cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.

OBJECTIVES:

* Confirm that the management of infants with newly diagnosed stage IV neuroblastoma without MYCN amplification treated with etoposide and carboplatin and cyclophosphamide, doxorubicin, and vincristine followed by surgery does not require intensive high-dose chemotherapy consolidation.
* Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in these patients.
* Determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients.

OUTLINE: This is a multicenter study.

Patients receive VP-CARBO chemotherapy comprising etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses.

Patients without disease progression receive 2 additional courses of VP-CARBO chemotherapy. Patients with metastatic complete response (CR) undergo surgical resection of primary disease.

Patients with disease progression after 2 or 4 courses of VP-CARBO chemotherapy receive CADO chemotherapy comprising cyclophosphamide IV over 1 hour on days 1-5, doxorubicin IV over 6 hours on days 4 and 5, and vincristine IV on days 1 and 5. Treatment repeats every 21 days for 2 courses.

After 2 courses of CADO chemotherapy, patients with metastatic CR undergo surgical resection of primary disease. Patients with residual disease receive 2 additional courses of CADO chemotherapy. Patients with residual disease after 4 courses of CADO chemotherapy are removed from the study. Patients with metastatic CR after additional CADO chemotherapy undergo surgical resection of primary disease.

Patients are followed within 6 months and then annually for 5 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed newly diagnosed stage IV neuroblastoma or ganglioneuroblastoma

  * Metastases to bone, CNS, or pleura/lung by x-ray or CT scan
* No MYCN amplification (i.e., fewer than 10 copies)

PATIENT CHARACTERISTICS:

Age:

* Under 12 months at diagnosis

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

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria

OBJECTIVES:

I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study.

Patients are randomly assigned to 1 of 2 groups to receive cysteine hydrochloride orally twice daily, 2 capsules with breakfast and 2 with lunch. Group 1 receives cysteine hydrochloride in drug ingestion period 1 followed by placebo in period 2. Group 2 receives placebo in period 1 followed by cysteine hydrochloride in period 2. Both groups ingest placebo for 1 week between the periods. Each drug ingestion period lasts 8 weeks.

Follow up phone calls are made at the end of months 1 and 3. All patients schedule follow up visits at the end of each drug ingestion period.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Documented erythropoietic protoporphyria Determination of elevated protoporphyrin within the past year Experiencing photosensitivity --Prior/Concurrent Therapy-- No concurrent use of betacarotene --Patient Characteristics-- Other: Not pregnant or nursing Fertile female patients must use effective contraception while on study and for 3 weeks thereafter
Effect of Vitamin D3 Supplementation on Insulin Resistance- The DIR Study

Insulin resistance is a state where the body does not respond as it should to the insulin it produces. Individuals who are insulin resistant are at increased risk of both heart disease and type 2 diabetes; importantly, diabetes more than doubles the risk of heart disease, independent of other recognised risk factors. Interventions that prevent or reverse insulin resistance may help to attenuate risk of heart disease and diabetes. A number of randomised controlled trials provide proof of concept evidence regarding a beneficial effect of vitamin D on insulin resistance and other cardiovascular risk markers but experts have stated that further studies are required. Importantly, these studies should use appropriate endpoints, provide a high enough dose of vitamin D to optimise vitamin D status, and they should be conducted in clearly defined populations, The vitamin D trial we propose addresses these issues and aims to evaluate a potentially straightforward and low cost health care intervention for populations at highrisk of heart disease and diabetes. Specifically, this study would provide clinically relevant information on the metabolic effects of optimising vitamin D status in these high risk patients. This has clear economic and social implications given the current, and projected, burden of heart disease and diabetes.

This study will investigate the effect of vitamin D3 supplementation on insulin resistance and cardiovascular risk factors in people at high risk of type 2 diabetes and cardiovascular disease using the gold standard euglycaemic hyperinsulinaemic clamp method.


Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance (Fasting glucose \<7.0 mmol/L (126mg/dl) and 2hr post-glucose load 7.8-11.0 mmol/L (140-199 mg/dl) or Impaired fasting glucose 5.6-6.9 mmol/L (100-125mg/dL) defined according to American Diabetes Association
* Sub-optimal vitamin D status (\<50nmol/L)

Exclusion Criteria:

* Diabetes mellitus
* Established cardiovascular disease
* Psychiatric problems
* Pregnant or lactating
* Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
* Excessive alcohol consumption (\>28 Units/week men or \>21 Units/week women)
* Already taking vitamin D supplements \> 10 µg/d
* Medical conditions or medications that could influence vitamin D metabolism
* History of kidney stones
* Hypercalcaemia
* Hyperparathyroidism
* Significant liver and renal disease (liver function tests \>3x upper limit of normal and glomerular filtration rate \<30ml/min)
Bereavement Management - Description, Assessment and Care

This study aims to develop a risk assessment tool to identify bereaved in risk of complicated grief reactions and to implement a bereavement management programme in primary health care based on the Dual Process Model of coping with bereavement. Furthermore to enhance bereavement care in general practice and to enhance patients' self-management in bereavement care.

In Denmark alone there are approximately 55.000 deaths annually which leave approximately 200.000 bereaved close relatives. International studies show that 10-15% of bereaved persons develop complications following the death of a close relative. If those studies hold true, approximately 20 - 30.000 individuals annually will develop complications as a result of suffering a loss, and there is hardly any knowledge of how bereavement is treated or even legitimized in primary care and referred on to specialized (psychological or psychiatric) care. The field of bereavement is in need of studies that validate the theoretical underpinnings of the research area, enhanced assessment of predictive risk factors and updated intervention methods: in short a scientifically valid management programme.

Eligibility Criteria:
Inclusion Criteria:

* Newly bereaved from one of the inclusion facilities.
* 18 years or older.
* Danish citizen.
* Able to understand and speak Danish.
* Informed consent.
* Mentally able to cooperate

Exclusion Criteria:

* Patients with known substance abuse.
* Patients with recently (within 5 years) diagnosed psychopathological disorders that trigger psychotic episodes.
Behavioral and Neurofunctional Correlates of Intentional Motor Behaviors Towards Edible Stimuli in Normal-weight Subjects

This study aims to investigate, through behavioural tests combined with advanced neurofunctional methods, the neural bases of intentional behaviours towards edible stimuli using explicit and implicit paradigms in normal-weight subjects.

This knowledge will then be expanded with the study of associations between behavioral/neurofunctional measures and blood/hummon parameters.


Eligibility Criteria:
Inclusion Criteria:

* Normal weight (Body mass index - BMI - comprised between 18.6 and 24.99.
* Absence of usual contraindications to MRI examination (e.g. pacemakers, fixed hearing implants, presence of metallic foreign bodies, intrauterine bodies, metallic splinters or fragments, metallic prostheses, screws, nails, fixed or mobile dental prostheses).
* Signature of informed consent and consent to cooperate in all study procedures.

Exclusion Criteria:

* Previous diagnosis of significant neurological disorders (brain damage or dementia), major psychiatric disorders or eating disorders (binge-eating disorder, bulimia).
* BMI less than 18.5 and greater than or equal to 25 Kg/cm2.
* Serious medical conditions, including but not limited to: hypertension, significant heart disease, disorders or illnesses that may compromise patient safety.
* Pregnancy and Claustrophobia.
A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

The primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris.

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel in comparison with IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12 in subjects with moderate to severe acne. IDP-120 is a gel for the topical treatment of acne.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 9 years of age and older
* Written and verbal informed consent must be obtained.
* Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit
* Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits
* Subjects must be willing to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

* Any dermatological conditions on the face that could interfere with clinical evaluations
* Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
* Subjects with a facial beard or mustache that could interfere with the study assessments
* Subjects who are unable to communicate or cooperate with the Investigator
* Subjects with any underlying disease that the Investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study
The Dreamy Jet Study

The goal of this clinical trial is to see if a device known as a jet-injection system can help deliver a single dose of a sedating medication with less pain and stress than current methods.

Participants will receive a dose of the sedative in their arm or thigh before their procedure at the sedation clinic.

This study will evaluate whether jet-injected ketamine can provide adequate sedation to perform minimally invasive procedures in children with heightened procedural sensitivity in a pediatric sedation clinic environment. Minimally invasive procedures include, but are not limited to, blood draws, IV placement, and immunizations.

Eligibility Criteria:
Inclusion Criteria:

* Referred to UW Health American Family Children's Hospital Pediatric Sedation Clinic for minimally invasive procedures such as blood draw, IV placement, or immunization
* Age 2-15 years
* Weight \<40kg

Exclusion Criteria:

* Participants with elevated intracranial pressure
* Participants with uncontrolled hypertension
* Participants who are pregnant or possibly pregnant (i.e., people of child bearing potential unable to provide a negative pregnancy test)
* Participants who received a dose of medication within 2 hours of their appointment with the intention of sedation (i.e., benzodiazepines, opioids, alpha-2 agonists, 1st generation antihistamines)
* Participants who are receiving medications which might enhance the sympathomimetic effect of ketamine (i.e., theophylline, aminophylline, amphetamine, or pseudoephedrine)
* Participants who are receiving medications that might interfere with the expected pharmacokinetics of ketamine (i.e., ketoconazole, clarithromycin, rifampin, or carbamazepine)
* Participant's parent/legal guardian requires a translator for communication about the patient's medical care
Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head in comparison to the standard treatment of isolated core decompression.

XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue.

The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the progression to collapse of the femoral head.

Prospective, open-label with blinded assessor, randomized, parallel, single-dose phase I-II clinical trial in which 24 patients affected with osteonecrosis of the femoral head ARCO grade I or II will enter the trial with the primary objective of assessing the feasibility and safety of "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in osteonecrosis of the femoral head. Secondary objectives are to assess the efficacy of the implantation by imaging (magnetic resonance imaging) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and WOMAC Index).

Patients will be randomized to one of the two treatment arms (core decompression and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue or the standard treatment of isolated core decompression). Thereafter, patients will be followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age (male and female)
* Osteonecrosis of the hip ARCO grade I or II
* Abscence of systemic or local infection
* Laboratory tests with no relevant abnormal findings that contraindicate the surgery.
* Informed Consent Form signed
* The patient is able to understand the nature of the study

Exclusion Criteria:

* Osteonecrosis of the hip secondary to femoral neck fracture
* Patients with no closed cartilage
* Surgical implants in the femoral head
* Septic arthritis
* Patients with severe renal insufficiency
* Patients expecting or with liver transplantation
* Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis.
* Pregnant woman or intended to become pregnant, or breath feeding
* Neoplasia within the previous 5 years, or without remission
* Immunosuppressive states
* The patient is legally dependent
* Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
* Cardiac pacemaker, allergy to contrast or any other condition that contraindicates the MRI with contrast agents
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
* The patient does not accept to be followed-up for a period thar could exceed the clinical trial length
Phase II Study of Anti-CD19 CAR-T Cells Treating Leukemia Children

The investigators will conduct a phase II clinical trial of autologous murine anti-CD19 chimeric antigen receptor T cells treating refractory or relapsed B acute lymphoblastic leukemia children in Beijing Boren Hospital. The study will be approved by the institutional review board of Beijing Boren Hospital, and informed consent will be obtained in accordance with the Declaration of Helsinki. All these participants will be matched the diagnostic criteria for (r/r) B-ALL according to the WHO classiﬁcation and complete morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis and leukemia fusion gene screening by multiplex nested reverse transcriptase-polymerase chain reaction (PCR). Participants will be eligible if they are heavily treated B-ALL who failed from re-induction chemotherapy after relapse or continued MRD+ for more than three months, and had positive CD19 expression on leukemia blasts by FCM (\>95% CD19). After CAR T-cell infusion, clinical outcomes including overall survival (OS), Disease-free survival (DFS), adverse effects and relapse will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as primary refractory or relapsed B-ALL. All the patients matched the diagnostic criteria of ALL according to the WHO classification and conducted morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis, screen of 56 leukemia-related fusion genes by multiplex nested reverse transcriptase-polymerase chain reaction (RT-PCR), and quantification of fusion genes by real-time PCR with ABL1 as reference. Extramedullary diseases (EMDs) were confirmed CD19+ by FCM and evaluated by positron emission tomography/computed tomography (PET/CT), CT, MRI or ultrasonography. The patient relapsed during chemotherapy or failed from re-induction chemotherapy (including first and second-generation TKIs) after relapse or had a persistent positive minimal residual disease (MRD) for three months. Patients had positive CD19 expression on leukemia blasts by FCM (\>95% CD19 positive);
* Age from 0 to 18 years old;
* Children candidates can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form;

Exclusion Criteria:

* Intracranial hypertension or unconscious;
* Acute heart failure or severe arrhythmia;
* Acute respiratory failure;
* Other types of malignant tumors;
* Diffuse intravascular coagulation;
* Serum creatinine and/or blood urea nitrogen over 1.5 times than normal range;
* Sepsis or other uncontrolled infection;
* Uncontrolled diabetes mellitus;
* Severe psychological disorder;
* Obvious cranial lesions with cranial MRI;
* More than 20 counts/ul leukemic cells in cerebrospinal fluid;
* More than 30% leukemic cells in the blood;
* Stage III WHO/ECOG score;
* Organ recipients;
* Pregnant or breastfeeding;
* Active, uncontrolled infection, including hepatitis B, hepatitis C or human immunodeficiency virus (HIV);
What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?

Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.

Institutional Review Board- Park Nicollet Institute approval was granted 3/2011 for 15 patients to be enrolled in pilot study of use of a bioabsorbable ventilation ear (PE) tube. IRB stated compliance with FDA as defined in 21 CFR, Part 56 and with regulations of DHHS. Federal assurance number FWA00000914. Prior to commencing this study, IRB approval was obtained and each participating clinician completed the NIH training for "Protecting Human Research Participants".

14 patients (15 ears) were enrolled in this study and were examined by 2 independent examiners at approximately 3, 6 and 12 week follow-ups. Lumen patency and time to complete resorption were documented by each examiner. There were no adverse reactions. This pilot study suggests that there is utility for a bioabsorbable ear tube made from gelatin material, as the device was found to break down over the expected time frame and remained functional long enough to have clinical utility.

Eligibility Criteria:
Inclusion Criteria:

* meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube)

Exclusion Criteria:

* none
Incentive Processing and Learning in Anorexia Nervosa and Bulimia Nervosa

The purpose of this study is to investigate areas of the brain responsible for 'liking', 'wanting', and learning in adults with eating disorders using brain imaging techniques, computer tasks, a test meal, and self-report questionnaires and interviews. The investigators will study changes in brain activity using a procedure called functional magnetic resonance imaging (fMRI). This study will include 252 women with an eating disorder (63 AN-restricting type (AN-R), 63 AN-binge eating/purging type (AN-BP), 63 bulimia nervosa (BN)) and 63 healthy controls (HC) aged 18-39.

Aim 1: To examine neural differences in 'liking' and 'wanting' in ED relative to HC.

Aim 2: To examine differences in instrumental learning for reward and punishment in ED relative to HC.

Aim 3: To examine how 'liking' and 'wanting' drive instrumental learning in ED and predict clinical symptoms at baseline and 1 year later.

Exploratory Aim: To explore the associations of dopamine function, as measured by neuromelanin MRI (NM-MRI), with ED diagnosis and brain response to 'liking', 'wanting', and learning.


Eligibility Criteria:
Inclusion Criteria:

Eating Disorder Group:

* Between the ages of 18 and 39 years old
* Meet DSM-V criteria for AN-R, AN-BP, or BN

Healthy Control Group:

* Between the ages of 18 and 39 years old
* Have maintained 85% to 120% ideal body weight since menarche

Exclusion Criteria:

All Groups:

* Psychotic illness/other mental illness requiring hospitalization
* Current dependence on drugs or alcohol defined by DSM IV criteria. Additionally, positive test results for drug use on the day of the scan, apart of marijuana, will result in cancelling or rescheduling the scan because acute use will impact MRI measures.
* Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
* Neurological disorder, neurodevelopmental disorder, or history of head injury with \>30 min loss of consciousness
* Any contraindication to undergoing an MRI
* Primary obsessive compulsive disorder or primary major depressive disorder

Additional Exclusion Criteria for ED Group:

-If taking other psychotropic medication, any change in dosage in the 2 weeks before scanning

Additional Exclusion Criteria for Healthy Control Group:

* Meet criteria for the diagnosis of any psychiatric disorder currently
* Any history of binge eating or purging behaviors, including self-induced vomiting, laxative or diuretic misuse
* Use of any psychoactive or other medication known to affect mood or concentration in the last 3 months