Kornimate/medical-research-clean huggingface dataset:
preliminary evaluation of uptake in bone metastases and biodistribution of [68ga]p15-041

Conditions: Prostate Cancer; Bone Metastases

Summary: a phase1 study to demonstrate \[68ga\]p15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical \[99mtc\]mdp scan exclusion criteria: * estimated creatinine clearance (gfr) \< 30 ml/min (calculated), history of hyperparathyroidism, • inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
pharmacokinetic study to evaluate the effect of a single dose of guselkumab (cnto 1959) on cyp 450 enzyme activities after subcutaneous administration in participants with psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate the potential effects of a single dose of 200 milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe substrates of cytochrome p450 isozymes (cyp3a4, cyp2c9, cyp2c19, cyp2d6, and cyp1a2) in participants with moderate to severe psoriasis.

this is an open-label, multi-center study. the total duration of study will be approximately 17 weeks per participant, including screening phase (up to 4 weeks prior to first probe cocktail administration). participants will have 4 in-patient periods on day 1, 8, 15 and 36 (3 periods consisting of 3 days and 2 nights each and 1 consisting of 2 days and 1 night) followed by follow up period (up to day 92). all participants will receive a single 200 mg subcutaneous (sc) injection (2\*100 mg) of guselkumab on day 8 and probe cocktail on days 1, 15 and 36. blood samples will be collected for the evaluation of pharmacokinetics and immunogenicity at pre-dose and post-dose of study treatment. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (psa) for at least 6 months before day 1 * have a psoriasis area and severity index (pasi) greater than or equal to (\>=) 12 at screening * have an investigator's global assessment (iga) \>= 3 at screening * have an involved body surface area (bsa) \>= 10 percent (%) at screening * be a candidate for phototherapy or systemic treatment for psoriasis exclusion criteria: * has a history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac (including unstable cardiovascular disease, defined as a recent clinical deterioration (example, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months), vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, bleeding disorder, rheumatologic, psychiatric, or metabolic disturbances * have a pulse oximetry value less than (\<) 94 % at screening * genetically determined poor metabolizers of cyp2c9, cyp2c19, and cyp2d6 substrates * is currently undergoing or has previously undergone allergy immunotherapy for a history of anaphylactic reactions * has a transplanted organ (with exception of a corneal transplant greater than (\>) 3 months before day 1)

Keywords: psoriasis guselkumab cytochromes p450
a positron emission tomography/computed tomography (pet/ct) bone imaging study in patients receiving enzalutamide for castration-resistant prostate cancer (crpc)

Conditions: Prostate Carcinoma Metastatic to the Bone; Castration Resistant Prostate Cancer

Summary: the purpose of this study is to evaluate 18f-sodium fluoride positron-emission tomography / computed tomography (18f-naf pet/ct) imaging as a method for determining treatment response in metastatic bone lesions in patients who are receiving enzalutamide for castration-resistant prostate cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, or signet cell or small cell features; * presence of bone metastatic disease as assessed by at least two lesions on whole body metastable technetium-methylene diphosphonate (99mtc-mdp) bone scintigraphy; * throughout the study, ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (lhrh) analogue or prior bilateral orchiectomy (medical or surgical castration); * testosterone ≤ 1.73 nmol/l (≤ 50 ng/dl) at screening; * progressive disease on androgen deprivation therapy at screening defined as a minimum of two sequentially rising prostate-specific antigen (psa) values (psa1 \< psa2 \< psa3); * the screening psa (psa3) must be ≥ 2 μg/l (≥ 2 ng/ml). exclusion criteria: * prior enzalutamide, abiraterone acetate, aminoglutethimide, ketoconazole, radium ra 223 dichloride or other bone-targeting radionuclides, or cytotoxic chemotherapy in the crpc setting for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo); * treatment with hormonal therapy (eg, androgen receptor inhibitors, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than lhrh analogue therapy) within 4 weeks before enrollment; * initiation of new treatment with denosumab, bisphosphonates, or systemic corticosteroids for treatment of prostate cancer within 4 weeks before enrollment; * use of an investigational agent within 4 weeks before the screening visit; * radiation therapy to bone within 4 weeks before enrollment; * use of opiate analgesics for prostate cancer pain within 4 weeks before enrollment; * screening 99mtc-mdp bone scintigraphy showing a superscan; * visceral (eg, lung, liver) metastatic disease. adenopathy is allowed; * current or previously treated brain metastasis or active leptomeningeal disease; * history of seizure any time in the past for any reason or any condition that may predispose to seizures.

Keywords: cancer of the prostate
pain screening in refugee survivors of torture

Conditions: Pain, Chronic

Summary: the investigators are evaluating refugee torture survivors who are receiving services at the weill cornell center for human rights. there are two research questions in this study: if the current standard of care results in the under or missed diagnosis of pain and pain syndromes, and if a validated pain screening tool can supplement the current standard protocol used in the assessments of survivors of torture.

the research plan consists of three components: 1. the weill cornell center for human rights will coordinate with the research team regarding eligible subjects. 2. researchers will contact potential subjects utilizing interpreter services. 3. interested participants will be scheduled for an appointment for an examination by a pain physician and to complete the brief pain inventory.

Eligibility criteria:
inclusion criteria: * men and women from any country over the age of 18 * refugees receiving services from the weill cornell center for human rights exclusion criteria: * have not experienced torture * subjects whose representative does not believe that they are a good candidate for the study
appendicitis choice of treatment study

Conditions: Acute Appendicitis

Summary: a longitudinal observational/survey study evaluating patient centered decision making in the choice of treatment for acute appendicitis. survey evaluates patients experience with decision making and the types of decision support they receive.


Eligibility criteria:
inclusion criteria: * english speaking * diagnosed with acute appendicitis * considered by the treating clinical team to be eligible for treatment with surgery or with non operative treatment (antibiotics) * access to an internet connected device capable of taking the survey exclusion criteria: * patients who do not make their own medical decisions * patients who are not felt to be candidates for a decision between operative and nonoperative treatment by the treating clinical team * under 18 years of age

Keywords: decision making decisional conflict
auvergne-rhône-alpes-limousin research database for still's diseases in children and adults

Conditions: Still Disease

Summary: adult-onset still's disease is a polygenic autoinflammatory disease of unknown etiology. the autoinflammatory character individualizes it from autoimmune autoantibody diseases. clinically, it results in the classic triad associating hectic fever, evanescent rash and arthritis. although it is benign in the vast majority of cases, life-threatening complications can occur. by definition, the disease affects adults over 16 years of age, however most experts now agree that the adult form and the pediatric form belong to a pathological continuum: still's disease. in the absence of a specific biomarker, the diagnosis is still based on clinical and biological criteria, after the exclusion of differential diagnoses. classically, three evolutionary profiles of adult-onset still's disease are individualized, depending on the evolution of symptoms over time: * a monocyclic systemic form (30% of cases) characterized by clear systemic symptoms and in the foreground compared to the articular signs. this form evolves over several weeks to several months (on average 9 months), without exceeding a year. by definition, there is no recurrence; * a polycyclic systemic form (30% of cases) defined by the occurrence of at least two systemic or joint episodes, separated by clinical remission intervals greater than two months, or even several years. the symptoms of relapses are not always the same as the initial symptoms. the number and severity of relapses is unpredictable and varies widely from patient to patient, but symptoms tend to become less severe over time. * a chronic form, with predominant joint involvement (40%), resembling seronegative rheumatoid arthritis. systemic signs are present during the first outbreaks of the disease. subsequently, rheumatoid arthritis evolves on its own and one can see joint destruction or conversely ankylosing developments such as the classic bilateral, non-erosive fusing carpitis. there are reasons to believe that the evolving profile of patients has changed since the emergence and generalization of biotherapies. furthermore, no prognostic factor for the progression of adult-onset still's disease has been found so far. the differences between pediatric and adult forms need to be confirmed and becoming pediatric forms in adulthood is poorly described. the objective of this study is to set up a regional research database (auvergne-rhône-alpes-limousin) in order to describe the characteristics, treatment and evolution of patients with still's disease.


Eligibility criteria:
inclusion criteria: * children and adult diagnosed with still's disease in auvergne-rhône-alpes-limousin hospital exclusion criteria: * not applicable
venetoclax and lintuzumab-ac225 in aml patients

Conditions: Acute Myeloid Leukemia; Relapsed Adult AML

Summary: the study is a multicenter, open label phase i/ii trial. 1. to determine the maximum tolerated dose (mtd) of lintuzumab-ac225 added to venetoclax for patients with cd33 positive relapsed/refractory aml. (phase 1 portion) 2. to assess the percentage of patients with cr, crh, or overall response (cr + crh), up to 6 months after the start of treatment without receiving other aml therapies. (phase 2 portion)

the study is a multicenter, open label phase i and phase ii trial combining lintuzumab-ac225 with venetoclax in patients who have relapsed or refractory aml. the phase i portion is a dose-finding study which will enroll at least three patients at each dose level. patients in a dose level will be observed for a minimum of 4 weeks before dose escalation occurs. there is no dose escalation for any individual patient. the phase ii portion of the study will enroll patients at the mtd dose level of lintuzumab-ac225 as determined in the phase i portion of the study. the goal of the phase ii portion will be to further characterize the safety and efficacy of the mtd dose of lintuzumab-ac225.

Eligibility criteria:
inclusion criteria: 1. refractory or relapsed aml which will include: 1. refractory disease will be defined as at least 1 prior treatment with no remission. 2. relapsed disease will be defined as 5% or more blasts in bone marrow seen after remission. 3. patients with aml arising from myelodysplastic syndromes (including cmml) or myeloproliferative neoplasms (secondary aml, ts-aml) are also eligible. 2. circulating blast count ≤ 200/μl within 10 days prior to first cycle of treatment. hydroxyurea should be used to keep the peripheral blast count ≤ 200/μl until the first day of protocol treatment, to the extent that this is possible 3. ecog ≤ 2 4. estimated creatinine clearance ≥ 50 ml/min 5. ast and alt ≤ 3.0 x uln 6. bilirubin ≤ 3.0 x uln exclusion criteria: 1. active cns leukemia. 2. known hiv infection or known hepatitis b or hepatitis c infection (with a detectable viral load). 3. participant has received strong and/or moderate cyp3a inducers within 7 days prior to the initiation of study treatment. 4. secondary refractory aml (e.g., treated for current relapse without achieving remission); a. with the exception that single agent flt3 inhibitors, idh1/idh2 inhibitors are allowed for current relapse without achieving remission. 5. have received prior radiation to maximally tolerated levels to any critical normal organ. 6. clinically significant cardiac disease. 7. active, uncontrolled serious infection. 8. have other non-myeloid malignancy within 2 years of entry (with exceptions). 9. psychiatric disorder that would preclude study participation 10. previous solid organ transplant (prior treatment with sct is allowed but not if patient has gvhd or is still receiving immunosuppression/gvhd therapy).

Keywords: lintuzumab-ac225 venetoclax lintuzumab refractory aml
grouptraining for overactive bladder in adults

Conditions: Overactive Bladder

Summary: hypothesis:the effect of bladdertraining in groups for patients with oab (overactive bladder syndrome) equals the effect of bladdertraining individually for patients with overactive bladder. the effect of the training is measured in a 3 dimensional scope by the means of 3 primary outcome measures used in the statistical evaluation. symptoms of oab (either (1)urgencyepisodes or (2)urgencyincontinence) and (3)quality of life (vas score).

program consisting of 3 hourly sessions with bladdertraining and daily training with a pocket bladder schedule. patients are randomised either for groups or individual training with a continence nurse over a period of 2 months.

Eligibility criteria:
inclusion criteria: * women at the age of 18 and more * patients with overactive bladder exclusion criteria: * dominance of stress incontinence * not able to attend sessions * do not to understand danish * do not want training in groups or individual * hormonebalanced (if postmenopausal with added hormonetreatment for at least 2 months) * no treatment for oab up till 1 month before study and during study * no renal or neurological diseases, symptomatic cystitis or non regulated diabetes * no pregnancy during study * no normal gynecological examination * no operation in pelvis up till 3 month before studystart * no polyuria measured 2 times before studystart (\> 40 ml/ kg/ day) * no upstart of treatment with medication during studystart which according to the investigator can create symptoms of oab * no participation in other ct

Keywords: overactive bladder women bladder training groups
oral ivermectin versus topical permethrin to treat scabies in children and adults

Conditions: Scabies

Summary: scabies remains a frequent condition that affects adults and children. the aim of this study is to compare the efficacy and safety of two drug treatments against scabies in children and their close contacts. one group will apply topical permethrin 5% and the other group will receive oral ivermectin. both groups will be treated twice, once at inclusion and the second time 10 days later. both treatment regimens have been used widely and are safe to use.

scabies is a common condition, even in european countries, and the annual incidence seems to have increased over the past several years. children and infants represent one-third of patients with scabies. diagnostic features comprise pruritus, skin burrows and the delta jet wing dermoscopic sign. in many countries, topical permethrin is the first line therapy. moreover, oral treatment with ivermectin represents an interesting alternative therapy, usually used as one dose of 200μg/kg, and more and more frequently recommended as two doses (one on day 1 and one between day 8 and day 15) without strong evidence. management of scabies requires giving a treatment not only to the patient but also to the patient's close contacts. the objective of our study is to compare efficacy and safety of topical permethrin applied twice at day 1 and day 10 versus oral ivermectin given twice at day 1 and day 10 to treat scabies in children and their close contacts. children (2 to15 years) with scabies and their close contacts - or first circle- will be randomized 1:1 to receive permethrin or ivermectin. a clinical follow-up will be performed 28 days (v2) and 56 days (v3) after the inclusion, including a dermatological examination and to collect safety data.

Eligibility criteria:
inclusion criteria: * children or adult * for children, weight more than 15 kg * documented diagnosis of scabies, defined by positive dermoscopic examination. exclusion criteria: * previous scabies therapy during the past 4 weeks * known allergy to ivermectin or permethrin * widespread eczematization or impetiginization * liver or renal failure

Keywords: scabies children cluster permethrin ivermectin adults
impact of project wolbachia - singapore on dengue incidence

Conditions: Dengue

Summary: the study is a cluster-randomised controlled trial set in singapore, to assess if the deployment of male wolbachia-infected aedes aegypti mosquitoes can reduce dengue incidence in intervention clusters.

the study is designed as a parallel, two-arm, non-blinded cluster-randomised controlled trial to be conducted in high-rise public housing estates in singapore. the aim is to determine whether large-scale deployment of male wolbachia-infected ae. aegypti mosquitoes can significantly reduce dengue incidence in intervention clusters. the investigators will use the cluster-randomised design, with the study area comprising 15 clusters with a total area of 10.9 km2, covering approximately 722,000 residents in 1,700 apartment blocks. eight clusters will be randomly selected to receive the intervention, while the other seven will serve as non-intervention clusters. intervention efficacy will be estimated through two primary endpoints: (1) odds ratio of wolbachia exposure distribution (i.e. probability of living in an intervention cluster) among laboratory-confirmed reported dengue cases compared to test-negative controls, and (2) laboratory-confirmed reported dengue counts normalized by population size in intervention versus non-intervention clusters.

Eligibility criteria:
inclusion criteria: * dengue-suspected patients living in the intervention and non-intervention clusters whose blood samples are collected by a national network of diagnostic laboratories that support private clinics, public polyclinics, or public/private hospitals. * test positive cases: patients with virologically confirmed denv infection through rt-qpcr, testing positive for ns1 antigen or igm. a positive test for any of the three assays would classify the patient as a dengue case. * test negative controls: patients with negative test results for denv through rt-qpcr, ns1 antigen elisa, or denv igm.
validation of a new standardized clinical anemia evaluation score using a hb visual scale in nephrological patients

Conditions: Anemia

Summary: the clinical evaluation of anemia is usually done by examination of the palpebral conjontivae coloration. this appreciation remains crude and largely observer dependent, as no reference scale was successfully proposed,. a hb visual scale allowing the assessment of the degree of clinical anemia has been developed. its use has been validated so far in small patient groups in the following settings: blood donation, cardiac surgery, oncology and consultation of general practitioners. the objective of the present investigation is to validate the use of a hb visual scale for the clinical evaluation of anemia in patients with kidney disease patients


Eligibility criteria:
inclusion criteria: * patients with chronich kidney disease

Keywords: anemia visual scale nephrological patients anemia in nephrological patients
ketones in heart failure with reduced ejection fraction

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the purpose of this study is to understand the effects of a ketone drink on exercise capacity and other cardiovascular parameters in patients with heart failure. in heart failure, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. there may be several reasons why these symptoms occur. this study is assessing whether the ketone drink can improve these symptoms. this drink has been given status by food and drug administration as "generally regarded as safe". the use of deltag in this study is experimental. deltag has not been approved by the food and drug administration (fda) for the use being evaluated in this study.


Eligibility criteria:
inclusion criteria: 1. stable cardiovascular medical therapy for 2 weeks 2. participants will be required to have heart failure with reduced ejection fraction (left ventricular ef \</= 45%) and new york heart association (nyha) class ii or iii symptoms. in cases of ambiguity of functional status, reduced peak vo2 (\<85% predicted vo2) at the baseline visit can be used to confirm reduced exercise tolerance. exclusion criteria: 1. intentional ketogenic diet in the last week 2. cirrhosis or significant alcohol consumption 3. contraindications to stress testing, conditions that limit exercise, and other clinically-significant causes of exertional limitation (claudication with peripheral artery disease, atrial fibrillation and heart rate \>110 at rest, systolic blood pressure\>180 mmhg or diastolic blood pressure\>110 mmhg, infiltrative/hypertrophic cardiomyopathy, clinically significant pericardial disease, joint or neuromuscular disease that precludes exercise, acute coronary syndrome within the last 2 months, estimated glomerular filtration rate\<20 ml/min/1.73 m2, and hemoglobin \< 9 mg/dl). 4. clinically significant lung disease: supplemental oxygen (aside from obstructive sleep apnea), chronic obstructive pulmonary disease requiring home oxygen or exacerbation within the last 2 months requiring steroids or antibiotics, severe obstructive lung disease (gold stage 3). 5. \>/= moderate aortic stenosis, \>mild mitral stenosis, \> moderate aortic or mitral regurgitation 6. type 1 diabetes mellitus 7. implant of cardiac resynchronization therapy, cardiac contractility modulation, or barostim device within the previous 3 months. 8. systolic blood pressure \<90 mmhg 9. pregnant women 10. angina due to epicardial coronary disease or known presence of clinically-significant, unrevascularized epicardial coronary disease, in the investigator's opinion. 11. history of heart transplant, left ventricular assist device, or use of inotropic medication. 12. participation in another clinical study with an investigational product in the previous 4 weeks prior to enrollment. 13. conditions that may render the patient unable to complete the study

Keywords: heart failure ketones ketosis metabolism exercise