Kornimate/medical-research-clean huggingface dataset:
esketamine and perioperative depressive symptoms

Conditions: Depressive Symptoms; Esketamine; Perioperative Complication; Major Surgery

Summary: perioperative depressive symptoms (pds) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. however, none of treatments could resolve this clinical problem during limited perioperative period. the remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer s-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. the efficacy and safety of esketamine administrated intra-operatively for pds will be verified in this study. other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.


Eligibility criteria:
inclusion criteria: * patient undergoing elective major surgery * ages between 18 and 65 years old * moderate to severe depressive symptoms ( the patient health questionnaire-9 scores equal to or more than 10 and montgomery-åsberg depression rating scale scores equal to or more than 22 ) * signed informed consent exclusion criteria: * patients combined with aphasia or other conditions leads that patients inability to cooperate with the metal assessments; * tumor related injury of the 9th, 10th, 11th, 12th cranial nerve or patients need keeping intubation after surgery; * medical history of psychotic or bipolar disorder; * laboratory evidence of hormone levels disorder due to primary diseases; * body mass index more than 30 kg/㎡; * child-pugh grade b or c; * major depressive disorder with antidepressant therapy in the past 2 weeks before screening; * history of adverse events to ketamine or esketamine; * patients with repeated suicide attempts (qids-sr 12-item more than or equal to 3); * history of drug abused; * pregnant or breastfeeding woman.
effects of tcav and volume control ventilation on the distribution of aerated lung parenchyma in ards patients

Conditions: ARDS

Summary: acute respiratory distress syndrome (ards) is a severe form of acute respiratory failure with mortality rates reaching as high as 35%. management of ards is based on the treatment (if possible) of the underlying cause of ards and on invasive mechanical ventilation with positive expiratory pressure (peep). another strategy of invasive ventilation, time-controlled adaptative ventilation (tcav), is the application of specific settings to the airway pressure release ventilation (aprv) mode. tcav is based on a prolonged time at plateau pressure, creating a phase of continuous positive pressure, associated with brief release phases allowing the elimination of carbon dioxide. in prospective and retrospective clinical reviews, as well as in experimental animal studies, tcav has demonstrated improvements in oxygenation and lung function, with the ability to prevent ards. the thoracic computed tomography (ct) scan evaluates lung recruitment (re-aeration by positive pressure of non-ventilated lung territories) and the adverse effects of positive pressure on the parenchyma (hyperinflation). the objective of this study is to evaluate, with ct scans performed to assess lungs of patients with ards, the effects of tcav compared to a standard volumetric controlled ventilation, by measuring alveolar recruitment and over-distension.


Eligibility criteria:
inclusion criteria: * ards according to the berlin definition * invasive ventilation for no longer than 72 hours * patient requiring a diagnostic thoracic ct scan * consent of a family member or the person of trust * social security affiliation exclusion criteria: * use of iodinated contrast media injection before ct acquisitions * ards criteria present during 72 hours or more * severe copd * pneumothorax or other barotrauma-related complication * right ventricular failure other than acute cor pulmonale * absence of sedative agents and neuromuscular blockade * severe hemodynamic instability (norepinephrine \> 0.5 µg/kg/min) * va-ecmo assistance * pregnancy * absence of the capacity to give consent before admission to the icu

Keywords: mechanical ventilation
a trial for her2 positive breast cancer patients with metastatic disease

Conditions: Breast Neoplasms; Cancer of the Breast; Breast Cancer

Summary: this phase ii trial that includes gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and trastuzumab 8 mg/kg iv to be administered over 90 minutes on day 1 of the first cycle, then 6mg/kg as a 30 minute infusion administered on subsequent cycles.


Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed invasive breast cancer, with stage iv disease * tumors tested by ihc must be 3+ positive for her2 overexpression. tumors tested by fish must be positive by the specific fish assay for genetic amplification of her2. tumors that are 3+ by ihc but negative by fish assay are ineligible * patients must have measurable disease * patients may not have received prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer. * patients may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer, including taxane-based chemotherapy regimens. patients may not have received trastuzumab in the adjuvant setting unless disease free interval from completion of trastuzumab to time of relapse is greater than 12 months. exclusion criteria: * patients who have had prior gemcitabine chemotherapy and adjuvant trastuzumab and had less than 12- month disease free interval * patients with known leptomeningeal carcinomatosis
do corticosteroid injections during total knee replacement improve early clinical results?

Conditions: Osteoarthritis; Post-traumatic; Arthrosis

Summary: prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. one group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. a second group will get an injection in the knee during surgery that contains the same pain medications and antibiotic along with a corticosteroid to control inflammation. corticosteroids are anti-inflammatory medications, not to be confused with muscle-building anabolic steroids you may have heard about in the news. each patient will have an equal chance of being in either of the two groups. this study will test the safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation following total knee replacement.

information collected during your office visits: the patient will be asked for a brief medical history so that we may determine if the patient can participate in the study. a member of our research team will ask the patient a series of questions about his/her knee. the patient will be asked to answer this series of questions a total of 4 times over the course of 1 year. also, we will record how well the patient can bend and straighten your knee at these 4 office visits. we will have the patient rate the pain in his/her knee and ask the patient if he/she is satisfied with the surgery. if the patients have any complications, those will also be recorded. the patient will also have x-rays taken of the knee at the postoperative follow-up visits. this is the normal routine following total knee replacement. the x-rays will be read by the surgeon to help determine the success of the surgery. injection during total knee replacement surgery: all patients will receive an injection containing bupivicaine hcl, morphine, epinephrine, clonidine, cefuroxime, and normal saline that will be placed directly into the knee during surgery. in addition, approximately half of the patients in the study will also receive methylprednisolone acetate as part of the injection. information being collected during your hospital stay: during the hospital stay, information will be gathered for this study. a physical therapist will measure how well the patient can bend and straighten the knee. the amount of pain medication that was taken at the hospital will be recorded, and the number of days spent in the hospital will also be recorded.

Eligibility criteria:
inclusion criteria: * between ages of 18 and 95 * has elected to undergo total knee replacement exclusion criteria: * allergy to any of the medications used in the protocol * history of kidney disease * rheumatoid arthritis * any systemic conditions associated with chronic pain * history of deep knee sepsis in the affected extremity * unable to understand the questions used to obtain the knee society score * minors and prisoners will be excluded from the study

Keywords: arthroplasty replacement knee
preliminary efficacy and safety study of st101 in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study will investigate the ability of st101 to improve memory in people with alzheimer's disease. this study also will examine the safety and tolerability of the drug. this study is evaluating 3 different dose levels of st101 and placebo. patients will have a 1 in 4 chance of getting placebo.

alzheimer's disease (ad) is a progressive and fatal neurological illness. it produces changes in the brain that include loss of cells and accumulation of abnormal protein deposits. initial symptoms are cognitive, with deficiencies in short-term memory the most common symptom. as the disease progresses so does the severity of cognitive deficiency. loss of speech and immobility occur in the terminal stages there is no cure for ad and no marketed treatment that modifies the underlying disease process. available therapies improve some symptoms of ad by increasing brain concentrations of molecules involved in cognition. st101 differs from marketed therapies in that it has demonstrated two actions in animal research testing. it improves cognition and it also reduces the accumulation of abnormal protein deposits in the brain. these two properties suggest that st101 may be a promising agent for the treatment of ad. this study is designed as a preliminary dose exploration/proof-of-concept investigation of the ability of st101 to improve cognition during 12 weeks of administration.

Eligibility criteria:
inclusion criteria: * diagnostic evidence of mild to moderate alzheimer's disease. * ct or mri results within the past 12 months that rule out dementia due to non-alzheimer's etiology. * a reliable and capable caregiver. exclusion criteria: * subjects who reside in a skilled nursing facility. * subjects with b12 or folate deficiency. * subjects with chronic hepatic disease. * subjects with a recent history of hematologic/oncologic disorders. * subjects who have experienced a myocardial infarction with the past year. * dementia caused or complicated by other organic disease

Keywords: dementia alzheimer type senile dementia cognitive impairment
analgesic efficacy and safety of morphine versus methoxyflurane in patients with acute myocardial infarction

Conditions: ST Elevation Myocardial Infarction; Non ST Segment Elevation Acute Coronary Syndrome

Summary: the purpose of this study is to evaluate analgesic efficacy of inhaled methoxyflurane vs intravenous morphine in patients presenting with acute st-elevation (stemi) / non st-elevation acute coronary syndrome (nste-acs)

platelet activation plays a pivotal role in the pathophysiology of acute coronary syndromes (acs). pharmacological platelet inhibition with p2y12 receptor antagonists and aspirin, together with percutaneous coronary intervention (pci) are the cornerstone of treatment of acs patients. chest pain and anxiety are both associated with sympathetic activation, which increases workload of the heart. relieving of these symptoms in acute myocardial infarction (ami) is expected to improve the balance between the demand for oxygen and its supply. morphine, apart from its analgesic effects, also alleviates the work of breathing and reduces anxiety. however, despite its favourable analgesic and sedative actions, morphine also exerts adverse effects, which include vomiting and reduction of gastrointestinal motility. these side effects affect the intestinal absorption of oral drugs co-administered with morphine. previously performed randomized studies revealed unfavourable influence of morphine on the pharmacokinetics of ticagrelor resulting in weaker and retarded antiplatelet effect. methoxyflurane was shown to be effective and well tolerated for the management of acute traumatic pain with a rapid onset of analgesia. as it does not affect the μ-opioid receptors, which inhibit propulsive motility and secretion of the gastro-intestinal tract, methoxyflurane is not expected to decrease or delay absorption or effects of orally administered drugs, including p2y12 inhibitors, as well as to exert any other negative impact in patients with acs. before pci for the index acs, after obtaining informed consent patients will be enrolled and randomly assigned with a secure on-line system in 1:1 ratio to one of two study arms. patients in the intervention arm will receive methoxyphlurane administered by inhalation, whereas patients in the control arm will obtain morphine administered intravenously.

Eligibility criteria:
inclusion criteria: * diagnosis of st-elevation myocardial infarction (stemi) or non-st-elevation acute coronary syndrome (nste-acs) * patients aged from 18 to 80 years exclusion criteria: * pregnancy * manifest infection or inflammatory state * cardiogenic shock during screening for eligibility * respiratory failure * heart failure (nyha class iii or iv during screening for eligibility) * uncontrolled hypertension (systolic blood pressure \>180 mmhg or diastolic blood pressure \>100 mmhg)
health-related quality of life of patients with neurogenic bladder

Conditions: Neurogenic Bladder Dysfunction

Summary: bladder management has a major impact on the quality of life in patients with neurogenic bladder dysfunction. this a prospective investigation of the effects of the method for bladder evacuation on the health-related quality of life in patients with neurogenic bladder dysfunction. the changes in health-related quality of life over time (longitudinal investigation) and the differences between the different methods for bladder evacuation will be investigated. patients will be given a standardized and validated questionnaire annually for 10 years.


Eligibility criteria:
inclusion criteria: * individuals with neurogenic bladder dysfunction exclusion criteria: * insufficient dexterity to fill in the questionnaire * insufficient proficiency in the german or french language
targeted imaging of glutamate carboxypeptidase ii with dcfpyl-pet

Conditions: Schwannomas; Malignant Tumors

Summary: to use 18f-dcfpyl imaging agent and pet/ct to detect none prostate cancer solid malignancies and schwannoma tumors.

the purpose of this protocol is to extend our existing patient base from those with prostate cancer to those with any solid malignancy - as well as patients with schwannoma, a non-malignant solid tumor that also over-expresses gcp ii. using our first generation imaging agent, \[18f\]dcfbc, we have shown that we could detect gcp ii in tissue specimens of patients with a variety of cancers, and vestibular schwannoma. we have also shown that gcp ii may not only be present in the neovasculature of solid (non-prostate) tumors, but also reside within the tumor epithelium itself. we have shown that to be the case for melanoma, in particular. our goal is to leverage the broad utility of our gcp ii targeted imaging agents for managing other cancers. in addition to schwannoma, the cancers we intend to target include but will not be restricted to: head and neck cancer, salivary gland tumors, renal cell carcinoma, transitional cell carcinoma, colorectal cancer, gastric cancer, neuroendocrine cancer, glioblastoma, melanoma, pancreatic cancer, non-small cell lung cancer, soft tissue sarcoma, breast cancer, endometrial cancer, ovarian cancer, lymphoma and multiple myeloma.

Eligibility criteria:
inclusion criteria: 1. greater than or equal to 18 years of age 2. biopsy-proven cancer or schwannoma diagnosis 3. no contraindications to pet scanning to include pregnancy, etc. for females of childbearing potential, negative serum pregnancy test obtained within a 10-day period prior to pet study 4. patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. exclusion criteria: 1. administered a radioisotope within 5 physical half-lives prior to pet imaging 2. in female subjects pregnancy.
effects of a red/gold/ir led combination light on reduction of fat

Conditions: Body Image; Diabetes Mellitus, Type 2

Summary: an open-label evaluation of the effects of a red/gold/ir led combination light on reduction of fat. the results shall be compared to previous results from a comparator device utilizing only red led monotherapy for the non-invasive reduction in fat layer for body contouring.

the combination of gold/red/ir light is theorized to enhance the effect of the deeper penetrating red/ir light with the photomodulated effects of gold light. the light is positioned alongside the patient as they lay, or sit on a treatment table. a light panel is mounted to an articulating arm for positioning the light at the correct treatment position above the patient (non-contact). the effects of a red/gold/ir combination led light therapy device on circumferential reduction of fat will be measured, and the overall health of the patients will be monitored using blood tests.

Eligibility criteria:
inclusion criteria: * study participant is 18 years of age or older. * diagnosed with adult-onset (type 2) diabetes. * obesity exclusion criteria: * photosensitive condition or medication. * active chemotherapy treatment or other cancer treatment. * pregnant, possibly pregnant or planning pregnancy prior to the end of study participation. * developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements. * chronic stomach conditions (ibs, crohn's, ulcerative colitis, etc.)
multi-beam intensity-modulated radiation therapy for node-positive breast cancer

Conditions: Breast Cancer

Summary: this study is being performed to understand the safety of a new radiation treatment called "multi-beam intensity modulated radiation therapy" ( imrt). currently, the standard way of giving radiation is with "simplified" imrt, which uses only 2 beams of radiation. "multi-beam" imrt works by using 6-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the breast, chest wall, and the lymph nodes. at the same time, multi-beam imrt may allow the dose to the heart, lungs, and nearby tissue to be lowered, especially when the internal mammary lymph nodes need to be targeted by radiation.


Eligibility criteria:
inclusion criteria: * female gender * age ≥18 years * an invasive primary breast cancer of any histology arising from breast parenchyma * patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection * pathologic confirmation of metastatic disease in at least one regional lymph node. regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. thus, any t stage is allowed as long as the n stage is ≥1 and m stage is 0. * patient signed study-specific consent form. exclusion criteria: * patients with distant metastasis. * patients who are pregnant or breastfeeding. * patients with psychiatric or addictive disorders that would preclude obtaining informed consent. * time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months. * estimated life expectancy judged to be less than one year by patient's treating radiation oncologist. * prior radiation therapy to the ipsilateral or contralateral breast or thorax. * primary breast cancer is a lymphoma or sarcoma histology. * patients with a history of non-skin malignancy \<5 years prior to the diagnosis of breast cancer. * patients requiring radiation to the bilateral breasts.

Keywords: breast radiation multi-beam intensity-modulated radiation post mastectomy post partial mastectomy node-positive breast cancer 10-025
the impact of carvedilol posology on clinically significant portal hypertension

Conditions: Clinically Significant Portal Hypertension

Summary: carvedilol has emerged as the preferred non-selective β-blocker (nsbb) for treating portal hypertension. however, there is still a debate in dosing regimen, specially regarding dose interval, with a potential lower bioavalability in once daily regimens. the aim of this study is to assess the acute effects of carvedilol posology in patients with clinically significant portal hypertension (csph), as a surrogate marker of bioavailability. in this experimental study, patients with csph receiving carvedilol twice daily were asked to supress the night dose of carvedilol, in order to have a dose interval of approximately 24 hours. spleen stiffness measurement (ssm) by transient elastography (te) was performed and compared with ssm prior or under treatment. same procedure was applied to liver stiffness measurement (lsm).


Eligibility criteria:
inclusion criteria: * patients with csph (defined as a lsm 25 kpa or ssm over 45kpa prior to introduction of carvedilol) exclusion criteria: * non-responders to non-selective β-blockers (nsbb) * nsbb other than carvedilol * dosing regimen other than twice daily * no ssm or lsm within 3 months prior to the beginning of the study * body mass index (bmi) \> 30 m/kg2 * contraindications to nsbb use * portal venous thrombosis * refusal to participate in the study * failure to comply to the study regimen

Keywords: portal hypertension carvedilol elastography
self-help for stress related to covid-19

Conditions: Stress

Summary: this is a study on internet-based self-help for stress related to the covid-19 pandemic. college and university students who score in the moderate or higher range on a stress measure during the covid-19 pandemic will be invited to participate in this study. participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the covid-19 pandemic or care as usual. stress and psychosocial symptoms will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.


Eligibility criteria:
inclusion criteria: * moderate or higher stress as assessed using stress subscale of the depression anxiety stress scales-short form * current student at a college or university in the united states * able to provide consent * proficient in english exclusion criteria: * below age 18 * failure to meet any of above inclusion criteria * current participant in separate randomized controlled trial being conducted by this research group examining efficacy of silvercloud health interventions

Keywords: self-help internet cognitive-behavioral therapy positive psychology covid-19
a study of the safety and efficacy of gatifloxacin in patients with bacterial conjunctivitis

Conditions: Bacterial Conjunctivitis

Summary: the study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis


Eligibility criteria:
inclusion criteria: * clinically diagnosed with bacterial conjunctivitis exclusion criteria: * signs and/or symptoms of conjunctivitis for more than 96 hours * signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis * clinical diagnosis of chlamydia in either eye