cyrilzakka/clinical-trials huggingface dataset:
Multicenter Study Evaluating the FixNip™ NRI Safety and Performance

A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.

This is a Prospective, Open label, Single arm, Multicenter Study enrolling female patients with a history of breast cancer following breast conservation surgery or mastectomy with breast reconstruction, seeking reconstruction of the breast nipple and areola complex.

The study is designed to evaluate the long-term safety and performance of the FixNip NRI in patients undergoing nipple reconstruction procedure.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 22-70 years.
* Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study.
* History of breast cancer post mastectomy with breast implant or partial mastectomy (lumpectomy) of the central segment of the breast seeking reconstruction of the nipple and/or areola complex.
* At least 3 months post breast reconstruction surgery.
* Baker scale grade I or II capsular contracture.
* No evidence of any systemic or chronic disease that might influence wound healing and infection rate.
* Event free post breast and/or nipple reconstruction procedure, i.e. no skin infections or related infections that mandated antibiotic therapy, no wound dehiscence or any other related medical complications.
* Pinch test of intended nipple location on affected breast of at least 15 mm.
* Patient is willing to postpone tattooing until the end of follow-up period.
* Patient is willing and able to give their written informed consent.

Exclusion Criteria:

* Active malignant disease.
* Subject has a chronic disease or any medical status that, according to surgeon discretion, prohibits from inclusion in the study i.e. diabetes.
* History of tendency to produce hypertrophic scars or keloids.
* Current use of any medications that can interfere with wound healing, impair the immune system functionality, or impair blood clotting mechanisms.
* Active infection within the last 30 days.
* Pregnant or nursing women.
* Connective tissue disease.
* 'Lupus disease' defined as Systemic Lupus Erythematous or Discoid Lupus, or scleroderma defined as Progressive Systemic Sclerosis per history.
* Chronically treated with steroids or steroid therapy in a 3month period before surgery.
* Demonstrate psychological characteristics, which, in the opinion of the Investigator and/or consulting physician(s) are incompatible with the risks, involved with the surgical procedure, prosthesis and compliance with follow-up recommendations.
* Past or current capsular contracture defined as Baker III or IV.
* Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Parental Knowledge, Attitude and Practice Towards Oral Health of Their Children

The aim of this study is to assess the parental knowledge, attitude and practice towards oral health of their children in relation to caries experience.

Primary teeth are important as much as permanent teeth. Dental plaque is considered the major cause of dental diseases, it begins to adhere to the teeth after eruption. Therefore, regular dental care for children becomes essential. Children at preschool age lack the awareness of primary teeth importance, the knowledge in dental health care and the ability to maintain adequate oral health. Hence, it is the parents' responsibility to take care of their children's teeth in collaboration with dentists and their advices.

A good understanding of the parental knowledge, attitudes, beliefs and awareness regarding oral health is essential for the effectiveness of oral health promotion efforts aim at improving the dental health of young children. It has been found that the more positive the attitude of parents is towards dentistry; the better their children's dental health status.

Children from low-income and underprivileged families have been found to have high caries prevalence and poor oral health. Therefore, it is important to assess the knowledge and attitude of parents, as their behaviour towards their children oral health is of a huge impact. This may also have implications on early dental visits aimed for prevention rather than restorative treatment. So, parents' knowledge and attitude have a significant influence on the children's dental and gingival health. Lack of parental knowledge and positive attitudes regarding primary teeth create barriers to early preventive dental care.

In addition, studying and understanding parental dental knowledge and attitude would be of a good help in effective planning for well-targeted dental health promotional campaigns by shedding the light on the knowledge gaps and negative attitudes of the parents regarding dental health

Eligibility Criteria:
Inclusion criteria:

* Parents of children with Primary dentition.

Exclusion criteria:

* Parents of children with psychological problems.
* Parents of children with chronic illness.
* Parents who refuse to participate.
Atorvastatin ± Aspirin in Lynch Syndrome Syndrome

The goal of this study is to investigate that a common cholesterol lowering agent (atorvastatin) alone or combining with a nonsteroidal anti-inflammatory drug (aspirin) would reduce the risk of colorectal cancer (CRC) in high-risk individuals with Lynch syndrome.

This is an exploratory biomarker trial to assess the ability of atorvastatin (common cholesterol lowering agent) alone or combining with aspirin (a nonsteroidal anti-inflammatory drug) to reduce the risk of colorectal cancer in high-risk individuals with Lynch Syndrome. Subjects will be stratified based on their prior history of polyps/cancer to receive atorvastatin without or with aspirin for 6 weeks. Blood and normal colon biopsies will be obtained at Day 0 and at 6 weeks on study. Tissue endpoints for analysis include cell proliferation, apoptosis and changes in gene expression. Circulating lipid profiles and metabolic function, and post-treatment questionnaires will be used to assess the acceptability of the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 18 years of age or older
* Able to read and sign an informed consent document in English
* Eligible subjects will have molecular evidence of Lynch Syndrome (mutation in MLH1, MSH2, MSH6, EPCAM or PMS2)
* History of colorectal cancer if surgically cured and \> 1 year from completion of adjuvant chemotherapy

Exclusion Criteria:

* Are \<18 years of age
* Unable to read and sign an informed consent document in English
* Have active cancer or are less than 3 years post hormonal maintenance therapy for cancer
* Have statin intolerance or contraindication for aspirin or atorvastatin use
* Are pregnant or are actively breast feeding
Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing pain and swelling) associated with significant health problems. It is a difficult disease to manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints that can cause joint damage, deformity, and progressive disability and impairment. It is estimated that 1% of the world's population suffers from this disease.

The purpose of this research study is to determine if a change in inflammation seen on the ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years old
2. Has a diagnosis of rheumatoid arthritis
3. Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine)
4. Disease activity score DAS28/ESR \> 3.2 or all must be met: TJC (tender joint count)\>=4, SJC (swollen joint count)\>=4
5. Must be able to understand information in the Informed Consent and comply with study requirements
6. Total ultrasound synovitis (inflammation of joint-lining membrane) power Doppler score \>=1 for at least 2 joints and total synovitis score \>=1 for at least 1 joint

Exclusion Criteria:

1. Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20 inhibitors, IL-1 inhibitors, etc.)
2. Pregnancy or breast feeding
3. Daily prednisone \> 10mg (stable dose for at least 1 month)
4. Intra-articular steroid injection of the wrist or joints within last 2 months
5. History of a concomitant autoimmune disease such as lupus, psoriatic arthritis
6. History of cancer
7. Previous exposure to abatacept
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Solrikitug in Healthy Japanese and Non-Japanese Participants

A Phase 1, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Formulations of Subcutaneously Administered Solrikitug in Healthy Japanese and non-Japanese Participants


Eligibility Criteria:
Inclusion Criteria:

* At the time of initial screening, in general good health (age 18 to 55 years);
* Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring
* Participant must agree to use contraception during the treatment period and until follow-up
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions of the study

Exclusion Criteria:

* Pregnancy or breastfeeding during the study
* Chronic infection
* Treatment with prohibited medications.
A Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents

The purpose of this study is to refine, evaluate the feasibility, and to estimate the effect of the "healthy Living Study," a brief outpatient problem-solving intervention to promote healthy eating and activity habits in adolescents.

This study will refine, evaluate the feasibility, and estimate the effect of a brief problem-solving intervention to promote healthy eating and activity habits in adolescents. Intervention participants will receive 2 sessions of individual behavioral counseling on problem-solving skills utilizing educational videos, handouts, and worksheets. Intervention participants will be asked to generate unique health goals and practice utilizing problem-solving skills to achieve these goals.Control participants will receive standard of care. Outcomes will explore the ability to shorten the intervention, integrate the intervention into busy outpatient clinics, and estimate the effect of the intervention on confidence to maintain or improve healthy habits and to improve problem-solving skills.

Eligibility Criteria:
Inclusion Criteria:

* 13-18 years old
* Able to read and speak English
* Patient of the Lucile Packard Children's Hospital teen clinic, weight clinic, or mobile teen van

Exclusion Criteria:

* History of purging within the prior 12 months
The Effect of Using Interactive Mobile Application for the Management of Chemotherapy- Induced Nausea and Vomiting in Children

The aim of this study was to develop an interactive mobile application and to investigate the effect of this application on the management of nausea and vomiting symptoms by using it during chemotherapy treatment.

Intensive chemotherapy protocols are the most commonly used treatments in childhood cancers. While these protocols increase recovery rates, they may also cause some undesirable side effects. Nausea and vomiting are one of the most common toxic side effects associated with chemotherapy. The aim of this study was to develop an interactive mobile application and to investigate the effect of this application on the management of nausea and vomiting symptoms by using it during chemotherapy treatment.

The study will be conducted with 61 children between 8-18 years of age who received chemotherapy in the Pediatric Hematology-Oncology Clinic at Trakya University Health Research and Application Center. The study was planned as a randomized controlled study. Data will be collected with the "Information Form" and "Rhodes Adapted Rhodes Nausea and Vomiting Scale for Children". The interactive mobile application will be downloaded to the phones of the experimental group and this device will be used from the first chemotherapy day to the seventh day. While the experimental group evaluates their nausea and vomiting via mobile application twice a day, every 12 hours for one week, the control group will record their nausea and vomiting experiences in the "Nausea and Vomiting Diary". While the experimental group will be able to use the mobile application which consists of diverting attention, routine control will be applied to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Taking chemotherapy treatment,
* To be in the age range of 8-18,
* Volunteering to participate in research,
* Having the first course of chemotherapy,

Exclusion Criteria:

* Having a mental problem,
* Absence of vision, hearing and speech problems,
* Absence of problems with the gastrointestinal system,
* Being in the terminal period,
* Receiving sedation therapy,
Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

Although several studies have demonstrated beneficial effects of stem cell therapy in patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of response to therapy remain undefined. The aim of this registry is to pool long-term clinical data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy in an attempt to better define predictors of response to such treatment.

Registry will include all patients who underwent intracoronary or intramyocardial cell therapy as a part of clinical trials performed at UMC Ljubljana from January 2005 until January 2018. Patients will be followed on regular basis in a dedicated heart failure outpatient clinic, clinical data will be collected and stored in a secure central database. Data will be analyzed in periodic intervals by an independent Data monitoring board in an attempt to better define the predictors of clinical response to cell therapy in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patient inclusion criteria consisted of the following: age 18-65 years old, diagnosis of DCM according to the European Society of Cardiology position statement (9), optimal medical management for at least 6 months, left ventricular ejection fraction (LVEF) \<40%, and New York Heart Association functional Class III on stable medical therapy for at least 3 months before referral.

Exclusion Criteria:

* Patients with acute multi-organ failure or a history of hematologic neoplasms were not included.
Lees Screen in Concomitant Strabismus

Preoperative and postoperative Lees screen was done after concomitant horizontal strabismus surgery to detect any limitation in the field of operated muscle

Preoperative and postoperative Lees screen was done for concomitant esotropia and exotropia patients to record any change in ocular motility as regards underaction or overaction in the operated extra ocular muscles

Eligibility Criteria:
Inclusion Criteria:

* Concomitant esotropia
* Concomitant exotropia
* Above 10 years old patients

Exclusion Criteria:

* Restrictive and paralytic strabismus
* Previous strabismus surgery
* Mental disability
Korean Life-Style Modification Effects on Blood Pressure

In hypertension, lifestyle modification has been proven to be effective in reducing blood pressure while decreasing the risk of cardiovascular disease. The dietary approaches to stop hypertension(DASH) diet, sodium restriction and exercise has been shown to reduce systolic blood pressure by 8-14mmHg, 2-8mmHg and 4-9mmHg, respectively. The DASH-sodium diet has been shown to have additional systolic blood pressure lowering effect of 7.2mmHg, which is equal to adding one antihypertensive drug. However, as the dietary pattern is different in the Korean population, the investigators cannot implement the data from Western countries directly to the Korean population. For example, the consumption of dairy products is much smaller in the Korean population when compared to the western population. Therefore, the effectiveness of DASH-sodium diet and exercise on blood pressure lowering in the Korean population is not well defined. In this study, the investigators sought to determine the effectiveness of the DASH-salt diet and DASH-salt diet plus exercise on brachial blood pressure lowering. The study will be performed on untreated prehypertension patients and uncontrolled hypertensive patients undergoing anti hypertensive treatment with blood pressure measured between 140-159mmHg/90-99mmHg at the time of enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. Adult age \>20
2. If the subject not taken antihypertension, SBP and DBP must be the following result.

   SBP: 120\~159 mmHg , DBP: 80-99 mmHg
3. If the subject taken antihypertension, SBP and DBP must be the following result.

   SBP: 140-159mmHg ,DBP: 90-99 mmHg
4. BMI 18.5kg/m²\~44kg/m²
5. Patients voluntarily agreed to participate in this study
6. Non-pregnant women, Non-breastfeeding women, women of childbearing age must be negative in HCG result.

(not taking an oral contraceptive)

Exclusion Criteria:

1. If the subject not taken antihypertension, SBP and DBP must be the following result.

   * 120\>SBP\>159 mmHg, 80\>DBP\>99 mmHg
2. If the subject taken antihypertension, the number of three or more antihypertensive
3. If the subject taken antihypertension, SBP and DBP must be the following result.

   * 140\>SBP\>159 mmHg, 90\>DBP\>99 mmHg
4. having the target organ disease, the following disease.

   * Heart disease: Lt.venricular hyperplasia, Angina, MI, Coronary revascularization, Heart failure
   * Brain disease: Stroke, TIA, Dementia
   * Kidney disease:
   * Pheripheral artery disease
   * Retinopathy Disease
5. Cancer, Liver disease
6. Regular drinking alcohol above 14 cup of during 1 week.
7. Pregnant women, Women of childbearing age tested positive in HCG result.
8. Pregnant women, Breastfeeding women
9. screening test result CS
10. illiteracy, a foreigner, the person who can't read the consent
11. the person who had participated other study in 3 months.
12. the person who inappropriate to participate
LOWER URINARY TRACT SYMPTOMS

Lower urinary tract symptoms (LUTS) are observed in individuals with pathologies affecting the lower urinary system, such as detrusor overactivity, sphincter weakness, or sensory bladder disorder. LUTS can be categorized into storage, voiding, and post-micturition symptoms. Storage problems include increased frequency of urination, nocturia, urinary urgency, and incontinence. Voiding symptoms include decreased urine flow rate, hesitancy, and terminal dribbling, while post-micturition symptoms include post-micturition dribble and a sensation of incomplete bladder emptying. The prevalence of LUTS increases with age and is influenced by factors such as metabolic syndrome, gender, caffeine consumption habits, chronic psychological stress, bladder dysfunction, smoking, alcohol use, and constipation.

This study aims to investigate the prevalence of LUTS and contributing factors among medical students, a young population undergoing a stressful educational process.

A 43-question survey was prepared for all medical students from years 1 to 6. The survey included the Constipation Scoring System (CSS) to evaluate constipation, the Generalized Anxiety Disorder-7 (GAD-7) score to assess anxiety levels, and the Core Lower Urinary Tract Symptom Score (CLSS) to query LUTS. The survey also collected data on participants' dietary habits, smoking, alcohol and caffeine consumption, living conditions, age, gender, body mass index (BMI), and educational level. The study was approved by the local ethics committee of Gaziantep University (approval number 2024/234).


Eligibility Criteria:
Inclusion Criteria:

-All medical students from committee 1 to 6.

Exclusion Criteria:

* Participants who filled out the survey questions incompletely or incorrectly
* Participants who had additional diseases
* Participants who used medication for psychiatric or cardiac reasons
* Participants who had undergone surgery that could affect bladder function
ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients

The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of renal transplant recipients with renal impairment by reducing the progression of chronic allograft nephropathy. The development of atherosclerosis in the native arteries of the patients will also be explored.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient at least 18 years of age.
* Patient who has undergone a primary or secondary renal transplant 12-96 months ago from a living related or unrelated donor or a cadaveric donor.
* Patient receiving cyclosporine microemulsion with a C2-h level ≥ 400 ng/mL or tacrolimus with a C0-h level ≥ 4 ng/mL with or without mycophenolic acid or azathioprine plus or minus steroids.
* The immunosuppressive regimen must remain unchanged within the last 3 months.
* Patient with renal impairment defined as GFR between 30 and 70 mL/min/1.73 m\^2 by Cockcroft-Gault formula.

Exclusion Criteria:

* Patient who is recipient of multiple organ transplants.
* Patient with protein/creatinine ratio ≥ 150 (mg/mmol).
* Patient with a treated acute rejection episode within the last 3 months.
* Patient with any past or present BK-polyomavirus nephropathy.
* Patient with de novo or recurrent glomerular nephritis.

Other protocol defined inclusion/exclusion criteria may apply.
Testing the Competency-based Theory of Change for Suicide Risk Among Young Male Internet Users With Societal Masculinity

To propose a competency-based theory of change for reducing suicide risks among male Internet users with salient traits of societal masculinity; To test whether the theory of change using the competency-based model has additional effects on reducing self-harm and/or suicidal ideation in addition to the online social work treatment-as-usual model; To provide online social work service providers with evidence-based measures for reducing the risks of self-harm and/or suicide among young male Internet users.

This is a randomized waitlist-controlled trial of 60 participants examining the effects of a proposed competency-based model on self-harm relative to those of OSW alone. In the online survey (T0), subjects with self-harm or suicidal ideation will be invited to give informed consent, and then be randomly assigned to one of two groups: 1) OSW (control), or 2) OSW + six weekly sessions of competency-based physical training (intervention). They will be assessed at three measurement time points (T1 = one-month; T2 = three-month; and T3 = five-month from T0 at post-intervention). The intervention group is hypothesized to display a greater reduction in the primary outcomes of self-harm and suicidal ideation than the OSW group. Chi-square tests giving p \<=0.05 will indicate a goodness of fit of the linear mixed model, which address random effects in the data and handles intention-to-treat (ITT).

Eligibility Criteria:
Inclusion Criteria:

* Individuals who meet the cut-off of 1.0 on the Chinese Adult Suicidal Ideation Questionnaire (ASIQ4); Self-injury incidents in the past 12 months

Exclusion Criteria:

* Individuals with severe physical disabilities