Kornimate/medical-research-clean huggingface dataset:
ketamine infusion for treatment-resistant major depressive disorder

Conditions: Major Depressive Disorder

Summary: ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. the overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous n-methyl-d-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (trd). this is an open-label study (pilot).

patients will undergo two weeks of prospective observation, they will then receive ketamine iv 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. the schedule of administration will be twice a week for 3 weeks. after this phase, the patient will be followed with assessments every two weeks for three months. total duration of the study is 5 months.

Eligibility criteria:
inclusion criteria: * outpatients with severe treatment-resistant mdd * currently depressed * currently under regular psychiatric care * on an aggressive antidepressant regimen, stable for 4 weeks exclusion criteria: * no history of other major psychiatric illnesses, including bipolar disorder * no history of psychosis * no history of drug abuse * no major medical illness or unstable medical conditions

Keywords: treatment resistant suicidal ideation major depressive disorder
pet/ct (positron emission tomography/computed tomography) imaging for safety and tolerability and diagnostic performance of bay1075553 in patients with prostate cancer and healthy volunteers

Conditions: Diagnostic Imaging

Summary: pet/ct imaging study for evaluation of safety and tolerability and diagnostic performance of bay1075553 in patients with prostate cancer and in healthy volunteers


Eligibility criteria:
inclusion criteria: * part 1: healthy volunteers only -- males ≥ 40 years of age * part 2: prostate cancer patients * males ≥ 18 years of age * serum psa (prostate-specific antigen) value above normal. * patients had an mri and/or a positive \[11c\] - or \[18f\] -choline pet/ct for primary diagnosis (note: mri and \[11c\]-or \[18f\]-choline pet/ct are optional for primary prostate cancer patients) or recurrence detection of prostate cancer and the primary cancer disease (adenocarcinoma) is histologically confirmed * patients with primary prostate cancer have to be scheduled for prostatectomy * in patients with primary prostate cancer, histopathological evaluation has to show an adenocarcinoma with a gleason score of 3 + 3 or higher in at least two biopsies at any location in the prostate * patients with advanced primary or recurrent prostate cancer and a high likelihood to display lymph node metastasis, ideally scheduled for explorative pelvic lymphadenectomy, are to be preferably included * part 3: prostate cancer patients -- the criteria for eligibility of part 3 are identical to the ones of part 2. except it is now no longer a preference but mandatory to only enrol patients with a presumably high likelihood of metastatic disease, especially lymph node metastasis. exclusion criteria: * concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of bay1075553, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study * acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period * active inflammatory bowel disease within the last 6 months * acute prostatitis requiring medical treatment within the last 6 months * a non-urologic bacterial infection requiring active treatment with antibiotics within 3 months * active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years * patients with primary prostate cancer only: androgen ablation within 3 months before planned treatment * subject fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety

Keywords: prostate cancer neoplasm diagnostic imaging pet (positron emission tomography) -tracer pet-diagnosis
accuracy of pleth variability index (pvi) in children

Conditions: Scoliosis

Summary: plethysmographic variability index is a simple index accurate in predicting fluid responsiveness. the aim of this study was to investigate its accuracy in predicting fluid response to intravenous fluid challenge during scoliosis surgery in children.

the goal of the present study is to assess the validity of pvi in predicting the response to a fluid challenge during scoliosis surgery in children. during this observational non-interventional study, each fluid challenge will be monitored by esophageal doppler and pvi (massimo radical 5). anesthesia, surgery and intraoperative fluid administration id standardized according to our clinical protocol. an increase in indexed stroke volume (isv) by more than 15 % will define the positive response to the fluid challenge. fluid challenges will be performed in the supine position and in the prone position. statistical analysis will performed using the receiving operator characteristics (roc) curve with determination of the gray-zone allowing an error tolerance of 10 %.

Eligibility criteria:
inclusion criteria: * scoliosis surgery * age \< 18 years exclusion criteria: * heart or vascular diseases * rectal abnormalities * kidney failure * neuromuscular scoliosis

Keywords: plethysmographic variability index esophageal doppler scoliosis children age < 18 years scheduled for scoliosis surgery
effects of digital therapeutic in whole process management of lung cancer

Conditions: Application of Digital Therapeutic in Lung Cancer Whole Process Management

Summary: this trial will randomize patients into two groups, the treatment group will use the digital therapeutic application named 'uhealth' for the whole process management and the control group will use regular follow-up. the trial aims to look into the difference between quality of life, anxiety/depression index, emergency treatment times, hospital admission rate, treatment compliance, os, dfs and follow-up cost.


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed lung cancer; * patients have received surgery, neoadjuvant therapy, adjuvant therapy, radiotherapy or other chemotherapy, such as cytotoxic chemotherapy, targeted therapy and immunotherapy; * ecog (performance status) 0-1; * patients aged \> 18 years and \< 70 years; * the patients themselves or their family members are familiar with mobile and internet; exclusion criteria: * patients have disease progression in the screening period; * patients with symptomatic brain metastasis; * patients with dementia, schizophrenia or other psychological diseases that may affect the cognitive behavior; * other medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information; * women who are pregnant or in the period of breastfeeding.

Keywords: digital therapeutic whole process management lung cancer patient follow-up
cerebral microembolism during hemodialysis

Conditions: Complication of Dialysis; Thrombus Due to Renal Dialysis Device, Implant, or Graft; Cerebral Embolism

Summary: there is increasing evidence that renal replacement therapy (= continuous veno-venous hemodialysis) generates cerebral microembolism which is detectable on transcranial doppler ultrasound. the aim of this study is to monitor patients with transcranial doppler under two conditions: during hemodialysis and in a hemodialysis-free interval (in each period cerebral embolic load is detected during 30 minutes). the study hypothesis is that during hemodialysis the cerebral embolic load is significantly higher than in the hemodialysis-free interval.


Eligibility criteria:
inclusion criteria: * renal replacement therapy (continuous veno-venous hemodilalysis) on the in-house intensive care unit * age \> 18yrs and \< 90yrs exclusion criteria: * absent informed consent * preexistent neurological morbidity * neurocognitive disturbances * carotid artery stenosis \> 70% * patent foramen ovale * treatment with other extracorporeal devices * cardial pathology (valvular heart disease, prosthesis, endocarditis) * pregnancy, drug abuse * inclusion in an other clinical study * allergy against materials of the medical device used in the study (transcranial doppler) or temporal skin/bone lesions
a study for tyrosine kinase inhibitors discontinuation

Conditions: Leukemia

Summary: treatment of chronic myeloid leukemia (cml) has been revolutionized by the use of tyrosine kinase inhibitors including imatinib mesylate (gleevec, novartis laboratories). two other inhibitors of the bcr-abl kinase are currently on the market in france, nilotinib (tasigna®, novartis laboratories) in the first and second-line treatment and dasatinib (sprycel®, bristol-myers squibb laboratories) in second line. achieving a complete molecular response (cmr) in patients with chronic myeloid leukemia (cml) treated with tyrosine kinase inhibitors may be currently regarded as the ultimate level of reduction of residual disease. the pilot stop imatinib study has opened the way for a french prospective study of stopping imatinib, the stim study. the results of the stim study showed that almost 60% of patients exhibited molecular relapse, most frequently within the first 6 months after discontinuation. the parameters that are statistically associated with the loss of complete molecular response are the sokal score at diagnosis and the total duration of treatment with imatinib. criteria to define molecular relapse in treatment free remission patients are not well defined and validated. the aim of the study is to validate the loss of major molecular response as a robust criteria for tki resumption. the patient's population will be cml patients who are offered to discontinue therapy outside the stim strial.


Eligibility criteria:
inclusion criteria: * patient with chronic myelogenous leukemia * mors than 18 years old * intentionally stop treatment by tyrosine kinase inhibitor exclusion criteria: * inclusion in a prospective study * non intentionally stop (adverse event) * stop for disease progression * death patients

Keywords: myelogenous chronic bcr-abl positive
combination therapy with atelocollagen in epidural nerve block

Conditions: Degenerative Lumbar Spine Disease

Summary: "in this study, the investigators plan to evaluate muscle mass and pain relief 4 weeks after performing epidural nerve block and type i porcine atelocollagen injection into multifidus muscle in patients with chronic low back pain due to degenerative spinal disease for more than 6 months.


Eligibility criteria:
inclusion criteria: 1. patients scheduled for epidural nerve block for lower back pain 2. patients over 21 years of age 3. back pain lasting more than 6 months 4. patients with ineffective or insignificant effects of conventional drugs and nerve block for back pain 5. patients with spinal stenosis or disc herniation at the lumbar 4-5 or lumbar 5-sacral 1 level on mri, and the cross-sectional area of the multifidus muscle at the lesion site is less than 5 cm2 when measured by ultrasound. exclusion criteria: 1. when the degree of low back pain is 3 points or less on the 11-scale numeric rating scale (hereafter nrs) 2. if lower back pain has rapidly worsened within the last week 3. if you have other diseases that may cause low back pain: osteoarthritis of the hip joint, cancer, inflammatory arthritis, spondylitis, fibromyalgia, complex regional pain syndrome, herpes zoster, postherpetic neuralgia, etc. 4. when a diagnostic epidural nerve block is planned 5. in the case of receiving conservative treatment, procedure, or surgery other than oral drugs such as epidural nerve block or proliferation treatment for the treatment of lower back pain within 4 weeks of screening 6. when the low back pain assessed by nrs decreased by more than 50% after epidural nerve block in screening 7. if back surgery is planned within 3 months of the procedure 8. when nrs and odi measurements cannot be made 9. when collagen injection is contraindicated (eg when allergic to swine) 10. pregnant women 11. if you cannot read or agree to the consent form 12. if you are unable to sign the consent form yourself
early effect of glucocorticoid on incidence of persistent left bundle branch block (lbbb) post-tavr (eagle-tavr trial)

Conditions: Transcatheter Aortic Valve Replacemen; Left Bundle Branch Block

Summary: transcatheter aortic valve replacement (tavr) has become an established alternative for the treatment of severe symptomatic aortic stenosis irrespective of surgical risk. the development of new-onset left bundle branch block (lbbb) is the most common complication, which impairs outcomes after tavr. glucocorticoid has been proven safe and effective in arrythmia after cardiac surgery. the anti-inflammatory effect of glucocorticoid may alleviate the occurrence of lbbb and thus the prognosis. eagle-tavr is a multi-center, randomized, double blind, placebo-controlled trial. a total of 200 patients selected to undergo tavr will be randomized in a 1:1 ratio to the treatment with intravenous methylprednisolone 1mg/kg/day or placebo for 3 days started from the day of the procedure. according to the definition of the valve academic research consortium 3, persistent lbbb is defined as present lbbb at discharge or \>7 days post-tavr. the primary endpoint is the occurrence of new-onset lbbb at 30 days post tavr.


Eligibility criteria:
inclusion criteria: 1. age ≥ 65 years 2. selected to undergo transfemoral tavr based on heart team decision exclusion criteria: 1. allergic to methylprednisolone 2. patients with a prior pacemaker or high degree atrioventricular block 3. septicemia 4. life expectancy \< 1 year irrespective of heart disease (cancer, severe liver disease, severe renal disease, severe pulmonary, et al) 5. inability to provide written informed consent 6. participation in another clinical trial with an active intervention 7. patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed) 8. gastrointestinal bleeding 9. acute myocardial infarction within 1 month 10. intracardiac thrombus or vegetation

Keywords: tavr lbbb glucocorticoid
safety and efficacy study of brimonidine/timolol fixed combination in patients with glaucoma or ocular hypertension

Conditions: Ocular Hypertension

Summary: the purpose of this study is to assess the safety and efficacy of brimonidine/timolol fixed combination in patients with glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * clinical diagnosis of glaucoma or ocular hypertension in both eyes * patient requires iop-lowering in both eyes exclusion criteria: * uncontrolled medical conditions * contraindication to beta-andrenoceptor antagonist or brimonidine therapy
is it safe to do laparoscopic cholecystectomy for acute cholecystitis up to seven days?

Conditions: Acute Cholecystitis

Summary: objectives: to compare the safety of early (≤72h) versus late (\>72h-7days) laparoscopic cholecystectomy (lc) from symptom onset for acute cholecystitis (ac). background: as lc within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. so, we raised the question of safety and feasibility of performing lc to patients with ac who failed to have lc within 72h of acute attack. patients and methods: this was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with ac between september 2017 and april 2019. patients were randomly allocated into two equal groups assigned to lc; group e: within 72h of symptom onset, and group l: after 72h up to seven days from symptom onset.


Eligibility criteria:
inclusion criteria: * patients with ac within seven days from symptom onset * american society of anesthesiologist (asa) physical status ≤ ii * age from 21 to 60 years exclusion criteria: * patients with asa physical status \> ii * age \ 60 years * child classification b or c * choledocholithiasis * acute pancreatitis * severe sepsis * gallbladder perforation * pregnant women

Keywords: acute cholecystitis early laparoscopic cholecystectomy gallbladder disease late laparoscopic cholecystectomy
the clinical study of pitavastatin treatment for group of mild to moderate alzheimer's disease

Conditions: Alzheimer Disease; Hypercholesterolemia

Summary: some studies suggest that statin medications may be effective against alzheimer's disease. however, this has not been proven. the purpose of this study is to evaluate the efficacy of pitavastatin in patients with mild to moderate alzheimer's disease and hypercholesterolemia.

the pit-road study will include 50 patients who have taken donepezil more than 3 months stably. this study will see how the use of a particular statin medication, pitavastatin, affects adas-jcog score etc. and cholesterol. participants will be given a full information of the study and written informed consent should be obtained before entering the study. participants will take part in 5 visits over the course of 12 months. if participants have taken cholesterol lowering drug, they will have wash-out period at least 4weeks. participants will undergo 8 tests (adas-jcog etc., baseline and month 12 visits), complete a medical history questionnaire (baseline), complete medication side effect review through questionnaire and/or blood sample (all visits). participants will be randomly assigned to receive either pitavastatin or other cholesterol lowering medication for 12 months.

Eligibility criteria:
inclusion criteria: * alzheimer's disease patients (15 ≤ mmse total score ≤ 23, cdr "1" or "2") * patients with hypercholesterolemia * patients who have taken donepezil more than 3 months stably * both patients and care-givers must be more than 20 years old exclusion criteria: * women with pregnancy or breast-feeding * malignant tumor * cerebrovascular disorder or myocardial infarction prior to 12 weeks * heart failure \[new york heart association (nyha) class iii or iv\] * hepatic or renal dysfunction * severe hypertension * hypothyroidism, hereditary muscular disease, history of drug-induced myopathy * current involvement in another investigational drug study * alcoholism, drug abuse

Keywords: pitavastatin statins donepezil alzheimer's disease hypercholesterolemia adas-jcog alzheimer disease (mmse 15-23 and cdr1 or 2)
study of dietary n-3 fatty acids in patients with retinitis pigmentosa and usher syndrome

Conditions: Usher Syndrome; Retinitis Pigmentosa

Summary: objectives: i. examine the concentration of docosahexanoic acid (dha) and other n-3 fatty acids in plasma, erythrocyte, and adipose tissue in patients with various forms of retinitis pigmentosa and usher syndrome. ii. determine the synthesis and catabolism of dha from linolenic acid in these patients. iii. determine the synthesis, absorption, and catabolism of dha under different dietary conditions in these patients.

protocol outline: patients may participate in one or more of the arms of this study. arm i (adipose tissue study): adipose tissue is collected from the buttocks of patients with usher ii retinitis pigmentosa (rp), patients with non-usher rp, and control subjects. dietary histories are obtained from all patients and subjects. arm ii (isotope study): patients meeting the same criteria as in arm i receive oral d5-labeled linolenic acid and oral d4-labeled linolenic acid that is dissolved in oil and incorporated into foods. subjects must avoid eating fish and shellfish during the 35 days of the isotope study. blood samples are collected at 0, 8, 24, and 48 hours, daily on days 3-7, and then on days 10, 18, and 35. arm iii (flaxseed oil feeding): patients with all types of rp and control subjects receive flaxseed oil, a form of linolenic acid, for 12 weeks. subjects may also receive high oleic safflower oil or olive oil as a control fat for 12 weeks. subjects complete a diet history at the end of each fatty acid supplementation period. all subjects must follow a diet free of seafood and fish oil supplements.

Eligibility criteria:
protocol entry criteria: * retinitis pigmentosa, including: usher syndrome (types i and ii) simplex * the following inheritance patterns eligible: x-linked recessive; autosomal dominant; autosomal recessive

Keywords: usher syndrome ophthalmologic disorders rare disease retinitis pigmentosa
diagnostic accuracy of synovial biopsy for implant-related shoulder infections

Conditions: Total Shoulder Arthroplasty

Summary: the purpose of this study is to determine the efficacy of retrieving tissue samples via an x-ray guided needle that is inserted into the infected tissue in the shoulder. the procedure using the guided needle is called a synovial biopsy versus an open tissue biopsy, which is done at the time of surgery. by doing the synovial biopsy prior to a revision surgery, the investigators hope to avoid more invasive intervention if it is not needed. some patients may appear to have an infection but once the biopsy is taken and the results are read, there may not be an infection and therefore no need for a revision surgery.

the primary research objective is to assess the diagnostic accuracy of percutaneous synovial biopsy for detection of implant-related intra-articular shoulder infections (iisi). the secondary objectives are to document the frequency of pain associated with shoulder synovial biopsy and to determine the correlation and agreement of several indices of infection as a means of providing preliminary evidence toward a clinical decision rule to rule in or rule out the diagnosis of implant-related intra-articular shoulder infection. the third objective is to determine the rates of (re)infection, functional outcomes, and quality of life, over a two year follow up period following revision surgery. the fourth objective is to determine whether an association exists between the biopsy location within the joint and relative yield and positive culture rates. the fifth objective is to identify, develop, and validate tissue-specific biomarkers for the detection of iisi. it is our hypothesis that synovial biopsy is valid tool for use in the diagnosis of shoulder arthroplasty and fracture implant related infections.

Eligibility criteria:
inclusion criteria: 1. previous shoulder surgery including hemiarthroplasty, total shoulder arthroplasty or reverse total shoulder arthroplasty, or internal fixation for shoulder fractures 2. suspicion of infection, including acute fever and complaints of pain and/or stiffness post operatively 3. revision shoulder surgery for patients described in (1) 4. provide consent exclusion criteria: 1. signs or symptoms of bacteremia or sepsis requiring urgent treatment, which would preclude the possibility of synovial biopsy 2. unable to speak or read english/french 3. psychiatric illness that precludes informed consent

Keywords: shoulder infection