cyrilzakka/clinical-trials huggingface dataset:
PREVENPANC Project: a Spanish Multicenter Study for Pancreatic Cancer Prevention

Background: Pancreatic cancer (PC) is an aggressive cancer with only a 7% 5-year survival rate, primarily due to late-stage diagnosis. In Spain, its incidence is rising, and by 2030, it is expected to become the second leading cause of cancer-related death worldwide. Approximately 3% of PCs occur in the context of hereditary pancreatic cancer (HPC) predisposition syndromes. Studies have shown that up to 40% of genetic mutations associated with PC in individuals under 60 years old would not have been identified using traditional clinical criteria for genetic testing. Presymptomatic genetic testing is recommended for relatives of patients with hereditary syndromes to identify those at higher risk of PC and to include them in screening programs to alter the natural history of the disease. However, there is no robust evidence supporting the best tool for early diagnosis in at-risk individuals. Currently, screening relies on endoscopic ultrasound or magnetic resonance imaging, which yield suboptimal results.

Aims: By studying the clinical, molecular, and genetic characteristics of PC patients and their families, this project aims to identify factors conferring higher PC risk and to adopt preventive measures while evaluating the efficacy of current screening strategies. Additionally, the project includes a traslational subproject to identify new hereditary genes associated with increased PC risk and novel molecules (biomarkers, specifically miRNAs) with diagnostic potential. These biomarkers could serve as non-invasive tools to identify individuals at increased risk of PC through blood tests, enabling preventive measures or early diagnosis.

Given the low incidence of PC (albeit with high mortality), collaborative studies are essential to achieve meaningful results. The current project represents the first Spanish multicenter population-based registry for PC, integrating clinical data and biological sample collection alongside a control group. Its goal is to prevent PC and foster collaboration between basic research and clinical application in Spain within a proven collaborative framework.

Establishing the best strategy to detect high-risk individuals for PC within the general population.

Identifying new PC risk genes to expand the identification of at-risk individuals.

Determining effective prevention strategies for high-risk individuals. Creating a national network, "PREVENPANC," for collaborative PC research, including the collection of biological samples (blood) from all enrolled patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a recent diagnosis of pancreatic cancer in the general population.
* High-risk individuals under follow-up in high-risk clinics (hereditary syndromes, familial pancreatic cancer).

Exclusion Criteria:

* Patients under 18 years old.
* Patients who have undergone treatment for pancreatic cancer.
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting post-operative healing and re-mucosalization of the nasoseptal flap harvest site during endoscopic skull base surgery and the impact on patient and sinonasal morbidity.

Briefly, multiple agents exist and have been long-studied in endoscopic sinus and septal surgery, which include non-absorbable agents and biodegradable, absorbable synthetic agents including extracellular matrix (ECM) based compounds and synthetic biopolymers. The goal of these agents has often been to reduce sinonasal crusting, postoperative bleeding, and synechia formation. With advancements in postoperative adjuncts, many options now exist for postoperative sinonasal packing including medicated products such as steroid-impregnated stents and chitosan-based absorbable packs.

Lastly, with respect to intra-operative adjuncts designed to foster healing in the postoperative period, PuraGel, a RADA16 polypeptide hydrogel, was identified as an ECM-based solution, which aids in wound healing, adhesion prevention, and hemostasis at the completion of the case. In hydrogel format, this agent forms a synthetic matrix that serves as a scaffold for mucosal healing while serving as a mechanical barrier on tissue surfaces, thereby limiting scarring. To date, there have been no studies evaluating the role of this gel-based compound in the postoperative period in endoscopic skull base surgery.

Thus, amongst all of these agents that have been previously studied to some degree in patients undergoing endoscopic sinus surgery, there has been limited study on their role in endoscopic skull base surgery and utility in reducing sinonasal morbidity in the postoperative setting. Therefore, our goal was to investigate and compare the impact of varying sinonasal agents in the nasal cavity following endoscopic skull base surgery. We hypothesize that the absorbable, ECM-based gel compound (PuraGel) demonstrates an improvement on postoperative healing rate and sinonasal crusting with reduced patient morbidity and improved patient comfort when compared to non-absorbable agents.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient is undergoing endoscopic endonasal approach for the management of a skull base tumor or cerebrospinal fluid leak. Nasoseptal Flap must be harvested.
* Patient is undergoing surgery via bi-nostril approach requiring bilateral surgical dissection of the nasal cavity in approach to the skull base

Exclusion Criteria:

* Patient has evidence of radiographic baseline sinus disease consistent with acute or chronic rhinosinusitis (including nasal polyposis, prior septal perforation) on pre-operative CT sinus
* Patient has had prior sinonasal surgery or has undergone sinonasal radiation treatment
* Patient has a known coagulation disorder or immune deficiency.
TSA Exercise Prehabilitation in Older Adults

This is a randomized study to examine whether aerobic exercise training (AET) before total shoulder replacement (TSR) surgery reduces the incidence of post-operative delirium (POD) and shorten time to recovery in elderly patients. POD is a form of sudden change in mental function that can be experienced after undergoing surgery.

This randomized clinical trial will determine whether aerobic exercise training (AET) before total shoulder replacement (TSR) surgery reduces the incidence of post-operative delirium (POD) and shortens time to recovery in elderly patients. Delayed recovery affects up to 30% of surgical patients and imposes enormous costs on patients, caregivers, and society. Patients over 65 are four times more likely to experience POD, a form of sudden change in mental function that could be experienced after undergoing surgery. POD is associated with impaired daily functioning, longer hospital stay, more frequent institutionalization, and increased mortality.

Prevention of POD is a high clinical priority. Evidence suggests that an exaggerated inflammatory response contributes to POD. Human studies show that AET may exert anti-inflammatory effects. Furthermore, recent animal data show that AET attenuates the inflammatory response to surgery and prevents associated cognitive dysfunction.

The trial will enroll elderly patients undergoing TSR surgery to examine whether a low-cost intervention before surgery can improve clinical outcomes (reduction in POD and decrease recovery time). The effects of a 4-week AET program, specifically a type known as high-intensity interval training (HIIT), on the incidence of POD and time to recovery from fatigue and functional impairment. We will also analyze patients' immune state before and after surgery with modern techniques (high-dimensional mass cytometry). Understanding the immune-modulatory effects of AET will reveal mechanisms that can be targeted by interventions other than or in addition to exercise, which may benefit patients who are physically disabled or require urgent surgery, and help identify non-surgical diseases that may benefit from exercise.

Eligibility Criteria:
Patients scheduled for total shoulder replacement
The Turkish Version of the Parental Smartphone Use Management Scale (PSUMS)

Parental Smartphone Use Management Scale (PSUMS) was originally developed in English language to parents to educate adolescents and communicate with them about online behavior and safety, as well as to conduct plans to manage adolescents' internet and smartphone use. The purpose of this study was to translate and cross-culturally adapt the PSUMS.

Parental Smartphone Use Management Scale (PSUMS) was originally developed in English language to parents to educate adolescents and communicate with them about online behavior and safety, as well as to conduct plans to manage adolescents' internet and smartphone use. The purpose of this study was to translate and cross-culturally adapt the PSUMS. The study will include adults who have been using smartphones for at least the past month and have children aged 11-18. For cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. Within a 5-to-7 day period after first assessment, the participants completed the Turkish version of the Parental Smartphone Use Management Scale (PSUMS) to evaluate test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The correlations with the Turkish version of The Smart Phone Addiction Scale-Short Form for Adolescent and the Turkish version of PedsQL in Adolescents 13-18 years old will determine to check the validity.

Eligibility Criteria:
Inclusion Criteria:

* Working at Istanbul University-Cerrahpaşa Faculty of Health Sciences
* Having children using smart phones for at least the last one month
* Having children between aged 11 and 18 years.
* Being a volunteer to participate

Exclusion Criteria:

* Having any serious vision problems or cognitive impairment
* Having disabilities in understanding, speaking and reading Turkish
Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes

Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.

Chronic hyperglycemia is considered as a typical risk-factor that causes soft tissue inflammation and bone loss around natural teeth and implants. One possible explanation for this mechanism is that chronic hyperglycemia has the propensity to increase the levels of accumulated glycation end products (AGEs) in the serum and oral tissues that accelerates the production of proinflammatory cytokines that induce bone destruction around natural teeth and implants. However, it is relevant to indicate that dental implants in chronic hyperglycemia under ideal glycemic conditions can successfully osseointegrate and show predictable outcomes over long durations in both diabetic and non-diabetic patients.

Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.

Eligibility Criteria:
Inclusion Criteria:

* Patients with edentulous maxilla and mandible for at least 12 months.
* Patients have problems with mandibular denture retention and stability.
* Patients with a mandibular bone height measured on a panoramic x-ray between 15 and 25 mm at the mandibular symphysis region.

Exclusion Criteria:

* Patients who did not receive implants at the department clinic.
* Patients with more or less than 4 implants in the mandible.
* Patients with well controlled diabetics.
* Patients with relative contraindications, such as a history of parafunctional habits, daily smokers of more than 10 cigarettes, or alcoholism.
* Patients who have previously received head and neck radiation therapy; furthermore, patients receiving intravenous bisphosphonates, chemotherapy, or psychological disorders could jeopardize their cooperation.
The Impact of Exercise Methods on Human Body Functions and Metabolism

The objective of this study is to compare the effects of 8 months of yoga and walking exercise training on weight-related body fat and metabolic biomarkers in women. Participants will be randomly assigned to either a yoga group or a walking group. The yoga group will undergo 90-minute sessions, 3 times per week, while the walking group will engage in one-hour sessions, 6 times per week. Physical and metabolic markers will be measured at baseline and after 8 months of intervention.

This randomized controlled trial aims to investigate the differential impacts of yoga and walking exercise training on weight-related body fat and metabolic biomarkers in women over an 8-month period. The study will recruit women aged 18-65 years, who will be randomly assigned to either a yoga group or a walking group.

Yoga Group: Participants in the yoga group will attend 90-minute yoga sessions, 3 times per week.

Walking Group: Participants in the walking group will engage in one-hour fast-paced walking sessions, 6 times per week.

Outcome Measures: Physical and metabolic markers will be assessed at baseline and after 8 months of exercise intervention. The primary outcomes will include changes in body weight, BMI, visceral fat, and basal metabolism. Metabolic biomarkers such as serum leptin, glucose, total cholesterol (TC), apolipoprotein A (APOA), and apolipoprotein B (APOB) will also be measured.

Participants will be monitored for adherence to the exercise protocol and any adverse events throughout the study. Data will be collected during the intervention, and analyzed to determine the differential effects of yoga and walking on the measured outcomes.

The study aims to provide insights into the relative benefits of yoga and walking exercise regimens on women's health, particularly in terms of body composition and metabolic health, thereby informing future exercise recommendations and health interventions.

Eligibility Criteria:
Inclusion Criteria:

Female participants aged 18-65 years； Willing and able to participate in an 8-month exercise program； Generally healthy with no contraindications to physical activity； Ability to provide informed consent

Exclusion Criteria:

Current participation in a structured exercise program； Known cardiovascular, respiratory, or metabolic disorders that contraindicate exercise； Pregnancy or planning to become pregnant during the study period； Use of medications affecting metabolism or physical activity levels； Any other condition that, in the opinion of the investigators, would make participation unsafe or not feasible
Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

The purpose of this study is to investigate the bronchial inflammation and hyperresponsiveness after oil supplementation. Before and after oil supplementation the investigators measure decrease in lung function after exercise-challenge in a cold chamber and increase of inflammatory markers in the blood.

Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung function testing at rest and show a decrease in lung function when they do sports or an exercise-challenge. In a previous study the investigators could show, that the combination of exercise test and inhalation of cold air ist more sensitive and specific than exercise-challenge in ambient temperature.

It is known that omega - 3 -fatty acids could reduce the production of inflammatory mediators.

In this study the investigators will investigate the protective effect of oil supplementation with middle-chain and polyunsaturated fatty acids in an exercise-induced asthma provocation model.

Therefore the investigators will measure the decrease in lung function and a increase of inflammatory markers in the blood before and after oil supplementation.

Before and after the exercise-challenge the investigators will measure spirometry and body plethysmography. The investigators want to examine if the body plethysmography is more sensitive in the measurement of exercise induced bronchoconstriction than spirometry.

The investigators hypothesize that the oil supplementation can reduce bronchial inflammation and hyperresponsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Patients: Age ≥12 and 44 years
* known exercise induced asthma
* basic lung function FVC ≥ 75%, FEV1 ≥ 70%
* decrease in FEV1 after exercise ≥ 15%

Exclusion Criteria:

* lung function Forced vital capacity (FVC) \<75% and Forced expiratory volume in 1 second (FEV1) \<70%
* chronic diseases or infections (e.g. HIV, Tbc)
* pregnancy
* systemic corticosteroid-treatment
* inhalative corticosteroid therapy or leukotriene antagonists
* alcohol, substance or drug abuse
* smokers
* inability to capture extend and consequences of the study
A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's

The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.

The project goal is the development and early stage validation of a wearable sensor for dysphagia in patients with PD. The first phase of the program involves engineering goals relating to increasing the battery life of this sensor to 48 hours between charges and reducing the overall form factor size. The second phase of the program is to conduct focus groups with PD patients to assess sensor usability, set up burden, and design feedback. The third phase of the study will assess the feasibility of the sensor to detect and cue swallowing in a small cohort of PD patients.

Eligibility Criteria:
Inclusion criteria. Age ≥22. English speaking. Diagnosis of idiopathic Parkinson's disease of any Hoehn and Yahr stage (I-V), determined by a neurologist.

Mild to moderate sialorrhea defined as a score of ≥ 11\* on the Radboud Oral Motor Inventory for Parkinson's Disease (ROMP)-Saliva (C) subscale Subjects must be in the "on" phase of their medication during all study assessments. The "on" phase is defined as the period when the participant's medication is at peak effectiveness, minimizing motor fluctuations and enabling optimal motor function.

Study Exclusion Criteria. History of aspiration pneumonia within the past 12 months. Unable to swallow saliva without a maneuver. Actively receiving treatment for swallowing disorders or sialorrhea. Current alcohol/drug abuse. Diagnosed with neurological disorders other than PD. End stage dementia. History of head and neck cancer or surgery. Unable to demonstrate competency with the user-friendly sensor platform technology.

Known allergy to contrast material used during MBSS. Known allergy to sensor adhesive. Indwelling tracheostomy tube. Nasogastric (NG) feeding tube. Currently pregnant.
Comparison of Two Types of Braces in the Treatment of Rockwood Type III AC-dislocations

In a randomised prospective comparative Trial the investigators aim to compare the conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint.

The sling/brace will be worn for 6 weeks and the patients will be regularly checked clinically and radiologically.The investigators are interested in differences of shoulder function, Patient satisfaction as well as cosmetic and radiological results.


Eligibility Criteria:
Inclusion Criteria:

* First acute acromioclavicular dislocation Rockwood Type III

Exclusion Criteria:

* Previous injury to acromioclavicular Joint
* Previous surgery of acromioclavicular Joint
* Known hypersensitivity or allergy to fabric of investigational product
* Pregnancy
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Utilization of Confocal Microscopy During Cardiac Surgery

The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery. One of the most feared complication after heart surgery is heart block. This flexible fiberoptic confocal microscope will help discriminate between the various types of tissues in the heart and thus help avoid injury to the conduction tissue during surgery.

This is an interventional pilot study that proposes to evaluate the safety, logistical feasibility, and technological feasibility of using Fluorescite with fiberoptic confocal microscopy during cardiac surgery to discriminate between cardiac tissue and conduction tissue. During surgery to repair atrial septal defect, diluted Fluorescite will be added to the surface of the heart. The fiberoptic confocal microscope (Cellvizio 100 Series System with Confocal Miniprobe) will be used to record images in several different locations of the heart. The image files will be provided to blinded raters who will attempt to identify whether they contain cardiac tissue or conduction tissue. All subjects will be monitored while they are inpatient after surgery for any adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between 30 days and 21 years old
* Undergoing elective surgery for closure of atrial septal defect
* Both parents attend pre-operative clinic appointment, to provide 2 parent consent, or an adult participant (age 18-21) may provide consent for him/herself

Exclusion Criteria:

* Prior history of adverse reaction to fluorescein sodium
* Prior history of renal failure or abnormal renal function
* Baseline PR interval \> 220 msec or 98% for age
* Baseline HR \> 87% for age
* Underlying genetic syndrome associated with progressive AV block of sinus node dysfunction (e.g. Holt-Oram or NKX2.5)