cyrilzakka/clinical-trials huggingface dataset:
"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"

The purpose of this study is to evaluate etoricoxib efficacy in pain control, leg stiffness and functional recovery of patients suffering acute Achilles tendinopathy.

It is hypothesized that etoricoxib (120mg orally/day/7 days) efficacy is not inferior to diclofenac (150mg orally /day/7 days) for pain control in subjects suffering acute Achilles tendinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible if they are male between 18 and 50 years of age and they suffer acute Achilles tendinopathy (\<2 weeks). Diagnosis of Achilles tendinopathy is made by means of activity-related achillodynia, morning stiffness or pain, painful one-legged jumping test, tenderness and decreased sports performance (26). Subjects' age, race, affected tendon (right, left), activity, height and weight will be recorded.

Exclusion Criteria:

* Patients are excluded from the study if they have:
* Prior lower limb surgery or major trauma.
* Bilateral Achilles tendinopathy.
* History of lower limb radiculo-neuropathy or miopathy.
* Hypersensitivity to any NSAIDs.
* Used analgesic agents (NSAIDs, salicilates, narcotic) within 1 week
* Concurrent medical/arthritic disease (e.g. gout, lupus, rheumatoid arthritis).
* Other concurrent medical conditions including diabetes, hypertension, angina or congestive heart failure, ischaemic cardiopathy, malabsorption, morbid - Personal history of renal dysfunction, hepatic dysfunction or anemia
* Used corticosteroids, clopidogrel bisulphate, rifampin, quinolon antibiotics, antiepileptics, muscle relaxants, warfarin, ticlopidine, glucosamine, condroitin sulphate for \< 6 months prior to the study start. Patients taking low dose aspirin (100 mg) for cardioprotective benefit will be also excluded. Any other medication consumption will be considered by the investigator and the Ethical Committee.
* Any other condition which, in the opinion of the investigator, could confound the study results or pose a risk to the patient (for example, co-morbid conditions for which NSAIDs are contraindicated).
* History of psychotic illness, dementia or depression
* History of drug or alcohol abuse or dependence.
* Participated in any previous NSAIDs study and received active treatment, or in an investigational trial within 30 days prior to the first visit.
* Inability to communicate or to cooperate with the investigator.
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer

This pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with or without chemotherapy for head and neck cancer

PRIMARY OBJECTIVES:

I. To determine the complete response rate, decrease in severity, and time to complete response of oral mucositis related to head and neck cancer irradiation and chemotherapy after using L-lysine supplementation daily.

SECONDARY OBJECTIVES:

I. To determine the functional impact of use of L-lysine for oral mucositis on daily life as measured by the Functional Life Index-Cancer (FLIC) Questionnaire total score.

OUTLINE:

Patients receive L-lysine orally (PO) once daily (QD) until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up weekly until mucositis resolves.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically or pathologically proven cancer of the oropharynx, lip, oral cavity, larynx, hypopharynx, nasopharynx, and salivary glands
* Predicted life expectancy greater than 12 weeks
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Renal function with a calculated creatinine clearance of 55 ml/min or greater, per Cockcroft-Gault formula
* Patients undergoing radiation therapy with or without concurrent chemotherapy
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

* Use of illicit drugs, alcohol abuse, or tobacco abuse during treatment
* Subjects may not be receiving other investigational agents
* Inability or unwillingness to comply with radiation therapy and chemotherapy regimens
* Inability or unwillingness to take daily L-Lysine supplementation as prescribed
* Use of arginine supplementation
* History of renal failure or compromise
Understanding, Modulation and Memorization of Indicators Associated to Peri-implantitis

Communication strategies are encouraged to enhance patients´ understanding of potential events related to implant therapy such as peri-implantitis. Moreover, it is key to provide accurate information to patients receiving dental implants to reduce false expectations and to minimize the alterations concerning satisfaction. Information leaflets based in the "health-belief model" proved efficiency in improving health judgments, decisions and behaviors, in particular when supplemented with visual aids. Hence, it was the purpose of the present study to test the effectiveness of different communication strategies to enhance and modulate the understanding and memorization of risk indicators associated to peri-implantitis.

A prospective randomized controlled three-arm study is being conducted in accordance with the Declaration of Helsinki on human studies. Three groups are defined to test the hypothesis that visual aids improve the understanding, modulation and memorization of peri-implantitis and related indicators as follows:

* Test group1 - Leaflet with visual aid (L-VA): Information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included (supplementary figure 1). Relevant scientific bibliography supported the statements. Along, pictograms were supplemented to display the prevalence of disease with and without the known indicator.
* Test group2 - Leaflet with visual aid (L-NVA): Information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included (supplementary figure 2). Relevant scientific bibliography supported the statements. No pictograms were supplemented.
* Control group - No leaflet (NL): Only verbal information was provided to the patient during initial interview.

Patients will be randomly assigned to the tests or control groups according to the last digit of their chart number. As such, patients with records ending 1-4, 4-7 and 8-0 were included in test group1, test group2 and control group, respectively. When reached the total sample size of any of the groups, patients were only recruited for the remaining groups to complete the total sample size. A questionnaire based on the "health-belief model" will be collected from every eligible patient at baseline, 3- and 6-month follow-up


Eligibility Criteria:
The following inclusion criteria were applied: partially or completely edentulous patients aged 18-80 years and rehabilitated with implant-supported, single-crown fixed prostheses or implant-supported overdentures; smokers or non-smokers; absence of infectious disease at the time of implant placement; and absence of systemic disorders or medications known to alter bone metabolism. Subjects were excluded if they were pregnant; presented uncontrolled medical conditions or diseases (i.e., diabetes mellitus with HbA1c level \>8); or presented zygomatic or pterygoid implants. Patients with treated peri-implantitis/mucositis were likewise excluded.
US-guided Ilioinguinal Blocks Versus Local Infiltration

Injection of local anesthetic drugs is an effective way to freeze (block) nerves to achieve loss of sensation during surgery and satisfactory pain control afterwards. Many studies have shown that nerve block is associated with higher degree of success in controlling pain after open inguinal hernia repair. Nerve block can be administered by a single injection with a long acting local anesthetic agent using ultrasound guidance. This study is to compare different techniques for freezing the nerves responsible for pain after open inguinal hernia repair. Patients will be randomized to one of two groups. In the first group, participants will receive ultrasound-guided nerve block following induction of general anesthesia but prior to surgical procedure. In the second group, participants will receive local anesthetic injection directly into the wound by the surgeon prior to closure. The investigators will assess the level of pain control for 48 hours after the surgical procedure. Patients will be provided with additional medications for pain relief if necessary. The investigators will also contact participants to follow-up with regard to possible chronic groin pain after 3 months following the surgical procedure.

populations. It is well-known that inguinal hernia surgery can lead to significant degree of acute perioperative pain. At the same time, patients undergoing inguinal hernia operation are at increased risk to develop chronic neuropathic groin pain. In the literature, several approaches to prophylaxis and treatment of perioperative pain have been described including: infiltration of local anesthetics by surgeons, ilioinguonal/iliohypogastric nerve blocks, neuroaxial blockade, and caudal block in pediatric petients.

Recent studies have shown that ultrasound guided ilioinguinal/iliohypogastric nerve block is associated with increased level of safety, improved success rate, and reduction in dose of local anesthetic required compared to the "blind" technique.

The aim of our study is to investigate the role of ultrasound guided ilioinguinal/iliohypogastric nerve block in prevention of perioperative and persistent neuropathic pain following open inguinal hernia repair in comparison with infiltration of local anesthetics by surgeons. In the first randomized group of patients we will perform ultrasound guided ilioinguinal/iliohypogastric nerve block using the same types and amount of local anesthetics. In the second group, patients will receive infiltration of the same type and amount of local anesthetics by surgeons.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3
* Both gender
* 18 years and older
* Informed consent

Exclusion Criteria:

* ASA 4 and more
* Lack of informed consent
* Patients with history of chronic pain
* Patients on regular opioids
* History of allergic reaction to local anesthetics
* Medication or non-medication induced bleeding diastasis
* Infection at the site of injection
* Patients with bilateral hernias
* linguistic difficulties
Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure.

The aim of the study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy undergoing left ventricular assist device implantation.

End-stage ischemic cardiomyopathy (ICM) with non-graftable coronary arteries is a common and debilitating problem. The ultimate therapeutic goal in such cases is cardiac transplantation which is restricted by donor availability. Alternatively, left ventricular assist devices (LVAD) are increasingly used as bridge to transplantation or more recently as destination therapy in non-transplant candidates. Widely used second- and third-generation continuous-flow LVAD offer symptomatic relief and prolong life. However, LV unloading rarely improves native heart function in ischemic hearts. We aim to increase myocardial viability and improve native cardiac function in patients with end-stage ICM by injecting allogeneic bone marrow stem cells at the time of LVAD implantation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years
* End-stage heart failure due to ischemic cardiomyopathy that requires mechanical support according to current indications
* Ability to provide informed consent

Exclusion Criteria:

* Not willing to provide informed consent
The Effect of Sports and Arts on Job Engagement Among Physicians

The goal of this observational study was to learn about the relationship between the sociodemographic characteristics or leisure time activities of physicians and their job engagement.

The main question it aims to answer was: Do sports or artistic activities increase job engagement among physicians? A survey was administered to physicians, to collect sociodemographic and professional characteristics (including sports and artistic activities), followed by a face-to-face application of the Utrecht Work Engagement Scale (UWES-17).


Eligibility Criteria:
Inclusion Criteria:

* All physicians who agreed to participate in the study were included.

Exclusion Criteria:

* Those who did not complete the questionnaires were excluded.
Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography

Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer.

Objectives: 1) To establish the non-inferiority of the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer; and 2) To demonstrate in a comparative side-by-side feature analysis that interpretations based on the Planmed Sophie Nuance FFDM X-ray System are diagnostically non-inferior to SFM in the detection of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 40 years of age or older
2. Subject is presenting for routine breasts cancer screening (Cohort I) OR Subject has one or both breasts scored 4 or 5 on the BI-RADS scale as a result of SFM either for routine breast cancer screening or for follow-up or diagnostic mammography (Cohort II)
3. Subject's schedule permits the SFM and the FFDM to be performed no more than 30 days apart and with no intervention between the exams
4. Subject will provide prospective, written informed consent
5. Subject is considered capable of complying with study procedures including a willingness to return for a one-year follow-up exam -

Exclusion Criteria:

1. Subject is pregnant or possibly pregnant or planning pregnancy within the next 15 months
2. Subject has undergone a breast augmentation or breast implant? Has subject had any of the following breast procedures?

   Fine needle or cyst aspiration NOT Eligible if within past year Biopsy Not Eligible if within past year Lumpectomy (for breast cancer) Mastectomy (for breast cancer) Radiation therapy Breast reconstruction Breast reduction Not Eligible if within past year
3. Subject has had an invasive breast procedure or operation within the past year
4. Subject has significant existing breast trauma
5. Subject has a history of breast cancer treated with operation or radiation
6. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome

The aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with Down syndrome.

Patients will be enrolled at the S.C. Odontostomatologia dell'Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, Italy. After the collection of the periodontal clinical indexes (BoP%, PCR%, dental mobility, mMGI, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders.

Then, they will be randomly divided into two groups according to the home treatment:

* in the Trial group Biorepair Plus Parodontgel Intensive (containing microRepair®, hyaluronic acid, Lactobacillus Ferment and Aloe Barbadensis Leaf Juice Powder) will be used once a day for all the duration of the study
* in the Control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study.

Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint.


Eligibility Criteria:
Inclusion Criteria:

* not bedridden patients with Down syndrome
* gingival inflammation and bleeding

Exclusion Criteria:

* lack of compliance signalled by caregivers
* other systemic diseases
Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals

The purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline.

In a double blind, randomized manner, 40 free living males and females between 55 to 75 years with age-associated memory decline will ingest Brainphyt supplement or Placebo for 12 weeks. Cognitive function battery will be realized after 4 and 12 weeks of supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Be able to give written informed consent and to consume the investigational product daily for the duration of the study.
* Healthy males and females aged ≥ 55 and ≤ 75 years old.
* Body-mass index between 18.5 and 35.0 kg/m2
* Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance).
* Have age-associated memory impairment (AAMI) based on the following National Institute of Mental Health criteria, specified as scoring:

  1. Absence of dementia as determined by a score of \>24 on the Mini Mental State Examination (MMSE).
  2. ≤29 or ≤9 on the VPA I and II portions of the Wechsler Memory Scale IV, respectively
  3. A score on the MAC-Q of ≥25.
* Is in general good health, as determined by the investigator
* Ability to comply and understand the cognitive function practice tests
* Willing to maintain their habitual diet and exercise routines.
* Willing to maintain consistent sleep duration the evening before study visits.

Exclusion Criteria:

* Use of medications or supplements known to alter cognitive function within past 2 weeks
* Abnormal clinical laboratory test that may affect study outcome.
* History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurological disorders (including sleep disorders, head injuries, Alzheimer's disease, Parkinson's disease, stroke, inflammatory brain disease
* History or presence of cancer, except nonmelanoma skin cancer
* Uncontrolled hypertension/diabetes
* History of depression within past 24 months or use of psychotropic medications within 1 month of screening
* Planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study.
* History within previous 12 months of alcohol or substance abuse.
* History of heavy smoking (\>1 pack/day) within past 3 months
Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant

Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter.


Eligibility Criteria:
Inclusion Criteria:

* Availability of a 4/8 - 6/8 HLA-matched related donor or a 7/8 HLA-matched unrelated donor
* Receiving first allogeneic transplant
* KPS \>/= 70%
* MDS associated with TP53 mutation AND R-IPSS high or very high risk at diagnosis OR
* AML with adverse risk cytogenetics or molecular abnormalities according to the 2017 ELN risk stratification OR pre-transplant MRD by either flow cytometry, cytogenetics or FISH
* Less than 5% myeloblasts in the marrow pre-transplant

Exclusion Criteria:

* Poor cardiac function defined as LVEF \<45%
* Poor pulmonary function defined as FEV1, FVC, or DLCO \<50% predicted
* Poor liver function defined as bilirubin \>/=2.5mg/dL, AST/ALT \>3xULN
* Poor renal function defined as creatinine \>/=2.0mg/dL or CrCl \<40mL/min
* Ongoing or active systemic infection, active Hepatitis B or C virus infection, or known HIV positivity
* Patient requiring treatment with a moderate or strong inhibitor or inducer of CYP3A4 or a P-gp inhibitor within 7 days prior to starting preparative chemotherapy through Day +4 post-transplant
Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury

Effect of Early Memantine Administration on Outcome of Participents with Moderate to Severe Traumatic Brain Injury

Studying the effect of memantine on platelet, platelet/lymphocyte ratio (PLR) and C reactive protein (CRP) \& serum NSE levels in participents with moderate to severe TBI as well as outcome.

Investigators evaluate prognostic effect of memantine on participents with moderate to severe TBI. also to estimate which of platelet, platelet/lymphocyte ratio (PLR), C reactive protein (CRP) or serum NSE levels will be affected by administration of memantine in participents with moderate to severe TBI as a predictor of outcome.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe closed TBI with initial GCS of 4-12
* Age from 18 to 65 years of both sexes
* Able to tolerate enteral feeding and drug administration within the first 24 hours of TBI.

Exclusion Criteria:

* Open TBI or patients who would need open craniotomy later on.
* Comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours, acute or chronic renal insufficiency, hepatic diseases, autoimmune abnormalities, history of epileptic fits and known malignancies.

Patients with chest, cardiac, abdominal trauma or any other trauma requiring mechanical ventilation.

Patients with body mass index (BMI) \<18.5 or \> 34.9 kg/m2.
The Association Between Uterine Artery Notch and First Trimester Bleeding

The purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery Doppler.

A prospective study is designed and two groups will be studied; patients with abnormal uterine artery Doppler at second trimester (study group) and patient with normal uterine artery Doppler at second trimester (control group).The patients will be asked, as part of the routine history taken before the US about having first trimester bleeding during the current pregnancy.

The purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery Doppler.

A prospective study is designed and two groups will be studied; patients with abnormal uterine artery Doppler at second trimester (study group) and patient with normal uterine artery Doppler at second trimester (control group). Both the study group and the control group represent high risk pregnant patients and the Doppler flows are done as part of the patient's predictive risk for placental associated abnormalities. The patients will be asked, as part of the routine history taken before the US about having first trimester bleeding during the current pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with abnormal uterine artery Doppler at second trimester

Exclusion Criteria:

* Multi fetal pregnancies
* Patients without known gestational age (according to last month period or first trimester ultrasound
* Pregnancies with congenital structural or chromosomal anomalies
* Lack of prenatal care