cyrilzakka/clinical-trials huggingface dataset:
LEARN-6™: A Prospective, Observational Nursing Home Study

This is a prospective, multicenter, observational, hypothesis-generating study exploring mobility, Quality of Life and other physical performance measures among older, long-term stay Nursing Home residents with CKD, with versus without anemia. Enrolled patients will participate in the study up to a total of 26 weeks and be assessed at Weeks 1, 2, 14 and 26/End of Study. Based upon Week 1 hemoglobin and serum creatinine lab results, participants will be categorized into 1 of 4 groups.

Study Design: Multicenter, non-interventional, 26-week, prospective, observational study of older, long-term stay residents with CKD, with and without anemia, in US Nursing Homes.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years
* Long-term resident of NH as documented in medical record by Director of Nursing (DON) or Medical Director or as indicated in Minimum Data Set (MDS) Section Q
* Able to walk at least 1 step or propel wheelchair 1 revolution of wheel
* Able to follow a one-step instruction
* Written informed consent

Exclusion Criteria:

* Admitted to NH for short stay rehabilitation (anticipated stay less than 3 months)
* Receiving Renal Replacement Therapy (RRT)
* Major surgery within the past 3 months
* Life expectancy \< 6 months or receiving palliative care
* Currently enrolled in or has not yet completed at least 30 days since ending investigational device or drug study(s), or is receiving investigational agent(s)
* Currently is enrolled in an interventional trial
* Previously withdrawn from this study
Household Air Pollution and Pregnancy Outcome

Exposure to Household air pollution (HAP) from burning biomass fuels is responsible for an estimated 2.5 million premature deaths and 3.7% of the loss of disability-adjusted life years (DALY) every year in developing countries.52-54 Of all environmental risks, such as unsafe water, poor sanitation, climate change and lead exposure, HAP accounts for the most mortality and DALY.55 Despite the magnitude of the problems associated with HAP, research on its health effects has been hindered by lack of accurate data on exposure and health outcomes. There are few studies available that report HAP exposures and development of adverse pregnancy outcomes from households using biomass fuels.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who present to the hospital
* Who cook exclusively with either kerosene or firewood
* Before the fourteenth week of pregnancy as determined by ultrasound imaging

Exclusion Criteria:

* Smoking women or women with smoking family members
* Women with a high-risk pregnancy defined as:

  * Women with uncontrolled hypertension
  * Women greater than 35 years old carrying their first child
  * Women having triplets or more
  * Women who have had a previous C-section
  * Women carrying babies with fetal abnormalities or as determined by the obstetrician.
HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL

The overall objective of this pilot study is to determine the safety and feasibility of a hybrid closed-loop insulin delivery system for children and young adults with high risk acute lymphoblastic leukemia, during the induction chemotherapy phase while they are exposed to steroids and asparaginase that cause hyperglycemia.

The overall objective of this pilot study is to determine the safety and feasibility of a hybrid closed-loop insulin delivery system for children and young adults with high risk acute lymphoblastic leukemia, during the induction chemotherapy phase while they are exposed to steroids and asparaginase that cause hyperglycemia. Insulin therapy would be beneficial in reducing hyperglycemia-associated complications in this period and thereby could improve other outcomes. The primary objective of the current pilot proposal is to demonstrate that hybrid closed loop pump therapy is a safe to be used in children and young adults with high risk acute lymphoblastic leukemia. If successful, the results of this study will be used to plan and support a larger, multi-center clinical trial and a grant proposal.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ages 10 years old and above
2. Patients who are newly diagnosed with high-risk acute lymphoblastic leukemia
3. Patients who have started or will start an induction chemotherapy regimen containing steroid and asparaginase
4. Patients (if over 18 years of age) or parent/guardian (if the patient is under 18 years of age) must be fluent in reading and speaking English
5. Parent or guardian living in the home with the participant who also receives training on diabetes, CGM, HCL therapy, and the safety protocols

Exclusion Criteria:

1. Preexisting diabetes
2. Severe psychiatric disease or developmental delays, that might interfere with ability to provide informed consent
3. Active skin condition that would affect sensor placement
4. Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial, including but limited to:

   1. Significant chronic kidney disease (eGFR \<60) or requiring hemodialysis
   2. Significant liver disease
   3. History of adrenal insufficiency
   4. History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
   5. History of thyroid cancer
5. Use of intravenous or oral acetaminophen more than 60 mg/kg/day (maximum 4000 mg/day)
A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain.

The purpose of this study is to collect information on the:

* general information of a group of people such as their age, sex
* clinical information of the patients such as any other illness before having COVID 19.
* the number of COVID-19 patients who meet and follow the most up to date World Health Organization (WHO) recommendations for medication to treat COVID-19 (such as version 14, published 10Nov2023) compared to Kingdom of Bahrain national recommendations
* adult COVID-19 patients' health care resource use and outcomes within the 28-day period In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.

This study will be conducted in the Kingdom of Bahrain. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment and those not treated with nirmatrelvir, ritonavir.

This study will have about 3000 patients treated with Paxlovid™ therapy and 1000 were not. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.

The study will include patient information of those who:

* had COVID-19 infection during the study period from 16 February 2022 to 30 November 2022.
* are 18 years of age or older. This study will help to inform decision-making on use of Paxlovid at the national level.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:Age 18 years and older Patients with a diagnosis of COVID-19 whose information can be extracted from the I-Seha database

Exclusion Criteria:

There are no exclusion criteria for this study.
Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation

Postreperfusion syndrome (PRS) is a relatively common phenomenon in patients undergoing liver transplantation which is characterized by an acute drop in blood pressure immediately after the prefusion is restored to the transplanted liver. We hypothesized that PRS would be prevented when phenylephrine or epinephrine is administered immediately prior to reperfusion in liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

- adults scheduled to undergo liver transplantation

Exclusion Criteria:

- pediatric liver transplantation
The Effects of Erector Spinae Plane (ESP) Block on Surgery-related Stress Response in Cardiac Surgery With ERAS

Surgery-induced pain reveals its own metabolic and inflammatory responses, resulting in a further increase in noxious pathways that are already occurring. Even though it is difficult to distinguish whether the metabolic and inflammatory responses are pain-induced or surgical-induced, it is clear that pain can cause a response. This study aims to investigate the effects of erector spinae plane block on surgery-related stress response with enhanced recovery after cardiac surgery protocol.

The Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) program includes a perioperative multimodal, opioid-sparing pain management plan as an essential component of any comprehensive program. A multimodal pain management plan is nonopioid systemic analgesic agents, regional and local anesthetic techniques, and judicious use of opioids. This study aims to examine inflammatory and hematological parameters in patients who underwent cardiac surgery with ERAS, with and without preoperative bilateral erector spinae plane block (ESP). For this purpose, the presence of an obstacle ESP block application in the preoperative period will be investigated in patients who are prepared for cardiac surgery according to ERAS principles, and the patient's group will be determined accordingly. An analgesia protocol that does not include a regional technique will be applied to the patient in cases such as the patient's refusal to allow preoperative block and the presence of a situation that does not allow blockage in the block area. The perioperative characteristics of ERAS patients with and without ESP block will be examined, intraoperative lactate, and preop-postoperative hemogram-albumin-C reactive protein parameters will be recorded.

ERAS patients with ESP block: After preparation in accordance with the ERAS protocol, ultrasound-guided bilateral ESP block will be performed with 20 ml of 0.025% bupivacaine at T5-7 levels in patients taken to the operating room in the preoperative period, and will be administered intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.

ERAS patients without ESP block: After preparation according to the ERAS protocol, patients will be administered lidocaine, ketamine, paracetamol, and intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who will undergo open-heart surgery with ERAS protocol

Exclusion Criteria:

* Emergency surgeries
* Patients with allergic reactions to anesthesia and analgesia drugs to be used
* Patients who do not want to participate in the study voluntarily
* Severe systemic disease (kidney, liver, pulmonary, endocrine)
* Substance abuse history
* History of chronic pain
* Psychiatric problems and communication difficulties
* Patients who need revision due to hemostasis in the postoperative period
* Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.
The R4R Advance Care Planning Pilot Study

Affordable housing residents continue to experience multi-faceted insecurity and advance care planning (ACP) challenges even after obtaining secure housing, resulting in significant inequities in quality of care during times of cognitive incapacity. To promote proactive planning for affordable housing residents, this proposal is for a pilot study to test a novel trauma-informed care adapted advance care planning intervention with the following aims: to test initial efficacy of the intervention on ACP outcomes (Aim 1) and determine resident perceptions of intervention acceptability, appropriateness, and feasibility and perceived implementation barriers and facilitators (Aim 2). These data will support the development of a larger scale study of ACP interventions within a resiliency-based hub model to comprehensively support whole-person care and proactive planning for times of cognitive incapacity.

Long-term objectives and goals. Vanderbilt University School of Nursing (VUSN) and Urban Housing Solutions (UHS) - the second largest provider of affordable housing in Nashville - are partners with the long-term goal of reducing health disparities among medically-underserved UHS residents in Nashville. This partnership is developing resiliency hubs that will provide essential services and support within a communal setting at the housing facility. Previous literature and data findings support that similar populations to this community lack information about and access to advance care planning (ACP), which specifies their healthcare wishes during cognitive incapacitation or end-of-life, and nationwide research shows significant disparities regarding ACP participation among low-income populations. The short-term goal of the proposed work is to pilot test a Hybrid type 1, single-arm, pre-post intervention to assess the initial efficacy and implementation outcomes of a trauma-informed care (TIC)-adapted ACP intervention to improve learning and communication for times of decisional incapacity among UHS residents, within the context of a resiliency hub model. This is a necessary first step for developing a long-term research portfolio dedicated to addressing ACP disparities and promoting equitable end-of-life planning among low-income, medically-underserved populations.

Eligibility Criteria:
Inclusion Criteria:

* an adult (18+) residing in an affordable housing unit that does not have a completed advance directive

Exclusion Criteria:

* inability to provide informed consent or participate in the intervention due to cognitive, auditory, visual impairment or non-English language barrier
Do Penicillin-allergic Patients Presents a High Risk of Sinus Lift Failure

This retrospective study aims to evaluate clinical histories to determine if there is a relationship between patients allergic to penicillin and sinus lift failure and the possible post-operative complications that may arise.

Introduction: It is known that patients allergic to penicillin have a tendency to have greater failure of dental implants. It is believed that when prescribing non-penicillin antibiotics, such as clindamycin, the bacterial spectrum is not as wide as penicillin, and it is commonly associated with more drug-resistant microorganisms, such as Cloastridium difficile.

However, this statement, which is well studied in implants, has not been studied as much in sinus lift as a surgical technique.

Objectives

* Primary objectives: For that reason, the primary objective of this study is to evaluate retrospectively, if penicillin allergic patients presents higher risk of failure in lateral sinus lift procedure compared to none-allergic penicillin patients.
* Secondary objectives: Evaluate the differences, in terms of implant failure and intraoperative and post-operative sinus lift complications, between patients allergic to penicillin and those who are not allergic.

Materials and Methods: This retrospective study analyzed patients undergoing lateral sinus lift and rehabilitated with dental implants between the years 2004 and 2024 at the dental clinic of Universitat Internacional de Catalunya, Barcelona (UIC). This study will include adult patients in whom a lateral sinus lift with simultaneous or delayed implants was performed at the university. The clinical history should determine whether or not you are allergic to penicillin, the possible pre- and post-operative complications of the surgical intervention and the evaluation regarding the sinus lift surgery (whether it fails or not) and the subsequent placement of the implant.

Eligibility Criteria:
Inclusion Criteria: men and women over 18 years of age, patients undergoing at least one sinus lift procedure with simultaneous or deferred placement of implants; and patients' containing the following data: (1) Penicillin allergy: presence or absence; (2) Prescribed antibiotic guidelines; (3) Intraoperative complications: no complications, Schneider membrane's perforation; (4) Postoperative complications: No complications, fistula, infection, unspecific failure, hemorrhage, healing by second intention; (5) Results of sinus lift procedure: failure or not; (6) Results of implant placement: failure or not.

Exclusion Criteria: (1) Medical history that was not fully complied with; (2) Patients who did not attend follow-up visits.
Factors Associated With Complications of Cervical Necrotizing Fasciitis

Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or dental infections. The infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive care with radiologist and with early and repeated surgical debridement. Anti-inflammatory drugs have been incriminated by authors in the development of necrotizing fasciitis. Recently, a single-center study demonstrated that pharyngeal source of CNF and oral glucocorticoid intake before admission was associated with the occurrence of mediastinitis.

The aim of the study is to assess the incidence and factors associated with CNF complications, in particular mediastinitis. Secondary outcome is to describe patient characteristics, medical and surgical management.

Methods: A retrospective, observational, non-interventional multicentre study is conducted in nine intensive care units in France from January 2005 to December 2016.


Eligibility Criteria:
Inclusion Criteria:

- Patient admitted in ICU for management of cervical necrotizing fasciitis between 2005 and 2016.

Exclusion Criteria:

* Patients admitted in ICU for management of cervical abscess without cervical necrotizing fasciitis
* Age \< 18 years
Diagnosis of Structural Sacroiliitis in Patients With Suspicion of Spondyloarthritis (EchoSPA)

The aims of this study are: 1° to assess the value of pelvic radiography and sacro-iliac joint (SIJ) MRI compared to CT scan of SIJ for the diagnosis of structural sacro-iliitis and 2° to quantify structural elementary lesions on MRI and for the first time on CT-scan according to a SPARCC approach in a cohort of patients with a suspicion of spondyloarthritis (ECHOSpA).

Among the 489 patients of the cohort, MRI and CT examination of SIJ were performed simultaneously with pelvic radiographs in 173 patients. After harmonization, readers will be tested for inter-reader reproducibility for modified New York criteria, and scoring of each structural elementary lesion depicted on MRI (erosions, fat metaplasia, backfill, sclerosis and ankylosis) and on CT-scan (erosion, joint space narrowing, sclerosis and ankylosis). When acceptable inter-reader reproducibility will be obtained, exams will be blindly and independently scored by 2 readers (rheumatologist and/or radiologist) in the following order: 1/ pelvic radiographs, 2/ MRI, 3/ CT-scan. In case of discordance between readers for the diagnosis of sacroiliitis, an adjudicator will define the final diagnosis for each imaging method (senior rheumatologist or radiologist). Severity of each structural lesion will be scored quantitatively according to structural SPARCC approach. Only lesions observed in the synovial part of the SIJ on 2 successive slices will be taken into account.

Sensibility, specificity and concordance for the diagnosis of structural sacroiliitis for radiograph and MRI will be calculated with the CT-scan considered as the gold standard. Quantitative MRI and CT scores will be compared for each lesion: erosion, sclerosis and ankylosis. This quantitative approach will be used to explain cases of discordance or concordance for radiograph and MRI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected spondyloarthritis

Exclusion Criteria:

-
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease

Purpose: The purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.

Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS Deep Brain Stimulation Device for 12 month.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is aged 40 to 80 years old;
2. Subject with AD diagnosed according to the criteria for probable AD as defined by the National Institute of Neurological Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA);
3. Subject have received the diagnosis of AD within the past 2 years;
4. Subject have a CDR of 0.5 or 1.0;
5. Score between 20 and 28 on the Mini Mental State Examination
6. have been taking a stable dose of cholinesterase inhibitors for a minimum of 6 months.

Exclusion Criteria:

1. Patients with hearing impairment;
2. Failures of important organs and in severe conditions
3. Be reluctant or disabled to receive neuropsychological assessments;
4. Participate in other clinical trial;
5. Has a life expectancy of \< 1 year.
6. The investigator and/or enrollment review committee, would preclude participation in the study.
Corticosteroids for Children With Febrile Urinary Tract Infections

In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.

Because host inflammatory response is the final and most important step in the formation of renal scars, the use of anti-inflammatory agents may be the best strategy to reduce renal scarring. In animal studies, the use of corticosteroids has been shown to be effective in preventing post-pyelonephritic scarring. We will conduct a randomized, double-blind, placebo-controlled trial to determine the efficacy of 3 days of daily adjuvant dexamethasone on the incidence of renal scarring 4 to 6 months after a first febrile urinary tract infection (UTI). We hypothesize that the proportion of children with UTI who develop renal scarring will be lower among children who are treated with both dexamethasone and antibiotics as compared with children treated with antibiotics alone.

Eligibility Criteria:
Inclusion Criteria:

* Age: 2 months to 6 years
* Pyuria: ≥10 white blood cells per cubic millimeter (WBC/mm3) in an uncentrifuged specimen or ≥5 white blood cells per high power field (WBC/hpf) in a centrifuged specimen or ≥1+ leukocyte esterase (LE) on dipstick
* Fever: documented temperature of at least 101 °F or 38.3°C, measured anywhere on the body either at home or at doctor's office within 24 hours of diagnosis

Exclusion Criteria:

* Other concurrent systemic bacterial infection(s) such as meningitis or pneumonia;
* Planned admission to intensive care unit;
* Known bacteremia;
* Previous protocol defined UTI;
* Known major urinary tract anomalies (severe hydronephrosis, ureterocele, urethral valve, solitary or profoundly small kidney, multicystic dysplastic kidney, neurogenic bladder, pelvic or fused kidney);
* Congenital/acquired immunodeficiency;
* Bag urine collection
* Chronic diseases that could potentially interfere with response to therapy, such as chronic gastrointestinal conditions (i.e. malabsorption, inflammatory bowel disease), liver/kidney failure;
* Allergy to dexamethasone
* Antibiotic use within 7 days of enrollment (except if given in the last 48 hours)
* Systemic use of corticosteroids or other immunomodulating agents within 14 days of enrollment
* History of Kawasaki disease
* Sickle cell disease (not trait)