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

RATIONALE: Studying samples of 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 study is looking at biomarkers in cell samples from patients with acute myeloid leukemia.

OBJECTIVES:

* To determine the significance of regulation of microRNA-34a and microRNA-194 by C/EBPα during granulopoiesis in patients with acute myeloid leukemia with CEBPA mutations.
* To determine whether overexpression of micro RNA-34a and microRNA-194 in myeloid progenitors with C/EBPα mutations leads to granulocytic differentiation.
* To examine how microRNA-34a and microRNA-194 downregulate E2F3 during granulopoiesis.
* To determine the role of microRNA-34a and microRNA-194 in myeloid cell proliferation.

OUTLINE: Cryopreserved cell samples are collected for laboratory analysis, including mutation analysis, gene expression analysis, RNA analysis, and fluorescence-activated cell sorting (FACS) analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia with CEBPA mutations

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
An Analysis of Urinary Proteases as Biomarkers for Hepatocellular Carcinoma-101423

Specific urine proteases or groups of these enzymes can be reliable biomarkers and an effective gauge of response to therapy in patients with hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to provide written informed consent
* Must be between 18-90 years of age at the time of consent
* Ability to provide urine specimen at protocol-defined timepoints
* Must have treatment interventions planned that are directly related to liver disease (excluding those assigned to group 3-Controls)

Exclusion Criteria:

* Suspected inability, e.g. unwillingness to comply with study procedures or unwillingness to provide written consent
Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor

In this study, Al18F-PSMA-BCH PET/CT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors (including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.) , to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with suspected or clearly diagnosed PSMA positive-expressing tumors, including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.
2. Age is 18 or older; No gender limitation.
3. Signed the informed consent.
4. Willing and able to cooperate with all projects in this study.

Exclusion Criteria:

1. Patients with serious neurological diseases,or gastrointestinal tract disease, cardiovascular disease, liver disease, kidney disease, blood system disease, endocrine system disease, respiratory system disease, immune deficiency disease, etc
2. Claustrophobia.
3. Pregnant or lactation women.
4. Received experimental drug or device within 1 month.
Long Term Outcome After Ahmed Glaucoma Valve

Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.

The development of intraocular pressure, visual acuity, number of glaucoma medication, number of complications and necessity of revision operations after Ahmed glaucoma valve implantation for uncontrolled glaucoma is examined yearly for a period of 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from medically uncontrolled glaucoma
* Informed consent

Exclusion Criteria:

* healthy subjects
* under 18 years
Home Electrocardiogram (ECG) Monitoring After Heart Transplantation

The long-term goal of this research is to apply novel technology for detection of donor organ (allograft) rejection to improve patient outcomes following heart transplantation. The specific goal of this study is to determine whether daily monitoring of the transplant recipient's electrocardiogram (ECG) using a simple home device with transmission to an ECG Core Laboratory would provide an early biomarker for acute rejection. Despite routine immunosuppressant drug therapy, acute rejection is common, especially within the first 6 months following transplant surgery. To detect rejection, frequent endomyocardial biopsies of heart tissue are performed. An endomyocardial biopsy is a costly and invasive procedure performed in a hospital cardiac catheterization laboratory that has associated risks. Recent evidence suggests that acute allograft rejection causes delays in ventricular repolarization resulting in a longer QT interval on the ECG. The specific aims of the study are to: 1) determine whether an increase in the QT interval during the first 6 months following heart transplant is a sensitive and specific biomarker for acute rejection; and 2) determine the timing of QT interval increases relative to biopsy-diagnosed stages of mild/moderate/severe rejection. The potential benefit of finding a simple ECG biomarker of allograph rejection that could be measured at home is that it might yield earlier detection of rejection, allow more timely therapy and reduce mortality from acute allograft rejection.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* first heart transplant surgery
* not enrolled in other research studies that conflict with study design

Exclusion Criteria:

* clinically unstable at time of enrollment (i.e. clinical symptoms of allograph impairment)
Promoting Sustainable and Active Mobility Among Employees and Students

The aim of the study is to assess health data (heart rate variability, blood pressure, blood glucose, particulate matter pollution) and travel characteristics (length, duration and type of commute) on the way to and from work from members of the universities in Hannover (Germany).

Active mobility, (i.e. moving around using the own physical strength) has positive sustainability effects. The physically active way to and from college is a great untapped resources for health promotion. The aim of this sub-project is to examine the way to university in order to assess its effect on individual health depending on the means of transport.

In order to determine the status quo and changes in mobility behavior the investigators will use movement trajectories using smartphone apps or inexpensive trackers in a larger cohort, as well as more specified health measures including overweight status, blood pressure, blood glucose concentration, lack of exercise, particulate matter and risk of accidents in a smaller sub-cohort.

By linking this data with the personal characteristics surveyed in other sub-projects, an evaluation of the individual health status and the expected health benefits depending on the route to work can be created. This represents the database for identifying certain groups of people or status groups who could particularly benefit from targeted promotion of an active commute.

Eligibility Criteria:
Inclusion Criteria:

* living within 50km around the workplace

Exclusion Criteria:

* current participation in another interventional study
Effect of Semet (80 and 160 mcg) Versus Placebo in Euthyroid Patients With AIT

Over the past 10 years, several clinical studies have suggested that selenium supplementation may influence the natural history of AIT. Recently, Interferon gamma (IFNγ)-inducible chemokines (CXCL-9, -10 and -11) were shown to be elevated in the AIT patients. The aim of this prospective, randomized, controlled study is to evaluate the effect of two different doses of selenomethionine (80 or 160 mcg) versus placebo in euthyroid women with AIT, in terms of reduction of anti-thyroid antibodies and improvement of thyroid hypoechogenicity, over 24 months. Serum levels of selenium, CXCL-9, -10 and -11 and their regulators, Tumor necrosis factor alpha (TNFα) and INFγ, thyroid function and volume and the quality of life of AIT patients are also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic autoimmune thyroiditis defined by positivity of anti thyroperoxidase and/or anti thyroglobulin antibodies (\> or = 100 U/l) and thyroid hypoechogenicity

Exclusion Criteria:

* Presence of other thyroid disease but micronodules
* History of the malignancy in the past 5 years
* Drugs affecting immune system and/or thyroid function
* Pregnancy detected during screening or follow-up.
Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

The purpose of this study is to compare the sedation effect of dexmedetomidine and target controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing oral maxillofacial surgery.

Awake fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways undergoing oral maxillofacial surgery. Both optimal intubating conditions and patient comfort are paramount while preparing the patient for fibreoptic intubation. One challenge associated with procedure is to provide adequate sedation while maintaining patients' airway ventilation. Dexmedetomidine, because of its sedative,analgesic properties and minimal influence on patients' ventilation, might be a useful management for it. While with the development of target controlled infusion (TCI) technology, remifentanil sedation becomes a potential sedation in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* ASA grade I-III adult patients with difficult airway, who were undergoing elective oral maxillofacial surgery

Exclusion Criteria:

* pregnant or lactating female,
* long-term opioids or sedative medication,
* patients \< 18 years of age,
* severe bradycardia (HR \< 50 beats/min),
* hypotension (systolic pressure \< 90mmHg),
* any type of atrioventricular block on the ECG
Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for the Upper Limb

This research will provide data on evaluation of the effectiveness and safety of using a passive exoskeleton designed to reduce the negative impact of static and dynamic loads associated with lifting and holding weights and having workspace over head on the musculoskeletal system of workers. To evaluate a passive industrial exoskeleton for upper limb support, a protocol was developed in which individual production operations will be modeled.

This research will recruit 12 volunteers. During a 4-hour laboratory visit, each subject will perform two identical experimental tests: one test without an exoskeleton and another one using the exoskeleton. To avoid sequence bias, the test order will be randomized (balanced). The labor operation will be simulated. This operation's cycle will consist of lifting the load, which is 5-10 kg off the table, holding it over head and touching 4 points in order on a horizontal plate for 2 min. After this volunteer is resting for 1 min. The work will be performed for 105 minutes, then a break of 15 minutes, then 105 minutes of work. Heart rate (Polar) will be monitored. An ergospirometric device (Metamax) will be used to collect muscle activity data (Trust-M, Myoton), inertial sensors (Trust-M) will be used to evaluate the biomechanics of movements. In addition, questionnaires will be filled out for a subjective assessment of the use of exoskeleton prototypes (local discomfort scale, exoskeleton properties assessment questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals (based on medical screening)

Exclusion Criteria:

* musculoskeletal system diseases
* musculoskeletal injuries
* health deviations at the time of the study
Zanubrutinib in Patients with IgG4-Related Disease

The aim of this clinical trial is to evaluate the safety and efficacy of zanubrutinib in treating patients with IgG4-related disease

This will be a single-site, open-label study in symptomatic patients with IgG4-related disease affecting the submandibular and/or lacrimal glands. All patients will receive zanubrutinib orally at a dose of 80mg BID for 24 weeks.

The primary objective of this study is to demonstrate that zanubrutinib treatment reduces reduces the volume of the submandibular and/or lacrimal glands on PET/MRI at week 24 compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 85, inclusive, at the time of initial screening
* Have histopathologically confirmed IgG4-RD in the submandibular gland and/or the lacrimal gland confirmed by international consensus pathology criteria

  * Presence of a lymphoplasmacytic infiltrate with 10 IgG4+ plasma cells per high-power field and/or an IgG4+/IgG+ plasma cell ratio of 40%
* All women must test negative for pregnancy and agree to use a reliable method of birth control
* No current treatment with immunosuppressive medications other than prednisone 40mg daily (or other glucocorticoid equivalent) with stable dosing for 28 days

Exclusion Criteria:

* Unstable prescribed dose of glucocorticoids within 28 days prior to baseline
* Any treatment with a synthetic DMARD including but not limited to hydroxychloroquine, methotrexate, leflunomide, or sulfasalazine within 28 days prior to baseline
* Any treatment with a cytotoxic or immunosuppressive drug including but not limited to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or tacrolimus within 28 days prior to baseline
* Any treatment with a BTK inhibitor within 6 months before baseline
* Any treatment with a JAK inhibitor within 28 days prior to baseline
* Use of biologic agents including infliximab, abatacept, or tocilizumab within 56 days prior to baseline
* Use of a B cell depleting therapy (such as rituximab) within 12 months prior to baseline
* A history of, or current, inflammatory or autoimmune disease (that could affect the interpretation of safety or efficacy outcomes) other than IgG4-related disease
* Evidence of active tuberculosis, HIV, or hepatitis B or C infection
* History of cancer other than non-melanoma skin cancer, cervical dysplasia or carcinoma in situ (cured \>1 year), prostate cancer (cured \>5 years), or colon cancer (cured \>5 years)
Comparison of an Antibiotic Impregnated PICC Catheter Versus a Regular PICC Catheter in a Tertiary Care Setting

To determine whether antibiotic impregnated PICC catheters have a lower infection rate than a conventional PICC catheter in a tertiary care patient population. Secondary goals will be to determine if there is a difference between the two catheters with early and late infections, to determine the cost comparison including extra cost of treatment for a line related infection, to determine if there are any non-infectious related complication differences between the two catheters.

All patients who are referred to VIR for a PICC line will be evaluated to see if they satisfy the inclusion/exclusion criteria. The study will be discussed with those who do and informed consent will be obtained from those wishing to participate. The patient will then be randomized to one of two types of PICC lines. All lines will be placed by identical technique. This will include sterile technique, placement via a vein of the upper arm using ultrasound guidance, and positioning of the catheter tip under fluoroscopic guidance. A database of all catheters placed will be kept. Records will be reviewed at 1 week, 30 days, and 60 days by the Interventional Radiology Fellow.Review will include length of time catheter was in place, whether treatment was completed, whether catheter was removed prematurely, the clinical reason for removal, results of other imaging tests, and results of cultures on any catheters removed for suspicion of infection. Any non-infectious complications related to the catheter will also be noted. The reviewer will be blinded to which catheter was used during the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age
* Have been scheduled for a medically necessary PICC placement

Exclusion Criteria:

* Less than 18 years of age
Pain Relief During Photodynamic Therapy for Actinic Keratoses With a New Irradiation Protocol

This pilot study will try to minimize the pain during exposure to a new red light source (RhodoLED®, Biofrontera Bioscience GmbH, Leverkusen, Germany) used for PDT without compromising its effect on AKs.

The study design will have an open and prospective, two-armed, split-face design. Participants with AK lesions distributed symmetrically on the scalp, forehead, cheeks, torso, back, arms and/or dorsal parts of the hands are eligible for inclusion. The purpose is to investigate if a modified irradiation protocol can lower the pain while having the same effect on AK clearance rates as compared to the standard PDT irradiation protocol.

Before any study-related procedures are performed, the participants will be thoroughly informed about the study and will be given the opportunity to ask questions. The participants will thereafter sign and date the informed consent form. This constitutes as visit 0.

On visit 1, a randomization to either the standard or the modified irradiation protocol will be performed on one side of the face/body and the other irradiation protocol will then be applied on the other side of the face/body. The participants should have AKs on two comparable sites, i.e. two cheeks, arms or dorsal parts of the hands. One side will be randomized to receive PDT with BF200-ALA and irradiation with the RhodoLED® lamp and the other side will receive BF200-ALA and the Aktilite CL-128 lamp (PhotoCure ASA, Oslo, Norway), which is the traditional lamp used at our department as mentioned above.

The treatment will be given at visit 1. During the treatment, the participants will be asked continuously, every third minute, to estimate the pain on each treatment side using the visual analogue scale, VAS, (where 0 is no pain and 10 is the worst pain imaginable). At the end of the treatment, the participants will also be asked to summarize the treatment as a whole on the VAS-scale. After visit 1, the participants will fill in a follow-up diary form with questions regarding adverse effects (AEs) during the hours and days after the treatment. The efficacy of the treatment will also be assessed at a follow-up (FU) visit, visit 2. The investigators are aiming for a non-inferior analysis, i.e. the new modified irradiation protocol should be at least as good as the standard irradiation protocol. The randomization is blinded for the investigator at the FU visit to minimize the possibility of favoring one irradiation protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symmetrically distributed AKs on the scalp, forehead, cheeks, torso, back, arms and/or dorsal parts of the hands.
* Patients \>18 years of age who have signed a written informed consent.

Exclusion Criteria:

* Pregnant or breast-feeding.
* Participating in other clinical study at the same time or within 30 days.
* Conditions associated with poor protocol compliance, e.g. excessive use of alcohol or drug abuse.
Comparative Analysis Between Electrical Muscle Activity In Water And Soil

Muscle activity in the aquatic environment was investigated while performing different exercises by electromyography analysis, due to conflicting results in the literature in relation to the floor. This study evaluated and compared the electrical activity of the rectus femoris and biceps femoris, in aquatic method and on the floor, during flexion and knee extension exercises with and without load.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 35
* Sedentary (who engage in physical activity more than twice a week).

Exclusion Criteria:

* History of pain, trauma and / or surgery on the knee joint;
* Presence of musculo - skeletal
Prognostic Factors in Periampullary Tumors and Cysts

The project aims at analysing prognostic and predictive factors involved in diagnostics and surgical treatment of cysts and tumors in the pancreas and periampullary region using both clinical data and blood and tissue samples for biomarker development and validation.

From november 2021 an onward, study participants will be prospectively enrolled within the observational study. Before that, study participants are retrospectively enrolled. The study has a broad perspective including studies on clinical outcomes and prognostics based on patient and tumor characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Recommended surgery for tumor or cyst in the pancreas or periampullary region
* Information avalible in electronic journal files
* Informed consent (or deceased for retrospective part of the study)

Exclusion Criteria:

* No informed consent (and still alive at study initiation)
Question Prompt List for Common Hand Conditions

Patients with common hand conditions will be randomized to one of two groups- one will receive a question prompt list, the other will receive a list of 3 questions


Eligibility Criteria:
Inclusion Criteria:

* patients with common hand conditions

Exclusion Criteria:

-
Educational Intervention to Increase Physician Satisfaction and Effectiveness With a New Electronic Health Record

This study was intended to test the effects of adding a one-on-one educational intervention taught by a physician to a physician during their clinical work to improve their acceptance and satisfaction with a new inpatient electronic health record and ordering system.

This study was a randomized, parallel , non- blinded controlled trial of real-time, focused educational interventions in an intervention arm compared with usual training and support in the control arm. Improvement in performance, defined as the time between opening and closing a progress note, and number of notes completed after shift , were the primary outcomes. Physician satisfaction was a secondary outcome. Participants from one 550-bed Academic Independent Medical Center were invited to participate if they were full-time hospitalists or residents in internal medicine with no prior experience with the EPIC electronic health record.

Eligibility Criteria:
Inclusion Criteria:

* Internal Medicine physicians and resident physicians with inpatient clinical duties at the time of the EPIC electronic health record go-live (Feb 4, 2013)

Exclusion Criteria:

* Physicians whose duties did not include regular admissions and discharge of patients
* Physicians whose work was limited to teaching
* Physicians with prior experience in using EPIC systems for inpatient care .
* Physician assistants and nurse practitioners
A Study to Evaluate Rapid Throughput Screening for Human COVID-19 Infection

The purpose of this study is to assess the ability of an artificial intelligence smartphone-enabled point of care ECG to detect COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females age 18 or greater.
* Undergoing COVID-19 testing by PCR.
* Willing and able to provide informed consent.
* Pregnant females (minimal risk study, no risk from ECG).

Exclusion Criteria:

- Unwilling or unable to provide informed consent.