cyrilzakka/clinical-trials huggingface dataset:
Proximal Risk for Suicide in Adolescents

The central hypothesis is that biometric data can continuously monitor and allow for early identification/intervention of escalating suicidal symptoms. The rationale is that improved outpatient monitoring through wearable technology can create a more objective platform to provide the ability to identify a worsening condition and utilize patient-specific just-in-time therapeutics developed with mental health providers for suicidal adolescents.

Suicide rates have exponentially increased, and it is now the 2nd leading cause of death in adolescence, accounting for over 1.2 million annual emergency department (ED) visits. After an ED visit or attempt, up to 20% of adolescents will have a second attempt within 12 months, and almost half will have a repeat ED visit. This proposal's overall objectives are to investigate physiologic parameters and biometric data from wearable technology that is temporally related to suicidal behavior and develop a personalized, predictive tool that can improve outpatient identification of adolescent patients with suicidality before a crisis develops requiring an ED visit. The central hypothesis is that biometric data can continuously monitor and allow for early identification/intervention of escalating suicidal symptoms. The rationale is that improved outpatient monitoring through wearable technology can create a more objective platform to provide the ability to identify a worsening condition and utilize patient-specific just-in-time therapeutics developed with mental health providers for suicidal adolescents. To attain the overall objectives, I will pursue the following specific aims: (i) To evaluate whether HRV, combined with patient-specific risk factors, can be used to detect dynamic changes in suicide severity among a prospective cohort of acutely suicidal adolescents, (ii) To utilize machine learning to determine whether there is a temporal relationship/signature in the raw PPG signal before or immediately after changes in suicide severity reporting combined with patient-specific risk factors to develop a prediction tool for suicidality risk. These aims will be accomplished in three years through a prospective observational study enrolling acutely suicidal adolescents in the ED and an inpatient psychiatric unit. Ultimately, such knowledge can offer unique opportunities for early detection, just-in-time interventions, and support over 1.2 million suicidal adolescents presenting to EDs nationally.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 13-17 years
* presenting to the ED or inpatient psychiatric unit with a chief complaint of acute suicidality or attempt.

Exclusion Criteria:

* acutely agitated patients per the treating physician
* adolescents who are not medically cleared from a suicide attempt
* no legally authorized representative available to provide consent
* parental report of significant developmental delay or autism diagnosis
* prisoners
* non-English speaking.
Resource Use and Disease Course in Dementia (REDIC)

This project is based on a three-year program that aims to improve the knowledge of the socioeconomic consequences of dementia in Norway. By including patients with and without dementia in four different cohorts (from nursing homes, from memory clinics, home-dwelling persons with dementia and elderly persons without dementia), the project's aim is to describe the course of dementia, the economical cost of dementia and to look into possible risk factors for dementia.


Eligibility Criteria:
Memory clinic sample

Inclusion Criteria:

* All patients examined at a memory clinic with mild cognitive impairment or mild dementia

Exclusion Criteria:

* None

In-home care sample

Inclusion Criteria:

* Persons 70 years of age or older receiving in-home care from the municipality

Exclusion Criteria:

* None

Nursing-home sample

Inclusion Criteria:

* All persons admitted to the nursing home with an expected stay of more than four weeks.
* Participants should be 65 years or older, unless established dementia disease, in which case younger persons also will be included

Exclusion Criteria:

* Life expectancy of less than six weeks

Control sample

Inclusion Criteria:

* Persons 65 years or older without any sign of dementia

Exclusion Criteria:

* None
EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting

Multicenter, prospective, study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention. The primary endpoint is the rate of all stoke and death within 30 days of the procedure.

The purpose of this feasibility study is to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention. The feasibility study will involve a maximum of 50 subjects to be enrolled using the FiberNet® during clinically indicated percutaneous intervention of the carotid artery and followed through 30 days post procedure. Subject will be enrolled in up to 5 European Investigational Sites. The study is a prospective multi-center registry with sequential enrollment of qualified subjects who consent to participate and meet all entrance criteria.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for percutaneous stenting with target lesion located within common or internal carotid artery.
* Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
* Targeted vessel diameter for FiberNet placement between 1.75 mm and 7.0 mm.
* The investigator determines that all branch vessels distal to the target lesion and proximal to the proposed site of device deployment will be adequately protected.

Exclusion Criteria:

* Prior stenting of ipsilateral carotid.
* Planned treatment of contralateral carotid within 30 days.
* Experienced a myocardial infarction within the last 14 days.
* Undergone an angioplasty or PTCA/PTA procedure within the past 48 hours.
* Undergone cardiac surgery within the past 60 days.
* Has a planned invasive surgical procedure within 30 days.
* Suffered a stroke within the past 14 days.
* Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
* Total occlusion of the target vessel.
* Lesions within 2 cm of the ostium of the common carotid artery.
* A stenosis that is known to be unsuitable for stenting because of one or more of: Tortuous or calcified anatomy proximal or distal to the stenosis, Presence of visual thrombus, Pseudo occlusion (string sign).
* Serial lesions that requires more then one stent to cover entire lesion.
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab

This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.

Cohort A: Participants will be randomized to receive either a placebo or vilobelimab.

This record describes the default procedures and analyses for Cohort A. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.

This is a master protocol for a Phase 2 platform clinical trial to evaluate host-directed therapeutic candidates (i.e., investigational product, IP) for the treatment of hospitalized participants diagnosed with ARDS. The safety and efficacy of each IP will be studied within its own cohort (IP versus Placebo). All patients will continue to receive standard treatments for ARDS as per the investigator. An individual participant will complete the study in approximately 90 days. The study will include a screening period (\<24 hours from providing informed consent to treatment), in-hospital treatment period with IP/placebo starting on Day 1 through discharge from the hospital, and a follow-up period after discharge from the hospital through the end of study (Day 90 + 2 weeks). Outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). Functional status using the WHO Ordinal scale and Karnofsky scale will be collected. Resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival).

All participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ECG, Chest X-ray or CT scan, and questionnaires through Day 90. Exploratory biomarkers will be evaluated over time to facilitate clinical learning. This record only includes information relevant to the vilobelimab cohort.

Eligibility Criteria:
Inclusion Criteria:

The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.

* ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization

Exclusion Criteria:

* No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.
Dynamic Electronic Filter for Arterial Waveform Distortion

Invasive blood pressure (IBP) is the gold standard for arterial pressure (AP) monitoring in critically ill patients. Nevertheless, IBP may be affected by underdamping/resonance artifacts, that eventually lead to AP overestimation. In these cases, when a pulse contour method is applied, wrong hemodynamic data are also delivered by the monitor. In order to overtake this issue, MostCareUp (a PCM powered by Pressure Recording Analytical Method, PRAM), has been implemented with a dynamic electronic filter (EFMC) that automatically corrects the resonant AP waveform.

In order to test the EFMC, the electronically corrected AP and the derived cardiac output were compared with respective raw data corrected with the Accudynamic, an adjustable damping device specifically manufactured for normalizing the pressure waveform (in our study: the reference method).


Eligibility Criteria:
Inclusion Criteria:

- ICU patients with invasive blood pressure (radial artery) affected by underdamping/resonance artifacts;

Exclusion Criteria:

- Arrhythmias
Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage

The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage

In women with second trimester-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage.

Eligibility Criteria:
Inclusion Criteria:

* All women above 18 years of age
* between 13-26 weeks of gestation.
* Pregnancy is confirmed by a pregnancy test or ultrasound scan.
* missed abortion
* Normal general and gynecological examination.

Exclusion Criteria:

* Hemodynamically unstable.
* Suspected sepsis with temperature 38 °C.
* Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
* respiratory illnesses, recent liver disease, or pruritus of pregnancy.
* Presence of intrauterine contraceptive device (IUCD).
* Suspect or proven ectopic pregnancy.
* -Failed medical or surgical evacuation before the presentation.
* Known allergy to misoprostol.
PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron

This study has been designed to investigate the pharmacokinetic and safety profile of the co-administration of intravenous (IV) and transdermal granisetron, as well as characterise the pharmacokinetics of multiple transdermal dosing.

Sancuso® is designed to provide antiemetic prophylaxis for chemotherapy of up to 5 days duration. In exceptional clinical situations in which the patch is not applied at the appropriate time (i.e. 24-48 hours pre-chemotherapy), clinicians might use a single IV dose of granisetron to provide prophylaxis while the granisetron from the patch reaches a therapeutic plasma concentration.

Most chemotherapeutics are dosed in a single day, with a 2- or 3-week interval between doses; however, several regimens are administered over more than 5 days and others are given at frequencies (e.g. every 5 days). Thus, more than one patch may be required to provide continuous antiemetic prophylaxis. Characterisation of the pharmacokinetics of multiple transdermal dosing offers useful information for clinicians who treat patients with the latter types of regimens.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female Caucasian subjects
* Aged between 18 and 70 years, inclusive, at screening
* BMI between 20.0 and 29.9 kg/m², inclusive.
* Must demonstrate understanding of the purposes and risks of the study
* Must agree to follow the restrictions and schedule of study procedures

Exclusion Criteria:

* Current or previous disease, disorder, allergy or condition that could affect study conduct or laboratory assessments, or that presents undue risk from study medication or procedures.
* Physical examination or screening investigation result that indicates subject is unfit for the study.
* Scarring on upper arms.
* Positive virology, urine drugs of abuse or pregnancy test result (females of childbearing potential only).
* Recent use of prescribed or over the counter medication.
* Participation in any clinical study or loss of ≥ 400 mL of blood (e.g. been a blood donor) within the previous 60 days.
* Average weekly alcohol consumption of greater than 21 units (males) or 14 units (females), or habitually smokes ≥ 5 cigarettes or equivalent tobacco per day within the 6 months before the first study drug administration.
* Lactating female subjects and female subjects of childbearing potential who are not willing to use an acceptable form of contraception during and for 90 days after the study.
Efficacy and Safety of Oltipraz in the Patients With Non-alcoholic Fatty Liver Disease

Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK) activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1 (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c. Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18, under 75 years of age
* Patients with non-alcoholic fatty liver disease

Exclusion Criteria:

* Over 2 ratio of AST to ALT
* Type 1 diabetes mellitus (insulin-dependent diabetes mellitus)
* Disorder in liver function with an exception of non-alcoholic fatty liver (e.g. Virus infection, biliary atresia, autoimmune hepatitis and etc.)
* Patients who have been taken drugs induced fatty liver for over 3 month within 1 year of participation in this study; amiodarone, tamoxifen, methotrexate, tetracyclines, glucocorticoids, anabolic steroids, over usual dose of estrogen for hormone replacement therapy and valproate
* Patients who has been taken any medications that could affect the treatment for non-alcoholic steatohepatitis: insulin, insulin sensitizer(metformin, thiazolidinedione), high dose of vitamin E, high dose of UDCA, pentoxifylline, SAM-e, Betaine, types of Statin, types of fibrate and orlistat
* Patients who had a Bariatric surgery less than 6 month prior to the participation in the study
* Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc
* Any history of immune disorder which affect the changes in cytokine:

inflammatory bowel disease, autoimmune thrombocytopenic purpura, system lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatic arthritis and etc

* Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
* Patient who has been administered other investigational product within 1 month prior to the participation in the study
* Patient who is not allowed to get MRS test: pacemaker, shunt and etc
* Pregnant or nursing women
* Patient who considered ineligible for participation in the study as Investigator's judgment
Real-World Pharmacokinetic/Pharmacodynamic Study of Eravacycline in Critically III Patients

The aim of this study is to evaluate the efficacy of Eravacycline in the treatment of patients with bacterial infection and to assess the pharmacokinetics of Eravacycline and to establish a population pharmacokinetic model of Eravacycline.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female aged 18-75 years
* Not respond to initial empirical treatment, treatment time to reach Eravacycline steady-state concentration
* Empirical antimicrobial treatment is ineffective
* Eravacycline application for ≥ 3 days
* Understand and sign informed consent

Exclusion Criteria:

* Urinary tract infection
* Allergic to Eravacycline, Tigecycline antibiotics or any excipients or have previously experienced serious adverse reactions
* Any unstable or potentially endangering the safety of the subject and their compliance with the study as judged by the investigator; comorbidities or social circumstances that can make the subject unable to follow the study plan or even endanger the safety of the patient
* Patients expected to survive for no longer than 48h.
Outcome and Predictors of Mortality of Patients on Prolonged Mechanical Ventilation

Prolonged mechanical ventilation (PMV) and weaning failure are factors associated with prolonged hospital length of stay and increased morbidity and mortality. In addition to the individual challenges that stress patients and their families, the resource-intensive care these patients receive places a significant burden on the public health system. These burdens often persist over the long term, especially in the case of weaning failure with subsequent home mechanical ventilation (HMV).

This study will provide invaluable and in-depth knowledge of major sources of admission to ICU and will clarify the cause for the outcomes seen after prolonged mechanical ventilation in ICU admission, at Dessie comprehensive Hospital, the result of our study will also serve as a source or baseline information for future valuable researches to be undergone around the subject of interest.

The number of patients requiring prolonged mechanical ventilation after acute illness is increasing. Their long-term outcome is poor and has not improved significantly over the past 20 years. The symptom burden for patients is considerable, and family members often suffer from significant physical and emotional strain. Long-term survivors report lasting physical limitations, but their emotional health is generally good. Care for many patients requiring prolonged mechanical ventilation is shifting t post-intensive care unit settings. While this trend has resulted in cost savings for hospitals and payers, it has not had a major impact on patient outcomes.

Patients requiring prolonged mechanical ventilation consume a disproportionate amount of healthcare resources and clinician time. Measurement and knowledge of their outcomes will guide efforts to improve their care.

This study will be conducted in Dessie Comprehensive Specialized Hospital from August 2023 to January 2024. A retrospective cohort study will be conducted. Data will be checked, coded, entered, and analyzed using SPSS version 22 software. Descriptive statistics will be used to summarize data, tables, and figures for display results. Bivariate and multivariate analyses will be used to see the effect of the independent variable on the outcome variable. Variables that are significant on bivariate analysis at a p-value less than 0.2 will be taken to multivariate analysis. In multivariate analysis, a p-value of less than 0.05 will be used as a cut-off point for the presence of association. The strength of the association will be measured by 95% confidence interval and odd ratio.

Eligibility Criteria:
Inclusion Criteria:

* All charts of critically ill patients on prolonged mechanical ventilation in of Dessie Comprehensive Specialized Hospital during the study period.

Exclusion Criteria:

* Charts with incomplete information and missing values as well as those that are not available will be excluded from the study.
Retrospective Analysis of the Epidemiological Change and Determinants of Prognosis of Talaromycosisof Human Immunodeficiency Virus Negative Host in Guangxi

Through a multi-center large-sample retrospective study, the epidemiological changes of TSM in Guangxi have been reviewed, its incidence trend was understood to attract the attention of clinicians; the multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical remission rate, effective rate, recurrence rate, mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence indicators were clarified, and a therapeutic effect evaluation system was established, providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was identified to provide TSM with biological diagnostic indicators. Improve the level of understanding and diagnosis and treatment of HIV-negative TSM in the whole area. A comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of TSM in HIV-negative hosts. The observational indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical improvement time; level of decrease of fungus in the blood culture medium two weeks before treatment; recurrence; appearance of adverse drug reaction at the level 3 and above.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were HIV-negative adults who had talaromycosis that was confirmed by either microscopy or culture.

Exclusion Criteria:

* patients were HIV-infected adults who had talaromycosis that was confirmed by either microscopy or culture.
A Study of Music Therapy to Support Intrauterine Insemination

The purpose of this research is to learn if playing music in the room during an intrauterine insemination procedure decreases anxiety and pain for patients at the time of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* IUI must be performed in the Reproductive Endocrinology and Infertility offices at Mayo Clinic in Rochester.
* IUI procedure must be on a weekday.
* IUI procedure is scheduled to be completed by a nurse in the REI Department.

Exclusion Criteria:

* Not English speaking.
* IUI procedure on a weekend day.
* IUI procedure is scheduled with an MD provider (known or expected to be difficult).
* Planned IUI procedure is cancelled prior to undergoing the procedure.
* The patient has a documented diagnosis of complete hearing loss or significant hearing impairment in both ears.
* The patient has previous participated or declined enrollment in the study during a prior IUI procedure.