Kornimate/medical-research-clean huggingface dataset:
gut feeling: understanding the mechanisms underlying the antidepressant properties of probiotics

Conditions: Major Depressive Disorder

Summary: previous research has suggested that probiotics can improve depressive symptoms in patients with major depressive disorder (mdd), particularly when used in addition to antidepressants. the aim of this exploratory pilot study is to improve the investigator's understanding of the mechanisms underlying these effects. this study will assess the effects of an 8-week double-blind placebo-controlled probiotic intervention on the gut microbiome, inflammatory marker levels, brain activity and neurotransmitter levels in patients with mdd and their relationship to changes in mood. this study will also recruit a group of demographically-matched healthy controls for gut microbiome comparison with the mdd group (non-interventional).


Eligibility criteria:
inclusion criteria for mdd participants: * aged 18-55; * currently in a depressive episode according to dsm-5 criteria, who are currently on antidepressant treatment but remain symptomatic (ham-d17 score \>13); * on stable treatment regimen of an approved treatment for at least 6 weeks; * non-smokers; * for participants willing to take part in the neuroimaging component: right-handed, no contraindications, non-claustrophobic, weight \<126kg; exclusion criteria for mdd participants: * eating disorder, bipolar disorder, schizophrenia or psychotic symptoms; * substance dependence in the past year, except for caffeine; * active suicidal ideation; * use of probiotic supplements in the past 2 weeks, or regular use of a probiotic; * use of antibiotics in the past 12 weeks; * history of allergic reaction to any of the components of biokult; * history of history of a systemic medical illness; * current presence of significant gi problems or disease or history of major gi surgery; * pregnancy or breastfeeding; * following a dietary regimen unrepresentative of the general population (e.g. fasting or following a specific diet); * regular/current use of antacids, proton pump inhibitors, laxatives, antidiarrheals; inclusion criteria for healthy volunteers: * aged 18-55; * no current or historic presence of depression, other psychiatric disorder or substance dependence * no history of a systemic medical illness; * no family history of psychiatric disorder; * non-smoker; * not used probiotic supplements in the past 2 weeks, nor regular use of a probiotic; * not used antibiotics in the past 12 weeks; * no current presence of gastrointestinal disease, or history of major gi surgery; * no reported regular/current use of antacids, proton pump inhibitors, laxatives, antidiarrheals; * pregnancy or breastfeeding; * not currently following a dietary regimen or dietary restrictions unrepresentative of the general population (e.g. fasting or following a specific diet);

Keywords: probiotic depression microbiome bacteria
single center post approval proximal humerus fixation with the conventus cage ph™ device

Conditions: Proximal Humeral Fracture

Summary: the conventus cage™ ph (ph cage) system post-approval observational data collection study (study) is a single center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice.

the study is a prospective, non-randomized, post-market approval data collection study that is designed to collect device/procedure and outcome data on patients who have experienced proximal humerus bone fractures and received a ph cage. specifically, the study will provide: 1. patient outcome and performance data for the implant and implant procedure that that may be used to support scientific publications. 2. assurance of continued product safety and effectiveness.

Eligibility criteria:
inclusion criteria: * patient must be of at least legal age of consent according to applicable state law. * patient is able to understand and provide written consent exclusion criteria: * the ph cage should not be implanted in patients with suspected or known allergies to titanium or nickel. * pregnant female patients. * patients with current or history of mental illness and/or senility. * patients with current or history of alcoholism and/or chemical substance abuse. * patient has a medical condition(s) that preclude cooperation with the rehabilitation regimen. * patient has active infection at the operative site or other active systemic infection. * patient has a pathologic proximal humerus fracture. * patients proximal humerus fracture extends into the diaphysis. * patient has associated glenohumeral dislocation. * patient has known pre-existing rotator cuff disease. * patient has ipsilateral injury or concomitant surgery that will have a material impact on the study, such that the injury/surgery affects the patients' health status or the function of the injured extremity.

Keywords: proximal humerus fracture fixation trauma proximal humerus fixation
evaluation of a new device "orthèse diabète" in the healing of foot ulcers in diabetic patients

Conditions: Foot Ulcer, Diabetic

Summary: multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (probe methodology), comparing "orthèse diabète" with "conventional" removable devices in terms of healing of ulcers. - primary objective: evaluate the efficiency of "orthèse diabète" compared to "conventional" removable devices, in terms of the proportion of diabetic patients whose principal ulcer will heal completely at 3 months.

1. secondary objectives 1. proportion of patients whose principal ulcer will heal completely at 1, 2 and 6 months 2. proportion of patients in whom all initial plantar ulcers will heal completely at 1, 2, 3 and 6 months 3. percentage of area decrease of the plantar ulcers at 1, 2, 3 and 6 months 4. time to healing of the principal ulcer 5. appearance of new ulcers 6. requirement for amputation 7. incidence of the infectious complications 8. adherence of wearing 9. patient's satisfaction with the prescribed device 2. population 1. 13 centers/116 patients monitored for a period of 6 months maximum 2. experimental group: "orthèse diabète" a plantar off-loading custom-made removable device 3. control group: "conventional" removable off-loading systems among the devices available in france.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetic patients diagnosed according to the ada experts consensus \[ada 1997\] * over 18 years of age * with a sensory neuropathy (abnormal 10 g monofilament test, i.e. not perceived at least 2 times in 1 of the 3 areas explored : pulp of the great toe, 1st and 5th metatarsal heads) * without a severe arteriopathy defined by : abi \< 0,7 and/or tcpo2 \< 30 mm hg and/or big toe pressure \< 30 mm hg * with one or more plantar ulcerations with an area \> 0,25 cm² or an amputation (toes or transmetatarsal) open or sutured * not requiring a contralateral off-loading device * informed about the study and having given their informed and written consent to participate * registered with a social security scheme or with the cmu (beneficiary or entitled recipient) * having undergone a medical exam * not included in another protocol throughout the study exclusion criteria: * severe skin or osteoarticular infection requiring a parenteral antibiotic therapy or surgery * large ulcer of the ipsilateral leg \> 20 cm2 of area * contralateral above heel amputation * intercurrent disease prohibiting participation in the protocol * weight over 130 kg * person under tutorship or under curatorship * loss of functional and/or neuropsychological autonomy * pregnant or likely to be pregnant woman
exercise dose-response effects in prediabetes

Conditions: Pre-Diabetes

Summary: the purpose of the study is to evaluate the effects of different amounts and intensities of aerobic exercise training programs, with and without weight loss, in people who are at risk for diabetes. an additional purpose of the study is to evaluate the factors in the blood and in exercising muscles that contribute to the improvement in those risk factors. this information will be used to improve exercise training guidelines for improving cardiovascular and metabolic health in people with abnormal fasting glucose, also known as prediabetes.

729 subjects were consented, 288 participants were randomized.

Eligibility criteria:
inclusion criteria: * age: 45-75 years * moderately overweight determined by body mass index: 25.0 - 35.4 * fasting plasma glucose: \> 95 - \ 100 mg/dl o readings from two separate days, both being \> 95 (\> 100 after 2/15/2012)and one of the two being \< 126 * low density (ldl) cholesterol: \< 190 mg/dl * triglycerides: \< 600 mg/dl * resting blood pressure: \< 160/90 mmhg * inactive: exercise \ 18.0 - \< 40.0 ml/kg/min until 2/15/2012 when lower limit was adjusted to 12.0 ml/kg/min * medications: stable use of all medications for \> three months exclusion criteria: * smoker: tobacco use within the last 12 months * dieting or intending to diet * use of potential confounding medications, e.g. niacin containing drugs * history of diabetes, heart disease or taking medication for those conditions * history of hypertension (high blood pressure) not controlled with medication * pregnant or intending to become pregnant * unwillingness to undergo a three month control/run-in period, be randomized to any one of four intervention groups, submit to thigh muscle biopsies and all other study testing or continuously participate in a randomly assigned exercise training or lifestyle intervention program for six months * orthopedic limitations, musculoskeletal disease and/or injury * allergic to xylocaine (anesthetic or numbing medicine) * inability to give blood continuously through a catheter (please notify the study nurse of any difficulty you have experienced in the past when having your blood drawn; the study nurse will determine whether you are excluded for this reason) * unwillingness to exercise at least twice per week at the duke center for living health and fitness center during research study staff supervised times

Keywords: abnormal fasting glucose
mk0767 and sulfonylurea combination study (0767-027)

Conditions: Diabetes Mellitus, Type 2

Summary: this study will assess mk0767's ability vs. placebo to control blood glucose in patients with type 2 diabetes and to gauge whether fasting blood glucose is lowered, blood fats are improved, and insulin levels are impacted. this is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * type 2 diabetes with inadequate glycemic control * on sulfonylurea monotherapy * male or non-pregnant females * age 21 to 78 years, inclusive * on a stable dose of sulfonylurea for at least 2 weeks prior to visit 2/week-6 exclusion criteria: * history of type 1 diabetes * patient is currently on insulin (monotherapy or in combination with oral agent), rosiglitazone or pioglitazone or other ppar-y agonists, metformin agents * patients with history of or intolerance of ppar-y agonists
sleep-disordered breathing in postmenopausal women

Conditions: Sleep Apnea

Summary: the purpose of this study is to investigate the effectiveness of cpap treatment to co-morbidities of sleep apnea by looking the change of the consumption of medication of the co-morbidities before and after starting the cpap treatment.

sleep-disordered breathing (sdb) is frequently linked with cardiovascular diseases including stroke and type 2 diabetes, which increase the indirect costs of sleep apnea. also non-cardiovascular co-morbidities are possible but seldom studied. cpap treatment reverses the increased healthcare utilization seen before the sleep apnea diagnosis. previous studies addressing the cardiovascular co-morbidities in sdb have focused on obstructive sleep apnea and in male populations, but not on partial upper airway obstruction. partial upper airway obstruction is common in both genders but especially in women. according to investigators' clinical experience, women with partial upper airway obstruction are especially likely to have severe symptoms from their sdb. there are scarce data on cardiovascular co-morbidities associated with partial upper airway obstruction and the female gender. to study the prevalence of co-morbidities adding to the burden of sdb (periodic obstructive breathing and partial upper airway obstruction), investigators applied a conservative but robust strategy using the governmental database of medication reimbursed by the public health insurance system. investigators analyzed both the cardiovascular and non-cardiovascular co-morbidities in our clinical population of sdb, separately in patients with periodic obstructive breathing or with partial upper airway obstruction during sleep.investigators found that concomitant diseases ware common in sdb. asthma and/or copd were surprisingly frequent, and also chronic hypertension had an increased prevalence. in addition, males had diabetes mellitus and females hypothyroidism more than general population. the results emphasize the importance of diagnosis and treatment of the co-morbidities such as asthma, copd, hypertension, diabetes and thyroid insufficiency regardless if the patient has partial upper airway obstruction or obstructive sleep apnea. now, investigators hypothesize that cpap treatment reduces the consumption of medication of the co-morbidities of sleep apnea. therefore, a retrospective analyze of 5 year before and 5 year after starting the cpap treatment the medication consumption of the same population previously used will be conducted. to do this, the governmental database of medication reimbursed by the public health insurance system will be used.

Eligibility criteria:
inclusion criteria: * patient with sleep apnea * cpap treatment started and continued exclusion criteria: * no cpap treatment started

Keywords: sleep apnea co-morbidities of sleep apnea cpap treatment
descriptive analysis of g-csf use in patients with breast cancer, lung cancer, or lymphoma treated

Conditions: Breast Cancer; Lung Cancer

Summary: purpose: with the existing recombinant human granulocyte colony-stimulating factors (g-csfs) patents expiring and the fda approval of new biosimilar and innovator biologics, patients being treated with grade iii and iv myelosuppressive chemotherapy regimens will have additional therapeutic options. this observational study will describe the patient characteristics of new users of g-csfs. it will describe in the treatment cohorts a primary outcome of hospitalizations for febrile neutropenia. the bbcic will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator g-csfs.

additional information: to most effectively interpret results from this descriptive analysis it is important to consider that this protocol was not designed to support a hypothesis. this information is being provided to the public in the interest of transparency and for demonstrating the bbcic's distributed research network's (drn) ability to define exposures, outcomes, covariates and confounders. when published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the bbcic project. further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the bbcic is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.

Eligibility criteria:
inclusion criteria: * individuals with baseline period of 183 days with continuous medical and pharmacy coverage preceding the first prescription fill for g-csf * breast or lung cancer patients receiving their first cycle of grade iii and iv myelosuppressive chemotherapy regimen treated prophylactically with g-csf. exclusion criteria: during baseline 365 days, any patient with a claim for (or with) * chemotherapy drug. * skilled nursing facility (snf) or hospice care * diagnosis for a secondary breast cancer diagnosis * a second cancer diagnosis (i.e., not breast, lung, lymphoma) * bone marrow or stem cell transplant * radiotherapy * chemo cycle \>first: (exclude any chemotherapy cycles post the index g-csf date) * hiv/aids * hepatic disease * other non-oncology related neutropenia

Keywords: recombinant human granulocyte colony-stimulating factors g-csfs biosimilar biologics high neutropenia risk chemotherapy biologic and biosimilars collective intelligence consortium bbcic
end - vt cohort study

Conditions: Ventricular Tachycardia; Implantable Defibrillator User; ICD

Summary: ventricular tachycardia (vt) is a life-threatening cardiac rhythm disturbance which leads to sudden cardiac death (scd), ventricular fibrillation, electrical storm, hemodynamic collapse, and syncope. vt patients with cardiomyopathy (diseased/scarred cardiac muscle) have the highest risk of scd (\<1-4%) and recurrent vts (15-35%). although an implantable cardiac defibrillator (icd) is the most effective treatment option to prevent scd, it does not eliminate it. without vt prevention, recurrent vt and icd shocks may increase the risk of heart failure and death. the primary objective is to determine the optimal treatment strategy to maximize event-free survival among cardiomyopathy patients with ventricular tachycardia (vt) by the creation of a prospective, multicenter, longitudinal cohort. also, the investigators will evaluate the epidemiology of vt, adherence to guidelines, safety, effectiveness, and cost-effectiveness of current treatment options for secondary prevention of vt in the real-world canadian vt population.

the end-vt study is a multicenter, prospective, longitudinal real-world cohort study of patients with cardiomyopathy-related vt. patients with ischemic and non-ischemic cardiomyopathy are followed from their first vt event till at least 3 years of follow-up or death, whichever is first. outcomes of vt events are captured by icd remote monitoring and are adjudicated by experienced clinical investigators blinded to the center and treatments. the primary objective of end-vt is to determine the optimal treatment strategy to maximize event-free survival among cardiomyopathy patients with vt. the investigator will also assess the real-world burden of disease, treatment challenges, adherence to guidelines, sex differences, and safety, effectiveness, and cost-effectiveness of vt treatments.

Eligibility criteria:
inclusion criteria: 1. documented sustained ventricular arrhythmia (\>30 seconds as documented by an ecg, cardiac monitor, aed, and/or intracardiac pacemaker/icd electrograms (egms); 2. first (new) diagnosis of vt; 3. presence of or plan for icd implant during index hospitalization; 4. diagnosis of cardiomyopathy (ie. icm, hypertrophic, dilated, restrictive, arrhythmogenic cardiomyopathy, or other scar), 5. icd clinic follow-up planned, and 6. age \>18 years old exclusion criteria: 1) patients with vt due to a reversible cause
effect of teach-back method in colonoscopy

Conditions: Healthy

Summary: this study aims to evaluate the effect of the training given to the relatives of patients undergoing colonoscopy with the teach-back method on anxiety and knowledge level. research hypotheses: h1: the training given with the teach-back method decreases the anxiety level of patient relatives. h2: the training provided with the teach-back method increases the knowledge level of patient relatives.

teach-back technique is an effective educational method that enables a person to rephrase what he/she has learnt in his/her own words to show that he/she understands. there is no study evaluating the effect of the education to be given with the teach-back technique to the relatives of patients who will undergo colonoscopy. in addition, in this study, anxiety and knowledge levels of the relatives of the patients before and after the training will be discussed and will be a guide for future studies. the training to be given with the teach-back technique will increase the level of knowledge of the patient's relatives and ensure that they know what to expect at every stage of the procedure. at the end of the study, the participants will be asked about their level of satisfaction with the teach-back technique. according to the results of the study, it is expected that the use of teach-back technique in the education of patients and their relatives will increase.

Eligibility criteria:
inclusion criteria: * to have the ability to communicate verbally, * volunteering to participate in the research, * to be 18 years of age or older. exclusion criteria: * lack of verbal communication skills, * not volunteering to participate in the research, * being under 18 years old.

Keywords: colonoscopy teach-back anxiety education
shamrock versus lumbar ultrasound trident - ultrasound guided block of the lumbar plexus

Conditions: Hip Fractures; Anesthesia Local; Pain, Postoperative

Summary: the main objective of the trial is to complete a double-blinded randomized controlled trial of a lumbar plexus block with the shamrock technique versus the lumbar ultrasound trident technique by estimating the time of performance of lumbar plexus blocks in healthy volunteers. secondary objectives include a) estimates of number and depth of needle injections, distance of injection site from the midline, minimal electric nerve stimulation to trigger muscular response and the type of response, and volunteer discomfort during block injection, b) measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory block of the dermatomes t8-s3 and motor block of the femoral nerve, the obturator nerve, the hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e) perineural and epidural distribution of local anesthetics added contrast visualized on magnetic resonance imaging (mri) scanning, and f) cost-effectiveness for the shamrock technique versus the lumbar ultrasound trident technique for lumbar plexus block in healthy volunteers. the hypothesis is that the shamrock technique is faster to perform than the lumbar ultrasound technique, and that the success rate of the shamrock technique is equal to or higher than the lumbar ultrasound trident technique.


Eligibility criteria:
inclusion criteria: * male * age ≥ 18 years * volunteers who have given their written and oral consent to participate in the study after fully understanding the content and the limitations of the protocol * normal healthy volunteer (american society of anesthesiology (asa) classification i) exclusion criteria: * volunteers not able to cooperate for the study * volunteers not able to understand danish * daily use of analgesics * allergy against the medicines used in the study * drug abuse (according to the investigator's judgement) * alcohol consumption larger than the recommendations of the danish national board of health * volunteers in whom nerve blocks are not possible due to technical reasons * volunteers who meet any contraindication for mri including claustrophobia * volunteers who are incompetent, i.e. surrogate consent is not accepted

Keywords: hip surgery anesthesia perioperative analgesia