Kornimate/medical-research-clean huggingface dataset:
behavioral health interdisciplinary program - collaborative chronic care model (bhip-ccm) enhancement project 2.0

Conditions: Mental Health

Summary: this quality improvement project aims to help outpatient mental health teams, known as behavioral health interdisciplinary program (bhip) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or ccm). the investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align bhip teams' care practices more closely with the principles of the ccm.

this quality improvement project aims to help outpatient mental health teams, known as behavioral health interdisciplinary program (bhip) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or ccm). the investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align bhip teams' care practices more closely with the principles of the ccm. the two primary outcomes of this project are: 1. bhip team collaboration, as evidenced by improved scores in the role clarity and team primacy dimensions of the team development measure (tdm) 2. bhip team clinical effectiveness, as evidenced by reduction in mental health hospitalizations among veterans treated by the bhip teams that have received the two types of implementation strategies described above.

Eligibility criteria:
inclusion criteria: * note that treatment assignment will be at the facility level, and given the stepped wedge design, sites in waves 2-4 will cross over from centralized technical assistance to implementation facilitation. * at the provider level (for completing the tdm), the primary inclusion criterion is clinicians working on bhip teams at the participating medical centers. * at the patient level (for mental health hospitalizations, costs, and all-cause mortality), the primary inclusion criterion is veterans treated by the bhip teams at the participating medical centers. * note that, for mental health hospitalizations, separate sites have been identified as comparators using a balancing algorithm. exclusion criteria: * patients with a diagnosis of dementia in the electronic medical record.

Keywords: collaborative care
impact of manual lymphatic drainage on postoperative edema of the face and the neck after orthognathic surgery

Conditions: Maxillofacial Abnormalities; Post Procedural Discharge

Summary: orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. in postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias). achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being. the main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema.

orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. in postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias). achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being. the main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema. secondary objectives of the study are to assess impact of sessions of manual lymphatic drainage on patient comfort (pain, aesthetic discomfort, difficulty in breathing and discomfort in swallowing) and on ental well-being. patients allocated to the intervention group will have 13 sessions of manual lymphatic drainage and those allocated in control group will not. edema of patients will be measured at day 1, day 8, day 15 and day 22 after surgery by a different physiotherapist than physiotherapist achieving drainage sessions, blind to the randomization group of the patient. at the same time, comfort criteria will be assessed by a visual analogue scale and mental well-being with the general health questionnaire (ghq28).

Eligibility criteria:
inclusion criteria: * orthognathic surgery (mandibular osteotomy, maxillary osteotomy or both) * providing informed consent. exclusion criteria: * postoperative flexible restraint on the chin region. * inability to understand and/or follow all scheduled visits.

Keywords: maxillofacial orthognathic surgery manual lymphatic drainage
the acute, synergistic effects of protein and calcium on appetite and energy intake

Conditions: Healthy

Summary: high-protein meals have previously been shown to acutely reduce appetite and energy intake. more recently, meals higher in calcium have also been shown to increase feelings of fullness, circulating insulin and intestinal peptide concentrations and reduce appetite sensations. this study aims to assess whether calcium and protein act synergistically to acutely influence appetite and energy intake.


Eligibility criteria:
inclusion criteria: * male or female * bmi 18.5-29.9 kg/m2 * age: 18-40 years exclusion criteria: * smokers * food allergies * metabolic disorders (ie. type 2 diabetes)
a long-term safety and tolerability extension study evaluating atogepant for the prevention of chronic or episodic migraine

Conditions: Episodic Migraine; Chronic Migraine

Summary: this study will evaluate the long-term safety and tolerability of atogepant 60 mg daily for the prevention of migraine in participants with chronic or episodic migraine


Eligibility criteria:
inclusion criteria: - eligible participants who completed visit 7, and visit 8 if applicable, of study 3101-303-002 or study 3101-304-002 without significant protocol deviations and who did not experience an adverse event that may indicate an unacceptable safety risk. exclusion criteria: * participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative. * participants with an ecg indicating clinically significant abnormalities at visit 1. * participants with hypertension at visit 1. * participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded. * participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Keywords: episodic migraine chronic migraine
galantamine-cr and cognitive dysfunction in bipolar disorder

Conditions: Bipolar Disorder

Summary: the purpose of the study is to determine whether the investigational drug galantamine-cr (reminyl- controlled release capsule) is useful in improving problems with memory in bipolar patients with stable mood. this study is being done because a large proportion of patients with bipolar disorder experience significant memory problems, even when their mood is stable, after adequate treatment. these memory problems have been associated with poor daily social functioning. studying galantamine-cr in this population may provide a new clinical way to combat memory problems in stable patients with bipolar disorder.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnostic criteria for bipolar disorder * men or women aged 18-65 * a baseline hamilton-d17 score of \< 10 at screen visit * a baseline ymrs score of \< 10 at screen visit * no acute episodes of depression or mania for the previous 12 weeks. * written informed consent exclusion criteria: * subjects with current suicidal ideation * pregnant women or women of childbearing potential * serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease; history of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as als, parkinson disease and any movement disorders, etc) * history or current diagnosis of any of the following dsm-iv psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months * history of multiple adverse drug reactions * patients with mood congruent or mood incongruent psychotic features subjects who are active smokers or who stopped smoking less than 3 months prior to enrollment; clinical or laboratory evidence of hypothyroidism * patients who have had an episode of acute depression or mania during the 12 weeks prior to enrollment * patients who have had electroconvulsive therapy (ect) within the 6 months preceding enrollment * patients with physical contraindications to magnetic resonance spectroscopy (ferrous surgical clips, cardiac pacemakers, ferrous prosthesis) * patients taking any of the following medications: other cholinesterase inhibitors, succinylcholine, neuromuscular blocking agents, cholinergic agonists (e.g., bethanechol), cimetidine, ketoconazole, erythromycin, fluoxetine, paroxetine, and fluvoxamine
stress-reducing intervention in urothelial carcinoma

Conditions: Bladder Cancer

Summary: the aim of this interventional study is to test the heart-rate variability biofeedback intervention (hrv bi) in patients with muscle-infiltrating bladder carcinoma (mibc) treated with chemotherapy based on cisplatin in neoadjuvant setting followed by local therapy (standard of care, soc) compared to soc alone.

this is a prospective, interventional, clinical study with a target of 50 subjects and an anticipated total duration of 36 months. the goal of this study is to test the hrv bi in patients with mibc treated with total of 3 to 4 courses of chemotherapy gemcitabine 1000 mg/m2 + cisplatin 70 mg/m2 day 1 (gc, new course day 22) or methotrexate 30 mg/m2 day 1, doxorubicin 30 mg/m2 day 2, vinblastine 3 mg/m2 day 2, cisplatin 70 mg/m2 day 2 with pegfilgrastim 6 mg s.c. day 4 (ddmvac, new course day 15) in neoadjuvant setting followed by radical cystectomy or irradiation concomitantly with cisplatin 70 mg/m2 weekly (soc) and compare to soc. participants will undergo 4 sessions of hrv bi with the trainer where they will learn about the prognostic role of the vagal nerve in cancer and in reducing distress and pain, and how to perform deep paced breathing with the hrv monitoring. they will perform the training daily (3-times, minimum 7 minutes each) at home with the online control for 3 months. researchers will compare the effect of addition of 3-months training of hrv bi to soc on inflammation, hrv, quality of life (qol), cognitive functions, salivary cortisol slopes, sleep quality and treatment outcomes.

Eligibility criteria:
inclusion criteria: 1. patients older than 18 years. 2. evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy. 3. no prior chemotherapy. 4. no previous malignancy, except for basal-cell carcinoma of the skin within last 5 years. 5. adequate renal functions: measured or calculated (by cockcroft formula) creatinine clearance \> 60 ml/min. 6. absolute granulocytes count 1,500/mm3 or higher, platelets 100,000/mm3 or higher, bilirubin 1.5x the upper limit of normal value and lower. 7. adequate liver functions. 8. basic computer skills. 9. signed informed consent. exclusion criteria: 1. diabetes mellitus with symptomatic neuropathy. 2. using antiarrhythmic drugs, opiates and/or antidepressants. 3. implanted permanent pacemaker (ppm). 4. human immunodeficiency virus (hiv) infection. 5. not fitting inclusion criteria.

Keywords: muscle-infiltrating urothelial carcinoma neoadjuvant chemotherapy standard of care heart-rate variability biofeedback intervention inflammation quality of life cognitive functions salivary cortisol slopes circadian rhythms sleep quality
evaluating the renoprotective effect of milk thistle extract on patients with type ii diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: there is considerable evidence that increased blood glucose results in the generation of reactive oxygen species, ultimately leading to increased oxidative stress in a variety of tissues. this may lead to the activation of stress-sensitive intracellular signaling pathways, causing cellular damage and late complications of diabetes including renal injury. although the investigators understanding of how hyperglycemia-induced oxidative stress ultimately leads to tissue damage has advanced considerably in recent years, effective therapeutic strategies to prevent or delay the development of this damage remain limited. the flavonoid complex silymarin, an extract from the milk thistle, and its major pharmacological active component silibinin are free radical scavengers and potent membrane stabilizers by preventing lipid peroxidation. furthermore, during early stages of diabetes, flavonoids minimize oxidative stress, and inflammation which represent important factors in the development of diabetic nephropathy. in this study the investigators plan to evaluate the renoprotective effect of milk thistle extract on type ii diabetic patients with kidney disease.


Eligibility criteria:
inclusion criteria: * type ii diabetes * overt proteinuria defined by urinary albumin excretion \> 300 mg/24 hr in 2 consecutive determinations despite treatment with highest fda recommended doses of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker for at least 6 months. * treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin (if a thiazolidinedione is used, stable dose for at least 6 months) * treatment of hypercholesterolemia with (but not limited to) one medication from the class statins * presence of diabetic retinopathy * signing informed consent exclusion criteria: * type i diabetes * advanced chronic kidney disease defined by estimated gfr \< 30 ml/min/1.73 m2 * severely uncontrolled diabetes defined by hba1c \> 10% * uncontrolled hypertension defined by sbp \>160 mmhg or dbp \>100 mmhg despite antihypertensive therapy * secondary forms of hypertension with defined etiology other than diabetes mellitus * other renal diseases * history of solid organ transplantation * chronic heart failure with nyha class iii or iv * active infection * pregnancy * use of one of the following medications within 2 months prior to enrollment in the study: * non-steroidal anti-inflammatory agents * antioxidants supplements including: vitamin e, vitamin c, n-acetyl- cysteine (nac), pentoxyfilline, lipoic acid, fish-oil extracts (omega-3 fatty acids), soy extracts (isoflavones), green-tea preparations, pomegranate extracts, grape extracts * active malignancy * hepatitis virus or human immunodeficiency virus infections * history of drug or alcohol dependency * cigarette smoking * psychiatric or neurological condition, preventing aware consent to the study and/or adherence to the study protocol

Keywords: diabetic nephropathy type ii diabetes milk thistle extract silymarin
evaluation of the efficacy of cervical core exercises in persons with temporomandibular joint dysfunction

Conditions: Temporomandibular Joint Disorders

Summary: the aim is to reveal to what extent cervical core exercises affect the results of treatment in patients with temporomandibular joint dysfunction caused by myofascial pain syndrome. randomization will be carried out by dividing individuals who agree to participate in the study into 3 groups of 20 people.participants will be divided into three groups, and all three groups will receive treatment in 30-45 minute sessions a day, 2 days a week for 8 weeks.

the aim is to reveal to what extent cervical core exercises affect the results of treatment in patients with temporomandibular joint dysfunction caused by myofascial pain syndrome. randomization will be carried out by dividing individuals who agree to participate in the study into 3 groups of 20 people with the "research randomizer" program. randomization, evaluation and treatment of the groups will be done by different researchers. participants will be divided into three groups, and all three groups will receive treatment in 30-45 minute sessions a day, 2 days a week for 8 weeks. evaluation will be made at the beginning and at the eight week to see the short-term effects. rocabado exercises will be given to the first group, cervical core exercises will be given to the second group, and rocabado and cervical core exercises will be given together to the third group. after the initial evaluations, all exercises will be taught to the patients in the first week, they will be planned as home exercises in the following weeks, and online follow-up will be done via tele-rehabilitation.

Eligibility criteria:
inclusion criteria: * being diagnosed with temporomandibular disorder caused by myofascial pain syndrome * female gender aged 18 and over * volunteering to participate in the study * not having communication difficulties such as speaking and understanding turkish or not being able to understand the exercises. exclusion criteria: * having a history of acute trauma in and around the temporomandibular joint * having temporomandibular joint dysfunction due to neurological disease * having a history of surgical/invasive procedures or treatments on the temporomandibular joint * presence of infection or tumoral structure within intraoral structures * having a history of tooth loss or prosthetic tooth use * having a history of surgical procedure in the cervical area

Keywords: temporomandibular joint servical core exercise myofasial pain
design of a predictive score for contamination of pediatric blood cultures

Conditions: Bacteremia

Summary: the contamination rate for blood cultures is high in pediatrics, due to different sampling techniques and the difficulty of sampling small-weight children, thus favoring contamination of the devices at the time of sampling. it is also more difficult to distinguish contamination from true bacteremia in children at an early stage, notably due to the limited number of vials that can be taken at any one time. on a daily basis, clinicians are faced with the choice of whether or not to initiate probabilistic antibiotic therapy when faced with the result of a positive blood culture, particularly when identification is not yet available, but only direct examination. contamination has major consequences for patient management. studies in adults have shown that contamination increases hospital length of stay by 4 to 5 days, laboratory costs by +20% and recourse to intravenous antibiotic therapy by +39%. in children, studies came to the same conclusion, with greater prescription of antibiotics, particularly intravenous antibiotics, in patients with contaminated blood cultures than in patients with sterile blood cultures. it also showed that 26% of patients with contaminated blood cultures were initially hospitalized because of the positivity of this test. the aim of this research is to determine the factors associated with contamination, in order to create a predictive score that would help clinicians in their decision-making when receiving the blood culture result as "positive".


Eligibility criteria:
inclusion criteria: * having a blood culture in children's hospital in nancy * under 18 years old * in emergency department, medical department, intensive care unit or surgical department exclusion criteria: * immunodepression * post mortem blood culture * blood culture in onco-haematology department

Keywords: blood culture contamination predictive score
docohexanoic acid in hemodialysis patients

Conditions: Chronic Renal Failure

Summary: docohexanoic acid (dha), a dietary n-3 polyunsaturated fatty-acid omega-3 (n-3, pufa), showed potential beneficial effects in reducing all-cause mortality in hemodialysis (hd) patients. this clinical trial aimed to analyze whether dha supplementation was a modulator of erythropoietin (epo) response and inflammation in hemodialysis (hd) patients.

background. docohexanoic acid (dha), a dietary n-3 polyunsaturated fatty-acid omega-3 (n-3, pufa), showed potential beneficial effects in reducing all-cause mortality in hemodialysis (hd) patients. this clinical trial aimed to analyze whether dha supplementation was a modulator of erythropoietin (epo) response and inflammation in hemodialysis (hd) patients. methods. in single-blind, controlled clinical trial, 52 hd patients were randomized to either dha supplementation (650 mg dha/3 times/wk/post-hd session) or controls (usual medical-care) for 8-weeks. clinical data by collecting hemoglobin concentration (hb), weekly dose of epo, and erythropoietin resistance index (eri). the inflammatory response was measured using serum c-reactive protein (s-crp) and plasma homocysteine (thcy) at baseline (t0) and post-intervention (t1). mir-146a array was used as an inflammatory biomarker. post-intervention measures were analyzed at 4-weeks intervals and adjusted by baseline in a linear regression.

Eligibility criteria:
inclusion criteria: * age over 18 years * chronic stabilized hd treatment for at least 3 months with functional vascular access (arteriovenous fistula or permanent catheter) * equilibrated kt/v urea (ekt/v)higher than 1.2 * informed consent form signed exclusion criteria: * exposure to corticosteroids and anti-inflammatory drugs or hospital admissions in last 3 months * were with ongoing active illnesses, wasting, connective tissue disease, metastatic cancer or malignancy, hiv, uncontrolled chronic hepatic disease or transplantation prior to the start of the study. * patients with known hypersensitivity to any of fish intolerance or allergy, history of gastrointestinal bleeding, patients already receiving chronic anticoagulation therapy (antiplatelet agents or warfarin), and patients with terminal or life-threatening disease.