cyrilzakka/clinical-trials huggingface dataset:
Antibiotic Outbreak, Risk Factors for Never Event, Prediction of Inappropriate Use

In order to decrease inappropriate antibiotic use, drivers of inappropriate use must be identified locally. This study will focus on the MOST inappropriate use, which are defined as 'never events'. Previous work has shown that antibiotic use clusters over time. It is hypothesized that never events also cluster over time. Using electronic data capture strategies, an algorithm will be developed to quickly and accurately identify areas of antibiotic use concern. Secondly, a framework will be developed, utilizing antimicrobial consumption data and captured signals of inappropriate antimicrobial use to provide targets for antimicrobial stewardship efforts.

Appropriateness in antimicrobial prescribing has become a focal national and international issue. It has been estimated that upwards of 50% of antibiotic use is inappropriate. With this backdrop, a national strategic goal has been set by the United States White House to decrease inappropriate antibiotic use by 20% and 50%, respectively for inpatient and outpatient settings. In order to decrease inappropriate use, drivers of incorrect use must be identified at each local setting. The actual drivers of confirmed inappropriate use have been difficult to identify except when using time and resource intense chart reviews. Even the largest contemporary antibiotic consumption studies have not assessed appropriateness as it was 'outside of study scope'. Further, there is no consensus or agreement on what constitutes inappropriate use. These apparent omissions underscore the difficulty and complexity in attributing appropriateness of use for antimicrobials. Importantly, this study will focus on the MOST inappropriate use, which are defined as 'never events'. Previous work has shown that antibiotic use clusters over time. It is hypothesized that never events also cluster over time. Using electronic data capture strategies, an algorithm will be developed to quickly and accurately identify areas of antibiotic use concern. Secondly, a framework will be developed, utilizing antimicrobial consumption data and captured signals of inappropriate antimicrobial use to provide targets for antimicrobial stewardship efforts.

Eligibility Criteria:
Inclusion Criteria:

* receipt of inpatient intravenous vancomycin during proposed study period
* adults 18 years of age or older and less than 90 years of age

Exclusion Criteria:

* individuals who are not yet adults (infants, children, teenagers)
* pregnant women
* prisoners
Effects of Mindfulness Training on Burnout and Mood in Hospital Employees

The primary aims of the study are to 1) provide a hospital employee population with a mindfulness based stress reduction workshop and 2) evaluate the impact of this clinically validated group mindfulness intervention on burnout in health care employees. Secondary outcomes will be anxiety, depression, quality of life and self compassion.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Employees of Stanford Health Care
* Ability to attend a minimum of 4 out of 6 sessions

Exclusion Criteria:

* Non-English speaking
* Employees with severe medical or psychiatric conditions that prevent them from participating in the group format
Digital Solutions for Concussion

The objective of this study is to develop new digital solutions for patients with prolonged postconcussion symptoms, and investigate its usability, feasibility, and safety. The digital solutions consist of a 1) symptom mapping and clinical decision support system, and 2) a research-based system for home-based biofeedback treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 or older at the time of inclusion.
* Mild TBI as defined by having sustained a head injury with observed or self-reported alteration of consciousness, amnesia, or other relevant acute symptoms.
* PPCS according to the ICD-10 research criteria and PTH according to International Classification of Headache Disorders 3rd edition (ICHD-3). Operationalized as reporting 3 or more symptoms (including headache) on a moderate or greater intensity level on the RPSQ.
* Proficient in Norwegian language (oral and written)
* Signed informed consent

Exclusion Criteria:

* Serious psychiatric or somatic disease, or other patient-related factors, that based on an evaluation of the study personnel responsible for inclusion, will provide obvious challenges for adhering to the protocol, including using the devices.
* Less than three months of experience with smartphones
* Not having access to an iOS or Android smartphone
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Patients with SNF2 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. Five treatment arms were set up based on the whether they have exposed to CDK4/6 inhibitors before. The main purpose is to evaluate immune therapy in SNF2 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Eligibility Criteria:
Inclusion Criteria:

* Females ≥18 years and ≤ 75 years old;
* Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER\> 10% tumor cell positive is defined as ER positive, PR\> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
* Subtype of similarity network fusion-2 (SNF-2) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital
* Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
* Has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /L; platelet count \> 75x10ˆ9 /L, hemoglobin \> 9g/dL;
* Patients had received no previous chemotherapy or targeted therapy for metastatic disease
* Has adequate liver function and kidney function: serum creatinine
* ECOG score ≤ 2 and life expectancy ≥ 3 months;
* Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.

Exclusion Criteria:

* Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease

  * Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms);
  * Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
  * is pregnant or breast feeding;
  * Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
  * History of autoimmune disease
  * Positive test for human immunodeficiency virus
  * Active hepatitis B or hepatitis C
  * Uncontrolled pleural effusion and ascites
  * Thyroid dysfunction.
The RBANS-H in Older Adults With Normal Hearing or Age-related Hearing Loss

The present cross-sectional study aims to examine the cognitive capabilities of older adults, aged 50 to 89, with normal hearing or age-related hearing loss by means of the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals (RBANS-H). Secondly, the correlations between cognition on the one hand and hearing and speech reception capabilities on the other hand are investigated. For this purpose, twenty participants are included in the age categories 50 to 59, 60 to 69, 70 to 79 and 80 to 89, bringing the total number to 80. Three questionnaires are administered to the participants: the Health Utilities Index-2/3 (HUI 2/3), Dizziness Handicap Inventory (DHI) and a general questionnaire on education and profession, medical history, hearing aid use and tinnitus. Also an audiological examination is performed, including pure tone audiometry, speech in quiet and speech in noise audiometry. Finally, cognition is assessed using the RBANS-H.


Eligibility Criteria:
Inclusion Criteria:

* Hearing: Air conduction hearing thresholds according to age, based on the ISO standards
* Age: 50 - 89

Exclusion Criteria:

* History of any neurological disease
* History of otological surgery or disease
Evaluating FDA's Proposed Patient Medication Information Handout

The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users.

The main questions it aims to answer are:

How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension?

and

How does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information?

Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension.

The US Food and Drug Administration (FDA) has proposed a new one-page 'patient medication information (PMI) handout that can be provided with every prescription medication, in order to provide patients with the information they need to use their medications safely and effectively. The current proposal omits some decision-critical benefit information and had not been tested with potential users, potentially undermining its effectiveness.

The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users, compared with a revision adding drug benefit information and with the current drug information insert.

A randomized trial will be conducted with U.S. female adults 18-45 years, recruited in March, 2024. Participants will complete an online survey after being randomized to view 1 of the 3 information formats. Participants will be paid $10. Surveys are expected to take no more than 30 minutes to complete.

Participants will be randomized to receive either the one-page FDA-template PMI (FDA PMI), a modified template, which added information about drug benefits (Decision Critical PMI), or the existing drug information insert (standard drug information) for the drug, Mifeprex. All individuals will complete knowledge and usability questions and provide demographic information.

The main outcomes measured will be perceived usefulness and comprehension of the patient medication information.

Eligibility Criteria:
Inclusion Criteria:

* US geographic location
* 18-45 years of age
* assigned female sex at birth

Exclusion Criteria:

* \<18 years of age
* \> 45 years of age
* assigned a sex other than female at birth
The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients that will be randomized to one of the two groups. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.

This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients will be randomized to one of the two; one will receive standard of care IPC or TED stockings to help with circulation, the other group will use the geko device which is a newer device with Health Canada approval. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* At least 18 years old
* Undergoing kidney or kidney pancreas transplant surgery as the recipient
* Able and willing to provide written informed consent
* Absence of known peripheral vascular disease
* Body Mass Index of between 18 and 34
* Leg circumference at site of geko™ device placement is 24" or less

Exclusion Criteria:

* History of deep vein thrombosis
* Temporary or permanent cardiac pacing
* Patient is pregnant
* Any patient which may be excluded by way of warnings in the Manufacturer's Instructions for Use
* Any patient who requires an ECG electrode applied on the leg for continuous monitoring throughout therapy
* Previous leg(s) amputation
* Presence of any of the following in the site of intended device placement: cancerous lesion, swollen or infected or inflamed areas or skin eruptions i.e. phlebitis, thrombophlebitis, varicose veins
* History or signs of haematological disorders (especially in relation to clotting or coagulation disorders) including presence or history of thrombus formation
* BMI index \>36
* Patients with any neurological disorder or disease that would interfere with proper assessment and or conduct of the trial
* History of implantable brain or other stimulator
* Patients who can not tolerate the stimulation from the GEKO device
Applied Forces During Neonatal Intubation at Different Heights of the Resuscitation Table

The study aims to compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time and participants' opinion on the procedures were investigated.

This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table.

Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Some procedure-related aspects may affect the quality of the intubation. Optimizing the relative height between patient and operator may improve intubation procedures.

Objectives: To compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time, and participants' opinions on the procedures were investigated.

Methods: This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Participants will be Level III NICU/PICU consultants, and pediatric residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the forces applied on the neonatal manikin during the intubation. The secondary outcome measures will be the success of the first attempt, the total time of intubation, and participants' opinions about the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Level III NICU and PICU consultants, and pediatric residents

Exclusion Criteria:

* Refusal to participate
Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. A pre-operatively placed pancreatic stent across papilla can decrease the pressure gradient between pancreatic duct and duodenum. Therefore, the pancreatic juice flow is redirected from the pancreatic transection plane and leakage from pancreatic stump is much reduced. This study aims to evaluate whether pre-operatively placed pancreatic stent can prevent POPF by a randomized controlled trial.

A randomised-controlled trial is performed to evaluate the efficacy of preoperative pancreatic duct stenting in preventing post-operative pancreatic fistula after distal pancreatectomy with or without splenectomy. Patients will be randomised to pre-operative stent group or surgery alone group. Pre-operative pancreatic duct stenting will be performed 1-2 weeks before surgery. The stent will be removed 4 weeks after operation. The post-operative pancreatic fistula rate, morbidity, mortality and total length of stay were compared between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Elective distal pancreatectomy for primary pancreatic pathology

Exclusion Criteria:

* Informed consent not available
* Emergency distal pancreatectomy
* Presence of pancreatic duct stricture
* Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy)
* History of severe pancreatitis
Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)

To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi.

This is a Phase 1b, open-label, dose escalation, safety and tolerability study of Duvelisib (IPI-145) in combination with obinutuzumab in subjects with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi therapy.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Diagnosis of Chronic lymphocytic leukemia or Small lymphocytic lymphoma that meets at least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for treatment (Binet Stage ≥ B and/or Rai Stage ≥ I with symptoms)
* Measurable disease with a lymph node or tumor mass \>1.5 cm in at least one dimension as assessed by computed tomography (CT)
* Previous exposure to BTKi therapy and meets at least one of the below criteria:

  * Progressive disease while receiving a BTKi therapy, or stable disease as best response after 12 months of receiving a BTKi therapy
  * Discontinued a BTKi therapy due to BTKi treatment-related intolerance
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (corresponds to Karnofsky Performance Status \[KPS\] ≥60%)
* Subjects must be able to receive outpatient treatment and laboratory monitoring (where specifically indicated) at the institution that administers study drug for the entire treatment period

Exclusion Criteria:

* Richter's transformation or prolymphocytic leukemia
* Refractory to obinutuzumab (defined as progression or relapse \<12 months of receiving obinutuzumab monotherapy or \<24 months of receiving an obinutuzumab-containing regimen)
* Progressive disease while previously receiving a PI3K inhibitor (e.g. GS-1101 \[idelalisib\], duvelisib) or a serious/severe AE related to PI3K inhibitor treatment
* History of severe reaction to prior monoclonal antibody therapy (defined as a Grade 4 event and/or requiring permanent discontinuation)
* Human immunodeficiency virus (HIV) or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
* Prior, current, or chronic hepatitis B or hepatitis C infection
* History of tuberculosis treatment within the preceding 2 years
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed \[PRN\]), for a maximum of 168 doses within a 12-week treatment period.

A randomized, double-blind, placebo-controlled, parallel group, 3-arm study assessing efficacy, safety, and tolerability of two doses of BXCL501 in male and female subjects (65 years and older) with acute psychomotor agitation associated with dementia.

Approximately 150 subjects will participate in this study. Subjects will receive a single film consisting of BXCL501 40 µg dose or BXCL501 60 µg dose or placebo. Subjects must reside in a care facility where all study-related procedures and study drug dosing will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects must have a diagnosis of probable Alzheimer's disease based on NIA-AA criteria (2018). If subject biomarker data are unavailable, per the 2018 NIA-AA diagnostic criteria, the clinical diagnosis of probable AD will be based on the 2011 NIA-AA criteria
2. Episodes of psychomotor agitation (e.g., kick, bite, flailing)
3. Subjects exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior
4. A score of 0 to 20 on the Mini-Mental State Exam (MMSE) and require moderate to full assistance with activities of daily living
5. Subjects who read, understand, and provide written informed consent, or who have a LAR to provide consent on their behalf
6. Subjects who are deemed to be medically appropriate for study participation by the principal investigator
7. Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

1. Subjects with dementia or other memory impairment not due to probable AD.
2. Clinical diagnosis of probable AD should not be applied when there is evidence of a cerebrovascular incident temporally related to the worsening of cognitive function.
3. Subjects with agitation caused by acute intoxication.
4. Subjects with significant risk of suicide or homicide per the investigator's assessment.
5. Subjects who are medically unstable or in recovery. Note: Subjects with a remote (\>5 years) history of stroke may be included, regardless of size/location.
6. History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia.
7. Subjects with laboratory or ECG abnormalities.
8. Subjects who have received an investigational drug within 30 days prior to Screening.
9. Subjects who are currently suffering from substance abuse.
10. Subjects with a potential cause for delirium (relatively recent onset agitation and dementia)