cyrilzakka/clinical-trials huggingface dataset:
The Use of Home Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes

The aim of this study is to establish if the self-administered electronic Oral Glucose Tolerance Test kit can increase the annual uptake of screening for CFRD in children who are between 10 and 17 years of age with CF.

Cystic fibrosis related diabetes (CFRD) is the most common secondary complication of Cystic fibrosis. It affects nearly 20% of adolescents and 40-50% of adults. Undiagnosed CFRD is associated with significant decline in lung function and nutritional status with an increase in mortality. This emphasises the importance of screening for CFRD in children with CF to minimise the nutritional and pulmonary consequences of diabetes.

The UK CF trust guidelines, the European consensus statement and US Cystic Fibrosis Foundation clinical care guidelines recommend the 2hr (1.75g/kg) oral glucose tolerance test as a screening tool on an annual basis in all CF patients without CFRD.

The American Diabetes Association (A.D.A) recommends that annual screening for CFRD should begin by age 10 years in all CF patients who do not have CFRD. The European Consensus Statement on this is in agreement for screening to start at age 10 years. This standard is often applied within the United Kingdom.

The current gold standard screening tool, the Oral Glucose Tolerance Test, is resource intensive. This requires an individual/child and a parent to attend a clinical facility while fasted and requires trained health care professionals to take venous samples, analyse and interpret the results.

There are also problems encountered in standardising the test. The patient should be fasted and must travel to clinic for the test in the morning. The OGTT, if done at hospital, can therefore affect an individual's time off work, time off school, can cause inconvenience and expensive for an individual, parent and child to travel to clinic. The unpredictability of workload for hospital staff means that test times are often not strictly adhered to or accurately recorded. In patients with cystic fibrosis there is also an additional risk of cross infection when they attend the hospital for OGTT. These factors limit the uptake of OGTTs for screening in children with cystic fibrosis.

To overcome these issues a simple, disposable, self-administered electronic OGTT Kit containing everything required to perform the OGTT at home with simple written and pictorial instructions has been used in this study.

The aim of this study is to establish if the self-administered electronic Oral Glucose Tolerance Test kit can increase the annual uptake of screening for CFRD in children who are between 10 and 17 years of age with CF.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with cystic fibrosis who are between 10 years and 17years old and managed at Great Ormond Street Hospital.

Exclusion Criteria:

* Children who are diagnosed with cystic fibrosis related diabetes.
Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer

The death of prostate cancer patients is mainly due to metastatic castration-resistant prostate cancer. Though some new therapies has been tried to prolong the life-span of mCRPC patients, a dilemma was encountered for the drug-resistance. The PSMA RLT has been tested its efficacy and safety for the therapy of these patients. In our clinical trial, a new PSMA ligand will been used to be labeled with Ac225. This will be a prospective pilot clinical trial. 20 mCRPC patients who was incapable of 2rd ADT or chemotherapy will be recruited in this clinical tiral. The efficacy and safety of 225Ac-PSMA will be evaluated after the administration.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed prostatic adenocarcinoma.
* Clinically or imaging confirmed metastatic castration resistant prostate cancer.
* Conventional treatment failure or not available.
* PSMA avid of lesions confirmed by PSMA PET/CT.
* Hematopoietic function, kidney and liver function is normal.
* Can follow the study plan and can timely follow-up.
* Agree to sign the informed consent.

Exclusion Criteria:

* Pathological types other than the prostatic adenocarcinoma of prostate cancer.
* Not PSMA avid of lesions confirmed by PSMA PET/CT.
* Concurrent with other uncontrolled malignant tumours or five years, except for carcinoma in situ.
* Concomitant diseases are not suitable for radioactive therapy.
* Other conditions (religion, psychology, etc.) affect the informed consent, research plan, or not compliant of follow-up schedule.
A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure

This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.

The Manage HF study is a multicenter 12-week randomized controlled double-blind 2x2 factorial clinical trial. This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients. The clinical worsening intervention targets self-management of behaviors to prevent worsening of a patient's heart failure symptoms. The dietary sodium intervention promotes lower sodium intake. Eligible participants will be randomized to the dietary sodium intervention, the clinical worsening intervention, both interventions, or no intervention in a 1:1:1:1 manner, stratified by site, gender, and HF type (HFpEF versus HFrEF).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older at screening
2. Currently admitted or discharged from the hospital within the last 14 days with a diagnosis of acute or acute on chronic decompensated HF.
3. Based on one of the EF criteria (LVEF within 12 months of randomization. BNP or NT-proBNP criteria within 30 days prior to randomization):

   * Left ventricular ejection fraction (LVEF) ≤ 40%.
   * LVEF \>40% and BNP \> 175 pg/ml or NT-proBNP \> 700 pg/ml. Thresholds for NT-proBNP and BNP for LVEF \> 40% will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2.
4. Have a personal physician for follow-up
5. A smartphone with a compatible Apple or Android operating system installed and able to download and use ManageHF including accepting all permissions
6. A valid email address
7. Fluent in spoken and written English

Exclusion Criteria:

1. Contraindication to recommending a sodium restriction diet
2. Scheduled intervention for primary valvular heart disease will occur during the study period.
3. Cardiac resynchronization therapy (CRT) within 3 months prior to screening or current plan to implant CRT device during the study period.
4. Dialysis
5. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device.
6. Listed status 1, 2 or 3 for heart transplant
7. Implantation of a ventricular assistance device is expected within 3 months after randomization
8. Non-cardiac illness with expected survival of less than 3 months
9. Discharge to a setting other than home
10. Requirement for chronic inotropic therapy (e.g. milrinone, dobutamine)
11. Inability to use Withings devices due to equipment limitations or contraindications
12. Currently pregnant or intend to become pregnant during the study period.
Airway Macrophages and Sputum Milieu in Adult Subjects With Airflow Obstruction

Airway macrophage impairment is a central feature in the immunopathogenesis of chronic obstructive pulmonary disease, regardless of smoking status.

In the United States, a variety of farming operations can generate significant amounts of dust. Chronic organic dust exposure to workers in this industry can result in several respiratory health conditions including chronic bronchitis, chronic obstructive pulmonary disease (COPD), and exacerbations of asthma. Organic dust is a complex mixture containing particulate matter and microbial-associated components from gram positive and gram negative bacteria. Airway macrophages are key innate immune cells that are rapidly activated by exposure to inhaled toxins and organic dust.

The literature indicates that subjects with tobacco-induced chronic bronchitis/COPD have alveolar macrophages that have impaired function. It has been hypothesized that the impaired lung macrophage function may contribute to the increased susceptibility to infections and chronic bacterial colonization that is a central feature in subjects with chronic bronchitis/COPD. It is unknown at this time if impaired macrophage function is secondary to tobacco-induced effects, or is a central pathologic feature of chronic bronchitis/COPD.

We will explore the expression of innate immune cell surface molecule expression involved in antigen presentation, phagocytic ability, and ex vivo cytokine responses in airway macrophages obtained by induced sputum. We will also collect blood to determine if ex vivo stimulation of blood mimics the inflammatory responses observed with airway macrophages. Comparisons to our past findings in vitro studies, which demonstrated that repetitive organic dust exposure impairs monocyte derived macrophage immune cell surface markers and function, could then be made. This information could lead to future investigations centered on therapeutic interventions to prevent or reverse the underlying lung disease experienced by farmers in this industry.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable to participate in induced sputums
* Group One: Smoked less than 100 cigarettes in their lifetime Quit smoking greater than 10 years ago Pre-bronchodilator FEV1/FVC \> 70% Pre-bronchodilator FEV1 % predicted \> 80%
* Group Two: Greater than a 20-pack year tobacco history Smoked in the last two years Post-bronchodilator FEV1/FVC \< 70%
* Group Three:Have less than a 20-pack year tobacco history Quit smoking greater than 20 years ago Post-bronchodilator FEV1/FVC \< 70%

Exclusion Criteria:

* Personal history of lung cancer
* Pregnancy
* Personal history of autoimmune disease
* Currently taking oral/parental corticosteroids
* Personal history of upper or lower respiratory tract infection in the prior four weeks
Impact of the 'Reserved Therapeutic Space' Nursing Intervention: an Intervention Study in Acute Mental Health Units

Aims:

To evaluate the effectiveness of the "Reserved Therapeutic Space" intervention for improving the nurse-patient therapeutic relationship in acute mental health units in Spain, as well as its impact in terms of quality of care and patients' perceptions of coercion.

Design:

Multicenter intervention study with control group.

Methods:

The study will be carried out in 12 mental health units in Spain. Given the conditions of evaluation in real clinical practice, paired randomization will be performed to assign centers to intervention and control groups. The "Reserved Therapeutic Space" intervention to be tested has been co-designed and validated by both nurses and patients. The quality of the therapeutic relationship, the care received, and perceived coercion among patients will be assessed at baseline and at discharge using instruments validated in our context. An estimated 131 patients per group are expected to participate. Funding was granted in July 2021 by the Institute of Health Carlos III (PI21/00605, Ministry of Science and Innovation) and in October 2021 by the College of Nurses of Barcelona (PR-487/2021). The proposal was approved by all the Research Ethics Committees of participating centers.

Discussion:

This study is expected to demonstrate the effectiveness of a specific nursing intervention on patient health outcomes including the level of the therapeutic relationship, the quality of care, the level of coercion and other specific indicators for acute mental health units.

Impact:

This project will lead to changes in clinical practice, transforming the current models of organization and care management in mental health hospitalization units, promoting the quality of the therapeutic relationship and, ultimately, the quality of person-centered care.


Eligibility Criteria:
Inclusion Criteria:

* Adults hospitalized in mental health inpatient units who voluntarily consent to participate in the study

Exclusion Criteria:

* Adults hospitalized in mental health inpatient units who present a language barrier, mechanical restraint, contraindication by the clinical referent, cognitive impairment, or intellectual disability at the time of recruitment.
Pain and Fear of Venous Blood Collection in Children

Nurses are in the position of primary health care provider in relieving children's pain and fears of bloodletting in the wards where they work. As a result of this study, it is aimed to encourage nurses to apply non-pharmacological interventions during painful medical procedures, to facilitate the provision of necessary and different means of distraction to blood collection services, and to contribute to the development of in-house health policies and the preparation of appropriate clinical guides and to add an innovative perspective.


Eligibility Criteria:
Inclusion Criteria:

* 6-12 age group,
* children who need blood drawn for any reason
* have no disease that can cause chronic pain,
* no olfactory disorder
* no mental or neurological problems
* able to communicate
* speaks Turkish

Exclusion Criteria:

* those who did not give consent to the research by both the child and the parent
A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease

This trial is a late phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of KDT-3594 administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks in patients with advanced PD with levodopa.

This trial is a late phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of KDT-3594 administered once daily in patients with advanced PD with levodopa.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PD according to the Parkinson's disease society brain bank clinical diagnostic criteria of the UK Parkinson's Disease Society
* Patients who are being treated with levodopa or levodopa combination drugs and have any of the following troublesome symptoms or conditions:
* Patients with wearing-off phenomenon
* Patients with ON-/OFF-phenomenon
* Patients with no-on/delayed on phenomenon
* Patients with inadequate response to levodopa

Exclusion Criteria:

* Patients suspected of having parkinsonism other than PD based on medical history, physical findings, laboratory test values, dopamine transporter-single photon emission computed tomography (DAT-SPECT), etc.
* Patients who have undergone neurosurgical therapy for PD (e.g., stereotactic thalamotomy and pallidotomy and deep brain stimulation) or who are scheduled to undergo surgical therapy during the trial period
* Patients complicated with overt dementia or a Mini-Mental State Examination (MMSE) score of \< 24 at the start of the screening period
Detection of Microplastics in Human Granulosa Cells and in the Follicular Fluid of Women Undergoing ICSI Treatment

Plastic products have been used ubiquitously in the modern world for many decades - for example as packaging materials, textile fibers or molded parts. The general use and especially the improper disposal lead to enormous environmental pollution almost everywhere on earth.

Microplastics mainly originate from fragmentation of larger plastic objects or can be produced directly for the use in e.g. cosmetics or industrial dyes.

Microplastics have already been detected in fresh- and seawater, soil, food, but also in human blood and urine. The accumulation of microplastics in ovarian and testicular tissue in humans has not yet been investigated.

Plastic products have been used ubiquitously in the modern world for many decades - for example as packaging materials, textile fibers or molded parts. The general use and especially the improper disposal lead to enormous environmental pollution almost everywhere on earth. In particular microplastics, by definition plastic particles with a diameter of less than 5mm, could pose a hazard to animals, humans and nature. Microplastics mainly originate from fragmentation of larger plastic objects or can be produced directly for the use in e.g. cosmetics or industrial dyes.

Microplastics have already been detected in fresh- and seawater, soil, food, but also in human blood and urine. The accumulation of microplastics in ovarian and testicular tissue in humans has not yet been investigated.

The presence of microplastics in reproductive tissue could also have negative consequences for reproduction. In oysters, waterfleas and mice, an impairment of reproduction due to the bioaccumulation of microplastics has already been described. Overall, current understanding of the effects of microplastics on human fertility and overall mammalian health is very limited.

Samples will be analyzed using Raman spectroscopy and scanning electron microscopy.

Eligibility Criteria:
Inclusion Criteria:

* The patients to be included should be ≥18 years of age undergoing an intracytoplasmic sperm injection (ICSI) treatment. There is no upper limit for patient age.

Exclusion Criteria:

* none
Comparison of Solid Organ Transplant

Solid organ transplant (SOT) recipients have increased incidence of infections with MDRO pathogens. This difference leads to a disparity in antibiograms between SOT recipients and other hospitalized patients.

There is limited guidance for empiric antimicrobial therapy in this population. Local epidemiology plays a voluble role in managing infections empirically within the hospital setting. Antibiograms can serve as a critical tool in optimizing empiric antimicrobial decisions. Refining antibiogram data to specific populations such as SOT patients may allow for timelier and appropriate empiric use of antimicrobials, and improve clinical outcomes.

Time to appropriate therapy (antimicrobial testing susceptible in vitro to the pathogen identified) is of vital importance in management of serious infections. SOT may have different resistance rates at Methodist Dallas Medical Center making the applicability of the yearly hospital-wide antibiogram unknown for use in this specialized patient population. A SOT-Specific antibiogram may highlight common resistance patterns identified in pathogens seen in this patient population. Additionally, this investigation may further emphasize the importance of antimicrobial stewardship activities such as: appropriate empiric antibacterial decisions, de-escalation, and effective durations of therapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older

Exclusion Criteria:

* Missing data necessary to determine study outcomes
Ultrasound vs. Auscultation for Optimal Depth of the Cuffless RAE Tube

The aim of this study is to compare the ultrasound-guidance versus auscultation to confirm optimal insertion depth of the cuffless oral Ring-Adair-Elwyn (RAE) endotracheal tube in pediatric patients undergoing general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Children age under 7 years
* Undergoing general anesthesia
* Endobronchial intubation with cuffless oral RAE tube

Exclusion Criteria:

* Pulmonary disease
* Active upper respiratory tract infection
* History of upper or lower respiratory tract infection within 2 weeks
* Emergent operation
* Unstable vital sign
Reward-Based Recovery Outcomes Management for Opioid Use Disorder

A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* access to internet-enabled smartphone device
* primary DSM-5 opioid use disorder diagnosis
* receiving medication treatment for opioid use disorder with buprenorphine
* English language proficient

Exclusion Criteria:

* active suicidal ideation or psychotic symptoms
A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum, when given three times a day for 3 weeks to the hemodialysis (HD) patients with hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium carbonate or sevelamer hydrogen chloride.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent given
* Able to comply with the study procedures and medication
* On a stable HD regimen (at least 3 x per week) for ≥ 3 months
* Subject receiving calcium carbonate or sevelamer hydrochloride as a phosphate binder at screening, must have been on a stable regimen (dose and medication) for at least 1 month
* A mean serum inorganic phosphorous in the previous 3 tests : \> 5.5 mg/dL and \< 9.0 mg/dL
* Removal rate of blood urea nitrogen (BUN) ≥ 60%
* Rate of salivary flow by Saxon test ≥ 1 g/2 min

Exclusion Criteria:

* Blood purification therapy other than HD
* Current clinically significant intestinal motility disorder
* Possible parathyroid intervention during the study period
* History of malignancy and severe cardiovascular disorders such as heart disease, angina, congested heart failure, valve stenosis, atrial fibrillation and arrhythmia
* History of allergy against active ingredient
* Receipt of any investigational drug within 30 days of informed consent