Kornimate/medical-research-clean huggingface dataset:
safety of larazotide acetate in healthy volunteers

Conditions: Healthy

Summary: to demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of larazotide acetate.

clin1001-003 was a phase 1, randomized, double-blind, placebo controlled multi-dose study to determine the safety, tolerance, and pharmacokinetics (including food effect) of 3 dose levels of larazotide acetate in healthy volunteers. three (3) cohorts of 8 subjects, in which six (6) subjects in each cohort received larazotide acetate in escalating doses of 0.25 mg, 1 mg, or 4 mg tid for 10 days and two (2) subjects received placebo tid for 10 days, were studied. subjects maintained a standard gluten-free diet. subjects were dosed three times a day 30 minutes prior to meals except for the morning dosing on days 1, 5, and 10. for the morning dosing on days 1, 5, and 10 subjects, fasted overnight prior to dosing and for 2 hours post dose. subjects were evaluated for safety (medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms) throughout the study. serial blood samples were collected or pharmacokinetic determinations at baseline and 2 hours post morning dose on days 1, 2, 5, 6 and 10.

Eligibility criteria:
inclusion criteria: * healthy male and female subjects * bmi between 18 and 30. exclusion criteria: * subjects with clinically significant abnormal clinical lab results * hemoglobin \< 12g/dl * subjects with diarrhea within 3 days prior to treatment visit

Keywords: celiac disease larazotide acetate
effects of fast acting testosterone nasal spray on anxiety

Conditions: Anxiety

Summary: the proposed study will test the effects of a fast-acting testosterone nasal spray on the fear reactions of young men to two distinct anxiety challenges (social and nonsocial) using a double-blind randomized experimental design.

aim 1: test the hypothesis that men administered testosterone nasal spray will result in lower levels of anxiety (anticipatory and situational) and greater levels of approach behavior in response to two distinct (social and nonsocial) anxiety challenges relative to men administered placebo spray. aim 2: test the hypothesis that anxiety challenge type (social versus nonsocial) will moderate the effects of testosterone administration on subjects' responses to challenge. aim 3: test the hypothesis that rejection sensitivity - heightened sensitivity to evaluative threat - will moderate the effects of drug condition on response to the two anxiety challenge tests.

Eligibility criteria:
inclusion criteria: * male, 18 years of age or older exclusion criteria: * male breast cancer * obstructive sleep apnea * suspected or diagnosed prostate cancer * male breast cancer * obstructive sleep apnea * diabetes * heart disease * liver disease (e.g., hepatitis) * kidney disease * thyroid disease * tuberculosis or history if positive tb test * infection or fever in the past 7 days * surgeries within the last 6 weeks * anemia * gastrointestinal disease * respiratory disease (e.g., asthma or chronic bronchitis) * other (please list) * reynaud's disease * type 2 diabetes * diagnosed hypersensitivity to cold * warfarin (coumadin) for thinning blood * insulin or any oral drugs for diabetes * propranolol (inderal) * oxyphenbutazone * imipramine * any kind of corticosteroid drug * insulin * steroids * statins (i.e.., cholesterol lowering drugs) * sleeping pills * drugs to treat hormone disorders * antibiotics in the past 7 days * gastrointestinal disease * pain killers -
nursing management of irritable bowel syndrome (ibs) 2008

Conditions: Irritable Bowel Syndrome

Summary: the aim of this study is test the efficacy of a comprehensive self-management therapy to decrease abdominal pain/discomfort and improve quality of life in patients with irritable bowel syndrome (ibs) compared to ibs patients receiving their usual care.


Eligibility criteria:
inclusion criteria: * men and women must be: 18-70 years old, have had symptoms of irritable bowel syndrome (ibs) at least 6 mo prior to their diagnosis, and have had their diagnosis for at least 6 months, and the diagnosis had to be made by a health care provider (e.g., internist, gastroenterologist, family, nurse practitioner, physician assistant). * in addition, the subjects must be experiencing ibs symptoms as described in the rome-iii criteria.161 that is recurrent abdominal pain or discomfort at least 3 days a mo in the last 3 mo associated with 2 or more of the following: improvement with defecation, onset associated with a change in frequency or form (appearance) of their stool. * adults 50 or older must have a negative colonoscopy, sigmoidoscopy, abdominal ultrasonography, or barium enema. * anyone with a "red flag" symptom (e.g., lost 10 lbs without trying, blood in stool, anemia) will be contacted for additional clarification. exclusion criteria: * participants will be excluded if they are taking the following medications: antibiotics, daily use of anticholinergics, tricyclic antidepressants, calcium-channel blockers * have a medical history of abdominal surgery (except appendectomy, caesarian section, tubal ligation, laparoscopic cholecystectomy, hysterectomy, or abdominal wall hernia repair) * active organic gi disease, gluten intolerance (celiac disease), or chronic moderate to severe pain condition (e.g., low back pain, fibromyalgia) * recent travel to regions with endemic parasitic diseases * current mental health disorders (psychosis, bipolar disorder, current moderate to severe depressive episode, suicide attempt, drug or alcohol abuse or dependence within 2yrs) * cardiac valvular disease, immune compromised immunologic disorders (e.g., autoimmune conditions) * women who are pregnant, breast feeding, or planning to get pregnant in the next year

Keywords: irritable bowel syndrome cognitive therapy abdominal pain quality of life
the effect of etomidate on outcomes of trauma patients

Conditions: Trauma

Summary: rationale: the drug etomidate causes increased mortality if used for continuous sedation in mechanically ventilated patients; however, etomidate continues to be widely used as a single-bolus induction agent for endotracheal intubation because of its favorable hemodynamic properties. recent data have raised questions regarding the safety of using etomidate for even a single bolus in patients at risk of adrenal insufficiency, emphasizing the fact that single bolus doses of etomidate cause measurable adrenal suppression, and consequently may cause increases in vasopressor requirements and in hospital length of stay. alternative fda-approved induction agents, such as midazolam, may be safer than etomidate; however, no studies have formally compared these agents. research hypothesis: the investigators hypothesize that in critically ill trauma patients presenting to the emergency department requiring rapid sequence intubation, the hospital length of stay for patients given etomidate will be greater than for patients given midazolam for induction. specific aims: the specific aim is to determine the difference in hospital length of stay between trauma patients given etomidate and those given midazolam for induction during rapid sequence intubation in the emergency department. the investigators plan to compare the two groups in terms of hospital length of hospital stay, length of stay in the intensive care unit, and duration of intubation by performing a prospective, randomized, trial of critically ill trauma patients presenting to the emergency department requiring intubation. the investigators will also compare the mortality rates in these two groups while controlling for severity of illness and the use of steroids while hospitalized. significance: if the use of etomidate to induce anesthesia prior to intubation adversely affects the hospital length of stay of trauma patients, this length of stay might be reduced in such patients by using alternative agents for induction. since etomidate is currently in widespread use as an induction agent, the results of this study could have significant implications for patient management.


Eligibility criteria:
inclusion criteria: * all critically ill trauma patients (defined as patients over the age of 14 years requiring trauma team activation) who present to the ed in need of ventilatory support due to the severity of their illness and injuries. exclusion criteria: * age less than 14, do-not-resuscitate status, or cardiopulmonary arrest prior to arrival in the ed.
the effect of physical fatigue on different balance tests and brain activity in a healthy population

Conditions: Physical Fatigue; Return to Sport; Injury Prevention; EEG; Brain Activity; Balance

Summary: the main objective of this project is: 1. to assess the influence of physical fatigue on brain functioning during a balance and reaction time task in a healthy population. in a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population). the researchers will use a randomized, placebo controlled, counter-balanced, cross-over design. twenty healthy subjects will visit the lab 3 times. on the first visit (familiarisation trial), the investigators will collect the participants' characteristics. the participants will also be familiarized to the procedures and materials of the experiment during this first visit. the second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a pre-test checklist, a mental fatigue scale (m-vas) and motivation scale. in the mean time a little blood will be collected from the ear lobe to determine lactate and glucose levels; also, blood pressure will be checked. next, the subjects will carry out a y-balance test and a balance reaction-time test. session rate of perceived exertion (srpe) is measured to indicate how fatigued the participants feel due to the test battery; also, m-vas is collected once more, as well blood lactate, glucose and blood pressure. these measures are followed by either a physical fatigue inducing task (modified 30 seconds wingate protocol) or time-matched control task (sitting on the bike without pedalling). afterwards, researchers will collect blood lactate, glucose and blood pressure two times more; participants have to fill in m-vas (2x), perform the same y-balance test and balance reaction time test, and fill in the srpe scale one more time. heart frequency and eeg will be measured continuously during the trials.


Eligibility criteria:
inclusion criteria: * healthy (no neurological/cardiorespiratory/psychological/musculoskeletal disorders) * male and female * no medication * non-smoker * between 18 and 35 years old exclusion criteria: * back and/or lower extremity injuries during the past 6 months * bone/joint abnormalities * dizziness, history of loss of consciousness, any inner ear disorders * nervous system disorders or dysfunctions * uncorrected eye disorders/dysfunctions * illness * use of medication or any kind of drugs * use of alcohol, caffeine and heavy efforts 24 hours before each trial * not eating the same meal the night before and the morning of each experimental trial
an investigational immunotherapy study of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.


Eligibility criteria:
inclusion criteria: * histologic confirmation of adenocarcinoma of the prostate * evidence of stage iv disease on previous bone, ct, and/or mri scan * ongoing androgen deprivation therapy (adt) with a gonadotropin-releasing hormone (gnrh) analogue or bilateral orchiectomy * mandatory plasma and fresh or archival tumor tissue must be submitted exclusion criteria: * prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast * participants with active brain metastases * participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment other protocol defined inclusion/exclusion criteria could apply
effect of a casein and gluten free diet in mexican children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: assess the effect of a casein-free and gluten-free diet on gastrointestinal symptoms, clinical variables, and the composition of the intestinal microbiota in mexican children with autism spectrum disorder.

the objective of this quasi-experimental pre-post study with time series is to evaluate the effect of a casein-free and gluten-free diet on gastrointestinal symptoms, clinical variables, and the composition of the intestinal microbiota in mexican children with autism spectrum disorder. the main question it aims to answer is: does a casein free and gluten free diet promote a reduction in gastrointestinal symptoms, an improvement in clinical variables, and a state of eubiosis in the composition of the intestinal microbiota in mexican children with autism spectrum disorder? participants will undergo: an intervention of a casein-free and gluten-free diet for 3 months. sample collection before and after the nutritional intervention. clinical evaluations.

Eligibility criteria:
inclusion criteria: children between 4-10 years old diagnosed with autism spectrum disorder using the criteria established in the ados scale and the cars. exclusion criteria: children who have received: * antibiotics * antimycotics * probiotic supplements * prebiotic supplements * any medication that may alter the microbial composition of the patient, minimum one month prior to sampling. * children on a strict dietary regimen other than a casein-free and gluten-free diet. * children with celiac disease or who present any gluten-related disorder. * children with allergy to dairy products.

Keywords: gut microbiota gluten free diet casein free diet
identifying and overcoming barriers to diabetes management in the elderly: a cost-effective intervention study

Conditions: Diabetes

Summary: the purpose of this study is to find ways to identify barriers that affect self care in older adult with diabetes and to provide cost effective coping strategies to improve clinical, functional and psychosocial measures.

this is a study to evaluate whether short term focused intervention by a geriatric diabetes team to help overcome barriers to diabetes care in older adults will result in improved clinical, functional, and quality of life measures compared to usual care in a cost effective manner. in addition, we will assess whether the support network formed during intervention by the geriatric diabetes team will empower patients, resulting in long lasting improvement in parameters after intervention is completed.

Eligibility criteria:
inclusion criteria: * age 70 years and older * diagnosis of type 1 or type 2 diabetes * seen at joslin clinic or beth israel deaconess medical center for at least one year * hba1c 8% x 2 in past 6 months without fluctuation of more than 0.5% (i.e. stable poor control) * no major change in medications in past 3 months, e.g. addition of insulin or another hypoglycemic agent exclusion criteria: * patients with terminal diseases, e.g. malignancy with expected life expectancy of 12 months or less * patients who live more than 25 miles from joslin clinic/beth israel deaconess medical center * patients who live in an institutional setting (e.g. nursing home, group home, etc) * patients who are not able to complete outcome assessments, (e.g. poor vision, diminished mental capacity/severe cognitive decline, unable to speak/read/write english

Keywords: intervention cost effective elderly glycemic control
comparison of whole-body mri, circulating dna and pet-ct in staging, prognosis, and treatment response in patients with diffuse large cell b lymphoma

Conditions: Lymphoma, Diffuse Large B-Cell

Summary: the aim of the study is to compare the diagnostic performance of whole-body mri scan, positron emission tomography + ct, and circulating tumor dna in patients with hematologic malignancy called diffuse large cell b lymphoma (dlbcl) in staging and restaging, and prognosis.

patients newly diagnosed with dlbcl or patients with relapsed dlbcl who consent to participate in this study will apart from standard staging and restaging examination with pet/ct undergo whole-body mri (wbmri). from blood samples, the level of circulating tumor dna (ctdna) fragments will be estimated. these procedures will be repeated during restaging after primary treatment. the diagnostic accuracy of wbmri in initial staging and restaging will be compared with pet/ct as the gold standard. circulating tumor dna levels will be compared at baseline with staging from pet/ct. the change in levels of ctdna will be compared with the treatement response assessed by pet/ct. all three methods will be used as prognostic indicators.

Eligibility criteria:
inclusion criteria: * age ≥18 years * performance status according to the eastern cooperative oncology group between 0 and 3 * satisfactory clinical condition to participate in this study * adequate hematologic and renal functions * no contraindications to mri * recent or planned pet/ct at the institution * informed consent to participate. exclusion criteria: * history of indolent lymphoma * anti-lymphoma treatment initiated before pet/ct or wbmri * central nervous system lymphoma

Keywords: diagnostic performance whole body mri pet/ct ctdna
cortical excitability and treatment response in people with epilepsy

Conditions: Epilepsy

Summary: epilepsy is a medical condition marked by the occurrence of unpredictable, recurrent seizures. one-third of people with epilepsy continue to experience seizures, despite having attempted multiple forms of anti-seizure medication (asm). currently, response to asm is assessed on a trial-and-error basis as their efficacy can only be determined in hindsight. this causes delays in finding the proper treatment per individual. responsiveness of the outer brain layer to external stimuli, termed cortical excitability (ce), may be used as additional means of treatment evaluation. in this study, the investigators aim to measure ce before and after starting with asm, so as to determine whether indicators of ce can be used to predict favorable response to the medication. participants in this study are adult individuals with uncontrolled seizures that will start with the novel anti-seizure medicine cenobamate. the investigators hypothesize that, after starting with asm, the ce will decrease in people with epilepsy who show a favorable response to the medication. conversely, the investigators anticipate that the ce will not decrease in those that do not react to the mediation. the investigators will address this hypothesis by evaluating both brain activity (electroencephalography, eeg) during rest and during different types of stimulation (magnetic, light flashes). besides, the investigators will measure the subjective experiences of participants by using questionnaires on the quality of life and feelings of anxiety or depression. these measurements are performed at a baseline instance, just before starting with asm, and at two instances after start with the asm. participants in the study will track the occurrence of seizures - using a diary - from 12 weeks before asm start up till 12 months after asm start. the investigators will compare seizure frequency with both changes in brain activity and subjective experiences by the participants.


Eligibility criteria:
inclusion criteria: * in agreement with their own neurologist to initiate adjuvant treatment with cenobamate * diagnosed with refractory focal epilepsy, which means two asms failed to cause seizure freedom. * age of 18 years or older * having kept a seizure diary for the past 12 weeks * at least one seizure in the past 12 weeks. exclusion criteria: * photosensitive epilepsy * any device or structure in the skull or in close proximity of the head area containing metal, including cochlear implants, implanted neurostimulators, cardiac pacemakers and intracardiac lines. * persistent skull opening following trauma or surgery * evidence (clinical or radiological) of major structural abnormality of the motor cortex or pyramidal tracts * any major psychiatric condition such as a psychotic disorder * pregnancy * learning disabilities preventing the comprehension of oral and/or written instructions

Keywords: epilepsy transcranial magnetic stimulation evoked potentials, visual electroencephalography anticonvulsants seizures
effect of surgical approach on postoperative bleeding in patien arthroplasty

Conditions: Hip Arthropathy

Summary: the study is, in accordance with current legislation, definable as monocentric prospective observational. the primary outcome will be blood loss calculated on the basis of hemoglobin (hb) on the third postoperative day. adult patients who will undergo surgery of hip arthroplasty. patients will undergo: preoperative t0: clinical visit/medical history, completion of the vas questionnaire, blood sampling to assess hemoglobin values operative t1: hip arthroplasty surgery using one of the surgical approaches routinely used within our institute t2 - postoperative at 1 day from t1: vas questionnaire, evaluation of any adverse events t3 - postoperative at 3 days from t1: blood loss based on the values of hemoglobin (hb), assessment of any adverse events, and vas questionnaire t4- post operative at 45 days +/- 10 days from t1: evaluation of any events adverse, follow-up visit.

the presence of bleeding and pain after prosthesis surgery hip injuries can affect the patient's condition in the postoperative period increasing the length of hospital stay and slowing down the rehabilitation process. it is hypothesized that there are differences in terms of postoperative bleeding, postoperative pain and hospital stay time between different approaches surgical procedures in the treatment of hip osteoarthritis with arthroprosthesis. the adoption of a surgical approach that can reduce bleeding and pain could reduce the length of hospital stay in patients undergoing hip arthroplasty. the primary outcome will be blood loss calculated on the basis of hemoglobin (hb) on the third postoperative day. secondary objectives are postoperative pain assessment with questionnaire vas and length of hospital stay according to surgical approach used (anterior vs. posterolateral route). also evaluate any adverse events. adult patients who will undergo surgery of hip arthroplasty. the inclusion criteria are: * adult patients with coxarthrosis who are candidates for surgery hip arthroplasty * signing of the informed consent and consent to collaborate in all study procedures. the exclusion criteria are: * minors * pregnant women (self-declaration) * patients with bmi ≥ 30 * non-acceptance of informed consent * patients with prior unilateral hip reconstructive surgery or contralateral

Eligibility criteria:
inclusion criteria: * adult patients with coxarthrosis who are candidates for surgery hip arthroplasty * signing of the informed consent and consent to collaborate in all study procedures. exclusion criteria: * minors * pregnant women (self-declaration) * patients with bmi ≥ 30 * non-acceptance of informed consent * patients with prior unilateral hip reconstructive surgery or contralateral