cyrilzakka/clinical-trials huggingface dataset:
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.

This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and all subjects will receive OviTex.

Eligibility Criteria:
Inclusion Criteria:

1. Subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or missing tissue.
2. The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, or OviTex 1S Permanent.
3. The size of the implant needed for repair is expected to be less than or equal to 15 x 25 cm for OviTex LPR and 25 x 40 cm for OviTex Core Permanent and OviTex 1S Permanent.
4. Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
5. Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
6. Subject is able to complete Quality of Life (QoL) and pain questionnaires.
7. Subject is at least 21 years old.
8. Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.

Exclusion Criteria at Baseline:

1. Subject has a BMI of \> 40
2. Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
3. Subject is female and is pregnant or plans to become pregnant during the course of the study.
4. Subject has a life expectancy of \< 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
5. Subject has recent history of drug or alcohol abuse (in last 3 years).
6. Subject has an allergy to ovine-derived products.
7. Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
8. Subject has a strangulated hernia.

Exclusion Criteria Intraoperative:

1. Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
2. Subject unable to receive OviTex LPR, OviTex Core Permanent, or OviTex 1S Permanent time of surgery.
Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer

This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven metastatic prostate cancer
* Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.)
* Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.)
* Planned for EBRT
* ECOG 0 or 1
* Age 18 years or older

Exclusion Criteria:

* Prior radiotherapy to pelvis
* Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
* Any condition where radiotherapy is contraindicated
Organoid Models of Hepatocellular Carcinoma

A promising tool to elucidate the molecular characteristics of HCC are patient-derived organoids (PDOs), three-dimensional cultures of cells that self-organise according to tissue-specific patterns and can be used to test the susceptibility of a specific tumour to anticancer agents. In this study, PDOs for HCC will be developed that closely resemble the tumour microenvironment in vivo and mimic the crosstalk of the gut-liver axis to establish a correlation with patient prognosis and test the efficacy of available systemic therapies.

The objectives of the project will be 1) to develop HCC PDOs from tumour and non-tumour patient liver tissue obtained from surgical specimens or liver biopsies; 2) to evaluate genomic and transcriptomic changes resulting from the integration of HCC PDOs with patient-derived gut microbiota and host immune cells, and to assess the correlation with patient prognosis; 3) to exploit HCC PDOs to test the efficacy of systemic therapies (ICI and TKIs) and to understand possible modifying cofactors.

Researchers with laboratory experience have been recruited who will focus on the construction of PDOs and the analysis of immune-inflammatory pathways. State-of-the-art technologies will be used, in particular next-generation sequencing, flow cytometry, high-throughput genomic and transcriptomic analysis, ultrafiltration, drug screening, multiplex immunoassays and enzyme immunoassays. The project aims to study the mechanisms involved in the modulation of therapeutic efficacy in patients with HCC. Therefore, the experimental model could be a valuable support to be integrated into real clinical practice to maximise therapeutic efficacy through a fully customised strategy.

Eligibility Criteria:
Inclusion Criteria:

* Capacity to express informed consent;
* Age ≥18 years;
* Suspected radiological diagnosis of HCC or diagnosis of HCC with indications for surgical resection.

Exclusion Criteria:

* Age \< 18 years;
* Contraindications to liver biopsy (ascites, platelets\<50,000, INR\>1.7);
* Contraindications to HCC resection surgery;
* Active viral infection;
* Refusal to sign informed consent to participate in the study.
Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available AFO in Adult Stroke Patients

The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.

The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. Participants undergo testing in the gaitlab after using the new brace for a period of time. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 21 and 70 males and non-pregnant females
2. Diagnosis of stroke more than 1 year ago
3. Ambulatory at 0.5m/s or greater
4. Require unilateral AFOs to ambulate
5. Stable medical condition - no concomitant progressive diseases that could affect motor function
6. Ability to comply with directions and cooperate with research team

Exclusion Criteria:

1. Subjects who are currently receiving physical therapy for gait problems
2. Anticipated surgical or pharmacologic intervention for tone/contractures during the study period
3. Additional neurologic or musculoskeletal diagnoses that might impair gait (i.e., recent orthopedic interventions (6 weeks), unhealed fractures, significant degenerative joint disease, lower limb amputation, uncontrolled seizures)
4. Recent cardiac or active pulmonary disease, liable blood pressure
5. Recent back surgery
VIA Disc NP Registry

Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.

The Registry is intended to collect data for patients having received treatment with VIA Disc NP.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Understand and sign the informed consent form (as applicable)
* VIA Disc NP injection is scheduled for 1 or more levels

Exclusion Criteria:

* VIA Disc NP injection is not performed
TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus

To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus

Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.

Eligibility Criteria:
Inclusion Criteria

* Participants must be at least 18 years of age
* Participants must be able to complete all testing (all OCT scans)
* Participants must volunteer to be in the study and sign the consent form

Exclusion Criteria

* Subject with history of ocular disease or ocular pathology
Dignity Therapy for Patients With Early Dementia and Their Family

Developed by Harvey M. Chochinov in 2005, Dignity Therapy (DT) invites individuals with life-limiting illnesses to reflect on matters of importance to them and compiles them in a narrative document for the patient to share. DT has shown to improve quality of life and a sense of dignity, as well as supporting relatives in the process of grievance. Featuring a gradual loss of memories of the past, decline of cognitive functions and awareness of self, dementia can be regarded as a life-limiting or life-changing illness, which is often accompanied by significant psychological stress. DT may help patients and their relatives reduce this stress. Yet, no studies have been conducted to determine the benefits of DT in patients with early stage dementia (ESD). This study investigates the feasibility and acceptance of DT by patients with (very) mild dementia (CDR: 0.5 - 1.5) and their relatives, as well as their overall satisfaction. This study further seeks to determine the effects of DT on sense of dignity, quality of life, dyadic coping, and levels of anxiety and depression in a randomized controlled design.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Diagnosis of very mild dementia
* older 18 years of age
* Study partner (life partner, relative, close friend) available

Exclusion Criteria:

* Unable to speak and read German
* Physical or cognitive incapacity to participate
Cross-linked Hyaluronic Acid/dextranomer for the Treatment of Stress Urinary Incontinence

The investigators aimed to evaluate the effectiveness and safety of intraurethral cross-linked hyaluronic acid/dextranomer (CLHA/Dx) injection for the treatment of stress urinary incontinence (SUI) in women.

This single-center prospective pre-post interventional study was conducted between October 2025 and April 2025 with 60 women . Quality of life was evaluated with the Incontinence Quality of Life Scale (I-QoL) and the lower urinary tract symptoms of women were evaluated with the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS). Incontinence status was assessed via the Stamey Incontinence Grade scale. The need for additional treatment (re-injection, other surgical approaches, etc.) was recorded.

Participants were followed up to 6 months after intervention. All outcomes of interest and complications were evaluated/recorded at three preplanned visits (postoperative 1st, 3rd, 6th, months).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Stress Urinary Incontinence.
* Presence of incontinence during the Valsalva maneuver.
* Positive Marshall-Marchetti test result.
* Post-void residual urine volume of ≤100 mL.

Exclusion Criteria:

* Temporary urinary incontinence.
* Delirium.
* Urinary tract infection.
* Urethritis.
* Pure urge incontinence.
* Nocturnal enuresis.
* Decreased bladder compliance or detrusor contraction observed in urodynamic -studies.
* Leakage of urine with low bladder pressure.
* Psychiatric conditions (severe depression and anxiety).
* Body mass index (BMI) \&amp;gt; 35 kg/m².
* Use of medications that may influence bladder storage or emptying.
Rock Steady Boxing vs. Sensory Attention Focused Exercise

This study evaluates the effect on Rock Steady Boxing (RSB) and PD SAFEx on Parkinson's disease.

Both interventions produce benefits to the PD population. PD SAFEx has been proven to improve the motor symptoms of PD. However, research still needs to be conducted on the PD specific benefits associated with RSB. As such it an RCT is necessary to compare the effects of both interventions.

Eligibility Criteria:
Inclusion Criteria:

* must be able to understand verbal instructions in English
* diagnosed with idiopathic PD by a neurologist

Exclusion Criteria:

* if diagnosed with a neurological condition other than PD
* if participated in an exercise program at least 2-weeks prior to the start of the study
Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients

The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed with glaucoma

Exclusion Criteria:

* Under 18.
Mobile Application for IBD Patients With Biologics

Monitoring of biologic treatment in patients with inflammatory bowel disease (IBD) is important given the increased risk of infections. In this study we aim to evaluate the use of a mobile application to guide IBD patients and facilitate the monitoring of biologic treatment.

Biologic treatment can induce and maintain remission in patients with inflammatory bowel disease (IBD). However, biologics are associated with increased risk of infections. Therefore, it is important to regularly monitor patients during the course of therapy. This process can be time consuming for patients as well as clinicians. Mobile applications, have the potential to guide patients and facilitate monitoring of biologic treatment. In this study we aim to evaluate the use of a mobile application to guide IBD patients during biologic treatment. Adult patients with diagnosis of IBD treated with biologics will be included. The mobile application with personalised content will give patients information about their treatment, reminders for example when blood tests and questionnaires to check for adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of inflammatory bowel disease
* Treatment with infliximab or vedolizumab
* Ability to read and understand Dutch language

Exclusion Criteria:

* Patients recently started with biologic treatment
The Effect of Environmental Factors on Gastric Cancer Based on Macrogenome

The objectives of this study were to clarify how environmental factors such as air pollution affect the occurrence and development of gastric cancer; to identify patient-specific macrogenomic markers of gastric cancer; and to investigate the mechanism of gastric cancer development based on environmental factors and macrogenomic data.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* patients with preoperative diagnosis of gastric cancer confirmed by pathologic biopsy;
* no chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment;
* willing to participate in the study and sign the informed consent form;
* complete clinical data.

Exclusion Criteria:

* concurrent primary malignant tumor other than gastric cancer;
* patients with systemic diseases, such as severe cardiopulmonary;
* insufficiency, that affect the choice of treatment plan;
* not suitable for enrollment as assessed by the investigator;
* incomplete clinical data.
Prevalence of Mast Cell Activation Syndrome in Patients With EDS With Digestive Disorders

The aim of the study is to confirm the association between hypermobile Ehlers Danlos syndrome (hEDS) and mast cell activation syndrome (MCAS) in patients with digestive disorders managed in allergology departments.


Eligibility Criteria:
Inclusion Criteria:

* with hypermobile Ehlers Danlos syndrome
* with digestive disorders
* 14 years of age or older (minimum age for the MOS-SF 36 questionnaire)
* able to answer the questionnaires
* whose participation in a day hospital at Saint Vincent de Paul dedicated to the assessment of "functional digestive pain" is planned
* who do not object to the use of their health data for research purposes

Additional criteria for minors :

- No objection to the use of health data for research purposes by parents/guardians

Exclusion Criteria:

* under guardianship or curatorship
* having taken a long-term high-dose antihistamine treatment (H1 or H2) during the last two months, according to the following thresholds :

  * Desloratadine (\>5 mg/jour)
  * Bilastine (\>20 mg/jour)
  * Cetirizine (\>20 mg/jour)
  * Ebastine (\>10 mg/jour)
  * Fexofenadine (\>150 mg/jour)
  * Levocetirizine (\>5 mg/jour)
  * Loratadine (\>10 mg/jour)
  * Exocetiridine (5 mg/jour)
  * Mizolastine (\>10 mg/jour)
  * Rupatadine (\>10 mg/jour)
  * Polaramine (\>10 mg/jour)
  * Oxomemazine (\>2 mg/jour)
  * Hydroxyzine (\>25 mg/jour)
  * Doxylamine (\>15 mg/jour)
  * Cimetidine (\>200 mg/jour)
* Patients deprived of liberty, pregnant or nursing women
Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%)

Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not been showed until now when LVEF is altered.


Eligibility Criteria:
Inclusion Criteria:

* patients \>18 years old in the immediate post-operative period after cardiac surgery
* ASA 1 - 3
* Pre-operative LVEF≤45%
* Sedated with Ramsay score: 6
* Mechanically ventilated with tidal volume at 8ml/kg, PEEP at 0mmHg, I/Eat 0,5
* With hemodynamic failure: SAP≤90mmHg and/or inotropic or vasoactive drug started in the operating room and/or clinical sign of shock and/or CI ≤2,3l/min/m2
* Affiliation to Health Insurance
* Consent form signed

Exclusion Criteria:

* Cardiac arrhythmia: frequent atrial or ventricular extra systoles, atrial fibrillation
* Intracardiac shunt
* Weight less than 50 kg
* History of central nervous system illness
* Pulmonary oedema (clinical and/or radiological and/or wedge pressure\>18mmHg)
* Right ventricular failure suspected (CVP\> wedge pressure) or diagnosed (trans thoracic and/or transesophageal echocardiography)
* Acute kidney injury with oligoanuria
* Severe post operative bleeding (chest tubes volume of \>200ml/h for 3 hours or more)
* Severe hypoxia (PaO2/FIO2\< 100)
* Administrative control (patient under guardianship or curatorship)
Ketogenic Diet Improves Thrombocytopenia in Cancer Patients

The main purpose of this study is to evaluate whether dietary intervention through ketogenic diet can prevent or improve chemotherapy related thrombocytopenia in cancer patients.

In the study, 80 patients with malignant solid tumors undergoing chemotherapy were randomly assigned to the normal diet group, the strict ketogenic diet group, the circulating ketogenic diet group, and the autonomous ketogenic group. During the chemotherapy period, the corresponding dietary intervention was carried out, and the clinical data of patients before and after treatment were collected, including blood routine, blood ketone concentration, weight, blood sugar, blood lipids, adverse events, and changes in platelets before and after chemotherapy, Statistical analysis of data such as the change degree of platelets and the incidence of adverse events in each diet group before and after treatment was carried out to evaluate the impact of ketogenic diet on clinical indicators and adverse reactions of chemotherapy in cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 90, regardless of gender
* ECOG score ≤ 2 points
* Received or expected to receive radiotherapy and chemotherapy during tumor activity
* Body mass index 19-29
* Conscious and autonomous eaters

Exclusion Criteria:

* Patients with basic diseases of diabetes
* Complications such as severe liver and kidney dysfunction or digestive tract obstruction, inability to eat
* Those who have a preference for food and have strict requirements for dietary taste
* Disagree to sign informed consent
* Those whose physical conditions are determined by the doctor to be impermissible
Targeting the Skeletal Muscle to Treat Metabolic Dysfunction-associated Steatotic Liver Disease

Muscle changes including myosteatosis are reported as highly prevalent in metabolic dysfunction-associated steatotic liver disease (MASLD). Recent studies highlighted a link between muscle fat content and liver disease severity. Conversely, MASLD histological remission though diet or metabolic surgeries is also linked to a decrease in muscle fat content. Therefore, skeletal muscle appears as a potential target to treat MASLD.

In this monocenter interventional study, we will assess the impact of physical activity on muscle fat content and liver disease severity in MASLD as well as the mechanisms mediating the potential beneficial effects of exercise.

Eligibility Criteria:
Inclusion Criteria:

* confirmed MASLD at abdominal imaging
* confirmed excessive muscle lipid content at imaging
* stable weight

Exclusion Criteria:

* severe comorbidities including active malignancies, neuromuscular degenerative diseases
* contraindications to physical activity
* excessive alcohol consumption
The Effect of Music on Pain and Anxiety in Patients Receiving Chemotherapy During COVID-19

Introduction: This study has been conducted to determine the effect of music on pain and anxiety levels in patients receiving chemotherapy during COVID-19.

Methods: The research has been carried out in a real trial model with adult patients receiving chemotherapy. The sample of the study is consisted of 92 patients (45 in the experimental group and 47 for the control group). The data have been collected by the researcher with Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala) between March 2020 and July 2020, through the links sent to the phones of participants on the day they received chemotherapy.

Results: The mean scores obtained from the post-test STAI (53.11±4.77) and VAS (3.44±2.53) scales in the experimental group have been determined to statistically significantly decrease when compared to the pre-test measurement data (STAI:54.26±4.26; VAS:4.22±2.41) (p\<0.05). No statistically significant difference has been determined between pre-test and post-test mean scores of the patients in the control group.

Conclusion: It has been observed that music applications reduce the pain and anxiety levels of patients receiving chemotherapy during the COVID-19 process. It can be recommended to use music applications in the management of pain and anxiety symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Over the age 18,
* Being able to communicate,
* Being literate,
* Having no diagnosis of psychiatric,
* Have the necessary technological equipment (phone, internet, etc.)

Exclusion Criteria:

* Existing infection
* Receiving palliative chemotherapy