Kornimate/medical-research-clean huggingface dataset:
lactobacillus brevis cd2 preventing oral mucositis

Conditions: Mucositis

Summary: a pilot study on efficacy of lactobacillus cd2 lozenges in preventing oral mucositis (om) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. to test whether the probiotic lactobacillus brevis cd2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning regimen induced om in patients undergoing hsct. clinical activity will be defined as reduction in the incidence of chemotherapy induced om in the patients undergoing hsct.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * karnofsky performance score ≥ 70%. * confirmed histological diagnosis of multiple myeloma for which hsct is as approved modality of therapy * patients eligible to receive high-dose chemotherapy as part of conditioning regimen * concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on) * serum creatinine \< 1.8mg/dl * total bilirubin \< 2mg/dl * liver enzymes within three times of normal limit * expected survival \> 6 months. exclusion criteria: * pregnant women and lactating mothers * patients with history of hiv infection * patients who have taken any other investigational product in last 4 weeks * patients having untreated symptomatic dental infection * patients with who grade 3 or 4 oral mucositis * other serious concurrent illness * inconclusive hematological diagnosis * patients with signs and symptoms of systemic infections * patient's/guardian's refusal to sign informed consent
pilot study of green tea extract (polyphenon e®)in ulcerative colitis

Conditions: Mild to Moderately Active Ulcerative Colitis

Summary: green tea consists of several components, with most research focusing on the polyphenol fraction. the polyphenol fraction(-)-epigallocatechin-3-gallate (egcg)has been studied extensively as an anti-inflammatory agent as well as a preventative agent for cancer. it has been shown to effectively reduce the inflammation associated with animal models of inflammatory bowel disease. this clinical trial will determine the ability of egcg, in the form of polyphenon e®, to treat patients with mild to moderately severe ulcerative colitis.


Eligibility criteria:
inclusion criteria: * adult male or female with mildly to moderately active ulcerative colitis exclusion criteria: * off prohibited medications for proscribed period of time * evidence of infectious colitis * labs outside of range * pregnancy or lactation

Keywords: ulcerative colitis egcg green tea polyphenols inflammatory bowel disease colitis ibd green tea
rdea3170 bioavailability study

Conditions: Gout

Summary: this is a phase 1, randomized, open-label, 4-way crossover pharmacokinetic (pk) and pharmacodynamic (pd) study in healthy adult male subjects designed to assess the relative bioavailability of rdea3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single rdea3170 10 mg tablet. this study will also assess the effect of a low-fat and high-fat meal on the pk and pd of rdea3170 10 mg tablets.


Eligibility criteria:
inclusion criteria: * subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity * subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2 * subject has a screening serum urate level ≤ 7 mg/dl * subject is free of any clinically significant disease or medical condition, per the investigator's judgment exclusion criteria: * subject has a history or suspicion of kidney stones * subject has undergone major surgery within 3 months prior to screening * subject donated blood or experienced significant blood loss (\> 450 ml) within 12 weeks prior to day 1 or gave a plasma donation within 4 weeks prior to day 1 * subject has inadequate venous access or unsuitable veins for repeated venipuncture * subject has a screening serum creatinine value above the upper limit of normal during screening or at day -2 (admission) * subject cannot swallow multiple tablets * subject is a heavy caffeine drinker * subject is unwilling to comply with the dietary restrictions of the study * subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the investigator, may interfere with participation in the study
taurolidine containing antimicrobial cied wash to prevent infection

Conditions: Cardiac Implantable Electronic Device Infection

Summary: from january 1st 2020, any cied procedure conducted with adjunct tauropace™ cied and pocket irrigation is enrolled in a consecutive manner and followed up in one centre. follow-up is prospectively. before that date any cied procedure conducted with adjunct antispetic pocket and cied irrigation is evaluated retrospectively to form a comparable group.

all the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution, which could be 3% hydrogen peroxide (h2o2), taurolidine in a galenic formulation or tauropace™ (tp, tauropharm, bavaria, germany), during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a cied system at the authors' institute. before 01/01/2020, the choice of antimicrobial solution was at the operator's discretion. these procedures were evaluated retrospectively. with change of policy on the first of january 2020, in every consecutive patient and procedure only tp is used. patients were enrolled and followed consecutively in order of appearance. all cied procedures performed at the author's institute between 01/01/2017 and 28/02/2022 are included for analysis. patients who receive the galenic taurolidine formulation were excluded from analysis.

Eligibility criteria:
inclusion criteria: cied procedure, signs pic exclusion criteria: pic not signed, minor

Keywords: cardiac implantable electronic device infection, taurolidine
reduced-intensity allogeneic hematopoietic stem cell transplantation for malignant hematological diseases

Conditions: Hematological Neoplasms; Hematopoietic Stem Cell Transplantation

Summary: to evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (asct) for malignant hematological diseases

primary endpoints: 1. engraftment of donor cells 2. regimen related toxicities secondary endpoints: 1. disease-free survival 2. overall survival

Eligibility criteria:
inclusion criteria: * performance status 0-2 * ejection fraction \> 30% * ast/alt and bilirubin not \> 4 times normal * creatinine clearance greater than 70 ml/min. * fev1 greater than 1.0 and diffusion capacity greater than 40% * age 18-75 years * patients must be at high risk for conventional regimen related toxicity * malignant hematologic disease that would otherwise be considered treatable with asct exclusion criteria: * does not meet the above inclusion criteria

Keywords: allogenic stem cell transplant hematologic diseases
study to evaluate a single dose of apixaban in pediatric participants at risk for a thrombotic disorder

Conditions: Thromboembolism

Summary: cv185118 is a single dose apixaban pk/pd study in pediatric participants. the objective of this study is primarily to study the pk/pd of apixaban in pediatric participants at risk for thrombosis


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * participants with any stable disease that are at risk for a venous or arterial thrombotic disorder * neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to \<18 years of age * gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age * neonates: defined as newly born (within 4 weeks) * participants with any functional cvad (central venous access device) in the upper or lower venous system exclusion criteria: * current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the bms medical monitor, could impact the absorption of the study drug * active bleeding or high risk of bleeding * inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube \[ng tube\] or gastronomy tube \[g-tube\])
crome/cobalt respiration study

Conditions: Heart Failure

Summary: the goal of this study is to compare measured respiration rates in various subject scenarios and use conditions between capnography and the crome and cobalt icd and crt-d mri surescan devices (derived using a holter recorder).

this study will enroll subjects who have already received a medtronic crome or cobalt icd or crt-d mri surescan device and who meet all of the inclusion criteria and none of the exclusion criteria. subjects will be asked to complete various breathing/exercise activities while connected to a capnography monitor and a holter recorder and respiration rates from both devices will be compared for accuracy, with the capnography monitor being the source of truth.

Eligibility criteria:
inclusion criteria: 1. subject has an active crometm or cobalttm icd or crt-d mri surescantm system which has been implanted for at least 30 days and which has not yet reached the recommended replacement time (rrt) 2. subject is implanted with one of the following models of a true bipolar right ventricular lead manufactured by medtronic: * model 6946m * model 6947 * model 6947m * model 6935 * model 6935m 3. subject is ≥ 18 years of age 4. subject (or subject's legally authorized representative) is willing and able to provide written informed consent 5. subject is willing and able to comply with study procedures exclusion criteria: 1. subject has existing condition that necessitates the use of supplemental oxygen 2. subject has active acute respiratory infection or respiratory disorder that may affect ability to perform breathing or exercise activities, as assessed by the investigator 3. any concomitant condition that might endanger the subject through participation in the study or interfere with study procedures, as assessed by the investigator 4. subject has an active or suspected lead integrity issue, in the opinion of the investigator 5. subject is enrolled in another study that could confound the results of this study 6. subject has nyha class iv heart failure
double carbapenem as rescue strategy for the treatment of carbapenemase-producing klebsiella pneumoniae infections

Conditions: Carbapenem; Klebsiella Pneumonia

Summary: an observational two-center case-control study exploring the clinical impact of double-carbapenem use in a population of critically il patients with severe carbapenem-resistant klebsiella pneumoniae infection


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. icu admission between november 2012 and december 2015; 3. documented cr-kp invasive infection; 4. targeted antibiotic therapy lasting ≥ 72 hours exclusion criteria 1. klebsiella infection, susceptible to carbapenems 2. duration of antimicrobial therapy less than 72 hours 3. data not completely available from the electronically medical chart
d-serine monotherapy for schizophrenia

Conditions: Schizophrenia

Summary: a first generation of clinical studies, performed during the last decade, demonstrates that adjuvant treatment with compounds that enhance nmdar-mediated neurotransmission due to their agonistic activity at the nmdar-associated glycine (gly) site (e.g. gly, d-serine (dsr)) leads to significant symptom reductions in chronic schizophrenia patients.furthermore, preliminary findings suggest that treatment with nmdar-gly site modulators may also be beneficial as antipsychotic monotherapy in the proposed project, during a three year period, 60 schizophrenia patients that fulfill treatment resistance criteria will be randomly entered in a 10 week, two phase (fixed/flexible dose), parallel group, double blind controlled study assessing the efficacy of olanzapine (ola) (up to 40 mg/day) vs. dsr (up to 4000 mg/day) as antipsychotic monotherapy.clinical, neurocognitive, electrophysiological, and amino acids (i.e. gly, dsr) levels assessments will be performed during the study. the specific aims of the proposed project are: 1) to assess the efficacy and safety of dsr as a new medication for treatment refractory schizophrenia, and 2) to assess dsr effects in terms of relevant amino acids serum levels, neurocognitive performance, and relevant brain electrophysiological parameters. the overall importance of the proposed project consists of its potential to lay the foundations for an innovative type of intervention for treatment resistant schizophrenia patients.


Eligibility criteria:
inclusion criteria: 1. age 18-70; 2. diagnosis of schizophrenia/schizoaffective disorder according to dsm-iv criteria. 3. stable dose antipsychotic treatment for at least 4 weeks; 4. treatment refractoriness according to kane et al.(1988) criteria. exclusion criteria: 1. meeting criteria for other dsm-iv axis i diagnoses ; 2. substance abuse or alcoholism during entire lifetime; 3. are judged clinically to be at suicidal or homicidal risk; 4. female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception; 5. patients with known intolerance to ola treatment or who have failed an adequate trial of ola (at least 6 weeks) at high doses (20 mg/day or higher); 6. patients treated with depot antipsychotics or ect within the eight weeks prior to study entry.

Keywords: schizophrenia treatment resistance d-serine olanzapine treatment refractory schizophrenia
a proof-of-concept study to evaluate the efficacy and safety of rozanolixizumab to treat adult study participants with severe fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: the purpose of the study is to evaluate efficacy and safety of rozanolixizumab to treat adult study participants with severe fibromyalgia syndrome (fms).


Eligibility criteria:
inclusion criteria: * study participant must be ≥18 years and ≤70 years of age at the time of signing the informed consent form (icf) * study participant with a diagnosis of fibromyalgia as defined by the 2016 revisions to the 2010/2011 fibromyalgia diagnostic criteria (american college of rheumatology preliminary diagnostic criteria) plus the following characteristics during the screening period: 1. brief pain inventory-short form (bpi-sf) interference score ≥6. 2. study participant has been diagnosed with fibromyalgia syndrome (fms) for at least 6 months. 3. study participant has been having fms symptomatology for at least 2 years before enrollment - capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the icf and in the study protocol exclusion criteria: * study participant has been diagnosed with fibromyalgia syndrome (fms) for \>15 years * study participant has any systemic autoimmune inflammatory disease * study participant has any medical or psychiatric or separate chronic pain condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study or the ability to assess fms-related pain * study participant has severe renal impairment, defined as estimated glomerular filtration rate \<30 ml/min/1.73 m\^2, (calculated using modification of diet in renal disease \[mdrd\] study equation), at screening visit * study participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator * study participant has chronic inflammatory demyelinating polyneuropathy * study participant has a current or medical history of primary immunodeficiency * study participant is pregnant or lactating * study participant * has suicide attempt in the past 2 years (including an active attempt, interrupted attempt, or aborted attempt), * or had suicidal ideation with at least some intent to act in the past 6 months as indicated by a positive response (yes) to either question 4 or question 5 of the columbia suicide severity rating scale (c-ssrs) at screening or baseline (visit 3); * or is otherwise judged clinically to be at a serious suicidal risk based on the investigator's judgment

Keywords: phase 2 fibromyalgia rozanolixizumab
prevention of injury in military settings through the use of body awareness.

Conditions: Traumatic Injury

Summary: the position project aims to investigate the cognitive mechanism of postural body awareness as a risk factor for injury and as a target for a primary prevention strategy based on the resource optimization of armed forces (roaf) method.

physical activity and sport play an important role in the military environment to develop and optimize the operational capability of warfighters. nevertheless, the prevalence of injuries is high and the identification of risk factors accessible to primary prevention measures is a major challenge for the protection of warfighter health. military epidemiologic data show that the majority of injuries are acute fall-type injuries following a loss of balance. these data suggest that the quality of postural balance may influence the occurrence of injuries encountered during military physical activities. the high level of stress to which individuals are exposed during military physical activities could contribute to the degradation of postural balance quality. the position project aims to study the cognitive mechanism of postural body awareness as a risk factor for injury and as a target for a primary prevention strategy based on the resource optimization of armed forces (roaf) method. roaf could improve postural control and decrease the intensity of the psychobiological stress response, and thus reduce the incidence rate of fall injuries occurring during military physical activities.

Eligibility criteria:
inclusion criteria: * signing an informed consent to participate in the study * enrolled in the selection camp * be affiliated to a social security system exclusion criteria: * advanced roaf formation (over 10 hours) * refusal to participate * person covered by articles l1121-5 to l1121-8 of the public health code, namely * pregnant women, women in labour or nursing mothers, * person deprived of liberty by judicial or administrative decision, * persons subject to psychiatric monitoring under articles l3112-1 and l3113-1 who are not covered by the provisions of article l1121-8, * adult persons who are subject to a legal protection measure or who are unable to express their consent.
effects of a treadmill gait training protocol in a gamified virtual reality environment with tdcs in parkinson's disease

Conditions: Parkinson Disease

Summary: the study aims to compare the effects of treadmill gait training in a gamified virtual reality environment with tdcs versus treadmill gait training in a gamified virtual reality environment versus treadmill training in people with parkinson's disease.

treadmill gait training has been stablished as a solid gait rehabilitation option for people with parkinson's disease. however, gait training by itself fails to address the cognitive aspect needed for safe walking, which could be affected by situations in which concurrent tasks must be managed simultaneously to gait. it also lacks motivational aspects key to keep people with parkinson's disease adhered to treatment. virtual reality and gamification are posed as useful tools to address both these issues, turning training into a more engaging activity and allowing complicated gait situations to be trained in a safe environment. transcranial direct current stimulation (tdcs) could be combined with these mentioned treatment options, which could reinforce the learning of motor and cognitive skills during training. the aim of this study is to evaluate the effects of the inclusion of a gamified virtual reality environment to a treadmill gait training program with tdcs in pd compared to the same training protocol with virtual reality and without it

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease * stage ii - iii in the hoehn and yahr scale during on state * ability to walk for 10 minutes independently without stop exclusion criteria: * significant cognitive decline based on mini mental status examination (mmse \<23) * severe auditory or visual deficits * other neurological/psychiatric conditions * any kind of cardiovascular complications that contraindicates physical activity * clinical history of any brain surgery or deep brain stimulation device

Keywords: virtual reality gamification tdcs treadmill gait training dual task
an exploratory investigation of a supplement to support student learning

Conditions: Concentration Ability Impaired; Mental Fatigue

Summary: in this trial, the herbal supplement (geniusdrops) will be tested to see the effects it has on the dependent variables of interest. participants will take the supplement twice a day for a month and respond to surveys at study baseline, midpoint, and the conclusion of the study. the findings of this study will be used for marketing materials and to inform future trials using the supplement.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form and a parental assent form * must be experiencing issues with focus, mood, and memory * must be looking to improve classroom performance * gets easily distracted exclusion criteria: * diagnosis of add or adhd * currently taking a prescription medication meant to treat add or adhd * diagnosed with additional conditions that would not allow them to adhere to the protocol. * willing to take a supplement targeting improving mood, concentration, and focus
metabolic syndrome in patients with first-episode schizophrenia

Conditions: Metabolic Syndrome X; Schizophrenia

Summary: the metabolic syndrome (mets) is highly prevalent in patients with schizophrenia and is a major risk factor of type-2 diabetes, cardiovascular disease and early death. genetic factors, antipsychotic medication, sleeping disturbances and unhealthy lifestyle are possible causes of developing metabolic syndrome. several studies have investigated the metabolic side-effects of antipsychotic medication. however it is still unanswered how unhealthy lifestyle, comprising physical inactivity, smoking, unhealthy dieting, and sleeping disturbances adds to the metabolic risk of patients with schizophrenia. the aim of this study is to investigate the prevalence and development of mets in first-episode patients with schizophrenia and 1 year after onset of treatment. the study's main hypothesis is that physical inactivity, regardless of medication, is an independent risk factor for metabolic syndrome in patients with schizophrenia. in comparison inpatients with major depression and healthy controls, both matched on gender, age and level of education will be included in the study. it is anticipated that the study's results will provide new knowledge about the risk of developing metabolic syndrome in first-episode schizophrenia and how different risk factors contribute to this.


Eligibility criteria:
inclusion criteria: * patients with icd-10 diagnosed schizophrenia exclusion criteria: * antipsychotic medication \> 6 weeks before inclusion * physical disability * pregnancy * iq\< 55