Kornimate/medical-research-clean huggingface dataset:
the effect of negative pressure wound therapy on wound healing in major amputations of the lower limb

Conditions: Negative-Pressure Wound Therapy; Amputation; Wound Heal

Summary: the socioeconomic costs of problematic and delayed wound healing following lower limb amputations are enormous to the society. lower limb amputations is one of the longest known surgical treatments, but also one of the least investigated in the field of medical science. negative pressure wound therapy (npwt) has emerged as a great instrument to aid healing. studies have shown that it has a positive and measurable effect on wound healing following eg. total knee and hip replacements. the aim of this study is to evaluate the effect of a closed npwt on incidence of postoperative wound complications, in patients undergoing lower extremity amputation.

historically lower limb amputations have been performed to treat infection or trauma, usually in the setting of war. today however major amputations of the lower extremities (transfemoral- (tfa), knee disarticulations (kd) and transtibial amputations (tta)) are, in developed countries, usually performed in elderly patients with untreatable vascular disease, diabetes or a combination of both. this fragile group of patients are characterized by a high degree of comorbidity, mortality and both surgical and postoperative complications; included herein problems with wound healing. the tissue is typically poorly vascularized and prone to wound break-down, infections, necrosis etc. 10-40% of patients undergoing tfa, kd or tta have delayed wound healing and/or insufficient wound healing, resulting in problems with the aftercare, mobilization with a prosthesis and re-amputations. recent retrospective studies show that negative pressure wound therapy (npwt) may have beneficial effects on incisional healing following lower limb amputations. however to our knowledge it has never been reproduced in a prospective randomized controlled setting.the aim of this study is to investigate the effect of npwt with a pico®️ device (smith \& nephew) on the healing of the surgical wound following tfa, kd and tta.

Eligibility criteria:
inclusion criteria: * patients undergoing transfemoral, knee disarticulations and transtibial amputations by non-traumatic indication * uni or bilateral amputations or re-amputations exclusion criteria: * patients undergoing traumatic amputations * unwilling or unable to provide informed consent * inability to comply with planned study procedures * amputations due to malignancy

Keywords: vascular disease diabetes preventive care medical technology surgery
glycated albumin combined with body composition for gestational diabetes mellitus prediction

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: this study is going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, bmi, fat free mass and fat mass for gestational diabetes mellitus (gdm) diagnosis.

the prevalence of gdm is increasing all over the world. it has bad influence for both pregnant women and fetus. early treatment is useful for gdm prevention. therefore early screening is important for healthcare doctors to detect the potential patients. glycated albumin (ga) is an optimal index for blood glucose evaluation compared to hba1c, however it may be influenced by body weight and composition. the investigators are going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, bmi, fat free mass and fat mass for gestational diabetes mellitus (gdm) diagnosis. this study recruit pregnant women before 12 weeks of their pregnant age and test ga level and body composition via bioelectrical impedance analysis. during 24-28 weeks of pregnant age, all participants will do the glucose tolerant test for gdm diagnosis.

Eligibility criteria:
inclusion criteria: * age between 20-45 * healthy, without heart disease, liver or kidney dysfunction, immune system or metabolic or infectious disease, exclusion criteria: * diabetes that appeared before pregnancy * pregnant with medical disease, such as asthma, hypertension, cardiovascular diseases, kidney diseases or liver disease. * hormone use in the recent 1 year * assisted reproduction pregnancy * multiple births * cannot complete the blood test or body composition examination
validating the use of blood transcriptomic signatures for the diagnosis of active pulmonary tuberculosis

Conditions: TUBERCULOSIS, PULMONARY

Summary: isit-tb prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of mycobacterium tuberculosis.

this device will be investigated for use as a screening tool to facilitate diagnosis of atb in conjunction with risk assessment, clinical context and diagnostic information. whole blood samples will be collected in tempus™ blood rna tubes and processed on an automatized platform. the detection of a combination of under or over-expressed selected genes, constituting a transcriptional signature, will allow the characterization of atb.

Eligibility criteria:
inclusion criteria: * symptoms suggestive of tb disease: cough for more than two weeks plus at least one of the following: fever, malaise, weight loss, night sweats, haemoptysis, chest pain or loss of appetite. * willingness to give consent to take part in the study. * aged \>18 years old. * healthy control : no history of tb treatment, no respiratory symptoms, no evidence of active infectious disease, no history of close contacts of active pulmonary tb patients. exclusion criteria: * pregnant woman * a person who has received treatment for active tb or ltbi in the past 24 months

Keywords: tuberculosis mycobacterium infections bacterial infections diagnosis
minimally invasive liver surgery for metastases from colorectal cancer: oncologic outcome and prognostic factors

Conditions: Long-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic Indicators

Summary: only few reports exist on long-term survival after minimally invasive liver surgery (mils for colorectal liver metastases. no data are available assessing prognostic factors in the era of current modern treatment strategies. the aim of the current study is to analyze the long-term oncologic outcome after mils for metastases from colorectal cancer and determine prognostic indicators.


Eligibility criteria:
inclusion criteria: * patients with crlm * surgery: resection and/or ablation * preoperative chemotherapy and/or biological agents are allowed * postoperative chemotherapy and/or biological agents are allowed * simultaneous colorectal resection is allowed exclusion criteria: * primary liver cancer * benign liver tumors * pregnancy

Keywords: liver metastases colorectal cancer surgery prognosis
a post-market clinical trial to evaluate the performance and operation of the brevera breast biopsy system

Conditions: Breast Cancer Female

Summary: the brevera breast biopsy system integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. this post-market clinical trial will be performed to obtain clinical/operational data and feedback on the brevera breast biopsy system as compared to the current standard-of-care breast biopsy procedures


Eligibility criteria:
inclusion criteria: * female aged 18 years of age or older * subject has at least one breast imaging finding requiring biopsy for which images are available * subject is able to understand, read and sign the trial specific informed consent form after the nature of the trial has been fully explained to her exclusion criteria: * patients who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy. * patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.

Keywords: breast biopsy breast biopsy imaging stereotactic biopsy
safety and immunogenicity study of glaxosmithkline (gsk) biologicals' pneumococcal vaccine 2830930a administered in toddlers

Conditions: Infections, Streptococcal

Summary: the purpose of this study is to assess the safety, reactogenicity and immunogenicity of the gsk biologicals' pneumococcal vaccine 2830930a in toddlers aged 12 to 23 months at study entry.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) (lars) can and will comply with the requirements of the protocol. * a male or female between, and including 12 to 23 months of age at the time of vaccination. * written informed consent obtained from the parents/lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * born after a gestation period of at least 36 weeks. * previously completed three-dose vaccination course with synflorix. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * planned administration/administration of a vaccine containing diphtheria- or tetanus- toxoid or crm197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before the vaccine dose and ending 30 days after, with the exception of licensed influenza vaccines. * the licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines but should be documented in the "concomitant vaccination" of the electronic case report form. * 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 * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * family history of congenital or hereditary immunodeficiency. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * major congenital defects or serious chronic illness, including kawasaki's syndrome. * history of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile). * acute disease and/or fever at the time of enrolment. * administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during study period. * any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator. * previous receipt of a booster dose (fourth dose) of synflorix. * anaphylaxis following previous administration of vaccines.

Keywords: haemophilus influenzae safety pneumococcal vaccine streptococcus pneumoniae immunogenicity toddlers
ati-045 versus placebo in patients with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis; Atopic; Dermatitis; AD; Eczema

Summary: this study evaluates ati-045 versus placebo in patients with moderate-to-severe atopic dermatitis.

a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of ati-045 in patients with moderate-to-severe atopic dermatitis.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic atopic dermatitis that has been present for ≥ 6 months before the screening visit and with no significant ad flares during the past 4 weeks before screening * have active moderate to severe ad at screening and baseline visits * easi score ≥ 16 and ≥10% bsa at the screening and baseline visits * history of inadequate response to treatment for ad with topical medications; or determination that topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks) * patient applied a stable dose of non-medicated topical moisturizer (ideally once or twice daily) for ≥ 7 days prior to the baseline visit and agrees to continue use during study exclusion criteria: * treatment with any of the following: 1. intravenous immunoglobulin within 12 weeks prior to the baseline visit (w0d1) 2. systemic antibiotics within 2 weeks prior to the baseline visit (w0d1) 3. topical antibiotics within 1 week prior the baseline visit (w0d1) 4. topical medicated treatment that could affect atopic dermatitis should be prohibited for at least 2 weeks prior to baseline visit. example: topical corticosteroids, crisaborole, calcineurin inhibitors, ruxolitinib, roflumilast, tars, antimicrobials, medical devices, and bleach baths. 5. topical products containing urea within 1 week prior to baseline visit (w0d1) 6. doxepin, hydroxyzine, or diphenhydramine within 1 week prior to the baseline visit (w0d1) 7. patient has used systemic treatments (other than biologics) that could affect ad less than 4 weeks or 5 half-lives (whichever is longer) prior to the baseline visit (w0d1), including, but not limited to, retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids, baricitinib, upadacitinib, and abrocitinib. 8. biologics for ad treatments (such as dupilumab, tralokinumab, lebrikizumab, investigational biologics) within 5 half- lives or 12 weeks, whichever is longer prior to the baseline visit (w0d1) 9. an investigational drug (non-biologic) within 4 weeks or within 5 half-lives (if known), whichever is longer prior to the baseline visit (w0d1) 10. phototherapy and photochemotherapy for ad within 4 weeks prior to the baseline visit (w0d1) 11. a live (attenuated) vaccine within 12 weeks prior to the baseline visit (w0d1) * history of anaphylaxis following biologic therapy. * history of allergy to corticosteroids, diphenhydramine, hydroxyzine, cetirizine, or fexofenadine.
observational study of roactemra/actemra (tocilizumab) in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of roactemra/actemra in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological dmards or with one biological agent. data will be collected from each eligible patient initiated on roactemra/actemra treatment by their treating physician according to approved label for 6 months from start of treatment.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe rheumatoid arthritis * inadequate response (or intolerant) to non-biological dmards or one biologic agent * patients initiating treatment with roactemra/actemra on their physician's decision (in accordance with the local label), including patients who started treatment with roactemra/actemra in the 8 weeks prior to the enrolment visit exclusion criteria: * roactemra/actemra treatment more than 8 weeks prior to the enrolment visit * previous roactemra/actemra treatment in a clinical trial or for compassionate use * enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra * history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
evaluate pharmacokinetics and safety of bms-986177 in participants with normal renal function and with moderate or severe renal impairment

Conditions: Thrombosis

Summary: assess the pharmacokinetics, safety, and tolerability of a single dose of bms-986177 in participants with normal renal function and moderate to severe renal impairment.


Eligibility criteria:
inclusion criteria: * participants in groups b and c will be classified by renal function by egrf at screening and confirmed on day -1 * participants in group a will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments * participants in group a must have a body mass index of 18.0 to 32.0 kg/m2, inclusive * females must be of non-childbearing potential exclusion criteria: * participants in groups b and c cannot have an indwelling catheter for hemodialysis * participants in groups b and c cannot have had, nor be waiting for, an organ transplant other protocol defined inclusion and exclusion criteria could apply
cell therapy of cancer with allogeneic blood lymphocytes activated with recombinant interleukin-2 (ril-2) for metastatic solid tumors

Conditions: Tumors

Summary: the present protocol is designed to investigate the potential application of allogeneic cell-mediated immunotherapy in metastatic solid tumors similarly to the well established graft versus leukemia (gvl) effects in patients with hematologic malignancies. patients with metastatic solid tumors resistant to conventional modalities will be eligible to participate in a treatment program based on the administration of non-myeloablative immunotherapy (i.e. fludarabine, cytoxan) followed by interferon injections; subsequently the patients will be treated with mismatched alloreactive donor lymphocytes activated in vitro and in vivo with ril-2. the aim of this study is based on the recognition of foreign tumor cell surface alloantigens.


Eligibility criteria:
inclusion criteria: consenting patients (age \< 70) will be eligible for participation in the study involving selective anti-tumor immunotherapy provided the following criteria are met: * evidence of cancer not expected to be cured with conventional modalities * pediatric patients: chemotherapy-resistant neuroblastoma stage 4 and sarcomas. adult patients: metastatic breast cancer, malignant melanoma, renal cell cancer and selected cases of ovarian cancer, gastrointestinal cancer, small-cell and non-small cell lung cancer with non-bulky metastatic disease, and metastatic prostate cancer. * patients with measurable disease evaluable for response with anticipated life expectancy \> 3 months. * patients must be \> 2 weeks off of anti-cancer or potentially immunosuppressive treatment. * adequate ambulatory performance status (karnofsky \> 80%; ecog 0-1) to enable outpatient treatment. * compliant and cooperative patients anticipated to be evaluable for response according to the investigator's assessment. * hla-compatible (fully matched or single locus mismatched) donor available for allogeneic stem cell transplantation. exclusion criteria: * patients with bulky disease or patients with brain metastases resistant to chemo-radiotherapy. * patients with a significant history or current evidence of potentially severe cardiovascular or lung disease, or other disease or clinical condition that may not permit accomplishing the planned treatment or drawing conclusions. * hepatic and/or renal failure. * evidence of serious active infection requiring antibiotic therapy. * pregnancy. * contraindication for donation due to donor disease: hiv-1; hepatitis b surface antigen (hbsag) positivity.

Keywords: metastatic solid tumor mismatch allogeneic cell mediated immunotherapy
diagnostic errors in anaphylactic shock

Conditions: Diagnostic Error

Summary: diagnostic accuracy and quality of management in anaphylactic shock is assessed in three conditions: expected, unexpected with no distractor, unexpected with distractor

participants: physicians taking part in voluntary workshops. participants are allocated to teams of three design: prospective, randomized, single-blind setting: simulated anaphylactic shock intervention: participants are allocated to 3 versions of the scenario: 1) expected, 2) unexpected but no distractor, 3) unexpected with distractor

Eligibility criteria:
inclusion criteria: * physicians taking part in voluntary simulator workshops exclusion criteria: * refusal to participate or to being videorecorded
bacterial and fungal microbiota of patients with severe viral pneumonia with covid-19

Conditions: Sars-CoV2

Summary: observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with sars-cov-2. covid-19 patients will be compared to historical critically ill controls with no sars-cov-2 infection.

observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with sars-cov-2. covid-19 patients will be compared to historical critically ill controls with no sars-cov-2 infection. respiratory and fecal microbiota (microbial and fungal) will be determined in covid-19 patients on bronchoalveolar lavage and rectal swab. inflammatory biomarkers will also be measured in covid-19 patients. characteristics of study patients will be collected at icu admission and during icu stay.

Eligibility criteria:
inclusion criteria: for the covid-19 group: with a confirmed severe lung infection with cov2-sars-cov2 admitted to the icu. for the control group: * historic cohort of non sars -cov2-infected adults admitted to the icu (between march and october 2019), * that was investigated for fecal microbiota in a previous study (control patients in a fecal microbiota study in patients included in the seat study). exclusion criteria: * for the covid-19 group: * lack of coverage patients who received antibiotic therapy within 6 weeks prior to covid-19 symptomatology, * pregnant women, * severe immunosuppression: neutropenia \< 0.5 g/l, chemotherapy \< 6 months, bone marrow transplant recipients, hiv with cd4+ lymphocytes \< 0.4 g/l * impossible to perform bronchoalveolar lavage, * non-socially insured, * refusal to participate in the social study
effects of respiratory physiotherapy in critically ill patients ventilated for more than 48 hours

Conditions: Mechanical Ventilation

Summary: this study aimed to determine the impact of providing chest physiotherapy on the duration of mechanical ventilation, intensive care length of stay, intensive care and hospital mortality in mechanically ventilated patients.


Eligibility criteria:
inclusion criteria: * patients aged more than 18 years, admitted to the icu needing mechanical ventilation for longer than 48 hours exclusion criteria: * patients with ventilatory failure due to neuromuscular dysfunction