cyrilzakka/clinical-trials huggingface dataset:
Correlation Between OCT and mFERG Findings With VA After Vitrectomy Surgery for Retinal Detachment

Correlation between optical coherence tomography and multifocal electroretinogram findings with visual acuity after vitrectomy surgery for Retinal detachment.

Although the anatomical success rate of vitreoretinal surgery has improved over the last decade, visual results remain compromised? Patients with macula-off retinal detachments (RDs) can have poor visual recovery, specific color vision defects, or metamorphopsia postoperatively despite successful retinal reattachment. In these cases, subtle changes in the foveal structure may be causing visual disturbances that can be difficult to identify during standard clinical examinations such as slit lamp biomicroscopy or binocular indirect ophthalmoscopy .reported a possible association between incomplete visual recovery and the presence of residual subretinal fluid (SRF) postoperatively.

Optical coherence tomography (OCT) is a non-invasive technique that provides information about the morphology of the retina, and especially of the macular area in vivo. Some studies support the idea that OCT determines structural changes in the macula that are correlated with subjective visual function, including visual acuity (VA) in patients with vitrectomy for retinal detachment. Additionally, multifocal electroretinogram (m fERG) evaluation can be helpful in assessing macular function in post-vitrectomy. However, to date, there are relatively few reports concerning the combined use of OCT and m fERG for the correlation between retinal morphology and function of the macula in patients with vitrectomy for retinal detachment surgery. The purpose of our study is to determine whether a significant correlation exists between the amplitude of m fERG, visual acuity, and the morphological OCT changes by in the macula after vitrectomy for retinal detachment

Eligibility Criteria:
Inclusion Criteria:

* patients with successful vitrectomy for retinal detachment.

Exclusion Criteria:

* The patients who had vitrectomy for reasons other than retinal detachment surgery
* Patients who had done scleral buckle surgery
* Patients with media opacity are prevented from doing retina imaging.
* Failed or recurrent vitrectomy surgery
Increasing Colorectal Cancer Screening Among Filipino Americans

Develop and evaluate in a randomized trial an educational small group intervention to increase colorectal cancer screening among Filipino Americans.

The purpose of this research study is to increase colorectal cancer (CRC) screening among older Filipino Americans, specifically the use of fecal occult blood tests (FOBTs). We will design a culturally specific intervention, an educational small group discussion with a Filipino health professional. The effect of the intervention will be tested with 620 Filipino Americans. Subjects will be recruited at community-based organizations and churches and invited to join a 1 1/2 hour discussion of health issues with their partner and some of their friends. A third of the subjects will discuss exercise (control group), another third will discuss CRC and receive an FOBT kit, and the remaining third will discuss CRC and will not receive an FOBT kit. Three months after the group session, subjects in the CRC (intervention) groups will receive a letter reminding them to get screened. All subjects will be interviewed before and 6 months after the group sessions to assess CRC screening levels in the three groups. Self-reported CRC screening will be verified by a review of their medical records.

Eligibility Criteria:
Inclusion Criteria:

* Being: a Filipino American,
* Member of or affiliated with participating community agencies, between the ages of 50 and 70,
* Not up-to-date with colorectal cancer screening at baseline

Exclusion Criteria:

* Being younger than 50 or older than 70 years,
* Not being a member or not affiliated with participating community agencies,
* Not being Filipino American or up-to-date with colorectal cancer screening at baseline
Long-term Outcomes for Acute Myeloid Leukemia Patients

This international observational study aims at examining the patterns of health-related quality of life differences between long-term acute myeloid leukemia patients and their healthy peers from the general population.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of all subtypes of de novo AML, according to WHO criteria (at least 20% blasts in the bone marrow), except acute promyelocytic leukemia (APL).
* Age at AML diagnosis ≥ 18 years,
* Date of AML diagnosis at least 5 years before study enrollment,
* AML-free status at study enrollment,
* Written informed consent provided.

Exclusion Criteria:

* Major cognitive deficit or psychiatric problems hampering a self-reported evaluation,
* Not speaking and reading the language of the participating country,
* More than 75 years at the time of study enrollment,
* Receiving any active treatment for AML at the time of study enrollment.
Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients

The primary aim of this study is to compare the effectiveness of ORI and rcSO2 in predicting hypoxia early in obese patients who are sensitive to hypoxia. Our secondary aim is; To determine whether there is a correlation between the changing trend of ORI and rcSO2 in obese patients.

Standard noninvasive monitoring will be applied to the patients taken to the operating table, and heart rate, mean arterial pressure, peripheral oxygen saturation (SpO2), oxygen reserve index (ORI), regional cerebral oxygen saturation, etCO2 values will be recorded. Cerebral oximeter probe placed in the middle of the forehead (every second Cerebral oxygen saturation will be continuously monitored using a rcSO2 reading) (Massimo)Preoxygenation will be performed until the expiratory O2 concentration is 90% (during spontaneous ventilation, FIO2 will be kept between 100% 6 lt7min flow rate and EtCO2 30-35 mmHg). 2 mg midazolam, 2 ug General anesthesia with /kg fentanyl, 3 mg/kg propofol, 0.6 mg/kg rocuronium and 100% O2 will be applied and intubated with a videolaryngoscope. The breathing circuit will be disconnected from the endotracheal tube until the SpO2 drops to 94%. At that time, the breathing circuit will be connected and the patients will be ventilated with 100% FiO2, 8 ml kg-1 ideal body weight, targeted tidal volume, and 5 cm H2O positive end-expiratory pressure until the ORI plateaus. Throughout this process, ORI and cerebral oxygen saturation will be recorded continuously. ORI and rcO2 data will be compared at seven specific time points ( (1) during the basal period; (2) at the end of preoxygenation when ORI reaches a plateau; (3) at the beginning of intubation; (4) when SpO2 reaches 97%; (5) when SpO2 reaches 94% (6) ORI reaches a plateau again (during ventilation with 100% FiO2), and (7) SpO2 reaches baseline

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients
* The ages of 18-75
* Obese BMI (40\>BMI\>30 kgm\^2)
* Undergoing intubated elective surgery

Exclusion Criteria:

* Patients with significant cardiopulmonary comorbidities
* BMI\>40 kgm\^2 and BMI\<30 kg m\^2
* ASA\>3
* Patients under 18 years and over 75 years of age
Participatory Organizational Intervention for Improved Use of Assistive Devices for Patient Handling

Epidemiological studies have shown that patient transfer is a risk factor for back pain, back injuries and long term sickness absence, whereas consistent use of assistive devices during patient transfer is associated with reduced risk of back injury. In consequence, Danish hospitals have made great efforts to increase knowledge, availability and use of assistive devices to reduce work-related physical strain due to patient transfer. Yet, a recent survey among more than 300 nurses and nurses' aides showed that two thirds rarely uses assistive devices during patient transfer. Thus it seems relevant to investigate barriers, opportunities and practical solutions for increasing use of assistive devices among healthcare workers. The purpose of this study is to evaluate a participatory organizational intervention for improved use of assistive devices during patient transfer.


Eligibility Criteria:
At the department level:

Hospital departments with frequent patient handling will be eligible for participation in the cluster-randomized study.

At the individual level (questionnaire replies):

Inclusion Criteria:

* Healthcare workers with daily patient handling (based on questionnaire reply at baseline)

Exclusion Criteria:

* None
A Study of Multiple Doses of LY2922470 in Participants With Diabetes

The main purpose of this study is to determine the safety of LY2922470, taken as oral capsules, once or twice daily for approximately 28 days, in participants with diabetes. It also aims to determine how long the drug stays in the body and how it affects blood sugar levels. A screening appointment is required within 28 days before the start of the study and a follow up appointment is required approximately 14 days after the last study dose is taken.


Eligibility Criteria:
Inclusion Criteria:

* Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
* Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
* Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
* Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m\^2)
* Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study

Exclusion Criteria:

* Are currently participating in another clinical study or completed one in the last 30 days
* Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
* Have electrocardiogram (ECG) readings that are not suitable for the study
* Are infected with hepatitis B or hepatitis C
* Are infected with human immunodeficiency virus (HIV)
* Have donated blood equal to or more than 500 mL within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening
Identification of Patients at Risk of CKD After AKI

The investigators will investigate whether new kidney biomarkers can identify patients who are at risk of chronic kidney disease after an episode of moderate / severe acute kidney injury in ICU.

Acute kidney injury (AKI) is a common complication during critical illness and associated with serious short and long-term complications. Participants with AKI have an increased risk of developing dysfunction of other organs, including multi-organ failure, a longer stay in hospital and a higher risk of dying. Survivors remain at risk of complications, even if kidney function initially recovers. In particular, they are at high risk of developing chronic kidney disease, dialysis-dependent end-stage kidney disease and cardiovascular comorbidities. At present, the tools to identify patients at highest risk of chronic kidney disease (CKD) are very limited.

The investigators will recruit participants who had AKI whilst in ICU and are scheduled to be discharged from hospital. Within 3 days of discharge from hospital, blood and urine kidney biomarkers will be measured to explore whether there is a correlation with renal function 3 months later and to identify those at highest risk of CKD. In addition, quality of life at 3 months will be assessed.

Eligibility Criteria:
Inclusion Criteria:

critically ill adult patients who had AKI stage II or III whilst in ICU and are scheduled to be discharged from hospital

Exclusion Criteria:

1. known pre-existing end-stage kidney disease or advanced CKD (stage 3b or worse)
2. kidney transplant within the last 12 months
3. known primary renal disease
4. discharge from hospital for end-of-life care
5. transfer to another health care institution for ongoing in-patient care
6. not expected to survive for 3 months
7. pregnancy
8. lack of capacity to give consent
9. receiving regular dialysis at hospital discharge
10. CKD stage 3 or worse at hospital discharge
Effect of Family-Centered Empowerment Model

The objective of this study was to evaluate the effectiveness of a FCEM-focused hybrid CR program for survivors of myocardial infarction (MI). The study sought to compare the long-term impact of FCEM-based intervention with a standard CR program in terms of mortality rates and different aspects of health related quality of life (HRQoL), which includes soft outcomes such as levels of stress, anxiety, psychological distress, quality of life (QoL), and hard outcomes such as the percentage of ejection fraction (EF), independent functioning, and functional exercise capacity status.

The investigators conducted a triple-blind randomized controlled clinical trial study in patients admitted for MI to the CCU of an academic teaching hospital from June 2012 to January 2023. The study was approved by the institutional investigative review board at Tarbiat Modares University and Baqiyatallah University of Medical Sciences. Patients were block randomized to receive either standard home cardiac rehabilitation (CR) or CR using the Family-centered Empowerment Model (FCEM) strategy. Patients had not previously gone through CR programs. The difference between the two groups was not disclosed at any point. Patients consented knowing that they would receive cardiac rehabilitation, but without knowing the details. Patients and their designated family/friend were enrolled as a 'unit'. Patient empowerment was measured with FCEM questionnaires pre-intervention and post-intervention for a total of 9 assessments. Quality-of-life, perceived stress, state and trait anxiety, psychological distress, independent functioning, and functional exercise capacity status were assessed using the 36-Item Short Form Health Survey (SF-36), the 14-item Perceived Stress, the 20-item State and 20-item Trait Anxiety questionnaires, Kessler Psychological Distress Scale,Barthel Index (BI) activities of daily living index, six-minute walk test (6MWT), and free walking index (FWI), respectively. In addition, echocardiography was used to measure ejection fraction.

Eligibility Criteria:
Inclusion Criteria:

* Being within the age-range of 45 to 85 years old
* having the minimum literacy for reading and writing
* being hospitalized due to MI for the first time
* verification of MI by clinical symptoms
* enzyme-serum tests and cardiograph changes
* lack of participation in the any related educational course simultaneously with the execution of intervention
* patients' willingness toward participating in the research
* having no psychological problems
* ability to fill out the questionnaire and participating in the empowerment program.

Exclusion Criteria:

* any offending items from mentioned criteria.
d-Limonene +Radiation +Platinum Based Chemo for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma

This study explores the safety of d-limonene, a commercially-available dietary supplement (food) as a potential therapeutic for the severe dry mouth (xerostomia) experienced by patients with head and neck cancer as a side effect of their anti-cancer treatment.

Primary Objective:To determine the maximum tolerated dose (MTD) of d limonene when combined with radiation and platinum based chemotherapy in subjects with loco regionally advanced head and neck squamous cell carcinoma (HNSCC) based upon dose limiting toxicity (DLT)

Secondary Objective:

* To evaluate the feasibility and subject compliance with adjuvant administration of d limonene daily up to a maximum of 4 months after completion of chemoradiation
* To correlate the level of d-limonene measured in the plasma to the dose levels(s) administered to the subject
* To correlate the level of d limonene measured in the plasma to saliva flow rate and xerostomia questionnaire scores in subjects enrolled in this trial

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced loco regional squamous cell carcinoma of the nasopharynx (AJCC v8 Stage II IV); oropharynx (AJCC v8 Stage I III for HPV+ cancer, excluding T1 2N0; AJCC v8 Stage III IV for Human papillomavirus (HPV) negative cancer); larynx (AJCC v8 Stage III to IV); or hypopharynx (AJCC v8 Stage III to IV), scheduled to undergo chemoradiation. Patients with squamous cell carcinoma of the head and neck from an unknown primary site with involved nodes (N1 to 3) also qualify.
* Scheduled to received definitive RT with concurrent platinum based chemotherapy at Stanford
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
* Must be able to swallow d limonene gelcaps at the time of enrollment.
* Adequate hepatic function within 2 weeks prior to registration defined as follows: Bilirubin ≤ 2 mg/dL; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 times the upper limit of normal
* Adequate hematologic function within 2 weeks prior to registration defined as follows:

  * Absolute neutrophil count (ANC): ≥ 1,500/mm3
  * Platelets: ≥ 100,000/mm3
  * Hemoglobin: ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable).
* Adequate renal function defined as follows:

Serum creatinine ≤ 1.5 mg/dL within 2 weeks prior to registration or creatinine clearance (CC) ≥ 50 mL/min within 2 weeks prior to registration determined by 24 hour collection or estimated by Cockcroft Gault formula:

CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dL) x (72)\] CCr female = 0.85 x (CrCl male)

* Negative serum pregnancy test within 2 weeks prior to registration and agreement to use a birth control method during the entire duration of d limonene treatment for women of childbearing potential
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* History of allergic reactions attributed to citrus fruits
* Pregnant or lactating
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer

This trial is assessing how Bladder filling variations and thus mesorectal movements are less when radiotherapy treatment is received with an empty bladder in rectal cancer

The purpose of this study is to show that the variations of bladder volume and mesorectal movements are less with empty versus filled bladder in rectal cancer.

In this study, patient will be treated with 3D conformal radiotherapy (3D-CRT) radiotherapy with a filled bladder condition, as per standard care, in supine position. A total dose of 45 or 50 Gy in 25 fractions, 5 fractions per week is received.

A Chest, abdomen and pelvis imaging will be performed before treatment start. Patients receive planning CT scan with filled bladder and then with empty bladder on the same day. Only planning CT scan with filled bladder will be used patient treatment.

During radiotherapy treatment, patient will receive CBCTs with filled ans empty bladder on Day 1 ; 2 and 3 on the first week and once a week after.

Multiple parameters will be assessed before treatment (using planning CT scan) and during radiotherapy treatment (CBCTs) in empty ans filled bladder conditions : Bladder volume, mesorectal movements.

A dosimetric study will be performed in Intensity-modulated radiotherapy (IMRT) in empty and filled bladder conditions

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed rectal adenocarcinoma
* T2 N+ or T3 any N, eligible for radiotherapy or neo-adjuvant radio-chemotherapy treatment in a long course of 25 fractions
* Performance Status less or equal to 2
* Male or female 18 Years and older
* Creatinine clearance greater than or equal to 50ml/min
* Fertile patients must use effective contraception
* Written informed consent
* Patient must be affiliated to a Social Health Insurance

Exclusion Criteria:

* Previous treatment with pelvic radiotherapy
* Chronic inflammatory bowel disease in flare-up.
* Urinary catheterization, urinary diversion or cystectomy
* Hip prosthesis
* History of prostatectomy, or hysterectomy
* Urinary incontinence \> 2
* Pregnant or nursing patient
* Persons deprived of their liberty, as well as adults subject to a legal protection measure
* Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons
Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

Pregnant women who receive study counseling which includes gestational age specific written information in addition to the verbal counseling will have better knowledge of problems and outcomes of prematurity than women who receive standard counseling which consists of only verbal counseling.


Eligibility Criteria:
Inclusion Criteria:

* English speaking pregnant women who are between 23-34 weeks of gestation
* Who are 18 years and older
* Open to all ethnic groups.
* Admitted in preterm labor to Froedtert and Waukesha Hospitals labor and delivery unit.

Exclusion Criteria:

* Pregnant women who are known to have infants with congenital anomalies or other associated conditions apart from prematurity that could be a significant factor to the outcome of the baby.
* Pregnant women who have been included in this study and discharged at some point and again admitted for preterm labor will be excluded from the study.
* If a participant delivers before completing the Parent Knowledge Questionnaire, she will be excluded.
A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports

This study is a retrospective, observational, monocenter case series. The purpose of this study is to collect clinical data to describe the use of POLYSITE® and SEESITE® devices and verify overall safety and performance. This study is part of the Post-Market Clinical Follow-up (PMCF) activities of the PEROUSE MEDICAL manufacturer.

The primary data source for this study was patient's medical records from a French Hospital. The study population was defined as all patients who did receive POLYSITE® and SEESITE®. Data from a minimum of 50 patients were planned for the statistical review.


Eligibility Criteria:
Inclusion Criteria:

* Adult and pediatric population
* Patient who received the implantation of any POLYSITE® or SEESITE® implantable port referenced in the Annex 1 of the current protocol between 1st October 2016 and 31st December 2017

Exclusion Criteria:

* Patient who refused the data collection according to RGPD regulation applicable in France
* Patient who received the implantation of another device than those presented in Annex 1 of the current protocol.
* Patient who received the implantation of a POLYSITE® or SEESITE® implantable port after 31st December 2017