cyrilzakka/clinical-trials huggingface dataset:
Endurant for Challenging Anatomy: Global Experience Registry

The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database.

This study aims at answering two major questions:

1. Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm?
2. Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or minimum age as required by local regulations
* Indication for elective EVAR
* Challenging AAA anatomy
* Intention to electively implant the Endurant or Endurant II Stent Graft System©
* Signed informed consent form

Exclusion Criteria:

* Subjects with intolerance to contrast media
* Chimneys or fenestrated device procedures
* High probability of non-adherence to physician's follow-up requirements
* Current participation in a concurrent trial that may confound study results
Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study

Systolic Pressure Intervention Trial (SPRINT) is a large scale randomized trial of \~ 9250 adults aged 50 years or older with high cardiovascular risk sponsored by NIH. The study is designed to recruit 45% of the study population with Chronic Kidney Disease (CKD). The trial will test the effects of low systolic blood pressure (SBP) goal of \< 120 mm Hg versus the standard goal of \< 140 mm Hg on the primary composite of cardiovascular events and death. One of the pre-specified secondary outcome is the progression of kidney disease. In this ancillary named SPRINT - Factors affecting Atherosclerosis STudy (FAST), the investigators plan to take advantage of the unique opportunities afforded by the parent study to examine issues that are of significant public health importance.

This is an observational study in SPRINT participants. This study will examine mechanistically, the factors affecting the progression of atherosclerosis in CKD.


Eligibility Criteria:
Inclusion Criteria

* Systolic Pressure Intervention Trial (SPRINT) participants

Exclusion Criteria

* Contraindications to MRI (such as intracranial metal prostheses, weight \> 300 pounds, claustrophobia and certain types of hardware used in pacemakers, prostheses, etc.)
Use of Various Laser Systems in Peri-implatit

Objectives: In recent years, a new field of work has been created with the use of laser beam to provide titanium surface decontamination. The aim of this study was to evaluate the effect of various laser systems in smokers and non-smokers with peri-implantitis.

Materials and Methods: According to the study protocol, patients, who were diagnosed with peri-implantitis based on the clinical and radiographic evaluations, were divided into six groups: Group 1: smokers undergoing diode laser application; Group 2: smokers undergoing Erbium, chromium: yttrium, scandium, gallium, garnet (Er, Cr:YSGG) laser application; Group 3: smokers undergoing Erbium:yttrium-aluminum-garnet (Er:YAG) laser application; Group 4: non-smokers undergoing diode laser application; Group 5: non-smokers undergoing Er, Cr:YSGG laser application; and Group 6: non-smokers undergoing Er:YAG laser application. Peri-implant sulcus depth (SD), clinical attachment level (CAL), suppuration, modified plaque index (mPI), gingival index (GI), and modified sulcus bleeding index (mSBI) were recorded and peri-implant sulcus fluid (PISF) was collected to evaluate osteocalcin.


Eligibility Criteria:
Inclusion Criteria:

1. Presence of pocket in probing depth of ≥4 mm in at least one implant
2. No mobility in implant
3. Implants with bridge foot and opposite occlusion
4. Having no systemic disease that may affect the outcome of treatment
5. No systemic use of antibiotics for the last six months
6. Not receiving peri-implantitis treatment for the last three months
7. Individuals at the 30-60 years of age.

Exclusion Criteria:

1. Individuals who did not agree to participate in the study
2. Individuals receiving radiation therapy
3. Individuals using alcohol
4. Presence of pregnancy and lactation period
5. Individuals with parafunctional habits such as clenching or bruxism.
Clinical Study of Merlin's DiVeRt - Vascular Reconstruction Device and Delivery System

The objective of the proposed investigation is to assess the safety and effectiveness of the Merlin's DiVeRt system for the treatment of intracranial lesions.

Merlin is a manufacturer of Flow- Diverters (FD) for Neurovascular applications. The technology is based on a microporous polymer membrane which is delivered to the site of lesion treatment using a metal stent scaffold. The first device in its FD family is the XCalibur Aneurysm Occlusion Device (AOD) system, which is delivered on a rapid-exchange balloon catheter which goes in a 6-Fr guide-catheter. The AOD is CE-marked and has been involved in the treatment of over 70 clinical lesion/aneurysm cases. The same technology is now being made available in a self-expandable stent platform delivered on a 0.028" microcatheter. Merlin has performed the required in-silico, in-vitro and in-vivo tests to be confident of the device performance and now intends to proceed to the human clinical-trials. DiVeRt (Interventional) is a non CE mark device. The device is under clinical trial phase. The competent authority submission for the study has been completed in Spain, Turkey and Hungary.

The study will recruit patients with intracranial aneurysm (IA) or a lesion located in the anterior or posterior circulation. The analyses of the data from this safety and feasibility study will be descriptive.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
* Age 18-80 years.
* Subject has a target intracranial aneurysm (IA) or a lesion located in the anterior or posterior circulation.
* Subject has a target IA with a wide or large neck aneurysm or a lesion. The aneurysm type includes saccular, fusiform, dissecting or blister shapes.

Exclusion Criteria:

* Major surgery in the last 30 days.
* History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
* NIH Stroke Scale ( NIHSS) greater than or equal to 4
* Any known contraindication to treatment with flow diverters.
* Pregnant women.
* Participating in another clinical trial.
Etoricoxib for Postoperative Pain After Thyroid Surgery

The purpose of the study is evaluate the analgesic efficacy and safety profile of the Cox-2 specific analgesic Etoricoxib (arcoxia®) when administrated pre and postoperatively for controlling pain in adult patients undergoing thyroid surgery. Patients will be followed up in the immediate postoperative period, during the first postoperative (POD) day and in POD 2, 3 and 7. It is expected that with the addition of Etoricoxib, patients will experience less pain during the overall postoperative period and also a better quality of recovery when compared with the traditional analgesic regimen.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 and \<70 years
* body weight within normal ranges
* ability to understand the use of pain assessment scales and the PCA device

Exclusion Criteria:

* known allergy to any of the drugs utilized
* contraindication to opioid and non-opioid analgesic drugs
* a history of bleeding disorders, peptic ulceration or anticoagulant use within the last month
* pregnant or breast-feeding patients
* history of known or suspected drug abuse or patients who had taken NSAIDs within 24 h prior to surgery
Amino Acid Therapy for Hot Flashes in Postmenopausal Women

The purpose of this study is to determine the safety, tolerability, and effectiveness of the amino acid L-isoleucine in the treatment of hot flashes in postmenopausal women.

Hot flashes affect approximately 75% of postmenopausal women. Although hormone replacement therapy (HRT) is highly effective in reducing hot flashes, long-term HRT is associated with increased rates of breast cancer and heart disease. Safe, effective, and well-tolerated hot flash therapies are needed. The amino acids L-methionine and L-isoleucine have produced reductions in hot flash frequency. However, long-term L-methionine therapy may increase cardiovascular risks. This study will evaluate the short-term effects of L-isoleucine therapy. Data from this study will be used to conduct long-term studies in the future.

Participants in this study will be randomly assigned to receive one of two different L-isoleucine doses for 2 weeks. Clinic visits will be made at baseline, Week 1, and Week 10. Participants will record the frequency and severity of their hot flashes in a diary.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Experience over 5 hot flashes per day

Exclusion Criteria:

* Hormone Replacement Therapy (HRT) in the past 2 months
Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination

To establish safety, tolerability and pharmacokinetics of regorafenib and cetuximab in combination, and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors who are not candidates for standard therapy or in whom regorafenib or cetuximab is considered a standard treatment. Patients with metastatic colorectal cancer (mCRC) must have a record of K-ras gene mutational analysis available and no K-ras mutation is present.
* Male or female patients ≥ 18 years of age
* Women of childbearing potential must have a blood or urine pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment
* Life expectancy of at least 3 months
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment:

  * Platelet count ≥ 100,000/cubic millimeters (mm3), hemoglobin (Hb) ≥ 8.5 g/dl, leukocyte count \> 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,000/mm3
  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Mildly elevated total bilirubin (\< 6 mg/dL) is allowed if Gilbert's syndrome is documented.
  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
  * Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects whose cancer involves their liver).
  * Amylase and lipase ≤ 1.5 x ULN
  * Serum creatinine ≤ 1.5 times ULN and creatinine clearance (CLcr) ≥ 30 mL/min according to the Cockroft-Gault formula
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* Prior treatment with Regorafenib
* Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
* Non-healing wound, ulcer, or bone fracture
* Systemic anticancer therapy within 28 days
* Patients unable to swallow and retain oral medications
Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms

This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed presence of one or more specified gene polymorphisms (FTO, MC4R, LEP, LEPR).
* Overweight or obese status (BMI ≥ 25).

Exclusion Criteria:

- BMI \< 25
Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia

The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 years
2. Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML as defined by World Health Organization 2016 classification (Arber, 2016) excluding acute promyelocytic leukaemia (APL, French American-British M3 classification) with: relapsed or refractory disease and without established alternative therapy, or secondary to MyeloDysplastic Syndrome and without established alternative therapy or, newly diagnosed AML, not previously treated for AML and who are not candidate for intensive chemotherapy due to age or comorbidities.
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
4. Adequate haematological, renal and hepatic functions based on the last assessment performed within 7 days prior to the first Investigational Medicinal Product administration.

Exclusion Criteria:

1. Previous myeloproliferative syndrome (MPS).
2. Patients previously treated with any Mcl-1 inhibitor.
3. Patients who have not recovered from toxicity of previous anticancer therapy, including Grade ≥ 2 toxicity (except alopecia of any grade) according to the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) version 5.0, prior to the first IMP administration.
4. Severe or uncontrolled active acute or chronic infection.
5. Uncontrolled hepatitis B or C infection.
6. Known carriers of HIV antibodies, history of significant liver disease, active acute or chronic pancreatitis, active central nervous system disease.
7. Troponin \> ULN (Upper Limit of reference range) or Troponin T \> ULN if Troponin I cannot be assessed.
8. Clinically significant cardiac dysfunction (including New York Heart Association class ≥II heart failure, Left Ventricular Ejection Fraction (LVEF) \< 50% as assessed by echocardiography (ECHO) or Multi-Gated Acquisition (MUGA) scan).
9. QT prolongation defined as QTc (QT interval corrected for heart rate) interval (corrected with Fridericia's formula) \> 450 ms for males and \> 470 ms for females, obtained from triplicate 12-lead ECG.
10. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.
11. Uncontrolled arterial hypertension (systolic blood pressure (SBP) \> 150 mmHg or diastolic blood pressure (DBP) \> 95 mmHg).
Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients

The objective of this study will be to prospectively evaluate the response of a continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and maintain the AT activity within a specified range in adult patients that require extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Completed cardiac surgery with Cardiopulmonary Bypass and subsequently placed on venoarterial (VA) Extracorporeal Membrane Oxygenation (ECMO) support at any point during the ongoing hospitalization
* Serum Antithrombin \< 60%.

Exclusion Criteria:

* Heart transplantation during ongoing hospitalization
* Excessive bleeding (300 ml/hr of chest tube drainage for 2 consecutive hours)
* Weight \< 40 kg
* Allergy to goat products
* Anticoagulation with a direct thrombin inhibitor
* Religious exception to blood products
* Hypothermia (\< 34°C)
General or Regional Anesthesia for Hip Surgery

The purpose of this study is to determine whether general anaesthesia or regional anaesthesia is best for patients undergoing Total Hip Arthroplasty.

A randomized controlled trial (RCT) with a follow up time of 48 hrs. Patients scheduled for primary Total Hip Arthroplasty. A total of 120 patients randomly assigned to one of the two alternatives (general anaesthesia (GA) or regional anaesthesia (RA)).

General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (LOS) for patients undergoing total hip arthroplasty (THA).

Primary endpoint:

LOS.

Secondary endpoints:

Postoperative pain? Postoperative orthostatic function (dizziness) Time until the patient meets the discharge criteria from PACU How many patients will need at least one urinary bladder catheterisation

Eligibility Criteria:
Inclusion Criteria: patients with osteoarthritis scheduled for surgery

* patients that will require THA
* patients over 45 yrs and under 85 yrs.
* patients that understand the given information and are willing to participate in this study
* patients who have signed the informed consent document.
* patients belonging to ASA class I-III.

Exclusion Criteria:

* prior surgery to the same hip
* patients with a history of stroke, neurological or psychiatric disease that potentially could affect the perception of pain
* obesity (BMI \> 35)
* active or suspected infection
* patients taking opioids or steroids
* patients suffering from rheumatoid arthritis or an immunological depression
* patients who are allergic to any of the drugs being used in this study
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome

This is a multicenter, multiregional, open-label study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme replacement therapy (ERT), designed to treat both the peripheral and CNS manifestations of Mucopolysaccharidosis type II (MPS II; Hunter syndrome).

Participants, whose physicians feel they are deriving benefit, will have the opportunity to be reconsented into a safety extension and then an open-label extension for continued evaluation.


Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed diagnosis of MPS II
* Cohort A: Participants aged ≥5 to ≤10 years with neuronopathic MPS II
* Cohort B: Participants aged ≥1 to ≤18 years with non-neuronopathic MPS II, neuronopathic MPS II, or unknown phenotype
* Cohort C: Participants aged \<4 years with neuronopathic MPS II (this cohort can include participants ≥4 to ≤18 years of age if participant is a blood relative of a participant \<4 years of age)
* Cohort D: Participants aged ≤18 years with non-neuronopathic MPS II or neuronopathic MPS II with preexisting hepatomegaly who have never taken standard-of-care ERT
* Cohort E: neuronopathic MPS II participants aged ≥6 years at screening, non-neuronopathic MPS II participants \<6 or ≥17 years at screening, and neuronopathic MPS II participants ≥1 to ≤18 years at screening with a history of prior haematopoietic stem cell transplantation or gene therapy who have completed at least 48 weeks in Study DNLI-E-0001
* For participants receiving intravenous iduronate 2-sulfatase (IDS) ERT, tolerated a minimum of 4 months of therapy during the period immediately prior to screening.

Key Exclusion Criteria:

* Unstable or poorly controlled medical condition(s) or significant medical or psychological comorbidity or comorbidities that, in the opinion of the investigator, would interfere with safe participation in the trial or interpretation of study assessments
* Use of any CNS-targeted MPS II ERT within 3 months before study start for participants aged ≥5 years, and within 6 months before study start for participants aged \<5 years
* Use of IDS gene therapy or stem cell therapy at any time (except for participants in Cohort E)
* Clinically significant thrombocytopenia, other clinically significant coagulation abnormality, or significant active bleeding, or required treatment with an anticoagulant or more than two antiplatelet agents
* Contraindication for lumbar punctures
* Have a clinically significant history of stroke, status epilepticus, head trauma with loss of consciousness, or any CNS disease that is not MPS II-related within 1 year of screening
* Have had a ventriculoperitoneal (VP) shunt placed, or any other brain surgery, or have a clinically significant VP shunt malfunction within 30 days of screening
* Have any clinically significant CNS trauma or disorder that, in the opinion of the investigator, may interfere with assessment of study endpoints or make participation in the study unsafe
Comparative Study of Skin Prick Allergy Test Measurements Between Current Manual Procedure and Nexkin DSPT Device

Clinical trial with the aim to evaluate the level of agreement in wheal size measures in allergy skin prick testing (SPT) between the electro-medical device Nexkin DSPT® and the manual measurement procedure used in the daily practice.

The purpose of the trial is to evaluate the concordance of measurements obtained by the Nexkin DSPT device versus the measurements obtained manually.

A prospective clinical trial study was conducted at Clínica Universidad de Navarra. SPT will be tested in the same way as during a routine visit, with the only difference being that the images of the arm required for the device to operate will be captured. Nexkin DSPT device is a non-invasive device, which does not perform the procedure of puncture and appearance of papules. The device is only used to read the test results. There is no risk to the patient or the healthcare professionals involved in capturing images with the device. Device does not provide a diagnosis and it is not a substitute for sound medical judgment.

The study will prospectively include patients attending the allergy consultation (sample size calculated in 93 patients) with positive (histamine) and negative (saline solution) controls. Fifteen minutes later, two consecutive readings with the device and two manual readings were performed by two different nurses. The area of the histamine wheals was measured automatically by Nexkin DSPT and after the manual procedure measured manually by planimetry.

Eligibility Criteria:
Inclusion Criteria:

1. Patient to be tested with aeroallergen and/or food battery prick tests.
2. Patient over 12 years of age.
3. Patient, or his/her representative, who has given consent to participate in the study.
4. Patient who has not taken an antihistamine for more than 3 days.
5. Women of childbearing age who, at the time of taking the clinical history, declare that they are not pregnant.

Exclusion Criteria:

1. Patients who are to be tested with a prick number greater than 40.
2. Patients who are to be tested with a prick number less than 40, but for whom it is necessary to place more than two rows of allergens in at least one of the arms.
3. Patients who have taken an antihistamine within the previous 3 days.
4. Patients who are being treated with antidepressants or other drugs with an antihistamine effect.
5. Patients who suffer severe atopic dermatitis affecting the forearms.
6. Patients with dermographism.
7. Patients who are to undergo intradermal testing.
8. Pregnant women or women suspected of pregnancy.