Kornimate/medical-research-clean huggingface dataset:
intravitreal ranibizumab combined with panretinal photocoagulation in patients with proliferative diabetic retinopathy

Conditions: Diabetic Retinopathy; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases

Summary: to evaluate the efficacy of combination therapy with ranibizumab (rbz) and panretinal photocoagulation (prp) versus prp alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (pdr) as measured by mean change in visual acuity (va), mean change in central retinal thickness (crt) as measured by time-domain optic coherence tomography (td-oct) and incidence of vitreous hemorrhage (vh).

comparative efficacy of combined treatment including intravitreal injection of 0.5 mg of lucentis (ranibizumab) and laser photocoagulation for patients with proliferative diabetic retinopathy (pdr). objectives: primary objective: the primary objective will be to evaluate the efficacy of combined treatment with ranibizumab and laser photocoagulation versus laser photocoagulation alone in patients with severe pdr by the mean change in bcva at v7/m6 compared to baseline. the best visual acuity (bcva) measured by the early treatment diabetic retinopathy study (edtrs). secondary objectives: to evaluate differences in optic coherence tomography (oct) retinal thickness and total macular volume of combined treatment regiment including intravitreal injection of 0,5 mg of lucentis (ranibizumab) and laser photocoagulation for patients with pdr at visit 7 compared to the baseline assessments. to evaluate the percentage of patients that present with vitreous hemorrhage after the beginning of the laser treatment at visit 7 compared to the baseline assessments. strategic goal: the main goal of this study is to evaluate if the use of intravitreal ranibizumab in eyes submitted to pan-retinal photocoagulation (prp) due to pdr induces less macular edema and less vitreous hemorrhage and therefore leads to a better visual outcome

Eligibility criteria:
inclusion criteria: * naive proliferative diabetic retinopathy eyes. * best corrected-visual acuity at baseline \> 20/320 in the study eye * patients with and without diabetic macular edema * type ii diabetic subjects as defined by the world health organization aged ≥ 18 years. * women must be using effective contraception * ability to provide written informed consent. * indication of panretinal photocoagulation in both eyes exclusion criteria: * vitreous hemorrhage or pre-retinal hemorrhage * eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months * atrophy/scarring/fibrosis/ hard exudates involving the center of the macula. * cataract * any intraocular surgery within 6 months before trial enrollment * previous vitrectomy. * any of the following underlying systemic diseases: * history or evidence of severe cardiac disease or previous thrombus-embolic event

Keywords: proliferative diabetic retinopathy ranibizumab panretinal photocoagulation
13-cis retinoic acid (isotretinoin) and sperm production

Conditions: Men with Infertility

Summary: this study aims to evaluate the effectiveness of weekly administration of isotretinoin (40 mg) in increasing sperm production in men with oligozoospermia, a condition characterized by a low sperm count. participants will be randomized into two groups: one receiving isotretinoin and the other a placebo. the primary outcome will be the change in sperm production over 20 weeks of treatment.


Eligibility criteria:
inclusion criteria: * subjects will be infertile men (no pregnancy with partner with normal cycles and normal hysterosalpingogram despite \>1 year of unprotected intercourse). * abnormal sperm analyses with a total, motile sperm count of less than 10 million sperm as assessed by semen analysis on two occasions separated by one week. * male patients aged 21-55 years * affiliation with a social security system * ability to provide informed consent exclusion criteria: * -men participating in another clinical trial * clinically significant abnormal findings at screening * known genetic infertility (e.g. klinefelter syndrome or y-chromosome microdeletions), * hypogonadotropic hypogonadism (that might respond to gonadotropin injections), * severe mental health problems requiring medications * current therapy with retinoic acid (e.g. accutane) or vitamin a. * history of psychiatric disorders (e.g., depression, suicidal tendencies). * abnormal serum chemistry values according to local laboratory normal values which indicate liver or kidney dysfunction. * men currently receiving tetracycline containing medications * men who have used isotretinoin within eight weeks of the start of dosing * men with elevated serum triglycerides
shear wave elastography of prostate cancer

Conditions: Prostate Cancer

Summary: evaluation of significant shear wave elastography parameters for prostate biopsy and prostate cancer detection.

this study will evaluate the shear wave elastography (swe) parameters for prostate biopsy and prostate cancer detection.

Eligibility criteria:
inclusion criteria: * suspicious for prostate cancer with no pretreatment and prostata specific antigen (psa) \>4ng/ml or psa velocity \> 0.75 ng/ml per year or suspicious transrectal digital examination * status after external beam radiotherapy of the prostate in localized prostate cancer and suspicious for local prostate cancer recurrence exclusion criteria: * none.

Keywords: prostate cancer shear wave elastography prostate prostate biopsy
epigallocatechingallate (egcg) in cardiac al amyloidosis

Conditions: Primary Amyloidosis of Light Chain Type

Summary: in a proportion of patients with al amyloidosis there is no improvement of cardiac function despite hematologic response to treatment. the aim of the study is to assess whether treatment with egcg increases the rate of cardiac response in patients with al amyloidosis who completed chemotherapy.

this will be a phase ii open-label randomized trial. patients with al amyloidosis and cardiac involvement who have achieved at least partial hematologic response after chemotherapy will be randomized to receive standard supportive therapy (sst) or sst plus epigallocatechin gallate (egcg). after giving written informed consent, the patients will be evaluated for eligibility. briefly, the subjects with a biopsy-proven diagnosis of al amyloidosis who achieved at least partial response after chemotherapy, who are not planned to receive further chemotherapy and who have significant cardiac dysfunction will be considered eligible. the patients will be stratified according to the quality of hematologic response and to the severity of cardiac involvement. following stratification, the patients will be randomized to receive sst or sst plus egcg. the study comprises 3 periods: screening (including stratification and randomization), treatment (with evaluations of response every 2 months) followed by the end-of-treatment evaluation and follow-up. therapy will continue for up to 1 year. after treatment patients will be followed for 3 years.

Eligibility criteria:
inclusion criteria: * diagnosis of al amyloidosis. * age ≥18 years. * the patients must have been treated for al amyloidosis attaining hematologic response. * evidence of cardiac involvement at echocardiography (mean left ventricular wall thickness \>12 mm in the absence of other causes). * nt-probnp ≥650 ng/l exclusion criteria: * non-al (e.g. familial, senile) amyloidosis. * concomitant non-amyloid related clinically significant cardiac diseases. * need of further chemotherapy for al amyloidosis. * estimated glomerular filtration rate (egfr) \<30 ml/min per 1.73 m2. * uncontrolled infection. * inability to give informed consent. * previous or ongoing psychiatric illness (excluding reactive depression). * pregnant or nursing women.

Keywords: epigallocatechin gallate al amyloidosis
amlodipine 10mg drug use investigation

Conditions: Hypertension

Summary: in this survey, to collect the safety and efficacy information in the subjects who have been treated with amlodipine 5mg at least 4 weeks in daily practice.

all the subjects whom an investigator prescribes amlodipine (norvasc®) 10mg tablet should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: * male or female subjects who have been treated with amlodipine 5mg at least 4 weeks * the subjects who had not achieved target bp exclusion criteria: * subjects who have been prescribed amlodipine (norvasc®) 10mg tablet before

Keywords: enter10 hypertension japanese norvasc 10mg post marketing surveillance
effects of n-acetylcysteine on pulmonary function in high-risk patients undergoing off-pump coronary bypass surgery

Conditions: Coronary Artery Occlusion

Summary: the purpose of this study is to study the effects of n-acetylcysteine on pulmonary function in high-risk patients undergoing off-pump coronary bypass surgery.


Eligibility criteria:
inclusion criteria: * adult patients with euroscore ≥ 5 exclusion criteria: * patients in need of emergency surgery,acute renal failure patients, kidney transplanted patients, patients injected with nac 5days before planned surgery
her2 status in esophagogastric adenocarcinoma and its associations with patient's clinicopathological outcomes

Conditions: Esophagus Cancer; Gastric Cancer; HER2-positive Cancer; HER2-low Cancer

Summary: targeted therapies offer promise to improve oncologic outcomes in esophagogastric adenocarcinoma (ega). the landmark 'trastuzumab for gastric cancer (toga)' trial established the therapeutic value of human epidermal growth factor receptor 2 (her2) directed therapy in advanced gastric and esophagogastric junction adenocarcinoma, setting a standard of care. further studies, such as destiny-gastric01 and destiny-gastric02, have demonstrated the efficacy of antibody-drug conjugates (adcs) targeting her2-positive gastric and junctional tumours. the use of her2-directed therapies in the curative intent setting has more recently been evaluated with favourable outcomes in phase ii studies. however, data regarding the prevalence and prognostic significance of her2 overexpression among patients undergoing treatment with curative intent are limited. furthermore, few studies have evaluated the clinical significance of intratumoural and tumour-metastatic heterogeneity of her2 expression, and the finding of her2-low, in this context, which may have important implications for implementation of neoadjuvant targeted therapies in future. while limited single centre series have evaluated the clinicopathologic significance of her2 status in ega, no previous international multicentre study of this nature has been reported. the goal of this international, multi-center, retrospective observational study is to elucidate the prevalence and clinical significance of her2 expression in patients with ega across different regions globally. the study also aims to assess the clinical significance of her2 heterogeneity in a large, international cohort of patients with ega, and its association with clinicopathological outcomes in patients with advanced and recurrent disease.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed ega from 2000 to april 2024 across all stages of disease * primary tumour her2 status tested as routine in all patients with ega * patients aged 18 years or over exclusion criteria: - patients with esophageal squamous cell carcinoma

Keywords: esophageal cancer gastric cancer her2-positive cancer her2-low cancer targeted treatment
a study of guselkumab in pediatric participants with moderately to severely active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.


Eligibility criteria:
inclusion criteria: * weight greater than or equal to (\>=) 10 kilogram (kg) at the time of consent for screening * a pathology report to support a documented diagnosis of ulcerative colitis (uc) must be available in the source documents. there is no maximum duration for which a participant needs to be diagnosed with uc. if the pathology report to support a documented diagnosis of uc is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of uc. * moderately to severely active uc, defined by a baseline modified mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening mayo endoscopy subscore \>= 2 as determined by a central review of the video of the endoscopy * medically stable based on physical examination, medical history, and vital signs, performed at screening. any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator * participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids exclusion criteria: * have uc limited to the rectum only or to less than (\<) 20 centimeter of the colon * presence of a stoma * has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline * have severe colitis or have evidence of crohn's disease (cd)
focal therapy for localized prostate cancer

Conditions: Prostate Cancer

Summary: to evaluate the cancer control for prostate cancer patients treated with focal therapy.

traditional treatments for localized prostate cancer are radical prostatectomy and radiotherapy. however, they would carry side effects including urinary incontinence, sexual dysfunction, radiation cystitis and proctitis, leading to great impact on quality of life. focal therapy of is another emerging treatment strategy for localized prostate cancer. it aims on ablation of the tumor with sparing of healthy prostatic tissue in order to minimize the injury to urinary and sexual function. besides, owing to the improvement of multiparametric magnetic resonance imaging (mpmri), the investigators can localize the prostate cancer more precisely and the accessibility of focal therapy is also increased. literature showed focal ablation of hifu or cryotherapy for low and intermediate-risk prostate cancer patients yielded in brilliant outcomes. biopsy in post-treatment one year showed 87% and 94.6% were negative for clinically significant cancer, respectively. up to 92% of patients did not need salvage treatment in two years. ninety-one to one hundred precent of patients had no urinary incontinence, and 74% and 81.5% had no erectile dysfunction, respectively. this prospective study aims to evaluate the cancer control and quality of life for prostate cancer patients treated with focal therapy.

Eligibility criteria:
inclusion criteria: * biopsy-proven unilateral prostate cancer, the other side insignificant cancer (gleason 6 or less and maximal cancer core length 4mm or less) is allowed * clinical t2a or less * gleason 4+3 or less * serum psa less than 20 ng/ml exclusion criteria: * t2b or higher * gleason 4+4 or higher * serum psa 20 or higher * lymph node or distant metastasis * previous treatment with prostatectomy, radiotherapy, androgen deprivation therapy, hifu, or cryoablation
oxytocin effect on attentional bias towards emotional expression faces in individuals with high and low autistic traits: a functional magnetic resonance imaging (fmri) study

Conditions: Healthy

Summary: to investigate whether oxytocin alter attentional bias towards emotional expression faces in individuals with high and low autistic traits, and the brain mechanism of this effect

in the present study, investigator plan to use a double-blind, between-subject placebo controlled design.firstly, all healthy male subjects' autistic trait levels will be assessed by the autism spectrum quotient (asq) and only subjects with higher or lower asq score will be recruited in the next experiment and divided into high and low subgroup. then, subjects are randomly assigned to receive either intranasal administration of oxytocin (24 iu) or placebo. 45 min later, subject need to complete an attentional bias task named rapid serial visual presentation (rsvp) task in fmri scanner.

Eligibility criteria:
inclusion criteria: * healthy subjects without past or current psychiatric or neurological disorders exclusion criteria: * history of head injury; * claustrophobia; * medical or psychiatric illness.

Keywords: oxytocin attentional bias autism
interactive stepping exercise on memory

Conditions: Amnestic Mild Cognitive Impairment; Interactive Stepping Exercise; Memory; Cognitive Function; Executive Function

Summary: this is a randomized controlled trail. a total of 28 individuals with amci will be randomly assigned to either the ise group or control group. the ise intervention conducts three times a week for 16 weeks. outcomes are measured at baseline and after intervention. the primary outcomes are the chinese version verbal learning test (cvvlt), selective reminding test (srt), and logic memory test (wechsler memory scale). the secondary outcomes are montreal cognitive assessment (moca) for cognitive function, and trail making test part a \& b (tmt-a \& b), stroop test, and 25-item executive interview (c-exit 25) for executive function.


Eligibility criteria:
inclusion criteria: * age≥50 years * complained of memory impairment * chinese version verbal learning test 10-minute delays ≤ 6 words * mmse score≥24 and cdr score=0.5 * activities of daily living are intact * dsm-iv criteria for the diagnosis of dementia is not met exclusion criteria: * any significant neurologic disease other than suspected incipient alzheimer's disease * psychotic features, contraindication of exercise... which could lead to difficulty complying with the protocol

Keywords: square stepping exercise amnestic mild cognitive impairment interactive stepping exercise memory cognitive function executive function
feasibility of home-based cardiac rehabilitation in patients with chronic heart failure (pilot-crhf)

Conditions: Heart Failure

Summary: the proposed study will determine the willingness of patients for participation. furthermore, the assessment of tests to identify eligible patients and the type of exercise intervention that goes along with a high patient compliance is crucial. also, more information about possible factors preventing patients from participating is required. therefore, if the patient is willing to participate, the investigators will assess patients' medical history, medication and qol as well as parameters of routine diagnostics (i.e. echocardiography, laboratory testing, mri). following, while the in-patient stay due to cardiac decompensation, the investigators will conduct several assessment-tests to determine the physical status, the exercise capacity and the cognitive function. moreover, physiotherapists will instruct the patients in the exercise program. after discharge from the hospital, physiotherapist will visit the patient at home to instruct them again in the exercises. then, the patients will conduct the program on their own for a period of 12 weeks. during the exercise period, a doctoral student will visit the patients at home every 3 weeks to check whether they are doing the exercises correctly and to determine whether there are any problems with the program. after the exercise period of 12 weeks, the baseline characteristics will be assessed again at the university hospital leipzig.

see above

Eligibility criteria:
inclusion criteria: * chronic heart failure irrespective of the ejection fraction * recent history of acute cardiac decompensation leading to hospitalization exclusion criteria: * patients not willing to participate * patients with orthopedic diseases limiting their mobility * cognitive diseases that hinder adequate participation in the opinion of the investigator * inpatient rehabilitation.
training to reconnect with emotional awareness therapy

Conditions: Traumatic Brain Injury; Alexithymia

Summary: to decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.

phase ii randomized, waitlist control (wlc) trial with 3-month follow-up to further establish proof of concept and early efficacy of treat (1:1 alexithymia treatment) for post-tbi alexithymia. it is anticipated that our target sample size is 44. the purpose of this study is to examine differences in post-treatment self-reported alexithymia and emotional self-awareness in participants with tbi randomized to treat or wlc. in addition to examining the differences in post-treatment self-reported emotion regulation (general), anxiety, anger, depression, positive affect (pa), global emotional function and quality of life in participants with tbi randomized to treat or wlc.

Eligibility criteria:
inclusion criteria: * tbi (injury due to a external physical force) * complicated mild, moderate, or severe tbi (defined by glasgow coma scale (gcs) in emergency department (ed) (≤12), or post traumatic amnesia (pta) (≥1 day),loss of conscientious (loc) (≥30 minutes),or positive head ct scan consistent with tbi) * at least 18 years or older * ≥1 year post-injury * adequate vision, hearing, speech, and comprehension * reliable mode of transportation * available for treatment during regular business hours * have moderate to high screening alexithymia score (tas-20 ≥52) * if participating in active psychological treatment prior to enrollment, their participation must be ongoing for 4 or more weeks exclusion criteria: * diagnosed with pre-morbid neurological disorder that could affect mood and cognition (e.g., stroke, alzheimer's disease, parkinson's disease); does not include controlled seizures * diagnosed with major psychiatric disorder (e.g., schizophrenia, borderline personality disorder) * severe depression and/or perceived risk to self or others * developmental disability (e.g. autism, developmental delay) * unstable or anticipated medication changes related to mood or emotion during study participation * having started psychological treatment less than 4 weeks prior to enrollment * actively participating in the traumatic brain injury model system (tbims) alexithymia outcome module

Keywords: brain injury
study to evaluate the safety and efficacy of cj-12420 in patients with erosive esophagitis

Conditions: Erosive Esophagitis; GERD

Summary: the purpose of this study is to investigate the optimal dose and administration methods of cj-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered cj-12420 to esomeprazole 40mg.


Eligibility criteria:
inclusion criteria: * aged between 20-70 * diagnosed with erosive esophagitis by esophagogastroduodenoscopy (egd) and classified into la grade a to d within 14 days before randomization to treatment exclusion criteria: * patients who cannot undergo egd * patients diagnosed with irritable bowel syndrome (ibs), inflammatory bowel disease (ibd), or suspected ibs * patients who took ppis within 2 weeks prior to study drug administration * long-term use of nonsteroidal anti-inﬂammatory drugs throughout the study * clinically significant abnormal laboratory values during screening

Keywords: p-cab apa(acid pump antagonist)