cyrilzakka/clinical-trials huggingface dataset:
Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1)

This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention.

Colorectal cancer incidence is increasing in developed countries specially among young adults due to risk factors as modern dietary, smoking, low physical exercise and obesity. Some foods (fruits, vegetables, nuts, other seeds and legumes) are assumed to prevent occurrence of colorectal cancer, while red and processed meat intake are strongly associated with increased risk of colorectal tumors. However, evidence on fish intake is still scarce, and the mechanisms and drivers of their potential health benefits are also only partially known. On the other hand, colonoscopy remains the gold standard for colon cancer screening. Our study aims to explore the relationship among fish intake, microbiota and molecular alterations during a colonoscopy screening program of healthy volunteers. This is a preliminary proof-of-concept study (ColoMAR-1) to evaluate the feasibility of the entire research program (ColoMAR-2).

The main objectives of this pilot are:

1. To determinate the feasibility of the entire research project obtaining data for all the study participants (colonoscopy, blood sample, feces sample and dietary questionnaire).
2. To evaluate the presence of precancerous lesions (colonic polyps) and colorectal malignant tumors in all the participants.
3. To find molecular alterations (Alkylating signature) in normal mucosa of right and left-sided colon samples.
4. To describe microbiota composition in all the participants.
5. To determinate correlation between dietary habits and clinical and molecular findings of the study.
6. To calculate the overall sample size of the entire research program (ColoMAR-2) in base to dietary patterns and Alkylating signature prevalence of the participants)

Eligibility Criteria:
Inclusion Criteria:

* 45 years old or more.
* Be willing to participate in the study.

Exclusion Criteria:

* Pregnancy
* Previous colorectal cancer.
* Familial colorectal cancer syndrome.
* Previous colonoscopy and colon polypectomy (last five years ).
* Inflammatory bowel disease.
* Medical contraindication for colonoscopy at investigator´s criteria.
CT C-spine Audit and Feedback

This is a prospective quality improvement study to assess the effect of using an audit-and-feedback process for emergency providers on utilization of computed tomography of the cervical spine. The objective of this study is to determine whether providing repeated individualized feedback on CT C-spine utilization to emergency providers alters their practice pattern and reduces overutilization. The investigators hypothesize that emergency providers who receive individualized feedback regarding their CT C-spine utilization on a regular basis will alter their practice pattern to reduce overutilization of this imaging study.


Eligibility Criteria:
Inclusion Criteria:

* Emergency medicine physician, nurse practitioner, or physician assistant
* Ordered at least 5 CT scans of the cervical spine on adult patients in the two-month pre-intervention period

Exclusion Criteria:

* Non-emergency providers
* Ordered few than 5 studies in the pre-intervention period
Effects of Horticultural Therapy on Elderly at Risk of Cognitive Decline

The objective of this study is to determine whether horticultural therapy would improve the psychological well-being older adults who are at risk of memory (cognitive) decline. 100 elderly subjects who are at risk of cognitive decline will be randomized into the active horticultural therapy or to the waitlist control group. Sessions will be conducted weekly for 9 months, and participants will be assessed at 3 time-points: at the start of the study, at 3 months and at 9 months.

It is hypothesized that participants who undergo horticultural therapy will perform better on neuropsychological tests when compared to control, and that they will have improved psychological well-being and functional outcomes.

Study participants comprise of community-dwelling elderly who are at risk of developing dementia, and will be selected from consenting participants from an existing community cognitive screening program.

This is an intervention study where 100 subjects will be randomized into an active horticultural therapy group, or a waitlist control group. Baseline demographic data will be collected at the start of the study. Assessments will be done at the start, at 3 months and at 6 months, which will include neuropsychological tests of cognitive functioning, psychological tests for depression and anxiety, assessment of psychosocial well-being, and tests of functional status.

The Horticultural Therapy intervention will be delivered by trained facilitators at the Therapeutic Garden at Hort Park, and consists of 1 hour sessions weekly for 9 months. The Horticultural Therapy program is designed to stimulate the senses through interaction with the tasks and the environment, promote social interaction and also to promote a sense of self-worth through completion of projects. It encompasses a range of activities including general gardening and also project-based craft activities.

The control group will be placed on a waiting list and only be contacted for assessments. They will receive intervention after the active treatment group at a later date.

Eligibility Criteria:
Inclusion Criteria:

1. Community-living elderly aged 60 years and above, AND 2.

1. Mild Cognitive Impairment based on clinical history and neuropsychological test scores (Z score \<0 and \>-1.5), OR
2. Subjective Memory Impairment based on self-report, OR (C) 2 or more risk factors for dementia such as family history, cerebrovascular disease, and cardiovascular risk factors

Exclusion Criteria:

1. Existing diagnosis of dementia, OR
2. Comorbid major mental illness (such as Major Depressive Disorder and Psychosis), OR
3. Severe or unstable life-limiting medical illness, OR
4. Severe physical impairment precluding participation in Horticultural Therapy
Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy

The purpose of this study is to examine in prospective, double-blinded randomised manner the ability of novel articaine-containing lozenge to enhance the procedure related compliance (compared to placebo) of the adult patients undergoing upper gastrointestinal endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* elective procedure
* weight over 40 kg
* American Society of Anesthesiology class I-III
* first upper GI endoscopy procedure
* finnish or/and swedish speaking

Exclusion Criteria:

* amide and/or esther local anaesthetic allergy
* paraben allergy
* Child-Pugh grade B/C liver failure
* renal insufficiency (calculated glomerular filtration rate under 60 ml/min/1.73 m2 according to Cockcroft-Gault scale )
* dementia
* those presenting with swallowing problem
* chronic pain condition
* chronic use of pain medication
* pregnancy
* lactation
Patterns of Eye Diseases Among Patients Attending The Eye Investigation Unit of Sohag University Hospital

The goal of the work: is to assess the patterns of eye diseases in patients attending the eye investigation unit of Sohag University Hospital.organize the community education. The main question it aims to answer is

* DOES eye disease blindness prevalence rate increase in women more than men?
* What is the rate of glaucoma and other ocular diseases that causes irreversible blindness among the attending patients? Patients attending to the eye investigation unit of Sohag University Hospital in the period from January 2025 to December 2025 are being observed in this work to determine the eye diseases prevalence.

This type of study is helpful to get an idea about the epidemiology of ocular disorders. It is necessary to organize the community education and ensure early treatment to reduce the prevalence of such diseases in the general population.

* Aim of the work: is to assess the patterns of eye diseases in patients attending the eye investigation unit of Sohag University Hospital.
* Study design: observational Cross-Sectional study.3
* Patients and methods: all patients attending to the eye investigation unit of Sohag University Hospital in the period from January 2025 to December 2025.
* Inclusion criteria: All patients referred to the eye investigation unit from the outpatient clinic of Sohag university hospital, private clinics or health insurance.
* Exclusion criteria:

  1. Patients unable to measure visual acuity.
  2. Patients unable to measure intraocular pressure.
  3. Mentally retarded patients.
  4. Undiagnosed patients.
* Time schedule:

  1. Twelve months for collection of data, writing the review of literature and methodology.
  2. Three months for analysis of data and writing the results.
  3. Three months for writing the discussion and conclusions.
* ethical considerations:

  1. The study adheres to Tents of Helsinki declaration.
  2. The study will be approved by the ethical committee of the faculty of medicine Sohag University.
  3. An informed written consent will be taken from all of the participants in the study or their guardians

Eligibility Criteria:
Inclusion Criteria:

- All patients referred to the eye investigation unit from the outpatient clinic of Sohag university hospital, private clinics or health insurance.

Exclusion Criteria:

* Patients unable to measure visual acuity.
* Patients unable to measure intraocular pressure.
* Mentally retarded patients.
* Undiagnosed patients.
Kinesia 360 Parkinson's Monitoring Study

Kinesia 360 is an ambulatory symptom monitoring device for Parkinson's Disease (PD). The aim of this study is to investigate the impact, validation, and usability of the Kinesia 360 system.

This is a five-month study of 45 subjects (approximately 15 subjects per site), consisting of adult volunteers that have been clinically diagnosed with Parkinson's disease. Subjects will have a confirmed history of motor fluctuation with a variety of Parkinson's disease symptom severities. All subjects will user the Kinesia 360 system and complete motor diaries several times per month during the study period. Symptom reports will be provided to the treating clinical team. Motor function, quality of life, engagement, and satisfaction with care will be tracked throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's Disease,
* History of motor fluctuations (2 hrs/day of Off time and/or 1 hr/day of troublesome dyskinesia)
* Fluent in English

Exclusion Criteria:

* Inability to carry out study activities
* Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety
* Subjects who have dementia, exhibited by Montreal Cognitive Assessment (MoCa) score of 22 or less.
* Subjects who have had Deep Brain Stimulation (DBS) surgery less than 6 months prior to study enrollment, or who are deemed by the study investigator to be highly likely to undergo DBS surgery during the 6 month study period.
Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based Medications Changes

To determine the associations among biometric data and previously reported medication changes in the original MAPS study

1. Each center that previously reported making a medication change in a MAPS patient based on biometric information will complete a case report form detailing the rhythm, symptom, medication and dosage change, and which biometric(s) were used to make this decision.
2. Follow up at 6 months will be determined for all patients to assess the impact of the medication change.

Eligibility Criteria:
Inclusion Criteria:

* those that completed the MAPS study and that had medication changes based wholly or in part on biometric information.

Exclusion Criteria:

* Those patients from the MAPS study that did not have medication changes.
Intravenous Dexmedetomidine in Cesarean Section Under Spinal Anesthesia

The present study hypothesized that intravenous dexmedetomidine use during spinal anesthesia for cesarean section has a beneficial influence on hemodynamic stability and epigastric pain together with satisfactory analgesic effects and excellent safety profile for the mother and the newborn.

Background and aim: Hypotension and epigastric pain are commonly encountered during spinal anesthesia for cesarean section. Dexmedetomidine (DEX) is a highly selective α 2-adrenergic agonist. Its effects entail sympatholytic, sedative, anesthetic, and analgesic actions. The present randomized study aimed to evaluate the effect of intravenous DEX administration on the hemodynamic parameters and epigastric pain in women subjected to cesarean section.

Patients and Methods: This study is a randomized double-blinded controlled trial. Seventy patients were randomly assigned to one of two interventional groups: one group received spinal anesthesia and intravenous DEX (1µg/kg) and the other group received spinal anesthesia and placebo (saline). The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace. Primary Outcome parameters included frequency of hypotension episodes, frequency of ephedrine doses needed, sedation score and epigastric pain episodes. Secondary outcomes included time to onset of sensory and motor blocks, duration of sensory and motor blocks, operative duration, time needed to request of rescue analgesia, level of intrathecal block, and neonatal Apgar score at 1 and 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Full-term pregnancy and American Society of Anesthesiologists (ASA) physical status I/II in women scheduled for elective cesarean section

Exclusion Criteria:

* Severe hepatic or renal disease
* Severe cardiopulmonary disease
* Thyroid disorders multiple allergies prematurity
* Known fatal abnormality
* Known chronic gastrointestinal problems with epigastric pain e.g. peptic ulcer and reflux esophagitis.
Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms.

Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation.

Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.

In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older,
* Rectal endometriosis on preoperative imaging with no other digestive location,
* Symptomatic patient (Acute pelvic pain \> 3), in failure of drug treatment,
* Endometriotic lesion visible on ultrasound and confirmed on MRI,
* Centralized MRI, reviewed and validated by the MRI review committee,
* No current pregnancy and no pregnancy plan during the study period,
* Patient agreeing not to change her hormonal treatment throughout the study period,
* Patient accepting the constraints of follow-up defined in the framework of the study,
* Patient affiliated to French health insurance.

Exclusion Criteria:

* Ongoing urogenital infection,
* Anorectal anatomy incompatible with HIFU treatment,
* Overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible,
* History of segmental rectal resection or discoid resection,
* Patient with an implant located less than 1 cm from the treatment area,
* Inflammatory disease of the colon,
* Allergy to latex,
* No scheduled endometriosis procedures during study follow-up,
* Treatment of endometriosis in the context of pregnancy desire for which a 3-month delay is not appropriate
* Patient with contraindications to MRI,
* Patient who has already received HIFU treatment for a rectal endometriotic lesion,
* Patient who does not speak or read French,
* Patient deprived of liberty following a judicial or administrative decision,
* Patient in labor or nursing,
* Patient under guardianship or curatorship
Transcriptional and Proteomic Analysis of Acute Kidney Injury

Acute kidney injury is associated with worsened outcome for critically ill patients. Sepsis-associated and non-septic cardiothoracic surgery associated AKI have been reported, nonetheless, precise pathomechanistic differences as well as detectability of transcriptional and proteomic changes in correlation with imaging and plasma markers are unclear.

Acute kidney injury is a common and detrimental finding in critically ill/sepsis patients as well as non-septic patients post cardiothoracic surgery. In many cases renal replacement therapy is required and an acute kidney injury is linked to increased morbidity and mortality in intensive care patients. Using routinely obtained clinical samples as well as imaging data, this observational trial investigates the transcriptomic and proteomic determinants detectable in septic and non-septic AKI patient subsets and their correlation with outcome and AKI diagnostic parameters.

Eligibility Criteria:
* Inclusion criteria:

  * study consent;
  * KDIGO\>=2;
  * vasoplegia and/or sepsis or elective nephrectomy.
* Exclusion criteria:

  * Age\<18 years;
  * pregnancy/nursing;
  * preexisting CKD with eGFR\<60m/min;
  * dialysis; former ogran transplantation;
  * HIV; hematologic malignancies;
  * immunsuppression;
  * 4h post biopsy non-pausable effective anticoagulation;
  * pre-existing coagulopathy
Mesenchymal Stromal Cells for Degenerative Meniscus Injury

The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.

This is a prospective, unicentric, randomized, open-label, single-dose, two-arm, blinded assessor pilot study in which 20 patients with degenerative meniscus injury grade 3 (Crues et al.) will enter the study with the primary objective of assessing the efficacy of the treatment by VAS of pain at 12 month. Secondary objectives are to evaluate the safety and efficacy through imaging procedures and clinical questionnaires (IKDC, KOOS, Lysholm and SF-36.

Patients will be randomized to one of the two treatment arms (XCEL-M-ALPHA and standard rehabilitation program or standard rehabilitation program alone). Thereafter, patients will be followed for 12 months.

Imaging assessment will be performed by an independent blinded radiologist.

Eligibility Criteria:
Inclusion Criteria:

* Patient between 40 and 60 years of age
* Degenerative meniscus injury grade 3 (Crues et al.)
* Indication of conservative treatment
* Normal alignment of the knee (between 3º varus and 10 º valgus)
* Patient is able to follow a rehabilitation program
* Informed consent given by the patient in writing
* Patient is able to understand the trial.

Exclusion Criteria:

* Traumatic meniscus injury
* Surgical intervention to the affected knee
* Local or systemic infection
* Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
* Significant abnormal laboratory tests that contraindicates participation in the trial.
* Pregnant women or intend to become pregnant or breast-feeding
* Neoplastic process within the previous 5 years or without complete remission.
* The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
* Legally dependant patient.
* The patient does not accept to be followed-up for a period that could exceed the clinical trial length
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation

The patients about to undergo kidney transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent with the date of the patient must be obtained.
* Patient between 18-70 years of age receiving the primary kidney.
* Female patients must have a negative pregnancy test prior to the enrolment.
* Female patients of child bearing potential must agree to practice effective birth control during the study.

Exclusion Criteria:

* Kidney re-transplantation patients or received an organ transplantation other than a kidney.
* PRA\>10% in the previous 6 months.
* Patient who need antibody induction therapy.
* Patient with significant liver disease, defined as having continuously elevated \>2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days.
* Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
* Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy.
* Patient is HIV or HBsAg positive.
* Patient is allergic to Prograf or macrolide antibiotics.