Kornimate/medical-research-clean huggingface dataset:
the claricor trial: effect of clarithromycin on mortality and morbidity in patients with ischemic heart disease

Conditions: Heart Disease; Cardiovascular Disease

Summary: a growing body of evidence links chlamydia pneumoniae to the progression of coronary heart disease. the purpose of this study is to determine the positive and negative effect of 14 days treatment with clarithromycin 500 mg daily in patients already suffering from stable coronary heart disease. the participants will be followed for at least two years after the treatment. abbott laboratories supplied clarithromycin and placebo tablets.

basic science suggests a fundamental role for inflammation in mediating all stages of coronary heart disease (chd), and a large number of clinical studies have reported an association between markers of inflammation and chd. consequently, infectious agents have been proposed as promoters of atherosclerosis and/or acute coronary syndrome (acs). many studies have suggested a relation between chlamydia pneumoniae (c. pneumoniae) infection and chd, and c. pneumoniae has been demonstrated in atherosclerotic tissue. macrolide antibiotics are effective in eradication of c. pneumoniae from atherosclerotic plaques. two small trials showed significant beneficial effects of macrolides on cardiovascular morbidity in patients with acs. to corroborate and extend these findings, we undertook a randomised, placebo-controlled trial with clarithromycin in patients with stable chd in order to test the hypothesis that intervention with a macrolide would reduce cardiovascular risk with regard to mortality and morbidity.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 85 years and * previous acute myocardial infarction (ami) or * previous or present angina pectoris and * signed informed concent exclusion criteria: * ami or unstable angina pectoris within the last three months * revascularisation (ptca or cabg) within the preceding six months * severe heart failure (new york heart association (nyha) functional class iv) * known impaired renal or hepatic function * active malignancy * intolerance to macrolides * treatment with methylxanthines, carbamazepine, cisapride, astemizole, terfenadine, or coumarin anticoagulants * earlier inclusion in the claricor trial or participation in another drug trial within four weeks * participation in other clinical trials within one month before this trial * individuals incapable of managing own affairs or not able to sign written consent * lack of written consent * women of childbearing age not using reliable contraceptives * breast feeding women

Keywords: coronary heart disease clarithromycin macrolides cardiovascular mortality chlamydia pneumoniae
nightmare deconstruction and reprocessing pilot

Conditions: Nightmare

Summary: this is a single-arm, multisite (2 sites) pilot trial that is evaluating nightmare deconstruction and reprocessing (ndr) for treating posttraumatic nightmares and insomnia in up to 30 military service members and veterans. study aims are to test ndr's plausibility and tolerability and to test methodologic feasibility of collecting heart rate variability (hrv), electrodermal activity (eda), and actigraphy data via a wristband device and peripheral blood samples within a pre-specified circadian window. treatment consists of 8 sessions over 8 weeks. participants are assessed at study visits 0, 1, and 7 and 1-month follow-up. psychometric assessments include the disturbing dreams and nightmare severity index, pittsburgh sleep quality index, and clinician-administered ptsd scale for dsm-5.

the current study is testing ndr, a three-stage treatment that integrates exposure, reprocessing, and rescripting of nightmare images to alleviate nightmare and insomnia severity. study aims are to test ndr's plausibility and tolerability and to test the methodologic feasibility of collecting daily hrv, eda, and actigraphy data via the e4 wristband as well as peripheral blood samples for assay at three time points. participants are active duty military or veterans (n = 30) ages 18 to 64 with posttraumatic nightmares and insomnia. participants undergo 8 ndr treatment visits over 8 weeks and complete a 1-month follow-up. psychometric measures of nightmare (disturbing dreams and nightmare severity index) and insomnia (pittsburgh sleep quality index) are administered at each visit. objective measurement of sleep disturbance is done via the empatica e4 wristband. in-session distress is measured using the 1-item subjective units of distress scale (suds), and e4 hrv and eda data during exposure to nightmare images. bdnf, il-2, il-6, and tnf alpha are being assayed from blood samples taken immediately after visit 0 (baseline), visit 1 (first in-session exposure to nightmare images), and visit 7 (final in-session exposure to nightmares). to control for circadian factors regulating the expression of bdnf and inflammatory cytokines, all blood samples are collected between 0900 and 1200.

Eligibility criteria:
inclusion criteria: * active duty servicemembers and deers-eligible veterans * ddnsi score ≥ 10 * psqi score \> 5 exclusion criteria: * current imminent risk of suicide * psychotic or bipolar disorders * untreated moderate to severe sleep apnea/hypopnea, circadian rhythm disorders, or narcolepsy * current use of prazosin for nightmares * self-reported alcohol use \> 4x/ week and \> 3 drinks per occasion * concurrent evidence-based or experimental treatment directly targeting nightmares, insomnia, or ptsd * initiation of or change in psychotropic medications for ptsd, nightmares, insomnia, depression, or anxiety in the past 8 weeks * inability to recall nightmare content * inability to comply with requirement to wear e4 wristband and upload daily

Keywords: nightmares sleep disturbance posttraumatic
a risk prediction model for hypothermia after laparoscopic gastrointestinal tumor surgery

Conditions: Hypothermia; Anesthesia

Summary: the incidence of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors is high. hypothermia increases the risk of postoperative complications and medical costs. early warning can effectively reduce the incidence of postoperative hypothermia in patients. multivariate prediction models help identify high-risk patients and reversible factors. at present, there are few reports on the risk factors and prediction models of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors. therefore, this study aims to clarify the risk factors of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors. four machine learning algorithms, traditional logistic regression analysis, decision tree, random forest and naive bayes, were used to establish risk prediction models. according to the tripod statement, c-index, hosmer-lemeshow ( h-l ) test and decision curve analysis ( dca ) were used to evaluate the prediction and fitting effects of the models in all aspects, and the optimal model was selected and verified. provide reference for subsequent research.


Eligibility criteria:
inclusion criteria: * the types of surgery included laparoscopic radical gastrectomy for gastric cancer, duodenal cancer, colon cancer, rectal cancer and small bowel cancer. age ≥ 18 years ; the anesthesia method was general anesthesia ; elective surgery. exclusion criteria: * patients with abnormal body temperature such as fever and hypothermia before operation ; patients who need low temperature to protect organs during operation ; patients who were converted to laparotomy during the operation ; a clear diagnosis of sweat gland dysfunction ; patients with external auditory canal active disease ; reject participants.
improving well-being after tbi through structured volunteer activity

Conditions: Traumatic Brain Injury

Summary: the purpose of this project is to determine if participating in volunteer activity improves the psychological well-being of individuals with traumatic brain injury (tbi).


Eligibility criteria:
inclusion criteria: * has sustained a documented tbi that required inpatient rehabilitation; * is at least one year post tbi; * is age 18 or older; * is able to commit to completing the entire three month volunteer placement; * is english or spanish speaking; * receives written medical release from a physician to participate in this intervention; * is rated a level 1-2 on the supervision rating scale (functionally independent during the day); * provides informed consent to participate exclusion criteria: * is employed or engaged in regularly scheduled volunteer work outside of the intervention; * obtains a score of 25 or above on the swls, which is 0.5 sd above the tbims ndb mean; * unable to travel to assessments and placement; even with study transportation assistance; * has been convicted of a felony, which would prohibit volunteer placement; * unable to communicate effectively to complete standardized assessments; * has cognitive impairment that precludes completion of baseline testing;

Keywords: traumatic brain injury volunteering well being cortisol
use of the ozone in periodontal treatment

Conditions: Chronic Periodontitis

Summary: the purpose of this study is to evaluate the clinicaland laboratory (as oxidative stress and pro-inflammatory mediators) effects of the use of gaseous ozone in periodontal treatment in addition to scaling and root planning. the study population consisted of 40 patients with cp (chronic periodontitis). it was performed with two groups; the test group, and the control group. srp plus gaseous ozone \[1 w (100 mj, 10 hz)\] was applied to the test group. the control group, on the other hand, had only srp.the clinical periodontal parameters were performed and saliva samples were taken before srp (baseline) and 1 month after treatment. the periodontal examination involved assessing the plaque index, gingival index , probing depth, and clinical attachment level. the total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine, myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were determined in the saliva samples.

the study has been designed in a randomized parallelly-controlled and double-blinded design as a full-mouth clinical trial. the duration of the study was 1 month. the study was performed with two groups; the test group, and the control group. srp plus gaseous ozone \[1 w (100 mj, 10 hz), (n=20)\] was applied to the test group. the control group, on the other hand, had srp plus placebo (n=20). the patients were distributed in random order to the 2 groups (each group had 20 patients). one patient in the ozone group and 2 patients in the control group left the study. the following clinical periodontal parameters were performed immediately before srp (baseline), and 1 month after treatment for each test and control groups. plaque index, gi, pd and cal were recorded. all clinical parameter measurements were used a manual periodontal probe (pcp- 12, hu-friedy, chicago, il, usa). the total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine, myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were determined in the saliva samples.

Eligibility criteria:
inclusion criteria: 1. patients having had generalize cp which were agreed upon by consensus at the world workshop in periodontics in 1999 \[24\]; 2. three or more teeth having at least two quadrants with probing depth between 4 and 6 mm and radiographic signs of bone loss; 3. aged 30 years and above; 4. a minimum of 20 teeth. exclusion criteria: 1. received periodontal therapy within the last 12 months; 2. systemic diseases which could affect periodontal treatment outcomes; 3. having taken systemic antibiotics within the last 6 months; 4. pregnancy or breast-feeding for female patients.

Keywords: periodontal treatment ozone oxidative stress
botulinum toxin to improve lower blepharoplasty scar

Conditions: Other Degenerative Disorders of Eyelid and Periocular Area

Summary: the combination of botulinum toxin for crow feet (lateral part of orbicularis oculi muscle) and lower blaphaloplasty might have reduces the tension on the end of lower blaphaloplasty incision whereas the scar is more visible on patient. the main aim of this trial is to investigate whether the injection of botulinum toxin into the bilateral orbicularis oculi muscles could improve the appearance of the scar after lower blepharoplasty.

the main aim of this double blind randomized trial is to examine whether immediate post-operative injection of botulinum toxin into lateral part of bilateral orbicularis oculis muscles (the injection technique of crow feet) can improve scar formation for lower blepharoplasty patients. this is a double blind randomized controlled trial primarily designed to compare the scarring after secondary cleft lip repair with immediate post-operative botulinum toxin injection into the into bilateral lateral orbicularis oculi muscles in patients with lower blepharoplasty. there will be 2 main groups in this study:- 1. study group (group i): immediately after lower blepharoplasty surgery 3 injections of 2.5u of botulinum toxin over lateral part of orbicularis oculi muscle. 2. control group (group ii): there will be the same amount of normal saline injection after lower blepharoplasty. follow-up assessments vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month follow up. visual analogue scale they were asked to score the scars on the photographs using a standard visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar). photographic measurement: a ruler will be placed just below the surgical scar. using photoshop cs5, the scar width can be measured. chi-square will be used to analyze the demographic data ( i.e. gender) the independent t-student test will be used to analyze the statistical significance between the two groups. the dosage of botox that the investigators use for crowfeet is very tiny. and this is a common clinic practice. systemic insult is unlikely to happen. if an allergic reaction occurred it will be treated according to the severity of allergy and diphenhydramin po or iv form or systemic corticosteroid will be given.

Eligibility criteria:
inclusion criteria: 1. adult ≥ 45 years old. 2. lower eyelid rhytidosis and dermatochalasis. 3. lower eyelid steatoblepharon and pronounced nasojugal groove 4. written informed consent given by patient. exclusion criteria: 1. less than 45 years old 2. without written informed consent. 3. combined other craniofacial anomalies

Keywords: lower blepharoplasty, botulinum toxin, scar
ibedrift- a trial comparing a new approach to musculoskeletal pain consisting of education and peer involvement to treatment as usual

Conditions: Neck Pain Musculoskeletal; Back Pain Lower Back

Summary: a randomized controlled trial comparing a new approach to musculoskeletal pain consisting of education and peer involvement to treatment as usual. all local government employees in 1-3 norwegian municipalities will be invited to participate.

the purpose of the study is to systematically test a new treatment method for musculoskeletal pain in norway. the intervention focuses on attempting to treat musculoskeletal pain outside the traditional medical system as much as possible, to avoid the establishment of a patient identity and passive patient behavior. in addition, participants are given reasons to stay active, and not advice to stay active. ibedrift is a randomized controlled trial with the aim of studying the effect of a new treatment regime for musculoskeletal pain, focusing on didactic information about low back pain with peer support. those participants not in the control group will have the option of contacting a peer advisor, a non health professional trained by the ibedrift crew to give information about back pain and reasons to stay active. for those who have not recovered within a short period of time, and who are randomized to full treatment, the peer advisor can send them directly to health personnel for a brief intervention consisting of a medical examination with screening for conditions that need treatment, counseling and education. the intervention was done in 2 norwegian municipalities for all local government employees. randomization was done at the level of working units (schools, offices etc) which allows for more message containment.

Eligibility criteria:
inclusion criteria: * all employees above 18 years exclusion criteria: * cancer * known congenital musculoskeletal disease * cauda equina syndrome

Keywords: musculoskeletal pain brief cognitive intervention cognitive behavior therapy intervention study health prevention workplace intervention
ocular hypotensive efficacy of ar-102

Conditions: Glaucoma

Summary: a double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of ar-102 in subjects with elevated intraocular pressure. the null hypothesis is that the ocular hypotensive efficacy of each dose of ar-102 ophthalmic solution will not be different from that of its vehicle.

a double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of ar-102 in subjects with elevated intraocular pressure.

Eligibility criteria:
inclusion criteria: * 18 years of age or greater (male, or female not of childbearing potential). * diagnosis of open angle glaucoma (oag) or ocular hypertension (oht) in the study eye(s). * corrected visual acuity by etdrs in each eye of +1.0 logmar units or better exclusion criteria: * known hypersensitivity to any component of the formulation or to topical anesthetics * previous glaucoma intraocular surgery or laser procedures in study eye(s) * clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study. * participation in any study involving an investigational drug within the past 30 days.

Keywords: glaucoma
the relationship between the change of resting energy expenditure and nutritional status .

Conditions: Peritonitis; Resting Energy Expenditure; Nutrition

Summary: peritonitis is a common and devastating complication in patients on peritoneal dialysis (pd). it is a known fact that persistent inflammatory state and nutritional deterioration are closely associated with increased mortality in pd patients.and resting energy expenditure(ree) is significantly increased in acute and chronic inflammation in patients with chronic kidney disease (including dialysis patients).however,it is limited to the changing trend and duration of ree in peritonitis.investigators hypothesize that the increase in total energy consumption resulting from the increase of ree which may accompany with decreased energy intake will lead to negative energy balance and nutritional deterioration, which may affect the prognosis of patients.therefore,a prospective cohort study will be designed to dynamically research the change of ree accompanied with the nutrition status in peritonitis and provide the basis for peritonitis management in the future.


Eligibility criteria:
inclusion criteria: * receiving pd for\>3 months * age between 18 and 80 years * confirm diagnosis of peritonitis exclusion criteria: * disability * other acute complications: including systemic infections except for peritonitis, acute cardia-cerebrovascular disease in one month * active hepatitis and musculoskeletal diseases in the past * cancer and is treated with chemoradiotherapy within 1 year * severe edema of the whole body or a large amount of body cavity effusion * thyroid dysfunction * history of hormonal drugs use * during pregnancy or lactation * mental disorder
investigation of the cultural adaptation, validity, and reliability of the turkish version of the cap questionnaire

Conditions: Osteoarthritis; Back Pain; Fibromyalgia

Summary: the "cap questionnaire," developed by modifying the cap-knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described. the "cap questionnaire" is used in people with musculoskeletal pain and diagnostic subgroups of osteoarthritis, back pain, and fibromyalgia. there is no turkish version of the cap questionnaire. this study aims to investigate the cultural adaptation, validity, and reliability of the turkish version of the "cap questionnaire."

chronic pain is a symptom shared by many musculoskeletal conditions, even when disease management is optimized. musculoskeletal pathologies are reported to be an essential therapeutic target in pain management. however, these pathologies often do not adequately explain the pain or the reason for its persistence. central sensitization is the increased sensitivity of central nervous system (cns) neurons to a standard nociceptive input. pain that increases in intensity and distribution beyond that explained by musculoskeletal pathology has been termed "nociplastic pain." measuring these cns aspects of pain is a prerequisite for understanding their mechanistic basis and predicting future pain and responses to treatment. chronic pain is associated with cns dysfunction in several areas, including depression, anxiety, pain catastrophizing, cognitive dysfunction, sleep disturbance, and fatigue. considering the increasing importance of assessing mood-related pain (nociplastic pain) the "cap questionnaire," developed by modifying the cap-knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described.

Eligibility criteria:
inclusion criteria: * people with musculoskeletal pain and in diagnoses with oa, back pain, or fm * above 18 years of age * informed consent of the participant exclusion criteria: * diagnosis of uncontrolled/other clinically significant diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.) * pregnant women

Keywords: nociplastic pain central sensitization back pain osteoarthritis fibromyalgia pain