cyrilzakka/clinical-trials huggingface dataset:
Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel

The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patient must provide written informed consent prior to participating in this protocol
* Patient must have been prescribed TECELRA®
* Patient's commercially manufactured product does not meet the commercial release specification
* Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with Adaptimmune
* Repeat leukapheresis is not feasible or is not clinically appropriate per Investigator assessment
* The Investigator has confirmed a favorable benefit:risk profile, following sponsor evaluation of the NC afami-cel, and deems proceeding with treatment under this EAP is in the best interest of the patient
* Patient deemed medically fit and stable to receive NC afami-cel per Investigator assessment
* Female patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy

Exclusion Criteria:

* Patient has contraindication(s) as per the TECELRA® USPI
* Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A\*02:05P
Comparison of the Effectiveness of LLLT and ESWT in Plantar Fasciitis Treatment

The aim of this study is to compare the efficacy of extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) in terms of pain, disability, activity limitation, gait speed, and cadence in patients with plantar fasciitis (PF).


Eligibility Criteria:
Inclusion Criteria:

* Experience pain on the medial tuberosity or medial process of plantar fascia within the past one month
* Diagnosed with plantar fasciitis

Exclusion Criteria:

* arthritis in the foot or ankle
* Cardiac arrhythmia or pacemaker
* Previous foot or ankle surgery
* Cancer or tumor, acute trauma
* BMI over 40 kg/m2
* Corticosteroid injection in the last 6 months
Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease

Alzheimer's disease is a neurodegenerative disease. Numerous studies have reported that β-amyloid (Aβ) is an important marker for the diagnosis of AD. 18F-92 molecular probe is a novel molecularly targeted imaging agent, which can rapidly penetrate the blood-brain barrier and has high affinity and selectivity for Aβ protein. In this study, 18F-92 PET/CT was used to monitor the regional distribution and the degree of deposition in patients with Alzheimer's disease, and compared with clinical symptoms (neuropsychometry) to evaluate its application value in the diagnosis of AD.

Healthy volunteers as well as patients meeting Alzheimer's criteria will be recruited for this study.

We will use PET/CT imaging technology to scan each participant's whole body or head and collect image data for analysis to evaluate the distribution and metabolism of 18F-92 in the subject's body. Time from drug injection to scan completion is approximately 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Patients or their families complain of significant memory impairment;
* Objective memory impairment (e.g., tests of article identification, recall, delayed memory);
* Meets Alzheimer's criteria for DSMIV and NINCDS-ADRDA;
* Be able to obtain complete diagnosis and treatment records and be able to carry out long-term follow-up;
* Signed written consent.

Exclusion Criteria:

* Nervous system diseases: including brain tumors, craniocerebral trauma, multiple sclerosis, epilepsy, etc.;
* Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis;
* Pregnancy or lactation.
Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

This is prospective research study which will include patients with recurrent or metastatic squamous cell carcinoma of the head and neck, esophagus and anal canal starting on first-line platinum based chemotherapy or any line of immunotherapy treatment.This study aims to characterize the dynamic changes in genomic, epigenetic, immune profiling and imaging data during treatment with systemic therapy. Patients will have archived tumor samples requested as well as blood samples collected at up to four time points to analyze these changes. Imaging data will be derived from patients' routine CT scans before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a histological or cytological diagnosis of Squamous Cell Cancer of the head and neck, esophagus or anal canal who have radiologically confirmed recurrent or metastatic disease.
2. Patients must be of adequate fitness, ECOG 0-1 for systemic therapy, with either standard chemotherapy, immunotherapy or within the context of a clinical trial.
3. Patients must be commencing on a new treatment at time of consent, this can be first line platinum based chemotherapy, or immunotherapy, any line.
4. Patients must be ≥ 18 years old.
5. Patients must have provided voluntary written informed consent.

Exclusion Criteria:

None
Confocal Laser Probe to Treat Barrett's Esophagus

The purpose of this study is to further validate the use of probe-based confocal laser endomicroscopy (pCLE) for the evaluation of Barrett's Esophagus and associated neoplasia in a larger patient base.

Subject Population

Approximately 100 subjects will be recruited, age greater than 18 years. Subjects will be recruited from OCF, OMC Kenner who are undergoing EGD for either 1) screening for Barrett's Esophagus because of long-standing GERD of greater than 5 years; 2) surveillance of known Barrett's Esophagus; or 3) therapy for known Barrett's Esophagus. They will be asked to volunteer for participation at the time of their EGD. These subjects are being recruited because of a high suspicion or known diagnosis of Barrett's Esophagus in this cohort.

Procedures

Patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction. Photographs will be taken and digitally stored. Biopsies (which are part of the routine diagnosis and surveillance of Barrett's) will be targeted based on the microscopic images. The histologic findings on the biopsy specimens will be compared to the microscopic images to determine the accuracy of the probe-based microscopy in predicting pathology.

The time commitment for the patient is included in the time to undergo endoscopy and is roughly 30 minutes to an hour, including recovery time. The research will occur at OMC, Jefferson Highway and Ochsner Medical Center, Kenner.

Eligibility Criteria:
Inclusion Criteria:

* Must be greater than 18 years of age
* currently undergoing EGD
* previous diagnosis of Barrett's Esophagus
* long-standing GERD of greater than 5 years
* undergoing therapy for previously diagnosed Barrett's Esophagus

Exclusion Criteria:

* Under 19 years of age
SSTR PET/CT for Preoperative N Stage Evaluation in GEP-NETs

The research aims to prospectively include patients with GEP-NENs, undergo preoperative imaging assessment (including PET/CT and contrast-enhanced CT), and accurately delineate lymph node regions. Through postoperative pathological reports, the diagnostic performance of lymph node metastasis (LNM) in GEP-NENs is evaluated. Factors influencing the diagnostic accuracy of SSTR-PET/CT and contrast-enhanced CT are also investigated.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old;
2. Patients diagnosed with GEP-NEN by surgical pathology;
3. Complete medical records including basic information and treatment process;
4. Patients who have undergone preoperative contrast-enhanced CT and 68Ga-SSTR-PET/CT, and have consented to the 68Ga-SSTR-PET/CT project in the Nuclear Medicine Department.

Exclusion Criteria:

1. Presence of concomitant malignancies;
2. Cases diagnosed pathologically as non-GEP-NEN.
Melanocortin Gene Expression in Lymphocytes of Polymyalgia Patients

Polymyalgia rheumatica (PMR) is a systemic inflammatory disorder with unknown etiology and overlapping symptoms with giant cell arthritis and rheumatoid arthritis (RA). The proteomic profile of PMR patients remains uncharacterized and biomarker studies very limited. The primary aim of this study was to thoroughly investigate the lymphocyte expression of melanocortin receptors, and the serum proteome during glucocorticoid treatment of PMR with a focus on acute-phase reactions, the complement system, and pro-inflammatory cytokines.

Polymyalgia rheumatica (PMR) is a prototypic systemic inflammatory disease with overlapping symptoms similar to late onset rheumatoid arthritis (RA), giant cell arthritis (GCA), and cancer \[1\]. The etiology of PMR remains largely unknown, but it has been suggested that an age-related decline in the adaptive immune system might play a role in an over-compensatory inflammatory innate immune response \[2\]. Some genes and polymorphisms involved in initiation and regulation of inflammation have been associated with PMR \[3,4\] and polymorphisms are more predominant in the Northern European than Mediterranean population \[5\]. PMR has been somewhat successfully treated with glucocorticoids (e.g. prednisone) for more than half a century \[6\]. Due to the lack of causative molecular knowledge about the driving factors of inflammatory activation, and lack of treatment alternatives, glucocorticoids are still applied as the first line treatment today \[7\]. Relapses are common during standard glucocorticoid treatment \[8\], and randomized trials have failed to provide new treatment options \[9,10\]. However, recent progress in GCA treatment \[11\] have paved the way for biological treatment of PMR.

Only few serological biomarkers have been associated to PMR pathogenesis and disease activity while the pathogenesis of RA has been more thoroughly investigated. Hence, there is an unmet need to elucidate the pathophysiology of PMR. In this pilot-study, we therefore explored the potential to identify new serological markers at disease onset, which could be responsive to glucocorticoid treatment, which could be linked to PMR pathology. We did this using state-of-the-art quantitative proteomics profiling to investigate serum proteins from PMR patients before and after treatment with glucocorticoids for three months. In addition, we compared these patients with DMARD naïve RA patients, and healthy controls for potential molecular similarities. Hence, we applied advanced, qPCR to investigate lymphocyte expression, and mass spectrometry (MS) to measure serum proteins, and compared the results with serum cytokines.

Eligibility Criteria:
Inclusion Criteria:

* The PMR diagnosis fulfilled the ACR 1987 criteria \[20\]. Additional inclusion criteria were elevated CRP, and sedimentation rate, ultrasound verified synovitis \[21\], and \].

Exclusion Criteria:

* no cancer related findings on computed tomography (CT) of the abdomen, and chest X-ray to increase specificity as described by ACR 2012 classification criteria \[22
Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures

The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the chondral (unossified) epiphysis. MRI gives a perfect view of these fractures. The safety and feasibility of non-operative treatment based on MRI findings in children with elbow fractures has not been investigated in a Danish setting. If safe and feasible, the use of MRI could dramatically lower the need for surgery in children with LHCF.

The treatment of LHCF has historically most often been surgical with open reduction and fixation. The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the unossified chondral epiphysis and therefore physicians often opt for open surgical treatment. MRI; however, gives a perfect view of these fractures. This project investigates the safety and feasibility of non-operative treatment of LHCF based on MRI performed without sedation or anesthesia and seeks to dramatically lower the need for surgery. Objectives are to describe functional outcome, radiological healing, secondary fracture displacement and any complications after two years. The investigators hypothesize that undisplaced and minimally displaced LHCF can be treated non-operatively based on MRI findings with good functional outcomes after two years. A cohort study design is used to follow 50 children with LHCF.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute Lateral humeral condyle fracture
* Fracture \<5 days old
* Fracture with \<5 mm of displacement on plain radiographs
* Parental informed consent obtained

Exclusion Criteria:

* Contraindication(s) to performing an MRI
* Unable to participate in follow-up
* Existing bone pathology
* Previous ipsilateral elbow fracture
Characterization of the Immunological Profile Patients With Post-polio Syndrome

Many patients with polio sequelae have persistent and progressive worsening more than 15 years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal pain. In these patients, there is a denervation process associated with insufficient reinnervation. The frequency of this syndrome post-polio (SPP) is of the order of 20 to 60% according to the studies. In the literature, several studies have advanced the hypothesis of immune dysregulation to this late degradation, with greater expression of pro-inflammatory cytokines, and abnormal phenotypic expression of T cells in the bloodstream. In this context, the use of immunomodulatory immunoglobulin IV treatment was studied several times, with no significant result on pain, fatigue and muscle strength scores. In the absence of significant efficacy of immunoglobulin treatment, the objective of this study is therefore to define the immunological profile of patients with post-polio syndrome, compared with control subjects, in order to support the pathophysiology of this syndrome. to study the possible presence of an inflammatory syndrome associated with this syndrome. On the other hand, depending on the results found, referral to targeted therapies could be considered.


Eligibility Criteria:
Inclusion Criteria:

Subjects with Post-polio Syndrome :

* age ≥ 18 years
* meeting the definition of the SPP according to the criteria of Halstead et al. (1995)

Controlled subjects :

* age ≥ 18 years
* matched on sex and age (+/- 5 years) with subjects with PPS

Exclusion Criteria:

* intercurrent neurological pathology,
* uncontrolled cardiovascular risk factors
* pulmonary comorbidity
* endocrine disorders
* systemic inflammatory pathology, autoimmune disease, dry syndrome,
* renal failure
* anti-inflammatory treatment in progress or in the previous month, or immunoregulatory aim whatever its nature,
* patients with SPP who received polyvalent IV immunoglobulins in the 3 years prior to inclusion, or taking anticoagulants
Modified Surface of PLGA Nanoparticles in Smart Hydrogel

Nanoparticles containing antibiotic were prepared and incorporated in in situ gel to treat recurrent endodontic infections

Enterococcus faecalis is the main cause of endodontic infections and form biofilm on dentin, resulting in treatment-resistant periradicular lesions. To overcome these problems, antibacterial nanoparticles were used because of their small size, sustained release and positive charge which interact with the negatively charged surface of bacterial cell causing its destruction. In this light, Ciprofloxacin hydrochloride (CIP) in chitosan coated PLGA nanoparticles (CIP-CS-PLGA-NPs) and free CIP were embedded in Pluronic® 407/188 to form thermosensitive gels(F1) and (F2) respectively, that were investigated in terms of viscosity, gelation temperature and in-vitro release. The antibacterial efficacy of F1 and F2 were clinically investigated on patients then compared to CIP and Ca(OH)2 pastes by determining bacterial reduction percent and biofilm inhibition assay

Eligibility Criteria:
Inclusion Criteria:

* Root canal filled single rooted teeth with post treatment disease manifested by one or more of the following signs and symptoms:
* History of recurrent acute and/or chronic periapical abscess
* Pain on palpation and/or percussion at least after one month of previous procedure
* Radiographic evidence of bone loss either as a new developing lesion or an increase in the size of a pre-existing one.

Exclusion Criteria:

* Teeth that were badly broken down indicated for extraction or with difficult isolation
* Immuno-compromised patients.
* Patients with history of taking antibiotics orally.
* Periodontally affected teeth.
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer

The purpose of this study is to evaluate the efficacy and safety of an adjuvant treatment of therapeutic cancer vaccine (AST-301, pNGVL3-hICD) in patients with HER2-low expression (IHC 1+ or 2+ and ISH-) and hormone receptor-negative(ER-, PR-) breast cancer with residual disease after neoadjuvant treatment.

Patients will be randomized 1:1 to either the Experimental arm (combination of AST-301/rhuGM CSF and standard adjuvant therapy) or the Control arm (combination of placebo/rhuGM CSF and standard adjuvant therapy). Standard adjuvant chemotherapy will be pembrolizumab or capecitabine.

Adjuvant therapy will be administered in compliance with the NCCN guideline for breast cancer (Version 8, 2021), and IP (AST-301) will be administered 3 times every 3 weeks in the adjuvant treatment period, with a booster administered at 24 weeks (±7 days) post the third dose of IP administration.

Survival follow up will be performed to determine invasive Disease Free survival(iDFS).

Not provided

Eligibility Criteria:
Key Inclusion Criteria:

* Has a residual invasive cancer in the breast(non-pCR) after neoadjuvant treatment
* Has stage I, II, or III disease prior to surgery per American Joint Committee on Cancer (AJCC)
* HER 2 1+ by IHC or HER2 2+by IHC without gene amplification by ISH, as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* Hormone receptor (ER and PR) negative by ASCO/CAP guidelines
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Demonstrates adequate organ function.

Key Exclusion Criteria:

* Has a history of hypersensitivity or other contraindications to rhGM-CSF
* Has a history of invasive malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or carcinoma in situ.
* Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs
* Has a history of autoimmune disease or inflammatory disease
* Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
* Is pregnant or breastfeeding or expecting to conceive children
A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder

It's a double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients.

We think that the treatment of the OAB with Propantheline could reduce nocturia and frequency in sixty percent.

Double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients

Treatment Group Propantheline Bromide: 15mg, three times daily for 08 weeks.

Control Group Placebo 03 times daily

Case definition Clinically defined OAB patients (ICS criteria), infected by HTLV-1. Frequency was defined as more than 08 daytime voids. Nocturia was defined as more than 02 voids after sleeping.

Inclusion criteria More than 18 year. HTLV-1 infected patients with overactive bladder. Negative culture of urine. Without neurological impairment.

Exclusion criteria Persistently positive urine culture

History of:

Allergy to medication, head or spinal trauma. Head and neck, neurological,spinal, lower abdominal or pelvic surgery. Stroke. Users of urinary catheters.

Eligibility Criteria:
Inclusion Criteria:

* HTLV-1 infection
* More than 18 years
* Negative urine culture
* No neurological damage

Exclusion Criteria:

* Diabetes
* Persistently positive urine culture
* Pelvic, head, urological or gynecological surgery
* Stroke
To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)

This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 65 years of age, inclusive at time of signing the ICF.
2. Subjects with low to moderate risk defined as NEWS COVID-19 infection as confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay 72 hours prior to clinical trial enrollment.

Exclusion Criteria:

1. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note patients with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
2. Significant history, clinical manifestation of any medical disorder or any comorbid conditions which in the opinion of the investigator may interfere with the study
The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor

To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor

1. To identify the intra-tumor heterogeneity of elasticity
2. To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor


Eligibility Criteria:
Inclusion criteria:

(1) Patients with radiographic evidence of pulmonary lesions

Exclusion criteria:

1. Age \< 20 y/o
2. Patients who cannot hold their breath for 5 seconds
3. Inadequate shear-wave propagation of lung tumor