cyrilzakka/clinical-trials huggingface dataset:
GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)

This multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (OA) that are randomized to treatment with either genicular artery embolization (GAE) using Embosphere Microspheres or steroid injection over a period of 24 months.

This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.

Eligibility Criteria:
Key Inclusion Criteria:

Provides written informed consent

Age ≥21 years

Mild to severe knee pain, defined as a WOMAC Pain score of ≥8 out of 20 (in the target knee)

Pain refractory to conservative therapies for at least 90 days prior to enrollment/randomization.

Kellgren-Lawrence grade 1, 2, 3 or 4

Key Exclusion Criteria:

Planned major surgical or endovascular procedures ≤ 30 days after the index procedure.

Advanced atherosclerosis

Known history of rheumatoid or infectious arthritis.

Prior knee replacement surgery of the target knee.
Outcome Following Antidepressant Treatment on Possible Endo-Phenotypes for Major Depression

The purpose of this study is to determine whether outcome following antidepressant treatment can be used as a tool to evaluate endo-phenotypes for depression.

The research in depression has for some years focused at the identification of endo-phenotypes. Endo-phenotypes are heritable biological or psychological markers, which are more commonly found in patients and their healthy relatives than in the general population.

Recent studies point at disturbed regulation of the hypothalamic-pituitary-adrenocortical (HPA) system as a possible endo-phenotype for depression.

The hypothesis of AGENDA are that endo-phenotypes are affected by treatment with antidepressants in healthy first degree relatives.

AGENDA is a four week randomized, placebo-controlled, double-blind trial in which first degree relatives of patients with the diagnosis of depression are randomised in to two groups, which are treated with either placebo or antidepressant medicine (Cipralex). We expect to include 80 healthy subjects, with the predisposition for depression, since one of their parents or siblings recently was treated for depression.

The subjects will be examined before and after four weeks of treatment by a thorough interview concerning psychiatric symptoms (SCAN), including depressive symptoms, personality, perceived stress and cognitive function. The effect of antidepressant on stress is measured with saliva-cortisol and by the response to the combined dexamethasone corticotropin-releasing (CRH) hormone test. Additionally, MR and PET scans of the 5-HT4 receptor function will be conducted before and after 4 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Offsprings or siblings of patients with major depression
* Born in Denmark with European parents and grandparents
* For women; not pregnant or breastfeeding
* Written informed consent

Exclusion Criteria:

* Somatically illness or other handicaps which make participation in the study impossible
* Daily intake of drugs interfering with corticosteroids or escitalopram
* Hypersensitivity to escitalopram, dexamethasone or human corticotropin-releasing hormone
* Former medical or psychological treatment for diseases in the affective or schizophrenic spectrum
* Ongoing addiction of alcohol or psychoactive drugs
Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients

The transradial access (TRA) is currently the preferred approach for percutaneous coronary intervention (PCI). However, in patients with ACUTE ST-segment elevation myocardial infarction (STEMI) after emergency PCI, the high incidence of THE radial artery RAO limits the future choice of the radial artery for percutaneous intervention. The literature reported that distal transradial access (dTRA) significantly reduced RAO after elective PCI, but the application of dTRA in emergency PCI in STEMI has not been reported. We have completed 126 cases of dTRA undergoing emergency PCI after STEMI, which has been preliminarily confirmed to be safe and effective. A single-center, open, prospective, randomized controlled study is planned to compare the use of dTRA and TRA in emergency PCI in STEMI patients. The primary endpoint was the INCIDENCE of RAO within 24 hours after surgery. This clinical study verified that dTRA compared with TRA could reduce the RAO incidence of STEMI patients after emergency PCI. The project will explore a new artery approach to reduce RAO, and provide a basis for the selection of artery approach in STEMI emergency PCI patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of STEMI
* To undergo emergency PCI treatment
* Palpable pulsation of the radial artery and distal radial artery

Exclusion Criteria:

* Arteriovenous fistula of radial artery and cephalic vein has been performed with regular hemodialysis
* Suspicious left main block of electrocardiogram
* Had used the radial artery percutaneous interventional treatment before
* Cardiogenic shock
Biomarker To Evaluate Protein Profiles of Neutropenic Fever/Infection With Acute or Chronic Leukemias

The purpose of this study is to measure, in pilot/observational study, panels of circulating proteins in real time at the onset of neutropenic fever/infection in patients with acute or chronic leukemias undergoing chemotherapy or other biologic treatment. And to generate preliminary trend results in panels of circulating proteins longitudinally during the period of neutropenia and to correlate those values to clinical/laboratory data and patient outcomes.

To identify potential biomarkers for the prediction of NF, we performed serial measurements of nine biomarkers \[C-reactive protein (CRP), protein C, interleukin (IL)-6, IL-8, IL-10, IL-1β, tumor necrosis factor-α, monocyte chemotactic protein-1, and intercellular adhesion molecule-1\] using a multiplex ELISA array platform every 6-8 hours in patients undergoing myelosuppressive chemotherapy for hematologic malignancies.

Eligibility Criteria:
Inclusion Criteria:- Age \>= 18

* Pre-admission (ATU, ITA) or inpatient status
* absolute neutrophil count (ANC) \<= 1500/mm\^3
* Patients with acute myeloid or lymphoid leukemia who:

  * are admitted with newly diagnosed disease and have not yet received induction chemotherapy
  * are admitted with neutropenic fever after receiving post-remission chemotherapy or are admitted for post-remission chemotherapy
* Patients with chronic myeloid leukemia or a chronic lymphoid leukemia/disorder who have received chemotherapy or other disease-specific treatment in the last 30 days where the ANC of \<=1500/mm3 is considered by the treating physician to be at least possibly treatment-related
* An intravenous line or catheter (Hickman, port, portacath, or peripherally inserted central venous catheter \[PICC\] line) must be in place at the time of protocol participation/study start, but will not be inserted solely for the purposes of the study.
* Whenever possible, patients will be consented and blood monitoring will be initiated before the first dose of antibiotic, but if not possible, at no time will standard of care measures will be delayed or interrupted for the purposes of study enrollment.
* Patients must be able to understand the nature of the study and give written informed consent.

There are no exclusion criteria. Anyone who does not meet inclusion criteria will be excluded.
Amphotericin B Cholesteryl Sulfate Complex for Injection(ABCD) in the Treatment of Invasive Candidiasis and Invasive Aspergillosis

This is an open, multicenter clinical trial of ABCD for invasive candidiasis and invasive aspergillosis.

This study will evaluate the safety, efficacy and population pharmacokinetic characteristics of ABCD in the treatment of invasive candidiasis and invasive aspergillosis. About 60 patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis;
2. Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication;
3. Female subjects must meet one of the following conditions: surgical sterilization;menopause for at least 1 year;a negative result of serum/urine pregnancy test before enrollment.
4. Signed Informed Consent Form.

Exclusion Criteria:

1. Allergic to ABCD or azole antifungal drugs；
2. For IC patients, administration of more than 48 hours of systemic antifungal treatment within 96 hours before enrollment; or 1 dose of amphotericin B in 7 days;
3. For IA patients, administration of more than 96 hours of systemic antifungal therapy for this infection before enrollment, or 1 dose of amphotericin B in 7 days;
4. Patients with Candida endocarditis, osteomyelitis, arthritis, endophthalmitis, abscess of liver and/or spleen, suppurative thrombophlebitis, or central nervous system infection;
5. Patients with a history of drug abuse or drug dependence;
6. Chronic pulmonary aspergillosis (duration ≥ 3 months), aspergilloma or allergic bronchopulmonary aspergillosis;
7. Patients are known to have mixed invasive Candida or Aspergillus infections and/or ABCD is known to be ineffective;
8. Patients with abnormal liver function;
9. Patients with reduced renal function who require or are currently undergoing hemodialysis or peritoneal dialysis;
10. Hypokalemia, which cannot be corrected before trial treatment;
11. Expected survival time is less than 2 months;
12. Patients with cardiac function of New York Heart Association（NYHA）class III/IV;
13. Positive for HIV antibody;
14. Pregnant or lactating women;
Clinical Performance Evaluation of the NeuMoDx™ EBV Quant Assay 2.0 in Immunocompromised Transplant Patients

The NeuMoDx EBV Quant Assay 2.0 study is a multi-center, observational clinical investigation designed to evaluate the performance of the NeuMoDx EBV Quant Assay 2.0 in quantifying Epstein-Barr virus (EBV) DNA levels in plasma samples from immunocompromised transplant patients. The study compares the NeuMoDx EBV assay's performance against an FDA-cleared comparator assay under routine clinical use conditions, utilizing both the NeuMoDx™ 96 and NeuMoDx™ 288 Molecular Systems. The aim is to demonstrate the quantitative concordance and clinical utility of the assay in monitoring EBV DNA levels as part of patient management.

This study is an observational, multi-center, open-labeled, prospective, and retrospective clinical evaluation aimed at assessing the performance of the NeuMoDx EBV Quant Assay 2.0 on the NeuMoDx™ 96 and NeuMoDx™ 288 Molecular Systems. Plasma samples are collected from immunocompromised patients undergoing solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT) who are at risk of EBV infection or reactivation. The study includes both fresh and frozen plasma specimens obtained as part of routine clinical care.

The primary objective is to demonstrate the quantitative concordance of the NeuMoDx EBV assay when compared to the cobas® EBV assay (Roche Diagnostics Corporation) using a predefined set of performance criteria. The study also assesses the equivalence of performance between the two NeuMoDx systems (NeuMoDx™ 96 and NeuMoDx™ 288) in quantifying EBV DNA levels across a range of clinical specimens. Secondary objectives include evaluating the assay's performance across different viral load concentrations and subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised transplant patients (Solid Organ Transplant (SOT) or Hematopoietic Stem Cell Transplant (HSCT)).
* Fresh and frozen plasma specimens derived from whole blood collected with EDTA as an anticoagulant.
* Residual fresh or frozen EDTA plasma specimens obtained from routine testing, including specimens collected from the same subject at different timepoints.
* Sufficient sample volume 1.6- 2.0 ml for testing with 2 assays plus discordant testing.
* EDTA plasma samples have been stored under the following conditions:
* 2-8° C up to 7 days and/or -20° C +/- 2° C or colder for up to 6 months following the separation of plasma from whole blood. Or fresh EDTA plasma samples that have not been stored loaded onto the NeuMoDx™ system immediately after they have been separated from whole blood.
* Frozen samples have not gone through more than two freeze/thaw cycles.

Exclusion Criteria:

* Specimens not collected according to the manufacturer's instructions or study protocol.
* Lack of clear subject identification or label on a residual plasma sample
* Unable to obtain required medical chart information.
* Obvious physical damage to the residual sample.
* Specimens that have remained onboard the NeuMoDx System for longer than 8 hours prior to processing.
Entire Papilla Preservation Technique in the Treatment of Periodontal IntraBony Defects: a 1-year Follow-up Study

The aim of this study was to investigate the radiographic and clinical outcomes associated with the whole papilla preservation technique in the treatment of isolated intraosseous defects in patients with stage III periodontitis. The records of 17 systemically healthy patients (12 women and 5 men) diagnosed with stage III periodontitis who underwent the whole papilla preservation technique three months after nonsurgical periodontal treatment were evaluated. The following clinical parameters were recorded at baseline and after treatment: full mouth plaque score (FMPS), full mouth bleeding score (FMBS), probing depths (PD), clinical attachment level (CAL) and gingival recession (GR). The early healing index (EHI) score was assessed 1 week after surgery in both groups. CAL gain was determined as the primary outcome. Baseline data as well as follow-up assessments at 1 month, 3 months, 6 months and 1 year were analyzed to determine the efficacy and long-term outcomes of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* • Systemically healthy individuals.

  * Patients who underwent reconstructive periodontal surgery following the completion of non-surgical treatment.
  * Presence of at least one isolated two- or three-wall intrabony defect with probing depth (PD) ≥7 mm, clinical attachment level (CAL) ≥7 mm and at least 4 mm intrabony component involving predominantly the interproximal area of the affected tooth
  * Full-mouth plaque score (FMPS) and full-mouth bleeding score ≤20%

Exclusion Criteria:

* Individuals who smoke
* Individuals with uncontrolled systemic disease
* Individuals using drugs that affect periodontal tissues
* Individuals during pregnancy and breastfeeding
* Presence of single-walled intraosseous defects
* Flood restoration
* Inadequate endodontic treatment
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be quite long lasting and debilitating. Dextrose injection with a small needle has been notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with sterile water injection for temporomandibular(jaw) dysfunction, also known as TMD.

Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of symptom diminishment, especially in the elderly. However studies out to 2-8 years show residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been utilized empirically for many years and a marked reduction in pain and luxation after intra-articular and pericapsular dextrose injection has been reported in a recent RCT. However, small study size and lack of a non injection control have prevented any definitive conclusions as the additional efficacy of including dextrose in the injectate. The mechanism of action of dextrose injection was originally thought to be via a brief stimulation of the inflammatory cascade with resultant production of growth factors. However, non-inflammatory dextrose effects on growth factor production have been demonstrated, and, more recently, dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). This has the theoretical benefit of reducing pain, regardless of the status and position of the intraarticular cartilage or degree of degenerative change of the TMD. The primary goal of this study is to evaluate the ability of dextrose injection versus saline injection to reduce pain and improve functional complaints referable to the temporomandibular joint.

Eligibility Criteria:
Inclusion Criteria:

more than 3 month history of :

* Facial Pain NRS rating \> 5/10
* Jaw symptom rating \> 5/10
* Jaw function issues seen on examination

Exclusion Criteria:

* Any potential acute dental issue
* Rheumatic inflammatory disease
* Chronic intake of NSAIDs or corticosteroids.
* Pain in other body location worse than jaw pain
* Pain 10/10 in other body location.
A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects

PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male, or female subjects of non childbearing potential.
* Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight \>50 kg

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?

This study is to see if a high response to the TTG screening test for celiac disease is as accurate as the current method of diagnosing celiac disease which entails a general anesthetic and upper endoscopy to obtain biopsies of the small intestine. If the screening blood test is highly accurate, then some patients that are being evaluated for celiac disease may not require an upper GI endoscopy and can be treated more quickly. If they respond to the therapy then they will be deemed to have celiac disease.

All patients scheduled for upper GI endoscopy will be approached for recruitment into the study. A minimum of 4 small intestinal biopsies will be taken from all subjects and controls. All TTG specimens will be run through the hospital laboratory. Intermediate level TTG values 20-100 will be assessed separately and as part of the larger group. An optional part B of the study will assess the frequency of lactose intolerance in subjects prior to the start of a gluten free diet.

Eligibility Criteria:
Inclusion Criteria:

Inclusion-All patients planned to undergo upper GI endoscopy with biopsies.

Exclusion Criteria:

Exclusion-refusal to participate, not planning to have biopsies performed with the endoscopy.
Diagnostic Performance of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer

Following numerous retrospective studies and Phase-3-Studies with promising results, \[18F\]PSMA-1007 has been approved by european authorities. Therefore, it is a growing deployment of this diagnostic method anticipated. This study aims to investigate the diagnostic performance and clinical impact in a real-world-evidence in the context of regular clinical care. The evidence generated by this approach is supposed to assist in optimizing the management of prostate cancer patients.

The advent of PSMA diagnostics and therapy has constituted a paradigm shift in the management of prostate cancer, supplanting other clinical and radiological diagnostic techniques. Consequently, \[18F\]PSMA-1007 (Radelumin®) has been approved in several EU countries, most recently in Germany in 2024, for use in primary staging of high-risk prostate cancer and re-staging in the context of biochemical recurrence (BCR). This may be regarded as a landmark in the management of prostate cancer, with the potential to markedly enhance the uptake of PSMA-PET diagnostics in the coming years.

The intention is to generate evidence-based data in everyday clinical practice with this so-called Real-World-Evidence (RWE) study. The planned study will facilitate a more detailed analysis of the diagnostic accuracy of Radelumin® in everyday clinical practice. This will involve dedicated examinations of certain subgroups and the prospective generation of a complete, high-quality database for future use of artificial intelligence (AI).

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Conduct of \[18F\]PSMA-1007 PET Imaging in the context of regular clinical care

Exclusion Criteria:

* Technical Flaws in the acquisition protocol
Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs

This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of gastric neuroendocrine tumor.
* Clinical diagnosis of Type I gastric NET: neuroendocrine tumor arising from atrophic body gastritis (ABG diagnosis should be based on hypergastrinemia and histological confirmation of gastric body atrophy on multiple biopsies performed in gastric antrum and body).
* Previous esophagogastroduodenoscopy: all visible NETs resected with R0 margin, confirmed no visible gastric NETs left, multiple biopsies taken to evaluate gastric atrophy and ECL status.
* No tumor metastases confirmed by endoscopic ultrasonography, CT scan or somatostatin receptor scintigraphy.
* SSA therapy is recommended by physician for disease management, and has not yet begun.
* Written informed consent obtained prior to treatment to be consistent with local regulatory requirements.

Exclusion Criteria:

* Pathological grading as G3 NET (Ki-67\>20%).
* Patients with a known hypersensitivity to somatostatin analogs.
* Known gallbladder or bile duct disease, acute or chronic pancreatitis.
* Known medical condition related with prolonged QT interval.
* Pregnant or lactating women.
* Patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
* Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for \> 5 years will be allowed to enter the trial.
* Patients with a history of non-compliance to medical regimens.