cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth

As a new emerging technology for the diagnosis of dental caries, near-infrared imaging requires further research and validation to determine its effectiveness. This study aims to compare near-infrared imaging with cone-beam computed tomography (CBCT) to validate the efficiency of near-infrared imaging in diagnosing proximal caries using large-scale clinical data through retrospective cross-sectional studies.


Eligibility Criteria:
Inclusion Criteria:

* Permanent dentition
* Participants aged 12 and above
* Patients who have undergone iTero Element 5D oral scanning, as well as CBCT imaging, intraoral photography, and clinical oral examination within 1 week
* CBCT or iTero Element 5D oral scanning indicating proximal caries

Exclusion Criteria:

The following teeth were excluded:

* Third molars
* Teeth with gross loss of tooth structure (cavitated carious lesions extending to the occlusal or buccal/lingual surfaces)
* Teeth with amalgam fillings and their adjacent teeth
* Teeth with crown restorations and their adjacent teeth
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DC-853 in Healthy Participants

The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy participants.

Participation could last up to 7 weeks


Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to understand and comply with the requirements of the study, as judged by the Investigator.
* Participants must have a body mass index (BMI) ≥ 18 and ≤ 35 kilograms per meter squared (kg/m2).

Exclusion Criteria:

* History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical study or expose the participant to undue risk as judged by the Investigator.
* Malignancy within the past 5 years of screening with the exception of in situ removal of basal cell carcinoma, resected benign colonic polyps, or adequately treated cervix carcinoma in-situ.
* Planned major surgery within duration of the study or the 30 days following study completion.
* Females who are pregnant, breast feeding, lactating or plan to be pregnant during the study period or 90 days after.
* History of any drug and/or alcohol abuse in the past 2 years prior to screening.
Postoperative Opioid and Respiratory Depression in Opioid Naive and Chronic Opioid Patients

Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients. Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Outcome: Respiratory deviations four hours after opioid administration

Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients within the first four hours following opioid administration in addition to the chronic dose, using a continuously wireless monitoring system.

Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Continuous wireless monitoring data of peripheral tissue oxygenation (SpO2) and respiratory rate (RR) was conducted in postoperative patients. Data were stratified into opioid-naïve and chronic opioid patients, based on their preoperative opioid history. Patients who did not receive opioids postoperatively were served as the control group. Data was evaluated one hour before and four hours after opioid administration. The primary outcome was the cumulative duration of SpO2 \<88%.

Eligibility Criteria:
Inclusion Criteria:

* Patients from studies WARD Surgery Observational \[gov: NCT03491137\]
* The control group from WARD Surgery Randomized Controlled Trial \[gov: NCT04640415\]

Exclusion Criteria:

* Less than 30 minutes of continuous monitoring data within the 60-minute window prior to opioid administration
* Less than 120 minutes (\<50% of theoretical maximum) of monitoring data available during the four-hour observation period
* Patients who received transdermal fentanyl as postoperative opioid
* Patients with a baseline saturation or respiratory rate below the prespecified thresholds
* Patients with a BMI of ≥40 or diagnosed with COPD were excluded in the analysis of SpO2 \<92%
Xylitol Versus Saline in Chronic Sinusitis

Is a xylitol nasal rinse better or worse than saline on patient satisfaction.

In this pilot study, the investigators plan to compare the efficacy of twice daily xylitol nasal rinse with saline rinse which is the current standard, on outcomes such as quality of life and exacerbations.

Eligibility Criteria:
We now have two arms to this study.

Group I: Immunocompetent subjects with chronic rhinosinusitis

Inclusion Criteria:

* 56 Adult subjects (18 or older) presenting to the ENT(ears, nose, throat) clinics who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:

  * Anterior and/or posterior mucopurulent drainage
  * Nasal obstruction
  * Facial pain, pressure, and/or fullness
  * Decreased sense of smell
* In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.

Exclusion Criteria:

* Cystic fibrosis
* Fungal sinusitis
* Immunocompromised status (use of long term oral steroids (\> 30 days), AIDS, active malignancy or chemotherapy)
* Known Ciliary disorders
* Sinonasal tumors
* Pregnancy

Group 2: CRS with antibody deficiency

* 56 Adult subjects (18 or older) presenting to the Allergy clinic who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:

  * Anterior and/or posterior mucopurulent drainage
  * Nasal obstruction
  * Facial pain, pressure, and/or fullness
  * Decreased sense of smell
* In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.

Exclusion criteria:

Cystic Fibrosis Sinonasal tumors Pregnancy
Differential Characteristics of Neuropathy in Type 2 Diabetics With and Without Lower Extremity Wounds

The primary purpose of this study is to determine the degree of loss of epidermal nerve fibers near a foot wound in patients with diabetic foot ulcers. The secondary purpose will be to determine whether the degree of epidermal nerve fiber loss, the clinical examination, nerve conduction studies or the molecular profile correlates with appearance of lower extremity ulcers in patients with diabetes.

Neuropathy is a common complication of diabetes seen in up to 43% of patients with diabetes. The relationship between neuropathy and diabetic lower extremity wounds is strong and in fact, 80% of patients with an existing diabetic foot ulcer (DFU) have neuropathy. Understanding the factors that contribute to the increased risk of wounds in patients with neuropathy is important in creating optimal strategies to reduce this risk.

Traditionally, the severity of diabetic neuropathy has been evaluated using the clinical exam and nerve conduction studies. More recently, new techniques such as intra-epidermal nerve fiber density have shown promise in evaluating neuropathy especially the small nerve fiber neuropathies that might affect pain sensation and autonomic function. There are also new molecular markers that may correlate with the risk of neuropathy that may also be useful in clinically evaluating the diabetic patient with neuropathy.

The primary purpose of this study is to determine the degree of loss of epidermal nerve fibers near a foot wound in patients with diabetic foot ulcers. The secondary purpose will be to determine whether the degree of epidermal nerve fiber loss, the clinical examination, nerve conduction studies or the molecular profile correlates with appearance of lower extremity ulcers in patients with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Type 2 Diabetes defined as HgA1c ≥ 5.9%
* Must be willing and able to provide written Informed Consent

Exclusion Criteria:

* Active osteomyelitis
* Gangrene
* Purulent drainage
* Any experimental drugs applied topically or taken by mouth within 4 weeks of study entry
* INR \> 2.5
M-Health for Teen Substance Abuse and Mental Illness Pilot

The study is exploring the ease and ability to integrate a mobile application in outpatient behavioral health treatment. There are two major aims to the study: 1) Determine feasibility and acceptability of integrating a mobile app into behavioral health treatment for adolescents with co-occurring substance use and mental health disorders, and 2) identify initial signal of effect on engagement and/or treatment outcomes among youth who use the mobile app.

The purpose of the trial will be to demonstrate the feasibility of the proposed methodology (rate of recruitment, retention at 4-month follow-up, study procedures) as well as estimates of effect on key variables (patient engagement, patient symptoms, use of e-tools, treatment efficiency) in preparation for future studies in this line evaluating the utility of the mobile app.

Eligibility Criteria:
Inclusion Criteria for Adolescents:

* Aged 14-17 years
* Current substance use disorder (SUD)
* Co-occurring mental health disorder
* Treatment-seeking
* English-speaking (Only English documents will be used throughout the course of this research study)

Exclusion Criteria for Adolescents:

* Younger than 14 or older than 17
* Endorsement of active suicidal or homicidal ideation
* Active mania or psychosis
* Significant cognitive disability, developmental delays, or pervasive developmental disability
* No history of outpatient psychotherapy.

Inclusion Criteria for Providers

* Clinician delivering outpatient dual diagnosis treatment (i.e., for co-occurring SUDs and mental health disorders)
* Therapist with at least a Master's degree in a counseling related field
Semi-automatic assessMent of Aortic Roots by Three-dimensional transoEsophageal echocaRdiography (SMARTER)

The progress in surgery of the aortic root and the evolution of transcatheter aortic valve replacement as an alternative to surgical treatment in selected patients have refocused the need for quantitative imaging of the aortic root during transcatheter aortic valve replacement and valve-sparing aortic root surgery. In this study, we aim to assess the ability of semi-automated quantitative modeling (eSie Valves, Autovalve prototype version, Siemens Medical Solutions, USA) of the aortic valve and root in patients with clinical normal aortic valve and root, who are indicated for both 3D transesophageal echocardiography (TEE) and computed tomographic (CT) due to atrial fibrillation or patent foramen ovale. Measures of the aortic valve and root obtained by 2D TEE, 3D TEE and CT are compared, and the ability of the semi-automated 3D TEE modeling software is tested. Given the workflow advantages of automation, this 3D TEE approach may enhance the clinical adoption of routine 3-dimensional imaging beyond CT.

Recent developments in aortic root interventions have focused on the need for 3-dimensional imaging of the aortic functional anatomy. The progress in surgery of the aortic root and the evolution of transcatheter aortic valve replacement as an alternative to surgical treatment in selected patients have refocused the need for quantitative imaging of the aortic root during transcatheter aortic valve replacement and valve-sparing aortic root surgery. In this study, we aim to assess the ability of semi-automated quantitative modeling (eSie Valves, Autovalve prototype version, Siemens Medical Solutions, USA) of the aortic valve and root in patients with clinical normal aortic valve and root, who are indicated for both 3D transesophageal echocardiography (TEE) and computed tomographic (CT) due to atrial fibrillation or patent foramen ovale. Measures of the aortic valve and root obtained by 2D TEE, 3D TEE and CT are compared, and the ability of the semi-automated 3D TEE modeling software is tested. Given the workflow advantages of automation, this 3D TEE approach may enhance the clinical adoption of routine 3-dimensional imaging beyond CT.

Eligibility Criteria:
Inclusion Criteria:

* both transesophageal echocardiography (TEE) and computed tomographic (CT) are referred by cardiologists
* apparent normal aortic valve and root structure
* written consent

Exclusion Criteria:

* post-operation of aortic valve
* severe cardiomyopathy
* cardiac functional insufficiency (NYHA III or IV)
* contraindications for either TEE or cardiac CT angiography
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability

Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study-specific procedures including the genetic sampling and analyses
* Volunteers will be males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive.
* Provision of signed, written, and dated informed consent for optional genetic research. If a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the volunteer.
* Male volunteers should be willing to use barrier contraception, ie, condoms from the day of first dosing until 2 weeks after dosing with the IP in Treatment Period 5.
* Females must have a negative pregnancy test at screening and on admission to the CPU (including check-in at each treatment period), must not be lactating and must be of non childbearing potential, confirmed at screening

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP
* Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
Patients' Expectations About Effects of Robotic Surgery for Cancer

Robotic surgery for common surgical procedures is on the rise despite limited evidence to support its clinical benefit. We intend to to map and characterize the prevalence of the patients'expectation that robotic surgery might be superior to open or laparoscopic procedures and to identify the sociodemographic, clinical and organisational factors associated with this expectation.

With the progress of modern medicine, minimally invasive surgical technology has become the main theme in the field of contemporary surgery. As a rising star, the Da Vinci robotic surgery system provides surgeons with a more comprehensive surgical vision, more flexible instrument control, finer anatomy, and more natural comfort compared to open surgery and laparoscopic surgery. However, due to the lack of long-term theoretical basis, the evidence to support its clinical benefits is limited, and its application is limited by related postoperative complications and high operation-related costs. At present, the number of Da Vinci robotic surgery is steadily increasing around the world, but what are the expectations of patients that robotic surgery may be better than open or laparoscopic surgery? It is also unclear what reasons are related to this established expectation. Therefore, we intend to map and characterize the prevalence of the patients' expectation that robotic surgery might be superior to open or laparoscopic procedures and to identify the sociodemographic, clinical and organisational factors associated with this expectation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Cancer
* Have undergone tumor resection with Da Vinci Robotic Surgery System
* Volunteer to participate in the study

Exclusion Criteria:

* Patients with mental illness
* Cognitive dysfunction
* Cannot complete the questionnaire independently
Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation

The purpose of this study is to investigate whether heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations.

We hypothesize that heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations. Severity of asthma will be characterized using a modified Becker Clinical Asthma Score (CAS) based upon the acuity of physical signs for four clinical characteristics (respiratory rate, wheezing, I/E ratio, and accessory muscle use). Scoring will occur at the time of enrollment and every 4 hours thereafter until the patient meets hospital discharge criteria. All scoring using the CAS will be performed by an independent physician, nurse or respiratory therapist blinded to the subject treatment arm. All children will receive standard cardiopulmonary monitoring and treatment, consisting of supplemental oxygen delivered as needed by either nasal cannula or face mask to maintain oxygen saturation \>90%, maintenance intravenous fluids, corticosteroid therapy and nebulized albuterol therapy. After written informed consent, eligible children will be randomized to one of two study groups using a sealed envelope technique:

Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox.

Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age 2 -18 years;
* Previous history of asthma;
* Hospital admission for acute asthma exacerbation;
* Clinical asthma score greater than or equal to 3

Exclusion Criteria:

* Less than 2 years old or over 18 years old;
* Known allergy or hypersensitivity to ß-agonists;
* Require mechanical ventilation (invasive or non-invasive);
* Require FiO2 \>0.4;
* Failure to obtain informed consent;
* Enrollment in another investigational drug or asthma protocol;
* Incipient respiratory failure including but limited to respiratory acidosis(pCO2\>60 torr), altered mental status and/or excessive work of breathing.
Epidural Analgesia and Maternal Fever During Labor

Women who receive epidural analgesia during labor are more likely to develop fever than those who do not. Maternal fever during labor can produce various harmful effects on both mothers and infants. The investigators speculate that the effect of epidural analgesia is associated with the development of maternal fever, i.e., better analgesia is associated with higher risk of maternal fever.

Epidural related maternal fever (ERMF) refers to the phenomenon of increased body temperature of parturient after receiving epidural analgesia during labor. Women who receive epidural labor analgesia are more likely to have fever than those who do not. In a systematic review, 20-33% of parturients receiving neuraxial analgesia developed fever during labor, compared with only 5-7% of those without neuraxial analgesia. Maternal fever can interfere with women's laboring process, decrease the sensitivity of the uterus and cervix to oxytocin, and lead to dystocia and increased surgical delivery rate. The investigators note that the rate of ERMF is lower in patients receiving lower density neuraxial blockade. The study is designed to test the hypothesis that the effect of epidural analgesia is associated with the development of maternal fever, i.e., better analgesia is associated with higher risk of maternal fever.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Nulliparae with single term cephalic pregnancy;
* Preparing to give vaginal delivery under epidural analgesia.

Exclusion Criteria:

* Basal body temperature ≥37.3°C;
* Presence of serious pregnancy complications (such as severe preeclampsia, placenta accreta, HELLP \[Hemolysis, Elevated Liver enzymes, Low Platelet count\] syndrome, placenta previa, abruption of placenta, or hyperthyroidism);
* History of hyperthyrodism, including hyperthyrodism in pregnancy;
* Taking sedatives and/or analgesics within one week before planned delivery;
* American Society of Anesthesiologists classification \>class III;
* Contraindications to epidural puncture, including central nervous system diseases (such as poliomyelitis), spinal diseases (such as intraspinal mass, lumbar disc herniation, history of spinal trauma, etc.), abnormal blood coagulation, etc.;
* Presence of infections, including obstetric infections, systemic infections (such as sepsis, bacteremia), or infections at the puncture site or adjacent sites;
* Other conditions that are considered unsuitable for study participation;
* Refused to participate in the study.