Kornimate/medical-research-clean huggingface dataset:
surgical site infection study

Conditions: Cava-pulmonary Anastomosis

Summary: the purpose of this study is to investigate the pharmacokinetics of cefazolin using both plasma and microdialysate sampling methods in children with single ventricle physiology undergoing their second palliation procedure. this will provide data to determine if the current standard dosing regimen of cefazolin is adequate to achieve and maintain tissue concentrations greater than the minimum inhibitory concentrations (mic) for common post-surgical pathogens that cause surgical site infections (ssis).

this study aims to sample interstitial fluid (if) of infants undergoing superior cava-pulmonary anastomosis (either glenn or hemi-fontan) cardiac surgical procedures who receive cefazolin as their surgical prophylactic antibiotic. cefazolin concentrations will then be determined in both microdialysate and plasma samples and used to define the pharmacokinetics of cefazolin at the tissue level and compare that to plasma pharmacokinetics. in addition, the data gathered will be used to assess how cardiopulmonary bypass (cpb), deep hypothermic cardiac arrest (dhca), and modified ultrafiltration (muf) affect tissue penetration of the prophylactically administered cefazolin. the study involves the use of microdialysis (md) and plasma sampling methods to determine the pharmacokinetic properties of cefazolin when used as a prophylactic antibiotic during the second palliation procedure (superior vena cava-pulmonary anastomosis) for infants with single ventricle physiology. this requires the use of microdialysis (md) catheters inserted into the left deltoid muscle in eligible subjects after the induction of general anesthesia as well as collection of microdialysate and blood samples throughout the duration of the procedure. cefazolin will be administered as standard of care. cefazolin concentrations in the collected samples will be measured via a validated high-performance liquid chromatography (hplc) and mass spectrometry assay. pharmacokinetic analyses will be performed.

Eligibility criteria:
inclusion criteria: * males or females with single ventricle physiology undergoing their second palliation procedure (typically performed between 3-6 months of age) * use of cefazolin as the prophylactic antibiotic during the operation * written informed consent provided by the parent or legal guardian exclusion criteria: * use of prophylactic antibiotic other than cefazolin during the operation * anatomic or other abnormalities of the upper arm that would preclude insertion of a microdialysis catheter * known renal or hepatic function

Keywords: pharmacokinetics cefazolin microdialysis sampling interstitial fluid skeletal muscle plasma children
the value of using mini-oral pulse steroid therapy along with non cultured epidermal cell suspension (nces) in stable resistant vitiligo

Conditions: Vitiligo

Summary: assessing the additive value of mini-oral pulse steroid therapy in surgical treatment of acral and difficult to treat sites of vitiligo


Eligibility criteria:
inclusion criteria: * patients with non-segmental vitiligo (nsv) with acral or resistant lesions over the elbows and knees, that has not responded to conventional treatment * stability for ≥ 1 year * age ≥18 years * lack of topical treatment for at least 1 month prior to surgery and systemic treatment for at least 3 months prior to surgery. exclusion criteria: * non acral nsv responsive to conventional treatment modalities * active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges or koebnerization in \< 1 year * age \< 18 years. * pregnant females. * patients with hypertension, diabetes or tuberculosis * topical treatment in the past month and systemic treatment in the past 3 months.

Keywords: vitiligo surgery mini-oral pulse steroid therapy resistant
non-invasive epicutaneous transfontanel intracranial pressure monitoring in children under the age of one: a novel technique

Conditions: Hydrocephalus

Summary: investigators compare the icp of two standard spiegelberg icp-probes in children, which underwent an operation due to craniosynostosis.

the investigators compare the icp of two standard spiegelberg icp-probes in children, which underwent an operation and implantation of an external ventricle drain or a subdural icp monitoring devise. the second icp probe is fixed epicutaneously on the skin over the frontal fontanel. the hourly measured icps within 24 hours postoperatively were compared with the bland-altman two methods analysis.

Eligibility criteria:
inclusion criteria: child with open fontanel need of icp monitoring exclusion criteria: closed fontanel no need of icp monitoring

Keywords: noninvasive icp monitoring
study of du-176b aged 80 years or older

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular nvaf aged 80 years or older who are ineligible for available oral anticoagulation therapy.


Eligibility criteria:
inclusion criteria: * patients with nonvalvular atrial fibrillation (nvaf) aged 80 years or older who are ineligible for available oral anticoagulation therapy exclusion criteria: * patients with active bleeding * patients who have poorly controlled hypertension * patients who have liver dysfunction accompanied with disorder of blood coagulation

Keywords: anticoagulants du-176b edoxaban factor xa oral prevention atrial fibrillation
the meadow project (mending the effects of alcohol and depression on women) and the bridge program (connecting recovery treatment and behavioral health)

Conditions: Alcohol Dependence; Depression

Summary: the aim of this study is to evaluate an interpersonally-focused intervention (interpersonal psychotherapy) for women with co-occurring alcohol dependence and depression. a sub-protocol has been added to pilot the current study with men with co-occurring alcohol dependence and depression.

co-occurring alcohol dependence and major depression (ad-md) is a serious and common public health problem, yet one that is largely unaddressed by conventional chemical dependency treatment. among alcohol dependent patients, co-occurring depression is associated with poorer treatment outcomes, increased risk for relapse, worse long-term social and functional adjustment, and higher probability of dire outcomes such as suicide. treatment research on ad-md patients is needed to inform effective practice. this study provides an initial test of the applicability of interpersonal psychotherapy for alcohol dependent women with major depression (ipt-admd). the goal of the proposed research project is to refine and test a behavioral intervention that addresses women's co-occurring alcohol dependence and depression within a cohesive interpersonal frame. in phase 1 of the project, ipt-admd will be piloted with 15 ad-md women enrolled in a mica (mentally-ill chemical abusers) group treatment program. findings from phase 1 will be used to refine the treatment, assessment, and therapist training procedures. in phase 2, a randomized controlled trial with 60 ad-md women will be conducted 1) to determine ipt-admd's feasibility and acceptability as an adjunct to standard mica group treatment, and 2) to assess the comparative effects of ipt-admd to treatment-as-usual individual therapy (tau-it). compared to tau-it, ipt-admd is hypothesized to lead to greater reductions in women's drinking frequency, drinking intensity, and depressive symptoms, and to improved interpersonal functioning. in addition to the current intervention study comparing ipt-admd with tau-it, we are piloting ipt-admd with men in a sub-protocol of the main study. the target population of the bridge program will be men with alcohol dependence and co-occurring major depression. we hypothesize that ipt will be feasible and acceptable and will improve drinking frequency and intensity; depressive symptoms; and interpersonal functioning. the proposed sub-protocol will allow us to determine if future clinical trials of ipt should include both male and female patients with co-occurring alcohol dependence and depression.

Eligibility criteria:
inclusion criteria: * current alcohol dependence and major depression exclusion criteria: * bipolar disorder * psychosis or schizophrenia

Keywords: depression alcohol dependence women psychotherapy men
comparative effectiveness of a peer-led o2 infoline for patients and caregivers

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: about 1 million individuals in the us have a prescription for supplemental oxygen (o2). using o2 can prolong life and increase quality of life. patients often do not use their oxygen as prescribed, which means that they are not benefiting as much as they could be from this therapy. the purpose of this study is to evaluate whether a peer-led o2 infoline for patients and caregivers (pelican) will increase adherence to supplemental oxygen prescription and improve health in patients with chronic obstructive pulmonary disease (copd).

the copd foundation operates a peer-led telephone-based information line, but its effectiveness in promoting adherence to o2 therapy and patient-centered outcomes is unknown. our overall hypothesis is that a patient-centered peer-led o2 infoline for patients and caregivers (pelican) will increase adherence and improve health. we have developed a broad-based collaboration with patients/caregivers, advocacy groups, a national o2 supplier, and others to conduct a 3-arm pragmatic clinical trial, to evaluate the comparative effectiveness of proactive vs. reactive pelican interventions vs. usual care on adherence to o2 (primary outcome) and on other patient-centered outcomes (secondary outcomes).

Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. physician diagnosis of copd 3. physician prescription for home o2 for 24hrs/day, 7 days/week 4. willing to use home o2. 5. working telephone number. exclusion criteria: 1. unable to read and speak english. 2. discharge to home hospice or expected survival less than 6 months.

Keywords: chronic obstructive pulmonary disease (copd) supplemental oxygen adherence telephonic education peer coaching
oral nutritional supplement preferences in patients with cancer

Conditions: Neoplasms; Malnutrition

Summary: patients diagnosed with cancer have a particularly high risk of developing malnutrition due to the disease itself and due to symptoms of cancer treatments that can affect food intake such as reduced appetite, nausea, fatigue, and alterations in taste and smell. nutritional treatment is essential in the prevention and treatment of malnutrition. oral nutritional supplements (ons) are often recommended to cancer patients who need to increase their nutritional intake and are unable to meet their nutritional requirements by consumption of normal food alone. however, patient compliance with ons depends on sensory acceptability of such products. therefore, the objective of this study is to investigate preferences of sensory characteristics of ons among cancer patients. additionally, possible associations between taste and smell alterations and dietary intake, malnutrition risk, and quality of life will be investigated. the results from this study will optimize recommendations of ons in the clinical setting and encourage new efforts among manufacturers in developing acceptable sensory characteristics of ons to cancer patients. findings from this study will contribute to improving nutritional treatment for cancer patients.


Eligibility criteria:
inclusion criteria: * ambulatory patients diagnosed with lung cancer * patients receiving cancer treatment of different types * age 18 years or more * provided signed informed consent * understand written and oral norwegian exclusion criteria: * severe mental or cognitive disorders * contraindication to consume ons (dysphagia, inability to swallow oral nutritional supplements) * allergic or intolerant to any of the ingredients in the ons * terminally ill patients (\<3 months to live) * a clinically significant disease or condition that could, in the investigator's opinion make the patient unfit for the study
coronary computed tomography (ct) angiography versus standard therapy in the emergency room

Conditions: Chest Pain

Summary: the purpose of this study is to determine the usefulness of ccta (coronary computed tomography angiography) in the emergency room setting to diagnose and predict the outcome of patients with chest pain who have a low to moderate risk of heart disease. and to also determine if the use of ccta(coronary computed tomography angiography) is more cost effective (cost less) than the current standards of care treatments. to determine if patients who present to the emergency room w/low to moderate probability of having an acs (acute coronary syndrome) prefer ccta (coronary computed tomography angiography)-based care compared to standard algorithm based care.


Eligibility criteria:
inclusion criteria: * 25 years of age or older * experiencing chest pain exclusion criteria: * pregnant * at high risk for acs (acute coronary syndrome)
metastatic breast carcinoma and women sexual quality of life

Conditions: Metastatic Breast Carcinoma

Summary: sexual health is one of the relevant parameters for assesing the quality of life. improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase. the purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.

we use a quantitative methodology to assess quality of female sexual life, quality of life and quality o relationship with validated scientific questionnaires. the sexual and emotional intimacy will be explored by semi structured interview, not mandatory for patients.

Eligibility criteria:
inclusion criteria: * women with metastatic breast cancer * age ≥ 50 and \< 70 years old * diagnosis of metastatic breast cancer at least 6 months prior to study participation * patient living with a partner * menopausal women (absence of menstruation for 1 year minimum) * ecog performance status ≤ 2 * affiliated to public health system * informed and having expressed her non-opposition exclusion criteria: * patient in exclusive palliative care * single or not living in a couple * non-menopausal patient

Keywords: cancer sexuality quality of life intimacy bisf-wbrief index of sexual functioning for women questionnaire quality of life questionnaire (eortc qlq-br23): partnership questionnaire (partnerschaftsfragebogen; pfb)
conditioned placebo effects and treatment of hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to compare the unconditioned and conditioned effects of placebo capsules in the treatment of patients with borderline hypertension (bh).

design narrative: this study will compare the unconditioned and conditioned effects of placebo capsules in the treatment of patients with borderline hypertension (bh). the use of placebos is routine in trials of antihypertensive medication, but the placebo is nearly always given before the active drug, and most studies have relied on traditional clinic measurement of blood pressure (bp). however, ambulatory bp monitoring (abpm) is the gold standard for evaluating the effectiveness of any antihypertensive treatment, and placebo effects on abp have mostly been negligible. however, there is also evidence that when a placebo is given after the active drug, there may be a more profound effect. a long series of both animal and human studies by the co-principal investigator (dr. ader) have shown that such learned or classically conditioned placebo effects may have genuinely therapeutic effects. one such study, which will provide the basis for the current study, found that placebo given after the active drug lowered home bp, but abp was not evaluated. the current study will extend the previous one, and will be performed in community health centers, in a culturally diverse, economically disadvantaged population. 120 patients with untreated bh will have their bps monitored by clinic, home, and abp recording. after a 4-week run-in period of telephone-linked home monitoring (continued throughout the study) they will be randomized to 3 groups: no drug, active drug (a beta blocker-diuretic combination), or matching placebo. this will enable evaluation of the unconditioned placebo effect. for the next 4 weeks all 3 groups will receive active drug. abpm and clinic bp will be measured at the end of each period. for the final period patients in each group will be randomized to no drug or placebo. abpm and clinic bp will be measured after 2 weeks, but home bp will continue until bp returns to 140/90 mmhg. it is hypothesized that the conditioned placebo effect will result in a delayed return of bp to pretreatment levels, and the inclusion of the no drug group will distinguish this from the effects of drug washout. to promote and assess compliance with the medications, electronic containers (memscaps) will be used. the demonstration of a conditioned placebo effect that produces a sustained reduction of bp could result in more economical treatment with fewer side effects.

Eligibility criteria:
no eligibility criteria
dexmedetomidine versus dexamethasone with levobupivacaine in interscalene block

Conditions: Postoperative Analgesia; Postoperative Complications

Summary: the investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.

sixty patients were enrolled and divided into three groups 20 each, group c received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. group h received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. group d received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. the primary outcome was the postoperative pain which was assessed by visual analog score(vas), the secondary outcomes were the onset and duration of sensory and motor block, the total amount of analgesic requirement, and blood cortisol level.

Eligibility criteria:
inclusion criteria: * sixty healthy patients asa i-ii * aged 18-60 years * of both sexes * scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled. exclusion criteria: * patients with a history of any allergic reactions to levobupivacaine, dexamethasone or α2 agonists * all patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - patients who were under treatment by α2 agonist or antagonists * pregnant women * psychiatric patients * patients with a previous history or clinical evidence of central or peripheral neurological disease * coagulopathy or anticoagulant/antiaggregant therapy * contralateral phrenic nerve paresis * patients who have an infection at the site of the block. * every patient who had an anatomical or vascular abnormality in the upper extremity were excluded from this study.

Keywords: dexmedetomidine dexamethasone interscalene
feasibility and acceptability of a body dissatisfaction program in eating disorders patients

Conditions: Eating Disorders

Summary: the cognitive model of eating disorders (ed) highlights dysfunctional cognitive patterns common to the different subtypes. body dissatisfaction, which can be defined as the negative and subjective evaluation of one's body shape, i.e., negative thoughts and emotions concerning one's body image and the origin of pathological behaviours with the aim of modifying one's weight and body shape, thus appears to be a central transdiagnostic concept in the ed. it is, moreover, described as a major factor in the development, maintenance and relapse of the various types of ed. it is suggested that acceptance and commitment therapy (act) may be beneficial in treating body dissatisfaction insofar as body image inflexibility appears to influence the relationship between body image appraisal and coping strategies. act, which aims to develop psychological flexibility, appeared to us as a promising tool to manage body dissatisfaction in ed. the investigators therefore aim to evaluate the feasibility and acceptability of a psychological management group for body dissatisfaction (9 or 10 weekly group session), based on act therapy, in patients suffering from an ed.


Eligibility criteria:
inclusion criteria: * women over 16 years * eating disorder, according to dsm-5 criteria (all types of eating disorder are included: anorexia, bulimia, binge eating disorder, ...) * marked body dissatisfaction * bmi \> 17.5 kg/m2 exclusion criteria: * refusal to participate * current severe psychiatric condition other than an ed that may impair patients' ability to attend the group * pregnant or breastfeeding women * protection measure or deprivation of liberty by administrative decision

Keywords: psychiatry acceptance and commitment therapy body dissatisfaction
ultrasound-guided erector spinae plane block versus paravertebral block for perioperative analgesia in patients undergoing open splenectomy

Conditions: Analgesia

Summary: there are very few randomized controlled trials in open splenectomy surgery, which compare paravertebral block with esp block. the purpose of this randomized controlled trial is to compare the efficacy of ultrasound-guided paravertebral block with esp block for perioperative analgesia in open splenectomy .


Eligibility criteria:
inclusion criteria: * patients who will be scheduled for indicated open splenectomy surgery in the supine position via left subcostal ,midline or letf subcostal with midline extention incisions * physical status american society of anesthesiologists (asa) ii or iii. exclusion criteria: * patients who refuse to participate * patients with body mass index (bmi) \>35 kg/m2 * infection at the site of injection * coagulopathy, severe thrombocytopenia \<50×103 * spine deformity * history of opioid dependence * polytrauma patients with dorsal spine fracture * urgent abdominal exploration for splenectomy in heamodynamically unstable patients * history of allergy to opioids or local anesthetics * history of allergy to opioids, or local anaesthetics.