Kornimate/medical-research-clean huggingface dataset:
effect of bacillus subtilis de111® on daily bowel movements

Conditions: Bowel Movement Regulation; Occasional Constipation; Occasional Diarrhea

Summary: the purpose of this study is to determine the efficacy of bacillus subtilis de111® probiotic for regulation of bowel movements.

the purpose of this study is to determine the efficacy of the probiotic b. subtilis de111® for regulation of bowel movements. a single capsule containing 1 x 10\^9 cfu b. subtilis is to be consumed once a day per participant. 50 adults (18-65 years of age at the time of participation) suffering from occasional constipation and/or diarrhea will be enrolled. participants will be double-blindly and randomly assigned to either the probiotic (bacillus subtilis) or the placebo (maltodextrin) group. efficacy will be assessed with participant-reported bowel movement (bm) records. as a secondary outcome, the study will provide further insight into the tolerance of the supplement. tolerance will be assessed using a digestive health questionnaire and blood samples to analyze pertinent metabolic biomarkers. participants will be asked to complete a daily dietary intake record as well. prior to capsule consumption, participants will complete a two-week pre-testing phase in order to provide a more inclusive diagnostic baseline. this phase will consist of daily bm and dietary intake record keeping.

Eligibility criteria:
inclusion criteria: * participants suffering from occasional constipation and/or diarrhea will be eligible for participation. exclusion criteria: * blood crp levels for each participant will be monitored at days 0, 60 and 105 of this study. participants with crp levels greater than 5mg/l on day 0 of the study will be excluded from further participation as this level is indicative of underlying inflammatory bowel disease. participants excluded under such conditions will be instructed to seek further treatment with their health care provider.

Keywords: bowel movement regulation occasional constipation occasional diarrhea gastrointestinal health
post marketing study on pluvicto in korea

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: post marketing study on pluvicto in korea

this is open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of pluvicto in patients with mcrpc in the real-world setting in south korea.

Eligibility criteria:
inclusion criteria study participants eligible for inclusion in this study must meet all of the following criteria: 1. male adult patient age ≥ 18 2. subject who are being treated with pluvicto or whose treatment plan is finalized and scheduled to be administered at the time of consent by physician in accordance with the approved indication in south korea 3. subject who provided the written informed consent prior to the study enrollment exclusion criteria study participants meeting any of the following criteria are not eligible for inclusion in this study: 1. subject whose medical record is not accessible 2. subject who is not willing to provide the informed consent

Keywords: metastatic castration-resistant prostate cancer mcrpc pms rmp pluvicto korea
alternate day vs. daily iron supplementation in iron depleted women in the philippines

Conditions: Iron-deficiency

Summary: iron is very important for our body and performs vital tasks. iron deficiency is a worldwide health problem. the prevalence of anemia in women of reproductive age in southeast asia is estimated to be 46.6% in 2019, with iron deficiency being one of the main reasons for anemia. there are different approaches to treat iron deficiency. one of them is the use of iron supplements. recommended iron supplement treatments today often differ in dose, regimen and length. experts recommend a dose of 80-200 mg of iron taken either daily or on several days per week, depending on the severity of the iron deficiency (with or without anemia). from certain guidelines lower amounts of iron are also recommended, as this could lead to fewer side effects.previous studies have shown that both daily and multiple days per week administration can be effective in treating iron deficiency. recently, several successive iron supplementation studies in zurich showed that 24 h after ingestion of an oral dose of \>60mg iron, the absorption of iron in the body is impaired. in addition it was measured that iron supplements taken only every other day instead of every day are absorbed about 30-50% better and have fewer side effects. little is known about the long-term effect of this alternating regimen on iron status and side effects.with this 6-months study in the philippines, the investigators want to compare two different supplementation regimens with oral iron to see if there is any difference in the iron status, intestinal inflammation levels, and side effects, and therefore if it would be better to take the iron supplements every 2 days instead of daily.


Eligibility criteria:
inclusion criteria: * female, 18 to 45 years old, * sf levels \<25 µg/l, * hb levels 11-15.5 g/dl * normal body mass index (18.5-25 kg/m2), * in possession of a mobile phone on which the study app can be loaded * signed informed consent exclusion criteria: * elevated crp \> 5 mg/l * any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) affecting iron metabolism, * use of medication which may interfere with iron absorption, gut physiology and iron metabolism * consumption of iron supplements within 2 weeks prior to study start and of additional iron supplements during the study period * difficulties with blood sampling, * known hypersensitivity or allergy to iron or placebo capsules in the given amount (ferrous sulfate, mannitol, silica) * pregnancy, breastfeeding * known or suspected non-compliance, drug or alcohol abuse * cigarette smokers
impact of large-volume pleural effusions on heart function

Conditions: Bilateral Pleural Effusion

Summary: the physiologic basis for relief from dyspnea after therapeutic thoracentesis remains poorly understood. improvement of the heart and lung function may contribute to the dyspnea relief. but there is no data support this phenomenon. transthoracic echocardiogram (tte) is a non-invasive viewing of the heart, which can quickly assess the heart function through real-time images. the investigators performed thoracentesis on patients with large-volume pleural effusions, and utilized tte to access the change of heart and lung function before and after this medical procedure.

patients with large pleural effusions often experience dramatic and immediate relief from dyspnea after therapeutic thoracentesis. although this is a well-recognized phenomenon, the physiologic basis for such relief remains poorly understood. primary physiologic basis for the relief in dyspnea after thoracentesis may include the improvement of the heart and lung function. in some cases the improvement in breathlessness cannot be attributed to the improvement of gas exchange, due to the atelectatic lung(not fully expansion of the lung). transthoracic echocardiogram (tte) is a non-invasive, real-time viewing of the internal parts of the heart using ultrasound, which can get highly accurate and quick assessment of the various heart images, though which doctors can quickly assess a patient's heart valves and degree of heart muscle contraction.

Eligibility criteria:
inclusion criteria: 1. the estimated amount of effusion is above 500 ml; 2. drainage was not performed within 1 month before admission; 3. assigned informed consent. exclusion criteria: 1. physical weakness which is difficult to withstand the thoracentesis; 2. the happening of serious pleural reaction or reexpansion pulmonary edema on previous thoracentesis; 3. allergy to the anesthetic; 4. coagulation dysfunction, severe bleeding tendency; 5. serious mental illness who do not cooperate; 6. suspected with pleural hydatid disease; 7. skin infection around supine positioning; 8. severe heart function insufficiency who cannot lay on the back; 9. for a variety of reasons that cannot accept regular follow-up; 10. refused to sign the informed consent; 11. other conditions that is not suitable for the test.

Keywords: thoracentesis pleural effusions transthoracic echocardiogram lung volume measurements
personalized depression treatment supported by mobile sensor analytics

Conditions: Depression

Summary: the current best practice guidelines for treating depression call for close monitoring of patients, and periodically adjusting treatment as needed. this present study seeks to develop and investigate an innovative digital system, depwatch, that leverages mobile health technologies and machine learning tools to provide clinicians objective, accurate, and timely assessment of depression symptoms to assist with their clinical decision making process. specifically, depwatch collects sensory data passively from smartphones and wristbands, without any user interaction, and uses simple user-friendly interfaces to collect ecological momentary assessments (ema), medication adherence and safety related data from patients. the collected data will be fed to machine learning models to be developed in the project to provide weekly assessment of patient symptom levels and predict the trajectory of treatment response over time. the assessment and prediction results are then presented using a graphic interface to clinicians to help them make critical treatment decisions. the main question the present clinical trial aims to answer are as follows: 1. feasibility of the digital tool, depwatch, to assist clinicians in depression treatment and inform their clinical decision process 2. effectiveness of the digital tool, depwatch, to improve depression treatment outcomes all study participants will carry the depwatch app on their smartphones and wear a fitbit provided by the study team during the study period. they will also complete brief questionnaires via the app at specific time intervals throughout the study period.


Eligibility criteria:
inclusion criteria: * age 18 year or older * moderate level of depression as defined by a score of ≥ 11 on the 16 item quick inventory of depressive symptomatology (qids) self-report questionnaire * initiating a pharmacological treatment for depression as monotherapy or adjunctive treatment or reporting a dose increase with their existing depression treatment. exclusion criteria: * diagnosis of a primary psychotic disorder such as schizophrenia or schizoaffective disorder * currently active substance use disorder (within 1 month of enrollment) dominating clinical scenario * other clinically significant medical of psychiatric conditions that may adversely affect participants' study participation and/or affect their adherence to study protocol (as determined by study clinician) e.g., significant cognitive deficits

Keywords: depression smartphone
safety and efficacy of tp10, a complement inhibitor, in adult women undergoing cardiopulmonary bypass surgery

Conditions: Myocardial Ischemia; Coronary Arteriosclerosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency

Summary: the purpose of this study is to determine if the study drug (tp10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.

during cardiac surgery, a substance called "complement" is released by the body. this complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, or heart failure. the purpose of this study is to determine if the study drug (tp10), which blocks complement release, can reduce such side events and be taken safely in women.

Eligibility criteria:
inclusion criteria: * female * to undergo high-risk cardiac surgery with cardiopulmonary bypass pump (cpb) * cabg alone or with valve surgery exclusion criteria: * acute myocardial infarction (heart attack) within a 3 days of entering the study * conditions that may interfere with interpretation of electrocardiogram data * history of immune deficiency syndrome * planned supplemental cardiac surgery or other surgery * pregnancy or lactation

Keywords: cardiac bypass cabg complement activation
18f-fluciclovine pet/ct impact on predicting clinical outcome of 177lu-psma-617 therapy in patients with prostate cancer

Conditions: Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Metastatic Prostate Cancer; Male Urogenital Diseases; Prostatic Diseases; Urogenital Diseases, Male; Genital Diseases, Male; Neoplasms; Neoplasms by Site; Urogenital Neoplasms; Genital Neoplasms, Male

Summary: this a single-center, prospective, exploratory study. patients with metastatic castration-resistant prostate cancer (mcrpc) scheduled to undergo lutetium labelled prostate-specific membrane antigen radioligand therapy (lupsma rlt) at the west los angeles va (wla-va) will be imaged with a baseline f-18 fluorodeoxyglucose positron emission tomography/computed tomography 18f-fdg pet/ct and a 18f-dcfpyl pet/ct (18f-dcfpyl (2-(3-{1-carboxy-5-\[(6-18f-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography/computed tomography , as per standard of care in our institution. all patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (psma pet) after the 2nd, 4th, and 6th lupsma rlt cycle. in this prospective study, an18f-fluciclovine positron emission tomography/computed tomography ( axumin pet/ct )will be additionally obtained at baseline (pre-lupsma rlt), and after the 2nd, 4th, 6th lupsma rlt cycles. axumin pet/ct will be acquired within 7 days from the psma pet. this study is open to veterans only.

the imaging analysis will consist in obtaining quantitative measurements of lesion uptake on the pre- and post-lupsma rlt (lesion and whole-body suvmax, suvmean and tumor volume) at each time point on all pet/ct scans. pet metrics at the lesion- and whole-body level will be compared among different pet radiopharmaceuticals at the same time point, and changes over time will be assessed. all patients will be followed-up at our institution and clinical outcome will be correlated to the imaging analysis assessment.

Eligibility criteria:
inclusion criteria: * patients with mcrpc scheduled to undergo lupsma rlt. * willingness to undergo multiple serial pet/ct scans pre- and post-lupsma rlt. * ability of providing written informed consent. exclusion criteria: * less than 18 years-old at the time of radiopharmaceutical administration. * medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study procedures or compliance. * contraindications to lupsma rlt.

Keywords: prostate cancer pet/ct radioligand therapy metastatic castration-resistant prostate cancer psma pet
new antigens against glioblastoma

Conditions: Glioblastoma Multiforme

Summary: in this study the investigators will select and develop potential therapeutic monoclonal antibodies (mabs) for glioblastoma (gb). activities include tissue microarray (tma) to test monoclonal antibodies specificity and target distribution, selection of glioblastoma specific functional monoclonal antibodies, identification of candidate targets.


Eligibility criteria:
inclusion criteria: * age \> 18 years; * written informed consent exclusion criteria: * not-availability of informed consent
current pharmacological practices in severe covid-19

Conditions: COVID-19

Summary: the investigators aim to understand the variation in pharmacological therapies for the management of severe coronavirus disease 2019 (covid-19) in india and compare it to the recent available evidence. the ongoing pandemic of covid-19 has proven to be the greatest medical emergency of recent times. the evidence on the therapeutics has evolved significantly in last few months after initial use of re-purposed drugs. the objective of this study is to understand the current practices in the management of adults severe covid-19 in india.

the ongoing pandemic of covid-19 has proven to be the greatest medical emergency of recent times. the response of the medical world to this crisis has been unprecedented. the healthcare workers are caring for patients at the frontline while, scientists and researchers are discovering vaccines or effective treatment in shortest possible duration. the scale and effect of pandemic in india, being second most populous country of the world is enormous. as of december 30, 2020, india has crossed 10 million cases and 148,000 deaths from covid-19. india has second most number of cases only after united states of america (usa) and with third largest number of deaths. the ministry of health and family welfare (under government of india) has given periodical clinical management guidelines, with last updated on july 5, 2020 (version 5). in adults, severe covid-19 is defined as presence of any of the following dyspnea, a respiratory rate of 30 or more breaths per minute, a blood oxygen saturation (spo2) of 93% or less, a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (pao2:fio2) of less than 300 mm hg, or infiltrates in more than 50% of the lung field while critical covid-19 is defined as presence of acute respiratory distress syndrome (ards), sepsis or septic shock. the mortality in critical covid-19 is reported to be 25-49% in different studies. the evidence on the therapeutics for covid-19 has evolved significantly in last few months after initial use of re-purposed drugs. there are no recent guidelines available based on the current evidence for clinical management of covid-19. the investigators are planning for nation-wide multicentre cross-sectional survey on understanding participating physicians practices on choice of different pharmacotherapeutic agents available in india as of january 2021. the objective of this study is to understand the current practices of participating physicians in the management of adult patients with severe covid-19 in india and to determine future priorities.

Eligibility criteria:
inclusion criteria: physicians who are involved in management of adult patients with severe covid-19 in india exclusion criteria: pediatrician physicians who are not managing severe covid-19 patients or refused to participate.
caudal versus s1 transforaminal epidural steroid injection for the treatment of unilateral s1 radiculopathy

Conditions: Lumbosacral Radiculopathy

Summary: to compare the efficacies of two different interventional techniques (caudal epidural steroid injection and s1 transforaminal epidural steroid injection) for the treatment of unilateral s1 radiculopathy.

epidural steroid injections are commonly performed for the treatment of radicular pain resulting from a disc herniation. there are 3 different methods to deliver steroids to epidural area which are caudal, interlaminar and transforaminal routes. lower lumbar and sacral radiculopathies can be managed with caudal epidural steroid injection which is generally quite easier to perform in comparison to transforaminal injection. transforaminal epidural injection provides injectate to reach anterior epidural area and is the most target specific technique among others. in the present study investigators aim is to compare the success rates of these two different procedures regarding unilateral s1 radiculopathy. the patients referring to the pain medicine outpatient clinic of a university hospital for unilateral radicular pain and diagnosed s1 radiculopathy were planned to be randomized into these two different intervention groups.

Eligibility criteria:
inclusion criteria: * unilateral radicular pain resulting from a paracentral l5-s1 disc herniation causing s1 nerve root compression. exclusion criteria: * history of previous surgery, pregnancy, neurological disorders, bleeding diathesis, contrast medium allergy, spinal disorders, rheumatologic diseases

Keywords: epidural injection radicular pain disc herniation lumbosacral radiculopathy transforaminal injection caudal injection
mucosal gene expression defects in ibd

Conditions: Inflammatory Bowel Diseases

Summary: this study investigated the mucosal gene expression defects associated with active crohn's disease (cd)and ulcerative colitis (uc), and studied the effect of infliximab induced downregulation of inflammation and mucosal healing on these abnormalities, using whole genome gene expression microarrays.

infliximab, a monoclonal igg1 antibody to the pro-inflammatory cytokine tumor necrosis factor-alpha (tnf-α), was the first efficacious biological therapy for ibd. infliximab dramatically improved the quality of life in ibd patients. besides inducing and maintaining remission in refractory ibd patients, infliximab has achieved new treatment goals such as intestinal mucosal healing and a reduction in hospitalizations and surgeries on the long-term. however, up to 30% of ibd patients do not respond to this costly therapy and potentially harmful therapy, and in an extra 20-30% response is incomplete. the mechanism of resistance to infliximab is unknown and predictors of response to infliximab are currently lacking. the aim of this study was to investigate the mucosal gene expression defects associated with active crohn's disease (cd)and ulcerative colitis (uc), and to study the effect of infliximab induced downregulation of inflammation and mucosal healing on these abnormalities, using whole genome gene expression microarray technology on endoscopic-derived intestinal mucosal biopsies from control individuals and patients with active ibd, and this before and after their first infliximab treatment. sixty-one patients with inflammatory bowel disease, 19 with crohn's colitis, 18 with crohn's ileitis and 24 with uc, undergo a colonoscopy with biopsies before and 4-6 weeks after the first infliximab treatment. response to infliximab was defined based on endoscopic and histologic findings. a control group of 12 individuals was also included.total rna was isolated from biopsies, labelled and hybridized to affymetrix hgu133plus2.0 array. microarray data were analyzed using bioconductor software and ingenuity pathway analysis software. quantitative real time rt-pcr and immunohistochemistry were used to confirm microarray data.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of inflammatory bowel disease (crohn's disease or ulcerative colitis) * patients with inflammatory bowel disease refractory to corticosteroids and/or immunosuppression who had never been treated with biological therapy (anti-tnf treatment). exclusion criteria: -

Keywords: gene expression microarray inflammatory bowel disease infliximab