Kornimate/medical-research-clean huggingface dataset:
observational study of ketamine infusions for the treatment of chronic pain

Conditions: Chronic Pain

Summary: this observational study will collect prospectively specified data on patient characteristics and clinically relevant outcomes in patients who receive a ketamine infusion at stanford pain management center for the treatment of chronic pain, with the goal of identifying treatment responders and relationships between patient characteristics and treatment response.

ketamine is a type of anesthetic drug which has been used off-label to treat chronic pain. the effectiveness of intravenous ketamine and its duration of effect are not well-understood. there is high variability in response to ketamine, and it remains unclear which patient characteristics are associated with favorable outcomes. this observational study will collect a wide range of patient-reported outcomes via digital surveys: once at baseline before treatment, and up to 7 follow-up surveys for up to 12 months following a single ketamine infusion. survey data will be supplemented by clinical data obtained from electronic medical records.

Eligibility criteria:
inclusion criteria: * has been seen at stanford's pain management center for a doctor's visit at least once. * is scheduled to undergo at least 1 ketamine infusion for the treatment of any chronic pain condition. * have a valid email address and consents to receiving surveys by email. * able to read, understand, and respond to english-language surveys on an electronic device such as a cell phone, tablet, or computer. * able to read, understand, and provide written, dated informed consent. exclusion criteria: * has their ketamine infusion cancelled, which may occur before or after consenting to this study.

Keywords: ketamine chronic pain pain syndrome neuropathic pain complex regional pain syndrome intractable pain
connecticut child steps

Conditions: Anxiety; Depression; Trauma; Behavior Problems

Summary: connecticut child steps is a randomized controlled trail investigating the effectiveness of match-adtc in treating anxiety, depression, trauma, and/or behavioral problems in children seeking services at four department of children and families (dcf) funded clinics in the state of connecticut. the study will evaluate child outcomes following two forms of therapist training in the match model.

this randomized controlled trial (rct) will investigate the effectiveness of a modular, transdiagnostic treatment protocol for youth with anxiety, depression, trauma, and/or behavioral problems (match-adtc) in four dcf funded clinics in the state of connecticut. match synthesizes common elements found across dozens of evidence-based treatments into one model that is flexible and responsive to the complex needs of children and families. the rct will evaluate child outcomes following two forms of therapist training in the match model: (1) the 6-day match training only; (2) the 6-day match training plus weekly ongoing case consultation with a match consultant. participating children are between the ages of 7 and 15.

Eligibility criteria:
inclusion criteria: 1. 7 to 15 year old child and their caregivers 2. seeking services at community mental health clinics 3. primary problem or disorder related to anxiety, traumatic stress, depression, or conduct problems, or any combination of the four problems exclusion criteria: 1. child is outside of 7-15 age range 2. child does not have elevations in the areas of anxiety, depression, conduct, or posttraumatic stress 3. child is experiencing other primary clinical problems outside of match focus such as: * adhd identified as primary reason for seeking treatment * schizophrenic spectrum disorder including major depressive disorder with psychotic features * autism spectrum disorder including pervasive developmental disorder, asperger's disorder, child disintegrative disorder, rett's disorder * eating disorder including anorexia nervosa and bulimia nervosa * mental retardation 4. having been hospitalized for suicidal thoughts or behaviors within the past year 5. if the problem area of focus is beyond the scope of outpatient treatment and match (e.g., severe aggression, psychosis, severe current suicidal ideation) 6. if child does not have a primary caregiver that can be involved in treatment and complete research assessments

Keywords: anxiety depression trauma behavior problems evidence-based treatments manualized treatments cognitive-behavioral therapy youth mental health
development of an online act intervention for disorders of gut-brain interaction

Conditions: Clinically Meaningful Symptoms Levels of Symptoms of DGBI and Depression and/or Anxiety

Summary: the goal of this clinical trial is to develop and test the iactfordgbi intervention in a sample of swedish individuals with dgbi (disorders of gut-brain interaction). the first substudy of this project (substudy 1) aims to answer the following question: how can the design of iactfordgbi be tailored to meet the specific needs of individuals with dgbi and clinically meaningful symptoms of anxiety and depression? participants (individuals with symptoms compatible with a dgbi and anxiety and/or depression, and healthcare professionals working in dgbi) will be asked to: a) evaluate a preliminary version of the iactfordgbi intervention, consisting of self-guided online sessions. b) participate in online focus-group interviews and provide information on their views of a preliminary version of the iactfordgbi intervention


Eligibility criteria:
dgbi participants: inclusion criteria: 1. age between 18 and 75 years; 2. exhibiting clinical symptom severity for at least one dgbi diagnosis (assessed with the rome iv diagnostic questionnaire for functional gastrointestinal disorders in adults (palsson et al., 2016)); 3. clinically meaningful levels of depressive symptoms or anxiety: score ≥ 13 on the montgomery åsberg depression rating scale (madrs; depressive symptoms), or score ≥ 10 on the generalized anxiety disorder scale-7 (gad-7; anxiety symptoms; spitzer et al., 2006); 4. stable medication for psychiatric symptoms including anxiety, depression, and sleep problems for at least two months prior to intervention; 5. ability to read and write swedish; 6. access to a device (like a computer, tablet, or smartphone) with access to the internet and that can be used to attend video conferences and preview the intervention platform (i.e., have a microphone and speakers or headphones). exclusion criteria: 1. currently undergoing any form of psychological intervention; 2. increased risk of suicide (≥4 points on madrs item 9); 3. severe depression (≥34 points on madrs). healthcare professionals: inclusion criteria: a) being a healthcare professional currently working with dgbi patients.

Keywords: dgbi act anxiety depression
a study to evaluate the safety and efficacy of avtx-002 for the treatment of poorly controlled non-eosinophilic asthma.

Conditions: Non-Eosinophilic Asthma

Summary: the primary objective of this study is to evaluate the efficacy of avtx-002 compared with placebo in patients with poorly controlled non-eosinophilic asthma (nea).


Eligibility criteria:
inclusion criteria: * documented non-eosinophilic asthma diagnosis (\<300 eosinophils/μl). * symptoms consistent with a diagnosis of asthma that is poorly controlled as determined by an acq score ≥ 1.5. * poorly controlled asthma despite the use of a long-acting beta-agonists and inhaled corticosteroid for at least 3 consecutive months immediately prior to screening. * subjects must have had at least one asthma exacerbation in the last 24 months. exclusion criteria: * pulmonary disease other than asthma. * currently on biologic therapy. previous biologic therapy is permitted with adequate washout (12 weeks or 5 half-lives, whichever is longer). * use of systemic immunosuppressants within the last 6 months. * use of systemic corticosteroids within 6 weeks prior to screening or use of antibiotics within 4 weeks prior to screening. * subject has alanine aminotransferase (alt)/ aspartate aminotransferase (ast) \>5 upper limit of normal (uln) and/or serum creatinine concentration \>1.5 mg/dl. * subject has hemoglobin ≤10 g/dl, neutrophils ≤1,500/μl, and/or platelets ≤75,000/μl.

Keywords: non-eosinophilic asthma avtx-002
efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and the united states of america (usa). the aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: - male or female, age at least 18 years at the time of signing informed consent. - hba1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening exclusion criteria: - female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) - any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - history of pancreatitis (acute or chronic) - screening calcitonin equal to or above 50 ng/l - family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma - renal impairment defined as egfr (electronic case report form) below 60 ml/min/1.73 m\^2 as per ckd-epi (chronic kidney disease epidemiology collaboration) - subjects presently classified as being in new york heart association class iv - planned coronary, carotid or peripheral artery revascularisation on the day of screening - proliferative retinopathy or maculopathy requiring acute treatment - history or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
investigations of the effect of mk-7 on bone and glucose metabolism and arterial calcification

Conditions: Metabolic Bone Disorder

Summary: the aims of the present study are to investigate the effect of vitamin k2 on bone turnover, bone mass, bone structure, glucose metabolism, and arteriosclerosis. osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the western world. our hypotheses is that vitamin k2 (mk-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.

osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the western world. our hypotheses is that vitamin k2 (mk-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.

Eligibility criteria:
inclusion criteria: * postmenopausal women * 60-80 years * osteopenia exclusion criteria: * calcium metabolic, thyroid, liver or kidney disease * diabetes * obesity * myocardial infarction or other arteriosclerotic events * angina pectoris * vitamin d \< 50 nmol/l * treatment with vitamin k antagonists * use of vitamin k supplements in the last month or for more than 3 months at any time * treatment with drugs with known effects on bone metabolism or glucose metabolism. * smoking in the last 12 months * drug or alcohol abuse * allergy to calcium, vitamin d or vitamin k.
ruxolitinib and decitabine for high risk hematological malignancies

Conditions: Peripheral Blood Stem Cell Transplantation

Summary: the purpose of this study is to determine the efficacy and safety of ruxolitinib and decitabine intensified conditioning regimen in patients with high risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.

allogeneic hematopoietic stem cell transplantation should be offered to eligible patients with high risk hematological malignancies whenever feasible. to further improve the outcome of transplantation patients with high risk hematological malignancies, the investigators developed a modified bu/cy conditioning regimen intensified by ruxolitinib and decitabine. in this study, the investigators tested the efficacy and feasibility of the modified bu/cy conditioning regimen intensified by ruxolitinib and decitabine in patients with high risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.

Eligibility criteria:
inclusion criteria: 1. relapsed/refractory acute leukemia with indications for allogeneic hematopoietic stem cell transplantation; high risk acute leukemia with indications for allogeneic hematopoietic stem cell transplantation; 2. medium to high risk myelodysplastic syndrome, myeloproliferative disease, myelodysplastic syndrome/myeloproliferative disease, chronic myelomonocytic leukemia; 3. have matched sibling donors, ≥8/10 hla matched unrelated donors or haploidentical donors 4. all patients should aged 12 to 65 years; 5. liver function: alt and ast≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal; 6. renal function: creatinine ≤the upper limit of normal; 7. patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; 8. eastern cooperative oncology group (ecog) performance status ≤2; 9. have signed informed consent. exclusion criteria: 1. pregnant women; 2. patients with mental illness or other states unable to comply with the protocol; 3. aml patients with t (15;17);
pharmacokinetic response to bpi in burns

Conditions: Burns

Summary: the purpose of this study is to evaluate the safety of a protein called bpi that is naturally made by the body's white blood cells to fight infection.

this study will initially evaluate an fda approved investigational dosage and will measure the blood levels over time while bpi is being infused through a vein to see if the dose is potentially enough to obtain the desired effect. the drug will be started within 8 hours of burn injury and continued for 48 hours. patients will be followed on admission and through infusion in the burn icu where they will be monitored by icu standards. they will be seen regularly thereafter on post-burn days 1, 2, 3, 4, 7, 14 and 28 days while in the hospital. if the patient is discharged prior to the 28 day evaluation, they will be evaluated on or around the 28th day in the burn clinic. a blood sample will be obtained to look for potential genetic markers that may increase a burn patients' risk to develop infection in the post burn period.

Eligibility criteria:
inclusion criteria: * ages 13 years to 60 years old * sustained partial-thickness or full-thickness burn greater than 20% and less than 41% tbsa * parental consent (if subject is less than 18 years old) or individual (if subject is equal to or older than 18) signed, informed consent. * able to start bpi in infusion within 8 hours of burn injury. exclusion criteria: * age \> 61. * inhalational injury requiring mechanical ventilation. * partial and full thickness burns totaling \> 41% total body surface area * cardiac dysfunction, defined as the presence of any of the following: 1. new york heart class 3 or 4 heart failure. 2. unstable angina or acute myocardial infarction. 3. left ventricular ejection fraction known to be \< 35%. * electrical or lightening induced burn injury or any injury that required cardio-pulmonary resuscitation. * concomitant non-burn trauma with an iss \> 9. * non-survivable injury secondary to burn size - patients made dnr or comfort care due to burn size. * patients with known causes of immunosuppression: 1. known history of hiv/aids 2. chronic steroid use for underlying medical conditions (equivalent to 15 mg prednisone/day). 3. active oncolytic therapy for known malignancy * known or suspected pregnancy * known allergy to rbpi21
depressive symptoms and sexual dysfunction in traumatic spinal cord injury

Conditions: Spinal Cord Injuries; Male Sexual Dysfunction

Summary: aims: assess the relationship between sexual function and depressive symptoms in individuals with spinal cord injury.

method: observational study of 44 men with spinal cord injury, age above 18 years, injury time more than six months, sexually active and accompanied in recife referral hospitals. the degree of neurological impairment was assessed using the revised version in 2011 asia impairment scale (ais), depressive symptoms were detected by the beck depression inventory, and the evaluation of sexual function was obtained through the erectile function of international index (iief). descriptive statistics and bivariate analysis to assess the association were applied, with 0,05 significance level.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of traumatic spinal cord injury * injury time less than six months * sexually active exclusion criteria: * patients who had erectile dysfunction attributed to endocrine or metabolic disease order * those who underwent surgery in the genital area, such as radical prostatectomy or penile implant * cognitive impairment

Keywords: sexuality spinal cord injuries erectile dysfunction depression
trigger-point blockade in persistent pain after laparoscopical groin hernia repair

Conditions: Chronic Pain

Summary: groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life. this study examines the effect of ultra-sound guided blocks with local anesthesia in the groin in regard to pain relief and sleep quality. the hypothesis of the study is that a block will confer significant pain relief to patients with severe chronic pain following laparoscopical groin hernia repair.

this placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after laparoscopically assisted groin hernia repair, examines the effect of an ultra-sound guided local anesthetic block of a trigger-point, situated near the spermatic cord at the superficial inguinal ring.

Eligibility criteria:
inclusion criteria: * patients with persistent pain (\< 6 mo) after laparoscopical groin hernia repair * patients with maximal pain area 3 cm or less from the superficial inguinal ring * patients living in the capital region of denmark (region hovedstaden) or the region of zealand (region sjælland) exclusion criteria: * known allergy to bupivacaine or other local anesthetics of amide-type * declared incapable of making his/hers own affairs * does not comprehend danish in writing or speech * cognitive impairment to a degree influencing the testing reliability * known recurrence of the inguinal hernia * other surgical procedures performed in the groin or on the external genitals * neuropathy affecting the groin region caused by other conditions, e.g. post-stroke, multiple sclerosis, herniated intervertebral disc * abuse of alcohol or drugs * unable to cooperate with the sensory examinations

Keywords: herniorrhaphy surgical equipment chronic pain inguinal herniorrhaphy laparoscopy surgical outcome
concentrations of remifentanil for extubation

Conditions: Cough

Summary: condition of the state: (terminated, recruiting, etc.) terminated study design: main objective: compare the frequency and intensity of coughing at the time of extubation with two infusions of remifentanil that predict a plasma concentration (pc) of 3 - 4 and 2 - 3 ng/ml, through the technique of target controlled anesthesia

phase of the study: phase iv intervention: drug: u extubation other names: concentration 2 - 3 ng/ml dose of remifentanil according to the randomization: letter u between 2 - 3 ng/ml. the infusions that were used to reach the (pc) target were: group u = 2 - 3 ng/ml. 20 years old - 6.0 mcg/kg/h, 30 years old - 5.7 mcg/kg/h, 40 years old - 5.3 mcg/kg/h, 50 years old - 5.0 mcg/kg/h, 60 years old - 4.6 mcg/kg/h, 70 years old - 4.3 mcg/kg/h, 80 years old - 4.0 mcg kg/h. drug: extubation t other names: concentration 3 - 4 ng/ml dose of infusion of remifentanil to reach a (pc) 3 - 4 ng/ml, in the following manner: the assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient. the remifentanil dose was adjusted according to the randomization: group t = 3 - 4 ng/ml. 20 years old - 9.0 mcg/kg/h, 30 years old - 8.5 mcg/kg/h, 40 years old - 8.0 mcg/kg/h, 50 years old - 7.5 mcg/kg/h, 60 years old - 7.0 mcg/kg/h, 70 years old - 6.5 mcg/kg/h, 80 years old - 6.0 mcg kg/h. number of arms: 2 masking: the patient had masking with regards to the anesthetic procedure from the unfamiliarity per se of the same and by agents used in this that induced anxiolysis and hypnosis. to guarantee the masking to the viewer, which was the treating anesthesiologist, a nurse was trained in the adjustment of the infusion balloon. ten minutes before concluding the procedure and by request of the anesthesiologist, the nurse proceeded to locate balloon in such a way that the infusion could not be seen by the anesthesiologist, then opened the envelope and adjusted the infusion according to the randomization (u) o (t). the evaluation of the cough, its intensity and the ramsay were under the care of the anesthesiologist, who was unaware of the awakening infusion. allocation: two were allocated for the use: concentration of remifentanil of 2 - 3 ng/ml (group u) and concentration of remifentanil of 3 - 4 ng/ml (group t). recruitment: a patient was recruited between the period of january 2011 and july 2012.

Eligibility criteria:
inclusion criteria: * all patients aged 18-70 years * risk scale american society of anaesthesiologists physical status classification (asa) i and ii * undergoing elective ear surgery exclusion criteria: * patients who are contraindicated remifentanil * patients undergoing emergency surgery * pulmonary pathology (asthma - copd) * index of body mass greater than 35 * background of respiratory failure three weeks prior to the procedure * smokers

Keywords: extubation cough target controlled anesthesia (tacan)
high-dose vitamin d deficiency in burn injury

Conditions: Burn

Summary: high dose vitamin d (50,000iu) therapy may increase bone mineral density/bone mineral content after large burns.


Eligibility criteria:
inclusion criteria: * 5+ yrs * burn size 40% or greater * patient can remain around shriner hospital for children area for 16 weeks * agree to take vitamin d exclusion criteria: * age less than 5yrs * burn size less than 40% * pre-existing bone disease or healing fractures * underlying chronic disease-endocrine or cancer * kidney failure

Keywords: burn vitamin d nutrition burn recovery