Kornimate/medical-research-clean huggingface dataset:
cend-1 injection (qlc12102) in patients with advanced metastatic pancreatic ductal adenocarcinoma

Conditions: Pancreatic Cancer

Summary: the purpose of this study was to evaluate the preliminary safety, efficacy and pk characteristics of cend-1 in patients with advanced metastatic pancreatic ductal adenocarcinoma (chinese population).

this study is a multi-center, non-randomized, open-label phase ib/ii clinical study carried out in chinese patients with advanced metastatic pancreatic ductal adenocarcinoma.

Eligibility criteria:
inclusion criteria: * age: 18 to 80 years old, male or female. * patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma; * the eastern cooperative oncology group (ecog) score is 0 to 1. * the life expectancy is no less than 12 weeks. * according to the recist v1.1 evaluation criteria, the patient has at least one measurable lesion (exclude if there is only a target lesion located at a site previously treated with radiation); * the patient who is suitable for first-line treatment with a combined regimen of paclitaxel (albumin-bound type) and gemcitabine; exclusion criteria: * the patients who have been previously treated with chemotherapy or other drugs for pancreatic carcinoma, or who have been treated with other anti-cancer drugs, including chemotherapy, targeted therapy, immunotherapy, or biologics. * the patients who are known to be allergic to the investigatinal drug (cend-1 analogue) or its any excipient; * the patients with the following conditions: myocardial infarction, severe/unstable angina, nyha grade 2 or above cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention within 6 months before signing the icf; * the patients with symptomatic cns metastasis, leptomeningeal metastases, or spinal cord compression due to metastasis. however, the patients with symptomatic cns metastasis before first administration of the investigational drug, who is treated and stable for no less than 4 weeks, and the systematic hormone (any dose) treatment has been stopped for over 2 weeks, can be enrolled; * the patients with other active malignant tumors within 3 years before signing the icf. the cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast ductal, and papillary thyroid cancer are excluded. * the patients with human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome (aids), active hepatitis or co-infection with hepatitis b and c. * the patients who participated in any other drug clinical trial and administrated the investigational drug within 4 weeks before first dose;
exploring the gut-brain-behavior axis with biomarkers, probiotic efficacy, and artificial intelligence algorithms

Conditions: Autism Spectrum Disorder

Summary: this groundbreaking human study on the asd microbiome includes probiotic clinical trials, investigation of treatment biomarkers, machine learning/deep learning platform development for asd classification and prediction, and identification of diagnostic biomarkers. upon completion, the investigators anticipate publishing at least 12 sci papers and/or patents and establishing an auxiliary diagnosis platform for both clinical and academic purposes. the findings will offer new insights into the pathogenetic mechanisms, improving early detection, diagnosis, and treatment, ultimately advancing precision medicine for asd.

with an increased prevalence of autism spectrum disorder (asd) worldwide and in taiwan, asd demands urgent attention due to its lasting impact, unclear causes, and limited diagnostic and treatment options. recent studies highlight disruptions in the gut-brain axis, particularly in asd. building on pi gau's prior research on altered gut microbiota in autism spectrum disorder (asd), this proposed 4-year study aims to develop evidence-based probiotic intervention (gkb7) and treatment biomarkers for behavioral interventions (naturalistic developmental behavioral interventions, ndbi, and program for the education and enrichment of relational skills, peers®) through comprehensive assessments. the ultimate goal is to establish probiotic treatments and diagnostic/treatment biomarkers for asd utilizing a deep-learning multimodal auxiliary platform. specific aims: s.i to conduct a randomized, double-blind, placebo-controlled trial to assess the treatment effects of clostridium butyricum gkb7 on asd. s.ii to investigate the effect of ndbi intervention trials using metagenomics as the outcome measure. s.iii to evaluate the effect of peers® interventional trials with metagenomics as the outcome measure. s.iv to develop an artificial intelligence (machine/deep learning) multimodal auxiliary prediction platform that integrates environmental, behavioral/clinical, neurocognitive/imaging, and metagenomic data for asd diagnosis, subtyping, and impairment prediction. s.v to identify microbiome and metabolomic biomarkers and endophenotypes of asd, and to establish gut-brain-behavioral axes in asd.

Eligibility criteria:
inclusion criteria: * children and adolescents aged 4 to 15 who are clinically diagnosed with asd according to dsm-5 criteria and confirmed by the adi-r/ados. * caregivers cooperate with all the assessments and stool and blood collection. exclusion criteria: * a history of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression), neurological disorders, and substances use disorders. * difficulty following instructions. * consumption of antibiotics and yogurt or probiotic products two weeks prior to enrollment.
pre-exposure prophylaxis (prep) adherence enhancement guided by itab and drug levels for women

Conditions: HIV Prevention

Summary: the purpose of this study is to test a program that uses drug level monitoring, text messaging ("itab") and personalized counseling with hiv prevention services, including prep (medicine that can help prevent hiv infection when taken daily).

this is an open-label single-arm longitudinal clinical trial to estimate medication adherence and retention in a prep hiv prevention program that implements a combination intervention strategy that uses text-messages (itab) and a staged adherence counseling support strategy titrated from real-time drug levels in women at-risk for hiv acquisition. a total of 135 participants will receive the combined intervention of text messaging adherence reminders and adherence support. the text messaging system consists of daily, personalized, automated 2-way text messages to maintain adherence and retention. participants that have a low intracellular tenofovir diphosphate (tfv-dp) concentration will receive escalated, targeted adherence support. all participants will receive access to prep in accordance with standardized comprehensive methods of prescribing and clinical assessments that include safety monitoring as well as regular hiv and sexually transmitted infection (sti) screening. all participants will be followed for 48 weeks after enrollment and will receive a post study follow-up at 60 weeks. the primary endpoint will be measured at 48 weeks.

Eligibility criteria:
inclusion criteria: * female at birth and identifies as female gender * age 18 years or older * able to understand and provide consent in english or spanish * hiv negative by 4th generation test (ag/ab test) or combination of enzymeimmunoassay (eia) and hiv rna * creatinine clearance ≥ 60 ml/min (via cockcroft-gault formula) at-risk criteria (at least one): * condomless sex in the last 3 months with one or more male partners of unknown hiv status known to be at substantial risk of hiv infection (idu, bisexual, sex for goods, recently incarcerated, from a country with hiv prevalence \>1%, interpersonal partner violence); * sti (rectal or vaginal gonorrhea or syphilis) diagnosis during the last 6 months. * previous post-exposure prophylaxis (pep) use during the last 12 months. * has at least one hiv-infected sexual partner for ≥4 weeks. * sex for exchange of money, goods or services exclusion criteria: * pregnancy at enrollment. * any condition, which in the opinion of the provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to prep medication dosing, such as active, untreated or unstable major mental illness (i.e. untreated psychotic disorder). * use of prohibited medications, in particular, agents known to be nephrotoxic or drugs slow in renal excretion. * previous participation in an hiv vaccine trial. participants that were documented to have received only placebo are not excluded. * signs or symptoms suspicious for primary hiv infection (phi).

Keywords: prep pre-exposure prophylaxis hiv prevention
non-invasive biomarkers in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: background chronic airway inflammation is present in cystic fibrosis. non-invasive inflammometry may be useful in disease management. objective we studied 1) the ability of fractional exhaled nitric oxide and inflammatory markers (acidity, nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis factor-α, interleukin-2,-4,-5,-10) in exhaled breath condensate, to discriminate between cystic fibrosis and control children, and, 2) the relationship of biomarkers with control and severity of cystic fibrosis. methods in 98 children (48 cystic fibrosis / 50 controls), condensate was collected using a glass condenser. exhaled nitric oxide was measured using the niox®.


Eligibility criteria:
inclusion criteria: cf population * children known with cf were recruited from the outpatient clinics. cf disease was defined as a combination of typical clinical features (e.g. persistent pulmonary problems, meconium ileus, failure to thrive, steatorrhoe) and an abnormal sweat test (chloride \> 60 mm). uncontrolled cf was diagnosed by the paediatric pulmonologist based on a change in the presence or severity of respiratory symptoms in association with cf, and/or a decrease in lung function parameters compared to previous measurements during the last four weeks. control population * control children without lung disease were recruited from the outpatient clinic of the university hospital maastricht. the reasons of consultation were constipation and enuresis nocturna. all children completed the 'international study of asthma and allergies in childhood (isaac) questionnaire to exclude children with any (history of) airway or allergy complaints, in order to exclude asthmatic disease exclusion criteria: for both study populations: * diseases that may interfere with the results of the study (e.g. upper airway infection, heart disease, anatomic abnormalities of the airways and other chronic inflammatory diseases, such as crohns disease and rheumatoid arthritis) * mental retardation * inability to perform the ebc collection procedure * active smoking * use of the following medication: papaverin, sodium nitroprusside, angiotensin-converting enzyme (ace) inhibitors, oxymetazoline, l-arginine, or nitric oxide synthase (nos) inhibitors.

Keywords: childhood disease cystic fibrosis exhaled breath condensate exhaled nitric oxide airway inflammation non-invasive inflammatory markers controls children
clinical course of functional dyspepsia and factors predicting outcome in patients receiving medication-based treatment

Conditions: Functional Dyspepsia

Summary: functional dyspepsia (fd) is one of most common chronic gastrointestinal disorders. several types of drugs were demonstrated to be effective in reduction or remission of symptoms and severity of fd, including proton pump inhibitors (ppi), tricyclic antidepressant and prokinetics. however, the clinical course of fd after taking medication-based treatment was unknown. furthermore, 20-50% patients remained persistent or worsening of dyspepsia symptoms after treatment. previous studies have suggested psychological factors (eg. anxiety, sleep disturbance) were related to less improvement of symptoms in natural clinical course. however, there is limited evidence in terms of clinical and psychological factors for less improvement in patients receiving medication treatment for dyspepsia.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. patients who met rome iv criteria 3. normal upper endoscopy and abdominal ultrasonography within one year exclusion criteria: 1. patients with local or systemic diseases which may cause dyspeptic symptoms: known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; known acute or chronic injury of liver or kidney; obvious hematological abnormality, or endocrine and metabolic diseases; known malignancy; obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; other conditions which may be associated with dyspeptic symptoms (such as nsaids associated dyspepsia) 2. organ failure defined by marshall standard 3. severe psychiatric illnesses 4. known malignancy 5. pregnancy or lactation 6. unable to provide consent 7. suspected or identified bowel obstruction
deciphering the salutogenic effects of close relationships: psycho-physiological coregulation processes and their outcomes in couples coping with cardiovascular disease

Conditions: Acute Coronary Syndrome

Summary: the established attachment theory elucidates how early human bonds bring about functional neurophysiological alterations influencing the lifelong capacity for self and co- regulation within relationships. based on this framework, the study will investigate potential psycho-physiological co-regulation processes in couples coping with cardiovascular disease, which may explain the established link between relationship satisfaction and recovery outcomes. in the proposed prospective, longitudinal study, the investigators will follow 81 volunteer couples in which one member has experienced an acute coronary syndrome and assess their levels of interactive behavioral synchrony and the accompanying physiological synchrony (the mutual coordination of spouses' autonomic nervous systems), and stress buffering (reduced reactivity to stress in the individual) as assessed by heart rate variability, and galvanic skin response. it is hypothesized that higher levels of physiological synchrony and stress buffering will be associated with enhanced behavioral synchrony in the lab as well as patient outcomes three months later, on three dimensions: emotional (anxiety and depression reduction); behavioral (smoking cessation, medication adherence, cardiac rehabilitation participation) and physical (weight reduction, increased fitness).


Eligibility criteria:
inclusion criteria: * first acute coronary syndrome * in a committed relationship lasting over a year * registration at the cardiac prevention and rehabiliation center (cprc) exclusion criteria: * a history of previous cardiac events * a diagnosis other than acute coronary syndrome, co-morbid conditions (such as cancer), * lack of hebrew as a native language. * exclusion criteria for partners will be severe co-morbid conditions with life expectancy of less than 6 months (such as advanced cancer) and lack of hebrew as a native language.
gadoxetic acid-enhanced mr evaluation of hepatocellular carcinoma and dysplastic nodules in the cirrhotic liver

Conditions: Liver Cirrhosis; Carcinoma, Hepatocellular

Summary: a prospective intra-individual study to investigate the diagnostic performance of gadoxetic acid-enhanced mr for the patients with liver cirrhosis using thin-section whole-explant as standard of reference

liver cirrhosis is a progressive, diffuse disease of the liver characterized by hepatocyte necrosis, fibrosis, distortion of the normal hepatic architecture and a spectrum of nodular lesions that includes regenerative nodules (rn), dysplastic nodules (dn) and hepatocellular carcinomas (hcc). since hcc is the leading cause of death among the patients with liver cirrhosis, early and accurate diagnosis of hcc and its precursors by using optimal imaging technique is critical for its treatment and management. recently state-of-the-art magnetic resonance (mr) imaging with gadoxetic acid, which works both an extracellular and hepatocyte-specific contrast agent, has been increasing used to evaluate the patients with liver cirrhosis. several studies correlated gadoxetic acid-enhanced mr of hcc and hepatocellular nodules with the pathology from biopsy or surgical resection specimens. however, all of those studies are limited by its lack of complete correlation between pathologic and imaging findings and the resulting bias being toward the positive studies. ideally, the use of whole explant pathologic correlation would be helpful for exact characterization of hcc and its precursors on gadoxetic acid-enhanced mr. the question of our study is how accurate gadoxetic acid-enhanced mr is in the evaluation of the patients with cirrhotic liver to detect hcc and dysplastic nodules and, by using thin-section whole-explant correlation following liver transplantation as the reference standard.

Eligibility criteria:
inclusion criteria: * patients with known liver cirrhosis based on either histology, or a combination of physical examination, laboratory tests, and imaging data * patients with known liver cirrhosis based on either histology, or a combination of physical examination, laboratory tests, and imaging data exclusion criteria: * patients under 20 years of age * patients who have more than 10 nodules detected on hepatobiliary phase of gadoxetic acid-enhanced mr * patients who underwent transarterial chemotherapy or radiofrequency ablation * women who are pregnant, lactating or who are of childbearing potential * patients with any physical or mental status than interferes with the signing of informed consent * patients with a contraindication for mr * patients with impaired renal function (e.g. acute renal failure or egfr \< 30 ml/min/1.73m2) or patients on dialysis

Keywords: magnetic resonance image gadoxetic acid hepatocellular carcinoma liver cirrhosis
misoprostol for preventing postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: this hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 iu) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. the primary outcome will be measured blood loss of =\>500 mls within one hour after enrollment.


Eligibility criteria:
inclusion criteria: * women who have given birth to 1 or more live-born infants (para 1 or more) * vaginal delivery exclusion criteria: * refusal or inability to give informed consent * delivery regarded as abortion according to local gestational age limits * inability to take misoprostol sublingually * cesarean section * assisted vaginal delivery

Keywords: misoprostol active management postpartum hemorrhage maternal morbidity anemia developing countries
the sputum colour chart as a predictor of lung inflammation and proteolysis in non-cystic fibrosis bronchiectasis

Conditions: Non-cystic Fibrosis Bronchiectasis; Healthy

Summary: non-cystic fibrosis bronchiectasis patients (and controls) were recruited for the study. the investigators' aim was to study the relevance of clinical parameters in terms of underlying disease severity, proteolysis and inflammation in a diverse non-cystic fibrosis bronchiectasis population.

patients from the non-cystic fibrosis bronchiectasis (ncfb) outpatient clinic were recruited in our study from september 2009 till july 2010. control healthy subjects were recruited among peers of the patient or hospital staff during the same period. for the ncfb patients, underlying etiologies of ncfb and pseudomonas aeruginosa (pa) colonization status were analyzed and each patient was evaluated by means of spirometry (fvc and fev1), leicester cough questionnaire (lcq) and sputum colour chart (scc). scc assessment was both done by letting the patient predict his sputum purulence prior to sputum induction and by scc scoring after sputum harvest by the physician.

Eligibility criteria:
inclusion criteria: * diagnosis of ncfb, based on ct findings of bronchiectatic disease in the absence of cystic fibrosis (cf) as a cause. * stable exclusion criteria: * no recent exacerbation
the oxford optimisation of pci study (oxopt-pci study)

Conditions: Coronary Artery Disease

Summary: the oxopt-pci study addresses patients with coronary artery disease who are referred to the john radcliffe hospital because of the need for treatment with an intra-coronary stent (metal scaffold) for clinical reasons. although, this has become a highly standardised procedure it is still challenging for the clinician to assess the final success of this procedure at the end of intervention with conventional methods. this shortcoming can potentially translate into a worse clinical outcome for approximately 10 percent of all patients treated with an intra-coronary stent for this type of disease. this study (oxopt-pci) investigates if the use of blood flow measurements (namely measurement of fractional flow reserve (ffr)) and intravascular imaging (namely optical coherence tomography (oct)) after the implantation of a stent can improve the treatment result for these patients. both, ffr and oct are being used already in daily clinical routing but their usefulness especially in combination is not clear. in order to standardise the optimisation procedure we developed a specific algorithm to make sure that all patients receive the same optimisation measures based on the assessment of ffr and oct. the benefit of this specific optimisation algorithm will be assessed by measuring 1) indices of coronary blood flow, 2) intravascular imaging at the end of the procedure, and 3) by contacting the patients 12 months after stenting to verify the clinical mid-term success.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study * angiogram shows haemodynamically relevant lesion suitable for pci and suitable for the use of intravascular imaging (oct) exclusion criteria: * patients in whom safety or clinical concerns preclude participation * st-segment elevation myocardial infarction * presentation with cardiogenic shock * revascularization by mean of balloon angioplasty without stenting * contraindications to adenosine
study of the pf-04958242 blood concentrations of a capsule formulation of pf-04958242 compared to a solution formulation

Conditions: Healthy

Summary: this study will assess the relative bioavailability of a capsule formulation of pf-04958242, relative to a oral solution formulation of pf-04958242 in healthy adult subjects.

this study was previously posted by pfizer, inc. sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * healthy male and/or female (of non childbearing potential) subjects between the ages of 18 and 55 years * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * any condition possibly affecting drug absorption (eg, gastrectomy).

Keywords: pf-04958242 bioequivalence pharmacokinetics schizophrenia