cyrilzakka/clinical-trials huggingface dataset:
Parents of Young Adults With Type 1 Diabetes: An Exploratory Study

The purpose of this mixed-methods study is to explore the lived experience of parents of young adults ages 18 to 25 years with type 1 diabetes who are transitioning to independence, and to test the preliminary efficacy of a mobile education program to reduce parental distress.

As young adults with T1D navigate the transition process to independence, they often do so in partnership with their parents, who are tasked with providing support and guidance. At this time, however, no structured education program exists for these parents. In addition, little is known about their learning needs, levels of distress, and readiness to provide appropriate guidance for their emerging adult children. This represents a gap in the literature and an opportunity to undertake exploratory research to learn more about this population so that meaningful education and support can be provided.

Aim 1. To describe the lived experience and diabetes-specific educational needs of parents of young adults with type 1 diabetes who are transitioning to independence.

Aim 2. To measure the effect of a mobile diabetes education program on diabetes distress levels of parents of young adults ages 18 to 25 years who are transitioning to independence.

Eligibility Criteria:
Inclusion Criteria:

* (1) Ability to read and speak English
* (2) parent of a child aged ≥18 years and ≤25 years with a diagnosis with T1D
* (3) must have access to a smartphone or tablet or laptop/desktop computer with internet access.

Exclusion Criteria:

* (1) Significant medical comorbidity in the participant that could, in the opinion of the PI, affect participant's capacity to complete study follow up;
* (2) inability to read and speak English.
3T MRI CIED Post-Approval Study

The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).


Eligibility Criteria:
Inclusion Criteria:

* Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Subject is intended to be implanted or is within 30 days post-implant of a qualifying Medtronic 3T MR Conditional CIED system

Exclusion Criteria:

* Subject who is, or will be inaccessible for follow-up at a study site
* Subject with exclusion criteria required by local law (Europe, Central Asia \[ECA\] only)
* Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable
Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin

Follitropin delta is a rFSH, uniquely expressed in a human fetal retinal cell line, which owing to differences in glycosylation profile has a lower clearance and induces a higher ovarian response in humans than existing rFSH preparations when administered at equal doses of biological activity. A noninferiority clinical trial (ESTHER-1) in which individualized dosage of follitropin delta according to each patient's profile (AMH and weight) was compared to conventional follitropin alfa dosing for IVF have demonstrated that an individualized follitropin delta dosing is noninferior to conventional follitropin alfa with respect to ongoing pregnancy rate, ongoing implantation rate, and also live births, with a concomitant reduction in iatrogenic complications, including OHSS


Eligibility Criteria:
Inclusion Criteria:

* Women 18 to 42 years of age undergoing IVF/ICSI cycle
* IVF antagonist protocol
* Regular menstrual cycles of 24-35 days
* Presence of both ovaries

Exclusion Criteria:

* Endometriosis stage III/IV
* History of recurrent miscarriages, defined as ≥ 3 consecutive losses
* Women undergoing ovarian stimulation for oncologic or elective fertility preservation
* Women participating in any other research project
* Hypersensitivity to follitropin delta and/or human chorionic gonadotropin
* Use of Growth Hormone (GH) during the stimulation cycle
Bridge the Gap (BTG) - Black Youth Group

The goal of this clinical trial is to develop and preliminarily test a culturally adapted suicide intervention specifically for black youth. The main question it aims to answer:

-To evaluate the feasibility and acceptability of the group, as well as the preliminary efficacy of the group for decreasing suicidal thoughts and behaviors and increasing protective factors such as hope, positive ethnic identity, and family and peer support.

Participants will be asked to attend 10-week group intervention and complete pre-treatment and post-treatment assessment measures.


Eligibility Criteria:
Inclusion Criteria:

* 12-17 years old
* Identify as Black or African American or being of African descent
* Have current suicidal ideation or suicidal ideation within the last 30 days
* Have assent from the adolescent participant and consent from an individual's caregiver or guardian to participate.

Exclusion Criteria:

* An active psychotic disorder or current psychosis symptoms
* No history of suicide attempt(s) or suicide ideation in the past 30 days
* Cognitive deficits or a medical condition diagnosed from a medical provider that precludes full understanding of study materials as assessed through an inability to complete the pre-treatment CAMS SSF \& SSP
* Caregivers, guardians, and/or the patient refuse to participate.
The Influence of Needle-insertion Depth on Successful Epidurogram and Clinical Outcome in Caudal Epidural Injections

Caudal epidural injections have been commonly performed in patients with low back pain and radiculopathy. Conventional caudal epidural injections, which the needle is advanced into the sacral canal, present a potential risk of penetration of the epidural venous plexus or dura. The investigators hypothesized that a new caudal injection technique, which the needle only penetrates the sacrococcygeal ligament without being inserted into the sacral canal, might represent a safe alternative, with a lower incidence of intravascular injections and patient's discomfort during the procedure than the conventional technique. The study is designed to investigate the influence of the depth of the inserted needle on successful epidurogram and clinical outcome in caudal epidural injections under the ultrasound and digital subtraction angiography.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (20-80 years of age) who were scheduled to receive caudal epidural injection for lumbosacral radicular pain at our pain management clinic

Exclusion Criteria:

* pregnancy
* coagulopathy
* systemic infection
* any active infection at the injection site
* history of allergy to contrast media, local anesthetics, corticosteroid
* patients unable to communicate or patients with cognitive dysfunction
DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

A hybrid prospective/retrospective, multicenter, single-arm, data collection study.

Collect long-term follow-up data with x-rays and CT on subjects who received the DIAM™ Spinal Stabilization System through the original IDE protocol.

Data collected at one-time point from subjects with at least 5 years of follow-up data.

Eligibility Criteria:
Inclusion Criteria:

* Subject randomized to the DIAM arm and treated with the DIAM™Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study.
* Willing and able to consent to study procedures

Exclusion Criteria:

* NA
Regional Kale as Source of Lutein and Zeaxanthin to Improve Vision of AMD-patients

The age-related macular degeneration (AMD) is an age-dependent, multi-factorial disease. In Western industrial countries, it is the main cause of visual impairments. In Germany, approximately 4.5 million people suffer from AMD. Genetic as well as nutritional aspects are mainly important in AMD development. Until now, AMD-patients are advised to use supplements based on the carotenoids lutein and zeaxanthin, comprised in high doses and in isolated form. Results showing the effects of food items (kale, spinach) rich in lutein on improvement of vision are scarce. And how much is needed within the diet? Within the planned project, human intervention studies will investigate whether an oil-based kale extract or fresh kale can be used to improve vision of AMD-patients and persons aged 50+ (without AMD). The first study will use volunteers without AMD (\>18 y) to investigate if there is a dose-dependent effect of lutein and zeaxanthin (out of a kale extract) on macular pigment optical density (MPOD). This study will also compare the bioavailability of the carotenoids from the extract and from a supplement. A second study (also using volunteers without AMD, \>18 y) will compare the bioavailability of lutein and zeaxanthin from the extract and from kale purée. The third study will investigate the effect of the oil-based kale extract on improvements of MPOD and vision of AMD-patients and of a control group (volunteers 50+ without AMD).

Usually, the intestinal absorption of lutein and zeaxanthin is determined by analyzing changes in concentrations in blood plasma. A fast, non-invasive sampling will be evaluated to check the efficacy of an increased uptake of lutein. Thus, the project will test the usability of buccal mucosa cells to detect metabolic changes after an uptake of carotenoids. Besides, the determination of carotenoid contents in skin will be checked on its use as biomarker of carotenoids in plasma and macula.

Thus, the planned research project will evaluate two non-invasive markers of exposition on their usability as markers of absorption of lutein and zeaxanthin in blood and macula. In addition, the minimally needed dosage of lutein and zeaxanthin for AMD prevention will be determined to reduce the possible risk of currently recommended doses of these compounds. The project will also present alternatives (kale extract, kale purée) for AMD prevention and to improve vision to be used instead of currently used high-dose supplements.


Eligibility Criteria:
Inclusion Criteria:

* healthy, \> 18 years, written consent

Exclusion Criteria:

* uptake of dietary supplements, glaucoma
Assessing the Impact of Self-directed Care, Within a Medicaid-funded Environment,on Participation and Community Living

This project proposed to demonstrate the effectiveness, costs, and benefits to participation and community living self-directed care programming within a financially sustainable Medicaid managed care environment. The study examined outcomes associated with the implementation of a novel self-directed care (SDC) approach being implemented in Delaware County, Pennsylvania in which consumers were able to access a set amount of renewable funds per year and direct how they were spent, both to purchase the types and amounts of rehabilitation and treatment services they desire (and from whom they choose) and to purchase a broad-range of individualized resources and services that are generally outside of Medicaid funding (e.g., health club memberships, yoga classes, support in taking care of bills).


Eligibility Criteria:
Inclusion Criteria:

1. Adults between 18-65 who are currently receiving Medicaid-reimbursed services in Delaware County, Pennsylvania for either a schizophrenia-spectrum, major depression, or bipolar disorder;
2. Individuals with a cost profile within the 60-90% band of all Magellan-administered Medicaid recipients in the county (estimated service costs between $10,048 and $22,324); 3) No more than two inpatient hospitalizations of 10 days per stay, over a 2 year period prior to the study;

4) No hospitalization within 6 months of the study; 5) Ability to understand self-directed care requirement and express interest in working with a "recovery coach."

Exclusion Criteria:

1. do not speak English;
2. have a legal guardian;
3. are unable to give informed consent
The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient

High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle , and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy .

High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. Medial opening wedge high tibial osteotomy is a well established surgery for patients with medial compartment knee osteoarthritis its most notable advantages include the precision of intraoperative angular correction, absence of the risk of peroneal nerve palsy in fibular osteotomy, absence of leg shortening, and preservation of bone stock.

The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle , and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy .

Satisfactory outcomes after surgery require optimal realignment both in the sagittal and coronal planes; in fact, poor realignment could lead to unsatisfactory clinical outcomes. An unintentional increase in posterior tibial slope angle after medial opening wedge high tibial osteotomy may influence knee kinematics and stability in the sagittal plane, which could lead to anterior translation of the tibial plateau, anterior shift of the tibiofemoral contact area, and subsequent redistribution of pressure into the posterior tibial plateau (particularly in knees with injured anterior cruciate ligaments). These conditions could result in articular cartilage degradation and further knee disability

Eligibility Criteria:
Inclusion criteria

* Age: 20 : 65 years
* Genuvarus deformity
* 70° of range of motion
* Medial uni-compartmental osteoarthritis.

Exclusion criteria

* Posterior instability (relating to the posterior cruciate ligament)
* Body Mass Index under 30
* Sever Genuvarus \> 20 degree
Investigation of the Effect of Information on the Empowerment of Cancer Patients Using Question Prompt List: a Mixed Method Study

Brief Summary The goal of this study is to understand how patient empowerment and a Question Prompt List (QPL) can help cancer patients.

The main questions this study aims to answer are:

What are the views of nurses, physicians, and cancer patients on patient empowerment? Does using a Question Prompt List (QPL) improve patient empowerment and reduce anxiety? Researchers will collect qualitative and quantitative data by measuring patient empowerment and anxiety levels.

Who can participate? Cancer patients receiving treatment at Private Anadolu Medical Center Hospital Nurses and physicians working with cancer patients What will participants do? Answer survey questions about their experiences with empowerment, anxiety, and communication Participate in interviews to share their thoughts on patient empowerment Use a Question Prompt List (QPL) during medical consultations Why is this study important? Many cancer patients struggle with anxiety and lack of information about their care.

A Question Prompt List (QPL) may help patients ask better questions, feel more in control of their treatment, and reduce anxiety.

This study will contribute to oncology research and help develop a culture-specific QPL for use in cancer care.

This study will take place at Private Anadolu Medical Center Hospital from January 2023 to November 2024.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be over 18 years old.
* Must understand and speak Turkish.
* Must not have any condition preventing participation (e.g., advanced dementia, cognitive impairment, speech or hearing disorders).
* For healthcare professionals in the qualitative phase: Must have at least one year of experience in oncology.

Exclusion Criteria:

* Patients without regular outpatient follow-up visits.
* Patients with severe cognitive or physiological deterioration affecting participation.
* Patients who do not comply with the study process and requirements.
* Patients who voluntarily request to withdraw from the study.
Parasternal Block for Cardiac Surgery

This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Half of participants will receive General Anesthesia combined to parasternal block while the other half receive only General Anesthesia.

60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups:

1. Interventional (parasternal group)
2. Case control group The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.

The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective cardiac surgery
* Age over 18 years
* ASA I-IV
* Approval by the patient of informed consent

Exclusion Criteria:

* Allergy to local anesthetics
* Puncture site infection
* Lack of signing of informed consent
* Weight \<30 Kg
* Age \<18 years
* Emergency interventions
* ASA \> IV
* Sternal dehiscences
* Dementia (for difficulties in managing weaning from mechanical ventilation and pain)
Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

This is a Phase 2 study being conducted at multiple centers in the United States and France. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic melanoma as shown by the number of patients in the study who experience significant and durable tumor shrinkage.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented melanoma with metastases
* No more than 1 prior systemic therapy for metastatic disease (prior adjuvant therapy with interferon does not count as prior therapy for metastatic disease)

Exclusion Criteria:

* History of hemoptysis (coughing up of blood)
* Brain metastases
Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants with Increased Cardiometabolic Risk

The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated.

In a randomized crossover design, 30 older men and women with increased risk for cardiometabolic diseases consume 4 mixed meals, which differ in dietary pattern, protein source and protein quantity. Two meals are designed according to the Planetary Health Diet with legumes as primary protein source whereas the other two meals are designed according to the Western Diet with animal food as primary protein source. Two meals are designed as high protein meals (62 g of protein) and two meals are designed as low protein meals (36 g of Protein). Therefore, participants consume 4 different test meals, a Low and a High Protein Western Diet Meal and a Low and a High Protein Planetary Health Diet Meal in a randomized order. During a postprandial observation period of 6 hours, parameters of lipid metabolism (e.g., plasma triglycerides), glucose metabolism (e.g., plasma glucose, serum insulin), as well as markers of inflammation (e.g., IL-6) and vascular function (e.g., pulse wave velocity) are analysed. Furthermore, amino acid profile, neuropsychologic parameters (e.g., appetite) and satiety-associated hormones (e.g., Ghrelin) are investigated. Each intervention will be separated by a washout period of approximately 14 days.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* Non-smoking
* BMI: 27 - 34,9 kg/m2
* Waist circumference (women ≥ 80 cm, men ≥ 94 cm)
* Systolic blood pressure: ≥ 120 mmHg, diastolic blood pressure: ≥ 80 mmHg
* At least one of the following criteria
* Fasting triglycerides in serum: ≥ 150 mg/dL
* Fasting HDL-Cholesterol in serum: women \< 50 mg/dl, men \< 40 mg/dL
* Fasting C-reactive protein in serum: ≥ 2 mg/L
* Fasting glucose in plasma: ≥ 100 mg/dL

Exclusion Criteria:

* food intolerances and allergies (especially to legumes)
* Smoking
* malabsorption syndromes
* thyroid diseases
* impaired renal function
* chronic liver disease
* heart failure
* myocardial infarction
* insulin-dependent diabetes mellitus
* chronic inflammatory diseases
* tumors
* anemia
* immunosuppression
* intake of supplements (e.g., fish oil)
* Participation in another study
* other exclusion criteria at the discretion of the physician/ investigator