Kornimate/medical-research-clean huggingface dataset:
the efficacy of dexketoprofen and methylprednisolone in the acute low back pain

Conditions: Low Back Pain

Summary: many methods have been used in to treat low back pain. in this study, we aimed to investigate the efficacy of dexketoprofen alone and in combination with methylprednisolone in the treatment of low back pain in the emergency department using the visual analog scale (vas) and the oswestry disability index (odi).this prospective, randomized, single-blind study included 150 patients admitted to the emergency department of a university hospital. patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (group d) and those receiving dexketoprofen + methylprednisolone treatment (group dm). the efficacy of the treatments received by the patients was evaluated with the vas at minutes 0, 15, 30, and 60 and hour 48. statistical evaluations were also undertaken on the odi results evaluated at minute 0 and hour 48.


Eligibility criteria:
inclusion criteria: * patients aged over 18 and under 65 years. * the patients who presented to the emergency department with acute non-traumatic low back pain. * voluntarily agreed to participate in the study. exclusion criteria: * the patients who had used analgesics within the last six hours; * who has neurological deficits, cardiac or chest pain, liver, kidney, cardiac or pulmonary failure, chronic pain, * who has a history of dexketoprofen-related gastrointestinal bleeding or perforation, referred pain, neoplastic pain, a history of allergies to medications used in the study (methylprednisolone and dexketoprofen), or vision problems; * who indicated a pain intensity of 3 cm or less on the 10-cm vas scale line at the time of their presentation to the emergency department; pregnant and breastfeeding women; * the patients who were illiterate.

Keywords: low back pain dexketoprofen methylprednisolone visual analog scale oswestry disability index
study of short course radiation therapy for elderly patients with rectal cancer

Conditions: Cancer, Rectal

Summary: this study will help determine if a short course of radiation therapy is effective to treat rectal cancer in older patients. a shorter course of radiation treatment may be better tolerated than a longer course or surgery for the treatment of rectal cancer in the elderly.


Eligibility criteria:
inclusion criteria: * 70 years or older at time of diagnosis * no restrictions on gender or ethnicity * ability and willingness to make follow up appointments * pathologic diagnosis of rectal cancer * presentation could be symptomatic or asymptomatic * t1-t3 primary rectal adenocarcinoma as determined on trus, ct, or mri pelvis * peri-rectal node positive allowed * inability to tolerate radical surgery, as judged by geriatric oncology or surgeon and tumor board or patient refusal of surgery * inability to receive chemoradiation therapy, defined as concurrent chemotherapy and radiation doses of 45-50.4 gy, as judged by radiation, medical, or geriatric oncology * patients with dementia eligible if health care proxy (hcp) is available and supportive of follow up schedule exclusion criteria: * age under 70 years of age * ability and desire to receive definitive surgical intervention * ability and desire to receive concurrent chemoradiation therapy
early cognitive intervention in delirium

Conditions: Delirium; Cognitive Decline; Dementia

Summary: this is a randomized control trial to determine if early cognitive training and rehabilitation improve 4-month cognition in hospitalized older (\>=65 years old) delirious patients with and without alzheimer's disease and related dementias. enrolled patients will be randomized to receive cognitive intervention versus usual care at a 1:2 allocation ratio. patients assigned to the cognitive intervention group will receive cognitive training daily during hospitalization and cognitive rehabilitation weekly for 12 weeks after hospital discharge. patients will be evaluated for global cognition (primary outcome) and secondary outcomes at 4-months.


Eligibility criteria:
inclusion criteria: * 65 years or older * admitted through the ed * cognitive training can be initiated within 24 hours of ed presentation * delirious at enrollment exclusion criteria: * comatose * not able to follow simple commands or non-verbal prior to the acute illness (end-stage pre-illness adrd) * resides in a nursing home * prisoner * receiving hospice care * lives \> 100 miles away from the enrolling sites * non-english speaking * previously enrolled * deaf or blind * intravenous drug, crack or cocaine, or methamphetamine use within the past one year, or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial. * psychotic disorder or suicidal gesture requiring hospitalization with the past one year * discharged from the ed
efficacy and safety of memantine and sodium oligomannate in patients with moderate to severe alzheimer's disease

Conditions: Treatment; Efficacy; Safety; Alzheimer Disease

Summary: alzheimer's disease (ad) is the main cause of dementia. at present, ad is incurable. memantine is recommended for the treatment of moderate and severe ad patients. sodium oligomannate (gv-971) is a marine-derived oligosaccharide. it is proposed that it can reconstitute the gut microbiota, and inhibit neuroinflammation in the brain as observed in animal models. it reduces aβ deposition in the brain of aβ-transgenic mice. the reduction in both aβ deposition and neuroinflammation may synergistically contribute to the improvement of cognitive impairment and delay the progress of the disease. china food and drug administration（cfda）approved it for the treatment of mild to moderate ad in 2019. due to the different mechanism of memantine and gv-971, theoretically, they may synergistically improve cognitive function and delay disease progression. however, there is a lack of data on their effectiveness and safety. therefore, the purpose of this study is to compare the efficacy and safety of memantine and gv-971 monotherapy and combination therapy in patients with moderate to severe ad, which is of great significance for guiding the treatment of moderate and severe ad.


Eligibility criteria:
inclusion criteria: * age of 50-80 years old , either sex; * met the diagnostic criteria for suspected ad; * moderate to severe ad patients(5 points ≤mini-mental state examination total score≤14 points); * total hachinski ischemic scale (his) score ≤4 points; * memory loss for at least 12 months, with a progressive deterioration; * brain mri scan suggesting a significant possibility of ad; * no obvious physical signs during nervous system examination; * stable and reliable caregivers; * elementary school or higher education level; * signed an informed consent form. exclusion criteria: * previous nervous system diseases ; * mental illness; * unstable or severe heart, lung, liver, kidney, or hematopoietic diseases; * uncorrectable visual and auditory disorders; * simultaneous use of cholinesterase inhibitors, memantine or gv-971.
using parent engagement to improve the wellbeing of black premature infants with lung disease

Conditions: Chronic Lung Disease

Summary: the goal of this pilot study is to test the feasibility and acceptability of a collaborative goal setting intervention to improve parent engagement of black preterm infants with chronic lung disease in primary care. preliminary impact on child and parent outcomes will also be explored. the main questions it aims to answer are: 1) will parents complete a pre-visit questionnaire that asks about goals for the child? 2) does use of the pre-visit questionnaire help parents to achieve self-identified goals? participants will fill out a pre-visit questionnaire prior to the child's well visit. the participants will then complete two surveys after the visit (1 week and 2 months after).


Eligibility criteria:
inclusion criteria: * parent/legal guardian of child born prior to 37 weeks gestational age * parent/legal guardian of child with diagnosis of chronic lung disease or bronchopulmonary dysplasia, as defined by the child's clinical team at the time of hospital discharge * parent/legal guardian of child who identifies that child's race as black * english speaking exclusion criteria: * parent/legal guardian of child enrolled in palliative care or hospice services at time of hospital discharge * parent/legal guardian of child older than 12 months chronological age
evaluation of pain measurement device

Conditions: Pain

Summary: this longitudinal observational study will attempt to objectively measure pain with an experimental, non-invasive device. patients and volunteers will receive a baseline screening with psychophysical tests and questionnaires. investigators will apply the device to measure pain during routine clinical care and correlate patients pain ratings and analgesia requirements to that measured by the device. a more standardized approach with experimental pain stimuli will be pursued in human volunteer studies.


Eligibility criteria:
inclusion criteria: * age 18-100 years exclusion criteria: * inability to sign consent
patient recovery from heart surgery during the covid-19 pandemic

Conditions: Cardiac Surgery; COVID

Summary: this study will describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. this will include mortality, morbidity, health-related quality of life, event-specific distress and depression.

the overall aim of this study is to describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. this will include mortality, morbidity, health-related quality of life, event-specific distress and depression. all adult patients having cardiac surgery during the pandemic at st bartholomew's hospital will be approached to join this study. as of the end of march this is this is approximately 20 operations a week. questionnaires will be administered at five time points alongside a review of clinical notes. appropriate descriptive and summative statistics will be used to analyse outcomes. if sample size is adequate, possible associations/effect of the impact of the covid-19 pandemic on each of the recovery parameters included in the study will be determined. the differences in outcomes between those with and without covid-19 may also be analysed if the sample size is adequate. bias and loss to follow-up in observational cohort studies has been considered.

Eligibility criteria:
inclusion criteria: * undergoing cardiac surgery during the covid-19 pandemic (end date as yet unknown but inferred when elective surgery is reinstated) * discharge from hospital where operation was performed is being planned * able and willing to give informed consent exclusion criteria: * unable or unwilling to give written informed consent. this includes patients who are being transferred to another hospital and are considered too vulnerable or unwell to be approached (based on clinical judgement of the clinical care team) * unable or unwilling to give and/or complete the questionnaires * inability to understand written and/or verbal english

Keywords: cardiac surgery patient reported outcomes covid
chronic post breast surgery pain

Conditions: Breast Cancer

Summary: the purpose of this study is to learn if paravertebral block (pvb) will reduce chronic pain after surgery. our hypothesis is that chronic pain from breast surgery as a consequence of central sensitization can be prevented by blocking sensory input to the cns during surgery and the immediate post-operative period.


Eligibility criteria:
inclusion criteria: 1. female patient who are ≥ 18 and ≤ 80 years of age. 2. patient with diagnosis of breast cancer. 3. patient scheduled for modified radical mastectomy or lumpectomy with axillary node dissection 4. patient scheduled for one of the above listed surgeries with or without sentinel, partial, or complete axillary lymph node dissection 5. patients scheduled for one of the aforementioned surgeries with or without immediate or delayed reconstruction. exclusion criteria: 1. pre-existing peripheral neuropathy 2. pre-existing chronic pain 3. bilateral procedure 4. previous breast surgery, except biopsy 5. inability to read, write or speak english. 6. allergy to amide local anesthetics 7. contraindications to paravertebral nerve block including, but not limited to severe scoliosis of the spine, skin lesion overlying the block area, abnormal coagulation studies (some of these may not be known until after informed consent is obtained) 8. pregnancy 9. emergency surgery 10. previous recipients of peripheral nerve block. 11. medical professional whose experience includes caring for patients who have had peripheral nerve blocks.
e-mental health support for rural areas

Conditions: Depression

Summary: in the treatment of depression, primary care team play an important role, but they are most effective when inserted into a collaborative model of disease management. hypotheses:depressed patients treated in rural primary care clinics participating in a e-mental heath collaborative programme to manage depression achieve at least 20% better recovery rates in comparison with the control group three months after the baseline assessment. goal: to compare the effectiveness of a e-mental health collaborative programme with usual care in rural primary-care clinics. methodology: a clinical trial with two arms will be conducted in 13 community rural hospitals in chile. the active group will participate in a collaborative programme between primary care teams and specialized teams, with support from an electronic platform and a call center.the control group will receive usual care, according to the ministry of health's guidelines to depression.to evaluate inclusion criteria -depressive patients aged between 18 and 70 years- and exclusion criteria -current in treatment for depression- an interview will be used that will include the mini-international neuropsychiatric interview (mini) to evaluate depression .the principal outcome will be depressive symptoms measured with the beck depression inventory (bdi-i), and secondary outcome quality of life measured with the health survey (sf-36) at three and six months after baseline assessment.to detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, would require 152 depressed persons (76 to intervention and 76 to control group).a design effect of 1.35 based on an intraclass coefficient correlation (icc) of 0,03839 and 13 clinics were considered. after applying the design effect the sample needed increased to 206 depressed persons. considering a retention rate of approximately 85% 237 depressed cases will be needed. a program of this kind may be useful to assist primary care teams in remote areas of the country, in order to improve treatment outcomes for depression that is currently addressed at the primary care level.


Eligibility criteria:
inclusion criteria: * subjects aged 18 or more with a current major depressive episode according to diagnostic and statistical manual of mental disorders iv criteria (dsm-iv) exclusion criteria: * depressive treatment currently in process.

Keywords: primary health care computer communication network depression
evaluating of the impact of a connected and non-intrusive device in improving the screening of sleep apnea syndrome and the addressing of potentially pathological patients in hospital environment

Conditions: Sleep Apnea Syndromes; Metabolic Syndrome; Diabetes; Obese

Summary: diabetes, obesity and metabolic syndrome are closely linked to sleep apnea syndrome. indeed, diabetic and/or obese patients present an increased risk of sleep apnoea syndrome (sas), with a prevalence estimated at between 10 and 22%, depending on the study, and most of them requiring treatment with continuous positive airway pressure (cpap). in this sub-population of patients, only between 40% and 50% benefit from cpap.

there is therefore an under-referral of diabetic patients to treatment, perhaps linked to the way care is organized, which clogs up the circuit and slows down or even prevents access to care. the investigators would like to test a new organization of care to facilitate and intensify this screening.

Eligibility criteria:
inclusion criteria: * adult patients over 18 years old * diabetes mellitus (type 1 or 2), or obesity (bmi\>30kg/m²) or metabolic syndrome * hospitalized for at least one night in the endocrinology department * affiliated or entitled to a social security scheme * having received informed information about the study and having co-signed, with the investigator, the informed consent form for participation in the study exclusion criteria: * known and/or treated osas-type respiratory pathology * no signature of the informed consent form * minor or adult patients under guardianship or curatorship

Keywords: sleep apnea syndromes diabetes withings sleep analyzer epworth berlin
efficacy and safety of the mammalian target of rapamycin (mtor rapamycin) inhibitor in vascular malformations

Conditions: Cardiovascular Abnormalities

Summary: the phosphatidylinositol 3-kinase (pi3kinase)/protein kinase b (akt)/mammalian target of rapamycin (mtor) pathway plays a role on the development and the lymphatic-vascular organisations. the investigators want to study the efficacy and the safety of rapamycin, an mtor inhibitor.

the complex vascular malformations induce chronical pains and organic dysfunctions causing significant morbidity and mortality. therefore, the investigators need to establish guidelines in order to treat these pathologies. standard treatments such as surgery or interventional radiology are of limited efficacy and related to a high level of recurrences as well as complications. recent preclinical studies have shown the important role of the pi3kinase/akt/mtor pathway on the development and the lymphatic-vascular organisations suggesting an appealing therapeutic target to treat patients with complex vascular malformations. the aim of this clinical study is to prospectively evaluate the efficacy and the safety of the rapamycin, an mtor inhibitor, to treat children and adults with microcystic lymphatic malformations, general lymphatics abnormalities (gla) or complex vascular malformations for which conventional therapies as surgery or sclerotherapy are ineffective or associated with high risk of important complications.

Eligibility criteria:
inclusion criteria: * patients with complex vascular abnormalities to be threat by a systemic therapy * patients must have adequate liver function (ldl-cholesterol, triglycerides,...) * patients must have adequate organ function: neutrophils \>1500/mm³, hb \> 8,0 g et platelets\> 50.000/mm³ (no platelets limits for the kasabach merritt syndrome) * patients must have adequate renal function(normal creatinin depending on the age), clearance \> 70 ml/min/1.73m² and urin protein creatinine ratio \<0.3 g. * karnofsky or landry \> 50 exclusion criteria: * dental equipments or prosthesis interfering onto a radiological examen * other uncontrolled medical condition (uncontrolled diabetes, hypertension...) * concomitant drugs such as inhibitors/inducers of cytochrome p450 3a4 (cyp3a4) * immunocompromised patients, including known seropositivity for hiv * digestive problems modifying the absorption of rapamycin (gastric tube feeding accepted) * pregnant or nursing (lactating) women * prior treatment with phosphatidylinositol 3-kinase (pi3k) and/or mtor inhibitors

Keywords: vascular abnormalities
tranexamic acid in off-pump coronary surgery

Conditions: Off Pump Coronary Artery Bypass Surgery

Summary: the aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (opcab) surgery.

cardiac surgical procedures account for a large amount of allogeneic transfusion. although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (cpb), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after opcab. tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with cpb. about 30% of patients in opcab studies still receive a transfusion. a few small sample size studies concerned with the use of in opcab surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. the purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing opcab surgery. in addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.

Eligibility criteria:
inclusion criteria: * patients for elective offpump coronary artery bypass surgery exclusion criteria: * a history of bleeding disorders * active chronic hepatitis or cirrhosis * chronic renal insufficiency (serum creatinine \> 2 mg/dl) * preoperative anemia (hb \< 10 g/dl) * previous cardiac surgery * myocardial infarction \< 7 days before surgery

Keywords: tranexamic acid off-pump coronary artery bypass
care planning for older persons with multiple conditions: encouraging a tailored approach (comet): stage ii

Conditions: Polypharmacy

Summary: the purpose of the proposed project is to pilot-test in the clinic setting a computer-based clinical decision support system (cdss) designed to optimize medication prescribing for older persons with multiple chronic conditions and polypharmacy.


Eligibility criteria:
inclusion criteria: * veterans age 65 years and older. * patients should be diagnosed with diabetes and hypertension and be prescribed five or more medications. * patients receiving primary care at the west haven campus of va connecticut healthcare system. exclusion criteria: * unable to manage own medications because of cognitive impairment. * medications prescribed by physician outside of the va. * severe vision or hearing impairment.

Keywords: multiple chronic conditions