Kornimate/medical-research-clean huggingface dataset:
mindfulness meditation for health

Conditions: Alcohol Dependence

Summary: the purpose of this 52-week clinical trial is to see if the meditation-based intervention, adjunctive to standard of care therapy, can reduce relapse and improve psychological health among adults recovering from alcohol dependence.

the goal of this partially-blinded, two-arm clinical trial was to test whether the mindfulness meditation relapse prevention (meditation), combined with 'standard of care' (soc) therapy, is more effective in preventing a return to drinking than soc alone (wait-list control) among adult recovering alcoholics. the intervention was manualized and based on existing models. it was proposed that meditation may improve outcomes of interest through reduction of the severity of stress-related relapse risk factors such as perceived stress, anxiety, depression, craving and emotion dysregulation, and the level of stress-sensitive biomarkers (cytokine interleukin-6, liver enzymes). for this study, 123 adult alcohol dependent subjects were recruited from collaborating treatment centers, randomly assigned to one of two equal study arms, and followed for 26-weeks (period 1, randomized controlled trial, rct). the rct evaluated the efficacy of the meditation intervention using self-reported alcohol consumption as primary, and drinking-related harms and subject treatment satisfaction and adherence as secondary outcomes. it also gathered preliminary data on potential mechanisms of meditation action. after the completion of their 26-week rct (period 1), controls were eligible to receive the meditation intervention ("cross-over"), and all participants were followed-up for additional 26 weeks (non-randomized period 2). this study will provide evidence about the efficacy of meditation for alcohol relapse prevention, will further our understanding of relapse and the potential mechanisms of meditation action, direct future research and guide clinical decision-making.

Eligibility criteria:
inclusion criteria: * alcohol dependence diagnosis * completed at least 2 weeks of iop or (iop equivalent=at least 2 days per week) for alcohol dependence * sober since beginning of outpatient treatment * english fluency; ability to fill out surveys * permanent home address and telephone * at least 18 years old * score \>13 on the perceived stress scale exclusion criteria: * pregnant * alcohol abstinence \>14 weeks before enrollment * current, regular meditation * pre-existing bipolar, schizophrenia, or delusional disorder * regular drug use (other than tobacco) in last 2 weeks * inability to reliably participate

Keywords: alcohol dependence alcoholism substance use disorders substance abuse
a relative bioavailability study of two formulations of bcx7353

Conditions: Hereditary Angioedema

Summary: this is an open-label, randomized study to investigate the relative bioavailability of two formulations of bcx7353 and to determine if there is a food effect

in this study, 24 healthy subjects will be randomized to receive a single dose of two formulations of bcx7353 and one of the formulations administered with a high-fat meal. a 14-day washout period will separate each dose.

Eligibility criteria:
inclusion criteria: * written informed consent * acceptable birth control measures for male subjects and women of childbearing potential * complies with all required study procedures and restrictions exclusion criteria: * clinically significant medical history, current medical or psychiatric condition * clinically significant ecg finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline * current use, or use of any prescribed or over the counter medication, vitamins or herbal products within 14 days of day 1 * participation in any other investigational drug study within 90 days of screening * recent or current history of alcohol or drug abuse * regular recent use of tobacco or nicotine products * positive serology for hbv, hcv, or hiv * pregnant or nursing * donation or loss of greater than 400 ml of blood within the previous 3 months
exploring massage benefits for arthritis of the knee

Conditions: Osteoarthritis

Summary: the purpose of this study is to verify the efficacy of an 8-week course of manualized swedish massage for reducing pain and increasing function compared to light-touch bodywork, and usual care, in 222 adults with oa of the knee.


Eligibility criteria:
inclusion criteria: * 35 years of age or greater. * written confirmation of oa of the knee as provided by the participant's physician. * radiographically-established oa of the knee. * pre-randomization rating within a certain range on the visual analog pain scale (0 - 100 mm scale). * receiving care for diagnosed oa of the knee under the care of a board-certified primary care physician, with or without involvement of a board-certified rheumatologist. * patients with bilateral knee involvement will have the more severely affected knee designated as the study knee. * american college of rheumatology defined oa of the knee; specifically: a. knee pain b. satisfaction of at least three of the following six criteria: i. age great than 50 years ii. stiffness \< 30 minutes iii. crepitus iv. bony tenderness v. bony enlargement vi. no palpable warmth exclusion criteria: * presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout. * presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits. * signs or history of kidney or liver failure. * presence of asthma requiring the use of corticosteroid treatment. * use of oral corticosteroids within the past four weeks. * use of intra-articular knee depo-corticosteroids with the past three months. * use of intra-articular hyaluronate with the past six months. * arthroscopic surgery of the knee within the past year. * significant injury to the knee within the past six months. * presence of a rash or open wound over the knee. * unable to satisfy the treatment and follow-up requirements. * unable to provide written informed consent. * currently receiving massage therapy on a regular basis (at least twice a month). * knee replacement of study knee (ok if the knee not being studied has been replaced). * history of participating in the embark phase i or ii studies.

Keywords: massage osteoarthritis light touch swedish
sex-unique disparities in survival and resuscitation after out-of-hospital cardiac arrest - a danish analysis

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: the goal of this observational study is to investigate characteristics in out-of-hospital cardiac arrests (ohca) related to sex differences. the main questions it aims to answer are: * are there possible differences in help provision by bystanders, cardiopulmonary resuscitation (cpr), pre-hospital treatment by emergency medical services (ems)? * are there differences in the presence of shockable initial rhythm (sir) and survival rates after ohca at successive stages of treatment? researchers will compare all emergency medical services treated resuscitations in denmark between 2016 and 2021 to see if there are possible differences between sexes.

this analysis will be based on data from the national electronic based danish ohca registry. data on ohcas with resuscitative attempts in denmark have been collected in the electronic based danish medical service report system since 2016. the registry covers detailed data including the ems report, executive entries, and advanced text searches of prehospital charts. all cases go through an elaborate validation process where all identified events are read through manually by an external verification team. this ensures high quality of data, collected according to the utstein recommendations, throughout the approximately 5400 cases of ohca in denmark annually. during this verification process, supplementary sources of data are linked to each ohca, among others information about survival, localization, initiation of bystander cpr and ems personnel operation.

Eligibility criteria:
inclusion criteria: - all emergency medical services treated resuscitations in denmark between 2016 and 2021 exclusion criteria: - patients that are found dead at emergency medical service arrival, with sure death indicators such as rigor mortis or livores.

Keywords: sex differences ohca women sir cpr
facilitators and barriers to dental care in head and neck cancer patients

Conditions: Behavior

Summary: the aim of this study is to identify potential facilitators and barriers to dental care in head-neck cancer patients from the perspective of affected patients, dentists, and oncologists (specialists in radiotherapy and specialists in otolaryngology).

patients as well as dentists and oncologists will be interviewed in semi-structured individual interviews. the interview guide used will align with the 14 domains of the theoretical domains framework. through qualitative content analysis, both facilitators and barriers to dental treatment for head-neck cancer patients will be identified.

Eligibility criteria:
inclusion criteria: * patients with head and neck tumors whose health condition allows for the conduction of an interview * dentists practicing in germany * specialists in otorhinolaryngology practicing in germany * specialists in radiation therapy practicing in germany exclusion criteria: * missing consent for the study * health condition that does not allow the conduction of an interview

Keywords: interviews decision-making
peroral levosimendan in chronic heart failure

Conditions: Chronic Heart Failure; Heart Diseases

Summary: the study will investigate the efficacy of oral levosimendan in patients with chronic new york heart association (nyha) iiib-iv heart failure (hf) using a composite end-point evaluating patient symptoms, morbidity and mortality. the patients are on treatment for at least 6 months.

the patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.

Eligibility criteria:
inclusion criteria: * diagnosed chronic heart failure * severe symptoms (nyha iiib-iv) * optimal on-going oral treatment for hf * left ventricular ejection fraction less than or equal to 30% exclusion criteria: * severe obstruction of ventricular outflow tracts * acute myocardial infarction within 30 days before screening * cardiac surgery or coronary angioplasty within 30 days before screening

Keywords: levosimendan chronic heart failure oral administration
hemoperfusion in acute type a aortic dissection patients undergoing aortic arch operation (hpao)

Conditions: Acute Type A Aortic Dissection With Arch Involvement; Cardiopulmonary Bypass; Deep Hypothermic Circulatory Arrest

Summary: this study is a single-center, randomized, controlled, double-blind clinical trial. the main purpose of this study is to evaluate if hemoperfusion is sufficient to improve the prognosis of acute type a aortic dissection patients undergoing cardiopulmonary bypass and deep hypothermia circulatory arrest.


Eligibility criteria:
inclusion criteria: 1. patients aged 18 yr-75yr, regardless of gender 2. patients with acute type a aortic dissection and arch involvement (onset time ≤ 7 days) 3. able to understand and sign the informed consent exclusion criteria: 1. unable to understand and sign the informed consent 2. bmi ≥ 40 3. pregnant 4. active hemorrhage or thrombocytopenic purpura 5. previous history of liver diseasess, renal insufficiency or cerebrovascular diseases 6. preoperative organ malperfusion 7. previous history of cardiac surgeries 8. oral anticoagulant or antiplatelet drugs within one week of disease onset 9. hereditary connective tissue diseases such as marfan syndrome, ehlers-danlos and loeys-dietz syndrome
phase 4 study of the efficacy of losartan based therapy in hypertensives with and without diabetes

Conditions: Diabetes Mellitus; Hypertension

Summary: to study antihypertensive efficacy of 12 weeks of losartan based therapy resilo (losartan) and resilo-h (losartan+ hydrochlorothiazide) in uncontrolled hypertensive and diabetic hypertensive patients.

200 hundred subjects will be treated with a dose escalation regimen to achieve a target blood pressure. subjects with mild hypertension at baseline will be started with losartan 50 mgs and those with severe hypertension will be started with losartan h 100/25. after 6 weeks they will titrated if goal blood pressure not achieved. for mild hypertensive group this will be with losartan h 100/25 and for severe hypertensive group this will by addition of amlodipine 5 mg to regime. subjects with mild hypertension and diabetes at baseline will be started with losartan h 50/12.5 mg and those with severe hypertension with diabetes will be started with losartan h 100/25. after 6 weeks they will be titrated if goal blood pressure not achieved. for mild hypertensive-diabetic group this will be with resilo h 100/25 and for severe hypertensive group this will by addition of amlodipine 5 mg to regime. target blood pressure is systolic \ 60 years.

Eligibility criteria:
inclusion criteria: * willing to sign informed consent form. * patients of either sex above 18 years of age. * patients not previously diagnosed with hypertension and with sitting blood pressure \> 140/90 mmhg on two readings 15 minutes apart. * newly diagnosed hypertensive patients. * hypertensive patients on other antihypertensive therapies but not at goal * diabetes defined as patient on insulin therapy or oral diabetic therapy or fasting blood glucose on screening \> 7 mmol/l exclusion criteria: * patients with history of allergic reaction to any angiotensin ii antagonist or a thiazide diuretic * patients with history suggestive secondary hypertension * patients who have taken resilo or resilo-h or other losartan based treatment in past three months of study inclusion. * patients with chronic renal failure or who on screening has serum creatinine \>150 µmol/l * patients who is participating concurrently in another clinical trial.
lidocaine-ketamine versus ketamine for induction of anesthesia in septic shock patients

Conditions: Septic Shock

Summary: the aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.

most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. thus, induction of anesthesia in shocked patients might result in deleterious hypotension. patients with severe sepsis and septic shock frequently need surgical interventions. the best protocol for induction of anesthesia in septic shock patients is lacking. ketamine is an agent used for induction of anesthesia with known positive cardiovascular effects. however, these positive effects were reported in individuals with intact sympathetic nervous system. invitro studies showed that ketamine direct action on the cardiac muscles is negative. thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present. lidocaine is a drug with multiple local and systemic uses. having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.

Eligibility criteria:
inclusion criteria: * adult patients aged above 18 years * with septic shock * scheduled for general anesthesia exclusion criteria: * patients under 18 years * burn patients
surgical site infections at a west cameroon hospital

Conditions: Surgical Wound Infection

Summary: surgical site infections (ssi) constitute an important health concern in low and middle income countries, leading to prolonged hospital stay and increased costs. previous studies indicate that in africa up to 1/3 of patients undergoing surgery may be affected by a postoperative infection. the development and implementation of context-specific ssi prevention guidelines is important to reduce this complication. to deploy efficient context-specific measures, data on epidemiology and microbiology of these infections are needed. this means to adapt the prevention measures to the context-specific risk factors for surgical site infections in resource-limited settings, and to give locally adapted recommendations on antimicrobial therapy based on local resistance patterns. however, data in this respect are scarce in low and middle income countries. this present study will contribute to the needed epidemiology and microbiology data on ssi in cameroon. it will be carried out as a prospective cohort study at the mbouo protestant hospital in the west region of cameroon. the incidence, microbial spectrum and respective antimicrobial resistance of ssi as well as the risk factors of ssi will be systematically investigated. the study will include 300 patients at the hôpital protestant de mbouo (hpm) who underwent surgery and gave their informed consent for inclusion, the timeframe is 04/2021 - 11/2021. an active ssi surveillance system will be put in place for 30 postoperative days to diagnose ssi. expected outcomes: the incidence of ssi is likely to be higher than 10%. concerning risk factors, preoperative bodywashing and perioperative antibioprophylaxis is expected to be protective against ssi. up to 1/3 of ssi are expected to occur after hospital discharge. for the microbial spectrum, a high proportion of staphylococcus aureus is likely to be found. for the antimicrobial resistance no estimation can be give as data is non-existent in that region from the literature.


Eligibility criteria:
inclusion criteria: * patient underwent surgery at the hospital during study period exclusion criteria: * unconscious patients, mentally ill patients
the relationship between anticholinergic burden and postoperative complications after cardiac surgery in older adults

Conditions: Postoperative Complications

Summary: drugs with anticholinergic properties are widely prescribed in the elderly population, despite increasing evidence in the literature regarding side effects and adverse outcomes. as is known, many drugs have anticholinergic activity, which means that they block the binding of the neurotransmitter acetylcholine to the muscarinic receptor. in this case, the occurrence of anticholinergic side effects becomes inevitable. central effects such as cognitive impairment, dizziness, sedation, confusion or delirium, and peripheral effects such as dry mouth, dry eyes, constipation, urinary retention, and tachycardia begin to be seen in patients. anticholinergic load refers to the cumulative effect of taking one or more drugs with anticholinergic activity. this cumulative effect is a strong indicator of cognitive and physical deterioration, especially in the elderly population. it is also associated with adverse outcomes such as falls, impaired functioning, and higher rates of hospitalization and death. anticholinergic load scales include scales that facilitate the work of physicians used in clinical practice to predict anticholinergic side effects in humans. although there are many different scales used at this point, one of the scales with the highest validity and reliability in recent studies are anticholinergic cognitive burden scale (acb) and anticholinergic risk scale (ars). to the best of our knowledge, we could not find any study on postoperative complications, length of hospital stay and mortality after cardiac surgery with these scales. therefore, we aimed to examine the relationship between possible complications after cardiac surgery and anticholinergic load scales showing the cumulative effect of preoperative drugs.


Eligibility criteria:
inclusion criteria: * it is planned to include patients over the age of 65 who underwent cardiac surgery in the research population. * gender discrimination will not be considered. exclusion criteria: * those who are under the age of 65, * those who have non-cardiac surgery, * those whose drug records cannot be accessed
study of lm-108 as a single agent or in combination with pembrolizumab in subjects with advanced solid tumours

Conditions: Advanced Solid Tumor

Summary: a phase i/ii, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of lm-108 as a single agent or in combination with pembrolizumab in advanced solid tumors

a phase i/ii, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of lm-108 as a single agent or in combination with pembrolizumab in advanced solid tumors the study schedule includes screening visit (28 days prior to accept the investigational medicinal product (imp)), treatment visit (accept imp for the first time to the end of treatment (eot)/early withdrawal), and follow-up visit (28 days after the eot/early withdrawal).

Eligibility criteria:
key inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status of 0-1 2. histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy. 3. at least one measurable disease for expansion cohorts per response evaluation criteria in solid tumours (recist) v1.1. 4. subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose key exclusion criteria: 1. any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of ctcae v5.0 2. uncontrolled tumour-related pain 3. known central nervous system (cns) 4. uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures 5. use of inhaled corticosteroids 6. known history of autoimmune disease 7. use of any live attenuated vaccines within 28 days 8. have severe cardiovascular disease 9. uncontrolled or severe illness 10. history of immunodeficiency disease 11. active malignancies which are likely to require the treatment. 12. child-bearing potential female 13. have psychiatric illness or disorders note: other protocol defined inclusion/exclusion criteria may apply.