Kornimate/medical-research-clean huggingface dataset:
stroke of mindfulness: investigating physiological and psychological well-being

Conditions: Stroke; Stress; Anxiety; Depression

Summary: this study evaluates the impact of mindfulness-based interventions on psycho-social and physiological well-being among stroke survivors and their family caregivers. this study will employ a treatment wait-list cross-over design, with half the participants randomized to receive the intervention first (treatment group), while the other half receives the interventions 2 months following the end of the treatment phase (wait-list group).

stroke survivors face many concerns, including the physical, psychological, cognitive and psychosocial consequences of stroke, as well as impaired function and quality of life. also important for stroke survivors is the possibility of recurrence that may result in death and further disability. survivors depend on their caregivers to provide assistance for daily living tasks, emotional support and taking on new roles and responsibilities with changing social dynamics, often causing long-term strain. mindfulness-based interventions (mbis) are psychotherapeutic interventions which have been shown to improve psychological, physiological and psychosocial outcomes such as anxiety, depression, mental fatigue, blood pressure and overall quality of life. however, data is limited for stroke survivors and their caregivers, especially in asians. this study will evaluate the impact of mbis on the psychological well-being and perceived quality of life among stroke survivors and their family caregivers in singapore. this study employs a randomized treatment-waitlist crossover design with outcome measures administered before and after the intervention as well as at 3 months follow-up for the treatment group. the intervention consists of 4 weekly 2-hour mindfulness sessions. participants will be introduced, taught and guided in practice of mindfulness-based interventions that are focused on their (1) breath, (2) senses, (3) body and bodily movement, (4) feelings of empathy and compassion. pre- and post-intervention questionnaires will be conducted to assess symptoms associated with depression, anxiety, stress and perceived quality of life. blood pressure and heart rate variability recordings before and after intervention will also be noted.

Eligibility criteria:
inclusion criteria: * stroke survivors * family caregivers * able to speak and understand english fluently * comprehends and provides consent independently exclusion criteria: * cognitively impaired individuals with a mmse score of less than 20, moca score of less than 23 * depression and anxiety stress scale scores, dass, depression \>7, anxiety \>8, and stress \>13

Keywords: mindfulness stroke survivors caregivers
intraarticular corticosteroid therapy in perthes disease.

Conditions: Legg-Calve Perthes Disease

Summary: legg-calve-perthes disease (lcp) represents the loss of blood flow to the head of the femur, resulting in significant hip pain and potential long term disability. this study represents a single center, randomized, prospective, controlled study comparing the treatment of lcp with an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional nonoperative treatment.

legg-calve-perthes disease (lcp) represents the loss of blood flow to the head of the femur, resulting in significant hip pain and potential long term disability. the cause of lcp is still unknown, but tends to occur predominantly in boys from ages 4-12. for the majority of those affected, observation and symptomatic treatment with oral antiinflammatories, such as ibuprofen, is indicated. this study represents a single center, randomized, prospective, controlled study comparing the treatment of lcp with an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional nonoperative treatment. the investigators will test for improved outcomes by measuring functional outcomes (podci and askp questionnaires, stepwatch activity monitor), hip range of motion and visual-analog pain scales. the investigators hypothesize that injections of corticosteroids (potent, injectable antiinflammatories) will result in improved overall function through decreased pain and increased hip range of motion in this patient population.additional biological research will be performed. there is no human information on the inflammatory response that occurs in the hip joint of children with perthes disease, and there are no true animal models of perthes disease. to better understand the pathobiology of perthes disease, the collection of joint fluid from both hips may provide insight into the treatment of a disease for which we currently have no explanation of cause, and consequently no therapies

Eligibility criteria:
inclusion criteria: * age of 4 to 12 years * diagnosed with idiopathic osteonecrosis of the femoral head * symptoms less than 12 months old. exclusion criteria: * symptoms for more than 12 months * previous treatment other than anti-inflammatories, crutches or bed rest * subjects more than 8 years old or have a hand bone age greater than 6 years old and lateral pillar b or b/c disease. * bilateral hip disease * personal or family history of problems with general anesthesia * prior steroid treatment * previous diagnosis of: * asthma * identifiable rheumatologic condition * metabolic diseases (including but not limited to gaucher's disease or congenital hypothyroidism) * sickle cell disease * known pain syndrome * hip sepsis * prior malignancy (solid organ or bone marrow transplant) * blood clotting disorder
treatment shortening of drug-sensitive pulmonary tuberculosis using high dose rifampicin (hi-dori-3)

Conditions: Tuberculosis, Pulmonary

Summary: the purpose of this study is to investigate the effectiveness and safety of the regimen including high dose rifampicin for individualized duration (3 months after culture conversion) for the treatment of drug-sensitive pulmonary tuberculosis.


Eligibility criteria:
inclusion criteria: * documented positivity by sputum xpert mtb/rif assay * administration of current tuberculosis therapy (if any) for no more than 7 days (≤7) at the time of enrolment. exclusion criteria: * negative on xpert mtb/rif assay * resistance to rifampicin as detected by an xpert mtb/rif assay * known resistance to isoniazid, rifampicin, or pyrazinamide * hiv positive * cancer patient on anti-cancer chemotherapy * uncontrolled dm * chronic hepatitis, liver cirrhosis * any contraindications of drugs to be used

Keywords: tuberculosis rifampicin treatment shortening
sema 4a as a marker for inflammatory disease in multiple sclerosis

Conditions: Relapsing Multiple Sclerosis; Multiple Sclerosis

Summary: measure serum and cerebrospinal fluid sema4a levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or non-multiple sclerosis controls (patients without inflammatory central nervous system disease).

this pilot study proposal will further investigate whether semaphorin 4a (sema4a) elevation in cerebrospinal fluid (csf) and serum is a potential disease activity biomarker in patients with multiple sclerosis (ms). a total of 40 female subjects between the ages of 18-55 who meet the criteria of one of the following four groups will be enrolled to measure serum and csf sema4a levels: * group 1: newly diagnosed/untreated relapsing ms patients (rms) * group 2: clinically stable rms patients receiving disease modifying therapy (dmt) * group 3: rms patients receiving dmt with breakthrough disease * group 4: non-ms controls (patients without inflammatory cns disease) participants will provide blood and csf samples at baseline for sema4a analysis. follow up blood samples will be collected at 6 months and 12 months as part of lymphocyte subset analysis. participation will end after 12 months of follow up. the expected risks are related to blood draws and lumbar puncture. lumbar puncture will be performed under fluoroscopy to decrease risks of pain from repeated needle punctures, injury from incorrect placement of the needle, and post puncture csf leakage.

Eligibility criteria:
inclusion criteria: * female aged 18-55, inclusive at the time of consent * not pregnant at the time of the screening/baseline visit * able to understand the purpose, benefits, and risks of the study; willing and able to adhere to the study requirements; able and provide informed consent in english * meet the criteria of one of the four groups at the time of consent: * group 1: subjects who have recently been diagnosed with ms, have had a clinical attack within the last 6 months, have not received steroids in the last 30 days, and have not started on a disease modifying therapy * group 2: subjects with clinically stable relapsing ms, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on mri in the prior 4 weeks, who are receiving a fda-approved ms dmt * group 3: subjects with relapsing ms on a fda-approved dmt but with evidence of breakthrough disease, with a documented clinical relapse and/or gadolinium-enhancing lesion(s) on brain or spinal cord mri taken within the 4 weeks * group 4: subjects without evidence of inflammatory systemic or cns disease, who require csf removal for some other cause, such as for idiopathic intracranial hypertension or communicating hydrocephalus exclusion criteria: * there are no exclusion criteria for this study.

Keywords: multiple sclerosis relapsing multiple sclerosis semaphorin 4a sema4a disease modifying therapy biomarker
combining objective and subjective sedation assessment tools

Conditions: Critical Illness

Summary: the purpose of this study is to determine if the use of a device called the bis monitor in addition to the richmond agitation sedation scale will give better assessment of a subject's level of sedation.

patients in the intensive care unit (icu) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. the national guidelines for sedation management include a daily interruption of sedation performed once each morning. to determine the amount of sedation needed, the current standard practice is to use a system called the richmond agitation-sedation scale (rass). the patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved. the purpose of this study is to determine if the use of a device called the bis monitor in addition to the rass will give better assessment of a subject's level of sedation. the bis monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. it is approved by the u.s. food and drug administration (fda) for monitoring patients under sedation.

Eligibility criteria:
inclusion criteria: * patient in the icu * continuous iv sedation with propofol midazolam or dexmedetomidine * age \> 18 * expected to require mechanical ventilation for \>=48 hours exclusion criteria: * prisoners * no available space on forehead * continuous electroencephalography(eeg) monitoring * bifrontal brain injury * barbiturate coma therapy * known hypersensitivity to study medications * high risk for ethanol (etoh) withdrawal * resuscitation from cardiac arrest without recovery of mental status * moribund clinical state (death expected within 48 hours)

Keywords: mechanical ventilation human conscious sedation bispectral index monitoring critical care propofol
mime therapy vs motor imagery technique in bell's palsy

Conditions: Bell Palsy

Summary: bell's palsy, characterized by unilateral paralysis/paresis of facial muscles, is a condition with a significant impact on individuals' lives. it was first identified by scientist sir charles bell, and its sudden onset can lead to social, psychological, and emotional distress. left untreated, bell's palsy can have long-lasting effects on a patient's quality of life, including loss of facial muscle control, emotional stress, and communication difficulties. rehabilitation protocols encompass various physical therapy techniques, among which mime therapy and motor imagery technique have shown promise.

while rehabilitation protocols have shown promise in enhancing facial muscle control, reducing disability, and preventing long-term complications, there remains a critical gap in the literature regarding the comparative effectiveness of various rehabilitation techniques. currently, there is limited empirical evidence to guide healthcare professionals in selecting the most suitable rehabilitation approach for individual patients. the purpose of this study is to address this gap in knowledge by comparing two specific rehabilitation techniques: mime therapy and motor imagery technique. understanding which of these rehabilitation techniques is more effective can significantly influence clinical practice and patient care. by conducting a systematic comparison, this study aims to provide evidence-based recommendations to healthcare professionals in selection of appropriate rehabilitation protocol for bell's palsy patients.

Eligibility criteria:
inclusion criteria: * age 20-40 years * both male and female * patients diagnosed with bell's palsy * paralysis/paresis of all muscle groups of one side of face exclusion criteria: * patients diagnosed with facial palsy * patients with impaired cognition * patients diagnosed with other neurological diseases
providing expanded continuous labor support to pregnant women in new mexico with substance use disorders

Conditions: Pregnancy Related; Substance Use Disorders

Summary: this study will determine the feasibility of offering expanded continuous labor support by trauma- and addiction-trained medical paraprofessionals (i.e. doulas) at no cost to pregnant women receiving care for substance use disorders (sud). the long-term goal of this transdisciplinary multilevel intervention is ultimately to reduce a major existing behavioral health disparity in the state. this cross-campus multi-disciplinary collaboration, is in partnership with young women united (a research and policy organization in nm) and doulas of the unm birth companion program. through this partnership, women receiving combined ob/sud treatment at the milagro program at unmhsc will be offered expanded doula services.


Eligibility criteria:
inclusion criteria: * at least 18 years old * able to participate in informed consent * able to read, write, and speak english * gestation of at least 26 weeks at baseline (necessary because of short duration of study) * plan to give birth at unm. exclusion criteria: * active psychosis * current incarceration * identified by medical staff as unable for medical reasons to currently participate in the study * not interested in having doula support
personalizing preprocedural sedation for regional anesthesia

Conditions: Catastrophizing Pain

Summary: this is a prospective, randomized study in patients who receive a nerve block prior to surgery. the aim is to investigate whether individual differences in psychosocial and pain profiles may play a role in how patients experience sedation for regional anesthesia. the study will utilize a mixed-methods approach, including a randomized controlled intervention and semi-structured interviews, in order to systematically investigate the relationship between an individual patient's level of catastrophizing and efficacy of procedural sedation, while exploring patient satisfaction with the preoperative nerve block experience.

the primary quantitative outcome will be pain severity during nerve block placement. secondary quantitative outcome is patient satisfaction. validated psychometric assessment tools (pain catastrophizing scale) will be used to stratify patients according to baseline degree of pain catastrophizing (high versus low baseline pain catastrophizing). these groups will then be randomized to receive either titrated pharmacologic sedation (i.e., additional midazolam and fentanyl beyond a standard low midazolam dose) or intraprocedural educational reassurance. semi-structured interviews and qualitative analysis will be used to explore patient's experiences with nerve block placement and identify themes regarding what makes this experience more positive or negative for individuals with different characteristics.

Eligibility criteria:
inclusion criteria: * age≥18 * english speaking * willingness to undergo psychophysical testing * willingness to have nerve block performed * surgical or procedural patient * single shot nerve block exclusion criteria: * cognitive dysfunction that precludes communication * declines or is not eligible clinically to receive sedation with midazolam and/or fentanyl at discretion of the non-study clinical team (examples: frailty, cognitive dysfunction) * allergy or hypersensitivity to midazolam or fentanyl * declines nerve block * does not complete survey needed for randomization * current pregnancy and/or breastfeeding

Keywords: catastrophizing regional anesthesia nerve block preprocedural sedation
allergic versus non allergic hypersensitivity drug reaction (bddallergo)

Conditions: Allergic Hypersensitivity Drug Reaction Versus Non-allergic Hypersensitivity Drug Reaction Cross Reaction

Summary: the creation of a database containing the medical data of patients followed in allergology at the university hospital of grenoble will permit to study allergic versus non-allergic hypersensitivity drug reaction as well as the risk of cross-reactions between medicinal drugs belonging to the same pharmacological class. the main objectives of the study are to estimate and to compare the proportion of allergic hypersensitivity drug reaction and the proportion of non allergic hypersensitivity drug reaction, and to characterize these two types of hypersensitivity drug reaction on clinical, biological and chronological aspects. in a second time, ancillary study will be conducted in order to : * identify drugs that potentially induced histamine-liberation in patients diagnosed with non allergic hypersensitivity drug reaction * investigate the risk of cross-reactions between drugs belonging to the same pharmacotherapeutic class in patients diagnosed with allergic hypersensitivity drug reaction.

this study is an observational cohort study conducted at university hospital of grenoble. it include retrospectively and prospectively the patients followed in the allergology department for the realization of immunoallergological test after suspicion of hypersensitivity drug reaction. the data are collected in a database from medical consultation reports that are systematically reported to the pharmacovigilance regional center. an anonymization number is assigned for each patient included in the study.the data collected include patient's personal and family medical history, a clinical, biological and chronological description of the hypersensitivity reaction, the results of the immunoallergologic skin tests as well as the final diagnosis.

Eligibility criteria:
inclusion criteria: * cases where a non-iatrogenic cause was finally identified exclusion criteria: * for the estimation and comparison of the proportions, the patients who haven't carried out all their immunoallergologic tests investigations at the university hospital of grenoble are not included (this concerns patient who have realized only oral rechallenge test at hospital) * to realize the comparative analysis of allergic versus non-allergic hypersensitivity drug reaction : cases that are insufficiently documented on clinical, biological and / or chronological aspects are excluded. this concerns especially patients who realize immunoallergologic tests investigations after a skin reaction that occurred "in childhood".

Keywords: drug hypersensitivity, drug allergy, cross reaction
visilizumab for treatment of perianal fistulas in crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat crohn's disease in patients with at least one perianal fistula. the research is being conducted at up to 5 clinical research sites in the us and europe and is open to both men and women ages 18 to 70 years old. participants in the study will have a number of visits to a research site over a 17 month period. all study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work. visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against t cells. visilizumab selectively attacks problematic t cells and, in doing so, it may prevent them from causing inflammation. visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).

pdl biopharma, inc. was formerly known as protein design labs, inc.

Eligibility criteria:
inclusion criteria: * 18-70 years old * diagnosis of crohn's disease with fistula * test negative for clostridium difficile within 3 weeks * signed informed consent, including permission to use protected health information. exclusion criteria: * history of lymphoproliferative disorder or prior malignancy within 5 years or current malignancy * pregnant or nursing * hiv, hepatitis b or hepatitis c infection * presence of obstructive symptoms, confirmed by endoscopy, within 6 months * likely to require surgery in the next 6 months * serious or active infections within 1 year * active infections that require antibiotic therapy * serious infections that require iv antibiotics or hospitalization within 8 weeks * started or changed dose of sulfasalazine, 5-aminosalicylic acid (5-asa), antibiotics, probiotics, or topical therapies for crohn's within 2 weeks * had increased dose of corticosteroids within 2 weeks * received a live vaccine within 6 weeks * received any monoclonal antibodies or investigational agents within 3 months * received cyclosporine or tacrolimus (fk506) within 4 weeks * dose change or discontinuation of 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks * significant organ dysfunction * history of lymphoproliferative disorder * history of tuberculosis, mycobacterial infection, or positive chest x-ray * history of thrombophlebitis or pulmonary embolus * history of immune deficiency or autoimmune disorders (other than crohn's disease) * history of seizure with subtherapeutic levels of anticonvulsive medication within one week
patient satisfaction in stroke patients

Conditions: Stroke

Summary: the objective of this trial is to guarantee a follow-up of all stroke and transient ischemic attack (tia) patients. with this follow-up assessment long term effects of therapy and prevention measures can be detected and monitored. it is part of quality assurance.

primary efficacy endpoint: number of patients who state that they received all the information they want about the causes and nature of their illness key secondary endpoint(s): compliance/adherence with discharge medication. re-events. degree of disability. activities of daily living. mortality.

Eligibility criteria:
inclusion criteria: * all patients eligible exclusion criteria: * none

Keywords: stroke