cyrilzakka/clinical-trials huggingface dataset:
Real-time MRI for Evaluating Cardiac Volumetry

This study will compare the accuracy of a real-time Cine sequence in assessing cardiac volumetry.

This is a single-centre prospective study involving up to 570 patients with known or suspected cardiac disease referred for routine clinical cardiovascular magnetic resonance (CMR) assessment at Glenfield General Hospital, Leicester. In addition to standard multi-breath-hold steady-state free precession (SSFP) imaging (undertaken as part of the routine scan), each patient will also undergo additional imaging with a non-breath-hold multi-slice real-time cine sequence.

The primary outcome is the assessment of cardiac volumetry and function (end-diastolic volume, end-systolic volume, stroke volume, ejection fraction and myocardial mass) as measured by (1) the standard multi-breath-hold SSFP technique and (2) the non-breath-hold multi-slice real-time cine sequence. Secondary outcome measures will be (1) the time required for each scan, and (2) image quality for each scan. An additional secondary outcome will be to compare indexed cardiac volumes with those indexed according to measured body-surface area.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 years
2. Referred for routine CMR imaging
3. Willing and able to give informed consent
4. Willing and able to comply with the requirements of the study
5. Able to understand written English

Exclusion Criteria:

1. Severe claustrophobia
2. Absolute contraindications to CMR (those with CMR conditional or safe devices will be eligible for inclusion)
3. Unable to provide informed consent
4. Participants unable to understand written English
The Effect of Autoclave Cycles on the Mechanical Properties and Surface Roughness of NITI Archwires

The aim of this study is to evaluate the effect of different autoclave cycles (universal and rapid cycles) on the surface roughness and mechanical properties of NiTi archwires.

Three groups of 0.016 x 0.022 inch NiTi archwires (American Orthodontics, Wisconsin, USA) will be investigated in this study. The first group of wires will be investigated in the as-received form. The two other groups will be installed in the patients mouth for 4 weeks, and then retrieved, cleaned using ultrasonic cleaner, dried and packaged. The second group will be autoclaved through the rapid cycle (4 mins, 134oC) and the third group will be autoclaved through the universal cycle (20 mins, 121 oC). The autoclave used in this study is (Anthos A-17 Autoclave, Italy).

Each wire will be cut into 3 segments; 2 straight distal segment and one anterior curved segment. The distal segments will be used for tensile testing to derive the mechanical properties and the anterior segment will be used to measure the surface roughness.

The mechanical properties (load deflection curve) will be measured with a universal testing machine (Model 4466, Instron Corp, Canton, Mass) with a 1000-kg load cell at 37°C. Each wire segment will be placed in the jaws of the machine. A grip is positioned at each end of the wire with a distance of 40 mm between the jaws. The machine will be operated in the tensile mode with a crosshead speed of 5 mm per minute. Three characteristics of each sample will be quantified from the readouts: ultimate tensile strength (kg/mm2), elongation rate (%), and modulus of elasticity (kg/mm2).

Atomic force microscopy (AFM) is a non-invasive method for three dimensional analysis of surface roughness. Anterior archwire segments will be evaluated using the AFM (Anton Paar GmbH-Tosca200 AFM, Germany) employing the tapping mode 500 micrometer increment with a rate of 1 line per second. Average surface roughness (Sa) in nanometers will be obtained by software analysis (Mountains 8.2 Software-Digital Surf, Besancon, France). The average surface roughness of each specimen will be measured at three different sites and the mean (Sa) will then be calculated.

Eligibility Criteria:
Inclusion Criteria:

* patients with moderate crowding requiring leveling and alignment

Exclusion Criteria:

* severe crowding.
* extraction cases
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2

The purpose of the study was to conduct a pilot test of new tracers (\[18F\]FPRGD2 and \[18F\]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data.

The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.

The tracer \[18F\]FPRGD2 was not evaluated in this study. The protocol title was never amended to reflect this.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers:

1. Must be 18 years of age or older.
2. Must have no known medical problems and have had a full medical exam within 6 months of the study.
3. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
4. Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization).
5. Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose.

Cancer subjects:

1. Greater than 18 years-old at the time of radiotracer administration
2. Provides written informed consent
3. Diagnosed with advanced non-small cell lung cancer (NSCLC), breast cancer, pancreatic cancer and glioblastoma multiforme (GBM); patients will undergo bevacizumab or Cyberknife therapy
4. Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria

1. Less than 18 years-old at the time of radiotracer administration
2. Pregnant or nursing
PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)

This prospective pilot study is designed to provide preliminary data on the use of Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) in patients with neurofibromatosis-1 (NF1) associated optic glioma and plexiform neurofibroma (PN).

Subjects will undergo FDG-PET-MRI scans in place of standard of care imaging at 0 and 12 months, unless more frequent imaging is clinically indicated. Subjects and their family caregivers will also undergo serial interviews and complete questionnaires related to the psychosocial aspects of NF1.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with neurofibromatosis-1 with either optic glioma, due for imaging scan, or plexiform neurofibroma, due for imaging secondary to clinical signs or symptoms of progressive disease
* ≥ 6 years of age
* English-speaking
* If female of child-bearing potential, negative urine pregnancy test performed within 7 days prior to each FDG-PET-MRI
* Study-specific informed consent or assent obtained and signed

Exclusion Criteria:

* Unable to undergo FDG-PET-MRI without sedation
* Currently undergoing chemotherapy for progressing optic glioma
* Pregnant or lactating female
* Poorly controlled diabetes mellitus
* Presence of pacemaker, intracranial aneurysm clip, cochlear implant, metal halo device, epicardial pacemaker leads, or any other device that makes MRI unsafe
* Serum creatinine \> 1.8 mg/dL OR GFR \< 30 mL/min
* Unable to lie flat for \> 1 hour
* Body Mass Index (BMI) \> 35
Rebif New Formulation (RNF) Quality of Life (QOL) Study

To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).


Eligibility Criteria:
Inclusion Criteria:

1. Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria
2. Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
3. Subject currently using Rebiject II and 29 gauge needle
4. Subject is between 18 and 60 years old inclusive
5. Subject is able to read and understand English
6. Subject is willing to follow study procedures
7. Subject has given written informed consent and signed HIPAA
8. Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) Being post-menopausal or surgically sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (Confirmation required within 30 days prior to start of the study)

Exclusion Criteria:

1. Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
2. Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol.
3. Subjects who have previously been on Rebif New Formulation (RNF).
4. Subject with progressive forms of Multiple Sclerosis (MS).
5. Subject with history of any chronic pain syndrome.
6. Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
7. Subject has complete transverse myelitis or bilateral optic neuritis.
8. Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1.
9. Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment).
10. Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase \> 2.5 times the upper limit of the normal values.
11. Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
12. Subject suffers from other current autoimmune disease.
13. Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
14. Subject is pregnant or attempting to conceive
15. Visual or physical impairment that precludes completion of diaries and questionnaires.
Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy

The purpose of this study is to assess whether there is a difference between the TomoFix and Ellipse Intramedullary HTO Nail System in terms of bone regeneration in the tibial wedge by performing a CT-scan at 3 and 6-months postoperatively.

Malalignment of the knee joint causes arthritis in later life. Currently there are three surgical ways to treat knee arthritis: total knee replacement, partial knee replacement, and high tibial osteotomy (HTO). The former two very much focus on treating the effect of malalignment, i.e. removing the arthritic joint. However, HTO addresses the cause of the arthritis, namely the joint malalignment. This preserves the patient's joint and it means that a patient will start using the unaffected part of the knee joint more.

HTO involves cutting a wedge out the tibia to correct the alignment of that bone with the knee joint, to redistribute load from the affected medial part to lateral part. To keep the tibia in the new position, a medical nail device is attached to keep it in place and allow new bone to regenerate within the wedge. Currently, the market leader for HTO is the TomoFix (by DePuySynthes company) plate and nail device. As the name suggests, TomoFix is fixed at surgery and therefore the change in bone angle cannot be changed afterwards. It does mean that patients can be weight-bearing on the affected leg soon after the HTO procedure. A new CE-marked device is being tested in an interventional trial; it is produced by Ellipse Technologies. This device is an extendable nail and inserted intramedullary; following surgery the nail is tend slowly extended over a period of time until the bone correction is satisfactory.

The CISKO imaging study will assess whether there is a difference between the TomoFix and Ellipse system in terms of bone regeneration in the tibial wedge by performing a CT-scan at 3 and 6 months post-operatively. This will be quantified by two independent radiological reports. A secondary objective is to investigate patient satisfaction and also patient pain levels at these time intervals. The degree of bone healing is usually the main factor holding clinicians back when it comes to advising patients on what activities they can return to post-operatively. A difference in bone healing between the two systems may impact on the advice clinicians can give patients regarding recommencing more intense activities such as recreational sports, which ultimately could positively impact patients' health and well-being.

Eligibility Criteria:
Inclusion Criteria:

1. Indicated treatment with medial open wedge proximal tibial osteotomy, either with Tomofix device or Ellipse device
2. Provision of written informed consent
3. Males
4. Mental capacity

Exclusion Criteria:

1. Under age (\< 18 years)
2. Patients lacking mental capacity.
3. Females
4. Current use of nicotine products.
5. Patients who cannot understand English and therefore cannot be consented.
A Study of the Safety of IMOVAX Polio™ in China

This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in China.

Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city China.

Study participants will receive a single dose of IMOVAX Polio™ vaccine at 2, 3, and 4 months of age, respectively. Each participant will make a total of 7 visits. Safety will be monitored at each visit and up to 30 days after each vaccination.

Eligibility Criteria:
Inclusion Criteria :

* Subject is more than 2 months (60-89 days) old when receiving the first dose of polio vaccine.
* Subject's parents/legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio™ according to the schedule: one injection at 2, 3, 4 months old, respectively.
* Informed consent form obtained from the subject's parent/legal representative.
* Subject plan to live in the selected study sites for at least three months after inclusion.

Exclusion Criteria :

* Subject with a history of serious illness (e.g., hypersensitivity, seizure, convulsion, encephalopathy diseases)
* Known or suspected impairment of immunologic function
* Acute medical illness with or without fever within the last 72 hours
* Subject plan to leave the study sites for at least three months after inclusion
* Administration of immune globulin or other blood products within the last three months
* Participation in another clinical trial at the same time
* Contraindication to vaccination according to IMOVAX Polio™ leaflet.
A Diagnostic Accuracy Study Testing Fecal Biomarkers In Comparison To Endoscopic Examination

In this study it will be explored whether the levels of fecal biomarkers are associated with histologic inflammation of the intestinal mucosa and concomitant alteration of the mucosal permeability. The aim of the study is to assess the diagnostic accuracy of fecal biomarkers especially to detect the potential of differentiation between inflammatory and functional gastrointestinal diseases.

The following biomarkers will be examined in the stool of the participants: calprotectin, lactoferrin, pmn-elastase, human beta-defensin, zonulin, alpha-antitrypsin.

For this study inpatients and outpatients of the clinic for integrative medicine and naturopathy Bamberg, Germany, who had a routine gastroscopy and/or coloscopy with tissue biopsy or an endoscopy with confocal laser endomicroscopy and tissue biopsy were enclosed.

These patients, who were examined during a routine diagnostics, should submit an extra morning stool sample up to two weeks before or after the gastroscopy and/or coloscopy to generate the data of the fecal biomarker mentioned above.

On the basis of the biopsy samples generated through the routine examination we can determine the histology scores, Nancy Index and Riley Score. The determined scores, the data of the fecal biomarkers and the results of the confocal laser endomicroscopy as well as, if available, more clinical data such as the clinical activity index (CAI), the MAYO-Score/Disease Activity Index (DAI), the endoscopic Rachmilewitz-Index (REI) and the Questionnaire for inflammatory bowel disease (IBDQ) will be anonymised inserted into a SPSS data bank and will then be interpreted.

For the adequate description of the collective data of gender, age, blood levels and medication will be gathered and added to the data bank anonymised.

The calculated data will then be compared with the clinical evaluation of the patients with symptomatic irritable bowel syndrome, active inflammatory bowel diseases and patients with other gastrointestinal diseases.

The aim of this study is to develop improved methods for non invasive diagnostics of gastrointestinal diseases.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Signed declaration of consent
* Presence of a confirmed diagnosis of

  1. Inflammatory bowel diseases
  2. Irritable bowel syndrome
  3. Gastrointestinal diseases, except participants with diagnosis of group 1 or 2 (e.g. celiac disease, food allergies, microscopic colitis, diverticulosis, diverticulitis)
  4. Healthy controls as part of a preventive medical check-up

Exclusion Criteria:

* No indication for endoscopic examination as part of routine care
* Age under 18 years
Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants

Background and study aims

When an infant is born premature, the blood vessels in the eyes have not developed fully on the retina, and can start to grow incorrectly and result in blindness. To prevent this from happening, premature infants are often screened, and treated with laser or injections into the eye to prevent retinal detachment. A new treatment strategy with steroid eye drops have been found to prevent serious blood vessel growth. The treatment is commonly used in older children and adults to treat different inflammatory conditions, but how the drop is absorbed in premature infants and if there is any risk of side-effects is poorly investigated. The aim of this study is to document how the steroid drop is absorbed and excreted in premature infants and to study if there is a risk of any side effects.

Who can participate?

Premature infants born before gestational age week 30, that undergo eye-screening at Sahlgrenska University Hospital in Gothenburg and Skånes University Hospital in Malmö and Lund or at Helsingborg Hospital, in the need for steroid eye-drop treatment against pathological vessels. It is not possible to participate if the infant has received systemic steroid treatment 2 weeks prior to the eye-drop treatment, or has an ongoing ocular infection.

What does the study involve?

The study involves blood and saliva samples according to a specific protocol designed to be able to learn about the uptake and breakdown of the steroid in premature infants. Measurements of blood pressure, growth and a few urine samples will also be collected during the treatment period usually lasting for some weeks.

At 2.5 and 5 years of age, visual acuity, refractive errors and retinal thickness measurements will be noted.

What are the possible benefits and risks of participating?

The infant will receive steroid eye-drops that have been noted to heavily reduce the number of infants that develop retinal changes that require injections or laser treatment.

The blood samples have been reduced to an absolute minimum in volume and numbers, but will entail some extra samplings from the infant.

The infant will be rigorously checked with regard to any possible side effects from the steroid treatment. Possible but unlikely side effects from the low dose in eye drops are; elevated blood pressure, retarded growth, lowered endogenous steroid production during the eye-drop treatment, increase in blood glucose, and an increase in intra-ocular pressure.


Eligibility Criteria:
Inclusion Criteria:

* Infants screened for retinopathy of prematurity (ROP) at Sahlgrenska University Hospital in Gothenburg, at Skåne University Hospital in Malmö and Lund and at Helsingborg Hospital.
* zone I stage 1 or 2 ROP without plus disease, posterior zone II stage 2 ROP without plus disease, or zone II stage 3 ROP without plus disease. ROP needs to be documented by digital widefield photography and classification confirmed by two ophthalmologist.

Exclusion Criteria:

* ocular infection
* systemic steroid treatment within two weeks before the start of drop treatment
Glioblastoma and Individualized Therapies

The treatment of patients with World Health Organization (WHO) grade 4 malignant glioma has not seen any significant breakthrough the past years. Following surgery and radio / chemotherapy patients still experience a very high recurrence risk and the prognosis is dismal. The investigators observed patients with grade IV malignant glioma receiving individualized treatment based on their molecular profile including fully personalized vaccines.


Eligibility Criteria:
Inclusion Criteria:

* malignant glioma, IDH WT

Exclusion Criteria:

* na