cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Whole Body Examination by MRI Integrating the "Zero Time Eco" Sequence (ZTE, Pseudo-CT) for the Detection of Bone Lesions in Multiple Myeloma: Comparison With Pet / CT and Whole Body Scanner

To assess the added value of magnetic resonance imaging (MRI) of the skeleton compared to other validated techniques for the detection of bone lesions in patients with multiple myeloma.

The aim of our study is to offer patients benefiting from a diagnostic approach to myeloma by PET / CT, a whole body MRI examination (MRI-CE) comprising, in addition to the "classic bone marrow" sequences, a ZTE sequence (see below) . This study is being undertaken to compare and assess the complementarity of imaging techniques in the diagnostic management of this disease.

The stages of the work will be:

Optimizing bone marrow exploration sequences by MRI (F. Lecouvet, N. Michoux, Gaetan Duchêne).

Develop and validate a whole body-wide new MRI sequence "ZTE" capable of detecting and quantifying disease-induced osteolysis in the skeleton.

Optimize the reconstruction of these images (Deep Learning software developed with the firm GE), training of the reconstruction of ZTE images by correlation with the scanner (F. Lecouvet, N. Michoux, Gaetan Duchêne).

This approach is completely original, never having been evaluated: the ZTE sequence is a recent development, made available at CUSL on the new research MRI magnet.

The addition of this sequence to the already major information provided by MRI for the detection of the disease and the evaluation of its response (method of choice, see below) would constitute a major advance in establishing the diagnostic value of this technique. non-irradiating compared to other techniques (PET-CT, low dose scanner, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Patient with newly diagnosed multiple myeloma, for whom bone imaging is required for staging.
* Recurrent patient after intensive treatment (high dose chemotherapy, bone marrow transplant, etc.).
* Patient requiring a PET / CT considered as the technique of choice in these stages of the disease.

Exclusion Criteria:

* Implanted material incompatible with MRI.
* Severe claustrophobia.
* Pregnant women
Transfusion Rates in Total Hip Replacement Before/After the Implementation of a Patient Blood Management Program.

Retrospective observational study: impact of a peri-operative patient blood management program (PBM) on transfusion rates of patients undergoing elective hip replacement.

A Patient Blood Management (PBM) program was implemented in year 2019 in our institution: patient scheduled for elective total hip replacement underwent pre-operative screening about one month before surgery, and those with pre-operative hemoglobin \< 13 g/dl were screened for possible causes and treatment of anemia.

Data from two different time frames, before and after the implementation of the program, were collected to study the change in clinical outcomes such as transfusion rates, length of stay, etc.

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective hip replacement in the selected time-frame
* American Society of Anesthesiology (ASA) status 1-2-3
* age \>18

Exclusion Criteria:

* patients not undergoing screening as outpatients at pre-operative clinic
Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions

This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.

Primary Objective -Positive fluorescence signal in SLNs imaged by the Smart Goggles system.

Secondary Objectives

* Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
* Comparison of lesions detected by the Smart Goggles vs. lesions detected using SPY/Quest/PDE vs. gold standard of gamma probe and blue dyes.

Exploratory Objectives

-Collection of preliminary data for a future, powered study for lymphatic mapping in breast cancer

Study Design This is an unpowered pilot study to determine the sensitivity of the new Smart Goggles device, for detection of ICG fluorescence in SLNs of breast cancers in a clinical setting. The investigators have chosen to examine ICG as the contrast agent and breast cancer as the clinical target, because this agent is FDA-approved and is regularly used for lymphatic mapping (skin cancers). The study team will be applying ICG for the same length of time as the standard-of-care procedures including radiotracers and blue dyes. The study involves a single visit, lasting \~3-4 hours total. Multiple SLN biopsies will be performed if multiple SLNs are identified.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with at least 1 lesion of tumor of the breast
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Subjects who have been treated with radiation therapy on the chest.
* Has had previous sentinel lymph node biopsy
* Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid.
Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option

The purpose of this study is to evaluate the endoscopic diagnostic options of the endomicroscopy in patients with food intolerance.

Food allergy is with a prevalence of 2-4% a seldom disease. The endoscopy of the gastrointestinal tract and the histological analysis of taken biopsies of the intestinal mucosa are basic instruments in the diagnostic of food allergy. With modern high-resolution video endoscopy the intestinal mucosa can be investigated on inflamed areas and can evaluate several of differential diagnosis. With the implementation of a fluorescein based confocal laser endoscope the intestinal mucosa can be magnified 1000 fold, so that even next to the macroscopic investigation the cellular patterns can be analyzed. The laser endoscope offers for the first time an in vivo presentation of cellular structures. Our study group could utilise for the first time the laser endoscope in patients with colitis ulcerosa for cancer prevention. Hereby, the cancer prediction could be enhanced obviously. Furthermore, we conducted these investigations in more than 1500 patients und could present that this method is a safety method.

Based on these investigations we want to implement now the laser endoscope in the diagnostic field of food allergy. Patient wit food allergy generates through the intestinal mediators and histamine secretion an oedema, an increase of inflammatory cells, vasodilatation and expansion of lymph nodes. In comparison of patients with food allergy to healthy subjects, the degree of oedema formation, the amount of cell infiltration and the expansion of lymph nodes will be evaluated.

The aim of the present study is to detect these cellular structures in patients with food allergy and to open with that a new diagnostic option in patient with an allergy disease.

Eligibility Criteria:
Inclusion Criteria:

* new diagnosed and not treated patients with food allergy

Exclusion Criteria:

* decreased clotting (Quick \< 50%, platelet \< 50.000/µl)
* not given consent
* known allergy against fluorescein
* pregnant and breastfeeding woman
Stroke Recovery and Music or No Music

The primary outcome of this study is to determine the quantitative increase in connectivity, as measured by fMRI brain and calculated as a percent increase from baseline in patients with ischemic stroke. Eligible patients will receive a listening session of music or spoken word listening, 30 days to 5 years following ischemic stroke. Assessments will include modified Rankin Scale, National Institute of Health Stroke Scale, functional Magnetic Resonance Imaging, motor function tests, and neuropsychological evaluations. Assessments occur at baseline, day 45, and day 90 after starting listening sessions.

This is a prospective, investigator-blinded and outcome assessor-blinded, randomized, single-center study in subjects 18-90 years old who have sustained an ischemic stroke within 30 days to 5 years. Study subjects will be randomized 1:1 to receive one of two types of listening sessions: music or spoken word (language) listening. Each arm will enroll a total of ten subjects, with a total study population of 20 subjects. Subjects will follow a 90-day listening schedule.

Subjects will complete a baseline Montreal Cognitive Assessment (MoCA), National Institute of Health Stroke Scale (NIHSS), modified Rankin Score (mRS), motor function tests, neuropsychological evaluations and functional magnetic resonance imaging (fMRI) brain evaluation. Follow-up evaluations on day 45 (+/- 7 days) and on day 90 (+/-7days) and will include NIHSS/mRS, motor function tests, neuropsychological evaluations and fMRI Brain evaluation.

All subjects will continue to receive standard of care treatment for stroke as directed by their physician(s) regardless of study enrollment.

The primary objective is to determine the quantitative increase in connectivity, as measured by fMRI brain and calculated as a percent increase from baseline.

The secondary objectives include the effect of music and language listening in improving motor function and neuropsychological development in patients with an ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Ischemic Stroke 30 days to 5 years days prior to enrollment
2. Age 18-90
3. Modified Rankin Score (mRS) 1-3, inclusive, post-qualifying event (for a history of multiple strokes, baseline mRS is 0-1 AND a lower value than the qualifying mRS)
4. A measureable deficit either in motor or speech/cognition that can be assessed using standardized testing
5. Fluency in English (written and verbal)
6. Demonstrates willingness to participate in study and complete all schedule of events

Exclusion Criteria:

1. Severe cognitive impairment, as determined by investigator using the baseline MoCA score
2. Comorbid neurological disease that may interfere with rehabilitation
3. Psychiatric disorder or taking psychoactive medication that may interfere with completing study
4. Inability to complete music listening exercises
5. Alcohol or drug abuse
6. Hearing impairment
7. Contraindication to scheduled fMRI Brain evaluations
8. Pregnant women
Comparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries

Sleep-disordered breathing (SDB) is common in individuals with cervical spinal cord injuries, with studies suggesting prevalence rates ranging from 27% to 62%. The condition often leads to daytime sleepiness, fatigue, and poor participation in rehabilitation. Positive airway pressure therapy can be used to treat the condition; however, some individuals find continuous positive airway pressure (CPAP), which applies the same pressure during inhalation and exhalation, difficult to use. Bilevel positive airway pressure (BiPAP) offers different pressures for inhalation and exhalation, which may be more comfortable and potentially improve adherence in this patient population. However, limited evidence compares CPAP and BiPAP in individuals with cervical spinal cord injuries.

This pilot study will enroll 32 adult participants with cervical spinal cord injuries who have moderate to severe SDB (defined as an AHI of 15 events/hour or greater). Participants will be randomly assigned to either CPAP or BiPAP therapy for 4 weeks. Device usage per night will be measured, and data on daytime sleepiness, fatigue, and sleep quality will be collected at baseline, 2 weeks, and 4 weeks. The investigators aim to determine whether BiPAP improves adherence and symptoms compared to CPAP in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 19 years
* Cervical spinal cord injury (ASIA A, B, or C). This will include patients with upper (C1-C4) and lower (C5-C7) spinal cord injuries
* Presence of sleep disordered breathing, defined as AHI \> =15 events/hour by home sleep apnea test (HSAT)

Exclusion Criteria:

* On CPAP or BiPAP prior to spinal cord injury
* Hypoventilation syndrome (elevated venous carbon dioxide, PvCO2\>50 mm Hg)
Stress-relief Management for Treatment of Late Complications in Type 2 Diabetes

The purpose of this study is to determine whether a structured stress relief management program can prevent the progression of late diabetic complications in patients with type 2 diabetes.

Patients with type 2 diabetes and increased albumin excretion have an increased risk of renal failure and cardiovascular events. It has recently been shown, that psychosocial stress is an additional major risk factor contributing to the increased risk of cardiac events. However, it is not clear, whether a structured stress-relief training of patients reduces the risk of micro- and macrovascular damage in type 2 diabetes.

Comparisons: Conventional treatment of diabetes according to national guidelines is compared to conventional treatment plus structured stress relief management training.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes Type 2
* Albuminuria
* Age 30-70

Exclusion Criteria:

* Diabetes duration \< 3 years
* Preexisting non-diabetic kidney
* Psychiatric disorders
* Alcohol or drug abuse
* Malignant tumors or hematologic disorders
* Heart failure NYHA III-IV
* Acute coronary syndrome
QUality Of Life and surviVAl in carDIac arreSt Patients

QUO VADIS is a national observational study with the aim to describe clinical intervention and utilization of neuroprognostication tools in the management of patients admitted to ICU following cardiac arrest

Despite recent improvements in post-resuscitation care, about 50% of patients resuscitated from cardiac arrest die or have poor neurological prognosis. Post-anoxic brain injury is common after cardiac arrest and is a major cause of post-resuscitation mortality. Since there has been a significant investment in improving the emergency response to both in-hospital ad out-of-hospital cardiac arrest (IHCA and OHCA, respectevly) patients and reported improvements in short-term survival outcomes, the long-term neurological state and quality of life of survivors and their caregiver is of growing significance.

QUO VADIS is a national observational study created to describe clinical interventions and utilization of neuroprognostication tools in the management of patients admitted to ICU following cardiac arrest.

The aims of the study are:

* To create an Italian Registry that describes clinical interventions and neuroprognostication tools used in the management of patients admitted to ICU following cardiac arrest
* To evaluate, after one year from the cardiac arrest, the neurological outcome and the quality of life of the patients;
* To evaluate, after one year from the cardiac arrest, the quality of life of caregivers;
* To identify the most effective clinical intervention in the management of post-cardiac arrest patients admitted to ICU;
* To create a prognostic model for patients admitted to ICU after cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 14 years;
* Cardiac Arrest within 24 hours ICU admission

Exclusion Criteria:

* Absence of Informed consent;
* Age \< 14 years
Intact Cord Resuscitation in CDH

Isolated CDH is a rare disease (1/3500) and displays a wide range of severity and outcome. Despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20 to 50% according to different hospitals in France and abroad.

Several studies already showed the benefice of late cord clamping at birth on biological and physiological adaptation of newborns to life. Previous works also suggest a possible benefit of this procedure for babies with CDH.

This multicenter randomized clinical study aims to investigate the efficacy of intact cord resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in full term newborn infants with isolated CDH.


Eligibility Criteria:
Inclusion Criteria:

* Antenatal diagnosis of CDH
* No severe additional malformation or chromosomal diseases
* Full term (\>36 weeks gestational age)
* No inclusion in another antenatal trial
* Written informed consents from the parents

Exclusion Criteria:

* Preterm birth less than 37 weeks gestational age
* Other severe malformation(s) or chromosomal diseases
* Twin
* Parents who may have French language understanding difficulties may not participate to the study unless they receive appropriate assistance regarding the understanding of the formal consent forms needed to get included in the study. If included in the study, regarding their French understanding level, the parents may not be proposed the auto questionnaires and interviews led by the psychologist
Study of Gut Microbiome and Colorectal Tumors

Gut microbiota were assessed in 540 colonoscopy-screened adults by 16S rRNA gene sequencing of stool samples. Investigators compared gut microbiota diversity, overall composition, and normalized taxon abundance among these groups.

Colorectal cancer is a heterogeneous disease arising from at least two precursors-the conventional adenoma (CA) and the serrated polyp. A relationship between the human gut microbiota and colorectal cancer has been shown; however, its relationship to the different early precursors of colorectal cancer is understudied. This study tested, for the first time, the relationship of the gut microbiota to specific colorectal polyp types.

Eligibility Criteria:
Inclusion Criteria:

* Both men and women who have visited a gastroenterologist or surgeon, aged 18 or older will be included in this study.
* Both men and women residents in the United States, aged 18 or older will be included in this study.

Exclusion Criteria:

* Women who are pregnant will be excluded from participating in this study
* Subjects on ongoing antibiotic therapy will be excluded from participating in this study.
What is the Influence of a Different Thread Pitch Design on Bone Remodelling Around Conical Southern Oral Implants?

Patients who need more than 2 dental implants will be treated by the same implant type (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en 1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is registered around these implants. The role of the thread pitch design will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Periodontally-healthy or periodontally-treated patients
* Smokers are included
* All types of prosthetic indications are accepted but 2 IBT type implants with different threads have to be placed in one patient on the same day. Implants can be connected or not connected in the same jaw.

Exclusion Criteria:

* All other contra indications for implant surgery
* Guided bone regeneration or use of any substitutes
* No implantation in regenerated or augmented bone
* No immediate loading cases
Improving Adolescent Adherence to Hormonal Contraception

The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.


Eligibility Criteria:
Inclusion criteria:

* Sexually active females 16 to 24 years of age who present to a University of Texas Medical Branch (UTMB) clinic and request to initiate oral contraception for birth control.

Exclusion criteria:

* Women who are currently pregnant or breastfeeding.
* Women who wish to become pregnant within the next 12 months.
* Women who have a medical contraindication to use of estrogen (e.g., thromboembolic disease, acute liver disease, breast cancer, genital cancer, or undiagnosed genital bleeding).
* Women wishing to initiate use of a contraceptive method that is not oral, such as transdermal (the patch) or injectable (DMPA) methods, or the vaginal ring.
* Current and previous users of oral contraceptives.
A Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors

This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of daily oral administration of eFT508.

eFT508 is an oral, potent and highly selective inhibitor of mitogen-activated protein kinase interacting kinase (MNK) 1 and 2. Dysregulated translation of messenger RNA (mRNA) plays a role in the pathogenesis of multiple solid tumors and hematological malignancies. MNK1 and MNK2 integrate signals from several oncogenic and immune signaling pathways (including RAS, p38 and Toll-like receptors) by phosphorylating eukaryotic initiation of factor 4E (eIF4E) and key effector proteins. Phosphorylation of these regulatory proteins by MNK1 and MNK2 selectively regulates the stability and translation of a subset of cellular mRNA that control tumor growth, the tumor microenvironment and immune signaling. Nonclinical studies indicate that eFT508 shows activity against various types of solid tumors. These nonclinical studies support initiation of clinical development of eFT508 in patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
2. Pathologically documented diagnosis of advanced solid tumor malignancy that progressed after appropriate prior therapy or has no potential for cure with currently available treatments.
3. Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) outside of any prior radiation field.
4. At least 3 weeks post any treatments/therapies at the time of first dose.
5. Adequate bone marrow function.
6. Adequate hepatic function.
7. Adequate renal function.
8. Normal coagulation panel.
9. Negative antiviral serology.
10. Willingness to use effective contraception.

Exclusion Criteria:

1. Known central nervous system malignancy.
2. Gastrointestinal disease that may interfere with drug absorption.
3. Significant cardiovascular disease.
4. Significant ECG abnormalities.
5. Ongoing risk of bleeding due to active peptic ulcer disease, bleeding diathesis, or requirement for systemic anticoagulants. Use of heparin or thrombolytic agents for local maintenance or clearance of a central venous catheter is permitted.
6. Ongoing systemic bacterial, fungal or viral infection (with the exception of fungal infections of the skin or nails).
7. Pregnancy or breastfeeding.
8. Major surgery within 4 weeks before the start of study therapy.
9. Prior solid organ or bone marrow progenitor cell transplantation.
10. Prior therapy with any known inhibitor of MNK1 or MNK2.
11. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids (can be using topical or inhaled corticosteroids).
12. Use of drugs that might pose a risk of a drug-drug interaction within 4-7 days before the start of study therapy.