cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Salivary Galectin-8, Galectin-9 and RANKL Levels of Individuals With Different Periodontal Diseases

The aim of this study is; detection of Galectin-8, Galectin-9 and RANKL levels in saliva samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine Galectin-8, Galectin-9 and RANKL levels in the biological samples.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
* At least twenty permanent teeth in the mouth
* Non-smoker
* No medication for continuous use
* Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
* Not in pregnancy or lactation period.
* For the periodontitis group that has not received periodontal treatment in the last 6 months
* For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss
* For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss
* For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.

Exclusion Criteria:

* Any oral or systemic disease
* Regularly using a systemic medication
* During pregnancy or lactation
* Received periodontal treatment within the last 6 months.
* Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
* Smokers are not included in the study
A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)

The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will assess the use of the medication metformin to improve quality of life, exercise capacity, and improved outcomes in heart failure patients with pre-DM or early DM (type II).

If the patient participates in this study, the patient will receive the drug metformin for approximately 3 months. During the study the patient will undergo comprehensive testing which includes blood draws and echocardiograms. The patient will also fill out a questionnaire. The patient must be 18 years old to participate.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic HF of any etiology
* age ≥ 18 years
* fasting blood sugar equal or greater than 100 mg/dL, or pre-DM (HbA1c 5.7 - 6.4%) or early DM (HbA1c ≥ 6.5%)

Exclusion Criteria:

* current metformin therapy or other anti-diabetic therapy
* previous intolerance to metformin therapy
* renal dysfunction (Cr \>1.5 in men or \> 1.4 in women or creatinine clearance \< 60 ml/minute)
* history of lactic acidosis
* current or planned pregnancy or breast-feeding
Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use

Background: Mesh fixation is a critical step in laparoscopic Transabdominal Preperitoneal (TAPP) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. Fixation is more expensive than non-fixation.

Objective: To compare the efficiency of mesh fixation in laparoscopic TAPP surgical repair of inguinal hernia using sutured repair versus tacker use.

Patients and Methods: This prospective randomized comparative study was carried out on 60 patients who presented with a unilateral inguinal hernia and were assigned to laparoscopic TAPP hernia repair. Patients were randomly allocated into two equal groups (30 patients each); in group A, the mesh was fixed with a Titanium tacker, and in group B, the mesh was sutured and fixed with polypropylene 0.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years
* American Society of Anesthesiologists (ASA) physical status ≤ II
* Patients with body mass index (BMI) of 25 to 35 kg/m²
* Unilateral inguinal hernia

Exclusion Criteria:

* Age \< 21 years
* ASA physical status \> II
* Patients with body mass index (BMI) \> 35 kg/m²
* Pregnant women
* Bilateral inguinal hernia
* Large inguinoscrotal hernia
* Incarcerated hernia
* Recurrent hernia
* Strangulated hernia
* Prostatic diseases
* History of; Convulsions, Cerebrovascular accident, Previous neurological diseases
* Dysrhythmia
* Hypertension
* Ischemic heart disease
* Hyperthyroidism
* Liver or Renal impairment
* Alcohol or drug abuse
Myeloma Novel Drug Discovery Ver 1.2

Myeloma is a bone marrow cancer with over 5000 patients diagnosed in the UK each year. Researchers are committed to improving understanding of myeloma and developing more effective treatments with fewer side effects in order to improve patient outcomes. In order to do this, researchers are collecting samples of blood and bone marrow to test the activity of potential new treatments in the laboratory and to understand what may be the cause of some treatments not working.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who have a diagnosis, or suspected diagnosis, of myeloma or related plasma cell disorder
2. Participants who are undergoing a peripheral blood or bone marrow aspirate sampling for diagnostic, staging or follow-up purposes, before, whilst or after receiving anti-myeloma treatment
3. Participants aged 18 years of age or above
4. Participants willing to consent to an additional sample being taken at the time of their peripheral blood or bone marrow aspirate sampling

Exclusion Criteria:

1. Participants unable to provide consent
2. Participants with known active infectious diseases (e.g. HIV, Hepatitis B/C, COVID) that pose a risk to the use of the sample in the laboratory
Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery

Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.

Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.

- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.

The historic view that young children neither respond to, nor remember, painful experiences to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical patients experienced moderate or severe postoperative pain and 75% had insufficient analgesia.

-Pediatric acute pain services use techniques of concurrent or co-analgesia based on four classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), and acetaminophen (paracetamol).

Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.

Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.

- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.

Eligibility Criteria:
Inclusion Criteria:

* Age: 2-12 years.
* Weight: 15-40 kg.
* Sex: both males and females.
* ASA physical status: 1-II.
* Operation: surgery below umbilicus.

Exclusion Criteria:

* Allergic reaction to local anesthetics (LAs).
* Local or systemic infection (risk of meningitis).
* Coagulopathy.
* Intracranial hypertension.
* Hydrocephalus.
* Intracranial hemorrhage.
* Parental refusal.
* Hypovolemia.
* Spinal deformities, such as spina bifida or myelomeningocele.
* Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.
Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788

The primary objective of the study is to determine the safety and tolerability of multiple doses of orally administered EDP-788. Secondary objectives of the study are to describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after multiple doses of orally administered drug.

Three cohorts of subjects will be enrolled to receive either EDP-788 or placebo. The dose of EDP-788 will be increased with each successive cohort. In addition, a 4th cohort may be enrolled, depending on clinical findings (tolerability, safety, pharmacokinetics) observed in the first 3 cohorts. In each cohort, 8 subjects will receive a q12h oral dose regimen of EDP-788 (6 subjects) or placebo (2 subjects). All subjects receive multiple doses of study drug (EDP-788 or placebo).

Eligibility Criteria:
Key Inclusion Criteria:

* In good general health
* BMI between 18 - 32 kg/m2
* Women must be of non-childbearing potential (surgically sterilized)
* Normal electrocardiogram
* Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 17 - 19 day post-dosing visit

Key Exclusion Criteria:

* Hypersensitivity to macrolide antibiotics
* Abnormal laboratory values
* Gastroenteritis within 1 week of study drug administration
* Use of any investigational drugs within 28 days of study drug administration
* History of gastrointestinal surgery which may interfere with drug absorption
* Active Hepatitis B, Hepatitis C, or HIV infection
* Use of prescription or non-prescription drugs within 14 days of study drug administration
* Use of nicotine within 3 months of study drug administration
Study in HIV1-Positive, Virosuppressed Patients Currently inTreatment With Ritonavir-Boosted Protease Inhibitors (PI/r) Starting Cobicistat-Boosted Darunavir (DRV/c - Rezolsta)

The purpose of this study is to describe the effectiveness of darunavir/cobicistat (DRV/c)-based regimens, measured as maintenance of virological suppression 48 weeks after baseline, defined as the day when the treatment with DRV/c-based regimen is started, through collection of daily practice data in the Italian setting.


Eligibility Criteria:
Inclusion Criteria:

* Adult greater than or equal to (\>=18 years), male and female patients
* Documented Human Immunodeficiency Virus-1 (HIV-1) infection
* Eligible to darunavir/cobicistat (DRV/c) treatment according to Summary of Product Characteristics
* Patients who are able to understand the nature of the study and to provide their consent voluntarily having signed an Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
* Patients in stable (\>= 12 months) treatment with an Antiretroviral (ARV) therapy PI/ritonavir (PI/r)-based, being prescribed Rezolsta (DRV/c) by treating physician
* Patients virosuppressed (HIV-RNA less than \[\<\] 50 copies/milliliters) since at least 6 months, within their HIV treatment at the moment of enrollment; single values of HIV-RNA more than \[\>\] 50 copies/ml not confirmed (blips) will be considered acceptable; last value collected being \< 50 copies/ml

Exclusion Criteria:

* Patient currently enrolled in an interventional study
* Patient currently enrolled in an observational study sponsored or supported by Janssen
* Estimated Glomerular Filtration Rate (eGFR) \< 70 milliliters per minute (ml/min) if any co-administered agent (example emtricitabine, lamivudine, tenofovir disoproxil fumarate, or adefovir dipivoxil) requires dose adjustment based on creatinine clearance
* Pregnancy or breast feeding at enrollment
* Allergy or intolerance to sulphonamides
* Switch from darunavir/ritonavir (DRV/r) 600/100 bis in die (bid)
* Patient currently in mono PI/r therapy
* Patients to be treated within one year with Direct Acting Antivirals (DAAs) for Hepatitis C Virus (HCV) infection
* Chemotherapy scheduled
Vunakizumab in Adults with Spondyloarthritis

This prospective, single-arm, multicenter study is aimed to explore the efficacy and safety of Vunakizumab in adults with spondyloarthritis. The primary endpoint is the proportion of adults with spondyloarthritis achieving ankylosing spondylitis assessment score (ASAS) 40 at week 16 in the treatment of Vunakizumab.


Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years when signing the informed consent;
2. Patients diagnosed with spondyloarthritis (excluding psoriatic arthritis) and are eligible for biologic therapy;
3. The subjects voluntarily signed informed consent before the start of any procedures related to the study, were able to communicate with the investigators smoothly, understood and were willing to strictly abide by the requirements of the clinical research protocol to complete the study.

Exclusion Criteria:

1. Patients with severe hypersensitivity reaction to the active ingredient or any excipient of Vunakizumab;
2. fertile women (defined as all women with the physical requirements for pregnancy) and men who are pregnant or who are unwilling or unable to use highly effective birth control during the study and within 20 weeks after last receiving the study drug;
3. active infection with important clinical significance;
4. patients with moderate to severe heart failure (NYHA class Ⅲ/Ⅳ);
5. patients with malignant tumors who were receiving treatment or were not receiving treatment;
6. concomitant with other inflammatory diseases or severe autoimmune diseases, including but not limited to inflammatory bowel disease, which may affect the efficacy and safety evaluation according to the investigator's judgment;
7. any other condition that the investigator considers would prevent the subject from adhering to and completing the study protocol.
Post-stroke Delirium in Ischemic Stroke Patients

This study is to investigate the predictors of post-stroke delirium, develop and validate a nomogram of post-stroke delirium in the ischemic stroke patients.

Introduction: Post-stroke delirium (PSD) is associated with unfavorable prognosis. Effectively identifying risk factors of PSD and predicting PSD is of essential.

Methods: This is a prospective, single-centered, cohort study.

Eligibility Criteria:
Inclusion Criteria:

1. aged ≥18 years old;(2) ischemic stroke, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) scans;(3) patients or their agencies agree to participate in this study.

Exclusion Criteria:

1. brain dysfunction caused by non-vascular causes such as traumatic brain injury, brain tumor or metastatic brain tumor;(2) history of serious mental illness such as schizophrenia;(3) unable to cooperate to the assessment as deafness, blindness, aphasia, dysarthria;(4) be in coma \[Glasgow Coma Scale (GCS)≤8 points\] or sedation \[Richmond Agitation Sedation Scale (RASS)\<-3 points\], and do not ameliorate during study;(5) with incomplete data.
Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections

Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, aged 18 \~ 75 years (inclusive);；
2. Acute pyelonephritis or other complicated urinary tract infection.

Exclusion Criteria:

1. Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
2. Fungal urinary tract infection;
3. History of allergic to any carbapenem, cephalosporin, penicillin, other β -lactam drugs or other β -lactamase inhibitors;
4. Pregnant or breastfeeding women;
5. Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration;
6. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol.
Amflow-device Can Help Proper Ambu-bag Ventilation

This is a simulation study with a prospective randomized cross-over design. The aim of this study is to evaluate whether Amflow-assisted ambu-bag can delivery the accurate tidal volume compare to ordinary ambu-bag

Ambu-bag ventilation is an essential skill to the patients who needed ventilatory support. However, the delivery of appropriate amount of tidal volume by ordinary manual bag ventilation may be difficult. In addition, it require adequate training to rescurer.

We hypothesised that an Amflow assist ambu bag may be helpful to delivery accurate tidal volumes to the patients.

Participants performed bag-valve ventilation to manikin by ordinary technique and Amflow assist technique in our simulation centre. We measured each ventilation rate and ventilation volume in simulated scenario and we compare those between two technique.

Eligibility Criteria:
Inclusion Criteria:

* A healthy senior medical students who agree attend this study.

Exclusion Criteria:

* A participants who does not agree attend this study
Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence

The Investigators decided to examine whether the Paula method is more effective than Pelvic Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. In addition to the pad test and two urinary incontinence questionnaires, we will use other assessment tools such as; quality of life and sexual function which have been found to correlate significantly with pad test results. These results may indicate that menopausal women with Stress Urinary Incontinence may be more successful controlling incontinence if they will practice the Paula method as compared to PFMT.


Eligibility Criteria:
Inclusion Criteria:

* women after menopause (12 months with no period)
* aged 40 or more
* have a positive pad test leakage of 1-50 grams
* no systemic or local hormonal therapy
* literate in Hebrew and/or English

Exclusion Criteria:

* women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders)
* pelvic surgery within the last 6 months
* post hysterectomy or oophorectomy genital prolapse grade 3 or higher
Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion

Total knee replacement is often associated with severe postoperative pain, especially in the first 24 hours. Patient controlled analgesia (PCA) and continuous femoral block with PCA are commonly used to treat postoperative pain after total knee arthroplasty. However, PCAs use opioids. Opioids are excellent painkillers but their use is hampered by side effects such as nausea, vomiting, bowel dysfunction, urinary retention, pruritus, sedation and respiratory depression. We propose to test the hypothesis that adding a low dose lidocaine infusion to PCAs will lower the amount of opioids that these patients receive, thereby improving patient safety while still providing adequate analgesia. In addition, continuous femoral block has been shown to provide superior postoperative pain control when compared to morphine PCA. Therefore, postoperative pain levels of study subjects will be compared to those subjects who receive a combination of a continuous femoral block catheter with a PCA.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing a total knee arthroplasty
2. Be American Society of Anesthesiologist physical status 1,2, or 3
3. Be willing and capable of providing informed consent
4. Be English speaking

Exclusion Criteria:

1. Age greater than 80 years old or younger than 18 years old
2. Congestive hear failure
3. Hepatic insufficiency
4. Neurological disorders
5. Psychiatric disorders
6. Steroid treatment
7. History of atrial fibrillation
8. Chronic pain disorder with opioid treatment
Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial)

This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in patients with high-risk prostate carcinoma. Half of the participants will receive treatment with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will receive only abiraterone acetate, prednisone, and leuprolide.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent;
* Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with a minimum of 3 cores positive for tumour;
* Tumour biopsy tissue accessible for downstream evaluation;
* Must be candidates for radical prostatectomy and considered surgically resectable by urologic evaluation;
* High Risk D'Amico score defined as either PSA \> 20, Gleason score ≥ 8 as determined by the local pathologist; or T2c-3 based on DRE, pathologic review +/- imaging;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
* No evidence of metastatic disease or nodal disease as determined by radionuclide bone scans and computed tomography (CT)/magnetic resonance imaging (MRI); non-pathological lymph nodes must be less than 15 mm in the short (transverse) axis;
* Able to swallow the study drug(s) as prescribed and comply with study requirements;
* Required initial laboratory values:
* Absolute neutrophil count (ANC) ≥ 1500/μL;
* Platelet count ≥ 100,000/μL;
* Hemoglobin ≥ 90 g/L;
* Creatinine ≤ 175 μmol/L;
* Bilirubin ≤ upper limit of institutional normal (ULN);
* AST/ALT ≤ 1.5 × ULN.

Exclusion Criteria:

* Received an investigational agent within 4 weeks prior to screening;
* Stage T4 prostate cancer by clinical examination or radiologic evaluation;
* Hypogonadism or severe androgen deficiency as defined by screening serum testosterone below the normal range for the institution;
* Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer;
* Receiving concurrent androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to randomization;
* History of another malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer and non-muscle invasive bladder cancer;
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiovascular disease, unstable angina pectoris, cardiac arrhythmia that is symptomatic or requires active therapy; deep venous thrombosis within 3 months prior to randomization;
* Previous use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., enzalutamide, BMS 641988);
* Liver injury or disease (e.g., viral hepatitis, liver failure Child-Pugh Class C).