Kornimate/medical-research-clean huggingface dataset:
lexapro®'s efficacy after dose escalation in remission study

Conditions: Major Depressive Disorder

Summary: the purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder.

in this study, the investigators are going to examine the efficacy of escitalopram after dose escalation and evaluate remission rate. this study design is the double-blinded 6-week prospective study. it would be useful for clinicians because there were few study of high-dose antidepressant treatment in lack of remission in major depressive disorder patients. to control of bias, the investigators included patients with lack of remission after 4-week escitalopram treatment.

Eligibility criteria:
inclusion criteria: * age: 18 \~ 65 * patient with major depressive disorder according to dsm-iv criteria * patient have signed on the informed consent, and well understood the objective and procedure of this study. * madrs total score ≥ 18 * competent patient who is manage to answer the questionnaires. * in case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study. exclusion criteria: * in previous depressive episodes, no efficacy although more than one antidepressant treatment * allergy or hypersensitivity to escitalopram * diagnosed to schizophrenia or bipolar disorder or schizoaffective disorder (dsm-iv) * madrs 10 score ≥ 5, or patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion * pregnant or breast-feeding female patient * significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion * significant severe medical condition * patients who take antipsychotics or mood stabilizer or other psychiatric drugs excluding benzodiazepines or beta blockers or hypnotics * history of participating to other investigational drug trial within 1month prior to screening * investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator

Keywords: major depressive disorder, remission, escitalopram
virtual reality in chronic neck pain

Conditions: Neck Pain

Summary: the purpose of this study is to compare the effects of virtual reality, which encourages active neck movements, in individuals with chronic neck pain, with the control group receiving only neck exercises. participants will be randomly divided into two groups; half of them will be given only a neck exercises program, and the other half will be given neck exercises and virtual reality.

individuals with chronic neck pain tend to have low levels of endurance in deep neck flexor muscles. conservative treatments for neck pain, including posture education, strengthening, range of motion, motor control, flexibility, and proprioceptive training, are recommended in clinical guidelines. virtual reality has been shown to be beneficial in the treatment of various issues related to pain in previous systematic reviews. distracting attention is one of the mechanisms explaining the impact of virtual reality on pain. it is believed that virtual reality reduces pain perception by influencing pain pathways.

Eligibility criteria:
inclusion criteria: * ages 18 to 45 * having a history of non-traumatic neck pain persisting for more than three months * having a neck disability index score greater than 5 points * not having participated in a physiotherapy program for at least 3 months * being able to read and write in turkish to understand, interpret, and respond to the questionnaires exclusion criteria: * having a surgical history in the neck region * having cervical spine flexion, extension, and rotation range of motion \<10 degrees * having a history of rheumatologic, vestibular, neurological, or cardiopulmonary diseases * vertigo associated with neck pain * osteoporosis, vertebral fractures,spinal tumors * presence of radiculopathy or myelopathy * traumatic spinal cord injury * neck pain associated with progressive neurological deficits or loss of strength

Keywords: virtual reality exercise neck pain
subpectoral plexus block with multi-level tpvb for surgical anesthesia during primary breast cancer surgery

Conditions: Breast Cancer

Summary: the objective of this study is to compare two different doses of local anesthetics (10ml vs 20ml of 0.25% levobupivacaine) for subpectoral plexus block (sppb) in addition to ultrasound guided multi-level of thoracic paravertebral block (m-tpvb) for surgical anaesthesia for major primary breast cancer surgery.

primary breast cancer surgery is one of the most commonly performed surgeries worldwide. it is associated with significant acute postoperative pain and a high incidence of chronic postsurgical pain. regional anaesthetic techniques are shown to improve outcomes such as postoperative analgesia, nausea, vomiting, delirium and promote early recovery. currently majority of the breast cancer surgery is performed under general anaesthesia with a multimodal analgesic regimen with or without regional blocks. in fact, it is proved that breast cancer surgery can be done solely under regional anesthesia using multilevel thoracic paravertebral block (tpvb) with deep sedation, but rescue analgesia are often required intraoperatively, especially when surgeons handles the pectoralis muscle. current evidence suggest that pectoral nerves, which are often described as a pure motor nerves that control movements only, also able to send noxious stimulation such as pain from the pectoral muscles and its deep fascia (via afferent nociceptive fibers) to the brain. principal investigator proposes that adding a subpectoral plexus block (sppb) will stop a wider spectrum of afferent nociceptive fibers from sending any pain signals than having thoracic paravertebral block alone. however, there is no report on the amount of local anaesthetic (la) required to achieve surgical anaesthesia for breast surgery. the aim of this study is to evaluate the effectiveness of two different doses (10ml vs 20ml of 0.25% levobupivacaine) of local anaesthetic (la) for subpectoral plexus in addition to 3 levels of tpvb injections at t2, t4, and t6 under ultrasound guidance for surgical anaesthesia for major breast cancer surgery.

Eligibility criteria:
inclusion criteria: * scheduled for mastectomy, modified radical mastectomy or breast conservative surgery with lymph node biopsy and with or without axillary dissection exclusion criteria: * local skin site infection * coagulopathy * history of allergy to local anesthetics

Keywords: subpectoral plexus block thoracic paravertebral block primary breast cancer surgery
consistency of 3 consecutive lots of a novel hbv vaccine with single-blind safety evaluation using engerix™-b as control

Conditions: Hepatitis B

Summary: the purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted hbv vaccine. the safety of the candidate vaccine will be assessed using engerix™-b as control.

double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity. at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * a male or female between, and including, 15 and 50 years of age at the time of the first vaccination. * written informed consent obtained from the subject/ from the parents or guardians of the subject where applicable * free of obvious health problems as established by medical history and clinical examination before entering into the study. * if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s). * previous vaccination against hepatitis b * history of non-response to previous hepatitis b vaccination * known exposure to hepatitis b within the previous 6 weeks * history of hepatitis b infection * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * suspected or confirmed multiple sclerosis in the subject (applicable to centre 5/france only) * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * hepatomegaly, right upper quadrant abdominal pain or tenderness. * administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * pregnant or lactating female

Keywords: adjuvanted hepatitis b vaccine hepatitis b recombinant hepatitis b vaccine
efficacy of transfusions with platelets stored in platelet additive solution ii versus plasma

Conditions: Hemato-Oncologic Patients; Myelosuppression; Thrombocytopenia

Summary: the purpose of this study is to evaluate the clinical efficacy of transfusions with platelets stored in platelet additive solution ii compared to plasma storage.

introduction: utilization of platelet additive solutions (pass) for storage of platelets has several advantages, however randomised studies testing the clinical efficacy are scarce. a prospective, randomised study comparing the efficacy of transfusions with platelets stored in platelet additive solution ii (pas ii) versus plasma showed that ccis after transfusion with platelets stored in pas ii were significantly lower (1). major drawbacks of this study were the exclusion of patients with clinical factors known to increase platelet consumption and a limited number of patients. a multicenter, randomised study to investigate clinical efficacy of platelets stored in pas ii versus plasma, also including patients with factors of increased platelet consumption, was performed. methods: after consent patients \> 18 years, without hla- and/or hpa-alloantibodies, were randomised to receive pooled platelet concentrates (pc) suspended in either plasma or pas ii, leucoreduced, and stored up to 5 days. 1- and 24-hour cci were the primary endpoints. secondary endpoints were transfusion interval, adverse reactions and bleeding complications. an inclusion-period was defined as a maximum of 8 transfusions or 30 days after the first transfusion.

Eligibility criteria:
inclusion criteria:patients \> 18 years expected to receive platelet transfusions and informed consent - exclusion criteria:hla- and/or hpa- alloimmunization -

Keywords: thrombopenia platelet transfusion increment transfusion reactions bleeding complication
why are patients with absence seizures absent? a brain imaging study

Conditions: Childhood Absence Epilepsy

Summary: our study examines which different brain regions are involved in child absence seizures and how they are related to attention and cognition.

the fundamental mechanisms of altered brain function and impaired attention in childhood absence epilepsy (cae) are not known. absence seizures consist of brief 5-10 seconds episodes of unresponsiveness, associated with a 3-4 hz "spike-wave" discharge on electroencephalogram (eeg). cae affects 10-15% of children with epilepsy. in addition to the deficit during seizures, many children also suffer from milder attention impairment between absence episodes, which may not be due entirely to medications. impaired attention during and between absence seizures has a major negative impact on patient quality of life due to deficits in school performance, potential for injuries, and social stigma. recent studies suggest that impaired cognition in so-called "generalized" absence seizures may, in fact, depend on dysfunction in specific brain networks. our central hypothesis is: abnormal function in focal brain regions, such as the anterior cingulate/medial prefrontal cortex and medial thalamus, causes impaired attention both during and between seizures in cae. if confirmed, this may lead to innovative regional therapies targeted at improving impaired attention in cae. specifically, we hope to determine which specific cortical and sub-cortical networks are selectively involved when patients show impaired attention. using simultaneous eeg and functional magnetic resonance imaging (fmri), we will determine which brain regions are involved in absence seizures while using a continuous performance task (cpt) to test attention vigilance in the same patients. a few neuropsychology tests will then follow. patients will be reimbursed $100 as well as all travel and parking expenses. for more information, please visit www.yalecae.com

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of childhood absence epilepsy or juvenile absence epilepsy * no other serious health problems or neurological problems * 6 years or older exclusion criteria: * no history of myoclonic or tonic-clonic seizures

Keywords: absence epilepsy seizure brain
assessment of fibbroscan in diagnosing masld among the chinese population with obesity

Conditions: Fatty Liver Disease

Summary: the non-invasive evaluation of liver steatosis and fibrosis with fibroscan is a routinely procedure in clinical practice for people with obesity. however, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity. the goal of this observational study is to learn about the optimal application of cut-off values of for chinese people with obesity.


Eligibility criteria:
inclusion criteria: 1. patients aged 18 years or older who provided written informed consent 2. patients who schedule to undergo bariatric surgery and a liver biopsy (lb) for the investigation of suspected masld 3. patients who schedule to undergo fibroscan examination exclusion criteria: 1. patients with ascites or pregnant women 2. patients with any active implantable medical device (such as a pacemaker or defibrillator) 3. patients who have undergone liver transplantation 4. patients with cardiac failure and/or significant valvular disease 5. patients with haemochromatosis 6. patients who have refused to undergo lb or blood tests 7. patients with a confirmed diagnosis of active malignancy, or other terminal disease 8. patients participating in another clinical trial within the preceding 30 days
the archimedes biodegradable biliary and pancreatic stents

Conditions: Pancreatic Diseases

Summary: this is a prospective, phase ii, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ercp. on procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria. the patient will undergo the abs insertion and monitored and follow-up accordingly to biodegration variant.


Eligibility criteria:
inclusion criteria: * patients with an indication to position one ore more biliary plastic stents during ercp * patients with an indication to position a pancreatic plastic stent during ercp exclusion criteria: * age \< 18 y * life expectancy \< 1 m, * inability to pass a guidewire through stricture * contra-indication for endoscopy or interventional radiology * presence of partial gastric resection * unsigned informing consent form, icf * pregnancy * pseudo klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma
solute removal with high volume hemodiafiltration versus long high flux hemodialysis

Conditions: End-stage Renal Disease

Summary: this is a prospective cross-over study including 10 stable hemodialysis patients with chronic kidney disease stage 5. the cross-over study lasts 2 weeks with the study dialysis sessions at midweek. during one session, the patient will be dialyzed during 4 hours with high volume post dilution hemodiafiltration (hdf) with an fx800 hemodialyzer (fresenius medical care) and a blood flow of 300ml/min, dialysate flow of 500ml/min, and substitution flow of 75ml/min. during the other midweek session, the patient will be dialyzed during 8 hours with high flux hemodialysis (hd) with an fx80 hemodialyzer (fresenius medical care) and a blood flow of 200ml/min and a dialysate flow of 500ml/min. the hdf and hd sessions will be randomized. blood samples will be drawn pre and post dialysis from the arterial blood line, and after 30min after dialysis start, a blood sample will be drawn from the inlet and outlet line. at the dialysate outlet line, partial dialysate collection is performed at the outlet line. blood and dialysate samples will be analyzed for a broad range of retention solutes like small and water soluble solutes, middle molecules, and protein bound solutes. these data will be further used to calculate solute removal and evaluate any differences between the solute removal during high volume post dilution hdf and high flux hd.


Eligibility criteria:
inclusion criteria: * chronic kidney disease (ckd) stage 5 with hemodialysis or hemodiafiltration treatment for more than three months. * no vascular access related problems (arteriovenous (a/v) fistula, graft or bi-flow catheter) * double needle/lumen vascular access * no ongoing infection * singed informed consent form exclusion criteria: * inclusion criteria not met * known hiv or active hepatitis b or c infection (positive polymerisation chain reaction (pcr)) * pregnancy * unstable clinical condition (e.g. cardiac or vascular instability) * known coagulation problems * patients participating in another study interfering with the planned study.
feasibility study of finesse for bolus prandial insulin dosing compared to multiple daily injections

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate that finesse, for prandial insulin bolusing when used in conjunction with basal insulin, achieves equivalent glycemic control when compared to multiple daily injections and to evaluate its preference.

the aim of this feasibility study is to compare efficacy, device satisfaction and quality of life (qol) in people with type 1 or 2 diabetes delivering mealtime insulin using a novel insulin bolus-patch (finesse™; calibra medical, inc., redwood city, ca) versus current devices that deliver bolus insulin (pen/syringe). all subjects injected their basal insulin using their current pen/syringe.

Eligibility criteria:
inclusion criteria: * diabetes mellitus on intensive insulin therapy exclusion criteria: * insulin pump therapy * current use of nph or regular insulin * severe hypoglycemic episodes in prior 6 months * unstable cardiac disease, hepatic, or renal function

Keywords: autoimmune diseases diabetes mellitus endocrine system diseases glucose metabolism disorders immune system diseases insulin metabolic diseases
study evaluating potential interaction between sam-531 and gemfibrozil when co-administered

Conditions: Healthy

Summary: the purpose of this study is to evaluate the effects of multiple doses of gemfibrozil on the plasma concentration of a single dose of sam-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of sam-531 and gemfibrozil.


Eligibility criteria:
inclusion criteria: * body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg. * healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ecg readings. exclusion criteria: * presence or history of any disorder that may prevent the successful completion of the study. * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (gi), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Keywords: alzheimer disease
preventive strategies in acute respiratory distress syndrome (ards)

Conditions: ARDS

Summary: the investigators hypothesis is that patients at risk of ards, detected by lips (lung injury prediction score), under mechanical ventilation could benefit from a protective ventilatory strategy (used in ards treatment) in order to avoid or decrease the ards development. this would lead to a decrease in incidence, mortality and health care costs associated to this syndrome. this study will help to confirm the current evidence about low tidal volumes, evaluating adverse events of this strategy.

the main objective is to evaluate the effect of a protective ventilatory strategy by using lower tidal volumes compared to the use of traditionally volumes in ards development.

Eligibility criteria:
inclusion criteria: * patients within 12 hours after start of invasive mechanical ventilation (mv) and admitted to participating icu (it is recommended an inclusion as soon as possible during the first 3 hours). * lips \> 4 points. * absence of mild, moderate and severe ards criteria (berlin definition). * older than 18 year-old. * signed informed consent exclusion criteria: * bilateral pulmonary infiltrates in chest x-ray at admission. * mechanical ventilation \> 12 hours. * previous pneumonectomy or lobectomy. * severe cranial trauma (glasgow coma scale\<9) or cranial hypertension. * severe chronic pulmonary disease (gold iv). * admission from other hospital under mv. * limitation of therapeutic effort. * pregnancy. * acute pulmonary embolism. * participation in other interventional trials. * previous randomized in the proposed trial. * absence of informed consent.

Keywords: ards prevention protective mechanical ventilation low tidal volumes
effectiveness of helfer skin tap technique and shotblocker technique

Conditions: Pain

Summary: the purpose of this study is to examine the effectiveness of the helfer skin tap technique and the shotblocker technique in reducing pain in babies receiving intramuscular vaccination.

during immunization, babies feel pain from the injection and give behavioral reactions such as crying and struggling in response to this pain. pain-reducing methods (buzzy device, cold application, hot application, music, virtual reality, distracting cards, stress ball, etc.) are used during intramuscular vaccine injection in children. studies using the helfer skin tap technique and shotblocker technique, which are easy to apply and proven effective in reducing pain in infancy vaccination applications, are limited. therefore, this study aims to examine the effectiveness of the helfer skin tap technique and the shotblocker technique in reducing pain in babies receiving intramuscular vaccination.

Eligibility criteria:
inclusion criteria: * born between 38 and 42 weeks of gestation, * between 2 and 4 months old, * applying to the family health center for kpa (conjugated pneumococcal vaccine) application, * no congenital anomalies, birth asphyxia or any chronic disease exclusion criteria: * born prematurely or postmaturely * not between 2 and 4 months old * those who come to the family health center for the administration of other vaccines other than the kpa (conjugated pneumococcal vaccine) application administered via im route. * those with congenital anomalies, birth asphyxia or any chronic disease

Keywords: infant ıntramuscular vaccine helfer skin tap technique shotblocker pain