cyrilzakka/clinical-trials huggingface dataset:
Biomechanical Analysis of Arterial Tissue From Patient Suffering From Peripheral Artery Disease in the Lower Limb

The current treatment approaches for peripheral artery disease are largely unsatisfactory. Therefore, diseased tissue will be collected as well as patient-specific arterial geometries. The tissue will be tested microstructurally and mechanically to obtain data required to optimize treatment methods through in silico modeling.

Peripheral artery disease (PAD) is a severe cause of morbidity in patients. Common treatment approaches are too often still unsatisfactory. Angioplasty is commonly followed by restenosis, caused by overloading of the arterial tissue. This study is aimed at improving this treatment approach through the in silico simulation of arterial remodeling after balloon expansion. Such simulations require the input of a patient-specific geometry and the mechanical properties of (diseased) arterial tissue.

Patients scheduled for an above knee lower limb amputation due to critical ischemia will be recruited in this study. After the surgery, the femoralis superficialis will be collected, as well as the CT or MR angiogram obtained before the surgery. The arterial tissue will be mechanically tested to obtain material properties and the medical image will be used to determine the arterial geometry. A correlation study will be carried out to explore the possibility of including a predictive simulation of the restenosis outcome of balloon angioplasty in the clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from critical ischemia in the lower limb and undergoing above-knee amputation

Exclusion Criteria:

* The presence of any feature that will prevent tissue collection after the amputation
Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders

This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

This study will enroll 600 subjects over the next 4 to 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. Scheduled to undergo POEM

Exclusion Criteria:

1. Any contraindication to performing endoscopy.
2. Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
Learning From Online Video Education for Controlled Ovarian Stimulation

The Learning from Online Video Education (LOVE) study seeks to determine if online instructional videos on how to administer medication needed for in vitro fertilization (IVF) help improve the quality of life and reduce stress during the IVF process.

The Learning from Online Video Education (LOVE) is a randomized controlled trial that seeks to determine the effect of instructional online videos on medication administration on psychological well being during controlled ovarian stimulation.

The investigators hypothesize that usage of online instructional videos by women undergoing their first cycle of controlled ovarian stimulation for in vitro fertilization or oocyte cryopreservation improves measures of psychological well-being (Infertility Self Efficacy Scale, FertiQoL-T and Perceived stress scores) when compared to subjects that do not have access to this educational resource.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing first controlled ovarian stimulation cycle at the time of enrollment
* Has internet access

Exclusion Criteria:

* Had prior controlled ovarian stimulation cycle
* Does not have internet access
* Declines in person IVF medication teaching session
* Treating physician requests that patient not be approached for participation (any reason)
Effect of Short-term Synbiotic Treatment on Plasma P-cresol Levels in Hemodialysis Patients

The interest on gastrointestinal (GI) dysfunction in hemodialysis has been growing in the last years. it is now accepted that GI dysfunction in dialyzed patients may contribute to systemic microinflammation by promoting gut dysbiosis and bacterial translocation in the blood. Another mechanism by which GI dysfunction contributes to systemic symptoms is related to metabolic activity of the dysbiotic microflora growing in the gut of these patients to generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in hemodialysis patients. In the present paper the investigators investigated the effect of a probiotic/prebiotic mixture on plasma p-cresol concentrations and GI symptoms and in hemodialysis patients.

In patients with end stage renal disease, alterations in gut microbioma are posited to be responsible for gastrointestinal symptoms and generation of p-cresol, a uremic toxin, that has been associated to cardiovascular mortality.

This double blind randomized placebo controlled pilot study evaluates whether Probinul-neutro®, a synbiotic preparation that normalizes intestinal microflora, may lower plasma p-cresol concentrations and reduce gastrointestinal symptoms in hemodialysis patients.

Thirty patients on hemodialysis were randomized to receive either Probinul neutro® or placebo for four weeks. Total plasma p-cresol concentrations was assessed at baseline, and 15 and 30 days after treatment start. At the same study times, ease and frequency of defecation, upper and lower abdominal pain, stool shape, borborygmi and flatus were quantified by subjective assessment questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis
* age \>18 years

Exclusion Criteria:

* severe infections
* diabetes
* malignancy
* history of food intolerance
* autoimmune disorders
* severe malnutrition
* clinical conditions requiring artificial feeding
* kidney transplant
Prognostic Factors of Importance on Who Develops Chronic Low Back Pain

The incidence of low back pain (LBP) is increasing and prognostic factors for developing LBP are unclear. Based on questionnaires, different prognostic factors are being explored over time.

Despite massive efforts of trying to find predictors and prevention for LBP, it remains to be clarified, why some individuals develop severely disabling low back pain while others never experience noteworthy back pain. There is no evidence that numbers of chronically affected individuals have diminished; rather, the incidence of LBP has increased continuously over the last 20 years which is also reflected in rising numbers of lumbar surgical treatments. The prevalence and burden increase with age and prevention of LBP in an aging population seems more urgent than ever. As LBP is undoubtedly a multifaceted disorder that tends to fluctuate throughout life, there is a need for longitudinal research, exploring the effect of both life style and psychosocial factors on the development of chronic low back pain.

The aim of this study is to identify whether a history of low back pain during adolescence represents an increased risk of experiencing low back pain later in life.

Eligibility Criteria:
Inclusion Criteria:

This is an inception cohort based on pupils from schools in Elsinore. There are no formal inclusion criteria other tan being part of this cohort

Exclusion Criteria:

* No formal exclusion criteria but inability to understand/answer our questionnaire is per se an exclusion criteria
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4

The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in buprenorphine-naloxone maintained volunteers

Ongoing study - results not available at this time

Eligibility Criteria:
Inclusion Criteria:

Individuals must be at least 18 yrs of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use.

Exclusion Criteria:

Individuals with evidence of anti active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fed Conditions

The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to losartan potassium or any comparable or similar product.
Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia

The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.

This trial will be a double blind, randomized, crossover, controlled, and interventional trial. Each subject will test 6 study samples in a randomized order at 5 mL of volume first then at 10 mL (12 samples maximum). The trial will last a maximum of one hour (a single study visit).

The total sample size is 47 enrolled subjects, 33 subjects completed. Patients will be females and males aged between 18 and 85 years with mild proven dysphagia.

Eligibility Criteria:
Inclusion Criteria:

1. Mild dysphagia as defined by a score between 3 and 5 on the Dysphagia Outcome and Severity Scale
2. Patients aged between 18 and 85 years
3. Ischemic/hemorrhagic cerebral cause (stroke)
4. Able to understand French (oral and written)
5. Cognitive capacity enough to understand study procedures
6. Having health insurance (which in France is " social security")
7. Having signed the consent form.

Exclusion Criteria:

1. Any swallowing trouble not resulting from the current stroke
2. History of inhalation pneumopathy, i.e. any pulmonary inflammation linked to the path of a solid or liquid food in the respiratory system
3. Any physician diagnosed psychiatric illness
4. Patient with a digestive fistula
5. Any physician diagnosed food allergy
6. Any known allergy to barium or any compound of the contrast product
7. Confirmed or suspected perforated and occlusive syndrome
8. Pregnant or lactating women
9. Major respiratory disease needing oxygen (chronic respiratory insufficiency)
10. Subject who cannot be expected to comply with the study procedures, including consuming the test products.
11. Currently participating or having participated in another clinical trial during the month preceding the study
SPI-directed Analgesia for Vitreoretinal Surgeries

The aim of this randomized trial is to assess the efficacy of SPI-directed analgesia for vitreoretinal surgeries (VRS), presence of PONV and oculocardiac reflex (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.

Patients received general anaesthesia alone or combined with either preemptive analgesia using topical solution of 0,5% proxymetacaine or peribulbar block (0,5% bupivacaine with 2% lidokaine) or preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous infusion of acetaminophen in a doseof 10-15mg/kg of body weight.

Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parametres constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate in the study
* written consent to undergo general anaesthesia alone or combined with different techniques of pre-emptive analgesia and vitreoretinal surgery

Exclusion Criteria

* history of allergy to local anaesthetics or metamizole
* necessity of administration of vasoactive drugs influencing SPI monitoring
* pregnancy
Applying the "New Authority" Model in the Treatment of Poorly Controlled Diabetic Adolescents and Their Families

It is presumed that families of poorly controlled diabetic adolescents (type 1) would benefit from parents' counselling, guided by "the New Authority" model.

"The New Authority" model has been shown to be helpful in risk behaviors such as children's violence and school refusal. It is assumed the model would prove helpful in the risk behavior of lack of adherence to diabetes treatment regimen. The treatment is give to parents only, without the adolescent's participation. It is predicted to improve self care, parents' monitoring, family conflict and parents' helplessness.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of diabetes type 1
* condition duration a year or more

Exclusion Criteria:

* family does not speak Hebrew
* adolescent doesn't live at home
* serious psychiatric condition in the family
Echocardiographic Assessment of Intrapulmonary Vasodilatation: Agitated Saline Versus Polygeline

The purpose of the study is to evaluate agitated saline versus polygeline for detection of intrapulmonary vasodilatation in patients with cirrhosis.

Intrapulmonary vasodilatation is a frequent finding in patients with cirrhosis. Its diagnosis is established via contrast enhanced echocardiography. One used method is the contrast agent agitated saline and another frequently used method is the contrast agent polygeline. The purpose of this study is to compare these two echocardiographic contrast agents with respect to their ability to detect intrapulmonary vasodilatation.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* presence of liver cirrhosis
* evaluation for liver transplantation or transjugular intrahepatic portosystemic shunt

Exclusion Criteria:

* inadequate echocardiographic image quality
* allergies to echocardiographic contrast agents
* pulmonary valve stenosis
* pulmonary embolism
* relevant tricuspid regurgitation
* cardiomyopathy
Changes in Cytokine Levels After Dextrose Injection in Stage IV Knee Osteoarthritis

Twenty participants with severe arthritis will be enrolled. For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing. The remaining participants will be given dextrose injection at the end of the week. After one week dextrose injections will be given at one, two, three, four, five, and six months. Fluid will be withdrawn from the knee at time zero, one week, and three months. The hypothesis is that dextrose injection will cause a change in proteins in the knee consistent with improved repair signals, along with improving knee pain and function. .

Participants with stage IV knee osteoarthritis will be evaluated for eligibility and randomized 1 to 1 using an Internet randomization method to ensure random allocation.

At time zero all participants will receive aspiration of their knees from the suprapatellar pouch of 5.5 mL of synovial fluid for cytokine analysis. After that 10 of the participants will receive injection of 10 mL of 12.5% dextrose. The other 10 will receive no injection after aspiration. Pain levels will be measured at time zero, 15 minutes, two hours and 48 hours after aspiration with or without injection to gather information about the time course of analgesia.

At one week all participants will receive aspiration of 2.0 mL from the suprapatellar pouch for cytokine analysis, followed by injection of the remaining 10 participants with dextrose 12.5%. Pain levels will be measured at the same time intervals to complete evaluation of dextrose analgesia.

After two weeks injections will be open label with 10 mills of dextrose 12 and have percent injected at one, two, three, four, five, and six months. At the three month. Another 2 mL of synovial fluid will be sent to the laboratory for cytokine analysis.

Eligibility Criteria:
Inclusion Criteria:

* Knee pain for at least 6 months.
* Clinically diagnosed knee osteoarthritis.
* Weight-bearing radiograph consistent with high-grade medial compartment cartilage loss (Kellgren-Lawrence Grading Scale level IV).
* Confirmation of exposed subchondral bone by high-resolution knee ultrasonography.

Exclusion Criteria:

* Anticoagulation therapy.
* Inflammatory or post-infectious knee arthritis.
* Systemic inflammatory conditions.
* Knee flexion of less than 100 degrees.
* Knee extension of less than 165 degrees.
* Any Valgus
* Varus more than 15 degrees.
* Any knee injection in the past 3 months.
* BMI more than 40
* Gross synovial folds on ultrasound
* Elevation of sed rate, C reactive protein, rheumatoid factor or antinuclear antibody.
Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D Daily Supplements on Active Periodontal Therapy With Stage II Grade B Periodontitis Patients

Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D daily Supplements on Active Periodontal Therapy with Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.

This randomized clinical trial evaluates the effect of Omega- 3 versus Vitamin D regarding Clinical evaluation

1. Clinical attachment loss (CAL)
2. Probing pocket depth (PPD)
3. Modified sulcus bleeding index (mSBI)

Eligibility Criteria:
Inclusion Criteria:

* • Systemic healthy patients

  * Patients aged \> 25 years
  * Patients suffering from stage II periodontitis with grade B were included in this study, according to 2017 world workshop classification of periodontal disease (Papapanou et al. 2017).
  * Patients with interdental clinical attachment loss (CAL) of 3-4 mm
  * No history of previous periodontal therapy.
  * No taken medications known to interfere healing or periodontal tissue health such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs.
  * No previous periodontal surgery at involved sites.
  * Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
  * Neither taken antibiotics within the last three months nor nonsteroidal anti-inflammatory drugs within the last three months
  * Absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders
  * Absence of oral mucosal inflammatory conditions such as aphthous ulcers or lichen planus.

Exclusion Criteria:

* • Patients taking Omega- 3 or Vitamin D as a nutritional supplement were excluded from the study

  * Smoking habits
  * Pregnant and lactating mothers
  * Patients who have been received periodontal surgery in the study area during the last 6 months.
Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome

Moderate to severe obstructive sleep apnea syndrome (OSAS) (HAI hypopnea apnea index ≥ 15) is a common pathology, which affects 6 to 17% of the general population. The Alaska study, which involved 480,000 apneic patients newly fitted with CPAP, showed that 76.9% of patients were still under treatment for one year, 62.9% after two years, and 52.3% after three years.

All patients who recently diagnosed with OSAS in the Sleep Disorder Unit (unity de Pathologies du Sommeil et de la Vigilance, CHU d'AMIENS-PICARDIE, FRANCE) and who are requiring CPAP will be included. On the day of their hospitalization for the implementation of the CPAP therapy, patients will answer validated questionnaires to assess their level of motivation and adherence to the initiation of treatment but also to assess their knowledge and understanding of the disease and its treatment. These questionnaires will be repeated at the four-month and one-year follow-up consultations (+/- 21 days).

The aim of the study is to identify the prognostic factors of adherence to CPAP, leading to a better understanding and management of patients with sleep apnea syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥ 18 years old)
* Diagnosis of moderate to severe obstructive sleep apnea syndrome OSAS (AHI ≥ 15) by polygraphy or polysomnography performed in our Sleep disorder Unit
* Requiring CPAP therapy
* Informed consent

Exclusion Criteria:

* Patient previously treated with CPAP therapy
* Psychiatric illness destabilized
* Unstable medical condition (i.e. COPD exacerbation, acute cardiac dysfunction, etc.)
* Planned obesity or ENT surgery (because CPAP treatment is planned for a short period)
* Central or mixed apnea syndrome
* Patient under 18 years old
* Pregnant, parturient or breastfeeding woman
* Patient under guardianship, curators or deprived of liberty
* Patient participating in another research including an exclusion period still in progress at the pre-inclusion.
Dapagliflozin (DAPA) Effects in HFpEF

The purpose of this study is to determine whether treatment with Dapagliflozin (DAPA) for 6 months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart failure/preserved ejection fraction (HFpEF) and improve cardiac metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study specific procedures.
* Male or female.
* Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation.
* EF ≥ 50% + BMI ≥ 30 kg/m\^2
* Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥ 25 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized .

Exclusion Criteria:

* Type I diabetes.
* Type II diabetes with poor control (HgbA1C ≥ 10%).
* Recent hospitalization (\< 30 days) or revascularization (\< 90 days).
* Primary cardiomyopathy (such as amyloid).
* Constrictive pericarditis.
* Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator.
* Severe anemia (hemoglobin \< 9gm/dl.
* Significant left-sided valvular heart disease (\> mild stenosis, \> moderate regurgitation),
* Severe kidney disease (estimated glomerular filtration rate (GFR) \< 30) or liver disease,