Kornimate/medical-research-clean huggingface dataset:
ketamine versus etomidate for procedural sedation for pediatric orthopedic reductions

Conditions: Conscious Sedation Failure During Procedure

Summary: there are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. none have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. the investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. the investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.

there are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. none have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. the investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. the investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.

Eligibility criteria:
inclusion criteria: * age 5-18 years * extremity fracture requiring reduction with sedation in emergency department exclusion criteria: * allergy to etomidate, midazolam, fentanyl, ketamine, lidocaine * multi-system trauma * history of psychosis * pregnancy * illicit drug use * developmental delay * non-english speaker

Keywords: procedural sedation fracture reduction pediatric emergency medicine etomidate ketamine analgesia
study where healthy volunteers evaluate lofric catheters

Conditions: Catheterization

Summary: the purpose of this study is to evaluate healthy volunteers perception of catheterization with lofric catheters with new solvents in the manufacturing process. the subjects will be catheterized three times during one visit day. the hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * healthy volunteers * males age 18 years and over exclusion criteria: * known or suspected, current impairment of and/or decreased urethral sensibility * history of urethral disease * history of urinary tract infection within three months, or ongoing symptomatic urinary tract infection * use of medications that may affect the urethra's dryness (e. g. anti-cholinergic drugs or cortisone) * current drug, alcohol or other substance abuse * other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation * allergy to trimethoprim * suspected poor compliance with the protocol during the complete study period.
effect of mulligan technique versus core stability exercises on low back pain in post menopausal women

Conditions: Low Back Pain

Summary: this study will be conducted to compare the effect of mulligan technique and core stability exercises on low back pain in post menopausal women.

low back pain is a major health problem affecting majority of the people at some point of their life. mulligan techniques can correct positional faults that occur in the spine and, thus, once the pain generator is released, normal function returns and the muscle guarding around the affected joint is resolved. several studies have reported that along with the biomechanical changes, certain neurophysiological changes exist that occur at the spinal level after applying mulligan techniques, including changes in descending pain inhibitory systems and changes in central pain processing mechanisms. core stability exercises are usually used to strengthen the muscles around the abdominal, lumbar, and pelvic regions, because the muscles of these regions play an important role in stability as well as in controlling the lumbar posture by using tonic or postural muscles during whole-body exercises. so, this study will be conducted to provide new evidence and information about the efficacy of mulligan technique versus core stability exercises on low back pain in postmenopausal women, to manage this problem for these women and add new information to the field of physical therapy.

Eligibility criteria:
inclusion criteria: * sixty postmenopausal women (at least one year after stoppage of menses). * their age will be ranged from 50 to 60 years. * all of them are diagnosed with chronic low back pain. * their bmi will be less than 30 kg/ m2. * all of them are of sedentary lifestyle. * the score of pain will be 2 or more in a vas. exclusion criteria: * participants will be excluded from the study if they have: * spinal fractures or any other neurological disorders. * lumber disc herniation or spondylolithesis * body mass index more than 30 kg/m2. * pelvic pathology * gynecological diseases as chronic pelvic pain, uterine prolapse or retroversion flexion of the uterus.
efficacy of hyaluronic acid and platelet-rich plasma combination in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.


Eligibility criteria:
inclusion criteria: * knee pain for 4 months; * knee degenerative sign evaluated with x-ray with a kellgren-lawrence grade inferior to 3; * patients able to understand the study conditions and willing to participate for its entire duration; * patients who signed written informed consent. exclusion criteria: * severe knee osteoarthritis of grade 4; * diabetes mellitus; * rheumatoid arthritis; * ongoing malignancies; * certified allergic reactions towards the administered drugs ; * malalignment of mechanical axis of the lower limb (varus \> 10 °, valgus \> 10 °); * coagulopathies; * severe cardiovascular diseases; * ongoing infections; * immunodepression; * anticoagulants or anti-platelet agents; * haemoglobin \< 11 g/dl; * platelet count \< 150,000/mm\^3 * drug addiction; * alcoholism; * psychiatric disease; * pregnancy or breastfeeding.
impact of a behavioral tele-health program on the quality of recovery for patients undergoing total joint replacement surgery

Conditions: Opioid Dependence; Opioid Use; Pain, Joint

Summary: the quality of recovery after surgery is multi-factorial and includes both physical and mental factors. persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use. the investigators will be evaluating if the addition of a pain coach/councilor before and after surgery, through a tele health platform (lucidlane) can improve participant's recovery from major joint surgery.


Eligibility criteria:
inclusion criteria: * male or female patients between the ages of 21-90 years old * patient is opioid naive i.e hasn't used opioid medication for 30 days prior to surgery * patient willing to use lucid lane program to provide behavioral health support for up to 4 weeks before surgery and 4 weeks after surgery. * patient is willing to discuss lucid lane progress with palo alto va's medical team and prescribing clinicians. * patient is willing to sign a lucid lane client agreement. * patient is willing to sign an informed consent form exclusion criteria: * serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression. * active suicidal ideations * patient is on methadone or buprenorphine for treatment of opioid use disorder(i.e. for treatment of addiction, and not for treatment of pain) * patient unwilling to use or not possessing access to a device that allows for video visits(e.g. a smart phone, tablet, or computer) * patients who are in palliative care * unable to use english to participate in the consent process, the intervention or study assessments. * unable to provide informed consent to participate
sms reminders and treatment compliance and efficacy in patients with fgids

Conditions: Functional Gastrointestinal Disorders; Patient Compliance

Summary: the effect of sms follow-up on drug compliance and efficacy in patients with fgids has not been reported in the literature. we, therefore, conducted a prospective randomized controlled trial to investigate whether sms follow-up could improve treatment adherence in patients with fgids, which in turn would help symptom relief and improve treatment outcomes.

the irritable bowel syndrome (ibs) and other functional gastrointestinal disorders (fgids) are common and pose significant burdens to patients. although regular medications have substantial benefits for disease remission, many patients do not follow the recommendations of standard medication regimens given by physicians at the time of the visit, so how to improve patient compliance becomes even more important. many factors can affect drug compliance. forgetting seems to be one of the important reasons for poor compliance. in order to solve this problem, many studies such as drug charts/calendars, mini kits, etc. have been conducted in previous studies. at present, with the popularization of mobile phones, sms-based interventions are gradually being applied to various medical environments. compared with the phone, sms consumes less time and can be easily integrated into the patient's daily life. therefore, short messages may be more suitable for follow-up of patients outside hospital.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed fgids according to rome-iv * aged 18-70 years * with no obvious organic abnormalities exclusion criteria: * with organic gastrointestinal diseases * with psychiatric diseases or are taking psychotropic agents * with severe cardiopulmonary or other organ diseases * pregnant women

Keywords: functional gastrointestinal disorders, adherence
glycemic excursions in patients with type 1 diabetes mellitus using closed-loop systems

Conditions: Type 1 Diabetes Mellitus; Type 1 Diabetes Mellitus With Hypoglycemia; Drive

Summary: the study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy

this national multi-center prospective observational controlled study focuses on the safety of insulin pump closed-loop in patients over 18 with type 1 diabetes while driving. a total of 100 patients (treated with minimed 780 g + cgm) will be enrolled in the study group and 20 patients in the control group (treated by multiple daily injections (mdi) + cgm) at 10-20 study centers. after the inclusion and exclusion criteria evaluation and informed consent signing, each patient receives the patient diary. the diary will be used to record the times of observed events during the study period lasting ten days: periods of driving (from-to), periods of night sleep, periods of occupation, periods of physical activity, periods of stress (self-defined), an extra dose of insulin not covered by carbohydrates, an extra dose of carbohydrates not covered by insulin (more variables are required to hide a little bit the primary target of the study). cgm data obtained during the study period will also be downloaded at the end of the study period. finally, the data from the cgm and the patient diary will be compared and analyzed, especially regarding the course of glycemia during driving and the presence of hypoglycemia.

Eligibility criteria:
inclusion criteria study group: * type 1 diabetes * patients aged ≥18 year * diabetes duration ≥3 years * regularly driving (non-professional drivers only) * treated with insulin pump minimed 780 g for at least 6 months with closed-loop setting treatment * willing to fill in the study questionnaires * signed patient's informed consent form control group: * type 1 diabetes * patients aged ≥18 years * diabetes duration ≥3 years * regularly driving (non-professional drivers only) * treatment with multiple daily injections (mdi) of insulin therapy and the use of cgm for at least 6 months * willing to fill in the study questionnaires * signed patient's informed consent form exclusion criteria (for study and control groups) * professional drivers * pregnancy * inability to be present at the follow-up visit * inability to complete the study questionnaires * participation in another clinical study within the last 3 months

Keywords: type 1 diabetes mellitus driving closed-loop system
efficacy study of colistimethate sodium inhalation in patients with ventilator-associated pneumonia

Conditions: Ventilator Associated Pneumonia

Summary: there might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant gram-negative ventilator-associated pneumonia.

besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant gram-negative bacteria.

Eligibility criteria:
inclusion criteria: 1. age ≥ 20 years old 2. medical icu patients with invasive ventilator use ≥ 48 hours 3. multidrug resistant gram-negative bacteria obtained from lower respiratory tract exclusion criteria: 1. pregnancy 2. concurrent use of other antimicrobial agents active for isolated multidrug resistant gram-negative bacteria (as defined as resistant to carbapenem, fluoroquinolone, and anti-pseudomonas beta-lactams), such as tigecycline, aminoglycosides, and sulbactam 3. patients who refuse to receive any inhaled therapy

Keywords: colistimethate sodium inhalation
exercise and pregnancy: randomized clinical trial

Conditions: Preeclampsia; Gestational Diabetes

Summary: the effects of physical exercise on pregnancy remain to be elucidated. a randomized controlled trial will be conducted to study the impact of exercise on maternal and perinatal outcomes. our hypothesis is that physical exercise reduces preeclampsia incidence and improves birthweight when started early in pregnancy, with no impact on pregnancy duration, apgar scores and neonatal complications.

the study will include low risk pregnant women randomized to practice physical exercise beginning at 13 weeks, 20 weeks or no exercise group. the objectives are: 1. to describe and compare biological and obstetrical variables. 2. to study doppler flow velocimetry indexes. 3. to determine the association between physical exercise and maternal complications: preeclampsia, preterm labor, gestational diabetes and weight gain in pregnancy. 4. to determine the association between physical exercise and perinatal outcomes: apgar scores, birthweight, admission at intensive neonatal care unit, body composition and neonatal complications.

Eligibility criteria:
inclusion criteria: * gestational age \< 13 weeks * single pregnancy * alive fetus * no previous practice of physical activity exclusion criteria: * smoking * chronic maternal diseases * placenta praevia * history of preterm labor * bleeding

Keywords: physical exercise maternal complications preterm labor birthweight apgar scores
patient preference study in type-2 diabetes mellitus: discrete choice experiment (dce) to support novo nordisk's long-acting insulin

Conditions: Type-2 Diabetes Mellitus (T2DM)

Summary: the primary objective of this research is to assess t2dm patient preferences for a once weekly insulin treatment. the study involves a qualitative interview phase and quantitative survey phase with a discrete choice experiment (dce).


Eligibility criteria:
inclusion criteria: * patient is an adult aged 18 years or over * patient was diagnosed with type-2 diabetes mellitus (t2dm) greater than or equal to 180 days prior to the day of screening * patient is currently prescribed a diabetes treatment (e.g., metformin/sus, dpp4i, sglt2i, glp-1 ra and/or basal insulin) * patient is willing and able to provide written informed consent to participate for qualitative interviews: * patient is a fluent speaker of english and is able to read, write, and fully understand the english language * patient is a resident in canada for quantitative online survey: * patient is a fluent speaker of the local language (english/french/spanish or japanese) and is able to read, write and fully understand the local language * patient is a resident of either canada, france, spain or japan exclusion criteria: * patient is currently employing a basal-bolus insulin treatment regimen to manage their diabetes * patient is unwilling or unable to comply with the needs of the study or has a physical, behavioural or mental condition that, in the opinion of the recruiter may affect the patient's ability to take part in the study, understand the nature, scope and possible consequences of the study, or the responses they might provide.
perception and attitude toward estrogen therapy among surgically menopausal women

Conditions: Menopause, Premature; Hysterectomy; Ovariectomy; Estrogen Replacement Therapy; Attitude; Perception

Summary: the aim of this study is to survey patient's cognition and attitude about health-related quality of life, use of estrogen, experience of menopausal syndrome, compliance of medication, experience, and satisfaction for women who underwent hysterectomy and bilateral oophorectomy before menopause.

the cognition and attitude of menopausal women toward hormone replacement could have been changed since the report from whi in july 2002. previously, many women used hormone replacement to prevent cardiovascular disease and osteoporosis. recently, the use has been challenged, exaggerated, and also discussed both in media press and academic meetings. many women dare not to use them. the women who underwent hysterectomy and bilateral salpingo-oophorectomy before menopause may immediately face the problems caused by deficiency of female sex hormone. for this group of women, as yet there is no conclusion about whether the women should take hormone replacement therapy for a long time to osteoporosis, cardiovascular disease and other chronic disease. the arm for this study from whi is not closed yet. while the women in our area might have been influenced by this report and have changed their mind. it is essential for us to make a clear understanding about the cognition and attitude for hormone replacement therapy for women who underwent hysterectomy and bilateral salpingo- oophorectomy. therefore, it may be a pioneer study and worthwhile to do this study. data from a medical center from 2000 to 2004 will be examined for evidence of bilateral oophorectomy \& hysterectomy. the cause for the surgery will be confirmed by pathological findings. these women who were under 50 years of age will be candidate of the study. the women will be interviewed about their beliefs, and cognition, regarding their quality of life and health risks as well as their opinion on menopause and hormone replacement therapy.

Eligibility criteria:
inclusion criteria: * age under 50 * hysterectomy and bilateral oophorectomy exclusion criteria: * unwilling to answer the questionnaires

Keywords: menopause, premature hysterectomy ovariectomy estrogen replacement therapy knowledge perception attitude
study of clinical and laboratory variables associated with a direct oral anticoagulant bioassay higher among those aged over 75 years

Conditions: Atrial Fibrillation

Summary: the objective of this study was to investigate whether there is a link between clinical and biological variables and bioassay high xaban in elderly patients as part of an unscheduled hospitalization.


Eligibility criteria:
inclusion criteria: * age ≥ 75 years * entering sau or mpg (nantes university hospital) as part of an unscheduled hospitalization for acute or subacute disease (about mpg, will be included patients admitted to the department within 48 hours of calling the doctor) * in xaban to entry (dabigatran, rivaroxaban, apixaban) for non-valvular atrial fibrillation * in whom hemostasis tests will be prescribed as part of usual care * patient has given its verbal agreement exclusion criteria patients with the following criteria may not be included: * patients refusing to participate in the study * patients under guardianship * inability to obtain the date and time of the last dose of xaban

Keywords: atrial fibrillation oral anticoagulant bioassay elderly subject
surgery for recurrent intrahepatic cholangiocarcinoma

Conditions: Cholangiocarcinoma, Intrahepatic; Recurrence Cholangiocarcinoma; Re-hepatectomy

Summary: the investigators retrospectively reviewed the participants suffering from recurrent intrahepatic cholangiocarcinoma after curative resection and aimed to explore the predictive factors for recurrence and clarify the potential benefit of repeat hepatectomy or/with metastasectomy.


Eligibility criteria:
inclusion criteria: * r0 resection for intrahepatic cholangiocarcinoma at initial diagnosis. exclusion criteria: * (1)patient with r1 or r2 resection * (2)distant metastasis noted when laparotomy * (3)surgical mortality

Keywords: recurrent intrahepatic cholangiocarcinoma intrahepatic cholangiocarcinoma repeat hepatectomy metastasectomy
effect of a tailored program of physical activity and nutritional counseling on fatigue reduction in breast cancer patients receiving an adjuvant treatment

Conditions: Breast Cancer

Summary: cancer-related fatigue is by far the most common symptom affecting cancer patients. combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. we propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. to gain behavioral change towards pa and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.

cancer-related fatigue is by far the most common symptom affecting cancer patients. combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. we propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. to gain behavioral change towards pa and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.

Eligibility criteria:
inclusion criteria: * female patient with histologically proven breast cancer * 18-76 years old * patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 fec100, or 3fec100 + taxanes) followed by radiotherapy * satisfactory healing of breast and lymph nodes area * ability to understand the nature, goal and study methodology * consent to cooperate for clinical assessments * affiliation to a social security regime or beneficiary of equivalent social protection * written informed consent provided before any study specific procedures exclusion criteria: * her2 positive or metastatic cancer * any other primary tumor * contraindication to moderate physical activity * contraindication to adjuvant chemotherapy or radiotherapy * pregnancy or breast feeding * inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial

Keywords: comprehensive adjuvant care cancer-related fatigue therapeutic patient education physical activity nutritional counselling rehabilitation