cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting

The hypothesis is that application of Mupirocin to the nose before and after coronary artery bypass grafting surgery will reduce the incidence of surgical site infections.

Mupirocin applied to the nares is effective in eradicating nasal carriage of Staphylococcus species. Abundant evidence has documented that a majority of gram positive surgical site infections share bacterial phenotypes identical with nasal phage types. Conflicting literature exists regarding the efficacy of mupirocin in reducing the incidence of surgical site infections. A randomized prospective double-blind placebo-controlled trial is needed to help settle this question in the setting of coronary artery bypass grafting surgery where surgical site infections carry significant morbidity, cost, and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years old undergoing Coronary Artery Bypass Grafting Surgery (CABG) with or without concomitant cardiac valve surgery or other cardiac surgery,
* Median sternotomy wound
* Capable of informed consent

Exclusion Criteria:

* Allergy to mupirocin or components
* Pregnant or lactating females
* Emergency surgery
* Pre-existing ongoing infection
Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.

The purpose of this study is to demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.

Concurrent chemoradiotherapy (radiotherapy+ carboplatin + 5FU) is a validated treatment for patients with locoregional advanced head and neck cancers.

This study evaluates the outcome of induction chemotherapy (docetaxel, cisplatin, 5 FU) followed by radiation therapy + Erbitux for patients with head and neck carcinoma with almost one measurable lesion by RMI or CT scan.

We hope we can improve the progression free survival of 14% at two years .

Eligibility Criteria:
Inclusion Criteria:

* head and neck locally advanced,non metastatic carcinoma
* not suitable for surgery

Exclusion Criteria:

* non squamous cell head and neck cancer
* previous malignancy
* previous treatment
Prospective Study of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses

The purpose of this study is to report the intraoperative performance and postoperative outcomes of the Cionni-modified capsule tension ring implantation in eyes with subluxated lenses.

The introduction of endocapsular stabilising devices have significantly improved the management of zonular weakness, allowing for in-the-bag IOL implantation. The Cionni modified capsule tension ring (M-CTR) has an anterior eyelet that provides for fixation of the capsular bag without violating its integrity. Adult and pediatric studies have shown the usefulness of the M-CTR to manage zonular weakness. However, there are very few prospective studies that show the outcomes following implantation of the M-CTR and in-the-bag IOL on a longterm basis. Therefore, the investigators decided to carry out this study to report the intraoperative performance and postoperative outcomes on a longterm basis following M-CTR and in-the-bag intraocular lens (IOL) implantation.

Eligibility Criteria:
Inclusion Criteria:

* Subluxated Lenses
* Traumatic or Non-traumatic etiology

Exclusion Criteria:

* Dislocated Lenses
A Study to Assess the Effectiveness of an Investigational Drug in Elderly Subjects With Low Vitamin D Levels (0822A-009)

This study will assess the effectiveness of an investigational drug in elderly subjects with low vitamin D levels.


Eligibility Criteria:
Inclusion Criteria:

* Man or a woman 70 years old or older in general good health

Exclusion Criteria:

* Having any form of neurological impairments that may impair motor function.
Fireworks Eye Injuries During Festivals in Upper Egypt

The aim of this study is to explore and report the epidemiology and outcome of fireworks ocular injuries in Upper Egypt.

Primary outcome : type and severity of injury of fireworks eye trauma during festives.

Secondary outcome: demography, complications, and final visual outcome of fireworks eye injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending ocular emergency unit with fireworks eye injury during different festivals in 2024

Exclusion Criteria:

* patients presented with non-fireworks ocular injuries
Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)

Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells.

Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in.

This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.

The investigation of extracorporeal photopheresis (ECP) plus standard of care (SoC) (SoC+ECP) in chronic graft-versus-host disease (cGVHD) within prospective, randomized clinical studies is limited, despite its frequent clinical use.

This phase 1/pilot study was the first randomized, prospective study to investigate ECP use as first-line therapy in cGVHD, based on the 2015 National Institutes of Health (NIH) consensus criteria for diagnosis and response assessment.

Adult patients with new-onset (≤3 years of hematopoietic stem cell transplantation) moderate or severe cGVHD were randomized 1:1 to 26 weeks of SoC+ECP vs SoC (corticosteroids and cyclosporine A/tacrolimus) between 2011 and 2015. The primary endpoint was overall response rate (ORR), defined as complete or partial response, at week 28 in the intention-to-treat population (ITT).

Eligibility Criteria:
Inclusion Criteria:

To be eligible for inclusion in this trial, the patient must have moderate to severe chronic graft-versus-host disease \[defined by the National Institutes of Health (NIH) 2015 Consensus Criteria\] that started within 3 years after hematopoietic stem cell transplantation (HSCT).

Exclusion Criteria:

* Is intolerant to corticosteroids or hypersensitive to methoxsalen
* Received certain treatments during time periods disallowed by protocol
* Has infections and/or requires treatment that (per protocol or in the opinion of the investigator) might compromise:

  1. safety and well-being of participant or offspring
  2. safety of study staff
  3. analysis of results
Co-creation of Tools for Children and Adolescents with Suicidal Thoughts And/or Behaviour

Evidence shows that there are very few evidence-based tools or interventions specifically targeting suicidality in children and adolescents. It is crucial to address suicidal thoughts in these populations, as research indicates that discussing suicidality does not increase suicidal behavior but may instead reduce the associated risk. Furthermore, the field of suicide prevention increasingly incorporates digital technologies. Studies suggest that digital interventions targeting suicidality in young people show promise in enhancing knowledge, regulating emotions, developing coping skills, and managing suicidal thoughts and behaviors.

As part of this project, we will develop the following practical tools:

* A creative methodology for professionals to engage children and adolescents in talking about their suicidal thoughts.
* A self-help app for suicidal young people and their support networks. The development process will involve co-creation, with input from children and adolescents playing a central role.

A total of 30 children and adolescents aged 10 to 18 years, who have experienced suicidal thoughts in the past, will participate in this project. The co-creation sessions will be conducted in groups of up to 10 participants. Participants can attend a minimum of 1 and a maximum of 10 sessions, each lasting up to 1.5 hours. The sessions will be facilitated by researchers from VLESP and will take place at a location convenient for participants or in Ghent (the primary location of the research team). If preferred by participants, one or more sessions may also be held online.

For participants who do not wish to join a group, individual sessions can be arranged. Each session will be attended by two researchers, with the potential involvement of professionals specializing in tool development. Several potential developers will be invited to submit proposals for creating the tools, and the selection of the developer will be based on these submissions.

During the sessions, participants will review and evaluate various prototypes of the app. However, the prototypes will not be tested for effectiveness by the young participants.


Eligibility Criteria:
Inclusion Criteria:

* Aged 10-18 years
* Proficient in Dutch
* Has experienced suicidal thoughts in the past

Exclusion Criteria (as assessed by the care provider):

* Limited cognitive ability
* Currently experiencing an acute suicidal crisis
Intracranial Pressure After Decompressive Craniectomy

Observational study to investigate the natural course of intracranial pressure (ICP) after decompressive craniectomy (DC) using long-term telemetric ICP monitoring. Patients will have continuous ICP measurement performed during the admission to the neuro-intensive care unit (NICU) and after discharge weekly measurements sessions will be performed before and after cranioplasty.

Several studies have investigated and documented the effect of DC in lowering ICP in intracranial hypertension following acute brain injuries, e.g. severe traumatic brain injury. But the natural course of ICP in these patients after the acute phase in the NICU has never been investigated. Clinical experience suggests that a DC affects cerebrospinal fluid circulation and ICP, e.g. causing hydrocephalus or subdural hygromas.

The aim of this observational study is to document the natural course of ICP following DC and to investigate the effect of cranioplasty on ICP. This is done by implantation of a telemetric ICP sensor and weekly follow-up monitoring sessions after discharge from the NICU until 1 month after cranioplasty. The monitoring sessions will include standardized body positions to investigate postural ICP changes before and after cranioplasty. The project will also provide experience with telemetric ICP monitoring during the acute phase in a NICU setting.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* scheduled for a decompressive hemicraniectomy for elevated ICP or signs of intracranial herniation

Exclusion Criteria:

* skin damage in the frontal area where the telemetric ICP sensor is implanted
* lack of informed consent from next-of-kin or the patient's general practitioner
Thickness of the Plantar Fascia in Stretched and Relaxed Positions in Patients With Plantar Fasciopathy

This study will compare the thickness of the plantar fascia in stretched and relaxed positions in patients with plantar fasciopathy using ultrasonography.

The purpose of this observational study is to compare the thickness of the plantar fascia in stretched and relaxed positions of the most symptomatic heel in patients with plantar fasciopathy using ultrasonography.

In addition to this, we will compare measurements of the thickness of the plantar fascia in sagittal versus transversal transducer positions, compare pressure pain thresholds at the most tender spot of the plantar fascia in stretched and relaxed position using pressure algometry and investigate the association between the thickness of the plantar fascia and the pressure pain threshold. All measurements are performed bilaterally starting with the most symptomatic foot.

To compare thickness and pressure pain thresholds in stretched and relaxed positions of the plantar fascia paired-t-tests are used. To compare the most and least symptomatic sides paired-t-tests will be used.

The association between the thickness of the plantar fascia and pressure pain threshold will be investigated using the Pearson's correlation coefficient.

Eligibility Criteria:
Inclusion Criteria:

* History of plantar heel pain of at least 3 months
* Clinical presentation of pain and/or tenderness to palpation in the area of the medial tubercle of the calcaneus
* Average intensity of pain in the previous week equal to or greater than 3 on an 11-point visual analog scale (VAS)
* Thickness of symptomatic plantar fascia of 4 mm or greater

Exclusion Criteria:

* Age under 18
* Pregnancy
* History of systemic disease with manifestations similar to those of plantar fasciopathy
* Pain medication in the last 24 hours
* Steroid injection for plantar fasciopathy in the previous 6 months
* Previous heel surgery or fracture of the lower leg or foot
A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects

The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus (T1DM) with insulin-induced hypoglycemia. Additionally to compare the glycemic response observed after administration dasiglucagon with that of GlucaGen®.

This was a global, multicenter, randomized, parallel, and double-blind clinical trial confirming the efficacy and safety of dasiglucagon for insulin-induced hypoglycemia in patients with T1DM. The patients were randomized 2:1:1 to receive a single subcutaneous 0.6 mg dose of dasiglucagon, placebo, or a 1 mg dose of GlucaGen and followed for at least 28 days after receiving treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female or male subjects with type 1 diabetes mellitus (T1DM) for at least 1 year, diagnostic criteria as defined by the American Diabetes Association
* Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening
* Hemoglobin A1c \<10%

Exclusion Criteria:

* Previously treated with dasiglucagon (previously referred to as ZP4207)
* Known or suspected allergy to trial product(s) or related products
* Females who are pregnant according to a positive pregnancy test, are actively attempting to get pregnant, or are lactating.
* History of hypoglycemic events associated with seizures in the last year prior to screening
* History of severe hypoglycemia in the last month prior to screening
* Active malignancy within the last 5 years
* Current bleeding disorder, including anti-coagulant treatment
* Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor)
* Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial
* Clinically significant abnormal ECG at screening as judged by the investigator
* Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening
* Surgery or trauma with significant blood loss within the last 2 months prior to screening
* A positive result in the alcohol and/or urine drug screen at the screening visit. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day for women
PROMOTE: The Effect of a Six Week Prebiotic Supplementation on Wellbeing of Young Adults.

The study will investigate whether taking a prebiotic for six weeks helps to reduce morning cortisol levels in healthy young adults with mild to moderate stress compared to a placebo. Individuals should continue with their usual lifestyle during the study. Other factors of wellbeing will also be assessed.

PROMOTE is a double blinded parallel randomised controlled-trial investigating if prebiotic supplementation reduce awakening salivary cortisol response, reported as area under the curve compared to a maltodextrin placebo in healthy young adults with a mild-to-moderate self reported stress score. There will be a focus on biological secondary outcomes to better understand how supplementation may influence the microbiome using metabolomics and sequencing techniques. In addition to other measures of wellbeing captured by questionnaires and activity monitors.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-25 at time of recruitment
* Body Mass Index (18.5 - 29.9 kg) : Healthy - Overweight
* Stress score of 15≤ - ≥25 (DASS)
* Willing and with capacity to give informed consent to participate at time of recruitment
* Speak and comprehend English to a good standard
* In good general health
* Willing to provide stool, urine and blood (8mL) sample during intervention
* Willing to attend 4 visits to Southampton General Hospital Clinical Research Facility over 10-11 weeks

Exclusion Criteria:

* Consuming ≥ 14 units of alcohol/week (6 x 175 mL of wine, 6 pints of 4% beer)
* Learning or behavioural difficulties (assessed on individual basis)
* Planning a pregnancy in the next 6 months, pregnant, lactating or had a recent birth ≥6 months
* Currently smoking or using e-cigarette, vape
* Vulnerable adults (with self reported sever or very severe stress score (DASS)
* Unwilling to suspend existing probiotic / prebiotic supplementation (with additional 4 weeks washout) before starting study.

Medical exclusions:

* Actively involved in therapy or psychiatric intervention of a diagnosed mental health condition
* Prescribed psychotropic medication (Antidepressants, Monoamine Oxidase Inhibitors (MAOI's), Antipsychotics, sleeping pills, mood stabilisers etc)
* Allergic to milk, soy, corn, penicillin or fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPS)
* Currently prescribed laxatives, enemas, anti-coagulants or painkillers
* Existing medical condition: cancer, hepatobiliary surgery, diabetes or diagnosed gastrointestinal diseases (irritable bowel disease, ulcerative colitis)
* Involved in a recent pharmacology/psychological intervention, last 6 months
* Recent antibiotic prescription, last 6 months
7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication

The study aims to test the efficacy of 7 days vs. 14 days of Vonoprazan-triple therapy in the eradication of Helicobacter Pylori infection in adolescents and young children.

After being informed about the study details, all eligible participants (or their legal guardians) will give informed written consent to be involved. After a one week screening, eligible participants will be randomized to Vonoprazan plus Amoxicillin plus Clarithromycin triple therapy for either 14 days (group 1), or 7 days (group 2) at a 1:1 ratio. After the end of therapy, H. Pylori eradication will be evaluated after 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Participants in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain who are positive for H. Pylori infection by a standardized diagnostic test.
2. Pediatric patients with a clinical, laboratory, and endoscopic diagnosis of H.P.-positive gastritis and the other conditions necessary for H.P. eradication, according to the Maastricht V consensus report .

Exclusion Criteria:

1. allergy to any of the drugs used in the study
2. previous attempts to eradicate H.P.
3. receipt of antibiotics, PPIs, bismuth, H2 antagonists or probiotics within 4 weeks of the study.
4. Children with the diagnosis of any condition that might affect the absorption of drugs such as celiac disease or Crohn's disease.
5. hepatic impairment or kidney failure.
6. symptoms suggestive of functional disorders.
Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population

As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.


Eligibility Criteria:
Inclusion Criteria:

* A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
* History of confirmed influenza infection since a year from the date of previous vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* History of hypersensitivity to vaccines.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury

This is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of the efficacy of REGN475 in patients with pain due to thermal injury.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, ages 18 to 50, who have been hospitalized as a result of thermal injury
2. Moderate to severe procedural pain intensity (during wound care) on each of the initial assessment days

Exclusion Criteria:

1. Patients with burns caused by chemical exposure or electricity
2. Patients with inhalation injury or with evidence of pneumonia, cellulitis, or infection
3. Patients with traumatic musculoskeletal injuries (eg, bone fractures or dislocations) or traumatic head or chest injuries
4. Significant pre-injury concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, psychiatric (including significant anxiety or depression), lymphatic disease, or drug dependence (alcohol or drug abuse), that would adversely affect the patient's management, recovery, or affect mortality or the patient's compliance with protocol assessments.
5. Women who are pregnant or nursing