Kornimate/medical-research-clean huggingface dataset:
effect of 4-week oral administration of a fermented dairy product containing lactobacillus rhamnosus cncm i-3690, on subjective state anxiety levels in healthy women undergoing academic stress.

Conditions: Anxious Healthy Subjects

Summary: the purpose of this study is to assess the effect of lactobacillus rhamnosus cncm i-3690 consumption on subjective anxiety levels in healthy subjects undergoing academic stress.


Eligibility criteria:
inclusion criteria: * si01: free-living participant who fully understands and agree to the objectives of the study, who gave signed and dated informed consent * si02: women of 20 to 30 years of age inclusive * si03: participants who are healthy as determined by medical evaluation including medical and surgical history and full physical examination. * si04: body mass index (bmi) within the range 18 and 30 kg/m2 (bounds included). * si05: woman participants. * si06: student defending a bachelor's or master's thesis in front of a jury * si07: subject who regularly consumes dairy fermented products containing live bacteria and willing to consume 2 units of investigational product per day during the study. * si08: subject willing to strictly follow instructions on diet, medication and substance use for the entire duration of the study. exclusion criteria: * se01: subject with chronic gastrointestinal disorders or symptoms, with celiac disease, diagnosed type 1 or type 2 diabetes mellitus, with psychiatric disease including but not limited to depression and general anxiety disorder * se03: subject with food allergy, history of atopic conditions (eczema, allergic asthma, allergic rhino conjunctivitis) requiring active treatment, with first degree relatives with coeliac disease, inflammatory bowel disease (ibd) or type 1 diabetes, with known or suspected lactose intolerance * se4: subject with eating disorders, chronic or iatrogenic immunodeficiency (e.g. chemotherapy, hiv), presenting a severe evolutive or chronic pathology (e.g. cancer, tuberculosis, crohn's disease, cirrhosis, multiple sclerosis) * se5: subject with cardiac, respiratory (including asthma) or renal insufficiency, cardiomyopathy, valvulopathy and medical history of rheumatic fever and/or with a positive test for covid-19 infection or presenting any symptoms of covid infection in the past 2 weeks * se6: subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, and steroids prescribed in chronic inflammatory diseases, antiphlogistic, anti-inflammatory and ppis) * se7: subject who has planned to participate in another investigational study or subject involved in any other clinical study within the preceding month * se8: subjects planning to significantly change their diet during the period of the study or who have changed his/her dietary habits within the 4 weeks preceding the study (e.g. start of a diet high in fibres) * se9: pregnant woman or woman planning to become pregnant during the study; breast-feeding woman.

Keywords: anxiety, academic stress, healthy women, fermented diary product, randomized controlled trial
evaluation of blood glucose monitoring systems

Conditions: Diabetes

Summary: the purpose of this study was to evaluate the performance of a bayer blood glucose monitoring system (bgms) and two additional blood glucose monitoring systems (bgms) from other companies. all meter bg results were compared with plasma results obtained with a reference laboratory glucose method (ysi glucose analyzer).

the purpose of this study was to evaluate the performance of a bayer blood glucose monitoring system (bgms) and two additional blood glucose monitoring systems (bgms) from other companies. all meter bg results were compared with plasma results obtained with a reference laboratory glucose method (ysi glucose analyzer). performance of the three systems was evaluated across the glucose range of the bgmss using capillary blood. all testing and lancing was performed by study staff and some samples were tested from subject fingertips. additionally, some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels.

Eligibility criteria:
inclusion criteria: * males and females, 18 years of age or older * willing to complete all study procedures exclusion criteria: * blood borne infections like hepatitis or hiv or infections such as tuberculosis * hemophilia or any other bleeding disorder * pregnancy
anterior and posterior decompression surgery in individuals with cervical radiculopathy and headache

Conditions: Cervical Radiculopathy

Summary: this is a prospective observational register-based cohort study with 2 years follow-up with data from the national swedish spine register (swespine). the aim is to study the differences between anterior and posterior decompression surgery on neck-related disability, headache, and neck- and arm pain in individuals with cervical radiculopathy and headache. secondary, to study predictive factors for an improvement in neck-related disability, headache and neck- and arm pain after decompression srurgery. all individuals underwent either anterior or posterior decompression surgery and were operated between 2014-2021. patient-reported data was collected preoperatively (baseline), and at 1- and 2-year follow-ups and surgeon-reported data regarding the operation were collected directly after the operation. primary outcome is self-reported neck-related disability measured with neck disability index and secondary outcomes are headache, measured with an item about headache of neck disability index, and neck- and arm pain, measured with a 0 to 10-point numeric rating scale.


Eligibility criteria:
inclusion criteria: * underwent anterior cervical decompression surgery or posterior cervical foraminotomy with or without laminectomy for cervical radiculopathy 2014 - 2021 * age ≥ 18 years * preoperatively rated 1 (i have slight headaches, which come infrequently) - 5 (i have headaches almost all the time) on an item about headache of neck disability index (27) exclusion criteria: * myelopathy * previous neck surgery
proton therapy for unresectable cancer (ca) of pancreas

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to find out what effects, good and/or bad, proton radiation and chemotherapy has on you and your pancreatic cancer.

chemotherapy:capecitabine on radiation days proton radiation over 7 weeks consolidation chemotherapy:gemcitabine

Eligibility criteria:
inclusion criteria: pathologically confirmed adenocarcinoma of the pancreas. patients must be medically inoperable or have unresectable disease exclusion criteria: * evidence of distant metastasis; evidence of metastatic disease in the major viscera (organs), peritoneal seeding and/or ascites. * previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment. * prior surgical resection.

Keywords: pancreatic cancer unresectable proton radiation chemotherapy
safety and efficacy study in patients with major depressive disorder

Conditions: Depressive Disorder

Summary: the purpose of this study is to test if gsk163090 can reduce the symptoms of depression. the safety and how well the body can handle the drug will also be investigated. the study will be conducted in russia in hospitalised patients with severe depression. gsk163090 will be compared with placebo, which looks like the study drug but does not contain any active substance. subjects will be given either the study drug or the matching placebo.

this is a randomised, multi-centre, double-blind, placebo-controlled, repeat dose, parallel group study in male and female patients with severe depression requiring hospitalization. efficacy, safety and tolerability will be assessed in three treatment arms. the study will consist of a screening period, a treatment phase (up to 6 weeks) and a post-treatment follow-up visit. the study duration from screening to follow up will be approximately 9 weeks. subjects who pass screening will be randomized on day 1 to one of three treatment arms (low dose arm, high dose arm or placebo). each treatment arm will contain approximately 50 subjects. the subject's depressive symptoms will be assessed using the hamd17- cr.

Eligibility criteria:
inclusion criteria: * currently have severe depression (major depressive disorder - without psychotic features) * meet criteria (dsm iv-tr ) for current major depressive episode for at least 4 weeks but for no greater than 24 months * depression questionnaire (hamd17) total score greater than or equal to 24 * subject must read and able to give written informed consent * male or female 18 to 64 years * use appropriate birth control method * bmi 18.8 - 35.0 kg/m2 (inclusive) exclusion criteria: * primary diagnosis of other psychiatric disorders * thoughts of killing ones self or someone else * taking psychiatric medicine or therapy within the six months * has previously failed an adequate course of medication for mdd from two different classes of antidepressants. * unstable medical disorder or a disorder that would interfere with the action of the drug * abuse of alcohol or drugs * past history of serotonin syndrome or a history of clinical significant intolerance of ssris (class of drugs used for depression). * history of migraine headaches that respond to treatment with triptan medication. * history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure). * currently taking part in another clinical study or has done so within six months * pregnant, planning to become pregnant shortly or breastfeeding * history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy

Keywords: anti-depressant severe depression efficacy major depressive disorder major depressive episode
visn 20: prophylactic treatment of interferon-induced depression in hepatitis c patients

Conditions: Hepatitis C; Depression

Summary: the purpose of this study is to learn more about the effects of interferon and ribavirin combination therapy in people with hepatitis c. the specific aims are: * to assess how often depressive symptoms occur in patients taking combination alpha interferon plus ribavirin or pegylated interferon plus ribavirin therapy for hepatitis c, when depressive symptoms occur, and how severe the depressive symptoms are when they do occur; * to identify potential predictors for the development of depressive symptoms; * to identify if citalopram, an antidepressant medication, can prevent or lessen the severity of depressive symptoms brought about by interferon therapy.


Eligibility criteria:
inclusion criteria: * adult male or female, age 18 or older * planning to receive any brand of pegylated interferon/ribavirin combination therapy for chronic hcv (hepatitis c virus) exclusion criteria: * chronic liver disease other than chronic hcv * evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy * a history of organ transplantation * any known preexisting medical condition that could interfere with the patient's participation in the protocol, including: \*active seizure disorders requiring medication; \*history of major cns (central nervous system) trauma (as suggested by accident or other event leading to loss of consciousness, personality changes, etc) * any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids (e.g. oral or injection). * inability to read and write at a level sufficient to complete self-report forms * history of significant non-compliance with medical treatments and appointments * patients currently, or within the last three months, on a full therapeutic dose of antidepressant medication, or a dose of other medication such that it may significantly affect depressive symptomatology * patients with active depression in the previous 3 months and/or those with bdi (beck depression inventory)-ii greater than or equal to 15 at the time of study entry. * patients with bipolar disorder or history of bipolar disorder * patients with active psychotic symptoms or diagnosis of schizophrenia in the previous 3 months * active substance abuse, such as alcohol (greater than 80 gm/day), iv (intravenous) drugs, and inhaled drugs. if the patient has a history of substance abuse, in order to be considered for inclusion into the protocol, the patient must have been in a sustained remission for at least 6 months * patients receiving opiate agonist therapy (e.g., methadone maintenance therapy) within the past year, unless a program of testing for continued substance abuse is initiated (testing at entry and then randomly at least every 2-3 months) and the patient is withdrawn from study for any violation.

Keywords: hepatitis c depression interferon-alpha citalopram ribavirin antidepressive agents
transcranial alternating current stimulation on patients with delirium and critical illness (delitacs)

Conditions: Delirium

Summary: the goal of this clinical trial is to learn if transcranial alternating current stimulation can shorten the duration of delirium in intensive care setting. the main question it aims to answer: * is it possible to shorten the duration of delirium with transcranial alternating current stimulation? researchers will compare experimental treatment to sham. participants will receive experimental or sham treatment on maximum of two days depending on their delirium status. duration of delirium is recorded and reported as "days alive and free of delirium".

delirium is an acute-onset brain dysfunction related to extensive surgery or critical illness that leads to altered mental status and cognitive deficits. delirium is associated with an increased length of stay in the icu, cost of care, excessive mortality, and long-term cognitive and functional impairment. although numerous prophylactic methods have been proposed, currently, no pharmacological or non-pharmacological methods are clinically effective. patients with delirium have altered electroencephalography (eeg) findings among which most important are general slowing of eeg frequencies and dysconnectivity. faster eeg frequencies, especially alpha-, beta-, and gamma-bands, are correlated with higher cognitive functions, such as memory and orientation. transcranial alternating current stimulation (tacs) is a novel, noninvasive brain stimulation technology that cab modulate eeg frequencies by entraining of endogenous brain oscillations in response to exogenous stimuli. tacs has been shown to improve episodic memory, orientation, and cholinergic dysfunction in patients with alzheimer's disease. tacs also increases alpha and gamma frequencies in eeg, and an increase in these frequencies is associated with the improvement of clinical symptoms. tacs has been shown to target key components of delirium pathophysiology, such as slowing of eeg frequencies and cholinergic dysfunction. thus, we hypothesized that tacs could shorten the duration of delirium and decrease cognitive decline. we aim to test this hypothesis in a double-blind randomized trial and assess the effect of tacs on duration of delirium, eeg, biomarkers and long-term cognition.

Eligibility criteria:
inclusion criteria: * delirium in intensive care and duration of delirium for more than 24 hours. delirium is defined as 4 or more points on icdsc and -1 or more points on rass. exclusion criteria: * under 18 years of age, pregnancy, delirium tremens, epilepsy or history of seizures any time before first trial intervention, active psychotic disease, infection of central nervous system, acute intoxication, traumatic brain injury, stroke, intracranial bleeding and implanted electronic devices.

Keywords: delirium tacs brain stimulation intensive care
evaluation of iliac and renal artery for mechanism of intracranial aneurysm in adpkd

Conditions: Kidney Transplant; Complications; Polycystic Kidney Diseases; Aneurysm, Brain

Summary: adpkd is the most common form of hereditary kidney disease and is known to occur in 1 of 400 to 1000 population in the u.s. adpkd consists of 2.8% of patients receiving kidney transplantation in our center. it is known that adpkd is associated with vascular anomalies, including abdominal aneurysms, valvular anomalies and especially intracranial aneurysms. intracranial aneurysms occur in 9\~12% of the adpkd population which is higher than 2\~3% in the general population and is known to be associated with pkd1 or pkd2 heritage. until now, most of the studies regarding intracranial aneurysms in adpkd are conducted in animal models, and there are only few cellular studies conducted from human samples. while performing kidney transplantation to esrd adpkd patients, arterial tissues from nephrectomy specimens can be obtained. the objective of this study is to investigate the mechanism of intracranial aneurysm in adpkd patients by analyzing iliac and renal artery characteristics.

adpkd is associated with pkd1 gene on chromosome 16 and pkd2 gene on chromosome 4 and these gene respectively code polycystin 1 and polycystin 2. currently the hypotheses for increased intracranial aneurysm rate in adpkd patients is that mutation of polycystin is not only confined to nephron tissues but also in endothelial cells and vascular smooth muscle cells and results in mutation of vascular phenotype. also recent studies show polycystin complex causes cystic changes through mutation in primary cilia in renal epithelium. wild type endothelial cells respond to fluid shear stress by regulating levels of intracellular calcium and nitric oxide, however, pkd1 or pkd2 mutation in fetal aortic endothelial cells revealed loss of these responses. during kidney transplantation, bilateral nephrectomies are routinely performed to adpkd patients. in this study, blood, urine, iliac artery and renal artery tissues will be collected from adpkd patients receiving kidney transplantation to analyze the arterial characteristic and gene mutation of adpkd patients. the aim of this study is to evaluate mechanisms associated with intracranial aneurysm occurence in adpkd patients by analyzing the genetic mutation and vascular deformities of these patients.

Eligibility criteria:
inclusion criteria: * adpkd patients from ages 18 to 80 receiving kidney transplantation at asan medical center exclusion criteria: * those who refuse or are unable to provide consent form * pregnancy
a study to evaluate the safety and tolerability of rizatriptan for long term treatment of acute migraine in children and adolescents (mk-0462-086 am3)

Conditions: Acute Migraine With or Without Aura in Adolescents

Summary: to provide long term safety data for rizatriptan in children and adolescents. the primary hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of acute migraine in pediatric patients age 12-17 years.


Eligibility criteria:
inclusion criteria: * patient is between 12 and 17 years of age inclusive at screening visit 1 * patient weighs at least 20 kg (44 pounds) * patient has had a history of unilateral or bilateral migraine headache with or without aura \>6 months with ≥1 to ≤8 mild, moderate or severe migraine attacks per month in the 2 months prior to screening visit 1 * patient has a history of migraine defined by international headache society (ihs) migraine definitions * the parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and patient assent * for patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to visit 1 exclusion criteria: * patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation * patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours * patient has basilar or hemiplegic migraine headaches * patient has \>15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening * patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (hiv), any cancer, or any other significant disease * patient has a history cardiovascular problems or stroke * patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan * patient has demonstrated hypersensitivity to or experienced a serious adverse event in response to 3 or more classes of drugs (over-the-counter and prescription) * patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5ht1) agonists * patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs * patient is currently taking monoamine oxidase inhibitors, methysergide, or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required * patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening * patient is legally or mentally incapacitated

Keywords: acute migraine with or without aura in adolescents
exploring the experiences and outcomes of a summer intensive therapy program- mixed methods study

Conditions: Children With Neurodevelopmental Disorders

Summary: the purpose of this study is to assess the effectiveness of an interdisciplinary intensive therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders across the icf and to explore caregiver experiences and perspectives of the program.

the purpose of this study is to assess the effectiveness of an interdisciplinary intensive therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders across the icf and to explore caregiver experiences and perspectives of the program. research questions include: 1.) what are the effects of an intensive program on postural control and functional mobility for children with neurodevelopmental disorders? 2.) what are the effects of an intensive therapy program on dual tasking for children with neurodevelopmental disorders? 3.) what are the perceptions of caregivers of a multidisciplinary intensive therapy program for their children with neurodevelopmental disorders? data will be gathered before and after the intensive program as part of usual care and ambulatory children will be further assessed in the motion analysis lab. caregivers will complete a questionnaire about satisfaction with services and also a 4 question open-ended question survey about their experience with intensive therapy.

Eligibility criteria:
inclusion criteria: * children receiving therapy through children's therapy center's tiger intensive program and their caregivers from may 23, 2022, to aug 19, 2022. exclusion criteria: * none