cyrilzakka/clinical-trials huggingface dataset:
Testing a Scalable Model For ACEs-Related Care Navigation

The study is a randomized controlled trial of a telephone-based care coordination system for families who experienced Adverse Childhood Events (ACEs). The investigators will conduct the study in partnership with Kaiser Permanente School of Medicine (KPSOM) and 2-1-1 Los Angeles County (211LA), part of a national network of 2-1-1 call centers covering 93% of the US population. The study will test the effectiveness of 211LA in increasing referrals and services for families who screen positive for ACEs.

The trial will enroll 200 children ages 0-11 years from the three FQHCs partner clinics, who screen positive for at least 1 ACE during their clinical encounter. The research study team will randomize children 1:1 into intervention (connection to 211LA for ACEs care coordination + usual care) or control (usual care alone).

Primary outcomes will include number of referrals to, eligibility for, and receipt of ACE-related services among intervention group participants compared to controls.

The investigators will measure these outcomes through parent reported data and 211LA data at baseline and 6 months after enrollment.

Expected findings include higher referral and service rates by six months after enrollment among intervention group participants.

Eligibility Criteria:
Inclusion Criteria:

* A patient in one of the three partner community clinic systems (ChapCare, Via Care and NEVHC)
* Child aged 0 - 11 years old
* Parent or legal guardian of child at least 18 years of age
* Comfortable completing a survey by interview in English or Spanish

Exclusion Criteria:

* Child or sibling already enrolled in this study
* Child or sibling enrolled in the AMP Child Development study
Immunization Delivery in Obstetrics and Gynecology Settings

The purpose of this study is to determine if a multimodal immunization program carried out in obstetrics and gynecology (ob/gyn) practices would be more effective in improving ob/gyn patients' immunization rates, specifically for Tdap (Tetanus, Diphtheria, Pertussis), HPV (Human papilloma virus), and influenza vaccines, than the usual care provided to patients in ob/gyn practices.


Eligibility Criteria:
Inclusion Criteria:

1. 15 years of age or older when presenting for care
2. Patients who present for care one year prior to the start of the intervention and up to 21 months after the start of the intervention

Exclusion Criteria:

1. less than 15 years of age when presenting for care
2. patient is not eligible for any immunizations
A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome

The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.

This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.

Eligibility Criteria:
Inclusion Criteria:

* Participants with aqueous tear deficiency
* Literate, able to speak English or Spanish, and able to complete questionnaires independently
* Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
* Nasal or sinus surgery including nasal cautery or significant trauma
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
* Diagnosis of epilepsy
* Corneal transplant in either or both eyes
* Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
* A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit
Hypo-Combi Trial: Hypofractionated EBRT Plus HDR-BT Boost for Prostate Cancer

Hypo-Combi Trial: A Prospective Phase I/II Study of Combined Hypofractionated External Beam Radiation Therapy (EBRT) plus Interstitial High-Dose-Rate Brachytherapy (HDR-BT) for Intermediate/High Risk Prostate Cancer

The Phase I/II trial will prospectively assess the acute, early late and late gastrointestinal (GI), genitourinary (GU) and sexual toxicity of combined hypofractionated external beam radiation therapy (EBRT) plus high dose-rate brachytherapy (HDR-BT) schedule (total dose of EBRT 36 Gy/ in 12 fractions of 3 Gy plus HDR-BT with a total physical dose of 14 Gy in a single fraction) for patients with unfavourable intermediate/high risk (based on NCCN stratification guidelines) organ-confined prostate cancer, not requiring pelvic irradiation.

Eligibility Criteria:
Inclusion Criteria:

* The patient must consent to be in the study and must have signed an approved consent form
* Age \> 18 years old.
* Life expectancy of at least five years, excluding his diagnosis of prostate cancer.
* Histopathologically proven primary adenocarcinoma of the prostate
* The patient must be registered within 180 days following the histopathological confirmation of the malignancy
* Prostate volume \< 80ml
* International Prostate Symptom Score (IPSS) \< 18
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Patients with a history of non-prostate malignancies are eligible if they have been disease-free for 5 or more years prior to enrolment, are deemed by their physician to be at low risk for recurrence and they did not need pelvic radiotherapy as part of their treatment. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

Exclusion Criteria:

* Histopathological confirmation or suspicion in conventional or molecular imaging of regional or distant metastases
* Prior pelvic radiotherapy
* Known autoimmune disorders (e.g. inflammatory bowel disease, lupus, scleroderma)
* Prior TURP
* MRI non compatible metal implants
* Pre-existing fistulae
* Contraindication for general and spinal anaesthesia
* Inability to be placed in lithotomy position
* Any treatment with radiation therapy, chemotherapy, immunotherapy, biotherapy and/or hormonal therapy for the currently diagnosed prostate cancer prior to registration.
* History of non-prostate malignancy, apart from patients that have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence.
* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old

Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old

Two group RCT comparing usual care (midazolam) and distraction (tablet) on preoperative anxiety, emergence delirium, sedation/agitation, and vomiting in preschool children 3-5 years old.

Eligibility Criteria:
Inclusion Criteria:

* 3-5 year old children
* Scheduled for elective surgery
* American Society of Anesthesiologists physical status classification system: I - II

Exclusion Criteria:

* Children younger than 3 or older than 6
* Allergy to midazolam
* Cognitive or developmental delays
* American Society of Anesthesiologists physical status classification system: III - VI
* Anesthesia provider determines child is not eligible
* Children that are transferred to ICU after surgery
Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation

Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App in a prospective cohort.

Introduction This algorithm was validated earlier in a clinical trial with retrospective Data. The results were published accordingly.The algorithm is implemented in the commercial App Preventicus Heartbeats. DETECT AF is designed as prospective follow up trial.

Study design Prospective, blinded, multicenter international trial.

Methods

The subjects will be asked to position a smartphone on their index finger to allow their pulse curve to be recorded for five minutes. At the same time, an ecg will be recorded using an digital mobile ecg recorder as a reference.

Data will be collected on person-related information, comorbidities and medication (estimated overall duration/patient \<20 min). No follow-up is planned. Analogous to predecessor studies, the pulse wave curve data are coded with the patient's identification number (ID) and externally analyzed at Preventicus; based on the results, the subjects will be assigned to SR/AF groups. After evaluation of all files, the grouped results will be aggregated, unblinded and evaluated under monitoring.

Primary target parameters are the app's sensitivity and specificity in correctly detecting atrial fibrillation compared to an automatically interpreted ECG.

Secondary target parameters include the proportion of non-evaluable recordings in the overall study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of legal age,
* patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
* informed consent

Exclusion Criteria:

* Legally incompetent persons
Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region

Background:

Functional and aesthetic reconstruction of mandibular defects due to tumour invasion, osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good anatomic and symmetric reconstruction with stable occlusion and condylar position. Classically this was obtained by (pre)bending a reconstruction plate, and providing osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM software enabling a preoperative planning based on 3D models. This computer-assisted surgery (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as well as the effective reduction in operating time and financial implication.

Study design:

Retrospective study.

All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included. Accuracy will be measured between the planned and actual result, through segmentation of the mandible in Brainlab software. Parameters regarding ischemic time and financial cost will be obtained from the medical files.


Eligibility Criteria:
Inclusion Criteria:

* patients of all ages
* patients of both genders
* patients requiring mandibular reconstruction due to tumour invasion, osteoradionecrosis, osteochemonecrosis or trauma
* all patients undergoing bony reconstruction by free vascularised flap
* all patients treated between January 2013 and August 2016
* all patients where CAS was applied

Exclusion Criteria:

* all patients not eligible according to abovementioned criteria
Pulmonary Diffusion of Antibiotics in Patients Admitted for ARDS Following SARS-CoV-2 Pneumonia

Patients on mechanical ventilation (MV) following SARS-CoV-2 pneumonia frequently develop ventilator-associated pneumonia (VAP). The incidence of MVAP during SARS-CoV-2 infections ranges from 50 to nearly 90%. In addition, up to 80% of recurrences of VAP (a new episode, most often attributable to the same bacteria) have been described, reflecting the failure of the initial antibiotic therapy. This incidence is much higher than that described for other etiologies of acute respiratory distress syndrome (ARDS). The investigators hypothesize that during VAP, there is an alteration of the diffusion of intravenous antibiotics in the lung parenchyma in COVID-19 patients in relation to several factors characteristic of SARS-CoV-2 infection. This altered diffusion may explain the high number of recurrences of MVAP compared to non-COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patient over 18 years of age 2. Patient has given consent or consent obtained from the trusted person if the patient is not capable of consenting, after informed consent.

  3. Patient with ARDS 4. Patient requiring MV for ARDS (as defined by Berlin (15)), regardless of etiology (COVID-19 or other cause of ARDS) 5. Patient with suspected 1st episode of ARDS for which microbiological sampling is performed (bronchial aspiration, protected distal sampling (PDS), bronchoalveolar lavage (BAL)) 6. Patients who have received probabilistic antibiotic therapy within 24 hours of the microbiological sample, including piperacillin-tazobactam (PIP-TAZ) administered according to current recommendations.

  7. Patient who is a beneficiary of or affiliated to a social security system

Exclusion Criteria:

1. Patients for whom PIP-TAZ is administered as a discontinuous infusion.
2. Contraindication to the realization of a mini-LBA: patient whose respiratory state is too precarious for the realization of a mini-LBA for intra pulmonary antibiotics dosage (SpO2\<94% under FiO2 100% under VM), presence of a non drained pneumothorax, bronchial prosthesis, recent bronchial suture
3. Patient with a second episode of PAVM.
4. Patients with KDIGO stage ≥ 3 renal failure or extra-renal replacement therapy (creatinine measurement on the day of inclusion, performed as part of routine care).
5. Patient on ExtraCorporeal Membrane Oxygenation (ECMO) or ExtraCorporeal CO2 Removal (ECCO2R).
6. Pregnant or breastfeeding women, patients under guardianship or trusteeship, deprived of liberty
7. Patients who are moribund or for whom limitations of active therapies have been decided.
8. Any condition, which in the opinion of the investigator, would not allow the implementation of the study procedures.
Ultrasonographic Evaluation of Arteries of the Hand in Pediatric Patients

Ultrasound measurements of the ulnar artery and radial artery at different angles are obtained and compared to determine the optimal diameters for possible arterial cannulation in pediatric patients.

Radial artery cannulation is the most commonly used technique for invasive arterial catheterization in pediatric patients. Ultrasound guidance has significantly reduced cannulation success rates and complication risks. The ulnar artery presents an anatomical alternative to the radial artery and has emerged as a potential cannulation site. This study aims to comprehensively evaluate the suitability of the radial or ulnar artery for cannulation in pediatric patients.

Finding of this study objectives are

To obtain a large sample of pediatric patients from different age groups To measure arterial diameters using ultrasound at different angles and with ultrasound and to assess the optimal artery and the angle.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 or 2
* Patients scheduled for elective surgical procedures
* Informed consent must be obtained from both the patient and, if applicable, their parent or guardian.

Exclusion Criteria:

* Patients over 10 years of age
* Patients with congenital anomalies or syndromic conditions
* Abnormal Allen Test
* Skin Erosion or infection at the cannulation site
* Hematoma at the cannulation site
Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.

The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. Adherence data will be collected by the MEMS cap (Medication Event Monitoring System

Eligibility Criteria:
Inclusion Criteria:

* Any male or female 50 years of age or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation.

Exclusion Criteria:

* Age less than 50.
* Known allergy or sensitivity to topical Carac® in the subject.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study.
* Subjects should not receive surgical or cryotherapy while participating in the study.
* Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control
A Phase I Open Label Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Administered in Combination With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma

To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with either Lirilumab or Urelumab in subjects with multiple myeloma.

Allocation:

* Part1: Non-randomized
* Part2: Randomized

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects must have histological confirmation of multiple myeloma with measurable disease (per International Myeloma Working Group (IMWG) criteria):

  * Relapsed/refractory multiple myeloma, subjects who are post autologous transplant and have achieved very good partial response (VGPR) or complete response (nCR) with minimal residual disease (MRD)
Intubating Conditions During Propofol-remifentanil Anesthesia With Topical Lidocaine

When not using neuromuscular blocking agent, even at optimal dosage, target-controlled infusion (TCI) of propofol and remifentanil occasionally produce unsatisfactory intubating conditions. Therefore, the investigators evaluated that the effect of tracheal lidocaine on the intubating conditions for tracheal intubation during anesthesia induction of propofol and remifentanil TCI without neuromuscular blocking agent in day-case anesthesia.

Anesthesia was induced with propofol-remifentanil TCI with the effect-site concentration of 5μg/ml and 5ng/ml, respectively. After TCI, 3 ml of normal saline or 3 ml of 4% lidocaine was instilled to larynx and trachea, following intubation was performed.

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II patients undergoing general anesthesia for reduction of nasal bone fracture

Exclusion Criteria:

* bronchial asthma,
* COPD,
* hypertension,
* anticipated difficult airway
A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants

The purpose of this study is to evaluate the pharmacokinetics and safety of TMC278 after a single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed conditions in healthy Japanese adult male participants.

This is a single center, open-label (all study staff and participants will know the identity of the treatment assigned), single dose study in healthy Japanese adult male participants. The study consists of 3 phases: a screening phase up to 26 days; an inpatient phase from Day -2 to Day 8; and a follow-up assessment phase that occurs on Day 15 (± 2 days) or at the time of the participant's early withdrawal from the study. Participants who meet the selection criteria will be admitted to the investigational institute on two days before the dose (Day -2). All enrolled participants will receive orally (by mouth) a single dose of one TMC278 25 mg tablet on Day 1 within 10 minutes after completion of the standardized breakfast. Enrolled participants will remain in the investigational institute for the entire duration of the inpatient phase. Participants will be discharged on Day 8 after the completion of all required assessments. Blood samples for determination of plasma concentrations of TMC278 will be collected over a period of 168 hours (7 days). The maximum study duration for each participant is 45 days, including the screening phase, in-patient period, and follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy men
* body mass index (BMI) between 18.5 and 25.0 kg/m², inclusive and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current medical illness considered by the investigator to be clinically significant and should exclude the participant or that could interfere with the interpretation of the study results
* Laboratory abnormality of grade 2 or greater (defined by the World Health Organization Adult Toxicity Table) or clinically significant abnormal values as assessed by the investigators
* Clinically significant abnormal physical examination and vital signs at screening as assessed by the investigators
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), within 14 days before the dose of TMC278 25 mg tablet
* History of clinically significant drug or food allergies, especially known hypersensitivity and/or known allergy to TMC278 or any of the excipients of the formulation
The Contribution of Internal Maternal Resources to Creation of Motherhood. Comparison Among Mothers to Twins and Singleton

Delivery of twins or preterm infant is a very stressful episode to mothers. The purpose of this study is to characterize maternal psychological resources in dealing with this situation and compare it to mothers giving birth to singleton at term


Eligibility Criteria:
Inclusion Criteria:

* Study group: Mothers who give birth to twins or preterm infants
* Control: Mothers who give birth to singleton, full term infants

Exclusion Criteria:

* None
Nasal Nitric Oxide Levels in Eosinophilic Esophagitis (EoE)

This study is aimed at understanding whether oral nitric oxide levels can be used as a non-invasive marker for the diagnosis and management of patient with eosinophilic esophagitis (EoE).

Nitric oxide (NO) is produced by activated eosinophils and oral NO levels are known to be elevated in asthma and eosinophilic bronchitis. The measurement of oral NO is a non-invasive,easy to perform low cost procedure that is used frequently in the diagnosis and management of asthma. The diagnosis of eosinophilic esophagitis (EoE) requires conscious sedation, an upper endoscopy with biopsy, and histologic evaluation of the biopsy specimen. This is a costly and somewhat invasive procedure. If oral NO was elevated as a result of activity of esophageal eosinophils in EoE, the measurement of oral NO may potentially be a very convenient and useful test in the evaluation and treatment of EoE. We propose a pilot study to determine if oral NO levels are elevated in patients with eosinophilic esophagitis.

Eligibility Criteria:
Inclusion criteria:

* Subjects with dysphagia and active esophageal infiltration (esophageal eosinophilic count of \>/= 15 eos/hpf)
* Subjects with or without a clinical diagnosis of asthma

Exclusion criteria:

* Subjects with chronic cough
* Severe CAD
* MI within the last 3 months
* Cystic fibrosis
* Tuberculosis
* Chronic obstructive pulmonary disease (COPD)