cyrilzakka/clinical-trials huggingface dataset:
Swivel Convertible Child Safety Seat to Improve Usage

Child car safety seats (or "car seats") are an important tool to keep children safe in motor vehicle crashes, but are often misused by parents and caregivers. The installation of car seats can be time consuming and confusing. A new type of swivel car seat is being developed to potentially alleviate some of the typical frustrations that might lead to car seat misuse, specifically the visibility and usage of the top tether feature. This study aims to evaluate the new car seat product and determine whether the new design results in fewer installation errors compared to a traditional car seat.

Primary objective: To compare the number of top tether installation errors produced with a production-ready prototype swivel child safety seat vs. a traditional (control) seat.

Secondary objective: To assess self-reported preference and opinions on the swivel child safety seat design.

Background: A preliminary Phase I study has already been conducted, in which volunteer focus groups provided qualitative feedback on a new prototype design. For this Phase II study, the revised prototype will be quantitatively and qualitatively evaluated by a larger sample of volunteers. Volunteer adult participants will be asked to complete two car seat installations: one with the new swivel prototype, and one with a traditional control car seat. Basic instruction manuals will be provided. The types and frequency of installation errors for each car seat will be quantified, and qualitative feedback on the product designs will be collected via survey.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65
* Care provider to a child who is up to 4 years of age
* Have installed a child safety seat in the last 2 years
* Able to lift and install a child safety seat into a vehicle
* English speaking.

Exclusion Criteria:

* Not meeting any of the above
Lyric Self-replacement Clinical Investigation

This study is designed to investigate the effectiveness and safety of the Phonak Lyric self-replacement procedure, as compared to the HCP-replacement procedure.


Eligibility Criteria:
Inclusion Criteria:

* Meets requirements outlined on Lyric self-replacement candidacy form
* Current Lyric hearing instrument user with 3+ months of Lyric experience
* 22 years of age or older at the time of enrollment in the study
* Mild-to-moderately severe sensorineural hearing loss (bilaterally or unilaterally)
* Good understanding (read/write/speak) of the English language
* Willingness to comply with all study requirements

Exclusion Criteria:

* Does not meet requirements outlined on Lyric self-replacement candidacy form
* Difficulty understanding/reading instructions when corrected for vision loss
* Impairments that would restrict participation in any of the evaluations
* Ear health conditions present at baseline that prevent immediate device replacement
* Conditions that would indicate the need for medical referral prior to hearing aid fitting according to local regulations
Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting

Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China, to access whether RIC can and improve short-term prognosis.

Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. However, the effect of RIC in patients undergoing off-pump CABG is still unclear. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China, to access whether RIC can and improve short-term prognosis. Patients will be randomly assigned into RIC group and control group. The primary outcome is the occurrence of the major adverse cardiovascular and cerebrovascular events (MACCE) within the 3-month follow-up. The MACCE is defined as all-cause of death, myocardial infarction, stroke and coronary revascularization surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with coronary artery disease and require off-pump CABG surgery.
* Between 18 and 75 years old;
* Normal left ventricular systolic function (ejection fraction \>40%) and left ventricular end-diastolic internal diameter (\<60 mm) in the cardiac ultrasound tests;
* No or mild heart valve and great vessel abnormalities which do not require surgical intervention;
* Participants or their authorized relatives agree to participate in the clinical trial and sign the informed consent.

Exclusion Criteria:

* Severe tissue injuries.
* Myalgia, fractures and other peripheral vascular lesions.
* Bypass graft being the radial artery.
* Stenosis or severe malformations of the subclavian, jugular and femoral arteries and veins.
* Previous vagus nerve trunk dissection or vagus nerve block surgery.
* Other surgical operations at the same time.
* Patients with pre-existing severe cardiac insufficiency, acute coronary syndromes, malignant hypertension and cardiogenic shock.
* Severe coagulation abnormality or severe anemia.
* Severe mental disorder.
* Malignant tumors.
* Pregnant or lactating.
* Increased risk of treatment for patients, according to investigators.
* Refuse to sign the informed consent form.
Culturally Optimized Messages for Latinos

This project aims to redesign and optimize a deep-structure culturally-tailored healthy eating program and test its effectiveness in improving dietary outcomes, anthropometric, and blood pressure among 75 diverse Latinos, compared to surface-level messages.

This project aims to redesign and optimize a deep-structure culturally-tailored healthy eating program and test its effectiveness in improving dietary outcomes, anthropometric, and blood pressure among 75 diverse Latinos, compared to surface-level messages. The WELCOME study will be based on the RE-AIM framework with improved reach, adoption, implementation, and maintenance strategies. The intervention arm is a deep-structure cultural tailored text messages for distinct Latino heritages (e.g., Caribbean and non-Caribbean) informed by mixed-methods formative research, compared to surface-level healthy eating messages based on the USDA My Plate Spanish version. The program runs for 6 months: 2-months delivery phase + 2-months reinforcement phase + 2-months maintenance phase.

Eligibility Criteria:
Inclusion Criteria:

* age 25-65 y/o
* self-reported Hispanic/Latino heritage
* able to understand and answer questions in Spanish or English
* living in Massachusetts for the past year and not planning to move in the next year
* having a cellphone with the capacity of receiving and sending text messages and giving consent for the Study to text this number as part of the intervention

Exclusion Criteria:

1. self-reported diagnosis of cancer, diabetes or major stomach or heart condition (e.g.: gastrointestinal cancers, coronary heart disease, previous stroke or heart attack, severe dietary allergies or restrictions)
2. planning to move Massachusetts in the next year
3. currently pregnant
4. institutionalized (i.e.: hospital, prison, etc.).
Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

This pilot study aims to investigate whether intravenous immunoglobulin is safe and effective in alleviating perihematomal edema and neurologic deficits in patients with intracranial hemorrhage.

The trial consists of two groups: IVIg group and control group. Thirty patients will be recruited into IVIg group. Thirty Patients who are matched for age, gender, National Institutes of Health Stroke Scale scores, hematomal volumes, and locations of hematomas, will be selected into control group. Patients in control group just receive standard management, while those in IVIg group will receive standard management plus intravenous immunoglobulin therapy. The outcome assessor is blinded to the group assignments.

Eligibility Criteria:
Inclusion Criteria:

1. The first-ever primary supratentorial intracerebral basal ganglia hemorrhage 5-30ml.
2. 18-80 years old.
3. No longer than 72 hours from the acute ICH to medication.
4. Glasgow Coma Score ≥8.

Exclusion Criteria:

1. Occurrences of secondary intracerebral hemorrhage.
2. Significant past history of disability, modified Rankin Scale（mRS）≥1.
3. Currently taking antitumor drugs, immunosuppressive drugs, or immunomodulatory therapy.
4. Patients with pregnancy, Severe infection, severe heart dysfunction or renal and hepatic injuries.
5. Patients with contraindications for immunoglobulin.
This Study Aims to Assess the Performances of Optical Blood Pressure Monitoring Device, TBPC Product with Reference to ISO 81060-3:2022

In this study, according to the latest released ISO 81060-3:2022 standard requirements, non-invasive blood pressure measurement by cuff at the start and the end time points will be used as oCareTM BP100 start-to-end blood pressure calibration. The invasive arterial catheter (A-line) blood pressure measurement will be used as a reference invasive blood pressure monitor (BPM) equipment. The purpose of the study is to evaluate the stability of the device under evaluation (DUE) and its performance in blood pressure change tracking.

1. The primary goal (Stability Test): to validate the stability of the repeated measurements of DUE, and the corrected standard deviation of each analysis period shall not exceed 6 mmHg.
2. The secondary goal (Blood Pressure Change Tracking): to validate the consistency of DUE vs. the reference BPM equipment in blood pressure change tracking during the change evaluation interval.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be over 22 years old on the date of informed consent.
2. Subject who has undergone radial artery cannulation (A-line) (for medical purposes, specifically for arterial pressure monitoring.
3. Subject or his/her legal representative understand the written informed consent and willing to participate as evidenced by signing the informed consent.

Exclusion Criteria:

1. Pregnancy
2. Patients with an intra-aortic balloon pump
3. Patients with arm or finger injuries
4. Patients who have undergone vascular surgery for upper extremities or contraindications for local treatment upon upper extremities
5. Patients with A-line placement in the brachial artery
6. Participants are considered not suitable for inclusion after evaluation by the researchers (such as poor compliant mental status or health conditions, etc.)
7. Participants or his/her legal representative refuse to sign the informed consent form
The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair

The aim of this Observational Registry Study is to assess the short- and long-term clinical outcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal wall hernia surgeries by open or laparoscopic approach, according to the Instruction for use (IFU).

This is an observational multicenter registry study. One hundred consecutive, adult patients scheduled for primary and incisional abdominal wall hernia surgeries using Symbotex™ Composite Mesh will be reported in the ClubHernie online database, with standard data captured of all preoperative, perioperative and post-operative data, for patient's outcomes measurements.

Primary Objective:

Evaluate the incidence of peri-operative and post-operative complications, with postoperative evaluations occurring, at discharge , 1 week (D1 and D8 follow up), 1 month (D30 follow up), 1 year and 2 year follow up after primary and incisional abdominal wall hernia surgeries using Symbotex™ Composite Mesh by open or laparoscopic approach (such as anticipated device related complications such as pain, recurrence, complications related to adhesions, wound complications, other postoperative complications, (SAE).

This online database consists of a systematic and consecutive data entry of all patients treated for Inguinal Hernia and Ventral Hernia by the 30 French surgeon members, with standard data captured of all preoperative, perioperative and post-operative data.

The database is required to be completed anonymously. Quality data control of all data captured into the online database will be performed by coherence analysis by Club Hernie authorized representative;A statistical analysis plan will be developed by Covidien.

Study reported device-related events will be reviewed periodically to assess for any potential trends

Eligibility Criteria:
Inclusion Criteria:

* The first one hundred consecutive adult patients scheduled for primary and incisional abdominal wall hernia surgery by Club Hernie members surgeons using Symbotex™Composite Mesh ;- All patients regardless of gender ≥ 18 years of age presenting with ventral hernias.
* Patients will be informed by surgeon with a written information notice of the nature of the observational registry study.

Exclusion Criteria:

* No exclusion criteria outside the product IFU
Staphylokinase and ABO Group Phenotype: New Players in Staphylococcus Aureus Implant-associated Infections Development

The purpose of this study is to identify bacterial and/or clinical features involved in the pathogenesis of Staphylococcus aureus implant-associated infections (IAI). Materials \& methods: In total, 57 IAI S. aureus and 31 nasal carriage (NC) S. aureus isolates were studied. Staphylococcus aureus genetic background was obtained by microarray analysis. Multilocus sequence typing was performed to determine clonal complexes (CC). Biofilm production was investigated by resazurin and crystal violet methods


Eligibility Criteria:
Inclusion Criteria:

* infected patients with S. Aureus IAI infection
* noninfected patients screened for S. aureus nasal colonization at the orthopedic consultation ward

Exclusion Criteria:

* minor
A Study of JNJ-80202135 in Healthy Chinese Adult Participants

The purpose of this study is to assess the pharmacokinetic (PK) of nipocalimab following single intravenous (IV) administration in healthy Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be assessed as not clinically significant by the investigator and this determination must be recorded in the participant's source documents and initialed by the investigator
* Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* Serum immunoglobulin G (IgG) level must be greater than (\>) the lower limit of normal at screening
* Body mass index (BMI; weight \[kilograms {kg}\] per height\^2 \[meter square {m\^2}\]) between 18 and 27.9 kilograms per meter square (kg/m\^2) (inclusive), and body weight not less than 50 kg and less than or equal to (\<=) 110 kg at screening
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at Week 0 prior to administration of study intervention

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
* Serum albumin below the lower limit of normal at screening
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, acetaminophen, contraceptives, and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled until completion of the study
* Had major surgery, (example: requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 8 weeks after the last dose of study intervention administration
* Has an active, acute or a chronic infection (examples: bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or requires chronic treatment with anti-infectives (examples: antibiotics, antivirals)
Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery

The goal of this pilot clinical trial is to test the feasibility of conducting a randomized controlled trial that will examine the use of ropivacaine in the spinal anesthesia for patients undergoing elective 1- or 2-level lower spine surgery. This study aims to:

* Determine the rates of eligibility, recruitment, consent, and attrition
* Determine the acceptability among patients, surgeons, anesthesiologists, and nurses of doing spine surgery under spinal anesthesia
* Gather preliminary data on outcomes relevant to a future dose-finding study

Participants will be randomized to one of three treatment groups:

* General anesthesia with endotracheal tube
* Spinal anesthesia with bupivacaine
* Spinal anesthesia with ropivacaine


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are equal to or greater than 18 years old
* Undergoing elective one or two-level lumbar surgery via posterior surgical approach in the prone position (between L2-S1)
* Expected surgery duration of no greater than 2 hours
* ASA Physical Status Class 1 to 3
* Patient can have either spinal anesthesia or general anesthesia
* Able to provide consent and understand information in English, and capable of answering questions in English

Exclusion Criteria:

* Allergy to either ropivacaine, bupivacaine, or local anesthetics
* Contraindications to spinal anesthesia (i.e. coagulopathy or on anticoagulants, severe aortic or mitral valve stenosis, sepsis or bacteremia, thrombocytopenia, high intracranial pressure, infection at the puncture site)
* Surgery is expected to take more than 2 hours
* Emergency surgery
* Previously had back surgery at the level of the spine currently being operated on
* Comorbidities that require the patient to undergo general anesthesia
* Inability to stay still during the surgery
* Inability to move legs preoperatively
* Body Mass Index (BMI) \>35
* Multilevel severe spinal stenosis
The Effectiveness of the "MINDLiNG" Digital Mental Health Intervention

A study in South Korea assessed the effectiveness of the "MINDLiNG" digital mental healthcare program, targeting maladaptive personality traits, and found significant improvements in reducing stress, perfectionism, loneliness, and anxiety, while increasing self-esteem among participants. The study highlights the potential of digital solutions to address the high demand for mental healthcare services in South Korea.

This study conducted a randomized controlled trial to evaluate the effectiveness of a digital intervention program called "MINDLiNG" designed to target maladaptive personality traits, with four subprograms addressing perfectionism, low self-esteem, social isolation, and anxiety. Participants were assigned to one of these programs, and primary outcome measures varied accordingly, including the Perceived Stress Scale, Hewitt Multidimensional Perfectionism Scale, State Self-Esteem Scale, UCLA Loneliness Scale, and Beck Anxiety Inventory. The study anticipated treatment effects in both primary and secondary outcome measures for the treatment group compared to the waitlist group after 5 and 10 weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18 and 60
* Experiencing a moderate level of stress in their daily lives (PSS≥17) and meet a certain level of perfectionism (HMPS≥198), self-esteem (SSES≤57), loneliness (UCLA LS≥47), and anxiety (BAI≥16). The cutoff points for each scale are based on the top or bottom 25% of the frequency distribution suggested in the previous study.

Exclusion Criteria:

* In cases where there is difficulty understanding and reading Korean.
Evaluation of High School-based Relationship Education

This study is a randomized controlled trial testing the effectiveness of a program provided in Colorado high schools by the Center for Relationship Education based in Denver, Colorado. 14 schools are randomly assigned to either provide the Real Essentials curriculum as part of health or similar classes or teach these classes as usual. The study design includes surveys administered pre-program, post-program and at 6-month and 12-month follow ups. Primary study outcomes are increased knowledge of healthy relationships and reduced risky sexual behavior.


Eligibility Criteria:
Inclusion Criteria:

* Must be enrolled in designated classes at 14 participating high schools schools in Colorado

Exclusion Criteria:

-
Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases

Aim of the study;To record the vascular changes that may be present in the posterior segment of patients suffering from Inflammatory bowel diseases(IBD) using the optical coherence tomography angiography

a prospective study of 30 patients suffering from IBD referred from tropical department from Tanta University Hospital

-Patients demographic data e.g., sex, age, concomitant systemic diseases will be recruited. Presenting symptoms, physical examination results, laboratory and imaging findings, and received treatment of IBD will be recorded. Accurate grading of disease severity will be carried out by gastroenterology specialist.

All patients will be subject to Full ophthalmologic examination and fundus imaging. Imaging will include OCTA and fundus photography. OCTA will be performed using cirrus OCT (Zeiss, Inc., USA). High-quality 6 x 6 mm OCTA macular scans and 3 × 3-mm papillary scan with strong signal-noise ratio and adequate centration on the fovea and optic nerve head respectively will be selected. Segmentation will be used to evaluate superﬁcial and deep capillary retinal plexus projections in addition to the choriocapillaries. If errors in segmentation were detected, manual correction would be performed. The superﬁcial retinal capillary plexus (SCP) will be delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) will be segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL).

The vessel density metric from enface OCT angiogram will be used as an indicator of macular retinal and papillary perfusion. Vessel density (VD) analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area. Choriocapillaries flow voids will be computed to assess choriocapillaries circulation

Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohn's disease and ulcerative colitis either newly diagnosed or suffering from chronic disease on treatment will be included

Exclusion Criteria:

* Recent ophthalmological surgery.

  * Low quality ophthalmological exams.
  * Refractive errors greater than + 3 or - 3 spherical.
  * Retinopathies such as diabetic retinopathy.
  * Any type of retinal degenerations or retinal dystrophy.