cyrilzakka/clinical-trials huggingface dataset:
Short-Term Clinical Outcome of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing

The primary objectives of this clinical study include:

* Assess the rate of dislocation and fracture of THA using the new (the 4th generation) ceramic implants.
* Evaluate the survival rate of THA using the new alumina-zirconia (the 4th generation) composite ceramic bearing.
* Investigate the performance of the 4th generation ceramic implants mostly in patients younger than 50 years.
* Compare the preoperative and postoperative scores of Harris Hip Score, UCLA Activity Score and WOMAC.

This study will evaluate incidence of dislocation and short-term clinical outcome on patients who undergo large diameter 4th generation ceramic bearing total hip Arthroplasty ("THA") in comparison to historical data on 3rd generation CoC THA (28mm) patients. Specifically the study intends to address the following research topics:

1. The incidence of dislocation after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing.
2. The incidence of ceramic fracture after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing
3. The survival rate, wear rate, and incidence of osteolysis of THA with use of the 4th generation Ceramic Bearing
4. Range of motion improvement from preoperative to postoperative to support Korean sitting style after THA with use of the 4th generation Ceramic Bearing.
5. Clinical outcomes, activity level and QoL of patients with use of the 4th generation Ceramic Bearing.
6. The performance of THA with use of the new ceramic bearing mostly in patients younger than 50 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for primary Total Hip Replacement
* Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:

  1. Osteoarthritis
  2. Avascular necrosis
  3. Legg Perthes
  4. Rheumatoid Arthritis
  5. Diastrophic variant
  6. Fracture of the pelvis
  7. Fused hip
  8. Slipped capital epiphysis
  9. Subcapital fractures
  10. Traumatic arthritis
* Patients aged over 20
* Patients must be able to understand instructions and be willing to return for follow-up

Exclusion Criteria:

* Absolute contraindications include: infection, sepsis, and osteomyelitis
* Relative contraindications include:

  1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  2. osteoporosis,
  3. metabolic disorders which may impair bone formation,
  4. osteomalacia,
  5. distant foci of infections which may spread to the implant site,
  6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
  7. vascular insufficiency, muscular atrophy, or neuromuscular disease.
  8. pregnancy
Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization

Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization.

Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization.

Optimize image fusion algorithms for use in goal. Develop registration algorithms that result in maximal lesional overlap with a clinically relevant difference in an epicenter location of ≤ 2 cm for lesional identification and, ultimately ≤ 0.3 cm for interventional procedures.

Eligibility Criteria:
Inclusion Criteria:

* Focal lesion involving the liver or kidney bases on CT or MRI Imaging
* Liver lesion size \>5 mm and \<5 cm in diameter or renal lesion size is \>5 mm and \<4 cm in diameter
* Age \>18 years old
* Patient has provided written informed consent

Exclusion Criteria:

* Patient with cardiac pacemaker or defibrillator
* Pregnant or lactating woman
* Patient with severe IV contrast allergy (previous reaction to IV contrast not mitigated by appropriate premedication)
* Patient unable to give informed consent
A Service-Learning Program for Comprehensive Geriatric Assessment and Health Promotion in Older Adults

The GEROS Project aims to develop and implement a Service-Learning (S-L) program that integrates Comprehensive Geriatric Assessment (CGA) and health promotion, for students at the Faculty of Health Sciences and Welfare at the University of Vic - Central University of Catalonia (UVic-UCC). This initiative engages university students, healthcare professionals, and older adults (60+) in a participatory, intergenerational approach that fosters mutual learning and community engagement.

The study follows a non-experimental mixed-method design, involving students from Nursing, Physiotherapy, Human Nutrition and Dietetics, Occupational Therapy, and Psychology. Participants include older adults (60+) who can independently travel to the university.

The project is integrated into different subjects, in groups of 4-5 students, participants conduct a Comprehensive Geriatric Assessment (CGA), evaluating frailty using VIG-Frail, intrinsic capacity with ICOPE, quality of life with EUROQOL 5D-5L, and specific health indicators with Nursing Outcomes Classification (NOC).

To assess the program's effectiveness, several outcome measures will be analyzed including students' perceived knowledge, competencies, and skills, as well as older adults' awareness of their health status, lifestyle, and risk factors. Additionally, the satisfaction levels of both will be evaluated. The items will be evaluated using a 1-5 Likert Scale, and the analysis will be conducted with SPSS. Data recording will be carried out through REDCap.

The GEROS Project aligns with the United Nations' Sustainable Development Goals (SDGs), specifically SDG 3 (Good Health and Well-being) and SDG 10 (Reduced Inequalities). By offering care to the aging population and providing them with personalized health recommendations, the project promotes preventive strategies, active aging, and intergenerational learning.

Furthermore, GEROS integrates innovative educational methodologies, encouraging experiential learning, collaboration with healthcare professionals, and the development of practical skills in real-world contexts. The program's scalability and adaptability could serve as a model for other universities and healthcare institutions aiming to enhance geriatric care through service-learning initiatives.


Eligibility Criteria:
Inclusion Criteria:

A) For users:

* Any person aged 60 or older who can move to the facility (Faculty of Health Sciences and Welfare) independently or accompanied by a caregiver.

B) For students:

* Students from Nursing, Physiotherapy, Nutrition and Dietetics, Occupational Therapy and Psychology degrees of UVic-UCC.

Exclusion Criteria:

* For users: Individuals institutionalized in a long-term care institution.
Cardiothoracic Critical Care as Subspecialty and Its Core Competencies

The aim of this study is to develop a consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field, based on a Delphi consensus among a panel of experts in this field.

This study will use the Delphi process to conduct this study. This survey research involves Phase 1 and Phase 2 of questioning, each phase involves up to 3 rounds of questions to determine agreement or disagreement. Each round will take approximately 20 minutes to complete, and responses will remain completely confidential. For both phases, the questions will either be 7-point Likert or multiple choices. For both phases, the group of questions will be sent up to three times until agreement (up to 80% of agreement consensus). Questions that have obtained agreement will be removed in each round. The questions will help the experts and the research team understand where there is current agreement on, or topic that may need to be discussed/studied further to unify trainings.

Eligibility Criteria:
Inclusion Criteria:

* The participants will be experts in the field of Cardiothoracic Surgery Critical Care Medicine to better understand the training needs of the field. Experts must have been in practice for a minimum of 5 years and have at least 50% of practice in cardiothoracic intensive care units.
* The participants will have graduated from a critical care fellowship in either an administration, education, or research role.

Exclusion Criteria:

* Participants who do not meet the exclusion criteria will be excluded due to their lack of experience in the field.
Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison study in subjects with moderate to severe forehead wrinkles.

One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.

There are two formulations of BoNT-A available: Botox®/Vistabel®, Allergan and Dysport®/Azzalure®, Ipsen - Galderma. These formulations behave distinctly in different ways electrophysiologically and clinically and results obtained with one formulation cannot be extrapolated to the other. There are only few clinical research directly comparing the two formulations in the treatment of forehead lines.

Eligibility Criteria:
Inclusion Criteria:

1. Female Subjects of any race, from 18 to 65 years old
2. Moderate to severe horizontal forehead wrinkles at maximum contraction (2-3 on the Forehead Wrinkles Severity Scale) on both sides of the forehead
3. Negative urine pregnancy test at the Baseline visit for Subjects of childbearing potential

Exclusion Criteria:

1. Subjects with a washout period for procedure(s)/treatment(s) on the forehead less than:

   * Retinoid, microdermabrasion, or prescription level glycolic acid treatments 2 weeks
   * Non-ablative light treatments (e.g. Intense Pulsed Light, light-emitting diodes) 1 month
   * Ablative skin resurfacing
   * Non-ablative dermal treatment for skin tightening (e.g. radio-frequency treatments) 6 months
   * Treatment with a BoNT-A 12 months
   * Soft tissue augmentation (e.g. biodegradable products as collagen or hyaluronic acid preparations) 24 months
2. Subjects who undergone a surgical facelift;
3. Permanent or semi-permanent dermal fillers in the forehead area;
4. Known allergy or hypersensitivity to any botulinum toxin or any component of BoNT-A (1) and/or BoNT-A (2) (see package inserts);
5. Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics;
6. Pregnant women, nursing mothers, or women who are planning pregnancy during the study;
Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges

The purpose of this study is to test the effectiveness of a telehealth-delivered skills training versus active control group for middle and high school students with ADHD symptoms. Both programs will be delivered digitally (via Zoom).

Investigators will measure student functioning at baseline, post-group, and three-month follow-up. The primary outcomes are ADHD symptoms, student grade point average, and attendance as reported in the gradebook. Secondary outcomes include parent academic support, autonomy, academic motivation, and organization skills. Participant satisfaction with the group will be measured post-group. Group attendance and homework completion will also be measured.

120 middle and high school students with elevated ADHD symptoms will be recruited for this study, which will take place over the course of the 2021-2022 academic year. The recruitment strategy will be to distribute information about the study opportunity to educator email lists in South Florida (see appended email template). Educators will be instructed to share information about the study to the parents of students who perceive to experience ADHD symptoms in their schools, regardless of special education status or documentation of a disability.

Students who enroll will be randomly assigned to either receive the STAND-G strategy-based group or a peer-support-based, active control group. Investigators will blind participants and their parents to which group is the active treatment by informing parents and students that participant will be randomly assigned to one of two groups to help improve school difficulties in youth. The two groups will be of equal duration, both will be led by the same instructors; and will differ only in content (teaching strategies vs. facilitating peer support and problem-solving conversations).

Students (and their parents) will complete assessments at baseline, post-group, and three months post-group. School records will be obtained for all time points.

Eligibility Criteria:
Inclusion Criteria:

Students will be required to,

* be in the sixth through twelfth grade,
* have elevated ADHD symptoms
* documented impairment according to the SNAP
* documented impairment according to Impairment Rating Scale.
* Students must be 17.5 or younger at the time of enrollment to ensure that they are still under 18 at the expected completion of the study.

Parents of eligible students will also participate.

Exclusion Criteria:

Students may not be,

* in a self-contained special education classroom,
* possess intellectual disability
* be non-English speaking
* be older than 18 years old at time of enrollment
A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer

OncoVAX® is the first cancer vaccine that both prevents cancer recurrence and

addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase

IIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's

own cancer cells to mobilize the body's immune system to prevent the return of colon

cancer following surgery.

OncoVAX is an active specific immunotherapeutic (ASI) stimulating a patient's immune

response to autologous (patient-specific) tumor cells. It is comprised of sterile, live but

non-dividing tumor cells obtained following standard-of-care surgical tumor resection for

Stage II colon cancer. Within 35 days following surgery, patients are immunized with

OncoVAX to prevent disease recurrence, which is incurable and occurs in up to 35% of

patients. Patients are given three vaccinations once per week for three weeks, followed

by a booster vaccination after six months. A previously completed Phase III trial

published in The Lancet showed that OncoVAX cut the risk of recurrence by 61% in

patients with Stage II colon cancer. The primary endpoint is Disease-Free Survival:

defined as the time from curative surgery to the objective test confirming tumor

recurrence or death due to any cause. The secondary endpoints are Overall Survival

and Recurrence-Free-Interval. An interim analysis will be performed at a significance

level of 0.005 once 2/3 of anticipated events have occurred, resulting in a significance

level of 0.0483 at the end of the study. A total of 550 patients is planned, randomized

1:1 to receive OncoVAX® plus surgery (n=275) or surgery alone (n=275).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have Stage II (IIA = T3N0M0, IIB = T4aN0M0, IIC = T4bN0M0) disease.
* Patients must have undergone curative resection and have no evidence of residual or metastatic disease.
* Following curative resection patients must have a CEA within normal limits. If elevated prior to resection, it must return to normal within 21 days post surgery and prior to randomization.

Exclusion Criteria:

* Patients with prior radiation therapy or chemotherapy or a prior malignancy of any type will be excluded. However, subjects with prior, curatively-treated squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix will be eligible for participation in this study.
* Patients with more than one malignant primary colon cancer will be excluded.
A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Determine the Safety and Effectiveness of Azeliragon in the Treatment of Patients Hospitalized for Coronavirus Disease 2019 (COVID-19) or Pneumonia

A new drug called azeliragon could be used to treat patients with COVID-19 or other pneumonia infections but the researchers don't know. In this study, they are learning the effects of azeliragon patients hospitalized for COVID-19 or pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least two of the following signs or symptoms: cough, chest pain, shortness of breath, hypoxia (oxygen saturation \<90%)
* Clinical diagnosis of pneumonia or COVID-19 during the first 48 hours of hospitalization.
* Patients admitted to the hospital within the previous 48 hours (from time of admission to initial treatment dose.)
* Provide informed consent to participate in the study (by participant or legally-acceptable representative).

Exclusion Criteria:

* Patients for whom intubation within 24 hours of admission is considered likely.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3x upper limit of normal (ULN), OR total serum bilirubin \>2x ULN.
* Patients who were receiving dialysis as a regular treatment at the time of admission. (Participants are not excluded for historic need for dialysis.)
* Chronic liver disease with Child-Pugh class B of (7 to 9) or higher.
* Patients with an electrocardiogram (ECG) corrected QT interval (QTc) \> 500 ms.
* Patients requiring treatment with strong inhibitors of CYP2C8
* Females of childbearing potential who are pregnant, breastfeeding, and/or not using a highly-effective method of contraception (consistent with local regulations regarding the methods of contraception for those participating in clinical studies, including willingness to use 2 acceptable forms of contraception from screening until after the end of drug treatment. Acceptable forms include tubal ligation, male latex condom with or without spermicide, partner's vasectomy, diaphragm with spermicide, intrauterine device, cervical cap/sponge with spermicide, contraceptive sponge, female condom, hormonal contraceptive including oral, transdermal, vaginal ring, subcutaneous injection, or implanted rod.)
* Allergy to azeliragon or formulation excipients in the azeliragon or placebo capsule.
* Concurrent participation in another device or drug trial for treatment purposes. Trials with devices intended for diagnostic purposes only are allowable..
* Any other condition, including abnormal laboratory values that, in the judgment of the investigator, could put the participant at increased risk, or would interfere with the conduct or planned analysis of the study.
Vaginal Tactile Imaging for Pelvic Floor Prolapse

The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is female of 21 years or older, and
2. No prior pelvic floor surgery, and
3. One of the following:

Normal pelvic floor conditions, or POP Stage I affecting one or more vaginal compartment, or POP Stage II affecting one or more vaginal compartment, or POP Stage III affecting one or more vaginal compartment, or POP Stage IV affecting one or more vaginal compartment

Exclusion Criteria:

1. Active skin infection or ulceration within the vagina
2. Presence of a vaginal septum;
3. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
4. Ongoing radiation therapy for pelvic cancer;
5. Impacted stool;
6. Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
7. Severe hemorrhoids;
8. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
9. Current pregnancy.
Multi-Dimensional Genomic Dissection of Ring Chromosome 14 Syndrome

MD-RING will explore the hypothesis that position effects and TAD alterations act as an unprecedented pathomechanism in r(14)S. This will contribute to a better understanding of genotype-to-phenotype correlations, creating an important scientific resource for the study of this and other ring syndromes, with the ultimate objective to offer improved family counseling , patient care and to identify potential new therapeutic options.

Chromosome 14 ring syndrome \[r(14)S\] is a rare genetic disorder mainly characterized by complex and severe neurodevelopmental disorders, ranging from intellectual disability to aggressive/hyperactive behavior and drug-resistant epilepsy. Indeed, epilepsy is the most important clinical challenge in r(14)S, with enormous difficulty in controlling severe seizures and a strong need for innovative and effective treatments. Precision medicine for r(14)S patients would be greatly facilitated by knowledge of specific genes involved in pathogenesis. However, the pathophysiology of r(14)S is still largely unknown, and the identification of genotype/phenotype correlations is complicated by the co-occurrence of chromosome 14 rearrangements and the unknown degree of r(14) mosaicism in tissues most relevant to the disease. On the one hand, deletions of different sizes, from a few hundred Kbs to several Mbs, are often found in the terminal 14q region. These are an unlikely explanation for the severity and expressiveness of r(14) disease, since it has been observed that carriers of similar linear deletions of chromosome 14q rarely suffer from epilepsy. On the other hand, ring instability may promote increased monosomy of chromosome 14 in epilepsy-related areas of the brain (it is about 20% in peripheral blood).

Another fascinating hypothesis is that the mechanism and expressiveness of r(14) disease are driven primarily by the disruption of chromosome 14 conformation and positioning within the nucleus caused by its circularization, with dramatic effects on physiological interactions between genetic loci and, consequently, on gene regulation . This idea revives an unresolved question in cytogenetic disorders, whether the chromosomal abnormality itself produces a clinical phenotype beyond the pathogenic effects of the altered gene dosage. Rings can form from any chromosome, and most ring syndromes share largely similar clinical phenotypes. Severe epilepsy, for example, has been described in r(7), r(17), r(18), r(20), r(21) and r(22) syndromes in addition to r(14)S . This observation suggests that the presence of a loop within the nucleus may itself disrupt the balance of gene expression.

Eligibility Criteria:
Inclusion Criteria:

* Ten LCLs of r(14)S patients with 14q deletions of varying position and extent in 70%, and monosomy 14 of varying degree in 60%.
* Five LCLs of parents without cytogenetic alterations.

Exclusion Criteria:

* Ten LCLs of r(14)S patients with 14q deletions of varying position and extent in 70%, and monosomy 14 of varying degree in 60%.
* Five LCLs of parents without cytogenetic alterations.