cyrilzakka/clinical-trials huggingface dataset:
The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism

This is a prospective observation cohort investigation. Patients, that is participants, undergoing primary functional rhinoplasty will be evaluated in terms of measuring capillary blood lactic acid concentration in the nasal skin-soft tissue envelope immediately after the procedure and 7 days after the procedure.

The aim of our study is to test whether or not different rhinoplasty approaches and volume of the used autologous cartilage grafts impact the nasal skin-soft tissue metabolism.

This is a prospective observation cohort investigation.100 adult participants undergoing primary functional rhinoplasty between the January 2nd 2025 and January 2nd 2026 will be assessed in terms of measuring capillary blood lactic acid concentration in the nasal skin-soft tissue envelope immediately after the procedure and 7 days after the procedure. Prior to conducting the investigation, the participants will need to sign an informed consent for participating in the study, which would be previously approved by the ethics committee. For measuring capillary blood lactic acid concentration investigators are to use StatStrip® Lactate device and test strips. The volume of the used autologous cartilage autografts will be measured as well by using the water displacement method. Other used information regarding demographics and operation details will be drawn from the hospital's information systems, to which only medical personnel has an access. Using statistical analysis investigators are to perform the independent samples t-test, that is the Mann-Whitney U test, to analyze whether or not there is a difference in lactic acid concentration in participants undergoing open vs closed rhinoplasty approach. Furthermore by using Person's correlation coefficient method, the correlation between the used autologous cartilage grafts volume and lactate concentration will be assessed. The results of the lactic acid concentration will be interpreted with an assistance of the medical biochemistry and laboratory medicine specialist.

The aim of our study is to test whether or not different rhinoplasty approaches and volume of the used autologous cartilage grafts impact the nasal skin-soft tissue metabolism.

Since the investigation is to be performed during the regular working hours and since there is no intervention, no external funding will be necessary.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing primary functional rhinoplasty who comply with the study
* Adult patients undergoing primary functional rhinoplasty who have singed the informed consent, previously approved by the ethics commitee.

Exclusion Criteria: -

* patients with previous surgical procedures to the nose
* patients with greater previous injury or burns to the nasal skin
* patients with autoimmune skin conditions
* patients with significant cardiovascular diseases
* patients unwilling to comply with the study
* patients who do not want to sign the informed consent, previously approved by the ethics commitee.
Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study

This study was conducted to evaluate the Turkish validity and reliability of the Caregiver Contribution to Self-Care in Ostomy Patient Index, to evaluate the relatives of patients with stoma who contribute to their self-care in Turkish society, and to contribute to the nursing literature of the measurement tool.

This methodological type of research was carried out between September 2020 and January 2021 in a state and a university hospital in Tekirdağ. The research sample consisted of 223 individuals who contributed to the self-care of individuals with colostomy, ileostomy and urostomy who applied for outpatient control. In the analysis of the data, descriptive statistics, language and content validity, confirmatory factor analysis, item analysis, internal consistency and test-retest methods were used.

At the end of the study, it was determined that the scale was suitable for Turkish society and was valid and reliable in Turkish.

The "Caregiver Contribution to Self-Care in Ostomy Patient Index" scale consists of 22 items and 3 sub-dimensions. Scale items are evaluated with a 5-point Likert type. The first sub-dimension is "Caregiver Contribution to Self-Care Maintenance" consisting of 9 items; The second sub-dimension is "Caregiver Contribution To Self-Care Monitoring" consisting of 8 items and the third sub-dimension is " Caregiver Contribution to Self-Care Management" consisting of 5 items. The 18th item of the scale, which evaluates the state of experiencing complications, has a low factor load and was accepted as an add-on. The highest 110 points are obtained from the scale, and it is stated that as the total score from the scale increases, self-care also increases.

Eligibility Criteria:
Inclusion Criteria:

* speaking Turkish
* over 18 years old
* Not having a serious psychiatric diagnosis
* Giving written consent to participate in the study

Exclusion Criteria:

* severe visual or auditory problems
* caregivers who did not volunteer to participate in the study
Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix

The aim of the present project is to evaluate the frequency of distant metastases and clinically relevant relapse and mortality, respectively, of aNEN (Neuroendocrine Neoplasms of the Appendix) measuring 1 - 2 cm.

The investigators hypothesize that the mortality rate of aNET (Neuroendocrine Tumors of the Appendix) measuring 1 - 2cm is less than 1%. Furthermore, the investigators hypothesize that regional lymph node metastases of aNET measuring 1 - 2 cm are clinically not relevant and are not associated with reduced survival. The investigators therefore hypothesize that oncological right-sided hemicolectomy has no impact on long-term survival after complete resection of aNET measuring 1 - 2 cm and that the malignant potential quo ad vitam of these tumors is lower than the risk of oncological hemicolectomy.


Eligibility Criteria:
Inclusion Criteria:

* The investigators will include all patients with aNET measuring 1 - 2 cm and complete resection between 01.01.2005 and 31.12.2010 of the primary tumor.

Exclusion Criteria:

-
Image Biomarkers for Progression of AMD

To study qualitatively and quantitatively the Imaging Biomarkers (IBs) on Multi-modal Imaging with Novel technologies (MINT), in order to understand their role in prediction of the Age-related Macular Degeneration (AMD) progression in eyes with and without treatment. The understanding of IBs will allow early detection of AMD, prediction of its evolution, and guidance for the best options for stratified/individualized treatment of AMD.

The qualitative studies will explore use of OCT Angiography (OCTA), Swept Source OCT (SS-OCT), Ultra-Wide Field Fluorescein Angiography (UWF-FA), Adaptive Optic Scanning Laser Ophthalmoscopy (AO-SLO), Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO), Retro Mode Imaging (RMI) and other novel technologies for the retinal diagnosis. Morphologic qualitative IBs described in the literature like macular neovascularization pattern, retinal tubulations, choriocapillary preservation, retinal pigment epithelium atrophy, drusen patterns, etc as well as other IBPAMD original IBs classified in morphopathogenic categories like IBs related-to-MNV, IBs related-to-atrophy, IBs related-to macular chorio-retinal architecture, etc are analyzed in granular fashion by multi-modal imaging approach before and after different treatments for AMD.

The quantitative IBs assessment will be done in dual mode - classic and original to the IBPAMD trial. The lesions are quantitatively assessed on one hand, by using the classic measurements of the greatest diameter, total lesions area, vessels density, fractal dimension, etc, based on the classic concept of measurements expressed in absolute values (mm, mm2 or pixels). The same lesions are quantitatively assessed by using the original IBPAMD algorithm and software (SITE-app) that introduce a new concept in the quantification of the retinal lesions, the assessment of differences reported to the baseline.

Eligibility Criteria:
Inclusion Criteria:

* being male or female
* at least 18 years of age
* varied ethnic backgrounds (different ethnic groups have different structures of eye anatomy and we must be able to make ethnic subgroups to account for these differences)

Exclusion Criteria:

* vulnerable patients
* patients under 18
* pregnant (we exclude pregnant women because pregnancy often can alter eye anatomy)
* economically and educationally disadvantaged
* decision impaired
* homeless people.
China Ovarian Cancer BRCA Testing Study

This is a prospective, multi-center, observational study, the primary objective is to evaluate the prevalence of gBRCA/sBRCAm in newly diagnosed ovarian cancer patients and explore ovarian cancer treatment outcomes of different BRCAm status

This is a prospective, multi-center, observational study that will enroll consecutive patients with a confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or peritoneal cancer and who consent to a blood draw, a tissue sample analysis, and follow up for collection of data. 900 newly diagnosed ovarian cancer patients will be enrolled and evaluated for Breast Cancer Susceptibility genes BRCA1 and BRCA2 germline and somatic mutations (BRCAm). Approximately 170 BRCAm positive patients and 170 negative patients will be followed in the Follow-up Period. This study aims to answer very important questions regarding the prevalence of gBRCAm and sBRCAm in a population of newly diagnosed ovarian cancer patients, and the relationship of these mutations to patient treatment and clinical outcomes. These answers may be extremely helpful in the counseling and treatment of genetic risk in these populations and may aid in making treatment decisions in the future.

Eligibility Criteria:
Inclusion Criteria:

* Be able and willing to sign the informed consent form (ICF)
* Female aged 18 years or over
* Have histologically confirmed new diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made by one or more of the following:

  * standard staging laparotomy including bilateral salpingo-oophorectomy, omentectomy, and lymph node sampling and debulkingand/or
  * surgical resection and radiographic evidence consistent with Stage III or IV ovarian cancer
  * biopsy with radiographic evidence consistent with Stage III or IV ovarian cancer
* Have availability of paraffin-embedded archivedtumor tissue block (preferred) or,if a block is not possible, a minimum of twenty 5-μm unstained sections. (Tumor tissue should be archived at diagnosis. 10 slides is utilized for sBRCA testing after the enrolment. Another 10 slides is utilized for exploratory evaluation of HRR gene mutations in a retrospective way.)
* Have a diagnosis that is within 60 days of informed consent

Exclusion Criteria:

* Have a diagnosis of additional concurrent malignancies or previous diagnosis of another malignancy with current evidence of residual disease
* Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study
* Be currently participating in any other clinical trial for first-line treatment of ovarian cancer
* Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study
Effect of Short-term Oxygen During CPET in COPD

In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic obstructive pulmonary disease
* on optimized medical therapy and in stable condition for at least 4 week
* desaturate in the 6 minute walking test by at least 4% to values \<92%

Exclusion Criteria:

* unstable conditions
* pregnant women
* patients with relevant concomitant lung disease and severe daytime hypoxemia
The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.

Patients take tenofovir DF in combination with other antiretrovirals.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Have completed another study on tenofovir DF without toxicity.
* Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir.
* Are taking agents that affect kidney function, such as probenecid.
* Are receiving systemic chemotherapy.
* Are taking systemic corticosteroids.
* Are taking experimental drugs except those that are approved by Gilead.
* Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies.
* Are pregnant or breast-feeding.
Assessment of Decision Support System Software in Extraction and Anchorage Planning Among Adult Patients Using Computer Algorithm

It was introduced in dentistry to be used in innovative research and development in addition to facilitating the decision in complicated cases and ensure high patient care quality. In the field of Orthodontics in specific, many studies previously mentioned the idea of artificial intelligence showing very promising results and high degree of reliability. It was used in different domains in orthodontics like diagnosis, treatment planning, evaluation of treatment outcome

In this study, the aim is to access the efficiency of the new decision support system in determining whether the decision is extraction or non-extraction and the anchorage plan required for each case. This was performed in the past in many countries and those studies are published

Eligibility Criteria:
Inclusion Criteria:

1. Cases with well finished orthodontic treatment.
2. Cases with history of crowding more than 10 mm and requiring extraction.
3. Cases with no severe skeletal discrepancy.
4. Well documented cases with both pre-operative and post-operative records.
5. Patients with a full set of permanent teeth erupted

Exclusion Criteria:

1. Improperly finished orthodontic cases.
2. Cases with mild crowding managed by treatment options other than extraction.
3. Growing patients or showing any residual growth remaining in cephalometric analysis
4. Cases with severe skeletal discrepancy.
5. Poorly documented cases.
6. Patients not sticking to anchorage plan
Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation (ProCCESs AWARE)

In this multicenter project, we will introduce AWARE (electronic interface) Using a cloud-based technology . The goal of this project is to improve compliance with best practice through the use of a new acute care interface with built-in tools for error prevention, practice surveillance and reporting (ProCCESs AWARE - Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation).The goal of this project is to develop and test a novel acute care interface with built-in tools for error prevention, practice surveillance, decision support and reporting (ProCCESs AWARE - Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation). In preliminary studies, these novel informatics supports built on an advanced understanding of cognitive and organizational ergonomics, have significantly decreased the cognitive load of bedside providers and reduced medical errors. Using a cloud-based technology, AWARE will be uniformly available on either mobile or fixed computing devices and applied in a standardized manner in medical and surgical ICUs of five geographically diverse acute care hospitals predominantly serving Medicare and Medicaid patients. The impact of ProCCESs AWARE on processes of care and outcomes in study ICUs; expected to enroll more than 10,000 critically ill patients during the study period.


Eligibility Criteria:
Inclusion Criteria:

For the Primary Objective, all critically ill adult patient admitted to an ICU participating in the study will be eligible.

Exclusion Criteria:

For the Primary Objective, all children younger than 18years of age will be excluded.
Retinal and Choroidal Microvascular Parameters in School-age Children in a COVID-19 Infection Pandemic Peak in China

We designed this study to examine whether COVID-19 infection could lead to retinal and choroidal microvascular involvement in school-age children (6-18 years) in a pandemic peak in China.

This is an observational case-control study. One hundred school-age children who visited the Department of Ophthalmology at Guangzhou First People's Hospital in China from February 1, 2023 to March 31, 2023 were included in this study. Eighty children with COVID-19 infection were included in the case group. Controls without COVID-19 infection were matched to COVID-19 infection cases by a ratio of 1:4 using frequency matching on age and gender. The primary end point of this study is the retinal and choroidal microvascular changes in school-age children during the COVID-19 pandemic. Secondary endpoint is the

Eligibility Criteria:
Inclusion Criteria:

Totally 100 school-age children (6-18 years) were enrolled in this study. All subjects had visited the ophthalmology clinic for routine ocular examinations. Refraction after ciliary muscle paralysis, myopia ≥ -6.0 spherical diopter, astigmatism ≤ 2.5 cylindrical diopter.

Exclusion Criteria:

1. The child or guardian did not agree to participate in the study.
2. Children could cooperate to complete the ocular examination.
3. The child had previous diseases affecting visual function and fundus, except for the diagnosis of refractive error.
Heidelberg Engineering ANTERION Software Comparison Study

This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)


Eligibility Criteria:
Inclusion Criteria Normal Anterior Segment

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. Eye(s) with normal anterior segment

Exclusion Criteria Normal Anterior Segment

1. Active infection or inflammation in the study eye
2. Insufficient tear film or corneal reflex
3. Physical inability to be properly positioned at the study devices or eye exam equipment
4. Rigid contact lens wear 2 weeks prior to imaging
5. Soft lenses worn within one hour prior to imaging
6. Cataract grade ≥1.5

Inclusion Criteria Abnormal Anterior Segment

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5)

Exclusion Criteria Abnormal Anterior Segment

1. Active infection or inflammation in the study eye
2. Insufficient tear film or corneal reflex
3. Physical inability to be properly positioned at the study devices or eye exam equipment
4. Rigid contact lens wear 2 weeks prior to imaging
5. Soft lenses worn within one hour prior to imaging
Nursing Activity Score (Nursing Activities Score-NAS) Verification of Turkish Version

Various tools for measuring nursing workload have been described in the national and international literature. For this purpose, Cullen et al. The Therapeutic Intervention Scoring System (TISS)-28, created by Miranda et al. Nursing Activities Score (NAS) was created by revising by. NAS covers 80.8% of all nursing activities, surpassing the 43.3% coverage of TISS-28.

Critical Nursing Situation Index (CNSI) has been validated and adapted in our country and has been found to be a valid and reliable scale for the Turkish society. The aim of this study is to adapt the Nursing Activities Score (NAS) to Turkish and determine its correlation with CNSI scores.

Various tools for measuring nursing workload have been described in the national and international literature. The Therapeutic Intervention Scoring System (TISS)-28, which is designed to classify the nursing workload of patients in intensive care units according to the severity of their illness to be evaluated by a panel of experts, evaluates 43.3% of nursing activities. Miranda et al. In order to reduce possible erroneous evaluations, some changes were made to TISS-28 and the Nursing Activities Score (NAS) was created. NAS covers 80.8% of all nursing activities, surpassing the 43.3% coverage of TISS-28.

The Critical Nursing Situation Index (CNSI), which was finalized with 84 items developed by Binnekade et al., was validated and adapted in our country and was found to be a valid and reliable scale for the Turkish society.

In this study, which was carried out to adapt and validate the Nursing Activities Score (NAS) into Turkish, the internal consistency Cronbach's alpha coefficient was found to be p = 0.718 after a pilot study with a sample of 30 adult intensive care patients and 30 nurses. After the significant internal consistency obtained in the pilot study, it was aimed to examine the correlation of NAS internal consistency and CNSI scores in 150 work shift.

Eligibility Criteria:
Inclusion Criteria:

* Nurses who serve patients over the age of 18 who stay in Level 3 intensive care for at least 24 hours

Exclusion Criteria:

* Those nurses; Serving patients under the age of 18, Caring for patients who are scheduled to be discharged from intensive care within 24 hours, Those who change their workplace for any reason during the work shift Who did not agree to participate in the study