cyrilzakka/clinical-trials huggingface dataset:
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.

BACKGROUND; In this study, T1, T2, and T2\* represent parameters of magnetic resonance imaging (MRI).

The T1 relaxation time, also known as the spin-lattice relaxation time, is a measure of how quickly the net magnetization vector (NMV) recovers to its ground state in the direction of B0. T1 is assessed immediately post-contrast. A T1-weighted image (T1WI ) is one of the basic pulse sequences in MRI and demonstrates differences in the T1 relaxation times of tissues. A T1WI relies upon the longitudinal relaxation of a tissue's net magnetization vector (NMV).

T2 is a time constant for the decay of transverse magnetization arising from natural interactions at the atomic or molecular levels, and be considered the "natural" or "true" T2 of the tissue. However, in any nuclear magnetic resonance (NMR) experiment, transverse magnetization decays much faster than would be predicted by natural atomic and molecular mechanisms. Accordingly, T2 \* is the time constant for the decay of transverse magnetization as observed in a tissue during a MRI scan, and be considered the"effective T2" (represented as T2\*). T2\* is always ≤ T2. In this study, T2 \* is assessed after 24 hours.

OUTLINE:

Patients receive ferumoxytol intravenously (IV) and then undergo ferumoxytol-enhanced MRI up to 1 hour after infusion and up to 24 hours post-infusion.

PRIMARY OBJECTIVES:

* Establish magnetic resonance (MR) imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on relatively early post-contrast T1-weighted images.
* Establish MR imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on delayed postcontrast T2-weighted images.
* Establish T2-weighted MR imaging characteristics of iron-labeled mesenchymal stem cell (MSC) in osteonecrotic bone over time, before and after surgical core decompression and bone marrow implantation.
* Adding a second branch for patients who can not receive ferumoxytol but still getting the MRI exam. These patients will server as controls.

Eligibility Criteria:
INCLUSION CRITERIA

* Age 10 to 21 years
* Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis
* Informed consent with assent as appropriate.

EXCLUSION CRITERIA

* Contraindication to MRI
* Presence of metal implants
* Need for sedation or anesthesia
* Claustrophobia
* Hemosiderosis or hemochromatosis
* History of allergic reactions to similar compounds will be obtained and patients with positive history of allergic reactions will be excluded from the study
* Females who are pregnancy or nursing
Single Nucleotide Polymorphism (SNP) in Schizophrenia and Schizophrenia Spectrum Disorders: a Population Association Analysis With Hong Kong Chinese

Gamma-aminobutyric acid (GABA) is the principal inhibitory neurotransmitter in the mammalian central nervous system. It is involved in a wide spectrum of physiological functions, from sleep and sedation to convulsions. A defect in neurotransmission involving GABA in schizophrenia was first propsed in early 1970s, based on neuropathologcial evidence, yet there is a lack of molecular genetic evidence.

Recently, we carried out a pilot study on a region of the GABA-A receptor β2 subunit gene on chromosome 5 and found significant association for single nucleotide polymorphisms (SNPs) in the gene sequence with occurrence of schizophrenia. The current proposal aims to validate this important finding and to conduct a thorough scanning of the complete gene sequences of the GABA-A receptor subunit genes in this chromosomal region, including the three major subunits α1, β2 and γ2. We shall collect samples from Hong Kong Chinese subjects for a case-control study using haplotype maps and comparing the SNP haplotype frequencies in the receptor genes, and hence examine whether these genes are in association with schizophrenia, or other schizophrenia-spectrum disorders, including Alzheimer's disease presenting with psychotic symptoms.

Based on the observation that patients suffering from the catatonic subtype of schizophrenia respond particularly well to benzodiazepines, which bind specifically to GABA-A receptors, we shall also perform data analysis in terms of correlating SNP association with schizophrenia subtypes. Association of GABA-A receptor genes with schizophrenia would be a major step forward to determining whether these genes are susceptibility genes for schizophrenia, thereby paving the way to more effective diagnosis and treatment for this debilitating disease.


Eligibility Criteria:
Inclusion Criteria:

(For patients:)

* Diagnosis of schizophrenia under DSM-IV guidelines.

Exclusion Criteria:

(For controls:)

* Subjects who are known to have blood transmitted disease.
* Past or current alcohol and /or substance abuse.
* Past or current major medical and neurological conditions.

(For patients:)

* As for controls, excepr 3. "neurological conditions" does not include schizophrenia.
Patients With Chronic Hepatitis B and Low Viremia Not Receiving Antiviral Therapy

This observational long-term follow-up study will evaluate demographic, clinical, histological, biochemical, and virological parameters of patients with chronic hepatitis B and low viremia who do not require antiviral therapy according to current guidelines. Liver stiffness values as detected by FibroScan and ARFI will also be collected if available. All data will be collected at yearly intervals (minimum). Patients included in the study are followed for up to 10 years. The target sample size is \<1000.


Eligibility Criteria:
Inclusion Criteria:

* adult patient, age 18-79
* chronic hepatitis B
* HBV-DNA \< 100.000 IU/ml
* ALT ≤2 x ULN
* recent liver histology and/or FibroScan measurement
* willingness to sign informed consent

Exclusion Criteria:

* current or past antiviral therapy for hepatitis B
* chronic hepatitis B in immune tolerance phase (HBeAg positive, high viral load)
* co-infection with HIV, HCV
* malignant disease
* HCC or other liver tumor
Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function

The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial;
2. Male or female subjects aged 18 to 65 (including 18 and 65);
3. Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28);
4. The glomerular filtration rate should meet the following criteria (GFR, mL/min): Subjects with mild renal impairment: 60-89 mL/min; Subjects with moderate renal impairment: 30-59 mL/min.

Exclusion Criteria:

1. Suspected allergy to the study drug or any component of the study drug;
2. Patients with cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, sustained tachyarrhythmia, torsades de pointes (Tdp) or ventricular tachycardia, history of clinically significant T wave changes, myocardial infarction, angina pectoris;
3. People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy);
4. Patients with a history of gastric or intestinal surgery that may affect drug absorption;
5. Participants with renal insufficiency who were judged by the investigator to be ineligible for the study;
6. Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator;
7. Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period;
8. Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.
Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes

This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes for more than 6 months
* Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
* Body Mass Index (BMI) less than or equal to 40 kg/m2
* HbA1c 7.0-11.0%

Exclusion Criteria:

* Treatment with short acting insulin(s) for longer than 10 days
* Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
* Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months
Thoracentesis QI Study

Researchers will compare 3 standard of care methods of pleural fluid drainage during therapeutic thoracentesis. Patients are randomized to manual aspiration, vacuum bottle drainage or wall suction methods. Primary outcome is procedural time with secondary outcomes of pain and dyspnea scores.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Evidence of pleural effusion on imaging
* Clinical indication for thoracentesis

Exclusion Criteria:

* Age \<18
* Standard contraindication for thoracentesis procedure
* Patients on positive pressure ventilation
* Patients who have opted out of research in EPIC
Afamelanotide in Patients Suffering With Acne Vulgaris

This study aims to evaluate the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on quality of life in eligible patients.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an Investigator's global assessment (IGA) score of 2-3;
* Chronic course of acne vulgaris;
* Acne-related lesions both on the face, chest and back;
* Indication for treatment of acne vulgaris;
* Aged 18-30 years (inclusive);
* Fitzpatrick skin types I-III;
* Providing written Informed Consent prior to the performance of any study-specific procedure.

Exclusion Criteria:

* Female subjects;
* Diagnosis of severe acne vulgaris;
* Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the implant;
* Use of topical acne medication such as retinoids, benzoyl peroxide or topical antibiotics within 2 weeks prior to the first dose;
* Use of oral antibiotics for acne within 4 weeks prior to the first dose;
* Use of topical corticosteroids on the face, chest and back or systemic corticosteroids within the past 4 weeks prior to the first dose;
* Use of systemic retinoids within 6 months prior to the first dose;
* Use of anti-androgenic agents such as finasteride within 4 weeks prior to the first dose;
* Use of phototherapy devices for acne such as ClearLight™ or Zenozapper within 1 week prior to the first dose;
* Use of tanning booths or lamps within 1 week prior to the first dose;
* Active skin disease that may interfere with evaluation;
* Other forms of acne such as acne rosacea, acne excoriée, chloracne, acne conglobata, acne fulminans, acne inversa or drug-induced acne;
* Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo

This study will provide knowledge about the use of long-acting opioids for pain relief after primary knee arthroplasty. The investigators will compare depot tapentadol, depot oxycodone and placebo for effect on pain relief and side effects. The three study groups reflect the three different postoperative pain regimens that have been used the last years at St. Olavs Hospital, so investigators know that no patient will receive an inadequate pain treatment. The purpose of the study is to find which of the three treatments that gives the best pain relief with the least amount of side effects. The results will be of use for postoperative pain treatment for knee arthroplasty, but also for other types of major surgery. Similar studies that are not sponsored by pharmaceutical industry have not been published yet.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for knee arthroplasty at St. Olavs University Hospital
* consent in participation in the study

Exclusion Criteria:

* Contraindications for any of the study drugs
* Lactose intolerance
* Known hypersensitivity against any of the additives
* Chronic Obstructive Pulmonary Disease (COPD) grade 3 or 4
* Paralytic ileus
* Known alcohol or medical addiction/abuse
* History of asthma, urticaria or allergic reaction caused by acetyl salicylic acid or other NSAIDs
* Peptic ulcer
* Hemophilia
* Gastrointestinal bleeding
* Cerebrovascular bleeding
* Inflammatory bowel disease (ulcerous colitis, Crohn disease)
* Concomitant use of the following drugs: ACE-inhibitors, AT2-blockers, SSRI, Anti-psychotic drugs, MAO-inhibitors, Atazanavir and Nelfinavir (medicine used for HIV-infection)
* Known kidney failure (creatinin level above reference value)
* Known heart failure (NYHA III-IV)
* Pregnancy
* Women in fertile age with risk of pregnancy
* Nursing women
* operated under general anesthesia without use of spinal anesthesia
* using opioids on a regular basis except users of codeine or tramadol, or known former abuse of opioids
* Cognitive failure or other factors which make follow up impossible (for example language difficulties)
* No cell phone or internet connection at home (making follow up difficult)
22G FNA Needle vs. 22G ProCore Needle

The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.

In this randomized trial, the 22G standard fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound. Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.

Eligibility Criteria:
Inclusion Criteria:

-All patients with solid pancreatic mass lesions

Exclusion Criteria:

* Coaguloapthy,
* minors,
* prgenant patients
Prospective Cohort Study of the Clinical Applications for the Pathologic Type, Staging, and Grading of GIST

Evaluate the reliability of morphology standards for GIST pathologic type, staging and grading by retrospective analyzing clinical data; on this basis, establish a GIST standardized and individualized treatment mode to maximum benefit GIST patients, avoid under- and over-treatment.

1. Retrospective analysis of GIST cases in the recent five years: the GIST clinical data of Fudan University Zhongshan Hospital from 2007 January to 2012 December were collected. By reviewing the HE slides, GIST was evaluated by 12 indicators, NIH scheme and WHO standard. Accomplish the gene sequencing of KIT, PDGFRA, B-raf, and SDH. Follow up the patients about their treatment and prognosis. Analyze and compare the advantages and disadvantages of the histomorphology indicators, NIH scheme, and WHO standard.
2. Organize the first prospective cohort study of GIST individualized treatment based on the histomorphology. Obtain the evidence of histological assessment for GIST by following up patients for 3 years.
3. Establish an evaluation criteria based on the morphology of GIST. Make objective evaluations about GIST tumor size, tumor location and gene mutation status in the prognosis estimate. Make rules to effectively guide individualized treatment of GIST.

Eligibility Criteria:
All patients pathologically diagnosed with GIST during the period from 2013 to 2015
Natural History Study of GEMIN-5 Related Neurodevelopmental Disorder

This study will include a comprehensive retrospective chart review and a longitudinal prospective observational natural history study to characterize the phenotypic spectrum of GEMIN5-Related Neurodevelopmental Disorder. We aim to define the trajectory of this ultra-rare disease, core clinical features, characteristics at disease onset and diagnosis, neurological symptomatology, and neuroimaging findings over time. In this study, biological specimens (serum) will also be collected in a biorepository for translational research purposes.

This study will include individuals across the lifespan with molecularly confirmed GEMIN5 biallelic mutations.

This study will be ongoing indefinitely.

There are three main components to the study as are detailed below:

1. A retrospective chart review of UPMC medical records and other institutions' medical records, for all patients in the study. Families/patients will provide staff with a signed Release of Information, so that we can obtain a copy of the participants complete medical record which will be requested from previously treating physicians. This may include records from several disciplines, for example neurological and physical exams, neurodevelopmental testing (cognitive, motor, language and daily living skills), growth parameters, results to previous genetic testing, MRI, lab results including lumbar puncture studies, audiologic exam, vision screening, nerve conduction studies, ophthalmologic exam, swallow studies, co-morbidities, and family history.
2. An observational, longitudinal prospective study of patients seen at the UPMC Center for Neuogenomics (CCNG) clinic. Clinical data obtained as part of a typical CCNG visit include vital signs, measurements (weight, head circumference, length), a developmental history, neurodevelopmental testing (eg. cognitive, speech and language, motor skills, developmental skills, vision, hearing), and a comprehensive neurological exam, including an ataxia rating scale. Additionally, any neurodiagnostic results obtained clinically are reviewed if available, such as MRI brain and spine, EEG, and nerve conductions studies.
3. Patients who are seen at the CCNG clinic in person may opt to submit an optional research biological samples.

Primary endpoint:

Neurodevelopmental outcomes

Secondary endpoint (if available):

MRI - presence of cerebellar atrophy Survival Vision Hearing Biomarkers of disease

Eligibility Criteria:
Inclusion Criteria:

* Individuals with molecularly confirmed GEMIN5 biallelic mutations, ages 0 years and above

Exclusion Criteria:

* none
Study of Hepatic Responses in Patients Receiving Direct-acting Anti-HCV Drugs

This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to determine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood.

The introduction of new DAAs regimens that do not include IFN provides unique and novel opportunities to examine whether successful treatment-induced eradication of viral antigen results in reconstitution of T cell immunity. serum and liver tissue samples will be collected and stored in hopes of improving treatment and outcomes for future patients.

This study is designed to obtain and store samples of serum and liver tissue in HCV-infected patients being treated with DAA therapy.

A liver biopsy will be performed pre-treatment for research reasons. A small liver sample that is not required for pathologic analysis will also be stored. Patients will undergo another liver biopsy at either 4 or 12 weeks after initiation of DAA therapy.

Any patients with HCV-related liver disease (age \> 18) will be considered for this study.

Patients will have a 120 ml blood draw for research purposes at baseline and 12 weeks after stopping DAA treatment along with a 60 ml blood draw at 2, 4, 8, and 12 weeks of treatment.

The liver biopsy at baseline and then either at 4 or 12 weeks will be examined using molecular techniques to measure transcription of key genes involved in the antiviral response.

Eligibility Criteria:
Inclusion Criteria

* Signed informed consent
* Ages 18-70
* HCV-infected patients being treated with direct-acting antiviral (DAA) therapy.

Exclusion Criteria

* Pregnant women or females of childbearing potential that are not on contraception
* Institutionalized or mentally disabled persons
* Prisoners
* Unwilling or unable to provide informed consent
* Subjects who are HIV positive
* Anticipated inability to follow up
* Chronic anemia
* Platelet count \< 100 for liver biopsy patients who have documented fatty liver disease by ultrasound prior to enrollment
* Any patient with bleeding disorders or prolonged INR
* Abstinent or consuming less than two drinks of alcohol per day.
* Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).