cyrilzakka/clinical-trials huggingface dataset:
Ultrasound-Guided Photoacoustic Imaging for the Detection of Metastases in Inguinal Lymph Nodes

This early phase I trial studies how well ultrasound-guided photoacoustic imaging works in telling the difference between healthy and cancerous inguinal (groin) lymph nodes and how well it can detect certain features of lymph nodes, including size and shape in patients with cancer. Ultrasound-guided photoacoustic is a non-invasive imaging method that can detect and display characteristics of lymph nodes based on the level of oxygen in the cells. This imaging method may provide more accurate tumor staging and prevent unnecessary surgical interventions.

PRIMARY OBJECTIVE:

I. To estimate the mean difference in oxygen saturation (%sO2) between healthy and malignant inguinal lymph nodes using ultrasound-guided photoacoustic imaging (PAI) in cancer patients.

SECONDARY OBJECTIVE:

I. To examine the role of ultrasound-guided PAI in detecting metastases in the inguinal lymph nodes and ultrasound features of lymph nodes such as the size, shape of the lymph nodes.

OUTLINE:

Patients undergo standard of care ultrasound of the lymph nodes, then undergo ultrasound-guided PAI over 3-5 minutes. Patients then undergo standard of care ultrasound-guided fine needle aspiration (FNA) or biopsy a suspicious lymph node.

After completion of study, patients are followed up for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven primary malignancy
* Suspicious inguinal lymph nodes for metastasis on a conventional imaging modality
* Scheduled to undergo ultrasound-guided fine needle aspiration cytology or biopsy

Exclusion Criteria:

* Melanoma patients, since the melanocytes may have a "masking effect"
* The deeper inguinal lymph nodes (3-5 cm deep) and smaller (\< 1 cm in short axis) in dimensions will be excluded from the study
Prospective, RCT of Split Thickness Skin Grafts on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT

The single center, prospective, randomized trial includes in total 60 patients. We want to compare two different treatment methods for compression therapy for split thickness skin graft in lower leg. The patients are randomized to compression therapy with NPWT (negative pressure wound therapy) using the device PICO or using the compression bandage with Coban 2 lite.

Primary outcome is complete healing of the skin transplant 30 days postoperatively. Secondary outcomes will be to note frequency of infection, bleeding, loss of transplant etc.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Signed informed consent
* Surgical wound (excision of skin cancer)

Exclusion Criteria:

* Malignant melanoma
* Signs of infection
* Exposed tendon/bone in wound
* Burn/chronic wound
A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma

This multicenter, open-label, dose-escalating study will assess the safety and efficacy of DFRF4539A in patients with relapsed or refractory multiple myeloma. Cohorts of patients will receive multiple ascending doses of intravenous DFRF4539A every 3 weeks or weekly. Patients exhibiting acceptable safety and evidence of clinical benefit may receive DFRF4539A for up to 17 cycles. Anticipated time on study treatment is 1 year or until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients; \>/= 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Relapsed or refractory multiple myeloma for which no effective standard therapy exists
* One of the prior therapies must have included a proteosome inhibitor or an immunomodulatory drug
* Measurable disease as defined by protocol

Exclusion Criteria:

* Prior use of monoclonal antibody within 4 weeks before Cycle 1, Day 1
* Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1
* Toxicities from any previous treatment must be resolved prior to Cycle 1, Day 1, except for neuropathy
* Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
* Prior allogeneic stem cell transplant
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
* Grade \> 1 peripheral neuropathy
* Active infection at screening or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1, Day 1
* Positive for hepatitis B, hepatitis C or HIV infection
* Pregnant or lactating women or women who intend to become pregnant within the period of time of this study
Sexual and Urinary Function Improvement for Cancer Survivors

The purpose of this study is to test the efficacy of SUFICS-PACT to identify and treat sexual and urinary dysfunction in prostate cancer survivors at NYC H+ H/Bellevue, the oldest public hospital in the US. This study will evaluate the implementation of an adapted sexual and urinary function collaborative care model at NYC Health+Hospitals/Bellevue. The study will test the efficacy of this collaborative care model through a randomized controlled trial in the adult primary care clinic; the intervention arm will receive collaborative treatment consisting of a care manager who has specialty training in mental health and psychosexual counseling, a primary care nurse practitioner who leads symptom management, primary care physicians who supervise the team, and a team specialty consult liaison.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Have a diagnosis of prostate cancer
* Have sought care/treatment for prostate cancer

Exclusion Criteria:

* Patients under 18 years old
* Patients who have not sought care/treatment for prostate cancer
* Patients who are categorized as "vulnerable subjects," such as minors or incarcerated individuals.
Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers (PROTOVELIS)

The walk and bike practice are two physical activities the most cited for benefits of physical activity thanks to their progressive and soft characters adapted to patients suffering from chronic diseases (diabetes, obesity, cancer...) with muscular deficit cardio-respiratory.

However, cycling may, depending on the natural land, imply efforts and articular-muscular-tendon pressions more important particularly in hilly natural land.

Moreover, lots of physical and physiological barriers oppose to the bike practice in the population of patients with chronic diseases. The electric bike can be useful.

This electric bike will be powerful but safe, totally programmable to adapt to patients, slope, rehabilitation objectives but very easy to use.

From medicine, it is necessary to ensure a moderate and regular effort regarding patients.

To do this, it is necessary to individualize adjustments of electric bike to have a progressive rehabilitation program and a progressive load force.

It needs to dispose monitoring and evaluation tools in real situations outside (lots of physiological and technical sensors). The intelligent electric bike for health proposes to be in accordance to this specifications.

The investigators propose to validate the technical and organizational feasibility of workshops using the intelligent electric bike for health with different devices such as two connected vests (non-invasive) measuring on the one hand the cardiological and respiratory parameters (connected vest named : Etisens) and the other hand the kinetic energy of movement (connected vest named : Optimove).

The development of this ambulatory physiology platform and the engine brake create perspectives for an outdoor rehabilitation tool that for example could stimulate, on an altitude free-excursion, a mountain pass of Alpes doing the link of health, sport and well-being.

Eligibility Criteria:
Inclusion Criteria:

* Capacity to ride a bike
* Volunteer without a contraindication to moderate physical activity or cycling (acute coronary artery disease less than 2 years old, musculoskeletal problem of the spine or lower limbs incompatible with cycling).
* weight \< 125 kg
* volunteer available for an intervention of 2-3 hours twice a week during 1 month.

Exclusion Criteria:

* Person deprived of liberty or legal protection measure
Sub Urethral Sling With or With Out Anterior Repair

There is a concern about choosing adequate surgical options for stress urinary incontinence associated with vaginal prolapsed and still lack of evidence can be observed. In this study we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic organ prolapsed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be female
2. Subjective evidence of stress predominant symptoms on symptom specific questionnaire
3. Stress incontinence on urodynamics
4. Patients must be capable of filling in the symptom diary
5. Prolapse beyond the introitus

Exclusion Criteria:

1. Patients who are medically unfit to undergo surgical intervention.
2. Patients who have undergone previous continence surgery
3. Patients with voiding dysfunction
4. Patients with recurrent urinary tract infection
5. Patients who are not sure that their family is complete
rTMS Treatment for Positive and Negative Symptoms of Schizophrenia

This study will examine the effects of rTMS on the negative and positive symptoms of schizophrenia using 2 treatments in sequence applied to related brain areas.


Eligibility Criteria:
Inclusion Criteria:

1. are voluntary and competent to consent to treatment
2. have a diagnosis of schizophrenia or schizoaffective disorder
3. are between the ages of 18 and 75
4. are willing and able to adhere to the treatment schedule
5. Pass the TMS adult safety-screening (TASS) questionnaire
6. have normal thyroid functioning based on pre-study blood work. Patients may be reassessed for the study once thyroid levels have normalized.
7. are willing and able to cooperate with interviews and follow simple instructions

Exclusion Criteria:

1. do not pass the TASS Safety Screening Questionnaire
2. have a significant history of seizures
3. have active suicidal intent
4. are pregnant or may be pregnant. A pregnancy test will be performed for fertile women.
5. have failed a course of Electroconvulsive Therapy (ECT) in the current or previous episode
6. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, or head trauma resulting in loss of consciousness greater than or equal to 5 minutes
7. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
8. have had changes in dose or initiation of any psychotropic medication in the 4 weeks prior to screening. Patients may be re-screened once medications have been stable for 4 weeks.
9. currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease

This is an open-label expanded access trial of prGCD in patients with Gaucher disease who require enzyme replacement therapy (ERT) and who have been treated with imiglucerase but for whom the dose has been reduced or discontinued due to shortage of the product.

Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD), which have been mapped to chromosome 1 q21-q31, leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system. This accumulation leads to the visceral manifestations of hepatosplenomegaly, anemia and thrombocytopenia, as well as to the skeletal features and less frequently also to lung involvement.

prGCD is a plant cell expressed recombinant glucocerebrosidase enzyme for the treatment of Gaucher disease. Expression of proteins in plant cell culture is highly efficient, does not require post-expression modification of the protein, and is not susceptible to contamination by agents such as viruses that are pathological to humans.

prGCD safety will be observed in this treatment protocol of patients with non-neuronopathic Gaucher disease who require enzyme replacement therapy. Eligible patients will receive intravenous (IV) infusions of prGCD every two weeks. The dose of prGCD will be equal to each patient's previous imiglucerase dose before reduction or discontinuation due to shortage. The infusions will be administered at the selected medical center.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years or older
* Diagnosis of Gaucher disease treated historically with imiglucerase
* Able to provide written informed consent

Exclusion Criteria:

* Currently taking another experimental drug for any condition
* History of allergy to carrots
* Previous infusion reaction suspected to be allergic in nature to Cerezyme® or Ceredase® or receiving premedication to prevent infusion reactions
* Allergy to beta-lactam antibiotics
* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patient's compliance with the requirements of the study.
ERAS and Postoperative Recovery in Gynecologic Patients: A QoR-15 Study

The Quality of Recovery-15 (QoR-15) questionnaire is a widely used Patient-Reported Outcome Measure (PROM) for evaluating postoperative recovery, including pain, physical function, and emotional well-being. Enhanced Recovery After Surgery (ERAS) is a multidisciplinary care model designed to optimize perioperative management through standardized protocols.

For gynecological surgery, ERAS emphasizes preoperative education, early interventions (e.g., smoking cessation, anemia management, nutrition optimization), intraoperative strategies (e.g., fluid balance, nausea prevention, temperature control), and postoperative care (e.g., early mobilization, pain control, ileus prevention). However, while ERAS is gaining acceptance, its effectiveness can vary due to workload, patient variability, and institutional resources, and its superiority over traditional care remains inconclusive.

This study aims to objectively compare ERAS and traditional perioperative care using the QoR-15 questionnaire to assess patient satisfaction, recovery speed, surgical risk reduction, and complication prevention. Rather than solely promoting ERAS, this research seeks to evaluate its applicability, enhance personalized care, and provide scientific evidence for perioperative management optimization.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 80 years.
* Undergoing routine gynecological surgery, including total or subtotal hysterectomy, myomectomy, oophorectomy, gynecologic cancer staging surgery, cytoreductive surgery, and pelvic exenteration.
* Cancer patients with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Receiving either standard perioperative care or ERAS protocol-based care.

Exclusion Criteria:

* Age below 20 years.
* Lack of decision-making capacity.
* Undergoing emergency surgery.
* History of clinical depression.
* Undergoing palliative surgery.
* History of chronic pain.
Prediction of ARrhythmic Events With Positron Emission Tomography II

Sudden cardiac death continues to be a major contributor to mortality in patients with ischemic cardiomyopathy. While implantable defibrillators can prevent death from ventricular arrhythmias, our current approach to identify patients at highest risk primarily rests on demonstrating a reduction in left ventricular ejection fraction less than 35%. The purpose of this observational cohort study is to prospectively test whether this can be enhanced by quantifying the amount of sympathetic denervation, left ventricular end-diastolic volume or brain natriuretic peptide levels.

Using current guidelines based primarily on ejection fraction (EF), only one-quarter of patients receiving an implantable cardiac defibrillator (ICD) for the primary prevention of sudden cardiac arrest (SCA) require appropriate ICD therapy within 5 years. The NIH-sponsored PAREPET study (Prediction of ARrhythmic Events with Positron Emission Tomography, ClinicalTrials.gov, NCT01400334) identified four independent risk factors that predict SCA or ICD equivalent in patients with ischemic cardiomyopathy. Using retrospectively defined cut-points, the absence of these risk factors identified 38% of the cohort with a very low risk of SCA (\<1% per year). This rate is actually lower than the 1.5-2% annual rate of SCA among patients with coronary artery disease and mild left ventricular (LV) dysfunction, who are not considered candidates for a primary prevention ICD. This proposal will prospectively determine whether these risk factors can form the basis of a clinically applicable approach to identify a subgroup of patients who are candidates for an ICD, but are at low enough risk of SCA to have an ICD safely withheld. Our long-term goal is to develop better approaches to identify patients with coronary artery disease who are most likely to benefit from prevention of SCA with placement of an implantable defibrillator.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease (by cardiac catheterization or definite myocardial infarction)
* ICD implantation for the primary prevention of SCA
* Primary prevention patients with a Biventricular ICD

  * Eligible immediately when this is placed to prevent dysynchrony related to intermittent RV pacing and the native QRS duration is ≤ 130 msec in the absence of pacing.
  * Eligible 6 months after implantation when the native QRS duration prior to implant is \>130 msec or there is persistent RV pacing.
* Optimal medical therapy for heart failure.

Exclusion Criteria:

* Plans for coronary revascularization (due to the independent impact on SCA)
* Contraindication for PET (i.e. claustrophobia, pregnancy, physical limitation)
* Tricyclic antidepressant use (inhibits norepinephrine and LMI1195 uptake)
* Comorbidities limiting life expectancy \<2yr.
* Age \<18 years or inability to provide informed consent
* Primary prevention ICD/BiV recipients who have received an appropriate ICD shock prior to enrollment
Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)

The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 25 and 65 years
* ALS patients who can visit the clinic for six months
* Forced Vital Capacity (FVC) \> 70%
* Patients who can walk by themselves
* Change in ALSFRS-R score from -1 to -4 during 12 weeks before the initial administration
* Patients who are willing to give informed consent

Exclusion Criteria:

* Tracheotomy and invasive ventilation
* Pregnant or possibly pregnant female patients
* Female patients of childbearing potential who cannot practice contraception during and two years after the administration, and male patients who cannot practice contraception during and six months after the administration
* Patients with clinically significant conditions such as cardiovascular, respiratory, haematological, and renal diseases.
* Patients who are being treated with investigational drugs
* Patients who are treated with other ALS drugs within 2 weeks prior to the first administration
MSC for Severe aGVHD

Steroid-resistant acute graft-versus-host disease (aGVHD) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (HSCT), which cannot be significant benefit from the second-line therapies.The mesenchymal stem cells (MSCs) possess extensive immunomodulatory properties and are very promising to rescue the refractory aGVHD.This study aims to assess the efficacy and safety of MSCs for the treatment of the refractory aGVHD.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Aged \<65 years
* Patients with steroid-resistant severe aGVHD
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of MSCs.
Entereg Laparoscopic Colon Resection Study

Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been shown to increase postoperative bowel function in patients after open bowel resection surgery. It has been proven safe and effective for short-term in-house treatment. At the present there are several Drug Use Utilization Evaluation studies reporting results involving the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However, this study will be the first randomized, prospective, double-blind, placebo-controlled trial looking at this population. We propose that Entereg will decrease the length of stay by one day in the laparoscopic colon resection patient. We wish to perform a voluntary, double-blinded, placebo controlled study. We plan an enrollment population of 250 patients. Twelve milligrams of Entereg will be administered 30 minutes to 5 hours pre-op followed by 12 mg BID, up to 7 days or 15 total doses. The primary endpoint of the study will be length of stay. The time of GI-2 recovery (toleration of solid food and first bowel movement) and time to GI-3 recovery (toleration of solid food, and flatus or bowel movement) will be secondary endpoints.

Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion Date: May 2012, Estimated Primary Completion Date: Nov 2011.


Eligibility Criteria:
Inclusion Criteria:

Subject is scheduled to undergo laparoscopic (straight or hand assisted) elective colon resection with primary anastamosis Subject is \>18 years of age Subjects can be either male or female Negative pregnancy test (if patient is a premenopausal female) Medically stable as determined by the treating surgeon- i.e., subject has an American Society of Anesthesiologists Physical Status Score of I to III.

Subject understands the study procedures, agrees to participate in the study as per the study protocol, and has voluntarily provided informed consent Patients who will be receiving IV Opioid therapy post surgery for pain management.

Exclusion Criteria:

Subject is pregnant or lactating Subject is currently using opioids or has taken more than 3 doses of opioids (oral or parenteral) in the week prior to surgery.

Subject has complete bowel obstruction Subject is not able to understand the informed consent document or is unable to give informed consent Patients who will receive a thoracic epidural for pain management post surgery. Subject has any medical instability or any condition at screening/enrollment which, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject during the administration of study procedures.