Kornimate/medical-research-clean huggingface dataset:
study of the composition and bacterial diversity of the vaginal microbiota in healthy versus pathological conditions (bacterial vaginosis) using a targeted metagenomic approach (rna 16s)

Conditions: Vaginosis, Bacterial

Summary: it aims to determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).


Eligibility criteria:
inclusion criteria: * woman aged between ≥ 18 and ≤ 45 years old, * in good general health (outside the gynaecological sphere), i.e. no chronic pathology and not taking medication at the time of inclusion and/or long-term, * woman with a healthy or pathological vaginal flora according to amsel's clinical diagnosis and nugent's score : population with bacterial vaginosis (verification of at least the following 3 criteria + nugent score): * vaginal ph \> 4.5 * greyish, homogenous vaginal secretions adhering to the vaginal wall * characteristic vaginal odour of "rotten fish" after contact of the vaginal discharge with a few drops of 10% potash ("sniff test") * presence of "clue cells" in the microscopic examination of fresh vaginal secretions. clue cells are cells of the ectocervix lined with gram-negative bacilli. * nugent score ≥ 7 healthy population (verification of at least 3 following criteria + nugent score) : * absence of vaginal ph \> 4.5 * no greyish, homogenous vaginal secretions adhering to the vaginal wall * no characteristic vaginal odour of "rotten fish" after contact of the vaginal discharge with a few drops of 10% potash ("sniff test"). * absence of "clue cells" on microscopic examination of fresh vaginal secretions. clue cells" are cells of the ectocervix lined with gram-negative bacilli. * nugent score ≤3 * able and willing to participate in the research by complying with the procedures of the protocol, especially regarding vaginal sampling, * having given its free, informed and written consent. exclusion criteria: * patient during menstruation, * patient who has had vaginal sex within 48 hours, * patient with irregular menstrual cycles, * patient undergoing preventive or curative treatment for vaginal infections, * patients suffering from other diseases of the vagina (herpes, chlamydia, syphillis), * patients undergoing antibiotic or antifungal treatments or taken less than 3 months ago, * patient under probiotic or prebiotic complementation or taken less than a month ago, * patient with systemic or immunodeficient disease, * patient with an alcohol consumption of more than 2 glasses per day, * pregnant or breastfeeding woman, or woman planning to become pregnant within the next 8 weeks, or woman in the post-partum period, * patient unable to understand information related to the study (mental or linguistic disability), * patient participating or having participated within the previous 3 months in another clinical trial, or in a period of exclusion from a clinical trial, * patient not affiliated to a social security scheme.

Keywords: bacterial vaginosis
the role of spreader flaps in preventing of nasal obstruction

Conditions: Nasal Obstruction

Summary: nasal obstruction is a preventable complication of rhinoplasty, for which the spreader graft is the gold standard. more recently, the spreader flap technique has been espoused as an alternative to spreader grafting. herein we evaluated the efficacy of this technique in a randomized trial setting.

rhinoplasty is a common facial plastic surgery procedure, one complication of which is nasal vault narrowing and consequent nasal obstruction. recently, researchers have paid much attention to nasal valve area and especially to the role of upper lateral cartilage (ulc) in preserving of nasal patency, since a possible consequence of destructive techniques was permanent functional problems for patients. in addition to functional problems, it can cause some aesthetic problems such as the inverted-v deformity . accordingly, reconstruction of the midvault after dorsal reduction has been advocated and widely adopted. the gold standard for midvault reconstruction after dorsal reduction has been the spreader graft, first advocated by sheen . subsequently, its usage has been widened to include repair of the valve in the unoperated nose, and its efficacy well-documented. however, it can be a time-consuming procedure that requires the harvest of septal cartilage. therefore, some authors proposed the spreader flap as an alternative technique. while the results of the above mentioned articles proposed the efficacy of spreader flaps, none of them was a randomized trial and subjective methods were used for measurement of nasal breathing after rhinoplasty. nasal obstruction can be evaluated in different methods, both quantitative and subjective, the validity of each debated. for example, while the numeric form of visual analogue scale (vas) is commonly used, it is ultimately related to patients' subjective perception. alternatively, objective evaluation of nasal patency is also of common interest to many researchers, and various methods for objective measurement exist. among these different methods, acoustic rhinomanometry is an effective tool. however, some researchers debate the reliability of these results. herein we examine the efficacy of the spreader flap in preventing nasal obstruction after dorsal reduction using a randomized trial with both objective and subjective measures.

Eligibility criteria:
inclusion criteria: * patients who underwent rhinoplasty exclusion criteria: * revision rhinoplasty * congenital malformations * severe allergic rhinitis * nasal polyposis * sinusitis * deviated nose
comparison of the quadratus lumborum block and ilioinguinal iliohypogastric nerve block

Conditions: Post Operative Pain; Inguinal Hernia; Quadratus Lumborum Nerve Block

Summary: perioperative and postoperative pain control in pediatric patients is a frequently neglected issue. regional anesthesia applications reduce adverse drug events by minimizing opioid consumption and provide effective and safe analgesia. in recent years, quadratus lumborum block has emerged as an alternative regional anesthesia technique and it has been shown to provide analgesia as effectively as caudal block in children, and in a limited number of studies it has been said that it is more effective than transversus abdominis plane block. there are few studies in the literature comparing ilioinguinal iliohypogastic nerve block and quadratus lumborum block in children.

perioperative and postoperative pain control in pediatric patients is a frequently neglected issue. providing effective perioperative analgesia reduces surgical stress, making the postoperative period more comfortable both physiologically and psychologically, effective postoperative pain control reduces the length of stay in the hospital, and also contributes to the long-term positive personality development of children. physiological, pharmacokinetic and pharmacodynamic differences in children delay the metabolism and excretion of systemic analgesics, resulting in a prolonged effect and an increased risk of apnea. regional anesthesia applications reduce adverse drug events by minimizing opioid consumption and provide effective and safe analgesia. caudal block, which is a common regional anesthesia practice in inguinal hernia surgery in children, has disadvantages such as motor block and urinary retention. with the introduction of ultrasonography, peripheral block techniques such as transversus abdominis plane block and ilioinguinal iliohypogastric nerve block have been shown to provide effective and safe analgesia and have replaced central blocks. in recent years, quadratus lumborum block has emerged as an alternative regional anesthesia technique and it has been shown to provide analgesia as effectively as caudal block in children, and in a limited number of studies it has been said that it is more effective than transversus abdominis plane block. there are few studies in the literature comparing ilioinguinal iliohypogastric nerve block and quadratus lumborum block in children. the purpose of the study to compare the postoperative analgesic effectiveness of quadratus lumborum block and ilioinguinal iliohypogastric block in pediatric patients who underwent unilateral inguinal hernia operation.

Eligibility criteria:
inclusion criteria: * who were scheduled for unilateral inguinal hernia operation * with american society of anesthesiologists (asa) physical score i-ii * aged 2-7 years exclusion criteria: * patients with coagulopathy * skin infection at the block application site * bupivacaine allergy * neuropsychiatric disease

Keywords: quadratus lumborum nerve block postoperative pain inguinal herniae ilio-inguinal iliohypogastric nerve block
safety of dtpa-ipv/hib & dtpa-hbv-ipv/hib, followed by dtpa-ipv/hib vaccine in infants who received hepatitis b vaccine

Conditions: Haemophilus Influenzae Type b; Diphtheria; Tetanus; Poliomyelitis; Acellular Pertussis

Summary: to assess the safety and reactogenicity of the dtpa-hbv-ipv/hib vaccine and dtpa-ipv/hib vaccine. this dtpa-ipv/hib vaccine given at 3 and 4 months of age is co-administered with gsk biologicals' rotavirus vaccine or placebo. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

single group study. subjects in gsk biologicals' rotavirus study (rota-028) in singapore will be enrolled in this study.

Eligibility criteria:
inclusion criteria * subjects must have been enrolled in the rota-028 study. * subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * subjects should have received two doses of hepatitis b vaccine: at birth and at approximately one month of age. exclusion criteria * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
substantially improving the cure rate of high-risk brca1-like breast cancer

Conditions: Breast Cancer

Summary: investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase iii study in target population (stage iii, her2-negative, brca1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue.


Eligibility criteria:
inclusion criteria: * women and men with stage iii adenocarcinoma of the breast harboring signs of a breast cancer with features of homologous recombination deficiency (hrd) * age of 18-65 years * the tumor must be her2-negative * treatment must start within 8 weeks after the last surgical resection * eastern cooperative oncology group (ecog) performance status 0-1 exclusion criteria: * previous radiation therapy * previous chemotherapy * any previous treatment with a parp-inhibitor, including olaparib * pre-existing neuropathy from any cause in excess of grade 1 * chronic concomitant use of known strong or moderate cyp3a inducers

Keywords: stage iii her2 negative homologous recombination deficiency (hrd)
prediction of hepatitis c recurrence in liver transplant recipients

Conditions: Complication of Transplanted Liver; Hepatitis C, Chronic

Summary: the purpose of the study is to look at cells of the immune system to see if the cells are different among people with different risk factors that have received a liver transplant. we will enroll 50 patients receiving liver transplant and their donors. both donor and recipient must participate in the order for the recipient to participate in the study. we will take blood samples from these patients and their donors.

to establish whether in-vitro donor-specific immune reactivity patterns can differentiate between those liver transplant recipients who are positive for the hepatitis c virus (hcv) who are at high risk and those who are at low risk for graft loss secondary to early recurrence of hcv. an assessment of the recipient's donor-specific immune status can be achieved by measuring t-cell activity, specifically alloreactive primed (donor-specific) t cell activity. it has been shown that detection of ifn-y in short-term enzyme-linked-immunosorbent-spot (elispot) assay is consistent with the presence of primed memory t cells (6). in the transplantation setting, t cells of an allograft recipient that secret ifn-y after short in-vitro exposure to donor cells represent a prior sensitization of recipient to donor antigens in vivo. clinically interpreted - this priming event may signify the presence of an up-coming, or an on-going, rejection episode. our limited preliminary data suggest an additional potential clinical value for the in-vitro assessment of donor-specific ifn-y production in predicting those liver transplant recipients at higher risk for recurrence of hepatitis c.

Eligibility criteria:
inclusion criteria: * patients must be \>18 years of age * chronic hcv infection (and cirrhosis) - group 1 * hcv rna positive pre-transplant - group 1 * liver cirrhosis not due to hcv infection - group 2 exclusion criteria: * all patients \< than 18 years of age * patients with hepatitis c infection * candidates receiving multi-organ combined transplantation * patients who have received a previous liver transplantation * patients who are unable to understand english

Keywords: hepatitis c virus hcv hepatitis c (and cirrhosis) liver cirrhosis not due to hcv infection
studying biological markers of fatigue in women with residual invasive breast cancer enrolled on clinical trial nsabp-b-45

Conditions: Breast Cancer; Fatigue

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to fatigue. purpose: this research study is looking at biological markers of fatigue in women with residual invasive breast cancer enrolled on clinical trial nsabp-b-45.

objectives: * to collect serial blood specimens at each time point that quality of life and patient-reported outcome assessments are performed in women with residual invasive breast cancer concurrently enrolled on and participating in the behavioral and health outcomes component of clinical trial nsabp-b-45. * to prepare, separate, and store the blood specimens at the nsabp serum bank at baylor college of medicine breast center into components for future dna, rna, and plasma analysis. * to analyze specific proinflammatory cytokines, genetic polymorphisms, and rna expression arrays in collaborating laboratories at university of california, los angeles (ucla). * to examine the association between markers of inflammation and symptoms of fatigue among patients treated with sunitinib malate or placebo on clinical trial nsabp-b-45. * to examine the relationship between single-nucleotide polymorphisms in the promoter regions of il-1 and il-6 and symptoms of fatigue in these patients. * to examine the relationship between rna expression profiles and fatigue and compare the pattern of expression in these patients. outline: this is a multicenter study. patients undergo blood sample collection\* at baseline and then at 3, 6, 12, 18, and 24 months for analysis of plasma concentrations of inflammatory biomarkers (il-1ra, stnfrii, sil-6r, and c-reactive protein) by elisa; dna polymorphisms in the promoter regions of il-6 and il-1 by taqman pcr; and rna gene expression signaling pathways by rt-pcr assays and microarray. note: \*blood samples are collected at the same time points that the behavioral and health outcomes quality of life and patient-reported outcomes questionnaires are completed on clinical trial nsabp-b-45.

Eligibility criteria:
disease characteristics: * diagnosis of residual invasive breast cancer * stage ii, iiia, or iiib disease * her2/neu-negative disease * randomized to receive either sunitinib malate or placebo on clinical trial nsabp-b-45 * has not started therapy on clinical trial nsabp-b-45 * has completed baseline behavioral and health outcome questionnaires on clinical trial nsabp-b-45 * hormone-receptor status not specified patient characteristics: * menopausal status not specified prior concurrent therapy: * see disease characteristics

Keywords: fatigue her2-negative breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer
study of parkinson's early stage with deferiprone

Conditions: Parkinson's Disease

Summary: the goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in patients with parkinson's disease. participants will be randomized to receive one of four different dosages of deferiprone or placebo, and will take the assigned study product twice a day for nine months.

this study will enroll 140 patients who have been diagnosed with parkinson's disease within the last 3 years and are currently taking antiparkinsonian medication. there are four dosage cohorts, with patients in each cohort receiving either deferiprone tablets or placebo. at the baseline visit, participants will be randomized to a dosage cohort and to either active product or placebo within that cohort, and will take the assigned study product twice-daily for 9 months. they will come back to the study site for assessments at months 1, 2, 3, 4, 5, 6, and 9, and will need to have their blood count checked weekly, at either the study site or a local laboratory.

Eligibility criteria:
inclusion criteria: * male or female aged ≥18 to \< 80 years * body weight ≥60 kg but ≤100 kg * parkinson's disease diagnosed * absolute neutrophil count (anc) ≥1.5 x 10\^9/l (≥1.0 x 10\^9/l for black population) at screening * on a stable dose for at least 3 months prior to the screening visit of any of the following treatments at an l-dopa equivalent daily dose of up to 600 mg: * dopaminergic agonist alone * l-dopa alone * combination therapy with dopaminergic agonist and l-dopa * rasagiline * at an early stage of the disease, without motor fluctuations and/or l-dopa-induced dyskinesia exclusion criteria: * diagnosis of parkinson's disease more than 3 years prior to screening visit * hoehn and yahr stage ≥ 3 * atypical or secondary parkinsonism without dopa-sensitivity (e.g., vascular parkinsonism, supranuclear palsy, multisystem atrophy) * progressing axis i psychiatric disorders (psychosis, hallucinations, compulsive disorders, substance addiction, bipolar disorder, severe depression, anxiety) as assessed in a semi-structured interview in accordance with the diagnostic and statistical manual of mental disorders * not stabilized in terms of the current antiparkinsonian therapeutic regimen: already requires dose adaptation and/or is likely to require any change in dopamine therapy over the duration of the trial * current treatment with bromocriptine * current treatment with any antiparkinsonian drug other than those listed in the inclusion criteria * current treatment with coenzyme q10 or idebenone. (patients who are on these medications but stop taking them at least 2 weeks prior to baseline may be enrolled.) * current use of a deep brain stimulation (dbs) system. (patients who previously had a dbs system but have had it removed may be enrolled.)

Keywords: parkinson's disease deferiprone
interscalene block versus costoclavicular block for shoulder surgery

Conditions: Pain, Postoperative; Shoulder Pain; Surgical Procedure, Unspecified; Diaphragmatic Paralysis

Summary: interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. however, it is associated with a high incidence of hemidiaphragmatic paralysis (hdp) that may not be tolerated by patients with chronic pulmonary disease. this randomized controlled trial (rct) will compare ultrasound-guided interscalene block (isb) and costoclavicular infraclavicular block (ccicb) in patients undergoing arthroscopic shoulder surgery. the main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (pacu) as measured by a numerical rate scale (nrs) from 0 to 10. our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the pacu. the equivalence margin is set at 2 points.


Eligibility criteria:
inclusion criteria: * patients undergoing arthroscopic shoulder surgery * american society of anesthesiologists classification 1-3 * body mass index between 20 and 35 exclusion criteria: * adults who are unable to give their own consent * pre-existing neuropathy * coagulopathy * obstructive or restrictive pulmonary disease * renal failure * hepatic failure * allergy to local anesthetics * pregnancy * prior surgery in the corresponding side of the neck or infraclavicular fossa * chronic pain syndromes requiring opioid intake at home

Keywords: postoperative shoulder analgesia hemidiaphragmatic paralysis alternative blocks
covid-19 immune repertoire sequencing

Conditions: COVID; SARS-CoV 2; Corona Virus Infection; RDT; B Cell

Summary: this concerns a single-center prospective interventional cohort study. laboratory-confirmed covid-19 patients will be asked to donate blood at at least two different timepoints. this will allow us to investigate t and b cell evolutions during the course of infection and recovery. the expected duration of the study is four months or the total duration of the sars-cov-2 circulation in belgium (whichever is shortest).


Eligibility criteria:
inclusion criteria: * laboratory confirmed covid-19 acute infection * be older than 18 years of age * be hospitalized at the uza * willing and able to provide written informed consent by the participant or its legal representative (for instance in case of medical incapacitation) exclusion criteria: * younger than 18 years old * ambulatory patients