Kornimate/medical-research-clean huggingface dataset:
spl026 (dmt fumarate) in healthy subjects and mdd patients

Conditions: Major Depressive Disorder

Summary: spl026 (n,n-dimethyltryptamine \[dmt\] fumarate) is a psychedelic tryptamine being developed as a therapy for patients with major depressive disorder (mdd).

2-part study. part a in psychedelic-naïve healthy volunteers. part b in patients with mdd who score moderate-severe on ham-d. healthy volunteers will receive a single dose of spl026 in a dose-escalation parallel group study. patients will receive up to 2 single doses of spl026, 2 weeks apart. dose 1 will be randomised double-blind with placebo. dose 2 will be open label, active spl026. spl026 will be administered by iv injection. safety and tolerability, pk, pd and efficacy will be measured.

Eligibility criteria:
inclusion criteria: normotensive male or female, deemed healthy on the basis of a clinical history, physical examination, ecg, vital signs, laboratory tests of blood and urine, mini-international neuropsychiatric interview (mini) and beck scale for suicidal ideation (bss); willing to follow the contraception requirements of the trial; willing to refrain from psychedelic drug use (excluding the study drug) during the trial and ≥ 3 months afterwards; willing to be contacted by email and video call, and have online access; able to give fully informed written consent. part a only: psychedelic-naïve, ie have never taken a serotonergic psychedelic drug, in any form. must be 25 years or older. part b only: mdd diagnosis (as per dsm-v); not on antidepressant medication or willing to discontinue antidepressant medication (eg selective serotonin reuptake inhibitor \[ssri\] treatment) for a sufficient time before and during the study; no psychedelic drug use in the 6 months before dosing. exclusion criteria: pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception; clinically relevant abnormal findings at the screening assessment; acute or chronic illness (other than mdd \[part b only\]) or infection; clinically relevant abnormal medical history or concurrent medical condition (other than mdd \[part b only\]); positive tests for hepatitis b \& c, or hiv; severe adverse reaction to any drug; use of over-the-counter or prescribed medication (excluding oral contraceptives) within previous 28 days (paracetamol \[acetaminophen\] permitted up to 7 days, and antidepressant medication must have ceased for at least 14 days; 28 days for moais) before first dose of trial medication; drug or alcohol abuse; use of cannabis in the 24 h before each study visit; heavy smokers (\> 10 \[part a\] or \> 20 cigarettes \[part b\] daily); supine blood pressure, heart rate, or qtcf outside the acceptable ranges; participation in other clinical trials of unlicensed medicines, or loss of more than 400 ml blood, within the previous 3 months; phobia of needles or blood; possibility that volunteer will not cooperate with the study.
oct screening for diabetic macular edema at primary diabetes care visits

Conditions: Diabetes; Diabetic Macular Edema; Diabetic Retinopathy

Summary: the purpose of this protocol is to determine whether point of care optical coherence tomography (oct) imaging combined with an oct-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. the hypothesis is that oct imaging with an automated oct-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus as evidenced by: * current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes or * documented diabetes by american diabetes association and/or world health organization criteria * age greater than or equal to 18 years old * diabetes duration of 10 more years or last measured hba1c of 10% or more * able and willing to participate in study procedures and comply with study follow-up visits * able to give informed consent for study participation * not moving out of the study area during the 1 year follow-up period exclusion criteria: * unable to cooperate with the oct image acquisition procedure or other study procedures * unable or unwilling to comply with the study follow-up visits * unable or unwilling to sign form for release of retinal medical records

Keywords: diabetes diabetic macular edema diabetic retinopathy optical coherence tomography
high fat/high calorie trial in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to determine the safety, tolerability, and preliminary efficacy of long-term use of high fat/high calorie and high calorie diets in people with amyotrophic lateral sclerosis (als) (lou gehrig's disease).

weight loss is a common and severe symptom of amyotrophic lateral sclerosis (als), caused both from inadequate calorie intake and an increased metabolic rate. people with als are generally instructed to increase their calorie intake; however, the ideal amount and type of calories has not been studied. several studies in an animal model of motor neuron disease have shown that a high fat/high calorie diet can increase survival by as much as 38%. mice on a high fat diet also live longer than mice fed diets consisting of high protein or high sugar. we are therefore conducting a phase ii safety, tolerability, and preliminary efficacy trial in als of high fat versus high calorie versus normal diet. the normal diet will be calculated based on the number of calories needed to replace each participant's measured daily calorie requirement.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of als 2. male or female subjects aged 18 years or older 3. must already be tolerating tube feedings through either a gastrostomy tube (g-tube or peg) or jejunostomy tube (j-tube) 4. must require non-invasive ventilation (bipap) for less than 10 hours/day 5. women of childbearing potential must have a negative pregnancy test at screening and be non-lactating. exclusion criteria: 1. history of hepatitis including non-alcoholic steatohepatitis (nash), cholecystectomy, prior biliary disease such as gallstones 2. history of diabetes 3. history of prior myocardial infarction or stroke 4. laboratory values: screening alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 2.0 times the upper limit of normal or total bilirubin greater than 1.5 times the upper limit of normal 5. allergy to soy, fish, or milk products

Keywords: amyotrophic lateral sclerosis als motor neuron disease mnd fat lipid cholesterol omega-3 fatty acid diet tube feed gastrostomy peg adults with amyotrophic lateral sclerosis (als)
tau pet/ct in various tau-related disease patients

Conditions: Tauopathies; Neurodegenerative Diseases; Neurodegeneration

Summary: to evaluate the potential usefulness of 18f-s16/t807 positron emission tomography/computed tomography (pet/ct) for the diagnosis of primary and metastatic lesions in various tau-related disease patients.

subjects with various tau-related disease patients underwent 18f-s16/t807 pet/ct either for an initial assessment or for recurrence detection. lesions uptake was quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy of 18f-s16/t807 pet/ct were calculated.

Eligibility criteria:
inclusion criteria: - (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include mri, ct, tumor markers and pathology report); (iii) patients who had scheduled tau pet/ct scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the clinical research ethics committee. exclusion criteria: - (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Keywords: pet/ct mri tau
automated assessment of pvi using a novel ep recording system

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Summary: a prospective, multi-center study with the cathvision cube® system and the pvi analyzer software in radiofrequency (rf), cryo-balloon (cb), and pulse field ablation (pfa) procedures.

subjects with paroxysmal or persistent atrial fibrillation (af) who are indicated to undergo first pulmonary vein isolation (pvi) procedure and meet all eligibility criteria will be enrolled in the study. intracardiac signals will be passively recorded using the investigational cathvision cube® system in parallel with the conventional (ce marked) ep recording system. the investigational device will not be used for direct clinical care decisions or therapy. the validation of the automated algorithm for pvi will be performed offline the primary objective is to validate the pvi analyzer software with a novel ep recording system (cathvision cube® system) for assisting assessment of isolation status following pvi ablation. the secondary objective is to determine the feasibility of "real-time" assessment of pvi analysis and rhythm dependent performance using the pvi analyzer and cathvision cube® system.

Eligibility criteria:
eligible subjects will meet all of the following inclusion criteria: 1. subjects undergoing first-time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation 2. male or non-pregnant female aged ≥21 years. 3. able and willing to provide written informed consent prior to any clinical investigation related procedure eligible subjects will not meet any of the following exclusion criteria: 1. pregnant or nursing subjects. 2. current participation in another investigational drug or device study that interferes with this study. 3. subjects who, in the opinion of the investigator, are not candidates for this study. 4. patients who have had a prior ablation procedure 5. presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 6. life expectancy less than 12 month 7. subjects who, in the opinion of the investigator, are considered part of any vulnerable population.

Keywords: atrial fibrillation pulmonary vein isolation radiofrequency cryo balloon ablation software pulse field ablation
diagnostic accuracy and safety of dbv1605 for the diagnosis of non-ige mediated cow's milk allergy in children

Conditions: Cow's Milk Allergy

Summary: study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of dbv1605 for the diagnosis of non-immunoglobulin e (ige) mediated cow's milk allergy (cma) in children with symptoms suggestive of non-ige mediated cma.


Eligibility criteria:
disease group inclusion criteria: * male or female subjects aged \> 28 days to ≤ 24 months at screening visit * subjects with clinical symptoms suggestive of non-ige mediated cow's milk allergy * subjects with any type of diet containing daily products with cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) prior to screening visit or who have started a cow's milk elimination diet not more than 4 weeks prior to screening visit, * subjects/parents/guardians who agree to follow a strict cow's milk-free diet and other mammalian milks (such as sheep and goat's milk) as per study requirements. exclusion criteria: * subjects with an established diagnosis of non-ige mediated cma * breast-fed subject at screening visit * subjects with a convincing history of ige-mediated cma * subjects on a cow's milk protein-free diet including an aa-based formula or an extensively hydrolyzed formula initiated more than 4 weeks prior to screening visit. * generalized dermatologic disease (e.g. severe atopic dermatitis, ) extending widely on the skin. * any contraindication to a cow's milk challenge control group inclusion criteria: * male or female subjects aged \> 28 days to ≤ 24 months at screening visit * subjects having no medical history of any type of allergy * subjects who tolerate at least 200 ml of cow's milk or equivalent dairy foods daily within 4 weeks prior to screening visit exclusion criteria: * subjects with history of persistent gastro-intestinal symptoms * exclusively breast-fed subjects at screening visit

Keywords: non-ige mediated cma
a study of abiraterone acetate (jnj-212082) and prednisolone in patients with advanced prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess the safety and efficacy in korea or taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mcrpc) and with disease progression following treatment with a docetaxel-containing chemotherapy.

this is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mcrpc. the study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase. approximately 80 patients will be enrolled into this study. safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study. patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate (stage iv) * has documented prostate specific antigen (psa) progression according to protocol-specific prostate specific antigen working group (psawg) eligibility criteria * has undergone prior chemotherapy for prostate cancer with regimen(s) containing docetaxel * has an ongoing androgen deprivation with serum testosterone less than 50 ng/dl * has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment * eastern cooperative oncology group performance status less than or equal to 2 exclusion criteria: * active or uncontrolled autoimmune disease that may require corticosteroid therapy * serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * uncontrolled hypertension * hemoglobin less than or equal to 9.0 g/dl independent of transfusion * has abnormal liver function tests * surgery or local prostatic intervention within 30 days of the first dose

Keywords: prostate cancer metastatic-castration resistant prostate cancer prostate specific antigen abiraterone acetate jnj-212082 abiraterone prednisolone androgen deprivation docetaxel-based chemotherapy
clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this study conducted a systematic clinical observation of the clinical efficacy of ucb-mncs in the treatment of hormone-resistant or hormone-dependent ulcerative colitis, in order to observe its clinical safety and efficacy.

this study adopts a randomized and controlled clinical research design. patients are randomly divided into conventional treatment control group and ucb-mncs treatment test group. the control group is given conventional treatment: prednisone combined azathioprine or adalimumab; the test group is given conventional treatment combined ucb-mncs treatment, follow-up observations were carried out, in order to observe the clinical efficacy and safety of ucb-mncs in the treatment of hormone resistance or hormone-dependent ulcerative colitis.

Eligibility criteria:
inclusion criteria: * 1. western medicine diagnosis is consistent with patients with refractory ulcerative colitis. * 2. 18 years to 65 years，male or female. * 3. those who voluntarily participate in this clinical study and have signed an informed consent. exclusion criteria: * 1. patients with non-refractory uc. * 2. those who are pregnant or breastfeeding, or have a childbirth plan in the near future. * 3. people with severe allergies or allergies to known ingredients in basic treatments. * 4. patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney, and hematopoietic system. * 5. there are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon, rectal cancer, etc.. * 6. patients with mental disorders and intellectual disabilities. * 7. patients who have participated in clinical studies of other drugs in the past 3 months. * 8. those who are seriously ill and need emergency treatment. * 9. patients who are still undergoing other treatment options for ulcerative colitis. * 10. researchers believe that it is not suitable for entry.

Keywords: ulcerative colitis umbilical cord blood mononuclear cells safety and efficacy
a long-term follow-up of the hiv-nat cohort

Conditions: HIV Infections

Summary: with hiv/aids increasingly considered a chronic disease, 24-, or 48-week data from antiretroviral studies are no longer sufficient. only with long-term follow-up and outcome data will shed some much-needed light on the answers of questions that have stumped us for several years. data from a large observational cohort of patients treated with combination antiretroviral therapy will provide further insights into the long-term safety and durability of various antiretroviral therapeutic approached, the efficacy of hiv viral load and cd4 cell counts as predictors of disease progression and mortality, and the importance of adherence.

primary objective: to collect and evaluate long-term clinical outcomes of hiv infected participants previously enrolled in hiv-nat trials. secondary objective: to assess: 1. long-term consequences of initiation of antiretroviral as predicted by baseline cd4 cell count and/or baseline plasma hiv rna level 2. incidence of lipodystrophy and other metabolic complications in three different groups of patients initially treated with nrti-based regimens, nnrti-based regimens, or pi-based regimens 3. class-specific incidence of lipodystrophy and metabolic complications such as d4t versus azt, nevirapine versus efavirenz and individual pis (idv, sqv, kaletra, and atazanavir) 4. resistance profiles in patients on different antiretroviral regimens 5. long-term consequences of antiretroviral agents on cardiovascular, renal, hepatic, and endocrine function, skin, gastrointestinal system and urogentital tract 6. incidence of opportunistic infections or malignancy including hepatocarcinoma in patients with hiv/hcv or hiv/hbv co-infection 7. immune recovery syndrome 8. adherence to different antiretroviral regimens 9. quality of life

Eligibility criteria:
inclusion criteria: * hiv infected patients( children and adults) previously participated hiv-nat studies * hiv infected patients( children and adults) currently participate in hiv-nat trials * able to provide written consent exclusion criteria: * unable to provide written consent

Keywords: chronic hiv infection long term cohort of hiv infection
novel approach to conduction system pacing with use of ultrasound

Conditions: Conduction Block, Atrioventricular; Bundle-Branch Block

Summary: each year, over one million pacemakers are implanted globally using x-rays. recent developments have been aimed at determining which area of the heart is the best option for lead placement. an area in the septum separating the verticals called the left bundle branch area (lbba) has previously been identified as a safe and effective area for lead placement. however, as the lbba location is in the center of the heart, it is impossible to see the entire extent using x-ray. current practice requires x-ray guidance to estimate the location and pacing parameters to confirm proximity. implanting in lbba takes longer procedure times and higher exposure to x-ray radiation for both patients and hospital staff. over time, radiation poses an increased risk of cancer and other medical issues. this study will determine if using ultrasound can improve pacemaker lead implantation to the lbba. benefits to patients may include fewer attempts and more accuracy in lead deployment, thereby reducing risks and providing improved outcomes. benefits to healthcare delivery may include reduction in total procedure time, thereby allowing more cases per day to reduce waitlist, and reduced x-ray exposure to staff thereby reducing cumulative effects.


Eligibility criteria:
inclusion criteria: patients meeting the following criteria are eligible for the study: 1. male or female ≥18 years of age 2. eligible to have a single or dual chamber pacemaker implanted for lbbap 3. confirmed diagnosis of conduction tissue disease 4. the participant can understand the written informed consent/assent, provides signed and witnessed written informed consent/assent, and agrees to comply with protocol requirements. 5. good imaging quality determined on routine echocardiography exclusion criteria: patients will be excluded if any one of the following criteria is met: 1. any medical or psychiatric condition that, in the investigator's opinion, could jeopardize or compromise the participant's ability to participate in the study. 2. any acute active malignancy requiring treatment or life expectancy is deemed less than 1 year. 3. clinically significant disease that increases their risk of bleeding (hematological disorders, dialysis patient - anticoagulation does not apply) 4. history of alcohol or drug (other than caffeine) use disorder within 12 months of pacemaker implantation. 5. hepatic impairment defined as alt/ast \>3 × uln and/or total bilirubin \>uln, at screening. 6. the participant has any clinically significant illness, in the opinion of the investigator, prior to their pacemaker implantation 7. any other issues which, in the opinion of the investigator, will make the participant ineligible for study participation. 8. crt and icd implants. 9. pregnancy or female of childbearing age (if negative pregnancy test not provided).

Keywords: conduction system pacing left bundle branch area pacing his bundle pacing pacemaker ultrasound ntprobnp eq5d lvef