cyrilzakka/clinical-trials huggingface dataset:
Short Course of Amoxicillin for Erysipelas

The propose of this study is to determine whether a 6-day duration of oral amoxicillin treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral amoxicillin regimen. This trial will be open but evaluation will be perform by a blind evaluator.

To fight against increasing rate of bacterial resistance to antibiotics, several studies have demonstrated efficacy of short antibiotic course in e.g. acute streptococcal tonsillitis, community acquired pneumonia, and urinary tract infection. Erysipelas is an acute dermo-hypodermal infection due to streptococcus. To date no resistance of theses bacteria to amoxicillin was described. The diagnosis of erysipelas is clinical. Thus, short course of antibiotic is a good regimen to test in erysipelas treatment. To date there is no controlled trial concerning efficacy of oral amoxicillin in erysipelas treatment. Expected advantages of the demonstration of the non inferiority of a short and oral amoxicillin treatment in erysipelas are: reduction of antibiotic selective pressure, cost, adverse events caused by infusion and hospitalisation.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age
* First episode of erysipelas of a lower leg defined as

  * acute well delineate inflammation than had lasted less than 5 days
  * T°≥ 38°5 at least once during the past 5 days or chills.
  * Score ≥3 : oedema, erythema, pain each scored from 0 to 3 : 0= none, 1= moderate, 3= severe
* Written informed consent provided by the patient
* available health insurance
* accept conditions of the trial

Exclusion Criteria:

* Erysipelas for more than 5 days
* Score \< 3
* Septic shock
* Clinical signs of necrotizing cellulitis or fasciitis, bullous lesions related to necrosis, purpuric lesions or superficial cutaneous necrosis.
* Past history of erysipelas of the same lower leg
* Erysipelas not on the lower leg
* Bilateral erysipelas
* Bite occuring during the preceding 7 days.
* Diabetic foot
* patients who have previously received systemic antibiotherapy within the last 5 days (except one or two doses within last 24 hours)
* History of any hypersensitivity or allergic reaction to beta-lactam drugs
* Known renal or Hepatic failure
* Known HIV infection
* Female patients who are pregnant, lactating (breast milk feeding), or who are of child bearing potential and not using an acceptable method of birth control
* Impossibility to stop immunosuppressive treatment, systemic corticosteroids or nonsteroidal anti-inflammatory drugs.
* Severe gastrointestinal disease, dysphagia or any pathology preventing oral administration of treatment.
* Denied to sign written informed consent
* Unable or unwilling to adhere to the study-specified procedures and restrictions
* Evolutive cancer under treatment
Analyzing the Effect of Air Polishing on Tooth Surfaces With Two Imaging Methods

Micro-CT is a non-destructive imaging method with high resolution and allows to examine all tooth structures individually. Pre- and post-application images obtained by micro-CT can be superimposed and differences can be precisely detected. Intraoral scanners in CAD/CAM systems also provide non-destructive image scanning. CAD/CAM are systems that are widely used in dentistry today. Access to the device is easier than micro-CT. This study was focused on to compare two different imaging methods by assessing changes caused by sodium bicarbonate and glycine air polishing on the tooth surfaces.

The patients were recruited from individuals seeking periodontal and/or dental treatment at Kocaeli University, Faculty of Dentistry. The teeth samples were collected from the participants who have a single-rooted tooth with the gingival recession on all surfaces and need to be extracted. All patients who met the criteria were informed about the study. Patients who gave written informed consent were included. Before the teeth extractions, root surfaces were marked with a bur at the level of the gingival margin. Extractions were performed under local anesthesia with 2% xylocaine adrenalin. Fourteen single root extracted teeth were included into the study. The crown and exposed root surface were air polished using glycine and sodium bicarbonate powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree.

Samples were scanned before and after air polishing with a high-resolution micro-CT device. The scanning conditions were 100 kVp; 100-mA, 0.5-mm Al/Cu filter; 13.1-μm pixel size; and rotation at 0.2 steps. According to the manufacturer's instructions, each sample was rotated 360°. The mean scanning time was around 1hour. The teeth surfaces were digitalized before and after air polishing with an intraoral scanner. The mean scanning time was around 10 second. The virtual images of the scanned teeth were saved in stereolithography (STL) format. The defect volume was estimated.

The data were analyzed using commercially available statistical analysis software. Descriptive statistics that were used to analyze the results included the mean, standard deviation, median, minimum, and maximum. Mann-Whitney U test was performed to compare differences between two independent variables. Wilcoxon test was used to compare differences between two dependent variables. P-values less than 0.05 were considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

Being older than age of 18, Willing to participate the study, To have a single rooted tooth with gingival recession on all surfaces and need to be extracted, The tooth has to be free of caries, defects and restorations.

Exclusion Criteria:

Have history of infectious diseases like Hepatitis and/or HIV (+).
Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA

This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of type 2 diabetes mellitus
* Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be \>=7.0% and \<=10.0% at screening
* Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10 weeks prior to Visit 1 must be \>=7.0% and \<=9.0% at screening and \>=7.0% and \<=10.0% at placebo run-in
* Male and female patients on diet and exercise regimen who are pre-treated with OAD alone for at least 10 weeks prior to Visit 1 must be \>=7.0% and \<=10.0% at both screening and placebo run-in
* Age at informed consent must be \>=20 years
* BMI at screening must be \<=40 kg/m2
* Further inclusion criteria apply

Exclusion criteria:

* Uncontrolled hyperglycaemia with a glucose values \>270 mg/dL (\>15.0 mmol/L) after an overnight fast during switch/washout/placebo run-in period and confirmed by a second measurement
* Patients who are drug-naïve at screening visit or treat with any of insulin, thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks prior to informed consent.
* Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to informed consent
* Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during screening and/or switch/washout/placebo run-in period
* Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 (Japanese equation) as determined during screening and/or switch/washout/placebo run-in period
* Further exclusion criteria apply
Home-based Visual Training in Patients Implanted With Trifocal Diffractive Intraocular Lenses

This multicentre randomised controlled trial aimed to reduce the visual discomfort that patients implanted with trifocal diffractive intraocular lenses may experience after surgery. To this end, a visual training software (Optictrain) was developed in which Gabor patches were presented to the patient on a hand-held electronic device. Patients who met all inclusion criteria and consented to participate underwent half an hour of visual training per day for a period of 20 consecutive days remotely on a colourimetrically characterised Samsung Galaxy Tab A device on which the Optictrain software (n=30) or a placebo software (n=30), respectively, was pre-installed. Corrected and uncorrected near, intermediate and distance visual acuity (VA) and mesopic near and distance contrast sensitivity (CS) were measured monocularly and binocularly at two visits: during the first postoperative week (V0) and after 20 days of visual training with the assigned software (V1). The statistical analysis of the results obtained in the study has not yet been carried out.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 an 90 years
* Patients implanted with trifocal diffractive intraocular lenses
* Availability and motivation to perform the visual training assigned

Exclusion Criteria:

* Age under 18 or over 90 years
* Presence of irregular cornea, illiteracy or cognitive impairment
* History of eye surgery or presence of any active ocular disease
* Intraoperative complications leading to significant visual sequelae
* Patients implanted with monofocal, extended depth of focus or refractive multifocal IOLs
Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects

Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.

This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.

Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) or 1 NNRTI (nevirapine or efavirenz).

Patients will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.

The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 infected adults (=/+18 years old).
2. Patient having a diagnosis of HIV infection, on stable HAART including 2 NRTI/NtRTIs plus one of the following: 1 PI/ritonavir or ATV/unboosted or 1 NNRTI.
3. Undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) while on HAART.
4. Patient having at least one of the following conditions:

   * Antiretroviral-related gastrointestinal disturbances, or
   * Low patient's satisfaction associated with the current regimen posology (ritonavir use, ritonavir intolerance...), or
   * Any toxicity drug related.
5. Nadir CD4 cell count \> 350 cells/mm3.
6. Absence of resistance mutations in the RT or PR by (TrugeneTM)
7. Good treatment adherence.
8. Voluntary written informed consent.

Exclusion Criteria:

1. Virologic failure to a previous antiretroviral regimen.
2. Any antiretroviral resistance mutation in a previous resistance test.
3. Dual/mixed or X4 viruses detected at any time point, including the pre-treatment ES-Trofile test of the PBMC test done before treatment switch.
4. Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
5. Pregnancy or fertile women willing to be pregnant.
Vitamin C and Atrial Fibrillation After Cardiac Surgery

The purpose of this study is to determine if vitamin C decreases the chance of developing atrial fibrillation, a type of arrhythmia or irregular heartbeat, following cardiac surgery. This irregular heartbeat is a common occurrence following cardiac surgery, and occurs in about one third of patients. It poses extra risks to people who develop it. Our hypothesis is that Vitamin C will decrease the incidence of postoperative atrial fibrillation.

The development of atrial fibrillation (AF) following cardiac surgery is relatively common, occurring in approximately 25-60% of patients. Coronary artery bypass graft surgery (CABG) carries the lowest risk of AF development, with an incidence of approximately 25-30%, followed by cardiac valve and combined CABG/cardiac valve surgeries, with incidences up to 60%. AF development in patients undergoing cardiac procedures has been linked to increases in postoperative morbidity and mortality, including an increase in readmission to the ICU, stroke, reintubation, and 30-day and 6-month mortality. Patients who develop AF have also been shown to experience longer hospital stays, both in the ICU and overall.

While some other medications have been shown to decrease the risk of AF development, the use of beta-blockers peri- and postoperatively have shown the most promise, and are the standard of care for patients undergoing CABG surgery. However, patients experiencing AF have been shown to experience cardiac production of peroxynitrite, corresponding to a hypothesis that AF occurs through oxidative stress. Due to this correlation, supplementation of ascorbate has been proposed as a treatment to reduce the risk of AF development following cardiac surgery. Ascorbate is a potent peroxynitrite antagonist, and may therefore reduce oxidative stress and AF development following cardiac surgery. This trial aims to assess the efficacy of ascorbic acid in reducing the incidence of postoperative AF in patients undergoing elective or urgent CABG surgery, cardiac valve surgery, or a combination of the two. Our hypothesis is that ascorbic acid will decrease the incidence of postoperative AF development.

Eligibility Criteria:
Inclusion Criteria:

* Adults 50 years of age or older
* Undergoing elective or urgent coronary artery bypass graft surgery, valve surgery, or a combination of the two

Exclusion Criteria:

* Prior cardiac surgery
* History of atrial fibrillation
* Permanent or temporary pace maker
* Currently taking digoxin or Vaughan Williams Class I or III antiarrhythmic medications
* Known hyperoxaluria
* History of renal calculi
* History of allergic or hypersensitivity reaction to ascorbic acid products
* Currently taking 1 g or more of ascorbic acid supplementation daily
MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS

The study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the 2-year follow-up in the MOMENTUM 3 IDE trial. A total of 1028 subjects were enrolled in the MOMENTUM 3 IDE trial. Approximately 533 subjects were ongoing support at the 2-year follow-up and are eligible for enrollment in this PAS. This study will be conducted at sites that participated in the MOMENTUM 3 IDE trial which will include up to 69 centers in the United States.

Subjects on LVAD support after the MOMENTUM 3 IDE trial 2-year follow-up visit can be enrolled after providing consent to extended follow-up. They will be followed to 5 years post-implant or outcome (transplant, explant or death), whichever occurs first.

Subjects who have been transplanted, their device exchanged to another pump other than a HM II or HM3, or explanted after the MOMENTUM 3 IDE trial 2-year follow-up but prior to providing consent for this PAS can also be enrolled. Data between the 2-year follow-up visit and the date of pump exchange, explant, or transplant will be retrospectively collected.

Once enrolled, if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed.

In the event that a subject expired prior to providing consent, IRB approval will be obtained to collect the date and cause of death.

Eligibility Criteria:
Inclusion Criteria:

* Subject or legal representative has signed Informed Consent Form (ICF)
* Subject was enrolled in the MOMENTUM 3 IDE trial and was ongoing at the 2-year follow-up visit

Exclusion Criteria:

* Subject or legal representative does not consent to extended data collection after the MOMENTUM 3 IDE trial 2-year follow-up visit

Special Circumstance:

* Sites with patients who expired after the MOMENTUM 3 IDE trial 2-year follow-up visit but prior to signing the ICF for this PAS will obtain IRB approval to collect only the date and cause of death
Duration of IM Injection and Pain Intensity

This study was a single-group crossover clinical trial, where each participant acted as their own control. The study aimed to describe the relationship between perceived pain and the duration of intramuscular injections

The study was a single-group crossover clinical trial, where each participant acted as their own control. The study sample included 50 patients aged 25 to 55 who met the inclusion criteria of signing an informed consent form and requiring administration of a specific antibiotic via intramuscular injection, as prescribed by physicians.

Two intramuscular injections into the right and left Dorsal Gluteal Region (DRG) were recorded for each participant. One was administered by a nurse, according to the unit's routine, and took 5 seconds to complete. A day after, the same nurse gave the other injection in the opposite DGR, taking 40 seconds to administer. The five-second injections were considered the control group, while the 40 seconds injections were the intervention group. The order of interventions was randomized. The pain level was determined and recorded immediately after each injection.

The study was conducted between September 2019 to November 2019 in the emergency unit of an educational hospital in Istanbul. The data was collected using a Demographic Form, Facial Expressions Scale, and Visual Comparison Scale. Statistical analysis was performed using the Kolmogorov-Smirnov test, Mann-Whitney U test, Wilcoxon test, and Spearman correlation analysis, with a significance level of p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

Having a condition leads to prescribing Clindamycin 600 mg/4 ml intramuscularly Having no pain in the area of injection Absence of any tissue damage history at the site of injection

Exclusion Criteria:

Asking for withdrawal after signing the informed consent Intensifying the disease/condition at the time of the second injection Taking any analgesic medication before the application.
Response of Intracardiac Thrombus to Anticoagulants in Patients With Non-valvular Atrial Fibrillation (LYSIS)

This study aims to analyze changes in the immune status, metabolic status, and host microbiome community structure in non-valvular atrial fibrillation patients with intracardiac thrombus. Additionally, the study aims to analyze factors that influence the responsiveness and occurrence of adverse events related to anticoagulant therapy.

The researcher-initiated clinical cohort study is a national multicenter, retrospective-prospective study of non-valvular atrial fibrillation patients with intracardiac thrombus, based on molecular biology and multi-omics analysis. The study aims to analyze the changes in the body's immune status, metabolic status, and host microbiome community structure, as well as to analyze the factors that influence the responsiveness of intracardiac thrombus to anticoagulant therapy. The study also evaluates the occurrence of adverse events related to anticoagulation in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old, age ≤80 years old
* Patients with atrial fibrillation detected by routine surface 12-lead electrocardiography or Holter
* Transesophageal echocardiography confirmed the presence of cardiac thrombus, and the patient had not received any anticoagulant therapy

Exclusion Criteria:

* Echocardiography confirmed valvular heart disease
* Contraindications to anticoagulants
* Patients with the previous history of hemorrhagic stroke
* Low platelet count or functional platelet defects
* Congenital or acquired coagulation or bleeding disorders
* Abnormal liver function (liver enzymes \>2 times the upper limit)
* Renal failure (endogenous creatinine clearance \<30ml/min)
* Surgery was planned within the intended study time or had been operated within 30 days before the study
* Other comorbidities that can cause bleeding, such as tumors
* Patients with autoimmune diseases or immunodeficiency, or patients who are currently using immunosuppressants and immunomodulators
* Patients are currently participating in other clinical studies
Five Sessions Intervention to Facilitate Adaptation to Breast Cancer

To test the effects of 2 different 5-wk stress management interventions (cognitive behavioral training or relaxation training) vs. a time-matched 5-wk health education condition on psychosocial adaptation and physiological adaptation in women being treated for breast cancer. Participants assigned to either of the stress management conditions will show improved psychosocial adaptation and physiological adaptation compared to those assigned to the health education condition.

This is a randomized controlled trial comparing the effects of 5-wk group-based stress management interventions (cognitive behavioral therapy \[CBT\] or relaxation training \[RT\]) vs a time-matched 5-wk group-based health education (HE) condition on psychosocial adaptation (negative and positive mood, social disruption) and physiological adaptation (cortisol and immune function) in women with non-metastatic breast cancer who are undergoing primary treatment. Participants are recruited in the weeks after surgery and before the start of adjuvant chemotherapy or radiation, are assessed for baseline psychosocial and physiological adaptation indicators, and are then randomly allocated to either CBT, RT or HE. They are re-assessed for psychosocial and physiological adaptation at 6 and 12 month follow-up. Primary hypothesis is that women assigned to CBT or RT will show greater reductions in negative affect and social disruption, and greater increases in positive affect over time compared to women assigned to HE. Secondary hypothesis is that women assigned to CBT or RT will show greater decreases in cortisol and greater increases in immune functioning over time compared to those assigned to HE.

Eligibility Criteria:
Inclusion Criteria:

* women diagnosed with breast cancer at stage III or below who had recently undergone lumpectomy or mastectomy

Exclusion Criteria:

* prior cancer, prior psychiatric treatment for a serious disorder (e.g., psychosis, suicidality), lack of fluency in English and had begun adjuvant therapy at time of first assessment
Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis

Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Acute respiratory tract infection due to community- or hospital-acquired pneumonia

Exclusion Criteria:

* Consent card not signed
* Pregnancy
* Prisoners
* Aspiration pneumonitis
* Patients with ventilator-associated pneumonia