cyrilzakka/clinical-trials huggingface dataset:
18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor

The aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroendocrine tumors mainly in pheochromocytoma and paraganglioma (PPGL) and neuroblastoma (NB).

Pheochromocytoma and paraganglioma (PPGL) and neuroblastoma (NB) highly express norepinephrine transporter (NET) which is targeted by functional analogue of norepinephrine, 131I/123I-MIBG. However, low spatial resolution of 123/131I-MIBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MIBG SPECT and lead to poor diagnosis of small lesions. In addition, 123I-MIBG imaging is usually performed at 24 h after injection, while 131I-MIBG is performed at 48 h or even 72 h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG on nural crest tumors including PPGL and NB. Patients with histologically confirmed or clinically suspected neural crest tumor will be prospectively recruited in this study.

Eligibility Criteria:
Inclusion Criteria:

- The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed. Patients with histologically confirmed or clinically suspicious neural crest tumor.

For patients with neuroblastoma, subject should have a routine clinical 123I-MIBG scintigraphy (planar + SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit.

The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal. The subject is able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

- Patients are potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding.

Patients undergo surgery between the selection and inclusion visit. Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating. Patients who are not suitable to participate in the trial according to researchers.
A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS)

This study will test the feasibility and influence of a behavioral intervention called "Cuidando Juntos" in Latino caregivers of people with dementia. The study will examine if the intervention is well received by Latino caregivers and if the caregivers' social connectedness and loneliness is associated with their levels of stress, burden, and depression.


Eligibility Criteria:
Inclusion Criteria:

* Spanish speaking
* Latino caregivers are those who identify as the primary caregivers of a person with dementia, with whom they co-reside or live close by.
* must have an email address and access to the internet
* Caregivers should report at least a moderate level of stress

Exclusion Criteria:

* None
Use of HRV Measuring Hearing-aid Device to Detect Acute Stress

Validation of in-ear device to measure acute mental stress in comparison with a Polar H10 chest band. Stress is measured on the basis of heart rate variability.


Eligibility Criteria:
Inclusion Criteria:

* Dutch speaking and understanding
* Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally recognized representative) has been informed of all pertinent aspects of the study
* Age ≥ 50 years
* No contra-indications for the use of the receiver in-the-ear device (BiometRIC SR 26UAA01GF), and smartwatch and chest strap heartrate monitor

Exclusion Criteria:

* • Smokers

  * Obese patients (BMI \>30 kg/m2)
  * Presence of a pacemaker
  * Supraventricular tachycardias: atrial fibrillation, atrial flutter, frequent supraventricular extrasystole or frequent ventricular extrasystole
  * Otologic contraindications determined by licensed otolaryngologist
Diagnostic Errors in Anaphylactic Shock

Diagnostic accuracy and quality of management in anaphylactic shock is assessed in three conditions: expected, unexpected with no distractor, unexpected with distractor

participants: physicians taking part in voluntary workshops. Participants are allocated to teams of three design: prospective, randomized, single-blind setting: simulated anaphylactic shock intervention: participants are allocated to 3 versions of the scenario: 1) expected, 2) unexpected but no distractor, 3) unexpected with distractor

Eligibility Criteria:
Inclusion Criteria:

* Physicians taking part in voluntary simulator workshops

Exclusion Criteria:

* Refusal to participate or to being videorecorded
Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer

The effect of preoperative glycemic control measured by HbA1c on prostate cancer (PCa) outcome remains controversial. Thus, the investigators aim to examine the association of preoperative glycemic control with oncologic outcomes after radical prostatectomy (RP).

The investigators will prospectively collect the relevant data including preoperative HbA1c in 264 patients of PCa patients undergoing RP. The associations between clinical variables and risk of adverse pathological features and disease recurrence will be tested using a multivariate logistic regression and multiple Cox-proportional hazards model, respectively.

* This is the observational study as the single institutional, prospective cohort study. The investigators prospectively collect the clinicopathological information of the patients with prostate cancer (PCa) undergoing radical prostatectomy (RP).
* Particularly, the investigators check the variables, including age at surgery, body mass index, comorbidities, preoperative PSA levels, prostate volume measured by TRUS, preoperative HbA1c levels, biopsy Gleason score, positive biopsy cores, percent positive cores, clinical TMN staging, final pathological results (TMN stage, Gleason score, extraprostatic extension, seminal vesicle invasion, surgical margin positivity, postoperative biochemical recurrence (BCR), local recurrence, and distant metastasis during follow-up periods.
* The study protocol is same with routine follow-up schedule of the patients with PCa treated with RP. Typically, the investigators check the patients at 1, 3, 6, 9, 12, 18, 24, 30 and 36 months. However, according to the patients status and preference, follow-up schedule can be changed within 3 months at specific time points. Because the present study is the observational cohort study, not intervention study, subtle changes of follow-up schedule would not affect on the primary outcomes.
* Importantly, preoperative HbA1c should be checked within 1 month before operation, same as the routine preoperative laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer diagnosed with prostate biopsy
* Clinically localized PCa confirmed by prostate MRI and Bone scan
* Patients undergoing RP

Exclusion Criteria:

* Distant metastasis, preoperatively
* Preoperative hormone therapy
* Preoperative chemotherapy
* Radiation therapy
* Medications affecting glucose status other than diabetes mellitus
Phase 2 Study Applying MRD Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by ASCT - TAURUS

This is a multicenter, single arm, open-label, Phase 2 study in mutiple myeloma with newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan. The study is evaluating a technique called Mass Spectrometry Minimal Residual Disease (MS-MRD) using blood samples and compares it with the minimal residual disease (MRD) technique using bone marrow samples.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years of age, inclusive.
* Must have a new diagnosis of MM as per IMWG criteria.
* Measurable disease
* Newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
* Clinical laboratory values meeting the required criteria during screening and ≤3 days prior to receiving first study treatment dose.
* Adequate bone marrow function.
* Adequate liver function.
* Adequate renal function.
* A female of childbearing potential (FOCBP) must have two negative serum or urine pregnancy tests at screening including within 24 hours of the start of study treatment.
* Willing to practicing at least 1 highly effective method of contraception starting 4 weeks prior to start of study treatment, while receiving study treatment including during any dose interruptions, and for at least 3 months after the last dose of any component of the study treatment.

Exclusion Criteria:

* Prior or current systemic therapy or ASCT for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
* History of allogenic stem cell transplantation or prior organ transplant requiring immunosuppressive therapy.
* Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.
* Myelodysplastic syndrome or any malignancy within 24 months of signing consent. The only exceptions are malignancies treated within the last 24 months that are considered completely cured.
* Plasmapheresis ≤28 days of approval.
* Radiation therapy for treatment of plasmacytoma ≤14 days of approval of enrollment.
* Forced Expiratory Volume in 1 second (FEV1) \<50% of predicted normal.
* Concurrent medical or psychiatric condition or disease.
* Myocardial infarction ≤6 months of enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function.
* Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities.
* Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or the excipients of daratumumab, lenalidomide, bortezomib or dexamethasone.
* Pregnant or breast-feeding females
GIST in Hematopoietic Stem Cell Transplantation/Bone Marrow Transplantation

The purpose of this study is to assess the efficacy of using GIST language when speaking to patients about bone marrow and hematopoietic stem cell transplantation.

Hematopoietic stem cell/bone marrow transplantation (HSCT/BMT) is a high-risk, complicated procedure that is poorly understood by patients, posing a challenge for informed decision-making. One study found that 69.7% of patients needed more information about HSCT to make an informed decision. Furthermore, for most patients who seek HSCT/BMT as treatment, transplantation is the only viable option for long-term, disease-free survival. In light of limited options, it is often assumed that patients will choose to undergo transplantation by default, which might undermine efforts to ensure that patients are fully informed. Given the context in which the decision to undergo transplantation are made, there is a clear and present need to ensure that patients are properly informed about HSCT/BMT.

Unfortunately, this need does not seem to be adequately met. For example, studies have shown that patients tend not to remember rates of risks and complications. One study found that after completing HSCT, patients recalled a mortality risk rate lower than those provided by physicians at their initial consultation (20% vs. 30%, respectively). Findings such as this highlight the need to improve the informed consent process for patients confronting the decision to undergo HSCT/BMT.

The present study aims to improve the informed consent process by proposing a new approach to patient-physician communication, called Giving Information Simply and Transparently (GIST), that will train physicians to speak more understandably, with the goal of improving patients understanding of the procedures they intend to pursue. This approach is based upon Dr. Valerie Reyna's Fuzzy Trace Theory which posits that patients focus on the bottom-line gist of information when formulating their treatment preferences. Patient understanding will be tested via assessments administered after their consultation visit, 30 days after initiation of chemotherapy, and 100 days after initiation of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* acute myeloid leukemia with high or intermediate risk in first complete remission acute myeloid leukemia OR myelodysplastic syndrome beyond first remission chronic myeloid leukemia with accelerated phase or blast crisis acute lymphocytic leukemia Myeloma lymphoma with a sensitive relapse lymphoma with a resistant relapse first time undergoing consultation at this institution's HSCT/BMT program Fluent in English

Exclusion Criteria:

* Cognitively impaired
* Not fluent in English
Assessment of Music Experiences in Navigating Depression

The study team sought to scientifically investigate strategic subsets of depressed individuals or people prone to or at-risk of depression through music experiences of individual, group, and blended supported contexts. Meetings with the study multi-disciplinary team, included member of the Carnegie Hall Weill Music Institute and University affiliates, where the study team gathered quantitative and qualitative data in individual and group forums, measuring disease process and levels of participation. Through tabulation of participatory options with standardized depression and resilience measurements, the study team studied how live music could alter depressive symptoms over time and/or change negative influencers of mood, shift quality of life, and lead toward possibly enhanced disease trajectory outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Participants between the ages of 8-70 years with a clinical diagnosis of Major Depressive Disorder (MOD) who met the DSM-5 (2013) criteria for a Major Depressive Episode, and/or who identify themselves, or are identified by family, or referring clinicians as depressed, or are prone to depression
* Depressive episodes and/or showing symptoms of mild to moderate depression intensity
* Self-reported satisfactory bilateral hearing
* English or Spanish language fluency sufficient to complete the interviews and questionnaires

Exclusion Criteria:

* Axis I diagnosis, aside from MOD, considered the primary diagnosis
* Bipolar Disorder Type I or II,
* Axis II diagnosis such as antisocial or borderline.
* Arrhythmia,
* Pacemaker
* Prolapsed vertebral disc, and
* Recent back or neck injuries.
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury

This study will evaluate the effect of single transplantation of HuCNS-SC cells into the thoracic spinal cord of patients with sub-acute spinal cord injury.

Study subjects will receive immunosuppression for nine months following transplantation. All enrolled subjects will be followed for one year following transplantation and then will be enrolled in a separate long-term follow-up study for an additional four years.

Eligibility Criteria:
Inclusion Criteria:

* T2-T11 thoracic spinal cord injury based on American Spinal Injury Association (ASIA) level determination by the principal investigator (PI)
* T2-T11 thoracic spinal cord injury as assessed by magnetic resonance imaging (MRI) and/or computerized tomography (CT)
* ASIA Impairment Scale (AIS) Grade A, B, or C
* Minimum of six weeks post injury for the initiation of screening
* Must have evidence of preserved conus function
* Must be at stable stage of medical recovery after injury

Exclusion Criteria:

* History of traumatic brain injury without recovery
* Penetrating spinal cord injury
* Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma
* Previous organ, tissue or bone marrow transplantation
* Previous participation in any gene transfer or cell transplant trial
* Current or prior malignancy
Mindfulness-Based Intervention for Adolescents With Chronic Migraine

The goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes.

Mindfulness-based intervention (MBI) shows promise in adults with migraine, but research is limited in adolescents. The current study aims to advance behavioral treatments for adolescents with frequent migraine by adapting an existing empirically-supported MBI for adolescents (Learning to BREATHE) to meet the unique needs of adolescents with chronic migraine. In Phase I of the study, we will use feedback solicited from interviews with teens with chronic migraine, their parents, and healthcare providers documenting the experience of living with chronic migraine and on the content and delivery of the MBI to create an adapted telehealth group intervention specifically tailored for adolescents with frequent migraine. In Phase II of the study, the adapted MBI will be piloted in a single-arm trial with adolescents with frequent migraine to assess feasibility, acceptability, and preliminary clinical signals.

Eligibility Criteria:
Inclusion Criteria:

* Age 13 to 18 years
* Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
* Patient report of \>= 8 headache days per month
* PedMIDAS Score of \> 10 (at least mild headache-related disability)

Exclusion Criteria:

* Weekly or bi-weekly therapy with a licensed behavioral health provider
* Major comorbid medical condition (e.g., cancer, epilepsy)
* Active psychosis or suicidal ideation
* Inability to provide consent/assent
Cognitive Assessment for Stroke Patients: Reproductibility and Validity Study

After a CVA, all of the cognitive functions can be affected and analysed, but the presence of a language disorder may considerably hamper the evaluation of other functions.

The battery of rapid tests to screen for and quantify cognitive disorders, including the MMSE, the MOCA, the R-CAMCOG or the RBANS, are not suitable for aphasic patients because they contain items with a strictly verbal response. Because of this, inexperienced doctors cannot evaluate higher functions (other than language) of aphasics in routine practice. For the same reason, aphasics are regularly excluded from post-cva therapeutic protocols, whether or not the trial bears on the evolution of cognitive functions.

Nonetheless, it is possible to evaluate, at least roughly, all of the cognitive functions without resorting to language.

The investigator have developed , from validated tests and classical clinical manoeuvers, the Cognitive Assessment for Stroke Patients (CASP) :

* for the rapid screening (less than 15 minutes) and quantification of post-cva cognitive disorders (6 functions: language, apraxia, short-term memory, temporal orientation, impaired spatial/visio-construction and executive functions);
* the CASP can be used in most patients, including those with severe disorders of expression and moderate problems with comprehension, The format of these tests has been adapted so that severe disorders of expression (essentially left-hemisphere CVA), and left spatial impairment (right-hemisphere CVA) do not affect the ability to take the test. Its validity in terms of appearance and content were verified in 2011.


Eligibility Criteria:
Inclusion Criteria:

For CVA patients

* patients hospitalised in rehabilitation after a first recent hemispheric CVA (less than 6 weeks) ;
* aged \> 18;
* absence of severe disorders of oral comprehension (BDAE aphasia severity score \>2 for comprehension);
* whatever the severity of oral expression disorders;
* who have been given clear written and oral information, and after the doctor has verified their ability to understand the protocol.

For " Control " patients (to evaluate divergent validity)

* patients hospitalised in rehabilitation units or geriatrics taking part in this study;
* aged \> 18.

Exclusion Criteria:

For CVA patients

* patients who do not speak French;
* cognitive disorders known before the CVA;
* psychotic disorders known before the CVA;
* major visual disorders incompatible with reading, known before the CVA.

For " Control " patients (to evaluate divergent validity)

* patients who do not speak French;
* cognitive disorders known before the CVA;
* psychotic disorders known before the CVA;
* major visual disorders incompatible with reading, known before the CVA.
Use of Tachosil® for Lymph Sealing During Surgery

The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.

The aim of this non-interventional study (NIS) was to collect further knowledge on the routine use of TachoSil ® in lymph node surgery where its sealing property helps to reduce the rate of postoperative complications, especially of seroma formation. Some data are already available from gynecology, urology and thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Stationary patients undergoing lymph node resection.

Exclusion Criteria:

* Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.
Effect of Moringa Oleifera Leaf on Hemoglobin Levels in Anemia

The main objective of this study was to compare the results of hemoglobin levels between pregnant women in the treatment group and the control group. Participants will be subjected to anthropometric measurements, recall of food intake for 1 x 24 hours, check hemoglobin before and after being given the intervention and participants in the treatment group are given moringa leaf capsules and iron tablets while participants in the control group are only given iron tablets. Researchers will compare the final results of hemoglobin levels between the treatment group and the control group


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with 2nd and 3rd trimester of pregnancy
* Pregnant women with mild to moderate anemia At day 90 after treatment

Exclusion Criteria :

* Hypotensive pregnant women
* Pregnant women with Gemelli
* Pregnant women with chronic diseases (hepatitis and HIV)