cyrilzakka/clinical-trials huggingface dataset:
Performance and Tolerability of a New Medical Device Gel, a Randomized, Open Label, Parallel-group, Multicentre Study

Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms

Due to the potential toxicity that can result from the use of topical anesthetics to relieve the symptoms associated with gingival inflammatory conditions or gums trauma in infant, recently, products containing Hyaluronic Acid (HA) have been marketed in Europe. In particular, Bioplax Limited is developing several high molecular weight HA medical devices characterized by the absence of preservatives, alcohol and dyes; therefore, the administration of these products in infants is safe and can help creating a natural protective layer on the gingival tissue. In previous clinical trials with these high molecular weight HA medical devices it was noted a periodontal tissue/fluid balance with accelerated healing and repair properties that could be of interest either for accelerating the wound healing process or for treating the complex physical symptoms (i.e. soreness and swelling of gums, crying, sleeplessness) related to the teething in infants. These data were confirmed by a recent pilot study on 18 infants suffering by teething where the two formulation of the tested high molecular weight HA medical device evidenced, at the end of treatment period, a statistically significant reduction of pain, swelling, gingival rush, hyper-salivation and redness, from baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female infants aged between 3 and 36 months.
2. Teething diagnosed by the presence of at least 3 of the following clinical symptoms:

   * pain
   * swelling
   * hyper-salivation
   * redness
   * abnormal teeth depth.
3. At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.
4. Infants and parents who are in a general position to follow all study requirements.
5. Informed consent form signed by parents or legal representative.

Exclusion Criteria:

1. Infants in hospitalization and/or immobilization and/or confinement to bed.
2. Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems.
3. Use of topical oral Lidocaine, other topical oral anesthetic products and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion.
4. Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before.
5. Concomitant use during the period of study of NSAIDs and/or any other anesthetics (except Dentinox®-Gel N, for subjects allocated to group II of treatment).
6. Subjects with known family history of allergic or adverse reactions to drugs or substances.
7. Infants whose parents suffer from any form of psychiatric disorder or other condition which, in the opinion of the Investigator, might invalidate the required prescription and/or observation or complicate communication with the subject.
8. Infants simultaneously participating or having participated in the last month before Visit 1 in another clinical trial.
HBV/HCV/HIV in Belgian Prisons

To assess the prevalence of blood-borne viral infections in prisons in Belgium, screening will be executed in several prisons in Flanders, Brussels and Wallonia to obtain a geographical representative distribution.

Upon informed consent screening will be performed using whole capillary blood (finger prick testing) with three different tests for HCV Ab, HBsAg and HIV. Screening will be performed first. While awaiting the test result (15-20min), the participant can fill out a questionnaire (together with the study nurse), concerning risk factors for HCV, HBV and HIV infection. This questionnaire is filled out directly online, and will be immediately implemented in the encoded database. The database is set-up according to the rules of good clinical practice. (Castor EDC software). The results will be filled out immediately by the prison staff in this database after it is filled out by the participant, minimizing the risk of displacement of test results.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Imprisoned in one of the predefined prisons in Flanders Brussels or Wallonia participating in this trial
* Written informed consent obtained

Exclusion Criteria:

* Written informed consent not possible: (language barrier, illiteracy)
* Already participated in the study: re-entry within inclusion period in one of the prisons
Improving Hand Motor Function After Stroke: Role of Robotics

Two recent randomized clinical trials reported a significant contribute of Amadeo toward the recovery of hand motor function in acute stroke patients in association with physiotherapy and/or occupational therapy. However, no data are available in patients with chronic stroke, and the neurophysiological mechanisms underlying such clinical improvement need to be elucidated. Given that robotic devices harness brain plasticity to foster motor function recovery, a deeper understanding of the neurophysiological bases of Amadeo training could help clinician to realize patient-tailored rehabilitative training based brain plasticity knowledge. We planned a pilot randomized-controlled observer trial aimed at evaluating the effects of intensive robot-assisted hand therapy compared with intensive occupational therapy in chronic phase after stroke. We estimated that 40 patients per group will be required to demonstrate a greater effect of Amadeo as compared to occupational therapy, with an effect size of 0.5. Twenty chronic stroke patients (at their first-ever stroke) will be enrolled and randomized into two groups. The experimental group will be provided with Amadeo training. The Control group will be provided with occupational therapy executed by a trained physiotherapist.


Eligibility Criteria:
Inclusion Criteria:

* chronic stroke patients at their first-ever supratentorial stroke

Exclusion Criteria:

* presence of severe medical, psychiatric and cognitive abnormalities as to interfere with the treatment.
* controindications to the device use.
Expanded Access to Everolimus, for an Individual Patient With GIST (Gastrointestinal Stromal Tumors)(CTMS#18-0019)

Single patient treatment with everolimus.


Eligibility Criteria:
Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tolerance and Lipids in Man

Preliminary studies in rats and mice indicate that calanus oil reduce accumulation of intra-abdominal fat. Pilot studies in humans have shown no adverse effects. In the present study 120 subjects, males and females, 20-65 years old, BMI 25-30 kg/m2 will be included and given calanus oli 1 g twice daily versus placebo for 1 year. The hypothesis is that calanus oil will reduce intra-abdominal fat, improve glucose tolerance and lipid profile.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) 25-30 kg/m2
* age 20-65 years

Exclusion Criteria:

* diabetes
* coronary heart disease last 12 months
* unstable angina pectoris
* cancer diagnosed the last 5 years
* use of lipid lowering drugs
* seafood allergy
Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater.
* Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
* Corrected visual acuity in each eye equivalent to 20/200 or better
* Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic:

* Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
* Intraocular pressure \>36 mmHg
* Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
* Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
* Refractive surgery in study eye(s)
* Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
* Evidence of ocular infection and inflammation
* Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
* Central corneal thickness greater then 600 μm
* Any abnormality preventing reliable applanation tonometry of either eye

Systemic:

* Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
* Clinically significant systemic disease
* Participation in any investigational study within 30 days prior to screening
* Changes in systemic medication
* Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Reliability of the Preoperative Work-up in Patients Submitted to Surgery for Cystic Neoplasms of the Pancreas

Prospective, observational, cohort study to evaluate the reliability of preoperative work-up of patients submitted to surgery for pancreatic cystic neoplasms, in a tertiary referral center. A comparison between the preoperative diagnostic suspicion and the final pathologic report will be done.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of pancreatic cystic neoplasms
* indication to surgery

Exclusion Criteria:

* pregnancy, breastfeeding
Assessment of the Prevalence of Steatotic Liver Disease Associated with Metabolic Dysfunction in Patients with Heterozygous Familial Hypercholesterolemia

The main goal of the STEATO-FH study is to determine the prevalence of liver steatosis within the Heterozygous Familial Hypercholesterolemia patient population.

Investigators will include patients being followed for heterozygous familial hypercholesterolemia in their centers. The prevalence of hepatic steatosis will be studied non-invasively, using Fibroscan ®. In addition, coronary calcium score (CAC scores) will be evaluated and a biocollection will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 35 or over
* Consultation at Nantes, Rennes or Angers University Hospital during the inclusion period
* With a diagnosis of familial hypercholesterolemia defined by the presence of a genetic variant, ACMG classes 4 \& 5 on LDLR, APOB or PCSK9
* Patient not objecting to inclusion in study (no written objection)

Exclusion Criteria:

* Protected patients: minors, adults under guardianship, curatorship and/or safeguard of justice
* Pregnant or breast-feeding
* Active viral hepatitis
* Hemochromatosis
* Other genetic or autoimmune hepatitis
* Current treatment with a drug likely to cause hepatic steatosis, including amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals
* Current oral corticosteroid therapy unless dose has been stable for ≥ 3 months
* Current pathological alcohol consumption (≥ 60 g/day in men and ≥ 50 g/day in women)
Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B
* Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening.

Other inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis C, hepatitis D or HIV
* Patient previously received nucleoside(tide) therapy other than adefovir
* Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months

Other exclusion criteria may apply.
My Research Legacy Pilot Study

The My Research Legacy Pilot Study will establish a participant registry that collects self-reported health data and answers to online survey questions about individual daily choices, diets, and exercise; data from wearable devices; and, (optional) data from genome sequencing analysis. Individuals under the age of 50 who meet eligibility criteria will answer questions using the American Heart Association's (AHA) Life's Simple 7™ My Life Check v4.0 three times over the course of 6 months and transmit data from a Fitbit Charge 2 device. All other individuals who are interested in the study and meet entry criteria may also enroll.

2,000 Participant My Research Legacy Pilot Study

1. Day 0 - Enroll online, complete AHA's Life's Simple 7™ Survey Prospective participants will enroll in the research initiative via the My Research Legacy website (MyResearchLegacy.org). They will go through an online process in which they will answer brief, pre-qualifying questions before consenting to participate in the study.

   * Participants will attest to their age and US residence, and will provide a self-reported diagnosis of cardiovascular disease (myocardial infarction, atrial fibrillation, aortic dissection, systolic congestive heart failure/cardiomyopathy) and/or stroke.
   * Eligible participants will read and sign an online consent form.
   * Within the participant console, the participants will answer AHA's Life's Simple 7™ My Life Check v4.0 assessment.
   * Participants will be asked during the consent process if they will consent to provide medical records relevant to their diagnosis.
2. Day 90 Complete AHA's Life's Simple 7™ My Life Check v4.0 assessment; Start transmission from the Fitbit Charge 2.
3. Online Survey and contact Day 180 after enrollment, participants will receive an email requesting that they visit the participant console to repeat AHA's Life's Simple 7™ My Life Check v4.0 survey. Participants also have the option of determining whether or not they want to be contacted for future studies.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> or = to 18 years but \< 50 years.
2. History of one (or more) of the following:

   1. Myocardial infarction
   2. Stroke
   3. Aortic dissection
   4. Systolic heart failure/cardiomyopathy
   5. Atrial fibrillation
3. Individuals of any age \> or = 18 years who don't have above medical conditions but want to participate in the study.
4. Access to a computer and/or cell phone with internet access.

Exclusion Criteria:

1. Unwillingness to sign informed consent
2. No access to a computer and/or cell phone with internet access.
Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients

The purpose of this trial is to evaluate if the use of a newly developed lipid formulation versus fish oil would better enable the absorption of essential fatty acids after 12 weeks of supplementation.


Eligibility Criteria:
Inclusion Criteria:

1. Previously diagnosed CF according to established criteria (diagnosis of CF will be based on either two positive sweat chloride tests of \>60 mEq/L or the identification of two detectable mutations associated with CF)
2. Exocrine pancreatic insufficiency defined by pathological fecal elastase (\<15µg/g) found in the Medical History of the patient
3. Informed consent letter signed and dated by their parents or legal guardians before inclusion in the study, and assent signed and dated by the child if he or she is ≥ 14 years old

Exclusion Criteria:

1. Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or for CF-related conditions within 4 weeks prior to baseline
2. Exposure to another investigational drug or dietary supplements and enteral nutrition containing EPA and docosahexaenoic acid (DHA), Fish or the use of any other supplement containing fish oil within 4 weeks prior to baseline.
3. Treatment with intravenous antibiotics within 4 weeks prior to baseline
4. Newly started oral antibiotic treatment within 4 weeks prior to Baseline
5. History of solid organ or hematological transplantation
6. Ongoing immunosuppressive therapy (other than corticosteroids) within 3 weeks prior to baseline
7. Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to baseline
8. Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to baseline
9. Having donated blood or had a transfusion of blood/blood products during the trial and 3 months prior to screening or expected to do so during the study
10. Any bleeding disorders at screening
11. Patient who cannot be expected to comply with the study procedures.
12. Currently participating or having participated in another clinical trial within 8 weeks prior to baseline.
13. Any known food allergy
14. Incapacity to swallow capsules
Cellular and Molecular Events During Treatment of Actinic Keratosis With Imiquimod 5% Cream

Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin cells should also be visible using a special microscope. This study examines both types of changes.

The primary objective of this study was to assess apoptosis by examining the gene expression profiles of actinic keratosis (AK) lesions that were treated with imiquimod 5% cream or vehicle cream once daily 3 times per week for 4 weeks. Secondary objectives were to assess the utility of confocal microscopy (CM) to visually track cellular response to treatment with study cream compared with clinical and histological evaluations, and to evaluate the safety of treatment with imiquimod in subjects with AK on the balding scalp.

Eligibility Criteria:
Inclusion Criteria:

* Have actinic keratoses on balding scalp
* Discontinuation of tanning bed use
* Discontinuation of moisturizers
* Avoidance of retinol products

Exclusion Criteria:

* Uncontrolled, clinically significant medical condition
* Dermatologic disease other than actinic keratosis in treatment area
MobileMedMinder: A Networked Aide for Medication Compliances

The main aim of this study is to conduct a randomized control trial to compare MobileMedMinder, a mobile phone based medication reminder software product, with currently accepted and empirically supported methods for increasing medication compliance through reminders and tracking.


Eligibility Criteria:
Inclusion Criteria:

* Taking beta blockers, ACE or ARB, and hydralazine for treatment of HF.

Exclusion Criteria:

* Inability to understand informed consent
* Inability to read and understand English
Trunk Muscle Strength and Endurance in Chronic Ankle Instability

Evaluation of trunk muscle strength in patients of chronic ankle instability

This study will be conducted in the Isokinetic Laboratory. Sixty females with CAI will participate in this study. Their age will range from 18-30 years. They will be divided into two groups; the experimental and the control group. The experimental group will involve 30 females with CAI and the control group will involve 30 healthy females. The isokinetic strength of trunk muscles will be evaluated in a concentric mode of muscle contraction at an angular velocity 60°/sec. McGill test will be used to assess trunk muscle endurance.

Eligibility Criteria:
Inclusion Criteria:

* The initial sprain must have occurred at least 12 months prior to study enrollment.
* The most recent injury must have occurred more than three months prior to study enrollment (unassisted walking without limping for at least three months after injury).
* A history of the previously injured ankle joint giving way, recurrent sprain and/or feelings of instability.
* The injured/unstable ankle functionally weaker, more painful, looser, and less functional than the uninvolved ankle.
* The Oswesty Disability Index (ODI) score for both groups is from 0 to 20% (minimal disability) (Fairbank and Pynsent, 2000).

6- The Identification of Functional Ankle Instability questionnaire (IdFAI) score is less than 10 for the experimental group and 11 or more for the control group (Simon et al., 2012).

Exclusion Criteria:

* 1-A history of previous surgeries or fractures in either limb of lower extremity.

  2-Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least one interrupted day of desired physical activity.

  3-Any positive ﬁndings of the anterior drawer or talar tilt test (Hubbard and Kaminski, 2002).

  4-Any shoulder (Kibler et al., 2006) or elbow injuries (Ben Kibler and Sciascia, 2004).
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease

Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.

Subject population: up to 400 female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care at up to 50 global sites in the US, UK and Europe. Subjects will have clinical follow-up prior to discharge from the index intervention and at 30 days, 1, 2 and 3 years.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is a non-pregnant female ≥18 years of age
2. The subject meets indications for PCI and stent
3. The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion
4. The subject is willing to comply with protocol-specified follow-up evaluations
5. The subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Exclusion Criteria:

1. Subjects with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
2. Subjects presenting with cardiogenic shock at the time of the index procedure
3. Serious angiographic complication in the target vessel prior to treatment with coronary IVL including-severe dissection (Type D to F), perforation, abrupt closure, persistent slow-flow or persistent no reflow
4. Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines
5. Subject is enrolled in any study of an investigational device or drug that may interfere with study results
Impact of Face-to-face Meditation on Non-attachment to Self and Identity Threat

Meditation is widely recognized for its benefits on both physical and psychological health and more particularly on the prevention of depression relapse. However, despite a lot of literature showing its efficacy, the mechanisms of action underlying its benefits have yet to be specifically identified and empirically tested.

to understand these mechanisms actions, it is essential to distinguish meditative practices. Three different categories of meditation can be distinguished: "Attention Family", "Constructive Family" and "Deconstructive Family" with specific effects for each.

The aim of the study is to compare the effects of two types of meditation (focused attention and contemplation) on non-attachment to the self and identity threat

Eligibility Criteria:
Inclusion Criteria:

* male or female
* aged of 18 and more
* without diagnosed psychiatric pathology
* not practicing meditation
* agreeing to participate in the study

Exclusion Criteria:

- less than 18 years old