Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy of a heterologous prime/boost vaccine regimen of ad26.mos4.hiv and aluminum phosphate-adjuvanted clade c gp140 in preventing human immunodeficiency virus (hiv) -1 infection in women in sub-saharan africa

Conditions: HIV-1

Summary: the primary purpose of this study is to assess the preventive vaccine efficacy (ve), safety and tolerability of a heterologous prime/boost regimen utilizing ad26.mos4.hiv and aluminum-phosphate adjuvanted clade c gp 140 for the prevention of human immuno virus (hiv) infection in hiv-seronegative women residing in sub-saharan africa from confirmed hiv-1 infections diagnosed between the month 7 and month 24 visits.


Eligibility criteria:
inclusion criteria: * sexually active, defined as having had sexual intercourse with a male partner at least twice in the past 30 days prior to screening, and is considered by the site staff to be at risk for human immunodeficiency virus (hiv) infection * access to a participating hiv vaccine trials network (hvtn) clinical research sites (crs) and willingness to be followed for the planned duration of the study * willingness to discuss hiv infection risks and willing to receive hiv risk reduction counseling and appropriate referrals to minimize hiv acquisition, as applicable * negative beta human chorionic gonadotropin (beta-hcg) pregnancy test performed prior to vaccination on the day of initial vaccination. persons who are not of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing * participants must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until 3 months after the last vaccination exclusion criteria: * investigational research agents received within 30 days before first vaccination * hiv vaccine(s) received in a prior hiv vaccine trial. for volunteers who have received control/placebo in an hiv vaccine trial, the hvtn 705/hpx2008 (protocol safety review team) psrt will determine eligibility on a case-by-case basis * live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (example: measles, mumps, and rubella \[mmr\]; oral polio vaccine \[opv\]; varicella; yellow fever) * any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (example, tetanus, pneumococcal, hepatitis a or b) * immunosuppressive medications received within 6 months before first vaccination
pilot medical evaluation of the t50 test

Conditions: Renal Failure; Cardiovascular Diseases; Vascular Calcification

Summary: this pilot study aims to evaluate in an exploratory way the predictive power of a novel in vitro test (t50 calcification inhibition test, t50 cit), which measures the mineralization inhibition capacity of blood, in terms of its association with time to all-cause mortality in haemodialysis patients.

disturbances in mineral and bone metabolism centrally contribute to the exceedingly elevated risk for cardiovascular (cv) disease in dialysis patients. a novel in vitro test (t50 calcification inhibition test, t50 cit) has been developed, which measures the mineralization inhibition capacity of blood. this pilot study aims to exploratory examine the predictive power of baseline t50 cit and fetuin-a (protein which is centrally involved in the inhibition of the formation of crystalline hydroxyapatite) values in terms of their association with all-cause mortality in an unselected cohort of haemodialysis patients. moreover, the study shall investigate the association between baseline t50 cit and fetuin-a values with cv related mortality, all-cause hospitalization and cv related hospitalization. finally, the study aims to compare the predictive power of t50 cit values with a set of six established calcification-related parameters (albumin, phosphate, calcium, magnesium, bicarbonate and fetuin-a). after baseline blood sampling the patients will be followed for 2 years.

Eligibility criteria:
inclusion criteria: * informed consent signed and dated by study patient and investigator/authorised physician * minimum age of 18 years * incident and prevalent haemodialysis patients * three haemodialysis treatments per week exclusion criteria: * any condition which could interfere with the patient's ability to comply with the study * pregnancy (pregnancy test will be conducted with female patients aged \<= 55 years) or lactation period * participation in an interventional clinical study during the preceding 30 days

Keywords: renal replacement therapy haemodialsysis calcification inhibition test
efficacy of focused shockwave therapy in patients with cts

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is the most common entrapment of upper extremity. patients with cts will experience symptoms of pain, numbness of tingling sensation along the median nerve distribution. in more severe case, patients may have difficult manipulating objects that disturb function and patient's quality of life. extracorporeal shockwave therapy (eswt) is one of physical modalities that uses to treat many musculoskeletal disorders. for cts, previous evidence showed that eswt can improve symptoms, function as well as electrophysiologic parameters. however, standardized guidelines as well as the study in patients with moderate to severe cts has not been established. thus, the objective of the present study was to evaluate efficacy of eswt in term of symptoms, function, electrophysiologic parameters, as well as sonography of median nerve in patients with moderate to severe cts.

* the present study was a single-blinded randomized controlled trial comparing the efficacy of focused eswt (f-eswt) to conservative treatment in patients with cts. * 24 patients who was diagnosed as cts based on symptoms of cts and physical examination. they were randomly allocated into two groups (21 patients per group), mainly f-eswt plus conservative treatment and conservative treatment only. * outcome measures were bctq including symptom and function subscales, electrophysiologic parameters, and sonography to evaluate cross-sectional area (csa) of the median nerve. all measures were recorded at baseline, 3 weeks and 6 weeks of treatment. * statistical analysis was performed to determine changes within the same group and compare difference between the two groups.

Eligibility criteria:
inclusion criteria: 1. participants who were diagnosed as cts based on the american academy of neurology 2. participants who have electrodiagnostic evidence of cts according to american association of neuromuscular and electrodiagnostic medicine (aanem) guidelines for diagnosis of cts. the severity of median nerve compression at wrist was moderate to severe degree. 3. patients who were not treated by nsaids within 2 weeks prior to participating in the study. exclusion criteria: the below exclusion criteria were applied only on the affected hand that were enrolled to the study 1. history of previous carpal tunnel release. 2. receiving steroid injections for the treatment of cts 3. history of infection or severe inflammation on the wrist 4. contraindications for focused eswt, such as arrhythmias, pacemakers, bleeding disorders, pregnancy, severe osteoporosis, and cancer. 5. participants who refused or requested withdrawal from the study.

Keywords: carpal tunnel syndrome, eswt, shockwave therapy
a study to evaluate the efficacy and safety of sutetinib maleate capsule in locally advanced or metastatic nsclc

Conditions: Non-small Cell Lung Cancer

Summary: the main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer nsclc (uncommon egfr mutations only).

sutetinib is an investigational irreversible egfr tyrosine kinase inhibitor. egfr is a gene that makes a protein that is involved in cell growth and cell survival. mutated (changed) forms of the egfr gene and protein have been found in some types of cancer, including non-small cell lung cancer. these changes may cause cancer cells to grow and spread in the body. the purpose of this study is to explore how effective sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic nsclc with uncommon egfr mutations.

Eligibility criteria:
inclusion criteria: 1. age 18 years old and above, male or female 2. histopathological and/or cytopathological confirmation of locally advanced or metastatic nsclc 3. confirmation that the tumor harbors an uncommon epidermal growth factor receptor (egfr) mutation (tumor tissue biopsy) 4. at least one measurable lesion 5. eastern cooperative oncology group (ecog) score of 0, 1, or 2 6. a minimum life expectancy of \> 3 months 7. adequate bone marrow reserve, hepatic, renal, and coagulation function other inclusion criteria apply for participating in the study. exclusion criteria: 1. participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (egfr tki) for anti-tumor therapy prior to enrollment (cohort 1), or second generation egfr tki (cohort 2) 2. any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional chinese medicines indicated for the tumor within 2 weeks prior to enrollment; cohort 2: any egfr tkis within 5 half-lives. 3. use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome p450 isozyme 3a4 (cyp3a4) within 14 days or 5 half-lives, whichever is the longer, prior to enrollment 4. surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment 5. any unresolved toxicities from prior therapy greater than national cancer institute-common terminology criteria for adverse events version 5.0 (nci-ctcaev5.0) grade 1, at the time of screening except for alopecia 6. inability to swallow the study medication, any seriously (nci-ctcaev5.0 ≥ grade 3) chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption 7. active central nervous system metastases 8. any active infection which has not been controlled at screening other exclusion criteria apply for participating in the study.

Keywords: oncology sutetinib maleate capsule teligene cancer
human leukocyte antigen class ii (drb1 and dqb1) alleles and haplotypes frequencies in patients with pemphigus vulgaris among the russian population

Conditions: Pemphigus; Bullous Pemphigoid; Stevens-Johnson Syndrome; Toxic Epidermal Necrolyses

Summary: pemphigus is a rare autoimmune life-threatening blistering condition affecting skin and mucous membranes. pemphigus belongs to a family of polygenic disorders. several different genes encoding molecules regulate pemphigus autoimmunity. many trials focused on hla investigation. increased levels of certain hla class ii alleles frequencies in pemphigus have been reported in various populations. however, they were not investigated in the russian population. the aim of our study is to investigate hla class ii alleles and haplotypes in russian patients with pemphigus. methods patients and controls we are recruiting 120 patients with pemphigus. the diagnosis was based on clinical and histopathological findings and confirmed by immunofluorescent techniques (direct and indirect immunofluorescent tests). before sampling, written consent was obtained from each subject. a single blood sample for hla typing was obtained from all subjects. this study has been approved by the ethics committee of sechenov university, russia. phenotypic and allelic frequencies were compared with healthy blood donors (n=100) registered in sechenov university blood center.


Eligibility criteria:
inclusion criteria: * signed informed consent * age of patients \>18 years * confirmed diagnosis exclusion criteria: * no as pemphigus is a life-threatening condition
peace: pediatric antifungal comparative effectiveness

Conditions: Pediatric Invasive Candidiasis

Summary: the overarching objective is to develop new evidence-based treatment guidelines for invasive fungal diseases in children. to accomplish that, this protocol will focus on two specific aims: 1) compare the effectiveness of echinocandin versus amphotericin b or triazole antifungal therapy for pediatric invasive candidiasis and for the subset of patients with invasive candidemia; 2) characterize the incidence rate of inpatient pediatric invasive candidiasis per hospital admissions.

this study is a multicenter, national and international, prospective observational comparative effectiveness study. the primary aim of this study is to compare the effectiveness of echinocandin versus amphotericin b or triazole antifungal therapy for pediatric invasive candidiasis and for invasive candidemia. the primary effectiveness endpoint for study aim 1 is the comparison of global response at 14 days of antifungal therapy between antifungal therapeutic classes. the secondary effectiveness endpoints for study aim 1 are comparative effectiveness of the 1) global response to antifungal therapy after 30 days and 2) all-cause mortality at 30 days. the secondary aim is to characterize the frequency of pediatric candidiasis by describing the incidence of pediatric candidiasis relative to all pediatric admissions. for this aim, the investigators will use descriptive statistics to establish the frequency of hospital admissions involving an invasive candidiasis per total hospital admissions and total hospital days during the study period.

Eligibility criteria:
inclusion criteria: 1. males or females age \> 120 days and \<18 years 2. documented proven or probable case of invasive candidiasis 3. parental/guardian permission (informed consent, if required) and if appropriate, child assent (if required). exclusion criteria: 1) any history of prior candida infection within the previous 35 days (these patients will not be eligible for analysis in aim 1 but will be eligible for inclusion of aim 2)

Keywords: candida pediatric antifungal
management of nausea and vomiting in pregnancy and hyperemesis gravidarum: evaluation of clinical practices in five maternity hospitals in île-de-france

Conditions: He Study Focuses on Evaluating Current Clinical Practices Rather Than Testing an Intervention

Summary: this clinical trial aims to evaluate the adequacy of healthcare professionals' clinical practices regarding nausea and vomiting in pregnancy (nvp) and hyperemesis gravidarum (hg) with the recommendations of the national college of french obstetricians and gynecologists (cngof). the study involves 117 participants and follows an observational, cross-sectional, multicenter study design conducted in five maternity hospitals in île-de-france.


Eligibility criteria:
inclusion criteria: * midwives, obstetrician-gynecologists, and gynecology-obstetrics interns working in the labor and delivery units, high-risk pregnancy units, and obstetric-gynecological emergency units of the five selected maternity hospitals. exclusion criteria: * midwives or doctors in training (student midwives or medical externs) * midwives and obstetrician-gynecologists working in private practice

Keywords: nvp, hyperemesis gravidarum, clinical practices, adequacy, recommendations,cngof
inebilizumab and rituximab in neuromyelitis optica spectrum disorders

Conditions: Neuromyelitis Optica Spectrum Disorders

Summary: to compare the safety and efficacy of inebilizumab and rituximab in neuromyelitis optica spectrum disorders (nmosd) patients.

inebilizumab is a humanized anti-cd19 monoclonal antibody. cd19 is broadly expressed on b-lineage cells, particularly late-stage memory b-lymphocytes and plasma blasts. inebilizumab depletes antibody-secreting plasmablasts and some plasma cells. rituximab (rtx) is a chimeric anti-cd20 monoclonal antibody that promotes b-lymphocyte depletion through antibody-dependent cellular cytotoxicity (adcc)/complement-dependent cytotoxicity (cdc), promotes an immunoregulatory t-lymphocyte phenotype, and activates neutrophil/macrophage phagocytosis. this is a retrospective, multicentre, real-world study which aims to compare inebilizumab with rtx in neuromyelitis optica spectrum disorders patients. eighty patients from 8 centres in china will be enrolled.

Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years with anti-aqp4-igg seropositive nmosd as defined by 2015 nmosd diagnostic criteria by ipnd (international panel for nmo diagnosis). * 2. expanded disability status scale (edss) score ≤ 8 and ≥ 2.5 during the acute phase. * 3. patients have given their written informed consent. exclusion criteria: * 1. lactating and pregnant females. * 2. participate in other interventional studies within 30 days or within 5 half-lives of the investigational agent before received inebilizumab and rituximab (rtx). * 3. receipt of any experimental b-cell depleting agent within 6 months prior inebilizumab and rtx, and b-cells below the lower limit of normal * 4. known history of a severe allergy or reaction to any component of the investigational product formulation. * 5. known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization (including viral hepatitis, active tuberculosis or positive tuberculosis screening). * 6. history of alcohol, drug, or chemical abuse, or a recent history of such abuse \< 1 year prior to treatment. * 7. history of malignancies. * 8. combined with severe mental disorders and other conditions and unable to cooperate with follow-up.

Keywords: neuromyelitis optica spectrum disorders inebilizumab rituximab
hiv-hbv co-infection and liver disease

Conditions: HIV Infections; HIV-HBV Co-Infection

Summary: human immunodeficiency virus/hepatitis b virus (hiv/hbv) co-infections are frequently observed due to shared routes of transmission, with reported figures indicating 6-9% of hiv-infected individuals in developed countries are chronically infected with hbv. hiv infection impacts on the natural progression of hbv infection, increasing levels of hbv replication and the risk of liver-associated mortality. liver diseases associated with hbv are affected by the antiviral drugs used for hiv infection (toxic side effects), the current immune function in the patient, by improvements in the immune system brought about by control of the hiv infection, and by the development of resistance to the antiviral agents used for both the hepatitis b and the hiv infection. co-infection with hbv increases the risk for hepatotoxicity in those individuals receiving highly active antiretroviral therapy (haart) for their hiv infection. this study will recruit patients who are co-infected with hiv and hbv, and are currently taking or who are about to commence haart. the study cohort will include hiv-hbv co-infected individuals from the alfred hospital, the royal melbourne hospital and high case load gp clinics who are referred to the alfred hospital. the aim of the study is to investigate chronic hepatitis b and its impact on the progression of liver disease in hiv-infected persons receiving haart. this will be achieved by 6 monthly assessment with medical history, physical examination, bloods for markers of liver disease and hepatitis b activity and completion of questionnaires to measure adherence and alcohol use.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * hiv positive * 2 positive hepatitis b surface antigen results 6 months apart * provision of informed consent exclusion criteria: * unable to provide informed consent
static vs. articulating antibiotic spacer for periprosthetic joint infection in total knee arthroplasty

Conditions: Prosthetic Joint Infection of the Knee

Summary: the primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer.


Eligibility criteria:
inclusion criteria 1. male or female age 18 to 100 years of age. 2. preoperative diagnosis of bacterial infection by culture which would include a preoperative aspiration and at least three intraoperative cultures. the preoperative aspiration would also be sent for a cell count with differential. all patients would have an erythrocyte sedimentation rate (esr) and c-reactive protein (crp) drawn in the preoperative phase. patients with a negative preoperative aspiration, but an actively draining wound or draining sinus tract, would be considered as infected. intraoperative histopathology would also be obtained in all cases of infected total knee replacement at the time of the resection. 3. intact extensor mechanism. 4. adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft) 5. adequate bone stock for knee reconstruction 6. medical fitness for staged knee reconstruction exclusion criteria 1. known atypical infection (mycobacterial or fungal) 2. extensor mechanism disruption 3. inadequate soft tissue envelope requiring muscle flap or skin grafting 4. inadequate bone stock (t3 or f3 by the anderson orthopaedic research institute (aori) classification) 5. medical status precluding staged knee reconstruction 6. requirement for hinged knee reconstruction at the time of reimplantation 7. pregnant women - for women of child bearing age, a negative pregnancy test will be needed prior to enrollment to the study.
safety and efficacy of pot ptca balloon dilatation catheter for the optimal dilation after des implantation

Conditions: Coronary Artery Disease

Summary: the objective of this randomized control trial is to gain clinical insight on the use of pot ptca balloon dilatation catheter for the optimal dilation after drug-eluting stent implantation.

the current study is designed as a multicenter, randomized and prospective study aiming to compare the change in minimal stent area (mla) of pot ptca balloon dilatation catheter on patients with drug-eluting stent (des) implantation. based on the previous studies, the mla in the proximal and distal 3mm segments was 7.38 mm\^2 and 8.08 mm\^2 before non-compliant balloon (ncb) dilation, respectively. after ncb dilation, that msa in the proximal and distal 3mm segments was 7.53mm\^2 and 9.55mm\^2, respectively. as a result, a total of 48 patients with des implantation are randomized at a ratio of 1:1 to either pot ptca balloon dilatation catheter group (pot group) or quantum maverick balloon catheter group (ncb group) using a randomization schedule blocked by site.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures; 2. men and women 18 years and older; 3. patients with asymptomatic myocardial ischemia, stable or unstable angina, or acute myocardial infarction with symptoms lasting more than 12 hours; 4. the target lesions was de novo lesion; 5. reference vessel diameter of target lesion is between 2.25-4.0mm, and the lesion length is less than 15mm(visual inspection); 6. diameter stenosis of target lesion diameter ≥70% or ≥50%(visual) with ischemia evidence; 7. des was successfully implanted in target lesions; 8. timi 3 blood flow of target vessel before post-dilation. exclusion criteria: 1. subjects had clinical symptoms and/or ecg changes consistent with st-elevation myocardial infarction within 12 hours; 2. allergies to concomitant medications required by the balloon/stent system or protocol used in the study; 3. cannot tolerate dual antiplatelet therapy; 4. life expectancy is less than 6 months; 5. pregnant or lactating women; 6. participating in another clinical trial and has not completed the primary endpoint observation of the trial; 7. planned multiple operations, failed to follow the treatment prescribed in the protocol or affected data analysis and interpretation; 8. restenosis disease; 9. target lesions with severe calcification require rotary grinding treatment.