cyrilzakka/clinical-trials huggingface dataset:
Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

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

PURPOSE: This research trial studies biomarkers in samples from patients with high-risk neuroblastoma.

OBJECTIVES:

* To establish telomere length measurement by quantitative polymerase chain reaction (qPCR) as an alternative lengthening of telomeres (ALT) detection method in neuroblastoma (NB).
* To determine the frequency of ALT in high-risk NB and the characteristics of ALT+ NB.
* To establish C-circle (extra-chromosomal telomeric DNA circles) level as a marker of ALT activity in NB.
* To evaluate the prognostic significance of ALT in NB.
* To evaluate the utility of the C-circle assay for the detection of circulating tumor DNA in NB patients with an ALT+ tumor.

OUTLINE: Archived tumor tissue and serum samples are analyzed for telomere length measurement, frequency, and C-circle levels by PCR. Results are then compared with patients' age at diagnosis and outcomes including survival data (event-free and overall survival).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Snap-frozen neuroblastoma (NB) tumors collected at diagnosis (Objectives 1 to 3)

  * High-risk stage 3 or 4 NB AND MYCN non-amplified, i.e., exclude stage 4 infants who are not high-risk

    * Up to five high-risk (\> 18 months, unfavorable histology) stage 3/MYCN non-amplified tumors
  * Patients preferably treated on protocol COG-A3973 or similar protocols with myeloablative therapy
  * At least 3 years of follow-up for those with no event (current evidence suggests that ALT+ NBs often relapse late, i.e., 2 years or longer from diagnosis)
* NB tumor DNA collected at diagnosis (Objectives 2 \& 3)

  * High-risk stage 3 or 4 NB as for Objective 1, except for MYCN status
  * Stage 4 tumors are preferred; may include up to seven high-risk stage 3 tumors with similar distribution of MYCN-amplified and non-amplified tumors
* Frozen serum from NB patients (Objective 5; 2nd stage of project)

  * Paired serum obtained at diagnosis from patients with ALT+ or ALT- tumors identified in Objective 2

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Embozene Microspheres for Uterine Fibroid Embolization (UFE)

This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form.
* Pre-menopausal women age 30-50 years at time of enrollment
* Have been selected forUterine Fibroid Embolization (UFE) prior to entry to the study.

Exclusion Criteria:

* Patient has a history of pelvic malignancy
* Patient has an abnormal Pap smear within 12 months of the planned Uterine Fibroid Embolization procedure
* Patient with coexisting condition that might explain abnormal bleeding (including endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and ovarian cysts).
* Is at substantial risk for the need of organ transplantation, such as renal insufficiency.
* Patient has evidence of current or recent pelvic inflammatory disease or uterine infection.
* Patient with a severe contrast allergy or renal insufficiency that would represent a contradiction to the administration of iodine-based contrast agents.
* Patients unable to comply with the follow-up requirements of the study.
Cannabidiol - an in Vivo Innovative Drug Delivery Study

Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.

This study aims to investigate an innovative pharmaceutical preparation of cannabidiol. Thus, a comparative bioavailability study will be conducted, comparing cannabidiol capsules (reference formulation) with an intranasal cannabidiol gel (test formulation), with the further aim to find an appropriate dosing of the new pharmaceutical preparation. The intranasal administration may also be suitable to reduce the high variability in the bioavailability of cannabidiol observed for the current oral administration.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent given by the subject
* Negative drug screening at the time of screening
* Non-smoking
* In female participants in fertile age, reliable contraception, which means contraception's Pearl index is equal to or smaller than 1.
* Body Mass Index between 18.5 kg/m2 and 30 kg/m2

Exclusion Criteria:

* Lack of accountability
* Pregnancy or lactation phase in females at the time of screening
* Any known psychiatric or neurological illness in the participant's history.
* Known family history regarding psychiatric disorders with an increased lifetime risk for psychiatric disorders in the participant (investigators qualified judgement)
* Relevant use of cannabis (which is defined on the present state of knowledge as more than five times lifetime consumption and/or more than two consumptions during the last year)
* Consumption of any illicit drugs (except cannabis in history, see above)
* Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematologic or endocrinologic disorders or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, as assessed by the investigator
Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)

Proportion who would avoid splenectomy at 6 months of follow up

1. If urea breath test (+); omeprazole 20mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 1 week.

   Second line Helicobacter pylori eradication will be permitted after failure of first line treatment.
2. Anti-D Anti-Ro 50 μg/kg IV for 2 days (D1, 2)
3. Danazol maintenance (from D1): Danazol will be continued at least 3 months. The dose of danazol can be reduced according to the adverse effects, especially in premenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* 1.ITP is defined by

  * (a) a true thrombocytopenia on blood smear, (b) adequate megakaryopoiesis on bone marrow examination, (c) the absence of clinically apparent associated conditions or cause of thrombocytopenia
* 2.Steroid dependant ITP: more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis)
* 3.Steroid refractory ITP: a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)
* 4.18 years old or more

Exclusion Criteria:

* 1.Patients who have a cause of thrombocytopenia such as HIV infection, lymphoproliferative disease, liver disease, definite SLE or drug
* 2.Pregnancy
* 3.Splectomized patients
* 4.Rh- blood type
* 5.Hemoglobin \< 10g/dL
* 6.Known hypersensitivity to immunoglobulins
* 7.A positive direct antiglobulin test
* 8.Clinically relevant hepatic or renal disease
The Influence of LMA Cuff Pressure on Gastric Insufflation Assessed by Ultrasound in Pediatric Patient

Cuff inflation up to the maximum cuff pressure when using LMA flexible can cause sore throat and discomfort after the surgery, and if the surgery is unexpectedly prolonged, there can be a side effect that can cause ischemic damage around the neck. If keeping cuff pressure low will not increase gastric insufflation and there is no change in other outcome variables, keeping it low may have a positive effect on anesthesia management and outcome in children.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing general anesthesia with LMA flexible

Exclusion Criteria:

* Unstable vital sign, significant arrhythmia or hypotension, Shock
* anticipated difficult intubation or the patient who have facial deformity
* high risk of aspiration
* recent upper respiratory tract infection history
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment

A single oral dose study to investigate the PK and safety of olorofim in mild and moderately hepatically impaired subjects compared to subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 to 70 years of age inclusive, at the time of signing the informed consent.
* Body weight ≥50 kg and BMI within the range 18 to 35 kg/m2 (inclusive
* Subjects with mild hepatic impairment will have grade A Child-Pugh score of 5 to 6 at screening and Day -1:
* Subjects with moderate hepatic impairment: will have grade B Child-Pugh score of 7 to 9 at screening and Day -1
* Subjects with normal liver function must be in good health, as determined by a medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations
* Subjects with normal liver function are matched by gender, age (±10 years) and BMI (± 20%) to at least one hepatically impaired subject.

Exclusion Criteria:

* Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study
* Subjects with any history of convulsion (other than childhood febrile convulsion before the age of 6 years).
* Subjects who have any clinically significant allergic disease (excluding mild or seasonal allergies such as contact dermatitis or hay fever) as determined by the Investigator.
* Subjects with a history of or any concomitant active malignancy.
* Subjects with a history of drug or alcohol abuse.
* Subjects with, or with a history of, any clinically significant neurological, renal, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma), hematological, or other major disorders as determined by the Investigator.
* Subjects with signs or symptoms consistent with a COVID-19 infection at screening or Day -1
* Hepatically impaired subjects with liver transplantation, autoimmune liver disease, or drug-induced liver damage
is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?

The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk.

The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk. specifically, we will test the following hypotheses:1) at constant caloric intake, 2 high fat (40% fat, 45% CHO) diets ( margarine e nriched versus butter enriched) lead to higher fat and caloric content of human milk than the low fat diet (5% fat, 80% CHO); and 2) All 3 groups will have strikingly different milk fatty acid profiles (mirroring the dietary fatty acid profile).

Eligibility Criteria:
Inclusion Criteria:

* breast feeding women
* healthy
* on no medications

Exclusion Criteria:

* women on medications
Study Evaluating Vaccine in Adults With HIV

The main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs that are used to help immune response) have an acceptable safety profile in treating individuals with HIV.

A second purpose for this study is to understand how your immune system responds to the study vaccine with the adjuvants. Understanding these differences could be useful in several ways. First, it might help identify people whose disease is likely to respond to the study vaccine with the study adjuvants. Second, the information might be useful in developing other treatments for people whose disease does not respond to the study vaccine with the adjuvants.


Eligibility Criteria:
Inclusion Criteria:

* Must be HIV positive.
* Receiving stable HAART for a minimum of 6 consecutive months immediately before screening.
* CD4 T-cell count greater than 350 mm cubed/mL at time of screening and no reported CD4 T-cell count less than 250 mm cubed/mL at any time before screening.

Other Inclusions Apply

Exclusion Criteria:

* Any chronic symptomatic infection other than HIV.
* History of diagnosed autoimmune disease (currently active or under control).
* Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening (documented, unblinded placebo recipients from previous clinical trials may participate without this time restriction).

Other Exclusions Apply
Acute Effects of HIIT vs. MICT on HRV

Heart rate variability (HRV) is impaired in patients after myocardial infarction. Most studies so far have proved chronic beneficial effects of different types of exercise on HRV parameters. Data on acute effects of different types of exercise training (e.g. high intensity interval training \[HIIT\] and moderate intensity continuous training \[MICT\]) is scarce.

Patients in the study will perform both HIIT and MICT in a random order and in-between break of at least 48 hours. A 5-minute high resolution ECG recording will be performed before and immediately after both HIIT and MICT.


Eligibility Criteria:
Inclusion Criteria:

* myocardial infarction in last 120 days
* sinus rhythm

Exclusion Criteria:

* contraindications for exercise training
* uncontrolled dysrhythmias
* Heart Failure NYHA IV stage
* cognitive impairment
* pregnancy
Cryo Global Registry

Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry

The Cryo Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to evaluate and describe clinical performance and safety data in a broad patient population treated with a commercially available Arctic Front™ Family of Cardiac Cryoablation Catheters (hereafter referred to as "Arctic Front™ Cardiac Cryoablation Catheter System"). The cryoballoon ablation(CBA) procedure will be performed according to routine hospital practice. The study is expected to have a 24 month enrollment period. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age or minimum age as required by local regulations
* Planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter
* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion Criteria:

* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
* Subject with exclusion criteria required by local law
The Importance of Ghrelin for Glucose Metabolism After Sleeve Gastrectomy

The overall aim is to delineate the contribution of ghrelin to glucose tolerance after sleeve gastrectomy. The hypothesis is that decreased concentration of ghrelin after SG is of importance for improved insulin secretion and glucose tolerance seen after SG. The expectation is therefore that infusion of ghrelin will impair insulin secretion and glucose tolerance compared with a control day without ghrelin infusion.

Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are bariatric procedures. Overwhelming evidence support bariatric surgery as the most effective treatment for severe obesity and related metabolic comorbidities, particularly type 2 diabetes mellitus.

The mechanisms of improved glycaemic control after SG are not fully understood and differ from those of RYGB. Interestingly, there is demonstrated a markedly lower secretion of the orexigenic hormone ghrelin after SG compared with both RYGB and unoperated obese controls. Hence, the decreased level of ghrelin could be of major importance in relation to the improved glucose tolerance after SG.

Ghrelin is secreted from the gastric mucosa in the fasting state and decreases in response to food intake. Administration of exogenous ghrelin reduces insulin sensitivity and glucose tolerance in healthy humans and contributes to hyperglycaemia. In accordance, ghrelin receptor knockout in mice improves glucose sensitivity and enhances glucose-stimulated insulin secretion.

On this background the investigators hypothesize that the markedly reduced secretion of ghrelin after SG could therefore be of particularly importance for the improved glucose tolerance after this procedure.

This present study is complementary to an on-going study in SG operated subjects, where the role of ghrelin for appetite and insulin secretion during a mixed meal followed by an ad libitum meal are investigated. In the present study the effect of ghrelin on insulin secretion and insulin sensitivity is thoroughly investigated using methods eliminating the effect of other hormones on glucose metabolism.

Ghrelin will be infused in physiological doses aiming for plasma concentration after SG resembling the pre-operative plasma concentrations.

Specific aim is to evaluate the effect of ghrelin on both alpha and beta cell function as well as on liver and peripheral insulin sensitivity in individuals with SG using matched controls. The subjects will be investigated with both glucose and glycerol tracers, IVGTT and a hyperinsulinemic euglycaemic clamp.

Eligibility Criteria:
Inclusion Criteria:

* Sleeve gastrectomy-operated \> 12 months prior to inclusion
* Weight stable (+/- 3 kg during the last 3 months)
* Fasting glucose \< 7,0 mmol/l / HbA1c \< 48 mmol/mol pre- and postoperative
* Signed written informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Haemoglobin \< 6,5 mM.
Comparison of Different Drugs on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study

Participants were randomised to receive benzalkonium chloride-containing latanoprost (Xalatan) or preservative-free bimatoprost (Lumigan). Through this study, the investigators would like to analyze the impact of different antiglaucoma medications on ocular surface disease in glaucoma patients.

The purpose of our study is to assess the effect of antiglaucoma medication on ocular surface disease in glaucoma patients before and after treatment with different antiglaucoma medication. All included patients are newly diagnosed with glaucoma and received no previous antiglaucoma treatment. Medical records will be collected prospectively from Sep. 15th 2019 to Aug. 31st 2022. The symptoms and signs of ocular surface disease in each individual will be assessed with questionnaire and clinical exams, including the basal Schirmer's test, non-invasive tear film breakup time, meibography, and in vivo confocal microscopy before and at 1, 3, 6 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients are not diagnosed with glaucoma and don't receive any ocular hypotensive eye drops at our clinic.
* Patients accept the rules for follow-up visits for at least six months.

Exclusion Criteria:

* Patients are with a history of ocular trauma.
* Patients are with contact lens use.
* Patients are diagnosed with secondary glaucoma.
* Patients have significant diseases affecting the meibomian gland and ocular surface.
* Patients have poor IOP control that required additional ocular hypotensive eye drops.
An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator

The purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance.

This project aims to study the previously evaluated multi-module internet intervention Alcohol Help Center delivered with assistance from a health educator (AHC+A). The assistance will be in the form of email contact with the participant during the first two weeks after randomization. AHC+A will be tested against a group receiving access to the intervention without any such assistance (AHC).

The Investigators hypothesize that

1. participants allocated to AHC+A will display significant reductions in drinking (drinks preceding week/heavy drinking days preceding week) in 3- and 6-month follow ups compared to AHC
2. participants allocated to AHC+A will display greater engagement with the intervention in terms of a higher number of modules completed compared to AHC
3. engagement with the intervention will mediate any effects on drinking behavior.

A 2-arm parallel group randomized controlled trial will be used to test these specified hypotheses. Follow-ups will be conducted at 3 and 6 months after randomization. Online media advertisements will be used to recruit people with current alcohol problems, and will target people who are 'experiencing difficulties in controlling or cutting down on their drinking.' The advertisements will be placed across Canada using locations found successful in previous trials to rapidly recruit participants (e.g. Google AdWords).

Eligibility Criteria:
Inclusion Criteria:

* A score of 8 or more on the Alcohol Use Disorder Identification Test (AUDIT)
* A preceding week alcohol consumption of 14 standard drinks or more

Exclusion Criteria:

* Being under 18 years of age
Drug Use Study With Intuniv® in European Countries

This study will evaluate and characterize people who are taking Intuniv, analyze prescribing behaviors of physicians, and determine whether Intuniv was correctly prescribed in Belgium, Denmark, Finland, Germany, Ireland, Netherlands, Norway, Spain, Sweden, and the United Kingdom.

The study aims to characterize participants who are prescribed Intuniv® and describe prescribing patterns of Intuniv® among physicians in European countries.

This study will collect data from the following sources:

* Physician Survey: de-identified patient data provided by representative physicians in Belgium, Finland, Ireland, and the Netherlands, with a goal of data from up to 100 participants per survey wave.
* Database Survey: longitudinal patient-level prescription database in all other countries with data on approximately 5000 participants.

In the database study, actual prescription data are collected from electronic medical records and national registries. A prescriber survey will be conducted to evaluate health care professionals (HCPs) real-life practice. It will include data collection from the prescriber's (physician's) files and a web questionnaire, including de-identified data from up to 100 participants per survey wave.

Eligibility Criteria:
Inclusion Criteria:

* Prescribers of Intuniv®, i.e. physicians who know and have prescribed the drug at least once during the previous 12 months (or, for the first report, since country specific launch) (paediatricians, psychiatrists, neurologists and GPs).
* Participants who have been prescribed Intuniv® at least once during the reporting period.

Exclusion Criteria:

• Physicians who do not treat participants or who may have a conflict of interest (i.e. physicians employed by regulatory bodies or pharmaceutical industries).