Kornimate/medical-research-clean huggingface dataset:
covid-19: bcg as therapeutic vaccine, transmission limitation, and immunoglobulin enhancement

Conditions: COVID-19; Therapeutic Vaccine; BCG; SARS-CoV 2; Transmission

Summary: to date, there is no vaccine or treatment with proven efficiency against covid-19, and the transmissibility of the sars-cov-2 virus can be inferred by its identification in the oro-nasopharynx. the bacillus calmette guérin (bcg) has the potential for cross-protection against viral infections. this study evaluates the impact of previous (priming effect, from the titer of anti-bcg interferon-gamma) or current bcg exposure (boost with intradermal vaccine) on 1) clinical evolution of covid-19; 2) elimination of sars-cov-2 at different times and disease phenotypes; and 3) seroconversion rate and titration (anti-sars-cov-2 iga, igm, and igg).

prospective, randomized, double-blind, multicentre study with international design collaboration with central clinical and mechanistic outcomes with public health implications both epidemiological and therapeutic in the context of the pandemic of covid-19, an emerging disease, which quickly disrupted health services including brazil's unified health system (sus), as well as the entire productive force and economy worldwide. because it is recent, the basic evidence related to infection, such as incubation period, time of transmissibility, and seroconversion, is little known and the proposal's goals have the potential to redirect the vaccine. exploring bacillus calmette guerin (bcg) that presents significant potential for immune activation, with recognized safety in decades of previous experience and clear potential in the context under analysis, with low cost and available, ensuring wide accessibility, especially in the context of sus, on which it depends especially the most vulnerable portion of the brazilian population, notably in the covid-19 pandemic. non-specific effects of bcg caused by monocyte epigenetic reprogramming may result in increased production of pro-inflammatory cytokines, conferring innate (trained) immunity and protection against viral infections, including sars-cov-2 with the potential to positively impact clinical evolution, viral elimination, and seroconversion of covid-19 patients.

Eligibility criteria:
inclusion criteria: * \> 18 years of age; * laboratory or clinical-epidemiological confirmation of covid-19 (history of close or home contact with a laboratory-confirmed case who has fever or at least one of the respiratory signs or symptoms, in the last 14 days after contact, and for which it was not possible to carry out the specific laboratory investigation) exclusion criteria: * immunosuppressed patients of any kind; * pregnant women; * more than 14 days from the onset of symptoms; * not accept participation or non-signature of the ic; * undiagnosed cases, suspected or probable.

Keywords: bcg therapeutic vaccine covid-19 sars-cov 2 interferon gamma immunoglobulin immunemodulation transmission
the clinical study on combizym and bifidobacteri to prevent the recurrence of colon polyps

Conditions: Combizym; Bifidobacteri; Colon Polyps

Summary: the study hypothesis is whether digestion enzyme(combizym) and intestinal flora drugs(bifidobacteria) can decease recurrence rate of colon polyps

colon polyps has high recurrence rate in the digestion diseases. however, the reasons are not clear. the possible reasons for the recurrence of colon polyps include intestinal inflammation (e.g., ulcerative colitis), intestinal flora imbalance (the benefit intestinal bacteria reduced, which lead to diarrhea or constipation), long-term indigestion. the investigators propose to examine whether digestion enzyme (combizym) and intestinal flora drugs(bifidobacteria) can decease recurrence rate of colon polyps

Eligibility criteria:
inclusion criteria: -patients who have cutted colon polyps in one month, and the diagnosis were proved by pathological analysis exclusion criteria: * have organic or other functional disease * pregnant or breast-feeding
procalcitonin monitoring may decrease antibiotic use in the intensive care unit

Conditions: Sepsis

Summary: sepsis is common and is associated with significant mortality, morbidity and health-care costs. unfortunately, its diagnosis is not straightforward because its signs and symptoms are neither specific nor sensitive; in addition, microbiological cultures lack specificity, sensitivity and are plagued by high turn-around times. because the delay in the institution of antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in icu-patients, even when they are not needed. procalcitonin may not be the long sought for bio-marker to establish the diagnosis of sepsis but may help decrease the duration of the administered antibiotic courses once they are started.

recently, a number of studies have shown the utility of procalcitonin (pct) measurements in reducing the duration of antibiotic treatment in patients with respiratory tract infections presenting to the primary care setting or the emergency department. however, it remains unclear if a similar strategy can be effectively and safely implemented in the critical care setting. we attempt to address the controversy on this issue, by collecting, analyzing and interpreting the currently available relevant evidence. to this end, a systematic review and meta-analysis of the randomized controlled trials reporting on the outcomes of critically ill septic patients managed with or without a procalcitonin-based algorithm will be performed.

Eligibility criteria:
inclusion criteria: * randomized controlled trials (rcts) that report on the outcomes of critically ill patients managed with a procalcitonin-guided algorithm versus routine practice. * participants of any age with proven or suspected sepsis will be considered. - as routine practice, the investigators will consider the institution and discontinuation of antibiotics by the attending physicians with the aid of clinical signs, symptoms, microbiological data, well established laboratory parameters (i.e., white blood cell count) and widely accepted guidelines but without the knowledge of pct values. the investigators will set no limitations regarding the time, country or language of publications. the investigators will search for trials conducted in critically ill neonates and children. exclusion criteria: * the investigators will exclude studies that are not rcts and studies performed outside the icu, namely in the primary care setting, the emergency department or the clinic.

Keywords: antibiotics resistance bio-marker procalcitonin algorithm critically ill
cerclage for the reduction of extreme preterm birth in twin pregnancies with a short cervix or dilatation

Conditions: Preterm Birth

Summary: the goal of this clinical trial is to assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth \< 28 weeks of gestational age. the main question it aims to answer is: what is the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth \< 28 weeks of gestational age? participants will be randomly assigned to the intervention (cerclage) or comparison (no cerclage) group.

rationale: in the netherlands, 250 women with a twin pregnancy deliver at \< 28 weeks per year, resulting in 157 perinatal deaths. a vaginal cerclage could be an effective surgical method to reduce cervical insufficiency and with that preterm birth, but the evidence regarding its effectiveness on extreme preterm birth and (long term) neonatal outcome is lacking. objective: to assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth \< 28 weeks of gestational age. nature and extent of the burden and risks associated with participation, benefit and group relatedness: a vaginal cerclage is a minor and safe surgical procedure commonly performed in singleton pregnancies with a short cervix and a previous preterm birth in all the participating centers, thus there is experience in the participating hospitals. the results of this study will show whether a vaginal cerclage reduces extreme preterm birth in women with twin pregnancy and a short cervix, and its accompanying perinatal complications. if proven effective, the implementation of this intervention will have a huge impact on the lifelong health of these children and their families.

Eligibility criteria:
inclusion criteria: women (\> 16 years of age) with a twin pregnancy and: * an asymptomatic short cervix at routine ultrasound investigation (below 24 weeks of gestation) or * cervical dilatation (below 24 weeks of gestation) exclusion criteria: * women with a mono-amniotic twin pregnancy * women with twin pregnancy in which one or both children are diagnosed with a major structural, congenital or chromosomal abnormality that is likely to influence the composite adverse neonatal outcome. * women with dilatation of the cervix and signs of clinical intra-uterine infection, defined by the presence of fever ≥ 38 degrees celsius. * women with overt symptoms of preterm labour at time of measurement of short cervix (regular contractions, pprom, recurrent blood loss). * women with a placenta previa, defined as a placenta position covering the internal ostium of the cervix. * women who do not master the dutch of english language and therefore not able to give written consent

Keywords: preterm birth twin pregnancy cerclage
autobiographical memory organization in schizophrenia

Conditions: Schizophrenia

Summary: the aim of the study is to investigate the temporal organization of autobiographical memory in patients with schizophrenia. patients and control participants will be invited separately to participate in a 1hour walk in the city of strasbourg and at the same time, to carry an automatic camera around their neck, which is called sensecam®. pictures obtained with sensecam® will be later presented to the participants during the session of test. they will be asked to determine the chronological order of 12 pictures corresponding to 12 particular events of the tour. then they will be asked to watch the complete sequence of photos from the tour and to determine the beginning and ending of the events that have occurred during the tour. according to the investigators hypotheses, patients should have difficulty to find out the correct chronological order of the photos and to determine the appropriate beginnings and endings of the events


Eligibility criteria:
inclusion criteria: * for both patients and controls * male or female willing to participate and who have signed up the legal document * under the protection of health insurance for patients only * schizophrenia or schizo-affective disorder according to the dsm-iv-tr criteria * clinically stable for at least 2 months for controls only * no psychiatric history exclusion criteria: * for both patients and controls * current severe or unstable somatic illness * neurological history (epilepsia, brain injury, brain surgery...) * current substance use disorder (dsm-iv-tr) * current major depressive disorder (dsm-iv-tr) * mental retardation (iq \< 70) * pregnancy, breast feeding * current legal control for patients only * treatment comprising benzodiazepines * benzodiazepines intake during the last 3 weeks for controls only * psychotropic intake during the last 3 weeks

Keywords: cognition autobiographical memorycognitive remediation
the german keratoplasty registry of the german ophthalmological society (dog)

Conditions: Corneal Transplantation

Summary: aim of this study is to reflect on the changing trends in absolute numbers, surgical techniques and indications of corneal transplantations being performed in germany. the section cornea of the german ophthalmological society provides interim-assessments on a regular basis about the most up-to-date results of this long-term study.


Eligibility criteria:
inclusion criteria: all patients in germany treated with the different types of corneal transplantation since 2001. exclusion criteria: patients without corneal transplantation.

Keywords: keratoplasty registry, pkp, dsaek, dmek, dalk
duke lupus registry

Conditions: Systemic Lupus Erythematosus; Cutaneous Lupus

Summary: lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. lupus can affect anyone, but it is most common in younger women. the duke lupus registry will collect information and blood samples from patients with lupus (systemic lupus erythematosus or cutaneous lupus) seen in the duke rheumatology clinics. the goal of this registry is to understand how lupus changes over time so that we can improve the treatment of patients with lupus.

the duke lupus registry is a prospective cohort comprised of patients with lupus seen in the duke rheumatology clinic. the duke lupus registry has two main purposes: 1. improved patient care. by following disease activity scores and medication usage, we expect to improve our care of the patients seen in clinic. 2. future research on lupus outcomes. this may encompass a broad array of areas, including but not limited to cardiovascular health, pregnancy and fertility, infections, medication use, quality of life, and depression. at each office visit, patients will complete a questionnaire, physicians will measure lupus activity, and patients may be asked to provide a small blood sample. patients will not be required to make extra visits to duke in order to participate -- all paperwork and blood draws will occur during a regularly scheduled office visit with the physician.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus or cutaneous lupus * patient of a rheumatologist at duke university medical center exclusion criteria: * inability to travel to duke for follow-up visits * inability to speak english * not able to provide informed consent

Keywords: lupus systemic lupus erythematosus cutaneous lupus
local anesthesia in radial catheterization

Conditions: Anesthesia, Local; Coronary Artery Disease; Catheter Site Discomfort; Catheter Site Pain

Summary: a randomized clinical trial to test the efficacy of emla cream (lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (la) protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local anesthesia during transradial coronary angiography.

a total of 444 consecutive patients, who are referred for elective coronary angiography to 1st cardiology department cathlab, with the suspicion of coronary artery disease (cad) will be enrolled in this study. exclusion criteria are acute coronary syndrome, previous ipsilateral transradial approach, raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal barbeau's test and patient's refusal. baseline clinical, demographic and procedural data of the study population were recorded. participants will be randomly assigned to either the emla (ao) or the lidocaine group (la), by a randomization table. primary end-point: the perception of radial pain assessed during artery puncture and 30 minutes after sheath removal. secondary end-point: the number of puncture attempts, the total time required before successful sheath insertion, and the occurrence of radial artery spasm will be also documented in each group participants will be observed for 4 hours post angiography for development of local complications or side effects.

Eligibility criteria:
inclusion criteria: * referral for elective diagnostic coronary angiography exclusion criteria: * acute coronary syndrome, previous ipsilateral transradial approach, raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal barbeau's test and patient's refusal.
chlorhexidine vaginal and infant wash in pakistan

Conditions: Sepsis; Pregnancy

Summary: infection is a major health problem during birth in pakistan. this study will look at the possibility of using a septic wash to help improve health during birth in karachi, pakistan.

sepsis in mother and infant is a major cause of perinatal morbidity and mortality in low-resource settings. several studies have investigated the likelihood that an anti-bacterial agent, chlorhexidine, administered during labor and delivery to mother and infant could reduce the risk of infection and of subsequent maternal and infant morbidity and mortality. in this trial, chlorhexidine wash and placebo will be randomly administered to women in labor and newborn infants in a public hospital in karachi, pakistan. delivery attendants will administer 0.6% chlorhexidine solution every four hours until delivery (4 washes maximum) and one neonatal wash with the same solution. the control group will receive 200 ml of sterile physiologic saline solution. a total of 5000 women will be randomized in the hospital study, 2500 control and 2500 intervention. all women and infants will be evaluated 24 hours post delivery and at a 7-day follow-up. women who delivered at home will also receive a 28 days post-partum assessment. women will be carefully monitored for side effects to the dosage. in addition a community-based feasibility trial of 200 patients (100 chx, 100 control) will be completed.

Eligibility criteria:
inclusion criteria: * gravidas with living fetus delivering at home in the care of identified study birth attendant (community) or admitted to the identified hospital (civil hospital karachi) for delivery exclusion criteria: * contraindications to cervical exam (e.g., placenta previa) * active genital herpes or vulvovaginal ulceration * known or suspected allergy to chlorhexidine * fetus with face presentation * fetal death * unwilling/unable to give informed consent * less than 16 years of age

Keywords: chlorhexidine vaginal wash neonatal mortality sepsis global network maternal and child health women's health international pakistan
entrinsic - enpulse trial on search av+ influence

Conditions: Arrhythmia, Sinus

Summary: right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (av)-conduction. recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. the search av+ algorithm was designed to avoid ventricular pacing and support intrinsic av-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. the goal of the entrinsic study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated search av+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.


Eligibility criteria:
inclusion criteria: * patients with sinus node disease and an intrinsic av delay of maximal 260 ms * patients treated with a medtronic pacemaker with search av+ algorithm exclusion criteria: * patients with documented persistent atrial fibrillation within 6 months before implantation and slow av-conduction * new york heart association (nyha) iii/iv * instable angina pectoris * heart valve vitium * persistent av-block ii and iii * early diastolic mitral regurgitation * implantable cardioverter defibrillator * participation in other clinical studies * pregnancy or unreliable birth control * av-block under strain

Keywords: sinus node disease pacemaker dual chamber pacemaker
two biologically and clinically distinct entities: progressive versus stable multiple myeloma (mm) precursor conditions

Conditions: Multiple Myeloma; Smoldering Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance

Summary: the key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.


Eligibility criteria:
inclusion criteria: 1. diagnosis of mgus and smm will be made in accordance with the clinical diagnostic criteria set forth by the 2014 international myeloma working group (imwg) revised criteria.2 2. the diagnoses will be confirmed by either serum/urine protein electrophoresis, immunofixation and light-chain assays; or immunohistochemistry analyses of the bone marrow biopsy, or a combination of these tests. 3. age greater than or equal to 18 years. 4. eastern cooperative oncology group (ecog) performance status of 0-3. 5. the patient must be competent to sign an informed consent form. exclusion criteria: 1. a diagnosis of mm as defined as any patient with detectable m-protein in blood and/or urine, monoclonal plasma cells in the bone marrow, and evidence of end-organ damage based on the calcium elevation, renal failure, anemia, and bone disease (crab) criteria and/or myeloma-defining events. * patients who have received previous therapy for mm. * patients with known plasma cell or related lymphoid (e.g. lymphoplasmacytic lymphoma, amyloid light chain (al) amyloidosis) 2. confirmation of pathological diagnosis is required either from the initial pathology review report or review from the um/sccc hematopathologist in accordance with the clinical diagnostic criteria set forth by the international myeloma working group (imwg) or world health organization (who). tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the patient during sampling required for routine patient care or required testing on a university of miami (um) /sylvester comprehensive cancer center (sccc) research protocol will be used for diagnosis. 3. active symptomatic major organ disorder that would increase the risk of biopsy or other procedure, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction. * active concomitant medical or psychological illnesses that may increase the risk to the patient or inability to obtain informed consent, at the discretion of the principal investigator. * pregnant or breast-feeding women will not be eligible for any aspect of this protocol. * prisoners will be excluded.
clopidogrel resistance in stroke patients from different ethnicities

Conditions: Clopidogrel, Poor Metabolism of; Ischemic Stroke

Summary: clopidogrel is an anti-platelet agent used to inhibit blood clots. variation in response to clopidogrel has been reported among different population and may lead to reoccurring ischemic events. the aim of the present study is to evaluate the incidence of clopidogrel resistance in ischemic stroke patients from different ethnicities in northern israel and to find different strategies to overcome high platelet reactivity including clopidogrel dose adjustment or the choice of alternative agents. quantification of platelet aggregation will be determined by vasodilator stimulated phosphoprotein (vasp) assay.


Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent and to be compliant with protocol assessments. 2. ages 18 and above inclusive 3. both genders eligible for the study 4. diagnosis of ischemic cerebrovascular event exclusion criteria: 1. pregnant patients will be excluded 2. ages below 18 3. patients not able to provide informed consent