Kornimate/medical-research-clean huggingface dataset:
lidorestat (idd 676) for the treatment of diabetic neuropathy

Conditions: Diabetic Polyneuropathy

Summary: this clinical trial is to determine an effective dosage and to study the safety of an investigational drug -lidorestat (idd-676)- which is intended to stop or slow the progression of diabetic peripheral neuropathy.

diabetic peripheral neuropathy is one of the most important and serious complications of diabetes. it can cause pain and loss of sensation, loss of mobility and lead to chronic wounds and amputations. studies indicate 50% or more of people who have diabetes now have or will have significant neuropathy. several currently marketed or investigational drugs are available to treat the painful symptoms of diabetic peripheral neuropathy, but there are no approved drugs that have been shown to prevent or slow the progression of the neuropathy itself. the current clinical trial is an early phase ii study designed to investigate the safety of the investigational drug lidorestat (idd-676) and to determine the effect of various dose levels on important biochemical processes in the pathology of diabetic neuropathy. participants who enter and complete this study will, if the agent is successful, help in a very important way to bring an effective treatment from research laboratories to widespread availability for treatment. on the basis of the results of this study, large scale studies will be undertaken to support application for product registration and distribution in the u.s. and other countries throughout the world.

Eligibility criteria:
inclusion: * clinical diagnosis of type 1 or type ii diabetes with mild to moderate diabetic peripheral neuropathy. * healthy status except for diabetes * ability to make frequent clinic visits over a 7-month period. * willingness and ability to understand and sign consent form. exclusion: * pregnancy or breast feeding * presence of uncontrolled hypertension * history or presence of significant kidney or liver disease.

Keywords: ari diabetic polyneuropathy diabetic complications
study to evaluate ccs1477 (inobrodib) in haematological malignancies

Conditions: Haematological Malignancy; Acute Myeloid Leukemia; Non Hodgkin Lymphoma; Multiple Myeloma; Higher-risk Myelodysplastic Syndrome; Peripheral T Cell Lymphoma

Summary: a phase 1/2a study to assess the safety, tolerability, pk and biological activity of ccs1477 (inobrodib) in patients with non-hodgkin lymphoma, multiple myeloma, acute myeloid leukaemia or high risk myelodysplastic syndrome.

this includes patients with peripheral t-cell lymphoma.

Eligibility criteria:
inclusion criteria: * provision of consent * ecog performance status 0-2 * patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (nhl, mm and aml) * must have previously received standard therapy * adequate organ function exclusion criteria: * intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose * major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment * strong inhibitors of cyp3a4 or cyp3a4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment * strong inducers of cyp3a4 within 4 weeks of the first dose of study treatment * patients should discontinue statins prior to starting study treatment * cyp2c8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment * any unresolved reversible toxicities from prior therapy \>ctcae grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy) * any evidence of severe or uncontrolled systemic diseases * any known uncontrolled inter-current illness * qtcf prolongation (\> 480 msec)
reflectance confocal microscopy to diagnose mm & lm

Conditions: Melanoma (Skin); Lentigo Maligna

Summary: a reflectance confocal microscope is a machine which is able to examine the upper layers of the skin painlessly and without the need for taking a biopsy. we would like to examine the images taken by the confocal microscope to see if it can help more accurately identify lesions which are worrying rather than a benign mole. we are performing this study in patients in whom we have recommended excising a mole to exclude a cancer. if the results of the study show that the confocal microscope can help more accurately diagnose melanomas then this would reduce the number of biopsies that are taken that turn out not to be cancerous (ie unnecessary biopsies).

study design this is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo rcm as a diagnostic tool in the diagnosis of mm and lm. study endpoints the hypothesis of this study is that the use of rcm is would reduce the nne prior to definitive treatment by at least 30% from the current value of approximately 10. the secondary hypothesis is that the intra- \& inter-observer agreement for interpreting the rcm images will have kappa scores 0.6 or greater (indicating good agreement). setting and recruitment patients will be recruited from the outpatient clinics of the skin care network barnet, and from the outpatient clinics of the chase farm and barnet sites of royal free hospital nhs foundation trust. participants the number of true negative lesions examined in this study will be 654. it is anticipated that this will result in a total of 661 lesions being recruited. 10% of participants are expected to have more than one lesion sampled. the result of biopsy for each lesion will not be known until after the lesion has been included in the study. therefore lesions will be added to the study until the required number of true negatives has been included.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. patient with a pigmented lesion recommended for excision because of suspicion of mm or lm. 3. patient willing and able to give informed consent exclusion criteria: 1. recurrent mm or lm 2. patient on immunosuppresants 3. patient with significant co-morbidity or skin disease 4. patient not suitable for diagnostic biopsy 5. location of lesion unsuitable, inaccessible or impractical for scanning with rcm as determined by investigator

Keywords: confocal rcm imaging skin cancer
nationwide trends in incidence, healthcare utilization, and mortality in hospitalized acute myocardial infarction patients in taiwan

Conditions: Acute Myocardial Infarction

Summary: this was a retrospective study using the taiwan's national health insurance research database (nhird). the study employed two study designs for different purposes as follows: * a cross-sectional analysis was conducted to explore the annual incidence trends. * a longitudinal cohort study was conducted to assess baseline characteristics, treatment patterns, long-term healthcare utilization, and cause-specific mortality among incident ami patients. in each part, the study was conducted for ami, and separately for st-segment elevation and non-st- segment elevation myocardial infarction (stemi and nstemi)


Eligibility criteria:
inclusion criteria: cross-sectional analysis: * patients aged 20 years and older. * patients who had been admitted for ami, defined as primary or first secondary diagnosis of ami between 2014 and 2020. * the diagnosis of ami/ stemi/ nstemi was identified by the international classification of diseases, 9th revision, clinical modification (icd-9-cm) codes and 10th revision (icd-10-cm) codes. * incident cases of ami hospitalization were defined as no history of ami-related hospitalization or outpatient visit within 1 year before admission. longitudinal analysis: patients aged 20 years and older. * patients who had been admitted for ami, defined as primary or first secondary diagnosis of ami between 2014 and 2017. * the diagnosis of ami/ stemi/ nstemi was identified by icd-9-cm codes and icd-10-cm codes. (the icd-9-cm code and icd-10-cm codes were the same as above) * incident cases of ami hospitalization were defined as no history of ami-related hospitalization or outpatient visit within 1 year before admission. * the cohort entry date was defined as the admission date of incident ami hospitalization, and the index date was defined as the discharge date of incident hospitalization. exclusion criteria: none specified
dose finding of quetiapine fumarate 200mg vs 400mg in first episode psychosis

Conditions: Psychosis

Summary: the purpose of this study is determine the minimal effective dose and the impact on: 1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode 2. the final maintenance doses 3. the use of other medications 4. the amount of changes to other antipsychotic medication 5. the number of hospitalization days


Eligibility criteria:
inclusion criteria: * patients experiencing their first psychotic episode * male or female * aged 15-25 exclusion criteria: * previous treatment with antipsychotic medication (longer than 1 week) * history of a clinically significant physical illness * organic disorder presenting with psychotic symptoms

Keywords: first episode psychosis
pain relief intervention of meditation in renal disease (primer)

Conditions: Chronic Kidney Diseases; Renal Disease; Chronic Kidney Failure; End Stage Renal Disease

Summary: kidney disease subjects will be recruited to take part of a mindfulness-based stress reduction intervention for 8-10 sessions. all subjects will complete a baseline interview, one follow-up at 3 months and the close out interview at 5 months.

kidney disease subjects will be recruited from multiple locations within the rogosin institute dialysis center to take part of a mindfulness-based stress reduction intervention. the intervention consists of meet with a researcher and/or research assistant on a weekly basis. dialysis patients will receive the intervention individually while on dialysis. dialysis is an optimal time for conducting interventions as patients are there for 3-4 hours every 3 days. for 8-10 weeks (which will begin the week after the baseline interview). chronic kidney disease (ckd) patients will receive the intervention in group setting. key components of what the intervention consists relate to stress management, breathing, and meditation exercises, as well as, techniques aimed at improving relations with others, sense of mastery and purpose in life. additionally, during every point of contact, will be asked how often they utilized the strategies they were taught. this information will be helpful in understanding each person's individual level of mastery and proficiency in mindfulness-based stress reduction (mbsr). all subjects will complete a baseline interview, one follow-up at 3 months and the close out interview at 5 months.

Eligibility criteria:
inclusion criteria: * patients with chronic kidney disease (ckd) and esrd on dialysis for over 6 months and who are willing to consent. english speakers only, 18 years of age or older exclusion criteria: * patients with severe cognitive or psychiatric impairment will be excluded. patients who are not willing to provide consent.

Keywords: ckd, dialysis, esrd mindfulness-based stress reduction (mbsr)
the psychobiological effects of participation in a one-month insight meditation retreat

Conditions: Aging

Summary: the purpose of this study was to examine how participation in a 1 month intensive insight (vipassana) meditation retreat (a) affects biological markers of cellular aging, social affiliation, and inflammation, which are important for physical health, longevity, and behavior, and (b) to relate observed biological changes to baseline levels and changes in psychological traits, which may underlie improvements in personal adaptive functioning.

the investigators are specifically assessing the effects of retreat on telomere length and telomerase levels in participants' white blood cells, as well as plasma levels of interlukin-6 (il-6), to assess how the retreat experience impacts these markers of cellular aging and inflammation. the hypotheses are that retreat participation will increase both telomere length and telomerase activity, but decrease il-6 levels. the investigators will also assess the impact of retreat participation on oxytocin-a hormone involved in a number of physiological and behavioral processes, including affiliative bonds and stress responses-the hypothesis being that participation in the retreat will increase plasma oxytocin levels. the investigators will then explore how these and other biomarkers relate to psychological processes and personality traits, which may also be altered by participation in the meditation retreat.

Eligibility criteria:
inclusion criteria: * previous meditation experience equivalent to two 5-10 day residential meditation retreats exclusion criteria: * disclosure of potentially contagious blood-borne illness (e.g., hiv, hepatitis, etc.) or other illnesses that might interfere with telomere or telomerase measurement

Keywords: well-being, affiliation, inflammation
a post marketing surveillance on lutathera® in patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumor in korea

Conditions: Somatostatin Receptor-positive GEP-NET

Summary: this is a prospective, open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of lutathera in patients with somatostatin receptor-positive gep-net in the real-world setting in korea.


Eligibility criteria:
inclusion criteria: 1. patients who start lutathera treatment per clinical judgment, according to the locally approved labeling. - somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets) in adults. 2. patients who are willing to provide written informed consent. exclusion criteria: 1. patients with contraindication according to prescribing information for lutathera in korea.

Keywords: somatostatin receptor-positive gep-net lutathera observational prospective
pilot study: vr mind and vr mind+ intervention

Conditions: Social Phobia

Summary: the aim of the pilot study is feasibility, usability and safety assessment of vr mind intervention. in particular the subject of assessment will be: * the length of the laboratory session utilizing virtual reality exposure (feasibility), * the ergonomics and ease of use for both patients and system operators (usability), * the frequency of side effect occurrence as a result of virtual reality exposure (ie. vertigo) (safety). the results pilot study will be used in the designing a clinical trial aimed for testing efficacy and safety of vr mind intervention.

in this study, investigators will test the software developed by tomorrow sp. z o. o., named vr mind. the software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. the pilot investigators will be tested for the feasibility, usability and safety of the system in order to obtain information useful in further designs for the clinical trial. the research consists of four laboratory sessions. the first and the last session will be dedicated to participant assessment. during the second and third session the virtual reality scenarios (2 x 10 minutes for each session) will be presented to participants. the participants will be playing a role of someone who is giving a speech (public speaking scenario) and someone who is speaking on a phone in public (telephoning in public scenario).

Eligibility criteria:
inclusion criteria: 1. age: 18-50 y.o. 2. confirmed dsm-iv-tr criteria for social anxiety disorder (sad). 3. signing informed consent exclusion criteria: 1. occurrence of sad symptoms inconsistent with dsm-iv-tr criteria and with psychiatric interview (scid-i; structured clinical interview) 2. occurrence and/or recognition: 1. psychosis, 2. bipolar disorder, 3. mental retardation 3. exclusion based on interview: 1. pregnancy, 2. drug addiction, 3. alcohol addiction, 4. participating in the experimental session while intoxicated 5. (current) neurological treatment of chronic disease of central nervous system, 6. epilepsy, 7. paroxysmal vertigo, 8. presence of suicidal thoughts , tendencies or attempts, 9. participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs

Keywords: vr virtual reality social phobia vret virtual reality exposure therapy
curcumin and intravitreal dexamethasone in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the aim of the study is to explore the effect of a curcumin formulation in combination to intravitreal dexamethasone therapy in patients with diabetic macular edema on morphological retinal characteristics and retreatment times.

patients with diagnosis of clinically significant diabetic macular edema, confirmed by fluorangiography and oct, undergoing to intravitreal dexamethazone injection will be enrolled in the study. enrollment will take place according to the inclusion/exclusion criteria set by the protocol. the enrolled patients will be randomized for the addition or not of the curcumin formulation (2 tablets/die for 6 months) to intravitreal therapy.

Eligibility criteria:
inclusion criteria: * - patients with clinically significant diabetic macular edema in non-proliferative diabetic retinopathy, diagnosed by fluorangiography and oct * naive patients * patients with clinically significant dme who have not been treated for more than 3 months with anti-vegf therapy and for more than 6 months with intravitreal injection of dexamethasone * central retinal thickness (crt) at oct\> 300 microns * best corrected visual acuity (bcva) with etdrs tables at 4 meters not \<20/400 * ability to provide written informed consent and follow the procedures of the study exclusion criteria: * retinal pathologies other than diabetic macular edema * proliferative diabetic retinopathy * opacities that limit the execution and interpretation of diagnostic tests * surgical interventions in the study eye in the 3 months prior to the start of treatment * pregnancy * feeding time

Keywords: therapy for diabetic macular edema curcumin formulation (diabec)
stroke volume variations and pulse pressure variations undergoing artificial pneumothorax surgery

Conditions: Artificial; Complications, Heart

Summary: stroke volume variation (svv) and pulse pressure variation (ppv) have been thought to be sensitive predictors of fluid responsiveness in mechanically ventilated participants. in this paper, the investigators reported a special group of people to use svv and ppv during their operation. the maintenance of hemodynamic stability and the critical organ perfusion is crucial to the treatment for patients with artificial pneumothorax during esophageal surgery, because artificial pneumothorax causes incomplete ventilation of one lung. in addition, artificial pneumothorax may seriously affect theparticipant's heart and lung function, brings more challenges to the intraoperative anesthetic management, expecially in volume management. little information is available about the accuracy of svv and ppv to predict fluid responsiveness in participants with artificial pneumothorax during esophageal surgery. it is unclear whether it will affect the accuracy of svv and ppv, and whether it will cause the change of their threshold values. the investigators will discuss it in the passage and the investigators will give an preliminary mechanism to explain the results.

backgroud: this study aims to evaluate the ability of stroke volume variation (svv) and pulse pressure variation (ppv) to predict fluid responsiveness in mechanically ventilated participants with artificial pneumothorax during esophageal surgery. methods: 40 participants, diagnosed with esophageal cancer, undergoing thoracoscopic radical resection of esophageal cancer were studied. all the participants used vigileo/flotrac system for analysis. haemodynamic data such as map, hr, sv, svi, co, ci, svv, ppv were recorded before and after volume expansion (ve). fluid responsiveness was defined as an increase in svi≥10%(△svi≥10%). participants were divided into responders and non-responders by changes in △svi ≥10% and \< 10%. nonparametric wilcoxon rank sum test was used to compare the hemodynamic parameters of responders and non-responders before and after ve. pearson correlation analysis was used to analyze the values of svv, ppv and △svi. the receiver operating characteristic (roc) curve of each hemodynamic index was drawn to determine its accuracy and threshold.

Eligibility criteria:
inclusion criteria: must be arranged for thoracoscopic surgical treatment of esophageal cancer must be mechanically ventilated with artificial pneumothorax during the operation must be normal in allen test. exclusion criteria: hypertension coronary heart disease arrhythmia left ventricle ejection fractions \< 50% (ef\<50%) pulmonary hypertension congenital cardiovascular malformation peripheral vascular disease long-term history of oral vasoactive drugs
study of carrageenan's effect on insulin resistance in humans

Conditions: Diabetes Mellitus, Type 2; Insulin Resistance

Summary: the purpose of this study is to determine whether the ingestion of the common food additive carrageenan contributes to insulin resistance and thus to the pathogenesis of type 2 diabetes in humans.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) 18.5 - 29.9 kg/m² exclusion criteria: * any chronic illness * any ongoing medication * known infections * known liver disease * known renal insufficiency * alcohol consumption over 30 g/d * shift work