Kornimate/medical-research-clean huggingface dataset:
national, multicenter pms study "patient reported outcome" in breast reconstruction following mastectomy with tiloop bra

Conditions: Breast Reconstruction After Mastectomy

Summary: this multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the tiloop® bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation. the objective of this clinical investigation is to establish the feasibility, efficacy and safety of the tiloop® bra.


Eligibility criteria:
inclusion criteria: the tiloop®bra is designed to assist oncologically indexed skin sparing mastectomy or subcutaneous mastectomy with preservation of the nipple-areola-complex during primary breast reconstruction, secondary breast reconstruction or corrective breast surgery. patients shall be included if they meet all of the following criteria: clinical criteria (reason): * women with indication of prophylactic operation or oncoplastic operation with support of a mesh implant * women with histologically confirmed breast cancer or precancerosis or genetic pre-existing conditions with increased risk of breast cancer or with a family history * the health of women must comply with ecog (eastern cooperative oncology group) performance status 0-2 study-related inclusion criteria - legal reasons: * patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation * patient information has been handed out and all written consents are at hand. * patient is between 18 and 70 years old. exclusion criteria: patients must be excluded if any of the following conditions exist or cannot be excluded: device-related exclusion criteria (contraindications): pathological or physical condition precluding such as: * pregnancy or breast-feeding patients * known intolerance to the mesh-implants under investigation. study-related exclusion criteria - medical reasons: * metastatic breast cancer * medicamentous regulated diabetes with blood sugar level \>250 * inadequate bone marrow function with neutrophil granulocytes \<1500 and blood plates \< 10000/µl * patient with known contraindication to mesh-implants or plastic-reconstructive breast operations study-related exclusion criteria - legal reasons: * lack of written patients informed consent. * lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol. * patient is institutionalized by court or official order (mpg§20.3). * participation in another operative clinical investigation. it is thought that the study-related exclusion criteria will not significantly influence the sample of the population under investigation.

Keywords: breast reconstruction mastectomy mesh breast cancer
combination of anti-pd-1 antibody and chemotherapy in metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the prognosis of pancreatic cancer is extremely poor. nccn guidelines recommend folfirinox or modified-folfirinox as the first-line chemotherapeutic regimen. studies have shown that immunotherapy with anti-pd-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. here investigators intend to compare the therapeutic effects of modified-folfirinox alone and the combination of modified-folfirinox and anti-pd-1 antibody in patients with metastatic pancreatic cancer.

metastatic pancreatic cancer patients will be enrolled in this trial. investigators will assign patients to the treatment after randomization. the primary endpoint is overall survival. response rate, progression-free survival, drugs related side effects and other endpoints events will be recorded and analyzed, to assess the combination treatment with modified-folfirinox and anti-pd-1 antibody could or couldn't benefit the patients with metastatic pancreatic cancer.

Eligibility criteria:
inclusion criteria: * •pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (pdac). * recurrent disease or metastatic disease (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced ct, mri, and chest ct. pet/ct or other imaging examinations would be used if necessary. * never receive any systematic treatment or progression after fisrt line gemcitabine base chemotherapy * ecog score 0 or 1. * serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x uln. * alt and ast are less than 2 x uln. * signed informed consent. exclusion criteria: * •history of participation of other clinical trails within 4 weeks * history of autoimmune disease or other condition receiving glucocorticoid treatment * history of receiving chemotherapy within 2 weeks * history of radiotherapy and molecular target therapy within 2 weeks * history if active tuberculosis * history of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma * major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment. * hematological precancerous diseases, such as myelodysplastic syndromes. * evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest ct scan or chest x-ray findings * previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications) * preexisting neuropathy \> 1 (nci ctcae). * immune deficiency syndrome, such as active tuberculosis and hiv infection. * allograft requires immunosuppressive therapy or other major immunosuppressive therapies. * severe serious wounds, ulcers or fractures. * clinical evaluation is unacceptable

Keywords: pancreatic cancer anti-pd-1 antibody
vitamin d deficiency and pregnancy rates in women undergoing frozen embryo transfer

Conditions: Infertility

Summary: vitamin d receptors are present and differently expressed in murine endometrium and ovary throughout the estrous cycle , whereas knock-out experiments have shown that vitamin d receptor null mice experience uterine hypoplasia and impaired folliculogenesis. only few retrospective studies examining the role of vitamin d levels in infertile patients have been published up to date, whereas results are strongly contradictory, with some supporting that maternal vitamin d deficiency is associated with lower pregnancy rates and others demonstrating that vitamin d deficiency does not affect final reproductive outcome. finally, a recent retrospective study postulated that vitamin d deficiency may negatively affect pregnancy rates with an effect mediated through the endometrium, given that vitamin d deficiency was not correlated with ovarian stimulation characteristics or with markers of embryo quality in this study. in order to examine a potential negative effect of vitamin d deficiency on pregnancy rates, mediated through the endometrium, the aim of the current study was to examine the impact of vitamin d levels on pregnancy rates only in an infertile population undergoing embryo transfer of frozen-thawed embryos.


Eligibility criteria:
inclusion criteria: * all women undergoing a frozen et with 1 or 2 day 5 (blastocyst stage) embryo * age 18-39 exclusion criteria: * women \> or = 40 years old * ivm et * uterine abnormalities

Keywords: infertility
tissue microarray of hematological malignancies

Conditions: Hematological Malignancies

Summary: the aim of the study is to create new tools for improving management of patients with hematological malignancies by combining extensive clinical data from patients newly diagnosed with hematological malignancies and innovative laboratory analyses made on available tissue samples in regional biobanks from these patients.

firstly, clinical information is collected on all hematological malignancies diagnosed in our hospital district area retrospectively between the years 2000 and 2019. clinical outcomes, laboratory results, clinically relevant diagnoses, characteristics defining clinical stage and established prognostic parameters are gathered. simultaneously a tissue microarray (tma) of diagnostic samples is compiled using representative annotated tissue areas. this tma is used in combination with additional control material to identify prognostic and predictive biomarkers. a combined microarray dataset of hematological malignancies (hemap) is utilized to point out genes of possible drug targets, disease specific markers, prognostic markers, or predictive markers. the clinical datasets and hemap dataset is ultimately utilized to gain knowledge, new tools for prognostication and diagnostics, and targets for treatment. artificial intelligence -assisted differential diagnostics will be tested.

Eligibility criteria:
inclusion criteria: * hematological malignancy/neoplasm exclusion criteria: * non-sufficient data available

Keywords: leukemia lymphoma biomarker prognosis myeloma myelodysplasia myeloproliferative disorder diagnostics tissue microarray proteomics genomics clinical outcome biobanking digitalization data mining hematology oncology pathology bioinformatics real world data hematological malignancy survival treatment response
a study evaluating the safety and pharmacokinetics of qtorin rapamycin 3.9% anhydrous gel in the treatment of adults with pachyonychia congenita

Conditions: Pachyonychia Congenita

Summary: palv-08 is a multicenter, open-label treatment (olt) study enrolling adults with pachyonychia congenita (pc) with genotyped keratin mutations krt6a, krt6b, krt6c or krt16 who were previously enrolled in the palv-05 (vapaus) trial. the purpose of this olt study is to investigate the safety of long term exposure and pharmacokinetics (pk) of qtorin rapamycin 3.9% anhydrous gel or "ptx-022".


Eligibility criteria:
key inclusion criteria: * completed the palv-05 (vapaus) study * agree to contraceptive use key exclusion criteria: * females who are pregnant or breastfeeding * concomitant use of sirolimus or any sirolimus-containing medications (systemic or topical) * any significant concurrent condition that could adversely affect participation and/or the assessment of the safety and efficacy in the study * prior or planned treatment, including surgery or other medically necessary intervention deemed by the investigator that could adversely affect participation and/or the assessment of the safety and efficacy in the study
a cross-sectional online survey among saudi arabian population in the age group 18-40 years to assess whole grain (wg) awareness, consumption levels, and dietary habits around breakfast

Conditions: Diet, Healthy

Summary: in this online survey conducted suing the yougov consumer insights panel, the primary aims of this study are to provide for the first time an estimate of consumer awareness regarding wholegrains; their definitions and knowledge of potential benefits in the saudi arabia adult population and the he estimated consumption amongst saudi consumers. secondary objectives are to assess the breakfast habit, oat consumption \& health concerns amongst saudi consumers; identify socio-demographic and consumer characteristics associated with breakfast consumption, the types of foods consumed at breakfast, and fill gaps in knowledge regarding breakfast eating habits, commonly consumed breakfast foods.


Eligibility criteria:
inclusion criteria: * participants in online panel survey * age between 18 and 40 years * current resident of urban saudi arabia in jeddah, riyadh, \& dammam exclusion criteria: n.a.

Keywords: whole grain breakfast habit consumer
amikacin pharmacokinetic profile in plasma and tissue after an administration using impregnated dressings in burned patient population

Conditions: Burn Patients

Summary: the loss of skin barrier function after burn causes increased susceptibility to infections, which are the leading cause of morbidity and mortality in burn patients. topical antibiotics are one part of the therapeutic arsenal available to treat these infections. pseudomonas aeruginosa and staphylococcus aureus are the two major colonizing agents found in this population of patients. the use of dressings impregnated with amikacin is a common practice. actually, there are no available data on local and systemic effects with this antibiotic. the study of tissue and plasma pharmacokinetics of amikacin is therefore very important to secure and optimize this singular use of amikacin and improve the care of burn patients. the objective of the study is to describe the plasma and tissue pharmacokinetics of amikacin after dermal administration and impregnated dressing to estimate the pharmacokinetic parameters and their variability in a burned population. secondary objectives are to assess on the one hand the relationship between the effectiveness of treatment and the concentration of antibiotic at the site of tissue infection, and on the other hand to assess the relationship between plasma concentration and the toxicity found of this treatment. we would like also to note the efficacy of the antibiotic treatment in terms of: need for repeat surgery (new skin graft), healing time and hospital length of stay. blood samples and skin biopsies will be made for each patient to day 3 and day 7 after the start of treatment. the knowledge about the tissue concentrations obtained and a possible systemic absorption will then provide additional safety data and optimize the conditions of use of these dressings (dosage, frequency of administration) for effective treatment and safe.


Eligibility criteria:
inclusion criteria: - skin infection of burn (whatever the surface, depth or location) supported by percutaneous administration of amikacin age greater than 18 years patient can be under guardianship or trusteeship patient may present with cognitive impairment patients receiving social coverage patient who understood the objectives of the study, agreeing to participate in the study and who signed informed consent (or for which a trustee or guardian signed an informed consent if necessary) patient mastering the french language exclusion criteria: minor patient or pregnant or lactating deprived of liberty patient patient does not have insurance coverage patient does not agreeing to participate in the study patient allergic to amikacin or other antibiotic aminoglycosides
childhood influenza immunisation invitation trial in schools

Conditions: Influenza, Human

Summary: this study will investigate whether influenza vaccine uptake by school-age children (in school-based clinics) can be increased by making behavioural-insight informed changes to the invitation process which encourage parents to return consent forms.

previous research has shown that small changes to the invitation phrasing and/or process informed by understanding and insights into behaviour can be used to increase a desired behaviour (e.g. uptake of health checks, reducing primary care antibiotic prescribing). this trial will determine whether a behaviour-insight informed invitation letter and/or reminder short message service (sms)/email message can increase return of consent forms and thereby increase uptake of childhood flu vaccine in schools. the trial will take place within the existing national childhood immunisation programme in participating areas in england. randomisation will be at the school-level (stratified by local authority). all eligible children within a school will therefore be in the same arm of the trial and be subject to the same invitation process. outcome data will be routinely collected, school-level influenza vaccine uptake data. data will also be collected on the implementation of email/sms reminders in all schools. the analysis will investigate the main effects of the interventions and their interactions, take into account provider, local authority and school effects and explore the impact of other factors such as deprivation indicators. an analysis of letters used by providers of childhood influenza immunisation in schools not involved in the trial will also be conducted. all providers will be asked to submit a copy of their invitation letter for the 2016/17 programme and these will be analysed using the theoretical domains framework.

Eligibility criteria:
inclusion criteria: * attendance at a school where national childhood influenza immunisation programme is delivered by a provider participating in the trial * eligible for influenza immunisation exclusion criteria: * ineligible for influenza immunisation

Keywords: immunization behavioural insights children
accessible and affordable moisturizers for atopic eczema

Conditions: Childhood Atopic Dermatitis

Summary: aqueous (eua) cream, cetomacrogol (cmg) and emulsifying ointment (heb) are in south africa's essential drug list (edl) but are not available to most rural patients. to assess whether accessible moisturizers can be used as alternatives in atopic eczema (ad), a randomized controlled trial of patients with mild-to-moderate ad, aged 1-12 years was conducted. two separate sub-studies were conducted using a randomized controlled single (assessor) blind trial design. study 1 compared uea vs. liquid paraffin (unscented baby oil) for baths, all patients used heb as moisturiser. in study 2, 4 moisturisers were compared -heb, cmg, petroleum jelly and petroleum jelly/glycerine (2:1). assessments (scorad, poem, ness and iqdol) carried out at baseline, week 4, 8 and 12. routine topical steroids and antihistamines were continued as prescribed.


Eligibility criteria:
inclusion criteria: * patients with atopic dermatitis as defined by the united kingdom (uk) working party diagnostic criteria * atopic dermatitis patient with mild to moderate stable atopic eczema with parents/guardians willing and able to apply study moisturizers as directed and commit to attend all visits. exclusion criteria: * less than 1 year of age * patients with atopic dermatitis treated with systemic preparations

Keywords: atopic eczema moisturisers alternatives affordable
dose-ranging study of mometasone furoate (mk-0887/sch 032088) nasal spray in the treatment of children (ages 6-11) with seasonal allergic rhinitis (c95-161)

Conditions: Rhinitis, Allergic, Seasonal

Summary: the purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (mfns) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (sar). the mfns dose levels of 25, 100, and 200 mcg qd were compared with beclomethasone dipropionate (bdp), as an active control, and placebo.


Eligibility criteria:
inclusion criteria: * have at least a one-year history of seasonal allergic rhinitis which previously required treatment for tree and/or grass pollen * have a positive skin test response to an appropriate tree and/or grass seasonal allergen within the last year. * must be free of any clinically significant disease other than seasonal allergic rhinitis. * must be pre-menarcheal. exclusion criteria: * history of asthma which requires chronic use of inhaled or systemic corticosteroids. * current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. * history of rhinitis medicamentosa. * history of clinically significant nasal candidiasis. * history of multiple drug allergies or allergy/intolerance to corticosteroids or antihistamines. * history of upper respiratory tract or sinus infection that required antibiotic therapy within the previous 2 weeks, or viral upper respiratory infection within 7 days prior to screening. * history of nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow. * history of dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines. * history of investigational drug use in the last 30 days. * history of immunotherapy (desensitizing therapy), unless on a stable maintenance schedule for at least one month prior to screening.
assesment of the metabolomic signature in covid-19 patients

Conditions: COVID 19

Summary: metabolomics is the analysis of small molecules in a biological sample (cells, tissues or biological fluids). it can potentially detect very sensitively any change related to a pathology or exposure to a toxic agent. the analyses are fast, inexpensive and therefore applicable in routine, particularly in health care. given the emergence of this new disease, covid-19, there is a real need to better understand the pathophysiological mechanisms of sars-cov-2 infection. in this context, metabolomics could have a place and could lead to the development of interesting diagnostic or prognostic tools. the objective of this study is to identify, through the analysis of biological samples (blood and urine), whether there is a metabolomic signature in patients with covid-19.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age * affiliated to a social security scheme * consultant in the emergency department and/or being hospitalized for suspected sars cov infection * confirmation, after medical examination, of the need for a biological examination (this will negate the need for additional venipuncture) exclusion criteria: * patient who do not meet inclusion criteria * person subject to a guardianship order * opposition to the use of the data or samples (withdrawal of non-opposition) / sponsor's or investigator's decision
study investigating the safety and tolerability of multiple doses of pf-02545920 in subjects with schizophrenia

Conditions: Schizophrenia; Schizo-affective Disorder

Summary: to evaluate the safety and tolerability of multiple doses of pf-02545920 subjects with schizophrenia or schizo-affective disorder who are currently clinically stable and to evaluate the serum and urine pharmacokinetics of pf-02545920 and the n-desmethyl metabolite, pf-01001252, after multiple doses of pf-02545920 administered orally.


Eligibility criteria:
inclusion criteria: * subjects with dsm-iv diagnosis of schizophrenia or schizo-affective disorder for whom antipsychotic monotherapy is indicated. * subjects must be free from an acute exacerbation of psychosis for at least 3 months prior to screening. * current clinical global impression (cgi) of severity of illness score ≤ 3. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * evidence or history of a primary dsm-iv axis i diagnosis other than schizophrenia or schizoaffective disorder. * any condition possibly affecting drug absorption (e.g., gastrectomy).
comparison of the vividtrac® videolaryngoscope to direct laryngoscopy in adults under manual inline stabilization

Conditions: Endotracheal Intubation

Summary: this is a prospective randomized clinical study to be performed in adult patients ages 18 and older who are undergoing surgical procedures requiring endotracheal intubation. adult patients will be randomized to either the videotrac® laryngoscope or direct laryngoscopy and the time to intubation will be compared and recorded. patients in both treatment arms will receive manual inline stabilization. the study hypothesis is that the time to endotracheal intubation will be decreased in the vividtrac® video laryngoscope group when compared to direct laryngoscopy.


Eligibility criteria:
inclusion criteria: * patients will be 18 years old and older requiring endotracheal intubation exclusion criteria: * patients with increased pulmonary risk; * prior documentation of difficult endotracheal intubation; * elevated intracranial pressure; * those who lack legal representative consent

Keywords: breathing tube placement videotrac® laryngoscope direct laryngoscopy