants who are over 18 years of age * participants who have been diagnosed with osa * participants who have been established on cpap for ≥ 6 months * participants currently using a resmed nasal pillows mask exclusion criteria: * participants who are not able to provide written informed consent * participants who are unable to comprehend written and spoken english * participants who are pregnant * participants who are unsuitable to participate in the study in the opinion of the researcher * participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. copd, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection, lung injury) * participants who cannot participate for the duration of the trial * participants who are established on bi-level support therapy * participants who are not established on a resmed nasal pillows mask

Keywords: sleep sleep apnea osa cpap
relative bioavailability study of naproxen delayed-release tablets (375 mg)

Conditions: Rheumatoid Arthritis; Osteoarthritis

Summary: the purpose of this study is to demonstrate the relative bioavailability of naproxen delayed-release tablets (375 mg).


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
tap and ims for hipec

Conditions: Cytoreductive Surgery

Summary: it is important to decrease the postoperative pain in patients undergoing cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy. we will compare the transversus abdominis plane block with the transversus abdominis plane block plus intramuscular electrical stimulation in patients undergoing cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy.


Eligibility criteria:
inclusion criteria: -patients who are able to do daily activity and walk independently. exclusion criteria: 1. patients with history of preoperative abdominal surgery 2. patients who are unable to walk independently due to musculoskeletal disorder 3. patients who are allergic to local anesthetics 4. patients with chronic pain 5. patients with pacemaker 6. patients with endotracheal tube postoperatively 7. patients with history of substance abuse 8. pregnancy 9. patients who are unable to communicate due to mental disorder

Keywords: hyperthermic intra-peritoneal chemotherapy
reduction of prostate biopsy morbidity

Conditions: Prostate Cancer

Summary: prostate biopsy is typically performed via either the transrectal or transperineal approach. this study is a case-control study being done to determine if a novel prostate biopsy protocol incorporating a transperineal approach, rectal swab to detect resistant bacteria and broad antibiotic prophylaxis will reduce infectious complications and hospital readmission compared to current biopsy practices.

this will be a prospective multi-center cohort case-control study comparing a novel transperineal prostate biopsy protocol integrating measures to reduce post procedural infection (cases) to traditional transrectal prostate biopsies (controls). eligible subjects will be identified through administrative records in the urology clinics affiliated with maimonides medical center. eligible patients will be counseled about the risks and benefits of participation and offered enrollment into the study. demographic data including age, comorbidities and past medical history will be extracted from the medical record. men meeting inclusion/exclusion criteria will be prospectively enrolled. the novel transperineal protocol will include the following: (cases) 1. transperineal biopsy approach with avoidance of rectal flora 2. mri-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated 3. rectal swab to identify the presence of fluoroquinolone resistant (fqr) bacteria 4. multi-antibiotic prophylaxis 5. urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns. traditional biopsy protocol includes: (controls) 1. transrectal approach 2. standard 12-core template 3. surgeon-specific antibiotic prophylaxis 4. urine culture, prostate tissue culture and fqr rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

Eligibility criteria:
inclusion criteria: * male patients greater than 18 years of age * indication for prostate biopsy exclusion criteria: * female patients * male patients under 18 years of age * no indication for prostate biopsy
study to evaluate the efficacy and safety profile of ecohair in chemo-induced alopecia.

Conditions: Chemotherapy-induced Alopecia

Summary: this is a phase 2, single-center study designed to determine the effect of ecohair topical solution on scalp hair growth evaluated objectively ( images) and subjectively ( patient and investigator reports). a total of 22 subjects are planned to be enrolled, 15 in a prospective single-arm phase in which they will receive the study treatment and 7 controls. patients should have a clinical diagnosis of chemotherapy-induced alopecia.


Eligibility criteria:
inclusion criteria: * women diagnosed with stage i to iii breast/ovarian cancer aged 18 to 65 years. * receiving chemotherapeutic agents containing taxanes and/or anthracyclines. * willing to agree to shave thinning hair at baseline. * willingness to be photographed and consent to photographic disclosure. * able to understand and willing to sign an informed consent form. * willing and able to follow all study instructions and attend all study visits. * subjects taking thyroid replacement medication must be on stable doses for 6 months prior to enrollment and remain on the same maintenance dose throughout the study. * if female of childbearing age, must have a negative serum or urine pregnancy test at screnning (visit 0). use a highly effective method of contraception during the study; do not plan a pregnancy for the duration of the study. exclusion criteria: * use of any products or devices used to promote scalp hair growth (e.g., finasteride or minoxidil, l-tyrosine, cold caps). * sensitivity or allergy to any ingredient in the ecohair product. * active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or history of skin disease on the scalp that, in the opinion of the investigator, may interfere with the efficacy or safety evaluations of the study. * active scalp trauma or other condition affecting the scalp that, in the opinion of the investigator may interfere with the conduct of the study or evaluations. * the presence of a permanent or difficult to remove hairpiece or wig that, in the opinion of the investigator, will interfere with study evaluations if not removed at each visit. * failure to be able to perform assigned clinical visits.
ec-motion : extracorporeal membrane oxygenation and therapeutic drug monitoring of drugs of infection

Conditions: Infection

Summary: the objective of the study is to investigate the exposure difference between antibiotic studied patients in intensive care with extracorporeal membrane oxygenation and patients without extracorporeal membrane oxygenation. the exhibition is evaluated by population pharmacokinetic modeling.


Eligibility criteria:
inclusion criteria: * age over 18 years * hospitalisation in intensive care * treatment with ecmo or without ecmo * introducing sepsis treated with an anti-infective molecule studied (piperacillin) for less than 48 hours * with an arterial catheter * patient information or their next of kin according to the patients status. exclusion criteria: * pregnancy * major person under legal protection (backup justice, trusteeship, quardianship), person deprived of liberty

Keywords: extracorporeal membrane oxygenation patient in intensive care pharmacokinetic modeling
combination of metronomic capecitabine with camrelizumab for treatment of refractory solid tumor trial (cohort 1)

Conditions: Advanced Cervical Cancer

Summary: this is a single center phase 1 trail to observe safety and efficacy of metronomic capecitabine plus pd-l1 antibody camrelizumab as third-line regimen to treat her2 negative advanced gastric cancer patients. this study is one of the cohorts of a multi-cohort trial called combination of metronomic capecitabine with camrelizumab for treatment of refractory solid tumor (mccrest) trial.

her2 negative advanced gastric cancer patients who have disease progression after two standard regimens will be treated by metronomic capecitabine plus camrelizumab. metronomic capecitabine will be given as fixed dose (500mg bid) orally. camrelizumab will be given two-weekly (200mg once) intravenously. this regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Eligibility criteria:
inclusion criteria: 1. male/female patients aged≥18 years. 2. histologically confirmed gastric or gastric esophageal junction adenocarcinoma, without uncontrolled pleural effusion or ascites. 3. patients with advanced or metastatic disease who have disease progression after two standard regimens, with measurable or unmeasurable lesions. 4. her2 negative, mss or pmmr. 5. ecog performance status 0 or 2, expected lifetime≥3 months. 6. adequate organ function: absolute neutrophil count (anc) ≥1.5x109/l, white blood count ≥3.5x109/l, platelets ≥75x109/l, hemoglobin (hb) ≥70g/l, alt/ast ≤2.5x uln (for patient with liver metastasis alt/ast ≤5x uln), serum bilirubin ≤1.5x uln, serum creatinine ≤1.5x uln. 7. hbv infected patients (inactive/asymptomatic carrier, chronic or active) with hbv dna\<500iu/ml (or 2500 copies/ml). 8. pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. patients should keep contraception during treatment. 9. willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form. exclusion criteria: 1. pregnancy or children bearing potential. 2. brain or meningeal metastasis. 3. with second primary malignant diseases. 4. with uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone). 5. with uncontrollable complications 6. inadequate organ function 7. conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction). 8. known hypersensitivity reaction to any of the study drugs or components. 9. other unsuitable conditions determined by investigators.