cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Effectiveness of the Advancing Research and Clinical Practice Through Close Collaboration (ARCC)

The Institute of Medicine's (IOM) ambitious goal for at least 90% of clinical decisions to be evidence-based includes nursing interventions and practice. Models and frameworks have been developed to meet the demand for practice transformation. While magnet facilities require a commitment to evidence-based nursing practice, military facilities currently lack such a requirement but are instituting evidence-based practice (EBP) initiatives in a purposeful path toward developing high-reliability organizations. Currently, little is known regarding the effectiveness of specific EBP models and frameworks within the military culture. The purpose of this investigation is to determine the effectiveness of the Advancing Research and Clinical Practice through Close Collaboration (ARCC) model in an Air Force Medical Treatment Facility (MTF) beginning with nursing services.

Research questions:

1. What is the current state of organizational culture and readiness for EBP within the MTF's nursing services?
2. Will utilization of the ARCC model significantly improve EBP beliefs, knowledge, and practice in MTF nurses over a two-year period?
3. Is the ARCC model feasible for implementation in Air Force MTF's?

This study includes an intervention group (n=70) of active duty nurses and technicians who attend an intensive 5-day EBP Immersion Workshop and a control group (n=70) who do not. The intervention group will have access to specialized resources such as: a) Center for Transdisciplinary Evidence-Based Practice (CTEP) expert EBP mentors, b) EBP toolkit and resources, c) one year of free access to the Ohio State University (OSU) virtual library. Control group participants will have standard MTF education opportunities. Established valid and reliable survey measures (EBP attitudes, knowledge, beliefs) will be hosted electronically by CTEP at baseline, three, and twelve months. Online measures include institutional and nursing process measures (EBP implementation, policy changes, and publications) over the two-year study period. De-identified data from the anonymous survey measures will be shared by CTEP with this study team. Data analysis will include Student's t-tests to explore differences between groups. Repeated measures ANOVA or the nonparametric equivalent (Friedman's test or Skillings-Mack test) will be used to compare three time points within groups. Feasibility metrics and demographics will be reported with descriptive statistics.

Further study details as provided by David Grant Medical Center, Travis Air Force Base, California

Eligibility Criteria:
Inclusion Criteria:

* Nurse (active duty) assigned to DGMC
* Medical/Surgical technician (active duty) assigned to DGMC
* 15 month retain-ability from time of enrollment

Exclusion Criteria:

* Disciplines outside of Nursing (PA, MD, Occupational Therapy (OT), Physical Therapy (PT), etc.)
* Nurse/technician General Schedule (GS),VA, Contractor employed at David Grant Medical Center (DGMC)
* Anticipated/Scheduled Permanent Change of Station (PCS) in next 15 months
LEO 29102 Cream in the Treatment of Atopic Dermatitis

This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of atopic dermatitis defined according to Hanifin and Rajka
* IGA assessment scored as mild (2) to moderate (3) atopic dermatitis
* Treatment lesions located on the trunk and limbs
* Treatment lesions involving 3% to 10% of the total body surface area
* Patients of either gender between 18 years and 65 years of age

Exclusion Criteria:

* Systemic treatment with immunosuppressive drugs or corticosteroids within 6 weeks prior to randomisation
* Topical treatment with immunomodulators (pimecrolimus, tacrolimus) within 2 weeks prior to randomisation
* Topical treatment with corticosteroids from WHO groups II, III or IV within 1 week prior to randomisation
* Use of topical or systemic antibiotics within 2 weeks prior to randomisation
* PUVA or UVB therapy within 4 weeks prior to randomisation
* Clinical infection (viral, fungal or bacterial) on the treatment area
* Known or suspected severe renal insufficiency or severe hepatic disorders
* Patients with history of an immunocompromised disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome)
* Patients with concomitant serious disease (e.g., cancer) which might affect the AD treatment in this trial
* Females who are pregnant or are breast feeding
* Females intending to temporarily or permanently stop their hormonal contraceptive regime during and up to one month post study termination visit
Study on Prognosis of Acute-on-chronic Liver Failure Complicated by Bacterial or Fungal Infection

The subjects of this study were inpatients with ACLF who were admitted to Tongji Hospital in Wuhan from March 2023 to June 2025. After patients were enrolled, The patient's general information (gender, age, past medical history, etc.), complications (ascites, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding, etc.), laboratory tests (CRP, PCT, INR, WBC, fungal/bacterial diagnostic tests, etc.), symptoms and signs at the time of infection, and at admission (D1), D4, D7, D14, D21, etc.) were recorded Save the blood separately. The patients were divided into fungal infection group, bacterial infection group and non-infection group according to the infection status after admission.


Eligibility Criteria:
Inclusion Criteria:

1. TBIL ≥ 12 mg/mL and INR ≥ 1.5
2. Chronic hepatitis B

Exclusion Criteria:

(1) \<18 or \>80 years old; (2) primary hepatic or extrahepatic carcinoma; (3) with severe diseases of other organs or systems; (4) pregnancy; (5) imcomplete information
Factors Affecting Patients With Myofascial Temporomandibular Disorders

The aim of the study was to assess and compare the relationship between jaw function, neck disability, sleep quality, fatigue, and headache in patients with myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB) and without (non-SB).

The study was conducted on TMD patients who were willing to participate in the study between January and December 2020.

The case-control study included patients diagnosed with myofascial TMD by dental practitioners at regional hospitals referred for physiotherapy. Total of 200 myofascial TMD patients, comprising 91 identified as SB and 109 as non-SB were included in the study.

The Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales and indexes were used for both groups.

The effect of Sleep Bruxism (SB) on jaw function, neck problems, sleep quality, fatigue, and tension headache were evaluated.

The interactions of these factors and the importance of taking SB into consideration when evaluating and treating patients with TMD were examined.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of myofascial TMD according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
* pain for more than 6 months
* no therapeutic interventions reported for TMD or the neck in the last 6 months
* intellectual capacity to provide informed consent

Exclusion Criteria:

* not meeting the DC/TMD criteria
* diagnosis of psychiatric disease
* history of surgery related to the cervical region and/or TMJ
* cervical and/or TMJ malignancy
* trauma history
* proven specific pathologies such as fracture, or rheumatoid disease
* history of facial paralysis
* pregnancy
Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 1

Non-invasive neuromodulation, such as transcranial direct current stimulation ( tDCS) , is emerging as an important therapeutic tool with documented effects on brain circuitry, yet little is understood about h ow it changes cognition. In particular, tDCS may have a critical role to play in generalization, that is how training in one domain generalizes to unlearned or unpracticed domains. This problem has resonance for disorders with cognitive deficits, such as schizophrenia.

Understanding how tDCS affects brain circuity is critical to the design and application of effective interventions, especially if the effects are different for healthy vs. psychiatric populations. In previous research, one clue to the mechanism underlying increased learning and generalization with tDCS was provided by neuroimaging data from subjects with schizophrenia undergoing cognitive training where increases in thalamocortical (prefrontal) functional connectivity (FC) predicted greater generalization.

The premise of this proposal is that increases in thalamocortical FC are associated with the generalization of cognitive training, and tDCS facilitates these increases. The overarching goals of this proposal are to deploy neuroimaging and cognitive testing to understand how tDCS with cognitive training affect thalamocortical circuitry in individuals with and without psychosis and to examine variability in response within both groups.

Study 1 will compare right prefrontal, left prefrontal and sham tDCS during concurrent cognitive training over 12 weeks in 90 healthy controls. Study 2 (NCT03896438) will be similar in all aspects but will examine 90 patients with schizophrenia or schizoaffective disorder and include clinical assessments. Results of the study will provide crucial information about location of stimulation, length of treatment, modeled dosage, trajectory and durability needed to guide future research and interventions for cognitive impairments.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide consent and comply with study procedures.
2. Age 18 - 60 years old.
3. Estimated IQ range within the range: 70 ≤ IQ ≤ 115.
4. No Serious and Persistent Mental Illness (SPMI) or addictive disorder diagnosis as measured by the MINI (Mini International Neuropsychiatric Interview), or sleep disorder;
5. Ability to participate in three weekly 45' training sessions over 12 weeks and participate in four assessments.

Exclusion Criteria:

1. Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness \> 30 min, HIV).
2. Contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications: The research team will utilize the CMRR Center's screening tools and adhere to the screening SOP during enrollment of all research participants in this protocol. The CMRR Center's screening tools and SOP are IRB approved under the CMRR Center Grant (HSC# 1406M51205) and information regarding screening procedures is publicly available on the CMRR website (CMRR Policies / Procedures).
Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.


Eligibility Criteria:
Inclusion Criteria:

* Participant is judged to be in good health
* Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
* Participant's birth weight was \> 2490 g (\~5 lbs. 8 oz.)
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
* Parent(s) confirm their intention not to administer vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization

Exclusion Criteria:

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Participant is taking and plans to continue taking medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
* Participant participates in another study that has not been approved as a concomitant study by AN.
* Participant has an allergy or intolerance to any ingredient in the study product
* Participant has been treated with antibiotics within 1 week prior to enrollment
Combination Chemotherapy in Treating Patients With Advanced Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer.

OBJECTIVES:

* Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer.
* Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients.
* Determine the efficacy of this regimen in patients with measurable or evaluable disease.
* Evaluate the quality of life of these patients.

OUTLINE: This is a dose-escalation study of tipifarnib.

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral tipifarnib every 12 hours beginning on day 2. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients each receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which fewer than one third of the patients experience dose limiting toxicity.

Quality of life is assessed before treatment, on day 22 of each course, and at the end of treatment.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically proven advanced cancer for which no curative therapy exists

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 9 g/dL

Hepatic:

* Bilirubin normal
* SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)

Renal:

* Creatinine normal

Other:

* Unassisted oral or enteral intake sufficient to maintain a reasonable state of nutrition
* No concurrent medical condition that is likely to interfere with study participation
* No active visual disturbances that require intervention beyond corrective lenses
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior bone marrow transplantation
* No concurrent immunotherapy

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No prior high dose chemotherapy with bone marrow or stem cell rescue
* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent hormone therapy (except megestrol acetate)

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to 25% or more of bone marrow
* No concurrent radiotherapy (except palliative radiotherapy within the first 28 days of the study)

Surgery:

* Not specified

Other:

* At least 30 days since prior investigational therapy
* No concurrent investigational therapy
Family Engagement, Cross-System Linkage to Substance Use Treatment for Juvenile Probationers -- Phase 3

Developed from adapting and combining two evidence-based programs, Project CONNECT (a linkage-to-services program that targets barriers within the probation and substance abuse treatment systems) and TIES (a program that teaches family engagement skills to providers), Family CONNECT is a linkage-to-services program that targets both family and system-level factors to increase youth use of and retention in substance use services. Using Linkage Specialists embedded within probation departments, Family CONNECT will be implemented in two NYS probation departments. This proposed study will evaluate the impact of Family CONNECT on (1) youth referral from probation to substance abuse treatment, (2) youth and family engagement in substance abuse treatment, (3) youth enrollment/retention in substance abuse treatment, and (4) youth substance use and recidivism. Counts of youth referred, youth who start treatment, and youth retained in treatment will be obtained from the juvenile justice agency for 6-months pre-implementation of Family Connect (i.e. baseline) and during the implementation period of e-Connect; counts of youth recidivism will be obtained 6 months following the completion of Family Connect. This study will also identify family and probation organizational factors influencing Family CONNECT implementation in probation settings. 50 caregiver-youth dyads and up to 36 probation officers will be recruited as participants in the study. Caregiver-youth dyads will be evaluated at baseline, 2 and 6 months; probation officers at baseline, 6, 12, and 18 months; linkage specialists at baseline, 6, 12, and 18 months.


Eligibility Criteria:
Youth:

Inclusion Criteria

1. Between 10-18 years of age
2. English speaking
3. A caregiver who will participate in the study
4. MAYSI-2 score of ≥ 4 on any MAYSI-2 subscale; YASI mental health and substance use screen items; or other documented evidence of mental health or substance use problem
5. Currently on probation

Exclusion Criteria 1. Cognitively unable to complete the interview

Caregiver:

Inclusion criteria

1. Youth's legal guardian (or permission from legal guardian)
2. Youth who will participate
3. English speaking

Exclusion criteria:

1. Cognitively unable to complete the interview

Probation staff:

Inclusion criteria:

1. Currently employed at probation department

Exclusion criterion:

1. None
Effects of Fenofibrate on Adipocytokine Levels In Hypertriglyceridemic Patients

Fenofibrate increases adiponectin levels, but reduces leptin levels


Eligibility Criteria:
Inclusion Criteria:

* hypertriglyceridemia

Exclusion Criteria:

* chronic liver disease
Abuse and Addiction in ICU

Investigators are seeking to determine the impact of recent alcohol, smoking or psychotropic drug use prior to intensive care unit (ICU) admission on incidence of delirium and sedation requirements.

Study design: A prospective observational study, in a medical ICU of a tertiary university hospital.

Methods: For all new ICU admissions, a 1-page questionnaire including Alcohol Use Disorders Identification Test (AUDIT-C), smoking history and prior medication use was given to the patient or closest family members.

Delirium was assessed by trained ICU nurses using Intensive Care Delirium Screening Checklist and Richmond Agitation-Sedation Scale.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are older than 18 years of age
* New patients admitted to medical ICU for the 1st time during their stay in hospital

Exclusion Criteria:

* Had history of stroke or other primary neurologic disease
* GCS ≤ 8 prior to ICU admission
* Transferred from other ICU (except for emergency ICU stay which is limited to less than 36 hours)
* Not registered within 24 hours after admission
* Refused to participate
* If comatous state persists
* Delirium assessment is not possible due to newly developed neurologic disease, such as cerebral infarction
* Medical ICU stay less than 24 hours
* Readmission to medical ICU
Study of an External Responsive Neurostimulator System on Epileptiform Activity

This feasibility clinical investigation is designed to demonstrate that the NeuroPace external Responsive Neurostimulator (model eRNS-300) can safely deliver responsive electrical stimulation automatically to affect epileptiform activity. The eRNS-300 is based on an implantable neurostimulator that has been adapted for acute, external use in a hospital setting.

The Automated Response to Spontaneous Epileptiform Activity using the External Responsive Neurostimulator (eRNS) system clinical investigation involves subjects who are undergoing intracranial monitoring for the evaluation of epilepsy surgery and who are being monitored in the hospital's epilepsy monitoring unit. During the subject's participation, at the discretion of the investigator, the subject will be connected to the eRNS. The eRNS is an investigational device that attaches to standard intracranial electrode monitoring equipment to monitor the subject's seizure activity. It is anticipated that the subject may be connected to the eRNS for a period of time extending from one day to a few weeks. After the subject has enough seizures to complete their evaluation for epilepsy surgery, the physician may enable the responsive stimulation settings for the eRNS. The subject's participation in the clinical investigation will be complete prior to the removal of their intracranial electrodes.

Eligibility Criteria:
Inclusion Criteria:

* Subject is undergoing evaluation for epilepsy surgery in a manner consistent with the Surgery for Epilepsy, NIH Consensus Statement, 1990 Mar 19-21; 8(2); 1-20.
* Subject is implanted with intracranial electrodes.
* Subject is under constant medical supervision while implanted with the intracranial electrodes.
* Subject is twelve (12) years of age or older.

Exclusion Criteria:

* Subject is pregnant.
* Subject has a clinically significant or unstable medical condition that, in the opinion of the investigator, would make it inadvisable for the individual to participate.
* Subject has a progressive central nervous system disease or serious acute or ongoing systemic illnesses.
* Subject has an active psychosis, severe depression, suicidal ideation or psychiatric conditions associated with impaired judgment.
* Subject is considered at high risk, for any reason, by any of the investigators.
* Subject is implanted with a medical device that might interfere with the eRNS. (This includes, but is not limited to direct brain neurostimulators, pacemakers, implantable cardiac defibrillators, spinal cord stimulators, vagal nerve stimulators, cochlear implants)
The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients

After hCG trigger a large amount of exogenous progesterone is used for luteal phase support in many countries until 10th week of gestation. Instead we suggest the use of two small doses of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the endogenous progesterone production from the corpora lutea (CL).


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 40
* Normal menstrual cycles: 25-34 days
* Oligomenorrhea/amenorrhea or polycystic syndrome (defined according to the Rotterdam criteria 2004)
* BMI \>18 and \<35 kg/m2

Exclusion Criteria:

* Patients with \>14 follicles on day of trigger
* Previous hyperresponse with OHSS development
* Previous low response (less than 3 oocytes on a high dose of FSH stimulation)
* Endocrine disorders