Kornimate/medical-research-clean huggingface dataset:
study of hcd122 in adults with non-hodgkin's or hodgkin's lymphoma who have progressed after at least two prior therapies

Conditions: Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma

Summary: this study is to evaluate the highest tolerated dose, safety and activity of hcd122 in adults with non-hodgkin's or hodgkin's lymphoma who have received at least two prior therapies.


Eligibility criteria:
inclusion criteria: patients may be included in the study if they meet all of the following criteria: * patients must have confirmed diagnosis of hl or nhl (follicular, marginal zone / malt, diffuse large b-cell, or mantle cell) per real/who classification * patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy) * patients must be ≥ 18 years * patients must have life expectancy \> 3 months * patient must have adequate laboratory results * patients must have who performance status grade 0, 1, or 2 * patients must have at least one site of measurable disease * patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment. * patients must be willing and able to sign the informed consent form and comply with the study protocol exclusion criteria: patients will be excluded from the study if they meet any of the following criteria: * patients who have been treated with any anti-cd40 antibody * patients who have received prior allogeneic stem cell transplant * patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration * patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis * women of child-bearing potential (wcbp) who are pregnant or breast feeding. other protocol-defined inclusion/exclusion criteria may apply

Keywords: hcd122 cd40 nhl hl
safety, pharmacokinetics and efficacy study of mp-214 in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of mp-214 orally administered once daily to patients with schizophrenia. mp-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.


Eligibility criteria:
inclusion criteria: * patients meeting dsm-iv-tr criteria for schizophrenia * panss total score \<= 120 during the observation period * patients who have been treated with oral antipsychotics within 4 weeks before informed consent * patients whose consent is obtained from themselves in written form exclusion criteria: * patients who have defined as any mental disorder other than "schizophrenia" based on the criteria of dsm-iv-tr * history of drug or alcohol abuse * concurrent parkinson's disease * history of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder * patients who exhibit abnormalities on physical examination, have abnormal vital signs, ecg, or clinical laboratory values * current cataract during the observation period * history of shock or anaphylactoid symptoms to drugs the information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: schizophrenia antipsychotics dopamine d3/d2 antagonist
comparative analysis of transperineal versus transrectal approaches for mri-targeted biopsy of the prostate for the detection and characterization of prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using mri targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy.

prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the western hemisphere. definitive diagnosis of prostate cancer relies on biopsy of the prostate gland, which is historically performed by taking 12 random biopsies of the prostate by placing a needle through the rectum under ultrasound guidance. recently, advances in mri techniques have allowed identification of suspicious lesions within the prostate prior to biopsy, which has given rise to targeting biopsy cores to high-suspicion areas using fused ultrasound-mri images. however, the most commonly used transrectal approach to biopsy is associated with a growing rate of infectious complications as well as poor sampling of the anterior region of the prostate, which is furthest from the rectum.

Eligibility criteria:
inclusion criteria: * no contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) area of suspicion or known cancer focus on previously obtained mpmri of the prostate (at least one lesion with mri suspicion score \>3/5) exclusion criteria: * prior pelvic radiotherapy * evidence of urinary tract infection or significant urinary retention * prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpmri * no evidence of suspicious lesions on mpmri * irreversible coagulopathy * contraindication to sedation
prospective, randomized controlled study to evaluate the effect of artificial intelligence assisted optical diagnosis of advanced adenomas

Conditions: Advanced Adenoma

Summary: this study is a clinical validation of our developed a computer-aided optical dignosis of advanced adenoma using non-magnified nbi image. this study is a randomized clinical trial comparing endoscopists' optical recognition of advanced adenoma for sending to histological examination with our computer-aided system. the hypothesis of the study is that the developed computer-aided system increases the percent of sending actual advanced adenoma intelligence assisted optical diagnosis of advanced adenomas

colorectal polyp diagnosis is based on endoscopic resection and histological analysis. an accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. however, it should be noted this policy could only be applied in diminutive polys considering high proposition of advanced adenomas in polyps more than 5 mm. in addition, optical diagnosis criteria of advanced adenomas have not been validated for finding advanced adenomas among adenoma polyps. if as many as advanced adenomas as possible could be differentiated from non-advanced adenomas and be further sent for histological examination, this policy could be generalized to small polyps. considering this situation, the investigators tried to develop computer-aided optical dignosis of advanced adenoma using non-magnified nbi image with preliminary, satisfied results. in this study, the investigators next validate the investigators' developed computer-aided system for detecting advanced adenomas by comparing endoscopists' optical detection of advanced adenomas with or without the investigators' computer-aided system.

Eligibility criteria:
inclusion criteria: * endoscopists with nbi experience exclusion criteria: * endoscopists without colonoscopy and nbi experience
arteriovenous fistula cannulation practices and dialysis adequacy

Conditions: Arteriovenous Fistula; Hemodialysis; Dialysis Adequacy

Summary: arteriovenous fistulae are preferred among methods of providing blood access for hemodialysis. for each hemodialysis treatment, the fistula is cannulated usually with two needles. one, the arterial needle, allows the blood to be withdrawn from the patient into the dialysis circuit and then it is returned by the second or venous needle. the success of arteriovenous fistula cannulation is dependent on many variables and these are affect the dialysis adequacy.

as hemodialysis prescriptions are usually three times weekly (4 to 8 h), a fistula or graft for hemodialysis will be punctured twice each dialysis treatment or at least 312 times per year. to allow healing of the tissues damaged during each cannulation, optimal cannulation practice is required by rotation of the needle insertion sites each dialysis treatment. vascular access (va) has been justly described as both the lifeline and the achilles' heel of hemodialysis therapy, making blood purification itself possible while simultaneously often constituting a limiting factor in treatment adequacy.

Eligibility criteria:
inclusion criteria: * 18 and older years of age * have arteriovenous fistula * being on hemodialysis therapy for 4 hours a day on 3 days per week for at least 6 months * volunteering to participate in the study * have not communication problem exclusion criteria: * younger than 18 years old * not volunteering to participate in the study * have communication problem * being on shorter hemodialysis therapy for 4 hours a day on 3 days per week for at least 6 months

Keywords: arteriovenous fistula antegrade direction dialysis adequacy nursing care cannulation practices
transcutaneous laser therapy in chronic kidney disease

Conditions: Chronic Kidney Disease(CKD)

Summary: chronic kidney disease (ckd) affects approximately 10% of the global population, totaling over 800 million people. in taiwan, one in eight individuals is diagnosed with ckd. according to national health insurance data, acute kidney injury and ckd rank first in medical expenditures, imposing a significant burden on patients' quality of life and the national healthcare system. early intervention in ckd, especially for high-risk populations (e.g., individuals with diabetes or early-stage kidney dysfunction), can slow disease progression, delay the onset of kidney failure, and postpone the need for dialysis. transcutaneous venous laser therapy is a non-invasive treatment. current literature has demonstrated that it enhances blood circulation, alters blood and erythrocyte activity, and exhibits immunomodulatory, anti-inflammatory, and vasodilatory effects on the blood. additionally, it boosts mitochondrial activity, which is crucial as mitochondria act as the energy powerhouses of cells, providing the necessary energy for kidneys to maintain normal function. this project aims to investigate whether this non-invasive transcutaneous venous laser therapy can reduce inflammation, improve physical activity, and further enhance patients' quality of life. it also seeks to reduce patients' medical expenses and national health insurance costs.


Eligibility criteria:
inclusion criteria: * individuals aged \>20 years diagnosed with chronic kidney disease (ckd) stages 2-5. * estimated glomerular filtration rate (egfr) \< 90 ml/min/1.73m² (lasting for more than three months). * willing to provide routine blood test results before, during, and after each phase of the study. exclusion criteria: * acute kidney changes within the past three months (e.g., \>30% decline in egfr), or individuals with impaired consciousness, shortness of breath, or inability to follow instructions. * blood pressure exceeding 160 mmhg at the time of participation. * severe cardiovascular diseases (e.g., pacemaker implantation), upper limb trauma or infections, systemic lupus erythematosus, or skin cancer. * use of photosensitizing medications, pregnancy, or malignant tumors. * sensory nerve abnormalities, coagulation disorders, or the presence of kidney stones. * individuals with a hierarchical relationship to the study's principal investigator or team members (e.g., those from the same laboratory or having a student-mentor relationship).

Keywords: chronic kidney disease
sd-oct guided treatment of fungal chorioretinitis

Conditions: Fungal Retinitis

Summary: fungal chorioretinitis is a vision threatening condition.the investigators evaluate the efficacy of sd-oct role in the treatment

baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination and sd-oct was done.procedure included oral fluconazole treatment 1 tablet once for 14 days

Eligibility criteria:
inclusion criteria: - fungal chorioretinitis exclusion criteria: * vitritis * other macular lesion * macular scar

Keywords: fungal chorioretinitis oct
vitamin d receptor polymorphisms and non-melanoma skin cancer risk

Conditions: Skin Cancer, Non-Melanoma

Summary: the purpose of this study is to discover whether certain vitamin d receptor (vdr) gene polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (bcc) and/or cutaneous squamous cell carcinoma (scc) in an alabama population. participant demographic information such as physical characteristics (e.g., ethnicity), family history, and cancer diagnosis will be collected in order to determine if there are relationships between the gene polymorphisms, cancer diagnosis, and these characteristics.

the purpose of this study is to discover whether certain vitamin d receptor (vdr) gene polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (bcc) and/or cutaneous squamous cell carcinoma (scc) in an alabama population. participant demographic information such as physical characteristics (e.g., ethnicity), family history, and cancer diagnosis will be collected in order to determine if there are relationships between the gene polymorphisms, cancer diagnosis, and these characteristics. by identifying the vdr polymorphisms for the apa1, taq1, bsm1, and fok1 genes within the participant population and comparing the genotypes to controls, the investigators hope to demonstrate which gene polymorphisms indicate an increased risk for scc or bcc. inclusion- patients with a non-melanoma skin cancer. participants must be 50 years old or older. controls- patients without non-melanoma skin cancer and who have no family history of skin cancer. they must also be 50 years old or older; inclusion for both groups- english speakers and patients at the kirklin clinic during the months of our data collection. exclusion criteria will be patients younger than 50 years old or who have a diagnosis of melanoma or other type of cancer, or who are non-english speakers.

Eligibility criteria:
inclusion criteria: * patients with non-melanoma skin cancer (cases) * patients without non-melanoma skin cancer or history of non-melanoma skin cancer (controls) * age 50 and older * native english speakers * patients at kirklin clinic exclusion criteria: * age less than 50 * diagnosis of melanoma or other type of cancer * non-english speakers
impact of forest baths on emotional well-being in people with sub-clinical symptomatology of anxiety and depression

Conditions: Psychological Well-being

Summary: the investigators intend to evaluate patients aged 18 to 99 years with symptoms of anxiety and/or mild depression. a randomized controlled clinical trial will be carried out to evaluate the impact of the guided practice of forest bathing.

the practice of shinrin-yoku, also known as forest bathing, is an outdoor therapeutic modality with growing evidence suggesting positive effects on the psychological well-being and general health of individuals. however, its benefits have been studied mainly in asian countries, needing further research to assess whether its benefits are also generalizable to other european-mediterranean regions. to explore this question, the investigators intend to evaluate patients aged 18 to 99 years with symptoms of anxiety and/or mild depression. a randomized controlled clinical trial will be carried out to evaluate the impact of the guided practice of forest bathing. the participants will be randomly distributed in two arms, with a crossover design: arm a intervention + control; arm b control + intervention. participation in this study consists of the execution of two sessions of guided forest bathing practice, and the completion of online evaluation forms before and after each session of guided forest bathing practice, for 24 hours afterwards, as well as before and after the program as a whole. the study includes clinical assessments, emotional well-being, social support and other complementary indicators. for hypothesis testing, a linear model of univariate analysis of variance intrasubject design will be applied to the dependent variables, with three phase conditions (pre, post and follow-up) and two treatment conditions (intervention vs. control).

Eligibility criteria:
inclusion criteria: * men or women aged 18 to 65 years. * voluntary signature of informed consent. * symptomatology of anxiety and/or mild depression with mild interference in daily functioning. * motivation, attitude and ability to work in a group. * receptive attitude to learning new skills and sharing experiences. exclusion criteria: * serious psychiatric disorder: major depressive disorder with or without psychotic symptoms, uncompensated major depressive episode, dysthymic disorder, presence of suicidal ideation or suicide attempts, personality disorder. * lack of knowledge of catalan and spanish. * disconformity with acceptable standards of conduct.

Keywords: forest bath outdoor therapy psychological well-being rct
psychometric proprieties and validation of self-report measures of eating behaviors

Conditions: Obesity; Eating Disorders

Summary: obesity is a global epidemic and a major contributor to some of the leading causes of death. although research on overweight and obesity is constantly increasing, to date, in the italian panorama, there is a lack of (a) rigorous psychological measurement tools of obesity-related constructs and (b) analysis of the relationships between constructs (and indicators) involved in the development and maintenance of overweight and obesity. the present study aims to examine the psychometric properties of the main questionnaires for the assessment of eating behaviors in 3 groups of subjects (1) the general population (control group); (2) subjects with obesity without a comorbid diagnosis of an eating disorder; (3) subjects with obesity and a comorbid diagnosis of an eating disorder.

participants were selected in the main rehabilitation centers for the treatment of obesity and eating disorders (sample of subjects with obesity) and through an online survey (community sample). the survey lasted about 30 minutes and - together with selected demographic and biomedical information - required the completion of the following self-report measures: the binge eating scale (bes); the modified yale food addiction scale version 2 (myfas 2.0); the repetitive eating questionnaire (rep-eat); the measure of eating compulsivity (mec); the addiction-like eating behavioural scale (aebs); the three factor eating questionnaire 18 (tfeq-18); the eating disorders examination questionnaire-short form (edeq-sf); the palatable eating motive scale (pems); the weight sigma questionnaire (wssq); the emotional eating scale (ees); the somatic symptom scale 8 (sss8). before administration, all questionnaires were first translated from english (their original language) to italian by two bilingual translators, independently - then back-translated into english by another independent translator whose mother tongue was english to ensure equivalence between the translations. following, a purposive sample of respondents was asked to fill in the final version of each measure in order to assess its items' comprehensibility. in order to avoid halo effects, the questionnaires were presented to the subject in random order. the responders could withdraw the administration at any time, and contact a psychologist independent from the study in case of perceived emotional distress.

Eligibility criteria:
inclusion criteria: * bmi \> 30 kg/m2 (clinical sample) * diagnosis of an eating disorder (clinical sample) * age range 18-75 years * italian mother tongue * written and informed consent to participate exclusion criteria: * visual impairing * neurological problems * alcohol/drug abuse
lambre™ left atrial appendage closure system follow-up study

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the lambre™ left atrial appendage (laa) system registration trial. the follow-up time was 2 years, 3 years, 4 years and 5 years after left atrial appendage closure operation, to evaluate the long-term safety and effectiveness of lambre™ laa closure system.

all subjects who completed 1-year follow-up of the lambretm laa system registration trial will be conducted 2 years, 3 years, 4 years and 5 years follow-up by the telephone call. during the follow-up, the investigator or his/her designee will use a standardized form to record the occurrence of the subject's safety events and validity endpoint by telephone，and complete the safety and efficacy summary report. the endpoints of the study included compound events, macce events, stroke, haemorrhage and other events.

Eligibility criteria:
inclusion criteria: - patients who participated in the lambretm safety and efficacy study and completed the 1-year follow-up. the inclusion criteria of lambretm safety and efficacy study: 1. age\>=18, chads2 score\>=1 2. patients cannot be treated long-term with warfarin 3. eligible for clopidogrel and aspirin 4. provide written informed consent and agree to comply with the required follow-ups exclusion criteria: - exclusion criteria: patients who did not participate in the lambretm safety and efficacy study or did not complete 1-year follow-up lambretm safety and efficacy study. the exclusion criteria of lambretm safety and efficacy study: 1. need to take warfarin 2. presence of rheumatic, degenerative or congenital valvular heart diseases 3. early stage or paroxysmal atrial fibrillation 4. symptomatic patients with carotid artery disease (such as carotid stenosis\>=50%) 5. heart failure nyha grade iv 6. recent 30 days stroke or tia 7. presence of active sepsis or endocarditis 8. cardiac tumours or other malignancy with estimated life expectancy \<2 years 9. abnormal blood test; renal dysfunction 10. laa removed or heart implant patients 11. patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the lambre system 12. patients have a history of mechanical prosthesis operation 13. patients who are pregnant, or desire to be pregnant during the during the study 14. participation in other trials 15. a known allergy to nitinol 16. patients will not be able to complete the trial
htems treatment of diabetic polyneuropathy

Conditions: Diabetic Polyneuropathy

Summary: so far, there are no sufficient pharmacologic therapies for the treatment of diabetic neuropathy. therefore, we evaluated application of high-tone external muscle stimulation (htems) compared to placebo treatment in patients with diabetic neuropathy.

patients (n=80) with symptomatic diabetic neuropathy will be included into this randomized controlled trial. each intervention will be administered for a period of at least 30 min on at leat 5 days in a week. health impairments will be assessed using the neuropathy symptom score (nss) before, during and after intervention.

Eligibility criteria:
inclusion criteria: * symptomatic diabetic neuropathy * stable oral analgesic regimen exclusion criteria: * history of drug or alcohol abuse * cardiac pacemaker or defibrillator * pregnancy

Keywords: diabetes neuropathy pain htems