Kornimate/medical-research-clean huggingface dataset:
lactobacillus acidophilus and bifidobacterium animalis subsp. lactis, maintenance treatment in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine whether the lactic acid bacteria " lactobacillus acidophilus (la5) and bifidobacterium animalis subsp. lactis (bb12)" is effective as maintenance treatment in ulcerative colitis.


Eligibility criteria:
inclusion criteria: * patients with ulerative colitis ording to well-known diagnostic criteria and remission for at least one month, and with at least one relapse within the last year. exclusion criteria: * pregnancy and lactating * serious underlying disease other than uc * former gastrointestinal resections * medication for uc other than mesalazine * known allergic reactions towards compounds in the study drug. * expected lack of compliance due to mental state or language problems
effect of botox and vibration on bone in children with cerebral palsy

Conditions: Cerebral Palsy; Muscle Spasticity

Summary: cerebral palsy (cp) is a neuromuscular disorder that affects approximately 800,000 individuals in the u.s. an estimated 70-80% of these individuals have spasticity which affects ambulation and requires management. therefore, the treatment of spasticity is a primary goal of interventions for children with cp. one treatment widely used to reduce spasticity is botox because of its ability to temporarily paralyze a muscle. however, no studies have determined the effect of botox treatment on bone in humans. also, a low magnitude vibration treatment has been shown to improve bone structure in the lower extremity bones of children with cp. the aims of this study are: 1) to determine the effect of botox treatment in conjunction with a daily vibration treatment on bone mass and bone structure in children with spastic cp, and 2) to identify the mechanism that underlies the effect of botox and vibration on bone.

the investigators have been working with children diagnosed with cerebral palsy (cp) for the past 10 years. the investigators have found that bone structure is markedly underdeveloped and bone strength is severely compromised in children with cp. also, an increased fracture rate has been observed in the lower extremity bones of children with cp. there is evidence that botox, which is used to treat spasticity in cp, can improve motor function; however the effect of botox on human bone is unknown. there is also evidence that low magnitude vibration treatment can improve bone mass and bone structure. the overall goal of this current research study is to investigate the effect and mechanism of action of botox and vibration on bone in children with cp. the investigators will also examine the effect of botox on muscle volume. a total of 36 participants will participate in this study. the investigators will assess bone structure and muscle volume using mri. the investigators will assess bone mass using dual-energy x-ray absorptiometry (dxa).

Eligibility criteria:
inclusion (children with cp): 1. have spastic cp 2. between 2-12 years of age 3. recommended for botox treatment by their physician as part of their clinical care. those who accept botox treatment and those who do not accept botox treatment are both eligible for the study. 4. a score of 1-4 on the gross motor function classification scale (gmfcs) exclusion (children with cp): 1. botox treatment in the lower extremities within the last year 2. metal rods in both legs inclusion (typically developing children): 1. between 2 and 12 years of age. 2. match a child with cp for sex, age and race. exclusion(typically developing children): 1. neurological disorder 2. surgery in the lower extremities within the last year. 3. chronic medication use

Keywords: botox muscle strength
the inhibition of platelet antiaggregating activity of clopidogrel by atorvastatin detected by erythromycin breath test: a metabolic inhibition of hepatic cytochrome p450-3a

Conditions: Hypercholesterolemia; Thrombosis

Summary: the objective of this study is to determine if the action of the drug called clopidogrel, that you will start taking, will be decreased by another drug called atorvastatin, that you will also start taking. clopidogrel is an oral antiplatelet agent that has been shown to prevent strokes and heart attacks. atorvastatin is a cholesterol lowering agent. twenty adults 18-75 years of age requiring cholesterol-lowering agent and antiplatelet agent therapy will be recruited for this study during their cardiology clinic visitation. in one group, antiplatelet agent (clopidogrel) regimen will be administered first, then followed by cholesterol-lowering medication (atorvastatin). in the second group, atorvastatin will be administered first, followed by clopidogrel. a new test called the erythromycin breath test will be administered to you three times during the study to measure how your liver will metabolize these drugs. blood samples will also be obtained to assess platelet function. the criteria for exclusion are patient refusal or inability to give written consent, patients with allergic reaction to erythromycin, patients with known bleeding problems, liver disease, significant lung disease kidney disease and pregnancy. patients with psychiatric impairment and documented history of substance abuse will also be excluded from the study.


Eligibility criteria:
inclusion criteria: * males and females age 18-75 years of age without bias in racial and ethnic background, undergoing percutaneous coronary intervention requiring antiplatelet therapy: 1. patients presented to cardiology clinic requiring cholesterol lowering agent 2. patients presented to cardiology clinic requiring antiplatelet agent. exclusion criteria: * refusal or inability to give written consent * allergic reaction to erythromycin * have known bleeding problems, liver disease, significant lung disease kidney disease * pregnancy * psychiatric impairment and documented history of substance abuse

Keywords: platelet aggregation inhibitors cerebrovascular accident
london underground study - health effects of particulate matter

Conditions: Chronic Obstructive Pulmonary Disease

Summary: an average of 4.8 million journeys are made on the london underground every day and as the 'tube' has elevated airborne particulate matter concentrations compared to ambient air, this raises concern about the potential health impact of this environment. this study explores the health effects of particulate matter from the london underground on patients with copd and healthy volunteers. patients with copd and healthy participants will be invited to undertake a set 90 min journey on the london underground, and on a separate occasion (3-8 weeks apart), a 90 min journey on the london overground (as a proxy for a clean air london area while maintaining other aspects of a train journey). a series of clinical, physiological and inflammatory data will be collected before, during and after (at different time points) each of the sessions in order to compare their response in relation to exposure and/or to disease status.


Eligibility criteria:
inclusion criteria for both groups: * give informed consent * london resident for participants with copd: * gold stage 2 copd (fev1/fvc\ fev1\ fev1\<50%) and gold stage 4 (fev1/fvc\<70%;fev1\<30%) * no history of ischaemic heart disease for healthy volunteers: * no history of ischaemic heart disease. * normal lung function with no evidence of airflow obstruction. exclusion criteria for both participants with copd and healthy volunteers: * those with unstable ischaemic heart disease or copd. * current smokers and those who are ex-smokers of \<12 months duration. * those who work in the london underground or are occupationally exposed to - - high levels of vehicle traffic exposure on a frequent basis. * those who cannot walk for 30 mins. * involvement in another research study * those unable to give consent.

Keywords: copd chronic obstructive pulmonary disease particulate matter london underground
treatment of hepatorenal syndrome with terlipressin plus albumin vs albumin

Conditions: Cirrhosis; Hepatorenal Syndrome

Summary: hepatorenal syndrome is a common complication of cirrhotic patients. the prognosis of patients with hrs is very poor. it have been demonstrated that vasoconstrictors agents (terlipressin) plus albumin are effective in the reversal of the treatment. however, previous studies are pilot studies and they are not able to give information about an improvement in survival. this comparative randomized study was delineated to test the efficacy of terlipressin on survival.

phase 3

Eligibility criteria:
inclusion criteria: 1. patients with hrs type 1 or 2 with serum creatinine \>2 mg/dl 2. age between 18 and 75 years 3. written informed consent. 4. absence of exclusion criteria exclusion criteria: 1. hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule \> than 5 cm) 2. active infection with systemic inflammatory response syndrome 3. respiratory or cardiac dysfunction. 4. arteriopathy. 5. ischemic cardiopathy. 6. arterial hypertension ( \>140/90 mmhg during hospitalization )

Keywords: hepatorenal syndrome terlipressin albumin cirrhosis
phase 1/2, open label, dose escalation study of neod001 in subjects with light chain (al) amyloidosis

Conditions: Primary Amyloidosis

Summary: dose escalation study to determine the maximum tolerated dose of neod001 in approximately 30 subjects with al amyloidosis. expansion phase to evaluate safety, efficacy and pharmacokinetics of neod001 in 25 additional subjects at the maximum tolerated dose.

the purpose of the dose escalation phase of the study is to determine the maximum tolerated dose/phase 2 recommended dose of neod001 when given as a single agent intravenously in approximately 30 subjects with al amyloidosis. the purpose of the expansion phase of the study is to evaluate the safety, preliminary efficacy and pharmacokinetics of single agent neod001 at the maximum tolerated dose/phase 2 recommended dose in approximately 25 additional evaluable subjects.

Eligibility criteria:
inclusion criteria: 1. males and females aged ≥18 years; 2. ecog performance status (ps) 0-2; 3. diagnosis of systemic al amyloidosis (subjects with non-al amyloidosis are not eligible); 4. received at least one prior systemic therapy, which may include stem cell transplant, for al amyloidosis; 5. have adequate organ function; 6. ability to understand and willingness to sign informed consent prior to initiation of any study procedures. exclusion criteria: 1. secondary or familial amyloidosis; 2. life expectancy of \< 3 months; 3. symptomatic multiple myeloma; 4. hypersensitivities to other monoclonal antibodies; 5. known hiv infection; 6. women who are lactating; 7. any other condition or prior therapy, which in the opinion of the pi, would make the subject unsuitable for the study.

Keywords: al amyloidosis primary amyloidosis
dish data analysis study

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to perform extensive analyses of data from the dietary intervention study of hypertension (dish)..

background: dish was a multicenter, controlled, randomized study conducted in 1980-1983 of 496 patients, who were formerly participants in the hypertension detection and follow-up program and who had their blood pressure well controlled with medication. at dish baseline they were randomized to continue medication or to be withdrawn from antihypertensive medication to determine if weight reduction or sodium restriction/potassium increase interventions could maintain these people under blood pressure control without drugs. only the main findings regarding diastolic blood pressure control under the different diet regimens, were analyzed and reported during the course of dish funding. many questions which could be uniquely addressed by this comprehensive data base remained unexplored. design narrative: the investigators explored the questions dealing with demographic, clinical and physiologic predictors of relapse to the hypertensive state. they also analyzed the mortality experience of this cohort five years post dish in relation to the dish randomization groups and in relation to success in remaining off drugs during dish. they did this by querying the national death index to determine who of the dish participants died following the termination of dish. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
cobalamin absorption from fortified food

Conditions: Vitamin B-12 Deficiency; Achlorhydria

Summary: to determine b12 bioavailability from 14c-b12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.

cobalamin (vitamin b12) deficiency is highly prevalent in the us and worldwide. deficiency is most common in the elderly, with an average prevalence ≈25% over age 60 y. about 40% of older persons with low serum cobalamin have food cobalamin malabsorption (f-cm), in which gastric atrophy/achlorhydria and/or dysfunction is implicated. because of the prevalence of deficiency in those over age 60 y, it is generally recommended that the elderly consume a higher proportion of their cobalamin from fortified foods than what is recommended for younger people. however there is considerable debate about whether crystalline cobalamin is absorbed as well by the elderly with f-cm as it is by younger people, especially if it is added as a fortificant to food. the data to be collected in this study will provide information useful to on-going deliberations concerning the future fortification of wheat flour with vitamin b12 in the united states.

Eligibility criteria:
inclusion criteria: * good overall health * normal absorptive capacity (controls) or with a serum b12 \ 100 μg/l (acs). * all subjects must be available to complete the protocol exclusion criteria: * any chronic health disorder * anemia of any kind * renal insufficiency * excessive alcohol consumption * prior gi surgery * use of otc or prescription drugs that interfere with b-12 absorption or metabolism * use of vitamin supplements * pregnancy or lactation

Keywords: vitamin b-12
validation of covilus score in patients suspected of covid-19 infection in the emergency room

Conditions: Covid19; Lung Ultrasound; Respiratory Complication

Summary: covid-19 (english acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called sars-cov-2. the current pandemic has resulted in a significant number of admissions in the emergency room (er) due to suspicion of covid-19 infection. use of lung ultrasound is standard practice to diagnose acute respiratory failure in er. recently, typical lung ultrasonographic characteristics of covid-19 disease has been described. the investigators demonstrated that the association of 4 signs in pulmonary ultrasound associated with a clinical sign (covilus score) could predict the occurrence of a positive rt-pcr in patients suspected of covid-19 infection admitted to the emergency room. the investigators are going to conduct a new study to validate this covilus score in this type of patient. the main objective will be to validate the diagnostic performance of lung ultrasound in patients admitted to the emergency room with suspected covid19 infection.


Eligibility criteria:
inclusion criteria: * patients admitted to er for suspicion of covid-19 infection who has a sars-cov-2 rt-pcr test and for whom the emergency doctor decide to perform a lung ultrasound as part of the blue protocol * age\> 18 years old exclusion criteria: * patients \< 18 years of age * patients under guardianship or curators * pregnancy * poor echogenicity due to the presence of an acoustic barrier (pneumothorax, subcutaneous emphysema, etc.) * patients with a suspected or proven acute lung disease (pneumonitis, acute respiratory distress syndrome (ards)) * patients with chronic interstitial lung disease * patients who will refuse to give their consent.

Keywords: covid19 lung ultrasound respiratory complication triage
strong connections

Conditions: Depression

Summary: the purpose of this study is to compare two talking forms of therapy designed to help reduce depressive symptoms in teenagers: interpersonal psychotherapy for adolescents and treatment as usual.

interpersonal psychotherapy for adolescents (ipt-a) is a manualized short-term therapeutic intervention that has been shown to be efficacious in a number of randomized control trials for adolescent depression. the primary aim of the present study is to evaluate the feasibility of incorporating interpersonal psychotherapy for adolescents (ipt-a) into routine psychotherapeutic treatment at strong behavioral health: child and adolescent outpatient. the second aim of the present investigation is to examine changes in adolescent symptomatology, interpersonal functioning, perceived stress, and social support throughout the course of treatment. the third aim of the present study is to compare the effectiveness of ipt-a versus treatment as usual (tau) at reducing depressive symptoms among adolescents.

Eligibility criteria:
inclusion criteria: * age 12-18 * scoring in the clinically elevated range for depression using the beck depression inventory for youth exclusion criteria: * currently psychotic * do not speak english * currently participating in another form of mental health treatment * considered to need inpatient hospitalization * iq less than 70
cognitive behavioural analysis system of psychotherapy (cbasp) versus escitalopram in chronic depression

Conditions: Chronic Depression

Summary: 60 patients with chronic major depressive disorder according to dsm-iv will be included into the study. patients will be randomized to receive an open treatment either with cbasp, a psychotherapy for chronic depression, or pharmacological treatment with escitalopram for 28 weeks.

the psychotherapeutic treatment with cbasp will be conducted in 2 weekly sessions for the first 4 weeks, one per week thereafter until week 9, followed by one session every 2 weeks for 20 more weeks. the starting dose for escitalopram will be 10 mg/d for one week and will be increased to 20 mg/d after one week. the dosage can be reduced to 10 mg/d after day 7 to improve tolerance. th madrs-scale is the primary outcome measure; ratings will be performed by a blinded rater. if there is no improvement (reduction of less than 20% of the madrs), patients will be crossed over in terms of adding the other treatment at week 8. study patients will be asked to participate in fmri, genetic and pharmacological substudies.

Eligibility criteria:
inclusion criteria: * chronic mdd according to dsm-iv (modification: depressive symptomatology for at least one year), or recurrent mde (third or greater episode with the immediately preceding episode being no more than 2.5 years before the onset of the present episode) * age 18-65 * score of at least 18 on the montgomery-asberg-rating scale for depression (madrs) exclusion criteria: * acute risk for suicide * history of psychotic symptoms, bipolar disorder or dementia * severe substance-related abuse or dependence disorder * schizotypal, antisocial or borderline personality disorder * serious medical condition * severe cognitive impairment * absence of a response to previous adequate trial of the study medication/cbasp * hypersensitivity to escitalopram * treatment with a mao-inhibitor within 1 week before the initiation of study treatment

Keywords: chronic depression cbasp escitalopram depression trauma
life - lung cancer, immunotherapy, frailty, effect

Conditions: Non-small Cell Lung Cancer; Quality of Life; Brain Metastases; Venous Thromboembolism

Summary: the life study (lung cancer, immunotherapy, frailty, effect) is investigating the unselected 'real life' non-small cell lung cancer (nsclc) population treated with immune checkpoint inhibition.

the era of immune checkpoint inhibition (ici) has changed the treatment regimen for incurable non-small cell lung cancer. with that the hope of a more long-term survival has been introduced. ici is given as standard therapy for selected nsclc patients with incurable advanced or metastatic (stage iv) disease. for this group of patients clinical trial reports present a 3 year overall survival rate of around 30%. checkpoint inhibition is also known as programmed death 1 (pd-1) or programmed death-ligand 1 (pd-l1) inhibitors and the pd-l1 tumor proportion score is currently the only clinically applicable biomarker used for this patient selection. new prognostic and predictive biomarkers are therefore warranted.the real life unselected nsclc patient eligible for treatment with immunotherapy (check point inhibition) may be both older, with more comorbidity, more widespread disease and in poorer performance status than patients treated in clinical phase iii trials. in this prospective single center study, clinical patient data, peripheral blood and baseline pre-treatment tumor biopsies are collected from nsclc patients treated in any given treatment line with nivolumab, pembrolizumab or atezolizumab. besides baseline samples consecutive blood samples will be collected for cytokine profiling and measurement of circulating tumor dna (ctdna) and micro rna analysis. baseline mri of the brain screening for brain metastases and an extended ct-scan of thorax, abdomen and the lower extremities will be performed screening for venous thromboembolism (vte). this along with comorbidity screening tools and quality of life assessments will provide detailed mapping of both patient and disease characteristics of potentially more frail patients including those with untreated brain metastases. by also registering immune related adverse events (irae) prospectively in this study and doing additional blood samples in case of grade 3-4 toxicity, identification of biomarkers as predictors for effect and toxicity is durable. hopefully this will contribute to more optimized treatment courses for those nsclc patients to come.

Eligibility criteria:
inclusion criteria: * age \> 18 years * stage iv nsclc or recurrent nsclc. * squamous or non-squamous histology * any treatment-line - independent of prior treatment * candidate for checkpoint inhibitor (pd-1/pd-l1 targeting agents) immunotherapy * no previously known allergy to pd-1/pd-l1 targeting agents. * able to give written consent exclusion criteria: * none

Keywords: non-small cell lung cancer immunotherapy checkpoint inhibition biomarkers quality of life real life patients