Kornimate/medical-research-clean huggingface dataset:
a clinical trial of fluvoxamine for melancholia

Conditions: Depressive Disorder; Endogenous Depression; Melancholia

Summary: this study aims at investigating the special effectiveness of antidepressant effect of fluvoxamine for endogenous depression. the investigators also aim to assess the effect of fluvoxamine on the multimodal magnetic resonance imaging(mri), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. the investigators further aim to identify the predictors of fluvoxamine's antidepressant effeect using the above techniques.

this study aims at investigating the special effectiveness of antidepressant effect of fluvoxamine for melancholia. the investigators also aim to assess the effect of fluvoxamine on the multimodal magnetic resonance imaging(mri), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. the investigators further aim to identify the predictors of fluvoxamine's antidepressant effeect using the above techniques.

Eligibility criteria:
inclusion criteria: * adult (18-55 years, both sexes), with dsm-4 criteria for mdd without psychosis, as determined by a structured clinical interview mini international neuropsychiatric interview * moderate to severe depression, as defined by a pretreatment score ≥17 on the hdrs-17 scale * informed consent to participate in this study * ethinic han, right-handed, junior high school education or above exclusion criteria: * a history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented axis ii diagnoses; active suicidal intention, as determined by clinical interview * active or recent (\<12 months) substance abuse or dependence; excluding nicotine * presence of ect treatment in recent 6 months * period of pregnancy or lactation * hearing disorder or colour blindness * immediate relatives have bipolar disorder or mania disorder
pharmacokinetic study of continuous infusion of remazolam in mechanically ventilated patients in icu

Conditions: Intensive Care Unit; Mechanical Ventilation; Anesthesia; Liver Failure; Pharmacokinetics

Summary: to study the pharmacokinetics of continuous infusion of remazolam in icu mechanically ventilated critically ill patients, and the characteristics of pk in patients with liver failure; to explore whether liver failure affects the metabolism of remazolam by established population pharmacokinetics.


Eligibility criteria:
inclusion criteria: patients admitted to icu for tracheal intubation and mechanical; patients aged \>18 years; patients with expected mechanical ventialation time \>24 hours. exclusion criteria: patients on long-term anti-anxiety medication or sleeping pills; patients with known or suspected hypersensitivity to remimazolam; patients with severe central nervous system diseases; patients who do not wish to sign the informed consent form.

Keywords: remimazolam intensive care unit mechanical ventilation anesthesia sedation liver failure pharmacokinetics
single center study comparing mobis ii st vs mobis peek

Conditions: Lumbar Disc Disease

Summary: prospective randomized clinical study comparing signus mobis peek vs signus mobis ii st in patients with degenerative disc disease at one or two contiguous levels from l2-s1

the protocol includes skeletally mature patients both male and female, 18 to 89 years old, with degenerative disc disease (ddd) at one or two contiguous levels from l2-s1. ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. patients may also have up to a grade i spondylolisthesis or retrolisthesis at the involved level(s). patient should have completed at least six (6) months of non-operative treatment. patients may have had a previous non-fusion surgery at the involved spinal level(s) and will be followed clinically up to two years.

Eligibility criteria:
inclusion criteria: 1. the patient has symptomatic degenerative disc disease (ddd) at one or two contiguous levels from l2-s1. 2. the patient has documented conservative (non-operative) treatment for at least 6 months. 3. the patient has a vas back pain of ≥ 60 mm. 4. the patient has an odi ≥ 40%. 5. the patient is at least 18 years of age and skeletally mature. 6. the general condition of the patient is appropriate for surgery, as evaluated by the investigator. 7. the patient is willing and able to comply with study requirements. 8. the patient has agreed to participate in the study. exclusion criteria: 1. the patient has undergone any prior spinal fusion surgery at the proposed treatment level(s). 2. the patient has osteoporosis or severe osteopenia as determined by the investigator. a clinical score calculator may be utilized for females over 40 years of age. 3. the patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s). 4. the patient has diffuse multilevel neoplastic disease such that no adjacent normal segments exist for engagement or instrumentation. 5. the patient has an active infection. 6. the patient is pregnant or is planning on becoming pregnant in the next two years. 7. the patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues. 8. the patient has a known allergy to polyether ether ketone (peek), stainless steel or tantalum/titanium. 9. the patient is currently enrolled in an investigational spine study. 10. the patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease. 11. the patient has symptomatic fibrous arachnoiditis

Keywords: intervertebral disc degeneration lumbar spinal disease
incidence of hepatitis b virus (hbv) reactivation in hbsag negative/hbcab positive lymphoma patients treated with rchop

Conditions: Lymphoma

Summary: the aim of this study is to identify the incidence of hepatitis b virus reactivation rate in diffuse large b cell or high grade follicular lymphoma patients with prior resolved hepatitis b undergoing rchop immuno-chemotherapy.


Eligibility criteria:
inclusion criteria: * naive dlbcl or high grade fl patients * age range 18-75 years old * ecog performance status 0-3 * life expectancy of more than 3 months * adequate organ function * hbsag negative/hbcab positive at baseline exclusion criteria: * infection of hav,hcv,hiv * pregnant or lactating women * serious uncontrolled diseases

Keywords: hepatitis b virus reactivation hbsag negative hbcab positive lymphoma rituximab
multifocal brain magnetic stimulation in chronic ischemic stroke

Conditions: Stroke

Summary: transcranial magnetic stimulation for post-stroke upper-body motor deficits.

this study uses transcranial magnetic stimulation (magnetic pulses delivered through a specially designed cap worn on the head aimed at specific motor areas of the brain (brain areas responsible for the body's physical movements) to test whether upper-body motor function can be improved. this is a double-blind study where half of participants will receive active transcranial stimulation and the other half of the participants will receive no transcranial magnetic stimulation; all participants will wear the cap. participants and some members of the research team will not know who received active magnetic brain stimulation.

Eligibility criteria:
inclusion criteria: * patients aged 18-80 years; * clinical diagnosis of chronic ischemic stroke recovering for more than 3 months with unilateral motor deficits of arm and leg, or arm alone; -- exclusion criteria: * history of seizure; * epileptogenic activity (indicative of increased risk of seizures) on eeg; * any active unstable medical condition; * pregnancy; * schizophrenia, bipolar disorder, alcoholism, or substance abuse; * medications which in the investigator's clinical judgment significantly lower the seizure threshold; * presence of metal or electronic implants in the head (or any in the body that preclude mri) , including pacemakers, defibrillators, aneurysm clips, neuro-stimulators, cochlear implants, metal in the eyes, etc.; * any changes in medications prescribed for the treatment of stroke impairment within six weeks prior to inclusion in the study or at any time during the study. * botulinum toxin use within two months prior to the screening visit or any planned use of botulinum toxin during the study * changes in nihss and motor assessment scores between visit 1 and visit 2 indicating that the patient's impairment is not stable. the following cutoffs, based on research establishing clinically important differences, will be used for this determination: * national institutes of health stroke scale: a change in total score of more than 2 points in either direction, or a change in the motor extremity score of more than 1 point in either direction. * fugl-meyer assessment of sensorimotor impairment: a change of more than 5 points in either direction on the upper-extremity motor score for the affected arm. * action research arm test: a change of more than 5 points in either direction on the arat score for the affected arm. * any condition that precludes a high quality brain mri scan.

Keywords: stroke chronic ischemic stroke cerebrovascular accident (cva) ischaemic stroke
safety and efficacy of sitagliptin added to insulin therapy for type 2 diabetes

Conditions: Type 2 Diabetes

Summary: there is paucity of information about the combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin and insulin. this study aimed to retrospectively investigate the safety and efficacy of this therapeutic modality in japanese patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * outpatients with type 2 diabetes * addition of sitagliptin to insulin therapy * aged 20 years or older * hba1c of 6.9% or higher (ngsp) at the time of adding sitagliptin exclusion criteria: * history of hypersensitivity to sitagliptin * severe ketosis, diabetic coma, and/or precoma within 6 months before sitagliptin administration * sever infection and/or severe trauma, and/or patients who are scheduled to undergo / have recently underwent surgery * severe renal dysfunction (serum creatinine \[mg/dl\]: 2.5 or higher for men; 2.0 or higher for women) * ongoing treatment with glinide(s) * judgment as ineligible for the study by the attending physician
a single centre randomized study evaluating the safety and tolerability of gsk233705 in healthy volunteers.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study will investigate the safety and tolerability of inhaled doses of gsk233705 with a new formulation.

a single-centre, randomized, double-blind placebo-controlled, dose-ascending, cross-over study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of gsk233705 (50, 100 and 200âµg), formulated with the excipient magnesium stearate, in healthy volunteers.

Eligibility criteria:
inclusion criteria: * healthy male subjects 18-55 years old * non-smokers exclusion criteria: * any subject with breathing problems. * high blood pressure and heart abnormalities. * any subjects currently taking prescription and non-prescription medications.

Keywords: copd gsk233705, magnesium stearate,
effect of mirror therapy on unilateral neglect for patients after stroke

Conditions: The Effects of Mirror Therapy on Patients With Unilateral Neglect After Stroke

Summary: this is a single-blinded randomized controlled trial to investigate the effects of mirror therapy (mt), with reference to sham mirror (a glass wall) and control (a covered mirror), in reducing unilateral neglect for patients with stroke in 2 centres.

twenty-one subacute inpatients with left unilateral neglect after right-hemispheric stroke, recruited from 2 hospitals - hong kong and guangzhou, in 1 and a half years, were randomly assigned to three groups; mirror therapy, sham therapy (in the form of a transparent glass wall), and control (covered mirror). the treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks) movement practice for the hemiplegic arm involved 5 table-top tasks graded according to the severity of patients' arm impairments. blinded assessments were administered at baseline, 3-week postintervention, and 3-week follow-up upon completion of training.

Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke, confirmed by medical diagnoses compatible with a unilateral right lesion involvement (i.e. left hemiplegic), exhibited left visual field inattention or unilateral neglect by obtaining a total score of star cancellation subtest in the conventional battery of the behavioural inattention test ≤ 51 (out of 54); * stroke with onset of neurological condition ≤ 6 months previously; * have normal or corrected-to-normal visual acuity better than 20/60 (6/18) in the better eye; * with hemiplegic upper extremity functional levels 3-7 as rated by functional test for the hemiplegic upper extremity and is able to move against gravity; * ability to understand and follow simple verbal instructions, with mini-mental state examination ≥ 21; * ability to participate in a therapy session lasting at least 30 minutes; * consent to participant in the study exclusion criteria: * prior neurological or psychiatric disorders; * severe spasticity (modified ashworth scale \>3) over paretic arm; * history of recent botox injection or acupuncture to the paretic arm within the past three months; * participation in another clinical study elsewhere apart from the study site during recruitment

Keywords: stroke; unilateral neglect; mirror therapy; mirror visual feedback
evaluate safety and efficacy of pronavi microcatheter for use in endovascular interventions

Conditions: Coronary Artery Disease; Peripheral Arterial Disease

Summary: this is a prospective, multi-center, single-group post-market study. it is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old; 2. patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (pci); 3. patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronary chronic total occlusion (cto), or tortuous lesions, who plan to use pronavi microcatheter; 4. patients or their guardians who understand the purpose of the trial, voluntarily participate and sign the written informed consent, and are able to be followed up. exclusion criteria: 1. patients with clinical symptoms consistent with st-elevation myocardial infarction and/or ecg changes within 12 hours before the procedure; 2. patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media; 3. patients with in-stent occlusion; 4. patients with unprotected left main coronary artery disease; 5. women who are pregnant or lactating; 6. patients who are participating in clinical trials of other drugs or medical devices; 7. patients with contraindications to the investigational device; 8. other patients considered by the investigators to be unsuitable for this trial.
clinical efficacy and long term effects of transcranial direct current stimulation (tdcs) in children with attention deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder; Transcranial Direct Current Stimulation

Summary: attention-deficit/hyperactivity disorder (adhd) is the most commonly diagnosed neurodevelopmental disorder in childhood. patients with adhd present inattention, impulsivity and hyperactivity causing severe impairments on academic achievement, social and professional life and daily functioning. medications are effective in a majority of children with adhd, but about 30% do not respond or tolerate stimulants, and some parents refuse pharmacological treatments.transcranial direct current stimulation is a safe and non-invasive technique of brain stimulation used in several neurological and psychiatric disorders, and recently in adhd. in patients with adhd, tdcs stimulations targeted frontal regions improve executive and attentional functioning and daily life symptoms. the objective of this project is to evaluate the efficacy of tdcs (vs sham) during cognitive-remediation exercises on adhd symptoms (inattention, impulsivity and hyperactivity as defined by dsm-5) in children with adhd between 7 and 14 years of age.


Eligibility criteria:
* children, male or females presenting a sufficient compliance for participate aged 7-14 years at the time of visit 1 (enrolment/baseline). * children's parent or legally authorised representative must sign informed consent. the children must sign assent if applicable (depending of age and understanding). the principal investigator of the center where the child is included signs the document, certifying that the family and the child, or their authorised representative, have received informed consents. * children meet dsm-5 criteria for adhd (combined presentation) based on a clinical evaluation using questionnaire adhd-rating-scale (adhd-rs) and the kiddie schedule for affective disorders and schizophrenia french version (kiddie-sads). * subjects have a minimum adhd-rs total score of 32 at visit 1. * children have a minimum cgi of 4 at visit 1. * children have an age-appropriate intellectual level evaluated with wisc-5 (full iq \>80). * children in which stimulant medication have been tested previously and stopped for adverse effects could be included in the study after a wash out of at least seven days. exclusion criteria: * children have a neurological pathology or handicap: epilepsy, cerebral palsy, sequelae of brain injury (traumatic or ischemic or inflammatory...) * children have a comorbid psychiatric disorder: conduct disorders, autism, severe obsessive-compulsive disorder, mood disorder, bipolar illness, conduct disorder, psychosis, and substance abuse. * children under medication (stimulant or other psychotropic treatment, benzodiazepine, antidepressant, hypnotics and melatonin) or who did not respond previously to stimulant will not be included. * severe sleep disorder. * contraindication to tdcs.

Keywords: attention deficit hyperactivity disorder transcranial direct current stimulation
proton radiation therapy for spinal tumors

Conditions: Nerve Sheath Tumors; Neurofibroma

Summary: the purpose of this study is to determine if proton therapy can provide effective and safe treatment for malignant peripheral nerve sheath tumors of the spine and neurofibromas of the spine.

proton therapy may provide the benefits of local control or palliation, while reducing the risk associated with photon radiation, by delivering therapeutic doses to a well-defined target area with significant reduction in the integral dose. a dosimetry comparison of protons and photons at the university of florida proton therapy institute confirmed the feasibility of proton irradiation of these tumors with less exposure of normal tissue to radiation than expected with photon techniques. this reduced radiation exposure to uninvolved normal tissues is expected to decrease the risk of radiation-induced second malignancies and neoplasms.

Eligibility criteria:
inclusion criteria: * mpnsts that are biopsy-positive and resected, subtotally resected or unresectable. * symptomatic (pain, numbness, or weakness) nf1 neurofibromas that are biopsy-positive and unresectable or subtotally resected. * symptomatic nf1 neurofibromas that are unbiopsied and pet-negative, if the patient refuses biopsy/surgery or is medically inoperable. * asymptomatic nf1 neurofibromas with radiologic progression after surgery. * pet-positive, unbiopsied lesions in nf1 patients who refuse biopsy/surgery or are medically inoperable. exclusion criteria: * spinal instability. * metal stabilization hardware within the target area. * previously irradiated at this disease site. * spinal cord compression with complete loss of function.

Keywords: proton radiation therapy spinal tumors neurofibroma(nf1) malignant peripheral nerve sheath tumor(mpnst)
efficacy and safety of sitagliptin/metformin fixed-dose combination (fdc) compared to glimepiride in participants with type 2 diabetes mellitus (mk-0431a-202)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will assess the effect of sitagliptin/metformin fdc 50/1000 mg (janumet®), mk-0431a) compared with the effect of glimepiride on hemoglobin a1c (hba1c). the primary hypothesis is that after 30 weeks, sitagliptin/metformin fdc 50/1000 mg provides superior reduction in hba1c (mean change from baseline) compared to glimepiride.


Eligibility criteria:
inclusion criteria: * has type 2 diabetes mellitus * is currently not on an anti-hypoglycemic agent (aha) (off for at least 12 weeks) and has a visit 1/screening visit hba1c greater than or equal to 7.0% and less than or equal to 9.5%; or is currently on aha monotherapy or low-dose oral combination therapy (i.e., less than or equal to 50% maximum labeled dose of each agent) and has a visit 1/screening visit hba1c greater than or equal to 6.5% and less than or equal to 9.0% exclusion criteria: * has a history of type 1 diabetes mellitus or a history of ketoacidosis * has been on any investigational or approved glucagon-like peptide-1 (glp-1) analogue (such as exenatide, liraglutide, etc.), any investigational or approved dipeptidyl peptidase iv (dpp-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.) or a peroxisome proliferator-activated receptor (ppar) gamma agonist agent (such as rosiglitazone, pioglitazone, etc.) within 12 weeks of visit 1 * required insulin within the prior 12 weeks * has a hypersensitivity or contraindication to any sulfonylurea medication (such as glimepiride, glipizide, etc.), dpp-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.), or biguanide medication (such as metformin, etc.) * has inadequately controlled hypertension * has cirrhosis or active liver disease * has severe cardiac conditions * is obese * has human immunodeficiency virus (hiv)