cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Hernia Defect Obliteration With ProFlor-E

This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect

The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.

Eligibility Criteria:
Inclusion Criteria:

* patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias

Exclusion Criteria:

* ASA \>4 patients
A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis

Open-label, long-term extension study available to participants who have completed CNMAu8.201.

This open-label, long-term extension study is only available to participants who have completed CNMAu8.201 (VISIONARY-MS). The Week 48/End-of-Study Visit for study CNMAu8.201 (VISIONARY-MS) will serve to establish the Baseline for electrophysiological, functional, morphological vision testing, as well as the neurological and outcome assessments. Participants will receive open-label CNM-Au8 throughout the study. All participants will receive a daily dose of 30 mg CNM-Au8 for the entire open-label, long-term extension study. The dose for participants may be adjusted once efficacy and safety data from study CNMAu8.201 becomes available, which may occur after participants have already started this study. Based upon a review of data and Sponsor or PI recommendation, this open-label, long-term extension study may be discontinued once each participant reaches her/his 48-week visit.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have completed study CNMAu8.201.
* Able to understand and give written informed consent.

Exclusion Criteria:

* Lack of treatment compliance during participation in the CNMAu8.201 (VISIONARY-MS) study.
* Positive pregnancy test.
* Any history of previous malignancy, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix, post documented full resections, with clean margins.
* Based on the Investigator's judgment, any concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the participant, or lead to difficulty complying with the protocol; any untreated or unstable psychiatric disease including depression, bipolar and psychosis.
* Participant is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.

Following clinical and serology sample analysis conducted at the end-of-study visit for CNMAu8.201 (VISIONARY-MS), participants may be removed from this long term extension study if any of the following criteria are met, at the discretion of the Medical Monitor and/or Sponsor's Medical Representative:

* Positive serology for viral hepatitis B and/or C and/or human immunodeficiency virus (HIV).
* Abnormal liver function tests (aspartate aminotransferase \[ASAT\] or alanine aminotransferase \[ALAT\] \> 2x upper limit of normal range (ULN) or total bilirubin \> 2x ULN or alkaline phosphatase (AP) \> 3x ULN).
* Participants with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function (e.g., glomerular filtration rate \< 40 mL/min \[based on creatinine clearance according to Cockcroft-Gault equation\]), or those with low platelet counts (\<150 x 109 per liter) or eosinophilia (absolute eosinophil count of ≥500 eosinophils per microliter) at the EOS visit for CNMAu8.201 (Visionary-MS).
Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain

The main goal of this trial is to study the efficacy of Namisol® after a single dose of Δ9-THC in the treatment of pain resulting from chronic pancreatitis. Objective measures of pain processing, e.g. encephalography (EEG) and quantitative sensory testing (QST), are included to provide insight in underlying nociceptive processing.

The most important symptom in chronic pancreatitis (CP) is abdominal pain. Pancreatic pain is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance of the cannabis plant, has been shown in previous studies to be a promising analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an improved and reliable pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patient has chronic pancreatitis, diagnosed using the Marseille and Cambridge Classification System (addendum II).37
* Patient suffers from chronic abdominal pain typical for pancreatitis, meet the criteria for chronic pain according ISAP (intermittent or persistent pain on a daily basis in at least 3 months)38, and consider their pain must as severe enough for medical treatment (average NRS ≥ 3).
* Patient in the opioid group takes stable doses of opioids, e.g. morphine or tramadol, for the past 2 months on the day of screening. Stable dose intake is defined as a daily equivalent sum of opioid intake according medical prescription within a small deviation range as judged by the (principal) investigator.
* Patient in the non-opioid group does not take any opioids for the past 2 months on the day of screening.

Exclusion Criteria:

* Patient used any cannabinoid (by smoking cannabis or oral intake) for at least one year on the day of screening.
* Patient does not feel a pinprick test in the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
* Patient has a body mass index (BMI) below 18 or above 31.2 kg/m2.
* Patient suffers from serious painful conditions other than chronic pancreatitis or had any major pre-existing chronic pain syndrome.
* Patient has a (history of) a significant medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
* Patient uses any kind of concomitant medication that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient (e.g. HIV antivirals).
* Patient takes amitriptyline on a daily basis.
* Patient takes more than 20 mg benzodiazepines 6 hours prior or following intake of study medication (11 hour am) according prescription.
Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients

The effectiveness of thalidomide in treating inflammatory bowel disease has been widely recognized. Meanwhile, many serious adverse drug reactions were notified， but no reports on ovarian reserve function.Therefore, this study was to investigate the influence of thalidomide on function of ovarian reserve.

It will be divided two groups of patients according to the treatment itself . One group was treated by thalidomide, the other was other treatment excluding. It will detect the function of ovarian reserve before and after treatment in both two groups, to investigate the influence of thalidomide on function of ovarian reserve.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years old Diagnosis of patients with CD

Exclusion Criteria:

* Pregnancy or lactation Period of women have fertility program during the study Treatment not foot eight weeks after last IFX Central or peripheral nerve disease Abnormal in liver and renal function Heart function failure Malignant tumor Active tuberculosis
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON

The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance.

Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment.

The aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance.

We will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is routine practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or IVUS-guided PCI arm.

Patients will then have a follow-up contact at the time of hospital discharge, 8 month and 12 month after PCI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a de novo lesion (in the native coronary circulation) and planned to undergo drug-eluting stent implantation for indications according to the Japan and USA guidelines
* Patients aged between 20 and 85 years old
* Patients who has provided written informed consent

Exclusion Criteria:

* Patients with Acute Myocardial Infarction (AMI) within 3 months
* Patients with cardiogenic shock
* Patients with chronic heart failure
* Patients with renal failure (eGFR \<= 30 ml/min/1.73 m2 or Serum creatinine level \>=1.5mg/dL)
* Patients who are currently enrolled in other clinical trial which has possibility to influence the primary endpoint of OPINION trial.
* Patients planned use of bare metal stent
* Patients with 3-vessel diseases
* Planned surgery within 1 year
* Patient on dialysis
* Target lesion such as:

  * Left main coronary artery
  * Aorto-Ostial lesion location within 3mm of the aorta junction
  * Chronic total occlusion
  * Small vessel (reference vessel diameter \<2.5mm)
  * Coronary artery bypass graft
Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity

The goal of this clinical trial is to identify the recommended financial reimbursement amount for women with breast cancer enrolled in a clinical trial. The main questions it aims to answer are:

1. What is the recommended financial reimbursement amount in trial-enrolled women with breast cancer experiencing financial toxicity?
2. What do patients think about receiving a reimbursement for trial-incurred expenses?

Participants will receive a monthly reimbursement to compensate for their trial-incurred expenses in cohorts, which will de-escalate for the next participant cohort if patients find the reimbursement dose suitable (negative financial toxicity screen, reimbursement dose deemed acceptable/appropriate). Researchers will also use qualitative interviews to explore patient perceptions of the trial reimbursements.

Our overall objective is to innovatively use a dose-finding approach to identify the recommended reimbursement amount for women with breast cancer enrolled in a clinical trial. We hypothesize that optimal reimbursement for trial-related expenses will decrease patient financial toxicity and increase trial retention. The rationale is that understanding the impact of reimbursement for trial-related costs will aid in addressing socioeconomic barriers to trial participation, thus allowing for more diversity in trial enrollment and ensuring equitable efficacy of cancer treatments when used in real-world clinical settings.

Aim 1. Identify the recommended reimbursement amount in trial-enrolled women with breast cancer experiencing financial toxicity. We propose a pilot reimbursement dose de-escalation trial (continual reassessment method design; N=30) testing a monthly reimbursement for trial-enrolled patients who screen positive for financial toxicity. We will oversample patients who are Black (50%) or residing in rural locations (50%). Monthly patient-reported financial toxicity and reimbursement acceptability and appropriateness will be captured. Reimbursement dose will start at $1000 and de-escalate if patients find the reimbursement dose suitable (negative financial toxicity screen, reimbursement dose deemed acceptable/appropriate).

Aim 2. Explore patient perceptions of trial reimbursement amounts. Using semi-structured interviews, we will explore the effects of reimbursement on specific covered and uncovered trial-related costs, financial toxicity, and current retention and future participation in clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be women with breast cancer currently enrolled in the Investigation of Serial studies to Predict Your Therapeutic Response with Imaging and Molecular AnaLysis (I-SPY TRIAL 2) at the UAB Medical Oncology Clinic.

Exclusion Criteria:

* Non-English speakers
* Males
* Females without cancer
* Female cancer patients not enrolled in the I-SPY TRIAL 2
The Effects of Oscillatory Positive Expiratory Pressure (OPEP) Therapy in Patients with COPD

The goal of this non-pharmacologic interventional study is to learn if Oscillatory Positive Expiratory Pressure (OPEP) therapy can improve disease impact and respiratory system dynamics in patients with COPD. The main questions it aims to answer are:

Is OPEP therapy able to improve the impact of cough symptoms as measured on a validated symptom score? Is OPEP therapy able to improve the properties of the lung (called reactance) as measured by oscillometry?

Researchers will compare the results of the same tests performed before and after 4 weeks of OPEP treatment to see if OPEP treatment improves cough symptoms and lung mechanics.

* Participants with COPD will complete in-person baseline tests and will then receive the smart OPEP device.
* These participants will then use the smart OPEP device at home, at least twice a day, for 4 consecutive weeks.
* Finally, these participants will return to complete in-person end-of-study tests.

The objectives of this prospective, non-pharmacologic interventional cohort study are to determine the effect of four consecutive weeks of twice-daily or greater OPEP usage among patients with COPD with a chronic bronchitis (sputum-producing) phenotype on disease impact and on respiratory system dynamics. A 'dose-response' effect of OPEP use will also be investigated.

We hypothesize that a 4-week period of OPEP therapy among eligible patients with COPD with a chronic bronchitis (sputum-producing) phenotype will be associated with improved disease impact scores and airway mechanics.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females 40 years of age or more
2. Former/current smokers with a cigarette smoking history for 10 or more pack-years
3. Physician diagnosis of COPD previously confirmed by spirometry (FEV1/FVC less than 0.7) with 'mild' to 'very severe' (i.e. GOLD 1-4) COPD
4. Chronic bronchitis phenotype: Sputum production or presence of productive cough greater than 2 days/week in the last 3 months for at least 2 consecutive years, or presence of cough and phlegm almost every day or several times per week
5. Ability to participate without supplemental oxygen during all oscillometry testing
6. Ability to provide informed consent

Exclusion Criteria:

1. No COPD diagnosis
2. Bronchiectasis, cystic fibrosis, or any other known suppurative acute/chronic lung disease as the principal respiratory condition
3. Physician-diagnosed exacerbation and/or hospitalization for pulmonary symptoms in the 4 weeks preceding baseline testing
4. Current use of OPEP, or any use of OPEP in the 4 weeks preceding baseline testing
5. Current or recent participation in a standard Pulmonary Rehabilitation program in the 4 weeks preceding baseline testing or during the study
A Trial Comparing Efficacy of HM3 Versus F2 Lithotripters for Stone Fragmentation

The older lithotripter, HM3, has over 90% stone-free rate in most studies. However, it's less transportable than the new model, F2. There are no prospective trials performed to make a valid comparison between these 2 lithotripters in terms of efficacy of stone fragmentation and clinical outcomes.

Shock wave kidney stone treatment was introduced in the 1980's. It is the least invasive method to treat kidney stone disease. The unmodified Dornier HM3 has over 90% stone free rate in most studies. The MH3 requires immersion in a full bath, necessitating dedicated operative space. The new generation model F2 uses water cushion as a coupling medium and is easily transported. The generators used in both machines are also different. The newer model has the advantage of being more convenient due to portability and ease of use of the coupling medium, but there have been no prospective studies to compare these 2 machines in terms of efficacy of stone fragmentation and clinical outcomes. We seek to compare the HM3 with the F2 models in terms of stone free rates, complications and clinical outcomes to determine which machine is the most effective and will limit the need for additional stone procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with urolithiasis and choose to have ESWL treatment
2. Age 18-90 years old
3. Able to understand the informed consent

Exclusion Criteria:

1. Minors
2. Cognitively impaired
Health Effects of Consuming Olive Pomace Oil

Healthy and at risk (hypercholesterolemic) subjects consumed during 4 weeks 45 g/d of either olive pomace oil (OPO) or high oleic acid sunflower oil (HOSO) as the only dietary fat in a randomized, crossover trial. The effects on blood lipids, glucose homeostasis, endothelial function, inflammatory cytokines, oxidative stress biomarkers and anthropometry were measured.

This is the first study on the potential health effects of consumption of olive pomace oil.

After a 3-weeks run-in, 34 healthy and 30 hypercholesterolemic subjects were randomized to consume either OPO or HOSO (45 g/d) during 4 weeks, followed by a 3-week wash-out during which volunteers consumed the same amount of normal sunflower oil. During all the study, other dietary sources of fat (oil, nuts, butter, etc.) were restricted. Food intake was monitored by 3-d food records in each intervention stage and volunteers were instructed to maintain their normal physical and dietary habits (except for the changes in the consumption of other oils and fats).

At the beginning and end of each intervention stage, blood and urine samples were obtained, and blood pressure and anthropometric measurements were performed. A complete batch of analysis were performed, including serum lipids, endothelial function (flow mediated dilation (FMD), endothelial nitric oxide synthase (eNOS), vascular (VCAM-1) and intercellular (ICAM-1) cell adhesion molecules, E- and P-selectins), inflammatory and anti-inflammatory cytokines, glucose homeostasis/insulin resistance, antioxidant status and biomarkers of lipid oxidation (malondialdehyde (MDA), LDLox, ferric reducing antioxidant power (FRAP), oxygen radical absorbance capacity (ORAC), ABTS (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) quenching capacity) and anthropometry, along with determination of incretins, adipokines, and other clinical and hematological parameters.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (Total cholesterol \< 200 mg/dL; LDL-cholesterol \< 135 mg/dL)
* Hypercholesterolemic volunteers (Total cholesterol 200-300 mg/dL; LDL-cholesterol 135-175 mg/dL)

Exclusion Criteria:

* BMI \> 30 Kg/m2
* Smokers
* Vegetarians
* Pregnant women
* Medication/consumption of vitamins, dietary supplements
* On antibiotic treatment 3 months before starting the study
* Digestive disorders/pathologies (gastric ulcer, Chron's disease, inflammatory bowel syndrome, etc.)
* Food allergies/intolerances
Influence of Consecutive Strength- and Endurance Regimes on the Myonuclear Domain and Satellite Cell in the M. Vastus Lateralis of Old Healthy Men

Randomised training intervention.

Influence of consecutive training regime on the impact of the myonuclear domain and satellite cell

Sarcopenia

Despite that the muscle mass can be positively influenced by training, the loading with high weights and/or to the total exhaustion is for many old persons not possible.

Therefore we aim to enhance the myonuclei in the muscle fiber of old male subjects in a first phase by endurance training, in order to promote a more effective muscle growth in a second phase by resistance exercise.


Eligibility Criteria:
Inclusion criteria: -male

* no fever at the beginning and during the study
* between 60 years and 75 years
* non smokers
* no known cardiovascular and orthopaedic problems
* no cardiac pacemaker
* fulfilling the health criteria

Exclusion criteria: -female

* fever or cold at the beginning or during the study
* non MRI compatible metal implants
* under 60 years or over 75 years
* smoker
* cardiovascular or orthopaedic problems
* cardiac pacemaker
* not fulfilling the health criteria
Optical Elastography of Systemic Sclerosis Skin

The goal of this study is to develop a new way to assess skin thickness in patients with scleroderma (systemic sclerosis). The study will test how well a new imaging method called optical coherence elastography (OCE) compares to the current clinical method used to estimate skin thickness, the modified Rodnan Skin Score (mRSS).


Eligibility Criteria:
Inclusion Criteria for scleroderma patients:

* meet the 2013 American College of Rheumatology and the European League Against Rheumatism (ACR/EULAR) criteria for systemic sclerosis with limited or diffuse cutaneous involvement

Exclusion Criteria:

* have another skin disease other than systemic sclerosis
A Study to Assess Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting

The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).


Eligibility Criteria:
Inclusion Criteria:

* Participant with diagnosis of moderate or severe chronic plaque PSO documented in the medical chart.
* Participant who needs systemic biologic therapy and qualifies for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-Il-23p19 selected therapy before including the patient in the study.
* Participant aged greater than or equal to (\>=) 18 years at Inclusion.
* Written informed consent.

Exclusion Criteria:

* Participant unable or unwilling to comply with the requirements of the study.
* Participant who should not participate in the study for any reason at the discretion of the treating physician.
* Participants participating in a simultaneous clinical trial.
* Any contraindication against the use of Tildrakizumab according to the SmPC.
* Exposure to \>= 3 biologics prior to inclusion.
* Participant dependent on the investigator, e.g. as employee