Kornimate/medical-research-clean huggingface dataset:
comparing operative vs non operative treatment for pilonidal disease

Conditions: Pilonidal Disease

Summary: the goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation.

the goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation. patients with pilonidal disease can have significant pain and drainage at the gluteal cleft, and recurrent disease in this teenage and young adult population often leads to social embarrassment, isolation, and time off from work or school. effective therapy to prevent recurrent disease is urgently needed. the current standard of care is excision of pilonidal cyst. the research will consist of randomized 1:1 controlled trial comparing regular epilation regimen only vs. regular epilation regimen with surgical excision. the research will consist of patient surveys and clinical notes. surgical excision is not needed to be part of this research. all patients will receive surveys and their charts will be reviewed. at the point of treatment decision making, the patients will be randomized to one of the two options.

Eligibility criteria:
inclusion criteria: * patients at stanford healthcare with pilonidal disease. * patients over the age of 8yrs. exclusion criteria: * inability to read, write or understand english \*\*\*or spanish * intellectual disability precluding the patient from being able to comprehend or respond to the questionnaire

Keywords: pilonidal surgery pilonidal excision pilonidal recurrence
cognitive training for depression ii

Conditions: Major Depressive Disorder

Summary: this study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.

there is an urgent public health need to develop more effective and well tolerated treatments for patients with major depressive disorder (mdd); cognitive training interventions aiming to modify cognitive and affective processing abnormalities underlying mdd represent a promising new strategy. this research project translates a well established cognitive bias in major mdd, working memory bias, into a novel intervention target. in a double-blind, randomized, controlled study, mdd participants undergo 6 weeks of cognitive training sessions, with three sessions per week.

Eligibility criteria:
inclusion criteria: * primary, current axis i diagnosis of major depressive disorder according to dsm-iv criteria and ham-d-17 score between 16-27 * age 18-55 * able to give informed consent exclusion criteria: * a history of drug or alcohol abuse or dependence (dsm-iv criteria) within 6 months * visual impairment that would affect the ability to observe the computerized presentation of faces. * motor impairment that would affect the ability to provide a response by quickly pressing a button. * lifetime history of bipolar spectrum disorders or schizophrenia spectrum disorders. * primary, current axis i diagnosis other than major depressive disorder * primary, current axis ii personality disorder. * currently attending a cognitive-behavioral psychotherapy regimen * acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening) * pregnancy in women. pregnant women are excluded from the study because research has shown that hormonal changes that occur during pregnancy can mimic and/or influence symptoms of depression. including patterns of mood and cognition. these mood and cognitive changes could mask the effect of the cognitive training in this study, so pregnant women will be excluded for that reason. * enrolled participants can be currently taking medication but must be stabilized on their medication regimens before enrolling in the study (i.e., no medication has been started within 8 weeks, stopped within 6 weeks or titrated up or down within 4 weeks of study entry). accordingly, if a patient's medication status must change during the course of the study, we will discontinue them in the study. we do not anticipate that this will occur frequently, as again, patients' medication regimens must be stable before enrolling in the study. no medications will be discontinued for the purpose of enrollment into the study. subjects must exhibit no or only moderate alcohol use. subjects with current excessive use of alcohol (\> 8 ounces/day for men and \> 6 ounces/day for women) are ineligible for participation, as such drug use could confound the results.

Keywords: cognitive training depression
dexamethasone in total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: the purpose of this study is to determine the most efficacious and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.

study design: prospective randomized controlled trial scientific background: in contemporary total joint arthroplasty (tja), multimodal anesthesia and analgesia is used to improve postoperative pain, reduce opioid consumption, and minimize complications after surgery such as postoperative nausea and vomiting.1-3 multiple medications with varying mechanisms of action are used at different time points throughout the perioperative period to modulate different pain receptors. corticosteroids are a medication commonly utilized intraoperatively as part of contemporary multimodal protocols. corticosteroids are frequently used in tja due to their potent anti-inflammatory and anti-emetic properties. several studies have demonstrated that corticosteroids reduce postoperative nausea and vomiting as well as postoperative pain and opioid consumption.4-6 however, the optimal medication, dose, and number of doses of corticosteroid that should be administered in the perioperative period remain unknown. in addition, it remains unclear if corticosteroids can be safely used in patients with diabetes mellitus or if corticosteroids increase the risk of postoperative complications such as periprosthetic joint infection. thus, the purpose of our study is to determine the most efficacious and safest dose of corticosteroids that should be administered intraoperatively during tja.

Eligibility criteria:
inclusion criteria: * age \> 18 years * primary total knee arthroplasty * patients staying at least one night in the hospital after surgery exclusion criteria: * same day discharge age \< 18 years revision or partial total knee arthroplasty corticosteroid use within 3 months prior to surgery inflammatory arthritis current systemic fungal infection renal or liver failure prior adverse reaction to corticosteroid primary tka requiring hardware removal

Keywords: dexamethasone opioid consumption postoperative pain
cholesterol lowering treatment with psyllium husks and isolated soy protein in hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: despite improved treatment, cardiovascular disease remains one of the most common diseases and causes of death in the western world. hypercholesterolemia is a well known risk factor for developing cardiovascular disease. prevention and treatment are based in part on lowering ldl cholesterol. dietary and lifestyle changes always play an important part of the treatment and preventive effort, and conversion to a heart-healthy diet reduces ldl cholesterol by a mean 10%. further lowering of ldl cholesterol by means of food supplements have been demonstrated in numerous studies. cholesterol lowering food supplements include isolated soy protein and water soluble dietary fibre such as psyllium husks. postulated mechanisms of action responsible for the cholesterol lowering in these two food supplements are different, so there is a reason to expect an additive cholesterol lowering effect during concomitant treatment with both substances. the investigators want to investigate whether concomitant treatment with psyllium husks and isolated soy protein in addition to a heart-healthy diet results in a significantly greater reduction of ldl cholesterol in hypercholesterolemia, than single treatment with each of the substances.


Eligibility criteria:
inclusion criteria: * bmi 18,5 - 35 kg/m2 * ldl cholesterol \> 3,5 mmol/l exclusion criteria: * triglycerides \> 5,0 mmol/l * use of phytosterols, food supplements containing soy protein or water soluble fiber supplements * cardiovascular disease * diabetes mellitus * gastrointestinal disease * liver- og kidney disease * electrolyte imbalance * orlistat treatment * alcohol abuse * hypersensitivity to the interventional substances * pregnancy and nursing
validity and reliability study of the pain indicator behavior scale-brain damage (escid-dc)

Conditions: Pain; Brain Injuries; Behavior

Summary: a multicentre observational study to validate the adaptation of the pain indicator behavior scale (escid) for patients with acquired brain damage (escid-dc), as a measuring instrument.

non-commercial study. the study complies with the ethical principles of the declaration of helsinki, the recommendations of good clinical practice (gcp) and current legislation. the study has been approved with a favorable opinion by the ceim of the hospital universitario 12 de octubre. written consent will be requested from the participants and / or their relatives / representatives to participate in the study.

Eligibility criteria:
inclusion criteria: 1. age equal to or greater than 18 years. 2. inability to communicate verbally or motor. 3. have a artificial airway. 4. informed consent of the family member or representative of the patient. exclusion criteria: 1. previous pathology of cognitive impairment. 2. previous brain injury. 3. previous psychiatric disorder. 4. previous dementia. 5. previous chronic substance abuse. 6. previous chronic diabetics. 7. previous spinal cord injury. 8. previous severe polyneuropathy (diagnosed or suspected). 9. confirmed diagnosis of brain death. 10. continuous infusion of muscle relaxants and / or barbiturate coma. 11. level of deep sedation (rass -5).

Keywords: pain brain injury brain damage intensive critical unit nursing
study of minimed™ 640g insulin pump with smartguard™ in prevention of low glucose events in adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: a premarket, international multicenter, prospective, open label, adaptive, randomized controlled study. the aim is to evaluate the efficacy of sensor augmented pump therapy with minimed™640g and smartguard™in preventing hypoglycemic events in comparison with continuous subcutaneous insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia. the primary objective is to demonstrate a reduction in the mean number of hypoglycemic events when using the minimed™640g system with smartguard™ and the secondary objectives will aim at evaluating the difference in glycemic parameters and hba1c.


Eligibility criteria:
inclusion criteria: * age 24-75 years old at time of screening. * diagnosed with type 1 diabetes ≥10 years prior to screening. * on pump therapy for ≥ 6 months prior to screening. * not on real time continuous glucose monitoring for ≥ 3 months prior to screening. * hba1c value ≥5.8% and ≤10.0% as assessed by local lab ≤ 15 days prior to screening or performed at screening. * a documented severe hypoglycemia event ≤ 12 months prior to screening, or clarke score ≥4 assessed at time of screening, or * gold score ≥4 assessed at time of screening. * subject is willing to sign and date informed consent, comply with all study procedures and wear all study devices as required during the study. exclusion criteria: * untreated addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment. * subject is using pramlintide (symlin) sglt2 inhibitor, glp agonist at time of screening. * renal failure defined by creatinine clearance \<30 ml/min, as assessed by local lab test ≤ 3 months before screening or performed at screening at local lab. * hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment. * current pregnancy or intention to conceive. * any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, staphylococcus infection). * alcohol or drug abuse, other than nicotine, per investigator judgment. * any other disease or condition that may preclude the patient from participating in the study, per investigator judgment. * legally incompetent, illiterate or vulnerable person. randomization criteria: * if subjects meet the above criteria, as well as all of the following criteria assessed at the end of the run-in period, they may continue to participate in the treatment period of the study: * subject has worn two weeks the sensor with transmitter during the run-in period. * subject has shown acceptable tolerance of sensor wear, per investigator judgment. * subject performed ≥ 4 finger stick blood glucose measurements daily, as determined by carelink™ clinical data upload as the mean number of smbg/day over the past 14 days (smbg number / day ≥ 3.5 rounds up to 4). * subject showed ability to comprehend the pump training and study procedures, per investigator judgment.
a controlled, blinded study to validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool for distinguishing between bacterial and viral etiologies in pediatric patients presenting to the ed with suspicion of acute infection

Conditions: Viral Infection; Bacterial Infections; Antibiotic Misuse; Host Response Diagnostics

Summary: to externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called immunoxpert™, for differentiating between bacterial and viral etiologies in pediatric patients \>3 months old with suspicion of respiratory tract infection (rti) or fever without source (fws)


Eligibility criteria:
inclusion criteria: * documented peak temperature ≥ 38°c (100.4°f) (and) * symptom duration ≤ 7 days (and) * clinical suspicion of rti (or) * fever without a clear source (or) * acute gastroenteritis (or) * urinary tract infection exclusion criteria: * antibiotic treatment of over 48 hours' duration at time of presentation * another episode of febrile infection within the past 2 weeks * a proven or suspected hiv1, hbv, or hcv infection * congenital immune deficiency (cid) * active malignancy * current treatment with immune-suppressive or immune-modulating therapies, including without limitations: * use of high dose steroids \>1 mg/kg/day prednisone or equivalent in the past two weeks monoclonal antibodies, anti-tnf agents * intravenous immunoglobulin (ivig) * cyclosporine, cyclophosphamide, tacrolimus * g/gm-csf, interferons * other severe illnesses that affect life expectancy and quality of life such as: * moderate to severe psychomotor retardation * post-transplant patients * moderate to severe congenital metabolic disorder
craniosacral therapy as a self-help strategy for patients with chronic non-specific back pain

Conditions: Low Back Pain, Mechanical; Complementary Therapies; Progressive Muscle Relaxation

Summary: craniosacral therapy (cst) is a non-manipulative, very gentle manual treatment method. although the mechanisms of action have not yet been investigated sufficiently, initial clinical trials support cst efficacy/effectiveness in chronic pain disorders such as back pain, neck pain, and fibromyalgia. in clinical practice, therapists also report pain alleviating effects of cst self-help techniques, offered to patients within a group concept. yet, the effectiveness of teaching cst self-help techniques to medical laypersons has not yet been scientifically investigated. therefore, this study aims at collecting quantifiable data on the effectiveness and safety of a cst self-help group concept, developed for patients with chronic non-specific low back pain. the intervention group will receive 24 lessons of education and practice in cst self-help techniques over 12 weeks, while the control group will receive the same amount of self-help (education and practice) in progressive muscle relaxation. six and 12 months after randomization, longer-term effects will be investigated.


Eligibility criteria:
inclusion criteria: * chronic non-specific / functional lower back pain for at least 3 months * functional impairment: minimal 11 and maximal 41 points on the odi * willingness to participate in the group program and practice at home exclusion criteria: * specific back pain due to: * severe congenital or acute degenerative diseases * severe inflammatory musculoskeletal or rheumatic diseases * neurological diseases * status after actue trauma/whiplash * status after neoplasms in the area of the spinal column * acute severe comorbid mental illness or other acute severe comorbid somatic illness * pregnancy * current pension application * regular use of corticosteroids, opiates, muscle relaxants, or antidepressants * simultaneous participation in other clinical trials

Keywords: craniosacral therapy low back pain, chronic randomized controlled trial self-help
functional and physiological changes induced by pinhole glasses in presbyopia

Conditions: Pinhole

Summary: this study is aimed at presbyopic patients that do not require magnifying glass at close rage. the purpose of this study is to investigate the functional and physiological changes in eye induced by pinhole glass.


Eligibility criteria:
inclusion criteria: 1. age over 45 years 2. spherical equivalents(se) within ± 3.0 diopters(d) 3. normal ocular alignment exclusion criteria: 1. disturbance of accommodation due to any reasons such as an adie's pupil, parkinson's disease, a history of previous ocular surgery or trauma, and a history of systemic or topical medication that might affect accommodation 2. corneal pathologic features 3. glaucoma 4. cataracts of grade ii or greater by the lens opacities classification system iii (locs iii) 5. vitreous and retinal abnormalities that might limit the accuracy of testing

Keywords: presbyopia
extension to study on efficacy and safety of linzagolix for the treatment of endometriosis-associated pain (edelweiss 6)

Conditions: Endometriosis

Summary: the primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with abt (e2 1 mg / neta 0.5 mg), in the management of moderate to severe endometriosis-associated pain (eap) in women with surgically confirmed endometriosis.

this is a prospective, randomized, double-blind study. subjects who have completed the 6-month treatment period in 18-obe2109-003 - edelweiss 3 study (herein referred to as main study) will be invited to enter the present extension study. month 6 visit of the main study is a decision point for subjects to either end treatment and enter a post-treatment follow up (part of the main study), or to opt for a 6-month treatment extension. all subjects will receive once daily either linzagolix 75 mg alone (with abt placebo) or 200 mg combined with abt for 6 months. subjects who received placebo during the main study will be randomized to either linzagolix 75 mg alone (with abt placebo) or linzagolix 200 mg with abt. subjects who received active treatment during the main study will continue with the same treatment. double-dummy design will be used in order to maintain the blinding of the study. after end of treatment in the extension study (6-month treatment period: from month 6 to month 12), subjects will enter a post-treatment follow-up period of 6 months with no investigational medicinal product (imp) or - for subjects willing to continue treatment - a second extension study will be proposed.

Eligibility criteria:
inclusion criteria: the subject must have: * completed the 6-month treatment in the main study. * agree to continue to use only the analgesic rescue medication permitted by the protocol during the treatment and follow-up periods. * to continue to comply with the requirements of the study protocol for the duration of the extension study. exclusion criteria: the subject will be excluded if she: * is pregnant or breast feeding or is planning a pregnancy within the duration of the of the study (including the follow-up period). * likely to require treatment during the study with any of the restricted medications * has any other clinically significant gynecologic condition identified during the main study on transvaginal ultrasound (tvus), on endometrial biopsy or at the manual breast examination, which might interfere with the study efficacy and safety objectives. * met any of the main study discontinuation criteria

Keywords: dysmenorrhea dyspareunia dyschezia non-menstrual pelvic pain
acute cholecystitis with concomitant choledocholithiasis: unicentric study of prevalence and predictive factors

Conditions: Acute Cholecystitis; Choledocholithiasis

Summary: the management of cholelithiasis with choledocolithiasis is extensively known, whereas for acute calculous cholecystitis (acc) with choledocolithiasis or common bile duct stones (cbds), a common entity, there is a lack of protocols for optimising treatment. the main hypothesis of our study is: a correct stratification of the concomitant cbds probability at acc diagnosis would optimize its treatment as early targeted treatment could be performed. one-step management of acc with cbds by a specialised hepatobiliary team would represent a benefit to the patient in terms of morbi-mortality, admission time and number of admissions. the aim of our study is to identify high / intermediate probability criteria for cbds associated when diagnosing ca. this is a retrospective study of patients who were operated on with an emergent cholecystectomy in our center from 01/2012 to 12/2019.

data will be obtained from the hospital (consorci sanitari del maresme) clinical database. the ethics committee approval has been obtained.

Eligibility criteria:
inclusion criteria: * age ≥18 years exclusion criteria: * non urgent cholecystectomy

Keywords: acute cholecystitis choledocholithiasis urgent cholecystectomy risk factors