cyrilzakka/clinical-trials huggingface dataset:
The Diagnostic Value of Shear Wave Elastography

Background: The main goal when diagnosing thyroid nodules, is to differentiate the few malignant from the overwhelming background of benign nodules. Currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic thyroid surgery is necessary. Therefore, there is a need to develope the diagnostic tools for pre-operative diagnostic work-up of thyroid nodules.

The study will investigate a novel ultrasonographic technique called Shear Wave Elastography (SWE) in the pre-operative evaluation of thyroid nodules.

Aim:

To evaluate the diagnostic value of SWE in the pre-operative diagnosis of thyroid nodules in a tertiary surgical center.

Perspectives:

An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the economic and surgical resources.


Eligibility Criteria:
Inclusion Criteria:

* Nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery

Exclusion Criteria:

* Not undergoing thyroid surgery
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients

Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.

This is the first belgian feasibility study of HER2 imaging using a labelled monoclonal antibody, namely trastuzumab labelled with zirconium 89.

The aims of this study are:

I/ Evaluate the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab (based on the Groningen experience), through the analysis of the correlation between the FDG-PET/CT and the HER2 immunoPET.

II/ PET quantification of HER2 receptor by using the images and the blood pharmacokinetic of the tracer.

III/ In the subset of patients for whom biopsies of metastatic sites have not been carried out previously and are of an easy access, tissue will be acquired as part of the validation of the HER2 immunoPET and as an attempt to better understand the molecular heterogeneity of HER2 positive breast cancer at the time of relapse.

IV/Evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality

Eligibility Criteria:
Inclusion criteria:

1. All patients selected for this imaging study are patients scheduled to start trastuzumab-based therapy for advanced HER2 positive breast cancer (This includes trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy).
2. Histologically confirmed HER 2 positive (defined as FISH amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease.
3. Patients with FDG-PET positive metastatic lesions.
4. Brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease.
5. Patient planned to have metastatic site biopsy for HER2 status control.
6. Age ≥ 18 years
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
8. For women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception.
9. Agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions.
10. Signed written informed consent (approved by the Ethics Committee) obtained prior to any study procedure

Exclusion criteria:

1. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
2. Pregnant or lactating women
3. Current known infection with HIV, HBV, or HCV
4. Known severe hypersensitivity to trastuzumab
5. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
6. Patients with bone only metastases are not eligible
7. Psychiatric illness/social situations that would limit compliance with study requirements
8. Patients who received lapatinib within the 7 days prior to HER immunoPET/CT.
A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults

Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Removal of 2 to 4 impacted third molars

Exclusion Criteria:

* Pregnancy or breastfeeding
* Ibuprofen contraindications.
* Allergy to any of the intervention components.
Labetalol Infusion and Dexmedetomidine Infusion in Hypotensive Anesthesia

this study aims to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.

Hypotensive anaesthesia is the deliberate lowering of a patient's blood pressure during surgery. It is necessary during ear, nose and throat surgery for drying surgical field, ease in operation procedure and shortening of the duration of surgery. Labetalol is a unique parenteral anti-hypertensive drug that has selective α1 and non- selective β adrenergic antagonist effects. In humans, the β to α blocking potency ratio is 7: 1 for IV labetalol. Dexmedetomidine is highly selective alpha2 adrenergic agonist having several beneficial actions during the perioperative period. Activation of alpha2 adrenergic receptors in the brain and spinal cord inhibits neuronal firing causing hypotension and bradycardia. This study was designed to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists I, II (ASA I, II) patients who were candidate for Ear, Nose and Throat surgeries.
* Age: between 20 and 50 years

Exclusion Criteria:

* Patients with uncontrolled hypertension, variable degrees of heart block, congestive cardiac failure, coagulopathy, cerebral insufficiency, hepatic or renal abnormality
* Patients on beta blocker or clonidine
* Pregnant or lactating females
* Patients who were allergic to any of the anesthetic or hypotensive drugs used in the study
* Patient refusal to be included in the trial
Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery

The primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in a study population who is not amenable for the conventional surgical approach as current gold standard.

The presence of a significant mitral regurgitation (MR) seriously effects the patient's quality of life and is associated with an increased mortality rate. The operative treatment of MR - either mitral valve repair or replacement - is the current gold standard. However mere half of the patients with a severe and symptomatic MR actually undergo an operative treatment (EURO-HEART-SURVEY) due to restricted left ventricular ejection fraction, elderly patients with co-morbidities and high perioperative morbidity and mortality. In contrast, patients with severe and symptomatic MR not suitable for operation are treated with palliative medical therapy (heart insufficiency therapy). With the development of the MitraClip device - a minimal-invasive, percutaneous catheter-based technique - high-risk patients not suitable for surgery may receive a promising alternative treatment by approximating the mitral leaflets, thus creating a permanent leaflet coaptation and reducing or even abrogating the MR. The current data support the assumption of a safe and effective MR reduction with the MitraClip-System in inoperable high-risk patients with severe MR. But the feasibility still has to be proven in this special patient population.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* signed written consent
* symptomatic patients (NYHA-stadium ≥ III) for at least 3 months with an exploited medical heart insufficiency therapy
* increased perioperative risk with a logistic EuroScore ≥ 15 or STS-Score ≥ 15
* MR grade ≥ 2, amenable for MitraClip intervention assessed by an experienced interventional cardiologist
* Affirmation of in-operability by a "Heart-Team" consisting of either 1 cardiac surgeon and 1 cardiologist or 3 cardiologists

Exclusion Criteria:

* one essential cardiovascular event in the past 6 weeks; i. e. myocardial infarction, stroke, shock, cardiac decompensation, or the necessity of catecholamine therapy for haemodynamic stabilisation
* implantation of a biventricular pacemaker-device for cardiac resynchronisation therapy in the past 3 months
* solid tumor with a live expectancy \< 1 year
Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing

This case series aims to evaluate the effectiveness and tolerability of Oral Sulfate Solution (OSS) in patients who had previously experienced poor colonoscopy preparation.

This study aims to evaluate the effectiveness of Oral Sodium Sulfate (OSS) in patients who have had poor colon preparation in the past. The study includes patients who had issues during their previous colonoscopy, such as needing extensive washing, inadequate preparation, a recommendation for shorter surveillance intervals, or adequate preparation for larger polyps but not smaller lesions.

Poor colon cleansing during a colonoscopy can lead to more prolonged procedures, lower polyp detection rates, and the need for repeat procedures with shorter surveillance intervals. OSS is a low-volume osmotic agent that causes diarrhea and colon cleansing by drawing water into the intestine. Health Canada and the FDA have approved it, and it is given in two 177ml bottles in a split dose. OSS is known for its good effect, ease of use, and tolerability, and it may be a better option than traditional cleansing agents.

All participants will receive OSS and instructions for use before their next surveillance colonoscopy. The study will use questionnaires and patient diaries to assess the effectiveness of OSS and patient compliance and tolerability.

Eligibility Criteria:
Inclusion Criteria:

1. Patients Age 18 to 80 inclusive
2. Able to read and understand the English language
3. History of poor bowel prep defined as:

   * Required extensive washing, as noted in the narrative of the endoscopist report.
   * Inadequate preparation
   * Endoscopist recommended shorter interval surveillance due to poor prep
   * adequate for polyps \>5mm but not smaller lesions

Exclusion Criteria:

1. Patients who have inflammatory bowel disease
2. Patients with ileus or bowel obstruction
3. Patients with history of colorectal resection
4. Patients receiving combined upper and lower endoscopies
5. Patients with ascites
6. Patients with previously documented severe renal impairment
7. Unable to provide consent
8. Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)
9. Patients who have had a recent myocardial infarction(\<6months)
Validation of Noninvasive Blood Pressure Device

This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers.

The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Site 1; Stage 1 only: Subjects with a history of hypertension (\> 140/85 mmHg) or hypotension (\< 100/60 mmHg) within the last 3 months. Stage 2 only: No criterion for blood pressure
* Site 2; Stage 1 and 2: Subjects with systolic blood pressure \< 140/90 mmHg.
* Ability to provide informed consent

Exclusion Criteria:

* Febrile subjects
* Subjects displaying respiratory symptoms, or with suspected respiratory illness
* Subjects whose skin is not intact, e.g. wounded, in or at the vicinity of the cuff placement site
* Subjects with removed axillary lymph nodes or mastectomies
* Subjects with peripheral artery disease
* Pregnant women (patient reported)
* Subjects deemed not suitable for the study at the discretion of the investigator
Impact of Volume Imaging Using Diagnostic Ultrasound

Determine if volume imaging can diagnose bone, ligament, muscle injuries.

The investigators are attempting to determine if Volume imaging (a new type of ultrasound imaging)can accurately diagnose injuries of the muscle ligaments, tendons and bones when compared to conventional ultrasound imaging.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Must be scheduled to have a musculoskeletal (bone, ligament, muscle, tendon) ultrasound performed as part of their routine clinical care.

Exclusion Criteria:

* Unable to lie flat on ultrasound table.
* Subjects under 18 years of age
Quality of Life After Myocardial Infarction

This is an observational study to determine the association between social support and functional status after a myocardial infarct

Primary objectives:

Our primary objective is to determine among patients hospitalized for a myocardial infarction, the impact of emotional support on functional outcomes at two years as measured by a valid measure of functional health, the SF-36.

Secondary Objectives:

Our secondary objectives are:

1. To determine the types of social support which are perceived as being most helpful to patients.
2. To determine whether women and minority patients have unique views on the types of support that are helpful.
3. To determine among patients admitted for myocardial infarction, the impact of social support on length of stay and hospital readmissions.

Hypothesis:

Our hypotheses are as follows:

1. Patients who are hospitalized for a myocardial infarction and who have high emotional support will have better long-term functional status compared to those patients who have low support.
2. Patients with high emotional support will be more likely to adhere to protocols such as taking their medications, keeping appointment, and enrolling in cardiac rehabilitation.
3. Patients with high emotional support will have lengths of hospitalization which are shorter than their estimated geometric mean as compared to patients who have low support.
4. The types of social support which are perceived as most helpful in disease management will be influenced by gender and ethnicity.

Long-term Objectives:

The long-term objective is to determine the mechanisms by which social support impacts on functional health and to utilize this data to develop future interventions that can be targeted toward a culturally and ethically diverse cohort of patients with coronary artery disease. Overall, the goal is to use this data to prevent functional disability and improve quality of life among patients with coronary artery disease.

Eligibility Criteria:
* Patients who have had a documented myocardial infarction by EKG and laboratory criteria will be eligible. The attending cardiologist of these patients will be approached. Once the attending cardiologist declares that a patient is clinically stable enough for participation, they will be approached, told about the study, and asked if they wish to participate.
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer

This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.

Part A is a single-arm cohort (Cohort A, 40 to 110 participants) will evaluate safety and efficacy of margetuximab plus retifanlimab.

Part B Part 1 has 4 arms (50 patients/arm). Participants will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma

  1. Prior systemic perioperative treatment is allowed; however the participants must have had a disease-free interval of at least 6 months from end of chemo/surgery
  2. Participants receiving perioperative anti-HER2 therapy require testing of HER2 status for eligibility
  3. Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%) per central review
  4. Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment.
* Availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing
* Eastern Cooperative Oncology Group performance status of 0 or 1, verified within 3 days of Day 1
* Life expectancy ≥ 6 months
* At least one radiographically measurable target lesion
* Acceptable laboratory parameters and adequate organ function

Key Exclusion Criteria:

* Other malignancy that is progressing or required treatment within the past 5 years, with certain exceptions

  * Participants with known MSI-H status
* History of allogeneic stem cell or tissue/solid organ transplant
* Central nervous system metastases
* Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise

  * Prior neoadjuvant or adjuvant treatment with immunotherapy
A Randomized Placebo-controlled Multicenter Trial to Evaluate the Efficacy and Safety of JTR-161, Allogeneic Human Dental Pulp Stem Cell, in Patients With Acute Ischemic stRoke (J-REPAIR)

The objective of this study is to evaluate the safety and efficacy of a single intravenous administration of JTR-161 (allogeneic stem cell product derived from the dental pulp of healthy adult humans) to patients with acute ischemic stroke.

This study is comprised of 3 cohorts and conducted in the order of Cohort 1, Cohort 2 and Cohort 3.

Cohort 1 Arm-1: JTR-161, 1 × 10\^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects

The Data and Safety Monitoring Board (DSMB) and the Sponsor will decide whether Cohort 2 can be initiated or not.

Cohort 2 Arm-1: JTR-161, 3 × 10\^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects

DSMB and the Sponsor will decide whether Cohort 3 can be initiated or not and the dose of JTR-161 in Cohort 3.

Cohort 3 Arm-1: JTR-161, 1 × 10\^8 cells/subject or 3 × 10\^8 cells/subject, 30 subjects Arm-2: Placebo, 30 subjects


Eligibility Criteria:
Inclusion Criteria:

* Patients who have ischemic strokes in the anterior circulation
* Patients whose mRS is 0 or 1 prior to the onset of ischemic stroke
* Patients whose NIHSS score of ≥5 to ≤20 at screening
* Patients who can be administered dosing solutions within 48 h of stroke onset

Exclusion Criteria:

* Patients who have new ischemic lesion in the cerebellum or brainstem
* Patients whose consciousness level drops severely
* Patients whose infarct area is widespread
* Patients who have a clinically significant hemorrhagic transformation
* Patients who had seizures after onset of ischemic stroke
* Patients who have medical history of a neurological event such as stroke or clinically significant head trauma within 180 days prior to giving informed consent
* Patients who have poor blood pressure control
* Patients who have poor glycaemic control
* Patients who have one of the following complications

  1. Severe liver dysfunction
  2. Severe kidney dysfunction
  3. Severe heart failure
  4. Severe pulmonary dysfunction
* Patients who have severe infections
* Patients who have any neurological disorder affecting informed consent or study assessments
* Patients who have the malignant tumor, or medical history of malignant tumor within 2 years prior to the onset of ischemic stroke
* Patients who have a contraindication for MRI
* Patients who have thrombocytopenia
* Patients who have medical history of allergy to products derived from human tissues, bovine or porcine
* Patients who have medical history of allergy to streptomycin
* Patients who have undergone splenectomy in the past
* Patients who have a possibility of transient ischemic attack
* Patients who are scheduled to undergo revascularization (carotid endarterectomy, stent placement etc.)
Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Implant vs. a Bioabsorbable Nasal Dressing

The purpose of this study is to compare how two different post-surgical treatments that both deliver steroids to the frontal sinus opening affect your healing after frontal sinus surgery.

This is a single center, randomized \& controlled trial comparing the efficacy of the Propel mini stent or Propel contour stent vs. Nasopore impregnated with Triamcinolone Acetonide at reducing frontal sinus opening stenosis and polypoid edema after endoscopic sinus surgery in patients with chronic rhinosinusitis with polyposis. Eligible subjects who undergo standard of care bilateral frontal sinusotomy will have each frontal sinus randomly assigned to either a Propel mini or contour steroid eluding stent or a Nasopore nasal dressing impregnated with 2.5 ml of Triamcinolone Acetonide 40 mg/ml. Specific Propel stent will be chosen based on the shape of frontal sinus opening and best fit as decided by the operating Surgeon. Patients will be reassessed on approximately post-operative day 7, 14, 30, 90 days, 6 months, and 12 months at their standard of care follow-up visits. On the day 14 visit, the frontal sinus Propel stent and Nasopore will be completely removed per Standard of care. Video will be taken of the frontal sinus opening, and assessed for scarring/adhesions, presence of polypoid edema, frontal sinus patency, need for oral steroids or other interventions. Additionally, endoscopic scoring of frontal sinus by the above measures will be evaluated by 2 independent sinus surgeon reviewers. The reviewers will also be asked to rank the two frontal sinus openings as better, same or worse, compared to the opposite side

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older
* Diagnosis of chronic rhinosinusitis with nasal polyps based on the American Academy of Otolaryngology-Head and Neck Surgery guidelines
* Patient scheduled for bilateral endoscopic sinus surgery with evidence of bilateral frontal sinus disease based on Computed Tomography (Lund-Mackay score greater than or equal to 1)
* At the time of surgery bilateral frontal sinusotomy of type Draf 2a or 2b was performed using the same technique on both sides
* Bilateral endoscopic sinus surgery performed successfully without complication
* Frontal sinus opening diameter greater than 4.0 mm achieved (4 mm olive tipped suction easily passed into frontal sinus)

Exclusion Criteria:

* Any patient who had frontal sinus surgery for tumor
* Allergy to mometesone and/or triamcinolone
* Frontal sinusotomy type Draf 1 or Draf 3 performed
* One or both frontal sinus openings not amenable to implant placement
* Patients with chronic oral steroid dependent conditions
* Invasive fungal sinusitis
* Immune deficiency