cyrilzakka/clinical-trials huggingface dataset:
INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit

septic shock is the first cause of mortality in intensive care unit. Innate immunity is the body's first line of defense against pathogens

since their discovery, inflammasomes have an important role during inflammatory response following an aggression. There are intracytoplasmic multiprotein complex activated by cellular stress or infections and is responsible for the release of pro-inflammatory cytokines, including IL-1β. One study focused on the role of the NLRP3 inflammasome in monocyte during sepsis has shown its early alteration that is correlated with mortality. Most studies have analysed inflammasomes in nucleated cells, nevertheless, little is known about inflammasomes in platelets. The aim of the study is to analyze the activation of NLRP3 inflammasome in platelets and leukocytes during sepsis, from patients hospitalized in intensive care unit compare to a control group, until its resolution to better understand the pathophysiology of sepsis

Eligibility Criteria:
SEPSIS GROUP:

Inclusion Criteria:

* hospitalized in intensive care unit with central catheter
* age \> or = 18 years
* patients suffering from sepsis
* hospitalized from less than72 hours

Exclusion Criteria:

* patients with curatorship or guardianship
* pregnant women
* patients suffering from malignant blood disease
* patients suffering from disease associated with NLRP3 inflammasome activation

CONTROL GROUP:

Inclusion Criteria:

* hospitalized in intensive care unit with central catheter for other reason than infection
* age \> or = 18 years

Exclusion Criteria:

* patients with infection disease
* patients with curatorship or guardianship
* pregnant women
* patients suffering from malignant blood disease
* patients suffering from disease associated with NLRP3 inflammasome activation
PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and intracranial atherosclerotic disease are randomized to either drug or placebo.

The purpose of this study will be a dataset that lays the foundation for a randomized controlled trial of PCSK9 inhibition in intracranial atherosclerotic disease (ICAD) patients, designed to show a reduction in the primary endpoint of ischemic stroke recurrence. Such a trial would provide evidence for the utility of alirocumab to prevent recurrent stroke in ICAD. While we are proposing future studies to reduce recurrent ICAD stroke risk, it should be noted that, in the long term, our research may lead to effective primary ICAD stroke risk reduction through PCSK9 inhibition in patients at high risk of stroke identified through asymptomatic stenosis, post-contrast plaque enhancement (PPE) or intraplaque hemorrhage (IPH) on vwMRI.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ 18 years of age
* Ischemic stroke (≤ 1 month from onset) in one major vascular territory on diffusion-weighted MRI
* ICAD plaque of a "major intracranial artery," causing \>25% and \<99% stenosis
* Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), terminal ICA, and ACA (A1)
* Able to tolerate high-dose statin (atorvastatin 40-80 mg)

Exclusion Criteria:

* Stroke mechanism other than ICAD, including history of atrial fibrillation, hypercoagulability, ipsilateral arterial dissection or carotid stenosis \>50%, and rare causes of stroke such as vasculitis or CADASIL
* Bihemispheric stroke or simultaneous stroke in the anterior and posterior circulation
* Positive pregnancy test
* Gadolinium or PCSK9 inhibitor allergy
* Acute or chronic kidney disease with eGFR\<30 ml/min/1.73m2
* Pacemaker or other MRI contraindications per American College of Radiology guidelines33
* Inability to return for 1-year follow-up clinic visit and vwMRI
Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma

A case series of patient having mucoepidermoid carcinoma, had standard treatment protocol and surgeries and followup was performed and the patient postoperative quality of life and recurrent rate was recorded

This case series presents mucoepidermoid carcinoma. Palatal mass was resected with safety margin then immediate opturator inserted; superficial parotidectomy was also done for parotid lesion sparing facial nerve. Post-operative radiotherapy was recommended by pathologist due to evident perineural spread. The patient is tumor free after one year follow-up.

Clinical reports about synchronous multiple salivary tumors are very rare, consequently there is little known about its management and clinical presentation. Presence of one or more risk factor should favor expectation of multiple tumors and mandate examination of all salivary tissues. Each tumor should be diagnosed and treated separately according to its nature and extension.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from salivary gland tumor

Exclusion Criteria:

* healthy patients with no tumors
Effects of Low Glycemic Index Diet in Children With Drug-resistant Epilepsy

The goal of this clinical trial was to evaluate the effectiveness of a low glycemic index diet (LGID) on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy. Based upon the aims, the following hypotheses were tested:

1. LGID reduces seizure frequency in children with drug-resistant epilepsy.
2. LGID improves oxidative parameters in children with drug-resistant epilepsy
3. LGID improves quality of life and mental health in children with drug-resistant epilepsy

Participants were prescribed the LGID for 3 months.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements were collected. Diet compliance was evaluated by food consumption records during monthly follow-up visits (at 1 , 2, and 3 months).

The aim of this study was to evaluate the efficacy of a low glycemic index diet on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy.This study was a prospective, non-randomized, single centre intervention conducted in children with drug-resistant epilepsy. Low glycemic index diet was started on an out-patient basis. Children and their parents were educated about the diet and the effect of the diet on seizures. Children who were willing to follow the diet were included in the study. The research dietitian conducted interviews with patients and their parents at the beginning of the study to explain the principles of the diet.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements including oxidative stress parameters were collected. A 3-day dietary intake chart kept by the parents was reviewed at each monthly visit to check and reinforce compliance. Parents were asked to record the seizure frequency and severity in a seizure diary.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 4-18,
* being diagnosed with drug-resistant epilepsy,
* having more than one seizure per week,
* not having followed a ketogenic diet before.
* willing to come for regular follow up

Exclusion Criteria:

* children with known or suspected congenital metabolic, chronic, and systemic diseases in which ketogenic diet is contraindicated.
* non-compliance with the diet recommended by the patient and/or parents
* enteral tube or parenteral feeding
Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium

to record pulpal blood flow (PBF) changes associated with using 0.018-inch Nickel Titanium (NiTi) as the first alignment archwire during fixed orthodontic treatment.

Forty healthy patients with lower arch mild crowding with less than 2mm contact point displacement at any teeth were included. A split mouth study design was applied. Where each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch.

Patients were assigned into one of 2 groups based on archwire sizes used. Group (1); 0.014-inch and 0.018-inch NiTi and Group (2); 0.016-inch and 0.018-inch NiTi. A Laser Doppler Flowmeter was used to measure PBF at different time intervals (T0-T5).

Eligibility Criteria:
Inclusion Criteria:

* age 18-25 years
* Class I skeletal malocclusion
* Mild lower arches crowding.
* Contact point displacement less than 2 mm.
* No previous orthodontic treatment

Exclusion Criteria:

* Missing teeth
* Poor oral hygiene
* deep carious teeth
* history of previous trauma
* any medical conditions affecting blood vessels
* smokers
Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors

The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
2. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
3. Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
4. No evidence of distant metastases
5. No synchronous or concurrent head and neck primary tumors
6. Karnofsky score over 60
7. Adequate organ function including the following:

   1. Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
   2. Platelets count \>= 100 \* 10\^9/l
   3. Hemoglobin \>= 10 g/dl
   4. AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
   5. Total bilirubin \<= 1.5 times institutional ULN
   6. Creatinine clearance \>= 50 ml/min
   7. Serum creatine \<= 1 times ULN
8. Signed written informed consent

Exclusion Criteria:

1. Evidence of distant metastasis
2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery

The is a two-stage study. Stage 1 is to evaluate the safety, tolerability, PK and PD of ENN0403 in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass. Stage 2 is to evaluate the efficacy, safety, PK and PD of ENN0403 to prevent and treat AKI after multiple administraions in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and comply with the study requirements and able to provide written informed consent;
2. Age ≥18 and ≤85 years;
3. Male subjects (and their fertile female spouses/partners) do not have pregnancy plans during the screening period and within 3 months after the last dose, voluntarily take highly effective contraception, and must not donate sperm or ova. Only non-fertile women will be enrolled, and female subjects who meet the following criteria are not considered fertile: Postmenopausal status has been achieved, normal menstruation has stopped for at least 12 consecutive months with an FSH \>30 IU/L in the absence of other pathophysiological causes, or there is a medical record showing hysterectomy \\ bilateral tubal resection and/or bilateral ovariectomy.
4. Subjects must be scheduled for cardiac surgery requring cardiopulmonary bypass: Coronary artery bypass grafting (CABG) and/or heart valve surgery and/or aortic root, ascending aorta and aortic arch surgery;
5. Subjects have the risk of developing AKI with at least one of the following criteria: coronary artery bypass grafting combined with one or more heart valves surgery plus at least one risk factor for AKI; Multiple heart valves surgery plus at least one AKI risk factor; Coronary artery bypass grafting or aortic valve surgery combined with aortic root, ascending aorta, and aortic arch surgery (non-aortic dissection) plus at least one risk factor for AKI; Coronary artery bypass grafting alone or single heart valve surgery plus at least 2 risk factors for AKI.

Exclusion Criteria:

1. Receive ICD or permanent pacemaker implantation, mechanical ventilation, IABP, LVAD or other mechanical circulatory AIDS within 1 week before surgery;
2. Cardiopulmonary resuscitation is performed within 14 days prior to screening;
3. Abnormal renal function with eGFR\<20 mL/min/1.73 m2 within 30 days before screening;
4. Receive renal replacement therapy or the presence of AKI within 30 days before surgery, except for transient (≤5 days) stage 1 AKI after iodized contrast agent exposure;
5. Participate in other clinical trials within the past 1 month;
6. Have a known allergy to investigational drug or any of its constituents, or allery to any constituents used during the study;
7. Subjects with intractable hypotension, severe hypoxemia or other emergency during surgery.
Cross-sectional Study for Identification and Description of Severe Asthma Patients

This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.


Eligibility Criteria:
Inclusion Criteria:

* At least 12 years of age at study visit.
* Participants eligible for enrolment and entry into the study must meet the following definition of severe asthma, which is based on the definition of severe asthma described in the European Respiratory Society/ American Thoracic Society (ERS/ATS) Guidelines for severe asthma: Asthma which requires treatment with guideline suggested medications for Global Initiative for Asthma (GINA) steps 4-5 asthma for the previous year (i.e., at least 12 months).

Patients must be treated with high dose ICS PLUS at least one of the following: LABA, leukotriene modifier, theophylline, or continuous or near continuous systemic corticosteroid (i.e., maintenance systemic corticosteroid for ≥50% of the previous year).

SPECIAL CIRCUMSTANCE: If patient is on a fixed dose combination medication, then the maximum recommended dose of the ICS/LABA combination per local label is acceptable.

* Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Participants must be able to read, comprehend, and write at a level sufficient to complete study related materials. A parent or legal guardian must provide informed consent for participants less than 18 years of age at study visit (or less than minimum age to be considered an adult per local laws).

Exclusion Criteria:

Participants who have participated in an interventional clinical trial for asthma within the past 12 months prior to Visit 1 (NOTE: subjects participating in an observational study where an investigational product or procedure is not administered will not be subject to this exclusion criteria)
Profile and Antithrombotic Management of Patients With NVAF Attending Internal Medicine Departments in Spain (PERFILAR Study)

This is a national, multicenter, cross-sectional, observational study within a convenience sample of Internal Medicine departments from 100 hospitals in Spain which agree to participate in the study. This study will be a cross-sectional chart review which will require the collection of data from medical records and from face-to-face interviews conducted during the inclusion visit. Physician interviews are needed to collect three variables of interest, recommended by the Spanish Society of Internal Medicine as necessary data about profile and management of NVAF patients: cognitive deterioration based on the patient's responses, physician's assessment of the patient's life expectancy, and physician's opinion of the antithrombotic treatment previously prescribed. The investigators will only provide their opinion on previously prescribed therapies (i.e. prescribed before F2F). Hospitals to be contacted for the study include those known to participate in observational studies in Spain; the hospitals will therefore not be a random sample of Spanish hospitals.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Adult patients (≥18 years old)
* Patients diagnosed with Non-valvular atrial fibrillation (NVAF) any time prior to the inclusion date (prevalent or incident patients)
* Patients treated or not treated with an antithrombotic therapy
* Treated patients should have begun treatment prior to the inclusion visit
* Patients attending Internal Medicine departments, either for a hospital appointment (outpatients) or hospitalization (inpatients) for any reason)
* Patients which signed the informed consent

Exclusion Criteria:

* Patients diagnosed with valvular atrial fibrillation any time in their medical records
* Patients with anticoagulant treatment prescribed for venous thromboembolic disease any time prior to the inclusion date
* Patients which participated in any clinical trial with anticoagulant and/or antiplatelet agents in the previous six months
* Patients incapable of giving their informed consent
Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza

With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households. Households with an identified index case of influenza will be randomised into one of three intervention arms: 1. group, where the household will receive general information about transmission of influenza virus and means to prevent it (Controls); 2. group, which will receive surgical masks and be asked to wear them whenever they are in close contact with the index case or other persons of the household that became ill during the observation period; 3. group, which will be given and asked to wear surgical masks as well as to execute intensified hand hygiene.

In addition to assessing the secondary attack rate as our primary outcome measure, the investigators will also try to evaluate compliance to those interventions by questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* influenza like illness symptoms
* positive rapid test for influenza
* inclusion within 48h of symptom onset
* inclusion of at least 3 members of a household (including index case)

Exclusion Criteria:

* severe illness
* other cases of similar symptoms within 14 days before onset of symptoms in index patient
* severe asthma or COPD
* pregnancy of index
Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

Search for blood predictive marker (s) for cutaneous radiosensitivity


Eligibility Criteria:
Inclusion Criteria:

* Patient treated with surgery and radiotherapy (RT) for histologically proven Merkel carcinoma
* Previous radiotherapy treatment completed for at least 6 months
* Absence of prior treatment by chemotherapy or hormonotherapy
* Patient over 18 years of age
* Patient affiliated to a social security system
* Informed consent signed

Exclusion Criteria:

* Presence of another evolutionary cancer
* Re-irradiation in the same area
* Absence of available dosimetry data
* Patient under guardianship or curatorship or safeguard of justice
QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery

There are ca 900 new cases of kidney cancer in Finland/year. The curative therapy for kidney cancer is partial or total nephrectomy depending on the localization and the size of tumor. Main of these operations are laparoscopic.

Epidural analgesia is considered as most effective for the treatment of postoperative pain after open nephrectomy, but after laparoscopic operation parenteral and enteral opioids combined with paracetamol (acetaminophen) usually offer adequate postoperative pain relief. However, the need for opioids postoperatively may be high and side effects, such as sedation and nausea, are common. On the other hand epidural analgesia has some contraindications and risks for serious complications. Nevertheless, inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.

Recently quadratus lumborum block (QLB) has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. It is more beneficial than other peripheral blocks, since it covers also the visceral nerves. A single shot QLB has reported to last up to 48 hours.

Perineural dexamethasone added to local anesthetic has been reported to prolong the duration of analgesia of the perineural nerve block, but it's effect on the duration of QLB is not known.

90 kidney cancer patients with planned laparoscopic nephrectomy aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the postoperative cumulative opioid consumption. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and long term outcomes such as quality of life and persistent pain.


Eligibility Criteria:
Inclusion Criteria:

* patients with renal cancer coming to the laparoscopic radical nephrectomy

Exclusion Criteria:

* age under 18y or over 85y
* diabetes type 1 with complications
* no co-operation or inadequate finnish language skills
* persistent pain for other reason
* severe hepatic insufficiency or paracetamol (acetaminophen) is contraindicated for other reason
* any type of steroid in regular use
* oxycodone contraindicated
* medications changing notably paracetamol (acetaminophen) and/or ropivacaine metabolism in regular use