Kornimate/medical-research-clean huggingface dataset:
a study of rtms for cognitive deficits in chronic patients with schizophrenia

Conditions: Schizophrenia

Summary: in this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (dlpfc) high-frequency repetitive transcranial magnetic stimulation (rtms) on negative symptoms of schizophrenia. we evaluated the efficacy of rtms on cognition in patients with chronic schizophrenia.

this is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with schizophrenia on stable antipsychotic treatment were randomly assigned to active rtms treatment group (n=25) or a sham rtms treatment group (n=22). 25 patients in the active rtms group received 10 hz 110% rtms, while 22 patients were subjected to sham rtms, both being given 4-week treatment (5 days per week). efficacy of negative symptom was assessed with the scale for the assessment of negative symptoms (sans), the positive and negative symptom scale (panss) at baseline, the end of 4 weeks and 8 weeks. the cognitive function was assessed with cantab at baseline, the end of 4 weeks and 8 weeks .the side effects were assessed with treatment emergent symptoms scale at baseline and the end of 4 weeks.

Eligibility criteria:
inclusion criteria: 1. right-handed; 2. meeting the diagnosis of schizophrenia for at least 2 years; 3. had been on anti-psychotic medications for more than 12 weeks; 4. with unresolved negative symptoms (sans\>20). exclusion criteria: 1. with substance use disorders ; 2. with cerebral pathologies (e.g. seizure, aneurysm, stroke), intra-cranial metals, pacemakers, severe cardiovascular diseases; 3. receiving electroconvulsive therapy in the past 3 months.

Keywords: repetitive transcranial magnetic stimulation negative symptoms randomized controlled trial schizophrenia cognition
a long term extension of study nc19453 evaluating safety and efficacy of ro4607381

Conditions: Coronary Heart Disease

Summary: this 2 arm study will assess the long term safety and efficacy of ro4607381 in patients with coronary heart disease or a coronary heart disease (chd) risk equivalent who have completed study nc19453. patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie ro4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). the anticipated time on study treatment is 6 months post study nc19453, and the target sample size is approximately 100 individuals.


Eligibility criteria:
inclusion criteria: * patients who have completed treatment on study nc19453. exclusion criteria: * any significant lymph node abnormalities at the end of study nc19453.
a study of argx-110 in participants with advanced malignancies

Conditions: Neoplasms

Summary: the purpose of this study is to determine the optimal dose of argx-110 in participants with advanced malignancies and to assess efficacy of argx-110 (exploratory efficacy cohort 5 only).

phase i study conducted in participants whose tumors express the target of interest. pharmacokinetics (pk), pharmacodynamics (pd), biomarkers will be determined to support dose selection. phase ii study conducted in cutaneous t-cell lymphoma (ctcl) participants who are cd70 positive. pk, pd, biomarkers and immunohistochemistry (ihc) will be determined to assess efficacy.

Eligibility criteria:
inclusion criteria: * histological diagnosis of malignancy refractory to, or relapsing after standard therapy * solid tumors or t-cell malignancies positive for the cd70 antigen by immunohistochemistry/fluorescence-activated cell sorting (ihc/facs) within 56 days prior to administering the first dose of argx-110. ihc criterion: greater than \> 10 percent (%) of cd70 positive tumor cells * eastern cooperative oncology group (ecog) performance status of 0 or 1, or 2 * serum albumin greater than or equal to (\>=) 20 gram per liter (g/l) (solid tumor only) * ability to comply with protocol-specified procedures/evaluations and scheduled visits. in particular, the ability of the patient to undergo a tumor biopsy (optional for safety expansion cohort 4) exclusion criteria: * history or clinical evidence of neoplastic central nervous system (cns) involvement * history of another primary malignancy that has not been in remission for at least 1 year * systemic glucocorticoid administration at doses greater than physiological replacement (prednisolone 20 milligram \[mg\] equivalent) within 28 days of argx-110 first dose administration (for t-cell malignancies higher systemic dose can be allowed following discussion with sponsor) * major surgery within 28 days of argx-110 first dose administration * unresolved grade 3 or 4 toxicity from prior therapy, including experimental therapy

Keywords: malignancy
flavopiridol in treating patients with recurrent intermediate-grade or high-grade non-hodgkin's lymphoma or mantle cell lymphoma

Conditions: Lymphoma

Summary: phase ii trial to study the effectiveness of flavopiridol in treating patients with recurrent intermediate-grade or high-grade non-hodgkin's lymphoma or mantle cell lymphoma. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

objectives: i. determine the objective response rate to flavopiridol by patients with previously treated intermediate and high grade non-hodgkin's lymphoma and mantle cell lymphoma. ii. determine the toxicity of flavopiridol administered as a continuous infusion every 2 weeks in these patients. iii. study the pharmacokinetics of flavopiridol in these patients. outline: this is an open label, multi-institutional study. patients receive treatment on an outpatient basis. flavopiridol is administered as a continuous infusion over 72 hours every 2 weeks. patients receive a minimum of 4 cycles of therapy unless unacceptable toxicity or disease progression occurs. patients are followed until death.

Eligibility criteria:
disease characteristics: * histologically confirmed intermediate or high grade non-hodgkin's lymphoma (nhl) and mantle cell lymphoma with clinical or pathological evidence of recurrent disease * measurable or evaluable disease * cns metastases not requiring intravenous steroid therapy allowed patient characteristics: * age: 18 and over * performance status: calgb 0-2 * life expectancy: at least 12 weeks * absolute neutrophil count at least 1500/mm3 (unless due to bone marrow involvement by lymphoma) * platelet count at least 100,000/mm3 (unless due to bone marrow involvement by lymphoma) * at least 7 days since platelet transfusion * hemoglobin at least 9.0 g/dl * bilirubin no greater than 1.5 mg/dl * transaminases no greater than 2.5 times upper limit of normal * creatinine no greater than 1.5 mg/dl or creatinine clearance at least 60 ml/min * no significant uncontrolled medical or psychiatric illness * no active serious infection * not pregnant or lactating * fertile patients must use effective contraception * central venous catheter required prior to study entry prior concurrent therapy: * no more than 1 prior chemotherapy regimen * at least 4 weeks since prior chemotherapy and recovered from all toxic effects prior chemotherapy must contain anthracycline if intermediate or high-grade nhl other than mantle cell * no concurrent treatment with other chemotherapeutic or investigational antineoplastic drugs * at least 4 weeks since prior radiation therapy and recovered (site of only measurable disease must not be located within prior radiation therapy port) * no concurrent radiation therapy to any lesion

Keywords: recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult burkitt lymphoma recurrent mantle cell lymphoma
continuous local-anesthetic wound infusion for neck dissection

Conditions: Head and Neck Cancer

Summary: the goal of this study is to assess the efficacy of continuous local anesthetic wound infusion to improve quality of recovery following ablative surgery and neck dissection.

bilateral cervical plexus catheters are convenient and safe to place under the direct vision of the surgeons during ablative and neck dissection. the investigators hypothesize that continuous local anesthetic wound infusion to block bilateral cervical plexus will improve quality of recovery following ablative surgery and neck dissection. the primary endpoint is the quality of recovery, which will be assessed using the 15-item quality of recovery questionnaire (qor-15). secondary endpoints include numeric pain scale, number and proportion of patients on salvage analgesics, incidence of phrenic nerve block, incidence of recurrent laryngeal nerve block, length of post-anesthesia care unit (pacu) stay, length of post-operative hospital stay.

Eligibility criteria:
inclusion criteria: * over age 18; * patients with head and neck cancer undergoing ablative surgery and neck dissection. exclusion criteria: * patient refuse; * relatively contraindications: severe heart, liver, or kidney dysfunction, coagulation dysfunction, and local anesthetic allergy history; * intervention unlikely to be effective: drug abuse history, receiving other types of nerve block treatment; * unlikely to complete the follow-up: alcoholism, planned to replace wechat and phone within three months; the expected life span less than three months; * unable to cooperate with the questionnaire and use the patient-controlled analgesia pump.
panobinostat (lbh589): acute graft versus host disease (agvhd) prevention

Conditions: Graft Versus Host Disease; GVHD

Summary: this study will test pano in combination with tacrolimus/sirolimus (tac/sir) for acute gvhd prevention. the purpose of this study is to determine if panobinostat (pano) when used in combination with sirolimus and tacrolimus will help reduce the incidence of graft-vs-host disease (gvhd).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years or older at time of enrollment * signed informed consent * hematologic disorder requiring allogeneic hematopoietic cell transplantation * left ventricular ejection fraction (lvef) ≥ 45% by multiple uptake gated acquisition (muga) scan or echocardiogram * forced expiratory volume in one second (fev1), forced vital capacity (fvc), and diffusing lung capacity oxygenation (dlco) adjusted ≥ 50% of predicted values on pulmonary function tests * transaminases (ast, alt) \< 3 times upper limit of normal (uln) values * creatinine clearance calculated ≥ 50 ml/min * karnofsky performance status score ≥ 60%. * human leukocyte antigen (hla) matched 8/8 (a, b, c, drb1) related or unrelated donor exclusion criteria: * active infection not controlled with appropriate antimicrobial therapy * hiv, hepatitis b (hbcab positive but hbsag negative with undetectable viral load are eligible), or hepatitis c infection * sorror's co-morbidity factors with total score \> 4. important modification to co-morbidity index calculation: dlco adjusted will not be included in assessment of pulmonary risk, except those patients with dlco adjusted \< 50% who are excluded from the trial. * anti-thymocyte globulin (atg) as part of the conditioning regimen * cyclophosphamide as part of the conditioning regimen or for gvhd prophylaxis * pregnancy * histone deacetylase (hdac), dac, hsp90 inhibitors or valproic acid for the treatment of cancer within 30 days * patients who will need valproic acid for any medical condition during the study or within 5 days prior to first pano treatment * impaired cardiac function or clinically significant cardiac diseases, including any one of the following: any history of ventricular fibrillation or torsade de pointes; bradycardia defined as heart rate (hr)\ 480 msec; right bundle branch block + left anterior hemiblock (bifascicular block); patients with myocardial infarction or unstable angina ≤ 12 months prior to starting study drug; other clinically significant heart disease (e.g., new york heart association (nyha) class iii or iv , uncontrolled hypertension) as per discretion of principal investigator and/or treating physician; patients using medications that have a relative risk of prolonging the qt interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug with the exception of drugs listed on appendix b of study documents that are required for hematopoietic cell transplantation (hct) patients.

Keywords: hematologic disorder allogeneic hematopoietic cell transplantation
evaluation of the usefulness of a treat and extend regimen using ranibizumab for neovascular amd.

Conditions: Neovascular Age-related Macular Degeneration

Summary: to evaluate the visual outcome, number of injections and visits, and the effect of mental status of a treat and extend regimen in managing neovascular age-related macular degeneration with intravitreal ranibizumab.

treat and extend regimen (ter) may contribute to the improvement to a patients' mentality, since the treatment intervals are extended if there were no signs of recurrence. therefore, we have planned to examine the psychological impact of ter using hospital anxiety and depression scale (hads), in addition to the improvement of visual acuity and central retinal thickness.

Eligibility criteria:
inclusion criteria: * signed informed consent form * male or female of aged 50 years or older * typical amd and pcv patients * bcva of 24 letters or over exclusion criteria: * total lesion area of \>12 da or \>30.5 mm2 * the existence of subretinal hemorrhage area constituting ≥50% of total lesion area * the existence of scar or fibrosis area constituting ≥50% of total lesion area * the existence of rpe tear * prior treatment for wet amd * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd * the pregnant or lactating woman

Keywords: neovascular age-related macular degeneration ranibizumab treat and extend
breaking the cycle iv: military ptsd (mptsd) treatment study

Conditions: PTSD; Anger; Aggression

Summary: the study will compare the efficacy of trauma affect regulation: guide for education and therapy (target) vs. the best validated psychotherapy for adults with posttraumatic stress disorder (ptsd), prolonged exposure (pe). male military personnel and veterans suffering with ptsd and problems with anger after returning from military service in afghanistan (operation emerging freedom, oef) and/or iraq (operation iraqi freedom, oif) will be participants. the goal is to determine if a present-centered psychotherapy that teaches skills for emotion regulation and does not require re-telling of traumatic memories is as efficacious as the trauma memory-focused pe psychotherapy.

the study is based on a theoretical and clinical model that involves a series of associated risks that are set in motion by exposure to military-related traumatic stressors in iraq or afghanistan. trauma exposure places personnel at risk for ptsd, which in turn increases their risk of problems with anger and hostility, emotion dysregulation and experiential avoidance, and ultimately with alcohol abuse and aggression. the two types of treatments being compared, target (trauma affect regulation: guide for education and therapy) and pe (prolonged exposure), are both designed to directly reduce ptsd severity by reducing emotion dysregulation (target) and experiential avoidance (pe), and therefore are hypothesized to reduce the risk and severity of alcohol abuse and aggression- and thereby to reduce associated legal and societal costs.

Eligibility criteria:
inclusion criteria: * be a returning oef/oif military personnel or veteran * have experienced ptsd for the past month * have experienced anger and at least one act of aggression in the last month * be mentally able to provide a valid consent exclusion criteria: * currently be danger of suicide * currently abusing alcohol or other substances * been in an inpatient psychiatric or addiction treatment program in the past month

Keywords: ptsd anger aggression military
cortical activity and gait function for robotic gait training in hemiparetic stroke

Conditions: Stroke

Summary: effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke


Eligibility criteria:
inclusion criteria: * hemiplegic patients secondary to first cerebrovascular accidents * functional ambulation category score 3 * 3 months ≤ onset ≤ 12 months * korean mini-mental state examination score \> 24 exclusion criteria: * history of surgery of affected lower limb * fracture of affected lower limb

Keywords: robot-assisted gait training cortical activity gait kinematics stroke
a randomized, controlled trial of intranasal oxytocin as an adjunct to behavioral therapy for autism spectrum disorder

Conditions: Autism Spectrum Disorders

Summary: this 3-year study is a trial of cognitive behavioral therapy (cbt), with or without oxytocin (ot) augmentation, in young adults with autism spectrum disorders. participants will be randomly assigned to receive either a social skills-focused cbt intervention or a stress management/relaxation training cbt intervention. participants will also be randomized to receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. the design of the study will enable examination of the efficacy of cbt for young adults with autism spectrum disorders. the design of the study will also allow examination of whether oxytocin enhances the efficacy of cbt. the investigators will perform functional (fmri) and structural (mri) imaging with all participants prior to treatment. this will enable examination of the relations between measures of brain function and structure, and improvements in target symptoms over the course of treatment. the aim is to discover whether there are neural characteristics that can identify which participants with autism spectrum disorders are most likely to respond to cbt interventions and/or oxytocin treatment.


Eligibility criteria:
inclusion criteria: * age 18-40 * able to attend in person therapy sessions in boston * male * english-speaking * normal or corrected vision * no history of known genetic disorder, significant motor developmental difficulties, prematurity or brain injury * iq \> 90, as determined by the wasi * score above the cutoff on the reciprocal social interactions and the restricted, repetitive, and stereotyped behaviors domains on the adi-r, meet criteria for pdd or autism on the ados, and/or meet dsm-iv criteria for autism spectrum disorder according to clinician interview. exclusion criteria: * current use of certain endocrinologically relevant medications * current dependence on substances other than tobacco or caffeine * history of serious medical illness, including neurological, endocrine, cardiac, respiratory, and metabolic diseases that are counter-indications to oxytocin * severe, current psychiatric disorder (ie, current mania, severe depression, psychosis, suicidality, severe aggression) * long qt, as determined by baseline ekg * current participation in other psychotherapy additional exclusion criteria for mri scan only: participants who are mri-ineligible will be enrolled in the clinical trial portion of the study, but will not undergo the mri scan at mit. exclusion criteria for mri are: * presence of metal implants or other metal in the body * history of claustrophobia or inability to tolerate mri

Keywords: autism spectrum disorder social skills deficits cognitive behavioral therapy oxytocin young adult
appalachian partnership to reduce disparities (aim 2)

Conditions: HIV/AIDS; STI; HCV

Summary: by combining two strategies (i.e., peer navigation and mhealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed hiv, sti, and hcv prevention and care services among racially/ethnically diverse gbmsm and transgender women in rural appalachia. study investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased hiv, sti, and hcv testing.

this cbpr study will advance prevention science and practice through testing an innovative intervention to promote and support the use of needed hiv, sti, and hcv prevention and care services among gbmsm and transgender women; and developing priorities and recommendations to improve their health that will be disseminated to inform public health practice, research, and policy. by integrating peer navigation and mhealth strategies, the proposed study provides a unique opportunity to improve health among vulnerable, hidden, and neglected populations living in rural appalachia. findings from this research may inform strategies and approaches to address other health disparities in other rural populations.

Eligibility criteria:
inclusion criteria: * reside in one of the rural appalachian catchment countiesreside in one of the rural appalachian catchment counties * be ≥18 years of age * report being assigned male sex at birth and having had sex with at least 1 man in past 12 months * provide informed consent

Keywords: prep
bispectral index, suppression rate and emergence agitation in spine surgeries

Conditions: Emergence Agitation; Anesthesia Recovery; Bispectral Index Monitor

Summary: emergence agitation; generally refers to a situation that may occur after a surgical intervention or anesthesia. this situation describes the irritability and agitation of the patient during the recovery process and the period of recovery from anesthesia. recovery agitation may occur when the patient begins to recover and is usually a short-term condition. it resolves spontaneously. however, in some cases, this agitation may be more pronounced and disturbing. this may affect the patient\&#39;s condition and relaxation. rapid recovery from anesthesia in the clinic is also a risk factor for agitation. when the literature is examined, there are not enough studies on bis suppression ratio and its relationship with recovery agitation is not yet known enough. for this purpose, our study aimed to question this relationship.

there are not enough studies on bis suppression ratio, and its relationship with recovery agitation is not yet well known. for this purpose, our study aimed to question this relationship. for this purpose, patients\&#39; post-anesthesia recovery scores and perioperative bis and bis suppression rates will be compared.

Eligibility criteria:
inclusion criteria: * patients with asa score 1,2,3 * patients to be extubated in the postoperative operating room * patients without known vascular diseases will be included. exclusion criteria: * intraoperative surgery or aesthesia complication developments * those who need postoperative intensive care * patients who are not planned to be extubated in the operating room

Keywords: bispectral index emergence agitation spine surgery postoperative recovery