Kornimate/medical-research-clean huggingface dataset:
clinical outcomes following transcutaneous auricular neurostimulation to improve relapse prevention: a long-term follow-up study

Conditions: Opioid Use Disorder; Relapse

Summary: this is a prospective, observational, longitudinal study to assess clinical outcomes in the 12-months following participants' exit from protocol sbm-owp-03, delivering transcutaneous auricular neurostimulation to improve relapse prevention in opioid use disorder (restore; clinicaltrials.gov identifier: nct05053503). clinical outcome scores will be collected at study exit from protocol sbm-owp-03, 1 month, 3 months, 6 months, 9 months, and 12 months after study exit from protocol sbm-owp-03.


Eligibility criteria:
inclusion criteria: 1. consented participant for protocol sbm-owp-03, delivering transcutaneous auricular neurostimulation to improve relapse prevention in opioid use disorder (restore) 2. participant is english proficient 3. participant is able to provide informed consent and function at an intellectual level sufficient for study requirements exclusion criteria: 1. participant is unable to reliably receive and respond to assessments via email or telephone 2. participant has any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Keywords: relapse prevention
accuracy of gastric pocus in pediatric trauma

Conditions: Pediatric Trauma Patients

Summary: the goal of this observational study is to detect the predictive accuracy of the gastric pocus in pediatric trauma patients undergoing urgent and semi urgent operative procedures. the main question it aims to answer is : what is the predictive value of the gastric pocus in pediatric patients? participants are pediatric patients who will be scheduled for operative procedures within one hour of performing gastric pocus.

reflux aspiration of gastric contents is a critical concern in the perioperative setting, as it can result in severe complications such as aspiration pneumonia, acute respiratory distress syndrome, and even death. the risk is heightened during general anesthesia and is influenced by the quality and quantity of stomach contents. to mitigate this risk, the american society of anesthesiologists (asa) recommends fasting guidelines prior to elective procedures. however, factors like trauma, acute and chronic pain, opioid use, and certain medical conditions can delay gastric emptying, complicating adherence to these guidelines. recent advancements in ultrasound techniques enable comprehensive evaluations of the nature and volume of gastric contents, making this tool convenient, noninvasive, and applicable at the bedside with minimal contraindications.the perlas model has been developed to identify surgical patients with "at-risk" stomachs, aiding in preoperative planning and airway management during general anesthesia. this model facilitates decisions regarding rapid sequence induction (rsi) and the choice of airway management techniques. however, there is a notable lack of research focusing on the use of ultrasound techniques in pediatric trauma patients to determine their diagnostic performance and predictive accuracy regarding gastric contents. therefore, the aim of this study is to investigate the efficacy of pocus in assessing the nature and volume of gastric contents in pediatric trauma patients undergoing urgent and semi-urgent surgical procedures.

Eligibility criteria:
inclusion criteria: 1. pediatric patients who will be scheduled for operative procedures within an hour of performing gastric pocus. 2. age group 1-18 years 3. asa physical status (i-iii). 4. both gender exclusion criteria: 1. children with known abnormal upper git anatomy or prior upper git surgery. 2. children with wounds of the epigastrium precluding probe placement. 3. children deemed unable to tolerate the us probe
the study of gr1802 in patients with chronic rhinosinusitis with nasal polyps

Conditions: Chronic Rhinosinusitis with Nasal Polyps

Summary: this is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, pk, pd and immumogenicity of gr1802 injection in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (mfns) in patients with chronic rhinosinusitis with nasal polyposis (crswnp). patients will receive gr1802 injection or placebo every 2 weeks.

this is a multicenter, randomized, double-blind, placebo-controlled phase ii clinical trial evaluating the preliminary efficacy and safety of gr1802 injection in patients with chronic rhinosinusitis with nasal polyps. the study consists of a screening/run-in period (up to 4 weeks), a randomized, double blind treatment period (16 weeks) and a safety follow-up period (8 weeks). 70 subjects will be randomized 1:1 into the 300 mg first dose doubling q2w group and the placebo q2w group. throughout the dosing period, all subjects continued treatment with standard therapy at a stable dose. patient-reported outcome including nasal congestion score will be collected using patient diary. central reading will be implemented to nasal endoscopic nasal polyp score (nps) and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.

Eligibility criteria:
inclusion criteria: 1. bilateral crswnp with prior treatment with systemic corticosteroids (scs), and/or contraindicate to or intolerance to scs, and/or with prior surgery to nasal polyps 2. bilateral nps of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline. 3. ongoing symptoms of nasal congestion/obstruction(ncs score of 2 or 3 at screening and at baseline). 4. recorded use of intranasal corticosteroids for at least 4 weeks before screening exclusion criteria: 1. insufficient washout time for drugs that have an impact on the evaluation of efficacy and safety。 2. concurrent disease that may interfere with the evaluation of safety and efficacy in subjects, or affect the risk- benefit evaluation of subjects. eg. specific ongoing nasal diseases, severe asthma, active infection, severe cardiovascular disease, severe laboratory test abnormalities. 3. other.
gene expression following short term exposure to neoadjuvant endocrine therapy in invasive breast cancer

Conditions: Breast Cancer

Summary: the purpose of this pilot study is to see if taking anastrozole (arimidex) for 10 days causes changes in breast cancer cells. anastrozole (arimidex) is a drug used in the treatment of a type of breast cancer that depends on estrogen to grow. this type of breast cancer is called estrogen receptor positive breast cancer. anastrozole (arimidex) works by blocking an enzyme in your body called aromatase. aromatase is found in your muscles, fat, liver and in breast tumors. this enzyme is important for making estrogen in women who are no longer having menstrual periods. anastrozole decreases levels of estrogen in the body. we are interested in seeing if taking anastrozole for 10 days will cause changes in breast cancer cells. we will study cell processes such as how they make new blood vessels, how quickly the cells multiply, and how soon they die. we will also study which genes in the breast cancer tissues are turned on or off by taking anastrozole for 10 days.

this is an exploratory study utilizing micro-array technology and immunohistochemistry to test the hypothesis that changes in gene expression occur as an early event in response to endocrine therapy and that these changes can be correlated with changes in surrogate biological markers.

Eligibility criteria:
inclusion criteria: * postmenopausal patients, defined as one or more of the following criteria: documented history of bilateral oophorectomy, aged 60 years or more, aged 45-59 years and satisfying one or more of the following criteria: amenorrhea for at least 12 months and intact uterus amenorrhea for less than 12 months and follicle stimulating hormone (fsh) concentrations within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement therapy in the past. * clinically palpable or non-palpable t1c or greater, er positive invasive breast cancer diagnosed by outside core biopsy. * outside diagnosis of invasive breast cancer confirmed at mskcc * palpable or non-palpable breast mass \> 1cm highly suspicious for invasive breast cancer based on mammographic, ultrasound and/or physical examination findings and amenable to diagnostic core biopsy. * core biopsy diagnosis of er positive invasive breast cancer performed at mskcc * breast conserving surgery or mastectomy scheduled at mskcc. * informed consent obtained. exclusion criteria: * co-morbid conditions which would preclude use of aromatase inhibitors such as: previous hypersensitivity, severe hepatic insufficiency (sgot or sgpt three times the upper limit of normal), severe renal insufficiency (creatinine clearance \<10ml/min). prior radiation therapy to chest wall / breast. * neoadjuvant chemotherapy * hormone replacement therapy, tamoxifen or raloxifene treatment within past 3 months * er negative breast cancer * history of active malignancy within the previous 5 years (except for nonmelanoma skin cancer and breast cancer)

Keywords: breast anastrozole
probiotics attenuate postoperative cognition decline

Conditions: Necrosis of Femoral Head; Knee Osteoarthritis; Fracture of Neck of Femur; Lumbar Disc Herniation

Summary: the aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium.


Eligibility criteria:
inclusion criteria: 1. . age is greater than or equal to 65 years old 2. . can communicate normally 3. . selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia 4. . asa graded at i-ii level 5. . patient or family informed consent exclusion criteria: 1. . have a brain disease, or have a history of brain disease 2. .mmse check of less than 24 points. 3. . history of neurological and psychological disorders including ad, stroke, psychosis 4. . serious hearing or visual impairment 5. . preoperative systolic blood pressure \>190mmhg, or diastolic blood pressure \>100mmhg 6. . the patient or family refuses

Keywords: postoperative cognitive dysfunction postopeartive delirium probiotics
pharmacokinetics of daptomycin in critically ill patients receiving continuous venovenous hemodialysis (cvvhd)

Conditions: Critically Ill; Hemodialysis

Summary: daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. this antibiotic would be appropriate for use in the intensive care unit (icu) considering the severity of illness and high risk for infection within this hospital environment. while in the icu, patients may develop acute renal failure. approximately 75% of icu patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. continuous hemodialysis is becoming one of the most common forms of dialysis in the icu as it is a gentle type of dialysis provided over longer periods of time. the current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. the purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.

daptomycin is a fda approved antibiotic. this pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. the daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.

Eligibility criteria:
inclusion criteria: * =/\> 18 years of age * prescribed continuous venovenous hemodialysis (cvvhd) as determined by the primary physician * prescribed daptomycin as determined by the primary physician * informed consent granted exclusion criteria: * \< 18 years of age * allergy to daptomycin * patients being primarily treated with daptomycin for diagnosis of osteomyelitis, meningitis, or pneumonia without adequate concomitant use of other more effective antimicrobial agents as daptomycin is not indicated for primary treatment of these types of infections * inability to complete 48 hours of continuous venovenous hemodialysis (cvvhd) * concurrent use of other extracorporeal therapies such as extracorporeal membrane oxygenation (ecmo) or plasmapheresis and intermittent hemodialysis * inability to obtain informed consent * pregnant and/or breastfeeding women

Keywords: daptomycin pharmacokinetics renal replacement therapy critical illness intensive care units
daylight-pdt for aks: comparing two photosensitizers (bf-200 ala and mal)

Conditions: Multiple Actinic Keratoses

Summary: the aim of the study is to compare the efficacy of two photosensitizers, methyl-aminolaevulinate (mal) and 5-aminolaevulinic nanoemulsion (bf-200 ala) in the treatment of facial actinic keratosis. we use randomized, double-blinded prospective study design. the efficacy will be assessed clinically, histopathologically and immunohistochemically.

actinic keratoses (aks) are superficial premalignant skin lesions that can progress into an invasive or metastatic squamous cell carcinoma. aks can be treated with photodynamic therapy (pdt), of which cure rate compares to cryo surgery with an excellent cosmesis. in pdt the ak lesions are first curettaged, then a photosensitizer is applied on the skin and let to absorb for 3 hours. the skin is illuminated using a blue or red light source light source depending on the photosensitizer, which induces activation of protoporphyrin ix (ppix) and phototoxic reaction destroying the cancer cells. the approved photosensitizers in europe are methyl-aminolevulinic acid cream, (mal, metvix™, galderma), a patch containing 5-aminolevulinic acid (5-ala, alacare®, spirig ag) and 5-aminolevulinic acid gel (bf-200 ala, ameluz®, biofrontera ag) to be used with a red led light (630-635 nm). in north america a 5-aminolevulinic acid stick (5-ala, levulan® kerastick) can also be used with a blue light source (417 nm). ppix absorption peaks are within the visual spectrum of light, which allows ppix daylight activation. during natural daylight pdt (ndl-pdt) protocol, ppix is continuously activated during its development, whereas in conventional pdt (led-pdt) using red led lamps, large amounts of accumulated ppix are momentarily activated. since skin field cancerization refers to presence of different degrees of visible and invisible dysplastic changes, the whole area should be treated to prevent the development of non-melanoma skin cancers (nmscs). ndl-pdt enables treatment of field cancerization in one sitting whereas led-pdt may need repeated illuminations to cover the whole area. ndl-pdt results in enhanced cost-efficacy due to reduced staff expenses, since there's no need for sensitizer absorption and illumination. at the moment two photosensitizers have marketing authorization in finland, ala (ameluz®) and mal (metvix™). we are piloting a study comparing the efficacy of these two light sensitizers in ndl-pdt. the efficacy of the treatments will be assessed clinically, histopathologically and immunohistochemically.

Eligibility criteria:
inclusion criteria: * actinic keratoses symmetrically on face or scalp * age over 18 years * there must be at minumum one ak sized 6mm2 symmetrically on both sides * patients must be able to make the decision to attend independently exclusion criteria: * pregnancy * lactation * lack of compliance
quadratus lumborum block for postoperative analgesia after colostomy closure

Conditions: Postoperative Pain

Summary: patients undergoing abdominal procedures often require multimodal postoperative pain controls. truncal blocks such as quadratus lumborum (ql) block may be used adjunctively as a part of it. the investigators hypothesized that the ultrasound-guided ql block with transmuscular approach can provide adequate pain relief for colostomy closure as part of a multimodal pain control.


Eligibility criteria:
inclusion criteria: * a physical status between asa i and iii * 20 - 75 years of age * patient has signed an informed consent * without contraindication of ql block exclusion criteria * american society of anesthesiologists (asa) physical status ≥ 4 * any contraindication to nerve blocks (including coagulopathy, abnormal anatomy, infection at the planned ql injection site, and amide-type local anesthetic allergy) pregnancy or breast-feeding * severe obesity (body mass index≥ 35 kg/m2) * patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease * allergy to nsaids * infection at the ql injection site * patients with major psychosis or drug and alcohol abuse * patient unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia pump
the effect of complex decongestive therapy in patients with lymphedema

Conditions: Lymphedema; Urine Marking; Quality of Life; Edema

Summary: the aim of this study is to investigate objectively the effect of lymphatic fluid which is circulated with complex decongestive therapy on fluid excretion from the body in patients with lymphedema.

the lymphatic system is the accessory circulatory system that takes lymph fluid from the interstitial space and adds it to the blood circulation. it starts from the interstitial space. it consists of lymph vessels, lymph fluid and lymphatic organs. lymph fluid passes through many lymph nodes during its transport and is filtered in these nodules. the lymphatic system takes lymphatic fluid from the tissues and brings it to the venous part of the circulatory system. the main task of the lymph system is to reabsorb substances that cannot be absorbed by the blood circulation system. non-absorbable substances in the interstitial space are called lymphatic load. lymphatic load; it consists of protein, water, fat and cells. the aim of lymphedema treatment is to remove the protein-rich fluid accumulated in the interstitial space into the venous system. there are many factors in the flow of lymph fluid into the veins. the most important of these is the high filtration pressure that occurs when fluid is filtered through blood capillaries. lymph fluid flowing from the periphery to the center is generally affected by pressure changes and moves from where the pressure is high to where it is low. contraction of the muscles adjacent to the lymph vessels, pulsation of the neighboring arteries, and the effect of the smooth muscles in the lymph vessel wall also cause pressure changes. other factors include respiratory movements acting as a pump in the lymph flow, the actual pressure effect of abdominal pressure on the cisterna chyli, and negative intrathoracic pressure. complex decongestive physiotherapy is proven effective and considered the gold standard for the treatment of lymphedema. it increases the hydrostatic pressure that has decreased due to edema and helps the lymph fluid to re-enter the circulation. purpose of the study; to objectively investigate whether the lymph fluid added to the circulation through complex decongestive physiotherapy in lymphedema patients has an effect on fluid excretion from the body.

Eligibility criteria:
inclusion criteria: * female cases * cases diagnosed with lower extremity unilateral/bilateral lymphedema * having received or not received radiotherapy and/or chemotherapy exclusion criteria: * having received treatment for lymphedema in the last year * having metastatic disease * those diagnosed with severe heart failure and/or arrhythmia * arterial disorders * kidney diseases * infection in affected extremities * psychological disorders * diabetes * nephrotic syndrome * diuretic use * patients using chemotherapy and drugs that have toxic effects on the kidneys * those with liver cirrhosis, liver disease * neurological diseases
individual patient esmethadone (rel-1017) expanded access program

Conditions: Major Depressive Disorder; Depression

Summary: to provide expanded access of esmethadone (rel-1017) to patients with a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (rel-1017) who do not have access to other effective therapy and are not eligible for other clinical trials with esmethadone (rel-1017).

the expanded access program (eap) is intended to provide pre-approval access to esmethadone (rel-1017) for eligible patients who suffer from a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (rel-1017) as determined by the treating physician and have no satisfactory treatment options. this program is open in the united states and operates under the individual patient (also referred to as single patient) ind expanded access route in which the patient's treating physician serves as the sponsor. expanded access requests must be from the patient's treating physicians and submitted according to the relmada eap policy at https://www.relmada.com/our-portfolio/eap.

Eligibility criteria:
inclusion criteria: * patients who may potentially benefit from treatment with esmethadone (rel-1017) as determined by the treating physician. * have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory alternative treatment is available to treat the disease or condition. * are ineligible or unable to participate in any ongoing clinical study of the investigational product. * condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated risks. exclusion criteria: * history or presence of clinically significant health conditions which in the opinion of the investigator would negatively impact the safety of the participant. * history of qtc prolongation. * history of allergy or hypersensitivity to methadone or related drugs. * pregnant or planning to become pregnant. * breast-feeding or planning to breast-feed.

Keywords: rel-1017 esmethadone relmada antidepressant nmda receptor antagonist depression
emotional and physical health status of adults

Conditions: Pandemic, COVID-19; Adult ALL

Summary: to investigate the comparison of differences between emotional and physical health status of adults in covid-19 isolation period and controlled normalization period.


Eligibility criteria:
inclusion criteria: * to speak turkish * living in turkey in pandemic process. * between the ages of 20-60 years. * no communication problems. * being volunteer to participate in study. exclusion criteria: * having communication problems. * not completion the assessments.

Keywords: pandemia awareness general fatique quality of life sleep quality bodily pain status of physical activity