cyrilzakka/clinical-trials huggingface dataset:
Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers

Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems.

Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe.

This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers.

This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing.

Participants will be in the study up to one year.


Eligibility Criteria:
Volunteers will be consented. Then there will be a run-in period for the doctor to run some tests. If the tests show the study would be good for the patient, the doctor will enroll them as participants in the trial.

Inclusion Criteria:

To be considered for inclusion, a participant:

* Agrees to practice birth control for the duration of the study
* Has documented Type 1 or Type 2 diabetes and an HbA1C score of 10 or below
* Has protocol-defined sufficient blood pressure and flow to the foot
* Has stable medications for 2 weeks before treatment (other than diabetes medications or antibiotics)
* Is able and willing to attend scheduled visits and comply with study procedures
* If a smoker, agrees to try quitting and will accept counseling for it (Cohorts 2 and 3 only)
* Has documented informed consent for study enrollment
* Has had an uninfected, appropriately-sized diabetic ulcer on the foot for at least 4 weeks but not more than 1 year

Exclusion Criteria:

The doctor may not consider for inclusion a participant who:

* Is pregnant, nursing, or a prisoner
* Has had osteomyelitis in the foot with the ulcer in the last 30 days
* Has a history of poor compliance
* Has received drugs or therapies not allowed per protocol
* Has used an investigational product within the last 60 days
* Has ever received therapy for the study ulcer with any cell and/or tissue product (CTP)
* Has a study ulcer in a condition not appropriate for the study
* Has a medical condition or history that, per protocol or in the opinion of the study doctor, might put the safety of the participant in danger
Early IntraVenous Administration of Nutritional Support

The present trial will be conducted to verify if early supplemental parenteral nutrition in combination with nutritional counseling improves survival and the feasibility of chemotherapy, in addition to nutritional status, body composition, functional status and quality of life in treatment-naïve patients with metastatic gastric cancer at nutritional risk undergoing first-line chemotherapy.

Although it is known that nutritional support can improve clinical outcomes, the literature shows that only around 50% of cancer patients are able to satisfy estimated protein-calorie requirements. It is also emerging a strong correlation between nutritional status, particularly body composition, and adherence to active treatment. International guidelines suggest that parenteral nutrition (PN) is recommended in malnourished, hypophagic cancer patients suffering from gastrointestinal complications or with expected prolonged inadequate food intake, when enteral nutrition is not feasible. Although recent trials suggest that supplemental PN (SPN) could help to improve the nutritional status of malnourished cancer patients, there are no studies on the clinical effects of early SPN in cancer patients at nutritional risk receiving first-line chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of metastatic gastric and gastroesophageal cancer;
* no previous chemotherapy for metastatic disease;
* indication for a first-line chemotherapy with a combination of 2 drugs including platinum derivatives (plus Trastuzumab if HER2+) to be used by investigator's choice within the framework of good clinical practice and in agreement with current Italian Association of Medical Oncology guidelines;
* measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST);
* presence of nutritional risk (Nutritional Risk Screening 2002 score ≥3);
* availability of permanent venous access (Port, Groshong, PICC);
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
* availability of a home parenteral nutrition service to continue nutritional plan as scheduled;
* signed informed consent.

Exclusion Criteria:

* age \<18 years
* ECOG performance status \>2
* indication to complete artificial nutrition support (totally compromised spontaneous food-intake)
* contraindication to parenteral nutrition (abnormal glucose and electrolytes control, hyper-triglyceridemia, impaired hemodynamic control and fluid retention)
* availability of jejunostomy for nutritional purposes
* ongoing home artificial nutrition
* unfeasible home parenteral nutrition for social/familial reasons
* absence of caregivers
* patients refusal
Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

Epidural analgesia for childbirth may fail to provide adequate pain relief. At NYULMC, to maximize the likelihood that epidural analgesia will work well, the gravity flow technique is used when performing epidural procedures.

The gravity flow technique is not well known, and is therefore used in only a few hospitals. The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia in laboring women.

The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia in laboring women. This gravity flow technique was first described 26 years ago in 1991, and has been at NYU Langone for 15 years, since 2002. The technique has not been formally studied and this study is designed to enable assessment of the success rate of the gravity flow technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients requesting epidural analgesia for labor
* ASA physical status I to II
* Ability to speak and read English to fully comprehend the consent process

Exclusion Criteria:

* Combined spinal-epidural anesthesia
* Coagulopathy
* History of lumbar spine surgery
* Allergy or contraindication to any of the study medications
* Contraindication to epidural analgesia
* ASA physical status \>III
Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

The aim of this study was to evaluate the effect of oral lycopene and systemic steroids in the treatment of erosive oral lichen planus and compare between the two therapeutic modalities.

Twenty erosive lichen planus patients were recruited and randomly assigned in one of two groups, the test (lycopene) and control (corticosteroids) group.

Eligibility Criteria:
Inclusion Criteria:

* Erosive oral lichen planus patients with severe and extensive painful erythematous, erosive and/ or ulcerative lesions who are in need for systemic corticosteroid therapy

Exclusion Criteria:

* Pregnant females and smokers.
* Patients suggestive of having lichenoid contact/drug reactions.
* Patients suffering from any systemic disease as diabetes, liver disease, renal disease, any other autoimmune or collagen disease.
* Lesions showing histological features of dysplasia.
* Patients with skin lichen planus lesions.
A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period

Primary Objectives:

* Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs).
* Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs.

Secondary Objectives:

Main study and 6-month study extension period:

To assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy:

* The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c).
* Safety and tolerability.

Main study: The maximum study duration is approximately 12 weeks per patient (up-to 3-week screening period, 8-week treatment period, 3-day post treatment follow-up period).

Six-month study extension period: The maximum study duration is approximately 9 months (up-to 3-week screening period, 8-month treatment period, 3-day post treatment follow-up period).

Eligibility Criteria:
Inclusion criteria:

* Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.
* Patients who are motivated to lose weight.

Exclusion criteria:

* Type 1 diabetes mellitus.
* Body mass index \<27 kg/m2.
* Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) \>7.0%.
* Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.
* Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.
* Uncontrolled hypertension.
* Laboratory findings at the time of screening: amylase and/or lipase \>2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase \>1.5 ULN, total bilirubin \>1.5 ULN, serum creatinine levels ≥1.5 mg/dL \[males\]. ≥1.4 mg/dL \[females\], screening calcitonin ≥20 pmol/m, fasting serum triglycerides \>400 mg/dL.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.
* History of weight loss surgery.
* History of pancreatitis or pancreatectomy.
* Pregnant or lactating women.
* Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study in Patients With Erectile Dysfunction

The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.


Eligibility Criteria:
Inclusion Criteria:

* History of Erectile Dysfunction (ED) of at least 3 months duration.
* Anticipate having the same adult female sexual partner during the study.
* Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.

Exclusion Criteria:

* Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
* ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
* ED caused by untreated or inadequately treated endocrine disease.
* Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
* Severe renal or hepatic impairment, history of malignant hypertension.
* Presence or history of specific heart conditions.
Artificial Intelligence in ANOCA

Angina pectoris is diagnosed in \>180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events.

The origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA.

During CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical indication for comprehensive coronary function testing because of persisting chest discomfort at least 2 times per week despite current medical therapy.
2. Absence of obstructive coronary artery disease with an indication for revascularization, documented by means of recent coronary computed tomography angiography (CCTA) or invasive coronary angiography (with invasive coronary pressure measurements if clinically indicated).
3. Patient is willing and able to provide written informed consent.

Exclusion Criteria:

1. Absence of chest discomfort after initiation of medical therapy.
2. Language barrier preventing sufficient understanding and communication in Dutch.
The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention

Safety planning is a brief, ED-feasible intervention which has been demonstrated to save lives, and has been universally recommended by every recent expert consensus panel on suicide prevention strategies. In one popular version of the safety plan developed by Stanley et al, the patient is encouraged to write out the following items: identifying personal signs of a crisis; helpful internal coping strategies; social contacts or settings which may distract from a crisis; using family members or friends for help when in crisis; mental health professionals who can be contacted when in crisis; and restricting access to lethal means. In most emergency departments, safety-planning is done by clinical personnel such as psychologists or social workers, but these providers are often too busy to perform safety-planning well or have multiple other patient care responsibilities.

This study aims to find out if ED patients prefer to complete a safety plan with a peer supporter or clinical personnel. People who are visiting the emergency department for thoughts of self-harm will be asked to participate.

This project aims to answer the following three research questions: (1) In general, do ED patients with suicidal ideation/attempt prefer to interact with/receive support from peers with life experiences of suicide or clinical professionals who might have such life experiences or not? (2) Will patients with suicidal ideation/attempt accept a peer-delivered safety planning intervention as opposed to one delivered by clinical personnel? (3) Are peer-delivered safety plans of equal quality as those delivered by clinical personnel?

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for suicidal ideation (SI) or after a suicide attempt to the University of Arkansas for Medical Sciences (UAMS) Emergency Department (ED)
* Willingness to engage in safety planning with trained non-clinical staff
* English-speaking and English-writing (as translators will not be available for this study)

Exclusion Criteria:

* \<18 or \>89 years of age
* Patients appearing critically-ill
* Incarcerated or in police custody
* Currently intoxicated with alcohol or other substance
* ED staff objection to patient enrollment in study
* Unwilling or unable to complete the safety plan with a peer supporter
* Unwilling or unable to show the safety plan to clinical staff
A Phase I-II Study of HM781-36B Combined With Paclitaxel and Trastuzumab in HER-2 Positive Advanced Gastric Cancer

\[Phase I\] The main objective of this study is to evaluate the safety, tolerability and determine the Recommended Dose (RD) of HM781-36B(Poziotinib)combined with Paclitaxel and Trastuzumab

\[Phase II\] The main objective of this study is to evaluate anticancer activity through determination of response rate of HM781-36B(Poziotinib)combined with Paclitaxel and Trastuzumab in patients with HER-2 positive advanced gastric cancer

Besides the main objectives, there are other objectives as follows:

\[Phase I\]

1. To assess the pharmacokinetic profile of HM781-36B(Poziotinib) combined with Paclitaxel and Trastuzumab
2. To evaluate anticancer activity of HM781-36B(Poziotinib) combined with Paclitaxel and Trastuzumab in patients with HER-2 positive advanced gastric cancer
3. To evaluate PFS(Progression-Free Survival), TTP (Time To Tumor Progression), and DOR (Duration of Overall Response)

\[Phase II\]

1. To assess the safety, tolerability of HM781-36B(Poziotinib) combined with Paclitaxel and Trastuzumab
2. To evaluate tumor response through determination of disease control rate , PFS(Progression-Free Survival), TTP (Time To Tumor Progression), and DOR (Duration of Overall Response)

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed advanced gastric cancer including gastroesophageal junction adenocarcinoma
2. At least one measurable lesion defined by RECIST(v1.1)
3. FISH+ or IHC3+ (regardless of FISH results)
4. Age≥19
5. ECOG ≤ 2
6. Life expectancy ≥ 12 weeks
7. Adequate bone marrow and no abnormal heart and lung function
8. No radiotherapy, other anticancer drugs or immunotherapy is allowed during this study
9. Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Exclusion Criteria:

1. Patients with a history of hypersensitivity to Trastuzumab and who have been treated with medicine including Cremophor EL
2. Patients who have a current active malignancy other than gastric adenocarcinoma (with exception of non-melanoma skin cancer or cervical cancer in situ)
3. Patients who have previously received taxane-based chemotherapy
4. The presence of central nervous system metastases
5. Patients who have a blood tumor such as leukemia, or who had previously received, or are planning to receive, the bone marrow transplant
6. Patients with uncontrolled infection
7. Patients who have GI malabsorption or difficulty taking oral medication
8. Patients with following diseases are excluded:
9. Patients with psychiatric or congenital disorder which can affect adherence or make hard to follow the requirements of the protocol
10. Pregnant or breastfeeding women or women of childbearing who do not use an appropriate method of contraception (male patient should also use an appropriate method of contraception)
Value of Whole-body SPECT-CT CzT-based Camera (VERITON-CT) in the Assessment of Chronic Inflammatory Rheumatism With Axial Involvement

The diagnosis of chronic inflammatory rheumatism with axial involvement is not always easy, and is fraught with difficulties : radiological sacroiliitis is not an early sign of spondyloarthritis and the delay in detecting radiological signs contributes to the delay in diagnosis.

Nevertheless, spondyloarthritis is now the second most common chronic inflammatory rheumatic disease, affecting 0.43% of the french population.

The aim of this retrospective study is to evaluate the diagnostic performance of whole-body SPECT-CT CzT-based camera (VERITON-CT) in the assessment of chronic inflammatory rheumatism with axial involvement

MRI of the sacroiliac joints and thoracolumbar spine were used as a gold standard.

The present study was conducted by the Department of Rheumatology and Nuclear Medicine of the University Hospital Centre of Nancy (France).

An initial number of 51 hospitalised patients (35 females, 16 males) who underwent SPECT-CT CzT-based camera for polyarthralgia or spinal pain between November 2021 and February 2023 and initial suspicion of chronic inflammatory rheumatism were included in the study.

The investigators retrospectively reviewed the electronic medical records of the consecutive patients using medical softwares (DxCare or VNA Philips). The investigators collected demographic data (age, gender), clinical data (anamnesis, pain level (EVA) and location, standardized clinical activity scores like Ankylosing Spondylitis Disease Activity Score (ASDAS), Widespread Pain Index (WPI), symptom severity scale (SSS)), biological data (protein chain reaction in milligrams per litre), and medical imaging data (X-rays, MRI and CT scans).

The data collected was entered into an Excel spreadsheet protected by a security code.

For medical imaging data, the investigators performed a reading of the sacroiliac and thoracolumbar spine medical imaging under the supervision of an experienced rheumatologist specialising in chronic inflammatory rheumatism.

The investigators assessed the diagnostic performance of VERITON-CT (sensitivity, specificity), using MRI of the sacroiliac joints and thoracolumbar spine as the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalised patients (hospitalisation sector or day hospital)
* Patients who underwent SPECT-CT CzT-based camera for polyarthralgia or spinal pain between November 2021 and February 2023
* Patients who underwent axial MRI
* Initial suspicion of chronic inflammatory rheumatism

Exclusion Criteria:

* Patients who did not give their consent
* Patients with extravasation of contrast agent at the injection site
* Patients with a missing phase on SPECT-CT (Blood-Pool phase or Delayed phase)