cyrilzakka/clinical-trials huggingface dataset:
Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children

RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.

PURPOSE: Genetic study to learn more about genes involved in the development of central nervous system tumors in young children.

OBJECTIVES:

* Identify known genes that have significantly different levels of expression, using microarray gene chip analysis, in infants with newly diagnosed metastatic vs non-metastatic embryonal central nervous system tumors.
* Determine the protein expression of genes identified by microarray analysis that are involved in cellular functions that regulate angiogenesis, invasion, or metastasis in this patient population.
* Determine the quantity of gene expression of the confirmed translationally expressed genes using semi-quantitative polymerase chain reaction.

OUTLINE: This is a multicenter study.

Tumor samples are analyzed using microarray gene chip analysis. Differentially expressed genes are evaluated for protein expression by standard immunohistochemistry and/or Western blot analysis, and gene expression is further quantified by semi-quantitative polymerase chain reaction.

PROJECTED ACCRUAL: Approximately 80-100 patients (20-25 with metastatic disease and 60-75 with non-metastatic disease) will be accrued for this study within 4-5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed, newly diagnosed, primary intracranial embryonal central nervous system tumor

  * Medulloblastoma
  * Primitive neuroectodermal tumor
  * Medulloepithelioma
  * Ependymoblastoma
  * Neuroblastoma
  * Pineoblastoma
  * Atypical teratoid/rhabdoid tumor
  * Intracranial germ cell tumor
  * Choroid plexus carcinoma
  * M positive ependymoma
* Potential enrollment on PBTC-001 therapeutic protocol

PATIENT CHARACTERISTICS:

Age:

* Under 3

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Prior steroids allowed

Radiotherapy:

* No prior radiotherapy

Surgery:

* Not specified

Other:

* No concurrent investigational agents
Diffusion Weighted Magnetic Resonance Imaging for Preoperative Staging in Gastric Adenocarcinoma Patients

Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced disease stateS for the patients in which the surgery may be unnecessary to perform. Although there are many imaging techniques for this purpose, sensitivity and specificity of these techniques still remains to be low.Preoperative detection of peritoneal carcinomatosis and involvement of lymph nodes beyond D2 may prevent surgical procedures.

Removal of the determined lymph nodes according to the type of the surgery is the accepted surgical method. However, accurate determination of malignant lymph nodes may prevent dissection of some groups of the lymph nodes. These findings may cause a new definition of gastric lymph node dissection.

1. proven endoscopic diagnosis of gastric adenocarcinoma
2. for staging purposes, computed tomography for all patients
3. evaluation of benign and malignant lymph nodes according to computed tomography findings and mapping of the lymph nodes
4. to state precisely resectable patients according to computed tomography and anesthetic evaluation
5. evaluation of benign and malignant lymph nodes according to diffusion weighted magnetic resonance imaging findings and mapping of the lymph nodes
6. standard gastrectomy and D2 lymph node dissection
7. mapping of the lymph nodes after taking the specimen out
8. histopathological diagnosis of the lymph nodes and mapping
9. comparison of the results taken from computed tomography, diffusion weighted magnetic resonance imaging and histopathological analysis

Eligibility Criteria:
Inclusion Criteria:

* gastric adenocarcinoma proven by endoscopic biopsy;
* application of both computed tomography and diffusion weighted magnetic resonance imaging;
* standard gastrectomy and a D2 lymph node dissection;
* desire to attend the study protocol

Exclusion Criteria:

* preoperative neoadjuvant therapy;
* metastatic disease;
* undesired reaction to attend the study protocol
Adherence and Persistence to Inclisiran Among Early Users in Germany

The present study was a descriptive, non-interventional, retrospective cohort study aimed at evaluating early data on adherence, persistence, and treatment patterns among patients receiving inclisiran and other lipid-lowering therapies (LLT) in a real-world setting in Germany. Analysis was carried out using the IQVIA™ LRx database.


Eligibility Criteria:
Inclusion Criteria:

* Study subjects ≥18 years old who were prescribed an inclisiran dose.

Exclusion Criteria:

None
LIMIT Early Adiposity Rebound in Children

Childhood obesity is a strong predictor of adult obesity with health and economic consequences for the individual and society. Adiposity rebound (AR) is a rise in the Body Mass Index occurring between 3-7 years. Early adiposity rebound (EAR) occurs at a median age of 2 years and is a risk factor for later obesity. Events happening in "the first 1,000 days" play a role in obesity development. One of the key elements in this crucial time window is the gut microbiome, a highly dynamic organ that is sensitive to environmental exposure being linked to obesity development. Prenatal (dietary/lifestyle maternal factors and environmental exposure) and postnatal determinants (the type of feeding, sleep patterns, speed of growth) and environmental obesogenic pollutants may influence the infant microbial colonization, thus increasing the risk of EAR onset.

LIMIT will holistically identify the longitudinal interplay between the intestinal microbiome and infant/maternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with AR vs EAR, driving new mechanistic insights to create an EAR predictive model.

The study will evaluate a group of 150 mother-infant pairs, during the first four years of life at different follow-up.


Eligibility Criteria:
* Inclusion criteria: i) Infants of both sexes born to vaginal/caesarean delivery; ii) Gestational age: 37-42 weeks; iii) Italian-speaking parent; iv) 7 Ability of the parent/guardian to give informed consent; v) Ability of the mother to answer questionnaires.
* Exclusion Criteria: i) Infants with genetic/congenital diseases; ii) Infants selected for another clinical study; iii) Infants hospitalized immediately after birth; iv) Presence of gestational diabetes; v) Presence of hyperthyroidism during pregnancy; vi) Parents refusing to sign the informed consent.
The Effects of Omega-3 Fatty Acids in Renal Transplantation

Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary supplements containing omega-3 fatty acids are also commercially available. Some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and lipid-modulating effects. Other studies have not confirmed these findings. This study will investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.

There have been few interventional studies regarding the clinical effect of omega-3 fatty acids in renal transplantation. The aim of this study is to investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.

This study is a randomized double blinded placebo controlled interventional study of 132 Norwegian renal transplant recipients. It will investigate, on the one hand, the effect of omega-3 fatty acids on renal function and, on the other, the effect of omega-3 fatty acids on cardiovascular risk markers in renal transplant recipients.

8 weeks after transplantation, if renal function has stabilized, patients with a eGFR\>30 will be randomized to receive either 2,7 g eicosapentaenoic plus docosahexaenoic acid (3 capsules of Omacor a 1 g) daily or placebo. Baseline measurements will be performed before they start taking the study medication. The same measurements will performed again1 year after transplantation and the patients stops taking the study medication.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who have received a kidney transplant. Patients with a functioning kidney transplant, defined as eGFR\>30 ml/min. Signed informed consent.

Exclusion Criteria:

* Patients participating in clinical trials with other investigational drugs. Patients who received a deceased donor kidney from a donor \>75 years. Patients with a history of an allergic reaction or significant sensitivity to the study drug or drugs similar to the study drug.
Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas

The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been reformulated and been placed in a fatty bubble called a liposome. The reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be better at shrinking tumors and with reduced side effects. The purpose of this study is to see how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of Non-Hodgkin's lymphoma of B-cell origin: follicular large cell, diffuse large cell (including all B-cell variants), Burkitt or Burkitt-like lymphoma
* All stages of disease
* Measurable or evaluable tumor parameter(s)
* Age greater than 17 years old
* Karnofsky performance status greater or equal to 50%
* AGC greater or equal to 1.0; platelets greater or equal to 75,000(unless abnormal because of lymphoma)
* Bilirubin less or equal to 2.0; SGOT less or equal to 3 times upper limit of normal (unless abnormal because of lymphoma)
* Creatinine less or equal to 2.0 or creatinine clearance greater or equal to 60 ml/min (unless abnormal because of lymphoma)
* LVEF greater or equal to 45%
* Concurrent RT with or without steroids for emergency conditions secondary to lymphoma (i.e., CNS tumor, cord compression)are permitted
* Men and women of childbearing potential must agree to use adequate birth control for the duration of the therapy and for 3 months after completion of therapy
* Signed informed consent

Exclusion Criteria:

* Prior systemic cytotoxic therapy or RT for lymphoma
* Second active tumor, other than non-melanomatous skin ca and in-situ cervical cancer
* HIV seropositive
* Primary CNS lymphoma
* Pregnant or nursing women
* Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent, in the opinion of the PI
Evaluating the Glycemic Control wIth Vildagliptin and Metformin Combination Therapy.

To evaluate the changes from baseline in random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin.

Galvecta Plus is a combination of Vildagliptin and Metformin hydrochloride. Combination drug with complementary mechanisms of action, provides efficacy and allows to reach glycemic targets compared to continuing metformin monotherapy and is used as an oral hypoglycemic in Type II diabetes mellitus that shows potential to achieve better blood glucose without increasing the risk of hypoglycemia, exposing to weight gain and altering common cardiovascular risk factors (hypertension and lipid profile). The fact that Vildagliptin with metformin substantially enhances the incretin effect. Vildagliptin belongs to dipeptidyl peptidase-4 (DPP-4) inhibitor. Inhibition of dipeptidyl peptidase-4 (DPP-4) by Vildagliptin prevents degradation of glucagon-like peptide-1 (GLP-1) and reduces glycaemia in patients with type 2 diabetes mellitus, with low risk for hypoglycemia and no weight gain and metformin is a Biguanides with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with type 2 diabetes mellitus (DM).
* Patient with HbA1c levels greater than 7.0% who were naïve or were receiving monotherapy with oral hypoglycemic agent were eligible to participate in the study.

Exclusion Criteria:

* Patient with a history diabetic ketoacidosis, clinically significant liver or renal disease, congestive heart failure requiring pharmacological treatment, coronary artery percutaneous intervention or unstable angina within the past 6 month excluded from study
* Participants who are pregnant or with gestational DM
* Age over 80 years
* Hypersensitivity to any active ingredient.
The Efficacy and Acceptability of an Internet-Based Self-Help Program to Reduce Burnout

The goal of this clinical trial is to determine whether an internet-based self-help program reduces burnout in teachers. The study will also evaluate the program's acceptability which means assessing the extent to which users complete the program and find it useful. The main questions it aims to answer are:

* Does the program reduce the level of burnout in teachers?
* Does the program contribute to an increased sense of meaning for teachers?
* How much of the program do teachers finish?

This concurrent multiple-baseline single-case experimental study aims to assess the efficacy and acceptability of an internet-based self-help program designed to mitigate burnout among teachers. The self-help program, named MyLife, adopts an Acceptance and Commitment Therapy framework and comprises eight modules. Preceding the commencement of the study, the program was tailored to address the specific needs of teachers through collaboration with people with lived experiences and the administration of nationwide surveys. Additionally, the daily questions utilized in this single-case study design were meticulously crafted for this study. In this study no guidance other than reminders will be offered.

Participants will be instructed to:

* Engage with program content, including audio and text components, every three days over a four-week period.
* Respond to daily questions once in day for eight weeks and both before and after the study, utilizing scales and questionnaires.

The research questions are as follows:

1. To what extent does the program alleviate burnout among teachers?
2. Does the program foster a heightened sense of meaning in teachers' professional lives?
3. What is the completion rate of the program among participating teachers?
4. Does the program effectively diminish experiential avoidance?

Hypotheses:

1. Teachers participating in the MyLife program will experience a significant decrease in burnout levels compared to baseline measures.
2. The MyLife program will lead to a significant increase in the perception of meaning in teachers' professional lives.
3. MyLife program will have a good acceptability.
4. Participation in the MyLife program will be associated with a significant reduction in experiential avoidance among teachers.

Eligibility Criteria:
Inclusion Criteria:

* Being a teacher in Türkiye
* Having burnout symptoms related to the workplace.
* Able to use e-mail, internet and mobile phone
* Able to read fluently in Turkish

Exclusion Criteria:

* Currently prescribed psychotropic medication or any change in psychotropic medication in last two months
* Currently undergoing psychotherapy.
* Having thoughts of suicide or self-mutilation.
A Combined Cell Therapy Approach to the Treatment of Neuroblastoma

This study adds an experimental treatment with another type of cells, called dendritic cells. It is hoped that these cells may stimulate the immune system to react against neuroblastoma in much the same way that vaccines cause the immune system to react to certain viruses and bacteria. The physicians conducting this study have observed from previous research that neuroblastoma cells can be recognized by the immune system, and that they can be destroyed by immune cells.The main goal of this study is to see if giving participants this additional anti-Neuroblastoma vaccine reduces the risk of relapse following the Hematopoietic Stem Cell Transplant.

All patients who are enrolled in this study will receive all treatment at All Children's Hospital which is located at 501 6th Ave South, St. Petersburg, FL 33701. This includes autologous cell donation by apheresis, high dose cytotoxic therapy conditioning for autologous HPC transplant, post-transplant follow-up care, and all administration of dendritic cell vaccines and blood draws for post therapy immunological monitoring.

All preparation of cellular products, including hematopoietic progenitor cell products for autologous transplantation, and dendritic cell vaccine products, will be carried out in the Cell Therapy Facility located within the Moffitt Cancer Center, which is located at 12902 Magnolia Drive, Tampa, FL 33612.

Eligibility Criteria:
Inclusion Criteria:

* Must have a histological diagnosis of neuroblastoma or ganglioneuroblastoma and be either newly diagnosed with high risk disease or have failed previous treatment: Patients who have failed previous treatment may have had no more than one earlier autologous HPC transplant.
* Participant is expected to undergo autologous HPC transplantation that is consistent with standard of care.
* Must have the presence of residual resectable disease for which surgery is clinically indicated, and will be performed at Johns Hopkins All Children's Hospital.

Exclusion Criteria:

* Not an eligible candidate for collection by apheresis or HPC transplant.
* History of autoimmune disorder or immune deficiency disorder.
The Use of Nasal Phenylephrine in Infants With Bronchiolitis

Drops of either saline or phenylephrine are placed in the nose of infants less than 12 months of age to determine if it helps them to breathe easier.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 weeks to 12 months; admitting diagnosis of bronchiolitis; admitted to hospital's bronchiolitis pathway, admitted during weekdays, need for nasal suctioning.

Exclusion Criteria:

* Congenital heart disease, history of hypertension, previous wheezing, prior use of inhaled corticosteroids, gestational age at birth of \<34 weeks.
Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

The primary aim of this randomized controlled trial is to determine the acute antidepressant efficacy of interpersonal psychotherapy (IPT) in depressed patients with Parkinson's Disease.

The primary aim of this study is to determine whether IPT is more efficacious than an intervention that controls for non-specific factors (i.e., supportive psychotherapy) in reducing depressive symptoms. A secondary aim is to determine whether IPT is better than supportive therapy in improving quality of life, interpersonal functioning, attachment patters, and motor symptoms, and whether treatment gains are durable at 6-months follow-up. An exploratory aim of the study is identify moderators and mediators of treatment outcome. Patients who meet study criteria will be randomly assigned to either 12 sessions of IPT or 12 sessions of supportive therapy. The primary efficacy measure (Hamilton Depression Rating Scale) will be administered at baseline, weeks 6 and 12, and at 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with idiopathic Parkinson's disease and between stages 1 and 3 in the modified Hohn \& Yahr Clinical Staging Scale
* Diagnosis of a depressive disorder
* Score ≥ 12 on the 17-item Hamilton Depression Rating Scale
* Living independently

Exclusion Criteria:

* History of bipolar disorder or psychotic symptoms (other than drug induced)
* Substance-related disorders in the last 12 months
* Acutely suicidal or history of suicide attempts in the past 5 years
* Presence of cognitive deficits (i.e., score ≤ 24 on the Mini Mental Status Exam) or history of significant cognitive disorders
* Presence of other significant neurological problems
* Presence of unstable comorbid medical conditions
* Currently receiving psychotherapy
* Unable to attend weekly therapy sessions
Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery

This study is a randomized study that compares two commonly used post-operative pain reducing techniques by measuring the level of pain and use of pain medication after knee surgery.

Post-operative pain is a commonly associated with knee surgery. Treatment often includes an oral or intravenous (IV) narcotic regimen which often leads to nausea, vomiting and can cause consti-pation. These issues can contribute to the overall discomfort of the post-operative patient. Intra-operative injections and local nerve blocks have become common adjuncts to narcotics to reduce post-operative pain and the necessity for oral or IV narcotic use. The aim of this study is to com-pare analgesic use and clinical effects on post-operative pain management with intra-articular in-jection of 20ccs of 2% lidocaine with epinephrine at the start of the case plus 20ccs 0.5% mar-caine with epinephrine at the end of the case vs. adductor canal saphenous nerve blockade in pa-tients undergoing knee arthroscopy, as indicated by the need for rescue narcotics and patient pain scores. A randomized, single blinded study will be performed to evaluate post-operative pain control using VAS scores at 1, 2, 4, 8, 12, 24, 36, and 48hrs post-operatively, rescue narcotic use in the PACU, and total narcotic consumption over the same time period.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients
* Age 18 to 65 years

Exclusion Criteria:

* Allergy or intolerance to local anesthetics, NSAIDs, or opioids
* Inability to understand the consent or study process
* Any contraindication to regional anesthesia
* Known history of substance abuse
* Chronic home opioid therapy
* History of major neurologic deficit in operative limb
* Chronic pain syndromes
* Pregnancy and nursing women