cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Adhering Flowable Composite With and Without Adhesive Vs Flowable in Cervical Lesions

With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable composite with and without adhesive system will have the same clinical performance as conventional flowable composite in cervical caries lesions.

flowable composite is considered a gold standard in class V restorations due to its resilient character the prevents its dislodgement in this area. self-adhering flowable composite would simplify the clinical steps and claims to improve the adhesion.

Eligibility Criteria:
Inclusion Criteria:

* patients with anterior cervical carious lesions.
* Pulp asymptomatic vital carious anterior teeth.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Deep extensive carious cavities that may lead to the fracture of the tooth or pulpal affection.
* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
* Heavy smokers.
Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

The purpose of the study is to evaluate the ration of patients getting an lighten therapeutic strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM) in grade I (cohort 1) or metastatic (cohort 2) seminoma


Eligibility Criteria:
Inclusion Criteria shared:

* Histologically proved seminoma after orchiectomy
* Primary testicular or retroperitoneal
* Normal alpha-fetoprotein before and after orchiectomy
* No prior treatment with radiotherapy or chemotherapy
* Age \>= 18 years
* ECOG 0 to 2
* PNN \>= 1500, platelets \>= 100 000, bilirubin \<= the upper limit nromale
* ASAT (SGOT) and ALAT (SGPT) \<= 1,5 x the upper limit nromale
* Serum creatinine \<140 µmol / L (or clearance\> 60 mL / min)
* Information and signed informed consent before inclusion in the study
* Patient affiliated to a social security

Specific inclusion criteria for cohort 1:

* grade I

Specific inclusion criteria for cohort 2:

* grade IIB (retroperitoneal adenopathy diameter between 2 cm and 5 cm, regardless of the LDH)
* grade IIC (retroperitoneal adenopathy diameter higher than 5 cm, regardless of the LDH)
* grade III of good prognosis (supradiaphragmatic reach with ganglionic metastasis and LDH \< 2 times normal limit and/or supradiaphragmatic reach with pulmonary metastasis and LDH \< 2 times normal limit) either at initial diagnosis or relapse of a grade I seminoma)
* PET-TDM positive (pathological fixation on metastatic lesions)

Exclusion Criteria shared:

* Patient infected by HIV, Hepatitis B or C
* History, within 5 years, of cancer other than seminoma, except for treated skin cancer (Basal Cell) .
* visceral metastasis
* cerebral metastasis
* Any physical or mental condition incompatible with the treatment (to the investigator discretion)
* Uncontrolled or severe cardiovascular pathology
* Uncontrolled or severe hepatic pathology
* Persons deprived of liberty or under guardianship
* Unable to undergo medical monitoring due to geographical, social or psychological reasons
An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain

This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.

This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.

Eligibility Criteria:
Inclusion Criteria:

* abdominal ( non-laparoscopic abdominal surgeries) or orthopedic ( hip or knee joint replacement) surgery or other surgeries requiring multiple doses of parenterally administered NSAIDs over multiple days
* Expected stay \> 48 hrs

Exclusion Criteria:

* bilirubin \> 2.5 mg/dl
* prothrombin time is \> 20% above the upper limit of normal
* serum creatinine is \> 1.9 mg/dl at screening.
* known allergy or hypersensitivity to diclofenac, other NSAIDs,
Elective Mucosal Irradiation in Head-and-Neck Cancer of Unknown Primary

The optimal treatment of HNCUP remains controversial and lacks evidence from prospective randomized trials. The management of these patients relies primarily on surgery and radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains controversial. The main debate concerns the extent of the radiation field. Although pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been associated with significant toxicity and long-term morbidity (mostly xerostomia and dysphagia). Most single institution retrospective studies have not shown any advantage for more extensive irradiation.Therefore, elective mucosal irradiation may might be appropriate only for these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Carcinomas metastatic to cervical lymph node with unknown primary
2. Squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma
3. All patients must be suitable to attend regular follow-up and undergo toxicity assessment.
4. Stage T0, N1-3, M0 disease
5. Karnofsky score over 60
6. No significant cardiac, chest, gastrointestinal or renal morbidities

Exclusion Criteria:

1. Previous radiotherapy to the head and neck region
2. Previous malignancy except non-melanoma skin cancer
3. Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy

The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* has Type 1 or Type 2 diabetes mellitus
* has a history of chronic pain attributable to a symmetrical stocking distribution neuropathy in the lower extremities for a duration of at least six months but less than or equal to five years prior to Screening

Exclusion Criteria:

* has neuropathy secondary to non-diabetic causes
* has a significant neurological disorder or a condition that can cause symptoms that mimic peripheral neuropathy or might confound assessment of PDN
* has other chronic pain with intensity at or greater than the bilateral pain in the feet/toes
* is using an implanted medical device (eg, spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for the treatment of pain
* is pregnant or lactating
Effect of Telehealth Mindfulness on Sleep and Anxiety in Acquired Brain Injury Population

The goal of this study is to learn the effect of a telehealth mindfulness meditation program on sleep quality and anxiety in individuals with brain injury living in the community. The main questions it aims to answer are:

* Does an eight-session mindfulness meditation program change sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in individuals with acquired brain injury?
* Does an eight-session mindfulness meditation program change anxiety levels as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form in individuals with acquired brain injury?

Participants will:

* Complete eight sessions of mindfulness meditation over 4 to 5 weeks
* Complete two mindfulness meditation sessions per week.
* Complete two additional sessions for pre- and post-test measurements.

This is a pilot study examining the effects of a mindfulness meditation program on sleep quality and anxiety levels in individuals with acquired brain injury living in the community. Participants will receive a thirty-minute mindfulness meditation session. Each thirty-minute session will consist of five minutes of introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of education and discussion. Participants will need to complete eight sessions of mindfulness meditation and pre-and post-tests to be included in the data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Known diagnosis of acquired brain injury
* Score 19 or below on the Short Orientation-Memory-Concentration Test of Cognitive Impairment (SOMC)
* 18 years or older
* Can speak and comprehend English
* Have access to an internet connection and an electronic device

Exclusion Criteria:

• Diagnosis of aphasia.
ADVANCE- Automated Detection and Volumetric Assessment of ICH

To evaluate the performance of the Viz ICH VOLUME algorithm.

To evaluate the performance of the Viz ICH VOLUME algorithm to:

1. detect the presence of ICH on brain imaging,
2. measure the volume of ICH on brain imaging,
3. and to assess the algorithm processing time,
4. and the difference in time to notification, time to treatment, and clinical outcomes in comparison to standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 and older)
* Presenting with symptoms suspicious for an acute stroke / intracranial hemorrhage
* Having a complete imaging data set including NCCT +/- MRI, CTA and/or MRA

Exclusion Criteria:

* Subjects with poor or incomplete brain imaging.
Clinical Verification Evaluation of VeinViewer® Device

Measure accuracy of vein width using VeinViewer®, compared against ultrasound imaging as a gold standard


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* Must be able to read and understand English to understand the consent letter

Exclusion Criteria:

* Less than 18 years of age
* Unable to read and understand English to understand the consent letter
Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh

Background: In developing countries, many babies are born at home and the umbilical cord commonly becomes infected during the first week after birth, and can be deadly. Cleansing of the cord with a low-cost antiseptic like chlorhexidine may reduce the risk of these infections. Little is known, however, about the frequency of chlorhexidine cleansing needed to impact upon the overall presence of bacteria on the stump, or regarding the changes in bacteria during the first week of life when most cord infections occur.

Objectives: We will describe the profile of bacteria colonizing the umbilical cord stump of infants in rural Bangladesh and examine the role of topical chlorhexidine in altering colonization and progress of infection. We will compare the overall and bacteria-specific rate of colonization of the cord stump between infants receiving chlorhexidine cleansing of their cord through the first day or first week of life. We will also quantify the relationship between colonization of the cord stump with specific pathogens and the presence and severity of signs of umbilical cord infection (pus, redness, swelling) among these newborns.

Potential Impact: More information is needed on the impact of single versus repeated applications of chlorhexidine to the cord stump, as the number of cleansing may substantially influence the feasibility of widespread scale-up in many populations. The data generated from this proposed study will guide the most appropriate design of this simple intervention and will help inform specific treatment protocols for effective management of infants with signs of umbilical cord infections.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria:

* Not enrolled in parent trial
* First visited after 48 hours of life
Glucose:Fructose Versus Glucose Carbohydrate Ingestion and Endurance Performance

The primary objective is to show that multiple transportable carbohydrate ingestion is more effective in improving endurance performance compared to single transportable carbohydrate ingestion.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 18 to 60 years
* A history of competitive triathlon performance (≥ 2 years)
* Participation in at least four competitive triathlon events within the past 2 years
* Be in regular training for triathlon events
* A personal best time for a standard ½ Ironman race (1.9 km swim, 90 km cycle, 21.1 km run) in the last year of either:

  * ≤ 6 h 00 min, for men aged 18-40 years
  * or ≤6 h 05 min for men aged 40-50 years
  * or ≤6 h 20 min for men aged 50-60 years
* Alternatively, if not competed in ½ Ironman in the last year, at least one standard distance triathlon (1.5 km swim, 40 km cycle, 10 km run) within the last 12 months:

  * ≤2 h 13 min, for men aged 18-40 years
  * or ≤2 h 18 min for men aged 40-50 years
  * or ≤2 h 23 min for men aged 50-60 years
* Available to compete in the ½ Ironman events and complete all study requirements
* Experienced in using carbohydrate supplementation, as gels, bars, and drinks in training/racing, specifically at rates ≥60-90g/h)
* Experience of specific formulations may include both or only multiple and single transportable carbohydrates, thus a full assessment would be made prior to recruitment to ensure balance during randomization and account for any association with the primary outcome
* Obtained his (or his legal representative's) informed consent.

Exclusion Criteria:

* Failure to meet health requirements defined in the Health Questionnaire
* Prior known fructose intolerance
* Wheat intolerance or other precluding food or packaging-related allergies
* An existing injury affecting ability to race to best ability
* A chronic injury that may affect ability to complete the races
* Unable to carry out performance assessments and questionnaires correctly
* Unable to tolerate the treatment during the familiarization sessions
* Taking medications thought to interfere with the study outcomes
* Currently participating or having participated in another clinical study during the last four weeks prior to the beginning of this study
Place of Comprehensive Geriatric Assessment in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter)

The risk of diagnosis of cancer increases with age, especially breast cancer in elderly women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities, disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a multidimensional approach to determine geriatric profile, in helping the therapeutic strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten questions includes geriatric domains such as functional status, nutrition, mood, cognitive abilities and comorbidities. In elderly patients with breast cancer considered as fit (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and \< 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥ 4 underwent CGA if palliative care is considered.

Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before or after surgery.

The aims of this study are to assess the outcomes regarding the time of CGA, in elderly female patients with breast cancer management, and to define the optimal place of CGA in care pathway.


Eligibility Criteria:
Inclusion Criteria:

* First breast cancer localized, indication of surgery
* Onco-geriatric filter (FOG) \>= 1 ou \< 4

Exclusion Criteria:

* Male, less of 75 years old
* Contraindication of surgery
* Breast cancer with metastasis
* Onco-geriatric filter (FOG) = 0 or 4
Effect of Opposite Leg Position on Hamstring Flexibility in Patients With Mechanical Low Back Pain

PURPOSE: this study aimed to investigate the effect of opposite knee position on hamstring flexibility BACKGROUND Hamstrings tightness is one of the most common findings in patients with LBP. It is thought that, due to the attachments of hamstrings to the ischial tuberosity, hamstrings tightness generates posterior pelvic tilt and decreases lumbar lordosis, which can result in LBP.

HYPOTHESES There will be significant difference in the hamstring flexibility with changing position of opposite knee (flexed or extended) in patients with mechanical low back pain.

RESEARCH QUESTION: Will changing position of opposite knee (flexed or extended) affect the hamstring flexibility in patients with mechanical low back pain?

* The subject will be instructed to maintain 90° hip flexion in the supine position.
* Then asked to actively extend the knee joint.
* The degree of achieving active knee extension will be measured using a universal goniometer.
* The average of three active knee extension measurements will be recorded used as the hamstring muscle length for the data analysis (Dong-Kyu Lee, et al., 2018).
* This test will be done for the same limb with opposite leg extended and with opposite flexed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with history of back pain and assessed with Mechanical inflammatory low back pain index and have very high grade for mechanical component.
* Age ranges from 18-40 years.
* The body mass index of the subject is ≤25 kg/meter square.

Exclusion Criteria:

1. Previous trauma, fractures or surgery of the back.
2. Malignancy of the back.
3. Rheumatoid arthritis
4. Spondylolysis or spondylolithesis
5. History of lower extremity injury within 6 months prior to the study
Thrombophilia Assessment Under DOAC: Effectiveness of Activated Charcoal

Direct oral anticoagulants (DOAC) are anticoagulant molecules that act either directly on factor Xa (Apixaban, Rivaroxaban) or on factor IIa (Dabigatran).

AODs interfere with most coagulation tests, especially those performed by chronometric technique.

For this reason, part of the thrombophilia workup (protein S, search for lupus anticoagulants, antithrombin for patients on dabigatran) cannot be performed on DOACs at the HUS.

Recent studies have highlighted the effectiveness of activated charcoal to adsorb DOACs in order to perform certain hemostasis tests.


Eligibility Criteria:
Inclusion criteria:

* Adult subject (≥ 18 years of age)
* Blood sample already analyzed in a usual way in the laboratory as part of the care
* Subject not objecting to the reuse of his or her medical data for scientific research purposes.

Exclusion criteria:

- Insufficient sample
Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test

The objectives of this study are to determine if the left ventricle outflow tract (LVOT) gradients may be reproduced with dobutamine (DBT) provocation test in obstructive HCM patients under general anesthesia and to analyze the change in anatomic LVOT area and pressure gradients (PG) before and after septal myectomy.

If the DBT stress test can reproduce preoperative gradients in HCM patients during septal myectomy surgery, surgeons will have the opportunity to assess the quality of the surgical procedure depending on the obtained gradients with DBT stress test after surgery when gradients can't be reproduced during general anesthesia after myectomy, and decide if further myectomy is required, saving a re-operation on the patient in the future.

Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiomyopathy. Echocardiography is the noninvasive method of choice for the evaluation of morphologic and functional abnormalities in HCM. It is of paramount importance to distinguish between obstructive or non-obstructive HCM, based on the presence or absence of left ventricle outflow tract (LVOT) gradient using continuous wave Doppler (CWD), under resting and/or provocable conditions. HCM can then be divided into three different subgroups. When the gradient at rest is ≥ 30 mmHg the HCM is considered obstructive (HOCM); when the gradient is \<30 mmHg at rest but ≥ 30 mmHg with provocation, the HCM is considered latent obstructive, and finally, non-obstructive occurs when the gradient is \< 30mmHg at rest or with provocation.

The gold standard technique to treat symptomatic HOCM is the surgical transaortic septal myectomy, when the resting gradient or the provocable gradient is ≥50 mmHg. Hemodynamic conditions may change and lead to worsening or improvement in LVOT obstruction during general anesthesia. LVOT gradients during surgery should be measured under reproducible conditions possibly mimicking preoperative hemodynamics.

Dobutamine is a well-known inotropic agent, capable to induce sub-aortic gradients in HOCM. The development of a dynamic LVOT gradient during this test is a pharmacological phenomenon with no clinical significance, not been associated with increased frequency of chest pain, shortness of breath or ischemic wall motion abnormalities, because obstruction resolves after termination of dobutamine (DBT) infusion.

Eligibility Criteria:
Inclusion Criteria:

1. HOCM refractory to medical treatment with symptoms like syncope, angina or NYHA functional classes III and IV, with a resting gradient or provocable gradient equal or greater than 50 mmHg, requiring surgical intervention.
2. Absence of other cardiac or systemic diseases capable of producing hypertrophy.
3. Sinus rhythm.

Exclusion Criteria:

1. Patient refusal.
2. Patient unable to give consent.
3. TEE contraindication.
4. Different rhythm than sinus.
5. Other systemic diseases capable of producing hypertrophy.
6. Severe Aortic or coronary artery pathology.
Topical Umbilical Cord Care for the Prevention of Colonization and Invasive Infections

Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs). This study is a prospective, randomized controlled feasibility trial to evaluate three types of hygiene products on umbilical line stumps, on the effect of line colonization and subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be randomized into one of four study groups, three products against standard of care (no product). The three products that will be evaluated are currently being used in different capacities for skin care in the UVA NICU. The study hypothesizes that daily topical application of 1 or more antiseptic to the top of the umbilical stump will decrease colonization of the umbilical stump while umbilical lines are in place.

Umbilical catheter associated infections are higher (4.4 vs. 3.4 CLABSIs per 1000 line days) than other central lines such as PICCs and surgically placed CVLin the NICU. (www.CDC.gov - NSHN 2010 Report). Routine care of the skin entry site (e.g. central line dressing care) is standard for other central lines, but there is no standard for care of the umbilical stump while umbilical lines are in place.

In a pilot study to evaluate the relationship of umbilical stump colonization with gestational age, the number of days the catheter was in place, and the type of organisms, colonization was detected in 78% of patients. There was a direct correlation with colonization and line days as well as an inverse relationship with lower gestational age.

This pilot data supported the need for the study of interventions to reduce umbilical stump colonization, which may help decrease blood stream infections (BSIs) associated with umbilical lines in the NICU. The proposed study will evaluate feasibility of once daily product application.

Eligibility Criteria:
Inclusion Criteria:

\*≤7 days of life

\*Umbilical line(s) in place (UAC and/or UVC)

Exclusion Criteria:

\*Not meeting inclusion criteria