Kornimate/medical-research-clean huggingface dataset:
single ascending dose study of pcsk-9 inhibitor (ibi306) in healthy subjects.

Conditions: Hypercholesterolemia

Summary: ibi306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (pcsk9), preventing its interaction with the low-density lipoprotein cholesterol receptor (ldl-r) and thereby restoring ldl-r recycling and low-density lipoprotein cholesterol（ldl-c）uptake. this is a randomized, double-blind, placebo-controlled,single ascending dose study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of ibi306 in healthy adults.

ascending dose design includes 6 dose levels （25 mg, 75 mg, 150 mg, 300 mg, 450 mg and 600 mg). tolerance and safety data up to 14 days after dosing from all subjects of the previous cohort will be reviewed before proceeding to the next dose. total duration of the study per subject is 12 weeks.

Eligibility criteria:
inclusion criteria: * chinese healthy men or women aged 18 to 55 years old at screening (inclusive）; * serum ldl-c concentration between 1.8 mmol/l and 4.9 mmol/l (inclusive）at screening; * body mass index between 19 and 28 kg/m2 (inclusive); * willing to maintain the current regular diet and physical activity; * female subjects and male subject's partner who could become pregnant should take effective contraceptions during the treatment period and 6 months after dosing; * without any medical history of serious diseases; * willing to comply with protocol required visit schedule and visit requirements and provide written informed consent. exclusion criteria: * breast-feeding or pregnant women; * history of allergic reaction; * previously received any anti-pcsk-9 treatment; * vital signs, physical examination, clinical laboratory test, 12-lead ecg, and chest x-ray are abnormal with clinical significance; * not willing to stop intense physical activities (such as weight lifting or long-distance running) before 72 hours of the scheduled visits; * any hospitalization within one month before screening, or major surgery within six months before screening, or any other unstable medical condition; * received an investigational chemical agent within 30 days before dosing； * received an investigational biological agent within 90 days before dosing； * use of medications including over-the-counter medication within 14 days or less than 5 half-lifes of the agent; * use of herb,vitamins or nutraceutical in order to alter serum lipids; * positive screen of hepatitis b surface antigen, hepatitis c virus, human immunodeficiency virus or syphilis infection at screening； * history or clinical evidence of alcohol or drugs of abuse within 12 months before screening; * with any consumption of alcohol and caffeinated beverages within 72 hours prior to and during the trial; * blood donations or blood loss 200 ml and more within 2 months before screening; * history of organ transplantation or malignant tumor; * any conditions which, in the opinion of the investigator, would make the subject unsuitable for enrollment.
pocdoc lipids usability study for self-test use

Conditions: Hyperlipidemias

Summary: this study seeks to expand the approved indication of use for a ukca approved ivd device. pocdoc lipids is approved for professional use to measure the levels of lipids in a fingerprick blood samples. this study will investigate the usability of the device by untrained lay people in order to expand the device's utility to the self-test setting.


Eligibility criteria:
inclusion criteria: * signed informed consent form * subjects are legally competent and capable to understand character, meaning and consequences of the study * subjects own an approved mobile device (these will be available at the time of the study on the pocdoc website and a link will be contained in the pis) exclusion criteria: * being unable to give informed consent * \ 85 years * legally incompetent * language barriers potentially compromising an adequate compliance with study procedures
complex problem solving training in schizophrenic patients

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the primary purpose of the study is to assess whether a planning and problem-solving training is more effective in improving work therapy performance in patients with schizophrenia than traditional training programs addressing basic cognitive functions.

in patients with schizophrenia, cognitive deficits often lead to an impairment in daily life. this observation has led to the development of cognitive training packages aiming a improving these deficits. however, it is far from clear which level of cognitive functioning provides the best target for cognitive interventions. traditionally, training has aimed a basic cognitive functions like attention and memory. in the present study we aim at a higher-level of function, namely planning and problem-solving skills, which are trained using the software package plan-a-day. the primary hypothesis is that complex problem solving training improved functional capacity more than traditional training programs addressing basic cognitive function.

Eligibility criteria:
inclusion criteria: * patients with schizophrenic or schizoaffective disorder (dsm iv) * remitted positive symptoms (panss positive all ≤ 4), clinical stability * native german speaker * verbal iq \> 80 * visual acuity normal or corrected to normal exclusion criteria: * concurrent axis-i disorder * drug abuse during last 2 months * neurological or medical conditions potentially affecting cognition

Keywords: cognitive training complex problem solving goal management planning
performance of an investigational blood glucose monitoring system in a clinical setting

Conditions: Diabetes

Summary: the purpose of this study is to evaluate the performance of an investigational blood glucose meter with the contour sensor strip. it was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.


Eligibility criteria:
inclusion criteria: * males and females, 18 years of age and above * type 1 or type 2 diabetes * currently self-testing blood glucose at home at least twice daily * able to speak, read, and understand english * willing to complete all study procedures exclusion criteria: * currently pregnant * hemophilia or any other bleeding disorder * employee of competitive medical device company * cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
investigating the utilisation and effectiveness of originator and biosimilar anti-tnf agents

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis

Summary: an observational study investigating the utilisation and effectiveness of originator and biosimilar anti-tnf agents in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of rheumatoid arthritis (ra), psoriatic arthritis (psa) or ankylosing spondylitis (as) who are being treated at a participating opal clinic. exclusion criteria: -
a phase ii study evaluating jab-21822 monotherapy in adult patients with pancreatic cancer and other solid tumors harboring the kras p.g12c mutation.

Conditions: KRAS P.G12C; Pancreatic Cancer; Solid Tumor

Summary: patients with other advanced solid tumors (excluding nsclc and crc) who have progressed after prior systemic therapy or are intolerant and lack satisfactory alternative treatment options, aiming to evaluate the efficacy and safety of glecirasib in these patients.

this study is a single-arm, multicenter, open-label, basket-design, pivotal phase ii trial targeting adult patients with locally advanced or metastatic solid tumors harboring the kras p.g12c mutation. the included populations are: * patients with advanced pancreatic cancer who have progressed or are intolerant to prior gemcitabine-based chemotherapy regimens or folfirinox/mfolfirinox/nalirifox treatments. * patients with other advanced solid tumors (excluding nsclc and crc) who have progressed after prior systemic therapies or are intolerant and lack satisfactory alternative treatment options. the study aims to evaluate the efficacy and safety of glecirasib in these patient populations.

Eligibility criteria:
inclusion criteria: * patients with the kras p.g12c mutation confirmed through testing using prospectively validated companion diagnostic reagents or clinical trial assay (cta) methods. * histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors (excluding nsclc and crc). * patients with pancreatic cancer must have progressed or been intolerant to prior gemcitabine-based chemotherapy regimens or folfirinox/mfolfirinox/nalirifox treatment. patients with other types of solid tumors must have progressed or been intolerant to prior systemic therapies and lack satisfactory alternative treatment options. exclusion criteria: * previously received a kras g12c inhibitor. * history of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.) with clinical symptoms. * uncontrolled pleural effusion, pericardial effusion, or ascites. * mean qt interval corrected for heart rate using fridericia's formula (qtcf) ≥470 ms calculated from 3 electrocardiograms. * use of a drug with known risk of torsades de points (tdp) within 14 days prior to the first dose.
digital biomarker: blood based biomarkers in the primary care setting for alzheimer's disease

Conditions: Mild Cognitive Impairment

Summary: the primary objective of this study is to evaluate the feasibility of implementing blood-based biomarker testing for amyloid positivity designed to aid the early detection of alzheimer's disease and related dementia (adrd) in patients 65+ including the rate that patients and providers follow up abnormal blood-based biomarker testing.

this study is conducted to evaluate whether a new approach to screening patients for cognitive decline in primary care practices helps with earlier detection of alzheimer's disease. as part of the study, the provider subjects will receive training about the precivityad blood biomarker test offered by c2n diagnostics. they will be able to order the precivityad test for possible alzheimer's disease if their patient has an abnormal screening for cognitive impairment and consents to this study. patient subjects will have their blood drawn (1 teaspoon) for the precivityad blood test and will be asked to complete a surveys before and after the blood drawn. they will receive follow up phone calls within 1 to 4 weeks after they discuss the results of their blood test with their primary care.

Eligibility criteria:
inclusion criteria: * patients must be \> 65 years of age * any gender * is an established or new patient at one of the 6 participating iuhp pc sites * is able to provide informed consent (research portion only for the biomarker consent) or has a legally authorized representative (lar) who can provide informed consent * has a "red" dca screening in the last 12 months (a score of 0 or 1 out of 5) exclusion criteria: * patients who do not complete a dca screening for any reason * existing diagnosis of dementia documented in their medical record based on icd-10 codes
an evaluation of non-invasive icp monitoring in patients undergoing invasive icp monitoring via an intraparenchymal pressure monitoring device

Conditions: Intracranial Hypertension; Brain Injuries; Stroke; Hydrocephalus; Brain Neoplasms

Summary: invasive intracranial pressure (icp) monitoring is highly effective, but involves risks. hs-1000 measures icp non-invasively by assessing the acoustic properties of the patient's head. hs-1000 device, a proprietary non-invasive icp monitor, is expected to safely and accurately monitor icp with minimal discomfort to patients, and provide information about normal or elevated icp levels to the physicians.

a prospective study will be conducted on 80 patients with an inserted invasive intraparenchymal icp monitor. once a patient undergoes invasive icp monitoring, has a life expectancy of greater than 48 hours and is 14 years old and over at the screening visit, and has an intact/continuous dura layer, the patient will become a candidate for enrollment into the study. if the patient signs the informed consent or the patient's legal authorized representative signs on the patient's behalf, the patient will be enrolled into the trial. each enrolled patient will be monitored in parallel to the invasive icp monitor with the headsense's device. once the data collection is complete, results will be analyzed by comparing icp readings from both devices. the primary end-point of the study is to collect 60-120 minutes of icp monitoring data over two sessions of 30-60 minutes each for 80 neurosurgery patients of any etiology. the secondary endpoint of this study is evaluate the safety of the device as measured by incidence of adverse events and serious adverse events over each subject's 96 hours of participation.

Eligibility criteria:
inclusion criteria: * male and female subjects, aged 14 years old and over at screening visit * patient with invasive icp monitor due to suspected icp elevation, regardless of etiology * survival expectancy greater than 48 hours * subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol * subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study exclusion criteria: * subject with ear disease, ear trauma * subject with a punctured or discontinuous dura layer (must be intact) * subject with cerebral fluid (csf) leakage * known allergy or hypersensitivity to any of the test materials or contraindication to test materials * subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s) * any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g. mental condition)

Keywords: intracranial pressure noninvasive monitoring
a study to evaluate the safety and efficacy of adding enfuvirtide to oral highly active antiretroviral therapy (haart) in human immunodeficiency virus (hiv) patients with prior treatment experience

Conditions: HIV Infections

Summary: to assess the efficacy of enfuvirtide (fuzeon) added to haart compared to treatment with haart alone in achieving and maintaining viral load suppression.

this study consisted of two phases. in the induction phase patients were randomized at baseline 1 (bl1) in a 1:2 ratio to receive: * i1: haart or * i2: enfuvirtide (90 mg twice a day) + haart. participants who achieved viral suppression \< 50 copies/ml by week 24, confirmed by week 28 or earlier, qualified to enter the maintenance phase which started at baseline 2 (bl2), four weeks after confirmation of response. the maintenance phase consisted of three treatment groups: * m1: haart continued (patients from i1) patients on enf+haart (i2) were re-randomized (at a 1:1 ratio) at bl2 to: * m2: enfuvirtide stopped and haart continued * m3: enfuvirtide + haart continued. the duration of the maintenance phase was from bl2 up to 48 weeks after bl1. bl2 could start at the earliest at week 12 and at the latest week 32.

Eligibility criteria:
inclusion criteria: * hiv-1 infected adults \>=18 years of age; * currently on antiretroviral (arv) therapy; * previously treated with 2 or 3 different antiretroviral classes; * hiv-1 ribonucleic acid (rna) \>=1,000 copies/ml; * cluster differentiation antigen four (cd4) lymphocyte count \>=200 cells/mm\^3; * females of childbearing potential must be willing to use a reliable form of effective barrier contraception for the duration of the study and for 30 days after the last dose of study drug. exclusion criteria: * history of prior use of enfuvirtide or t-1249; * women who are pregnant, breastfeeding or planning to become pregnant during the study; * active, untreated opportunistic infection; * patients on treatment interruption, or patients interrupting arv therapy within 4 weeks of screening or during the screening period for reasons either than toxicity management.
effects of vaporized marijuana on neuropathic pain

Conditions: Neuropathic Pain; Reflex Sympathetic Dystrophy; Peripheral Neuropathy; Post-herpetic Neuralgia; Spinal Cord Injury; Multiple Sclerosis

Summary: this study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.

we conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. thirty-nine patients with central and peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog scale pain intensity. psychoactive side effects and neuropsychological performance were also evaluated.

Eligibility criteria:
inclusion criteria: * age greater than 18 and less than 70 * visual analogue scale (vas pain intensity) greater than 3/10 * a negative urine drug screening test, i.e., no evidence of iv drug abuse * neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury exclusion criteria: * presence of another painful condition of greater severity than the neuropathic pain condition which is being studied. * subjects with moderate-severe major depression, bipolar/mania, bipolar ii/hypomania and schizophrenia or schizoaffective disorder. * unstable type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl * history of traumatic brain injury * uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (tb), chronic obstructive pulmonary disease (copd), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs). * current use of marijuana (e.g., within 30 days of randomization) * pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test.

Keywords: cannabis marijuana neuropathy antinociception mood cognition neuropathic pain
a genomic analysis of evolution of epithelia ovarian tumors

Conditions: Epithelial Ovarian Cancer; Epithelial Ovarian Tumor of Borderline Malignancy; Driving Mutations; Progression-free Survival

Summary: epithelial ovarian carcinomatous and borderline components sometimes appeared in one patient. this study aims to analyze the genomic patterns of the carcinomatous and borderline components in the ovarian epithelial tissues. these tissues will be collected from paraffin section by microdissection to distinguish normal, carcinomatous and borderline tissues.


Eligibility criteria:
inclusion criteria: * confirmed primary epithelial ovarian borderline tumor with cancer * signed an approved informed consents * feasible for sampling exclusion criteria: * not meeting all of the inclusion criteria
efficacy and safety of jaktinib in patients with covid-19 pneumonia.

Conditions: COVID-19 Pneumonia

Summary: this was a randomized, double-blind, placebo-controlled parallel study.


Eligibility criteria:
inclusion criteria: * 18 years of age, male or female; * history of covid-19 infection within 1 week; * subjects with hrct consistent with viral pneumonia (judged by investigator) and meeting any of the following criteria: with fever, respiratory symptoms; shortness of breath present,rr ≥30 breaths/min. * clear consciousness, capable and voluntary informed consent. exclusion criteria: * unable to take tablets orally or suspected hypersensitivity to jaktinib, drugs of the same class, or their excipients, patients with severe gastrointestinal dysfunction affecting drug absorption; * any person meeting criteria for critical pneumonia; * patients considered unsuitable for this trial by the investigator.

Keywords: pneumonia covid-19 infection
impact of age at conization on obstetrical outcome: a case-control study

Conditions: Pregnancy Complications

Summary: the maternity ward attached to the colposcopy clinic was also the obstetrical referral center for the region and carried out approximately 2500 deliveries per year. the aim of the study was to assess whether an age younger than 25 years at conization affected future pregnancy outcome as an independent factor. a retrospective study of 115 women who underwent both loop electrosurgical excision procedure (leep) and subsequent pregnancy follow-up in a referral center was conducted. two groups were considered: patients younger than 25 years at the time of the loop electrosurgical excision procedure (n = 42) and 25 years or older (n = 73). analyzed data were occurrence of preterm adverse obstetrical event and, specifically, preterm labor (pl) and preterm rupture of membranes; stratification based on term of occurrence was performed: less than 37 weeks of amenorrhea (wa), less than 34 wa, and less than 26 wa.

the investigators conducted a retrospective observational study between january 2008 and december 2015 in a french colposcopic referral academic hospital. the maternity ward attached to the colposcopy clinic was also the obstetrical referral center for the region and carried out approximately 2500 deliveries per year. the aim of the study was to assess whether an age younger than 25 years at conization affected future pregnancy outcome as an independent factor. a retrospective study of 115 women who underwent both loop electrosurgical excision procedure (leep) and subsequent pregnancy follow-up in a referral center was conducted. two groups were considered: patients younger than 25 years at the time of the loop electrosurgical excision procedure (n = 42) and 25 years or older (n = 73). analyzed data were occurrence of preterm adverse obstetrical event and, specifically, preterm labor (pl) and preterm rupture of membranes; stratification based on term of occurrence was performed: less than 37 weeks of amenorrhea (wa), less than 34 wa, and less than 26 wa.

Eligibility criteria:
inclusion criteria: * female pregnant * underwent loop electrosurgical excision procedure during the studied period * delivered in their institution exclusion criteria: * patients having delivered elsewhere after loop electrosurgical excision procedure * early miscarriages (\<14 weeks of amenorrhea )

Keywords: leep preterm labor