Kornimate/medical-research-clean huggingface dataset:
pertussis (tdap) vaccination in pregnancy

Conditions: Pertussis; Pregnancy

Summary: despite good vaccination coverage, included in national immunization programs in developed countries, the number of reported pertussis cases is rising, also in very young infants. current immunization strategies fail to protect infants too young to be immunized with the licensed vaccine. different strategies are possible to close the gap of susceptibility between the loss of maternal antibodies and protection by vaccination. the main aim of the present study is to measure the influence of an adult pertussis booster in pregnant women, on the titer and duration of maternal antibodies in their infants. early humoral immunity will be assessed and the influence on vaccine response of the infant measured. the present study offers the opportunity to have new insights in neonatal immunological mechanisms against pertussis and a better understanding in strategies to protect infants against pertussis.


Eligibility criteria:
inclusion criteria: * women aged 18-35 years * willing to be immunized during pregnancy or * received already a pertussis vaccination during pregnancy, as advised by gynaecologist or general practitioner. * age matched controls will be identified in the same time period in the recruiting hospital. * availability for follow-up visits and phone call access through 16 months following delivery * willing to have infant immunized with hexavalent vaccine at 8.12 and 16 weeks and 15 months of age (= normal belgian schedule) with pediatrician, the general practitioner or at the centre for the evaluation of vaccination. * in the 18th-32nd week of a pregnancy at low risk for complications as determined by the obstetrician exclusion criteria:women: * serious underlying medical condition * history of a febrile illness (\>= 38° celsius) within the past 72 hours before injection * previous severe reaction to any vaccine * receipt of tetanus-diphtheria toxoid immunization within the past 1 month * receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (tdap) immunization in the last 10 years * receipt of a vaccine, blood product (excluding rhogam) or experimental medicine within the 4 weeks prior to injection through 4 weeks following injection * receipt of or plans to receive influenza vaccine within the 4weeks prior to or following injection. one month interval should be respected in order to evaluate eventual adverse events following one of both vaccines (fever, local symptoms). * high risk for serious obstetrical complication * anything in the opinion of the investigator that would put the participant at risk. exclusion criteria for the offspring: * serious underlying medical condition * no signed informed consent by both parents * severe reactions to any vaccine * anything in the opinion of the investigator that would put the participant at risk.

Keywords: pertussis infants vaccination pregnancy
real-life study of the characteristics of patients treated with ilaris® (canakinumab) for gouty arthritis in france

Conditions: Gouty Arthritis

Summary: this was a non-interventional, retrospective, cross-sectional, descriptive study, conducted on the national health data system (système national des données de santé, snds). the study did not modify the doctor-patient relationship, nor the management or follow-up of patients. patients with dispensation of canakinumab for gouty arthritis were selected over the period from 08 april 2018 to 07 april 2020; index date was defined as date of the first dispensation of canakinumab in community pharmacy during study period. patients were described at index date. medical history and comorbidities, and previous treatments for gouty arthritis were assessed during 3 years prior to index date. co-treatments of interest for which standard treatments for gouty arthritis were contraindicated or required precautions for use were assessed during 6 months prior to index date.


Eligibility criteria:
inclusion criteria: * received at least one reimbursement of ilaris® from 08 april 2018 to 07 april 2020. * benefited from at least one of the following healthcare consumptions during 3 years prior to index date: o at least one hospitalization with a main diagnosis or a related diagnosis in a medical unit summary or a significant associated diagnosis in a standardized discharge summary corresponding to the international classification of diseases, 10th revision (icd-10) code: * m10.0 "idiopathic gout" * m10.1 "saturnine gout" * m10.2 "medicated gout" * m10.3 "gout due to impaired renal function" * m10.4 "other secondary gout" * m10.9 "gout, unspecified" * and/or an active long-term disease (affection longue durée, ald) with an icd-10 code: "m10 gout" * and/or at least one dispensation of colchicine and urate-lowering therapy (allopurinol and/or febuxostat and/or benzbromarone and/or probenecid) at any time. exclusion criteria: none
daptomycin + meropenem versus ceftazidime in the treatment of nosocomial spontaneous bacterial peritonitis

Conditions: Cirrhosis; Ascites; Nosocomial Spontaneous Bacterial Peritonitis

Summary: nosocomial spontaneous bacterial peritonitis (sbp) is frequently caused by multi drug resistant bacteria. standard treatment of sbp could be ineffective. the aim of the study is to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial sbp.

spontaneous bacterial peritonitis (sbp) is a well known complication in patients with liver cirrhosis and ascites. nosocomial sbp is defined as sbp that occurs after 48 hours of hospitalization. it has been shown that patients with nosocomial sbp have a worse prognosis than patients with community-acquired sbp. it has also been shown that nosocomial sbp is frequently caused by multi drug resistant bacteria such as extended-spectrum-beta-lactamase (esbl) producing enterobacteria or meticillin - resistant staphylococcus aureus. currently the empirical treatment of sbp is the use of third generation cephalosporins or amoxicillin/clavulanic acid. in patients affected by nosocomial sbp these treatment could be ineffective. up to now an empirical approach with a broader spectrum strategy (such as an association between meropenem and daptomycin) has never been compared to standard therapy in the treatment of nosocomial sbp. thus, the aim of the study is to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial sbp in patients with cirrhosis.

Eligibility criteria:
inclusion criteria: * patients with liver cirrhosis and ascites * meets all criteria for nosocomial sbp as outlined below * ascitic fluid polymorphonuclear cells count \>250/mm3 * onset of signs and symptoms of infection after 72 hours of hospitalization exclusion criteria: * hepatocellular carcinoma beyond the milan criteria * abdominal surgery within 4 weeks * evidence of secondary peritonitis, pancreatitis or peritoneal carcinomatosis * significant heart or respiratory failure * allergy to ceftazidime, meropenem or daptomycin

Keywords: cirrhosis nosocomial spontaneous bacterial peritonitis ascites daptomycin meropenem ceftazidime nosocomial infection multi drug resistant bacteria sepsis albumin
iv antibiotics with lavage for severe pd peritonitis

Conditions: Peritonitis; Kidney Failure

Summary: this is a randomized controlled trial to evaluate whether a switch to intravenous antibiotics with adjunctive lavage can improve the outcome of severe peritoneal dialysis related peritonitis.

the standard treatment of peritoneal dialysis (pd) related peritonitis is intraperitoneal (ip) antibiotics. in severe cases not responding to the ip antibiotics treatment, timely tenckhoff catheter removal is needed. there is no known adjunctive measure that can improve the clinical outcome of the patients suffering from severe pd peritonitis. based on the past experience in the investigators' center, switching ip to intravenous route of antibiotics administration, together with adjunctive lavage was proposed to improve the clinical outcome of severe pd peritonitis, in particular a possible improved catheter salvage rate. this method will be evaluated in the present clinical trial.

Eligibility criteria:
inclusion criteria: * prevalent pd patients with age \>= 18 years old suffering from pd peritonitis * pd effluent white cell count \>1090/mm2 on peritonitis day 3 * lack of clinical response * informed consent available exclusion criteria: * pd peritonitis in association with exit site or tunnel infection * relapsing peritonitis (i.e. peritonitis caused by same organism within 4 weeks after completion of antibiotics therapy) * fungal peritonitis * mycobacterial peritonitis (both tuberculosis and non-tuberculosis species) * clinical suspicion of surgical peritonitis * penicillin- or cephalosporin allergy, that cefazolin and ceftazidime could not be used

Keywords: peritoneal dialysis lavage
survival rates and quality of life according to follow-up period after gastrectomy for gastric cancer (stofolup)

Conditions: Gastric Cancer; Recurrence; Quality of Life

Summary: this study is a multi-center, prospective, randomized controlled study. the aim of this study is to compare survival rates and to observe quality of life and nutritional status according to follow-up period in patients who underwent radical gastrectomy for stage 2 or 3 gastric cancer.

the hypothesis of this study is that the survival rates would be different between the 3 months and 6 months follow-up groups. the investigators expected survival differences of 6% and the anticipated 3-year overall survival is 83% in the 6 months follow-up group based on the previous 3 phase clinical trial. on the basis of this hypothesis, the sample size was calculated as 886 patients. patients who were diagnosed as stage 2 or 3 gastric cancer after gastrectomy will be assigned to 3 months or 6 months follow-up group. the planned examinations including blood test, x-ray , ct, endoscopy, and nutritional markers will be performed according to the protocol and each patients will be followed up for 3 years after enrollment. the primary endpoint is 3 year overall survival and secondary endpoints are other survivals such as 3-year disease-free survival and gastric cancer specific survival, quality of life, and nutritional parameters.

Eligibility criteria:
inclusion criteria: * patients aged 19 years or more * patients who are diagnosed with pathological stage ii or iii gastric adenocarcinoma according to the ajcc 8th edition * patients who can understand all information about the trial and decide for themselves whether to participate in this study exclusion criteria: * vulnerable patients such as pregnant and intellectual disability * patients who cannot undergo ct owing to poor kidney function or severe adverse effects * patients who are already in another study and cannot follow the schedule for this trial * patients who are diagnosed with a cancer other than gastric cancer within five years before the gastrectomy * patients being treated for a cancer other than gastric cancer
the influence of low frequency repetitive transcranial stimulation (r-tms) treatment on motor and cognitive measurements in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: the aim of the study is to test the effects of low frequency deep rtms using the novel h-coil on the motor, affective and cognitive deficits in patients with parkinson's disease (pd) and to establish its safety in this population. the investigators anticipate to recruit 10 patients to an open pilot study. all patients will receive an active rtms stimulation and will be given 12 treatment sessions, over a period of up to 4 weeks. each of the 12 daily treatment sessions (lasting about 30 minutes each), will be consisted of 25 stimulation trains over the prefrontal cortex (20hz trains, 2 seconds each with an inter-train interval of 20 seconds) and one train of 15 minutes at 1 hz over the the motor cortex. the following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30, 60, and 90: 1. unified parkinson's disease rating scale (updrs ) 2. clinical global impression of severity (cgis) 3. pegboard test. 4. tapping test 5. up \& go test 6. abnormal involuntary movement scale (aims) mood and affect beck depression inventory (bdi) cognition 1. mini mental state examination (mmse) 2. digit forward and backward tests. 3. word fluency. 4. frontal assessment battery (fab) side effects will be closely monitored by the researchers and will be promptly reported to the irb


Eligibility criteria:
inclusion criteria: * pd patients aged 40 years or older, diagnosed as idiopathic pd according to the uk brain bank criteria, with hoehn \& yahr stages ii - iv while "off". * participants on antidepressants should be at least 2 months on stable therapy exclusion criteria: * patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative. * patients on neuroleptics. * patients with dementia or any unstable medical disorder. * history or current unstable hypertension. * history of head injury or neurosurgical interventions. * history of any metal in the head (outside the mouth). * known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps. * history of migraine or frequent or severe headaches. * history of hearing loss. * the presence of cochlear implants * history of drug abuse or alcoholism. * pregnancy or not using a reliable method of birth control. * participation in current clinical study or clinical study within 30 days prior to this study
evaluation of the venous excess ultrasound score (vexus) after circulating volume modification in children.

Conditions: Blood Volume Expansion

Summary: venous overload has an impact on peripheral organ perfusion and on the short- and long-term prognosis of intensive care patients. the vexus ultrasound score is a new tool whose parameters can be used to estimate this impact. this score was initially evaluated and validated on an adult population. ) in children, there is only one study looking at the use and applicability of this vexus score, highlighting its feasibility in a paediatric population, as well as a possible correlation between elevated central venous pressure and altered renal doppler (one of the score's components).


Eligibility criteria:
inclusion criteria: children aged between 1 and 18 years, receiving extrarenal purification with uf \> 10 ml/kg, bleeding \> 10 ml/kg or vascular filling \> 10 ml/kg exclusion criteria: * refusal of the patient or opposition of one or both holders of parental authority. * minors with parental authority. * ultrafiltration time \> 6h. * curarized patient, known abnormality of the hepatorenal venous network. * patient agitated or poor tolerance of the examination. * parents under court protection, guardianship or curatorship.

Keywords: extra renal purification bleeding vascular filling
identification of psychoactive substance users in young adults (16 to 25 years old) visiting the emergency department

Conditions: Psychiatric Emergency; Drug Use

Summary: adolescence is a time for great physical and psychological change and it's often at that period of life that first use of psychoactive substances occurs. although addiction is rare in teenagers, psychoactive substances abuse can have serious long-term health consequences on them. this is therefore a priority for all healthcare providers to identify early use and abuse of drugs in the youth's population. the addictive process underlies environmental, genetic and individual causes. that is why it is somehow possible to identify individuals at risk based on some common sociological, cultural and environmental risk factors. due to the acute consequences of psychoactive substances abuses, emergency departments are main checkpoints for the screening of young drug users. indeed, one patient out of five admitted in an emergency department shows a positive blood alcohol concentration regardless of the reason for their admission. this rate is twice as high as in the overall population. hence, emergency departments are at the front-line for screening, caring, referral and transfer of psychoactive substances users. that is why the emergency department is the best place for this study. in 2004, the special consultations of young consumers were founded in order to deal with these special cases where dependence is not yet established or installed and care has to be adapted to the age. offering help to this age range represents a real challenge since only 20% of the teenagers come to visit this special consultations on their own initiative. the rest of teenagers are either obliged by their parents or sentenced by a court. the investigators assume that the repetition of care offered to the teenagers by repeated emergency admissions could trigger their own desire to overcome their drug use disorders and visit the addictionology department.


Eligibility criteria:
inclusion criteria: * all patients aged 16 to 25 admitted at the medical and psychiatric emergency department. * for adults: those who will agree to participate in this study * for minors from the age of 16: those who will agree to participate and want to exercise their rights by themselves or for whom one parent or legal guardian agrees for their participation. exclusion criteria: * patient who doesn't understand french * patient under legal protection measures or guardianship * confused person (gsc \< 15)
a study to evaluate the efficacy of microlyte matrix in the management of donor site wounds

Conditions: Wounds and Injuries

Summary: a study to to evaluate the efficacy of microlyte® matrix by demonstrating its superiority to the standard of care in the healing of donor site wounds in patients requiring split-thickness grafting, as well as to assess the occurrence of donor site wound infection, allergic reaction, pain and itching, and scarring at 12 weeks, assessed by patients using the patient and observer scar assessment scale (posas).

the proposed study is a randomized, controlled, open-label clinical trial to assess the efficacy in wound healing of the fda 510k cleared microlyte® matrix (k153756) in surgically created partial thickness donor site wounds \> 100 cm2 in size on patients and harvested at 12/1000th inch requiring split-thickness skin grafting. subjects are expected to be hospitalized as in-patients for approximately 7 days following initial donor site surgery. study visits conducted after hospital discharge must be conducted as out-patient clinic visits. each wound will be divided into proximal and distal halves with one half randomized to receive microlyte® matrix. kaltostat/tegaderm will be used as the control. thus, each patient is their own control removing the potential variability of the depth of donor site wounds between patients as a confounding factor. microlyte® matrix is a fda-cleared (k153756) antimicrobial dressing manufactured by imbed biosciences, inc. (madison, wi), which is an iso 13485 certified/fda qsr compliant facility. it is indicated for the management of partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic foot ulcers, first and second-degree burns, abrasions and lacerations, donor sites and surgical wounds.

Eligibility criteria:
inclusion criteria: 1. adult patients where creation of a donor site wound for any indication including chronic wound, burn wound, surgical/traumatic wound, and tumor excision. 2. donor site wound with a surface area of greater than 100 cm2 is required. 3. at least 18 years of age 4. provision of signed and dated informed consent form 5. stated willingness to comply with all study procedures and availability for the duration of the study 6. ability and willingness to adhere to the study intervention regimen and follow-up visits exclusion criteria: 1. age less than 18 years. 2. vulnerable population. 3. pregnant, lactating or nursing women. 4. unable to provide consent. 5. presumed unable to complete follow-up assessments. 6. prior adverse reaction or sensitivity to silver. 7. enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study. 8. presumed impairment of wound healing as with prescription drugs or medical diagnoses that have potential to impair wound healing at the discretion of clinical investigator, e.g., cancer, transplant status, autoimmune disease, severe malnutrition, etc. 9. any diagnosis with concern for 30 day mortality.

Keywords: donor skin graft wound partial thickness
communication and intimacy-enhancing therapy for men with early stage prostate cancer and their partners

Conditions: Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment; Sexual Dysfunction and Infertility; Sexuality and Reproductive Issues

Summary: rationale: participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners. purpose: this randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.

objectives: primary * to evaluate the feasibility and acceptability of conducting a randomized clinical trial evaluating communication and intimacy-enhancing intervention (ci) vs usual care (uc). * to collect descriptive information and basic psychometrics on proposed study measures. * to gather preliminary data regarding the impact of ci on couples' psychosocial adaptation, relationship closeness, and sexual intimacy in order to calculate power for a larger full scale trial. outline: this is a multicenter study. patients and their partners are randomized to 1 of 2 intervention arms. * arm i: patients and their partners receive communication and intimacy-enhancing intervention (ci) once a week comprising the following five 90-minute sessions: rationale and overview; basic communication; intimacy and sexuality; improving intimacy; and reflecting on changes and cancer survivorship. * arm ii: patients and their partners receive standard psychological and emotional care (usual care \[uc\]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician). physical impairment, psychological adjustment, relationship closeness, relationship communication, sexual function and satisfaction, male self-esteem, relationship satisfaction, intervention evaluation, and erectile dysfunction treatment utilization, and referral are assessed at 1 week post-intervention or at 6-8 weeks post baseline and then at 3 months (for patients and their partners in arm i) and at 8 weeks post-baseline and then at 3 months (for patients and their partners in arm ii). projected accrual: a total of 50 patients and 50 partners will be accrued for this study.

Eligibility criteria:
disease characteristics: * patient has a primary diagnosis of localized (early stage) prostate cancer * has undergone surgery within the past year * patient and partner married or cohabiting and relationship duration ≥ 1 year patient characteristics: * ecog performance status 0 or 1 at the time of initial recruitment * lives within 2-hour commuting distance from recruitment center (mskcc or fccc) * no significant self-identified hearing impairment that would preclude study participation prior concurrent therapy: * see disease characteristics

Keywords: psychosocial effects of cancer and its treatment sexual dysfunction and infertility sexuality and reproductive issues stage iib prostate cancer stage iia prostate cancer stage i prostate cancer