cyrilzakka/clinical-trials huggingface dataset:
Place of the Hevylite Test in the Evaluation of MRD in Myeloma

Study aiming at testing the positive predictive value of the Hevylite blood test in detecting minimal residual disease in myeloma compared to an invasive method requiring bone marrow sample by multi-parametric flow cytometry

Multiple Myeloma is a pathology for which treatments are constantly progressing. These treatments allow more and more patients to reach deeper and deeper responses. Currently, it is possible to detect very low levels of disease : this is called the evaluation of minimal residual disease. Its prognostic value is strong.

Two techniques currently prevail in the evaluation of minimal residual disease: high throughput sequencing (NGS) and multi-parameter flow cytometry. They are included in evaluation criteria defined by the International Myeloma Working Group (IMWG). These techniques have the advantage of being very sensitive, reaching 10-5 (cytometry: 50 events among 5 000 000 cells analysed) to 10-6 (NGS). Nevertheless, they are invasive for the patient (medullary specimen), require technical expertise and are not necessarily available in all hospitals.

The development of blood tests would cope with this constraints.

The Hevylite® assay is a simple, sensitive, automated and inexpensive immunologic technique that allows the accurate quantification of total IgG, Total IgG, Total IgA, Total IgA L, Total IgM, and Total IgM in the blood. Given its characteristics, the Hevylite assay could play a role in the definition of MRD and allow evaluation of residual disease in myeloma.

This study aims to evaluate the positive predictive value of the Hevylite test in the evaluation of residual disease in myeloma in comparison with multiparametric flow cytometry on the bone marrow.

Eligibility Criteria:
Inclusion criteria:

-All patients with myeloma in complete response defines as: Absence of monoclonal component on serum and urine electrophoresis Negative immunofixation on serum and urine Normal ratio of free light chains according to the standard Freelite® method

- Any number of treatment lines received

Exclusion criteria:

- No
Tapering Heart Failure Medication in Patients with Heart Failure with Recovered Ejection Fraction; Open Label Prospective Random Trial

Study start date is on Nov 27th 2024.

A patient with an initial ejection fraction (EF) of less than 40%, whose follow-up shows an improvement to an EF of 50% or higher, along with the left ventricular end-diastolic diameter returning to the normal range and taking 3 more heart failure medication randomed to drug tapering group ( RAS blocker or beta blocker) or continuing medication group.

Patients described above randomly assigned to drug tapering group and drug maintaining group.

Drug tapering group is 2 groups, which one is RAS blocker tapering group and others is beta blocker tapering group.

Drug tapering group is monitored ejection fraction, LV dimension and LV GLS by 1-3 month.

Eligibility Criteria:
Inclusion Criteria:

* initial echocardiogram ejection fraction less than 40%
* follow up echocardiogram ejection fraction over 50% and LVEDD index normal range
* NTprobnp criteria

  1. eGFR ≥60 ; less 440
  2. eGFR 45-59: less 980
  3. eGFR 30-44; less 1220
  4. eGFR \< 30 : less 5300
  5. in HD; no criteria for NTproBNP
* on more than 3 heart failure medication ( RAS blocker, beta blocker, mineral corticoid receptor antagonist, SGLT 2 inhibitor)

Exclusion Criteria:

1. under age 18 year
2. uncontrolled BP ( over 150/90)
3. coronary revascularization within 6 months
4. significant valve disease
5. arrhythmia requiring rate control
6. CKD with albuminuria ( over 30mg/g)
7. Pregnancy
Multimodal and Unimodal Analgesia in Cholecystectomy

Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* Patients older than 18 years old

Exclusion Criteria:

* Renal or hepatic or cardiac impairment patients
* Patients with chronic pain history
* Allergic patients after taking aspirin or other NSAIDs
* patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding
A Natural History Study of Neuronal Ceroid Lipofuscinosis Type 5 (CLN5)

CLN5 is a form of Batten Disease, a neurodegenerative disorder in children causing psychomotor regression, seizures, blindness, loss of ambulation and premature death, and has no available treatments.

The purpose of this study is to investigate the clinical characteristics and natural clinical progression of symptoms in individuals with CLN5. This natural history study is important to better understand disease course to be able to determine clinically relevant outcome measures for use in future clinical trials.

Neuronal Ceroid Lipofuscinosis (NCL) are comprised of a group of fatal neurodegenerative diseases caused by mutations in an enzyme or protein which results in the accumulation of toxic deposits in the eye, brain, skin, muscle and other cells.

CLN5 is a type of NCL, caused by homozygous or bi-allelic heterozygous variants in the CLN5 gene. Lack of CLN5 protein impairs the breakdown of certain proteins, leads to defective lysosomal trafficking, resulting in accumulation of toxic material and subsequent cell damage. CLN5 disease presents in childhood with neurological findings including motor clumsiness and attention disturbances, followed by progressive visual failure, psychomotor depression, epilepsy, and premature death.

No investigational product will be provided in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age at disease onset of ≤ 5 years of age.
2. Molecular genetic diagnosis confirming the presence of pathogenic or likely pathogenic variant(s) on both alleles (biallelic) of the CLN5 gene.

For Prospective Arm only:

1. Subject age of ≤ 9 years.
2. Hamburg motor and vision score of ≥ 1 at time of consent.
3. Subject must have a caregiver available to support the subject and attend visits with the subject.

Exclusion Criteria - All Subjects:

1. Has another neurologic disease or illness that may have caused cognitive decline before study entry.
2. Has a known pathogenic or clinically suspected mutation in a seizure associated genetic mutation besides CLN5.
3. Any prior participation in a study in which a gene therapy vector or stem cell transplantation was administered.
4. Participation in other investigational studies and non-interventional studies that have similar study assessments as this protocol while the subject is enrolled in this study is prohibited.
Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families

Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is two to three years. The patient physical and psychological sufferings in ALS are immense, and apart from Riluzole, there is no effective treatment. Care of advanced ALS have an estimated cost of 4-8 million NOK per year. Perhaps the most challenging topic of ALS care is the decision to extend ventilation support into the stages of disease that require treatment both during day and night. In these cases, treatment is clearly life-sustaining and although quality of life may be maintained, the burden of caregiving imposed upon family or health care workers is huge, regardless of tracheostomy (TIV) or non-invasive (NIV) modality.

The present study is a longitudinal questionnaire study in Norway measuring overall quality of life, health-related quality of life, and disease-specific quality of life in ALS patients, partners and children before and after the introduction of life sustaining ventilation support. The investigators aim to increase the knowledge on how life-sustaining ventilation support with NIV or TIV affects the quality of life in ALS patients, life partners and children. The results from the study may provide crucial information for clinicians and patients on one of the most difficult ethical issues of ALS treatment. The investigators anticipate that this information will facilitate a shared decision making processes, weighing benefits and disadvantages in a wider perspective.


Eligibility Criteria:
Inclusion criteria for patients:

1. A clinical diagnosis of probable ALS according to the revised El Escorial criteria
2. Progression of the illness leading the consulting physician to offer treatment with LTMV
3. Can communicate in Norwegian

Inclusion criteria for partners of ALS patients:

1. Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV
2. Can communicate in Norwegian

Inclusion criteria for children:

1. Children from 8 years and older having a parent who suffers from ALS with progression of the illness leading the consulting physician to offer treatment with LTMV
2. Can communicate in Norwegian

Exclusion criteria for patients, partners and children of ALS patients:

1. Potential participants with cognitive impairment or dementia.
Transcutaneous Vagus Nerve Stimulation in Private Healthcare Center

This non-randomized, open-label study has the objective to study the effects and feasibility of Transauricular Vagus Nerve Stimulation (TaVNS) for patients suffering from Generalized Anxiety Disorder (GAD), Chronic Pain (CP) and Irritable Bowel Syndrome (IBS) in a private healthcare centre.

The effects of TaVNS on GAD, CP and IBS. Participants were investigated during a 4-week period and a 2-month follow-up. Groups (GAD, CP, IBS) were assessed using questionnaires: Anxiety (Generalized Anxiety Disorder GAD-7); CP (Brief Pain Inventory Short Form Questionnaire) and IBS (Irritable Bowel Syndrome Severity Scoring System). TaVNS was performed using a standard transcutaneous electrical nerve stimulation (TENS) device and ear clip electrodes plugged into the concha area of the left ear. All participants received a bi-weekly 30 minutes stimulation (8 sessions). We defined three different TaVNS parameters for each group in hertz (Hz) and microsecond (µs), (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS: 3Hz-250µs).

Eligibility Criteria:
Inclusion Criteria:

1. Age range 20-65 years old
2. Patient suffering from either Generalized Anxiety Disorder, Chronic Pain scoring and Irritable Bowel Syndrome from moderate
3. Patients meet the scoring standard questionnaires: mild to severe
4. Patient can understand and answer the questions
5. Patient exhibits symptoms for at least six months

Exclusion Criteria:

1. Reading difficulties
2. Diagnosed left ear lesion
3. Measured blood pressure under 100/60 with or without anti-high blood pressure medicine
4. Active implant such as cochlear implant
5. Wounds and skin disease in the left ear
6. Recent head trauma or concussion
7. Cardiac pacemaker
8. Severe alcoholism
9. Left cervical vagotomy
10. Cholinergic or B blocking medicine
11. Recreative drugs
12. Diagnosed concomitant psychiatric comorbidity
13. Diagnosed concomitant personal disorders
14. Diagnosed pregnancy
15. Diagnosed concomitant severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic infectious diseases uncompensated
Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder

This is a multi-center, prospective, randomized, open-label, controlled trial with two parallel arms and blinded endpoint assessment.

It aims yo compare the 6-month efficacy of a group CBT program versus body-mediated intervention (meditation) children (7-13 years) with ADHD-associated FASD and emotional dysregulation via a measurement of the Aggressive Behaviors subscale score of the Dysregulation Profile subset of the CBCL scale.


Eligibility Criteria:
Inclusion Criteria:

* child with fetal alcohol spectrum disorder
* child with attention deficit disorder with / without hyperactivity
* child with a score upper than or equal to 180 points on the "Aggressive behavior", "Anxiety / Depression" and "Concentration problems" subscales of the CBCL
* child followed in La Reunion, Montpellier or Bordeaux University Hospital
* child whose parents are affiliated with social security
* child who accepts to participate and whose parents have given their consent

Exclusion Criteria:

* non-french speaking child or parents / non-creole speaking child or parents
* child who already participate to CBT or body mediation groups
Oral Cell DNA Adducts in Smokers

DNA adducts in the oral mucosa cells of 100 smokers from 3 ethnic groups - Native Hawaiians, Whites, and Japanese Americans with differing risks for lung cancer upon cigarette smoking will be quantified. DNA adducts of tobacco smoke carcinogens will be quantified using both targeted and untargeted approaches.

Using high resolution mass spectrometry, quantify known DNA adducts in oral mucosa cells of 100 smokers from each ethnic group - Native Hawaiians, Whites, and Japanese Americans. DNA adducts of tobacco-specific compounds, formaldehyde, and acrolein will be quantified.

2. Analyze the urine of 100 smokers and 100 non-smokers from each of these groups for mercapturic acids of acrolein and crotonaldehyde, as well as total nicotine equivalents and total NNAL (smokers only). These data will provide critical information relevant to the high risk of Native Hawaiians for lung cancer, and in relationship to the DNA adduct measurements of Specific Aim 1.

Eligibility Criteria:
Inclusion Criteria:

* currently smoke at least 5 cigarettes per day, self-identified Japanese Americans, European Americans, or Native Hawaiians.

Exclusion Criteria:

* no current use of other nicotine containing products, no acute or uncontrolled medical or psychiatric conditions, no greater than 14 alcoholic drinks per week, not pregnant, not breastfeeding, not currently taking any medications that affect relevant metabolic enzymes, no active infection.
Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation

to study the effect of oral gabapentin (5 mg/kg) on emergence agitation after desflurane anesthesia in pediatrics undergoing starbismus surgery


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients (2-6 years old), with an American society of Anesthegiologists physical status (ASA) I-II who were undergoing strabismus surgery (for more than one muscle)

Exclusion Criteria:

* failure to obtain consent, mental retardation or developmental delay, epilepsy, psychiatric or neurological diseases that impair communication, current use of gabapentin, psychotropic or opioids.
Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control

The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race population of poorly controlled diabetic Veterans. Also, the study aims to assess the effects of becoming a mentor on those who originally were mentees. It is expected that participants in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of race or ethnicity at the end of the intervention.

The primary objectives of this study are: (1) test the long-term effectiveness of a peer mentor model on improving glucose control, blood pressure, LDL levels, diabetes mellitus quality of life, and depression scores in a mixed race population of poorly controlled diabetic Veterans; (2) test the effectiveness of using former peer mentees as peer mentors as a means of creating a self-sustaining program; and (3) and test the effects of becoming a mentor on those who were originally mentees given a growing literature that being a mentor is good for your health. Secondary objectives include: (1) in those randomized to being a mentee, explore mentor characteristics associated with improved HbA1c.

This study will be a prospective randomized controlled trial. Outcomes to be measured include glycosylated hemoglobin, blood pressure, direct LDL, diabetes quality of life and depression.

The trial has two phases. In phase one, patients with poorly controlled diabetes are randomized to usual care or receiving peer mentoring. In phase two, poorly controlled diabetics are randomized to usual care or receiving peer mentoring from former mentees. Former mentees from phase 1 are also randomized such that they will have a 50% chance of becoming a mentor.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* All participants must have a diagnosis of Type 2 diabetics.
* Diabetes began after age 30
* Mentees: Have an HbA1c \> 8% on 2 different occasions in the course of 24 months, with at least one measure within 3 months of enrollment
* Mentors for Phase 1: Had an HbA1c of \> 8% in the past 3 years and an HbA1c \< (or equal to) 7.5% within 3 months of enrollment
* Mentors for Phase 2: Former mentee

Exclusion Criteria:

Exclusion Criteria:

* Does not speak English
* Unable to understand consents
* Severe speech impediment
* over the age of 75
Analgesic and Anti-inflamatory Effect of Vit. B

Vitamin C, also known as ascorbic acid, is a potent reducing agent and antioxidant that plays a crucial role in various metabolic processes.Vitamin B complex, a group of eight essential B vitamins, plays a crucial role in cellular metabolism, energy production, and maintaining nervous system health. There are few available studies on the effects of vitamin B injection on plasma inflammatory markers and its adjuvant analgesic effect along with the routine multimodal analgesia. Considering limited research and existing controversies in this field, the aim of present study is to evaluate the effects of preoperative and intraoperative vitamin B12 administration compared to vitamin C when used as a component of the multimodal analgesic technique in patients undergoing laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18-60 years)
* American Society of Anesthesiologists (ASA) classification I-II
* Patients undergoing laparoscopic cholecystectomy under general anaesthesia

Exclusion Criteria:

* Hypersensitivity to vitamin B complex or vitamin C
* History of chronic pain or use of opioids within the last month
* Patient with inflammatory conditions
* Severe renal or hepatic impairment
* Patient with intellectual disabilities.
The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

The purpose of this study is to assess the efficacy of Aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen

After being informed about the study, all patients who provide written informed consent and meet the eligibility requirements will be randomized in a triple-blind manner (participant, evaluator, and investigator) in a 1:1 ratio to Aprepitant (80 or 125 mg) + standard antiemetic regimen (once two hours before surgery) or placebo + standard antiemetic regimen(once two hours before surgery).

The standard antiemetic regimen will be Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old.
* Non-smokers.
* Obesity with BMI \> 30 kg/m2.
* Undergoing laparoscopic gastric sleeve.

Exclusion Criteria:

* Documented hypersensitivity to any component of the study regimen.
* Current treatment with: Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole) or Propulsid (cisapride).
* Allergy to opioid drugs used in the anesthetic protocol.
* Drug or alcohol abuse.
* Chronic nausea and vomiting.
* Previous bariatric procedures.
Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

The purpose of the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry is to study the contemporary natural history of children \<16 years of age newly diagnosed with inflammatory bowel disease. The project follows these children quarterly from diagnosis examining clinical, laboratory, and humanistic outcomes. Genetic and serologic monitoring is performed on the study population.

Observations of children with IBD often suggest a more severe course than that found in adults. Explanations for this are unclear, especially since children are less likely to engage in some behaviors (e.g., smoking) that may have a deleterious effect on disease course as noted in adults. In many ways children are a better "experimental model" of IBD because they don't have as many confounding medical factors as adults. Both Crohn's disease and ulcerative colitis are believed to result from a complex interaction of genetic and environmental factors (1). Recently, the gene CARD15/NOD2 on chromosome 16 has been identified in approximately 25% of Caucasian patients with Crohn's disease and is felt to be a significant predisposing factor to the development of fibrostenosing disease (2). Additionally, seropositivity for perinuclear antinuclear cytoplasmic factor (pANCA) has been demonstrated much more frequently in patients with ulcerative colitis than in those with Crohn's disease, while anti-Saccharomyces antibody (ASCA) is more common in the latter population (3). The importance of these serological abnormalities is not clear, though some data suggest an influence on the development of complications.

Our hypothesis is that phenotypic, genotypic and serologic characteristics may provide prognostic information on response to therapy and course in children with IBD. This type of prognostic information is particularly important as newer therapies are developed.

Eligibility Criteria:
Inclusion Criteria:

1. Definite diagnosis of ulcerative colitis, Crohn's disease, indeterminate colitis
2. Age up to 16 years and zero days at time of diagnosis
3. Informed consent/assent from parent/guardian and patient
4. Ability to be available for regular follow-up visits

Exclusion Criteria:

1. Diagnosis of IBD greater than 1 month prior to presentation to participating center
2. Age greater than 16 years and zero days
3. Inability to be available for regular follow-up visits