cyrilzakka/clinical-trials huggingface dataset:
Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

OBJECTIVES:

* To determine whether the pattern of global and TSG-specific promoter CpG island hypermethylation and gene silencing that we have shown characterizes MLL-rearranged (MLL-r) infant bilineage ALL is also characteristic of other subsets of MLL-r leukemia.

OUTLINE: Previously collected cryopreserved cells from diagnosis are analyzed for promoter methylation via HELP arrays, gene expression arrays, and RT-qPCR.

PROJECTED ACCRUAL: A total of 32 samples (8 from each of 4 biologically defined cohorts) will be analyzed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Available cryopreserved cells from diagnosis

  * At least 2 x 10\^7 viably cryopreserved cells
* One of the following biologically defined cytogenetics/molecular cohorts:

  * t(9;11)
  * t(11;19)
  * Other 11q23 translocations
  * Normal cytogenetics

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Efficacy of a Habit Reversal Treatment on Tic-symptoms

The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme in children and adolescents aged 8 to 18 years with tic disorders.

The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme for children and adolescents with tic disorders. This habit reversal treatment programme was developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and has already been evaluated in a pilot-study (Woitecki \& Döpfner, 2011, 2012).

Eligibility Criteria:
Inclusion Criteria:

* 8-18 years
* Diagnosis of chronic motor or vocal Tic (F95.1) or Tourette-Syndrome (F95.2)
* YGTSS total score F95.2\>13, F95.1\>9
* Tics are the main problems
* IQ\>80
* If medication, then has been stable for at least one months in medicated patients
* No change in medication treatment is planned
* Ability to participate in weekly outpatient treatment
* Acceptance of randomization

Exclusion Criteria:

* Diagnosis of Autism Spectrum Disorder or Psychosis
* Parallel continuous psychotherapy of tics or comorbid
Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) in Private Vaccination Sites in Buenos Aires, Argentina.

The TAK-003 vaccine, Qdenga, developed by Takeda, was approved by ANMAT in April 2023 and has been available in Argentina since November 2023 for individuals from 4 years old and without limit of age. Clinical trials demonstrate that Qdenga has a favorable safety profile, adequate immunogenicity for all four serotypes, and efficacy in preventing severe dengue in seropositive and seronegative subjects. However, there are currently limited real-world safety studies on TAK-003, particularly for adults over 60 years old.

The aim of this study is to evaluate Adverse Events Supposedly Attributed to Vaccination and Immunization (AEFI) for TAK-003 vaccine in vaccinated people at private vaccination centers in Buenos Aires metropolitan area.


Eligibility Criteria:
Inclusion Criteria:

* All individuals who were vaccinated with Qdenga at Vacunar centers since November 2023 still 1st November 2024, from 4 years of age with no upper limit in accordance with ANMAT approval and for whom safety data is available through the Vacunar centers passive surveillance systems.

Exclusion Criteria:

* Reports with insufficient information to characterize the AEFI will be excluded from the analysis.
Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)

The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with NASH

This is a 2-part, randomized, double-blind, multicenter, placebo-controlled study to evaluate the safety and efficacy of Vonafexor in patients with NASH who likely have stage F2 to F3 fibrosis at approximately 50 global clinical sites. Overall, approximately 114 eligible patients will be enrolled: 24 patients in Part A (Safety Run-in Cohort), followed by 90 patients in Part B.

In Part A, 24 patients will be randomized on Day 1 to 1 of 4 parallel treatment groups: 100 mg Vonafexor twice daily (BID), 200 mg Vonafexor once daily (QD), 400 mg Vonafexor QD, or placebo BID. In Part B, 90 patients will be randomized on Day 1 to 1 of 3 parallel treatment groups: 100 mg Vonafexor QD, 200 mg Vonafexor QD, or placebo QD.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Suspected diagnosis of NASH, evidenced by elevated alanine aminotransferase (ALT), liver stiffness compatible with F2 or F3 fibrosis and Liver Fat Content (LFC) ≥10% as measured by MRI
* Women of childbearing potential and male patients with female partners must agree to use a dual method of contraception

Exclusion Criteria:

* Evidence of worsening liver injury
* Previous diagnosis of other forms of non-NASH liver disease
* Use of Vitamin E, glitazones, glucagon-like Peptide-1 receptor agonists, ursodeoxycholic acid, or obeticholic acid within 90 days prior to screening
* History of cirrhosis or liver decompensation
* Known history of alcohol abuse or daily heavy alcohol consumption
* Pregnant or breastfeeding women
* Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus
* Patients with contraindications to MRI imaging
Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training

Long-term oxygen therapy is a fundamental treatment modality for patients with chronic hypoxaemic lung disease. Typically, oxygen is administered at a constant flow rate. However, due to fluctuating activity levels, patients' oxygenation status can vary, potentially leading to oxygen desaturation and increased dyspnoea.

Emerging evidence suggests that automatic oxygen titration - a method of adjusting oxygen flow in response to current oxygen saturation - may have acute advantages over constant oxygen flow.

The primary objective of this study is to investigate the effect of automatic oxygen titration compared to prescribed constant oxygen flow rates on patients' perceived dyspnoea during exercise endurance training.

Rationale:

Hypoxaemia is common in people with chronic lung disease and can affect exercise tolerance. Oxygen therapy is then recommended.

Oxygen supplementation is usually delivered at constant oxygen flow rates. Only a few studies have investigated the short-term effects of automated oxygen delivery compared to a constant oxygen flow rate during exercise tests (e.g. 6-minute walk test, shuttle walk tests). These studies have shown that automatic oxygen delivery can lead to an acute increase in exercise capacity, including an improvement in the perception of breathlessness. The use of automated oxygen delivery during endurance exercise has not been studied. The most common reason for stopping prolonged exercise in patients with chronic lung disease is dyspnoea. Therefore, the use of automatic oxygen delivery in a pulmonary rehabilitation clinic could be beneficial in the context of personalised therapy for patients requiring oxygen if it further reduces dyspnoea, potentially enabling the patient to train their endurance even better.

Therefore, the primary aim of this study was to investigate whether the use of automatic oxygen supplementation versus constant oxygen supplementation has a different effect on the perception of dyspnoea in patients with hypoxaemia during endurance exercise.

Design:

This study is designed as a randomised, double-blind, controlled cross-over trial. Participants will first undergo a cycle-based peak work rate test to determine their individual maximal peak work rate. They then take part in two sets of five endurance training sessions. One set is performed with a constant oxygen flow prescribed for each participant, while the other uses automatic oxygen titration. The order in which these two sessions are performed is randomised.

Eligibility Criteria:
Inclusion Criteria:

* Chronic lung disease
* Hypoxemia (pO2\< 55mmHg) under room air conditions (rest or during exercise) or SpO2\<88% during exercise
* established Long-term oxygen therapy or given indication for a Long-term oxygen therapy/ supplemental oxygen therapy for exercise
* Age: 18 to 80 years
* Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
* Written informed consent

Exclusion Criteria:

- Acute exacerbation of underlying pulmonary disease requiring cessation of exercise training.
Dental Isolation Methods in Pediatric Patients

The purpose of this study is to collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry, to compare the effectiveness of aerosol reduction between these methods, to identify the most effective way to manage aerosol during dental prophylaxis for pediatric patients and to provide clinical evidence to facilitate practice guidelines in dentistry related to COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 patients
* Receiving dental prophylaxis or restorative procedure not requiring sedation or nitrous oxide
* Ability to cooperate in the dental chair
* Parents speak/read either English or Spanish and consent to study
* Child, when age appropriate, can assent to study

Exclusion Criteria:

* Patients that do not meet the above criteria (including inability to cooperate or special health care need)
* Parents that do not speak/read either English or Spanish
* Children that do not assent (when age appropriate) to the study
Reward System Responses to Food Aromas

Food aromas are a part of foods' flavor, and can promote overeating. Alcohol consumption also stimulates appetite, and contributes to overeating while under alcohol's acute effects. Knowing the brain regions that respond to food aromas and alcohol, and how they are modified by the amount of body fat and alcohol exposure, will provide critical information about the neural systems that underlie loss of control of eating. Therefore, the main hypotheses of this study are that: A) Lean and obese subjects have different brain responses to food aromas that enhance desire to eat, and B) Acute alcohol intoxication i) enhances the brain's response to food odors, and ii) affects brain systems that inhibit or terminate eating. To test these hypotheses, we have modified functional magnetic resonance imaging (fMRI) paradigms successfully used to study alcoholic drink aromas in subjects at risk for alcoholism.

Food aromas are powerful appetitive cues that are intrinsic to foods' flavor and hedonic qualities, and such cues can facilitate overeating. Alcohol consumption similarly "primes" appetite, and contributes to overeating while under alcohol's acute effects. Knowing the brain loci that respond to such naturalistic appetitive stimuli, and how they are modified by body fat and alcohol exposure, will provide critical insights about the neural systems that underlie loss of control of eating. Therefore, the main hypotheses of this study are that: A) Lean and obese subjects have different limbic responses to the olfactory cues that enhance motivation to eat, and B) Acute alcohol intoxication i) potentiates the brain's reward system response to food odors, and ii) affects brain systems involved in behavioral inhibition and eating restraint. To test these hypotheses, we have modified functional magnetic resonance imaging (fMRI) paradigms successfully used to study alcoholic drink aromas in subjects at risk for alcoholism.

Eligibility Criteria:
Inclusion Criteria:

* non smoking, right handed women 18-40 years
* good health without self reported neurological or psychiatric disorder
* no indication of eating disorders
* normal sense of smell

Exclusion Criteria:

* pregnant,/breast feeding women
* history of drug abuse/dependence, positive drug screen for amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates or PCP
* DSM-IV axis I psychiatric disorders or head injury with loss of consciousness
* contraindications to MRI (ferrous material, claustrophobia)
The Real-time Optical Diagnosis Value of Optical Enhancement Endoscopy in Colorectal Sessile Serrated Adenomas/Polyps

When a polyp is found, we begin to wash it and observe it with OE mode 1.Then,the endoscopist gives a real-time optical diagnosis and the future surveillance interval.Finally,the polyp will be resected for the biopsy.

When discovering a polyp, the endoscopist uses water to wash it.Then, the endoscopist starts with i-scan 1 (OE mode 1) to observe the polyp closely .Nextly, the endoscopist give a real-time optical diagnosis with the blind of the history of patient. Considering the other polyps, the endoscopist gives a surveillance interval predictions according to the guide made by USMSTF.The confidence of the real-time optical diagnosis is divided into high confidence and low confidence.After the observation, the small and diminutive polyp will be resected and have the blinded pathology.

Eligibility Criteria:
Inclusion Criteria:

1. The high risk for colorectal cancer screening score
2. Patients with colorectal polyps reviewing

Exclusion Criteria:

* 1.Inflammatory bowel disease 2. Polyposis syndrome 3. A history of colorectal cancer or surgical resection 4. Poor bowel preparation5.Not signing the informed consent 6.Severe cardiopulmonary function failure lesions, severe hypertension, cerebrovascular disease, mental disorder and coma, pregnancy, lactation can't taking the colonoscopy.
CPG 7909 Injection in Non-Small Cell Lung Cancer

Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (Stage IIIB or IV according to AJCC).
* Patients must have measurable disease according to the RECIST criteria.

Exclusion Criteria:

* Prior treatment with chemotherapy; patients may have received prior radiotherapy.
* Patients with suspected or known CNS metastases.
Upregulation of Alpha-1 Receptors Upon Septic Shock?

The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. This will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).


Eligibility Criteria:
Inclusion Criteria:

* patients presenting to the CCU with septic shock : SBP\<90 mm Hg refractory to volume load (\>30 ml.kg-1 within 6 h before inclusion) thus in need administration of noradrenaline for \>1 h (0.1 mcg.kg-1.h-1 i.e. \>0.5 mg.h-1/70 kg) to maintain mean BP\>65 mm Hg.
* criteria for sepsis :temperature\>38.5 or \<36°C ; WBC\>12 000 or \<4000/ml ; tachypnea (\>20 cycles par min) or mechanical ventilation ; tachycardia : \>90 bpmin
* written informed consent by the patient or next of kin or signature by the investigators of the form "emergency inclusion"

Exclusion Criteria:

* age\<18 ans
* pregnancy
* mental illness making informed consent impossible
* Absence of consent as signed by the patient or next of kin or signature of "emergency inclusion form"
* individual without social security coverage or participating in another biomedical research
* Contre-indications to clonidine (uncorrected hypovolemia, sick sinus syndrom, III grade AV block)
* HR\<70 bp/min
* pre-exitus
The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

The purpose of this study is to evaluate the relationships between prostanoids and various outcomes such as sleep disturbance, hypertension and arteriosclerosis in patients with sleep apnea syndrome(SAS). In the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

SAS is characterized by abnormality during sleep and hypoxemia from apnea and hypopnea, followed by systemic inflammation and organ dysfunction like cardiovascular diseases. Systemic inflammation causes the activation of arachidonic acid metabolism, producing prostaglandins (PGs) and leukotrienes (LTs). In addition, significant relationships between PGD2 and PGE2 and sleep, PGF2α and hypertension, PGI2 and thromboxane and platelet aggregation and so on are reported. Therefore, it is hypothesized that many prostanoids affect the pathophysiology of SAS. However, the relationships between prostanoids and clinical outcomes in patients with SAS are unknown. Although CPAP is the major treatment of SAS, the effects of CPAP on prostanoids are not known, either. Thus, the purpose of this study is to evaluate those relationships.

Eligibility Criteria:
Inclusion Criteria:

* Subjects hospitalized in Kyoto University Hospital for careful examination of SAS

Exclusion Criteria:

* Subjects with severe respiratory diseases, severe heart diseases, severe vascular diseases, or severe diabetes mellitus.
* Subjects taking nonsteroidal anti-inflammatory drugs, steroids or immunosuppressants.
Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain.

More than 230 million surgical operations are been realized all over the world every year. A surgical intervention can cause postoperative acute pain. The management of postoperative acute pain is multimodal and the use of patient-controlled analgesia (PCA) is often a part of this Pain-Management.

Intravenous PCA has established itself as a therapeutic concept and constitutes the reference treatment for the management of postoperative acute pain for the first 48 hours. The PCA offers patients autonomy in managing their pain with the intravenous delivery of morphine on demand.

Since 2017 PCA Zalviso is marketed. It allows the sublingual administration of sufentanil and it does not require venous access. It seems interesting to allow the early rehabilitation of patients who are no longer limited in their movements by an infusion. However, its acquisition cost appears to be higher than that of the intravenous PCA. In order to verify this hypothesis, the investigators propose to compare the set of costs associated with the use of sublingual PCA with those of intravenous PCA in the management of acute postoperative pain (less than 72 hours) in the context of patients benefiting from the placement of a total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* adults
* patients able to express consent
* signed written informed consent form
* patient covered by national health insurance
* patient undergoing total knee arthroplasty and requiring postoperative analgesia with the use of a PCA (patient controlled analgesia)

Exclusion Criteria:

* minors
* obstruction to participate
* patient non covered by national health insurance
* patient requiring a stay in intensive care immediately after the surgery
* patient unable to use a PCA a assessed by the investigator
Meniscal Tear and Osteoarthritis Risk (MenTOR)

Adults with degenerative meniscal tear receiving arthroscopic surgical management or knee drainage (arthrocentesis) +/- intra-articular steroid injection will be recruited to this non-interventional cohort study. The aim is to investigate whether measurement of an individual's synovial fluid biomarker response to a degenerative meniscal tear with symptoms predicts symptomatic and functional outcome suggestive of osteoarthritis (OA) of the knee.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 30-60 years.
2. Participant able and willing to give informed consent.
3. Clinical assessment demonstrates mechanical symptoms suggestive of meniscal pathology (focal knee pain +/- 1 or more of: catching/locking, giving way, focal joint-line tenderness, effusion, McMurray's positive) within last 12 months.
4. Evidence on clinical MRI knee of meniscal tear.
5. Participant is either in secondary care or has the potential to be referred to secondary care due to severity of symptoms.
6. Patient has failed conservative therapy and elected for surgical arthroscopic treatment, or is due knee drainage/injection for clinical reasons.
7. Competency of the English language to complete questionnaires independently.

Exclusion Criteria:

1. Pre-existing advanced radiographic OA (KL grade 3-4) of index knee at baseline.
2. Evidence of anterior cruciate ligament rupture, or more extensive soft tissue injury.
3. History of an acute knee injury (within 12 weeks), or acutely locked knee
4. Known history of inflammatory/septic arthritis of index knee.
5. Knee replacement or other non-arthroscopic knee surgery (e.g. high tibial osteotomy) - previous or planned within 1 year of study start.
6. Index knee surgery within last 3 months, including meniscectomy.
7. Steroid injection to index knee in last 3 months.
8. Active other (treated) inflammatory disease or infection.
9. Positive pregnancy test.
10. Unable to provide blood samples.
11. Unable to give informed written consent.
Prolonged Grief and Suicide Among Veterans

The primary research question in this study will ask, among those receiving outpatient mental health services (MHS) at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC), how many suffer from Prolonged Grief Disorder (PGD)? Here, it is hypothesized that PGD will occur within the sample. A secondary aim of this study will be to investigate how often PGD co-occurs with posttraumatic stress disorder (PTSD) and/or depression. Also, while PGD has been shown to have an effect on self-directed violence (SDV) among civilians (Prigerson, Bridge et al., 1999), no studies yet have examined the relationship between PGD and SDV among Veterans. Therefore, it also is hypothesized that as PGD severity increases among the Veteran sample, risk for SDV will increase as well. Additional research aims also will be addressed in this study. For one, it will be assessed which grief symptoms are most often reported among the Veteran sample. Also, no study has yet to examine if there are neuropsychological differences between PGD and PTSD. Therefore, another research question here is whether PGD indeed is neuropsychologically different from PTSD. Here, the exploratory hypothesis is that PGD sufferers will respond to a measure of multiple components of cognition (e.g., planning, sequencing, concentration, multitasking, and memory efficiency) in a manner that is significantly different from PTSD sufferers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Not currently active duty in any branch of the military
* English-speaking
* Ability to adequately respond to specific questions regarding the informed consent procedure.
* Active case in Mental Health Services (MHS) at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC)

Exclusion Criteria:

* Currently active duty in any branch of the military
* Non-English-speaking
* Inability to adequately respond to questions regarding the informed consent procedure.