Kornimate/medical-research-clean huggingface dataset:
evaluation of dd-25 topical cream for the treatment of psoriasis vulgaris : proof of concept study

Conditions: Psoriasis Vulgaris

Summary: the purpose of this study is to determine the efficacy of dd-25, a new topical drug, on plaque psoriasis vulgaris. the study will include subjects at plaque stage from 5-20% body area involvement. a total of 30 subjects will be treated with cream application on affected areas twice daily for three weeks.the efficacy of the preparation will be documented by pasi score, global physician assessment and photos.

psoriasis vulgaris remains a widespread clinical entity with chronic outflares and various regimens of treatment, none of them definitive. a new safe and efficacious, external treatment is required for.

Eligibility criteria:
inclusion criteria: 1. subject age 18-60 2. diagnosis of ps by a dermatologist with lesions on arms, legs or trunk 3. subjects have stable plaque ps, mild to moderate form, body surface area of 5-20%. 4. subject understood and signed an informed consent form exclusion criteria: 1. guttate, erythrodermic, palm-plantar or pustular psoriasis as sole or predominant form of psoriasis. 2. hypersensitivity to sunlight; history of lupus, pmle, or any disease known to be worsened by uv light exposure 3. pregnancy, breast feeding 4. history of cancer, excluding non-melanoma skin cancer. 5. patients with history of ischemic heart disease (e.g. angina pectoris, myocardial infarction); cerebrovascular syndromes, peripheral vascular or uncontrolled hypertension. subjects with known severe hepatic and/or severe renal insufficiency. 6. any medical condition that, in the opinion of the investigator, would jeopardize the health of the patient during the course of this study. 7. systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within 4 months or 5 drug half-lives prior to checkup. 8. systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin d analogues, retinoids, immuno-suppressants) within the 8-week period prior to randomization. subjects using within the 8 week period prior to randomization puva or phototherapy. use of ssri or mao inhibitors. 9. subjects using one of the following topical drugs for the treatment of ps within 2 weeks prior to randomization: e.g. who group i-ii corticosteroids, retinoids, vit. d analogues, immunomodulators, anthracene derivatives, salicylic acid. 10. subjects with current participation in any other interventional clinical or subjects with any concomitant dermatological disorder(s) which might preclude accurate evaluation of the psoriasis

Keywords: psoriasis vulgaris plaque topical treatment
a trial to learn if different doses of regn17092 are safe in healthy adults

Conditions: Healthy Volunteers

Summary: the purpose of this study is to learn about the safety and tolerability of different doses of regn17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. this is the first time that regn17092 will be given to people. other aims are to assess: * how much of the study drug is in the blood at different times * whether the body makes its own antibodies against the study drug (which could make the drug less effective or lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. has a sars-cov-2 negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol 2. has received complete primary series of standard-of-care covid-19 vaccination per local guidance, completed at least 2 weeks prior to screening 3. has a body mass index (bmi) between 18 and 31 kg/m\^2 (inclusive) at the screening visit 4. is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram (ecg)s performed at screening and/or prior to administration of initial dose of study drug key exclusion criteria: 1. history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol 2. presents any concern to the investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study 3. was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit 4. has history of alcohol or drug abuse as determined by the investigator 5. has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food note: other protocol defined inclusion / exclusion criteria apply

Keywords: severe acute respiratory syndrome coronavirus (sars-cov-19) coronavirus disease 2019 (covid-19) vaccinated omicron variant
pharmacokinetics and safety of meropenem in infants below 90 days of age with probable and confirmed meningitis

Conditions: Meningitis

Summary: this phase i-ii multicenter international trial is designed to study the pharmacokinetics of meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis.

the primary objective will be to study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis. the secondary objectives are : * to describe the efficacy of meropenem on day 3, at end of allocated treatment (eoat), at test of cure (toc) and at follow up (fu). * to evaluate survival at fu * to evaluate further episodes of meningitis (relapse or new infection) occurring between toc and fu visits * to define the organisms causing neonatal meningitis * to describe the antibacterial susceptibility of meningitis-causing organisms and to describe the clinical and microbiological response according to this * to evaluate mucosal colonization by resistant organisms before and after treatment with meropenem * to evaluate bacterial eradication * to evaluate functional genetic parameters that may affect response to therapy

Eligibility criteria:
inclusion criteria: * informed consent form signed by the parents/carers * chronological age below 90 days inclusive * the presence of: * clinical signs consistent with bm (hyperthermia or hypothermia or temperature instability plus 1 or more neurological findings among coma, seizures, neck stiffness, apnoea, bulging fontanelle), * or csf pleocytosis (≥ 20 cells/mm3) * or a positive gram stain of csf. exclusion criteria: * presence of a csf device * proven viral or fungal meningitis * severe congenital malformations if the infant is not to expect to survive for more than 3 months * other situations where the treating physician considers a different empiric antibiotic regimen necessary * known intolerance or contraindication to the study medication * participation in any other clinical study of an investigational medicinal product * renal failure and requirement of haemofiltration or peritoneal dialysis * meningitis with an organism known to be resistant to meropenem

Keywords: meningitis neonates meropenem
cardiovascular and renal outcomes of integrated management of blood pressure and other cardiometabolic risks in hypertensives

Conditions: Cardiovascular Risk Factor; Hypertension; Renal Disease

Summary: this clinical trial is designed to study the cardiovascular and renal outcomes of hypertensives after an integrated management of blood pressure and other cardiometabolic risks. it is a multicenter prospective cohort study.


Eligibility criteria:
inclusion criteria: 1. outpatients from departments of cardiology, endocrinology, nephrology, neurology, geriatrics or general internal medicine. 2. diagnosed as hypertension. diagnostic criteria: 1)the office bp measured at the day of visit and at least one time before that day were above the cut-off values ( ≥140 mmhg sbp and/or ≥90 mmhg dbp); 2)for patients with normal bp at the day of visit, they should have already been given pre-treatment with antihypertensive drugs ≥ 2 weeks. 3. voluntary participation. exclusion criteria: 1. patients aged\< 18 years old. 2. patients without a definite diagnosis of hypertension(for instance, if the patient has been taking antihypertensive drugs irregularly, it is difficult to confirm the diagnosis of hypertension). 3. patients with a definite diagnosis of secondary hypertension. 4. patients are diagnosed dyslipidemia with clear cause, such as nephrotic syndrome, severe hypothyroidism, terminal stage of malignancy, etc. 5. patients are diagnosed end-stage renal disease, hemodialysis, and peritoneal dialysis patients. 6. patients diagnosed with mental abnormalities who are unable to complete the questionnaire. 7. patients have once participated in this research during this study cycle(to avoid repeated participation).
magnetic seizure therapy (mst) for the treatment of major depression

Conditions: Major Depressive Disorder

Summary: this two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of magnetic seizure therapy (mst) and contrast the therapeutic properties and side effects of two forms of mst in patients in a major depressive episode (mde).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder * age 18-75 * use of effective method of birth control for women of child-bearing capacity * willing and capable of providing informed consent * convulsive therapy clinically indicated * hamilton rating scale for depression (hrsd) ≥18 (24 item) exclusion criteria: * current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ect (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure) * pregnancy * history of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, or structural brain lesion * presence of devices that may be affected by rtms (pacemaker, medication pump, cochlear implant, implanted brain stimulator) * breast-feeding * history of head trauma with loss of consciousness for greater than 5 minutes * history of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder * vagus nerve stimulator implanted * history of substance abuse or dependence in past 3 months * failure to respond to an adequate course of ect in the current depressive episode * history of ect in the past 6 months
an observational study of pegasys in dual- or triple-therapy in patients with chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: this multicenter, observational study will assess the efficacy and the safety of pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis c. patients will receive pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. data will be collected for 96 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * diagnosis of chronic hepatitis c * patients receiving treatment with pegasys and/or copegus (ribavirin) and/or a protease inhibitor according to local label exclusion criteria: * contraindications against pegasys or copegus * not willing or unable to sign written informed consent form
noninvasive screening for fetal aneuploidy: a new maternal plasma marker

Conditions: Pregnancy; Aneuploidy; Down Syndrome; Edwards Syndrome

Summary: the purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (cvs) and/or genetic amniocentesis. the results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via cvs or amniocentesis.


Eligibility criteria:
inclusion criteria: * subject is female * subject is pregnant * subject is 18 years of age or older * subject provides a signed and dated informed consent * subject agrees to provide a 30-50ml blood sample * subject is at increased risk for down syndrome or other aneuploidies (greater than or equal to 35 years of age at time of delivery, elevated risk by maternal serum markers including triple, quad and integrated test, fetal birth defects or markers identified by ultrasound or family history of aneuploidy). * subject plans to undergo an amniocentesis and/or cvs procedure * subject agrees that the fish, karyotype, and/or qf-pcr results obtained via the invasive procedure will be provided exclusion criteria: * none

Keywords: down syndrome aneuploidy amniocentesis cvs
the predictive value of progesterone

Conditions: Subfertility

Summary: to evaluate a 5 ng/ml serum progesterone (p4) threshold policy for the addition of subcutaneous (sc) p4 in artificially prepared frozen embryo transfer cycles treated with vaginal p4. we assess whether the addition of sc p4 rescues cycles with serum p4 \ 5 ng/ml by comparing them with serum p4 cycles above the conventionally proposed cut-off of 10 ng/ml.


Eligibility criteria:
* embryo transfer between march 1st 2021 and march 31st 2023 * determination of progesterone on the day of embryo transfer

Keywords: progesterone embryo transfer
liver cancer prognosis investigation study

Conditions: Liver Neoplasms

Summary: this prospective cohort study is designed to explore the role of environmental, clinical, and genetic risk factors in the progression and prognosis of primary liver cancer (plc). we will recruit 5000 patients with newly diagnosed, previously untreated plc. the eligible patients will be asked to complete a baseline survey at the time of initial admission and be followed up every 3 to 6 months after discharge.

primary liver cancer (plc) is highly malignant and is particularly prevalent in china. multiple factors are involved in the development and progression of plc. several large-scale, prospective cohort studies have been established to identify environmental and genetic risk factors for the development of plc in the general population. however, few cohort studies have focused on determining risk factors beyond clinical prognostic factors for the progression of plc in patients with plc. therefore, we will conduct a prospective cohort study to examine the role of environmental, clinical, and genetic risk factors in the progression and prognosis of plc. we plan to recruit 5000 patients with newly diagnosed, previously untreated plc. a baseline survey will be conducted at the time of initial admission, with follow-up at 3 and 6 months after discharge for all patients and thereafter every 3 months for patients treated with interventional therapy and every 6 months for patients receiving surgery and other therapies. we will collect information on patients' demographics characteristics, clinical diagnosis and treatment, lifestyle, nutritional status, psychological and mental status, quality of life, anthropometric data, body composition, routine laboratory tests and examinations, and disease progression through structured questionnaires, physical examinations, and medical record reviews. deaths will be ascertained through medical records, death certificates, and next-of-kin. additionally, we will collect blood, urine, stool, and liver tissue samples.

Eligibility criteria:
inclusion criteria: * age 18-80 years, * diagnosed with primary liver cancer (icd-10: c22) (referring to the diagnostic criteria in the "primary liver cancer diagnosis and treatment guidelines (2024 edition)" and the "2024 csco guidelines for the diagnosis and treatment of biliary malignancies), * have not received any anti-tumor treatment (e.g., surgery, ablation, interventional therapy, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc), * signed informed consent. exclusion criteria: * have a history of other malignant tumors, * have a history of other serious chronic diseases (e.g., heart failure, liver failure, kidney failure, etc.), * expected survival time is no more than 3 months, * severe physical or mental disability.

Keywords: primary liver cancer hepatocellular carcinoma intrahepatic cholangiocarcinoma prognosis prospective cohort study
comparison of methods to improve abdominal aortic aneurysm (aaa) screening rates in the primary care setting.

Conditions: Abdominal Aortic Aneurysm

Summary: standard of care dictates that eligible patients should receive an abdominal aortic aneurysm (aaa) screening ultrasound. at present, different military primary care physicians utilize different methods at their discretion to ensure their patients get screened-telephone contact; mail-out reminders; referring patients for ultrasound directly from an office visit; as well as other methods-which we will refer to as "usual care". the purpose of this study is to improve screening rates for aaa and determine what notification methods are best at improving screening rates.

approximately 1700 male patients (dod beneficiaries) between the ages of 65-75 will be selected from their medical records. the information on the attached abstracted data sheet will be collected. as part of standard patient care operations, the family medicine and internal medicine departments will inform patients on the need to receive a aaa screening ultrasound, based on their primary care manager's (pcm) preference for clinical notification: 1. nurse initiated telephone consult (t-con) (see attached) 2. mail-0ut letter to the patient (see attached) 3. provider, nurse and technician education with point-of-care patient referrals , exam room flyer 4. control group (i.e. usual care) the provider, nurse and technician education will consist of a presentation given by the principal investigator (see attached powerpoint) to the family medicine and internal medicine clinic staff and the posting of exam room flyers in each family medicine and internal medicine exam room to prompt and encourage patient referrals for a aaa screening ultrasound. information requested on the attached abstracted data sheet will be used for initial identification of patients that should have a aaa screening ultrasound and again 3-4 months later to see if these same individuals received the procedure. all informational data sets will be totally de-identified by the research coordinator, nellis air force base, prior to releasing to the principle investigator. the data will then be analyzed by dr. anneke bush (whmc statistician) and the results will be provided to the principal investigator for analysis.

Eligibility criteria:
inclusion: * tricare insurance beneficiary (military insurance) receiving care at nellis afb * male patients (dod beneficiaries) between the ages of 65-75 years old. exclusion: * female patients. * non-english speaking. * patients who have already had abdominal ct scan, abdominal mri, aortography or aortic ultrasound. * patients already diagnosed with aaa

Keywords: abdominal aortic aneurysm
repurposing lithium for parkinson's disease: a rct

Conditions: Parkinson Disease

Summary: this study will examine the effects of lithium 20mg/day compared to placebo on mri and blood-based biomarkers among 20 early-stage parkinson's disease patients.

in observational studies, small daily doses of lithium have been associated with a 77% reduced risk of developing parkinson's disease (pd). in addition, lithium therapy has been effective in preventing neuronal death and behavioral symptoms in several pd animal models. recently, our group has shown 24-weeks of low-dose lithium therapy in pd to improve both mri and blood-based biomarkers implying that lithium may be slowing the progression of the disease. however, these findings stem from only three of four patients receiving mris. a larger study will be required to determine if these promising results can be replicated. the proposed study will enroll 20 additional pd patients who will be randomly assigned to receive either lithium 20mg/day or identically-appearing placebo capsules for 24 weeks. this will be a double-blind study meaning that neither the patients nor the study team will know to which therapy patients have been assigned. positive results from this study will support further research on lithium that could eventually support lithium as a disease-modifying therapy for pd that could improve patients' long-term prognoses.

Eligibility criteria:
inclusion criteria: * have pd for \<4 years diagnosed by a movement disorder specialist. have normal thyroid and renal function at the screening visit. have no previous exposure to lithium therapy. have no history of brain surgery. have no hx of brain imaging findings suggesting another neurological condition besides pd. have no use of tobacco or thc products for \>1 year. have stable pd medications for \>30 days without current need for adjustments in the investigator's opinion. have stable psychiatric and diuretic medications for \>60 days with no anticipated need for changes for at least 24 weeks. have no active medical or psychiatric condition that may interfere with study procedures in the investigator's opinion. exclusion criteria: * have pd for \>4 years or does not have pd. have abnormal normal thyroid and renal function at the screening visit. have previous exposure to lithium therapy. have history of brain surgery. have hx of brain imaging findings suggesting another neurological condition besides pd. have use of tobacco or thc products within the past year. have pd medication adjustments within 30 days or needs pd medication adjustments in the investigator's opinion. have psychiatric or diuretic medication adjustments within the last 60 days or is anticipated to need changes over next 24 weeks. have active medical or psychiatric condition that may interfere with study procedures in the investigator's opinion.

Keywords: parkinson's lithium free water disease-modifying therapy